MYMETICS CORP - Annual Report: 2010 (Form 10-K)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
þ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE FISCAL YEAR ENDED DECEMBER 31, 2010
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
FOR THE TRANSITION PERIOD FROM ______ TO _____
COMMISSION FILE NUMBER 000-25132
MYMETICS CORPORATION
(Exact name of Registrant as specified in its charter)
DELAWARE | 25-1741849 | |
(State or other jurisdiction of | (I.R.S. Employer | |
incorporation or organization) | Identification No.) |
c/o Mymetics S.A.
Biopole
Route de la Corniche, 4
1066 Epalinges (Switzerland)
Biopole
Route de la Corniche, 4
1066 Epalinges (Switzerland)
(Address of principal executive offices)
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: 011 41 21 653 4535
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK, $0.01 PAR VALUE
(Title of Class)
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT: NONE
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT:
COMMON STOCK, $0.01 PAR VALUE
(Title of Class)
Indicate by check mark if the registrant is a well-known seasoned issuer,
as defined in Rule 405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or Section 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed be Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). Yes
o No o
(the registrant is not yet required to submit Interactive Data)
Indicate by check mark if disclosure of delinquent filers pursuant to Item
405 of Regulation S-K (Section 229.405 of this chapter) is not contained herein,
and will not be contained, to the best of registrants knowledge, in definitive
proxy or information statements incorporated by reference in Part III of this
Form 10-K or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
o Large accelerated filer | o Accelerated filer | o Non-accelerated filer | þ smaller reporting company | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as
defined in Rule 12b-2 of the Exchange Act). Yes o No þ.
The aggregate market value of the voting common stock held by non-affiliates of
the registrant (assuming officers and directors are affiliates) was
approximately U.S. $30,054,027 as of December 31, 2010, computed on the basis of the closing price
on such date.
As of March 24, 2011, there were 213,963,166 shares of the registrants
Common Stock outstanding.
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FORWARD LOOKING STATEMENTS
The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking
statements, which are identified by the words believe, expect, anticipate, intend, plan
and similar expressions. The statements contained herein which are not based on historical facts
are forward-looking statements that involve known and unknown risks and uncertainties that could
significantly affect our actual results, performance or achievements in the future and,
accordingly, such actual results, performance or achievements may materially differ from those
expressed or implied in any forward-looking statements made by or on our behalf. These risks and
uncertainties include, but are not limited to, risks associated with our ability to successfully
develop and protect our intellectual property, our ability to raise additional capital to fund
future operations and compliance with applicable laws and changes in such laws and the
administration of such laws. These risks are described below and in Item 1. Business, Item 7.
Managements Discussion and Analysis of Financial Condition and Results of Operations, and Item
7A. Quantitative and Qualitative Disclosures About Market Risk included in this Form 10-K. Readers
are cautioned not to place undue reliance on these forward-looking statements which speak only as
of the date the statements were made.
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PART I |
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PART II |
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PART III |
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PART IV |
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EX-10.64 | ||||||||
EX-10.65 | ||||||||
EX-11.1 | ||||||||
EX-14.1 | ||||||||
EX-21.1 | ||||||||
EX-24.1 | ||||||||
EX-31.1 | ||||||||
EX-31.2 | ||||||||
EX-32.1 |
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PART I
ITEM 1. BUSINESS
THE CORPORATION
OVERVIEW
We are a vaccine company developing unique vaccines that focus on the mucosal layer as a first
line of defense against viruses entering the blood stream and the development of virosomes as a new
vaccine delivery platform. We believe that virosomes are the most promising vaccine delivery
systems since they do not use live attenuated or killed pathogens and increase the immunogenicity
and stability of the vaccine.
We currently do not make, market or sell any products, but we generate some limited revenue
through the licensing of certain of our technology. We believe, however, that our research and
development activities will result in valuable intellectual property that can generate significant
revenues for us in the future such as by licensing. Vaccines are one of the fastest growing markets
in the pharmaceutical industry. Vaccines have evolved from being an exclusively low price sector to
one where substantial prices may be paid for some vaccine products.
HISTORY AND DEVELOPMENT OF THE COMPANY
We were incorporated in July 1994 pursuant to the laws of the Commonwealth of Pennsylvania
under the name PDG Remediation, Inc. In November 1996, we reincorporated under the laws of the
State of Delaware and changed our name to ICHOR Corporation. In July 2001, we changed our name to
Mymetics Corporation.
In March 2001, we acquired 99.9% of the outstanding shares of the French registered company
Mymetics S.A. in consideration for shares of our common stock and shares of Class B Exchangeable
Preferential Non-Voting Stock of 6543 Luxembourg S.A., which are convertible into shares of our
common stock. In 2002, we acquired all but 0.01% of the remaining outstanding common stock of
Mymetics S.A. pursuant to share exchanges with the remaining stockholders of Mymetics S.A. The
terms of these share exchanges were substantially similar to the terms of the share exchange that
occurred in March 2001. In 2004, all the remaining convertible shares of 6543 Luxembourg S.A. not
already held by Mymetics Corporation were converted into shares of Mymetics Corporation. On
February 7, 2006, the Tribunal de Commerce in Lyon, France placed the French subsidiary Mymetics
S.A., under receivership (Redressement Judiciaire).
We own all of the outstanding voting stock of: (i) Mymetics S.A., a company originally
organized as Mymetics Management Sàrl in 2007 under the laws of Switzerland, (ii) 6543 Luxembourg
S.A., a joint stock company organized in 2001 under the laws of Luxembourg,(iii) Bestewil Holding
B.V. and (vi) its subsidiary Mymetics B.V. (formerly Virosome Biologicals B.V.) both of which are
organized under the laws of The Netherlands and were acquired in 2009. In this document, unless the
context otherwise requires, Mymetics and the Corporation refer to Mymetics Corporation and its
subsidiaries.
MYMETICS S.A.
Our Swiss subsidiary MYMETICS S.A. was founded in 2007 as MYMETICS MANAGEMENT Sàrl to facilitate
the conduct of our business in Switzerland. This includes managing our staff retirement and social
security contributions, leasing our Swiss premises and other such local tasks which a U.S.
registered company cannot easily conduct without significant legal and organizational costs. The
change in name and bylaws affected in 2009, from Société A Responsabilité Limitée (SARL) to Société
Anonyme (SA) is indicative of the transition from a pure service company status of this unit to a
development company in its own rights within Mymetics Corporation.
LUXEMBOURG 6543 S.A.
Our Luxembourg subsidiary, Luxembourg 6543 S.A., was founded in 2001 in connection with the
acquisition of Mymetics S.A. of France (formerly Hippocampe S.A.) by Mymetics Corporation.
Luxembourg 6543 S.A. is dormant.
BESTEWIL HOLDING B.V. and its subsidiary MYMETICS B.V.
On April 1, 2009 we entered into an agreement with Norwood Immunology Limited (NIL) for the
acquisition of Bestewil Holding B.V. (Bestewil) from its parent, NIL, under a Share Purchase
Agreement pursuant to which we agreed to purchase all issued and outstanding shares of capital
stock (the Bestewil Shares) of Bestewil from its parent, NIL, and all issued and outstanding
shares of capital stock of Virosome Biologicals B.V. which were held by Bestewil. Virosome
Biologicals B.V., the name of which was subsequently changed to Mymetics B.V., will continue to be
engaged in research and development activities in its own facilities in Leiden (Netherlands) under
the management of its founder, the original inventor of the virosome technology.
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PRODUCTS UNDER DEVELOPMENT
Our current pipeline has five vaccines in development. Four of the vaccines are proprietary: HIV-1,
malaria, herpes simplex virus type I and II(HSV-1 and HSV-II) and respiratory syncytial virus
(RSV), and one vaccine for intra-nasal influenza which is out-licensed to Solvay Pharmaceuticals
(now Abbott Laboratories). The vaccines in our portfolio are primarily prophylactic. The current
stage of development of these vaccines is shown in the table below:
Vaccine | Pre-Clinical | Phase I | Phase II | |||
HIV-1 |
X | |||||
RSV |
X | |||||
HSV |
X | |||||
Malaria |
X | X (ended in 2007) | ||||
Influenza |
X |
HIV-1 and AIDS
HIV-1 (human immunodeficiency virus type 1) is a retrovirus that gradually destroys the immune
system and ultimately leads to AIDS. HIV-1 is among the pathogens harboring the highest genetic
variation, leading to millions of variants, each rapidly mutating. Indeed, HIV-1 exists under many
different versions (aka clades), like members of a large family; they are different from, but
related to each other.
Our current prophylactic HIV-1 vaccine will be constituted of virosomes linked to concerved
antigens (epitopes) derived from the HIV-1 gp41 proteins from the clade B, the dominant clade found
in Europe and North America. Other conserved viral proteins are under investigation. The vaccine is
designed to trigger mucosal antibodies (IgG and IgA), for example in the vagina, and blood
antibodies (IgG). The rationale for the design of the vaccine was based on the observation that
certain people who are repeatedly exposed to HIV-1 do not contract infection; they were shown to
have mucosal antibodies in the semen or vaginal secretions against the HIV-1 gp41 that apparently
protect them. Mymetics vaccine is trying to reproduce Mother Nature.
Key scientific results with the HIV vaccine to date:
2005: Proof of Concept for inducing mucosal antibodies. Vaccination of rabbits with
virosomes-P1 elicited mucosal antibodies in the vagina and intestinal mucosa. P1 is a synthetic
peptide corresponding to the C-terminal end of the C-helix ectodomain of the gp41. In a laboratory
test, these antibodies strongly inhibited HIV-1 passage through the mucosal tissues, also called
trancytosis, confirming the potential of developing an HIV-1 vaccine that prevents infection at the
mucosal layer.
2006/2007: Mucosal antibodies in monkeys. Macaque monkeys (Macaca Mulatta), from Chinese
origin, showed after vaccination with virosomes-P1, specific mucosal antibodies, which were
detected in more than 90% of the animals and harboring the potential to block HIV-1 trancytosis.
2008: Full protection of monkeys against multiple vaginal challenges with live heterologous
clade B virus. Macaque monkeys from Chinese origin were vaccinated with both virosomes-modified
P1 and virosomes-rgp41 and received multiple intra-vaginal challenges with the live
SHIVSF162P3 virus. The vaccinated animals were not infected with the virus, while the
non-vaccinated control group was fully infected.
Dec 2008: Approval to start Phase I clinical trials. After the ground breaking results of
the monkey study in 2006 and 2008, we extended the monkey studies, while at the same time preparing
a first Phase I clinical trial. After submission of the complete file, we received approval in
sixteen days from the local Regulatory Agency in Belgium for Phase I clinical trial for testing the
MYMV101 drug product (with virosomes with the modified and lipidated P1).
Sep.- Oct. 2009: Production of the GMP-grade vaccine (MYMV101: virosomes-modified P1) for a
Phase I clinical trial in Belgium. European competent authorities require GMP-grade products for
clinical phase I. Currently in the U.S., GLP-grade products are required at this stage, while
GMP-grade products are required from phase II onwards. GMP-grade products are notoriously more
difficult and costly to produce than GLP-grade ones. Succeeding in the GMP production is considered
as a major achievement.
Dec. 2009 Dec. 2010: Phase I clinical trial proof of principle to demonstrate that
virosomes-modified P1 can induce mucosal antibodies in the genital tract of women, and to confirm
the immunogenicity data previously obtained on monkeys. The drug product MYMV101 was used as a
vaccine in a double-blind, placebo-controlled Phase I study at CEVAC (Ghent, Belgium), involving 24
healthy women randomized in 2 Panels to monitor safety and mucosal immunogenicity: Panel 1: 10
microgram/dose and Panel 2: 50 microgram/dose. In each Panel, 8 subjects received the vaccine and 4
subjects received the placebo through intra-muscular (weeks 0 and 8) and intra-nasal (weeks 16 and
24) administrations. The Phase I clinical trial had as primary objective to test the safety and
tolerance of the HIV-1 vaccine in healthy women. The secondary objective is to test to presence of
anti-bodies in the serum, and as ancilliry studies, to detect mucosal anti-bodies in the vaginal
and rectal secretions. The preliminary Phase I results indicate that there were no safety concerns
raised and that antibodies are detected in vaginal and rectal secretions of most vaccinated
subjects. Until the final report is released in May 2011, the data mentioned here are partial.
Sep.- Dec. 2010: NIH supplemental grant for Mymetics HIV-1 vaccine study at University of
California in Davis (UC Davis). This study on monkeys is an extension of the work done in China and
will address, following vaccination with virosomes modified P1 and virosomes-rgp41, the protection
on the Indian macaque monkeys, which are more susceptible to SHIV infection, respective to the
Chinese macaques tested in 2007-2008.
Next steps:
Until now Mymetics has financed the development of the HIV vaccine mainly through its own capital,
however, we continue to seek funding either through grants or through a partnership agreement to
perform the further development of the HIV vaccine. Besides the scheduled monkey study at UC Davis,
there will be other projects to identify the key defense mechanisms behind the protection triggered
by the Mymetics HIV-1 vaccine and investigate the role of each antigen constituting the vaccine.
Information obtained during these studies will be used as supportive data for the product
development and for answering some issues addressed in EMEA guidelines. New potential
collaborations have been identified with partners like Dr. Ruth Ruprecht from the Dana Farber
Cancer Institute at Harvard University and a potential project with a Pharmaceutical company,
2011: Further development of HIV-1 prophylactic vaccine. Following the Phase I clinical
trial we intend to further develop and optimize the HIV-1 prophylactic vaccine by adding an
additional antigen to elicit a broader antibody immune response against other conserved regions of
HIV-1 in order to minimize viral escape. Since 2007 we are developing at least one additional
antigen which is compatible with virosomes and the up-scale process. Mymetics is also opened to
collaboration/partnership for combining its virosome technology for inducing mucosal protection
with another technology designed for eliciting the cellular immune response or neutralizing
antibodies.
A combined Phase I and Phase II clinical trial is expected to start by Q4 2012, with Phase III
trials to follow in 2016, and an eventual market launch anticipated in 2021.
Respiratory Syncytial Virus (RSV)
Approach: The RSV vaccine consists of the reconstituted membrane of RSV containing the native
viral proteins, including also a lipopeptide, or other, adjuvant. In mice, our RSV vaccine was
shown to induce cellular and humoral immunity to the virus, with a balanced Th1/Th2 response,
resulting in protection against a live virus challenge, and without inducing enhanced disease (a
skewed Th1/Th2 response being the hallmark of enhanced disease). In cotton rats, a better model
than mice for RSV, the vaccine protected against a live virus challenge, without inducing enhanced
disease. In a direct comparison with the 1960s vaccine, another group of cotton rats was immunized
with formaldehyde-inactivated virus, and developed enhanced disease after vaccination and
challenge.
Key Results to date:
2007: First pre-clinical research on our RSV vaccine.
2008 and 2009: MedImmune repeated key experiments in order to obtain their own validation of the
results. Results were beyond their expectation but MedImmune decided not to continue the program.
Jun. 2010: Publication of Mymetics RSV results in scientific journal Vaccine.
2010: Conducting additional pre-clinical research and improving the manufacturing procedure of the
RSV virosomes.
We have improved the adjuvant ratio and continued further tests on cotton rats and mice at the
Universtiy of Groningen, Netherlands, showing that a lower adjuvant ratio still triggers protection
and the absence of enhanced disease.
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Next steps:
Our goal is to prepare a stable product that will be used for a combined Phase I/II trial at the
end of 2012. If the vaccine is safe, well tolerated and immunogenic during Phase I, we will
directly move to Phase II in 2013. The Company will seek to enter into a license agreement with a
major pharmaceutical company for a Phase III starting in 2015/2016 and a potential market launch in
2019.
We will continue process development and clinical development during 2011 for the vaccine
providing, for example, in-line virus purification and inactivation procedures, and develop
improved formulations of the vaccine, with augmented long term product stability. The additional
costs of this program to us are significant but minor, as compared to a clinical trial cost. The
product will then move into clinical development: up-scale production, assay developments,
pre-clincial batch for toxicology and GMP batch for Phase I, which will represent substantial cost.
We will also develop versions of the RSV vaccine which are based on enhancing the immune response
to selected epitopes, while reducing the potential for cross-reactivity with human proteins, along
the lines of our HIV-1 program to serve as future improved vaccines.
Intranasal Influenza
Approach: The intranasal influenza vaccine consists of the reconstituted membrane of influenza
virus, also containing a lipopeptide adjuvant. In mice, intranasal application of virosomes without
adjuvant does not induce immunity to influenza; however, incorporation of the lipopeptide in the
virosomes produces a candidate vaccine that does induce cellular immunity, as well as serum and
mucosal antibodies to the virus. The vaccine was licensed to Solvay Pharmaceuticals, a major
European pharmaceutical company, which was acquired by Abbott Laboratories.
Key results to date:
2005: The vaccine completed pre-clinical trials. A first milestone payment was received
from Solvay in the same year.
2006: Successful completion of Phase I trial. The vaccine was shown to be safe and well
tolerated and induced an immune response which was at least as good as that obtained with an
off-the-shelf injected vaccine. Subsequent milestone payment was received.
Next steps:
Solvay was planning a Phase II clinical trial under an out-licensing agreement with Mymetics. The
recent acquisition of Solvay by Abbott Laboratories has slowed down the vaccine trials.During the
fourth quarter of 2010, Mymetics has officialy asked Abbott about an update and the development
plan of the licensed vaccine.
From a cost perspective, there are little to no costs involved for us to further develop this
vaccine candidate, while Solvay will make a milestone payment after Phase III clinical trials and
royalty payments following the commercial launch of the vaccine.
Malaria
Approach: The malaria vaccine design is based on optimized mimicry of the native parasite protein
structure and eliciting antibodies against two stages of the parasite life cycle, unlike 90% of
vaccine candidates, which target only one or the other parasite. It is today among the rare
malaria vaccines able to also boost existing immune responses (it has both prophylactic and
therapeutic effects) in subjects that were previously exposed to malaria.
Key results to date:
2007: Mymetics acquired a Malaria vaccine project from Pevion Biotech (Ittigen,
Switzerland). A human clinical trial Phase Ia for the vaccine with two antigens (AMA-1 and CSP-1)
anchored to virosomes was successfully completed on adults in Switzerland. Results showed good
safety and tolerability, and the induction of blood antibodies.
2008 2009: Phase Ib in Tanzania on children and young adults. The clinical trial Phase Ib
in Tanzania evaluated the safety of the same antigens with virosomes on children and young adults
under native (endemic) conditions. The final report showed that the vaccine induced specific,
long-lasting antibody responses, which lasted for more than 12 months for the CSP-1 antigen.
Next steps:
Further development of the malaria vaccine will only be done based on grants or through an
out-licensing agreement. If funds become thus available, the following projects are proposed:
- | Launching antigen interference study with various combinations | ||
- | Launching toxicology studies with the best formulation susceptible to offer an improved protection in human exposed to Plasmodium falciparum. | ||
- | Launching a new Phase I trial with four or five antigens (peptides and proteins) at the Swiss Tropical Institute. |
Herpes Simplex Virus (HSV)
Approach: The current HSV vaccine candidate consists of the reconstituted membrane of HSV-1 or
HSV-2, also containing a lipopeptide, or other adjuvant. In mice, the virosome vaccine induces
better immunity than repeated near-lethal live virus infections, resulting in the induction of
neutralizing antibodies, with predominantly a Th1 profile, cellular immunity, and vaginal IgA.
Different routes of application are possible (intranasal, intramuscular).
Next steps:
We have identified the key elements of the vaccine that induce the protective immune response. A
version of the vaccine containing those elements is being produced and will be tested in
preclinical experiments. A sale or out-licensing of the vaccine is likely anticipated during or
after a Phase II clinical trial. We expect to start Phase I clinical trials in 2013, to be
followed by Phase II and Phase III clinical trials, resulting in expected market launch around
2021.
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STRATEGY
Our strategy is to extend the application of our key scientific approaches to new vaccines by:
| Exploiting the results and knowledge of mucosal protection based vaccines | ||
| Leveraging the effective and safe virosome vaccine technology and know-how | ||
| Advancing existing vaccine candidates only through Phase II clinical trials | ||
| Maintaining a comprehensive IP portfolio | ||
| Adopting a flexible cost model based on a combination of in-house expertise and best-in-class outsourcing | ||
| Entering into strategic partnerships with leading pharmaceutical companies |
Our vision is to become the market leader in the development of new generation mucosal and
virosomes based vaccines. We develop preventative vaccines that generate an efficient mucosal
protection through mucosal antibodies as first line of defense, while blood antibodies would act
synergistically, as a second line of defense.
To date, our focus has been on achieving very favorable results from the development of a core
vaccine pipeline of HIV-1 and malaria, while securing the IP and know-how for the virosome
technology and the mucosal based approach.
By using a lean and flexible operational platform and contracting with best-in-class partners, we
have avoided the upfront cost of in-house resources and gained access to the best existing
know-how. This has maximized the return on development and research.
MATERIAL THIRD PARTY AGEREEMENTS
For the development of its vaccines the Company has entered into several agreements in the
form of license agreements, exploitation agreements or co-ownership agreements with third parties.
These third parties provide specific experience and capabilities or provide access to specific know
how, which are not the core competence of Mymetics. The Company believes that the following third
party agreements are material. The following summaries of their material terms are qualified in
their entirety by reference to the agreements filed as exhibits to prior SEC filings by the Company
as set forth under Item 15 (Exhibits and Financial Statement Schedules).
INSERM
Co-Ownership Agreement dated January 8, 2008 for two patents PCT IB2005/001180 and PCT
IB2005/001182, related to Mymetcs HIV vaccine. Each party has a 50% ownership in the patents.
Mymetics pays all related maintenance charges for the two patents. Unless earlier terminated by
either party, the Co-Ownership Agreement terminates upon the earlier of the expiration date of the
longest-lived patent or the date where one of the co-owners becomes 100% owner of the patents.
Exploitation Agreement dated January 8, 2008 that allows Mymetics to have global rights to
develop, promote, produce, co-produce, sell and distribute HIV products based on any of the
following three patents: PCT IB2005/001180, PCT IB2005/001182 and PCT IB 2006/000466.
Milestone payments:
End of phase I: E70,000.
End of phase II: E120,000.
End of Phase III: E300,000.
First commercialization: E500,000.
Royalty payments in case of direct commercialization:
For sales below E250,000,000: a maximum of 1.5%.
For sales between E250,000,000 and E500,000,000: a maximum of 2.5%
For sales more than E500,000,000: a maximum of 4%.
Royalty payments in case of indirect commercialization, e.g. through Mymetics licensing of
third parties, is 40%.
The Exploitation Agreement terminates upon the later of: the expiration date of the
longest-lived patent, or, 10 years after the first date of commercialization of the product, unless
terminated by INSERM following market approval of the HIV products in the event (i)Mymetics does
not develop the product for a period more than six months, (ii) the exploitation of the product is
interrupted for a period of more than twelve months, or (iii) there is an absence of sales for
twelve months starting from the date of market approval.
PEVION
License Agreement dated March 1, 2007 for the exclusive use by Mymetics of the Pevion
virosomes for its HIV vaccine (HIV Agreement).
Milestone payments:
10% of all monetary consideration (excluding royalties) received from third Parties.
E400,000 if Mymetics starts phase I clinical trial.
E400,000 if Mymetics starts phase I clinical trial.
Royalties: 10% of all monetary consideration received by Mymetics.
The HIV Agreement is subject to termination by either party in writing following a notice
period of ninety days and in absence of such termination, will terminate in each country as of the
expiration date of the longest-lived product patent rights on a country-by-country basis.
Acquisition and License agreement dated May 19, 2008 for the Pevion virosomes and peptides for
the malaria vaccine (Malaria Agreement).
Milestone payments: E2,000,000 start of phase II clinical trial in Africa.
Royalties: maximum of 15% on all income generated from markets in which the
malaria vaccine is sold on a commercial basis.
The Malaria Agreement is subject to termination by either party in writing following a notice
period of ninety days and, in the absence of such termination, will terminate in each country as of
the expiration date of the longest-lived product patent rights on a country-by-country basis.
PXTHERAPEUTICS
Gp41 Manufacturing Technology Agreement dated 26 January 2009 between PX Therapeutics and
Mymetics under which PX Therapeutics agrees to transfer the know-how to manufacture recombinant
Gp41 for Mymetics HIV vaccine. The term of the agreement is for 5 years after the date of
signature and renewable at the request of Mymetics. Mymetics is allowed to terminate the contract
one month after the event of knowledge transfer has been confirmed by both parties.
Annual retainer of E200,000 until the earlier of five years or when the HIV vaccine is market
approved.
Milestone payments:
E600,000 after knowledge transfer
E900,000 when Mymetics has deposited and has received acceptance of the IMPD (or IND) with regulatory authorities, such as the FDA in the United States, to start a clinical trial.
E900,000 when Mymetics has deposited and has received acceptance of the IMPD (or IND) with regulatory authorities, such as the FDA in the United States, to start a clinical trial.
Royalty payments: 1% on all income generated from the commercialization of
the product.
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NORWOOD IMMUNOLOGY
Share Purchase Agreement dated March 5, 2009 pursuant to which Mymetics acquired Mymetics B.V.
from Norwood Immunology Ltd. Payments to Norwood are for the intranasal influenza vaccine,
Mymetics RSV vaccine and Mymetics HSV vaccine.
Intranasal Influenza vaccine: a milestone payment of E3,000,000 at the
start of a phase III clinical trial of Mymetics intranasal influenza
vaccine if the phase III clinical trial commences before April 1, 2013.
RSV vaccine: a milestone payment of E2,800,000 if Mymetics enters into a
license agreement for a RSV vaccine with a third party before April 1, 2011
and royalty payments of 50% on all income generated by Mymetics after the
commercialization of the RSV vaccine.
HSV vaccine: payments of 25% of all income generated by Mymetics. This
includes all upfront, milestone and royalty income received for Mymetics
HSV vaccine.
RESEARCH AND DEVELOPMENT EXPENSES
Research and Development Expenses of E3,083,000 in 2010 include E640,000 scientific staff
expenses and fees of our scientific consultants, E50,200 paid to scientific partners and suppliers
of scientific services, E830,000 for
support of virosomes licenses and the malaria license and preventive vaccine project and
E1,562,800 related to our AIDS vaccine clinical trial phase I.
INTELLECTUAL PROPERTY
| WO/1999/025377 (GP41 mutée) Method for obtaining vaccines for preventing the pathogenic effects related to a retroviral infection Mymetics Corp. Expiration date 16.11.2018 | ||
| WO/2005/010033 (GP41 ter) New soluble and stabilized trimeric form of GP 41 polypeptide Mymetics Corp. Expiration date 28.07.2024 | ||
| WO/2006/117586 (IgA GP41 eng loop) Antibody or a fragment thereof, having neutralizing activity against HIV but not against IL2 Mymetics Corp + INSERM Expiration date 01.05.2025 | ||
| WO/2006/117584 (Iga CDR3 long) Antibody or a fragment thereof, having neutralizing activity against HIV INSERM Expiration date 01.05.2025 | ||
| WO/2007/099446 (Virosome-P1) Virosome-like vesicles comprising gp41 derived antigens Mymetics Corp. + INSERM + Pevion Expiration date 01.03.2027 | ||
| US/61/202 215 (GP41 4th gen) Mymetics Corp. Expiration date 05.02.2029 | ||
| US/61/202 219 (Splitting GP41) Mymetics Corp. Expiration date 05.02.2029 | ||
| WO/2004/106366 (UK39) Methods for synthetizing conformationally constrained peptides, peptidomimetics and use of such peptidomimetics as synthetic vaccines Mymetics Corp. Expiration date 01.06.2024 | ||
| WO/2004/078099 (AMA49) Compositions and methods for the generation of immune response against Malaria Mymetics Corp. Expiration date 02.03.2023 | ||
| WO/1995/032706 (INEX) Virosome-mediated intracellular delivery of therapeutic agents Bestewil BV Expiration date 31.05.2015 | ||
| WO/2004/045641 (APRECS) Antigen-complexes Bestewil BV Expiration date 19.11.2023 | ||
| WO/2004/110486 (Lipopeptide) Functionally reconstituted viral membranes containing adjuvant Bestewil BV Expiration date 17.06.2024 | ||
| WO/2005/117958 (RSV) Vaccine compositions comprising virosomes and a saponin adjuvant Bestewil BV Expiration date 25.05.2025 | ||
| WO/2004071492 (DCPC) Virosome-like particles Bestewil BV Expiration date 12.02.2023 |
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COMPETITION
We have not yet developed an actual product or generated significant revenues. Our future
competitive position depends on our ability to successfully develop our intellectual property, and
to license or sell such intellectual property to third parties on financially favorable terms.
Although we believe that the results of our research and development activities have been
favorable, there are numerous entities and individuals conducting research and development
activities in the area of human biology and medicine, all of which could be considered
competitors.
The worldwide vaccine market is dominated by five large multinational companies: Sanofi
Pasteur S.A. (formerly Aventis Pasteur S.A.), Merck & Co., GlaxoSmithKline Plc, Pfizer-Wyeth and
Novartis-Chiron Inc. Other companies such as Progenics Pharmaceuticals, Inc., are developing
therapeutic HIV vaccines, i.e. vaccines that target HIV-infected persons in an attempt to control
the development of the disease.
While many of these individuals and entities have greater financial and scientific
capabilities, and greater experience in conducting pre-clinical and clinical trials, the Company
believes that its innovative approach to vaccine development is very competitive.
GOVERNMENTAL REGULATION
Our strategy was crafted in part to minimize the risks usually associated with Phase III
clinical trials, regulatory approvals and marketing, which are expected to be borne by one or more
future partners.
We contract with third parties to perform research projects related to our business. These
third parties are located in various countries and are subject to the applicable laws and
regulations of their respective countries. Accordingly, regulation by government authorities in the
United States, the European Union and other foreign countries is a significant factor in the
development, manufacture and marketing of our proposed products by our future partners and
therefore has a direct impact on our ongoing research and product development activities.
Any products that will be developed by our future partners based on our technology will
require regulatory approval by government agencies prior to commercialization. In particular, like
human therapeutic products, vaccines are subject to rigorous pre-clinical studies and clinical
trials and other approval procedures of the FDA and similar regulatory authorities in foreign
countries. In addition, various federal and state statutes and regulations will also govern, or
influence testing, manufacturing, safety, labeling, storage and record keeping related to such
products and their marketing. The process of obtaining these approvals and the subsequent
substantial compliance with appropriate federal and state statutes and regulations require the
expenditure of substantial time and financial resources. Obtaining royalties in the future will
depend on our future partners ability to obtain and maintain the necessary regulatory approvals.
Pre-clinical studies are generally conducted on laboratory animals to evaluate the
imunogenicity (induction of antibodies of the cellular response), first proof of potential efficacy
and safety of a product. In light of our limited financial resources, clinical trials of our
vaccines are conducted first in Europe under the European Union (EU) guidelines, a quicker and
less expensive approach than seeking FDA approval, which we intend to do after EU approval is
granted and we expect our financial resources to be greater. There is however no certainty that
such EU approval will be granted. The Phase I, II and III EU clinical trials are similar to those
required for FDA approval. The FDA requirements are addressed in this discussion.
The process which is described below is therefore to be considered as generic background
information which is relevant to the industry as a whole. As such process applies to drugs as well
as vaccines, the term drugs as used hereafter refers also to vaccines.
In the United States, any company developing new drugs must submit the results of pre-clinical
studies to the FDA as a part of an investigational new drug application, or IND, which application
must become effective before it can begin clinical trials in the United States. An IND becomes
effective 30 days after receipt by the FDA unless the FDA objects to it and the IND must be
annually updated. Typically, clinical evaluation involves a time-consuming and costly three-phase
process.
Phase I refers typically to closely monitored clinical trials and includes the initial
introduction of an investigational new drug into human patients or normal healthy volunteer
subjects. Phase I clinical trials are designed to determine the safety (metabolic and pharmacologic
actions of a drug in humans), the side effects associated with increasing drug doses and, if
possible, to gain early evidence on effectiveness (inductions of antibodies in our case). Phase I
trials also include the study of structure-activity relationships and mechanism of action in
humans, as well as studies in which investigational drugs are used as research tools to explore
biological phenomena or disease processes. During Phase I clinical trials, sufficient information
about a drugs pharmacokinetics and pharmacological effects should be obtained to permit the design
of well-controlled, scientifically valid, Phase II studies. The total number of subjects and
patients included in Phase I clinical trials varies but is generally in the range of 20 to 80
people. Bioanalyses on the clinical trial samples in different in vitro assays must be conducted
under good laboratory practice (GLP). At this stage, all techniques must be qualified according to
standard operating procedures (SOPs) but it is not required to have the assays validated.
Validating an assay consists of analyzing or verfiying the 8 or 9 assay parameters as described in
the US pharmacopeia or the ICH guidelines: 1) accuracy; 2) precision; 3) limit of detection; 4)
limit of qualification; 5) specificity; 6) linearity and range; 7) robustness; and 8) system
suitability.
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Phase II refers to controlled clinical trials conducted to evaluate the safety and
effectiveness of a drug for a particular indication or indications in patients with a disease or
condition under study and to determine the common short-term side effects and risks associated with
the drug. These clinical trials are typically well-controlled, closely monitored and conducted in a
relatively small number of patients, usually involving no more than several hundred subjects. For
prophylactic vaccines, a fraction of the enrolled subjects for the Phase II trials should ideally
correspond to people at higher risk to contract the infection due to their social and/or sexual
behaviors. At this stage, all identified and relevant techniques must be qualified and validation
should be initiated prior starting the phase II and full validation must be achieved at the end of
the phase II, prior launching Phase III. Completion of Phase II trials generally corresponds to the
stage of development where big Pharma have a high interest for the drug product.
Phase III refers to expanded controlled clinical trials, which many times are designated as
pivotal trials designed to reach end points that the FDA has agreed in advance, if met, would
allow approval for marketing. These clinical trials are performed after preliminary evidence
suggesting effectiveness of a drug has been obtained. Meanwhile, prophylactic vaccines are
different because the true evidence of effectiveness is obtained during the Phase III trials
involving an important fraction of the enrolled subjects with high risk of contracting the
pathogen, providing more statistical power. Depending on the vaccine tested, vaccinated subjects
are monitored over a period of few months to several years and the infection rate (protection) of
this group is compared to the placebo treated group. Phase III trials are intended to gather
additional information about the effectiveness and safety that is needed to evaluate the overall
benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.
Phase III clinical trials can include from several hundred to tens of thousands of subjects
depending on the specific indication being tested.
The FDA closely monitors the progress of each of the three phases of clinical trials that are
conducted in the United States and may, at its discretion, re-evaluate, alter, suspend or terminate
the testing based upon the data accumulated to that point and the FDAs assessment of the
risk/benefit ratio to the patient. Once Phase III trials are completed, drug developers submit the
results of pre-clinical studies and clinical trials to the FDA, in the form of a new drug
application, or NDA, for approval to commence commercial sales. In response, the FDA may grant
marketing approval, request additional information or deny the application if the FDA determines
that the application does not meet the predetermined study goals and other regulatory approval
criteria.
Furthermore, the FDA may prevent a drug developer from marketing a product under a label for
its desired indications, which may impair commercialization of the product.
If the FDA approves the new drug application, the drug becomes available for physicians to
prescribe in the United States. After approval, the drug developer must submit periodic reports to
the FDA, including descriptions of any adverse reactions reported. The FDA may request additional
studies, known as Phase IV clinical trials to evaluate long-term effects.
We will be required to comply with similar regulatory procedures in countries other than the
United States.
In addition to studies requested by the FDA after approval, a drug developer may conduct other
trials and studies to explore use of the approved compound for treatment of new indications. The
purpose of these trials and studies and related publications is to broaden the application and use
of the drug and its acceptance in the medical community.
At this time, neither we nor any of our partners have submitted any of its pre-clinical
results to the FDA. It is only in 2009 that the local Belgium Authority Approval to begin Phase I
human clinical trials for our HIV vaccine was received.
Our future partner(s) will have to complete an approval process, similar to the one required
in the United States, in virtually every foreign target market in order to commercialize product
candidates based on our technology in those countries. The approval procedure and the time required
for approval vary from country to country and may involve additional testing. Approvals (both
foreign and in the United States) may not be granted on a timely basis, or at all. In addition,
regulatory approval of prices is required in most countries other than the United States. We face
the risk that the resulting prices would be insufficient to generate an acceptable return to our
partner(s).
EMPLOYEES
Jacques-François Martin is our President and Chief Executive Officer. Additionally, there are
three full-time employees of Mymetics Corporation: Ronald Kempers, Chief Financial Officer and
Chief Operating Officer, Dr. Sylvain Fleury, Ph.D., Chief Scientific Officer, and Christian Rochet,
who resigned as our President and CEO effective July 1, 2009, but is currently employed by us as
Senior Advisor to the President. Ernest Luebke resigned as CFO effective July 30, 2010.
Our Swiss subsidiary, Mymetics S.A., has on its payroll three employees: Director of Finance,
Director of R&D and an Office Manager.
Mymetics B.V. has one full time executive officer (CSO) plus two full-time assistants.
As of December 31, 2010, our Luxembourg affiliate had no employees.
WWW.MYMETICS.COM
News and information about Mymetics Corporation are available on our web site,
www.mymetics.com.
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ITEM 1A. RISK FACTORS
You should carefully consider the risks described below together with all of the other
information included in this report on Form 10-K. An investment in our common stock is risky. If
any of the following risks materialize, our business, financial condition or results of operations
could be adversely affected. In such an event, the trading price of our common stock could decline,
and you may lose part or all of your investment. When used in these risk factors, the terms we or
our refer to Mymetics Corporation and its subsidiaries.
We are a company engaged exclusively in research and development activities, focusing
primarily on vaccine development. Our strategy was crafted in part to minimize the risks usually
associated with clinical trials, regulatory approvals and marketing, which we would expect to be
borne by our future partner(s).
WE HISTORICALLY HAVE LOST MONEY, EXPECT LOSSES TO CONTINUE FOR THE FORESEEABLE FUTURE AND MAY NEVER
ACHIEVE PROFITABILITY.
We historically have lost money. In the years ended December 31, 2010, and December 31, 2009,
we sustained net losses of approximately E11,428,000 and E10,186,000, respectively. At December 31,
2010, we had an accumulated deficit of approximately E53,518,000. Total cash disbursed since 1990
for operating activities, including research and development, is E43,528,000.
The amount of these losses may vary significantly from year-to-year and quarter-to-quarter and
will depend on, among other factors:
- | the timing and cost of product development; | |
- | the progress and cost of preclinical and clinical development programs; | |
- | the timing and cost of obtaining necessary regulatory approvals; | |
- | the timing and cost of sales and marketing activities for future products; and | |
- | the costs of pending and any future litigation of which we may be subject. |
We currently are engaged in research and development activities and do not have any
commercially marketable products. The product research and development process requires significant
capital expenditures, and we do not have any other sources of revenue to off-set such expenditures.
Accordingly, we expect to generate additional operating losses at least until such time as we
are able to generate significant revenues.
To become profitable, we will need to generate revenues to offset our operating costs,
including our general and administrative expenses. We may not achieve or, if achieved, sustain our
revenue or profit objectives, and our losses may increase in the future, and, ultimately, we may
have to cease operations.
In order to generate new and significant revenues, we must successfully develop and
commercialize our proposed products or enter into collaborative agreements with others who can
successfully develop and commercialize them. Our business plan is predicated on commercializing our
products in collaboration with others. Even if our proposed products are commercially introduced,
they may never achieve market acceptance and we may never generate significant revenues or achieve
profitability.
WE NEED TO RAISE SUBSTANTIAL ADDITIONAL CAPITAL TO FUND OUR OPERATIONS AND WE MAY BE UNABLE TO
RAISE SUCH FUNDS ON A TIMELY BASIS AND ON ACCEPTABLE TERMS.
We need to address our working capital needs to allow us to continue devoting our efforts to
development of the business instead of raising needed capital. If we must devote a substantial
amount of time to raising capital, it will delay our ability to achieve our business plan within
the time frames that we now expect, which could increase the amount of capital we need and could
threaten the success of our business if competitors are able to produce an effective vaccine to the
market ahead of us.
OUR LIMITED OPERATING HISTORY MAKES IT DIFFICULT TO EVALUATE OR PREDICT OUR FUTURE BUSINESS
PROSPECTS.
We have no operating history, and our operating results are impossible to predict because we
have not begun selling any products. We are in the development stage, and our proposed operations
are subject to all of the risks inherent in establishing a new business enterprise, including:
- | the absence of an operating history; | |
- | the lack of commercialized products; | |
- | insufficient capital; | |
- | expected substantial and continual losses for the foreseeable future; | |
- | limited experience in dealing with regulatory issues; | |
- | limited marketing experience; | |
- | an expected reliance on third parties for the commercialization of our proposed products; | |
- | a competitive environment characterized by numerous, well-established and well-capitalized competitors; | |
- | uncertain market acceptance of our proposed products; and | |
- | reliance on key personnel. |
The likelihood of our success must be considered in light of the problems, expenses,
difficulties, complications, and delays frequently encountered in connection with the formation of
a new business, the development of new technology, and the competitive and regulatory environment
in which we will operate. See Description of the Business.
Because we are subject to these risks, you may have a difficult time evaluating our business
and your investment in our company.
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OUR PROPOSED VACCINES ARE IN THE DEVELOPMENT STAGES AND WILL LIKELY NOT BE COMMERCIALLY INTRODUCED
BEFORE 2018, IF AT ALL.
Our proposed key products still are in the development stage and will require further
development, preclinical and clinical testing and investment prior to commercialization in the
United States and abroad. See Description of the Business. While we are pleased about the
progress made to date on these products, we cannot be sure that these products in development will:
- | be successfully developed; | |
- | prove to be safe and efficacious in clinical trials; | |
- | meet applicable regulatory standards or obtain required regulatory approvals; | |
- | demonstrate substantial protective or therapeutic benefits in the prevention or treatment of any disease; | |
- | be capable of being produced in commercial quantities at reasonable costs; | |
- | obtain coverage and favorable reimbursement rates from insurers and other third-party payers; or | |
- | be successfully marketed or achieve market acceptance by physicians and patients. |
We do not intend to undertake any product development beyond Phase II human clinical trials
(i.e., Phase III clinical studies) or be responsible for obtaining regulatory approval or marketing
the products. Nevertheless, even if we are successful in selling or licensing our products to
another pharmaceutical company, it is likely that any revenues we may receive in connection with
those arrangements will depend upon other companies sales, which will, in turn, depend upon the
factors stated above.
THE LOSS OF OUR PRINCIPAL EXECUTIVE OFFICERS WOULD DIMINISH OUR ABILITY TO ACHIEVE OUR BUSINESS
PLAN.
Messrs. Martin and Kempers play an important role in financing, achievement of our strategic
goals and administration. In addition, Dr. Fleury has been following, and associated with, our AIDS
vaccine project since 1998 and we believe that replacing him as CSO on time for successfully
prosecuting our pending patent applications would be extremely difficult. Accordingly, the loss of
any of these individuals might prevent the Company from achieving its business plan.
THE LOSS OF KEY SCIENTIFIC OR INDUSTRIAL PARTNERS WOULD DIMINISH OUR ABILITY TO ACHIEVE OUR
BUSINESS PLAN.
Certain components or know-how obtained from partners such as Protein eXpert S.A. and
PXTherapeutics, supplier of GMP grade engineered mutated gp41 protein, or Pevion Biotech Ltd.,
supplier and integrator of virosomes, are key components of our vaccines currently under
development. Accordingly, the loss of any of these components or know-how might prevent us from
achieving our business plan, despite the fact that contractual safeguards are in place.
OUR BUSINESS MODEL IS PREDICATED ON OUR BELIEF THAT WE WILL BE ABLE TO ENGAGE LARGE PHARMACEUTICAL
COMPANIES TO PARTNER WITH US IN THE DEVELOPMENT OF OUR PRODUCTS AND FAILURE TO DO SO WILL LIKELY
MAKE US UNATTRACTIVE AS AN ACQUISITION TARGET.
We anticipate that we will need a large pharmaceutical company to assist us with human trials
and financing. See Funding Requirements. Our failure to succeed in this endeavor will have a
dramatic adverse result regarding our financial needs and ability to successfully sell any products
that we develop.
IF WE FAIL TO OBTAIN REGULATORY APPROVAL TO COMMERCIALLY MANUFACTURE OR SELL ANY OF OUR FUTURE
PRODUCTS, OR IF APPROVAL IS DELAYED OR WITHDRAWN, WE WILL BE UNABLE TO GENERATE REVENUE FROM THE
SALE OF OUR PRODUCTS.
We must obtain regulatory approval to sell any of our products in the United States and
abroad. In the United States, we must obtain the approval of the FDA for each product or drug that
we intend to commercialize. The FDA approval process is typically lengthy and expensive, and
approval is never certain. Products to be commercialized abroad are subject to similar foreign
government regulation.
Generally, only a very small percentage of newly discovered pharmaceutical products that enter
preclinical development are approved for sale. Because of the risks and uncertainties in
biopharmaceutical development, our proposed products could take a significantly longer time to gain
regulatory approval than we expect or may never gain approval. If regulatory approval is delayed or
never obtained, our managements credibility, the value of our company and our operating results
and liquidity would be adversely affected. Furthermore, even if a product gains regulatory
approval, the product and the manufacturer of the product may be subject to continuing regulatory
review. Even after obtaining regulatory approval, we may be restricted or prohibited from marketing
or manufacturing a product if previously unknown problems with the product or its manufacture are
subsequently discovered. The FDA may also require us to commit to perform lengthy post-approval
studies, for which we would have to expend significant additional resources, which could have an
adverse effect on our operating results and financial condition.
Although we have conducted pre-clinical studies, costly and lengthy human clinical trials are
required to obtain regulatory approval to market our proposed vaccine, and the results of the
trials are highly uncertain. In addition, the number of pre-clinical studies and human clinical
trials that the FDA requires varies depending on the product, the disease or condition the product
is being developed to address and regulations applicable to the particular product. Accordingly, we
may need to perform additional pre-clinical studies using various doses and formulations before we
can begin human clinical trials, which could result in delays in our ability to market any of our
products. Furthermore, even if we obtain favorable results in pre-clinical studies on animals, the
results in humans may be different.
After we have conducted pre-clinical studies in animals, we must demonstrate that our products
are safe and effective for use on the target human patients in order to receive regulatory approval
for commercial sale. The data obtained from pre-clinical and human clinical testing are subject to
varying interpretations that could delay, limit or prevent regulatory approval. We face the risk
that the results of our clinical trials in later phases of clinical trials may be inconsistent with
those obtained in earlier phases. A number of companies in the biopharmaceutical industry have
suffered significant setbacks in advanced clinical trials, even after experiencing promising
results in early animal or human testing. Adverse or inconclusive human clinical results would
prevent us from filing for regulatory approval of our products. Additional factors that can cause
delay or termination of our human clinical trials include:
- | slow patient enrollment; | |
- | timely completion of clinical site protocol approval and obtaining informed consent from subjects; | |
- | longer trial time than foreseen to demonstrate efficacy or safety; | |
- | adverse medical events or side effects in immunized patients; and | |
- | lack of effectiveness of the vaccines being tested. |
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Delays in our clinical trials could allow our competitors additional time to develop or market
competing products and thus can be extremely costly in terms of lost sales opportunities and
increased clinical trial costs.
EVEN IF OUR PROPOSED PRODUCTS RECEIVE EU AND FDA APPROVAL, THEY MAY NOT ACHIEVE EXPECTED
LEVELS OF MARKET ACCEPTANCE, WHICH COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS, FINANCIAL
POSITION AND OPERATING RESULTS AND COULD CAUSE THE MARKET VALUE OF OUR COMMON STOCK TO DECLINE.
Even if we are able to obtain required regulatory approvals for our proposed products, the
success of those products is dependent upon market acceptance by physicians and patients. Levels of
market acceptance for our new products could be impacted by several factors, including:
- | the availability of alternative products from competitors; | |
- | the price of our products relative to that of our competitors; | |
- | the timing of our market entry; and | |
- | the ability to market our products effectively. |
Some of these factors are not within our control. Our proposed products may not achieve
expected levels of market acceptance. Additionally, continuing studies of the proper utilization,
safety and efficacy of pharmaceutical products are being conducted by the industry, government
agencies and others. Such studies, which increasingly employ sophisticated methods and techniques,
can call into question the utilization, safety and efficacy of previously marketed products. In
some cases, these studies have resulted, and may in the future result, in the discontinuance of
product marketing. These situations, should they occur, could have a material adverse effect on our
business, financial position and results of operations, and the market value of our common stock
could decline.
IF WE ARE UNABLE TO PROTECT OUR INTELLECTUAL PROPERTY, WE MAY NOT BE ABLE TO COMPETE AS EFFECTIVELY.
The pharmaceutical industry places considerable importance on obtaining patent and trade
secret protection for new technologies, products and processes. Our success will depend, in part,
upon our ability to obtain, enjoy and enforce protection for any products we develop or acquire
under United States and foreign patent laws and other intellectual property laws, preserve the
confidentiality of our trade secrets and operate without infringing the proprietary rights of third
parties.
Where appropriate, we seek patent protection for certain aspects of our technology. However,
our owned and licensed patents and patent applications may not ensure the protection of our
intellectual property for a number of other reasons:
- Competitors may interfere with our patents and patent process in a variety of ways.
Competitors may claim that they invented the claimed invention before us or may claim that we are
infringing on their patents and therefore we cannot use our technology as claimed under our patent.
Competitors may also have our patents reexamined by showing the patent examiner that the invention
was not original or novel or was obvious.
- We are in the development stage and are in the process of developing proposed products. Even
if we receive a patent, it may not provide much practical protection. If we receive a patent with a
narrow scope, then it will be easier for competitors to design products that do not infringe on our
patent. Even if the development of our proposed products is successful and approval for sale is
obtained, there can be no assurance that applicable patent coverage, if any, will not have expired
or will not expire shortly after this approval. Any expiration of the applicable patent could have
a material adverse effect on the sales and profitability of our proposed product.
- Enforcing patents is expensive and may require significant time by our management. In
litigation, a competitor could claim that our issued patents are not valid for a number of reasons.
If the court agrees, we would lose protection on products covered by those patents.
- We also may support and collaborate in research conducted by government organizations or
universities. We cannot guarantee that we will be able to acquire any exclusive rights to
technology or products derived from these collaborations. If we do not obtain required licenses or
rights, we could encounter delays in product development while we attempt to design around other
patents or we may be prohibited from developing, manufacturing or selling products requiring these
licenses. There is also a risk that disputes may arise as to the rights to technology or products
developed in collaboration with other parties.
It also is unclear whether efforts to secure our trade secrets will provide useful protection.
While we use reasonable efforts to protect our trade secrets, our employees or consultants may
unintentionally or willfully disclose our proprietary information to competitors resulting in a
loss of protection. Enforcing a claim that someone else illegally obtained and is using our trade
secrets, like patent litigation, is expensive and time consuming, and the outcome is unpredictable.
In addition, courts outside the United States are sometimes less willing to protect trade secrets.
Finally, our competitors may independently develop equivalent knowledge, methods and know-how.
CLAIMS BY OTHERS THAT OUR PRODUCTS INFRINGE THEIR PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS
COULD ADVERSELY AFFECT OUR FINANCIAL CONDITION.
The pharmaceutical industry has been characterized by frequent litigation regarding patent and
other intellectual property rights. Patent applications are maintained in secrecy in the United
States and also are maintained in secrecy outside the United States until the application is
published. Accordingly, we can conduct only limited searches to determine whether our technology
infringes the patents or patent applications of others. Any claims of patent infringement asserted
by third parties would be time-consuming and could likely:
- | result in costly litigation; | |
- | divert the time and attention of our technical personnel and management; | |
- | cause product development delays; | |
- | require us to develop non-infringing technology; or | |
- | require us to enter into royalty or licensing agreements. |
Although patent and intellectual property disputes in the pharmaceutical industry often have
been settled through licensing or similar arrangements, costs associated with these arrangements
may be substantial and often require the payment of ongoing royalties, which could hurt our gross
margins. In addition, we cannot be sure that the necessary licenses would be available to us on
satisfactory terms, or that we could redesign our products or processes to avoid infringement, if
necessary. Accordingly, an adverse determination in a judicial or administrative proceeding, or the
failure to obtain necessary licenses, could prevent us from developing, manufacturing and selling
some of our products, which could harm our business, financial condition and operating results.
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WE HAVE ANTI-TAKEOVER PROVISIONS IN OUR BYLAWS THAT MAY DISCOURAGE A CHANGE OF CONTROL.
Our bylaws contain provisions that could discourage, delay or prevent a change in control of
our Company or changes in our management that the stockholders of our company may deem
advantageous. These provisions
- | limit the ability of our stockholders to call special meetings of stockholders; | |
- | provide for a staggered board; | |
- | provide that our board of directors is expressly authorized to make, alter or repeal the bylaws; and | |
- | establish advance notice requirements for nominations for election to our board or for proposing matters that can be acted upon by stockholders at stockholder meetings. |
ITEM 2. PROPERTIES
Since March 1, 2009, we leased new office space in a campus recently established near Lausanne
(40 miles from Geneva) by the local state government to attract promising biotech companies. This
houses our scientific management and administrative operations. These facilities could be enhanced
in April 2011 with about 300 square meters of new
laboratory facilities on which Mymeticcs has taken an option. These facilities will be used to
perform the various testing on pre-clinical and clinical samples under Good Laboratory Practice
(GLP) and some product characterization work required by regulatory agencies and which cannot be
subcontracted to third parties, or if so, only at prohibitive costs and often not compatible with
our timeline. Developing this in-house expertise would favor a better control on the IP and
know-how.
During 2010 we also leased approximately 100 square meters of office space in Nyon,
Switzerland (20 miles from Geneva), at 14, rue de la Colombiere, presently used by the Senior
Advisor to the CEO. This contract has been terminated and the terms oblige Mymetics to pay until
February 28, 2011.
Bestewil Holding B.V. and its subsidiary Mymetics B.V operate from a similar biotechnology
campus near Leiden in the Netherlands, where they occupy 100 square meters for office and
laboratory use.
We also conduct research operations at the properties of various third parties, worldwide.
ITEM 3. LEGAL PROCEEDINGS
Neither we, nor our wholly owned subsidiaries 6543 Luxembourg S.A., Mymetics S.A., Bestewil
Holding B.V. nor its subsidiary Mymetics B.V. are presently involved in any litigation incident to
our business except as follows:
Pursuant to our indemnification obligations under Delaware law, our charter and the consulting
agreements with Christian Rochet and Ernst Luebke, respectively, we have paid a judgment for
173,000 entered against these two former officers and directors entered in November 2010 in a case
styled Luebke Rochet / Serres ref. 120494. The lawsuit was brought in the Tribunal de Commerce
in Lyon, France, by our former CEO, Dr. Pierre-Francois Serres, who sued Messrs. Rochet and Luebke
for an alleged breach of a shareholders agreement in 1998. Mr. Serres brought this case against
Messrs. Rochet and Luebke following the dismissal of the case he filed against us for an alleged
unlawful termination of Mr. Serres by Messrs. Rochet and Luebke in 2003. We are appealing the
decision.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
PART II
ITEM 5. | MARKET FOR REGISTRANTS COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES |
(a) Market Information. The Corporations common stock is quoted on the OTC Bulletin Board
under the trading symbol MYMX
The following table sets forth the quarterly high and low sales price per share of our common
stock for the periods indicated. The prices represent inter-dealer quotations, which do not include
retail mark-up, mark-down or commission and may not necessarily represent actual transactions.
FISCAL QUARTER ENDED | HIGH | LOW | ||||||
2009 |
||||||||
March 31 |
$ | 0.190 | $ | 0.170 | ||||
June 30 |
0.189 | 0.160 | ||||||
September 30 |
0.160 | 0.135 | ||||||
December 31 |
0.119 | 0.110 | ||||||
2010 |
||||||||
March 31 |
$ | 0.195 | $ | 0.100 | ||||
June 30 |
0.210 | 0.101 | ||||||
September 30 |
0.170 | 0.101 | ||||||
December 31 |
0.175 | 0.090 |
(b) | Stockholders. At March 24, 2011, we had approximately 650 holders of record of our common stock, some of which are securities clearing agencies and intermediaries. | ||
(c) | Dividends. We have not paid any dividends on our common stock and do not intend to pay any dividends in the foreseeable future. | ||
(d) | Securities Authorized for Issuance under Equity Compensation Plans. |
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EQUITY COMPENSATION PLAN INFORMATION
The following table provides information about the common stock that may be issued upon the
exercise of options, warrants and rights under all of the Companys existing equity compensation
plans as of December 31, 2010.
Number of Securities remaining | ||||||||||||
Number of Securities to be | Weighted Average Exercise | available for issuance under | ||||||||||
issued upon exercise of | Price of Outstanding | equity compensation plans | ||||||||||
Options, Warrants and | Options, Warrants and | (excluding securities | ||||||||||
Plan | Rights | Rights | reflected in column (a)) | |||||||||
Category | (a) | (b) | (c) | |||||||||
Equity Compensation Plans Approved by Security |
||||||||||||
Holders (1) |
442,500 | (2) | U.S. $ | 0.97 | ||||||||
Holders (3) |
4,350,000 | U.S. $ | 0.15 | |||||||||
Total |
4,792,500 | U.S. $ | 0.23 | 207,500 | ||||||||
(1) | Equity compensation plans approved by security holders include (i) the Companys 1994 Amended and Restated Stock Option Plan. (ii) its 1995 Qualified Incentive Stock Option Plan and (iii) our 2001 Stock Option Plan. | |
(2) | Includes (i) 442,500 shares of common stock underlying options granted under the registrants 2001 Stock Option Plan. | |
(3) | In June 2010 our Board of Directors approved a 2009 Stock Incentive Plan that will need authorization by our stockholders. We have granted 4,350,000 options under that Plan. |
In additon, Mymetics granted Norwood Immunology Limited (NIL) an option to acquire shares of
Mymetics common stock equal to the result obtained by dividing $9,609 by the Conversion Price. As
part of the Share Purchase Agreement, if Mymetics had issued shares of capital stock in connection
with a financing to repay the Bridge Loan that had more favorable financial rights and preferences
than the original conversion price or other terms, NIL had the right, at its election, to acquire
those shares at the better terms. Since the Company converted the Bridge Loan to finance the
acquisition at $0.50 in September 2010, the result is that the option allows NIL to acquire
19,218,450 shares of common stock.
Further, on July 1 2010, Mymetics issued a warrant to Round Enterprises providing the right to
buy 32 million shares of Mymetics common stock at a price of US $0.25 per share. The warrant is
valid from July 1, 2010 until June 30, 2013.
ISSUANCES OF UNREGISTERED SECURITIES
Set forth below is information regarding our sales of unregistered securities during the
period commencing on January 1, 2010 and ending on March 24, 2011. These issuances were made
pursuant to individual contracts that are discrete from one another and in reliance on the
exemption from registration provided by Section 4(2) of the Securities Act of 1933, and/or
Regulation D promulgated under the Securities Act, as transactions by an issuer not involving any
public offering to persons who are sophisticated in such transactions and who had knowledge of and
access to sufficient information about us to make an informed investment decision. Among this
information was the fact that the securities were restricted securities.
- | On February 15, 2010, a new investor was issued 150,000 common shares of Mymetics Corporation at $.132 per share, as fee for services rendered. | |
- | On February 15, 2010, a new investor was issued 50,000 common shares of Mymetics Corporation at $.132 per share, as fee for services rendered. | |
- | On September 13, 2010, an existing investor was issued 1,550,000 common shares of Mymetics Corporation at $.13 per share, as fee for services rendered. |
ITEM 6. SELECTED FINANCIAL DATA
Not Applicable
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ITEM 7. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
GENERAL
The following discussion and analysis of the results of operations and financial condition of
us for the years ended December 31, 2010 and 2009 should be read in conjunction with our audited
consolidated financial statements and related notes and the description of our business and
properties included elsewhere herein.
RESULTS OF OPERATIONS YEAR ENDED DECEMBER 31, 2010 COMPARED TO YEAR ENDED DECEMBER 31, 2009
We received grant income of E4,000 and E13,000 for the years ended December 31, 2010 and 2009,
respectively. We also received E150,000 and E136,000 related to license agreement fees for the
years ended December 31, 2010 and 2009, respectively. We recorded a gain of E68,000 through the
sale of equipment. The lack of product revenue is directly attributable to our focus on research
and development. We believe that this focus will continue for the foreseeable future. Future
revenues could be affected by local and other economic conditions, technology, competitive forces,
and/or challenges to our intellectual property.
Research and development expenses decreased to E3,083,000 in the current period from
E6,364,000 in the comparative period of 2009, a decrease of 51.56%. This is mostly attributable to
licensing costs and the increased activity required to achieve acceptance to begin Phase I clinical
trials of our HIV vaccine in the year 2009.
General and administrative expenses increased by 2.34% to E3,320,000 in the year ended
December 31, 2010 from E3,244,000 in the comparable period of 2009, primarily as a result of a
decrease in the exercise price on outstanding warrants, offset by reduced costs for our continuing
investor relations efforts.
Induced conversion cost of E807,000 incurred in the year ended December 31, 2010 resulted from
a reduction in the conversion price of shareholder debt. No such expense was incurred in the
comparative period of 2009.
Interest expense increased by 36.12% to E2,834,000 in the year ended December 31, 2010 from
E2,082,000 in the comparable period of 2009 due to additional secured convertible loans outstanding
and amortization of debt discount.
The fair value of acquisition-related contingent consideration increased by E1,276,000 in the
year ended December 31, 2010 compared to a decrease of E(1,614,000) in the comparable period of
2009.
CRITICAL ACCOUNTING POLICIES AND MANAGEMENT ESTIMATES
The preparation of consolidated financial statements in accordance with accounting principles
generally accepted in the United States of America requires management to use judgment in making
estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and
expenses, and related disclosure of contingent assets and liabilities. Certain of the estimates and
assumptions required to be made relate to matters that are inherently uncertain as they pertain to
future events. While management believes that the estimates and assumptions used were the most
appropriate, actual results could differ significantly from those estimates under different
assumptions and conditions. The following is a description of those accounting policies believed by
management to require subjective and complex judgments which could potentially affect reported
results.
REVENUE RECOGNITION AND RECEIVABLES
As a development stage company, we have not generated any material revenues since we commenced
our current line of business in 2001, and management does not anticipate generating any material
revenues on a sustained basis unless and until a substantial licensing agreement or other
commercial arrangement is entered into with respect to our technology.
However, should we engage in any form of commercial activity, a revenue recognition and
receivables policy according to the following principles would be implemented:
Revenue related to the sale of products is recognized when all of the following conditions are
met: persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or
determinable, and collectability is reasonably assured. Receivables are stated at their outstanding
principal balances. Management reviews the collectability of receivables on a periodic basis and
determines the appropriate amount of any allowance. Based on this review procedure, management has
determined that the allowances at December 31, 2010 and 2009 are sufficient. We charge off
receivables to the allowance when management determines that a receivable is not collectible. We
may retain a security interest in the products sold.
RESEARCH AND DEVELOPMENT
Research and development costs are expensed as incurred.
CURRENCY TRANSLATION
Our reporting currency is the Euro because substantially all of our activities are conducted
in Europe. Non-Euro assets and liabilities of our subsidiaries are translated at the rate of
exchange at the balance sheet date. Revenues and expenses are translated at the average rate of
exchange throughout the year. Unrealized gains or losses from these translations are reported as a
separate component of comprehensive income. Transaction gains or losses are included in general and
administrative expenses in the consolidated statements of operations. The translation adjustments
do not recognize the effect of income tax because we expect to reinvest the amounts indefinitely in
operations.
IN-PROCESS RESEARCH AND DEVELOPMENT
In-Process research and development (referred to as IPR&D) represents the estimated fair value
assigned to research and development projects acquired in a purchased business combination that
have not been completed at the date of acquisition and which have no alternative future use. IPR&D
assets acquired in a business combination after January 1, 2009, are capitalized as
indefinite-lived intangible assets. These assets remain indefinite-lived until the completion or
abandonment of the associated research and development efforts. During the period prior to
completion or abandonment, those acquired indefinite-lived assets are not amortized but are tested
for impairment annually, or more frequently, if events or changes in circumstances indicate that
the asset might be impaired.
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IMPAIRMENT OF LONG-LIVED ASSETS
Long-lived assets, which include property and equipment, and the license contract, are
assessed for impairment whenever events or changes in circumstances indicate the carrying amount of
the asset may not be recoverable. The impairment testing involves comparing the carrying amount to
the forecasted undiscounted future cash flows generated by that asset. In the event the carrying
value of the assets exceeds the undiscounted future cash flows generated by that asset and the
carrying value is not considered recoverable, impairment exists. An impairment loss is measured as
the excess of the assets carrying value over its fair value, calculated using a discounted future
cash flow method. An impairment loss would be recognized in net income in the period that the
impairment occurs.
GOODWILL
Goodwill, which represents the excess of purchase price over the fair value of net assets
acquired, is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic
assessment for impairment by applying a fair value based test. Goodwill is assessed for impairment
on an annual basis as of April 1st of each year or more frequently if events or changes
in circumstances indicate that the asset might be impaired. The impairment model prescribes a
two-step method for determining goodwill impairment. In the first step, we determine the fair value
of our reporting unit using an enterprise value analysis. If the net book value of our reporting
unit exceeds the fair value, we would then perform the second step of the impairment test which
requires allocation of our reporting units fair value to all of its assets and liabilities using
the acquisition method prescribed under authoritative guidance for business combinations with any
residual fair value being allocated to goodwill. An impairment charge will be recognized only when
the implied fair value of our reporting units goodwill is less than its carrying amount.
CONTINGENT CONSIDERATION
We account for contingent consideration in a purchase business combination in accordance with
applicable guidance provided within the business combination rules. As part of our consideration
for the Bestewil acquisition, we are contractually obligated to pay additional purchase price
consideration upon achievement of certain commercial milestones and future royalties. Therefore, we
are required to update our assumptions each reporting period, based on new developments, and record
such amounts at fair value until such consideration is satisfied.
STOCK BASED COMPENSATION POLICY
Compensation cost for all share-based payments is based on the estimated grant-date fair
value. The Company amortizes stock compensation cost ratably over the requisite service period.
RECENT ACCOUNTING PRONOUNCEMENTS
See Note 1 of Notes to Consolidated Financial Statements for a full description of recent
accounting pronouncements including the respective dates of adoption and effects on results of
operations and financial condition.
BUSINESS PLAN
We subcontract our research project modules to best of class research teams. We pay for and
coordinate the work, consolidate the results, and retain all associated intellectual property. On
rare occasions, we execute partnership agreements with companies offering technologies that can
enhance our products. As human clinical trials have been initiated, access to our owned laboratory
facilities becomes necessary. We have an option on a pre-lease agreement for such facilities in the
new Biopole campus established by the local state government near Lausanne. These facilities are
expected to become available by mid-2011 or end of 2011.
We will continue in the foreseeable future to outsource to specialized third parties all human
clinical trials of our vaccines, such process being complex and highly regulated.
Our business plan is predicated by the size and availablility of our resources, which preclude
us from pursuing our human clinical trials beyond phase II, which normally involves no more than
250-300 volunteers and a cost in the range of $5-10 million per phase I and II trial cycle. In
contrast, phase III trial for a prophylactic vaccine involves up to 30,000 patients and several
testing centers spread over two or more continents. The high number of volunteers, as well as the
logistical complexity of such an undertaking, implies a cost-per-volunteer in the $10,000 to
$12,000 range, or up to $360 million per phase III trial. Similarly, the cost and complexity of the
vaccine registration procedure with the relevant European agencies can be very expensive. The cost
of registration with the U.S. Food and Drug Administration (FDA) is generally significantly higher
due to a variety of factors, including, potential product liability claims.
In light of the significant phase III costs, we expect to sign a partnership agreement with
one or more of the major pharmaceutical companies active in the preventive vaccine market as soon
as human clinical phase II trials are completed. Such partnership agreements typically involve an
initial cash payment with covers the initial costs of R&D up to that time plus an adequate margin
of profit, followed by a series of payments associated with specific milestones and finally,
royalties on any sales of end products, assuming these have been approved by the various regulatory
authorities involved, such as the FDA.
We are trying to achieve this for the HIV-1 vaccine by 2012, which has successfully completed
the Phase I in Belgium. Malaria is the other vaccine that already completed successfully a Phase Ia
(adults in Switzerland) and more recently a Phase Ib (children in Tanzania). Partnership for HIV-1
and malaria phase II and III might also involve non-profit entities like the Bill and Melinda Gates
Foundation or governmental agencies like the NIH. These dates are based on our results, which have
been encouraging so far.
We will enter into negotiations with potential pharmaceutical partners as soon as positive
intermediary results will be observed in view of a partnership agreement as described above.
Dream Vaccines Foundation
We attempted to establish Dream Vaccines Foundation as a 501(c)3) public charity in the United
States. Due to the cost and complexity of the registration process as well as to resource
limitations, this endeavor has been terminated and the entity will be liquidated.
LIQUIDITY AND CAPITAL RESOURCES
We had E1,811,000 cash at December 31, 2010, compared to E2,959,000 at December 31, 2009.
As a development stage company, we have not generated significant material revenues since the
current line of business was commenced in 2001, and we do not anticipate generating significant
material revenues on a sustained basis unless and until a major licensing agreement or other
commercial arrangement is entered into with respect to its technology.
As of December 31, 2010, we had an accumulated deficit of approximately E53.5 million and
incurred losses of E11,428,000 in the year ended December 31, 2010. This compares with losses of
E10,186,000 in the year ended December 31, 2009. These losses are principally associated with the
research and development of our HIV vaccine and RSV vaccine technologies, the acquisition of its
malaria project from Pevion Biotech Ltd. and the acquisition of Bestewil and Mymetics B.V. We
expect to continue to incur expenses in the future for research, development and activities related
to the future licensing of our technologies.
Accounts payable of E1,340,000 at December 31, 2010, decreased from E1,540,000 at December 31,
2009.
Net cash used in operating activities was E7,870,000 for the year ended December 31, 2010,
compared to E11,046,000 for the year ended December 31, 2009. The major factor in 2010 was costs
incurred in connection with our first HIV vaccine human clinical trial Phase I, which began in
December 2009.
Investing activities provided cash of E109,000 for the year ended December 31, 2010, primarily
due to proceeds from the sale of equipment. Investing activities used cash of E5,082,000 for the
year ended December 31, 2009, primarily for the acquisition of Bestewil BV.
Financing activities provided cash of E6,633,000 for the year ended December 31, 2010, which
includes new debt needed to fund 2010 operations, compared to E18,582,000 for the year ended
December 31, 2009, which includes new debt needed to fund 2009 operations and the purchase of
Bestewil.
Our major shareholder, a member of our Board of Directors and another previous investor have
made available an aggregate E27,982,000 in the form of notes payable, the details of which are
described in Note 3 of our financial statements.
The Companys budgeted cash outflow, or cash burn rate, for 2011 is approximately E10,100,000
for research and fixed and normal recurring expenses, assuming the ability to obtain the necessary
financing and without taking into account any grants that may be obtained.
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Our monthly burn rate is only relevant as regards administration expenses and amounts to
E235,000. Other expenditures related to vaccine research and development have either already been
spent during the first quarter of 2011 or will be spent in the very near future as the service
companies we contract to perform our clinical trials always require advance, generally non
refundable, payments.
2011 budget | 12 Months | |||
GMP lots production & Human Clinical Trials
Phase Ib (HIV) |
E | 3,500,000 | ||
RSV and HSV |
3,000,000 | |||
Further Virosome R&D |
800,000 | |||
Administration |
2,800,000 | |||
Total |
E | 10,100,000 | ||
Management expects the cash outflow on R&D to increase but this should be compensated by
administrative savings to give an overall decrease in 2011 over 2010 as we increase our research
and development activities, and proceed with current, or prepare for new, human clinical trials and
compliance duties associated with the signing of a partnership agreement with a major
pharmaceutical company.
Administration costs include E1,300,000 in gross salaries and related payroll costs for three
of the Companys executive officers, and payments under various consulting contracts.
Jacques-François Martin is our President and Chief Executive Officer. Additionally, there are
three full-time employees of Mymetics Corporation: Ronald Kempers, Chief Financial Officer and
Chief Operating Officer, Dr. Sylvain
Fleury, Ph.D., Chief Scientific Officer, and Christian Rochet, who resigned as our President and
CEO effective July 1, 2009, but is currently employed by us as Senior Advisor to the President.
In addition, our Swiss subsidiary, Mymetics S.A., has three employees on its payroll: Director
of Finance, Director of R&D and an Office Manager. Mymetics BV has one full time executive officer
(CSO) and two full-time assistants.
Included in administration costs are E400,000 of legal fees to outside corporate counsel,
E200,000 audit and review fees to the Companys independent accountants, and E220,000 in finance
and acquisition expenses.
We intend to continue to incur additional expenditures during the next 12 months for
additional research and development of our HIV, RSV and HSV vaccines. These expenditures will
relate to the continued testing of its prototype vaccines and are included in the monthly cash
outflow described above. Additional funding requirements during the next 12 months are needed to
prepare for the next clinical trial for our HIV vaccine and to prepare for a Phase I clinical trial
for our RSV vaccine.
In the past, we have financed our research and development activities primarily through debt
and equity financings from various parties.
We anticipate that our normal operations will require approximately E10,100,000 in the year
ending December 31, 2011. We will seek to raise the required capital from equity or debt
financings, donors and/or potential partnerships with major international pharmaceutical and
biotechnology firms. However, there can be no assurance that it will be able to raise additional
capital on satisfactory terms, or at all, to finance its operations. In the event that we are not
able to obtain such additional capital, we will be required to further restrict or even cease our
operations.
RECENT FINANCING ACTIVITIES
During 2010, our principal source of funds has been shareholder loans. Two short term
convertible loans with a carrying amount of E5,988,000 were converted into Mymetics common shares
at a conversion price of $0.50 per share with an exchange rate of $1.3486 per Euro. This event has
also fixed the conversion price at $0.50 per share for the Norwood convertible loan and the Norwood
option (see note 7).
During 2010, Round Enterprises provided three loans to the Company for a total of E4,400,000.
The first loan was issued on July 1, 2010 for a total amount of E2,200,000; the second loan was
issued on September 30, 2010 for a total amount of E1,100,000 and the third loan was issued on
December 16, 2010 for a total amount of E1,100,000.
These three loans have a duration of 12 months and each carry an interest rate of 5% per
year.
On July 1 2010, Mymetics issued a warrant to Round Enterprises providing the right to buy 32
million shares of Mymetics common stock at a price of US $0.25 per share. The warrant is valid from
July 1, 2010 until June 30, 2013. This warrant has been accounted for by taking its proportional
fair value, which was calculated by the Black Scholes methodology using a hundred fourty percent
historical volatility, a three year expected term, a zero percent dividend yield and a three
percent risk free rate. This proportional fair value was accounted for as a debt discount on the
E2,200,000 loan issued on the same date and amortizing that discount over 12 months as interest
expense.
We have filed or are in the process of filing several new grant applications with European as
well as U.S. Institutions in relation to our HIV-1 and malaria vaccines.
We anticipate using our current funds and those we receive in the future both to meet our
working capital needs and for funding the ongoing vaccines pre-clinical research costs for our RSV
and HSV while preparing for further clinical trials for our HIV-AIDS vaccine.
Management does not anticipate that our existing capital resources will be sufficient to fund
our cash requirements through the next six months. We do not have enough cash presently on hand,
based upon our current levels of expenditures and anticipated needs during this period, and will
need additional funding through future collaborative arrangements, licensing arrangements, and debt
and equity financings under Regulation D and Regulation S under the Securities Act of 1933. We do
not know whether additional financing will be available on commercially acceptable terms when
needed.
If management cannot raise funds on acceptable terms when needed, we may not be able to
successfully commercialize our technologies, take advantage of future opportunities, or respond to
unanticipated requirements. If unable to secure such additional financing when needed, we will have
to curtail or suspend all or a portion of our business activities and could be required to cease
operations entirely. Further, if new equity securities are issued, our shareholders may experience
severe dilution of their ownership percentage.
The extent and timing of our future capital requirements will depend primarily upon the rate
of our progress in the research and development of our technologies, our ability to enter into a
partnership agreement with a major pharmaceutical company, and the results of our present and
future clinical trials.
To date, we have generated no material revenues from our business operations and are unable to
predict when or if we will be able to generate revenues from licensing our technology or the
amounts expected from such activities. These revenue streams may be generated by us or in
conjunction with collaborative partners or third party licensing arrangements, and may include
provisions for one-time, lump sum payments in addition to ongoing royalty payments or other revenue
sharing arrangements.
OFF-BALANCE SHEET ARRANGMENTS
None
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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not Applicable
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The consolidated financial statements and supplementary data required with respect to this
Item 8, and as identified in Item 14 of this annual report, are included in this annual report.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Under the supervision and with the participation of the Companys management, including its
Chief Executive Officer and Chief Financial Officer the Company conducted an evaluation of the
effectiveness of the Companys disclosure controls and procedures, as defined in Rule 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934 (the Exchange Act), as of the end of the
period covered by this annual report. Based on this evaluation, the Companys Chief Executive
Officer and Chief Financial Officer concluded as of December 31, 2010 that the Companys disclosure
controls and procedures were not effective such that the information required to be disclosed in
the
Companys United States Securities and Exchange Commission (the SEC) reports is recorded,
processed, summarized and reported within the time periods specified in the SEC rules and forms,
and is accumulated and communicated to the Companys management, including its Chief Executive
Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required
disclosure.
Managements Annual Report on Internal Control over Financial Reporting
Based on its evaluation under the framework in Internal Control Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway Commission, the Companys management,
with the participation of its Chief Executive Officer and Chief Financial Officer, concluded that
its internal control over financial reporting was not effective as of December 31, 2010, due to
existence of a material weakness, as described below. A material weakness is a control deficiency,
or combination of control deficiencies in internal control over financial reporting, such that
there is a reasonable possibility that a material misstatement of the annual or interim financial
statements will not be prevented or detected on a timely basis.
This annual report does not include an attestation report of the Companys registered public
accounting firm regarding internal control over financial reporting. Managements report was not
subject to attestation by our registered public accounting firm pursuant to the Dodd-Frank Wall
Street Reform and Consumer Protection Act, which permanently exempts non-accelerated filers from
complying with Section 404(b) of the Sarbanes-Oxley Act of 2002.
Attached as exhibits to this Form 10-K are certifications of Mymetics Chief Executive Officer
(CEO) and Chief Financial Officer (CFO), which are required in accordance with Rule 13a-14 of
the Securities Exchange Act of 1934, as amended (the Exchange Act). This Controls and
Procedures section includes information concerning the controls and controls evaluation referred
to in the certifications.
Material Weakness Identified
Subsequent to filing its Form 10-Q for the quarter ended September 30, 2010, the Company
determined that a reduction in the conversion price of shareholder debt and adjustments to the
terms of a stock option should have been recorded as expenses, resulting in material adjustments
that were required to appropriately account for these changes. As a result, the Company has
concluded that there is a weakness regarding the identification, evaluation, and adoption of
applicable accounting guidance in a timely manner. The Company is currently evaluating how to
effectively remediate this material weakness. In this regard, the Company continues to review its
internal controls and procedures, including its internal control over financial reporting, and
intends to make changes aimed at enhancing their effectiveness.
Changes in internal Control over Financial Reporting
With the changes of the CFO position, where Mr. Luebke was replaced by Mr. Kempers as the new
CFO, we have reviewed and adjusted our internal control procedures and authorization procedures to
reflect this change.
Inherent Limitations on Effectiveness of Controls
Our management, including the CEO and CFO, does not expect that the Disclosure Controls or our
internal control over financial reporting will prevent or detect all errors and all fraud. A
control system, no matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control systems objectives will be met. The design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Further, because of the inherent limitations in all control
systems, no evaluation of controls can provide absolute assurance that misstatements due to error
or fraud will not occur or that all control issues and instances of fraud, if any, within our
company have been detected.
These inherent limitations include the realities that judgments in decision-making can be
faulty and that breakdowns can occur because of simple error or mistake. Controls can also be
circumvented by the individual acts of some persons, by collusion of two or more people, or by
management override of the controls. The design of any system of controls is based in part on
certain assumptions about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all potential future conditions.
Projections of any evaluation of controls effectiveness to future periods are subject to risks.
Over time, controls may become inadequate because of changes in conditions of deterioration in the
degree of compliance with policies or procedures.
ITEM 9B. OTHER INFORMATION
None
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Our number of directors is established at six, divided into three classes, designated as Class
I, Class II and Class III. The term of the Class I directors will expire at the Companys 2013
annual meeting of stockholders, the term of the Class II directors will expire at the 2011 annual
meeting of stockholders, and the term of the Class III directors will expire at the 2012 annual
meeting of stockholders. A plurality of the votes of the shares of the registrants common stock
present in person or represented by proxy at the annual meeting and entitled to vote on the
election of directors are required to elect the directors. The Board members have three year terms
and in the absence of a vote at an annual meeting of stockholders, they continue for successive
three year terms until they are replaced or resign.
The following table sets forth information regarding each of our current directors and
executive officers:
EXPIRATION | ||||||||||||||||
OF TERM AS | ||||||||||||||||
NAME | CURRENT POSITION WITH THE COMPANY | AGE | A DIRECTOR | |||||||||||||
Jacques-François Martin (Class II) |
Chief Executive Officer, President
and Director (appointed July 1, 2009) |
66 | 2012 | |||||||||||||
Ernst Luebke (Class I) |
Director (appointed July 31, 2003) |
65 | 2010 | |||||||||||||
Sylvain Fleury, Ph.D. (Class III) |
Chief Scientific Officer (appointed
November 3, 2003) and Director (appointed January 11, 2006) |
47 | 2012 | |||||||||||||
Christian Rochet (appointed July 31, 2003) |
Senior Advisor to the President | 61 | 2011 | (Class II) | Director | |||||||||||
Thomas Staehelin
|
Director | 63 | 2012 | (Class II) | ||||||||||||
Ernest M. Stern
|
Director | 60 | 2010 | (Class I) | ||||||||||||
Marc Girard, DVM, D.Sc.
|
Vice Chairman Scientific Advisory Board | 74 | n/a | |||||||||||||
Ronald Kempers
|
Chief Financial Officer (appointed August 1, 2010) |
43 | n/a |
JACQUES-FRANCOIS MARTIN
Mr. Martin is the Chief Executive Officer, President and a Director of Mymetics. Mr. Martin is
also chairman and CEO of Parteurop, a biotech consulting company, and has a long history in
biotechnology and public health. Prior to joining Mymetics in July 2009, he had been president of
The Vaccine Fund, now GAVI Fund; he was CEO of Rhone-Poulenc Pharma in Hamburg, Germany before
joining Institut Mérieux as vice-president of sales and marketing in 1976. He became CEO of
Pasteur-Mérieux in 1998, where he was instrumental in the merger with Connaught Laboratories Ltd in
Toronto. From 1996 to 1999, Mr. Martin was a member of the board of the French Institut National de
la Santé et de la Recherche Médicale (INSERM). He is a past member of the GAVI Working Group and
the Strategic Advisory Council of the Bill & Melinda Gates Childrens Vaccine Programme and was a
board member of the International AIDS Vaccine Initiative (IAVI). Mr. Martin holds an MBA from the
Ecole des Hautes Etudes Commerciales, is a member of the French Academy of Technologies and an
officer in the French Order of Merit.
Key Director Qualifications: Mr. Martin has extensive vaccine industry experience to assist raising
the Companys credibility in the scientific community and to assist with introductions to strategic
partners, including large pharmaceutical companies.
ERNST LUEBKE
Mr. Luebke was Chief Financial Officer from July 31, 2003 until July 30 2010. Prior to joining
Mymetics, Mr. Luebke spent over 21 years as an independent international business consultant and
was the founder of several companies active in the medical and biotech sectors. Together with Mr.
Rochet, he became a major shareholder of Mymetics former French subsidiary Mymetics S.A. (f.k.a.
Hippocampe S.A.) in 1997, and was a director of that company between 1999 and 2001. On July 31,
2003, Mr. Luebke was elected as Director and appointed as Chief Financial Officer and Treasurer of
Mymetics. Mr. Luebke was further appointed Secretary of Mymetics on August 29, 2003. Mr. Luebke
resigned as Director on December 31, 2010.
Key Director Qualifications: Mr. Luebke has extensive international finance and biotech industry
experience to assist the Company with its financing efforts and collaborations with commercial and
public institutions in the vaccine field.
SYLVAIN FLEURY, Ph.D.
Dr. Fleury was appointed as our Chief Scientific Officer in November 2003 and as a Director on
January 11, 2006. Following a scientific audit in 1997, Dr. Fleury was the first consultant
recommending to the Swiss investors the development of the parental biotech company that became
later Mymetics Corporation. Dr. Fleury has a broad knowledge in molecular and cellular Immunology
and antigen design, with over 20 years of expertise in infectious diseases and HIV-1/AIDS field.
Researcher at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne from 1997 to 2003,
working on the immune regeneration in HIV-1 infected subjects and gene therapy. Dr. Fleury obtained
his B.Sc. in Microbiology in 1985 from the University of Montreal (Canada), his M.Sc. in Virology
in 1988 from the Institut Armand-Frappier (Laval, Canada) and his Ph.D. in Immunology in 1992 from
the Clinical Research Institute of Montreal, Canada. Dr. Fleury also worked at the Columbia
Hospital in New-York before doing his post-doc training from 1993 to 1996 at the National
Institutes of Allergy and Infectious Diseases (NIAID/NIH) in Bethesda (Maryland, USA). Consultant
for several biotechs, Dr. Fleury is a recipient of numerous awards; published in leading scientific
journals with a high impact such as Science, Cell, Nature, Nature Medicine and Circulation.
Key Director Qualifications: Dr.Fleury has extensive scientific experience in the vaccines that the
Company is developing and in the delivery system of these vaccines to maximize the effectiveness of
the vaccines.
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RONALD KEMPERS
Chief Operating Officer (since July 1, 2009) and was appointed Chief Financial Officer on
August 1 2010. Senior business leader and entrepreneur, over 15 years of international business
management, business development and finance experience with leading global corporations (Hewlett
Packard, Oracle) and medical and IT start-ups. Mr. Kempers has a M.Sc. in Business Administration
from the Erasmus University, Rotterdam School of Management and has continued further education
with various executive courses, among which at IMD, Lausanne.
CHRISTIAN ROCHET
Mr. Rochet is a Director of Mymetics and was its former Chief Executive Officer. Prior to
joining Mymetics in July 2003, he had been an independent business consultant on development and
diversification strategies for over 21
years. He became a major shareholder of Mymetics former French subsidiary Mymetics S.A.
(f.k.a. Hippocampe S.A.) in 1997, on the scientific advice of Dr. Sylvain Fleury, Ph. D., and was a
director of that company between 1999 and 2001. On July 31, 2003, Mr. Rochet was elected as
President and Director and appointed as Chief Executive Officer of the Company. Mr. Rochet resigned
as President and CEO of Mymetics effective July 1, 2009, and is currently employed by the Company
as Senior Advisor to the President.
Key Director Qualifications: Mr. Rochet has international finance and biotech industry experience
to assist the Company with its financing efforts in Europe and the United States and strategic
alliances with vaccine companies and French and Swiss educational and scientific institutions.
DR. THOMAS STAEHELIN
Dr. Staehelin is Senior Managing Partner of Fromer, Schultheiss and Staehelin, a law firm
located in Basel, Switzerland. Dr. Staehelin focuses primarily on corporate and tax law. Dr.
Staehelin has served as a member of this law firm since 1975. Dr. Staehelin also serves on the
boards of various Swiss companies and is Chairman of the Chamber of Commerce of the Basel region.
In addition, Dr. Staehelin is Managing Director of the Swiss Association of privately held Swiss
Companies and is a member of the Board of economiesuisse, The Swiss Business Federation. Dr.
Staehelin received his Ph.D. degree in Law from the University of Basel. He formerly served as a
member of the cantonal parliament of Basel.
Key Director Qualifications: Dr. Staehelin has significant international business experience,
financial expertise through his role as a lawyer and board member of many companies conducting
business on a global basis and knowledge of the Swiss legal system to assist the Company with its
Swiss subsidiaries.
ERNEST M. STERN
Ernest M. Stern was appointed as a Director in January 2008. Mr. Stern is a partner in the
law firm of Akerman Senterfitt LLP, which serves as outside U.S. counsel of Mymetics, where he
specializes in securities and corporate law, representing public companies, investment banks and
venture funds, and is the engagement partner for Mymetics. Mr. Stern received his undergraduate
degree from Bowdoin College (Phi Beta Kappa, summa cum laude), and his J.D and LL.M (Taxation)
degrees from Georgetown University Law Center (Case and Note Editor, Law and Policy in
International Business).
Key Director Qualifications: Mr. Stern has extensive international business experience and contacts
through his representation as a U.S. lawyer of many companies engaged in international business,
knowledge of state and federal laws applicable to the Company and finance knowledge.
MARC GIRARD, DVM, D. SC.
Professor Girard has been a Consultant to Mymetics since January 2004. Prior to joining
Mymetics, Professor Girard served as Director General, Fondation Merieux, in Lyon, France between
2001 and 2003. Between 1999 and 2001, Professor Girard served as Director, European Research Center
for Virology and Immunology (CERVI), Lyon, France. Professor Girard has also taught as a professor
since 1966, most recently between 1984 and 1999 at the Institut Pasteur, Paris, France where he
also served as the Head of Laboratory of Molecular Virology, Department of Virology, Institut
Pasteur, Paris between 1980 and 1999. During his career, Professor Girard has served the medical
community in a variety of capacities, including as Head, HIV Vaccine Task Force, French National
Agency for AIDS Research (ANRS), Paris between 1988 and 1998, the Chairman, Department of Virology,
Institut Pasteur, Paris between 1997 and 1999 and the Chairman, European Consortium for an HIV
Vaccine (EuroVac), Brussels between 1999 and 2002. Professor Girard received his D.V.M. (Alfort
Veterinary College) in 1960, his D. Sc. (University of Paris) in 1967 and completed a post doctoral
fellow in 1966 through studies with Prof. James Darnell, MIT, then Albert Einstein College of
Medicine and Prof. David Baltimore and Renato Dulbecco of the Salk Institute. Professor Girard is
also the published author of several articles in his field of study.
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SCIENTIFIC ADVISORY BOARD
In 2009 a ten member Scientific Advisory Board (SAB) was created, made up of eminent
intellectuals from around the world with expertise related to the Companys products as follows:
| Chairman of the Scientific Advisory Board Dr. Stanley Plotkin, Emeritus Professor Wistar Institute, University of Pennsylvania, consultant to Sanofi Pasteur, developed the rubella vaccine in 1960s; worked extensively on the development and application of other vaccines including polio, rabies, varicella, rotavirus and cytomegalovirus as well as senior roles at the Epidemic Intelligence Service, U.S. Public Health Service; Aventis Pasteur (medical and scientific director); and Sanofi Pasteur (executive advisor). | |
| Vice Chairman of the Scientific Advisory Board Dr. Marc Girard, has over 20 years of experience in the HIV-1 research field, past Director of the Mérieux Foundation and a consultant to the WHO and former Chairman of EuroVac (European Consortium for HIV vaccine). | |
| Dr. Morgane Bomsel, Cochin Institute, France | |
| Dr. Ruth Ruprecht, Harvard University, Dana Farber Cancer Institute, Boston USA | |
| Dr. Ronald H. Gray, Johns Hopkins University, Baltimore, USA | |
| Dr. Malegapuru William Makgoba, University of KwaZulu-Natal, Durban, South Africa | |
| Dr. Souleymane Mboup, Cheikh Anta DIOP University, Dakar, Sénégal | |
| Dr. Juliana McElrath, University of Washington, Seattle, USA | |
| Dr. Odile Puijalon, Pasteur Institute, Paris, France | |
| Dr. Caetano Reis e Sousa, Cancer Research UK, London, UK |
AUDIT COMMITTEE
The Companys board of directors has appointed Ernest M. Stern and Dr. Thomas Staehelin to
serve as members of its Audit Committee. The board of directors has determined that Dr. Staehelin
qualifies as our audit committee financial expert and is independent as that term is defined
under NASDAQ Rule 4200(a)(15).
CODE OF ETHICS
The registrant has adopted a Code of Ethics that applies to its executive officers, including
its chief executive officer, as well as to the entire staff of the Company. A copy of the Code of
Ethics is filed as an exhibit to Form 10-K annual report for the year ended December 31, 2010,
hereby incorporated by reference.
MEETINGS OF THE BOARD OF DIRECTORS
In 2010, our Board of Directors held ten meetings, one of which was conducted by telephone
conference call, and acted by unanimous written consent four times. All directors attended at
least 75% of the total number of Board meetings. The Board of Directors has determined that Mr.
Stern is independent within the meaning of Section 10A and Rule 10A-3 of the Exchange Act. The
Company does not have a formal policy regarding attendance by members of the board of directors at
our annual meetings of stockholders since we did not hold an annual meeting in 2010.
Shareholders may contact our Board of Directors by mail addressed to the entire board of
directors, or to one or more individual directors, at c/o Mymetics S.A., Biopole, Route de la
Corniche 4, CH-1066 Epalinges, Switzerland, Attn: Secretary. All communications directed to our
board of directors or individual directors in this manner will be relayed to the intended
recipients.
We do not have a separate nominating committee and do not believe that such a committee is
required at this time given our emphasis on research and development rather than active revenue
generating business and our limited shareholder base.
DIRECTORS FEES
Our non-executive directors became eligible for compensation of E10,000 each for their
services as directors in 2010.
SECTION 16(a) BENEFICIAL OWNERSHIP REPORTING COMPLIANCE
Section 16(a) of the Securities and Exchange Act of 1934, as amended, requires that executive
officers, directors and persons who own more than 10% of a registered class of the Companys equity
securities to file reports of ownership and changes of ownership with the SEC within specified due
dates. These persons are required by SEC regulations to furnish the Company with copies of all such
reports they file. Based solely on the review of the copies of such reports furnished, we believe
that, with respect to our fiscal year ended December 31, 2010, all of our executive officers,
directors and 10% stockholders filed all required reports under Section 16(a) in a timely manner,
except as follows: Dr Fleury due to incompatibility between the respectively Swiss and French legal
procedures with the electronic filing procedure of the SEC.
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ITEM 11. EXECUTIVE COMPENSATION
Compensation Committee Report
The Compensation Committee of the Board of Directors (the Committee) is composed of one
employee Director, Mr. Jacques-François Martin, our President and CEO, and two non-Executive
directors, Mr. Ernst M. Stern and Mr. Thomas Staehelin. The Compensation Committee does not have a
charter.
The Committee met with management to review and discuss the Compensation Discussion and
Analysis disclosures that follow. Based on such review and discussion, the Committee recommended to
the Board of Directors that the Compensation Discussion and Analysis be included in this Annual
Report on Form 10-K, and the Board has approved that recommendation.
Compensation Discussion and Analysis
The Committee is responsible for reviewing and approving the compensation paid to executive
officers of the Company, including salaries, bonuses, stock grants and stock options. Following
review and approval by the Committee, action pertaining to executive compensation for the two named
executive officers, Ronald Kempers, CFO and Sylvain Fleury, CSO for 2010 is reported to the full
Board of Directors for further consideration.
Compensation Philosophy
The Companys compensation of executive officers and its philosophy regarding executive
compensation is comprised of the following characteristics:
(i) | Competitive base salary; | ||
(ii) | Granting stock awards as a portion of the total compensation, which vest over a certain number of years; and | ||
(iii) | Granting performance-based bonuses either in cash or common stock. |
We believe our executive compensation should be designed to allow us to attract, motivate and
retain executives of a high caliber to permit us to remain competitive in our industry. We desire
to maintain for now a uniformity of base salary compensation in light of the contributions each of
the three principal executives has either made, or is expected to make, to our ability to remain in
business and achieve the level of success that we have reached in meeting scientific results,
primarily to date with the HIV-AIDS vaccine. We take into account the compensation paid at
similarly situated companies, both within and outside of our industry, when determining executive
compensation. We believe that by granting shares of our Common Stock to our executives which vest
over a certain number of years, we will be able to encourage executives to remain with us.
Additionally, individual performance of the executive is considered as a factor in determining
executive compensation, as well as the overall performance of the Company, which, since we are
pre-revenue and primarily involved in research and development, includes, but is not limited to,
fund raising and meeting our business plan milestones on time and within budget, including
successful conclusion of strategic partner agreements and achieving the regulatory approvals to
commercialize the HIV-AIDS and malaria vaccines, rather than earnings, revenue growth, cash flow
and earnings per share which would be more typical for a company generating revenues and earnings.
The Committee also uses subjective criteria it deems relevant in its reasonable discretion.
Compensation of Chief Executive Officer
Mr. Rochet joined the Company on July 31, 2003 as its Chief Executive Officer. Mr. Rochet was
paid a base salary of E96,000 in calendar year 2004, the first full year of his employment by the
Company. The Company had very little cash and Mr. Rochet deferred a significant portion of his
salary in 2004, 2005, and 2006. As a result of Mr. Rochets efforts, we were able to stay in
business and achieve important scientific goals for our HIV-AIDS vaccine that encouraged investment
in us. Mr. Rochets salary was first increased to E120,000 in 2005, then E180,000 in 2006 and
E216,000 in 2007 based upon his success in fund raising for the Company and negotiating an
agreement with Pevion Biotech Ltd. to acquire the malaria vaccine. Mr. Rochet resigned as our
President and CEO effective July 1, 2009 and became the Senior Advisor to the new President on a
full-time basis with an annual salary of E108,000. Mr. Rochet is further entitled to finders fees
of 3% on all funding amounts raised through his efforts. As of December 31, 2010, Mr. Rochets
contract can be terminated giving one month notice.
Mr. Jacques-François Martin joined us on July 1, 2009 as our President and Chief Executive
Officer for an annual compensation of E240,000.
Compensation of Chief Financial Officer
As of January 1, 2010, Mr. Luebkes annual salary was converted into CHF300,000, which is
approximately equal to his previous salary of E216,000 at the exchange rate at that time and
included also the employers share of social contributions. A contractual clause allowing for a 3%
success fee upon sale of the Company to, or licensing of technology to, a major partner has been
deleted in favor of stock options. Mr. Luebke resigned as CFO on July 30 2010 and was replaced by
Ronald Kempers the Chief Operating Officer.
Compensation of Chief Scientific Officer
Dr. Fleury was the Companys Scientific Consultant from July 31, 2003 until November 3, 2003
when he was appointed Chief Scientific Officer. Dr. Fleury was paid a base salary of E96,000 in
calendar year 2004, the first full year of his employment by the Company. The Company had very
little cash and Mr. Fleury deferred a significant portion of his salary in 2004, 2005, and 2006.
As a result of Mr. Fleurys efforts, the Company achieved important scientific goals for its
HIV-AIDS vaccine that encouraged investment in the Company. Dr. Fleurys salary was first
increased to E120,000 in 2005, then E180,000 in 2006 and E216,000 in 2007 based upon his success in
the animal studies leading to the Companys ability to commence Phase I clinical trials for its
HIV-AIDS vaccine in addition to his role in the negotiations in concluding an agreement with Pevion
Biotech Ltd. to acquire the malaria vaccine. As of January 1, 2010, Dr Fleurys salary has been
converted into CHF300,000, which is approximately equal to his previous salary of E216,000 at the
exchange rate at that time and included also the employers share of social contributions. A
contractual clause allowing for a 3% success fee upon sale of the Company to, or licensing of
technology to, a major partner was deleted in favor of stock options.
Compensation of Chief Operating Officer
Mr. Kempers joined us on July 1, 2009 as Chief Operating Officer and was appointed Chief
Financial Officer on August 1, 2010. Mr. Kempers was paid a base salary of CHF300,000 in calendar
year 2010.
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SUMMARY COMPENSATION TABLE
The following table sets forth for the last three fiscal years information on the annual
compensation earned by our directors and officers.
Changes in | ||||||||||||||||||||||||||||||||||||
Pension Value and | ||||||||||||||||||||||||||||||||||||
Nonqualified | ||||||||||||||||||||||||||||||||||||
Non-Equity | Deferred | |||||||||||||||||||||||||||||||||||
Stock | Option | Incentive | Compensation | Total | ||||||||||||||||||||||||||||||||
Salary | Bonus | Awards | Awards | Plan | Earnings | Compensation | Annual | |||||||||||||||||||||||||||||
Name and Principal Position | Year | (E) | (E) | (E) | (E) | (E) | (E) | (E) | Compensation | |||||||||||||||||||||||||||
Christian J.-F. Rochet (PEO) |
(1a) | 2010 | E108,000 | (5) | | | | | | | E108,000 | (5) | ||||||||||||||||||||||||
2009 | E180,000 | (5) | | | | | | | E180,000 | (5) | ||||||||||||||||||||||||||
2008 | E216,000 | (5) | | | | | | | E216,000 | (5) | ||||||||||||||||||||||||||
Jacques-François Martin (PEO) |
(1b) | 2010 | E240,000 | (5) | | | | E196,427 | | | E436,427 | (5) | ||||||||||||||||||||||||
2009 | E120,000 | (5) | | | | | | | E120,000 | (5) | ||||||||||||||||||||||||||
2008 | | | | | | | | | ||||||||||||||||||||||||||||
Ernst Luebke (PFO) |
(2) | 2010 | E163,200 | (5) | | | | E 20,974 | | | E184,174 | (5) | ||||||||||||||||||||||||
2009 | E216,000 | (5) | | | | | | | E216,000 | (5) | ||||||||||||||||||||||||||
2008 | E216,000 | (5) | | | | | | | E216,000 | (5) | ||||||||||||||||||||||||||
Sylvain Fleury, Ph. D. |
(3) | 2010 | E216,000 | (5) | | | | E 29,364 | | | E245,364 | (5) | ||||||||||||||||||||||||
2009 | E216,000 | (5) | | | | | | | E216,000 | (5) | ||||||||||||||||||||||||||
2008 | E216,000 | (5) | | | | | | | E216,000 | (5) | ||||||||||||||||||||||||||
Ronald Kempers |
(4) | 2010 | E216,000 | (5) | | | | E 92,881 | | | E308,881 | (5) | ||||||||||||||||||||||||
2009 | E108,000 | (5) | | | | | | | E108,000 | (5) | ||||||||||||||||||||||||||
2008 | | | | | | | | | ||||||||||||||||||||||||||||
Thomas Staehelin, Dr. |
(6) | 2010 | E 10,000 | | | | | | | E 10,000 | (6) | |||||||||||||||||||||||||
2009 | E 10,000 | | | | | | | E 10,000 | (6) | |||||||||||||||||||||||||||
2008 | E 10,000 | | | E77,000 | | | | E 87,000 | (6) | |||||||||||||||||||||||||||
Ernie Stern |
(7) | 2010 | E 10,000 | | | | | | | E 10,000 | (7) | |||||||||||||||||||||||||
2009 | E 10,000 | | | | | | | E 10,000 | (7) | |||||||||||||||||||||||||||
2008 | E 10,000 | | | E77,000 | | | | E 87,000 | (7) |
(1a) | Mr. Rochet has been Mymetics President and Chief Executive Officer from July 31, 2003 to July 1, 2009. | |
(1b) | Mr. Martin has been Mymetics President and Chief Executive Officer from July 1, 2009. | |
(2) | Mr. Luebke has been Mymetics Chief Financial Officer and Treasurer since July 31, 2003 and our Secretary since August 29, 2003 and resigned as Chief Finanical Officer on July 30 2010. | |
(3) | Dr. Fleury has been appointed as Mymetics Chief Scientific Officer on November 3, 2003. | |
(4) | Mr.Kempers has been Mymetics Chief Operating Officer since July 1, 2009 and was appointed Chief Financial Officer on August 1 2010. | |
(5) | See below Employment Agreements. | |
(6) | Dr. Staehelin is a member of the Board of Directors and of the Audit Committee of the Company. He was elected on July 2nd, 2007 as non-executive director and eligible for annual compensation of E10,000 for attendance at the Board meetings, whether in person or by telephone, and was awarded 500,000 shares of the Corporations common stock. | |
(7) | Mr. M. Stern is a member of the Board of Directors and of the Audit Committee of the Company. He was elected on January 21st, 2008 as non-executive director and eligible for annual compensation of E10,000 for attendance at the Board meetings, whether in person or by telephone, and was awarded 500,000 shares of the Corporations common stock. |
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The tables entitled OPTION EXERCISES AND STOCK VESTED, PENSION BENEFITS, NONQUALIFIED
DEFERRED COMPENSATION and DIRECTOR COMPENSATION and the respective discussions related to those
tables have been omitted because no compensation required to be reported in those tables was
awarded to, earned by or paid to any of the named executive officers or directors in any of the
covered fiscal years.
Employment Agreements
Under the Executive Employment Agreement for Christian Rochet, he was employed as CEO for five
years commencing July 1, 2006. Mr. Rochet received an annual salary of E216,000, and was entitled
to cash bonuses of 3% of all payments to be received from industry partners of the Company. If Mr.
Rochet were terminated without cause or he terminated for good reason, he was entitled to a
lump-sum payment equal to the greater of 24 months of his salary or the remaining term of his
employment agreement. Mr. Rochet resigned as President and CEO of Mymetics effective July 1, 2009,
Mr. Rochet is currently employed by us under a Consulting Agreement as Senior Advisor to the
President (to be reviewed on monthly basis from January, 2011). Under this Consulting Agreement,
Mr. Rochet receives an annual salary of CHF 150,000, which is approximately equal to E108,000.
Christian Rochet is further entitled to finders fees of 3% on all funding amounts raised through
his efforts.
Under the Executive Employment Agreement for Ernst Luebke, he was employed as CFO for five
years commencing July 1, 2006. Mr. Luebke received an annual salary of E216,000. During the
employment period, at the discretion of the Board and the Compensation Committee and based on the
companys performance and individual achievements, The executive shall be eligible for an annual
bonus to be paid in cash, stock or stock options. Retroactive to January 1, 2010, Mr. Luebkes
salary has been converted into CHF300,000, which is approximately equal to his previous salary of
E216,000, which included also the employers share of social contributions. Mr. Luebke resigned as
Chief Financial Officer on July 30 2010.
Under the Executive Employment Agreement for Sylvain Fleury Ph.D., he is employed as CSO for
five years commencing July 1, 2006. Dr. Fleury receives an annual salary of E216,000. During the
employment period, at the discretion of the Board and the Compensation Committee and based on the
companys performance and individual achievements, The executive shall be eligible for an annual
bonus to be paid in cash, stock or stock options. If Dr. Fleury is terminated without cause or he
terminates for good reason, he is entitled to a lump-sum payment equal to the greater of 24 months
of his salary or the remaining term of his employment agreement. Retroactive to January 1, 2010,
Dr. Fleurys salary has been converted into CHF300,000, which is approximately equal to his
previous salary of E216,000, which included also the employers share of social contributions.
Under the Executive Employment Agreement for Ronald Kempers, he is employed as COO for five
years commencing July 1, 2009. Mr. Kempers receives an annual salary of CHF300,000, which is
approximately equal to E216,000 and is entitled to participate in the stock incentive plan. If Mr.
Kempers is terminated without cause or he terminates for good reason, he is entitled to a lump-sum
payment equal to the greater of 12 months of his salary or the remaining term of his employment
agreement.
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ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
The following table sets forth information about the beneficial ownership of our common stock
as of March 24, 2011, by: (a) each of our named executive officers; (b) each of our directors; (c)
each person known to the management to be the beneficial owner of more than 5% of our outstanding
voting securities; and (d) all of our current executive officers and directors as a group. The
following is based solely on statements and reports filed with the Securities and Exchange
Commission or other information we believe to be reliable.
There were 213,963,166 shares of our common stock outstanding on March 24, 2011. Beneficial
ownership has been determined in accordance with the rules of the Securities and Exchange
Commission. Except as indicated by the footnotes below, we believe, based on the information
furnished, that the persons and entities named in the tables below have sole voting and investment
power with respect to all shares of common stock that they beneficially own, subject to applicable
community property laws.
In computing the number of shares of common stock beneficially owned by a person and the
percentage ownership of that person, shares of common stock subject to options or warrants held by
that person that are currently exercisable or exercisable within 60 days of March 24, 2011, are
deemed outstanding. These shares of common stock, however, are not deemed outstanding for the
purposes of computing the percentage ownership of any other person.
NAME AND ADDRESS OF | TITLE | AMOUNT AND NATURE OF | ||||||||||
BENEFICIAL OWNER | OF CLASS | BENEFICIAL OWNERSHIP | PERCENT OF CLASS | |||||||||
Round Enterprises Ltd. St. Peter Port, Guernsey |
Common | 59,650,905 | 27.88 | % | ||||||||
Dr. Thomas Staehelin (1) Director |
Common | 12,479,907 | 5.83 | % | ||||||||
Ernst Luebke (1) Secretary and Director |
Common | 8,329,546 | (2) | 3.89 | % | |||||||
Christian Rochet (1)
Former Chief Executive Officer, and Director |
Common | 4,580,389 | (3) | 2.14 | % | |||||||
Dr. Sylvain Fleury (1)
Chief Scientific Officer, and Director |
Common | 6,500,000 | (4) | 3.04 | % | |||||||
Jacques-François Martin (1)
Chief Executive Officer, President and Director |
Common | 1,580,307 | 0.74 | % | ||||||||
Mr. Ernest M. Stern (1) Director and outside Counsel |
Common | 1,500,000 | 0.70 | % | ||||||||
Prof. Marc Girard (1)Consultant and member of the SAB |
Common | 500,000 | (5) | 0.23 | % | |||||||
Prof. Morgane Bomsel (1)Consultant and member of the SAB |
Common | 500,000 | (6) | 0.23 | % | |||||||
Mr. Ronald Kempers (1) CFO and COO |
Common | 100,000 | 0.05 | % | ||||||||
All current executive officers and
directors as a group (7 persons) |
Common | 35,070,149 | 16.39 | % |
(1) | Address is Mymetics Corporation, c/o Mymetics S.A., Biopole, Route de la Corniche 4, CH-1066 Epalinges (Switzerland). | |
(2) | Of which 2,829,546 acquired prior to being elected as director and appointed as officer, 1,000,000 acquired through conversion of unpaid salary and expenses, of which 500,000 was sold in July 2010, and 5,000,000 acquired as bonus. | |
(3) | Of which 1,627,009 acquired prior to being elected as director and appointed as officer, 1,000,000 acquired through conversion of unpaid salary and expenses and 6,000,000 acquired as bonus, of which 4,046,620 was sold during year 2010. | |
(4) | Of which 500,000 issued for services, 1,000,000 acquired through conversion of unpaid salary and expenses and 5,000,000 acquired as bonus. | |
(5) | Of which 500,000 issued for services and 500,000 acquired through conversion of unpaid fees and expenses. 500,000 have been sold in 2006. | |
(6) | 500,000 issued for services rendered. |
23
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ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
During 2010, there were no transactions, and there are currently no proposed transactions, to
which we were, are or will be a party in which the amount involved exceeds $120,000 and in which
any of our directors, executive officers or holders of more than 5% of our common stock, or an
immediate family member of any of the foregoing, had or will have a direct or indirect interest.
Furthermore, it is our intention to ensure that all future transactions, including loans,
between us and our officers, directors and principal stockholders and their affiliates are on terms
no less favorable to us than those that could be obtained from unaffiliated third parties.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
The following table provides information about the fees billed to us for professional services
rendered by Peterson Sullivan LLP during fiscal years 2010 and 2009:
2010 | 2009 | |||||||
Audit Fees |
$ | 75,839 | $ | 76,072 | ||||
Audit-Related Fees |
| | ||||||
Tax Fees |
15,905 | 13,755 | ||||||
All Other Fees |
| | ||||||
Total |
$ | 91,744 | $ | 89,827 | ||||
Audit Fees. Audit fees consist of fees for the audit of our annual financial statements or services
that are normally provided in connection with statutory and regulatory annual and quarterly filings
or engagements.
Audit-Related Fees. Audit-related fees consist of fees for assurance and related services that are
reasonably related to the performance of the audit or review of our financial statements and are
not reported as Audit Fees. During fiscal 2010 and 2009, no services were provided in this
category.
Tax Fees. Tax fees consist of fees for tax compliance services, tax advice and tax planning. During
fiscal 2010 and 2009, the services provided in this category included assistance and advice in
relation to the preparation of corporate income tax returns.
All Other Fees. Any other fees not included in Audit Fees, Audit-Related Fees or Tax Fees.
Pre-Approval Policies and Procedures.
Our audit Committee pre-approved all services to be provided by Peterson Sullivan LLP.
24
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PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a)(1)
|
Index to Financial Statements | |
Report of Independent Registered Public Accounting Firm | ||
Consolidated Balance Sheets | ||
Consolidated Statements of Operations and Comprehensive Loss | ||
Consolidated Statements of Changes in Shareholders Equity (Deficit) | ||
Consolidated Statements of Cash Flows | ||
Notes to Consolidated Financial Statements | ||
(a)(2)
|
ALL OTHER SCHEDULES HAVE BEEN OMITTED BECAUSE THEY ARE NOT APPLICABLE OR THE REQUIRED INFORMATION IS SHOWN IN THE FINANCIAL STATEMENTS OR NOTES THERETO. | |
(3)
|
List of Exhibits | |
2.1
|
Share Exchange Agreement dated December 13, 2001 between the Corporation and the stockholders of Mymetics S.A. listed on the signature page thereto (1) | |
2.2
|
Share Exchange Agreement dated December 13, 2001 between the Company and the stockholders of Mymetics S.A. listed on the signature page thereto (1) | |
2.3
|
Purchase Agreement dated October 17, 1998 between the Company and the majority stockholders of Nazca Holdings Ltd. (2) | |
2.4
|
Amendment to the Purchase Agreement dated October 17, 1998 between the Company and the majority stockholders of Nazca Holdings Ltd. (3) | |
2.5
|
Revised Purchase Agreement dated July 28, 1999 between the Company and the majority stockholders of Nazca Holdings Ltd. (4) | |
2.6
|
Share Exchange Agreement dated July 30, 2002 between the Company and the stockholders of Mymetics S.A. listed on the signature page thereto (5) | |
3(i)
|
Articles of Incorporation of the Company (as amended through May 10, 2002) (6) | |
3(ii)
|
Bylaws (7) | |
4.1
|
Form of Specimen Stock Certificate (8) | |
4.2
|
Form of letter regarding Warrant (8) | |
4.3
|
Form of Share Exchange Agreement (8) | |
9.1
|
Voting and Exchange Trust Agreement dated March 19, 2001, among the Company, 6543 Luxembourg S.A. and MFC Merchant Bank S.A. (8) |
25
Table of Contents
10.1
|
Services Agreement dated May 31, 2001, between the Company and MFC Merchant Bank, S.A.(7) | |
10.2
|
Employment Agreement dated May 3, 2001, between Pierre-Francois Serres and the Company (7) | |
10.3
|
Indemnification Agreement dated March 19, 2001, between the Company and MFC Bancorp Ltd. (7) | |
10.4
|
Agreement dated for reference May 15, 2000, between the Company and Maarten Reidel (7) | |
10.5
|
Preferred Stock Redemption and Conversion Agreement dated for reference December 21, 2000, between the Company and Sutton Park International Ltd. (10) | |
10.6
|
Preferred Stock Conversion Agreement dated for reference December 21, 2000, between the Company and Med Net International Ltd. (11) | |
10.7
|
Preferred Stock Conversion Agreement dated December 21, 2000, between the Company and Dresden Papier GmbH (11) | |
10.8
|
Assignment Agreement dated December 29, 2000, among the Company, Mymetics S.A. and MFC Merchant Bank S.A. (1) | |
10.9
|
Credit Facility Agreement dated July 27, 2000, between MFC Merchant Bank, S.A. and the Company (1) | |
10.10
|
Amended Credit Facility Agreement dated for reference August 13, 2001, between MFC Merchant Bank, S.A. and the Company (16) | |
10.11
|
Second Amended Credit Facility Agreement dated for reference February 27, 2002, between MFC Merchant Bank, S.A. and the Company (16) | |
10.12
|
Amended and Restated Credit Facility Agreement dated for reference February 28, 2003, among MFC Merchant Bank, S.A., MFC Bancorp Ltd., and the Company (16) | |
10.13
|
Guarantee dated for reference February 28, 2003, by MFC Bancorp Ltd. to MFC Merchant Bank S.A. (16) | |
10.14
|
Shareholder Agreement dated March 19, 2001, among the Company, the Holders of Class B Exchangeable Preferential Non-Voting Shares of 6543 Luxembourg S.A. signatory thereto and 6543 Luxembourg S.A.(8) | |
10.15
|
Support Agreement dated March 19, 2001, between the Company and 6543 Luxembourg S.A. (8) | |
10.16
|
1995 Qualified Incentive Stock Option Plan (12) | |
10.17
|
Amended 1994 Stock Option Plan (13) | |
10.18
|
2001 ICHOR Company Stock Option Plan (7) | |
10.19
|
Employment Agreement dated March 18, 2002, between the Company and Peter P. McCann (14) | |
10.20
|
Consulting Agreement dated August 31, 2001, between the Company and Michael K. Allio (8) | |
10.21
|
Amendment to Consulting Agreement dated August 21, 2002, between the Company and Michael K. Allio (16) | |
10.22
|
Employment Agreement dated March 18, 2002, between the Company and Dr. Joseph D. Mosca (15) | |
10.23
|
Separation Agreement and Release dated January 31, 2003, between the Company and Peter P. McCann (16) | |
10.24
|
Director and Non-Employee Stock Option Agreement dated July 19, 2001, between the Company and Robert Demers (8) | |
10.25
|
Director and Non-Employee Stock Option Agreement dated July 19, 2001, between the Company and Michael K. Allio (8) | |
10.26
|
Director and Non-Employee Stock Option Agreement dated July 19, 2001, between the Company and John M. Musacchio (8) | |
10.27
|
Director and Non-Employee Stock Option Agreement dated July 19, 2001, between the Company and Patrice Pactol (8) |
26
Table of Contents
10.28
|
Director and Non-Employee Stock Option Agreement dated July 19, 2001, between the Company and Pierre-Francois Serres (8) | |
10.29
|
Director and Non-Employee Stock Option Agreement dated July 23, 2002, between the Company and Pierre-Francois Serres (16) | |
10.30
|
Director and Non-Employee Stock Option Agreement dated July 23, 2002, between the Company and Patrice Pactol (16) | |
10.31
|
Director and Non-Employee Stock Option Agreement dated July 23, 2002, between the Company and Robert Demers (16) | |
10.32
|
Director and Non-Employee Stock Option Agreement dated July 23, 2002, between the Company and John M. Musacchio (16) | |
10.33
|
Director and Non-Employee Stock Option Agreement dated July 23, 2002, between the Company and Michael K. Allio (16) | |
10.34
|
Director and Non-Employee Stock Option Agreement dated August 21, 2002, between the Company and Michael K. Allio (16) | |
10.35
|
Director and Non-Employee Stock Option Agreement dated June 20, 2002, between the Company and Peter P. McCann (16) | |
10.36
|
Director and Non-Employee Stock Option Agreement dated July 23, 2002, between the Company and Peter P. McCann (16) | |
10.37
|
Director and Non-Employee Stock Option Agreement dated February 6, 2003, between the Company and Peter P. McCann (16) | |
10.38
|
Patent Pledge Agreement dated November __, 2002 among Mymetics S.A., Mymetics Deutschland GmbH, the Company and MFC Merchant Bank S.A. (16) | |
10.39
|
Third Amendment to the Credit Facility Agreement dated for Reference December 31, 2006, between MFC Merchant Bank, S.A. and the Company (17) | |
10.40
|
Fourth Amendment to the Credit Facility Agreement dated for Reference February 16, 2005, between MFC Merchant Bank, S.A. and the Company (17) | |
10.41
|
Consulting Agreement dated for reference January 1, 2004, between the Centre Hospitalier Universitaire Vaudois (CHUV), the Company and Dr. Sylvain Fleury, Ph.D. (18) | |
10.42
|
Consulting Agreement dated for reference January 1, 2004, between the Company and Professor Marc Girard, DVM, D.Sc. (18) | |
10.43
|
Cooperation and Option Agreement dated March 10, 2005, between the Company and Pevion A.G. (18) | |
10.44
|
Consulting Agreement dated March 23, 2005, between the Company and Northern Light International. (18) | |
10.45
|
Sixth Amended Credit Facility Agreement dated for reference December 31, 2005, between MFC Merchant Bank, S.A. and the Company (19) | |
10.46
|
Employment Agreement dated July 1, 2006, between the Company and Dr. Sylvain Fleury (20) | |
10.47
|
Employment Agreement dated July 1, 2006, between the Company and Christian Rochet (20) | |
10.48
|
Employment Agreement dated July 1, 2006, between the Company and Ernst Luebke (20) | |
10.49
|
License Agreement dated March 1, 2007, between the Company and Pevion Biotech Ltd. (21) |
27
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10.50
|
Settlement Agreement dated March 19, 2007 between Mymetics and MFC Merchant Bank S.A. (22) | |
10.51
|
Co-ownership Agreement dated January 8, 2008 between the Company, INSERM and Pevion Biotech Ltd. (23) | |
10.52
|
Co-ownership Agreement dated January 8, 2008 between the Company and INSERM (23) | |
10.53
|
Exploitation Agreement dated January 8, 2008 between the Company and INSERM (23) | |
10.54
|
Non-Executive Director Agreement dated 21 January between the Company and Mr Ernest M Stern.(24) | |
10.55
|
NGIN Material Transfer Agreement dated 11 February 2008 between the Company, Institute Cochin, Université Paris Descartes and Pevion Biotech.(25) | |
10.56
|
Acquisition & License Agreement dated 19 May 2008 between the Company and Pevion Biotech Ltd. (26) | |
10.57
|
Extension of Convertible Note Maturity Date Agreement dated 22 August 2008 between the Company, Anglo Irish Bank and Round Enterprises Ltd. (27) | |
10.58
|
Gp41 Manufacturing Technology Agreement dated 26 January 2009 between the Company and PX Therapeutics (28) | |
10.59
|
Share Purchase Agreement pursuant to which Mymetics purchased all issued and outstanding shares of capital stock of Bestewil Holding B.V. (Bestewil) from its parent, Norwood Immunology Limited (NIL), and all issued and outstanding shares of capital stock of Virosome Biologicals B.V. now held by Bestewil. (29) | |
10.60
|
Resignation of Prof Marc Girard as Head of vaccine development for reasons of personal health. (30) | |
10.61
|
Completion of Share Purchase Agreement pursuant to which Mymetics purchased all issued and outstanding shares of capital stock of Bestewil Holding B.V. and Virosome Biologicals B.V. including Unregistered Sales of Equity Securities, Financial Statements and Exhibits. (31) |
28
Table of Contents
10.62
|
Completion of Share Purchase Agreement pursuant to which Mymetics purchased all issued and outstanding shares of capital stock of Bestewil Holding B.V. and Virosome Biologicals B.V. including Unregistered Sales of equity Securities, further Financial Statements and Exhibits. (32) | |
10.63
|
Election of Jacques-François Martin as a member of the Board of Directors and Chairman of the Board, resignation of Christian Rochet as President and CEO and agreement of Jacques-François Martin to serve as President and CEO. (33) | |
10.64
|
Consulting Agreement dated September 1, 2009, between the Company and Mr. Christian Rochet. | |
10.65
|
Resignation of Ernest Luebke as Chief Finance Officer and Board member. | |
11.1
|
Statement Regarding Calculation of Per Share Earnings. | |
14.1
|
Code of Ethics. | |
21.1
|
List of Subsidiaries | |
24.1
|
Powers of Attorney (included on the signature page hereto) | |
31.1
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14 of the Securities Exchange Act of 1934 | |
31.2
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14 of the Securities Exchange Act of 1934 | |
32.1
|
Section 1350 Certification of Chief Executive Officer and Chief Financial Officer |
(1) | Incorporated by reference to the Companys Schedule 14C filed with the Securities and Exchange Commission on April 26, 2001. | |
(2) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on October 22, 1998. | |
(3) | Incorporated by reference to the Companys report on Form 8-K/A filed with the Securities and Exchange Commission on April 15, 1999. | |
(4) | Incorporated by reference to the Companys report on Form 8-K/A filed with the Securities and Exchange Commission on August 13, 1999. | |
(5) | Incorporated by reference to the Companys Amendment No. 1 to Form S-1 filed with the Securities and Exchange Commission on August 8, 2002. | |
(6) | Incorporated by reference to the Companys report on Form 10-Q for the quarter ended March 31, 2002, filed with the Securities and Exchange Commission on May 15, 2002. | |
(7) | Incorporated by reference to the Companys report on Form 10-Q for the quarter ended June 30, 2001, filed with the Securities and Exchange Commission on August 14, 2001. | |
(8) | Incorporated by reference to the Companys Registration Statement on Form S-1, File No. 333-88782, filed with the Securities and Exchange Commission on May 22, 2002. |
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(9) | Incorporated by reference to the Companys report on Form 8-K/A filed with the Securities and Exchange Commission on August 9, 2000. | |
(10) | Incorporated by reference to Schedule 13D/A filed by MFC Bancorp Ltd. with the Securities and Exchange Commission on dated January 2, 2001. | |
(11) | Incorporated by reference to the Companys report on Form 10-K for the fiscal year ended December 31, 2000, filed with the Securities and Exchange Commission on March 14, 2001. | |
(12) | Incorporate by reference to the Companys Registration Statement on Form S-8, File No. 333-15831, filed with the Securities and Exchange Commission on November 8, 1996. | |
(13) | Incorporated by reference to the Companys Registration Statement on Form S-8, File No. 333-15829, filed with the Securities and Exchange Commission on November 8, 1996. | |
(14) | Incorporated by reference to the Companys report on Form 10-K for the fiscal year ended December 31, 2004, and filed with the Securities and Exchange Commission on March 29, 2002. | |
(15) | Incorporated by reference to the Companys report on Form 10-Q for the quarter ended March 31, 2002, filed with the Securities and Exchange Commission on May 15, 2002. | |
(16) | Incorporated by reference to the Companys report on Form 10-K for the fiscal year ended December 31, 2005, and filed with the Securities and Exchange Commission on March 27, 2003. | |
(17) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on February 18, 2005. | |
(18) | Incorporated by reference to the Companys report on Form 10-K for the fiscal year ended December 31, 2004, filed with the Securities and Exchange Commission on March 30, 2005. | |
(19) | Incorporated by reference to the Companys report on Form 10-K for the fiscal year ended December 31, 2005, filed with the Securities and Exchange Commission on April 17, 2006. | |
(20) | Incorporated by reference to the Companys report on Form 10-Q for the period ended June 30, 2006, and filed with the Securities and Exchange Commission on August 21, 2006. | |
(21) | Incorporated by reference to the Companys report on Form 10-K for the fiscal year ended December 31, 2006, filed with the Securities and Exchange Commission on April 17, 2007. | |
(22) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on March 21, 2007. | |
(23) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on January 14, 2008. | |
(24) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on January 25, 2008. |
30
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(25) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on February 19, 2008. | |
(26) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on May 19, 2008. | |
(27) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on June 30, 2008. | |
(28) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on January 30, 2009. | |
(29) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on March 5, 2009. | |
(30) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on March 9, 2009. | |
(31) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on June 16, 2009. | |
(32) | Incorporated by reference to the Companys report on Form 8-K/A filed with the Securities and Exchange Commission on June 22, 2009. | |
(33) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on June 23, 2009. | |
(34) | Incorporated by reference to the Companys Statement on Form 4, filed with the Securities and Exchange Commission on July 28, 2009. | |
(35) | Incorporated by reference to the Companys Statement on Form 3 filed with the Securities and Exchange Commission on July 14, 2010. | |
(36) | Incorporated by reference to the Companys Statement on Form 3 filed with the Securities and Exchange Commission on August 9, 2010. | |
(37) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on August 10, 2010. | |
(38) | Incorporated by reference to the Companys report on Form 8-K filed with the Securities and Exchange Commission on September 13, 2010. | |
(39) | Incorporated by reference to the Companys Statement on Form 4 filed with the Securities and Exchange Commission on December 2, 2010. | |
(40) | Incorporated by reference to the Companys Statement on Form 3 filed with the Securities and Exchange Commission on December 20, 2010. | |
(c) | Financial Statements |
31
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REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders
Mymetics Corporation and Subsidiaries
Epalinges, Switzerland
Mymetics Corporation and Subsidiaries
Epalinges, Switzerland
We have audited the accompanying consolidated balance sheets of Mymetics Corporation (a development
stage company) and Subsidiaries as of December 31, 2010 and 2009, and the related consolidated
statements of operations and comprehensive loss, changes in shareholders equity (deficit), and
cash flows for the years ended December 31, 2010 and 2009, and for the period from May 2, 1990
(inception) to December 31, 2010. These financial statements are the responsibility of the
Companys management. Our responsibility is to express an opinion on these financial statements
based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. The
Company has determined that it is not required to have, nor were we engaged to perform, an audit of
its internal control over financial reporting. Our audit included consideration of internal
control over financial reporting as a basis for designing audit procedures that are appropriate in
the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the
Companys internal control over financial reporting. Accordingly, we express no such opinion. An
audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Mymetics Corporation (a development stage company) and
Subsidiaries as of December 31, 2010 and 2009, and the results of their operations and their cash
flows for the years ended December 31, 2010 and 2009, and for the period from May 2, 1990
(inception) to December 31, 2010, in conformity with accounting principles generally accepted in
the United States.
The accompanying consolidated financial statements have been prepared assuming the Company will
continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the
Company has not developed a commercially viable product and, therefore, has not been able to
generate revenue, which has resulted in significant losses. These conditions raise substantial
doubt about the Companys ability to continue as a going concern. Managements plans regarding
these matters are also described in Note 1. These consolidated financial statements do not include
any adjustments that might result from the outcome of these uncertainties.
/S/ PETERSON SULLIVAN LLP
Seattle, Washington
March 28, 2011
March 28, 2011
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Table of Contents
MYMETICS CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
December 31, 2010 and 2009
(In Thousands of Euros)
(A Development Stage Company)
CONSOLIDATED BALANCE SHEETS
December 31, 2010 and 2009
(In Thousands of Euros)
2010 | 2009 | |||||||
ASSETS |
||||||||
Current Assets |
||||||||
Cash |
E | 1,811 | E | 2,959 | ||||
Receivables officer |
13 | 6 | ||||||
Receivables other |
87 | 39 | ||||||
Prepaid expenses |
30 | 34 | ||||||
Total current assets |
1,941 | 3,038 | ||||||
Property and equipment, net of accumulated
depreciation of E212 and E100 at December 31,
2010 and 2009, respectively |
76 | 232 | ||||||
License contract, net of accumulated
amortization of E337 at December 31, 2010
and E144 at December 31, 2009 |
2,357 | 2,550 | ||||||
In-process research and development |
2,266 | 2,266 | ||||||
Goodwill |
6,671 | 6,671 | ||||||
E | 13,311 | E | 14,757 | |||||
LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT) |
||||||||
Current Liabilities |
||||||||
Accounts payable |
E | 1,340 | E | 1,540 | ||||
Taxes and social costs payable |
26 | 41 | ||||||
Current portion of notes payable
to related parties, net of unamortized debt discount of
E600 at December 31, 2010 (none at December 31, 2009) |
3,872 | 5,740 | ||||||
Total current liabilities |
5,238 | 7,321 | ||||||
Convertible notes payable to related parties,
less current portion |
23,510 | 21,722 | ||||||
Convertible notes payable other |
2,718 | 2,593 | ||||||
Acquisition-related contingent consideration |
3,212 | 1,936 | ||||||
Total liabilities |
34,678 | 33,572 | ||||||
Shareholders Equity (Deficit) |
||||||||
Common stock, U.S. $.01 par value;
495,000,000 shares authorized; issued 213,963,166
at December 31, 2010 and 196,063,630 at December 31, 2009 |
1,888 | 1,754 | ||||||
Preferred stock, U.S. $.01 par value;
5,000,000 shares authorized; none issued or outstanding |
| | ||||||
Additional paid-in capital |
29,602 | 20,840 | ||||||
Deficit accumulated during the development stage |
(53,518 | ) | (42,090 | ) | ||||
Accumulated other comprehensive income |
661 | 681 | ||||||
(21,367 | ) | (18,815 | ) | |||||
E | 13,311 | E | 14,757 | |||||
The accompanying notes are an integral part of these financial statements.
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MYMETICS CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended December 31, 2010 and 2009 and
the Period from May 2, 1990 (Inception) to December 31, 2010
(In Thousands of Euros, Except Per Share Data)
(A Development Stage Company)
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended December 31, 2010 and 2009 and
the Period from May 2, 1990 (Inception) to December 31, 2010
(In Thousands of Euros, Except Per Share Data)
Accumulated | ||||||||||||
During | ||||||||||||
Development | ||||||||||||
Stage | ||||||||||||
(May 2, 1990 to | ||||||||||||
December 31, | ||||||||||||
2010 | 2009 | 2010) | ||||||||||
Revenues |
||||||||||||
Sales |
E | 150 | E | 136 | E | 510 | ||||||
Interest |
4 | 1 | 39 | |||||||||
Gain on extinguishment of debt |
| | 774 | |||||||||
Gain on sales of equipment |
68 | | 68 | |||||||||
Government grants |
4 | 13 | 82 | |||||||||
226 | 150 | 1,473 | ||||||||||
Expenses |
||||||||||||
Research and development |
3,083 | 6,364 | 23,749 | |||||||||
General and administrative |
3,320 | 3,244 | 21,325 | |||||||||
Bank fee |
1 | 2 | 938 | |||||||||
Induced conversion cost |
807 | | 807 | |||||||||
Interest |
2,834 | 2,082 | 6,868 | |||||||||
Change in the fair value of
acquisition-related
contingent consideration |
1,276 | (1,614 | ) | (338 | ) | |||||||
Goodwill impairment |
| | 209 | |||||||||
Depreciation |
115 | 82 | 727 | |||||||||
Amortization of intangibles |
193 | 144 | 337 | |||||||||
Directors fees |
20 | 42 | 336 | |||||||||
Other |
1 | | 11 | |||||||||
11,650 | 10,346 | 54,969 | ||||||||||
Loss before income tax provision (benefit) |
(11,424 | ) | (10,196 | ) | (53,496 | ) | ||||||
Income tax (provision) benefit |
(4 | ) | 10 | (22 | ) | |||||||
Net loss |
(11,428 | ) | (10,186 | ) | (53,518 | ) | ||||||
Other comprehensive income (loss) |
||||||||||||
Foreign currency translation
adjustment |
(20 | ) | (4 | ) | 661 | |||||||
Comprehensive loss |
E | (11,448 | ) | E | (10,190 | ) | E | (52,857 | ) | |||
Basic and diluted loss per share |
E | (0.06 | ) | E | (0.05 | ) | ||||||
The accompanying notes are an integral part of these financial statements.
34
Table of Contents
MYMETICS CORPORATION AND SUBSIDIARIES
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY (DEFICIT)
For the Period from May 2, 1990 (Inception) to December 31, 2010
(In Thousands of Euros)
(A Development Stage Company)
CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS EQUITY (DEFICIT)
For the Period from May 2, 1990 (Inception) to December 31, 2010
(In Thousands of Euros)
Accumulated | ||||||||||||||||||||||||||||
Other | ||||||||||||||||||||||||||||
Deficit | Comprehensive | |||||||||||||||||||||||||||
Accumulated | Income - Foreign | |||||||||||||||||||||||||||
Additional | During the | Currency | ||||||||||||||||||||||||||
Date of | Number of | Par | Paid-in | Development | Translation | |||||||||||||||||||||||
Transaction | Shares | Value | Capital | Stage | Adjustment | Total | ||||||||||||||||||||||
Balance at May 2, 1990 |
||||||||||||||||||||||||||||
Shares issued for cash |
June 1990 | 33,311,361 | E119 | E | | E | | E | | E | 119 | |||||||||||||||||
Net losses to December 31, 1999 |
| | | (376 | ) | | (376 | ) | ||||||||||||||||||||
Balance at December 31, 1999 |
33,311,361 | 119 | | (376 | ) | | (257 | ) | ||||||||||||||||||||
Bank fee |
| | 806 | | | 806 | ||||||||||||||||||||||
Net loss for the year |
| | | (1,314 | ) | | (1,314 | ) | ||||||||||||||||||||
Balance at December 31, 2000 |
33,311,361 | 119 | 806 | (1,690 | ) | | (765 | ) | ||||||||||||||||||||
Effect on capital structure resulting
from a business combination |
March 2001 | 8,165,830 | 354 | (354 | ) | | | | ||||||||||||||||||||
Issuance of stock purchase warrants in
connection with credit facility |
March 2001 | | | 210 | | | 210 | |||||||||||||||||||||
Issuance of shares for bank fee |
March 2001 | 1,800,000 | 21 | (21 | ) | | | | ||||||||||||||||||||
Issuance of shares for bank fee |
June 2001 | 225,144 | 3 | (3 | ) | | | | ||||||||||||||||||||
Issuance of shares for cash |
June 2001 | 1,333,333 | 15 | 2,109 | | | 2,124 | |||||||||||||||||||||
Exercise of stock purchase warrants in
repayment of debt |
June 2001 | 1,176,294 | 13 | 259 | | | 272 | |||||||||||||||||||||
Exercise of stock purchase warrants for
cash |
December 2001 | 3,250,000 | 37 | 563 | | | 600 | |||||||||||||||||||||
Net loss for the year |
| | | (1,848 | ) | | (1,848 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | 100 | 100 | ||||||||||||||||||||||
Balance at December 31, 2001 |
49,261,962 | 562 | 3,569 | (3,538 | ) | 100 | 693 | |||||||||||||||||||||
Exercise of stock options |
March 2002 | 10,000 | | 8 | | | 8 | |||||||||||||||||||||
Issuance of stock purchase warrants for
bank fee |
June 2002 | | | 63 | | | 63 | |||||||||||||||||||||
Exercise of stock purchase warrants in
repayment of debt |
July 2002 | 1,625,567 | 16 | 396 | | | 412 | |||||||||||||||||||||
Issuance of remaining shares from 2001
business combination |
August 2002 | 46,976 | 1 | (1 | ) | | | | ||||||||||||||||||||
Net loss for the year |
| | | (3,622 | ) | | (3,622 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | 97 | 97 | ||||||||||||||||||||||
Balance at December 31, 2002 |
50,944,505 | 579 | 4,035 | (7,160 | ) | 197 | (2,349 | ) | ||||||||||||||||||||
35
Table of Contents
Accumulated | ||||||||||||||||||||||||||||
Other | ||||||||||||||||||||||||||||
Deficit | Comprehensive | |||||||||||||||||||||||||||
Accumulated | Income - Foreign | |||||||||||||||||||||||||||
Additional | During the | Currency | ||||||||||||||||||||||||||
Date of | Number of | Par | Paid-in | Development | Translation | |||||||||||||||||||||||
Transaction | Shares | Value | Capital | Stage | Adjustment | Total | ||||||||||||||||||||||
Issuance of shares for services |
September 2003 | 400,000 | 4 | 29 | | | 33 | |||||||||||||||||||||
Shares retired |
October 2003 | (51 | ) | | | | | | ||||||||||||||||||||
Issuance of shares for services |
November 2003 | 1,500,000 | 12 | 100 | | | 112 | |||||||||||||||||||||
Issuance of shares for cash |
December 2003 | 1,500,000 | 12 | 113 | | | 125 | |||||||||||||||||||||
Issuance of stock purchase warrants for
financing fee |
December 2003 | | | 12 | | | 12 | |||||||||||||||||||||
Net loss for the year |
| | | (2,786 | ) | | (2,786 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | 453 | 453 | ||||||||||||||||||||||
Balance at December 31, 2003 |
54,344,454 | 607 | 4,289 | (9,946 | ) | 650 | (4,400 | ) | ||||||||||||||||||||
Issuance of shares for services |
January 2004 | 550,000 | 5 | 27 | | | 32 | |||||||||||||||||||||
Issuance of shares for cash |
January 2004 | 2,000,000 | 17 | 150 | | | 167 | |||||||||||||||||||||
Issuance of stock purchase warrants for
financing fee |
January 2004 | | | 40 | | | 40 | |||||||||||||||||||||
Issuance of shares for cash |
February 2004 | 2,500,000 | 21 | 187 | | | 208 | |||||||||||||||||||||
Issuance of stock purchase warrants for
financing fee |
February 2004 | | | 62 | | | 62 | |||||||||||||||||||||
Issuance of shares for services |
April 2004 | 120,000 | 1 | 11 | | | 12 | |||||||||||||||||||||
Issuance of shares for bank fee |
May 2004 | 500,000 | 4 | 62 | | | 66 | |||||||||||||||||||||
Issuance of shares for cash |
May 2004 | 2,000,000 | 16 | 148 | | | 164 | |||||||||||||||||||||
Issuance of shares for services |
August 2004 | 250,000 | 2 | 26 | | | 28 | |||||||||||||||||||||
Issuance of shares for cash |
August 2004 | 1,466,667 | 12 | 128 | | | 140 | |||||||||||||||||||||
Issuance of stock purchase warrants for
financing fee |
August 2004 | | | 46 | | | 46 | |||||||||||||||||||||
Issuance of shares for services |
September 2004 | 520,000 | 4 | 29 | | | 33 | |||||||||||||||||||||
Issuance of shares for cash |
September 2004 | 50,000 | | 4 | | | 4 | |||||||||||||||||||||
Issuance of shares for services |
October 2004 | 2,106,743 | 16 | 132 | | | 148 | |||||||||||||||||||||
Issuance of shares for services |
November 2004 | 2,000,000 | 15 | 177 | | | 192 | |||||||||||||||||||||
Issuance of shares for cash |
November 2004 | 40,000 | | 4 | | | 4 | |||||||||||||||||||||
Net loss for the year |
| | | (2,202 | ) | | (2,202 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | 191 | 191 | ||||||||||||||||||||||
Balance at December 31, 2004 |
68,447,864 | E | 720 | E | 5,522 | E | (12,148 | ) | E | 841 | E | (5,065 | ) | |||||||||||||||
36
Table of Contents
Accumulated | ||||||||||||||||||||||||||||
Other | ||||||||||||||||||||||||||||
Deficit | Comprehensive | |||||||||||||||||||||||||||
Accumulated | Income - Foreign | |||||||||||||||||||||||||||
Additional | During the | Currency | ||||||||||||||||||||||||||
Date of | Number of | Par | Paid-in | Development | Translation | |||||||||||||||||||||||
Transaction | Shares | Value | Capital | Stage | Adjustment | Total | ||||||||||||||||||||||
Issuance of shares for services |
January 2005 | 500,000 | 4 | 83 | | | 87 | |||||||||||||||||||||
Issuance of shares for services |
March 2005 | 200,000 | 2 | 33 | | | 35 | |||||||||||||||||||||
Issuance of shares for services |
March 2005 | 1,500,000 | 11 | 247 | | | 258 | |||||||||||||||||||||
Issuance of shares for services |
April 2005 | 60,000 | 1 | 10 | | | 11 | |||||||||||||||||||||
Issuance of shares for cash |
May 2005 | 52,000 | | 5 | | | 5 | |||||||||||||||||||||
Issuance of shares for cash |
June 2005 | 50,000 | | 3 | | | 3 | |||||||||||||||||||||
Issuance of shares for cash |
June 2005 | 50,000 | | 3 | | | 3 | |||||||||||||||||||||
Issuance of shares for cash |
June 2005 | 343,500 | 3 | 14 | | | 17 | |||||||||||||||||||||
Issuance of shares for cash |
June 2005 | 83,300 | 1 | 3 | | | 4 | |||||||||||||||||||||
Issuance of shares for cash |
June 2005 | 100,000 | 1 | 4 | | | 5 | |||||||||||||||||||||
Issuance of shares for cash |
July 2005 | 144,516 | 1 | 6 | | | 7 | |||||||||||||||||||||
Issuance of shares for cash |
July 2005 | 144,516 | 1 | 6 | | | 7 | |||||||||||||||||||||
Issuance of shares for cash |
July 2005 | 144,516 | 1 | 6 | | | 7 | |||||||||||||||||||||
Issuance of shares for cash |
August 2005 | 206,452 | 2 | 8 | | | 10 | |||||||||||||||||||||
Issuance of shares for cash |
August 2005 | 50,000 | | 2 | | | 2 | |||||||||||||||||||||
Issuance of shares for services |
September 2005 | 500,000 | 4 | 8 | | | 12 | |||||||||||||||||||||
Issuance of shares for services |
September 2005 | 500,000 | 4 | 8 | | | 12 | |||||||||||||||||||||
Issuance of shares for services |
September 2005 | 500,000 | 4 | 8 | | | 12 | |||||||||||||||||||||
Issuance of shares for services |
September 2005 | 300,000 | 3 | 5 | | | 8 | |||||||||||||||||||||
Issuance of shares for services |
September 2005 | 68,000 | 1 | 1 | | | 2 | |||||||||||||||||||||
Issuance of shares for services |
September 2005 | 173,200 | 1 | 3 | | | 4 | |||||||||||||||||||||
Issuance of shares for cash |
October 2005 | 87,459 | 1 | 2 | | | 3 | |||||||||||||||||||||
Issuance of shares for services |
October 2005 | 185,000 | 2 | 6 | | | 8 | |||||||||||||||||||||
Issuance of shares for cash |
October 2005 | 174,918 | 1 | 5 | | | 6 | |||||||||||||||||||||
Issuance of shares for cash |
October 2005 | 116,612 | 1 | 3 | | | 4 | |||||||||||||||||||||
Issuance of shares for cash |
November 2005 | 116,611 | 1 | 3 | | | 4 | |||||||||||||||||||||
Issuance of shares for cash |
November 2005 | 390,667 | 3 | 3 | | | 6 | |||||||||||||||||||||
Issuance of shares for services |
November 2005 | 20,000 | | | | | | |||||||||||||||||||||
Issuance of shares for services |
November 2005 | 20,000 | | | | | | |||||||||||||||||||||
Issuance of shares for services |
November 2005 | 20,000 | | | | | | |||||||||||||||||||||
Issuance of shares for services |
November 2005 | 500,000 | 5 | 9 | | | 14 | |||||||||||||||||||||
Issuance of shares for services |
December 2005 | 140,000 | 2 | 2 | | | 4 | |||||||||||||||||||||
Issuance of shares for cash |
December 2005 | 390,667 | 3 | 3 | | | 6 | |||||||||||||||||||||
Issuance of shares for cash |
December 2005 | 390,666 | 3 | 3 | | | 6 | |||||||||||||||||||||
Issuance of shares for cash |
December 2005 | 6,000,000 | 50 | 200 | | | 250 | |||||||||||||||||||||
Net loss for the year |
| | | (1,939 | ) | | (1,939 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | (98 | ) | (98 | ) | ||||||||||||||||||||
Balance at December 31, 2005 |
82,670,464 | 837 | 6,227 | (14,087 | ) | 743 | (6,280 | ) | ||||||||||||||||||||
37
Table of Contents
Accumulated | ||||||||||||||||||||||||||||
Other | ||||||||||||||||||||||||||||
Deficit | Comprehensive | |||||||||||||||||||||||||||
Accumulated | Income - Foreign | |||||||||||||||||||||||||||
Additional | During the | Currency | ||||||||||||||||||||||||||
Date of | Number of | Par | Paid-in | Development | Translation | |||||||||||||||||||||||
Transaction | Shares | Value | Capital | Stage | Adjustment | Total | ||||||||||||||||||||||
Issuance of shares for services |
January 2006 | 2,500,000 | 21 | 31 | | | 52 | |||||||||||||||||||||
Issuance of shares for cash |
January 2006 | 4,000,000 | 33 | 132 | | | 165 | |||||||||||||||||||||
Issuance of shares for services |
January 2006 | 100,000 | 1 | 2 | | | 3 | |||||||||||||||||||||
Issuance of shares for cash |
March 2006 | 1,500,000 | 12 | 38 | | | 50 | |||||||||||||||||||||
Issuance of shares for cash |
March 2006 | 2,500,000 | 21 | 62 | | | 83 | |||||||||||||||||||||
Issuance of shares for cash |
March 2006 | 250,000 | 2 | 6 | | | 8 | |||||||||||||||||||||
Issuance of shares for cash |
March 2006 | 1,500,000 | 12 | 38 | | | 50 | |||||||||||||||||||||
Issuance of shares for services |
April 2006 | 100,000 | 1 | 4 | | | 5 | |||||||||||||||||||||
Issuance of shares for cash |
May 2006 | 300,000 | 2 | 3 | | | 5 | |||||||||||||||||||||
Issuance of shares for cash |
May 2006 | 300,000 | 3 | 7 | | | 10 | |||||||||||||||||||||
Issuance of shares for cash |
May 2006 | 2,350,000 | 18 | 82 | | | 100 | |||||||||||||||||||||
Debt Conversion non cash |
May 2006 | 1,000,000 | 8 | 31 | | | 39 | |||||||||||||||||||||
Issuance of shares for cash |
June 2006 | 2,600,000 | 20 | 80 | | | 100 | |||||||||||||||||||||
Debt Conversion non cash |
July 2006 | 1,000,000 | 8 | 72 | | | 80 | |||||||||||||||||||||
Debt Conversion non cash |
July 2006 | 1,000,000 | 8 | 72 | | | 80 | |||||||||||||||||||||
Debt Conversion non cash |
July 2006 | 1,000,000 | 8 | 72 | | | 80 | |||||||||||||||||||||
Debt Conversion non cash |
July 2006 | 500,000 | 4 | 36 | | | 40 | |||||||||||||||||||||
Issuance of shares for services |
November 2006 | 300,000 | 2 | 4 | | | 6 | |||||||||||||||||||||
Issuance of shares for cash |
November 2006 | 1,300,000 | 10 | 90 | | | 100 | |||||||||||||||||||||
Issuance of shares for cash |
November 2006 | 1,280,000 | 10 | 90 | | | 100 | |||||||||||||||||||||
Issuance of shares for cash |
December 2006 | 1,320,000 | 10 | 90 | | | 100 | |||||||||||||||||||||
Issuance of shares for cash |
December 2006 | 1,320,000 | 10 | 90 | | | 100 | |||||||||||||||||||||
Issuance of shares for cash |
December 2006 | 330,000 | 3 | 22 | | | 25 | |||||||||||||||||||||
Net loss for the year |
| | | (1,585 | ) | | (1,585 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | 4 | 4 | ||||||||||||||||||||||
Balance at December 31, 2006 |
111,020,464 | 1,064 | 7,381 | (15,672 | ) | 747 | (6,480 | ) | ||||||||||||||||||||
38
Table of Contents
Accumulated | ||||||||||||||||||||||||||||
Other | ||||||||||||||||||||||||||||
Deficit | Comprehensive | |||||||||||||||||||||||||||
Accumulated | Income - Foreign | |||||||||||||||||||||||||||
Additional | During the | Currency | ||||||||||||||||||||||||||
Date of | Number of | Par | Paid-in | Development | Translation | |||||||||||||||||||||||
Transaction | Shares | Value | Capital | Stage | Adjustment | Total | ||||||||||||||||||||||
Issuance of shares for cash |
January 2007 | 650,000 | 5 | 45 | | | 50 | |||||||||||||||||||||
Issuance of shares for services |
January 2007 | 300,000 | 2 | 6 | | | 8 | |||||||||||||||||||||
Issuance of shares for services |
January 2007 | 200,000 | 2 | 4 | | | 6 | |||||||||||||||||||||
Issuance of shares for services |
January 2007 | 250,000 | 2 | 5 | | | 7 | |||||||||||||||||||||
Issuance of shares for services |
February 2007 | 250,000 | 2 | 5 | | | 7 | |||||||||||||||||||||
Issuance of shares for cash |
February 2007 | 1,420,000 | 11 | 99 | | | 110 | |||||||||||||||||||||
Issuance of shares for cash |
February 2007 | 325,000 | 2 | 22 | | | 24 | |||||||||||||||||||||
Issuance of shares for cash |
March 2007 | 650,000 | 5 | 45 | | | 50 | |||||||||||||||||||||
Issuance of shares for cash |
March 2007 | 8,712,000 | 115 | 875 | | | 990 | |||||||||||||||||||||
Debt Conversion non cash |
March 2007 | 12,500,000 | 94 | 2,505 | | | 2,599 | |||||||||||||||||||||
Issuance of shares for services |
April 2007 | 100,000 | 1 | 13 | | | 14 | |||||||||||||||||||||
Issuance of shares for services |
April 2007 | 200,000 | 1 | 25 | | | 26 | |||||||||||||||||||||
Issuance of shares for services |
April 2007 | 1,000,000 | 7 | 67 | | | 74 | |||||||||||||||||||||
Issuance of shares for cash |
May 2007 | 1,000,000 | 7 | 140 | | | 147 | |||||||||||||||||||||
Issuance of shares for cash |
May 2007 | 750,000 | 6 | 105 | | | 111 | |||||||||||||||||||||
Debt Cancellation non cash |
May 2007 | | | 242 | | | 242 | |||||||||||||||||||||
Debt Conversion non cash |
June 2007 | 9,469,000 | 70 | 891 | | | 961 | |||||||||||||||||||||
Issuance of shares for cash |
June 2007 | 5,393,000 | 40 | 760 | | | 800 | |||||||||||||||||||||
Issuance of shares for services |
June 2007 | 261,250 | 2 | 25 | | | 27 | |||||||||||||||||||||
Issuance of shares for services |
June 2007 | 261,250 | 2 | 25 | | | 27 | |||||||||||||||||||||
Issuance of shares for officer compensation |
June 2007 | 2,500,000 | 19 | 318 | | | 337 | |||||||||||||||||||||
Issuance of shares for officer compensation |
June 2007 | 2,500,000 | 19 | 318 | | | 337 | |||||||||||||||||||||
Issuance of shares for officer compensation |
June 2007 | 4,000,000 | 30 | 508 | | | 538 | |||||||||||||||||||||
Issuance of shares for officer compensation |
June 2007 | 1,000,000 | 7 | 127 | | | 134 | |||||||||||||||||||||
Issuance of shares for officer compensation |
June 2007 | 6,000,000 | 45 | 762 | | | 807 | |||||||||||||||||||||
Issuance of shares for services |
June 2007 | 135,000 | 1 | 12 | | | 13 | |||||||||||||||||||||
Issuance of shares for cash |
June 2007 | 2,250,000 | 17 | 12 | | | 29 | |||||||||||||||||||||
Issuance of shares for cash |
July 2007 | 5,550,000 | 42 | 1,208 | | | 1,250 | |||||||||||||||||||||
Issuance of shares for cash |
August 2007 | 933,333 | 7 | 193 | | | 200 | |||||||||||||||||||||
Issuance of shares for services |
August 2007 | 1,000,000 | 7 | 66 | | | 73 | |||||||||||||||||||||
Issuance of shares for services |
August 2007 | 1,000,000 | 7 | 66 | | | 73 | |||||||||||||||||||||
Issuance of shares for services |
August 2007 | 100,000 | 1 | 7 | | | 8 | |||||||||||||||||||||
Issuance of shares for services |
September 2007 | 300,000 | 2 | 21 | | | 23 | |||||||||||||||||||||
Issuance of shares for cash |
September 2007 | 1,666,667 | 12 | 344 | | | 356 | |||||||||||||||||||||
Cancellation of shares for collateral |
September 2007 | (2,000,000 | ) | | | | | | ||||||||||||||||||||
Issuance of shares for cash |
October 2007 | 2,350,000 | 17 | 483 | | | 500 | |||||||||||||||||||||
Issuance of shares for cash |
November 2007 | 2,966,666 | 21 | 623 | | | 644 | |||||||||||||||||||||
Issuance of shares for services |
December 2007 | 500,000 | 3 | 48 | | | 51 | |||||||||||||||||||||
Net loss for the year |
| | | (9,294 | ) | | (9,294 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | (75 | ) | (75 | ) | ||||||||||||||||||||
Balance at December 31, 2007 |
187,463,630 | 1,697 | 18,401 | (24,966 | ) | 672 | (4,196 | ) | ||||||||||||||||||||
39
Table of Contents
Accumulated | ||||||||||||||||||||||||||||
Other | ||||||||||||||||||||||||||||
Deficit | Comprehensive | |||||||||||||||||||||||||||
Accumulated | Income - Foreign | |||||||||||||||||||||||||||
Additional | During the | Currency | ||||||||||||||||||||||||||
Date of | Number of | Par | Paid-in | Development | Translation | |||||||||||||||||||||||
Transaction | Shares | Value | Capital | Stage | Adjustment | Total | ||||||||||||||||||||||
Issuance of shares for services |
January 2008 | 800,000 | 6 | 79 | | | 85 | |||||||||||||||||||||
Issuance of shares for services |
January 2008 | 200,000 | 1 | 20 | | | 21 | |||||||||||||||||||||
Issuance of shares for cash |
February 2008 | 1,000,000 | 7 | 326 | | | 333 | |||||||||||||||||||||
Issuance of shares for services |
March 2008 | 500,000 | 3 | 73 | | | 76 | |||||||||||||||||||||
Issuance of shares for services |
March 2008 | 500,000 | 3 | 73 | | | 76 | |||||||||||||||||||||
Issuance of shares for cash |
June 2008 | 300,000 | 2 | 94 | | | 96 | |||||||||||||||||||||
Issuance of shares for cash |
June 2008 | 1,300,000 | 8 | 492 | | | 500 | |||||||||||||||||||||
Issuance of shares for services |
July 2008 | 2,000,000 | 13 | 239 | | | 252 | |||||||||||||||||||||
Issuance of shares for services |
August 2008 | 250,000 | 2 | 39 | | | 41 | |||||||||||||||||||||
Issuance of shares for cash |
December 2008 | 1,000,000 | 7 | 319 | | | 326 | |||||||||||||||||||||
Net loss for the year |
| | | (6,938 | ) | | (6,938 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | 13 | 13 | ||||||||||||||||||||||
Balance at December 31, 2008 |
195,313,630 | 1,749 | 20,155 | (31,904 | ) | 685 | (9,315 | ) | ||||||||||||||||||||
Issuance of shares for services |
March 2009 | 250,000 | 2 | 36 | | | 38 | |||||||||||||||||||||
Issuance of stock options for acquisition |
April 2009 | | | 601 | | | 601 | |||||||||||||||||||||
Issuance of shares for services |
May 2009 | 250,000 | 1 | 27 | | | 28 | |||||||||||||||||||||
Issuance of shares for services |
September 2009 | 250,000 | 2 | 21 | | | 23 | |||||||||||||||||||||
Net loss for the year |
| | | (10,186 | ) | | (10,186 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | (4 | ) | (4 | ) | ||||||||||||||||||||
Balance at December 31, 2009 |
196,063,630 | 1,754 | 20,840 | (42,090 | ) | 681 | (18,815 | ) | ||||||||||||||||||||
Issuance of shares for services |
March 2010 | 200,000 | 2 | 18 | | | 20 | |||||||||||||||||||||
Issuance of warrant with debt |
July 2010 | | | 1,200 | | | 1,200 | |||||||||||||||||||||
Induced conversion cost |
September 2010 | | | 807 | | | 807 | |||||||||||||||||||||
Warrant modification cost |
September 2010 | | | 484 | | | 484 | |||||||||||||||||||||
Issuance of shares for services |
September 2010 | 1,550,000 | 12 | 147 | | | 159 | |||||||||||||||||||||
Issuance of shares on conversion of debt |
September 2010 | 16,149,536 | 120 | 5,868 | | | 5,988 | |||||||||||||||||||||
Stock compensation expense options |
| | 238 | | | 238 | ||||||||||||||||||||||
Net loss for the year |
| | | (11,428 | ) | | (11,428 | ) | ||||||||||||||||||||
Translation adjustment |
| | | | (20 | ) | (20 | ) | ||||||||||||||||||||
Balance at December 31, 2010 |
213,963,166 | E | 1,888 | E | 29,602 | E | (53,518 | ) | E | 661 | E | (21,367 | ) | |||||||||||||||
The accompanying notes are an integral part of these financial statements.
40
Table of Contents
MYMETICS CORPORATION AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2010 and 2009 and
the Period from May 2, 1990 (Inception) to December 31, 2010
(In Thousands of Euros)
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2010 and 2009 and
the Period from May 2, 1990 (Inception) to December 31, 2010
(In Thousands of Euros)
Total | ||||||||||||
Accumulated | ||||||||||||
During | ||||||||||||
Development | ||||||||||||
Stage | ||||||||||||
(May 2, 1990 to | ||||||||||||
December 31, | ||||||||||||
2010 | 2009 | 2010) | ||||||||||
Cash Flows from Operating Activities |
||||||||||||
Net loss |
E | (11,428 | ) | E | (10,186 | ) | E | (53,518 | ) | |||
Adjustments to reconcile net loss to net cash
used in operating activities |
||||||||||||
Change in the fair value of acquisition-related
contingent consideration |
1,276 | (1,614 | ) | (338 | ) | |||||||
Depreciation |
115 | 82 | 727 | |||||||||
Amortization of intangibles |
193 | 144 | 337 | |||||||||
Goodwill impairment |
| | 209 | |||||||||
Fees paid in warrants |
| | 223 | |||||||||
Gain on sales of equipment |
(68 | ) | | (68 | ) | |||||||
Gain on extinguishment of debt |
| | (774 | ) | ||||||||
Services and fees paid in common stock |
179 | 89 | 5,403 | |||||||||
Stock compensation expense-options |
238 | | 238 | |||||||||
Amortization of debt discount |
600 | | 810 | |||||||||
Induced conversion cost |
807 | | 807 | |||||||||
Warrant modification cost |
484 | | 484 | |||||||||
Changes in operating assets and liabilities,
Receivables |
(55 | ) | 1 | (30 | ) | |||||||
Accounts payable |
(200 | ) | 374 | 1,921 | ||||||||
Taxes and social costs payable |
(15 | ) | 16 | 26 | ||||||||
Other |
4 | 48 | 15 | |||||||||
Net cash used in operating activities |
(7,870 | ) | (11,046 | ) | (43,528 | ) | ||||||
Cash Flows from Investing Activities |
||||||||||||
Patents and other |
| | (393 | ) | ||||||||
Proceeds from sale of equipment |
137 | | 137 | |||||||||
Purchase of property and equipment |
(28 | ) | (140 | ) | (251 | ) | ||||||
Acquisition of subsidiary, net of cash acquired of E58 |
| (4,942 | ) | (4,942 | ) | |||||||
Cash acquired in reverse purchase |
| | 13 | |||||||||
Net cash used in investing activities |
109 | (5,082 | ) | (5,436 | ) | |||||||
Cash Flows from Financing Activities |
||||||||||||
Proceeds from the issuance of
common stock and warrants |
| | 11,630 | |||||||||
Borrowings from shareholders |
| | 972 | |||||||||
Increase in notes payable and other
short-term advances |
6,633 | 18,582 | 39,132 | |||||||||
Decrease in notes payable and other
short-term advances |
| | (1,490 | ) | ||||||||
Loan fees |
| | (130 | ) | ||||||||
Net cash provided by financing activities |
6,633 | 18,582 | 50,114 | |||||||||
Effect of foreign exchange rate on cash |
(20 | ) | (4 | ) | 661 | |||||||
Net increase (decrease) in cash |
(1,148 | ) | 2,450 | 1,811 | ||||||||
Cash, beginning of period |
2,959 | 509 | | |||||||||
Cash, end of period |
E | 1,811 | E | 2,959 | E | 1,811 | ||||||
Non-cash investing and financing activities |
||||||||||||
Issuance of warrant in conjunction with
note payable |
E | 1,200 | E | | ||||||||
Issuance of shares on conversion of notes
payable |
E | 5,988 | E | | ||||||||
The accompanying notes are an integral part of these financial statements.
41
Table of Contents
MYMETICS CORPORATION AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Note 1. The Company and Summary of Significant Accounting Policies
Basis of Presentation
The amounts in the notes are rounded to the nearest thousand except for share and per share
amounts.
Mymetics Corporation (the Company or Mymetics) was created for the purpose of engaging in
vaccine research and development. Its main research efforts have been concentrated in the
prevention and treatment of the AIDS virus and malaria. The Company has established a network which
enables it to work with education centers, research centers, pharmaceutical laboratories and
biotechnology companies. On April 1, 2009 the Company successfully closed its acquisition of
Bestewil Holding BV and Mymetics BV (previously Virosome Biologicals BV) and, as a result, has
further increased the pipeline of vaccines under development to include (i)Herpes Simplex which is
at the pre-clinical stage, (ii)influenza for elderly which is at clinical trial Phase II and is
being developed in collaboration with Solvay Pharmaceuticals (now Abbott Laboratories), and (iii)
Respiratory Syncytial Virus (RSV) which is at the pre-clinical stage.
These financial statements have been prepared treating the Company as a development stage company.
As of December 31, 2010, the Company had not performed any stage III clinical testing and a
commercially viable product is not expected for several more years. As such, the Company has not
generated significant revenue. For the purpose of these financial statements, the development stage
started May 2, 1990.
These financial statements have also been prepared assuming the Company will continue as a going
concern. The Company has experienced significant losses since inception resulting in a deficit
accumulated during the development stage of E53,518 at December 31, 2010. Deficits in operating
cash flows since inception have been financed through debt and equity funding sources. In order to
remain a going concern and continue the Companys research and development activities, management
intends to seek additional funding. Further, the Companys current liabilities exceed its current
assets by E3,297 as of December 31, 2010, and there is no assurance that cash will become available
to pay current liabilities in the near term. Management is seeking additional financing but there
can be no assurance that management will be successful in any of those efforts.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its subsidiaries.
Significant intercompany accounts and transactions have been eliminated.
Foreign Currency Translation
The Company translates non-Euro assets and liabilities of its subsidiaries at the rate of exchange
at the balance sheet date. Revenues and expenses are translated at the average rate of exchange
throughout the year. Unrealized gains or losses from these translations are reported as a separate
component of comprehensive income. Transaction gains or losses are included in general and
administrative expenses in the consolidated statements of operations. The translation adjustments
do not recognize the effect of income tax because the Company expects to reinvest the amounts
indefinitely in operations. The Companys reporting currency is the Euro because substantially all
of the Companys activities are conducted in Europe.
Cash and Cash Flow Disclosure
Cash deposits are occasionally in excess of insured amounts. No interest was paid in
2010 and 2009.
Revenue Recognition
Revenue related to the sale of products is recognized when all of the following conditions are met:
persuasive evidence of an arrangement exists, delivery has occurred, the price is fixed or
determinable, and collectability is reasonably assured.
Grant revenue is recognized when the associated costs are incurred.
Receivables
Receivables are stated at their outstanding principal balances. Management reviews the
collectability of receivables on a periodic basis and determines the appropriate amount of any
allowance. Based on this review procedure, management has determined that the allowances at
December 31, 2010 and 2009 are sufficient. The Company charges off receivables to the allowance
when management determines that a receivable is not collectible. The Company may retain a security
interest in the products sold.
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Property and Equipment
Property and equipment is recorded at cost and is depreciated over its estimated useful life on
straight-line basis from the date placed in service. Estimated useful lives are usually taken as
three years.
License Contract
The license contract was acquired as part of the acquisition of Bestewil. It is amortized over 14
years on a straight-line basis.
In-Process Research and Development
In-Process research and development (referred to as IPR&D) represents the estimated fair value
assigned to research and development projects acquired in a purchased business combination that
have not been completed at the date of acquisition and which have no alternative future use. IPR&D
assets acquired in a business combination after January 1, 2009, are capitalized as
indefinite-lived intangible assets. These assets remain indefinite-lived until the completion or
abandonment of the associated research and development efforts. During the period prior to
completion or abandonment, those acquired indefinite-lived assets are not amortized but are tested
for impairment annually, or more frequently, if events or changes in circumstances indicate that
the asset might be impaired.
Impairment of Long-Lived Assets
Long-lived assets, which include property and equipment, and the license contract, are assessed for
impairment whenever events or changes in circumstances indicate the carrying amount of the asset
may not be recoverable. The impairment testing involves comparing the carrying amount to the
forecasted undiscounted future cash flows generated by that asset. In the event the carrying value
of the assets exceeds the undiscounted future cash flows generated by that asset and the carrying
value is not considered recoverable, impairment exists. An impairment loss is measured as the
excess of the assets carrying value over its fair value, calculated using a discounted future cash
flow method. An impairment loss would be recognized in net income in the period that the impairment
occurs.
Goodwill
Goodwill, which represents the excess of purchase price over the fair value of net assets acquired,
is carried at cost. Goodwill is not amortized; rather, it is subject to a periodic assessment for
impairment by applying a fair value based test. Goodwill is assessed for impairment on an annual
basis as of April 1st of each year or more frequently if events or changes in
circumstances indicate that the asset might be impaired. The impairment model prescribes a two-step
method for determining goodwill impairment. In the first step, the Company determines the fair
value of its reporting unit using an enterprise value analysis. If the net book value of its
reporting unit exceeds the fair value, then the second step of the impairment test is performed
which requires allocation of the Companys reporting units fair value to all of its assets and
liabilities using the acquisition method prescribed under authoritative guidance for business
combinations with any residual fair value being allocated to goodwill. An impairment charge will be
recognized only when the implied fair value of the reporting units goodwill is less than its
carrying amount.
Contingent Consideration
The Company accounts for contingent consideration in a purchase business combination in accordance
with applicable guidance provided within the business combination rules. As part of the
consideration for the Bestewil acquisition, the Company is contractually obligated to pay
additional purchase price consideration upon achievement of certain commercial milestones and
future royalties. Therefore, the Company is required to update the assumptions at each reporting
period, based on new developments, and record such amounts at fair value until such consideration
is satisfied.
Research and Development
Research and development costs are expensed as incurred.
Taxes on Income
The Company accounts for income taxes under an asset and liability approach that requires the
recognition of deferred tax assets and liabilities for expected future tax consequences of events
that have been recognized in the Companys financial statements or tax returns. In estimating
future tax consequences, the Company generally considers all expected future events other than
enactments of changes in the tax laws or rates.
The Company reports a liability, if any, for unrecognized tax benefits resulting from uncertain
income tax positions taken or expected to be taken in an income tax return. Estimated interest and
penalties, if any, are recorded as a component of interest expense and other expense, respectively.
The Company has not recorded any liabilities for uncertain tax positions or any related interest
and penalties at December 31, 2010 or 2009. The Companys United States tax returns are open to
audit for the years ended December 31, 2007 to 2010. The returns for the Luxembourg subsidiary
LUXEMBOURG 6543 S.A., are open to audit for the year ended December 31, 2010. The returns for the
Swiss subsidiary, Mymetics S.A., are open to audit for the years ended December 31, 2007 to 2010.
The returns for the Netherlands subsidiaries, Bestewil B.V. and Mymetics B.V., are open to audit
for the year ended December 31, 2010.
43
Table of Contents
Earnings per Share
Basic earnings per share is computed by dividing net loss attributable to common shareholders by
the weighted average number of common shares outstanding in the period. The weighted average number
of shares (including shares issuable) was 202,059,230 for the year ended December 31, 2010 and
195,728,698 for the year ended December 31, 2009. Diluted earnings per share takes into
consideration common shares outstanding (computed under basic earnings per share) and potentially
dilutive securities. For the year ended December 31, 2010, the total potential number of shares
issuable of 138,634,271 includes 82,623,321 potential issuable shares related to convertible loans,
51,218,450 potential issuable shares related to warrants, and 4,792,500 potential issuable shares
related to outstanding options granted to employees. Options, warrants and convertible debt were
not included in the computation of diluted earnings per share because their effect would be
anti-dilutive due to net losses incurred. For the year ended December 31, 2009, the total potential
number of shares issuable of 87,810,109 includes potential issuable shares related to warrants,
options, and convertible loans.
Preferred Stock
The Company has authorized 5,000,000 shares of preferred stock. No shares are issued or outstanding
at December 31, 2010 or 2009. The preferred stock is issuable in several series with varying
dividend, conversion and voting rights. The specific series and rights will be determined upon any
issuance of preferred stock.
Stock-Based Compensation
Compensation cost for all share-based payments is based on the estimated grant-date fair value. The
Company amortizes stock compensation cost ratably over the requisite service period.
The issuance of common shares for services is recorded at the quoted price of the shares on the
date the services are rendered. For the years ended December 31, 2010 and 2009, 1,750,000 and
750,000 shares with a fair value of E179 and E89 respectively, were issued to individuals as fee
for services rendered.
On April 1, 2009 Mymetics issued an option to Norwood Immunology Limited (NIL) as part of its
acquisition of Bestewil Holding B.V. (Bestewil). See Note 2. Mymetics also granted stock options
to employees in 2010. See Note 5.
Estimates
The preparation of financial statements in conformity with United States generally accepted
accounting principles requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates.
Fair Value Measurements
Fair value guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs
used in measuring fair value. These tiers include:
Level 1Quoted prices in active markets for identical assets or liabilities.
Level 2Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities; quoted
prices in markets that are not active; or other inputs that are observable
or
can be corroborated by observable market data for substantially the full
term of the assets or liabilities.
Level 3Unobservable inputs that are supported by little or no market activity
and
that are significant to the fair value of the assets or liabilities.
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Table of Contents
Fair Values of Financial Instruments
The Company generally has the following financial instruments: cash, receivables, accounts payable,
taxes and social costs payable, acquisition-related contingent consideration, and notes payable.
The carrying value of cash, receivables, accounts payable, and taxes and social costs payable
approximates their fair value based on the short-term nature of these financial instruments. The
carrying value of acquisition-related contingent consideration is equal to fair value since this
liability is required to be reported at fair value. Management estimates that it is not practicable
to estimate the fair value of the notes payable due to the unique nature of these instruments.
Concentrations
The Company enters into scientific collaboration agreements with selected partners such as
Pevion Biotech Ltd., a Swiss company that granted Mymetics exclusive licenses to use their virosome
vaccine delivery technology in conjunction with the Companys AIDS and malaria preventive vaccines
under development. Under this agreement, Pevion Biotech is committed to supply the actual Virosomes
and perform their integration with the Companys antigens, which requires proprietary know-how, at
Pevions premises. The agreement includes specific mechanisms to mitigate the risk of losing a key
component of Mymetics vaccines should Pevion become unable to meet its commitment.
Recently Issued Accounting Standards
In September 2009, the FASB ratified authoritative guidance relating to revenue recognition in
multiple element arrangements, which is effective for fiscal years beginning after June 15, 2010
and may be applied retrospectively or prospectively for new or materially modified arrangements
with early adoption permitted. The guidance provides greater ability to separate and allocate
arrangement consideration in a multiple element revenue arrangement. In addition, it will require
the use of estimated selling price to allocate arrangement considerations, therefore eliminating
the use of the residual method of accounting. The Company does not believe the adoption of this
standard will have a material impact on its financial statements.
In December 2010, the FASB issued an update under Topic 350, Goodwill and Other Intangible
Assets, where testing for goodwill impairment is a two-step test. When a goodwill impairment test
is performed (either on an annual or interim basis), an entity must assess whether the carrying
amount of a reporting unit exceeds its fair value (step 1). If it does, an entity must perform an
additional test to determine whether goodwill has been impaired and to calculate the amount of this
impairment (step 2). This update is effective for the fiscal years and interim periods within those
years, beginning after December 15, 2010. The Company is in the process of determining the impact
the adoption of this standard might have on its financial statements.
Note 2. Receivables
2010 | 2009 | |||||||
Receivable officer |
E | 13 | E | 6 | ||||
Receivable other |
261 | 200 | ||||||
274 | 206 | |||||||
Allowance for doubtful accounts |
(174 | ) | (161 | ) | ||||
E | 100 | E | 45 | |||||
Note 3. Transactions with Affiliates
Mr. Ernest M. Stern, the Companys outside U.S. counsel, is both a director of the Company and a
partner in Akerman Senterfit LLP, the firm retained as legal counsel by the Company. Fees paid to
the law firm in the years ended December 31, 2010 and 2009, amounted to E111 and E105,
respectively.
Three of the Companys major shareholders have made available an aggregate E27,982 in the form of
notes payable. Conversion prices on the Euro-denominated convertible debt have been fixed to a
fixed Euro/US dollar exchange rate.
During the year ending December 31, 2010, two short term convertible loans with a carrying amount
of E5,988 were converted into Mymetics common shares at a conversion price of $0.50 per share with
an exchange rate of $1.3486 per Euro. The original conversion price of these loans was $0.80, but
in order to induce the lender to convert, the lower conversion price of $0.50 had to be accepted.
This event has also fixed the conversion price at $0.50 per share for the Norwood convertible loan
and the Norwood option (see Note 7). The advantage of this lower conversion price for the lender
has been treated in accordance with ASC Subtopic 470-20-40. The difference in the fair value of the
shares issuable based on the terms of the original conversion price and the fair value of the
shares actually issued based on the inducement terms is recorded as an expense of E807.
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Table of Contents
The details of these notes and other loans and contingent liabilities are as follows:
Fixed | ||||||||||||||||||||
Conversion | EUR/USD | |||||||||||||||||||
Lender | 1st-Issue | Principal | Duration | Interest | Price | Rate | ||||||||||||||
Price | Date | Amount | (Note) | Rate | (stated) | Conversion | ||||||||||||||
Round Enterprises Ltd. |
06/29/2010 | E | 2,200 | (5) | 5% pa | None | ||||||||||||||
Round Enterprises Ltd. |
09/30/2010 | E | 1,100 | (8) | 5% pa | None | ||||||||||||||
Round Enterprises Ltd. |
12/17/2010 | E | 1,100 | (9) | 5% pa | None | ||||||||||||||
Total Short Term
Principal Amounts |
E | 4,400 | ||||||||||||||||||
Accrued Interest |
E | 72 | ||||||||||||||||||
Total Short Term
Notes to
Related Parties |
E | 4,472 | ||||||||||||||||||
Unamortized debt
discount |
E | (600 | ) | (10) | ||||||||||||||||
Net Short Term Notes
to Related
Parties, net of
unamortized
debt discount |
E | 3,872 | ||||||||||||||||||
Eardley Holding A.G. (1) |
06/23/2006 | E | 143 | (2) | 10% pa | US$ | 0.10 | N/A | ||||||||||||
Anglo Irish Bank S.A. (3) |
10/21/2007 | E | 500 | (2) | 10% pa | US$ | 0.50 | 1.4090 | ||||||||||||
Round Enterprises Ltd. |
12/10/2007 | E | 1,500 | (2) | 10% pa | US$ | 0.50 | 1.4429 | ||||||||||||
Round Enterprises Ltd. |
01/22/2008 | E | 1,500 | (2) | 10% pa | US$ | 0.50 | 1.4629 | ||||||||||||
Round Enterprises Ltd. |
04/25/2008 | E | 2,000 | (2) | 10% pa | US$ | 0.50 | 1.5889 | ||||||||||||
Round Enterprises Ltd. |
06/30/2008 | E | 1,500 | (2) | 10% pa | US$ | 0.50 | 1.5380 | ||||||||||||
Round Enterprises Ltd. |
11/18/2008 | E | 1,200 | (2) | 10% pa | US$ | 0.50 | 1.2650 | ||||||||||||
Round Enterprises Ltd. |
02/09/2009 | E | 1,500 | (2) | 10% pa | US$ | 0.50 | 1.2940 | ||||||||||||
Round Enterprises Ltd. |
06/15/2009 | E | 5,500 | (2, 4) | 10% pa | US$ | 0.80 | 1.4045 | ||||||||||||
Eardley Holding A.G. |
06/15/2009 | E | 100 | (2, 4) | 10% pa | US$ | 0.80 | 1.4300 | ||||||||||||
Von Meyenburg |
08/03/2009 | E | 200 | (2) | 10% pa | US$ | 0.80 | 1.4400 | ||||||||||||
Round Enterprises Ltd. |
10/13/2009 | E | 2,000 | (2) | 5% pa | US$ | 0.25 | 1.4854 | ||||||||||||
Round Enterprises Ltd. |
12/18/2009 | E | 2,200 | (2) | 5% pa | US$ | 0.25 | 1.4338 | ||||||||||||
Total Long Term
Principal Amounts |
E | 19,843 | ||||||||||||||||||
Accrued Interest |
E | 3,667 | ||||||||||||||||||
Total Long Term
Convertible Notes
to Related Parties |
E | 23,510 | ||||||||||||||||||
Total Convertible Notes
to Related
Parties, net of
unamortized
debt discount |
E | 27,382 | ||||||||||||||||||
Norwood Secured Loan |
04/03/2009 | E | 2,500 | (6) | 5% pa | US$ | 0.50 | 1.2812 | ||||||||||||
Total Principal
Amount |
E | 2,500 | ||||||||||||||||||
Accrued Interest |
E | 218 | ||||||||||||||||||
Total Convertible
Note Payable other |
E | 2,718 | ||||||||||||||||||
Norwood Contingent
Liability |
E | 3,212 | (7) | |||||||||||||||||
TOTAL LOANS, NOTES,
AND CONTINGENT LIABILITY |
E | 33,312 | ||||||||||||||||||
(1) | Private investment company of Dr. Thomas Staehelin, member of the Board of Directors and of the Audit Committee of the Company. Face value is stated in U.S. dollars at $190,000. | |
(2) | The earlier of: (i) The date that the Company has sufficient revenues to repay, or (ii) upon an event of default. The loan is secured against IP assets of Mymetics Corporation. | |
(3) | Renamed Hyposwiss Private Bank Genève S.A. and acting on behalf of Round Enterprises Ltd. which is a major shareholder. | |
(4) | The loan is secured against 2/3rds of the IP assets of Bestewil Holding BV. | |
(5) | The earlier of (i) June 30, 2011 or (ii) upon an event of default. The term of the loan agreement started on July 1, 2010. | |
(6) | Under the terms of the acquisition of Bestewil B.V., as part of the consideration, the Company issued to Norwood Immunology Limited (NIL) a convertible redeemable note (the Note) in the principal amount of E2,500 with maturity 36 months after the closing date and bearing interest at 5% per annum. The note is secured against one third of Bestewil common stock. | |
(7) | Under the terms of the acquisition of Bestewil BV, as part of the consideration, the Company is committed to make further payments to NIL in the event that certain stated milestones for the development of vaccines are achieved. These have been considered on a risk probability basis. | |
(8) | The earlier of (i) September 30, 2011 or (ii) upon an event of default. | |
(9) | The earlier of (i) December 16, 2011 or (ii) upon an event of default. | |
(10) | On July 1 2010, Mymetics issued a warrant to Round Enterprises providing the right to buy 32 million shares of Mymetics common stock at a price of US $0.25 per share. The warrant is valid from July 1, 2010 until June 30, 2013. This warrant has been accounted for by taking its proportional fair value, which was calculated by the Black Scholes methodology using a hundred fourty percent historical volatility, a three year expected term, a zero percent dividend yield and a three percent risk free rate. This proportional fair value was accounted for as a debt discount on the E2,200 loan issued on the same date and amortizing that discount over 12 months as interest expense. |
Required future payments on long-term debt are as follows as of December 31, 2010:
2011 |
E | 4,472 | ||
2012 |
2,718 | |||
Contingent liability to Norwood (milestones and royalties) |
3,212 | |||
Contingent on ability to repay |
23,510 | |||
E | 33,912 | |||
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Table of Contents
Note 4. Income Taxes
The reconciliation of income tax on income computed at the federal statutory rates to income tax
expense is as follows:
2010 | 2009 | |||||||
U.S. Federal statutory rates on loss from operations |
E | (3,884 | ) | E | (3,466 | ) | ||
Effect of foreign statutory rate differences |
80 | 185 | ||||||
Effect of exchange rate changes |
(1,182 | ) | 36 | |||||
Permanent differences |
873 | (549 | ) | |||||
Increase in valuation allowance |
4,087 | 3,781 | ||||||
Other |
30 | 3 | ||||||
Income tax provision (benefit) |
E | 4 | E | (10 | ) | |||
Deferred tax asset is composed of the following:
2010 | 2009 | |||||||
Licenses capitalized for United States tax purposes |
E | 1,252 | E | 1,279 | ||||
License contract basis difference |
(801 | ) | (867 | ) | ||||
IPR&D basis difference |
(770 | ) | (770 | ) | ||||
Stock options |
81 | | ||||||
Other |
59 | 54 | ||||||
Net operating loss carry forwards |
||||||||
United States |
15,401 | 11,818 | ||||||
Switzerland |
669 | 459 | ||||||
The Netherlands |
335 | 228 | ||||||
Luxembourg |
176 | 174 | ||||||
16,462 | 12,375 | |||||||
Less valuation allowance for deferred tax asset |
(16,462 | ) | (12,375 | ) | ||||
Net deferred tax asset |
E | | E | | ||||
The Companys provision for income taxes was derived from U.S., Swiss, Netherlands and Luxembourg
operations. At December 31, 2010, the Company had estimated net operating loss carry forwards which
expire as follows (the Luxembourg losses do not expire):
United States | Luxembourg | Switzerland | The Netherlands | |||||||||||||
2011 |
E | 597 | E | | E | | E | | ||||||||
2012 |
1,093 | | | | ||||||||||||
2013 |
| | | | ||||||||||||
2014 |
| | | | ||||||||||||
2015 |
| | | | ||||||||||||
2016-2028 |
43,785 | | 2,675 | 1,341 | ||||||||||||
Perpetual |
| 801 | | | ||||||||||||
E45,475 | E | 801 | E | 2,675 | E | 1,341 | ||||||||||
Note 5. Stock Options
2001 Qualified Incentive Stock Option Plan
The Companys board of directors approved a Stock Option Plan on June 15, 2001, which provides for
the issuance of up to 5,000,000 shares of the Companys common stock to employees and non-employee
directors.
For the year ended December 31 2010, the Board of Directors of Mymetics awarded 4,350,000 incentive
stock options to the employees and officers of the Company. Incentive stock options were awarded on
June 30, 2010, for a total of 3,350,000 shares with an exercise price of USD 0.14 per share, of
which 1,850,000 vested immediately and 1,500,000 vest in equal quantities over the next three
years. As part of the employment contract with the CFO of Mymetics, 1,000,000 employee incentive
stock options were issued on July 1, 2010 with an exercise price of USD 0.19 per share, of which
250,000 vested immediately and 750,000 vest in equal quantities over the next three years. No
options were issued in the year ended December 31, 2009.
The Company recognized compensation expense related to the issued option grants of E238 and nil for
the years ended December 31, 2010 and 2009, respectively. These amounts were recognized as research
and development expense and general and administrative expense based on the specific recipient of
the award for the years ended December 31, 2010 and 2009, respectively. As of December 31, 2010, a
total of 2,250,000 shares of common stock with unrecognized compensation cost of E140 are unvested.
The cost is expected to be recognized ratably through June 2013.
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A summary of activity related to stock options under the 2001 Stock Option Plan is represented
below:
Weighted | ||||||||||||||||||||
Weighted | Average | |||||||||||||||||||
Average | Remaining | Aggregate | ||||||||||||||||||
Number of | Exercise Price | Exercise | Contractual | Intrinsic | ||||||||||||||||
Shares | Range | Price | Term (Years) | Value | ||||||||||||||||
Outstanding,
December 31, 2008 |
442,500 | $ | 0.12 to $3.50 | $ | 0.97 | |||||||||||||||
Granted |
| | | |||||||||||||||||
Forfeited |
| | | |||||||||||||||||
Outstanding,
December 31, 2009 |
442,500 | $ | 0.12 to $3.50 | $ | 0.97 | |||||||||||||||
Granted |
4,350,000 | $ | 0.14 to $0.19 | $ | 0.15 | |||||||||||||||
Forfeited |
| | | |||||||||||||||||
Outstanding,
December 31, 2010 |
4,792,500 | $ | 0.12 to $3.50 | $ | 0.23 | 8.44 | $ | 103 | ||||||||||||
Exercisable,
December 31, 2010 |
2,542,500 | $ | 0.12 to $0.19 | $ | 0.29 | 7.80 | $ | 61 | ||||||||||||
The aggregate intrinsic value of the stock options fluctuates in relation to the market price of
our common stock.
The range of exercise prices for options outstanding and options exercisable under the 2001 Stock
Option Plan at December 31, 2010 are as follows:
Number of | ||||||
shares | Exercise Price | |||||
17,500 | $ | 3.50 | ||||
50,000 | $ | 3.15 | ||||
50,000 | $ | 2.50 | ||||
100,000 | $ | 0.55 | ||||
1,000,000 | $ | 0.19 | ||||
3,425,000 | $ | 0.14 | ||||
150,000 | $ | 0.12 |
A summary of the status of the Companys nonvested options as of December 31, 2010 and changes
during the year ended December 31, 2010 are presented below:
Number of | ||||||||
Shares | Weighted Average | |||||||
Underlying | Grant Date Fair | |||||||
Nonvested options | Options | Value | ||||||
Nonvested at December 31, 2009 |
| | ||||||
Granted |
4,350,000 | $ | 0.11 | |||||
Vested |
(2,100,000 | ) | $ | 0.10 | ||||
Nonvested at December 31, 2010 |
2,250,000 | $ | 0.12 | |||||
The estimated fair value of the options on the date of grant was calculated using Black Scholes
option pricing model and the following assumptions:
Years ended December 31, | ||||
2010 | 2009 | |||
Closing market price of common stock |
$0.135 $0.16 | | ||
Estimated volatility |
140.31% 140.40% | | ||
Risk free interest rate |
3.00% | | ||
Expected dividend rate |
| | ||
Expected life |
1.5 3.9 years | |
As of December 31, 2010, the 2001 Stock Option Plan has 207,500 shares available for future grants
of stock options.
Not included in the above table are the 19,218,450 options issued as part of the acquisition of
Bestewil described in Note 7.
The Company will issue new shares upon the exercise of any options.
Note 6. Commitments and Contingencies
Total rent expense per year was E194 for 2010 and E179 for 2009. The lease of the Companys Nyon,
Switzerland facility expires in 2011; the lease of the Companys Lausanne, Switzerland facilities
expires in 2016.
Future lease payments expected on the above office leases are as follows for the years ending
December 31, 2010.
Office Rent Expected | 2011 | 2012 | 2013 | 2014 | 2015 | Thereafter | ||||||||||||||||||
NYON |
E | 3 | E | | E | | E | | E | | E | | ||||||||||||
LAUSANNE |
E | 113 | E | 137 | E | 137 | E | 137 | E | 137 | E | 34 | ||||||||||||
LEIDEN |
E | 48 | E | 48 | E | 12 | E | | E | | E | | ||||||||||||
TOTAL |
E | 164 | E | 185 | E | 149 | E | 137 | E | 137 | E | 34 |
As per an agreement signed on December 22, 2008, PX Therapeutics has granted the license rights of
the general know-how of Gp41 manufacturing technology to Mymetics for five years. During this
period, the Company pays to PX Therapeutics an annual fee of E200 until the expiration date of
December 23, 2013.
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Note 7. Acquisition of Bestewil
On April 1, 2009 Mymetics and NIL closed the acquisition of Bestewil Holding B.V. (Bestewil) from
its parent, NIL, under a Share Purchase Agreement pursuant to which Mymetics agreed to purchase all
issued and outstanding shares of capital stock (the Bestewil Shares) of Bestewil from its parent,
NIL, and all issued and outstanding shares of capital stock of Virosome Biologicals B.V. which were
held by Bestewil. Mymetics paid NIL E5,000 (the Cash Consideration)raised from bridge financing
(the Bridge Loan)and issued to NIL a convertible redeemable note (the Note) in the principal
amount of E2,500 due 36 months after the closing date, bearing interest at 5% per annum,
convertible into shares of the Companys common stock at a conversion rate of $0.50 (the
Conversion Price since September 2010) and secured by the Companys pledge of 1/3rd of the
Bestewil Shares. The reduction of the Conversion price from $0.80 to $0.50 in September 2010 did
not result in an extinguishment and reissuance of the note, nor did it result in a material
adjustment in the consolidated financial statements. In addition,
Mymetics granted NIL an option to acquire shares of Mymetics common stock equal to the result
obtained by dividing $9,609 by the Conversion Price. As part of the Share Purchase Agreement, if
Mymetics had issued shares of capital stock in connection with a financing to repay the Bridge Loan
that had more favorable financial rights and preferences than the original conversion price or
other terms, NIL had the right, at its election, to acquire those shares at the better terms. Since
the Company reduced the conversion price of the Bridge Loan to finance the acquisition from $0.80
to $0.50 in September 2010 (see note 3), the result is that the option now allows NIL to acquire
19,218,450 shares of common stock. Prior to this, the option allowed NIL to acquire 12,011,531
shares of common stock at $0.80 per share. The difference between the fair value calculation of the
option at the original exercise price of $0.80 and the now established $0.50 per share is E484 and
has been recorded as a general and administrative expense and an increase in additional paid-in
capital. The fair values were calculated with standard Black Scholes methodology using the
following assumptions:
Risk free interest rate |
0.38 | % | ||
Expected dividends |
0 | % | ||
Expected term |
1.5 | years | ||
Volatility |
131.92 | % |
Further contingent consideration to be paid under the Share Purchase Agreement includes:
| A payment of up to E2,800 in cash in the event of a license agreement being signed by April 1, 2011 with a third party to access Bestewil intellectual property and know-how in the field of Respiratory Syncytial Virus (RSV License); | ||
| A payment of up to E3,000 in cash should a third party commence a Phase III clinical trial by April 1, 2013 for Mymetics Intranasal Influenza Vaccine licensed from Bestewil; | ||
| A payment of 50% of Mymetics net royalties received from a Respiratory Syncytial Virus license (RSV license), payable in cash, maximum amount unlimited; and | ||
| A payment in cash, maximum amount unlimited, of 25% of any net amounts received by Mymetics from a third party Herpes Simplex Virus license (HSV license) based upon Bestewil intellectual property. |
Under the terms of the Share Purchase Agreement, Mymetics has entered into an employment agreement
with Antonius Stegmann, CSO of Virosome Biologicals B.V. (renamed Mymetics B.V.).
The acquisition of Bestewil has expanded Mymetics current portfolio of vaccines and vaccine
candidates.
The acquisition of Bestewil has been recorded as a business acquisition. In a business acquisition,
the purchase price of an acquired entity is allocated to the assets acquired and liabilities
assumed based on their estimated fair values at the date of acquisition.
The Company has concluded the measurement period for estimating the fair value of the purchase
consideration. The fair value of the purchase consideration for the Bestewil acquisition on April
1, 2009 was as follows:
As | Measurement | |||||||||||
Initially | Period | As | ||||||||||
Recorded | Adjustments | Adjusted | ||||||||||
Cash paid to Norwood |
E | 5,000 | E | | E | 5,000 | ||||||
Convertible note payable issued |
2,500 | | 2,500 | |||||||||
Equity options issued |
601 | | 601 | |||||||||
Contingent consideration: |
||||||||||||
Royalties for Influenza
Vaccine |
| 1,800 | 1,800 | |||||||||
Royalties for RSV |
700 | 729 | 1,429 | |||||||||
Royalties for HSV |
750 | (429 | ) | 321 | ||||||||
Total purchase consideration |
E | 9,551 | E | 2,100 | E | 11,651 | ||||||
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The range of the undiscounted amounts the Company could pay in contingent consideration is not
determinable since it is based on sales of vaccines that are yet to be developed. The fair value of
the contractual obligations to pay the contingent consideration recognized on the acquisition date
was determined based on a risk-adjusted, discounted cash flow approach. This fair value measurement
is based on significant inputs not observable in the market and thus represents a Level 3
measurement within the fair value hierarchy. The resultant cash flows were discounted using a
discount rate of 25%, which the Company believes is appropriate and is representative of a market
participant assumption.
The options to acquire 12,011,531 shares of common stock had a grant date fair value of E0.05 using
the following assumptions:
Expected volatility |
157.60 | % | ||
Risk-free interest rate |
0.65 | % | ||
Expected term in years |
1.5 | |||
Dividend yield |
0.00 | % |
The Companys fair value estimates of the purchase price consideration are assigned to the assets
acquired and liabilities assumed based on their estimated fair values as of April 1, 2009:
Purchase Price Allocation | ||||
Assets: |
||||
Current assets |
E | 90 | ||
License contract (Intranasal Influenza Vaccine) |
2,694 | |||
In-process research and development (HSV and RSV) |
2,266 | |||
Goodwill |
6,671 | |||
Property and equipment |
98 | |||
Other non-current assets |
7 | |||
Total assets |
11,826 | |||
Liabilities: |
||||
Current liabilities |
175 | |||
Total liabilities |
E | 175 | ||
Total purchase consideration |
E | 11,651 | ||
The above allocation is final. The license contract will be amortized over 14 years.
The fair value of the in-process research and development assets and license contract were
estimated using an income approach and Level 3 inputs. Under this method, an intangible assets
fair value is equal to the present value of the incremental after-tax cash flows (excess earnings)
attributable solely to the intangible asset over its remaining useful life. To calculate fair
value, the Company used risk-adjusted cash flows discounted at rates considered appropriate given
the inherent risks associated with each type of asset. The Company believes that the level and
timing of cash flows appropriately reflect market participant assumptions. Cash flows were
generally assumed to extend either through the patent life underlying each product.
The Company derived the estimated cash flows from the existing license in the case of the Solvay
contract and the projected revenues of drugs developed with in-process research and development.
The fair value of in-process research and development also includes an existing royalty payable by
the Company to Norwood based on the net sales derived from drugs that use the IPR&D technology. The
discount rate applied to the estimated cash flows for all intangible assets acquired was 25%. We
believe the discount rate used is consistent with what a market participant would use.
The E6,671 of goodwill was assigned to the vaccine development reporting unit, which is the only
reporting unit as of December 31, 2010. The goodwill recognized is attributable primarily to the
potential additional applications for the acquired patents, expected corporate synergies, the
assembled workforce of Bestewil and other factors. None of the goodwill is expected to be
deductible for income tax purposes.
Note 8. Fair Value Measurements
As of December 31, 2010, the Company held a liability for acquisition-related contingent
consideration that is required to be measured at fair value on a recurring basis.
The Companys acquisition-related contingent consideration is measured at fair value on a recurring
basis using Level 3 inputs.
The following table presents changes to the Companys acquisition-related contingent consideration
for the years ended December 31, 2010 and 2009:
Fair Value Measurements Using Significant | ||||||||
Unobservable Inputs (Level 3) | ||||||||
Acquisition-related Contingent Consideration | ||||||||
2010 | 2009 | |||||||
Balance at January 1 |
E | 1,936 | E | 3,550 | ||||
Change in fair value recorded
in earnings |
1,276 | (1,614 | ) | |||||
Balance at December 31 |
E | 3,212 | E | 1,936 | ||||
As of December 31, 2010, the fair value of the acquisition-related contingent consideration
increased from the acquisition date primarily due to timing, as cash payments get closer.
Note 9. Intangible Assets
Intangible assets consisted of the following at December 31, 2010 and December 31, 2009:
December 31, 2010 | December 31, 2009 | |||||||
Indefinite-lived intangibles: |
||||||||
In process research and development |
E | 2,266 | E | 2,266 | ||||
Definite-lived intangibles: |
||||||||
License contract |
E | 2,694 | E | 2,694 | ||||
Less accumulated amortization |
(337 | ) | (144 | ) | ||||
2,357 | 2,550 | |||||||
Other intangibles, net |
E | 4,624 | E | 4,816 | ||||
Amortization of intangibles amounting to E193 and E144 has been recorded during the years ended
December 31, 2010 and 2009, respectively. Amortization for the years 2011 through 2015 is expected
to be E192 per year.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Mymetics Corporation |
||||
By: | /s/ Jacques-François Martin | |||
Name: | Jacques-François Martin | |||
Title: | Chief Executive Officer and Director |
March 28, 2011
By: | /s/ Sylvain Fleury | |||
Name: | Sylvain Fleury, Ph.D. | |||
Title: | Chief Scientific Officer and Director |
March 28, 2011
By: | /s/ Ernest Stern | |||
Name: | Ernest Stern | |||
Title: | Director |
March 28, 2011
By: | /s/ Dr. Thomas Staehelin | |||
Name: | Thomas Staehelin | |||
Title: | Director | |||
March 28, 2011