Axogen, Inc. - Quarter Report: 2008 September (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
x
|
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF
1934
|
For
the
quarterly period ended September
30, 2008
or
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: 0-16159
LECTEC
CORPORATION
(Exact
name of registrant as specified in its charter)
Minnesota
|
41-1301878
|
|
(State
or other jurisdiction of
|
(I.R.S.
Employer
|
|
incorporation
or organization)
|
Identification
No.)
|
|
1407
South Kings Highway, Texarkana, TX
|
75501
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(903)-832-0993
(Registrant's
telephone number, including area code)
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last
report)
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 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.
|
Large
accelerated filer o
|
|
Accelerated
filer o
|
|
|
|
|
|
Non-Accelerated
filer o
(Do not check if a smaller reporting company)
|
|
Smaller
reporting company x
|
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
November 19, 2008 the registrant had 4,290,026 shares of common stock
outstanding.
LECTEC
CORPORATION
REPORT
ON FORM 10-Q FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30,
2008
Table
of Contents
Part
I - Financial Information
Item
1.
|
Financial
Statements
|
I-1
|
|
Item
2.
|
Management's
Discussion and Analysis of Financial Condition and Results of
Operations
|
I-9
|
|
Item
3.
|
Quantitative
and Qualitative Disclosures About Market Risk
|
I-12
|
|
Item
4.
|
Controls
and Procedures
|
I-12
|
Part
II - Other Information
Item
1.
|
Legal
Proceedings
|
II-1
|
|
Item
1A.
|
Risk
Factors
|
II-1
|
|
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
II-1
|
|
Item
3.
|
Defaults
Upon Senior Securities
|
II-1
|
|
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
II-1
|
|
Item
5.
|
Other
Information
|
II-1
|
|
Item
6.
|
Exhibits
|
II-2
|
|
|
Signature
Page
|
II-3
|
|
Forward-Looking
Statements
From
time
to time, in reports filed with the Securities and Exchange Commission (including
this Form 10-Q), in press releases, and in other communications to shareholders
or the investment community, the Company may provide forward-looking statements
concerning possible or anticipated future results of operations or business
developments which are typically preceded by the words “believes,” “wants,”
“expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar
expressions. Such forward-looking statements are subject to risks and
uncertainties which could cause results or developments to differ materially
from those indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, the Company’s dependence on
royalty payments from Novartis Consumer Health, Inc., which is selling an adult
vapor patch licensed by the Company, the Company’s dependence on key personnel
and Board of Director members, the success or failure of any attempt by the
Company to protect or enforce its patents and territories of coverage and the
outcome of pending litigation, the issuance of new accounting pronouncements,
the availability of opportunities for licensing agreements related to patents
that the Company holds, limitations on market expansion opportunities, and
other
risks and uncertainties as described in the “Cautionary Statements” filed as
Exhibit 99.01 to the Company’s Form 10-KSB for the year ended December 31, 2007
and updated in Exhibit 99.1 to our Form 10-QSB for the quarter ended March
31,
2008.
PART
1 - FINANCIAL INFORMATION
ITEM
1 - CONDENSED FINANCIAL STATEMENTS AND NOTES TO CONDENSED FINANCIAL
STATEMENTS
LECTEC
CORPORATION
CONDENSED
BALANCE SHEETS
September
30,
|
|
December
31,
|
|
||||
ASSETS
|
|
2008
|
|
2007
|
|||
(Unaudited)
|
|||||||
CURRENT
ASSETS:
|
|||||||
Cash
and cash equivalents
|
$
|
410,107
|
$
|
832,925
|
|||
Royalty
receivable
|
14,022
|
100,431
|
|||||
Prepaid
expenses and other
|
131,041
|
62,877
|
|||||
Total
current assets
|
555,170
|
996,233
|
|||||
OTHER
ASSETS:
|
|||||||
Office
equipment
|
6,633
|
-
|
|||||
Patent
costs
|
49,607
|
42,918
|
|||||
Prepaid
insurance - director and officer
|
30,419
|
60,838
|
|||||
86,659
|
103,756
|
||||||
TOTAL
ASSETS
|
$
|
641,829
|
$
|
1,099,989
|
|||
LIABILITIES
AND SHAREHOLDERS’ EQUITY
|
|||||||
CURRENT
LIABILITIES:
|
|||||||
Accounts
payable
|
$
|
24,947
|
$
|
13,407
|
|||
Accrued
expenses
|
52,903
|
57,767
|
|||||
Discontinued
operations
|
130,000
|
130,000
|
|||||
Total
current liabilities
|
207,850
|
201,174
|
|||||
COMMITMENTS
AND CONTINGENCIES
|
|||||||
SHAREHOLDERS’
EQUITY:
|
|||||||
Common
stock, $.01 par value; 15,000,000 shares
|
|||||||
authorized;
4,290,026 and 4,176,048 shares
|
|||||||
issued
and outstanding at September 30, 2008
|
|||||||
and
December 31, 2007, respectively
|
42,900
|
41,760
|
|||||
Additional
contributed capital
|
12,652,219
|
12,198,278
|
|||||
Accumulated
deficit
|
(12,261,140
|
)
|
(11,341,223
|
)
|
|||
433,979
|
898,815
|
||||||
TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
$
|
641,829
|
$
|
1,099,989
|
The
accompanying notes are an integral part of these condensed financial
statements.
I-1
LECTEC
CORPORATION
CONDENSED
STATEMENTS OF OPERATIONS
(Unaudited)
Three
Months Ended
September
30,
|
Nine
Months Ended
September
30,
|
||||||||||||
2008
|
|
2007
|
|
2008
|
|
2007
|
|||||||
REVENUE
- ROYALTY AND LICENSING FEES
|
$
|
14,022
|
$
|
-
|
$
|
40,125
|
$
|
-
|
|||||
OPERATING
EXPENSES
|
599,869
|
469,283
|
974,197
|
770,043
|
|||||||||
Loss
from operations
|
(585,847
|
)
|
(469,283
|
)
|
(934,072
|
)
|
(770,043
|
)
|
|||||
Interest
income
|
3,008
|
12,288
|
14,155
|
40,631
|
|||||||||
NET
LOSS
|
$
|
(582,839
|
)
|
$
|
(456,995
|
)
|
$
|
(919,917
|
)
|
$
|
(729,412
|
)
|
|
WEIGHTED
AVERAGE COMMON SHARES OUTSTANDING:
|
|||||||||||||
Basic
and diluted
|
4,290,026
|
4,175,371
|
4,269,227
|
4,162,245
|
|||||||||
LOSS
PER COMMON SHARE:
|
|||||||||||||
Basic
and diluted
|
$
|
(0.14
|
)
|
$
|
(
0.11
|
)
|
$
|
(0.22
|
)
|
$
|
(0.18
|
)
|
|
The
accompanying notes are an integral part of these condensed financial
statements.
I-2
LECTEC
CORPORATION
CONDENSED
STATEMENTS OF CASH FLOWS
(Unaudited)
Nine
Months Ended September 30,
|
|||||||
2008
|
|
2007
|
|||||
Cash
flows from operating activities:
|
|||||||
Net
loss
|
$
|
(919,917
|
)
|
$
|
(729,412
|
)
|
|
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|||||||
Compensation
expense related to stock options
|
455,080
|
332,925
|
|||||
Amortization
of patent costs
|
16,591
|
17,210
|
|||||
Changes
in operating assets and liabilities:
|
|||||||
Royalty
receivable
|
86,409
|
-
|
|||||
Prepaid
expenses and other
|
(37,745
|
)
|
26,617
|
||||
Accounts
payable
|
11,540
|
14,677
|
|||||
Accrued
expenses
|
(4,863
|
)
|
(18,491
|
)
|
|||
Net
cash used in operating activities
|
(392,905
|
)
|
(356,474
|
)
|
|||
Cash
flows from financing activities:
|
|||||||
Proceeds
from the exercise of stock options
|
-
|
18,087
|
|||||
Net
cash provided by financing activities
|
-
|
18,087
|
|||||
Cash
flows from investing activities:
|
|||||||
Purchase
of office equipment
|
(6,633
|
)
|
|||||
Investment
in patents
|
(23,280
|
)
|
-
|
||||
Net
cash used in investing activities
|
(29,913
|
)
|
-
|
||||
Net
decrease in cash and cash equivalents
|
(422,818
|
)
|
(338,387
|
)
|
|||
Cash
and cash equivalents - beginning of period
|
832,925
|
1,281,785
|
|||||
Cash
and cash equivalents - end of period
|
$
|
410,107
|
$
|
943,398
|
The
accompanying notes are an integral part of these condensed financial
statements.
I-3
LECTEC
CORPORATION
Notes
to Condensed Financial Statements
September
30, 2008 and 2007
(Unaudited)
(1) Basis
of Presentation
The
accompanying condensed financial statements include the accounts of LecTec
Corporation (the “Company”) as of September 30, 2008 and December 31, 2007 and
for the three and nine month periods ended September 30, 2008 and 2007,
respectively. The Company’s condensed financial statements have been prepared in
accordance with accounting principles generally accepted in the United States
of
America and should be read in conjunction with the Company’s Annual Report on
Form 10-KSB for the year ended December 31, 2007. The interim condensed
financial statements are unaudited and in the opinion of management, reflect
all
adjustments necessary for a fair presentation of results for the periods
presented. Results for interim periods are not necessarily indicative of results
for the full year.
(2) Business/Premises
Summary and Critical Accounting Policies
Business
Summary
The
Company is an intellectual property licensing and holding company. The Company
earns royalties and licensing fees from licensing agreements pertaining to
the
Company’s patents. The Company has one licensing agreement (“Novartis Agreement”
or “Agreement”) with Novartis Consumer Health, Inc. (“Novartis”), which pays
royalties to the Company from time to time, within the terms of the Agreement,
based upon a percentage of Novartis’ net sales of licensed products. Previously,
the Company was a contract manufacturer of hydrogel topical patches which were
sold to major pharmaceutical customers until the Company ceased its
manufacturing operations in December 2004. The Company holds multiple domestic
and international patents based on its hydrogel technology. A hydrogel is a
gel-like material having an affinity for water and similar compounds. These
gels
are ideal for delivering medication onto the skin.
Corporate
Office Relocation and Premises Summary
The
Company is currently finalizing a second lease amendment (the “Second Lease
Amendment”) that will allow for the Company to remain in the
Edina, Minnesota premises until December 31, 2008. This will allow adequate
time to vacate the premises and to move and dispose of remaining items at that
facility. The monthly lease will remain at $2,400 per month. The terms of the
Second Lease Amendment are the same as described below.
In
May, 2008, the Company entered into a lease amendment (the “Lease Amendment”)
amending its lease dated May 23, 2003, between the Company and SMD Lincoln
Investments (the “Minnesota Lease”), regarding the Company’s previous
headquarters located at 5610 Lincoln Drive, Edina, Minnesota (the “Leased
Premises”).
The
Lease Amendment provided for a reduction in the amount of office space leased
by
the Company at the Leased Premises from 14,316 square feet to 3,299 square
feet.
In addition, pursuant to the Lease Amendment, the Company will pay a monthly
rent of approximately $2,400. The Lease Amendment did not extend the term of
the
Minnesota Lease, which expired on August 31, 2008. The Company had previously
negotiated with property management that the Company could stay in the Leased
Premises until September 30, 2008 for a lease rate of $2,400 per month to allow
the Company additional time to vacate its current space. The Company intends
to
vacate its Leased Premised by December 31, 2008.
On
July
23, 2008, the Company moved its corporate headquarter facilities from Edina,
Minnesota to Texarkana, Texas. In connection with this relocation, the Company
entered into a Lease Agreement with Lockaway Storage, Inc. (the “Lessor”) on
July 23, 2008 (the “Texas Lease”), pursuant to which the Company agreed to lease
approximately 1,200 square feet of space located at 1407 South Kings Highway,
Texarkana, Texas 75501, for a term of 6 months, beginning on August 1, 2008
and
ending on February 1, 2009. The monthly lease rate is $650 per month during
the
term of the Texas Lease, and the Company must also pay its pro rata share of
the
costs and expenses incurred by the Lessor to operate the common areas of the
office and warehouse complex. The Texas Lease may be extended for a period
of 6
or 12 months commencing at the expiration of the original lease term, at the
option of the Company, at a monthly lease rate of $700. The Texas Lease contains
customary representations, warranties and covenants on the part of the Company
and the landlord. The Company believes this is an ideal location based upon
favorable local lease rates, secure premises, tax advantages, community
responsibility, etc.
I-4
On
July,
23, 2008, the Company also opened an office in India, Level 2, Connaught Place,
Bund Garden Road, Pune (India), 411001, to explore research, development and
manufacturing opportunities for its advanced skin interface technologies and
products. The Company chose India because the Company considers it one of the
most robust, globally competitive, and cost-efficient locations for the
development and manufacturing of pharmaceutical and medical products. The
Company also wanted to have better access to the pool of well-educated
scientific and engineering talent available in India. As of July 23, 2008,
the
Company has paid in advance $2,086 (including refundable security deposit of
$250) for this lease, which expires on July 31, 2009.
Critical
Accounting Policies
The
Company’s most critical accounting policies include:
Revenue
Recognition.
Royalty
and licensing fees are recognized when earned under the terms of the Novartis
Agreement, based upon sales information of licensed products sold by Novartis,
and collection is reasonably assured.
Patent
Costs.
The
carrying value of patent costs is reviewed periodically or when factors
indicating impairment are present. Any impairment loss is measured as the amount
by which the carrying value of the assets exceeds the fair value of the assets.
The Company believes no such impairment currently exists.
Royalty
Receivable. The
Company grants credit to its only customer, Novartis, in the normal course
of
business and under the terms contained in the Agreement. Novartis pays royalty
income within the terms defined in the Agreement. At September 30, 2008, the
Company had an outstanding royalty receivable with Novartis of $14,022.
Management believes, based upon past collection experience, that any and all
amounts due from Novartis outstanding from time to time are fully
collectible.
Use
of Estimates. In
preparing financial statements in conformity with accounting principles
generally accepted in the United States of America, management is required
to
make estimates and assumptions that affect certain reported amounts of assets
and liabilities and the 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.
Share-Based
Compensation.
In
December 2004, the Financial Accounting Standards Board (“FASB”) issued
Statement of Financial Accounting Standards (“SFAS”) No. 123(R), Share-Based
Payment,
which
requires that compensation cost relating to share-based payment transactions
(including the cost of all employee stock options) be recognized in the
financial statements. That cost is measured based on the estimated fair value
of
the equity or liability instruments issued. SFAS No. 123(R) covers a wide range
of share-based compensation arrangements including share options, restricted
share plans, performance-based awards, share appreciation rights, and employee
share purchase plans. SFAS No. 123(R) replaces SFAS No. 123, Accounting
for Stock-Based Compensation,
and
supersedes Accounting Principles Board (“APB”) Opinion No. 25, Accounting
for Stock Issued to Employees.
The
Company was required to apply SFAS No. 123(R) effective January 1, 2006. Thus,
the Company's financial statements reflect the cost for (a) all share-based
compensation arrangements granted after December 31, 2005 and for any such
arrangements that are modified, cancelled, or repurchased after that date,
and
(b) the portion of previous share-based awards for which the requisite service
had not been rendered as of that date, based on the grant date estimated fair
value.
On
September 26, 2008, the Compensation Committee of the
Board
of Directors of the Company granted stock options to each of the three members
of the Board of Directors of the Company, as well as to its sole employee.
The
terms of the options granted to the four individuals were identical except
that
the options granted to Mr. William Johnson, the Company’s only employee,
qualified as incentive stock options under the Internal Revenue Code of 1986,
as
amended, while each of the three Directors of the Company was granted
non-qualified stock options. Mr. William Johnson, Mr. C. Andrew Rollwagen and
Dr. Daniel Sigg each received an option to purchase 16,000 shares of the
Company’s common stock at $4.00 per share and Mr. Judd Berlin received an option
to purchase 66,000 shares of the Company’s common stock at $4.00 per share. All
of the options are fully vested and exercisable as of the date of grant and
will
expire on September 26, 2018. All of the options were granted under plans
previously approved by the Company’s shareholders and the exercise price for the
options were issued at a price equal to the fair market value of the Company’s
common stock on the date of grant. All of the options provide that termination
of service as a Director or employee of the Company for any reason other than
for cause will not affect the terms of the option or cause the option to
terminate.
I-5
The
Company recorded share-based compensation expense of $455,080 or $0.11 per
share
for the three and nine months ended September 30, 2008. The fair value of the
options granted were determined utilizing the Black-Scholes-Merton option
pricing model. All of the Company’s options were fully vested as of September
30, 2008 and there were no modifications to existing grants, during the three
and nine month periods ended September 30, 2008 and 2007.
Recent
Accounting Pronouncements:
In
December 2007, the FASB issued SFAS No. 141R, (revised 2007), Business
Combinations.
SFAS
141R significantly changes the accounting for business combinations in a number
of areas including the treatment of contingent consideration, pre-acquisition
contingencies, transaction costs, in-process research and development, and
restructuring costs. In addition, under SFAS 141R, changes in an acquired
entity’s deferred tax assets and uncertain tax position after the measurement
period will impact income tax expense. SFAS 141R is effective for fiscal years
beginning after December 15, 2008. In December 2007, the FASB issued SFAS No.
160, Noncontrolling
Interests in Consolidated Financial Statements, an amendment of ARB No
51.
SFAS
160 changes the accounting and reporting for minority interests, which will
be
recharacterized as noncontrolling interests and classified as a component of
equity. This new consolidation method significantly changes the accounting
for
transactions with minority interest holders. SFAS 160 is effective for fiscal
years beginning after December 31, 2008. These standards will change our
accounting treatment for business combinations on a prospective
basis.
In
February 2008, the FASB issued FASB Staff Position (“FSP”) FAS 157-2,
Effective
Date of FASB Statement No. 157,
(“FSP
FAS 157-2”), which delays the effective date of SFAS No. 157 for all
nonrecurring fair value measurements of non-financial assets and liabilities
until fiscal years beginning after November 15, 2008. The Company has elected
to
defer the adoption of the nonrecurring fair value measurements disclosures
of
non-financial assets and liabilities. The adoption of FSP FAS 157-2 is not
expected to have a material impact on the Company’s financial
statements.
(3) Loss
Per Common Share
Basic
loss per common share is computed by dividing net loss by the weighted average
number of common shares outstanding. Diluted loss per common share is computed
by dividing net loss by the weighted average number of common shares outstanding
and common share equivalents related to stock options and warrants when
dilutive. Common stock options to purchase 269,200 shares of common stock were
outstanding during the three and nine months ended September 30,
2008.
Common
stock options and warrants to purchase 393,200 shares of common stock were
outstanding during the three and nine months ended September 30, 2007.
Because
the Company had a loss from operations during the three and nine months ended
September 30, 2008 and 2007, those shares were excluded from the loss per share
computations because they were antidilutive.
(4) Income
Taxes
The
provision for income taxes for the three and nine months ended September 30,
2008 and 2007, was offset by a valuation allowance for deferred taxes. No
federal or state income tax benefit was provided for the three and nine months
ended September 30, 2008 and 2007, as the realization of such benefit is not
reasonably assured.
(5) Novartis
Supply and License Agreement
In
July,
2004, the Company entered into a supply and licensing agreement with Novartis,
effective January 1, 2004. By December 31, 2004, the supply portion of the
Agreement was completed and the Company no longer manufactured any product.
The
Company moved into its Edina, Minnesota facility in February 2005 after vacating
its previous manufacturing facility in Minnetonka, Minnesota. Under the
Agreement, the Company granted Novartis an exclusive license (the “License”) to
all of the intellectual property of the Company to the extent that it is used
or
is useful in the production of the vapor patches that Novartis is selling under
the Agreement. The License will continue in effect for the duration of the
patents’ life permitted under applicable law. Upon the expiration of the patents
included in the licensed intellectual property, Novartis will have a
non-revocable, perpetual, fully paid-up license to the intellectual property
used or useful in the production of vapor patches for the pediatric and the
adult cough/cold market. Novartis is required by the Agreement to pay royalties,
at an agreed upon percentage, to the Company based on net sales of vapor patches
by Novartis for each year the License is in effect.
I-6
In
June
2006, Novartis issued a nationwide recall of all of its Triaminic® vapor patch
products. In a press release issued by Novartis pertaining to the recall,
Novartis explained that the recall was “due to the serious adverse health
effects that could result if the product is ingested by a child removing the
patch and chewing on it.” At the same time that Novartis announced this
voluntary recall, the U.S. Food and Drug Administration (“FDA”) issued a release
warning consumers “not to use the Triaminic Vapor Patch due to reports of
serious adverse events associated with accidental ingestion by children.”
According to news reports, the recall resulted from an adverse event experienced
by a child who suffered a seizure after chewing on a Triaminic Vapor Patch.
Novartis confirmed to the Company that the patch involved in this incident
was
not manufactured by the Company. As a result of this recall, the Company has
been proactive in assisting Novartis to resolve the FDA issues surrounding
the
product recall and thereby restore the Company’s royalty income stream. The
Company has met with Novartis representatives to discuss how to prevent an
incident where a child or pet chews or ingests a patch.
In
January 2007, the Company engaged an independent consulting firm to audit
royalties due to the Company pursuant to the Agreement. In January 2008 the
Company was paid $21,946 as settlement for underpaid royalty income and audit
costs.
To
address the product recall described above, the Company filed a provisional
patent application with the U.S. Patent and Trademark Office (the “USPTO”) in
April 2007 for an adhesive patch with an aversive agent. The intention of the
provisional patent is to introduce an aversive agent into patches that would
be
so repulsive, a child or pet would not want to chew, swallow, or ingest a patch,
yet not impair the intended patch functionality. The Company’s new
child-proof/pet-proof patch technology is primarily designed to prevent children
from ingesting a patch, but the aversive agent will protect anyone, including
adults with dementia (i.e. Alzheimer disease) or even family pets, from chewing
a discarded patch. It is expected that this technology can be applied to
numerous patch formulations, most importantly patches potentially harmful if
ingested (i.e. nicotine patches, Alzheimer’s patches, estrogen patches,
osteoporosis patches, nitroglycerin patches, lidocaine patches, contraceptive
patches, antidepressant patches, or any future developed patch). The Company
has
received a pending trademark under the name of SAFEPATCH™.
In
April
2007, the Company was informed that the USPTO had completed a re-examination
of
a patent pertinent to the Agreement and the Company was issued a re-examination
certificate. The patent is entitled "Non-Occlusive Adhesive Patch for Applying
Medication to the Skin" and covers the design for adhesive patches, which
contain a reservoir of medication to be delivered into the body by absorption
through the skin and inhalation of vapors.
In
July
2007, Novartis began shipping a new adult vapor patch product in the United
States for the 2007/2008 cough and cold season. Novartis has not announced
whether it will re-introduce a vapor patch for the pediatric
market.
During
the three and nine month periods ended September 30, 2008, the Company recorded
royalty income of $14,022 and $40,125, respectively, based upon information
provided by Novartis related to royalties due to the Company from sales of
the
adult vapor patch during this period. The Company did not record any revenue
for
the comparable periods of 2007 due to the product recall discussed
above.
(6) Discontinued
Operations
The
liability for discontinued operations at both September 30, 2008 and December
31, 2007 consisted of a reserve for sales returns and credits of $130,000 for
sales prior to the discontinuance of operations in 2004.
(7) Equity
Transactions
Stock
Options
On
September 26, 2008, the Compensation Committee of the
Board
of Directors of the Company granted stock options to each of the three members
of the Board of Directors of the Company, as well as to its sole employee.
The
terms of the options granted to the four individuals were identical except
that
the options granted to Mr. William Johnson, the Company’s only employee,
qualified as incentive stock options under the Internal Revenue Code of 1986,
as
amended, while each of the three Directors of the Company was granted
non-qualified stock options. Mr. William Johnson, Mr. C. Andrew Rollwagen and
Dr. Daniel Sigg each received an option to purchase 16,000 shares of the
Company’s common stock at $4.00 per share and Mr. Judd Berlin received an option
to purchase 66,000 shares of the Company’s common stock at $4.00 per share. All
of the options are fully vested and exercisable as of the date of grant and
will
expire on September 26, 2018. All of the options were granted under plans
previously approved by the Company’s shareholders and the exercise price for the
options were issued at a price equal to the fair market value of the Company’s
common stock on the date of grant. All of the options provide that termination
of service as a Director or employee of the Company for any reason other than
for cause will not affect the terms of the option or cause the option to
terminate.
I-7
Warrants
In
connection with the sale of the Company’s corporate facility during 2003, the
Company issued warrants to an outside party to purchase 200,000 shares of the
Company’s common stock. The warrants were exercisable, and could be exercised on
a cashless basis, and entitled the holder to purchase the Company’s common stock
at $0.90 per share until February 25, 2008.
On
February 21, 2008, the warrant holder exercised, on a cashless basis, the
warrant. Accordingly, the warrant holder forfeited a number of shares underlying
the warrant with a “fair market value” (calculated pursuant to the warrant
agreement) and received 113,978 shares of the Company’s common stock upon
exercise of the warrant. As a result of the cashless exercise, the Company
did
not receive any cash proceeds from the exercise. As of the filing date of this
Form 10-Q, the Company has no outstanding warrants.
I-8
ITEM
2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
OVERVIEW
The
Company’s strategy is to evaluate and promote its current intellectual property
portfolio for licensing purposes to domestic and foreign manufacturers to enable
them to use the Company’s proprietary patch technology to produce or sell
topical patch products in the future. This effort will also enhance the
Company’s options with respect to future licensing opportunities, and may
attract potential merger or acquisition candidates or the sale of the Company.
The Company is taking steps to strengthen its patent portfolio for territories
of use, including the United States, Europe, and other countries. The Company
is
also focused on strengthening its position with respect to the protection of
its
rights related to its current intellectual property portfolio. It is currently
management’s intent to fund operations with royalty income from licensing
agreements or from other income derived from the protection of patent rights
pertaining to the Company’s intellectual property.
PATENTS
AND TRADEMARKS
The
Company has several U.S. and international patents related to its patch
technology. Eighteen issued U.S. patents and forty-two issued international
patents are currently assigned to the Company. The Company has four U.S. patent
pending applications including provisional applications (see below) and two
foreign applications. The patents most pertinent to the Company’s major products
have a remaining legal duration ranging from five to fourteen years. The Company
also holds three registered U.S. trademarks.
In
2008
and 2007, the Company filed for two new provisional patents, which include
(i)
adding an aversive agent to our licensed patch or other patches to prevent
ingestion by children or pets and (ii) a hand sanitizing patch that will kill
targeted infectious organisms. The hand sanitizing patch will be dry, thereby
rendering the patch harmless in the event that it is licked, chewed or exposed
to the eye.
Issued
patents can later be held invalid by the patent office issuing the patent or
by
a court. The Company cannot be certain that its patents will not be challenged,
invalidated, circumvented, or that the rights granted under the Company’s
patents will provide a competitive advantage.
The
Company uses both patents and trade secrets to protect its proprietary property
and information. To the extent the Company relies on confidential information
to
maintain its competitive position, there can be no assurance that other parties
will not independently develop the same or similar information.
On
July
25, 2008, the Company filed a Complaint for patent infringement against five
companies, alleging that the defendants have infringed upon two of the Company’s
patents relating to its medicated patch technology. The Company has disclosed
details of the pending lawsuit in previous SEC filings. In October, 2008, all
five of the defendants in these lawsuits filed answers to the Company’s
complaint. The Company is scheduled to appear in court on December 3, 2008
for a
scheduling conference. See PART II, ITEM 1 of this Form 10-Q for additional
information.
COMPARISON
OF THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2008 AND
2007
Results
of Operations
The
Company recorded royalty income of $14,022 and $40,125, respectively, for the
three and nine months ended September 30, 2008. The Company did not record
any
royalty income during the three or nine months ended September 30, 2007 as
a
result of the previously discussed product recall by Novartis. (See Note 5
of
Notes to Condensed Financial Statements in this Form 10-Q). The royalty income
recorded during the three and nine month periods ended September 30, 2008 was
based on information provided by Novartis.
Operating
expenses increased $130,585 to $599,868 for the three months ended September
30,
2008, from operating expenses of $469,283 for the comparable period in 2007.
The
increase in operating expenses resulted primarily from an increase in
compensation expense related to the issuance of stock options of $455,080 in
2008 versus compensation expense of $332,925 in 2007, coupled with increases
in
consulting expenses relating to the Company’s efforts to strengthen its patent
protection rights and associated increases in legal costs. For the nine months
ended September 30, 2008, operating expenses increased $204,154 to $974,197,
from $770,043 for the nine months ended September 30, 2007. The increase in
operating expenses resulted from increases in compensation expense related
to
the issuance of stock options, consulting, legal, and accounting costs related
to efforts the Company is undertaking to enforce its patent
portfolio.
I-9
The
Company anticipates that it can further reduce operating expenses since many
expenditures have been a one time expenditure. In addition, the Company will
also reduce its operating expenses as a result of relocating its corporate
office, reducing its rental/lease obligations, and decrease utility expenses.
However, these savings may be offset with costs related to additional actions
the Company decides to take with respect to protecting its intellectual
property.
The
Company recorded a net loss of $(582,839), or $(0.14) per basic and diluted
share for the three months ended September 30, 2008, compared to a net loss
of
$(456,995), or $(0.11) per basic and diluted share, for the same period in
2007.
For the nine months ended September 30, 2008, the Company recorded a net loss
of
$(919,917), or $(0.22) per basic and diluted share, compared to a net loss
of
$(729,412), or $(0.18) per basic and diluted share, for the same period in
the
2007. The increase in net loss for the three and nine month periods ended
September 30, 2008 from the comparable periods in 2007 is due to the increase
in
operating expenses, partially offset by the increase in royalty income discussed
above.
Income
Taxes
The
provision for income tax benefits for the three and nine months ended September
30, 2008 and 2007 was offset by a valuation allowance for deferred taxes.
No
federal or state income tax benefit was provided for the three and nine months
ended September 30, 2008 and 2007, as the realization of such benefits is not
reasonably assured.
Effect
of Inflation
Inflation
has not had a significant impact on the Company’s operations or cash
flow.
Liquidity
and Capital Resources
Cash
and cash equivalents decreased $422,818 for the nine month period ended
September 30, 2008, to $410,107, from cash and cash equivalents of $832,925
at
December 31, 2007. The decrease in cash and cash equivalents resulted primarily
from the Company incurring legal, consulting, and other costs related to the
Company protecting its patent portfolio, which was partially offset by royalty
payments of
$126,535 received during 2008, relating to sales of licensed adult vapor patch
product by Novartis.
There
were no material commitments for capital expenditures at September
30, 2008 or 2007.
The
Company had working capital of $347,320 and a current ratio of 2.67 at September
30, 2008 compared to working capital of $795,059 and a current ratio of 4.95
at
December 31, 2007. The decline in working capital and the current ratio at
September 30, 2008, compared to December 31, 2007, was primarily due to the
net
loss of ($919,917) which included non cash compensation expense of $455,080
that
the Company incurred during the nine months ended September 30,
2008.
Shareholders’
equity decreased $464,836 to $433,979 at September 30, 2008 from $898,815 at
December 31, 2007, due to the net loss the Company incurred during the nine
months ended September 30, 2008.
The
Company is cautious about preserving its current cash position with respect
to
its current litigation efforts and the ability to sustain normal operations
going forward. The Company is exploring the possibility of raising additional
capital to allow the Company to sustain normal operations in addition to
proceeding with research and development efforts in India and China relating
to
the Company’s hand sanitizer patch, its patch with aversive agent, and related
testing research. Without an infusion of cash, the royalty income received
from
Novartis may not be sufficient to fund our efforts. The Company earns interest
on its available cash. Interest income earned during the three and nine month
periods ended September 30, 2008 was $3,008 and $14,155, respectively (3.0%
average annual interest). Interest income earned during the three and nine
month
periods ended September 30, 2007 was $12,288 and $40,631, respectively (4.9%
average annual interest).
The
Company’s working capital requirements are dependent upon its receipt of
adequate levels of royalty and licensing income to fund its operations. The
Company currently estimates that it will receive $80,000 to $150,000 per year
in
royalty income based upon revised royalty estimates provided by Novartis.
Royalty income is uncertain because it is subject to factors that the Company
cannot control. There can be no assurance that the anticipated revenue stream
or
the anticipated expenses will be as planned, or that the Company will be
successful in negotiating other licensing opportunities with Novartis or other
companies, due to the uncertainties and risks described in the “Cautionary
Statements” included as Exhibit 99.01 to the Company’s annual report on Form
10-KSB for the fiscal year ended December 31, 2007 and Form 10-QSB for the
first
quarter ended March 31, 2008.
I-10
CRITICAL
ACCOUNTING POLICIES
Management
believes that the Company has not adopted any critical accounting policies
which, if changed, would result in a material change in financial estimates,
financial condition, results of operation or cash flows for the three months
ended September 30, 2008 and 2007. The critical accounting policies appear
in
Note 2 of Notes to Condensed Financial Statements in this Form
10-Q.
I-11
ITEM
3. QUANTITATIVE
AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS
Not
Applicable.
ITEM
4. CONTROLS AND PROCEDURES
Under
the supervision and with the participation of our management, including our
principal executive officer and principal financial officer, we have evaluated
the effectiveness of the design and operation of our 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”), that are designed to ensure that
information required to be disclosed by us in reports we file or submit under
the Exchange Act is recorded, processed, summarized and reported within the
time
periods specified in the SEC’s rules and forms, and that such information is
accumulated and communicated to our management, including our Chief Executive
Officer and Chief Financial Officer, and Board of Directors, as appropriate,
to
allow timely decisions regarding required disclosure. Based upon this
evaluation, the principal executive officer and principal financial officer
have
concluded that, as of the end of the period covered by this report, our
disclosure controls and procedures were effective.
During
the three months ended September 30, 2008, there were no changes in the
Company’s internal control over financial reporting (as defined in Rule
13a-15(f) under the Exchange Act) that has materially affected, or is reasonably
likely to materially affect, the Company’s internal control over financial
reporting.
I-12
PART
II -OTHER INFORMATION
ITEM
1 - LEGAL PROCEEDINGS
On
July
25, 2008, the Company filed a complaint for patent infringement (the
“Complaint”) against five companies, including Chattem, Inc., Endo
Pharmaceuticals, Inc., Johnson & Johnson Consumer Company, Inc., The
Mentholatum Company, Inc. and Prince of Peace Enterprises, Inc. (collectively,
the “Defendants”) in the U.S. District Court for the Eastern District of Texas.
The Complaint alleges, among other things, that the Defendants have infringed
two of the Company’s patents (the “Patents”), which relate to the Company’s
medicated patch technology. The Company is seeking to enjoin the Defendants
from
infringing the Patents and to recover monetary damages related to such
infringement, as well as interest and litigation costs. In October 2008, all
five of the Defendants filed answers (the "Answers") in response to the
Complaint denying the Company's claims therein, and asserting certain
affirmative defenses and counterclaims against the Company, including assertions
that the Patents are invalid and unenforceable, and claims for attorneys' fees
and costs. On October 20, 2008, the Company filed its replies to the Answers,
denying such counterclaims and affirmative defenses, including the claims that
the Patents are invalid and unenforceable. The Company is scheduled to appear
in
court on December 3, 2008 for a scheduling conference.
ITEM
1A - RISK FACTORS
Not
Applicable.
ITEM
2 - UNREGISTERED SALES OF EQUITY SECURITIES
AND USE OF PROCEEDS
None.
ITEM
3 - DEFAULTS UPON SENIOR SECURITIES
None.
ITEM
4 - SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
ITEM
5 - OTHER INFORMATION
None.
|
II-1
ITEM
6 - EXHIBITS
Exhibit
No.
|
Description
|
3.01
|
Articles
of Incorporation of LecTec Corporation, as amended (Incorporated
herein by
reference to the Company’s Form S-1 Registration Statement (file number
33-9774C) filed on October 31, 1986 and amended on December 12,
1986).
|
3.02
|
Bylaws
of LecTec Corporation (Incorporated herein by reference to the Company’s
Form S-1 Registration Statement (file number 33-9774C) filed on October
31, 1986 and amended on December 12, 1986).
|
31.01
|
Certification
of Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002, filed herewith.
|
31.02
|
Certification
of Principle Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002, filed herewith.
|
32.01
|
Certification
Pursuant to 18 U.S.C. §1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, filed herewith.
|
99.01
|
Cautionary
Statements (Incorporated herein by reference to Exhibit 99.01 to
the
Company’s Report on Form 10-QSB for the quarter ended March 31,
2008).
|
II-2
SIGNATURES
Pursuant
to the requirements 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.
LECTEC CORPORATION | |||
Date:
|
November
19, 2008
|
By
/s/ Judd A. Berlin
|
|
Judd
A. Berlin
|
|||
Chief
Executive Officer, Chief Financial Officer, &
Director
|
|||
(principal
financial officer and duly authorized officer)
|
|||
II-3
EXHIBIT
INDEX
Exhibit
No.
|
Description
|
3.01
|
Articles
of Incorporation of LecTec Corporation, as amended (Incorporated
herein by
reference to the Company’s Form S-1 Registration Statement (file number
33-9774C) filed on October 31, 1986 and amended on December 12,
1986).
|
3.02
|
Bylaws
of LecTec Corporation (Incorporated herein by reference to the Company’s
Form S-1 Registration Statement (file number 33-9774C) filed on October
31, 1986 and amended on December 12, 1986).
|
31.01
|
Certification
of Principal Executive Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002, filed herewith.
|
31.02
|
Certification
of Principle Financial Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002, filed herewith.
|
32.01
|
Certification
Pursuant to 18 U.S.C. §1350, as Adopted Pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, filed herewith.
|
99.01
|
Cautionary
Statements (Incorporated herein by reference to Exhibit 99.01 to
the
Company’s Report on Form 10-QSB for the quarter ended March 31,
2008).
|