UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

 

 

InterMune, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

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 ý No o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes ý No o

 

As of April 30, 2004, there were 31,990,893 outstanding shares of Common Stock, par value $.001 per share, of InterMune, Inc.

 

 

INDEX

 

Item
		Part I.
		Financial Information
1.		Financial Statements (unaudited):
		a.     Condensed Consolidated Balance Sheets at March 31, 2004 and December 31, 2003
		b.     Condensed Consolidated Statements of Operations for the three-months ended March 31, 2004 and 2003
		c.     Condensed Consolidated Statements of Cash Flows for the three-months ended March 31, 2004 and 2003
		d.     Notes to Condensed Consolidated Financial Statements
2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations Risk Factors
3.		Quantitative and Qualitative Disclosures About Market Risk
4.		Controls and Procedures
		Part II.
		Other Information
2.		Changes in Securities, Use of Proceeds and Issuer Purchases of Equity Securities
5.		Other Information
6.		Exhibits and Reports on Form 8-K
		Signatures

 

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PART I—FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

INTERMUNE, INC.

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited, in thousands, except share and per share data)

 

		March 31, 2004			December 31, 2003
ASSETS
Current assets:
Cash and cash equivalents		$	181,095		$	42,071
Available-for-sale securities		129,797			174,036
Accounts receivable, net		12,132			13,270
Inventories		17,107			20,062
Prepaid expenses		3,891			2,417
Total current assets		344,022			251,856
Property and equipment, net		9,318			9,621
Acquired product rights, net		21,201			21,978
Restricted cash		1,675			1,675
Notes receivable from employees		706			698
Other assets		7,092			2,673
Total assets		$	384,014		$	288,501
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	12,155		$	20,281
Accrued compensation		4,800			6,357
Other current liabilities		22,344			23,363
Total current liabilities		39,299			50,001
Deferred rent		1,341			1,256
Convertible notes		267,000			149,500
Commitments:
Stockholders’ equity:
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively		—			—
Common stock, $0.001 par value, 51,000,000 shares authorized; 31,887,117 and 31,845,011 shares issued and outstanding at March 31, 2004 and December 31, 2003, respectively		32			32
Additional paid-in capital		483,980			483,697
Deferred stock compensation		(138		)	(217		)
Accumulated other comprehensive income		379			400
Accumulated deficit		(407,879		)	(396,168		)
Total stockholders’ equity		76,374			87,744
Total liabilities and stockholders’ equity		$	384,014		$	288,501

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 

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INTERMUNE, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited, in thousands, except per share amounts)

 

		Three Months Ended March 31,
		2004			2003
Product sales:
Actimmune		$	32,921		$	37,925
Others		5,207			2,481
Total product sales, net		38,128			40,406
Costs and expenses:
Cost of goods sold		9,688			9,787
Amortization of acquired product rights		777			940
Research and development		18,267			31,895
Selling, general and administrative		16,686			13,666
Acquired research and development and milestone payments		—			1,750
Total costs and expenses		45,418			58,038
Loss from operations		(7,290		)	(17,632		)
Other income (expense):
Interest income		845			1,140
Interest expense		(2,258		)	(2,442		)
Other expense		(3,008		)	—
Net loss		$	(11,711	)	$	(18,934	)
Basic and diluted net loss per common share		$	(0.37	)	$	(0.60	)
Weighted average shares used in computing basic and diluted net loss per common share		31,814			31,535

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 

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INTERMUNE, INC.

 

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited, in thousands)

 

		Three Months Ended March 31,
		2004			2003
Cash flows used for operating activities:
Net loss		$	(11,711	)	$	(18,934	)
Adjustments to reconcile net loss to net cash used for operating activities:
Amortization of deferred compensation, net of reversals		(118		)	(217		)
Non-cash stock compensation		68			17
Acquired research and development and milestone payments		—			1,750
Amortization and depreciation		1,790			1,819
Loss on early extinguishment of convertible debt		3,008			—
Deferred rent		85			115
Changes in operating assets and liabilities:
Accounts receivable		1,138			765
Inventories		2,955			(2,862		)
Other assets		(1,467		)	(2,524		)
Accounts payable and accrued compensation		(9,683		)	(2,003		)
Other accrued liabilities		(1,019		)	2,209
Net cash used for operating activities		(14,954		)	(19,865		)
Cash flows from investing activities:
Purchase of property and equipment		(389		)	(712		)
Purchase of acquired product rights, including research and development and milestone payments		—			(18,750		)
Purchases of available-for-sale securities		(12,828		)	(121,417		)
Sales of available-for-sale securities		28,652			93,234
Maturities of available-for-sale securities		28,394			32,981
Net cash provided (used) by investing activities		43,829			(14,664		)
Cash flows from financing activities:
Proceeds from issuance of common stock, net		412			77
Repurchase of convertible subordinated notes		(54,663		)	—
Repayment of notes receivable from stockholder		—			5
Proceeds from convertible senior notes, net		164,400			—
Net cash provided by financing activities		110,149			82
Net increase (decrease) in cash and cash equivalents		139,024			(34,447		)
Cash and cash equivalents at beginning of period		42,071			101,683
Cash and cash equivalents at end of period		$	181,095		$	67,236
Supplemental disclosure of cash flow information:
Accrued milestone payment		$	10,400		$	—

 

See accompanying Notes to Condensed Consolidated Financial Statements.

 

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INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

 

1.             SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of presentation

 

The accompanying unaudited condensed consolidated financial statements of InterMune, Inc. (“InterMune,” “we,” “our” or “us”) have been prepared in accordance with generally accepted accounting principles for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of our management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments, consisting only of normal recurring adjustments, necessary to present fairly our financial position, results of operations and cash flows for the interim periods presented. The balance sheet at December 31, 2003 has been derived from audited financial statements at that date, but does not include all disclosures required by generally accepted accounting principles for complete financial statements.

 

Certain information and footnote disclosures usually included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted. The accompanying interim condensed consolidated financial statements should be read in conjunction with our audited financial statements and the notes thereto included in our annual report filed with the SEC on Form 10-K for the year ended December 31, 2003. The results of operations for the interim periods presented are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year.

 

Principles of consolidation

 

The accompanying unaudited condensed consolidated financial statements include the accounts of InterMune and its wholly owned subsidiaries, InterMune Canada Inc. and InterMune Europe Limited. All intercompany accounts and transactions have been eliminated. To date, the operations of InterMune Canada Inc. and InterMune Europe Limited have been immaterial.

 

Use of estimates

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and 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 and assumptions.

 

We evaluate our estimates and assumptions on an ongoing basis, including those related to reserves for doubtful accounts, returns, charge backs, discounts and rebates; excess inventories; inventory purchase commitments; and accrued clinical and preclinical expenses.  We base our estimates on historical experience and on various other specific assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources.

 

Cash, cash equivalents and available-for-sale securities

 

Cash and cash equivalents consist of highly liquid investments with original maturities, when purchased, of less than three months. We classify all debt securities as available for sale. Cash equivalents and available-for-sale securities are carried at fair value, with unrealized gains and losses, and are reported as other comprehensive income, a separate component of stockholders’ equity. We have estimated the fair value amounts by using available market information. The cost of securities sold is based on the specific identification method.

 

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Non-cancelable purchase obligations for inventory

 

Because of the long lead times required to manufacture our products, we enter into non-cancelable obligations to purchase our inventory. We evaluate the need to provide reserves for contractually committed future purchases of inventory that may be in excess of forecasted future demand. In making these assessments, we are required to make judgments as to the future demand for current or committed inventory levels. We are also required to make judgments as to the expiration dates of our products, since our products can no longer be used after their respective expiration dates. In an effort to help manage our inventory levels of Actimmune, we are conducting an ongoing study to determine whether its expiration period may be lengthened. As part of our excess inventory assessment for all of our products, we also consider the expiration dates of our products to be manufactured in the future.

 

Significant differences between our current estimates and judgments and future estimated demand for our products and the useful life of our inventories may result in significant charges for excess inventory or purchase commitments in the future. These differences could have a material adverse effect on our financial condition and results of operations during the period in which we recognize an inventory reserve.

 

Fair value of other financial instruments

 

Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which we believe approximates fair value because of the short-term maturity of these instruments. The fair value of our convertible subordinated debt and convertible senior debt at March 31, 2004 was $100.0 million and $181.6 million, respectively, which we determined using available market information.

 

Concentration of risks

 

Cash equivalents and investments are financial instruments that potentially subject us to concentration of risk to the extent recorded on the balance sheet. We have established guidelines for investing excess cash relative to diversification and maturities that we believe maintain safety and liquidity. We invest our excess cash in debt instruments of the U.S. federal and state governments and their agencies and high-quality corporate issuers, and, by policy, restrict our exposure to any single corporate issuer by imposing concentration limits. To minimize the exposure due to adverse shifts in interest rates, we maintain investments at an average contractual maturity of approximately two years.

 

Our revenues and trade receivables are concentrated with a few customers. We perform credit evaluations on our customers’ financial condition and limit the amount of credit extended when necessary. However, we generally do not require collateral on accounts receivable. Concentrations of credit risk, with respect to accounts receivable, exist to the extent of amounts presented in the financial statements. Three customers represented 59%, 10% and 10%, respectively, of total accounts receivable at December 31, 2003, and one customer represented 62% of total accounts receivable at March 31, 2004. No other customer represented more than 10% of accounts receivable at December 31, 2003 or March 31, 2004.

 

Product sales to customers representing 10% or more of total sales during the three-month periods ended March 31, 2004 and 2003, respectively are as follows:

 

Customer		2004		2003
Caremark		8	%	10	%
Merck Medco		10	%	12	%
Priority Healthcare		59	%	60	%

 

Risks from third-party manufacturer concentration

 

We rely on a single source manufacturer for each of our products. Actimmune is produced solely by Boehringer Ingelheim Austria GmbH (BI Austria) for all clinical and commercial supplies. Infergen is produced solely by Amgen Inc. Amphotec, marketed as Amphocil outside of the United States, is produced solely by Ben

 

7

 

Venue Laboratories Inc. (Amphotec and Amphocil are referred to collectively in this Report as “Amphotec.”) Any extended interruption in the supply of any of our products could cause us to fail to meet clinical or commercial demand.

 

We purchase commercial and clinical products from BI Austria in a foreign currency.  This exposes us to foreign currency exchange rate risk.  To protect against currency exchange risks on forecasted foreign currency expenditures for commercial product, we have instituted a foreign currency cash flow hedging program that started during April 2004.  We hedge portions of our forecasted foreign currency inventory expenditures with forward contracts. In accordance with FAS 133, hedges related to anticipated transactions are designated and documented at the hedge’s inception as cash flow hedges and evaluated for hedge effectiveness at least quarterly.

 

Inventories

 

Inventories consist principally of raw materials and finished good products and are stated at the lower of cost or market. Cost is determined by the first-in, first-out (FIFO) method.

 

Property and equipment

 

Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, which are generally three to five years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the assets.

 

Acquired product rights

 

Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the FDA for marketing, are typically capitalized and amortized ratably over the estimated life of the products, typically ten years. At the time of acquisition, we estimate the product’s life based upon the term of the agreement, the patent life of the product and our assessment of future sales and profitability of the product. We assess this estimate regularly during the amortization period and adjust the asset value or useful life when appropriate. Initial payments for the acquisition of products that, at the time of acquisition, are under development or are not approved by the FDA for marketing, have not reached technical feasibility and have no foreseeable alternative future uses are expensed as research and development. Accumulated amortization of these intangible assets was $14.9 million at March 31, 2004.

 

Impairment of long-lived assets

 

In accordance with SFAS No. 144, “ Accounting for the Impairment or Disposal of Long-Lived Assets,” if indicators of impairment exist, we assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we will measure the amount of such impairment by comparing the carrying value of the asset to the present value of the expected future cash flows associated with the use of the asset.  See Note 8 below for additional disclosures concerning the $4.8 million impairment charge.

 

Revenue recognition and revenue reserves

 

We recognize revenue upon shipment when title passes to a credit-worthy customer, and record reserves for estimated returns, rebates, chargebacks and cash discounts. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We are able to make reasonable and reliable estimates of product returns based on historical experience. We review all sales transactions for potential rebates, chargebacks and discounts each month and believe that our reserves are adequate. We include shipping and handling costs in cost of goods sold.

 

Research and development expenses

 

Research and development (or R&D) expenses include salaries, contractor and consultant fees, external clinical trial expenses performed by contract research organizations, in-licensing fees and facility and administrative

 

8

 

expense allocations. In addition, we fund R&D at research institutions under agreements that are generally cancelable at our option. Research costs typically consist of applied and basic research and preclinical and toxicology work. Pharmaceutical manufacturing development costs consist of product formulation, chemical analysis and the transfer and scale-up of manufacturing at our contract manufacturers. Clinical development costs include the costs of Phase I, II and III clinical trials. These costs, along with the manufacturing scale-up costs, are a significant component of research and development expenses.

 

We accrue costs for clinical trial activities performed by contract research organizations based upon the estimated amount of work completed on each study. These estimates may or may not match the actual services performed by the organizations as determined by patient enrollment levels and related activities. We monitor patient enrollment levels and related activities to the extent possible; however, if we underestimate activity levels associated with various studies at a given point in time, we could record significant R&D expenses in future periods when the actual activity level becomes known. We charge all such costs charged to R&D expense.

 

Advertising costs

 

We expense advertising costs as incurred.

 

Income taxes

 

In accordance with SFAS No. 109, “Accounting for Income Taxes,” we determine a deferred tax asset or liability based on the difference between the financial statement and tax basis of assets and liabilities as measured by the enacted tax rates, which will be in effect when these differences reverse. We provide a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized.  Accordingly, the net deferred tax assets have been fully offset by a valuation allowance.

 

Comprehensive income (loss)

 

SFAS No. 130, “Reporting Comprehensive Income,” requires components of other comprehensive income, including unrealized gains or losses on our available-for-sale securities, to be included in total comprehensive income (loss). Total comprehensive loss for each of the periods presented are disclosed in Note 5 below.

 

Net loss per share

 

We compute basic net loss per share by dividing the net loss for the period by the weighted average number of common shares outstanding during the period.  We deduct shares subject to repurchase by us from the outstanding shares to arrive at the weighted average shares outstanding. We compute diluted net loss per share by dividing the net loss for the period by the weighted average number of common and common equivalent shares outstanding during the period. We exclude potentially dilutive securities, composed of incremental common shares issuable upon the exercise of stock options and common shares issuable on conversion of our convertible notes, from diluted net loss per share because of their anti-dilutive effect.

 

Stock-Based Compensation

 

We follow APB Opinion No. 25, “Accounting for Stock Issued to Employees,” (“APB 25”) in accounting for stock-based incentives. In October 1995, the FASB issued SFAS No. 123, “Accounting for Stock Based Compensation,” (“SFAS 123”) and in December 2002, the FASB issued SFAS No. 148, “Accounting for Stock-Based Compensation — Transition and Disclosure.” Although these pronouncements allow us to continue to follow the APB 25 guidelines for the measuring and recording of employee stock-based compensation expense, we are required to disclose the effect on net loss and net loss per share as if we had applied the fair value recognition provisions of SFAS 123 to stock-based employee compensation.  The following tables provide such disclosure (in thousands, except per share amounts):

 

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		Three Months Ended March 31,
		2004			2003
Net loss, as reported		$	(11,711	)	$	(18,934	)
Add: Stock-based employee compensation expense, included in reported net loss		(118		)	(217		)
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards		(2,359		)	(6,174		)
Pro forma net loss		$	(14,188	)	$	(25,325	)
Net loss per share:
Basic and diluted—as reported		$	(0.37	)	$	(0.60	)
Basic and diluted—pro forma		$	(0.45	)	$	(0.80	)

 

The pro forma impact of applying SFAS 123 for the three months ended March 31, 2004 and 2003, respectively, does not necessarily represent the pro forma impact in future quarters or years.

 

We estimate the fair value of each option grant on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions:

 

		Three Months Ended March 31,
		2004		2003
Expected stock price volatility		80	%	83	%
Risk-free interest rate		3.13	%	1.75	%
Expected life (in years)		4.1		5.7
Expected dividend yield		—		—

 

We estimate the fair value of the employees’ stock purchase rights using the Black-Scholes option-pricing model with the following weighted average assumptions:

 

		Three Months Ended March 31,
		2004		2003
Expected stock price volatility		81	%	87	%
Risk-free interest rate		2.0	%	2.6	%
Expected life (in years)		2.0		2.0
Expected dividend yield		—		—

 

The Black-Scholes option pricing model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable.  This model also requires the input of highly subjective assumptions including the expected stock price volatility.  Because our outstanding stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect this estimate, we believe the Black-Scholes model does not provide a reliable single measure of the fair value of our stock options.

 

2.             RECENT ACCOUNTING PRONOUNCEMENTS

 

In January 2003, the FASB issued FASB Interpretation No. 46, “Consolidation of Variable Interest

 

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Entities, an Interpretation of ARB No. 51” (“FIN 46”).  FIN 46 requires certain variable interest entities to be consolidated by the primary beneficiary of the entity if the equity investors in the entity do not have the characteristics of a controlling financial interest or do not have sufficient equity at risk for the entity to finance its activities without additional subordinated financial support from other parties. FIN 46 is effective for all new variable interest entities created or acquired after January 31, 2003. For variable interest entities created or acquired prior to February 1, 2003, the provisions of FIN 46 must be applied for the first interim or annual period ending after March 15, 2004. The adoption of FIN 46 did not have a material impact on our consolidated financial statements.

 

3.             INVENTORIES

 

Inventories consisted of the following (in thousands):

 

		March 31, 2004			December 31, 2003
Raw materials		$	552		$	552
Finished goods		16,555			19,510
Total inventories		$	17,107		$	20,062

 

4.             OTHER ACCRUED LIABILITIES

 

Other accrued liabilities consisted of the following (in thousands):

 

		March 31, 2004			December 31, 2003
Accrued clinical trial costs		$	5,517		$	4,882
Accrued interest		1,204			3,940
Payable to Eli Lilly		10,000			10,000
Royalties payable		5,379			4,254
Other accrued liabilities		244			287
Total other accrued liabilities		$	22,344		$	23,363

 

5.             COMPREHENSIVE INCOME (LOSS)

 

Comprehensive income (loss) is comprised of net income (loss) and other comprehensive income (loss).  The only component of other comprehensive income (loss) is unrealized gains (losses) on available-for-sale securities.  The following table summarizes the components of total comprehensive income (loss) during the first three months of 2004 and 2003 (in thousands):

 

		Three Months Ended March 31,
		2004			2003
Net loss, as reported		$	(11,711	)	$	(18,934	)
Change in unrealized gains (losses) on securities available-for-sale		(21		)	27
Comprehensive loss		$	(11,732	)	$	(18,907	)

 

6.             DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION

 

We have determined that we have only one reportable segment because we have organized our business around its functional lines.

 

Net product sales consisted of the following (in thousands):

 

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		Three Months Ended March 31,
		2004			2003
Actimmune		$	32,921		$	37,925
Infergen		3,998			1,649
Amphotec		1,209			832
Total net product sales		$	38,128		$	40,406

 

The following table summarizes total net product sales from external customers by geographic regions.  Revenues are attributed to countries based on the location of the customer (in thousands):

 

		Three Months Ended March 31,
		2004			2003
United States		$	37,014		$	39,731
Other countries		1,114			675
Total net product sales		$	38,128		$	40,406

 

7.             CONVERTIBLE SUBORDINATED NOTES

 

On July 5, 2001, we completed a public offering of $149.5 million aggregate principal amount of 5.75% convertible subordinated notes due July 15, 2006 (the “Subordinated Notes”). The Subordinated Notes are unsecured and rank junior to all of our future unsecured and unsubordinated debt. The Subordinated Notes are convertible at any time at the option of the holder into our common stock at a conversion price of $38.40 per share, subject to adjustment in certain circumstances. Offering expenses of $5.1 million related to the sale of the Subordinated Notes have been included in other assets and are amortized to interest expense over the expected life of the Subordinated Notes.

 

In February 2004, we purchased $52.5 million in principal amount of our outstanding Subordinated Notes with the proceeds received from the sale of our 0.25% convertible senior notes due March 1, 2011 (see Note 8). We paid a total of $55.0 million related to the purchase, which included $0.4 million for accrued interest on the purchased Subordinated Notes, and a premium of $2.2 million recognized as a loss on the early extinguishment of debt. We also recognized a non-cash charge of $0.8 million on unamortized deferred issuance costs associated with the extinguished debt.

 

8.             CONVERTIBLE SENIOR NOTES

 

In February 2004, we issued 0.25% convertible senior notes due March 1, 2011 in an aggregate principal amount of $170.0 million (the “Senior Notes”). The Senior Notes are convertible into our common stock at a conversion price of approximately $21.63 per share, subject to adjustment in certain circumstances. Interest on the Senior Notes is payable semiannually in arrears on March 1 and September 1 of each year. The Senior Notes are unsecured and rank on parity with all of our other existing and future senior unsecured debt and prior to all subordinated indebtedness. We intend to use the net proceeds of $164.4 million from this offering to purchase or redeem, before and/or during the third quarter of 2004, our outstanding Subordinated Notes. As of March 31, 2004, we had purchased an aggregate of  $52.5 million in principal amount of our outstanding Subordinated Notes (see Note 7).  However, we may determine not to purchase or redeem all of our outstanding Subordinated Notes.  Offering expenses of $5.6 million related to the sale of the Senior Notes have been included in other assets and are being amortized to interest expense over the life of the Senior Notes, or seven years.

 

9.             GUARANTEES AND INDEMNIFICATIONS

 

In November 2002, the FASB issued Interpretation No. 45, “Guarantor’s Accounting and Disclosure Requirements for Guarantees, including Indirect Guarantees of Indebtedness of Others” (“FIN 45”). FIN 45

 

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requires that upon issuance of a guarantee, the guarantor must recognize a liability for the fair value of the obligations it assumes under that guarantee.

 

As permitted under Delaware law and in accordance with our Bylaws, we indemnify our officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at our request in such capacity. We terminate the indemnification agreements with our officers and directors upon the termination of their employment, but the termination will not affect claims for indemnification relating to events occurring prior to the effective date of termination. The maximum amount of potential future indemnification is unlimited; however, our director and officer insurance policy limits our exposure and may enable us to recover a portion of any future amounts paid. We believe the fair value of these indemnification agreements is minimal. Accordingly, we have not recorded any liabilities for these agreements as of March 31, 2004.

 

ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This Quarterly Report on Form 10-Q contains certain information regarding our financial projections, plans and strategies that are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements involve substantial risks and uncertainty. You can identify these statements by forward-looking words such as “may,” “will,” “expect,” “intend,” “anticipate,” “believe,” “estimate,” “plan,” “could,” “should” and “continue” or similar words. These forward-looking statements may also use different phrases.

 

We have based these forward-looking statements on our current expectations and projections about future events. These forward-looking statements, which are subject to risks, uncertainties and assumptions about us, may include, among other things, statements which address our strategy and operating performance, and events or developments that we expect or anticipate will occur in the future, including, but not limited to, statements in the discussions about:

 

•              product and product candidate development;

 

•              governmental regulation and approval;

 

•              sufficiency of our cash resources;

 

•              future revenues, including those from product sales and collaborations, and future expenses;

 

•              pending securities and shareholder derivative class action litigation;

 

•              our research and development expenses and other expenses; and

 

•              our operational and legal risks.

 

We believe it is important to communicate our expectations to our investors. However, there may be events in the future that we are not able to predict accurately or which we do not fully control that could cause actual results to differ materially from those expressed or implied in our forward-looking statements. Because these forward-looking statements involve risks and uncertainties, there are important factors that could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, but not limited to, the following:

 

•              regulatory, supply and competitive factors;

 

•              general economic conditions;

 

•              the uncertain, lengthy and expensive clinical development and regulatory process;

 

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•              whether we will be able to obtain, maintain and enforce patent and other intellectual property rights;

 

•              changes in budget constraints;

 

•              reimbursement risks associated with third-party payors;

 

•              patient enrollment and retention in clinical trials;

 

•              changes in industry practices; and

 

•              one-time events.

 

You should also consider carefully the statements under the heading “Risk Factors” below, which address additional factors that could cause our results to differ from those set forth in the forward-looking statements. Any forward-looking statements are qualified in their entirety by reference to the factors discussed in this Report, including those discussed in this Report under the heading “Risk Factors” below. Because of the factors referred to above, as well as the factors discussed in this Report under the heading “Risk Factors” below, could cause actual results or outcomes to differ materially from those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking statements. Further, any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

 

Critical Accounting Policies

 

Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe are reasonable. These estimates are the basis for our judgments about the carrying values of assets and liabilities, which in turn may impact our reported revenue and expenses.  Actual results may differ from these estimates under different assumptions or conditions.

 

An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, and if different estimates that reasonably could have been used, or changes in the accounting estimate that are reasonably likely to occur periodically, could materially change the financial statements. We believe there have been no significant changes during the three-month period ended March 31, 2004 to the items that we disclosed as our critical accounting policies and estimates under Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” in our Annual Report on Form 10-K for the year ended December 31, 2003.

 

Overview

 

InterMune is an independent biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology. In 2003, we reorganized our business by curtailing investment in non-core areas and focusing our commercial and development efforts in pulmonology and hepatology. We have a revenue base provided primarily by our two core marketed products, advanced-stage clinical programs addressing a range of unmet medical needs with attractive potential commercial markets and several strategic non-core assets that we believe provide us the opportunity to create value.  The substantial majority of our revenues are generated from Actimmune.

 

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Marketed Products

 

Our two core marketed products are Actimmune (interferon gamma-1b), approved for the treatment of severe, malignant osteopetrosis and chronic granulomatous disease, and Infergen (consensus interferon alfacon-1), approved for the treatment of chronic hepatitis C virus, or HCV, infections.

 

Co-Promotion

 

On March 26, 2004, we entered into an agreement with Baxter Healthcare Corporation under which we will promote Baxter’s product Aralast in the United States for the treatment of hereditary emphysema.

 

Product Development

 

Drug development in the United States is a process that includes several steps defined by the U.S. Food and Drug Administration, or FDA. The process begins with the filing of an Investigational New Drug Application, or IND, which if successful, allows for the opportunity for clinical study of the potential new medicine. Clinical development typically involves three phases of clinical trials: Phase I, II and III. In our experience, clinical development accounts for an average of seven years of a drug’s total development time. The FDA may require, or companies may pursue, additional clinical trials, known as Phase IV clinical trials, after a product is approved. The results of Phase IV clinical trials can confirm the effectiveness of a drug and can provide important safety information to supplement the FDA’s voluntary adverse drug reaction reporting system. The most significant costs associated with clinical development are Phase III clinical trials, as they tend to be the longest and largest studies conducted during the drug development process. It is not uncommon for a drug that appears promising in a Phase II clinical trial to fail in a more rigorous and reliable Phase III clinical trial.

 

The successful development of our product candidates is highly uncertain. Product development costs and timelines can vary significantly for each product candidate and are difficult to accurately predict. Various statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of each product. The lengthy process of seeking these approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect our business. In responding to a New Drug Application, or NDA, a Biologic License Application, or BLA, or an NDA or BLA supplement, the FDA may grant marketing approval (i.e., a license), request additional information or refuse to approve the application if it determines that the application does not provide an adequate basis for approval.

 

We have a late-stage development pipeline in the areas of pulmonology and hepatology.

 

•              Pulmonology

 

In pulmonology, we are developing two therapies for the treatment of idiopathic pulmonary fibrosis, or IPF, and one therapy for Hermansky-Pudlak Syndrome, or HPS. IPF is a fatal disease for which there is no FDA approved therapy. We believe that there are approximately 83,000 patients with IPF in the United States. We are developing what we believe to be the two most promising and most clinically advanced compounds for the treatment of IPF—Actimmune and pirfenidone. We initiated a pivotal Phase III clinical trial of Actimmune for the treatment of patients with IPF in December 2003. We have rights to develop and commercialize Actimmune for a broad range of diseases in the United States, Canada and Japan. We are collaborating with Boehringer Ingelheim International GmbH (BI International), which has similar rights in Europe and the rest of the world, to develop and commercialize interferon gamma-1b under the trade name Imukin. We expect to announce our plans regarding a clinical development program for pirfenidone in IPF in 2004. We are also developing pirfenidone for HPS, a rare, fatal, fibrotic lung disease caused by genetic factors for which there is no FDA approved therapy.

 

•              Hepatology

 

In hepatology, we are focused on expanding treatment options for patients suffering from HCV infections. We are developing once-daily Infergen in combination with ribavirin therapy for the treatment of patients suffering

 

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from chronic HCV infections who have failed to respond to the current standard of care, pegylated interferon-alpha 2 in combination with ribavirin therapy. These patients are referred to as hepatitis C nonresponders. We believe that there are approximately 150,000 hepatitis C nonresponders in the United States, and that this patient population is growing rapidly. We expect to initiate a Phase III trial of once-daily treatment with Infergen in combination with ribavirin therapy for hepatitis C nonresponders in the first half of 2004. In addition, we are developing once-daily Infergen in combination with Actimmune with and without ribavirin for the treatment of hepatitis C nonresponders. We have initiated a Phase II clinical trial of this combination.  We completed our Phase I trial of a pegylated form of Infergen, PEG-Alfacon-1, for the treatment of chronic HCV infections in 2003.  The PEG-Alfacon-1 development program will be lengthy and very expensive, and the duration and expense carry significant risk.  Accordingly, we are considering alternative development plans and business collaborations that could increase the speed and decrease our risk and expense for this program.  Once we have completed our analysis of alternative development plans and assessed the value that a partnership could bring to PEG-Alfacon-1, we will announce our plans, which, if we are unable to enter into a collaboration on favorable terms, may include a discontinuation of the program.

 

Non-Core Strategic Assets

 

Consistent with our focused strategy on pulmonology and hepatology, we intend to capture value from our assets outside these core areas, and are seeking partners for certain of these assets.  In particular, we are looking for a partner to assume the future development investment in oritavancin and are in the process of divesting Amphotec.  We are also evaluating Actimmune in ovarian cancer in an ongoing Phase III trial.  We will make a decision as to the future of this program when we receive data from a prospectively planned interim analysis of progression-free survival, which we anticipate in mid-2005.

 

Operating History

 

We have a limited history of operations, which makes accurate prediction of future operating results difficult or impossible. We expect that our quarterly and annual results of operations may fluctuate for the foreseeable future due to a number of factors, including, but not limited to, those described under the heading “Risk Factors” in this Report.

 

We have sustained losses on a quarterly and an annual basis since inception. As of March 31, 2004, we had an accumulated deficit of $407.9 million. We expect to incur losses through at least the end of 2004 or beyond. Our loss from operations was $7.3 million for the three-month period ended March 31, 2004, and $17.6 million for the same period in 2003. These losses resulted from costs incurred in the development and commercialization of our products and product candidates and the acquisition of new technology.  Our expenses have consisted primarily of those incurred for research and development, sales and marketing and general and administrative costs associated with our operations.

 

Core Product and Product Development Status

 

The following chart shows the status of our core product and product development programs as of March 31, 2004:

 

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		Pre-clinical		Phase I		Phase II		Phase III
Pulmonology
Actimmune
Idiopathic pulmonary fibrosis								X
Pirfenidone
Idiopathic pulmonary fibrosis						X
Hermansky-Pudlak syndrome								X
Next-generation interferon gamma		X
Hepatology
Daily Infergen + Ribavirin
Hepatitis C nonresponders								X
Daily Infergen + Actimmune
Hepatitis C nonresponders						X
PEG-Alfacon-1
Chronic hepatitis C virus infections				X
Next-generation interferon gamma		X
Strategic Non-Core Programs
Actimmune
Ovarian cancer								X
Oritavancin
Complicated skin and skin-structure infections								X

 

Results of Operations

 

Revenue

 

Total product revenues were $38.1 million and $40.4 million for the three-month periods ended March 31, 2004 and 2003, respectively, representing a decrease of 6%. Actimmune revenues were $32.9 million and $37.9 million for the three-month periods ended March 31, 2004 and 2003, respectively, representing a decrease of 13%.  The underlying demand for Actimmune declined modestly in the first quarter of 2004 versus the same period of 2003; however, the decrease in Actimmune revenues was exaggerated due to specialty distributors increasing their inventory levels during the first quarter of 2003.  Infergen revenues were $3.9 million and $1.6 million for the three-month periods ended March 31, 2004 and 2003, respectively, representing an increase of 144%.

 

We experienced a decrease in the underlying demand for Actimmune during the first quarter of 2004. We believe that the rate of patient referrals by physicians and the average duration of therapy are among

 

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the key uncertainties that will affect demand for Actimmune and our Actimmune revenue and total product revenue in future periods. The patient referral rate reflects the number of new patients who are being newly prescribed Actimmune, although these patients may elect not to have those prescriptions filled.  We believe that the following factors are among those that may affect the patient referral rate for Actimmune: better screening of patients by physicians; lower physician or patient interest; the publication of results of our initial Phase III IPF clinical trial, GIPF-001, in the New England Journal of Medicine and the negative editorial that accompanied the publication; and that physicians may be holding some patients for screening and potential enrollment in our Phase III IPF clinical trial, GIPF-007, who would otherwise be put on Actimmune therapy.  During the first quarter of 2004, the patient referral rate that we observed was significantly lower than we expected; however, we observed an increase in the average duration of therapy that was significantly greater than expected.  We believe that it is too early to determine the net effects of the lower patient referral rate and the increased average duration of therapy, along with other factors, on future Actimmune revenue and total product revenue.

 

Cost of goods sold

 

Cost of goods sold included product manufacturing costs, royalties, inventory adjustments and distribution costs associated with our revenues. Cost of goods sold were $9.7 million and $9.8 million for the three-month periods ended March 31, 2004 and 2003, respectively.  The cost of goods sold, as a percentage of revenues, were 25% and 24% for the three-month periods ended March 31, 2004 and 2003, respectively. The increase for the 2004 period, versus the same period in 2003, was primarily due to the mix of products sold during the period.

 

Amortization of acquired product rights

 

We recorded amortization of acquired product rights of $0.8 million and $0.9 million for the three-month periods ended March 31, 2004 and 2003, respectively.  The amounts recorded for the three-month periods ending March 31, 2004 and 2003, respectively, were comprised of the amortization charges related to the acquisition of Amphotec and Infergen product rights and interferon gamma-1b patents.  The decrease for the 2004 period, versus the same period in 2003, was primarily due to a charge of $4.8 million taken in the third quarter of 2003 for the impairment of Amphotec product rights which reduced the remaining carrying value of the intangible asset being amortized.

 

Research and development expenses

 

Research and development expenses were $18.3 million and $31.9 million for the three-month periods ended March 31, 2004 and 2003, respectively, representing a decrease of $13.6 million, or 43%.  The decrease for the 2004 period, versus the same period in 2003, was primarily due to lower spending on oritavancin of $7.6 million, PEG-Alfacon-1 of $4.1 million and Actimmune development programs of $1.4 million.  We continue to expect our research and development expenses for fiscal year 2004 to be lower than fiscal year 2003 primarily due to decreased spending on research and development projects that are not aligned with our strategic focus in pulmonology and hepatology.

 

Selling, general and administrative expenses

 

Selling, general and administrative expenses were $16.7 million and $13.7 million for the three-month periods ended March 31, 2004 and 2003, respectively, representing an increase of $3.0 million, or 22%.  The increased spending in 2004, versus the same period in 2003, was primarily due to increased level of spending of $2.1 million for programs supporting our products, Actimmune and Infergen, along with relocation and recruiting expenses of $0.4 million associated with our reorganization, and increased legal expenses of $0.4 million.

 

Acquired research and development and milestone payments

 

We recorded a charge of $1.8 million for acquired research and development and milestone payments for the three-month period ending March 31, 2003.  The charge in 2003 related to certain milestone payments made in the period as a result of the commencement of the Phase I clinical trial for PEG-Alfacon-1. We expensed this amount as acquired in-process research and development and milestone payments because PEG-Alfacon-1 was in clinical

 

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development, had not reached technical feasibility, and had no foreseeable alternative future uses.

 

Interest income

 

Interest income decreased to $0.8 million for the three-month period ended March 31, 2004 compared to $1.1 million for the three-month period ended March 31, 2003.  The decreases in interest income reflected declining investment yields on our cash and short-term investments resulting from lower market interest rates on our investment portfolio.

 

Interest expense

 

Interest expenses decreased to $2.3 million for the three-month period ended March 31, 2004 compared to $2.4 million for the three-month period ended March 31, 2003.  The interest expenses for both periods were primarily comprised of interest expense on our $149.5 million aggregate principal amount of our 5.75% convertible subordinated notes issued in July 2001 and which will mature in July 2006.  The slight decrease in interest expense is due to the repurchase of $52.5 million of our 5.75% convertible subordinated notes during the 2004 period which was partially offset by interest expense on our 0.25% convertible senior notes issued in February 2004.

 

Other expense

 

Other expenses of $3.0 million for the three-month period ended March 31, 2004 were comprised of a $2.2 million premium paid and a non-cash charge of $0.8 million due to the acceleration of deferred issuance costs.  Both of these charges were associated with our repurchase of $52.5 million in principal amount of our 5.75% convertible subordinated notes.

 

Liquidity and Capital Resources

 

At March 31, 2004, we had available cash, cash equivalents and available-for-sale securities of $310.9 million.  The primary objective of our investment activities is to preserve principal while at the same time maximizing yields without significantly increasing risk. To achieve this objective, we invest our excess cash in debt instruments of the U.S. federal and state governments and their agencies and high-quality corporate issuers, and, by policy, restrict our exposure to any single corporate issuer by imposing concentration limits.

 

Operating activities used $15.0 million in cash during the three-month period ended March 31, 2004, primarily due to the loss from operations of $7.3 million, a decrease in accounts payable and accrued compensation totaling $9.7 million, offset by a decrease in inventories of $3.0 million. The decrease in accounts payable and accrued compensation was primarily a result of payments made during the 2004 period for inventories acquired during the fourth quarter of 2003. The decrease in inventories is due to product sales and reduced inventory purchases during the first quarter of 2004. Details concerning the loss from operations can be found elsewhere in this report under the heading "Results of Operations."

 

Investing activities provided $43.8 million in cash during the three-month period ended March 31, 2004, due in part to maturities and sales of short-term investments totaling $57.0 million, offset by $12.8 million of short-term investment purchases and purchases of property and equipment of $0.4 million.  Cash provided by investing activities increased by $58.5 million for the 2004 period, compared to the same period in 2003, primarily due to the increase in maturities and sales of available-for-sale securities net of purchases of available-for-sale securities of $39.4 million, and $18.8 million paid in the 2003 period related to the purchase of acquired product rights, including research and development and milestone payments.

 

Cash provided by financing activities of $110.1 million for the three-month period ended March 31, 2004 was primarily due to the receipt of net proceeds of $164.4 million related to the issuance of $170.0 million in 0.25% convertible senior notes due March 2011.  These proceeds were offset by the purchase of $52.5 million in principal amount of our outstanding 5.75% convertible subordinated notes due July 2006.  We paid a total of $55.0 million related to the purchase, which included $0.4 million for accrued interest on the convertible subordinated notes, and a

 

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premium of $2.2 million recognized as a loss on the early extinguishment of debt.  We intend to use the remaining net proceeds from the offering of convertible senior notes due March 2011 to purchase or redeem before and/or during the third quarter of 2004 the remaining outstanding principal amount of our 5.75% convertible subordinated notes due 2006.  However, we may determine not to purchase or redeem all of our 5.75% convertible subordinated notes due 2006.

 

We do not have any “special purpose” entities that are unconsolidated in our financial statements. We have no commercial commitments with related parties, except for ongoing payments to the SGO Group LLC in connection with the oritavancin acquisition from Lilly. Nicholas Simon, a former member of our Board of Directors who resigned in February 2003, was a principal in the SGO Group at the time of the acquisition. We have no loans with related parties, except for executive loans to Dr. Marianne Armstrong, our Senior Vice President of Regulatory/Medical Affairs and Drug Safety, and Dr. Lawrence Blatt, our Senior Vice President of Preclinical and Applied Research. Both of these loans were in place prior to the enactment of the Sarbanes-Oxley Act of 2002.

 

We believe that we will continue to require substantial additional funding in order to complete the research and development activities currently contemplated and to commercialize our product candidates. We believe our existing cash, cash equivalents and available-for-sale securities, together with anticipated cash flows from our operations, will be sufficient to fund our operating expenses, debt obligations and capital requirements under our current business plan through at least the end of 2005. However, this forward-looking statement is based upon the risks identified in this report; our current plans and assumptions, which may change; and our capital requirements, which may increase in future periods. Our future capital requirements will depend on many factors, including, but not limited to:

 

•              the commercial performance of any of our products or product candidates in development that receive commercial approval;

 

•              our ability to partner our development and commercialization programs and the establishment of other collaborative relationships;

 

•              the progress of our research and development efforts;

 

•              the scope and results of preclinical studies and clinical trials;

 

•              the costs, timing and outcome of regulatory reviews;

 

•              determinations as to the commercial potential of our product candidates in development;

 

•              the pace of expansion of administrative expenses;

 

•              the status of competitive products and competitive barriers to entry;

 

•              the pace of expansion of our sales and marketing capabilities, in preparation for product launches;

 

•              product costs;

 

•              the payments of annual interest on our long-term debt;

 

•              the extent to which we purchase or redeem our outstanding 5.75% convertible subordinated notes due 2006 prior to maturity; and

 

•              whether we must repay the principal in connection with our convertible debt obligations.

 

As a result, we may require additional funds and may attempt to raise additional funds through equity or debt financings, collaborative arrangements with corporate partners or from other sources. We have no commitments for such fund raising activities. Additional funding may not be available to finance our operations

 

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when needed or, if available, the terms for obtaining such funds may not be favorable or may result in dilution to our stockholders.

 

RISK FACTORS

 

An investment in our common stock is risky. Stockholders and potential investors in shares of our stock should carefully consider the following risk factors, which hereby update those risks contained in the “Risk Factors” section of our Annual Report on Form 10-K that was filed with the SEC on March 12, 2004, in addition to other information and risk factors in this Report. We are identifying these risk factors as important factors that could cause our actual results to differ materially from those contained in any written or oral forward-looking statements made by or on behalf of InterMune. We are relying upon the safe harbor for all forward-looking statements in this Report, and any such statements made by or on behalf of InterMune are qualified by reference to the following cautionary statements, as well as to those set forth elsewhere in this Report.

 

Risks Related to the Development of Our Products and Product Candidates

 

We may not succeed in our development efforts or in growing product revenues.

 

We commenced operations in 1998 and have incurred significant losses to date. Our revenues have been limited primarily to sales of Actimmune. Although we are developing Actimmune for the treatment of idiopathic pulmonary fibrosis (IPF) and ovarian cancer, Actimmune will not be marketed for either of these diseases before 2006, if at all. We market Infergen for the treatment of chronic hepatitis C virus (HCV) infections, but Infergen revenues may fail to meet our stated earnings guidance for 2004, or to grow significantly in subsequent years. We are developing pirfenidone for the treatment of IPF, but pirfenidone will not be marketed for any diseases before 2011, if at all. We are developing PEG-Alfacon-1, a pegylated form of Infergen, for the treatment of chronic HCV infections, but the development of PEG-Alfacon-1 will be lengthy and very expensive and carries significant risk.  Accordingly, we are looking for a development partner for PEG-Alfacon-1.  If we are unable to enter into a development collaboration for PEG-Alfacon-1 on favorable terms, we may discontinue the program.  PEG-Alfacon-1 will not be marketed for any diseases before 2010, if at all. Although we market Amphotec for invasive aspergillosis, we do not believe that it will provide sufficient revenue to us in the near future, if ever, and, consequently, we have decided to divest Amphotec. We are developing oritavancin for the treatment of complicated skin and skin-structure infections and have completed a Phase II clinical trial of oritavancin for the treatment of bacteremia, but we do not intend to market or co-market oritavancin. Accordingly, we are looking for a partner to assume the future investment in oritavancin. We may be unable to conclude either a sale of Amphotec or a partnering transaction for oritavancin in the near term or on favorable terms, if at all.

 

Clinical development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials.

 

To gain approval to market a product for treatment of a specific disease, we must provide the FDA and foreign regulatory authorities with clinical data that demonstrate the safety and statistically significant efficacy of that product for the treatment of the disease. Clinical development is a long, expensive and uncertain process, and delay or failure can occur at any stage of any of our clinical trials. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after promising results in earlier trials. Success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful. For example, we recently reported that our exploratory Phase II clinical trial evaluating Actimmune for the potential treatment of advanced liver fibrosis caused by HCV in patients who have failed standard antiviral therapy failed to meet its primary endpoint. As a result, we do not intend to conduct further development of Actimmune for the treatment of liver fibrosis. We are also terminating our Phase II clinical trial of Actimmune for the treatment of non-Hodgkin’s lymphoma, as it is not aligned with our current strategic focus.

 

We are conducting a Phase III clinical trial of Actimmune as a treatment for IPF. However, Actimmune may not demonstrate safety or statistically significant efficacy with respect to the primary or secondary endpoints of the protocol of that clinical trial or any additional clinical trial. If the Phase III clinical trial were to fail to demonstrate statistically significant efficacy, we would likely abandon the development of Actimmune for the treatment of IPF, which could harm our business and may result in a precipitous decline in our stock price.

 

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We do not know whether our planned clinical trials will begin on time, or at all, or will be completed on schedule, or at all.

 

The commencement or completion of any of our clinical trials may be delayed or halted for numerous reasons, including, but not limited to, the following:

 

•      the FDA or other regulatory authorities do not approve a clinical trial protocol or place a clinical trial on clinical hold;

 

•      patients do not enroll in clinical trials at the rate we expect;

 

•      patients experience adverse side effects;

 

•      patients die during a clinical trial for a variety of reasons, including the advanced stage of their disease and medical problems that are not related to our products or product candidates;

 

•      third-party clinical investigators do not perform our clinical trials on our anticipated schedule or consistent with the clinical trial protocol and good clinical practices, or other third-party organizations do not perform data collection and analysis in a timely or accurate manner;

 

•      our contract laboratories fail to follow good laboratory practices;

 

•      the interim results of the clinical trial are inconclusive or negative;

 

•      sufficient quantities of the trial drug may not be available; or

 

•      our trial design, although approved, is inadequate to demonstrate safety and/or efficacy.

 

Our development costs will increase if we have material delays in our clinical trials or if we need to perform more or larger clinical trials than planned. For example, our development costs related to Actimmune as a treatment for IPF are increasing due to our need to conduct an additional Phase III clinical trial. If there are any significant delays for this or any of our other current or planned clinical trials, our financial results and the commercial prospects for our products and product candidates will be harmed, and our prospects for profitability will be impaired.

 

Preclinical development is a long, expensive and uncertain process, and we may terminate one or more of our current preclinical development programs.

 

We may determine that certain preclinical product candidates or programs do not have sufficient potential to warrant the allocation of resources. Accordingly, we may elect to terminate our programs for and, in certain cases, our licenses to, such product candidates or programs.

 

Risks Related to Government Regulation and Approval of our Products and Product Candidates

 

If we fail to comply with FDA or other government regulations prohibiting the promotion of off-label uses and the promotion of products for which marketing clearance has not been obtained, it could result in regulatory enforcement action by the FDA or other governmental authorities, which would harm our business.

 

Physicians may prescribe commercially available drugs for uses that are not described in the product’s labeling and that differ from those uses tested by us and approved by the FDA. Such off-label uses are common across medical specialties. For example, even though the FDA has not approved the use of Actimmune for the treatment of IPF, we are aware that physicians are prescribing Actimmune for the treatment of IPF. Substantially all of our Actimmune revenues are derived from physicians’ prescriptions for off-label use. We are also aware that physicians are prescribing Infergen in combination with ribavirin therapy for the treatment of chronic HCV infections, even though the FDA has not approved this combination for the treatment of chronic HCV infections. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict

 

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manufacturers’ communications on the subject of off-label use. Companies may not promote FDA approved drugs for off-label uses. Accordingly, we may not market Actimmune for the treatment of IPF, or Infergen in combination with ribavirin therapy for the treatment of chronic HCV infections. The FDA and other governmental authorities actively enforce regulations prohibiting promotion of off-label uses and the promotion of products for which marketing clearance has not been obtained. We engage in medical education activities that are subject to scrutiny under these regulations. Failure to comply with these regulations can result in regulatory enforcement action by the FDA or other governmental authorities, any of which would have an adverse effect on our revenues, business and financial prospects.

 

If the FDA imposes significant restrictions or requirements related to our products for any disease or withdraws its approval of any of our products for any disease for which they have been approved, our revenues would decline.

 

The FDA and foreign regulatory authorities may impose significant restrictions on the use or marketing of our products or impose ongoing requirements for post-approval studies. Later discovery of previously unknown problems with any of our products or their manufacture may result in further restrictions, including withdrawal of the product from the market. Our existing approvals for diseases, and any new approval for any other disease that we target, if granted, could be withdrawn for failure to comply with regulatory requirements or to meet our post-approval commitments. If approval for a disease is withdrawn, we could no longer market the affected product for that disease. In addition, governmental authorities could seize our inventory of such product, or force us to recall any product already in the market, if we fail to comply with FDA or other governmental regulations.

 

If our clinical trials fail to demonstrate to the FDA and foreign regulatory authorities that any of our products or product candidates are safe and effective for the treatment of particular diseases, the FDA and foreign regulatory authorities may require us to conduct additional clinical trials or may not grant us marketing approval for such products or product candidates for those diseases.

 

Our failure to adequately demonstrate the safety and effectiveness of any of our products or product candidates for the treatment of particular diseases will delay or prevent our receipt of the FDA’s and foreign regulatory authorities’ approval and, ultimately, may prevent commercialization of our products and product candidates for those diseases.

 

The FDA and foreign regulatory authorities have substantial discretion in deciding whether, based on the benefits and risks in a particular disease, any of our products or product candidates should be granted approval for the treatment of that particular disease. Even if we believe that a clinical trial has demonstrated the safety and statistically significant efficacy of any of our products or product candidates for the treatment of a disease, the results may not be satisfactory to the FDA or foreign regulatory authorities. Preclinical and clinical data can be interpreted by the FDA and foreign regulatory authorities in different ways, which could delay, limit or prevent regulatory approval. If regulatory delays are significant or regulatory approval is limited or denied altogether, our financial results and the commercial prospects for those of our products or product candidates involved will be harmed, and our prospects for profitability will be impaired.

 

For example, we recently reported results from our confirmatory pivotal Phase III clinical trial of oritavancin for the treatment of complicated skin and skin-structure infections. However, in two additional small clinical pharmacology trials, we observed adverse events that were inconsistent with the safety profile observed in prior clinical trials of oritavancin. Since the cause of the inconsistency is unknown, the FDA has requested an additional clinical safety trial be completed prior to the submission of a New Drug Application, or NDA, for oritavancin. Because of this additional clinical trial, we will incur additional development costs and we will be significantly delayed in, or indefinitely prevented from, receiving approval for oritavancin for the treatment of complicated skin and skin-structure infections.

 

The pricing and profitability of our products may be subject to control by the government and other third-party payors.

 

The continuing efforts of governmental and other third-party payors to contain or reduce the cost of healthcare through various means may adversely affect our ability to successfully commercialize our products. For

 

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example, in most foreign markets, the pricing and/or profitability of prescription pharmaceuticals are subject to governmental control. In the United States, we expect that there will continue to be federal and state proposals to implement similar governmental control. For example, federal legislation was enacted on December 8, 2003 which provides a new Medicare prescription drug benefit beginning in 2006 and mandates other reforms. Although we cannot predict the full effects on our business of the implementation of this new legislation, it is possible that the new Medicare benefit, which will be managed by private health insurers, pharmacy benefit managers and other managed care organizations, will result in decreased reimbursement for prescription drugs, which may further exacerbate industry-wide pressure to reduce the prices charged for prescription drugs. In addition, increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. These new and any future cost-control initiatives could decrease the price that we would receive for Actimmune, Infergen, Amphotec or any other products we may develop in the future, such as oritavancin, PEG-Alfacon-1 or pirfenidone, which would reduce our revenues and potential profitability.

 

Our failure or alleged failure to comply with anti-kickback and false claims laws could result in civil and/or criminal sanctions and/or harm our business.

 

We are subject to various federal and state laws pertaining to health care “fraud and abuse,” including anti-kickback laws and false claims laws. Anti-kickback laws make it illegal for a prescription drug manufacturer to knowingly and willfully solicit, offer, receive or pay any remuneration in exchange for, or to induce, the referral of business, including the purchase or prescription of a particular drug. The federal government has published regulations that identify “safe harbors” or exemptions for certain payment arrangements that do not violate the anti-kickback statutes. Due to the breadth of the statutory provisions and the absence of guidance in the form of regulations or court decisions addressing some of our practices, it is possible that our practices might be challenged under anti-kickback or similar laws. False claims laws prohibit anyone from knowingly presenting, or causing to be presented, for payment to third party payors (including Medicare and Medicaid) claims for reimbursed drugs or services that are false or fraudulent, claims for items or services not provided as claimed or claims for medically unnecessary items or services. Our activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of Medicaid rebate information and other information affecting federal and state and third-party payment for our products, and the sale and marketing of our products, are subject to scrutiny under these laws. For example, we are one of what we believe to be a number of companies that have received letters from the Office of the Florida Attorney General directing us to keep certain records relating to its Medicaid rebate reporting until the Office of the Florida Attorney General has concluded an investigation that was initiated by the state following large false claims act settlements by other manufacturers. We have not been asked to produce any records or otherwise been advised of the nature of the allegations against us, if any. Violations of fraud and abuse laws may be punishable by criminal and/or civil sanctions, including fines and civil monetary penalties, as well as the possibility of exclusion from federal health care programs (including Medicare and Medicaid). If the government were to allege that we were, or convict us of, violating these laws, there could be a material adverse effect on us, including a decline in our stock price. Our activities could be subject to challenge for the reasons discussed above and due to the broad scope of these laws and the increasing attention being given to them by law enforcement authorities.

 

Risks Related to Manufacturing and Our Dependence on Third Parties

 

The manufacturing and manufacturing development of our products and product candidates present technological, logistical and regulatory risks, each of which may adversely affect our potential revenues.

 

The manufacturing and manufacturing development of pharmaceuticals, and, in particular, biologicals, are technologically and logistically complex and heavily regulated by the FDA and other governmental authorities. The manufacturing and manufacturing development of our products and product candidates present many risks, including, but not limited to, the following:

 

•    before we can obtain approval of any of our products or product candidates for the treatment of a particular disease, we must demonstrate to the FDA’s and other governmental authorities’ satisfaction that the drug manufactured for the clinical trials is comparable to the drug manufactured for commercial use;

 

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•    it may not be technically feasible to scale up an existing manufacturing process to meet demand or such scale-up may take longer than anticipated; and

 

•    failure to comply with strictly enforced good manufacturing practices regulations and similar foreign standards may result in delays in product approval or withdrawal of an approved product from the market.

 

Any of these factors could delay clinical trials, regulatory submissions and/or commercialization of our products for particular diseases, interfere with current sales, entail higher costs and result in our being unable to effectively sell our products.

 

Our manufacturing strategy, which relies on third-party manufacturers, exposes us to additional risks as a result of which we may lose potential revenues.

 

We do not have the resources, facilities or experience to manufacture any of our products or product candidates ourselves. Completion of our clinical trials and commercialization of our products requires access to, or development of, manufacturing facilities that meet FDA standards to manufacture a sufficient supply of our products. The FDA must approve facilities that manufacture our products for commercial purposes, as well as the manufacturing processes and specifications for the product. We depend on third parties for the manufacture of our product candidates for preclinical and clinical purposes, and we rely on third parties with FDA approved manufacturing facilities for the manufacture of our products for commercial purposes.

 

Our manufacturing strategy for our products and product candidates presents many risks, including, but not limited to, the following:

 

•      if market demand for our products is be less than our purchase obligations to our manufacturers, we may incur substantial penalties and substantial inventory write-offs;

 

•      manufacturers of our products are subject to ongoing periodic inspections by the FDA and other regulatory authorities for compliance with strictly enforced good manufacturing practices regulations and similar foreign standards, and we do not have control over our third-party manufacturers’ compliance with these regulations and standards;

 

•      when we need to transfer between manufacturers, the FDA and foreign regulatory authorities must approve these manufacturers’ facilities and processes prior to our use or sale of products they manufacture for us. This requires new testing and compliance inspections. Delays in transferring manufacturing technology between third parties could delay clinical trials, regulatory submissions and commercialization of our product candidates. For example, we are transferring the manufacturing of oritavancin from Eli Lilly and Company to a third-party manufacturer, and our third-party manufacturer’s finished product has not yet demonstrated a comparable safety profile to that demonstrated by Lilly’s oritavancin product. If the finished oritavancin product of our third-party manufacturer does not have a comparable safety profile to that demonstrated by Lilly’s oritavancin product, our ability to commercialize or partner oritavancin would be slowed or halted, which would significantly harm our business;

 

•      our manufacturers might not be able or refuse to fulfill our commercial needs, which would require us to seek new manufacturing arrangements and may result in substantial delays in meeting market demand;

 

•      we may not have intellectual property rights, or may have to share intellectual property rights, to any improvements in the manufacturing processes or new manufacturing processes for our products;

 

•      our product costs may increase if our manufacturers pass their increasing costs of manufacture on to us;

 

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•      if third-party manufacturers do not successfully carry out their contractual duties or meet expected deadlines, we will not be able to obtain or maintain regulatory approvals for our products and product candidates and will not be able to successfully commercialize our products and product candidates. In such event, we may not be able to locate any necessary acceptable replacement manufacturers or enter into favorable agreements with such replacement manufacturers, if at all; and

 

•      if our agreement with a third-party manufacturer expires, we may not be able to renegotiate a new agreement with that manufacturer on favorable terms, if at all. If we cannot successfully complete such renegotiation, we may not be able to locate any necessary acceptable replacement manufacturers or enter into favorable agreements with such replacement manufacturers, if at all.

 

Any of these factors could delay clinical trials, regulatory submissions or commercialization of our products for particular diseases, interfere with current sales, entail higher costs and result in our being unable to effectively sell our products.

 

Our agreements with third-party manufacturers may restrict our ability to establish alternative sources of products in a timely manner or at an acceptable cost, which may cause us to be unable to meet demand for our products and to lose potential revenues.

 

Our key supply agreements provide that the manufacturer is our exclusive source of supply for the product, except under certain circumstances. For example, Boehringer Ingelheim Austria (BI Austria) is currently our exclusive manufacturer for Actimmune. Under our agreement with BI Austria, we cannot seek a secondary source to manufacture Actimmune until BI Austria has indicated to us its inability or unwillingness to meet our requirements. Under our agreement with Amgen Inc. for Infergen, Amgen is our exclusive manufacturer of Infergen. Even if we believe that Amgen will be unable to meet our requirements for the manufacture of Infergen, we cannot transfer the Infergen manufacturing process to a secondary source unless Amgen has materially breached its manufacturing obligations. If we are delayed in establishing a secondary supply source for Actimmune or Infergen, or cannot do so at an acceptable cost, we may suffer a shortage of commercial supply of that product or a high cost of product, either of which would have a material and adverse effect on our revenues, business and financial prospects.

 

We rely on third parties to conduct clinical trials for our products and product candidates, and those third parties may not perform satisfactorily.

 

If our third-party contractors do not successfully carry out their contractual duties or meet expected deadlines, we may be delayed in or prevented from obtaining regulatory approvals for our products and product candidates, and may not be able to successfully commercialize our products and product candidates for targeted diseases. We do not have the ability to independently conduct clinical trials for our products and product candidates, and we rely on third parties such as contract research organizations, medical institutions and clinical investigators to perform this function. Our ability to monitor and audit the performance of these third parties is limited. If these third parties do not perform satisfactorily, our clinical trials may be extended or delayed, resulting in potentially substantial cost increases to us and other adverse impacts on our product development efforts. We may not be able to locate any necessary acceptable replacements or enter into favorable agreements with them, if at all.

 

Risks Related to the Commercialization of Our Products and Product Candidates

 

There are significant regulatory, supply, intellectual property and competitive barriers to entry that may prevent us from successfully marketing or developing Infergen or PEG-Alfacon-1 for the chronic HCV infections market.

 

We have expanded our commercialization efforts regarding Infergen in the United States for the treatment of chronic HCV infections. However, we believe that there are significant regulatory, supply, intellectual property and competitive barriers to Infergen’s penetration of the chronic HCV infections market, including the following:

 

Regulatory.    We believe that market acceptance of and demand for Infergen for the treatment of chronic HCV infections may depend upon our ability to market Infergen in combination therapy with ribavirin or other anti-viral drugs. Before we may market Infergen for use in combination therapy with ribavirin or any other anti-viral

 

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drug, we will need to obtain FDA approval for such combination. To seek and obtain such approval, we will need to supplement Infergen’s current FDA license with data that support combination use of Infergen and ribavirin or another anti-viral drug for increased effectiveness in treating chronic HCV infections. We cannot be certain how long it would take us to submit such data and obtain such an approval from the FDA, if at all. Seeking FDA approval for Infergen combination therapy may, in certain circumstances, involve our complying with FDA patent certification and notice provisions relating to ribavirin that could result in deferral for up to 30 months or, in the case of judicial intervention, longer, of FDA approval pending the outcome of ongoing patent infringement litigation.

 

Supply.    Amgen is our exclusive manufacturer of Infergen. If Amgen is unable or refuses to meet our requirements for the manufacture of Infergen, we would be unable to meet market demand for Infergen. In addition, we have limited control over the cost of goods for Infergen. If we are unable to purchase Infergen at an acceptable cost, it would have a material and adverse effect on our revenues, business and financial prospects. Although we have an existing manufacturing process for PEG-Alfacon-1 that has been sufficient to meet our needs to date, there are technical challenges to scaling-up that process to meet anticipated commercial demand. There is no assurance that we will successfully complete any required scale-up.

 

Intellectual Property.    Our competitors and their strategic partners have substantial and extensive patent rights in connection with combination therapy of interferon alpha and ribavirin for the treatment of chronic HCV infections. For example, we are aware of three U.S. patents that relate to the use of interferon alpha and ribavirin to treat chronic HCV infections. These patents expire in 2015, 2016 and 2017, respectively. We believe that these patents may prevent us from marketing Infergen in combination therapy with ribavirin for certain patients. If, because of these patents, we are unable to market Infergen or PEG-Alfacon-1 with ribavirin, the commercial prospects for Infergen or PEG-Alfacon-1 are likely to be reduced and our prospects for profitability may be impaired. Further, we believe that our competitors and their strategic partners may obtain additional patent rights in connection with filed patent applications for combination therapy of interferon alpha and other anti-viral drugs for the treatment of chronic HCV infections. If those patent applications were to issue, we may be unable to market Infergen or PEG-Alfacon with ribavirin or with another anti-viral drug, reducing the commercial prospects for Infergen and our prospects for profitability.

 

In addition, we are aware of a U.S. patent that relates to the use of pegylated interferon alpha to treat chronic HCV infections. This patent expires in 2016. We believe that this patent may prevent us from marketing PEG-Alfacon-1 for the treatment of chronic HCV infections. If because of this patent we are unable to market PEG-Alfacon-1 for the treatment of chronic HCV infections, the commercial prospects for PEG-Alfacon-1 are likely to be reduced. Also, we believe that our competitors and their strategic partners have substantial and extensive patent rights relating to pegylation technology in general and the use of pegylated interferon alpha for the treatment of chronic HCV infections in particular. Further, several third parties have substantial and extensive patent rights in connection with the use of pegylation to modify biologically active compounds generally.

 

Although we have licensed from Amgen rights to PEG-Alfacon-1, we may not have, and may not be able to license on commercially reasonable terms, if at all, sufficient rights to all the intellectual property necessary for us to commercialize PEG-Alfacon-1 for the treatment of chronic HCV infections. For example, our competitors and their strategic partners have substantial and extensive patent rights in connection with interferon alpha and its recombinant production. Specifically, we are aware of two U.S. patents that relate to interferon alpha polypeptides, DNAs encoding the same, host cells transformed with such DNA and processes for the production of interferon alpha polypeptides from such DNAs and host cells. These patents expire in 2019 and 2020, respectively. We believe that these patents may prevent us from marketing PEG-Alfacon-1, which would have a material adverse effect on our business.

 

Competition.    Pegylated interferon alpha products may have an advantage over non-pegylated products because they circulate longer in the body, permitting a less frequent dosing schedule and enhancing efficacy in some patients infected with the HCV virus. Because our competitors Schering-Plough Corporation and Roche Laboratories have commenced marketing their respective pegylated interferon alpha products, Infergen has a significant disadvantage in the market with respect to the frequency of administration. In addition, both of these companies have obtained and will likely continue to obtain significant patent protection relating to their respective products.

 

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Further, specific targeted agents directed against HCV may be effective in reducing the amount of virus in infected chronic HCV patients. If the use of these specific targeted anti-HCV agents proves to be effective in the treatment of chronic HCV infections, then the use of interferon-based therapies for chronic HCV infections may diminish, which would harm our business.

 

Valuation.    If the use of interferon-based therapies for chronic HCV infections were to diminish, this could impact the recoverability of the Infergen-related intangible asset. During the quarter ended December 31, 2003, we conducted a detailed assessment of the current and future market potential of Infergen and PEG-Alfacon-1, including, but not limited to, the impact of competing products on the market potential of these interferon-based therapies. This assessment resulted in no reduction of the carrying value of the Infergen-related intangible asset. If we are unable to achieve results consistent with those assumed in our detailed assessment, it may be necessary to perform a future detailed assessment, which could result in a reduction of the carrying value of the Infergen-related intangible asset. This could have a material adverse effect on our financial condition and results of operations during the period in which we recognize a reduction.

 

We rely on one customer for approximately 59% of our total product sales. If this customer does not continue to sell our products at its current levels, our business will be harmed.

 

During the three-month period ended March 31, 2004, one customer accounted for approximately 62% of our outstanding receivables and 59% of our total product sales. If this customer or any other customer that sells a significant portion of our products were to experience financial difficulties, or otherwise became unable or unwilling to sell our products, our business would be harmed. Additionally, any reduction, delay or loss of orders from our key customers could harm our revenues.

 

If the specialty pharmacies and distributors that we rely upon to sell our products fail to perform, our business may be adversely affected.

 

Our success depends on the continued customer support efforts of our network of specialty pharmacies and distributors. The use of specialty pharmacies and distributors involves certain risks, including, but not limited to, risks that these specialty pharmacies and distributors will:

 

•      not provide us with accurate or timely information regarding their inventories, the number of patients who are using our products or product complaints;

 

•      not effectively sell or support our products;

 

•      reduce their efforts or discontinue to sell or support our products;

 

•      not devote the resources necessary to sell our products in the volumes and within the time frames that we expect;

 

•      be unable to satisfy financial obligations to us or others; or

 

•      cease operations.

 

Any such failure may result in decreased product sales and lower product revenues, which would harm our business.

 

Even if regulatory authorities approve our products or product candidates for the treatment of the diseases we are targeting, our products may not be marketed or commercially successful.

 

Our products and product candidates are expensive, and we anticipate that the annual cost for treatment for each of the diseases for which we are seeking approval will be significant. These costs will vary for different diseases based on the dosage and method of administration. Accordingly, we may decide not to market any of our products or product candidates for an approved disease because we believe that it may not be commercially successful. Market acceptance of and demand for our products and product candidates will depend on many factors, including, but not limited to:

 

•      cost of treatment;

 

•      pricing and availability of alternative products;

 

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•      ability to obtain third-party coverage or reimbursement for our products or product candidates to treat a particular disease;

 

•      perceived efficacy relative to other available therapies;

 

•      shifts in the medical community to new treatment paradigms or standards of care;

 

•      relative convenience and ease of administration; and

 

•      prevalence and severity of adverse side effects associated with treatment.

 

If third-party payors do not provide coverage or reimburse patients for our products, our revenues and prospects for profitability will suffer.

 

Our ability to commercialize our products or product candidates for particular diseases is highly dependent on the extent to which coverage and reimbursement for our products is available from:

 

•      private health insurers, including managed care organizations;

 

•      governmental payors, such as Medicaid, the Public Health Service or the Veterans’ Administration; and

 

•      other third-party payors.

 

Significant uncertainty exists as to the coverage and reimbursement status of pharmaceutical products, particularly with respect to products that are prescribed by physicians for off-label use. If governmental and other third-party payors do not provide adequate coverage and reimbursement levels for our products, market acceptance of our products will be reduced, and our sales will suffer. Many third-party payors provide coverage or reimbursement only for FDA approved indications. If any large or many third-party payors decide to deny reimbursement for Actimmune used to treat IPF, sales of Actimmune would decline, and our revenues would suffer. Often, such third-party payors make the decision to reimburse an off-label product based on a compendium listing. Actimmune has no such listing. If it does not receive such a compendium listing, additional third-party payors, including Medicaid, may decide to deny reimbursement for Actimmune used to treat IPF, and fewer physicians may prescribe Actimmune for such treatment. If either of these were to occur, sales of Actimmune would decline and our revenues would suffer.

 

The activities of competitive drug companies, or others, may limit our products’ revenue potential or render them obsolete.

 

Our commercial opportunities will be reduced or eliminated if our competitors develop or market products that, compared to our products or product candidates:

 

•      are more effective;

 

•      have fewer or less severe adverse side effects;

 

•      are better tolerated;

 

•      have better patient compliance;

 

•      receive better reimbursement terms;

 

•      are more accepted by physicians;

 

•      are more adaptable to various modes of dosing;

 

•      have better distribution channels;

 

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•      are easier to administer; or

 

•      are less expensive.

 

Even if we are successful in developing effective drugs, our products may not compete effectively with our competitors’ current or future products. Our competitors include larger, more established, fully integrated pharmaceutical companies and biotechnology companies that have substantially greater capital resources, existing competitive products, larger research and development staffs and facilities, greater experience in drug development and in obtaining regulatory approvals and greater marketing capabilities than we do.

 

Risks Related to Our Intellectual Property Rights

 

We may not be able to obtain, maintain and protect certain proprietary rights necessary for the development and commercialization of our products or product candidates.

 

Our commercial success will depend in part on obtaining and maintaining patent protection on our products and product candidates and successfully defending these patents against third-party challenges. Our ability to commercialize our products will also depend in part on the patent positions of third parties, including those of our competitors. The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and involve complex legal and factual questions. No consistent policy regarding the breadth of claims allowed in biotechnology patents has emerged to date. Accordingly, we cannot predict with certainty the scope and breadth of patent claims that may be afforded to other companies’ patents. We could incur substantial costs in litigation if we are required to defend against patent suits brought by third parties, or if we initiate suits to protect our patent rights.

 

The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:

 

•      we were the first to make the inventions covered by each of our pending patent applications;

 

•      we were the first to file patent applications for these inventions;

 

•      others will not independently develop similar or alternative technologies or duplicate any of our technologies;

 

•      any of our pending patent applications will result in issued patents;

 

•      any of our issued patents or those of our licensors will be valid and enforceable;

 

•      any patents issued to us or our collaborators will provide a basis for commercially viable products or will provide us with any competitive advantages or will not be challenged by third parties;

 

•      we will develop additional proprietary technologies that are patentable; or

 

•      the patents of others will not have a material adverse effect on our business.

 

Others have filed and in the future may file patent applications covering uses and formulations of interferon gamma-1b, interferon alpha, pegylated versions of these products and other products in our development program. If a third party were issued a patent that blocked our ability to commercialize any of our products for any or all of the diseases that we are targeting, we would be prevented from commercializing that product for that disease or diseases unless we obtained a license from the patent holder. We may not be able to obtain such a license to a blocking patent on commercially reasonable terms, if at all.

 

We license certain patents and trade secrets relating to Actimmune from Genentech, Inc; relating to Infergen from Amgen Inc.; relating to pirfenidone from Marnac, Inc. and KDL GmbH; and relating to oritavancin from Eli Lilly and Company. If we breach any of our agreements with Genentech, Amgen, Marnac and KDL or

 

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Lilly, any of these licensors could terminate the respective license, and we would have no further rights to utilize the licensed patents or trade secrets to develop and market the corresponding products.

 

We have licensed certain patents relating to interferon gamma-1b, the active ingredient in Actimmune, from Genentech. Certain of the U.S. patents covering DNA vectors and host cells relating to interferon gamma-1b expire in 2005 and 2006. In addition, a U.S. patent relating to the composition of interferon gamma-1b expires in 2014. Other material U.S. patents relating to interferon gamma-1b expire between 2009 and 2013.

 

We have licensed U.S. and Canadian patent rights relating to Infergen, a type of interferon alpha, from Amgen. Two of Amgen’s U.S. patents relating to Infergen’s active ingredient, the interferon alfacon-1 molecule, expire in 2004. However, the U.S. Patent and Trademark Office recently issued a Certificate of Extension of Patent Term, officially extending the term of one of these patents by five years, to 2009. After expiration of the extended patent term in 2009, we would rely on a U.S. patent related to the use of interferon alfacon-1 at a dose within the range of 2 million to 30 million units of interferon alfacon-1 per administration for the treatment of chronic HCV infections to block others from marketing interferon alfacon-1 for the treatment of chronic HCV infections at these doses. When this patent expires in 2011, we will not be able to use this patent to block others from marketing Infergen or other forms of interferon alfacon-1 for the treatment of chronic HCV infections in the United States.

 

Our competitors and their strategic partners have substantial and extensive patent rights in connection with the use of interferon alpha to treat a variety of diseases. Further, we believe that our competitors and their strategic partners may obtain additional patent rights in connection with filed patent applications for interferon alpha. We are uncertain of the extent to which the currently issued patents and any additional patents of our competitors that may issue will prevent us from marketing Infergen for the treatment of certain diseases. If because of these patents we are unable to market Infergen for a range of diseases, the commercial prospects for Infergen will be reduced and our prospects for profitability may be impaired. In addition, our competitors and their strategic partners have substantial and extensive patent rights in connection with the use of pegylated interferon alpha to treat a variety of diseases. Although we have licensed from Amgen rights to PEG-Alfacon-1, we may not have, and may not be able to license on commercially reasonable terms, if at all, sufficient rights to all the intellectual property necessary for us to commercialize PEG-Alfacon-1.

 

We are aware of the settlement of a lawsuit involving Infergen filed in 1997 by Biogen, Inc. against Amgen in the U.S. District Court for the District of Massachusetts. The suit alleged that the manufacture of Infergen infringed three Biogen U.S. patents relating to vectors for expressing cloned genes, methods of making vectors and expressing cloned genes, and host cells. All claims in the lawsuit were dismissed with prejudice by order of the court in December 2001 under a confidential settlement agreement entered into between Biogen and Amgen. Although Amgen has informed us that the settlement agreement applies to Infergen, we do not know the terms of the settlement agreement or how the terms of the settlement may affect our ability to commercialize Infergen in the United States. The settlement agreement may have a material adverse effect on our ability to commercialize Infergen in the United States.

 

We have licensed from Marnac and KDL rights to a U.S. patent related to the use of pirfenidone for the treatment of fibrotic disorders, including the use of pirfenidone for the treatment of IPF. After the U.S. patent expires in 2011, we will not be able to use this patent to block others from marketing pirfenidone for fibrotic disorders, including IPF. In addition, we are aware of two international patent application publications relating to manufacturing processes for pirfenidone. If either or both of these patent applications were to result in a granted patent or patents, and if any such granted patent or patents were to be interpreted to cover the manufacturing process for pirfenidone, we believe that such patent or patents may enable the patent holder to block our ability to commercialize pirfenidone unless we obtained a license under such patent or patents. We cannot predict whether we would be able to obtain such a license under commercially reasonable terms, if at all. If we were not able to obtain such a license under the patent or patents on commercially reasonable terms, or at all, it would have a material adverse effect on our ability to commercialize any pirfenidone product.

 

We have licensed certain patents throughout the world relating to oritavancin from Lilly. After patents related to the composition of oritavancin expire in 2015, we will not be able to use such patents to block others from marketing oritavancin. In addition, we are aware of two U.S. patents, and corresponding European, Australian, Korean, Canadian and Japanese patents, that relate to a molecule that is produced during the manufacture of

 

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oritavancin. A derivative of this molecule is retained in the final oritavancin product. If any of these patents were interpreted to cover the oritavancin manufacturing process, any molecules formed during the manufacturing process, or the final oritavancin product itself, we believe that such patent or patents could enable the patent holder to block our ability to commercialize oritavancin unless we obtained a license under such patent or patents. We cannot predict whether we would be able to obtain a license on commercially reasonable terms, if at all. If we were not able to obtain such a license under the patents on commercially reasonable terms, or at all, it would have a material adverse effect on our ability to commercialize oritavancin.

 

We generally do not control the patent prosecution of technology that we license from others. Accordingly, we are unable to exercise the same degree of control over this intellectual property as we would exercise over technology that we own. For example, if Genentech fails to maintain the intellectual property licensed to us, we may lose our rights to develop and market Actimmune and may be forced to incur substantial additional costs to maintain or protect the intellectual property or to compel Genentech to do so.

 

The combination of our products with other drugs may have a greater therapeutic effect in treating certain diseases than our products alone. In some cases, third parties hold patents either on the potential companion drugs or on combination therapies that include our products. We may not be able to negotiate licenses or other rights to potential companion drugs on reasonable terms, or at all. If we are not able to negotiate these licenses or other rights, the market for our products may be diminished.

 

We rely on trade secrets to protect technology where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. We protect these rights mainly through confidentiality agreements with our corporate partners, employees, consultants and vendors. These agreements generally provide that all confidential information developed or made known to an individual during the course of their relationship with us will be kept confidential and will not be used or disclosed to third parties except in specified circumstances. In the case of employees and consultants, our agreements generally provide that all inventions made by the individual while engaged by us will be our exclusive property. We cannot be certain that these parties will comply with these confidentiality agreements, that we will have adequate remedies for any breach, or that our trade secrets will not otherwise become known or be independently discovered by our competitors. Under some of our research and development agreements, inventions discovered in certain cases become jointly owned by our corporate partner and us and in other cases become the exclusive property of one of us. It can be difficult to determine who owns a particular invention, and disputes could arise regarding those inventions.

 

Our research collaborators and scientific advisors have some rights to publish our data and proprietary information in which we have rights. Such publications may impair our ability to obtain patent protection or protect our proprietary information.

 

Litigation or third-party claims of intellectual property infringement could require us to spend substantial time and money and could adversely affect our ability to develop and commercialize products.

 

Our commercial success depends in part on our ability and the ability of our collaborators to avoid infringing patents and proprietary rights of third parties. Third parties may accuse us or our collaborators of employing their proprietary technology in our products, or in the materials or processes used to research or develop our products, without authorization. Any legal action against our collaborators or us claiming damages and/or seeking to stop our commercial activities relating to the affected products, materials and processes could, in addition to subjecting us to potential liability for damages, require our collaborators or us to obtain a license to continue to utilize the affected materials or processes or to manufacture or market the affected products. We cannot predict whether we or our collaborators would prevail in any of these actions or whether any license required under any of these patents would be made available on commercially reasonable terms, if at all. If we are unable to obtain such a license, we or our collaborators may be unable to continue to utilize the affected materials or processes or manufacture or market the affected products or we may be obligated by a court to pay substantial royalties and/or other damages to the patent holder. Even if we are able to obtain such a license, the terms of such a license could substantially reduce the commercial value of the affected product or products and impair our prospects for profitability.  Accordingly, we cannot predict whether or to what extent the commercial value of the affected product or products or our prospects for profitability may be harmed as a result of any of the liabilities discussed above.  Furthermore, infringement and other intellectual property claims, with or without merit, can be expensive and time-consuming to litigate and can divert management’s attention from our core business.

 

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Risks Related to Our Financial Results and Other Risks Related to Our Business

 

If physicians do not prescribe Actimmune or prescribe it less often for the treatment of IPF, our revenues will decline.

 

Physicians may choose not to prescribe Actimmune or provide fewer patient referrals for Actimmune for the treatment of IPF because:

 

•      Actimmune is not approved by the FDA for the treatment of IPF, and we therefore are unable to market or promote Actimmune for the treatment of IPF;

 

•      in our initial Phase III clinical trial, Actimmune failed to meet the primary and secondary endpoints;

 

•      physicians prefer to enroll their patients in our Phase III clinical trial of Actimmune or one of our competitors’ trials for the treatment of IPF;

 

•      Actimmune does not have a compendium listing;

 

•      physicians’ patients are unable to receive or lose reimbursement from a third-party reimbursement organization;

 

•      physicians are not confident that Actimmune has a clinically significant treatment effect for IPF;

 

•      a competitor’s product shows a clinically significant treatment effect for IPF; or

 

•      physicians believe that the article and editorial in the January 8, 2004 issue of the New England Journal of Medicine were negative concerning Actimmune as a treatment for IPF.

 

If physicians do not prescribe Actimmune for the treatment of IPF for the above reasons or any other reasons, our revenues will decline.  In addition, the patient referral rate may decline.   The patient referral rate reflects the number of new Actimmune prescriptions written by physicians, and the referral rate that we observed during the first quarter of 2004 was significantly lower than we expected. If this new lower rate of patient referrals continues, our Actimmune revenue and total revenue may decline.

 

If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully execute our business plan.

 

We believe our existing cash, cash equivalents and available-for-sale securities, together with anticipated cash flows from our operations, will be sufficient to fund our operating expenses, debt obligations and capital requirements under our current business plan through at least the end of 2005. However, our current plans and assumptions may change, and our capital requirements may increase in future periods. We have no committed sources of capital and do not know whether additional financing will be available when needed, or, if available, that the terms will be favorable to our stockholders or us. If additional funds are not available, we may be forced to delay or terminate clinical trials, curtail operations or obtain funds through collaborative and licensing arrangements that may require us to relinquish commercial rights or potential markets, or grant licenses on terms that are not favorable to us. If adequate funds are not available, we will not be able to successfully execute our business plan.

 

If we continue to incur net losses for a period longer than we anticipate, we may be unable to continue our business.

 

We have lost money since inception, and our accumulated deficit was approximately $407.9 million at March 31, 2004. We expect to incur substantial additional net losses prior to achieving profitability, if ever. The extent of our future net losses and the timing of our profitability are highly uncertain, and we may never achieve profitable operations. We are planning to expand the number of diseases for which our products may be marketed, and this expansion will require significant expenditures. To date, we have generated revenues primarily through the sale of Actimmune. However, since we do not expect to seek FDA approval for the use of Actimmune for the treatment of IPF for at least four more years, Actimmune revenues may not continue to increase or may decrease.

 

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We have not generated significant operating profits to date from our products. If the time required for us to achieve profitability is longer than we anticipate, we may not be able to continue our business.

 

Failure to accurately forecast our revenues could result in additional charges for excess inventories or non-cancelable purchase obligations.

 

We base many of our operating decisions on anticipated revenue trends and competitive market conditions, which are difficult to predict. Based on projected revenue trends, we acquired inventories and entered into non-cancelable purchase obligations in order to meet anticipated increases in demand for our products. However, more recent projected revenue trends resulted in us recording charges during the quarters ended September 30, 2003 and December 31, 2003 for excess inventories and non-cancelable purchase obligations. If revenue levels experienced in future quarters are substantially below our expectations, especially those revenues from sales of Actimmune and/or Infergen, we could be required to record additional charges for excess inventories and/or non-cancelable purchase obligations.

 

If we are unable to divest Amphotec, we may need to record another impairment charge for Amphotec, which would have a material adverse effect on our financial condition and results of operations.

 

The recoverability of the carrying value of the Amphotec-related intangible asset that we acquired in 2001 is based on its ability to generate a profit from sales. During the quarter ended September 30, 2003, we recorded a charge of $4.8 million for the impairment of Amphotec product rights.  This impairment charge reduced the remaining carrying value of the intangible asset recorded in 2001 when we acquired the product. This reduction was based on our detailed assessment of the current and future market potential of Amphotec, which took into account that sales levels have been lower than we expected and that Amphotec is not aligned with our new strategic focus in pulmonology and hepatology. If we are unable to divest the product or to achieve results consistent with those assumed in our assessment, it may be necessary to further reduce the remaining carrying value of the Amphotec intangible asset. This would have a material adverse effect on our financial condition and results of operations during any period in which we recognize any such reduction.

 

If product liability lawsuits are brought against us, we may incur substantial liabilities.

 

The testing, marketing and sale of medical products entail an inherent risk of product liability. If product liability costs exceed our liability insurance coverage, we may incur substantial liabilities. Whether or not we were ultimately successful in product liability litigation, such litigation would consume substantial amounts of our financial and managerial resources, and might result in adverse publicity, all of which would impair our business. We may not be able to maintain our clinical trial insurance or product liability insurance at an acceptable cost, if at all, and this insurance may not provide adequate coverage against potential claims or losses.

 

Our use of hazardous materials, chemicals, viruses and radioactive compounds exposes us to potential liabilities.

 

Our research and development activities involve the controlled use and disposal of hazardous materials, chemicals, infectious disease agents and various radioactive compounds. Although we believe that our safety procedures for handling and disposing of such materials comply with the standards prescribed by state and federal regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials. In the event of such an accident, we could be held liable for significant damages or fines.

 

Insurance coverage is increasingly difficult to obtain or maintain.

 

While we currently have insurance for our business, directors and officers, and property and products, first- and third-party insurance is increasingly more costly and narrower in scope, and we may be required to assume more risk in the future. If we are subject to third-party claims or suffer a loss or damage in excess of our insurance coverage, we may be required to share that risk in excess of our insurance limits. Furthermore, any first- or third-party claims made on our insurance policies may impact our future ability to obtain or maintain insurance coverage at reasonable costs, if at all.

 

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Budget or cash constraints may force us to delay our efforts to develop certain products in favor of developing others, which may prevent us from meeting our stated timetables and commercializing those products as quickly as possible.

 

Because we are an emerging company with limited resources, and because research and development is an expensive process, we must regularly assess the most efficient allocation of our research and development resources. Accordingly, we may choose to delay our research and development efforts for a promising product candidate to allocate those resources to another program, which could cause us to fall behind our initial timetables for development. As a result, we may not be able to fully realize the value of some of our product candidates in a timely manner, since they will be delayed in reaching the market, or may not reach the market at all.

 

We face certain litigation risks that could harm our business.

 

We have had numerous lawsuits filed against us asserting various claims, including several securities class actions and a shareholder derivative lawsuit. The results of complex legal proceedings, such as these, are difficult to predict. Moreover, many of the complaints filed against us do not specify the amount of damages that the plaintiffs seek, and we therefore are unable to estimate the possible range of damages that might be incurred should these lawsuits be resolved against us. While we are unable to estimate the potential damages arising from such lawsuits, certain of them assert types of claims that, if resolved against us, could give rise to substantial damages. Thus, an unfavorable outcome or settlement of one or more of these lawsuits could have a material adverse effect on our financial position, liquidity or results of operations. Even if these lawsuits are not resolved against us, the uncertainty and expense associated with unresolved lawsuits could seriously harm our business, financial condition and reputation. Litigation can be costly, time-consuming and disruptive to normal business operations. The costs of defending these lawsuits could be quite significant, and certain costs, such as those below a deductible amount, are not covered by our insurance policies. The defense of these lawsuits could also result in continued diversion of our management’s time and attention away from business operations, which could harm our business.

 

Failure to attract, retain and motivate skilled personnel and cultivate key academic collaborations will delay our product development programs and our business development efforts.

 

We had 251 employees as of April 30, 2004, and our success depends on our continued ability to attract, retain and motivate highly qualified management and scientific personnel and on our ability to develop relationships with leading academic scientists. Competition for personnel and academic collaborations is intense. We are highly dependent on our current management and key scientific and technical personnel, including Daniel G. Welch, our Chief Executive Officer and President, as well as the other principal members of our management. Our success will depend in part on retaining the services of our existing management and key personnel and attracting and retaining new highly qualified personnel. In addition, we may need to hire additional personnel and develop additional academic collaborations as we continue to expand our research and development activities. We do not know if we will be able to attract, retain or motivate personnel or cultivate academic collaborations. Our inability to hire, retain or motivate qualified personnel or cultivate academic collaborations would harm our business and hinder the planned expansion of our business.

 

Our indebtedness and debt service obligations may adversely affect our cash flow.

 

Our annual debt service obligations on both of our outstanding convertible notes are approximately $6.0 million per year in interest payments. We intend to purchase or redeem, before and/or during the third quarter of this year, all of our outstanding 5.75% convertible subordinated notes due 2006 with the proceeds of the recent issuance of our 0.25% convertible senior notes due 2011. As of March 31, 2004, we had purchased an aggregate of $52.5 million in principal amount of our 5.75% convertible subordinated notes due 2006.  However, we may determine not to purchase or redeem all of our 5.75% convertible subordinated notes due 2006. Should any such purchase or redemption occur, we would record a charge for any unamortized debt issuance costs and for any premium paid in connection with such purchase or redemption.  In connection with the purchase of our outstanding convertible subordinated notes due 2006 during the three month period ended March 31, 2004, we recorded a premium of $2.2 million recognized as a loss on the early extinguishment of debt and recognized a non-cash charge of $0.8 million on unamortized deferred issuance costs associated with the extinguished debt.  We intend to fulfill our current debt service obligations, including repayment of the principal, both from cash generated by our

 

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operations and from our existing cash and investments. If we are unable to generate sufficient cash to meet these obligations and need to use existing cash or liquidate investments in order to fund our current debt service obligations, including repayment of the principal, we may have to delay or curtail research and development programs.

 

We may add additional lease lines to finance capital expenditures and may obtain additional long-term debt and lines of credit. If we issue other debt securities in the future, our debt service obligations will increase further.

 

Our indebtedness could have significant additional negative consequences, including, but not limited to,

 

•      requiring the dedication of a substantial portion of our expected cash flow from operations to service our indebtedness, thereby reducing the amount of our expected cash flow available for other purposes, including capital expenditures;

 

•      increasing our vulnerability to general adverse economic and industry conditions;

 

•      limiting our ability to obtain additional financing;

 

•      limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we compete; and

 

•      placing us at a possible competitive disadvantage to less leveraged competitors and competitors that have better access to capital resources.

 

To the extent that we do not purchase or redeem our outstanding 5.75% convertible subordinated notes due 2006 or receive stockholder approval to increase our authorized shares of common stock, we may not be able to deliver shares of common stock upon conversion of our outstanding 0.25% convertible senior notes due 2011, which would affect our reported net income or loss.

 

We currently have 51,000,000 authorized shares of common stock. As of April 30, 2004, we had:

 

•      31,990,893 shares of common stock issued and outstanding;

 

•      2,526,042 shares of common stock reserved for issuance upon conversion of our 5.75% convertible subordinated notes due 2006;

 

•      7,858,811 shares of common stock reserved for issuance upon conversion of 0.25% convertible senior notes due 2011;

 

•      5,252,057 shares of common stock reserved for issuance upon exercise of outstanding options; and

 

•      3,235,450 shares of common stock reserved for future option grants and future purchases in accordance with our employee stock purchase plan and employee and director stock option plans.

 

Excluding outstanding and reserved shares, we currently have a sufficient number of shares of common stock available for issuance upon conversion of 0.25% convertible senior notes due 2011.  However, we have reserved, subject to stockholder approval at our 2004 annual meeting of stockholders, an additional 1,250,000 shares of common stock for issuance under our employee and director stock option plans.  We have also asked our stockholders to approve an increase in our authorized shares of common stock at our 2004 annual meeting of stockholders.  If our stockholders approve the increase in our authorized shares of common stock, we will have a sufficient number of shares available for issuance upon conversion of our 0.25% convertible senior notes due 2011.  If, however, our stockholders do not approve the increase in our authorized shares of common stock but approve the 1,250,000 share reserve increase under our employee and director stock option plans, we may not have a sufficient number of shares of common stock available for issuance upon conversion of 0.25% convertible senior notes due 2011 unless we purchase or redeem a sufficient number of our outstanding 5.75% convertible subordinated notes, which we may not do.  We have the option under our 0.25% convertible senior notes due 2011 to deliver cash in lieu

 

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of shares and will effectively be required to exercise this option if we do not have sufficient shares available for issuance. As an accounting matter, during any period in which we do not have sufficient authorized but unissued shares of common stock, without giving effect to reserved shares, we are required to account for the conversion feature of our 0.25% convertible senior notes due 2011 as a derivative. During any period in which we are required to use derivative accounting, any increases and decreases in the fair value of the conversion feature will result in a non-cash charge or credit, respectively, which will affect our reported net income or loss.

 

We may not have the ability to raise the funds necessary to finance any required redemptions of our outstanding convertible notes, which might constitute a default by us.

 

We may be required to redeem all or part of our outstanding convertible notes upon the occurrence of certain events designated in the indentures governing these notes. Although the indentures governing these notes allow us in certain circumstances to pay the applicable redemption prices in shares of our common stock, if a designated event were to occur, we may not have sufficient funds to pay the redemption prices for all the notes tendered. We have not established a sinking fund for payment of these notes, nor do we anticipate doing so. In addition, any future credit agreements or other agreements relating to our indebtedness may contain provisions prohibiting redemption of these notes under certain circumstances, or expressly prohibit our redemption of these notes upon a designated event or may provide that a designated event constitutes an event of default under that agreement. If a designated event occurs at a time when we are prohibited from purchasing or redeeming these notes, we could seek the consent of our lenders to redeem these notes or attempt to refinance this debt. If we do not obtain consent, we would not be permitted to purchase or redeem these notes. Our failure to redeem tendered notes would constitute an event of default under the respective indentures, which might constitute a default under the terms of our other indebtedness.

 

Risks Related to our Common Stock

 

We may fail to meet our publicly announced revenue and/or expense projections and/or other financial guidances, which would cause our stock to decline in value.

 

There are a number of reasons why we might fail to meet our revenue and/or expense projections and/or other financial guidance, including, but not limited to, the following:

 

•      if only a subset of or no affected patients respond to therapy with any of our products or product candidates;

 

•      the actual dose or efficacy of the product for a particular condition may be different than currently anticipated;

 

•      the treatment regimen may be different in duration than currently anticipated;

 

•      treatment may be sporadic;

 

•      we may not be able to sell a product at the price we expect;

 

•      we may not be able to accurately calculate the number of patients using the product;

 

•      we may not be able to supply enough product to meet demand;

 

•      there may be current and future competitive products that have greater acceptance in the market than our products do;

 

•      we may decide to divest a product;

 

•      our development activities may proceed faster than planned;

 

•      we may decide to change our marketing and educational programs;

 

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•      clinical trial participation may reduce product sales; or

 

•      physicians’ prescriptions or patient referrals for Actimmune may decline.

 

If we fail to meet our revenue and/or expense projections and/or other financial guidances for any reason, our stock would decline in value.

 

Our stock price may be volatile, and an investment in our stock could decline in value.

 

The trading price of our common stock has been and is likely to continue to be extremely volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including, but not limited to, the following:

 

•      our failure to meet our publicly announced revenue and/or expense projections and/or other financial guidances;

 

•      adverse results or delays in clinical trials;

 

•      actual or anticipated variations in quarterly operating results;

 

•      announcements of technological innovations;

 

•      our failure to commercialize additional FDA approved products;

 

•      our decision not to initiate a planned clinical trial;

 

•      new products or services offered by us or our competitors;

 

•      changes in financial estimates by securities analysts;

 

•      announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;

 

•      issuances of debt or equity securities; or

 

•      other events or factors, many of which are beyond our control.

 

In addition, the stock market in general, and the NASDAQ National Market and biotechnology companies in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of actual operating performance. Periods of volatility in the market price of a company’s securities frequently results in securities class action and shareholder derivative litigation against that company. This type of litigation can result in substantial costs and a diversion of management’s attention and resources, as discussed in more detail above.

 

If our officers, directors and certain stockholders choose to act together, they may be able to significantly influence our management and operations, acting in their own best interests and not necessarily those of other stockholders.

 

At March 31, 2004, our directors, executive officers and greater than 5% stockholders and their affiliates beneficially owned approximately 63% of our issued and outstanding common stock. Accordingly, they collectively may have the ability to significantly influence the election of all of our directors and to significantly influence the outcome of corporate actions requiring stockholder approval. They may exercise this ability in a manner that advances their own best interests and not necessarily those of other stockholders.

 

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Substantial sales of shares may negatively impact the market price of our common stock.

 

If our stockholders sell substantial amounts of our common stock, including shares issued upon the exercise of outstanding options or conversion of our outstanding convertible notes, the market price of our common stock may decline. In addition, the existence of our outstanding convertible notes may encourage short selling by market participants. These sales also might make it more difficult for us to sell equity or equity related securities in the future at a time and price that we deem appropriate. We are unable to predict the effect that sales may have on the then-prevailing market price of our common stock.

 

We have filed registration statements covering shares of common stock issuable upon the exercise of options and other grants pursuant to our stock plans, as well as the shares of common stock issuable upon conversion of our 5.75% convertible subordinated notes due 2006.  We also plan to file a shelf registration statement covering the resale of our 0.25% convertible senior notes due 2011 and the common stock issuable upon conversion of these notes during our fiscal second quarter. In addition, some of the holders of common stock that are parties to our amended and restated investor rights agreement are entitled to registration rights.

 

We have implemented anti-takeover provisions, which could discourage, prevent or delay a takeover, even if the acquisition would be beneficial to our stockholders.

 

The existence of our stockholder rights plan and provisions of our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders. These provisions:

 

•      establish a classified board of directors so that not all members of our board may be elected at one time;

 

•      authorize the issuance of up to 5,000,000 shares of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and hinder a takeover attempt;

 

•      limit who may call a special meeting of stockholders;

 

•      prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders; and

 

•      establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings.

 

In addition, Section 203 of the Delaware General Corporation Law, which prohibits business combinations between us and one or more significant stockholders unless specified conditions are met, may discourage, delay or prevent a third party from acquiring us.

 

ITEM 3 . QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

The securities in our investment portfolio are not leveraged, are classified as available-for-sale and are, due to their short-term nature, subject to minimal interest rate risk. We currently do not hedge interest rate exposure. Because of the short-term maturities of our investments, we do not believe that a change in market rates would have a significant negative impact on the value of our investment portfolio.

 

The primary objective of our investment activities is to preserve principal while at the same time maximizing yields without significantly increasing risk. To achieve this objective, we invest our excess cash in debt instruments of the U.S. federal and state governments and its agencies and high-quality corporate issuers, and, by policy, restrict our exposure to any single corporate issuer by imposing concentration limits. To minimize the exposure due to adverse shifts in interest rates we maintain investments of shorter effective maturities.

 

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The table below presents the principal amounts and weighted-average interest rates by year of effective maturity for our investment portfolio:

 

		2004			2005			2006			2007		2008		2009 and thereafter			Total			Fair value at March 31, 2004
		(in millions)
Assets:
Cash equivalent and available-for-sale securities		$	258.3		$	32.0		$	1.2				—		—			$	291.5		$	294.0
Average interest rate		1.3		%	1.5		%	1.8		%			—		—			—			—
Liabilities:
5.75% Convertible subordinated notes due 2006		—			—			$	97.0		—		—		—			$	97.0		$	100.0
Average interest rate		—			—			5.75		%	—		—		—			—			—
0.25% Convertible senior notes due 2011		—			—			—			—		—		$	170.0		$	170.0		$	181.6
Average interest rate		—			—			—			—		—		0.25		%	—			—

 

We have some obligations in foreign currencies, principally the purchase of Actimmune inventory, which is denominated in Euros.

 

ITEM 4 . CONTROLS AND PROCEDURES

 

Evaluation of disclosure controls and procedures.    Based on our management’s evaluation, and with the participation of our Chief Executive Officer and Chief Financial Officer, as of the end of the period covered by this Report, our Chief Executive Officer and Chief Financial Officer have concluded that, subject to limitations described below, our disclosure controls and procedures (as defined in Securities Exchange Act Rules 13a-15(e) and 15d-15(e)) are effective to ensure that the information we are required to disclose in reports that we file or submit under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in Securities and Exchange Commission rules and forms.

 

Changes in internal controls.    There was no change in our internal control over financial reporting during our first quarter of fiscal 2004 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on the effectiveness of controls.    Our management, including our chief executive officer and chief financial officer, does not expect that our control systems will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within InterMune have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our chief executive officer and chief financial officer have concluded, based on their evaluation as of the end of the period covered by

 

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this Report, that our disclosure controls and procedures were sufficiently effective to provide reasonable assurance that the objectives of our disclosure control system were met.

 

PART II—OTHER INFORMATION

 

ITEM 2. CHANGES IN SECURITIES, USE OF PROCEEDS AND ISSUER PURCHASES OF EQUITY SECURITIES

 

On February 17, 2004, we completed a private placement of $170.0 million aggregate principal amount of 0.25% convertible senior notes due 2011 (the “Senior Notes”). The initial purchasers of the Senior Notes were Morgan Stanley & Co. Incorporated, Banc of America Securities LLC, Credit Suisse First Boston LLC, Harris Nesbitt Corp. and RBC Capital Markets Corporation (the “Initial Purchasers”).  The offering price of the notes was 100% of the principal amount of the notes, less an aggregate underwriting discount of 3%, or $5.1 million. The sale of the Senior Notes to the Initial Purchasers was exempt from registration in reliance on Section 4(2) and Regulation D under the Securities Act of 1933, as amended, as a transaction not involving a public offering.

 

The notes were re-offered by the Initial Purchasers to qualified institutional buyers in reliance on Rule 144A under the Securities Act. The holders of the Senior Notes may convert the Senior Notes into shares of our common stock at a conversion rate of 46.2283 shares per each $1,000 principal amount of Senior Notes, which is equivalent to a conversion price of approximately $21.63 per share.

 

The conversion rate is subject to adjustment in certain circumstances. We have reserved 7,858,811 shares of our authorized common stock for issuance upon conversion of the Senior Notes. The Senior Notes are convertible at any time before the close of business on the maturity date, or March 1, 2011.

 

The Senior Notes are senior, unsecured obligations that rank senior to our 5.75% convertible subordinated notes due 2006.  Accordingly, our 5.75% convertible subordinated notes rank subordinate in right of payment to the Senior Notes.

 

ITEM 5. OTHER INFORMATION

 

As required by Section 10A(i) of the Securities Exchange Act of 1934, our Audit Committee pre-approved payments for the non-audit services performed by Ernst & Young LLP, our independent auditors, during the period covered by this Quarterly Report. These services related to tax compliance assistance, tax consultations, stock option plan compliance, and other technical, financial reporting and compliance services.

 

ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K

 

(a)                              Exhibits:

 

EXHIBIT NUMBER		DESCRIPTION OF DOCUMENT
3.1		Certificate of Incorporation of Registrant. (1)
3.2		Certificate of Ownership and Merger, dated April 26, 2001. (2)
3.3		Bylaws of Registrant. (1)
3.4		Certificate of Amendment of Amended and Restated Certificate of Incorporation of Registrant. (3)
4.1		Specimen Common Stock Certificate. (1)
4.2		Amended and Restated Investor Rights Agreement, dated January 7, 2000, between Registrant and certain holders of the common stock. (1)
4.3		Indenture, dated as of July 5, 2001, between Registrant and The Bank of New York. (4)
4.4		Stockholder Rights Agreement, dated July 17, 2001, between Registrant and Mellon Investor Services LLC. (5)

 

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4.5		Registrant’s Certificate of Designation of Series A Junior Participating Preferred Stock. (5)
4.6		Indenture, dated as of February 17, 2004, between Registrant and The Bank of New York.(6)
4.7		Registration Rights Agreement, dated as of February 17, 2004, by and among Registrant, Morgan Stanley & Co. Incorporated, Banc of America Securities LLC, Credit Suisse First Boston LLC, Harris Nesbitt Corp. and RBC Capital Markets Corporation. (6)
10.73		Purchase Agreement, dated as of February 10, 2004, by and among Registrant and Morgan Stanley & Co. Incorporated, Banc of America Securities LLC, Credit Suisse First Boston LLC, Harris Nesbitt Corp. and RBC Capital Markets Corporation. (7)
10.74**		Aralast Promotion Agreement, dated as of March 26, 2004, by and between Registrant and Baxter Healthcare Corporation. (7)
10.75		Consulting Agreement by and between Registrant and Peter Van Vlasselaer dated April 2, 2004. (7)
31.1		Certification required by Rule 13a-14(a) or Rule 15d-14(a).
31.2		Certification required by Rule 13a-14(a) or Rule 15d-14(a).
32.1*		Certification required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350).

 

(1)           Filed as an exhibit to the Registrant’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on February 2, 2000 (No. 333-96029), as amended by Amendment No. 1 filed with the Commission on February 18, 2000, as amended by Amendment No. 2 filed with the Commission on March 6, 2000, as amended by Amendment No. 3 filed with the Commission on March 22, 2000, as amended by Amendment No. 4 filed with the Commission on March 23, 2000 and as amended by Amendment No. 5 filed with the Commission on March 23, 2000.

 

(2)           Filed as an exhibit to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2001.

 

(3)           Filed as an exhibit to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2003.

 

(4)           Filed as an exhibit to the Registrant’s Current Report on Form 8-K on July 10, 2001.

 

(5)           Filed as an exhibit to the Registrant’s Current Report on Form 8-K on July 18, 2001.

 

(6)           Filed as an exhibit to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2003.

 

(7)           Filed herewith.

 

*              This certification accompanies the Periodic Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed “filed” by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.

 

**           Confidential treatment has been requested with respect to certain portions of this exhibit. Omitted portions have been filed separately with the Securities and Exchange Commission.

 

(b)           Reports on Form 8-K:

 

On January 29, 2003, we filed a current report on Form 8-K describing and furnishing the press release announcing our earnings for the year and quarter ended December 31, 2003, which press release included our condensed consolidated balance sheets and statements of operations for the period.

 

On February 11, 2004, we filed a current report on Form 8-K updating our business description and risk factors.

 

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On February 11, 2004, we filed a current report on Form 8-K describing and filing the press release announcing that we had entered into an agreement for the sale of $170 million of our 0.25% Convertible Senior Notes Due 2011 through a Rule 144A private placement offering to qualified institutional buyers.

 

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:	May 7, 2004		InterMune, Inc.
		By:	/s/ SHARON SURREY-BARBARI
			Sharon Surrey-Barbari
			Chief Financial Officer and Senior Vice President of Finance and Administration (Principal Financial and Accounting Officer and Duly Authorized Officer)

 

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