Axogen, Inc. - Quarter Report: 2009 September (Form 10-Q)
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ | 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
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 incorporation or organization) |
(I.R.S. Employer Identification No.) |
|
1407 South Kings Highway, Texarkana, TX | 75501 | |
(Address of principal executive offices) | (Zip Code) |
(903)-832-0993
(Registrants 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 þ NO o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months
(or for such shorter period that the registrant was required to submit and post such files). YES o NO o
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 | Smaller reporting company þ | |||
(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). YES o NO þ
As of November 16, 2009 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, 2009
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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 Companys
dependence on royalty payments from Novartis Consumer Health, Inc., which is selling an adult
vapor patch licensed by the Company, the Companys 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, the outcome of pending patent infringement litigation against
Chattem, Inc., Johnson & Johnson Consumer Company, Inc., a subsidiary
of Johnson & Johnson, and Prince of Peace Enterprises, Inc., the issuance of new accounting
pronouncements, information disseminated on internet message boards from posters expressing
opinions that may or may not be factual, the availability of opportunities for licensing
agreements related to patents that the Company holds, limitations on market expansion
opportunities, the inclusion of a going-concern qualification in the Companys Form 10-K for the
year ended December 31, 2008 from the Companys independent registered public accounting firm, and
other risks and uncertainties as described in Risk Factors included in Item 1A as filed in the
Companys Form 10-K for the year ended December 31, 2008.
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PART
1 FINANCIAL INFORMATION
ITEM
1 CONDENSED FINANCIAL STATEMENTS AND NOTES TO
CONDENSED FINANCIAL STATEMENTS
LECTEC CORPORATION
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS
September 30, | December 31, | |||||||
2009 | 2008 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 227,482 | $ | 332,848 | ||||
Infringement and royalty receivable |
123,937 | 32,586 | ||||||
Prepaid expenses and other |
65,965 | 88,823 | ||||||
Total current assets |
417,384 | 454,257 | ||||||
FIXED ASSETS: |
||||||||
Office equipment |
6,633 | 6,633 | ||||||
Accumulated depreciation |
(2,360 | ) | (701 | ) | ||||
4,273 | 5,932 | |||||||
OTHER ASSETS: |
||||||||
Patent costs |
34,311 | 43,775 | ||||||
Prepaid
insurance director and officer |
| 20,279 | ||||||
34,311 | 64,054 | |||||||
TOTAL ASSETS |
$ | 455,968 | $ | 524,243 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 47,000 | $ | 26,155 | ||||
Accrued expenses |
92,225 | 54,901 | ||||||
Discontinued operations |
130,000 | 130,000 | ||||||
Total current liabilities |
269,225 | 211,056 | ||||||
SHAREHOLDERS EQUITY: |
||||||||
Common stock, $.01 par value; 15,000,000 shares
authorized; 4,290,026 shares
issued and outstanding at September 30, 2009
and December 31, 2008 |
42,900 | 42,900 | ||||||
Additional contributed capital |
12,652,219 | 12,652,219 | ||||||
Accumulated deficit |
(12,508,376 | ) | (12,381,932 | ) | ||||
186,743 | 313,187 | |||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 455,968 | $ | 524,243 | ||||
The accompanying notes are an integral part of these condensed financial statements.
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LECTEC CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2009 | 2008 | 2009 | 2008 | |||||||||||||
REVENUE: |
||||||||||||||||
Royalty and licensing fees |
$ | 24,215 | $ | 14,022 | $ | 76,633 | $ | 40,125 | ||||||||
Infringement income |
| | 600,000 | | ||||||||||||
TOTAL REVENUE |
24,215 | 14,022 | 676,633 | 40,125 | ||||||||||||
OPERATING EXPENSES |
155,221 | 599,869 | 803,809 | 974,197 | ||||||||||||
Loss from operations |
(131,006 | ) | (585,847 | ) | (127,176 | ) | (934,072 | ) | ||||||||
INTEREST INCOME |
32 | 3,008 | 732 | 14,155 | ||||||||||||
NET LOSS |
$ | (130,974 | ) | $ | (582,839 | ) | $ | (126,444 | ) | $ | (919,917 | ) | ||||
WEIGHTED AVERAGE COMMON
SHARES OUTSTANDING: |
||||||||||||||||
Basic and diluted |
4,290,026 | 4,290,026 | 4,290,026 | 4,269,227 | ||||||||||||
LOSS PER COMMON SHARE: |
||||||||||||||||
Basic and diluted |
$ | (0.03 | ) | $ | (0.14 | ) | $ | (0.03 | ) | $ | (0.22 | ) | ||||
The accompanying notes are an integral part of these condensed financial statements.
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LECTEC CORPORATION
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine Months Ended September 30, | ||||||||
2009 | 2008 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (126,444 | ) | $ | (919,917 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation expense |
1,659 | | ||||||
Compensation expense related to issuance of stock options |
| 455,080 | ||||||
Amortization of patent costs |
16,189 | 16,591 | ||||||
Changes in operating assets and liabilities: |
||||||||
Infringement and royalty receivable |
(91,351 | ) | 86,409 | |||||
Prepaid expenses and other |
43,137 | (37,745 | ) | |||||
Accounts payable |
20,845 | 11,540 | ||||||
Accrued expenses |
37,324 | (4,863 | ) | |||||
Net cash used in operating activities |
(98,641 | ) | (392,905 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchase of office equipment |
| (6,633 | ) | |||||
Investment in patents |
(6,725 | ) | (23,280 | ) | ||||
Net cash used in investing activities |
(6,725 | ) | (29,913 | ) | ||||
Net decrease in cash and cash equivalents |
(105,366 | ) | (422,818 | ) | ||||
Cash and
cash equivalents beginning of period |
332,848 | 832,925 | ||||||
Cash and
cash equivalents end of period |
$ | 227,482 | $ | 410,107 | ||||
The accompanying notes are an integral part of these condensed financial statements.
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LECTEC CORPORATION
Notes to Condensed Financial Statements
September 30, 2009 and 2008
Notes to Condensed Financial Statements
September 30, 2009 and 2008
(Unaudited)
(1) Basis of Presentation
The accompanying condensed financial statements include the accounts of LecTec Corporation
(the Company) as of September 30, 2009 and December 31, 2008 and for the three and nine month
periods ended September 30, 2009 and 2008, respectively. The Companys 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 Companys Annual Report on Form
10-K for the year ended December 31, 2008. 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 Companys 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 that 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 that has an affinity for water and similar compounds. These
hydrogels are ideal for delivering medication onto the skin.
Corporate Office and Premises Summary
The Companys principal executive office is located in Texarkana, Texas where it leases
approximately 1,200 square feet of warehouse and office space. The lease began in August 2008 and
expires on February 1, 2010. The Company intends to renew this lease before it expires.
The Company currently has three leased facilities as of September 30, 2009.
In January 2009, 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 Companys previous headquarters located at 5610 Lincoln Drive, Edina,
Minnesota (the Leased Premises). The Lease Amendment will continue to renew for successive
one-month periods until the Minnesota Lease is terminated by the landlord upon 30 days written
notice to the Company or by the Company upon 90 days written notice to the landlord. The Company
uses the space for liquidating saleable assets and managing an orderly wind down of operations at
this facility. The Company maintains approximately 3,300 square feet of space at this facility.
In July 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 was $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. In February 2009, the Company
renewed its Texas Lease until February 1, 2010 at a monthly lease rate of $700 per month. The
Texas Lease contains customary representations, warranties and covenants on the part of the Company
and the landlord.
In July 2008, the Company opened an office in India, which is located at 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 to be one of the most robust,
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globally competitive, and cost-efficient locations for the development and manufacturing of
pharmaceutical and medical products. The Company also wants to have better access to the pool of
well-educated scientific and engineering talent available in India. This lease expired on July 31,
2009. The Company gave written notification of its intent to renew this lease until July 31, 2010
and subsequently made a payment of $1,456 in August 2009 to fulfill the Companys rental obligation
for the renewal period.
Critical Accounting Policies
The Companys 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
when collection is reasonably assured. Infringement revenues are recognized when agreements are
reached and signed 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 to
the Company pursuant to the terms of the Agreement. At September 30, 2009, the Company had an
outstanding royalty receivable with Novartis of $23,937 which was subsequently paid on October 30,
2009. The Company records royalty income based on information provided by Novartis. Management
believes, based upon past collection experience, that amounts due from Novartis outstanding from
time to time are fully collectible.
Infringement Receivable. In May 2009, the Company entered into a settlement agreement and
mutual release with the Mentholatum Company (see Note 9 of this Form 10-Q for details of the
settlement agreement). At September 30, 2009 the Company had an outstanding receivable of $100,000
with the Mentholatum Company which was subsequently received on October 20, 2009. As of the date
of the filing of this Form 10-Q, the Company has received all amounts due from the Mentholatum
Company pursuant to the terms of the settlement agreement and mutual release.
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, 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. The Company accounts for share-based compensation in
accordance with 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. The
Company did not record any share-based compensation during the three and nine month periods ended
September 30, 2009. During the three and nine month periods ended September 30, 2008, the Company
recorded compensation expense of $455,080.
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 Companys 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 Companys common stock at $4.00 per share and Mr. Judd Berlin received an option to
purchase 66,000 shares of the Companys 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 Companys shareholders and the
exercise price for the options were issued at a price equal to the fair market value of the
Companys 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. As a result of this transaction,
the Company recorded share-based compensation expense of $455,080 or $0.11 per share for the three
and nine month periods ended September 30,
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2008. The fair value of the options granted were
determined utilizing the Black-Scholes-Merton option pricing model. All of the Companys options were fully vested, and there were no modifications to existing grants,
during the three and nine month periods ended September 30, 2009 and 2008.
Off-Balance Sheet Arrangements The Company does not have any off-balance sheet arrangements
(as such term is defined in Item 303 of Regulation S-K) that are reasonably likely to have a
current or future effect on our financial condition, changes in financial condition, revenues or
expenses, operating results, liquidity, capital expenditures or capital resources.
Recent Accounting Pronouncements:
In February 2008, the Financial Accounting Standard Board (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 adoption of FSP FAS
157-2 did not to have a material impact on the Companys financial position or results of
operations.
In April 2008, the FASB issued FSP FAS 142-3, Determination of the Useful Life of Intangible
Assets (FSP FAS 142-3). FSP FAS 142-3 amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful life of a recognized intangible asset
under Statement of Financial Accounting Standards (SFAS) No. 142, Goodwill and Other Intangible
Assets (SFAS 142). The intent of FSP FAS 142-3 is to improve the consistency between the useful
life of a recognized intangible asset under SFAS 142 and the period of expected cash flows used to
measure the fair value of the asset under SFAS No. 141R (revised 2007), Business Combinations, and
other generally accepted accounting principals. FSP FAS 142-3 is effective for financial
statements issued for fiscal years beginning after December 15, 2008, and interim periods within
those fiscal years. The adoption of FSP FAS 142-3 did not have a material impact on the Companys
financial position or results of operations.
In April 2009, the FASB issued FSP FAS 107-1 and APB 28-1, Interim Disclosures about Fair
Value of Financial Instruments (FSP FAS 107-1). FSP FAS 107-1 essentially expands the disclosure
about fair value of financial instruments that were previously required only annually to also be
required for interim period reporting. In addition, FSP FAS 107-1 requires certain additional
disclosures regarding the methods and significant assumptions used to estimate the fair value of
financial instruments. FSP FAS 107-1 is effective for interim and annual periods ending after June
15, 2009. The adoption of FSP FAS 107-1 did not have a material impact on the Companys financial
position or results of operations.
In May 2009, the FASB issued SFAS No. 165, Subsequent Events (SFAS 165). SFAS 165
establishes general standards of accounting for and disclosure of events that occur after the
balance sheet date but before financial statements are issued or are available to be issued. It
requires disclosure of the date through which an entity has evaluated subsequent events. The
Company adopted SFAS 165 in the second quarter of 2009 and the adoption of SFAS 165 did not impact
the Companys financial statements. The Company has evaluated all events or transactions that
occurred after September 30, 2009 up through November 16, 2009, the date the Company issued these
financial statements. The Company has disclosed a subsequent event that occurred in November 2009
in Note 12 of Notes to Condensed Financial Statements in Part I, Item 1 of this Form 10-Q.
In June 2009, the FASB issued SFAS No. 168, The FASB Accounting Standards Codification and
The Hierarchy of Generally Accepted Accounting Principles. This standard replaces SFAS No. 162,
The Hierarchy of Generally Accepted Accounting Principles, and establishes only two levels of U.S.
generally accepted accounting principles (GAAP), authoritative and non-authoritative. The FASB
Accounting Standards Codification (the Codification) will become the source of authoritative,
nongovernmental GAAP, except for rules and interpretive releases of the Securities and Exchange
Commission (SEC), which are sources of authoritative GAAP for SEC registrants. All other
non-grandfathered, non-SEC accounting literature not included in the Codification will become
non-authoritative. This standard is effective for financial statements for interim or annual
reporting periods ending after September 15, 2009. As the Codification was not intended to change
or alter existing GAAP, it will not have any impact on the Companys 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
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options to purchase 264,000 shares of common
stock with a weighted average exercise price of $3.94 per share were outstanding during the three
and nine months ended September 30, 2009. Common stock options and warrants to purchase
269,200 shares of common stock with a weighted average exercise price of $3.93 were outstanding
during the three and nine months ended September 30, 2008. Because the Company had a loss from
operations during the three and nine months ended September 30, 2009 and 2008, 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, 2009 and
2008, 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, 2009 and 2008, 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. 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 to the Company at
an agreed upon percentage based on net sales of vapor patches by Novartis for each year the License
is in effect.
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 was proactive in assisting
Novartis to resolve the FDA issues surrounding the product recall in order to restore the Companys
royalty income stream. The Company met with Novartis representatives to discuss how to prevent an
incident where a child or pet chews or ingests a patch and also discussed potential opportunities
related to other patents the Company holds, including pending patent applications that the Company
has applied for.
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 by Novartis
as settlement for underpaid royalty income and audit costs.
In April 2007, the Company was informed that the U.S. Patent and Trademark Office (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 through the inhalation of vapors.
Beginning in July 2007, Novartis began shipping the adult vapor patch product in the United
States, Canada, and Mexico for the cough, cold, and flu seasons. Novartis has not announced
whether it will re-introduce a vapor patch for the pediatric market.
Currently, the product is marketed under the Theraflu brand name by Novartis as VaporPatch.
Novartis advertises and markets the VaporPatch via TV commercials, information on Novartis
website, and various stores continue to shelve and sell the VaporPatch product. The Company
continues to receive royalty income under the terms of the Novartis Agreement.
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During the three and nine months ended September 30, 2009, the Company recorded revenue of
$24,215 and $76,633, respectively, for royalties received under the Agreement. During the three
and nine months ended September 30, 2008, the Company recorded revenue of $14,022 and $40,125,
respectively, for royalties received under the Agreement.
(6) Discontinued Operations
The Company ceased manufacturing operations of topical patches and sold all of its
manufacturing assets related to the production of patches to its only remaining customer, Novartis,
as of December 31, 2004. The liability for discontinued operations at September 30, 2009 and
December 31, 2008 consisted of a reserve for sales returns and credits of $130,000 related to sales
prior to the discontinuance of operations.
(7) Equity Transactions
Warrants
In connection with the sale of the Companys corporate facility during 2003, the Company
issued warrants to an outside party to purchase 200,000 shares of the Companys common stock. The
warrants were exercisable, and could be exercised on a cashless basis, and entitled the holder to
purchase the Companys 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
Companys 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.
(8) 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 Companys
major products have a remaining legal duration ranging from approximately five to fourteen years.
The Company also holds three registered U.S. trademarks.
In 2008 and 2007, the Company filed for two 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 is intended to be dry, thereby rendering the patch harmless in the event that it is licked,
chewed or exposed to the eye. The Company can give no assurance to the intended purpose of the
claims related to these patents until these patents are issued
On September 11, 2009 the international patent for the hand sanitizing patch was published. A
published patent does not mean the patent has been issued. Based upon information from the
Companys patent attorneys, it can take up to three years for a patent to be issued once it has
been published, however, the application does give the Company a priority date. This applies to
our U.S. and our international applications for the hand sanitizer and aversive agent patches.
Issued patents can later be held invalid by the patent office issuing the patent or by a court
of law. The Company cannot be certain that its patents will not be challenged, invalidated,
circumvented, or that the rights granted under the Companys patents will provide a competitive
advantage.
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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 Companys 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 Companys complaint. The Company appeared in court on December 3, 2008 for a scheduling
conference.
In February 2009, the Companys legal counsel filed with the Court a motion to preliminarily
enjoin the defendants from infringing the Companys patents pending a jury trial scheduled for
January 11, 2011. A hearing on this preliminary injunction
motion was scheduled for November 12, 2009, in Texarkana, Texas. The
Company subsequently cancelled this hearing due to legal
considerations after it agreed to settle with a second defendant in
the action. The Company will continue to
pursue settlement options with respect to the other defendants. The Company can not give any
assurance as to the outcome of future negotiations. See PART II, ITEM 1 of this Form 10-Q for
additional information.
(9) Mentholatum Settlement
On May 29, 2009, the Company entered into a Settlement Agreement and Mutual Release (the
Mentholatum Settlement Agreement) with the Mentholatum Company (Mentholatum) to settle the Companys claims
against Mentholatum that Mentholatum infringed two of the Companys patents (PatentsInSuit)
related to its medicated patch technology (the
Litigation). Pursuant to the Mentholatum Settlement
Agreement, Mentholatum will pay the Company an aggregate of $600,000 in $100,000 monthly
installments from May through October 2009. In addition, under
the Mentholatum Settlement Agreement (a) the
Company agreed to dismiss the Litigation against Mentholatum with prejudice, (b) the parties agreed
to mutual general releases of all claims other than their prospective obligations under the
Mentholatum Settlement Agreement and claims arising after the date of
the Mentholatum Settlement Agreement, (c) the Company
agreed not to sue Mentholatum or Rohto Pharmaceutical Co., Ltd., the parent company of Mentholatum,
for any infringement of the PatentsInSuit, any patent that claims priority, directly or
indirectly, from the PatentsInSuit, or any foreign counterparts of the PatentsInSuit
(collectively, the Patents), (d) the Company agreed not to transfer the Patents unless the
transferee agrees to be bound by the covenant not to sue described above in clause (c), and (e).
Mentholatum and Rohto agreed not to challenge the validity or enforceability of the Patents.
As of September 30, 2009, Mentholatum had paid the Company $500,000 pursuant to the terms of
the Mentholatum Settlement Agreement, and as of October 20, 2009, the Company had been paid the entire $600,000
pursuant to the terms of the Mentholatum Settlement Agreement. The proceeds received from this settlement have been reduced by the amounts due to the Raider firm. The Companies contingent fee, out of pocket expenses, and other costs incurred related to depositions of parties in the infringement lawsuits and other related costs. After these expenses the company received net cash proceeds of approximately $300,000 from the Mentholatum settlement.
(10) Officer Reimbursement
The accounts payable balance of $47,000 at September 30, 2009 includes $30,000 that the Board
of Directors has determined to pay to Judd Berlin, the Companys Chief Executive Officer. The
Board of Directors determined to make the payment to Mr. Berlin to compensate him for the loss of
his foreign earned income exclusion of $87,600. The estimated tax implication to Mr. Berlin is
approximately $30,000. The forfeiture of his deduction results from Mr. Berlin spending more than
30 days in the United States to attend meetings and depositions on behalf of the Company. The
Board of Directors has determined that the $30,000 will be paid to Mr. Berlin out of proceeds
received from future infringement settlements, if any.
(11) Going Concern
The Company has incurred operating losses, accumulated deficits and negative cash flows from
operations during the last several years. As of September 30, 2009, the Company had an accumulated
shareholders deficit of $12,508,376. At September 30, 2009, the Company had substantial doubt
that its existing cash and cash equivalents would be sufficient to fund operations through 2010 and
beyond based upon its current cash on hand, its anticipated operating expenses, costs the Company
is likely to incur related to its pending patent infringement litigation, receipt of sufficient
royalty income, and uncertainties about the potential settlements the Company may receive as a
result of its ongoing litigation efforts. The going concern issue will be mitigated by the Companys settlement on November 6, 2009 with Endo Pharmaceuticals Inc. which
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will provide the Company
with additional cash in December 2009. See Note 12 of Notes to Condensed Financial
Statements in Part I, Item 1 for more information.
The Company is exploring means to raise additional capital including future patent
infringement settlements, to allow the Company to sustain normal operations in 2009 and beyond and
proceed with R&D efforts in India and China
relating to the Companys hand sanitizer patch, its patch with aversive agent, other patents
the Company holds, and related testing and research efforts. In addition to these efforts to raise
additional capital, the Companys strategy includes pursuing additional licensing agreements with
interested companies; negotiating additional patent infringement settlement agreements; potential
partnering arrangements with Novartis or other companies; evaluating merger and acquisition
possibilities; and exploring partnerships with domestic and foreign manufacturers to develop and
commercialize the Companys proprietary patch technology.
The Companys financial statements do not include any adjustments related to recoverability
and classification of asset carrying amounts or the amount and classification of liabilities that
might result should the Company be unable to continue as a going concern.
(12) Subsequent Event
On November 6, 2009, the Company and Endo Pharmaceuticals Inc. (Endo), executed a Term Sheet
that set forth the terms of a settlement and license agreement pursuant to which the parties would
settle the Companys claims against Endo that Endo infringed the
PatentsInSuit in the Litigation. On
November 11, 2009, the Company entered into such Settlement and
License Agreement (the Endo Settlement
Agreement) with Endo and issued a press release announcing
its entry into the Endo Settlement
Agreement. On November 12, 2009 the Company filed a Form 8-K with the Securities and Exchange
Commission disclosing this event.
Pursuant
to the Endo Settlement Agreement, Endo will pay the Company a onetime license fee of
$23,000,000 and the Company will grant to Endo an exclusive license to the PatentsInSuit for use
in the field of prescription pain medicines and treatment. In
addition, under the Endo Settlement
Agreement: (a) the parties agreed to the dismissal of the Litigation with prejudice and without
costs; (b) the Company agreed to release all claims against Endo that were asserted by or could
have been asserted by the Company against Endo in the Litigation or that relate to, arise from or
are in any manner connected to the PatentsInSuit; (c) Endo agreed to release all claims against
the Company that were asserted by or could have been asserted by Endo against the Company in the
Litigation; (d) the Company agreed not to sue Endo for any infringement of any U.S. or foreign
patents or patent applications owned or controlled by the Company as
of November 11, 2009, any continuation,
continuationinpart or divisional of any such patent,
any U.S. patent resulting from the reissue or reexamination of any of
such patents and any U.S. or
foreign patent or patent application claiming common priority with
any of such patents; and (e) the
Company agreed not to transfer either of the
PatentsInSuit or any other such patent unless the transferee agrees in
writing to the terms and conditions of the Endo Settlement Agreement.
The Company anticipates receiving approximately $16 million in net cash proceeds from this
settlement. The agreement also calls for payment on or before December 15, 2009. From these
proceeds the Company intends to replenish the trust fund it has with the Rader Firm with $1 million
dollars to fund ongoing patent litigation. If funds are not completely expended, then the
remaining cash balance in the trust fund will revert to the Company. Additionally, the Company
estimates that it will have to pay federal and state taxes of approximately $1 to $1.5 million
dollars related to this transaction.
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ITEM 2 MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
OVERVIEW
The Companys 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 Companys
proprietary patch technology to produce or sell topical patch products in the future. This effort
will also enhance the Companys 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 managements intent to fund operations with royalty income from
licensing agreements or from other income derived from the protection of patent rights pertaining
to the Companys intellectual property.
In February 2007, the Company engaged a consulting firm to conduct an extensive market
research and intellectual property analysis of its patent portfolio and technology. The Company
subsequently evaluated emerging markets as a strategic growth opportunity for the Company and
determined that India has significant potential. The Company has opened an office in India and is
specifically evaluating R&D opportunities, strategic partnerships and potential licensing
opportunities.
In April 2007, the Company was granted a re-examination certificate that expanded the
Companys prior claims related to a patent the Company holds. The Company continues to take steps
to evaluate its current position in light of this event, including market research studies, product
testing, and using other outside resources in conjunction with other efforts to gather and document
information to aid in the protection of the Companys patent rights.
In June 2006, Novartis issued a nationwide recall of all of its vapor patch products sold
under the Novartis Agreement. See Note 5 of Notes to Condensed Financial Statements in Part I,
Item 1 for more information.
In 2007, Novartis launched an adult vapor patch product in the United States for the cough,
cold and flu season. This was a significant development for the Company in its effort to restart
its revenue stream. As a result of the launch of the adult vapor patch, the Company is, once
again, receiving royalty income based upon sales of these vapor patch products under the terms of
the Novartis Agreement.
In 2008, the Company retained a contingent fee legal firm to enforce the Companys rights
related to potential patent infringement claims by the Company. As a result, the Company has sued
five potential patent infringers. The Company has made a motion for a preliminary injunction in
the U.S. District Court for the Eastern District of Texas against the defendants that would prevent
the defendants from selling potentially infringing products until the Companys claims are
resolved.
In May 2009, the Company executed a settlement agreement and mutual release with one of these
defendants and subsequently settled with another defendant in
November 2009. See Notes 9 and 12 of Notes to
Condensed Financial Statements in Part I, Item 1 for more information. The Company was scheduled
for a hearing in Texarkana, Texas on November 12, 2009 relating
to the preliminary injunction motion
it filed in the Litigation. The Company
subsequently cancelled this hearing due to legal considerations after
it agreed to settle with a second defendant in the action. The Company will continue to pursue settlement options with respect to the
other defendants. The Company can not give any assurance as to the outcome of future negotiations.
The Company continues to explore opportunities with other companies that may have an interest
in our technology and patent portfolio. The Company is also exploring opportunities surrounding R
& D.
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COMPARISON OF THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2009 AND 2008
Results of Operations
The Company recorded revenue of $24,215 and $676,633 for the three and nine month periods
ended September 30, 2009, respectively. The Company recorded revenue of $14,022 and $40,125 for
the three and nine month periods ended September 30, 2008, respectively. The increase in revenue
for the nine month period ended September 30, 2009 over the comparable period in 2008 was primarily
due to an increase in infringement revenue of $600,000. Royalty income also increased $10,193 and
$36,508 for the three and nine month periods ended September 30, 2009, respectively, from the
comparable periods in 2008. The increase in royalty income for the three and nine months periods
ended September 30, 2009 over the comparable period in 2008, was due to stronger sales of licensed
products in Mexico. The royalty income recorded during the three and nine month periods ended
September 30, 2009 and 2008 was based on information provided by Novartis.
Operating expenses decreased $444,648, to $155,221 for the three months ended September 30,
2009, from operating expenses of $599,869 for the comparable period in 2008. The decrease in
operating expenses resulted primarily from the Company recording compensation expense of $455,080
related to the issuance of stock options during the third quarter ended September 30, 2008. For
the nine months ended September 30, 2009, operating expenses decreased $170,388 to $803,809, from
$974,197 for the nine months ended September 30, 2008. The decrease in operating expenses is due
primarily due to a reduction in compensation expense of $455,080 coupled with a reduction in
general operating expenses which were partially offset by expenses incurred in connection with the
Companys patent infringement lawsuit, including approximately $300,000 in litigation settlement
fees, and consulting, legal, other out of pocket expenses.
The Company recorded a net loss of $(130,974), or $(0.03) per basic and diluted share for the
three months ended September 30, 2009, compared to a net loss of $(582,839), or $(0.14) per basic
and diluted share, for the same period in 2008. The improvement in the net loss of $451,865 for
the three month period ended September 30, 2009 from the comparable period in 2008 is primarily due
to the Company not recording any compensation expense for the three months ended September 30, 2009
compared to the Company recording compensation expense of $455,080 during the three months ended
September 30, 2008. For the nine months ended September 30, 2009, the Company recorded a net loss
of $(126,444), or $(0.03) per basic and diluted share, compared to a net loss of $(919,917), or
$(0.22) per basic and diluted share, for the same period in the 2008. The improvement in the net
loss of $793,473 for the nine month period ended September 30, 2009 compared to the net loss for
the comparable period in 2008 is due to an increase in infringement income of $600,000, and an
increase in royalty income of $36,508, coupled with reductions in general operating expenses
including lack of compensation expense of $455,080, which was partially offset by increases in
costs of approximately $300,000 associated with the Companys litigation efforts.
Income Taxes
The provision for income tax benefits for the three and nine month periods ended September 30,
2009 and 2008 was offset by a valuation allowance for deferred taxes. No federal or state income
tax benefit was provided for the three and nine month periods ended September 30, 2009 and 2008, as
the realization of such benefits is not reasonably assured.
Effect of Inflation
Inflation has not had a significant impact on the Companys operations or cash flow.
Liquidity and Capital Resources
Cash and cash equivalents decreased $105,366 for the nine month period ended September 30,
2009, to $227,482, from cash and cash equivalents of $332,848 at December 31, 2008. The decrease
in cash and cash equivalents resulted primarily from the Companys ongoing expenses to maintain
current operations of the Company.
The Company had no material commitments for capital expenditures at September 30, 2009 or
2008.
The Company had working capital of $148,159 and a current ratio of 1.55 at September 30, 2009
compared to working capital of $243,201 and a current ratio of 2.15 at December 31, 2008. The
decline in working capital and the
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current ratio at September 30, 2009, compared to December 31,
2008, was primarily due to the net loss of $(126,444) the Company incurred during the nine months
ended September 30, 2009.
Shareholders equity decreased $(126,444) to $186,743 at September 30, 2009 from $313,187 at
December 31, 2008, due to the net loss generated by the Company during the nine month period ended
September 30, 2009.
In June 2008, the Company entered into a contingent fee agreement with Rader, Fishman & Grauer
PLLC (Rader firm), its legal counsel in the pending patent infringement litigation (See Part II,
Item 1 of this Form 10-Q for additional details). Under the agreement, the Rader firm will receive
a percentage of any recovery in the litigation or other proceeds resulting from a settlement of the
litigation as its primary compensation for representing the Company in this matter. The Company is
also obligated (i) to reimburse the Rader firm for its out-of-pocket expenses in connection with
the litigation, and (ii) to engage and pay for expert services needed in the litigation, provided
that the Companys obligation to advance such funds and pay such expert expenses will be suspended
if the Companys cash levels fall below certain thresholds. Thereafter, if the Companys cash
levels exceed such thresholds, or there is a recovery in or other proceeds from the litigation,
then the Rader firm will be reimbursed for any expenses it has covered while such advances and
payments were suspended. Pursuant to the Agreement the Company has with the Rader firm, a trust
account was established for the purpose of funding out of pocket expenses and advances made by the
Company for incurred expenses. The trust account earns nominal interest and the Company has
recorded interest income of $511 for the nine months ended September 30, 2009. Through September
30, 2009, the Company has paid approximately $152,000 (net of interest income) in advances and out
of pocket expenses from the trust fund to the Rader firm. The trust fund balance as of September
30, 2009 was $5,036. The Company has also paid additional costs outside of the trust fund of
approximately $67,000 for expert services and deposition costs. The Company is also obligated to
pay the Rader firm a percentage of any proceeds it receives from settlement of its pending
lawsuits.
The Company is diligent about preserving its current cash flow with respect to its current
litigation efforts and its ability to sustain normal operations going forward. The Company is
exploring 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 Companys
hand sanitizer patch, its patch with aversive agent, and other patents the Company holds, as well
as related R & D and testing research. Without adequate cash or additional infringement settlement
income, the royalty income received from Novartis, or other sources may not be sufficient to fund
our efforts.
The Company earns interest on its available cash in addition to the trust arrangement the
Company has with the Radar firm. Interest income earned during the three and nine month periods
ended September 30, 2009 was $32 and $732, respectively. Interest income earned during the three
and nine month periods ended September 30, 2008 was $3,008 and $14,155, respectively. The current
average interest the Company earns on its available cash is less than 1%. The decrease in interest
income for the three and nine month periods ended September 30, 2009 from the comparable periods in
2008, results from a decrease in the Companys cash available for investment and a general decline
in interest rates because of the current economic conditions.
The Companys working capital requirements are dependent upon receipt of adequate levels of
royalty and licensing income to fund its operations. The Company currently estimates that it will
receive $80,000 to $100,000 per year in royalty income based upon historical royalty income and
subsequent cash received from Novartis. Royalty income is uncertain because it is subject to
factors that the Company cannot control.
The Company entered into a settlement agreement and mutual release with Mentholatum for
$600,000, which was payable in $100,000 monthly installments from May through October 2009, which
provided cash flow for the Company and a short term cash infusion that offset the Companys net
cash usage of approximately $35,000 per month. The proceeds received from this settlement have been reduced by the amounts due to the Raider firm. The Companies contingent fee, out of pocket expenses, and other costs incurred related to depositions of parties in the infringement lawsuits and other related costs. After these expenses the company received net cash proceeds of approximately $300,000 from the Mentholatum settlement.
On November 6, 2009, the Company and Endo executed a Term Sheet that set forth the terms of a
settlement and license agreement pursuant to which the parties would settle the Companys claims
against Endo that Endo infringed two of the Companys patents related to the Companys medicated
patch technology. On November 11, 2009, the Company entered into such Settlement and License
Agreement with Endo. Under the terms of the Settlement Agreement, Endo will pay the Company a
onetime license fee of $23,000,000 and the Company will grant to Endo an exclusive license to the
PatentsInSuit for use in the field of prescription pain medicines and treatment. The Company
anticipates receiving approximately $16 million in net cash proceeds from this settlement. The
agreement also calls for payment on or before December 15, 2009. From these proceeds the Company
intends to replenish the trust fund it has with the Rader Firm with $1 million dollars to
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fund ongoing patent litigation. If funds are not completely expended, then the remaining cash balance
in the trust fund will revert to the Company. Additionally, the Company estimates that it will
have to pay federal and state taxes of approximately $1 to $1.5 million dollars related to this transaction. See Note 12 of Notes to Condensed
Financial Statements in Part I, Item 1 for more information.
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 new licensing opportunities
with Novartis or other companies, raising additional capital, prevailing in its patent infringement
claims or otherwise settling such claims with the defendants, due to the uncertainties and risks
described in Risk Factors in Item 1A. filed on Form 10-K for the period ending December 31, 2008.
GOING CONCERN
We have incurred operating losses, accumulated deficit and negative cash flows from operations
during the last several years. As of September 30, 2009, the Company has an accumulated
shareholders deficit of $12,508,376. These factors, among others, raise substantial doubt about
our ability to continue as a going concern. The going concern issue will be mitigated by the Companys
settlement on November 6, 2009, with Endo Pharmaceuticals Inc. which will provide the Company
with additional cash in December 2009. See Note 12 of Notes to Condensed Financial
Statements in Part I, Item 1 for more information. Our financial statements included in this Form
10-Q do not include any adjustments related to recoverability and classification of asset carrying
amounts or the amount and classification of liabilities that might result should we be unable to
continue as a going concern. 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 new
licensing opportunities with Novartis or other companies, raising additional capital including
settlement income from future patent infringement negotiations, due to the uncertainties and risks
described in Risk Factors in Item 1A. filed on Form 10-K for the year ended December 31, 2008.
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, 2009 and 2008. The critical
accounting policies appear in Note 2 of Notes to Condensed Financial Statements in this Form 10-Q.
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ITEM 3. | QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS |
Not Applicable.
ITEM 4T. | CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
The Company maintains disclosure controls and procedures as defined in Rules 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 SECs rules and forms, and that such information is accumulated and communicated to our
management, including our principal executive officer and principal financial officer, and Board of
Directors, as appropriate, to allow timely decisions regarding required disclosure. In designing
and evaluating our disclosure controls and procedures, management recognizes that disclosure
controls and procedures, no matter how well conceived and operated, can provide only reasonable
assurance of achieving the desired objectives, and we necessarily are required to apply our
judgment in evaluating the cost-benefit relationship of possible disclosure controls and
procedures.
Our management, including our principal executive officer and principal financial officer,
evaluated the effectiveness of the design and operation of our disclosure controls and procedures
as of September 30, 2009 and concluded that our disclosure controls and procedures were effective.
Changes in Internal Controls Over Financial Reporting
During the quarter ended September 30, 2009, there were no changes in the Companys internal
control over financial reporting (as defined in Rule 13a-15(f) and 15d15(f) under the Exchange
Act) that have materially affected, or are reasonably likely to materially affect, the Companys
internal control over financial reporting.
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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. (Ticker: CHTT), Endo Pharmaceuticals, Inc. (Ticker:
ENDP), Johnson & Johnson Consumer Company, Inc. (Ticker: JNJ), The Mentholatum Company, Inc
(Division of Rohto Pharmaceuticals, Ticker RPHCF.PK), and Prince of Peace Enterprises, Inc.
(Private Company) (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 Companys patents (the PatentsInSuit), which relate to the Companys medicated patch
technology. The Company is seeking to enjoin the Defendants from infringing the PatentsInSuit 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 Companys claims therein, and asserting certain affirmative defenses and
counterclaims against the Company, including assertions that the PatentsInSuit 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 PatentsInSuit are invalid and unenforceable.
On December 3, 2008, the Companys counsel in the litigation, Rader, Fishman & Grauer PLLC
(the Counsel), participated in a scheduling conference in this case. As a result of that
conference, the Court scheduled a Markman hearing for May 6, 2010 and a final pretrial conference
for January 3, 2011. Based on the schedule established by the Court, it is clear that pursuing the
Companys claims in this litigation through trial will be a lengthy process.
In February 2009, Counsel filed with the Court a motion to preliminarily enjoin the five
defendants from infringing the Patents pending the trial.
On May 29, 2009, the Company entered into a Settlement Agreement and Mutual Release (the
Mentholatum Settlement Agreement) with the Mentholatum Company (Mentholatum) to settle the Companys claims
against Mentholatum that Mentholatum infringed the PatentsInSuit in the Litigation. Pursuant to the Mentholatum Settlement
Agreement, Mentholatum paid the Company an aggregate of $600,000 in $100,000 monthly
installments from May through October 2009. In addition, under the Mentholatum Settlement Agreement (a) the
Company agreed to dismiss the Litigation against Mentholatum with prejudice, (b) the parties agreed
to mutual general releases of all claims other than their prospective obligations under the Mentholatum Settlement Agreement and claims arising after the date of the Mentholatum
Settlement Agreement, (c) the Company agreed not to sue Mentholatum or Rohto Pharmaceutical Co., Ltd., the parent company of Mentholatum,
for any infringement of the PatentsInSuit, any patent that claims priority, directly or
indirectly, from the PatentsInSuit, or any foreign counterparts of the PatentsInSuit, (d) the Company agreed not to transfer any such patents
unless the transferee agrees to be bound by the covenant not to sue described above in clause (c), and (e).
Mentholatum and Rohto agreed not to challenge the validity or enforceability of such patents.
As of September 30, 2009,
Mentholatum had paid the Company $500,000 pursuant to the terms of the Settlement Agreement, and as of October 20, 2009, the Company had been paid the entire $600,000
pursuant to the terms of the Mentholatum Settlement Agreement. The proceeds received from this settlement were
reduced by the amounts due to the Rader firm per the Companys contingent fee arrangement, out of
pocket expenses, and other costs incurred related to depositions of parties in the infringement
lawsuits, travel expenses, and other related costs. The Company received approximately $300,000 in
net cash proceeds from the Mentholatum settlement.
In July 2009, the presiding judge in the eastern district of Texas, granted the remaining
defendants a Joint Motion for an Extension of Time regarding the Companys Motion for Preliminary
Injunction. The defendants opposition briefs were filed by the end of August 2009. The Companys
response to those briefs was filed by the end of September 2009. While some of the other
scheduling order dates were modified, the Markman hearing and final pretrial trial dates remained
unchanged The Company is being diligent in moving the infringement lawsuit forward but can give no
assurance as to the outcome or settlement of the suit against the remaining defendants. The
Company was scheduled for a hearing in Texarkana, Texas on November 12, 2009 relating to the
preliminary injunction motion filed against the defendants in the Litigation. The Company subsequently cancelled this hearing
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due to
legal considerations after it settled with a second defendant in
November 2009. The Company will
continue to pursue settlement options with respect to the other defendants. The Company can not
give any assurance as to the outcome of future negotiations.
On November 6, 2009, the Company and Endo Pharmaceuticals Inc. (Endo), executed a Term Sheet
that set forth the terms of a settlement and license agreement pursuant to which the parties would
settle the Companys claims against Endo that Endo infringed the PatentsInSuit. On
November 11, 2009, the Company entered into such Settlement and
License Agreement (the Endo Settlement
Agreement) with Endo and issued a press release announcing its
entry into the Endo Settlement
Agreement. On November 12, 2009 the Company filed a Form 8-K with the Securities and Exchange
Commission disclosing this event.
Pursuant
to the Endo Settlement Agreement, Endo will pay the Company a onetime license fee of
$23,000,000 and the Company will grant to Endo an exclusive license to the PatentsInSuit for use
in the field of prescription pain medicines and treatment. In addition, under the Endo Settlement
Agreement: (a) the parties agreed to the dismissal of the Litigation with prejudice and without
costs; (b) the Company agreed to release all claims against Endo that were asserted by or could
have been asserted by the Company against Endo in the Litigation or that relate to, arise from or
are in any manner connected to the PatentsInSuit; (c) Endo agreed to release all claims against
the Company that were asserted by or could have been asserted by Endo against the Company in the
Litigation; (d) the Company agreed not to sue Endo for any infringement of any U.S. or foreign
patents or patent applications owned or controlled by the Company as
of November 11, 2009, any continuation,
continuationinpart or divisional of any such patent,
any U.S. patent resulting from the reissue or reexamination of any
such patents and any U.S. or
foreign patent or patent application claiming common priority with
any of such patents; and (e) the
Company agreed not to transfer either of the
PatentsInSuit or any other such patent unless the transferee agrees in
writing to the terms and conditions of the Endo Settlement Agreement.
The Company anticipates receiving approximately $16 million in net cash proceeds from this
settlement. The agreement also calls for payment on or before December 15, 2009. From these
proceeds the Company intends to replenish the trust fund it has with the Rader Firm with $1 million
dollars to fund ongoing patent litigation. If funds are not completely expended, then the
remaining cash balance in the trust fund will revert to the Company. Additionally, the Company
estimates that it will have to pay federal and state taxes of approximately $1 to $1.5 million
dollars related to this transaction.
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ITEM 1A RISK FACTORS
Item 1A (Risk Factors) of our most recently filed Form 10-K sets forth information relating
to important risks and uncertainties that could materially have an adverse effect on our business,
financial condition, or operating results. In addition, the Company was given a going concern
qualification by the Companys external auditors which raises doubt about the Companys ability to
continue as a viable entity. There have been no material changes to the risk factors described in
our most recently filed Form 10-K; however, those risk factors continue to be relevant to an
understanding of our business, financial condition, and operating results, etc. Accordingly,
potential and current investors should review and consider these risk factors in making any
investment decision with respect to our securities. An investment in our securities continues to
have a high degree of risk.
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.
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ITEM 6 EXHIBITS
Exhibit No. | Description | |
3.01
|
Articles of Incorporation of LecTec Corporation, as amended (Incorporated herein by reference to the Companys 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 Companys 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. |
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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 16, 2009 | By /s/ Judd A. Berlin | |||
Judd A. Berlin | ||||
Chief Executive Officer, Chief Financial Officer, & Director (Principal Executive Officer and Principal Financial Officer) |
||||
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EXHIBIT INDEX
Exhibit No. | Description | |
3.01
|
Articles of Incorporation of LecTec Corporation, as amended (Incorporated herein by reference to the Companys 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 Companys 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. |