MEI Pharma, Inc. - Quarter Report: 2009 November (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
[X]
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For
the quarterly period ended September 30, 2009
OR
[ ]
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: 000-50484
Marshall
Edwards, Inc.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
51-0407811
|
(State
or other jurisdiction of
|
(I.R.S.
Employer Identification No.)
|
incorporation
or organization)
|
140
Wicks Road, North Ryde, NSW, 2113 Australia
(Address
of principal executive offices) (Zip Code)
(011)
61 2 8877- 6196
Registrant’s
telephone number, including area code:
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by 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 x 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
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
definition of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer o
|
Non-accelerated
filer x
|
Accelerated
filer o
|
Smaller
reporting entity o
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).Yes o No x
As of
October 31, 2009 the number of shares outstanding of the issuer’s common stock,
$0.00000002 par value, was 73,463,233.
MARSHALL
EDWARDS, INC.
INDEX
PART
I
|
FINANCIAL
INFORMATION
|
Page
|
Item
1:
|
Financial
Statements (Unaudited)
|
|
Consolidated
Balance Sheets as of September 30, 2009 and June 30, 2009
|
3
|
|
Consolidated
Statements of Operations for the three months ended September 30, 2009 and
2008 and for the period from December 1, 2000 (inception) through
September 30, 2009
|
4
|
|
Consolidated
Statements of Cash Flows for the three months ended September 30, 2009 and
2008 and for the period from December 1, 2000 (inception) through
September 30, 2009
|
5
|
|
Consolidated
Statement of Stockholders’ Equity
|
6
|
|
Notes
to Consolidated Financial Statements
|
7
|
|
Item
2:
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operation
|
18
|
Item
3:
|
Quantitative
and Qualitative Disclosures about Market Risk
|
26
|
Item
4T:
|
Controls
and Procedures
|
27
|
PART
II
|
OTHER
INFORMATION
|
|
Item
6:
|
Exhibits
|
28
|
SIGNATURES
|
29
|
2
PART
I FINANCIAL INFORMATION
Item
1: Financial
Statements
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except share and per share data)
September
30,
|
June
30,
|
|||||||
2009
|
2009
|
|||||||
(unaudited)
|
||||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$ | 15,233 | $ | 19,067 | ||||
Prepaid
expenses and other current assets
|
54 | 289 | ||||||
Total current
assets
|
15,287 | 19,356 | ||||||
Total
assets
|
$ | 15,287 | $ | 19,356 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$ | 1,270 | $ | 736 | ||||
Accrued
expenses
|
930 | 3,186 | ||||||
Amount
due to related company
|
282 | 221 | ||||||
Total current
liabilities
|
2,482 | 4,143 | ||||||
Stockholders'
equity:
|
||||||||
Preferred
stock, $0.01 par value, authorized 100,000 shares,
|
||||||||
none
outstanding
|
- | - | ||||||
Common
stock, $ 0.00000002 par value, 113,000,000 authorized
|
||||||||
shares;
shares issued and outstanding: 73,463,233 at
|
||||||||
September 30,
2009 and 73,463,233 at June 30, 2009
|
- | - | ||||||
Additional
paid-in capital
|
78,124 | 78,124 | ||||||
Deficit
accumulated during development stage
|
(65,319 | ) | (62,911 | ) | ||||
Total
stockholders' equity
|
12,805 | 15,213 | ||||||
Total
liabilities and stockholders' equity
|
$ | 15,287 | $ | 19,356 |
See
accompanying notes to the consolidated financial statements.
3
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF OPERATIONS
(In
thousands, except share and per share data)
(Unaudited)
Three
Months Ended
September
30,
|
Period
from December 1,
2000
(Inception) through
September
30,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Revenues:
|
||||||||||||
Interest and
other income
|
$ | 26 | $ | 96 | $ | 2,672 | ||||||
Total
revenues
|
26 | 96 | 2,672 | |||||||||
Operating
expenses:
|
||||||||||||
Research and
development
|
(503 | ) | (2,078 | ) | (33,546 | ) | ||||||
License
fees
|
(1,500 | ) | - | (21,500 | ) | |||||||
Selling,
general and administrative
|
(431 | ) | (269 | ) | (12,938 | ) | ||||||
Total operating
expenses
|
(2,434 | ) | (2,347 | ) | (67,984 | ) | ||||||
Loss
from operations
|
(2,408 | ) | (2,251 | ) | (65,312 | ) | ||||||
Income
tax expense
|
- | (1 | ) | (7 | ) | |||||||
Net
loss arising during development stage
|
$ | (2,408 | ) | $ | (2,252 | ) | $ | (65,319 | ) | |||
Net
loss per common share:
|
||||||||||||
Basic
and diluted
|
$ | (0.03 | ) | $ | (0.03 | ) | ||||||
Weighted
average number of common shares outstanding
|
73,463,233 | 71,910,438 |
See
accompanying notes to the consolidated financial statements.
4
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(In
thousands)
(Unaudited)
Three
Months Ended
September
30,
|
Period
from December 1, 2000 (Inception) through
September
30,
|
|||||||||||
2009
|
2008
|
2009
|
||||||||||
Operating
activities
|
||||||||||||
Net
loss arising during development stage
|
$ | (2,408 | ) | $ | (2,252 | ) | $ | (65,319 | ) | |||
Adjustments to
reconcile net loss to net cash
|
||||||||||||
(used in)
provided by operating activities:
|
||||||||||||
Share
based payments
|
- | 65 | 1,732 | |||||||||
Changes
in operating assets and liabilities:
|
||||||||||||
Prepaid
expenses and other current assets
|
235 | 46 | (54 | ) | ||||||||
Accounts
payable
|
534 | (417 | ) | 1,270 | ||||||||
Accrued
expenses
|
(2,256 | ) | 20 |
930
|
||||||||
Amounts due to
related company
|
61 | (188 | ) | 282 | ||||||||
Net
cash used in operating activities
|
(3,834 | ) | (2,726 | ) | (61,159 | ) | ||||||
Financing
activities
|
||||||||||||
Net
proceeds from issuance of common stock
|
- | 9,924 | 76,392 | |||||||||
Net
cash provided by financing activities
|
- | 9,924 | 76,392 | |||||||||
Net
(decrease)/increase in cash and cash equivalents
|
(3,834 | ) | 7,198 | 15,233 | ||||||||
Cash
and cash equivalents at beginning of period
|
19,067 | 19,743 | - | |||||||||
Cash
and cash equivalents at end of period
|
$ | 15,233 | $ | 26,941 | $ | 15,233 |
See
accompanying notes to the consolidated financial statements.
5
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
CONSOLIDATED
STATEMENT OF STOCKHOLDERS’ EQUITY
(In
thousands, except share data)
(Unaudited)
Common
Stock
|
Additional
paid in capital
|
Deficit
accumulated during development stage
|
Total
|
|||||||||||||
(shares)
|
||||||||||||||||
Balance
at June 30, 2009
|
73,463,233 | $ | 78,124 | $ | (62,911 | ) | $ | 15,213 | ||||||||
Net
loss arising during development stage
|
- | - | (2,408 | ) | (2,408 | ) | ||||||||||
Comprehensive
Loss
|
(2,408 | ) | ||||||||||||||
Balance
at September 30, 2009
|
73,463,233 | $ | 78,124 | $ | (65,319 | ) | $ | 12,805 |
See
accompanying notes to the consolidated financial statements.
6
MARSHALL
EDWARDS, INC.
(A
Development Stage Company)
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
1.
Basis of Presentation and Summary of Significant Accounting
Policies
Marshall
Edwards, Inc. (“MEI”) including its wholly-owned subsidiary Marshall Edwards Pty
Ltd (“MEPL”) (together, the “Group” or the “Company”) is a development stage
company incorporated in December 2000 as a wholly-owned subsidiary of Novogen
Limited (“Novogen”). As of the date of this Quarterly Report, Novogen
owns approximately 71.3% of the outstanding shares of the Company’s common
stock.
The
Company’s financial statements have been prepared in accordance with U.S.
generally accepted accounting principles or “GAAP” for the interim financial
information and with the instructions to Form 10-Q and Article 10 of Regulation
S-X of the Securities Exchange Act of 1934 as amended. Accordingly, they do not
include all of the information and footnotes required by GAAP for complete
financial statements. We believe all adjustments (consisting only of normal
recurring adjustments) considered necessary for a fair presentation have been
included herein. Operating results for the three months ended September 30, 2009
are not necessarily indicative of the results that may be expected for the year
ending June 30, 2010 or any other future period. The balance sheet at June 30,
2009 has been derived from the audited financial statements at that date. You
should read these financial statements and notes in conjunction with the audited
financial statements for the year ended June 30, 2009 which are included in the
Company’s Annual Report on Form 10-K filed with the Securities and Exchange
Commission.
Principles
of Consolidation
The
consolidated financial statements include the accounts of MEI and its
wholly-owned subsidiary MEPL. Significant intercompany accounts and transactions
have been eliminated on consolidation.
Estimates
The
preparation of the consolidated financial statements, in conformity with
accounting principles generally accepted in the U.S., requires management to
make estimates and assumptions that affect the amounts reported in the financial
statements and the accompanying notes. Actual results could differ from those
estimates.
Revenue
Recognition
Interest
The only
revenue earned to date is interest on cash balances, which is recognized on an
accruals basis.
7
Cash
and Cash Equivalents
Cash on
hand and in banks and short-term deposits is stated at its nominal value. The
Company considers all highly liquid investments, with a maturity of three months
or less when purchased, to be cash equivalents. Highly liquid investments with
stated maturities of greater than three months are classified as short-term
investments. The Company’s cash, held in the U.S., is deposited in financial
institutions that are FDIC insured. These deposits are in excess of the FDIC
insurance limits. The Company also holds cash with Australian financial
institutions. Cash deposits held in Australian banks are guaranteed by the
Australian Government up to a maximum amount of A$1 million per
account.
Income
Taxes
Income
taxes have been provided for using the liability method. Under this method,
deferred tax assets and liabilities are recognized and measured using enacted
tax rates in effect for the year in which the differences are expected to be
recognized. Valuation allowances are established against the recorded deferred
income tax assets to the extent that management believes that it is more likely
than not that a portion of the deferred income tax assets are not realizable.
There is a full valuation allowance against net deferred tax
assets.
The
Company accounts for any uncertain tax position by using a two step approach.
Step one, recognition, requires a company to determine if the weight of
available evidence indicates that a tax position is more likely than not to be
sustained upon audit, including resolution of related appeals or litigation
processes, if any. Step two, measurement, is based on the largest amount of
benefit, which is more likely than not to be realized upon ultimate settlement.
Additionally, tax positions for which the timing of the ultimate resolution is
uncertain are recognized as long term liabilities.
The
Company’s major tax jurisdictions are the U.S. and Australia and its tax years
since inception remain subject to examination by the appropriate governmental
agencies in those jurisdictions due to its tax loss position.
Fair
Value of Financial Instruments
The
carrying amounts of the Company’s financial instruments, including cash and cash
equivalents and accounts payable, approximate fair value. Fair value has been
determined based on the fair value of identical investments in active markets.
All cash and cash equivalents are classified as level 1 as defined by the fair
value hierarchy.
Foreign
Currency Translation
The
financial statements of MEPL have been translated into U.S. dollars. Assets and
liabilities are translated into U.S. dollars using the exchange rates in effect
at the balance sheet date. Income statement amounts have been translated using
the average exchange rate for the periods. Realized gains and losses from
foreign currency transactions are reflected in the consolidated statements of
operations.
Translation
of MEPL’s financial statements into U.S. dollars does not have a material impact
on the Company’s financial position.
8
Research
and Development Expenses
Research
and development expenses relate primarily to the cost of conducting human
clinical and pre-clinical trials of the licensed cancer compounds. Research and
development costs are charged to earnings in the period incurred.
Clinical
development costs are a significant component of research and development
expenses. Estimates have been used in determining the expense liability under
certain clinical trial contracts where services have been performed but not yet
invoiced. The actual costs of those services could differ in amount and timing
from the estimates used in completing the financial statements.
At June
30, 2009 the Company had accrued $1,181,000 in relation to claims received for
clinical trial expenses in connection with the termination of enrollment into
the OVATURE Phase III clinical trial. Following negotiations the Company has
paid $649,000 during the quarter and has accrued $266,000 as at September 30,
2009 representing management’s best estimate of the final amounts payable for
claims received.
License
Fees
Costs
incurred related to the acquisition or licensing of products that have not yet
received regulatory approval to be marketed, or that are not commercially viable
and ready for use or have no alternative future use, are charged to earnings in
the period incurred.
The
license agreements with Novogen may be cancelled without penalty by MEPL by
giving three months notice. Therefore license fees due under these license
agreements are recognised as an expense when the milestone event
occurs.
Stock-Based
Compensation
The
Company’s 2008 Stock Omnibus Equity Compensation Plan provides for the grant of
options to the Company’s directors, employees, employees of the Company’s
affiliates and certain of the Company’s contractors and
consultants.
The
Company recognizes the cost of goods acquired or the expense for services
received in a share-based payment transaction when it obtains the goods or as
services are received. The Company recognizes a corresponding increase in equity
or a liability depending on the classification of the share-based instrument
granted.
Basic
and Diluted Loss Per Share
In
computing basic earnings or loss per share, the dilutive effect of stock options
and warrants are excluded, whereas for diluted earnings per share they are
included unless the effect is anti-dilutive.
Stockholders’
Equity
Ordinary
share capital is recognized at the fair value of the consideration received by
the Company. Any transaction costs arising on the issue of shares are recognized
directly in equity as a reduction in the share proceeds received.
9
Deferred
Offering Costs
Where
costs associated with a capital raising have been incurred at balance date and
it is probable that the capital raising will be successfully completed after
balance date, such costs are deferred and offset against the proceeds
subsequently received from the capital raising.
2.
Loss Per Share
The
following table sets forth the computation of basic and diluted net loss per
common share:
Three
Months Ended
September
30,
|
||||
2009
|
2008
|
|||
(In
Thousands, except share and per share data)
|
||||
Numerator
|
||||
Net
loss arising during development stage
|
(2,408)
|
(2,252)
|
||
Numerator
for diluted earnings per share
|
$ (2,408)
|
$ (2,252)
|
||
Denominator
|
||||
Denominator
for basic earnings per share:
|
||||
Weighted
average number of shares used in computing net loss per share, basic and
diluted
|
73,463,233
|
71,910,438
|
||
Dilutive
potential common shares
|
73,463,233
|
71,910,438
|
||
Basic
and diluted earnings per share
|
$ (0.03)
|
$ (0.03)
|
During
the period presented, the Company had warrants and stock options outstanding
that could potentially dilute basic earnings per share in the future, but were
excluded from the computation of diluted net loss per share as the effect would
have been anti-dilutive. Since the Company has a loss for all periods presented,
diluted and basic earnings per share are the same. The outstanding warrants and
stock options consist of the following potential common shares:
As
at September 30,
|
||||
2009
|
2008
|
|||
(Number
of warrant shares)
|
||||
Warrants
exercisable prior to July 11, 2010 at an exercise price of
$4.35
|
2,815,258
|
2,815,258
|
||
Warrants
exercisable prior to August 6, 2012 at an exercise price of
$3.60
|
2,185,598
|
2,185,598
|
||
Warrants
exercisable prior to August 6, 2012 at an exercise price of
$3.00
|
248,364
|
248,364
|
||
Warrants
exercisable prior to July 30, 2013 at an exercise price of
$2.17
|
46,083
|
46,083
|
||
Stock
options exercisable prior to January 28, 2014 at an exercise price of
$0.63
|
50,000
|
-
|
||
Common
shares issuable upon exercise of outstanding warrants
|
5,345,303
|
5,295,303
|
10
3. Expenditure
Commitments
At
September 30, 2009, the Company had contractual obligations for the conduct of
clinical trials, pre-clinical research and development and manufacturing process
development of approximately $2,178,000. Of the expenditure commitments,
clinical trial amounts are based on the assumption that all patients enrolled in
clinical trials will complete the maximum number of allowed treatment cycles.
The amounts, assuming all treatment cycles are completed, are expected to be
incurred as follows:
(In
thousands)
|
Payment
due by period
|
|||||||||||||||||||
Contractual
Obligations
|
Total
|
less
than 1 Year
|
1 -
3 Years
|
3 -
5 Years
|
More
than 5 Years
|
|||||||||||||||
Purchase
Obligations
|
$ | 2,178 | $ | 1,547 | $ | 346 | $ | 285 | $ | - | ||||||||||
Total
|
$ | 2,178 | $ | 1,547 | $ | 346 | $ | 285 | $ | - |
No
amounts have been included for future payments to Novogen which may arise in
connection with the Phenoxodiol License Agreement, the License Agreement for
Triphendiol and NV-143, the License Agreement for NV-128, the Services Agreement
or the Manufacturing License and Supply Agreement as future payments under the
terms of the agreements are subject to termination provisions. The terms of the
agreements, including future payments, are detailed in Note 5 “Related Party
Transactions.”
The
Company is not currently a party to any material legal proceedings.
The
Company’s certificate of incorporation provides that it will indemnify Novogen
in connection with certain actions brought against Novogen by any of the
Company’s stockholders or any other person.
Pursuant
to the terms of a Guarantee and Indemnity Agreement, the Company has guaranteed
the payment and performance of the obligations of MEPL to Novogen and its
subsidiaries, Novogen Laboratories Pty Limited and Novogen Research Pty Limited,
under the Phenoxodiol License Agreement, the Manufacturing License and Supply
Agreement and the Services Agreement. Novogen has guaranteed the performance of
the obligations of Novogen Research Pty Limited under the Phenoxodiol License
Agreement and the obligations of Novogen Laboratories Pty Limited under the
Manufacturing License and Supply Agreement to MEPL. Each of the Company and
Novogen’s obligations in the Guarantee and Indemnity Agreement are absolute,
unconditional and irrevocable.
11
4.
Segment Information
The
Company’s focus is the clinical development and commercialization of its
licensed cancer compounds. The business contains two major segments based on
geographic location.
Three
Months Ended
September
30, 2009
|
Three
Months Ended
September
30, 2008
|
|||||||||||||||
(In
Thousands)
|
||||||||||||||||
USA
|
Australia
|
USA
|
Australia
|
|||||||||||||
Loss
from operations
|
$ | (20 | ) | $ | (2,388 | ) | $ | (253 | ) | $ | (1,999 | ) | ||||
Segment
assets
|
11,689 | 3,598 | 20,854 | 6,166 |
5.
Related Party Transactions
License
Agreement for Phenoxodiol, as amended
In
September 2003, the Company entered into a license agreement pursuant to which
Novogen’s subsidiary, Novogen Research Pty Limited, granted to MEPL a worldwide
non-transferable license under its patents and patent applications and in its
know-how to conduct clinical trials and commercialize and distribute phenoxodiol
products (the “Phenoxodiol License Agreement”). The Phenoxodiol License
Agreement covers uses of phenoxodiol in the field of prevention, treatment or
cure of cancer in humans, delivered in all forms except topical applications.
The license is exclusive until the expiration or lapsing of the last relevant
Novogen patents or patent applications in the world and thereafter is
non-exclusive. MEPL may terminate the Phenoxodiol License Agreement by giving
three months notice to Novogen. MEPL paid $5,000,000 to Novogen in February 2004
which was the first lump sum license fee payment due under the terms of the
Phenoxodiol License Agreement. Also, MEPL paid $2,000,000 to Novogen in January
2005 and $4,000,000 in January 2006 which were the annual milestone license fee
payments due under the Phenoxodiol License Agreement. The Company paid a second
lump sum license fee of $5,000,000 to Novogen in July 2006 following the raising
of funds in a private placement or PIPE. This license fee was due on the later
of November 1, 2003 or such later date when the cumulative total of all funds
received from debt or equity issuances and revenue received from
commercialization (income other than sales) and sales of phenoxodiol products
exceeded $50,000,000. Following the PIPE capital raising which closed on July
11, 2006, the funds received from equity issuances exceeded $50,000,000 which
triggered this license fee payment. Future amounts payable to Novogen under
terms of the Phenoxodiol License Agreement are as follows:
1. Until
the expiration of the exclusivity period of the license, MEPL must pay Novogen
2.5% of all net sales and 25% of commercialization income. After the exclusivity
period of the license, 1.5% of net sales must be paid to Novogen. The
preconditions to such payments have not yet occurred.
The
“Exclusivity Period” ends on the later of:
(a)
|
the
date of expiration or lapsing of the last patent right in the patents and
patent applications set out in the Phenoxodiol License Agreement with
Novogen; or
|
12
(b)
|
the
date of expiration or lapsing of the last licensed patent right which MEPL
would, but for the license granted in the Phenoxodiol License Agreement,
infringe in any country in the geographical territory covered by the
Phenoxodiol License Agreement by doing in that country any of the things
set out in the Phenoxodiol License
Agreement.
|
2. In addition to the amounts above,
the License Agreement for Phenoxodiol was amended in June 2006 and April 2007 to
provide that upon the earliest receipt (the “Approval Date”) by MEPL of the
first:
(i)
|
approval
by the U.S. Food and Drug Administration (the “FDA”) of a New Drug
Application (“NDA”) for
phenoxodiol;
|
(ii)
|
approval
or authorization of any kind to market phenoxodiol in the United States;
or
|
(iii)
|
approval
or authorization of any kind by a government agency in any other country
to market phenoxodiol,
|
MEPL will
be required to pay Novogen Research Pty Limited $8,000,000, together with
interest on such amount from (and including) December 31, 2006 to (but
excluding) the Approval Date. Thereafter, MEPL will be required to make license
milestone fee payments of $8,000,000 to Novogen Research Pty Limited on
December 31 of the year of the Approval Date and on December 31 of
each year thereafter during the exclusivity period under the Phenoxodiol License
Agreement.
No
license fees have been accrued in respect of phenoxodiol at September 30,
2009.
License
Agreement for Triphendiol and NV-143
In May
2006, the Company entered into a second license agreement with Novogen for two
oncology compounds, triphendiol and NV-143 (the “License Agreement for
Triphendiol and NV-143”). Triphendiol is being developed initially in oral form
for the treatment of pancreatic and bile duct cancer and has completed initial
Phase I(a) human testing. NV-143 is targeted for the treatment of melanoma, also
in oral dose form, and is in the pre-clinical stage. The License Agreement for
Triphendiol and NV-143 is an agreement under which Novogen’s subsidiary, Novogen
Research Pty Limited, grants to MEPL a worldwide non-transferable license under
its patents and patent applications and in its know-how to conduct clinical
trials and commercialize and distribute triphendiol and NV-143 products. The
License Agreement for Triphendiol and NV-143 covers uses of triphendiol and
NV-143 in the field of prevention, treatment or cure of cancer in humans
delivered in all forms except topical applications. The license is exclusive
until the expiration or lapsing of the last relevant Novogen patents or patent
applications in the world and thereafter is non-exclusive. MEPL may terminate
the agreement by giving three months notice to Novogen. The Company is required
to make payments under the terms of the License Agreement for Triphendiol and
NV-143 with Novogen as follows:
1. A
lump sum license fee of $1,000,000 is payable to Novogen on the commencement
date of the license in consideration of the license granted. This initial lump
sum license fee was paid to Novogen in May 2006.
2. In
further consideration of the license granted, MEPL must pay to Novogen the
following milestone license fees upon the occurrence of the corresponding
milestone as set forth below;
13
a) the
first license product containing triphendiol to reach a milestone as set forth
below; and
b) the
first licensed product containing NV-143 to reach a milestone as set forth
below.
The
milestone license fees are:
|
i)
|
$1,000,000
on the date an Investigation New Drug Application (“IND”) for the licensed
product goes into effect or the equivalent approval of a government agency
is obtained in another country. If this event does not occur before March
31, 2008 then this amount will be due on this date. The amount of
$1,000,000 was paid to Novogen on March 31, 2008 under the terms of this
agreement;
|
|
ii)
|
$2,000,000
on the date of enrollment of the first clinical trial subject in a Phase
II clinical trial of the licensed product. If this event does not occur
before June 30, 2009, then this amount will be due on this date; The
amount of $2,000,000 was paid to Novogen on June 30, 2009 under the terms
of this agreement;
|
|
iii)
|
$3,000,000
on the date of enrollment of the first clinical trial subject in a Phase
III clinical trial of the licensed product. If this event does not occur
before December 31, 2011, then this amount will be due on this date;
and
|
|
iv)
|
$8,000,000
on the date of first receipt of a NDA for the licensed product from the
FDA or equivalent approval from a government agency in another country. If
this event does not occur before December 31, 2013, then this amount will
be due on this date.
|
3. MEPL
must pay Novogen royalties of 5.0% of all net sales and 25% of commercialization
income for the term of the license. The royalty rate is reduced by 50% if the
licensed patent rights in any country or territory expire, lapse, are revoked,
do not exist or are assigned to MEPL and the product is entirely manufactured
and supplied in such country.
4. Minimum
royalties of $3,000,000 per year are payable following the date of first receipt
of an NDA for a licensed product from the FDA (or equivalent approval from a
government agency in any other country) until the expiration of the
term.
No
license fees have been accrued in respect of triphendiol or NV-143 at September
30, 2009.
License
Agreement for NV-128
On August
4, 2009, the Company, through MEPL, entered into a license agreement with
Novogen pursuant to which Novogen granted to MEPL an exclusive, worldwide,
non-transferable license under its patents and patent applications and in the
intellectual property rights related to its know how to conduct clinical trials,
commercialize and distribute NV-128 (the “NV-128 Licence Agreement”). NV-128 is
an investigational cancer compound which has been shown in pre-clinical
laboratory studies to promote cancer cell death by targeting a pro-survival
regulatory pathway (the AKT-mTOR pathway). The NV-128 License Agreement covers
the use of NV-128 in the field of prevention, treatment and cure of cancer in
humans delivered in all forms except topical applications. The NV-128 License
Agreement remains in effect until (i) the expiration or lapsing of the last
relevant patents or patent applications in the world or (ii) Novogen’s
assignment to MEPL of the last relevant patents or patent applications in the
world so that MEPL may assume the filing, prosecution and maintenance of such
patents or patent applications. Thereafter, the license becomes a non-exclusive,
perpetual and irrevocable license covering any remaining intellectual property
rights related to the know how with respect to NV-128.
14
1. The
Company paid U.S. $1,500,000 to Novogen Research in August 2009, which was the
first lump sum license fee payment under the terms of the license
agreement.
2. Future
amounts payable to Novogen upon the achievement of certain milestones are as
follows:
|
i)
|
$1,000,000
on the date an IND for the licensed product goes into effect or the
equivalent approval of a government agency is obtained in another country.
If this event does not occur before December 31, 2011 then this amount
will be due on this date;
|
|
ii)
$2,000,000 on the date of enrollment of the first clinical trial subject
in a Phase II clinical trial of the
licensed
|
|
product.
If this event does not occur before December 31, 2012, then this amount
will be due on this date;
|
|
iii)
|
$3,000,000
on the date of enrollment of the first clinical trial subject in a Phase
III clinical trial of the licensed product. If this event does not occur
before December 31, 2014, then this amount will be due on this date;
and
|
|
iv)
|
$8,000,000
on the date of first receipt of a NDA for the licensed product from the
FDA or equivalent approval from a government agency in another country. If
this event does not occur before December 31, 2017, then this amount will
be due on this date.
|
3. MEPL
must pay Novogen royalties of 5.0% of all net sales and 25% of commercialization
income for the term of the license.
4. Minimum
royalties of $3,000,000 per year are payable following the date of first receipt
of an NDA for a licensed product from the FDA (or equivalent approval from a
government agency in any other country) until the expiration of the
term.
The
license agreement is able to be cancelled without penalty by MEPL by giving
three months notice.
Amended
and Restated License Option Deed
On
September 24, 2003, MEPL and Novogen Research Pty Limited entered into an
Amended and Restated License Option Deed (the “License Option Deed”). The
License Option deed grants MEPL an exclusive right to accept and an exclusive
right to match any proposed dealing by Novogen of its intellectual property
rights with a third party relating to synthetic compounds (other than
phenoxodiol) that have known or potential applications in the field of
prevention, treatment or cure of cancer in humans in all forms other than
topical applications.
Amended
and Restated Services Agreement
On
September 24, 2003, the Company, Novogen and MEPL entered into an Amended and
Restated Services Agreement (the “Services Agreement”). The Company does not
currently intend to directly employ any staff. Under the terms of the Services
Agreement, Novogen or its subsidiaries have agreed to provide services
reasonably required by the Company relating to the development and
commercialization of phenoxodiol and other licensed products, including
triphendiol and NV-143. Novogen has agreed to provide these services at cost
plus a 10% mark-up. The Company may terminate the Services Agreement on three
months written notice to Novogen.
15
Transactions
giving rise to expenditures amounting to $683,000 and $683,000 were made under
the Services Agreement with Novogen during the three months ended September 30,
2009 and 2008, respectively. Of these amounts, $487,000 and $442,000 related to
service fees paid to Novogen for research and development services provided in
the three months ended September 30, 2009 and 2008, respectively, reflecting the
time spent by Novogen research staff on the development of phenoxodiol,
triphendiol and NV-143. Additionally, $196,000 and $241,000 of the total
expenditures during the three months ended September 30, 2009 and 2008,
respectively, related to costs incurred for administration and accounting
services provided by Novogen.
At
September 30, 2009 and 2008, $282,000 and $241,000, respectively, were due and
owing to Novogen under the Services Agreement and are included in amounts due to
related company.
Manufacturing
License and Supply Agreement
On
September 24, 2003, MEPL and Novogen Laboratories Pty Limited, a subsidiary of
Novogen, entered into an amended and restated manufacturing license and supply
agreement (the “Manufacturing License and Supply Agreement”). Under the terms of
the Manufacturing License and Supply Agreement, MEPL has granted to Novogen
Laboratories Pty Limited an exclusive, non-transferable sub license to
manufacture and supply phenoxodiol in its primary manufactured form. Novogen
Laboratories Pty Limited has agreed to supply phenoxodiol to MEPL for the
clinical trial development program and phenoxodiol’s ultimate commercial use.
Phenoxodiol supplied by Novogen under the terms of this agreement will be
charged at cost plus a 50% markup.
There
were no transactions under the Manufacturing License and Supply Agreement with
Novogen during the three months ended September 30, 2009 and for three months
ended September 30, 2008.
At
September 30, 2009 and September 30, 2008 no amount was due and owing to Novogen
under the Manufacturing License and Supply Agreement
Novogen
has taken the strategic decision not to manufacture large scale Active
Pharmaceutical Ingredients for cancer drugs, including phenoxodiol, as these can
be more economically supplied by third parties with particular expertise in this
area.
6.
Equity
The
Company entered into a Securities Subscription Agreement dated as of July 28,
2008 with Novogen and OppenheimerFunds, Inc. (“Oppenheimer”) pursuant to which
the Company sold 2,908,295 and 1,700,000 shares of common stock to Novogen and
Oppenheimer, respectively, with Oppenheimer acting as adviser to each of the
following parties severally and not jointly: (i) Oppenheimer International
Growth Fund; (ii) Mass Mutual International Equity Fund; (iii) Oppenheimer
International Growth Fund/VA; (iv) AZL Oppenheimer International Growth Fund;
(v) OFITC International Growth Fund; and (vi) OFI International Equity Fund, at
a purchase price of $2.17 per share, the consolidated closing bid price of the
Company’s common stock as quoted by the Nasdaq Market Intelligence Desk at 4:00
PM EST on July 28, 2008.
16
The
shares were registered under the Securities Act of 1933, as amended (the
“Securities Act”), under a Shelf Registration Statement on Form S-3 (File No.
333-149807). The Company received net proceeds of $9.8 million from the sale of
the shares.
Following
the closing of the registered direct offering described above in July 2008,
Novogen retained approximately 71.3% of the Company’s common stock.
In July
2008, the Company also issued a warrant to Mr. John O’Connor exercisable for
46,083 shares of common stock, as consideration for investor relations services
rendered by him to the Company. The warrant has an exercise price of $2.17 per
share. The warrant may be exercised immediately and expires five years from the
date of issuance, on July 30, 2013. The warrant has not been registered under
the Securities Act. The Company issued the warrant to Mr. O’Connor in a private
placement made in reliance upon the exemption from securities registration
afforded by Section 4(2) of the Securities Act.
In
January 2009, the Company filed a registration statement on Form S-8 (File No.
333-156985) with the SEC registering 7,000,000 shares of common stock eligible
for issuance under the Marshall Edwards, Inc. 2008 Stock Omnibus Equity
Compensation Plan.
In
January 2009, the Company issued a stock option exercisable for 50,000 shares of
common stock to Associate Professor Gil Mor of Yale University in recognition of
his contribution to the development of phenoxodiol under the Marshall Edwards,
Inc. 2008 Stock Omnibus Equity Compensation Plan. The options have an exercise
price of $0.63. The options are exercisable immediately and expire five years
from date of issue.
7.
Contingent Liabilities
In
relation to the claims received in connection with the termination of enrollment
into the OVATURE Phase III clinical trial, the Company has finalized
negotiations and signed a Deed of Release. The Company believes that it does not
have any further liability in relation to claims made other than amounts
provided in the accounts at September 30, 2009.
Under the
terms of the license agreements with Novogen, milestone license fee payments are
payable upon achieving certain milestones. Details of the payments due under
these agreements are detailed in Note 5 “Related Party Transactions.” The
license agreements are subject to termination provisions.
8. Significant Events After
Balance Date
The
subsequent event information has been evaluated up to November 10, 2009.
17
Item
2: Management’s
Discussion and Analysis of Financial Condition and Results of
Operation
Special
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q includes forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended (the
“Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”). All statements other than statements of historical
facts contained in this Quarterly Report, including statements regarding the
future financial position, business strategy and plans and objectives of
management for future operations, are forward-looking statements. The words
“believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,”
“should,” “plan,” “expect,” and similar expressions, as they relate to us, are
intended to identify forward-looking statements. We have based these
forward-looking statements largely on current expectations and projections about
future events and financial trends that we believe may affect our financial
condition, results of operations, business strategy and financial needs. These
forward-looking statements are subject to a number of risks, uncertainties and
assumptions, including, among other things:
· our
inability to obtain required additional financing or financing available
to us on acceptable terms, particularly in the context of the global
financial crisis;
|
· our
inability to maintain or enter into, and our dependence upon,
collaboration or contractual arrangements necessary for the
clinical
development of phenoxodiol and other drug candidates;
|
· our
limited operating history;
|
· our
failure to successfully commercialize our product candidates;
|
· our
termination of new enrollment into the OVATURE Phase III clinical
trial;
|
· costs
and delays in the clinical development program and/or receipt of U.S. Food
and Drug Administration (the “FDA”)
or other required governmental approvals, or the failure to obtain such
approvals, for our product candidates;
|
· uncertainties
in clinical trial results;
|
· our
inability to maintain or enter into, and the risks resulting from our
dependence upon, collaboration or contractual arrangements necessary for
the development, manufacture, commercialization, marketing, sales and
distribution of any products;
|
· our
inability to control the costs of manufacturing our products;
|
· continued
cooperation and support of Novogen Limited, our parent
company;
|
· competition
and competitive factors;
|
· our
inability to protect our patents or proprietary rights and obtain
necessary rights to third party patents and intellectual property to
operate our business;
|
18
· our
inability to protect our patents or proprietary rights and obtain
necessary rights to third party patents and intellectual property to
operate our business;
|
· our
inability to operate our business without infringing the patents and
proprietary rights of others;
|
· costs
stemming from our defence against third party intellectual property
infringement claims;
|
· difficulties
in enforcement of civil liabilities against our officers and directors who
are residents of jurisdictions outside the U.S.;
|
· general
economic conditions;
|
· the
failure of any products to gain market acceptance;
|
· technological
changes;
|
· government
regulation generally and the receipt of the regulatory
approvals;
|
· changes
in industry practice; and
|
· one-time
events.
|
These
risks are not exhaustive. Other sections of this Quarterly Report on Form 10-Q
may include additional factors which could adversely impact our business and
financial performance. In addition, our business and financial performance may
be affected by the factors that are discussed under “Risk Factors” in the Annual
Report on Form 10-K for the year ended June 30, 2009. Moreover, we operate in a
very competitive and rapidly changing environment. New risk factors emerge from
time to time and it is not possible for us to predict all risk factors, nor can
we assess the impact of all factors on our business or the extent to which any
factor, or combination of factors, may cause actual results to differ materially
from those contained in any forward-looking statements.
You
should not rely upon forward looking statements as predictions of future events.
We cannot assure you that the events and circumstances reflected in the forward
looking statements will be achieved or occur. Although we believe that the
expectations reflected in the forward looking statements are reasonable, we
cannot guarantee future results, levels of activity, performance or
achievements.
The
following discussion is qualified in its entirety by, and should be read in
conjunction with, the more detailed information set forth in the financial
statements and the notes thereto appearing elsewhere in this Quarterly Report on
Form 10-Q.
Overview
Our main
focus since commencing operations has been to undertake human clinical testing
of phenoxodiol. Our operations were expanded to include the additional licensed
drug candidates triphendiol and NV-143. In August 2009, we entered into a third
license agreement for the drug candidate NV-128. During fiscal year 2007, we
commenced the Phase III clinical trial (known as “OVATURE”).
19
We
reached agreement under the Special Protocol Assessment process with the FDA on
the design of our OVATURE pivotal study protocol for phenoxodiol. The trial is
designed to test the ability of phenoxodiol to restore sensitivity of late-stage
ovarian cancers to carboplatin, a standard form of therapy for ovarian
cancer.
In April
2009, we announced the termination of enrollment into the OVATURE Phase III
trial and our intention to undertake an un-blinded analysis of the available
data from the trial. The patients currently enrolled in the trial
will continue their treatment according to the study
protocol. However, ceased recruiting new patients and the available
data from 142 completed and current patients will be analyzed for safety and
efficacy outcomes.
We intend
to allocate our current funds of approximately $15 million to completing the
OVATURE data analysis of 142 patients, pursuing negotiations for out-licensing
phenoxodiol should evidence of efficacy and safety emerge from the OVATURE
analysis, initiating the triphendiol clinical program and continuing the
pre-clinical program for NV-128.
We
believe that the proceeds from the registered direct offering which closed in
July 2008 and savings generated from ceasing the OVATURE trial will provide us
with sufficient cash resources to fund these operations over the next twelve
months.
We will,
however, need additional funds in order complete the planned clinical
development programs beyond the current objectives.
As of
September 30, 2009, we had accumulated losses of $65,319,000.
We have
not generated any revenues from operations since inception other than interest
on cash assets. We have incurred losses since inception and expect to incur
operating losses and generate negative cash flows from operations for the
foreseeable future.
We do not
employ any staff directly but obtain services from Novogen under the Services
Agreement.
Expenses
to date have consisted primarily of costs associated with conducting the
clinical trials of phenoxodiol, including OVATURE, costs incurred under the
Phenoxodiol License Agreement, as amended, the License Agreement for Triphendiol
and NV-143, the License Agreement from NV-128, the Services Agreement and the
Manufacturing License and Supply Agreements with Novogen and its subsidiaries,
including the costs of the clinical trial drug supplies.
To date,
operations have been funded primarily through the sale of equity
securities.
As at the
date of the Quarterly Report, Novogen owns approximately 71.3% of the
outstanding shares of our common stock.
20
Critical
Accounting Estimates
The
preparation of the consolidated financial statements in conformity with
accounting principles generally accepted in the U.S. requires management to make
estimates and assumptions that affect the amounts reported in the financial
statements and the accompanying notes. Actual results could differ from those
estimates.
Clinical
Trials Expenses
Estimates
have been used in determining the expense liability under certain clinical trial
contracts where services have been performed but not yet invoiced. The actual
costs of those services could differ in amount and timing from the estimates
used in completing the financial statements.
Generally
the costs, and therefore estimates, associated with clinical trial contracts are
based on the number of patients, drug administration cycles, the type of
treatment and the outcome being measured. The length of time before actual
amounts can be determined will vary depending on length of the patient cycles
and the timing of the invoices by the clinical trial partners.
Clinical
trial expenses of $838,000 have been accrued at September 30, 2009. These
estimates are based on the number of patients in each trial and the drug
administration cycle.
At June
30, 2009 we had accrued $1,181,000 in relation to claims received for clinical
trial expenses in connection with the termination of enrollment into the OVATURE
Phase III clinical trial. Following negotiations we have paid $649,000 during
the quarter and have accrued $266,000 as at September 30, 2009 representing
management’s best estimate of the final amounts payable for claims
received.
Stock
Based Compensation
On
December 9, 2008, we adopted the Marshall Edwards, Inc. 2008 Stock Omnibus
Equity Compensation Plan (the “2008 Stock Omnibus Equity Compensation Plan”) and
cancelled the Marshall Edwards, Inc. Share Option Plan (the “Share Option
Plan”). No options were issued under the Share Option Plan. The 2008 Stock
Omnibus Equity Compensation Plan provides for the issuance of a maximum of
7,000,000 shares of common stock in connection with the grant of options and/or
other stock-based or stock-denominated awards to our non-employee directors,
officers, employees and advisors. To date, we have issued options exercisable
for 50,000 shares of common stock under the 2008 Stock Omnibus Equity
Compensation Plan.
We
account for stock based payments by estimating the fair value of the options
issued. The costs of these equity-settled transactions are determined using a
binomial model to calculate the fair value at the date on which they are
granted. With respect to the fair value of the warrant representing 46,083
warrant shares issued to Mr. John O’Connor on July 30, 2008, in
consideration for investor relations services rendered, and stock options
representing 50,000 shares of common stock issued to Associate Professor Gil Mor
of Yale University on January 28, 2009, in recognition of his contribution to
the development of phenoxodiol under the 2008 Stock Omnibus Equity Compensation
Plan, the following assumptions were used:
21
July
30, 2008
|
January
28, 2009
|
|
Dividend
yield
|
0%
|
0%
|
Expected
volatility
|
81%
|
111%
|
Historical
volatility
|
81%
|
111%
|
Risk-free
interest rate
|
3.36%
|
1.70%
|
Expected
life of warrant
|
5
years
|
5
years
|
Warrant
fair value
|
$1.41
|
$0.50
|
The
dividend yield reflects the assumption that the current dividend payout, which
is zero, will continue with no anticipated increases. The expected life of the
warrant is based on historical data and is not necessarily indicative of
exercise patterns that may occur. The expected volatility reflects the
assumption that the historical volatility is indicative of future trends, which
may also not necessarily be the actual outcome.
Results
of Operations
Three
Months Ended September 30, 2009 and 2008
We
recorded a consolidated loss of $2,408,000 and $2,252,000 for the three months
ended September 30, 2009 and 2008, respectively.
Revenues: We received interest
on cash assets and cash equivalents and short term investments of $26,000 for
the three months ended September 30, 2009 compared to $96,000 for the three
months ended September 30, 2008. The decrease was due to lower cash balances and
lower interest rates earned by our cash deposits.
Research and Development:
Research and development expenses decreased $1,575,000 to $503,000 for the three
months ended September 30, 2009 compared to $2,078,000 for the three months
ended September 30, 2008. The reduction was due to the termination of the
enrollment in the OVATURE Phase III clinical trial and associated cost savings
.
Selling, General and Administrative:
Selling, general and administrative expenses increased by $162,000 to
$431,000 for the three months ended September 30, 2009 compared to $269,000 for
the three months ended September 30, 2008. The increase was due to net foreign
exchange movements (described below), partially offset by reduced spending on
legal fees, reduced travel expenses and reduced share based payment expenses
which were not incurred in the three months ended September 30,
2009.
Foreign
exchange gains/(losses) are included in selling, general and administrative
expenses and occur when revaluing cash denominated in foreign currencies and
upon consolidation of our wholly owned subsidiary Marshall Edwards Pty Ltd
(“MEPL”). MEPL uses U.S. dollars as its functional currency and also engages in
transactions in foreign currencies. Further, MEPL’s accounts and financial
statements are denominated in Australian dollars. Translation of MEPL’s
financial statements into U.S. dollars did not have a material impact on our
financial position.
22
However,
exchange rates are volatile in the current market resulting from the global
financial crisis and there is a possibility that foreign exchange gains/losses
may have a material impact in future periods. At September 30, 2009, we had not
established a foreign currency hedging program. Net foreign exchange losses
during the three months ended September 30, 2009 were $90,000 compared with
foreign exchange gains of $408,000 during the three months ended September 30,
2008.
Liquidity
and Capital Resources
At
September 30, 2009, we had cash resources of $15,233,000 compared to $19,067,000
at June 30, 2009. The decrease was due to the expenditures in the clinical trial
program and other corporate expenses incurred in the period. Funds are invested
in short term money market accounts, pending use.
On July
28, 2008 we entered into a securities subscription agreement with Novogen and
OppenheimerFunds, Inc. (“Oppenheimer”) pursuant to which we sold 2,908,295 and
1,700,000 shares of common stock to Novogen and Oppenheimer, respectively, with
Oppenheimer acting as adviser to each of the following parties severally and not
jointly: (i) Oppenheimer International Growth Fund; (ii) Mass Mutual
International Equity Fund; (iii) Oppenheimer International Growth Fund/VA; (iv)
AZL Oppenheimer International Growth Fund; (v) OFITC International Growth Fund;
and (vi) OFI International Equity Fund, at a purchase price of $2.17 per share,
the consolidated closing bid price of our common stock on July 28, 2008. The
shares were registered under the Securities Act of 1933, as amended (the
“Securities Act”) under a Shelf Registration Statement on Form S-3 (File No.
333-149807). We received gross proceeds of $10 million from the sale of the
shares.
Following
the closing, in July 2008, of the registered direct offering described above,
Novogen retained approximately 71.3% of our common stock.
In July
2008, we issued a warrant to Mr. John O’Connor exercisable for 46,083 shares of
common stock, as consideration for investor relation services rendered by him to
us. The warrant has an exercise price of $2.17 per share. The warrant may be
exercised immediately and expires five years from the date of issuance, on July
30, 2013. The warrant has not been registered under the Securities Act. We
issued the warrant to Mr. O’Connor in a private placement made in reliance upon
the exemption from securities registration afforded by Section 4(2) of the
Securities Act.
In
January 2009, we issued a stock option exercisable for 50,000 shares of common
stock to Associate Professor Gil Mor of Yale University in recognition of his
contribution to the development of phenoxodiol under the Marshall Edwards, Inc
2008 Stock Omnibus Equity Compensation Plan. The option has an exercise price of
$0.63 per share of common stock. The options are exercisable immediately and
expire five years from date of issue, on January 28, 2014.
Given the
current state of the global financial markets, we do not expect to be able to
raise additional capital through the issuance of equity or debt in this calander
year.
23
Source
and Uses of Cash
Cash
Used in Operating Activities
Cash used
in operating activities for the three months ended September 30, 2009 was
$3,834,000 compared to $2,726,000 for the same period in 2008.
Cash
Requirements
The
Company intends to allocate its current funds of approximately $15 million to
completing the OVATURE data analysis of 142 patients, pursuing negotiations for
out-licensing phenoxodiol should evidence of efficacy and safety emerge from the
OVATURE analysis, initiating the triphendiol clinical program and continuing the
pre-clinical program for NV-128.
Specifically
we intend to:
·
|
Continue
the clinical development of the drug candidate
triphendiol;
|
·
|
Continue
the pre-clinical development of NV-128. In August 2009 we completed
negotiations with Novogen to in-license the mTOR inhibitor NV-128, which
has shown compelling preclinical results to date. In consideration of the
license granted to us we paid Novogen a license fee of
$1,500,000.
|
Ongoing
operations, including the conduct of the pre clinical and clinical trial
program, will continue to consume cash resources without generating revenues. In
order to obtain the additional funding necessary to conduct our business, we may
need to rely on collaboration and /or licensing opportunities. We cannot assure
you that we will be able to raise the funds necessary to fund our programs or
find appropriate collaboration or licensing opportunities.
Payments
to Novogen
Future
payments to Novogen under the terms of the Phenoxodiol License Agreement, as
amended and the License Agreement for Triphendiol and NV-143 and the License
agreement for NV-128 are detailed in Note 5 of the financial statements “Related
Party Transactions” on page 12 of this Quarterly Report on Form
10-Q.
We will
also be required to make payments to Novogen under the Services Agreement and
Manufacturing License and Supply Agreement if future clinical supplies of drug
product are sourced from Novogen.
We do not
intend to incur any significant capital expenditures in the foreseeable
future.
Off-Balance
Sheet Arrangements
We do not
currently have any off-balance sheet arrangements.
24
Contractual
Obligations
For
details of our contractual obligations at September 30, 2009 see Note 3 to the
financial statements “Expenditure Commitments” on page 11 of this Quarterly
Report on Form 10-Q.
25
Item
3: Quantitative
and Qualitative Disclosures about Market Risk
Interest
Rate Risk
Our
exposure to market interest rates relates primarily to the investments of cash
balances.
We have
cash reserves held primarily in U.S. and Australian dollars and we place funds
on deposit with financial institutions which are generally at call.
We do not
use derivative financial instruments. We place our cash deposits with high
credit quality financial institutions, and, by policy, limit the amount of
credit exposure to any single counter-party. We are adverse to principal loss
and we ensure the safety and preservation of our invested funds by limiting
default risk, market risk and reinvestment risk.
We
mitigate default risk by depositing funds with high credit quality financial
institutions and by constantly positioning the portfolio to respond
appropriately to a significant reduction in a credit rating of any financial
institution.
We have
no interest rate exposure due to rate changes for long-term debt.
We do not
consider the effects of interest rate movements to be a material risk to our
financial condition.
Foreign
Currency Risk
We
conduct our business in various currencies, primarily in U.S. dollars and
Australian dollars, Euros and British pounds. At September 30, 2009, we had not
established a foreign currency hedging program. Net foreign exchange losses
during the three months ended September 30, 2009 were $90,000 compared with net
exchange gains of $408,000 during the three months ended September 30, 2008.
Foreign exchange gains and losses occur upon consolidation of MEPL, which uses
U.S. dollars as its functional currency and also engages in transactions in
foreign currencies. MEPL’s accounts are denominated in Australian dollars.
Translation of MEPL’s financial statements into U.S. dollars did not have a
material impact on our financial position.
We do not
consider the effects of foreign currency movements to be a material risk to our
financial condition.
26
Item
4T: Controls
and Procedures
Evaluation
of Disclosure Controls and Procedures
At the
end of the period covered by this Quarterly Report, our management, with the
participation of our principal executive officer and principal financial
officer, evaluated the effectiveness of our disclosure controls and procedures
(as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). Based on
this evaluation, our principal executive officer and principal financial officer
have concluded that our disclosure controls and procedures are effective to
ensure that information required to be disclosed by us in reports that we file
or submit under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in SEC rules and forms and have ensured that
information required to be disclosed by us in such reports is accumulated and
communicated to our management, including our principal executive officer and
principal financial officer, as appropriate to allow timely decisions
regarding required disclosures.
There
were no changes in our internal control over financial reporting during the
period covered by this Quarterly Report that have materially affected, or are
reasonably likely to materially affect, the Company’s internal control over
financial reporting.
27
PART
II OTHER INFORMATION
Item
6: Exhibits
Exhibit
Index
Exhibits
31.1
|
Certification
required by Rule 13a-14(a) or Rule 15d-14(a)
|
31.2
|
Certification
required by Rule 13a-14(a) or Rule 15d-14(a)
|
32.1
|
Certification
required by Rule 13a-14(b) or Rule 15d-14(b) and section 1350 of Chapter
63 of Title 18 of the United States Code (18 U.S.C
1350).
|
|
28
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this Quarterly Report to be signed on its behalf by the undersigned,
thereunto duly authorized.
MARSHALL
EDWARDS, INC.
/s/ DAVID SEATON
David R.
Seaton
Chief
Financial Officer
(Duly
Authorized Officer and Principal Financial Officer)
Date:
November 10, 2009
29
Exhibit
31.1
CERTIFICATION
I,
Christopher Naughton, certify that:
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of Marshall Edwards,
Inc.;
|
2.
|
Based
on my knowledge, this Quarterly Report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this Quarterly Report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this Quarterly Report, fairly present in all material respects
the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this Quarterly
Report;
|
4.
|
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and
have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within the
entities, particularly during the period in which this Quarterly Report is
being prepared;
|
(b)
|
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
(c)
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in the Quarterly Report our conclusions about the
effectiveness of this disclosure controls and procedures, as of the end of
the period covered by this Quarterly Report based on such evaluation;
and
|
(d)
|
Disclosed
in this Quarterly Report any change in the registrant’s internal control
over financial reporting that occurred during the registrants first fiscal
quarter that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting.
|
5.
|
The
registrant’s other certifying officer and I have disclosed, based on our
most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s
board of directors:
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date:
November 10, 2009
/s/CHRISTOPHER NAUGHTON
Christopher
Naughton
Chief
Executive Officer
30
Exhibit
31.2
CERTIFICATION
I, David
Ross Seaton, certify that:
1.
|
I
have reviewed this Quarterly Report on Form 10-Q of Marshall Edwards,
Inc.;
|
2.
|
Based
on my knowledge, this Quarterly Report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to
make the statements made, in light of the circumstances under which such
statements were made, not misleading with respect to the period covered by
this Quarterly Report;
|
3.
|
Based
on my knowledge, the financial statements, and other financial information
included in this Quarterly Report, fairly present in all material respects
the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this Quarterly
Report;
|
4.
|
The
registrant’s other certifying officer(s) and I are responsible for
establishing and maintaining disclosure controls and procedures (as
defined in Exchange Act Rules 13a-15(e) and 15d-15(e) ) and internal
control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f)) for the registrant and
have:
|
(a)
|
Designed
such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its
consolidated subsidiaries, is made known to us by others within the
entities, particularly during the period in which this Quarterly Report is
being prepared;
|
(b)
|
Designed
such internal control over financial reporting, or caused such internal
control over financial reporting to be designed under our supervision, to
provide reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting
principles;
|
(c)
|
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures
and presented in the Quarterly Report our conclusions about the
effectiveness of this disclosure controls and procedures, as of the end of
the period covered by this Quarterly Report based on such evaluation;
and
|
(d)
|
Disclosed
in this Quarterly Report any change in the registrant’s internal control
over financial reporting that occurred during the registrants first fiscal
quarter that has materially affected, or is reasonably likely to
materially affect, the registrant’s internal control over financial
reporting.
|
5.
|
The
Company’s other certifying officer and I have disclosed, based on our most
recent evaluation of internal control over financial reporting, to the
registrant’s auditors and the audit committee of the registrant’s board of
directors:
|
(a)
|
All
significant deficiencies and material weaknesses in the design or
operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record,
process, summarize and report financial information;
and
|
(b)
|
Any
fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant’s internal control
over financial reporting.
|
Date: November 10,
2009
/s/ DAVID SEATON
David R.
Seaton
Chief
Financial Officer
31
Exhibit
32.1
CERTIFICATION
Pursuant
to the requirement set forth in Rule 13a-14(b) or Rule 15d-14(b) of the
Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of
Title 18 of the United States Code (18 U.S.C. § 1350), Christopher Naughton, the
President and Chief Executive Officer of Marshall Edwards, Inc. (the
“Registrant”), and David R. Seaton, the Chief Financial Officer of the
Registrant, each hereby certifies that, to his knowledge:
1.
|
The
Registrant’s Quarterly Report on Form 10-Q for the period ended September
30, 2009, (the “Form 10-Q”) to which this Certification is attached as
Exhibit 32.1, fully complies with the requirements of Section 13(a) or
Section 15(d) of the Securities Exchange Act of 1934, as amended;
and
|
2.
|
The
information contained in the Form 10-Q fairly presents, in all material
respects, the financial condition of the Registrant at the end of the
period covered by the Form 10-Q and results of operations of the
registrant for the period covered by the Form
10-Q.
|
These
certifications accompanying the Form 10-Q to which they relate, are not deemed
filed with the Securities and Exchange Commission and are not to be incorporated
by reference into any filing of the registrant under the Securities Act of 1933,
as amended, or the Securities Exchange Act of 1934, as amended (whether made
before or after the date of the Form 10-Q), irrespective of any general
incorporation language contained in such filing.
Dated:
November 10, 2009
/s/CHRISTOPHER NAUGHTON
Christopher
Naughton
Chief
Executive Officer
/s/ DAVID SEATON
David R.
Seaton
Chief
Financial Officer
32