BRISBANE, Calif., July 23, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced results from operations for the second quarter and six months ended June 30, 2012. InterMune also reported a successful and early conclusion of negotiations for the reimbursement price of Esbriet® (pirfenidone) in Germany. Effective September 15, 2012, the net ex-factory Esbriet price in Germany will be 26,999 €, or approximately $33,000 per patient per year, representing an approximate 10% discount from the current price.
InterMune reported Esbriet net revenue in the second quarter of 2012 of $5.5 million, an increase of 13 percent from $4.9 million in the first quarter of 2012. The initial commercial launch of Esbriet was in Germany in September 2011. Esbriet is InterMune's product marketed in Europe for adults with mild-to-moderate idiopathic pulmonary fibrosis (IPF), a chronic and ultimately fatal disease of the lungs.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We are very pleased to have negotiated with the German authorities a strong price for Esbriet, the first orphan drug that has undergone pricing and reimbursement review under Germany's new AMNOG law. The conclusion of this favorable pricing and reimbursement negotiation brings welcome clarity and confidence to German physicians regarding the reimbursement status of Esbriet.
"Esbriet continues to be one of the most successful orphan product launches in Germany, achieving revenues and new patient starts consistent with the best of these launches after nine months of marketing," Mr. Welch continued. "Esbriet is on track to become the drug of choice among pulmonologists in Germany who care for IPF patients, and has begun displacing so-called triple combination therapy. We believe that in addition to the positive news announced today regarding the pricing and reimbursement of Esbriet in Germany, favorable market conditions for Esbriet exist that will support the continued growth of Esbriet revenues in Germany."
Esbriet® (pirfenidone) in GermanyInterMune provided the following additional details related to the Esbriet launch in Germany:
Additional Clinical Development and Business Highlights Esbriet® (pirfenidone):
Actimmune® (gamma interferon-1b):
Second Quarter and First Half 2012 Financial Results (Unaudited)As a result of the June 19, 2012 divestiture of Actimmune® (interferon gamma-1b), historical and current period Actimmune revenue, cost of goods sold and operating costs will be reported in discontinued operations in this and future financial statements and therefore do not appear in the comparisons below regarding on-going operations.InterMune reported total revenue in the second quarter of 2012 of $5.5 million, compared with $1.3 million in the second quarter of 2011. Total revenue in the second quarter of 2012 consisted solely of revenue from sales of Esbriet in Europe, primarily in Germany. There were no Esbriet sales in the second quarter of 2011, as Esbriet's initial commercial launch was in Germany in September 2011. InterMune reported total revenue for the first six months of 2012 of $10.4 million, compared with $2.6 million in the first six months of 2011. Total revenue in the first six months of 2011 consisted solely of revenue from the company's research collaboration with Roche, which was completed in June 2011.Research and development (R&D) expenses in the second quarter of 2012 were $25.2 million, compared with $20.1 million in the second quarter of 2011, an increase of 25 percent. R&D expenses were $48.4 million for the six months ended June 30, 2012, compared with $36.9 million in 2011, an increase of 31 percent. Higher R&D expenses in both the three- and six-month periods of 2012, compared with the same periods in 2011, reflect expenses related to conduct of the ASCEND trial, which was initiated in July 2011.
Selling, general and administrative (SG&A) expenses were $25.6 million in the second quarter of 2012, compared with $21.6 million in the same period a year earlier, an increase of 19 percent. SG&A expenses were $51.9 million in the first six months of 2012, an increase of 33 percent from $39.0 million in the same period of 2011. The increased spending for the three- and six-month periods in 2012, compared with the same periods in 2011, are primarily attributable to the creation of InterMune's European infrastructure and investments in the launch and pre-launches of Esbriet in Germany and other EU countries.
Net income for the second quarter of 2012 was $0.5 million, or $0.01 per basic and diluted share, compared with a net loss of $39.9 million, or $0.68 per share, in the same quarter of 2011. Net loss for the first six months of 2012 was $46.1 million, or $0.71 per share, compared with a net loss of $72.0 million, or $1.25 per share, in the comparable six months of 2011. The net income (loss) in the three- and six-month periods of 2012 reflects income from discontinued operations of $51.4 million related to the divestiture of the company's rights to Actimmune, which was completed on June 19, 2012.As of June 30, 2012, InterMune had cash, cash equivalents and available-for-sale securities of approximately $393.7 million, including $55.0 million from the divestiture of the company's rights to Actimmune, prior to transaction-related expenses.
Guidance for 2012 Revenue and Expenses The company today provided forward-looking guidance for Esbriet revenue in 2012, and reiterated its operating expense guidance for 2012, provided on June 20, 2012:
Conference Call and Webcast DetailsInterMune will host a live webcast of a conference call today at 8:30 a.m. EDT to discuss business highlights and financial results for the second quarter and first six months of 2012. Interested investors and others may participate in the conference call by dialing 800-891-8257 (U.S.) or +1-212-271-4651 (international), conference ID# 21600194. A replay of the webcast and teleconference will be available approximately three hours after the call.
To access the webcast, please log on to the company's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A telephonic replay will be available for 10 business days following the call and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140 (international), and entering conference ID# 21600194. The webcast will remain available on the company's website until the next earnings call.
About InterMune InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases. In pulmonology, the company is focused on therapies for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung disease. Pirfenidone, the only medicine approved for IPF anywhere in the world, is approved for marketing by InterMune in the EU as Esbriet® and is currently in a Phase 3 clinical trial to support regulatory registration in the United States. InterMune's research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious pulmonary and fibrotic diseases.
For additional information about InterMune and its R&D pipeline, please visit www.intermune.com.
Forward-Looking Statements This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to our expectations for Esbriet® (pirfenidone) as an important therapy in the treatment of patients with IPF, including becoming the drug of choice for pulmonologists in Germany, our expectation regarding continued growth of Esbriet revenues in Germany, our expectation that physicians in Germany can prescribe Esbriet without concern for their healthcare budgets, our anticipated timing of concluding pricing and reimbursement discussions and initiating commercial launches for Esbriet in France, Italy, Spain, the United Kingdom and other EU countries, our expectations regarding headcount in our EU commercial organization and the functions of such personnel, our expectation regarding the timing and nature of full enrollment in, and results of, the ASCEND study and the prospects of success thereof, and our expectations regarding the aggregate amount of Actimmune royalties. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Other factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 29, 2012 (the "Form 10-K"), most recent quarterly report on Form 10-Q filed with the SEC on May 10, 2012 (the "Form 10-Q") and other periodic reports filed with the SEC, including but not limited to the following: (i) the risks related to the uncertain, lengthy and expensive clinical development process for the company's product candidates, including having no unexpected safety, toxicology, clinical or other issues and having no unexpected clinical trial results such as unexpected new clinical data and unexpected additional analysis of existing clinical data; (ii) risks related to the regulatory process for the company's product candidates, including the possibility that the results of the new 52-week Phase 3 clinical trial (ASCEND) having an FVC endpoint may not be satisfactory to the FDA for InterMune to receive regulatory approval for pirfenidone in the United States; (iii) risks related to unexpected regulatory actions or delays or government regulation generally; (iv) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue; (v) government, industry and general public pricing pressures; (vi) risks related to our ability to successfully launch and commercialize Esbriet in the EU, including successfully establishing a commercial operation in the EU and receiving favorable governmental pricing and reimbursement approvals in each EU country; and (vii) InterMune's ability to obtain or maintain patent or other proprietary intellectual property protections. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K, Form 10-Q and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at www.intermune.com.Esbriet® is a registered trademark of InterMune, Inc.Financial tables follow:InterMune, Inc.PRELIMINARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(unaudited, in thousands, except per share amounts)Three Months EndedSix Months EndedJune 30,June 30,2012201120122011Revenue, net Esbriet
- Collaboration revenue-1,329-2,629
Total revenue, net5,5381,32910,4182,629Costs and expenses: Cost of goods sold3,323-4,183- Research and development25,16620,08448,37836,922 Selling, general and administrative25,64221,63851,92639,009
Total costs and expenses54,13141,722104,48775,931Loss from operations(48,593)(40,393)(94,069)(73,302)Interest income159121304259Interest expense(2,237)(1,086)(4,442)(2,873)Other expense(139)11(1,124)(95)Loss from operations before income taxes(50,810)(41,347)(99,331)(76,011)Income tax expense69-134-Loss from continuing operations (50,879)(41,347)(99,465)(76,011)Discontinued operations:Income from discontinued operations371,4531,9934,014Gain on sale of discontinued operations51,335-51,335-Income from discontinued operations51,3721,45353,3284,014Net income (loss)
(71,997)Basic and diluted net income (loss) per common share:
(1.25)Shares used in computing basic net income (loss) per share64,94358,92464,85857,657Shares used in computing diluted net income (loss) per share65,19358,92464,85857,657InterMune, Inc.PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS(unaudited, in thousands)June 30,December 31,20122011Cash, cash equivalents and available-for-sale securities
425,110Acquired product rights, net18,75019,250Other assets31,62428,263 Total assets
472,623Total other liabilities
34,205Convertible senior notes240,250240,250Stockholders' equity162,592198,168 Total liabilities and stockholders' equity
|SOURCE InterMune, Inc.|
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