e10vq

10-Q 1 f13208e10vq.htm FORM 10-Q e10vq

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

Form 10-Q


þ		QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

		For the quarterly period ended September 30, 2005
OR

o		TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

		For the transition period from to

Commission File Number: 0-29801

InterMune, Inc.

(Exact name of Registrant as specified in its charter)


Delaware		94-3296648
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

3280 Bayshore Blvd., Brisbane, California 94005

(Address of principal executive offices, including zip code)

(415) 466-2200

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes þ No o

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

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No þ

As of October 31, 2005, there were 32,691,437 outstanding shares of common stock, par value $0.001 per share, of InterMune, Inc.

INTERMUNE, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2005

INDEX


Item		Page

PART I. FINANCIAL INFORMATION
1.	Financial Statements (unaudited):
	a. Condensed Consolidated Balance Sheets at September 30, 2005 and December 31, 2004		1
	b. Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2005 and 2004		2
	c. Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2005 and 2004		3
	d. Notes to Condensed Consolidated Financial Statements		4
2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations		15
3.	Quantitative and Qualitative Disclosures About Market Risk		46
4.	Controls and Procedures		46
PART II. OTHER INFORMATION
1.	Legal Proceedings		48
6.	Exhibits		49
Signatures			50
EXHIBIT 10.1
EXHIBIT 31.1
EXHIBIT 31.2
EXHIBIT 32.1

PART I — FINANCIAL INFORMATION


Item 1.	*Financial Statements*

INTERMUNE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS


	September 30,			December 31,
	2005			2004

	(Unaudited, in thousands,
	except per share data)
ASSETS
Current assets:
Cash and cash equivalents	$	55,838		$	55,769
Available-for-sale securities		64,215			127,256
Accounts receivable, net of allowances of $3,109 at September 30, 2005 and $3,403 at December 31, 2004		13,627			12,098
Inventories, net		21,913			32,990
Prepaid expenses and other current assets		5,691			3,478

Total current assets		161,284			231,591
Property and equipment, net		8,113			8,261
Acquired product rights, net		15,271			18,875
Other assets		8,877			7,284

Total assets	$	193,545		$	266,011

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable	$	18,901		$	29,448
Accrued compensation		8,432			7,746
Other accrued liabilities		25,061			24,513

Total current liabilities		52,394			61,707
Deferred rent		1,621			1,513
Convertible notes		170,000			170,000
Commitments and contingencies (Note 7)
Stockholders’ equity (deficit):
Convertible preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued and outstanding at September 30, 2005 and December 31, 2004, respectively		—			—
Common stock, $0.001 par value, 70,000 shares authorized; 32,587 and 32,583 shares issued and outstanding at September 30, 2005 and December 31, 2004, respectively		33			33
Additional paid-in capital		493,181			492,663
Deferred stock compensation		(3,991	)		(5,845	)
Accumulated other comprehensive income		855			1,586
Accumulated deficit		(520,548	)		(455,646	)

Total stockholders’ equity (deficit)		(30,470	)		32,791

Total liabilities and stockholders’ equity	$	193,545		$	266,011

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS


			Three Months Ended						Nine Months Ended
			September 30,						September 30,

			2005			2004			2005			2004

			(Unaudited, in thousands, except per share data)
Product sales:
	Actimmune		$	25,793		$	30,063		$	79,390		$	94,333
	Infergen			10,161			6,223			25,290			14,150
	Others			667			1,218			2,091			3,043

		Total product sales, net		36,621			37,504			106,771			111,526
Costs and expenses:
	Cost of goods sold			16,548			12,270			36,765			30,801
	Amortization of acquired product rights			715			774			2,825			2,327
	Research and development			21,983			16,297			64,337			54,929
	Selling, general and administrative			22,172			17,111			70,673			51,817

		Total costs and expenses		61,418			46,452			174,600			139,874

Loss from operations				(24,797	)		(8,948	)		(67,829	)		(28,348	)
Other income (expense):
	Interest income			1,006			768			3,073			2,557
	Interest expense			(312	)		(616	)		(936	)		(4,775	)
	Other income (expense)			335			(4,064	)		790			(7,072	)

Net loss			$	(23,768	)	$	(12,860	)	$	(64,902	)	$	(37,638	)

Basic and diluted net loss per common share			$	(0.74	)	$	(0.40	)	$	(2.02	)	$	(1.18	)

Weighted average shares used in computing basic and diluted net loss per common share				32,272			31,988			32,156			31,912

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS


					Nine Months Ended
					September 30,

					2005			2004

					(Unaudited, in thousands)
Cash flows used for operating activities:
	Net loss				$	(64,902	)	$	(37,638	)
		Adjustments to reconcile net loss to net cash used for operating activities:
			Amortization and depreciation			6,304			5,319
			Provision for inventories			7,193			2,904
			Non-cash stock compensation and amortization of deferred compensation, net of reversals			1,478			818
			Loss on early extinguishment of convertible debt			—			7,072
			Gain on translation of foreign currency denominated payables			(756	)		—
			Deferred rent			108			203
		Changes in operating assets and liabilities:
			Accounts receivable			(1,529	)		1,495
			Inventories			3,884			10,715
			Other assets			(4,509	)		(372	)
			Accounts payable and accrued compensation			(9,860	)		(14,521	)
			Other accrued liabilities			547			—

				Net cash used for operating activities		(62,042	)		(24,005	)

Cash flows from investing activities:
	Purchases of property and equipment					(1,935	)		(1,172	)
	Purchases of available-for-sale securities					(70,276	)		(93,104	)
	Sales of available-for-sale securities					57,369			44,557
	Maturities of available-for-sale securities					75,948			103,146

				Net cash provided by investing activities		61,106			53,427
Cash flows from financing activities:
	Proceeds from issuance of common stock, net					893			1,496
	Repurchase of convertible subordinated notes					—			(154,452	)
	Proceeds from convertible senior notes, net					—			164,247
	Other					112			232

				Net cash provided by financing activities		1,005			11,523

Net increase (decrease) in cash and cash equivalents						69			40,945
Cash and cash equivalents at beginning of period						55,769			42,071

Cash and cash equivalents at end of period					$	55,838		$	83,016

See accompanying Notes to Condensed Consolidated Financial Statements.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)


1.	ORGANIZATION


	*Overview*

InterMune, Inc. (“InterMune,” “we,” “our,” or “us”) is an independent biopharmaceutical company focused on developing and commercializing innovative therapies in pulmonology and hepatology. Our revenue base is provided primarily from sales of our two core products, Actimmune® and Infergen®. We also have a number of advanced stage clinical programs addressing a range of unmet medical needs with attractive potential commercial markets as well as one remaining non-core asset, oritavancin, that we are seeking to divest.


2.	SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES


	*Basis of Presentation*

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information. The financial statements include all adjustments (consisting only of normal recurring adjustments) that we believe are necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of results to be expected for the full fiscal year.


	*Principles of consolidation*

The consolidated financial statements include the accounts of InterMune and its wholly-owned subsidiaries, InterMune Canada Inc. and InterMune Ltd. (U.K.). All inter-company accounts and transactions have been eliminated. To date, the operations of InterMune Canada Inc. and InterMune Ltd. (U.K.) have been immaterial.


	*Use of estimates*

The preparation of financial statements in conformity with U.S. 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, product returns, charge backs, cash discounts and rebates, excess inventories, inventory purchase commitments, and accrued clinical and preclinical expenses and allowed manufacturing development costs. We base our estimates on historical experience and on various other specific assumptions that we believe are 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.


	*Non-cancelable purchase obligations for inventory*

Because of the long lead times required to manufacture our products, we enter into non-cancelable purchase obligations. We regularly evaluate the need to provide reserves for contractually committed future purchases 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 our products. 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 best manage the procurement and distribution of Actimmune in 2004 we successfully completed the necessary testing to extend the expiration period of Actimmune from 30 months to a total of

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

36 months. 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 under non-cancelable purchase obligations. 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. For example, in 2003 and 2004, we had contractual obligations to purchase approximately 1.0 million and 1.8 million vials of commercial Actimmune, respectively, from our supplier. During the quarter ended September 30, 2005, we amended our contractual obligation with our supplier to eliminate previously required purchases for 2005 and reduce the obligation for future purchases. As part of our regular quarterly forecast process and following this amendment, an analysis of existing Actimmune inventory from previous years’ contractual purchases was completed and compared to current and projected sales trends. As a result of this analysis, we charged $7.2 million, or $0.22 per share, to cost of goods sold during the quarter ended September 30, 2005 for excess inventory from previous years’ contractual purchases. During the quarter ended September 30, 2004, we charged $2.9 million to cost of goods sold for contractual purchase commitments for inventory in excess of forecasted needs.


	*Foreign currency and derivative instruments*

From time to time, we use derivatives to manage our market exposure to fluctuations in foreign currencies. We record all derivatives on the balance sheet at fair value. For derivative instruments that are designated and qualify as a cash flow hedge (i.e., hedging the exposure to variability in expected future cash flows that is attributable to a particular risk), the effective portion of the gain or loss on the derivative instrument is reported as a component of other comprehensive income and realized as earnings in the same period or periods during which the hedged transaction affects earnings. The gain or loss on the derivative instruments in excess of the cumulative change in the present value of future cash flows of the hedged transaction, if any, is recognized in current earnings during the period of change. We do not use derivative instruments for speculative purposes.

We purchase commercial and clinical products from Boehringer Ingelheim (“BI”) in a foreign currency. This exposes us to foreign currency exchange rate risk. To protect against currency exchange risks on forecasted foreign currency cash payments for the purchases of Actimmune from BI, we have instituted a foreign currency cash flow hedging program. As a result, we consider hedging portions of our forecasted foreign currency cash payments with forward contracts. When the dollar strengthens significantly against the foreign currencies, the decline in the value of future foreign currency expenses is offset by losses in the value of the option or forward contracts designated as hedges. Conversely, when the dollar weakens, the increase in the value of future foreign currency purchases is offset by gains in the value of the 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.

At September 30, 2005, net realized gains on derivative instruments included in accumulated other comprehensive income were $1.1 million. Such amount will be recognized as a reduction of cost of goods sold ratably as the related units of Actimmune are sold. At September 30, 2005, there were no outstanding derivative instruments.


	*Inventories*

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

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)


	*Acquired product rights*

Initial payments for the acquisition of products that, at the time of acquisition, are already marketed or are approved by the U.S. Food and Drug Administration, or FDA, for marketing are capitalized and amortized ratably over the estimated life of the products, typically ten years. At the time of acquisition, the product life is estimated 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 uses are expensed as research and development costs. Acquired product rights at September 30, 2005 consist of payments made for the acquisition of rights to Infergen and certain patent rights related to interferon gamma-1b. Accumulated amortization of these intangible assets was $11.8 million and $17.2 million at September 30, 2005 and December 31, 2004, respectively. Accumulated amortization at December 31, 2004 includes $7.5 million related to Amphotec, a product we divested in May 2005. Amortization expense for acquired product rights for each of the next five years and thereafter is expected to be as follows — $2.9 million for each of the annual periods ended September 30, 2006, 2007 and 2008; $2.7 million for the annual period ended September 30, 2009, $2.4 million for the annual period ended September 30, 2010 and $1.5 million thereafter.


	*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.


	*Revenue recognition and revenue reserves*

We recognize revenue generally upon delivery when title passes to a credit-worthy customer and record reserves for estimated product returns, rebates, chargebacks and cash discounts against accounts receivable. We are obligated to accept from customers the return of pharmaceuticals that have reached their expiration date. We believe that we are able to make reasonable and reliable estimates of product returns, rebates, chargebacks and cash discounts based on historical experience and other known or anticipated trends and factors. 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.

We recognize Aralast co-promotion revenue upon receipt of the co-promotion funds from Baxter. The co-promotion revenue calculation is dependent upon national sales data which lags one quarter for reporting purposes, and therefore, estimates are not used. Co-promotion revenue is recognized based on a percentage of Baxter’s sales of Aralast to pulmonologists.


	*Research and development expenses*

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

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

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 and other third parties based upon the estimated amount of work completed on each study as provided by the CRO. 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 using available information; 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 to R&D expenses.


	*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 upon conversion of our convertible notes, from diluted net loss per share because of their anti-dilutive effect.

The securities excluded were as follows (in thousands):


	Three Months				Nine Months
	Ended				Ended
	September 30,				September 30,

	2005		2004		2005		2004

Shares issuable upon exercise of stock options		6,778		5,256		6,778		5,256
Shares issuable upon conversion of convertible notes		7,859		7,859		7,859		7,859

The calculation of basic and diluted net loss per share is as follows (in thousands, except per share data):


	Three Months						Nine Months
	Ended						Ended
	September 30,						September 30,

	2005			2004			2005			2004

Net loss	$	(23,768	)	$	(12,860	)	$	(64,902	)	$	(37,638	)

Basic and diluted net loss per common share:
Weighted-average shares of common stock outstanding		32,573			31,993			32,553			31,944
Less: weighted-average shares subject to repurchase		(301	)		(5	)		(397	)		(32	)

Weighted-average shares used in computing basic and diluted net loss per common share		32,272			31,988			32,156			31,912

Basic and diluted net loss per common share	$	(0.74	)	$	(0.40	)	$	(2.02	)	$	(1.18	)


	*Stock-Based Compensation*

We follow APB Opinion No. 25, “Accounting for Stock Issued to Employees,” (“APB 25”) in accounting for stock-based incentives as permitted by Statement of Financial Accounting Standard No. 123, “Accounting for Stock Based Compensation,” (“SFAS 123”), subsequently amended by SFAS 148, “Accounting for Stock-Based Compensation — Transition and Disclosure.” Although these pronouncements

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

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.

When the exercise price of the employee or director stock options is less than the deemed fair value of the underlying stock on the grant date, we record deferred compensation for the difference. We amortize deferred compensation using the graded vesting method over the vesting period of the award, generally four years. For restricted stock grants, we record the fair value on the date of grant as deferred compensation, which is amortized as the underlying shares vest. We record options or stock awards issued to non-employees at their fair value as determined in accordance with SFAS 123, which we recognize over the related service period and periodically re-measure as the underlying options vest.

The following tables provide the pro forma information required by SFAS 123 (in thousands, except per share data):


	Three Months						Nine Months
	Ended						Ended
	September 30,						September 30,

	2005			2004			2005			2004

Net loss, as reported	$	(23,768	)	$	(12,860	)	$	(64,902	)	$	(37,638	)
Add: Stock-based employee compensation expense, included in reported net loss		500			611			1,478			772
Deduct: Total stock-based employee compensation expense determined under fair value based method for all awards		(5,191	)		(3,868	)		(12,695	)		(6,406	)

Pro forma net loss	$	(28,459	)	$	(16,117	)	$	(76,119	)	$	(43,272	)

Net loss per share:
Basic and diluted — as reported	$	(0.74	)	$	(0.40	)	$	(2.02	)	$	(1.18	)

Basic and diluted — pro forma	$	(0.88	)	$	(0.50	)	$	(2.37	)	$	(1.36	)

The pro forma impact of applying SFAS 123 for the three and nine months ended September 30, 2005 and 2004, respectively, does not necessarily represent the pro forma impact in future periods.

We estimated 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						Nine Months
	Ended						Ended
	September 30,						September 30,

	2005			2004			2005			2004

Expected stock price volatility		71	%		76	%		71	%		76	%
Risk-free interest rate		4.2	%		3.6	%		4.2	%		3.3	%
Expected life (in years)		6.7			5.2			6.6			5.1
Expected dividend yield		—			—			—			—

The weighted-average fair values per share of options granted for the nine month periods ended September 30, 2005 and 2004 were $8.45 and $9.37, respectively.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

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


	Three Months						Nine Months
	Ended						Ended
	September 30,						September 30,

	2005			2004			2005			2004

Expected stock price volatility		74	%		79	%		76	%		80	%
Risk-free interest rate		3.2	%		2.4	%		2.9	%		2.5	%
Expected life (in years)		2.0			2.0			2.0			2.0
Expected dividend yield		—			—			—			—

The weighted-average fair value for shares issued under the employee stock purchase plan for the nine month periods ended September 30, 2005 and 2004 were $8.51 and $12.76, respectively.

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.


	*Recent accounting pronouncements*

In December 2004, the FASB issued SFAS No. 123 (revised 2004), Share-Based Payment (SFAS 123R), which is a revision of SFAS 123. SFAS 123R supersedes APB 25. SFAS 123R requires all share-based payments to employees and directors, including grants of stock options, to be recognized in the statement of operations based on their fair values, beginning with the first quarterly period after June 15, 2005, with early adoption permitted. On April 14, 2005, the Securities and Exchange Commission adopted a new rule that amended the compliance dates for SFAS 123R such that we are now allowed to adopt the new standard effective January 1, 2006. The pro forma disclosures previously permitted under SFAS 123 no longer will be an alternative to financial statement recognition. We expect to adopt SFAS 123R on January 1, 2006.

Under SFAS 123R, we must determine the appropriate fair value model and related assumptions to be used for valuing share-based payments, the amortization method for compensation cost and the transition method to be used at the date of adoption. The transition methods include modified prospective and retroactive adoption options. Under the retroactive options, prior periods may be restated either as of the beginning of the year of adoption or for all periods presented. The modified prospective method requires that compensation expense be recorded for all unvested stock options and restricted stock at the beginning of the first quarter of adoption of SFAS 123R, while the retroactive methods would record compensation expense for all unvested stock options and restricted stock beginning with the first period restated. We are currently evaluating the requirements of SFAS 123R as well as option valuation methodologies related to our employee and director stock options and employee stock purchase plan. Although we have not yet determined the method of adoption or the effect of adopting SFAS 123R, we expect that the adoption of SFAS 123R could have a material impact on our consolidated results of operations and net loss per share. The impact of adoption of SFAS 123R will depend on, among other things, the levels of share-based payments granted in the future, the method of adoption and the option valuation method used.


3.	AMPHOTEC DIVESTITURE

In May 2005, we divested the Amphotec product line, including all related assets, to Three Rivers Pharmaceuticals, LLC (“Three Rivers”). The resulting loss, which was not material, is included in other expenses in our year to date results of operations. In accordance with our agreement with Three Rivers, we may receive contingent payments based on Three Rivers meeting future specified sales targets of Amphotec.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)


4.	INVENTORIES

Inventories consist of the following (in thousands):


	September 30,		December 31,
	2005		2004

Raw materials	$	—	$	550
Finished goods		21,913		32,440

Total	$	21,913	$	32,990


5.	COMPREHENSIVE LOSS

Comprehensive loss is comprised of net loss and other comprehensive income (loss). We include in other comprehensive income (loss) changes in the fair value of derivatives designated as effective foreign currency cash flow hedges and unrealized gains and losses on our available-for-sale securities. Comprehensive loss is as follows (in thousands):


	Three Months						Nine Months
	Ended						Ended
	September 30,						September 30,

	2005			2004			2005			2004

Net loss	$	(23,768	)	$	(12,860	)	$	(64,902	)	$	(37,638	)
Change in unrealized gain (loss) on available-for-sale securities		84			5			25			(489	)
Change in realized and unrealized gain (loss) on foreign currency hedges		(406	)		306			(756	)		754

Comprehensive loss	$	(24,090	)	$	(12,549	)	$	(65,633	)	$	(37,373	)

Accumulated other comprehensive income consists of the following (in thousands):


	September 30,			December 31,
	2005			2004

Net unrealized loss on available-for-sale securities	$	(213	)	$	(238	)
Change in unrealized gain on foreign currency hedges		1,068			1,824

Accumulated other comprehensive income	$	855		$	1,586


6.	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 the option of the holder 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 existing and future senior unsecured debt and prior to all subordinated indebtedness. In addition, the Senior Notes are effectively subordinated to any existing and future secured debt to the extent of the value of the collateral securing such debt. As of September 30, 2005, we had no secured debt and no senior obligations. Offering expenses of $5.8 million related to the sale of the Senior Notes were recorded in other assets and are being amortized to interest expense over the term of the Senior Notes, which is seven years from the date of issuance.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)


7.	COMMITMENTS AND CONTINGENCIES


	*Leases*

We have a non-cancelable lease for facilities, which expires in 2011. In January 2005, we entered into an operating lease agreement to sublease an additional 12,988 square feet of office space at our headquarters location. As a subtenant we will use the premises for general office and administrative purposes only. The sublease term is for 36 months. In addition, we have entered into auto leases for our field sales force that extend up to five years.

The following is a schedule by year of future minimum lease payments of all leases at September 30, 2005 (in thousands):


	Operating
Year	Leases

2005	$	1,282
2006		5,262
2007		5,191
2008		4,329
2009		4,155
Thereafter		5,753

	$	25,972

The operating leases for our facilities require letters of credit secured by a restricted cash balance with our bank. The amounts of each letter of credit approximates six to twelve months of operating rent payable to the landlord of each facility and are effective until we reach profitability. At September 30, 2005 and December 31, 2004, restricted cash under these letters of credit amounted to $1.4 million and $1.7 million, respectively.


	*Purchase Commitments*

We have purchase commitments with BI and Amgen, Inc. for the manufacture and supply of Actimmune and Infergen, respectively. During this quarter, our supply agreement with BI was amended to reduce a portion of our purchase commitments. As a result of this amendment and based on the U.S. Dollar-Euro exchange rate as of August 1, 2005, our minimum contractual purchase obligations totaled $132.3 million and are committed through the year 2012. Of these commitments, we have $10.9 million and $25.6 million of outstanding fixed purchase order commitments that become due and payable in 2005 and 2006, respectively. Our contractual obligation to BI is denominated in Euros and is not currently hedged. In accordance with the terms of our amended agreement with BI, we have guaranteed a minimum annual dollar purchase amount in 2007 and through the remainder of the term of the agreement. In the event that we do not order a sufficient quantity of vials based on forecasted demand such that we do not meet the minimum annual dollar purchase amount, we are required to pay to BI the difference. In any given year that we are required to make this payment, our gross margin percentage would be adversely affected.


	*Contingent Payments*

We will be required to make contingent milestone payments to the owners of our licensed products or the suppliers of our drug compounds in accordance with our license, commercialization and collaboration agreements in the aggregate amount of $230.7 million if all of the milestones per the agreements are achieved. These milestones include development, regulatory approval, commercialization and sales milestones.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)


	*Legal Proceedings*

On June 25, 2003, a purported securities class action entitled Johnson v. Harkonen and InterMune, Inc., No. C 03-2954-MEJ, was filed in the United States District Court for the Northern District of California. Three additional class action complaints entitled Lombardi v. InterMune, Inc., Harkonen and Surrey-Barbari, No. C 03 3068 MJJ (filed on July 1, 2003); Mahoney Jr. v. InterMune Inc., Harkonen and Surrey-Barbari, No. C 03-3273 SI (filed on July 14, 2003); and Adler v. Harkonen and InterMune Inc., No. C 03-3710 MJJ (filed on August 3, 2003), were filed in the same court, each making identical or similar allegations against us, our former chief executive officer and our former chief financial officer. On November 6, 2003, the various complaints were consolidated into one case by order of the court, and on November 26, 2003, a lead plaintiff, Lance A. Johnson, was appointed. A consolidated complaint titled In re InterMune Securities Litigation, No. C 03-2954 SI, was filed on January 30, 2004. The consolidated amended complaint named us, and our former chief executive officer and our former chief financial officer, as defendants and alleges that the defendants made certain false and misleading statements in violation of the federal securities laws, specifically Sections 10(b) and 20(a) of the Exchange Act, and Rule 10b-5. The lead plaintiff sought unspecified damages on behalf of a purported class of purchasers of our common stock during the period from January 7, 2003 through June 11, 2003. The parties settled this case in May 2005 and a final settlement was approved by the court in August 2005. The settlement was funded in large part by the Company’s insurance carrier. As part of the settlement we included approximately $2.0 million of selling, general and administrative expense in our first quarter 2005 financial results to reflect certain potential costs of this settlement, and we did not record any additional charges for this matter since that time.

On July 30, 2003, a stockholder, Michael Adler, purporting to act on our behalf filed a derivative action entitled Adler v. Harkonen, et al., No. CIV 433125, in the California Superior Court for the County of San Mateo against our directors, our former chief executive officer and our former chief financial officer. We were also named as a nominal defendant solely in a derivative capacity. The derivative action was based on the same factual allegations and circumstances as the securities class actions and alleged state law claims for breach of fiduciary duty, abuse of control, gross mismanagement, waste of corporate assets and unjust enrichment. The derivative action sought unspecified damages, injunctive relief and restitution. The parties settled this case in August 2005 and the amount was not material to the financial statements.

On March 19, 2004, plaintiff Joan Gallagher filed an action against us and other defendants in the United States District Court for the Eastern District of Pennsylvania. Ms. Gallagher alleged that during her employment with InterMune, we actively marketed, and required our sales force to market, Actimmune for a purpose for which the drug was not approved by the FDA, specifically for the treatment of idiopathic pulmonary fibrosis, in violation of “public policy,” including the purported public policies of the Food Drug and Cosmetic Act, the Pennsylvania Controlled Substance, Drug, Device and Cosmetic Act and the Pennsylvania Unfair Trade Practice and Consumer Protection Law. Ms. Gallagher alleged that she was wrongfully terminated from InterMune in violation of public policy due to her refusal to engage in the alleged off-label marketing. The parties settled this case in July 2005. The settlement amount was included in our second quarter results of operations, and we did not record any additional charges for this matter in the third quarter of 2005.

On November 9, 2004, we received a subpoena from the U.S. Department of Justice requiring us to provide the Department of Justice with certain information relating to Actimmune, including information regarding the promotion and marketing of Actimmune. We are cooperating with the Department of Justice in this inquiry. Although we cannot predict whether the outcome of this inquiry will have a material adverse effect on our business, it is possible that we will be required to pay a substantial civil fine in connection with the settlement of this matter. At this time we cannot predict the magnitude of such a fine or the impact the payment of such a fine may have on our future business operations.

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)


8.	DISCLOSURES ABOUT SEGMENTS OF AN ENTERPRISE AND RELATED INFORMATION

We have determined that, in accordance with SFAS No. 131, we operate in one segment, because operating results are reported only on an aggregate basis to our chief operating decision makers. We currently market Actimmune in the United States for the treatment of chronic granulomatous disease and severe, malignant osteopetrosis and Infergen in the United States for chronic hepatitis C virus infections. Prior to its divestiture in May 2005, we also marketed Amphotec worldwide for invasive aspergillosis.

Our net revenues by product for the three and nine months ended September 30, were as follows (in thousands):


		Three Months				Nine Months
		Ended				Ended
		September 30,				September 30,

		2005		2004		2005		2004

Actimmune		$	25,793	$	30,063	$	79,390	$	94,333
Infergen			10,161		6,223		25,290		14,150
Others			667		1,218		2,091		3,043

	Total net product sales	$	36,621	$	37,504	$	106,771	$	111,526

Our net revenue by region for the three and nine months ended September 30, were as follows (in thousands):


		Three Months				Nine Months
		Ended				Ended
		September 30,				September 30,

		2005		2004		2005		2004

United States		$	36,564	$	36,865	$	106,359	$	109,269
Other countries			57		639		412		2,257

	Total net product sales	$	36,621	$	37,504	$	106,771	$	111,526

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. 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. Four customers represented 41%, 14%, 13% and 11%, respectively, of total accounts receivable at September 30, 2005, and three customers represented 47%, 14% and 12%, respectively, of total accounts receivable at December 31, 2004. No other customer represented more than 10% of accounts receivable at September 30, 2005 or December 31, 2004.

Revenues from customers representing 10% or more of total revenues during the nine months ended September 30, 2005 or September 30, 2004, were as follows:


Customer	2005		2004

Priority Healthcare Corporation		45%		60%
Caremark		17%		12%
Merck Medco		6%		11%


9.	SUBSEQUENT EVENT

On November 3, 2005, we entered into an agreement with BI for the transfer of the manufacturing process for Infergen from Amgen to BI and for the clinical and commercial supply of Infergen (the “Agreement”). The Agreement generally provides for the exclusive supply by BI and the exclusive purchase by us of Infergen. However, Amgen remains our manufacturer for Infergen until the transfer of the

INTERMUNE, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS — (Continued)

manufacturing process from Amgen to BI is completed and BI is approved by the FDA as our manufacturer for Infergen.

Upon execution of the Agreement, we have made a payment to BI of approximately $14.5 million and are obligated to make three additional payments to BI in the aggregate amount of approximately $11.7 million upon the achievement of three separate milestones tied to the manufacturing process transfer. Currently, there are no annual minimum purchase obligations imposed upon InterMune for Infergen unless and until results from InterMune’s daily Infergen® Phase III clinical trial (the “DIRECT trial”) become available and such results are positive at which time BI and InterMune shall cooperate and work together in good faith to commence and conclude negotiations on the annual minimum and maximum purchase obligations for InterMune and the annual minimum and maximum supply obligations of BI. If BI is not able to supply all of our requirements for Infergen, we may choose an additional manufacturer. This agreement extends through December 31, 2015 and may be renewed for additional five year periods. Either party may have the right to terminate this Agreement for certain specified events.


Item 2.	*Management’s Discussion and Analysis of Financial Condition and Results of Operations.*

Forward-Looking Statements

This Quarterly Report on Form 10-Q (the “Report”) 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 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,” “continue” or the negative of such terms or similar words or expressions. 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;

	•	our research and development expenses and other expenses; and

	•	our operational and legal risks, including potential developments with the Department of Justice inquiry.

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 statement. 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. When used in the Report, unless otherwise indicated, “InterMune,” “we,” “our” and “us” refers to InterMune, Inc.

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 U.S. generally accepted accounting principles. 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-and nine-month periods ended September 30, 2005 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, 2004.

Executive Overview

We are an independent biopharmaceutical company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. Pulmonology is the field of medicine concerned with the diagnosis and treatment of pulmonary, or lung, conditions. Hepatology is the field of medicine concerned with the diagnosis and treatment of disorders of the liver. We were incorporated in California in 1998 and reincorporated in Delaware in 2000 upon becoming a public company. Our revenue base is provided primarily from sales of our two core products, Actimmune and Infergen. Since 2003, sales of Actimmune have been declining on a year to year basis. Significant resources have been applied to the marketing of Infergen contributing to its recent growth. We also have a number of advanced-stage clinical programs addressing a range of unmet medical needs with attractive potential commercial markets as well as one non-core asset, oritavancin, that we are seeking to divest. We have sustained losses in every year since inception and, as of September 30, 2005, we had an accumulated deficit of $520.5 million and a capital deficit of $30.5 million.

Approved Products

Our two marketed products are Actimmune® (interferon gamma-1b), approved for the treatment of patients with severe, malignant osteopetrosis and chronic granulomatous disease (“CGD”) and Infergen® (consensus interferon alfacon-1), approved for the treatment of patients with compensated liver disease who have chronic hepatitis C virus (“HCV”) infections. For the nine months ended September 30, 2005, Actimmune accounted for approximately 74% of our product revenues, and substantially all of those revenues were derived from physicians’ prescriptions for the off-label use of Actimmune in the treatment of idiopathic pulmonary fibrosis (“IPF”).

Research Programs


	*• Hepatology*

We have a preclinical research program in the hepatology area. In September 2002, we entered into a drug discovery collaboration agreement with Array BioPharma, Inc. (“Array”) to discover certain novel small molecule NS-3 protease inhibitors for the treatment of hepatitis C. In late 2004, we amended the Array agreement to provide for the acquisition of certain intellectual property rights from Array. In April 2005, we initiated a second research collaboration with Array with respect to a new hepatology target.

Results presented at the Digestive Disease Weekly medical conference in May 2005 have identified protease inhibitors as a promising therapeutic class. We are advancing our own HCV protease inhibitor program and have completed several preclinical studies on a series of compounds. We have selected one compound for toxicology studies in support of a potential IND submission. We are in the process of determining whether or not we will enter into a partnership to help us develop this protease inhibitor program. Pending discussions with the FDA and irrespective of whether or not we enter into a partnership for this program, we expect to file an IND for this protease inhibitor in 2006.

In addition, we are pursuing research related to other small molecules for unspecified hepatology targets.


	*• Pulmonology*

We have a preclinical research program in pulmonology focused on the discovery of small molecule therapeutics.

Development Programs

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


	*• Hepatology*

In hepatology, we are focused on expanding treatment options for patients suffering from chronic HCV infections. Patients who have never been treated with interferons are referred to as “naïve” patients. We are developing once-daily Infergen in combination with ribavirin therapy for the re-treatment of patients suffering from chronic HCV infections who are reported to have detectable HCV after at least twelve weeks of previous pegylated interferon alpha 2 in combination with ribavirin therapy. Approximately 50% of naïve patients show a sufficient and sustained virologic response (the most commonly used measure of treatment effectiveness) to this initial treatment. The remaining patients that do not show a sufficient and sustained virologic response to pegylated interferons plus ribavirin are referred to as hepatitis C “PEG nonresponders.” We believe that there are approximately 200,000 hepatitis C PEG non-responder patients in the United States. We initiated a Phase III trial of once-daily treatment with Infergen in combination with ribavirin therapy for hepatitis C PEG nonresponder patients (the “DIRECT trial”) in June 2004 and announced in July 2005 that patient enrollment was completed. Results from independent investigator studies of daily Infergen plus ribavirin in the U.S. and Europe suggest sustained virologic response rates that are substantially higher than alternative treatments for PEG nonresponders. We hope to confirm these findings in the DIRECT trial. The DIRECT trial is progressing on schedule through the treatment stage of the study. We met with the FDA on October 24, 2005 to discuss our proposed plan to complete the additional clinical work that we believe would satisfy the requirements for the registration of once-daily Infergen in combination with ribavirin therapy. We plan to provide more specifics around the details and timing of our registration plan once we receive written feedback from the FDA from this meeting. We anticipate obtaining top-line data from the DIRECT trial in the first half of 2007.

We have been developing once-daily Infergen in combination with Actimmune, with and without ribavirin, for the treatment of hepatitis C PEG nonresponder patients. We initiated a Phase IIb clinical trial of this combination in May 2004. Although an independent Data Safety Monitoring Board has approved the continuation of the first three cohorts already enrolled, our decision regarding the future of this trial will depend on data from the first phase of the Phase IIb trial.

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. We do not currently expect to develop this program unless a suitable development partner for this program can be found.


	*• Pulmonology*

In pulmonology, we are developing two therapies for the treatment of IPF. IPF is a fatal disease characterized by progressive scarring, or fibrosis, of the lungs, which leads to the deterioration and destruction of lung function. There is no FDA approved therapy for IPF. Based on available data, we believe that there are approximately 83,000 patients with IPF in the United States. We are developing two clinically advanced compounds for the treatment of IPF, Actimmune and pirfenidone.

We initiated a second Phase III clinical trial of Actimmune for the treatment of patients with IPF (the “INSPIRE” trial) in December 2003. The INSPIRE trial required the enrollment of approximately 600 patients which we anticipate will be completed by the end of 2005. However, to ensure the trial has adequate statistical power, we recently conducted a sample size re-evaluation and determined that the overall mortality rate observed at this early point in the trial was somewhat lower than forecast in the study protocol. Consequently, as provided in the protocol, we made the decision in October 2005 to increase the sample size of the trial by an additional 200 patients to increase the likelihood that the protocol-specified number of events will have occurred by the time the trial is scheduled to conclude by the end of 2007. These additional patients bring the total size to approximately 800 patients. We expect to receive top-line data from the INSPIRE trial in early 2008.

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 BI, which has similar rights in Europe and the rest of the world, to develop and commercialize interferon gamma-1b under the trade name Imukin®. Actimmune has been granted orphan drug designation for IPF in the United States. Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs intended to treat a rare disease or condition, which is generally a disease or condition that affects fewer than 200,000 individuals in the United States. This designation provides seven years of market exclusivity in the United States upon the FDA’s first approval of the product for the orphan designation provided that the sponsor complies with certain FDA specified conditions. EMEA orphan drug designation provides for ten years of market exclusivity in Europe.

We are developing pirfenidone for the treatment of IPF and we currently plan to initiate a Phase III clinical program for pirfenidone in this regard. This program will involve approximately 550 patients, will include two separate multi-national Phase III trials and will have lung function as the primary endpoint. We expect to initiate this program in the first half of 2006. In 2004, the FDA and the European Medicines Agency (“EMEA”) granted us orphan drug designation for pirfenidone for the treatment of IPF. We are also supporting the development of pirfenidone for pulmonary fibrosis associated with Hermansky-Pudlak Syndrome, a fatal, fibrotic lung disease caused by genetic factors for which there is no FDA approved therapy, by providing free drug product to the National Institute of Health for continuing clinical work.


	*• Ovarian Cancer*

We are also evaluating Actimmune in patients with ovarian cancer in an ongoing Phase III trial (the “GRACES trial”). We will review this program based on the outcome of a planned interim analyses of progression-free survival and overall survival. These are event driven analyses performed by an independent Data Safety Monitoring Board that we anticipate will occur in late 2005 or the first quarter of 2006.


	*• Other Assets*

Our oritavancin asset does not fit within our core focus areas of pulmonology and hepatology. Therefore, we have been attempting to divest this non-core asset for the past two years.

Product Development Status

The following chart shows the status of our product development programs as of September 30, 2005:

Preclinical

Phase I

Phase II

Phase III

Pulmonology

Actimmune

Idiopathic pulmonary fibrosis

Pirfenidone

Idiopathic pulmonary fibrosis

Next Generation Interferon Gamma

Hepatology

Daily Infergen + ribavirin

Hepatitis C re-treatment patients

Daily Infergen + Actimmune +/- ribavirin

Hepatitis C re-treatment patients

PEG-Alfacon-1

Chronic hepatitis C virus infections

NS-3 Protease Inhibitor program

Other Assets

Actimmune + Standard-of-Care Chemotherapy

Ovarian cancer

Oritavancin

Complicated skin and skin structure infections

Results of Operations


	*Revenue*

Total product revenues were $36.6 million and $37.5 million for the three-month periods ended September 30, 2005 and 2004, respectively, representing a decrease of 2%. This decrease was primarily attributable to decreases in sales of Actimmune and Amphotec, a product line we divested in May 2005, partially offset by an increase in Infergen sales. For the three-month periods ended September 30, 2005 and 2004, Actimmune accounted for approximately 70% and 80%, respectively, of our net product revenues, and substantially all of these revenues were derived from physicians’ prescriptions for the off-label use of Actimmune in the treatment of IPF.

Total product revenues were $106.8 million and $111.5 million for the nine-month periods ended September 30, 2005 and 2004, respectively, representing a decrease of 4%. This decrease was primarily attributable to decreases in sales of Actimmune and Amphotec partially offset by increased sales of Infergen. For the nine-month periods ended September 30, 2005 and 2004, Actimmune accounted for 74% and 85%, respectively, of our net product sales, and substantially all of these sales were derived from physicians’ prescriptions for the off-label use of Actimmune in the treatment of IPF.

There are a number of variables that impact Actimmune revenue including, but not limited to, the level of U.S. enrollment in our INSPIRE Trial, new patients started on therapy, average duration of therapy, new data presented at medical conferences and publications in medical journals, reimbursement and patient referrals from physicians. In the third quarter of 2005, Actimmune revenues declined 14% to $25.8 million from $30.1 million during the same period in 2004.

In the third quarter of 2005, Infergen revenue increased 63% to $10.2 million from $6.2 million in the same period in 2004. We continue to see strong growth in Infergen demand as measured by prescriptions written for vials. For the three months ended September 30, 2005, Infergen demand, as measured by the number of prescribed vials, grew 123% from the same period of 2004.


	*Cost of goods sold*

Cost of goods sold included product manufacturing costs, royalties and distribution costs. Cost of goods sold were $16.5 million and $12.3 million for the three-month periods ended September 30, 2005 and 2004, respectively. The gross margin percentage for our products was 55% and 67% for these periods in 2005 and 2004, respectively. The increase as a percentage of sales in the cost of goods sold for the third quarter of 2005, when compared to the same period in 2004, was primarily the result of a charge of $7.2 million, or $0.22 per share, to cost of goods sold for excess inventory from previous years’ contractual purchases.

In 2003 and 2004, we had contractual obligations to purchase approximately 1.0 million and 1.8 million vials of commercial Actimmune, respectively, from BI. During the quarter ended September 30, 2005, we amended our contractual obligation with BI to eliminate previously required purchases for 2005 and reduce the obligation for future purchases. As part of our regular quarterly forecast process and following this amendment, an analysis of existing Actimmune inventory from previous years’ contractual purchases was completed and compared to current and projected sales trends. As a result of this analysis, we charged $7.2 million to cost of goods sold during the quarter ended September 30, 2005 for excess inventory from previous years’ contractual purchases. In accordance with the terms of our amended agreement with BI, we have guaranteed a minimum annual dollar purchase amount in 2007 and through the remainder of the term of the agreement. In the event that we do not order a sufficient quantity of vials based on forecasted demand such that we do not meet the minimum annual dollar purchase amount, we are required to pay to BI the difference. In any given year that we are required to make this payment, our gross margin percentage would be adversely affected.

Cost of goods sold was $36.8 million and $30.8 million for the nine-month periods ended September 30, 2005 and 2004, respectively. The gross margin for our products was 66% and 72%, respectively, for these periods in 2005 and 2004. This increase in cost of goods sold is attributable to the same reason noted above for the increase in cost of goods sold for the three month period.

Exchange rate fluctuations between the U.S. dollar and the Euro may adversely affect cost of goods sold on Actimmune purchased from BI. We have, in the past, utilized forward exchange contracts to partially offset the effect of exchange rate fluctuations on purchases. However, no forward exchange contracts have been established to date in 2005.


	*Amortization of acquired product rights*

We recorded amortization of acquired product rights of $0.7 million for the three-month period ended September 30, 2005 and $0.8 million for the three-month period ended September 30, 2004. The amounts recorded for the three-month periods ending September 30, 2005 and 2004 were comprised of the amortization charges related to the acquisition of Amphotec (until its May 2005 divestiture), Infergen and interferon gamma-1b patents.

We recorded amortization of acquired product rights of $2.8 million and $2.3 million for the nine-month periods ended September 30, 2005 and 2004, respectively. The amortization charges for both 2005 and 2004 were related to the acquisition of Amphotec, Infergen and interferon gamma-1b patents. The increase for the 2005 period compared to the same period in 2004 was due to a charge of $0.8 million taken in the first half of 2005 for the impairment of Amphotec/ Amphocil product rights in connection with the divestiture of this brand, which was completed in May 2005.


	*Research and development expenses*

Research and development expenses were $22.0 million and $16.3 million for the three-month periods ended September 30, 2005 and 2004, respectively, representing an increase of $5.7 million or 35%. The increase in spending for the three-month period ended September 30, 2005 compared with the same period in 2004 was primarily due to progress made on our three ongoing Phase III clinical trials and the advancement of our pre-clinical HCV protease inhibitor program. Research and development expenses were $64.3 million and $54.9 million for the nine-month periods ended September 30, 2005 and 2004, respectively, representing an increase of $9.4 million, or 17%. The increase for the nine-month period ended September 30, 2005 compared with the same period in 2004 was primarily due to a $7.4 million increase for the pulmonology development program and a $9.3 million increase for the hepatology development program. These increases in development programs were offset by a decrease of $2.6 million for the oncology development program; a $1.8 million decrease in our non-core oritavancin and Amphotec programs (a substantial majority of the expenses related to oritavancin); and a $2.9 million decrease in non-specific research and development programs.

The following table lists our current product development programs and the research and development expenses recognized in connection with each program during the indicated periods. The category title “Programs-Non specific” is comprised of facilities and personnel costs that are not allocated to a specific development program or discontinued programs. Our management reviews each of these program categories in evaluating our business. For a discussion of the risks and uncertainties associated with developing our products, as well as the risks and uncertainties associated with potential commercialization of our product candidates, see the Risk Factors below including those under the headings “Risks Related to the Development of Our Products and Product Candidates” and “Risks Related to Manufacturing and Our Dependence on Third Parties.”

Our development program expenses for the nine-months ended September 30, were as follows (in thousands):


Development Program	2005		2004

Pulmonology	$	19,424	$	12,024
Hepatology		19,634		10,311
Oncology		11,594		14,148
Anti-infectives(1)		495		2,342
Programs — Non-specific		13,190		16,104

Total	$	64,337	$	54,929


(1)	Includes amounts related to oritavancin and Amphotec; a substantial majority of the expenses are related to oritavancin.

A significant component of our total operating expenses is our ongoing investments in research and development and, in particular, the clinical development of our product pipeline. The process of conducting the clinical research necessary to obtain FDA approval is costly, time consuming, and variable with respect to the timing of expense recognition. Current FDA requirements for a new human drug to be marketed in the United States include:


	•	the successful conclusion of preclinical laboratory and animal tests, if appropriate, to gain preliminary information on the product’s safety;

	•	the filing with the FDA of an IND to conduct human clinical trials for drugs;

	•	the successful completion of adequate and well-controlled human clinical investigations to establish the safety and efficacy of the product for its recommended use; and

	•	the filing by a company and acceptance and approval by the FDA of an NDA or BLA for a drug product to allow commercial distribution of the drug.

In light of the factors mentioned above, we consider the active management and development of our clinical pipeline to be crucial to our long-term success. The actual probability of success for each candidate and clinical program may be impacted by a variety of factors, including, among others, the quality of the candidate, the validity of the target and disease indication, early clinical data, investment in the program, competition, manufacturing capability and commercial viability. Due to these factors, it is not possible to give accurate guidance on the anticipated proportion of our research and development investments by program or the future cash inflows from these programs.


	*Selling, general and administrative expenses*

Selling, general and administrative expenses were $22.2 million and $17.1 million for the three-month periods ended September 30, 2005 and 2004, respectively, representing an increase of $5.1 million or 30%. The increased spending for the three-month period ended September 30, 2005 compared with the same period in 2004 was primarily related to an increased level of sales and marketing expenses supporting Infergen, including the 31-representative Infergen sales force hired in the fourth quarter of 2004, and approximately

$1.8 million of legal expenses related to litigation and ongoing legal matters. The legal matters are described in Part II, Item 1 of this Report.

Selling, general and administrative expenses were $70.7 million and $51.8 million for the nine-month periods ended September 30, 2005 and 2004, respectively, representing an increase of $18.9 million or 36%. The increased spending for the nine-month period ended September 30, 2005, versus the same period in 2004, was primarily related to an increased level of sales and marketing expenses supporting Infergen, $2.0 million of legal expense associated with the settlement of the shareholder class action lawsuit and employee lawsuit and $3.4 million of legal expenses related to litigation and ongoing legal matters. The legal matters are described in Part II, Item 1 of this Report.


	*Interest income*

Interest income increased to $1.0 million for the three-month period ended September 30, 2005, compared to $0.8 million for the three-month period ended September 30, 2004. Interest income increased to $3.1 million for the nine-month period ended September 30, 2005, compared to $2.6 million for the nine-month period ended September 30, 2004. The increase in interest income in the three-month and nine-month periods ended September 30, 2005 reflects increasing investment yields on our cash and short-term investments resulting from higher market interest rates, partially offset by lower cash and investment balances.


	*Interest expense*

Interest expense decreased to $0.3 million for the three-month period ended September 30, 2005, compared to $0.6 million for the three-month period ended September 30, 2004. Interest expense decreased to $0.9 million for the nine-month period ended September 30, 2005, compared to $4.8 million for the nine-month period ended September 30, 2004. The decrease in interest expense in the three-month and nine-month periods ended September 30, 2005, reflects the 2004 repurchase of all of our $149.5 million 5.75% convertible subordinated notes due in July 2006 and the impact of the issuance of our $170 million 0.25% convertible senior notes due in March 2011.


	*Other income (expense)*

Other income (expense) was $0.3 million income for the three-month period ended September 30, 2005 compared to other expense of $4.1 million for the three-month period ended September 30, 2004. Other expense of $4.1 million for the three-month period ended September 30, 2004 included a charge of $2.8 million for the repurchase of all of the remaining $97.0 million of the 5.75% convertible subordinated notes due in July 2006 and the acceleration of $1.3 million of the deferred debt issuance costs associated with these notes. Other income (expense) reflected income of $0.8 million for the nine-month period ended September 30, 2005, comprised of a gain on currency exchange partially offset by the loss on the Amphotec divestiture. This compares to $7.1 million expense for the nine-months ended September 30, 2004. Other expense of $7.1 million for the nine-month period ended September 30, 2004 included a charge of $5.0 million for the repurchase of all $149.5 million of our 5.75% convertible subordinated notes due in July 2006 and the acceleration of $2.1 million of the deferred debt issuance costs associated with these notes.

Liquidity and Capital Resources

At September 30, 2005, we had available cash, cash equivalents and available-for-sale securities of $120.1 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 $62.0 million in cash during the nine-month period ended September 30, 2005, primarily due to the loss from operations of $64.9 million and a decrease in accounts payable and accrued compensation of approximately $9.9 million. This use of cash was partially offset by a decrease in inventories

of $11.1 million. The decrease in accounts payable and accrued compensation was primarily a result of payments made during the second quarter of 2005 for inventories received during the fourth quarter of 2004. The decrease in inventories is primarily due to a $7.2 million charge recorded to cost of goods sold for excess inventory from previous years’ contractual purchases. Details concerning the loss from operations can be found above in this Report under the heading “Results of Operations.”

Investing activities provided $61.1 million in cash during the nine-month period ended September 30, 2005, due in part to maturities and sales of short-term investments totaling $133.3 million, offset by $70.3 million of short-term investment purchases and purchases of property and equipment of $1.9 million. Cash provided by investing activities increased by $7.7 million for the 2005 period, compared to the same period in 2004, primarily due to a reduction in purchases of available-for-sale securities.

Cash provided by financing activities of $1.0 million for the nine-month period ended September 30, 2005 was primarily due to the receipt of proceeds from issuance of common stock. Cash provided by financing activities of $11.5 million for the nine-month period ended September 30, 2004 was primarily due to the receipt of net proceeds of $164.2 million related to the issuance of $170.0 million in 0.25% convertible senior notes due March 2011. These proceeds were offset by the repurchase of $154.5 million in principal amount of our outstanding 5.75% convertible subordinated notes due July 2006.

We do not have any “special purpose” entities that are unconsolidated in our financial statements as of September 21, 2005. We have no commercial commitments with related parties. We have no loans with related parties, except for an executive loan of $0.2 million to Dr. Marianne Armstrong, our Senior Vice President of Regulatory/ Medical Affairs and Drug Safety, and an executive loan of $0.2 million to 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 in 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 2006. 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 extent to which we purchase or redeem our outstanding 0.25% convertible senior notes due 2011 prior to maturity; and

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

As a result, we will require additional funds and plan to 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 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 Quarterly Report on Form 10-Q for the period ended June 30, 2005, 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 derived from physicians’ prescriptions for the off-label use of Actimmune in the treatment of IPF. Although we are developing Actimmune for the treatment of IPF and ovarian cancer, Actimmune may not be marketed for IPF before 2008, if at all, and will not be marketed for ovarian cancer before 2007, if at all. We market Infergen for the treatment of HCV infections, but Infergen revenues may fail to grow significantly. We are developing pirfenidone for the treatment of IPF, but pirfenidone will not be marketed for any diseases before 2010, if at all. The development of PEG-Alfacon-1, a pegylated form of Infergen, for the treatment of chronic HCV infections will be lengthy and very expensive and carries significant risk. We do not currently expect to develop the PEG-Alfacon-1 program unless a suitable development partner is found. We have determined that continued development of oritavancin is non-strategic and therefore we are attempting to divest oritavancin. We may be unable to conclude a sale of oritavancin in the near term or on favorable terms, if at all.

We may fail to develop our products on schedule, or at all, for the reasons stated in this “Risks Related to the Development of Our Products and Product Candidates” section of this Report. If this were to occur, our costs would increase and our ability to generate revenue could be impaired. In addition, we may need to raise capital in amounts greater than we anticipate in order to continue our development activities as planned. If additional capital is not available, we may be forced to curtail our development activities or cease operations.


	*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 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 conducting a second Phase III clinical trial of Actimmune as a treatment for IPF, our INSPIRE trial. 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 would seriously harm our business and would result in a significant decline in our expected Actimmune revenue.


	*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 withdraw or die during a clinical trial for a variety of reasons, including adverse events associated with the advanced stage of their disease and medical problems that may or may not be 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 are not 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 increased due to our need to conduct an additional Phase III clinical trial, as our first Phase III clinical trial of Actimmune for the treatment of IPF failed to show a significant effect on the primary endpoint of progression-free survival or on secondary endpoints of lung function and quality of life. In addition, we recently conducted a blinded pre-specified sample size re-evaluation in the INSPIRE trial that was a part of the original study protocol to determine if the observed aggregate mortality rate to date was consistent with the mortality assumptions underlying the trial design. At this early stage of the trial, the aggregate mortality rate observed was somewhat lower than the projections used in designing the trial. To increase the likelihood of reaching the total number of deaths upon which the trial is powered by the time the trial is scheduled to conclude in late 2007, we decided to increase the trial size by an additional 200 patients, bringing the total trial size to approximately 800 patients. However, there is no guarantee that this increase in patient numbers will in fact result in an aggregate mortality rate necessary to reach the mortality projections. In this event, the scheduled completion of this trial would extend past late 2007. 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 toward them. Accordingly, we may elect to terminate our

programs for and, in certain cases, our licenses to, such product candidates or programs. If we terminate a preclinical program in which we have invested significant resources, we will have expended resources on a program that will not provide a full return on our investment and missed the opportunity to have allocated those resources to potentially more productive uses. In this regard, we did not recover the resources spent on the development of Amphotec when we divested Amphotec in May 2005.


	*We will not be able to recover our total investment in our non-core assets through divestiture, which could harm our business and our results of operations.*

In 2003, we refocused our business by curtailing investment in non-core areas and focusing our commercial and development efforts in pulmonology and hepatology. As a result, we have divested Amphotec and are in the process of attempting to divest oritavancin. We are also evaluating Actimmune in patients with ovarian cancer in our ongoing GRACES Phase III trial. We will review this program based on the outcome of a planned interim analyses of progression-free survival and overall survival. These are event driven analyses performed by an independent Data Safety Monitoring Board that we anticipate will occur in late 2005 or the first quarter of 2006. We have spent significant resources in the acquisition and development of these assets. We may in the future determine that additional product candidates or programs are not consistent with our future business strategy. We may not be able to recover our investment in some or all of these assets in full. In such event, we will have expended resources on programs that will not provide a full return on our investment and missed the opportunity to have allocated those resources to potentially more productive uses.

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


	If we fail to comply or have failed in the past to comply with FDA or other government regulations prohibiting the promotion of off-label uses and the promotion of products for which marketing approval has not been obtained, it could result in regulatory enforcement action by the FDA or other governmental authorities, including a substantial fine, either of which could 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 and prescribing daily administration of Infergen for the treatment of chronic HCV infections, even though the FDA has not approved this combination or dosing regimen for the treatment of chronic HCV infections. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA and other governmental agencies do, however, restrict manufacturers’ communications on the subject of off-label use. Companies may not promote FDA approved drugs for off-label uses. Accordingly, we may not promote Actimmune for the treatment of IPF, or Infergen in combination with ribavirin therapy, or the daily Infergen regimen 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 approval has not been obtained. The federal government has levied large civil and criminal fines against manufacturers for alleged improper promotion, and the FDA has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunction under which certain promotional conduct is changed or curtailed. We are aware of at least one instance in which the Office of the Inspector General has sought criminal penalties and a corporate integrity agreement against a pharmaceutical manufacturer requiring that company to pay substantial fines and to monitor certain promotional activities to ensure compliance with FDA regulations. We engage in medical education activities that are subject to scrutiny under the FDA’s regulations relating to off-label promotion. While we believe we are currently in compliance with these regulations, the regulations are subject to varying interpretations, which are evolving.

If the FDA or any other governmental agency initiates an enforcement action against us and it is determined that we violated prohibitions relating to off-label promotion in connection with past or future

activities, we could be subject to civil and/or criminal sanctions such as those noted above in this risk factor, any of which would have an adverse effect on our revenues, business and financial prospects. On November 9, 2004, we received a subpoena from the U.S. Department of Justice requiring us to provide the Department of Justice with certain information relating to Actimmune, including information regarding the promotion and marketing of Actimmune. We are cooperating with the Department of Justice in this inquiry. Although we cannot predict whether the outcome of this inquiry will have a material adverse effect on our business, it is possible that we will be required to pay a substantial civil fine in connection with the settlement of this matter. At this time we cannot predict the magnitude of such a fine or the impact the payment of such a fine may have on our future business operations.

In addition, some of the agreements pursuant to which we license our products, including our license agreement relating to Actimmune, contain provisions requiring us to comply with applicable laws and regulations, including the FDA’s restriction on the promotion of FDA approved drugs for off-label uses. As a result, if it were determined that we violated the FDA’s rules relating to off-label promotion in connection with our marketing of Actimmune, we may be in material breach of our license agreement for Actimmune. If we failed to cure a material breach of this license agreement, we could lose our rights to Actimmune under the agreement.


	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 additional 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. In this regard, the FDA has conducted routine inspections of our manufacturing contractors, and some were issued a standard “notice of observations.” While we believe that all of these observations are being appropriately corrected, failure to correct any deficiency could result in manufacturing delays. 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. For example, we have ongoing Phase IV post-marketing commitments to the FDA relating to Actimmune for the treatment of osteopetrosis and Infergen for the treatment of HCV. Our failure to adequately address these ongoing Phase IV commitments could result in a regulatory action or restriction, such as withdrawal of the relevant product’s approval by the FDA. 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.

For a description of restrictions relating to the off-label promotion of our products, please see the risk factor titled, “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 approval has not been obtained, it could result in regulatory enforcement action by the FDA or other governmental authorities, which would harm our business” above.


	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 reported results from our confirmatory pivotal Phase III clinical trial of oritavancin for the treatment of complicated skin and skin-structure infections (“CSSSIs”). However, in two additional small clinical pharmacology trials, we observed adverse events, primarily phlebitis and rash, 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 (“NDA”), for oritavancin. Because of the need to perform an additional clinical trial, further development of oritavancin for the treatment of CSSSIs will require additional investment. We are seeking to divest oritavancin.


	*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 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 that 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 or any other products we may develop in the future, 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. Subject to certain exceptions, the 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, could become subject to scrutiny under these laws.

In addition, pharmaceutical companies have been prosecuted under the False Claims Act in connection with their “off-label” promotion of drugs. For information regarding allegations with respect to “off-label” promotion by us, please see “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 approval has not been obtained, it could result in regulatory enforcement action by the FDA or other governmental authorities, including a substantial fine, either of which could harm our business” above.

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 substantial fine, decline in our stock price, or both. 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:


	•	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. For example, the FDA has conducted routine inspections of our manufacturing contractors, and some were issued a standard “notice of observations.” While we believe that all of these observations are being appropriately corrected without further comment or action from the FDA, failure to correct any deficiency could result in manufacturing delays.

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. These third parties include BI, Amgen and Cardinal Health. We have long-term supply contracts with BI for Actimmune, with Amgen for Infergen and with Cardinal for pirfenidone. However, if we do not perform our obligations under these agreements, they may be terminated.

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 less than our purchase obligations to our manufacturers, we may incur substantial penalties and substantial inventory write-offs. For example, in accordance with the terms of our amended agreement with BI, we have guaranteed a minimum annual purchase amount in 2007 and through the remainder of the term of the agreement. In the event that we do not order a

sufficient quantity of vials based on forecasted demand such that we do not meet the minimum annual purchase amount, we are required to pay to BI the difference. In any given year that we are required to make this payment, our gross margin percentage would be adversely affected;

• 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 the new manufacturers’ facilities and processes prior to our use or sale of products it manufactures for us. This requires demonstrated compatibility of product, process and 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 have transferred the manufacturing of oritavancin from Eli Lilly to a new third-party manufacturer, and the new third-party manufacturer’s finished product has not yet demonstrated a comparable safety profile to that demonstrated by Eli Lilly’s oritavancin product. If the finished oritavancin product of the new third-party manufacturer does not have a comparable safety profile to that demonstrated by Eli Lilly’s oritavancin product, our ability to divest oritavancin may be adversely affected;

• 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;

• 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 in a timely manner, 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 in a timely manner, 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, BI is currently our exclusive manufacturer for Actimmune. Under our agreement with BI, we cannot seek a secondary source to manufacture Actimmune until BI has indicated to us its inability or unwillingness to meet our requirements. Amgen is currently our exclusive manufacturer of Infergen. In December 2004, we amended our Licensing and Commercialization Agreement with Amgen to allow us to transfer the manufacturing of Infergen from Amgen to a new supplier. Even if we were to begin working with a new supplier to manufacture Infergen, it could take several

years to transfer the Infergen manufacturing process to a secondary source. 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 higher 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 all of 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


	If we are not able to obtain required regulatory approvals to change Infergen’s label to provide for daily dosing and to market Infergen in combination with ribavirin for Hepatitis C re-treatment patients, our revenues, business and financial prospects would be adversely affected.

We believe that market acceptance of and demand for Infergen for the treatment of chronic HCV infections may depend upon our ability to change Infergen’s label to provide for daily dosing and to market Infergen in combination therapy with ribavirin for Hepatitis C re-treatment patients. Before we may change Infergen’s label or market Infergen for use in combination therapy with ribavirin for Hepatitis C re-treatment patients, we would need to obtain FDA approval. To seek and obtain such approval, we would need to supplement Infergen’s current FDA license with data that support daily use of Infergen and the 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. In June 2004, we initiated a Phase III clinical trial designed to evaluate the safety and efficacy of daily Infergen in combination with ribavirin for the re-treatment of patients chronically infected with HCV who are reported to have detectible HCV after at least 12 weeks of previous pegylated interferon alfa-2 plus ribavirin therapy. However, we cannot provide assurance that this trial will be successful. In addition, if we are able to gain FDA approval for Infergen and ribavirin combination therapy, we may become involved in litigation involving patents held by third parties covering use of interferon alpha and ribavirin combination therapy. If we are unable to obtain FDA approval of daily dosing of Infergen and for these new uses for Infergen, we will be unable to market Infergen in combination with ribavirin or other anti-viral drugs, and our revenues, business and financial prospects would be adversely affected.


	If Amgen is unable or refuses to meet our requirements for the manufacture of Infergen in sufficient quantities or at an acceptable cost in the future to meet anticipated commercial demand, our revenues, business and financial prospects would be adversely affected.

Amgen is currently our exclusive manufacturer of Infergen. In December 2004, we amended our Licensing and Commercialization Agreement with Amgen to allow us to transfer the manufacturing of Infergen from Amgen to a new supplier. Even if we were to begin working with a new supplier to manufacture Infergen, it could take several years to transfer the Infergen manufacturing process to a secondary source. 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, which would harm our ability to generate revenue. 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.


	*Existing patents and patents acquired by others in the future may limit our ability to market our products for the treatment of chronic HCV infections.*

Our competitors and their strategic partners have substantial and extensive patent rights related to 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. It is possible that these patents could adversely impact or prevent our efforts to market Infergen in combination therapy with ribavirin. If these patents adversely impact our ability to market Infergen or PEG-Alfacon-1 with ribavirin, it is possible that the commercial prospects for Infergen or PEG-Alfacon-1 could be reduced and our prospects for profitability may be impaired. Further, it is possible 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-1 with ribavirin or with another anti-viral drug, reducing the commercial prospects for Infergen and PEG-Alfacon-1 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. It is possible that this patent could adversely impact or prevent us from marketing PEG-Alfacon-1 for the treatment of chronic HCV infections. If this patent impacts our ability to market PEG-Alfacon-1 for the treatment of chronic HCV infections, the commercial prospects for PEG-Alfacon-1 could be reduced. Our competitors and their strategic partners may have patent rights relating to pegylation technology in general and the use of pegylated interferon alpha for the treatment of chronic HCV infections in particular. These patents may adversely impact the commercial prospects for PEG-Alfacon-1.

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.


	Because our competitors’ pegylated interferon alpha products permit less frequent dosing than non-pegylated products, Infergen, which is not pegylated, is at a competitive disadvantage with respect to frequency of administration, which may impede its ability to gain acceptance with physicians and patients.

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, which is a non-pegylated interferon alpha product, may be at a significant disadvantage. As a result, these competing products may impede Infergen’s ability to gain acceptance with physicians and patients and thus our ability to generate revenue. In addition, both of these companies have obtained and it is likely they will continue to obtain significant patent protection relating to their respective products.


	*If non-interferon-based products prove to be safe and effective in the treatment of chronic HCV infections, our business and financial prospects will be adversely affected.*

Specific targeted agents directed against HCV may be effective in reducing the amount of virus in infected chronic HCV patients. Results presented at the Digestive Disease Weekly medical conference in May 2005 have provided additional support of protease inhibitors as a promising target against HCV. If the use of

the protease inhibitor or other specific targeted anti-HCV agents proves to be effective in the treatment of chronic HCV infections, the use of interferon-based therapies, like Infergen for chronic HCV infections may diminish, which would harm our business.


	If we are unable to achieve results that are consistent with our assessment of the current and future market potential of Infergen and PEG-Alfacon-1, we may be required to take a charge to the carrying value of our Infergen-related intangible asset that would have a material adverse effect on our financial condition and results of operations.

If the use of interferon-based therapies, including Infergen, for chronic HCV infections were to diminish or not grow as we expect, this could impact the recoverability of the Infergen-related intangible asset, which was $13.5 million as of September 30, 2005. We have conducted detailed assessments 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. These assessments 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 45% 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 nine months ended September 30, 2005, Priority Healthcare Corporation accounted for approximately 45% of our total product sales and 41% of our outstanding receivables. If Priority Healthcare Corporation 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 in any period or harm our business generally. On October 14, 2005, Express Scripts, Inc. announced that it had acquired Priority Healthcare Corporation. We are uncertain what implications, if any, this may have on our business.


	*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. A specialty pharmacy is a pharmacy that specializes in the dispensing of injectable or infused medications for complex or chronic conditions, which often require a high level of patient education and ongoing management. 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;

	•	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 U.S. Public Health Service Agency 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, third-party payors make the decision to reimburse an off-label prescription based on whether that product has a compendium listing. The drug compendia list approved indications that products have received from the FDA. The compendia also evaluate the body of clinical evidence to determine whether an off-label use of products should be listed in the compendia as medically appropriate. A compendium listing of an off-label use is many times a requirement by payors, such as Medicare and private payors, to approve that use. To receive a compendium listing for the use of Actimmune in the treatment of IPF, we would have to complete an application and submit clinical data regarding the use of Actimmune in the treatment of IPF. We will evaluate whether we apply for a compendium listing based upon the publication of certain data in peer reviewed journals whose publication is outside of our control. If we file for a compendium listing and are unable to acquire a compendium listing for Actimmune for the treatment of IPF, additional third-party payors may decide to deny reimbursement for Actimmune for the treatment of 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.

Some third-party payors have denied coverage for Actimmune for the treatment of IPF for a variety of reasons, including the cost of Actimmune, the fact that IPF is not an FDA approved indication for Actimmune or a third-party payor’s assessment that a particular patient’s case of IPF has advanced to a stage at which treatment with Actimmune would not have a significant effect. We believe that approximately 60-70% of the patients who seek coverage for Actimmune for the treatment of IPF from private third-party payors are able to obtain coverage. While coverage trends have not changed significantly in the last two years, major health plans could further restrict coverage or adopt a policy of no coverage.

Medicare generally does not provide coverage for drugs, like Actimmune, that are administered by injection in the home. However, in connection with the Medicare Prescription Drug Improvement and Modernization Act of 2003, Medicare has recently discussed the possibility of refusing to provide coverage for products for a specific indication unless the product has been approved by the FDA for that indication. If Medicare were to make a formal decision not to cover the off-label use of products, it may have a negative impact on the willingness of private third-party payors to provide coverage for the off-label use of products such as Actimmune.


	*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;

	•	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 has been or is in the future issued a patent that blocked our ability to commercialize any of our products, alone or in combination, for any or all of the diseases that we are targeting, we would be prevented from commercializing that product or combination of products 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. If we cannot obtain, maintain and protect the necessary proprietary rights for the development and commercialization of our products or product candidates, our business and financial prospects will be impaired.


	*If we breach our license agreements, we may lose our ability to develop and sell our products.*

We license certain patents and trade secrets relating to Actimmune from Genentech, Inc; relating to Infergen from Amgen; relating to pirfenidone from Marnac and KDL; and relating to oritavancin from Eli Lilly. If we breach any of our agreements with Genentech, Amgen, Marnac and KDL or Eli Lilly, any of these licensors may be able to 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, which could adversely affect our revenues and financial prospects.


	Since the pirfenidone molecule is in the public domain and the patent we licensed from Marnac is limited to specific methods of use of pirfenidone, we may be subject to competition from third party products with the same active pharmaceutical ingredients as our product candidate.

Composition of matter patent protection for pirfenidone molecule has expired in the United States and elsewhere. Marnac and others have obtained patents in the United States and elsewhere relating to methods of use of pirfenidone for the treatment of certain diseases. 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. Marnac has retained rights under other U.S. and foreign patents for the use of pirfenidone to treat diseases other than fibrotic disorders. It is possible that Marnac will license these patent rights to third parties to develop, market, sell and distribute pirfenidone for these indications in the United States and elsewhere. It is also possible that a third party may develop pirfenidone for the treatment of certain diseases that are not covered by patents held by Marnac or those we licensed from Marnac. If Marnac or others were to license their method of use patents for non anti-fibrotic indications to a third party, or if a third party were to develop pirfenidone for a use that is not covered by any patents and such third parties successfully developed pirfenidone for non-fibrotic indications, we could face competition from third party products with the same active pharmaceutical ingredient as our product candidate. If a third party were to

obtain FDA approval for the use of pirfenidone for an indication before we did, such third party would be first to market and could establish the price for pirfenidone. This could adversely impact our ability to implement our pricing strategy for the product and may limit our ability to maximize the commercial potential of pirfenidone. The presence of a lower priced competitive product with the same active pharmaceutical ingredients as our product could lead to use of the competitive product for our anti-fibrotic indications. This could lead to pricing pressure for pirfenidone, which would adversely affect our ability to generate revenue from the sale of pirfenidone for anti-fibrotic indications.


	*Over time, we will lose our ability to rely upon the intellectual property we currently own to prevent competing products, which may impair our ability to generate revenues.*

We have licensed certain patents relating to interferon gamma-1b, the active ingredient in Actimmune, from Genentech. 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 also previously purchased certain patents relating to interferon gamma analogs from Amgen in 2002 including a U.S. patent issued August 30, 2005 which will expire on August 30, 2022. When these various patents expire, we will be unable to use these patents to try to block others from marketing interferon gamma-1b in the United States.

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, expired 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 for the treatment of HCV infections while reducing the occurrence of Grade 3 or Grade 4 toxicities 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 HCV infections in the United States. Another U.S. patent that we have licensed from Amgen covers the use of interferon alfacon-1 for the treatment of HCV patients who have failed to respond to previous interferon treatment. This patent expires in 2016.

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 although we may be able to extend our U.S. exclusivity for IPF if we gain FDA approval for IPF under orphan drug designation. The pirfenidone molecule itself has no composition of matter patent protection in the United States or elsewhere. Therefore, we have no ability to prevent others from commercializing pirfenidone for (i) uses covered by the other patents held by Marnac and third parties, or (ii) other uses in the public domain for which there is no patent protection. We are relying on exclusivity granted from orphan drug designation in IPF to protect pirfenidone from competitors in this indication. The exclusivity period in the United States begins on first NDA approval for this product in IPF and ends seven years thereafter. In addition, a third party could develop pirfenidone for another non-fibrotic disease that also qualifies for orphan drug designation and could be granted seven years exclusivity in that indication. Additionally, in Europe we have already been granted orphan drug designation by the EMEA. We anticipate having ten years of exclusivity in Europe for pirfenidone for the treatment of IPF following first marketing approval in Europe. We cannot provide any assurance that we will be able to maintain this orphan drug designation.

We have licensed certain patents throughout the world relating to oritavancin from Eli 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.

Once our patents expire, we will be subject to competition from third parties who will be able to use the intellectual property covered by these patents, which could impair our ability to generate revenues.


	*Our competitors and others may have or may obtain rights that may limit or prevent us from developing and commercializing our products and product candidates.*

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. It is possible 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 these patents adversely impact our ability to market, or prevent us from marketing, 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.

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.


	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. As noted in the immediately preceding risk factor, 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.


	*If the owners of the intellectual property we license fail to maintain the intellectual property, we may lose our rights to develop our products or product candidates.*

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.


	If our employees, consultants and vendors do not comply with their confidentiality agreements or our trade secrets otherwise become known, our ability to generate revenue and profits may be impaired.

We rely on trade secrets to protect technology where it is possible that 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 or company 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. If our trade secrets become known, we may lose a competitive advantage and our ability to generate revenue may therefore be impaired.


	By working with corporate partners, research collaborators and scientific advisors, we are subject to disputes over intellectual property, and our ability to obtain patent protection or protect proprietary information may be impaired.

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. These disputes could be costly and could divert management’s attention from our business. 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, which could impair our ability to generate revenues.

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 another trial for the treatment of IPF;

	•	Actimmune does not have a compendium listing, often a criterion used by third-party payors to decide whether or not to reimburse off-label prescriptions;

	•	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.

Net sales of Actimmune for the nine months ended September 30, 2005 were $79.4 million, compared to $94.3 million for the nine months ended September 30, 2004, a decline of 16%. Net sales of Actimmune for the quarter ended September 30, 2005 were $25.8 million, compared to $30.1 million for the quarter ended September 30, 2004 representing a decrease of 14%. If physicians do not prescribe Actimmune for the treatment of IPF for the above reasons or any other reasons, our Actimmune revenues will continue to decline. Revenues for Actimmune may have been adversely affected by the publication of an article and a related editorial in the January 8, 2004 issue of the New England Journal of Medicine regarding the results of our initial Phase III trial of Actimmune for the treatment of IPF. The article concluded that “(i)n a well-defined population of patients with idiopathic pulmonary fibrosis, (Actimmune) did not affect progression-free survival, pulmonary function, or the quality of life. Owing to the size of and duration of the trial, a clinically significant survival benefit could not be ruled out.” The related editorial that appeared in the January 8, 2004 New England Journal of Medicine, among other things, cast doubt on our study’s indication of “increased survival among patients who were compliant with interferon gamma-1b treatment” by stating, “(i)t should be emphasized that survival data based on one year of observation in a disease with an unknown date of onset and a life expectancy of two to five years after diagnosis may be very misleading.” The editorial concluded by stating, “(s)tudies of other promising agents ... are indicated, since interferon gamma-1b has not proved to be the answer.”


	*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 2006. 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 $520.5 million at September 30, 2005. 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, Actimmune sales have decreased in recent periods. We have not generated 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 of $7.2 million for the three months ended September 30, 2005 for excess inventories from previous years’ contractual purchases. 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. For additional information relating to difficulties we have experienced forecasting revenues, see the risk factor titled, “We may fail to meet our publicly announced revenue and/or expense projections and/or other financial guidance, which would cause our stock to decline in value” below.


	*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. While we believe that our clinical trial and product liability insurance currently provides adequate protection to 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, which may not be covered by or may exceed our insurance coverage.


	*We face certain litigation risks that could harm our business.*


	*Insurance coverage is increasingly difficult to obtain or maintain.*

While we currently maintain clinical trial and product liability insurance, directors’ and officers’ liability insurance, general liability insurance, property insurance and warehouse and transit insurance, 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.


	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.


	*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 356 employees as of October 31, 2005, 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. None of our employees, including members of our management team, has a long-term employment contract, and any of our employees can leave at any time. 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.


	If we do not continue to successfully implement our plan to improve our internal control over financial reporting and disclosure controls and procedures, investors and current and potential collaborative partners could lose confidence in our financial reporting, which could harm the market price of our common stock and our business.

In connection with management’s assessment of our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) as of December 31, 2004, we determined that we had a material weakness in our financial statement close process, primarily related to the accurate presentation of disclosures in the notes to our financial statements in accordance with U.S. Generally Accepted Accounting Principles and the rules and regulations of the SEC. This material weakness in our financial statement close process arose from the lack of sufficient finance staff with proficiency to interpret such principles and rules and inadequate review and approval procedures. As a result of the material weakness noted above, our management concluded that our internal control over financial reporting and disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) was not effective as of December 31, 2004.

While audit and other procedures can compensate for problems with internal control over financial reporting and disclosure controls and procedures, our ability to provide reliable financial and other information to investors depends upon the effectiveness of our internal control over financial reporting and disclosure controls and procedures. We have implemented and continue to implement remedial measures to improve our internal control over financial reporting. However, if we are not successful in improving our internal control over financial reporting and disclosure controls and procedures, investors and current and potential collaborative partners could lose confidence in the reports we file with the SEC, which could harm the market price of our common stock and our business.

Risks Related to our Common Stock


	*We may fail to meet our publicly announced revenue and/or expense projections and/or other financial guidance, 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;

	•	negative publicity about the results of our clinical studies may reduce demand for our products and product candidates;

	•	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;

	•	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 guidance for any reason, our stock could decline in value. In this regard, as a result of changing market dynamics for Actimmune, on April 29, 2004, we removed our Actimmune and total revenue guidance for the year ending December 31, 2004 that was provided on January 29, 2004. Our stock price decreased by $3.30, or 18%, to $14.71 by the close of business on April 30, 2004, the day after we removed this guidance.


	*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. During the twelve-month period ended September 30, 2005, the closing price of our common stock on the Nasdaq National Market ranged from $9.99 to $18.14. Our stock price could be subject to wide fluctuations in response to a variety of factors, including, but not limited to all the factors discussed in this “Risk Factors” section.

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.

We have recently had several lawsuits filed against us, as discussed under the risk factor titled, “We face certain litigation risks that could harm our business.”


	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 September 30, 2005, our directors, executive officers and greater than 5% stockholders and their affiliates beneficially owned approximately 45% 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, such as mergers or a financing in which we sell more than 20% of our voting stock at a discount to market price. They may exercise this ability in a manner that advances their own best interests and not necessarily those of other stockholders. This concentration of ownership could also depress our stock price.


	*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 the approximately 9,340,737 shares of common stock that are either issuable upon the exercise of outstanding options or reserved for future issuance pursuant to our stock plans as of September 30, 2005. We have also filed a shelf registration statement covering the resale of our 0.25% convertible senior notes due in 2011 and the 7,858,811 shares of common stock issuable upon conversion of those notes. 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 with respect to approximately 6,500,000 shares of our common stock as of September 30, 2005.

On October 29, 2004, we entered into an Amended and Restated Standstill Agreement with Warburg Pincus Equity Partners, L.P. and certain of its affiliates (“Warburg Pincus”) that permits Warburg Pincus to acquire up to 25% of our outstanding common stock in the open market. Under this agreement, Warburg Pincus may acquire up to 25% of our outstanding common stock and we have granted Warburg Pincus certain registration rights with respect to its holdings. The restriction on Warburg Pincus’ acquisition of additional shares of our common stock expires on October 29, 2007. In exchange for allowing Warburg Pincus to increase its ownership stake, Warburg Pincus has granted the independent members of our board of directors the right to vote the shares of InterMune common stock owned by Warburg Pincus in excess of 19.9%. In addition, Warburg Pincus has agreed to certain limitations on the manner in which it may dispose of its ownership interest in InterMune. In connection with this transaction, we also amended our stockholder Rights Plan to allow Warburg Pincus to acquire up to 25% of our outstanding common stock. Jonathan S. Leff, a member of our board of directors, is a managing director of Warburg Pincus LLC and a partner of Warburg Pincus & Co., which are affiliates of Warburg Pincus Equity Partners, L.P.


	We have implemented anti-takeover provisions, which could discourage, prevent or delay a takeover, even if the acquisition would be beneficial to our stockholders, or frustrate or prevent any attempts by our stockholders to replace or remove our current management or Board of Directors.

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. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is

responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. 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.

Risks Related to our Outstanding Notes


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

As of September 30, 2005, our annual debt service obligation on the $170.0 million in aggregate principal amount of our 0.25% convertible senior notes due March 1, 2011 was $0.4 million. We intend to fulfill our current debt service obligations, including repayment of the principal, both from cash generated by our 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.


	*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.*

If a designated event, such as the termination of trading of our common stock on the Nasdaq National Market or a specified change of control transaction, occurs prior to maturity, we may be required to redeem all or part of our 0.25% convertible senior notes due 2011. We may not have enough funds to pay the redemption price for all tendered notes. Although the indenture governing the 0.25% convertible senior notes due 2011 allows 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 our outstanding 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 our outstanding notes under certain circumstances, or expressly prohibit our redemption of our outstanding 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 our outstanding notes, we could seek the consent of our lenders to redeem our outstanding notes or attempt to refinance this debt. If we do not obtain consent, we would not be permitted to purchase or redeem our outstanding notes. Our failure to redeem tendered notes would constitute an event of default under the indenture for the notes, which might constitute a default under the terms of our other indebtedness.


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.

The table below presents the principal amounts and weighted-average interest rates by year of maturity for our investment portfolio as of September 30, 2005 by effective maturity (in millions, except percentages):


																		Fair Value at
												2009 and						September 30,
	2005			2006			2007			2008		Beyond			Total			2005

Assets:
Available-for-sale securities	$	38.6		$	17.7		$	7.7			—		—		$	64.0		$	64.2
Average interest rate		3.3	%		3.8	%		3.8	%		—		—			3.5	%		—
Liabilities:
0.25% convertible senior notes due 2011		—			—			—			—	$	170.0		$	170.0		$	149.0
Average interest rate		—			—			—			—		.25	%		.25	%		—

Foreign Currency Market Risk

We have obligations denominated in Euros for the purchase of Actimmune inventory. In the nine months ended September 30, 2005, we used foreign currency forward contracts to partially mitigate this exposure. We regularly evaluate the cost-benefit of entering into such arrangements and had no foreign currency hedge agreements outstanding at September 30, 2005.


Item 4.	*Controls and Procedures.*

Evaluation of Disclosure Controls and Procedures.

As of the end of the period covered by this quarterly report on Form 10-Q, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures, or “disclosure controls.” This controls evaluation was performed under the supervision and with the participation of management, including our CEO and CFO. Disclosure controls are controls and procedures designed to reasonably assure that information

required to be disclosed in our reports filed under the Exchange Act, such as this Report, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls are also designed to reasonably ensure that such information is accumulated and communicated to our management, including the CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure. Based upon the controls evaluation, our CEO and CFO have concluded that, as a result of the matters discussed below with respect to our internal control over financial reporting, our disclosure controls were effective as of the end of the period covered by this Report.

Internal Control Over Financial Reporting

Management assessed our internal control over financial reporting as of December 31, 2004, the end of our fiscal year. As previously disclosed in the Annual Report on Form 10-K for the year ended December 31, 2004, as a result of this assessment, we identified a material weakness in our financial statement close process. Management identified this material weakness as being due to insufficient controls related to the preparation and review of our annual consolidated financial statements and accompanying footnote disclosures in accordance with U.S. generally accepted accounting principles and the rules and regulations of the SEC. The insufficient controls identified included a lack of finance staff with the proficiency to interpret such principles and rules, and inadequate review and approval procedures to prepare external financial statements in accordance with U.S. generally accepted accounting principles and the rules and regulations of the SEC.

Remediation Actions to Address Material Weaknesses in Internal Control over Financial Reporting

Management believes that actions that we have taken since December 31, 2004 have addressed the material weaknesses in our financial statement close process. We intend to continue to monitor our internal control over financial reporting, and if further improvements or enhancements are needed, we will take steps to implement such improvements or enhancements.

Changes in Internal Control Over Financial Reporting

There have been no changes to our internal controls over financial reporting during the three months ended September 30, 2005 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

CEO and CFO Certifications

Attached as exhibits to this Report, there are “Certifications” of the CEO and the CFO required by Rule 13a-14(a) of the Securities Exchange Act of 1934, or the Rule 13a-14(a) Certifications. This Controls and Procedures section of the Report includes the information concerning the controls evaluation referred to in the Rule 13a-14(a) Certifications and it should be read in conjunction with the Rule 13a-14(a) Certifications for a more complete understanding of the topics presented.

Limitations on the effectiveness of controls.

Our management, including our CEO and CFO, 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 CEO and CFO have concluded, based on their evaluation as of the end of the period covered by this Report, that our disclosure controls and procedures were effective to provide reasonable assurance that the objectives of our disclosure control system were met.

PART II — OTHER INFORMATION


Item 1.	*Legal Proceedings.*

the settlement of this matter. At this time we cannot predict the magnitude of such a fine or the impact the payment of such a fine may have on our future business operations.


Item 6.	*Exhibits.*


Exhibit
Number			Description of Document

	3	.1	Amended and Restated Certificate of Incorporation of InterMune.(1)

	3	.2	Certificate of Ownership and Merger, dated April 26, 2001.(2)

	3	.3	Bylaws of InterMune.(1)

	3	.4	Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(3)

	3	.5	Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(4)

	10	.1*	Amendment No. 3 to Data Transfer, Clinical Trial and Market Supply Agreement, dated January 27, 2000, between InterMune and Boehringer Ingleheim Austria, GmbH.(5)

	31	.1	Certification required by Rule 13a-14(a) or Rule 15d-14(a).(5)

	31	.2	Certification required by Rule 13a-14(a) or Rule 15d-14(a).(5)

	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).(5)


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

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

(4)	Filed as an exhibit to the InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004.

(5)	Filed herewith.


	*	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.


**	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.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.


	InterMune, Inc.


	By:	/s/ Norman L. Halleen



	Chief Financial Officer and Senior Vice President,
	Finance (Principal Financial and Accounting
	Officer and Duly Authorized Officer)

Date: November 7, 2005

INDEX TO EXHIBITS


Exhibit
Number			Description of Document

	3	.1	Amended and Restated Certificate of Incorporation of InterMune.(1)

	3	.2	Certificate of Ownership and Merger, dated April 26, 2001.(2)

	3	.3	Bylaws of InterMune.(1)

	3	.4	Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(3)

	3	.5	Certificate of Amendment of Amended and Restated Certificate of Incorporation of InterMune.(4)

	10	.1*	Amendment No. 3 to Data Transfer, Clinical Trial and Market Supply Agreement, dated January 27, 2000, between InterMune and Boehringer Ingelheim Austria, GmbH.(5)

	31	.1	Certification required by Rule 13a-14(a) or Rule 15d-14(a).(5)

	31	.2	Certification required by Rule 13a-14(a) or Rule 15d-14(a).(5)

	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).(5)


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

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

(4)	Filed as an exhibit to the InterMune’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2004.

(5)	Filed herewith.


	*	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.


**	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.


		sufficient quantity of vials based on forecasted demand such that we do not meet the minimum annual purchase amount, we are required to pay to BI the difference. In any given year that we are required to make this payment, our gross margin percentage would be adversely affected;

	•	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 the new manufacturers’ facilities and processes prior to our use or sale of products it manufactures for us. This requires demonstrated compatibility of product, process and 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 have transferred the manufacturing of oritavancin from Eli Lilly to a new third-party manufacturer, and the new third-party manufacturer’s finished product has not yet demonstrated a comparable safety profile to that demonstrated by Eli Lilly’s oritavancin product. If the finished oritavancin product of the new third-party manufacturer does not have a comparable safety profile to that demonstrated by Eli Lilly’s oritavancin product, our ability to divest oritavancin may be adversely affected;

	•	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;

	•	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 in a timely manner, 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 in a timely manner, if at all.