UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
For the quarterly period ended December 31, 2005
OR
For the transition period from to
Commission file number: 0-26642
MYRIAD GENETICS, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
of incorporation or organization)
Registrant’s telephone number, including area code: (801) 584-3600
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, or a non-accelerated filer. See definition of “accelerated filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act. Check one:
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of February 1, 2006 the registrant had 39,128,622 shares of $0.01 par value common stock outstanding.
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INDEX TO FORM 10-Q
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MYRIAD GENETICS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)
Current assets:
Cash and cash equivalents
Marketable investment securities
Prepaid expenses
Trade accounts receivable, less allowance for doubtful accounts of $1,645 at Dec. 31, 2005 and $1,395 at June 30, 2005
Other receivables
Total current assets
Equipment and leasehold improvements:
Equipment
Leasehold improvements
Less accumulated depreciation and amortization
Net equipment and leasehold improvements
Other assets
Current liabilities:
Accounts payable
Accrued liabilities
Deferred revenue
Total current liabilities
Stockholders’ equity:
Preferred stock, $0.01 par value, 5,000 shares authorized, no shares issued and outstanding
Common stock, $0.01 par value, 60,000 shares authorized; issued and outstanding 39,127 at Dec. 31, 2005 and 30,862 at June 30, 2005
Additional paid-in capital
Accumulated other comprehensive loss
Accumulated deficit
Total stockholders’ equity
See accompanying notes to condensed consolidated financial statements (Unaudited).
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
Revenues:
Predictive medicine revenue
Research revenue
Total revenues
Costs and expenses:
Predictive medicine cost of revenue
Research and development expense
Selling, general and administrative expense
Total costs and expenses
Operating loss
Other income (expense):
Interest income
Other
Net loss
Basic and diluted loss per share
Basic and diluted weighted average shares outstanding
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CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Cash flows from operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Loss on disposition of assets
Bad debt expense
Share-based compensation expense
Changes in operating assets:
Trade accounts receivable
Net cash used in operating activities
Cash flows from investing activities:
Capital expenditures
Purchases of other assets
Purchases of marketable investment securities
Proceeds from sales and maturities of marketable investment securities
Net cash used in investing activities
Cash flows from financing activities:
Net proceeds from public offering of common stock
Net proceeds from common stock issued under share-based compensation plans
Net cash provided by financing activities
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
The accompanying condensed consolidated financial statements have been prepared by Myriad Genetics, Inc. (the “Company”) in accordance with accounting principles generally accepted in the United States of America for interim financial information and pursuant to the applicable rules and regulations of the Securities and Exchange Commission. The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. In the opinion of management, the accompanying financial statements contain all adjustments (consisting of normal and recurring accruals) necessary to present fairly all financial statements in accordance with accounting principles generally accepted in the United States. The condensed consolidated financial statements herein should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the fiscal year ended June 30, 2005, included in the Company’s Annual Report on Form 10-K for the year ended June 30, 2005. Operating results for the three and six month periods ended December 31, 2005 may not necessarily be indicative of results to be expected for any other interim period or for the full year.
The preparation of financial statements in conformity with United States generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
On July 1, 2005 the Company adopted the provisions of Financial Accounting Standards Board Statement No. 123R, Share-Based Payment(Statement 123R). Statement 123R sets accounting requirements for “share-based” compensation to employees, including employee stock purchase plans, and requires companies to recognize in the statement of operations the grant-date fair value of stock options and other equity-based compensation.
In 2003 the Company adopted the 2003 Employee, Director and Consultant Stock Option Plan (the 2003 Plan) under which 2.7 million shares of common stock have been reserved for issuance upon the exercise of options that the Company grants from time to time. An additional 1.2 million shares of common stock were reserved for Company grants at a special shareholder meeting on January 6, 2006. Additional shares represented by options previously granted under the Company’s 2002 Amended and Restated Employee, Director and Consultant Stock Option Plan (the 2002 Plan) which are canceled or expire after the date of stockholder approval of the 2003 Plan without delivery of shares of stock by the Company and any shares which have been reserved but not granted under the 2002 Plan as of the date of stockholder approval of the 2003 Plan are available for grant under the 2003 Plan. The number of shares, terms, and exercise period are determined by the board of directors on an option-by-option basis. Options generally vest ratably over four or five years and expire ten years from the date of grant. The exercise price of options granted is equivalent to the fair market value of the stock at the date of grant. The Company also has an Employee Stock Purchase Plan under which a maximum of 600,000 shares of common stock may be purchased by eligible employees. During the quarter ended December 31, 2005, the Company issued 62,596 shares of common stock under the Employee Stock Purchase Plan.
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The fair value of each option grant is estimated on the grant date using the Black-Scholes option-pricing model. Expected option lives and volatilities used in fair valuation calculations are based on historical data of the Company and the related expense is recognized on a straight-line basis over the vesting period.
Share-based compensation expense included in the consolidated statements of operations for the three and six months ended December 31, 2005 was approximately $490,000 and $729,000, respectively. As of December 31, 2005, there was approximately $5.2 million of total unrecognized share-based compensation cost related to share-based compensation granted under our plans that will be recognized over a weighted-average period of 3.7 years.
Statement 123R applies only to awards granted after the required effective date. Awards granted prior to the Company’s implementation of Statement 123R were accounted for under the recognition and measurement principles of APB Opinion No. 25, Accounting for Stock Issued to Employees, and related Interpretations. Accordingly, no stock-based compensation cost is reflected in net loss in the accompanying condensed consolidated statement of operations for the three and six months ended December 31, 2004, as all options granted under the Company’s plans had exercise prices equal to the market value of the underlying common stock on the date of grant. In anticipation of adopting Statement 123R, in April 2005 the Company announced that it had accelerated the vesting of unvested stock options previously awarded to employees and non-employee members of the board of directors. The following table illustrates the effect on net loss and loss per share if the Company had applied the fair value recognition provisions of SFAS No. 123, Accounting for Stock-Based Compensation, to stock-based employee compensation for periods presented prior to the Company’s adoption of Statement 123R:
Net loss, as reported
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards, net of tax related effects
Pro forma net loss
Loss per share:
Basic and diluted – as reported
Basic and diluted – pro forma
The components of the Company’s comprehensive loss are as follows (in thousands):
Unrealized loss on available-for-sale securities
Comprehensive loss
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Loss per common share is computed based on the weighted-average number of common shares and, as appropriate, dilutive potential common shares outstanding during the period. Stock options and warrants are considered to be potential common shares.
Basic loss per common share is the amount of loss for the period available to each share of common stock outstanding during the reporting period. Diluted loss per share is the amount of loss for the period available to each share of common stock outstanding during the reporting period and to each share that would have been outstanding assuming the issuance of common shares for all dilutive potential common shares outstanding during the period. In calculating loss per common share the net loss and the weighted average common shares outstanding were the same for both the basic and diluted calculation. As of December 31, 2005 and 2004, there were antidilutive potential common shares of 7,909,656 and 6,746,444, respectively. Accordingly, these potential common shares were not included in the computation of diluted loss per share for the periods presented, but may be dilutive to future basic and diluted earnings per share.
The Company’s business units have been aggregated into three reportable segments: (i) research, (ii) predictive medicine, and (iii) drug development. The research segment is focused on the discovery of genes and protein pathways related to major common diseases. The predictive medicine segment provides testing to determine predisposition to common diseases. The drug development segment is focused on the development of therapeutic products for the treatment and prevention of major diseases.
The accounting policies of the segments are the same as those described in the basis of presentation (note 1). The Company evaluates segment performance based on results from operations before interest income and expense and other income and expense.
Predictive
medicine
Drug
development
Three months ended Dec. 31, 2005:
Revenues
Segment operating income (loss)
Three months ended Dec. 31, 2004:
Six months ended Dec. 31, 2005:
Six months ended Dec. 31, 2004:
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Total operating loss for reportable segments
In November 2005, the Company received $139.7 million in net proceeds from an underwritten public offering of 8,050,000 shares of common stock pursuant to the Company’s outstanding shelf registration on Form S-3 (Registration No. 333-123914). The Company has approximately $151.1 million of securities available for sale under the shelf registration statement.
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We are a leading biotechnology company focused on the development and marketing of novel therapeutic and predictive medicine products. We employ a number of proprietary technologies that permit us to understand the genetic basis of human disease and the role that genes and their related proteins play in the onset and progression of disease. We use this information to guide the development of new healthcare products that will treat major diseases and assess a person’s risk of disease later in life.
We believe that the future of medicine lies in the creation of new classes of drugs that treat the underlying cause, not just the symptoms, of disease and that may be useful in disease prevention. By understanding the genetic basis of disease, we believe we will be able to develop drugs that are safer and more efficacious. In addition, we believe that advances in the emerging field of predictive medicine will improve our ability to determine which patients are subject to a greater risk of developing these diseases and who therefore would benefit from preventive therapies.
Myriad researchers have made important discoveries in the fields of cancer, Alzheimer’s disease and infectious diseases such as AIDS. These discoveries point to novel disease pathways that may pave the way for the development of new classes of drugs. We intend to develop and, subject to regulatory approval, market our therapeutic products in the areas of cancer, Alzheimer’s disease and viral disease.
Therapeutic products in development
We currently have three drug candidates in six clinical trials and a number of drug candidates in late-stage preclinical development. Our most advanced drug development programs are described below:
MPC-6827: drug candidate for solid cancer tumors and brain metastases. Our drug candidate MPC-6827 is a novel, small-molecule tubulin inhibitor that is being studied in two Phase 1 human clinical trials. These trials use an escalating dose regimen designed to evaluate the safety and pharmacokinetic
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profile of MPC-6827 in patients with advanced solid tumors and metastatic brain tumors, respectively. In preclinical studies, MPC-6827 showed better activity against a range of human tumors in mouse xenografts than the standard of care treatments for those cancers. In addition, MPC-6827 demonstrated the ability to effectively cross the blood-brain barrier and was not subject to multiple drug resistance. This drug candidate has demonstrated activity in preclinical studies against tumors of the prostate, breast, pancreas, colon and skin (melanoma). According to the American Cancer Society, these cancers are expected to account for approximately 642,000 new cases in 2005 in the United States alone. In addition, according to the National Cancer Institute, it is estimated that there were as many as 170,000 new cases of brain metastases in 2005.
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Therapeutic product pipeline
Molecule
Therapeutic Area
Status
Flurizan
Alzheimer’s disease
Phase 3
Phase 2 Follow-on
Flurizan – MPC-7869
Prostate cancer
Phase 2b
MPC-6827
Brain metastases
Phase 1
Solid tumors
MPC-2130
Blood cancers and metastatic tumors
MPI-49839
AIDS
Preclinical
MPC-0920
Thrombosis
MPC-4505
Emesis
Predictive medicine products
Predictive medicine analyzes genes and their mutations to assess an individual’s risk for developing disease later in life. Armed with this risk assessment information, individuals can increase surveillance and take action to prevent or delay the onset of disease.
To date, we have launched four commercial predictive medicine products. We market these products through our own 115-person sales force in the United States and we have entered into marketing collaborations with other organizations in selected foreign countries. Predictive medicine revenues were $23.4 million and $44.9 million for the three and six months ended December 31, 2005, representing increases of 33% and 41% over the same three and six months in 2004. Our predictive medicine gross profit margins were 73% for the three and six months ended December 31, 2005, compared to 71% for the same three and six months in 2004. Our current commercial predictive medicine products are described below:
COLARIS®: predictive medicine product for colon cancer and uterine cancer. COLARIS is a comprehensive analysis of the MLH1 and MSH2 genes for determining a person’s risk of developing colon cancer or uterine cancer. Individuals who carry a deleterious mutation in one of the two colon cancer genes in the COLARIS test have a greater than 80% lifetime risk of developing colon cancer and women have a 60% lifetime chance of developing uterine cancer. Highly effective preventive measures include colonoscopy and the removal of precancerous polyps. Through proper screening and polyp removal, colon cancer is a preventable disease. Colorectal cancer is the second leading cause of cancer
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deaths in the United States, with approximately 145,000 new cases expected to be diagnosed in 2005. Familial forms of colorectal cancer are estimated to account for 10% to 30% of all cases according to the American Society of Clinical Oncologists. The test is currently priced at $1,950 and is covered by all major health maintenance organizations and health insurance providers in the United States.
We have devoted substantially all of our resources to undertaking our drug discovery and development programs, operating our predictive medicine business, and continuing our research and development efforts. Our revenues have consisted primarily of sales of predictive medicine products and research payments. We have yet to attain profitability and, for the three and six months ended December 31, 2005, we had net losses of $8.0 million and $17.2 million, respectively. As of December 31, 2005 we had an accumulated deficit of $196.4 million.
We expect to incur losses for at least the next several years, primarily due to the expansion of our drug discovery and development efforts, the initiation and continuing conduct of human clinical trials, the launch of new predictive medicine products, the continuation of our internal research and development programs, and expansion of our facilities. Additionally, we expect to incur substantial sales, marketing and other expenses in connection with building our pharmaceutical and predictive medicine businesses. We expect that losses will fluctuate from quarter to quarter and that such fluctuations may be substantial.
Critical Accounting Policies
Critical accounting policies are those policies which are both important to the portrayal of a company’s financial condition and results and require management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are as follows:
Revenue Recognition. Research revenues include revenues from research agreements, milestone payments, and technology licensing agreements. In applying the principles of SAB 104 to research and technology license agreements we consider the terms and conditions of each agreement separately to
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arrive at a proportional performance methodology of recognizing revenue. Such methodologies involve recognizing revenue on a straight-line basis over the term of the agreement and based on costs incurred relative to the total estimated contract costs (cost-to-cost method). We make adjustments, if necessary, to the estimates used in our cost-to-cost calculations as work progresses and we gain experience. The principal costs under these agreements are for personnel expenses to conduct research and development and also include costs for materials and other direct and indirect items necessary to complete the research under these agreements. Actual results may vary from our estimates. Payments received on uncompleted long-term contracts may be greater than or less than incurred costs and estimated earnings and have been recorded as other receivables or deferred revenues in the accompanying consolidated balance sheets. We recognize revenue from milestone payments as agreed-upon events representing the achievement of substantive steps in the development process are achieved and where the amount of the milestone payments approximates the value of achieving the milestone. We recognize revenue from up-front nonrefundable license fees on a straight-line basis over the period of our continued involvement in the research and development project.
Predictive medicine revenues include revenues from the sale of predictive medicine products, related marketing agreements, and forensic DNA analysis fees. Predictive medicine revenue is recognized upon completion of the test or analysis and communication of results. Up-front payments related to marketing agreements are recognized ratably over the life of the agreement.
Allowance for Doubtful Accounts. The preparation of our financial statements requires us to make estimates and assumptions that affect the reported amount of assets at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Trade accounts receivable are comprised of amounts due from sales of our predictive medicine products. We analyze trade accounts receivable and consider historic experience, customer creditworthiness, facts and circumstances specific to outstanding balances, and payment term changes when evaluating the adequacy of the allowance for doubtful accounts. Changes in these factors could result in material adjustments to the expense recognized for bad debt.
Share-Based Payment Expense. Financial Accounting Standards Board Statement No. 123R, Share-Based Payment (Statement 123R) sets accounting requirements for “share-based” compensation to employees, including employee stock purchase plans, and requires us to recognize in our consolidated statements of operations the grant-date fair value of our stock options and other equity-based compensation. The determination of grant-date fair value is estimated using an option-pricing model, which includes variables such as the expected volatility of our share price, the exercise behavior of our employees, interest rates, and dividend yields. These variables are projected based on our historical data and experience. Changes in any of these variables could result in material adjustments to the expense recognized for share-based payments.
New Accounting Pronouncements
Financial Accounting Standards Board Statement No.154, Accounting Changes and Error Corrections, (Statement 154) changes the accounting for, and reporting of, a change in accounting principle. Statement 154 requires retrospective application to prior period’s financial statements of voluntary changes in accounting principle and changes required by new accounting standards when the standard does not include specific transition provisions, unless it is impracticable to do so. Statement 154 is effective for accounting changes and corrections of errors in fiscal years beginning after December 15, 2005. We do not anticipate that the adoption of Statement 154 will have a material impact on either the financial position or operating results of the Company.
Results of Operations for the Three Months Ended December 31, 2005 and 2004
Predictive medicine revenue is comprised primarily of sales of predictive medicine products, and also includes some marketing fees and forensic DNA analysis fees. Predictive medicine revenues for the three
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months ended December 31, 2005 were $23.4 million compared to $17.5 million for the same three months in 2004, an increase of 33%. Increased sales, marketing, and education efforts have resulted in wider acceptance of our products by the medical community and increased revenues for the three months ended December 31, 2005. There can be no assurance that predictive medicine revenues will continue to increase at historical rates.
Research revenues are comprised of research payments received pursuant to collaborative agreements, amortization of upfront technology license fees and milestone payments. Research revenues for the three months ended December 31, 2005 were $3.9 million compared to $2.1 million for the same three months in 2004. This 87% increase in research revenue is primarily attributable to revenues associated with the delivery of research data pursuant to a research collaboration. We expect that our continued focus will be on our internal drug development and predictive medicine programs and we plan to continue to de-emphasize external research collaborations. Research revenue from our research collaboration agreements is recognized using a proportional performance methodology. Consequently, as these programs progress and costs increase or decrease, revenues may increase or decrease proportionately.
Predictive medicine cost of revenue for the three months ended December 31, 2005 was $6.3 million compared to $5.1 million for the same three months in 2004. This increase of 22% in predictive medicine cost of revenue is primarily due to the 33% increase in predictive medicine revenues for the three months ended December 31, 2005 compared to the same three months in 2004. This increase was partially offset by a reduction in royalty obligations as well as technology improvements and efficiency gains in the operation of our predictive medicine business. These changes also contributed to an increase in our gross profit margin, which was 73% for the three months ended December 31, 2005 compared to 71% for the same three months in 2004. There can be no assurance that predictive medicine gross profit margins will continue to increase at historical rates.
Research and development expenses for the three months ended December 31, 2005 were $19.0 million compared to $14.5 million for the same three months in 2004. This increase of 31% was due in part to increased costs associated with our ongoing clinical trials as well as increased costs associated with our drug discovery and drug development programs. These increases added approximately $2.0 million to our research and development costs for the three months ended December 31, 2005 compared to the same three months in 2004. Increased costs associated with a new research collaboration as well as technology development in our clinical laboratory added approximately $2.5 million to our research and development costs for the three months ended December 31, 2005 compared to the same three months in 2004. We expect to incur significant increases in our research and development expenses over the next several years as we expand clinical trials for our product candidates currently in clinical development, including Flurizan, advance our other product candidates into clinical trials, and expand our research and development activities. We expect that these expenses will continue to fluctuate from quarter to quarter based on changes in our research programs and the progression of our drug development programs.
Selling, general and administrative expenses consist primarily of salaries, commissions and related personnel costs for sales, marketing, executive, legal, finance, accounting, human resources, business development, allocated facilities expenses and other corporate expenses. Selling, general and administrative expenses for the three months ended December 31, 2005 were $11.6 million compared to $10.6 million for the same three months in 2004. This increase of 9% was primarily attributable to general increases in costs to support the 33% growth in our predictive medicine business and our therapeutic development efforts. We expect our selling, general and administrative expenses will continue to fluctuate depending on the number and scope of new product launches and our drug discovery and drug development efforts.
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Results of Operations for the Six Months Ended March December 31, 2005 and 2004
Predictive medicine revenues for the six months ended December 31, 2005 were $44.9 million compared to $32.0 million for the same six months in 2004, an increase of 41%. Increased sales, marketing, and education efforts, coupled with publications concerning the clinical utility of our products have resulted in wider acceptance of our products by the medical community and increased revenues for the six months ended December 31, 2005. There can be no assurance that predictive medicine revenues will continue to increase at historical rates.
Research revenues for the six months ended December 31, 2005 were $7.5 million compared to $4.4 million for the same six months in 2004. This 72% increase in research revenue is primarily attributable to revenues associated with the delivery of research data pursuant to two research collaborations which resulted in increased research revenues of approximately $5.3 million for the six months ended December 31, 2005 compared to the same six months in 2004. This increase was partially offset by the successful completion of research collaborations in the prior year, which resulted in decreased research revenues of approximately $2.2 million. Research revenue from our research collaboration agreements is recognized using a proportional performance methodology. Consequently, as these programs progress and costs increase or decrease, revenues may increase or decrease proportionately.
Predictive medicine cost of revenue for the six months ended December 31, 2005 was $12.1 million compared to $9.4 million for the same six months in 2004. This increase of 29% in predictive medicine cost of revenue is primarily due to the 41% increase in predictive medicine revenues for the six months ended December 31, 2005 compared to the same six months in 2004. This increase was partially offset by a reduction in royalty obligations as well as technology improvements and efficiency gains in the operation of our predictive medicine business. These changes also contributed to an increase in our gross profit margin, which was 73% for the six months ended December 31, 2005 compared to 71% for the same six months in 2004. There can be no assurance that predictive medicine gross profit margins will continue to increase at historical rates.
Research and development expenses for the six months ended December 31, 2005 were $37.5 million compared to $27.7 million for the same six months in 2004. This increase of 35% was due in part to increased costs associated with our ongoing clinical trials as well as increases in our drug discovery and drug development programs. These increases added approximately $7.1 million to our research and development costs for the six months ended December 31, 2005 compared to the same six months in 2004. Increased costs associated with a new research collaboration as well as technology development in our clinical laboratory added approximately $2.7 million to our research and development costs for the six months ended December 31, 2005 compared to the same six months in 2004.
Selling, general and administrative expenses for the six months ended December 31, 2005 were $22.5 million compared to $20.6 million for the same six months in 2004. This increase of 9% was primarily attributable to general increases in costs to support the 41% growth in our predictive medicine business and our therapeutic development efforts. We expect our selling, general and administrative expenses will continue to fluctuate depending on the number and scope of new product launches and our drug discovery and drug development efforts.
Liquidity and Capital Resources
Cash, cash equivalents, and marketable investment securities increased $121.3 million, or 106%, from $113.8 million at June 30, 2005 to $235.1 million at December 31, 2005. This increase is primarily attributable to the public offering of $139.7 million (net proceeds) of our common stock in November 2005. This increase was partially offset by expenditures for our ongoing clinical trials, internal research and drug development programs and other expenditures incurred in the ordinary course of business. As a result of changes in cash, cash equivalents, marketable investment securities, and interest rates, interest
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income for the three and six months ended December 31, 2005 was $1.6 million and $2.5 million, compared to $687,000 and $1.3 million for the same three and six month periods in 2004, representing increases of 140% and 87%, respectively.
Net cash used in operating activities was $17.9 million during the six months ended December 31, 2005 compared to $16.1 million used in operating activities during the same six months in 2004. Prepaid expenses increased by $3.4 million between June 30, 2005 and December 31, 2005, primarily due to the purchase of lab supplies and the prepayment of investigator grants for our ongoing Phase 3 clinical trial of Flurizan. Trade accounts receivable increased $2.6 million between June 30, 2005 and December 31, 2005, primarily due to increases in predictive medicine sales during the same period. Accounts payable increased by $2.8 million between June 30, 2005 and December 31, 2005, primarily due purchases of lab supplies, equipment, and amounts related to our clinical trials. Accrued liabilities decreased by $2.5 million between June 30, 2005 and December 31, 2005, primarily as a result of payments for predictive medicine sales and marketing commissions.
Our investing activities used cash of $55.7 million during the six months ended December 31, 2005 and used cash of $6.3 million during the same six months in 2004. Investing activities were comprised primarily of purchases and maturities of marketable investment securities and capital expenditures for research equipment.
Financing activities provided cash of $142.6 million during the six months ended December 31, 2005 and provided cash of $1.0 million during the same six months in 2004. In November 2005 we received $139.7 million in net proceeds from an underwritten offering of 8.1 million shares of our common stock pursuant to our outstanding shelf registration statement on Form S-3 (Registration No. 333-123914). Following the offering we have approximately $151.1 million of securities available for sale under the shelf registration statement. During the six months ended December 31, 2005 we received $2.8 million from the exercise of stock options and the purchase of our common stock from our Employee Stock Purchase Plan.
We believe that with our existing capital resources, we will have adequate funds to maintain our current and planned operations for at least the next two years, although no assurance can be given that changes will not occur that would consume available capital resources before such time and we may need or want to raise additional financing within this period of time. Our future capital requirements, cash flows, and results of operations could be affected by and will depend on many factors that are currently unknown to us, including:
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Effects of Inflation
We do not believe that inflation has had a material impact on our business, sales, or operating results during the periods presented.
Certain Factors That May Affect Future Results of Operations
The Securities and Exchange Commission encourages companies to disclose forward-looking information so that investors can better understand a company’s future prospects and make informed investment decisions. This Quarterly Report contains such “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.
Words such as “may,” “anticipate,” “estimate,” “expects,” “projects,” “intends,” “plans,” “believes” and words and terms of similar substance used in connection with any discussion of future operating or financial performance, identify forward-looking statements. All forward-looking statements are management’s present expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those described in the forward-looking statements. These risks include, but are not limited to: our inability to further identify, develop and achieve commercial success for new products and technologies; our ability to discover drugs that are safer and more efficacious than our competitors; our ability to develop predictive medicine products that help assess which patients are subject to greater risk of developing diseases and who would therefore benefit from new preventive therapies; the possibility of delays in the research and development necessary to select drug development candidates and delays in clinical trials; the risk that clinical trials may not result in marketable products; the risk that we may be unable to successfully finance and secure regulatory approval of and market our drug candidates, or that clinical trials will be completed on the timelines we have estimated; uncertainties about our ability to obtain new corporate collaborations and acquire new technologies on satisfactory terms, if at all; the development of competing products and services; our ability to protect our proprietary technologies; patent-infringement claims; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading “Item 8.01 Other Events - Risk Factors” in our Current Report on Form 8-K filed with the Securities and Exchange Commission on October 28, 2005.
In light of these assumptions, risks and uncertainties, the results and events discussed in the forward-looking statements contained in this Quarterly Report or in any document incorporated by reference might not occur. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this Quarterly Report or the date of any document incorporated by reference in this Quarterly Report. We are not under any obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. All subsequent forward-looking statements attributable to us or to any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section.
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We maintain an investment portfolio in accordance with our Investment Policy. The primary objectives of our Investment Policy are to preserve principal, maintain proper liquidity to meet operating needs and maximize yields. Our Investment Policy specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment.
Our investments consist of securities of various types and maturities of three years or less, with a maximum average maturity of 12 months. These securities are classified as available-for-sale, which are recorded on the balance sheet at fair market value with unrealized gains or losses reported as part of accumulated other comprehensive income. Gains and losses on investment security transactions are reported on the specific-identification method. Dividend and interest income are recognized when earned. A decline in the market value of any marketable investment security below cost that is deemed other than temporary results in a charge to earnings and establishes a new cost basis for the security.
The securities held in our investment portfolio are subject to interest rate risk. Changes in interest rates affect the fair market value of the marketable investment securities. After a review of our marketable securities as of December 31, 2005, we have determined that in the event of a hypothetical ten percent increase in interest rates, the resulting decrease in fair market value of our marketable investment securities would be insignificant to the consolidated financial statements as a whole.
In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
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PART II - Other Information
Neither the Company nor any of its subsidiaries is a party to any material legal proceedings.
None.
On November 10, 2005, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”). A quorum of 26,951,746 shares of Common Stock of the Company (of a total of 30,945,935 shares outstanding as of the record date, or 87.09%) was represented at the Annual Meeting in person or by proxy, which was held to vote on the following proposals:
Proposals 1 and 3 were adopted, and Proposal 2 was not adopted, with the vote totals as follows:
Proposal 1:
Walter Gilbert, Ph.D.
Arthur H. Hayes, Jr., M.D.
Dennis H. Langer, M.D., J.D.
Immediately following the Annual Meeting, Robert S. Attiyeh and John T. Henderson, M.D. continued to serve as Directors for terms expiring at the 2006 Annual Meeting, and Peter D. Meldrum, Mark H. Skolnick, Ph.D., and Linda S. Wilson, Ph.D. continued to serve as Directors for terms expiring at the 2007 Annual Meeting, and until their successors are duly elected and qualified.
Proposal 2:
For
Against
Abstain
Broker Non-vote
20
Proposal 3:
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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.
Date: February 6, 2006
By:
/s/ Peter D. Meldrum
Peter D. Meldrum
President and Chief Executive Officer
(Principal executive officer)
/s/ Jay M. Moyes
Jay M. Moyes
Chief Financial Officer
(Principal financial and chief accounting officer)
22