Axogen, Inc. - Quarter Report: 2009 March (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 March 31, 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 (Do not check if a smaller reporting company) |
Smaller reporting company þ |
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 May 11, 2009 the registrant had 4,290,026 shares of common stock outstanding.
LECTEC CORPORATION
REPORT ON FORM 10-Q FOR THE QUARTERLY PERIOD ENDED MARCH 31, 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, 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, the inclusion of a going-concern qualification in the report from the Companys
independent registered public accounting firm for fiscal 2008, 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
March 31, | December 31, | |||||||
2009 | 2008 | |||||||
(Unaudited) | ||||||||
ASSETS |
||||||||
CURRENT ASSETS: |
||||||||
Cash and cash equivalents |
$ | 242,259 | $ | 332,848 | ||||
Royalty receivable |
74,693 | 32,586 | ||||||
Prepaid expenses and other |
65,924 | 88,823 | ||||||
Total current assets |
382,876 | 454,257 | ||||||
FIXED ASSETS: |
||||||||
Office equipment |
6,633 | 6,633 | ||||||
Accumulated depreciation |
(1,254 | ) | (701 | ) | ||||
5,379 | 5,932 | |||||||
OTHER ASSETS: |
||||||||
Patent costs |
37,986 | 43,775 | ||||||
Prepaid insurance director and officer |
10,140 | 20,279 | ||||||
48,126 | 64,054 | |||||||
TOTAL ASSETS |
$ | 436,381 | $ | 524,243 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
CURRENT LIABILITIES: |
||||||||
Accounts payable |
$ | 68,783 | $ | 26,155 | ||||
Accrued expenses |
58,872 | 54,901 | ||||||
Discontinued operations |
130,000 | 130,000 | ||||||
Total current liabilities |
257,655 | 211,056 | ||||||
COMMITMENTS AND CONTINGENCIES |
||||||||
SHAREHOLDERS EQUITY: |
||||||||
Common stock, $.01 par value; 15,000,000 shares
authorized; 4,290,026 shares
issued and outstanding at March 31, 2009
and December 31, 2008 |
42,900 | 42,900 | ||||||
Additional contributed capital |
12,652,219 | 12,652,219 | ||||||
Accumulated deficit |
(12,516,393 | ) | (12,381,932 | ) | ||||
178,726 | 313,187 | |||||||
TOTAL LIABILITIES AND SHAREHOLDERS EQUITY |
$ | 436,381 | $ | 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 | ||||||||
March 31, | ||||||||
2009 | 2008 | |||||||
REVENUE ROYALTY AND LICENSING FEES |
$ | 42,107 | $ | 21,029 | ||||
OPERATING EXPENSES |
177,099 | 187,912 | ||||||
Loss from operations |
(134,992 | ) | (166,883 | ) | ||||
INTEREST INCOME |
531 | 7,181 | ||||||
NET LOSS |
$ | (134,461 | ) | $ | (159,702 | ) | ||
WEIGHTED AVERAGE COMMON SHARES
OUTSTANDING: |
||||||||
Basic and diluted |
4,290,026 | 4,227,401 | ||||||
LOSS PER COMMON SHARE: |
||||||||
Basic and diluted |
$ | (0.03 | ) | $ | (0.04 | ) | ||
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)
Three Months Ended March 31, | ||||||||
2009 | 2008 | |||||||
Cash flows from operating activities: |
||||||||
Net loss |
$ | (134,461 | ) | $ | (159,702 | ) | ||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||
Depreciation expense |
553 | | ||||||
Amortization of patent costs |
5,789 | 4,951 | ||||||
Changes in operating assets and liabilities: |
||||||||
Royalty receivable |
(42,107 | ) | 76,502 | |||||
Prepaid expenses and other |
33,038 | 17,351 | ||||||
Accounts payable |
42,628 | 44,326 | ||||||
Accrued expenses |
3,971 | 1,546 | ||||||
Net cash used in operating activities |
(90,589 | ) | (15,026 | ) | ||||
Cash flows from investing activities: |
||||||||
Purchase of office equipment |
| | ||||||
Investment in patents |
| (9,022 | ) | |||||
Net cash used in investing activities |
| (9,022 | ) | |||||
Net decrease in cash and cash equivalents |
(90,589 | ) | (24,048 | ) | ||||
Cash and cash equivalents beginning of period |
332,848 | 832,925 | ||||||
Cash and cash equivalents end of period |
$ | 242,259 | $ | 808,877 | ||||
The accompanying notes are an integral part of these condensed financial statements.
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LECTEC CORPORATION
Notes to Condensed Financial Statements
March 31, 2009 and 2008
Notes to Condensed Financial Statements
March 31, 2009 and 2008
(Unaudited)
(1) Basis of Presentation
The accompanying condensed financial statements include the accounts of LecTec Corporation
(the Company) as of March 31, 2009 and December 31, 2008 and for the three month periods ended
March 31, 2009 and 2008. 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 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 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 currently has three leased facilities as of March 31,
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 such 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. The Company believes this is an ideal location based upon favorable local lease
rates, secure premises, tax advantages, community responsibility, etc.
In July, 2008, the Company 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 to be one of the most robust, globally competitive, and cost-efficient locations for
the development and manufacturing of pharmaceutical and medical products. The Company
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also wants to have better access to the pool of well-educated scientific and engineering
talent available in India. This lease expires on July 31, 2009. The Company has given written
notification of its intent to renew this lease until July 31, 2010. The lease will cost the
Company less than $1,500 per year during 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.
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 March 31, 2009, the Company had an
outstanding royalty receivable with Novartis of $74,693, which was subsequently collected during
April 2009. 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, 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 months ended March 31, 2009 and 2008,
respectively.
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 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
Companys financial position or results of operations.
In December 2007, the FASB issued SFAS No. 141R (revised 2007), Business Combinations (SFAS
141R). SFAS 141R significantly changes the accounting for business combinations in a number of
respects as 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 entitys 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, Non-controlling Interests in Consolidated
Financial Statements, an amendment of ARB No 51 (SFAS 160). SFAS 160 changes the accounting and
reporting for minority
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interests, which will be recharacterized as non-controlling 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 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities (SFAS 159). SFAS 159 permits companies to choose to measure many financial
instruments and certain other items at fair value. The objective is to improve financial reporting
by providing companies with the opportunity to mitigate volatility in reported earnings caused by
measuring related assets and liabilities differently without having to apply complex hedge
accounting provisions. SFAS 159 is effective for fiscal years beginning after November 15, 2007.
The Company has not elected to value any financial instruments at fair value.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value and establishes a framework for measuring fair value in accounting
principals generally accepted in the United States of America. More precisely, this statement sets
forth a standard definition of fair value as it applies to assets or liabilities, the principal
market (or most advantageous market) for determining fair value (price), the market participants,
inputs, and the application of the derived fair value to those assets and liabilities. SFAS 157 is
effective for all full fiscal and interim periods beginning after November 15, 2007. On December
14, 2007, the FASB issued staff position FAS 157-b, which deferred the effective date of SFAS 157
for one year, as it relates to nonfinancial assets and liabilities. The adoption of SFAS 157, as
it relates to financial assets and liabilities, had no material impact to the Companys financial
position or results of operations.
(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 264,000 and 155,200 shares of
common stock with a weighted average exercise price of $3.94 and $3.88 were outstanding as of
March 31, 2009 and 2008, respectively. Because the Company had a loss from operations during the
three months ended March 31, 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 months ended March 31, 2009 and 2008, was offset
by a valuation allowance for deferred taxes. No federal or state income tax benefit was provided
for the three months ended March 31, 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 (4 to 14 years) 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
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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 has met with
Novartis representatives to discuss how to prevent an incident where a child or pet chews or
ingests a patch and discussions regarding the same are ongoing.
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.
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. Novartis continues to advertise and market the adult patch
via TV commercials and various stores continue to shelve and sell this vapor patch. As a result,
the Company is once again receiving revenue under the Novartis Agreement.
Currently, the Company continues to explore mutual opportunities with Novartis under the
Agreement including partnering, merger or acquisition possibilities, and exploring opportunities
relating to other patents the Company holds. The Company is also pursuing other opportunities,
including research and development (R&D), in an effort to enhance and add to the Companys
revenue stream, and is evaluating licensing opportunities related to other patents the Company
holds.
During the three months ended March 31, 2009 and 2008, the Company recorded revenue of $42,107
and $21,029, respectively, for royalties covered 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 for the three months ended
March 31, 2009 and 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 five to fourteen years. The Company
also holds three registered U.S. trademarks.
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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 Companys 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 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. See PART II, ITEM 1 of this Form 10-Q for additional information.
(9) Going Concern
The Company has incurred operating losses, accumulated deficits and negative cash flows from
operations during the last few years. As of March 31, 2009, the Company had an accumulated
shareholders deficit of $12,516,393. The Company does not believe its existing cash and cash
equivalents will be sufficient to fund operations through 2009 based upon its current cash on hand,
its anticipated operating expenses, and costs the Company is likely to incur related to its pending
patent infringement litigation. These factors, among others, raise substantial doubt about the
ability of the Company to continue as a going concern.
The Company is actively pursuing means to raise additional capital to allow the Company to
sustain normal operations in 2009 and proceed with R&D efforts in India and China relating to the
Companys hand sanitizer patch, its patch with aversive agent and related testing research efforts.
In addition to these efforts to raise additional capital, the Companys strategy includes pursuit
of additional licensing agreements with interested companies; potential partnering arrangements
with Novartis; evaluation of merger and acquisition possibilities; and exploration of 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.
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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 its license agreement with the Company. 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.
During 2008, the Company retained a contingency 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 is resolved.
The Company can not give any assurance as to the outcome of the motion for the preliminary
injunction filed against the defendants in the ongoing lawsuit.
COMPARISON OF THE THREE MONTHS ENDED MARCH 31, 2009 AND 2008
Results of Operations
The Company recorded royalty income of $42,107 and $21,029 for the three months ended March
31, 2009 and 2008, respectively, an increase of $21,078. The increase in revenue was primarily due
to an increase in royalty income from sales of licensed product in Mexico. The royalty income
recorded during the three month periods ended March 31, 2009 and 2008 was based on information
provided by Novartis.
Operating expenses decreased $10,813, to $177,099 for the three months ended March 31, 2009,
from operating expenses of $187,912 for the comparable period in 2008. The decrease in operating
expenses resulted primarily from a decrease in facility lease expenses, a reduction in patent
related costs, and a reduction in consulting costs. The Company believes that its operating
expenses will decrease further because some of the costs the Company has incurred in the past have
been one-time expenses of approximately $35,000. In addition, the Company has reduced its
operating expenses as a
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result of
relocating its corporate office, to Texarkana, Texas, which has reduced its rental obligations and
utility expenses. The Company estimates it has saved approximately $30,000 annually or $2,500 per
month as a result of the relocation to Texarkana, TX. However, these savings may be offset with
costs related to additional actions the Company decides to take with respect to protecting its
intellectual property portfolio.
The Company recorded a net loss of $(134,461), or $(0.03) per basic and diluted share for the
three months ended March 31, 2009, compared to a net loss of $(159,702), or $(0.04) per basic and
diluted share, for the same period in 2008. The improvement in net loss of $25,241 for the three
month period ended March 31, 2009 from the comparable period in 2008 is due to the decrease in
operating expenses, combined with the increase in royalty income discussed above, and a decrease in
interest income of $6,650.
Income Taxes
The provision for income tax benefits for the three month periods ended March 31, 2009 and
2008 was offset by a valuation allowance for deferred taxes. No federal or state income tax
benefit was provided for the three month periods ended March 31, 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 $90,589 for the three month period ended March 31, 2009,
to $242,259, 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 March 31, 2009 or 2008.
The Company had working capital of $125,221 and a current ratio of 1.49 at March 31, 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 current ratio at March 31, 2009, compared to December 31, 2008,
was primarily due to the net loss of ($134,461).
Shareholders equity decreased $134,461 to $178,726 at March 31, 2009 from $313,187 at
December 31, 2008, due to the net loss the Company incurred during the three months ended March 31,
2009.
In June 2008, the Company entered into a contingency fee agreement with Rader, Fishman &
Grauer PLLC, 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. As of the date of the filing of this Form 10-Q, the Company has expended
approximately $121,000 under the agreement for advances made to the Rader firm and payments for
expert services.
The Company is cautious about preserving its current cash position with respect to its current
litigation efforts and its ability to sustain normal operations going forward. The Company is
pursuing 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 related testing research. Without an
infusion of cash, 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. Interest income earned during the three
month periods ended March 31, 2009 and 2008 was $531 and $7,181, respectively. The average
interest the Company earns on its available cash is less than 1%.
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The Companys 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 $100,000 per year in royalty income based upon historical royalty income and cash receipt activity from 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 new licensing
opportunities with Novartis or other companies, or in raising additional capital, 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 March 31, 2009, the Company has an accumulated shareholders
deficit of $12,516,393. These factors, among others, raise substantial doubt about our ability to
continue as a going concern. 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, or in raising additional capital, due to the uncertainties and risks
described in Risk Factors in Item 1A. filed on Form 10-K for the period 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 March 31, 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 March 31, 2009 and concluded that our disclosure controls and procedures were effective.
Changes in Internal Controls Over Financial Reporting
During the quarter ended March 31, 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 has materially affected, or is 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 Patents), which relate to the Companys 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 Companys 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.
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.
As of the date of the filing of this Form 10-Q, the Company has received the Preliminary
Invalidity Contentions from each of the Defendants. Counsel representing the Company and the
Defendants are continuing the discovery and deposition process. As of the date of the filing of
this form 10-Q, four persons have been deposed.. The Company and its engaged counsel are diligent
in moving this lawsuit forward.
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. 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: May 14, 2009 | By | /s/ Judd A. Berlin | ||
Judd A. Berlin | ||||
Chief Executive Officer, Chief Financial Officer, & Director (principal financial officer and duly authorized 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. |