InterMune Inc. (ticker: ITMN, exchange: NASDAQ) News Release - 10/24/01
--------------------------------------------------------------------------------
InterMune Announces Third Quarter 2001 Financial Results
BRISBANE, Calif., Oct. 24 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN) today announced financial results for the third quarter ended September 30, 2001. Total product sales recorded in the third quarter of 2001 were $11.3 million, compared to $3.8 million for the same period in 2000. Sales of lead product Actimmune(R) (Interferon gamma-1b) for the third quarter of 2001 were $10.3 million, compared to $3.8 million in the third quarter of 2000, an increase of 169%. InterMune reported a net loss of $15.5 million, or $0.56 per share in the third quarter 2001, compared to a net loss of $5.4 million, or $0.25 per share for the same period in 2000.
"We are very pleased with the continued strong growth in product sales," said W. Scott Harkonen, M.D., President and CEO of InterMune. "With enrollment now complete in the Phase III trial of Actimmune(R) for the treatment of idiopathic pulmonary fibrosis, along with the placement of additional specialists in the field, we expect strong sales momentum to continue over the next 12 months. Most significant this quarter was our acquisition of oritavancin, which provides us with a second Phase III product with blockbuster potential. With the addition of oritavancin, we will have eight Phase III clinical trials that will produce significant clinical milestones for investors over the next 18 months."
Research and development expenses were $13.3 million for the three months ended September 30, 2001, compared to $4.7 million in the same period in 2000. The increase was due primarily to increased costs of clinical trial expenses for Actimmune(R) in new disease indications. Research and development expenses for the third quarter of 2001 also included an up-front license fee paid to Maxygen, Inc. to develop next-generation interferon gamma products.
Selling, general and administrative expenses were $9.4 million and $3.0 million for the three-month periods ended September 30, 2001 and 2000, respectively. This increase was attributable primarily to the expanded number of field specialists and increased corporate staffing, as well as related expenses necessary to support the expansion of the Company's operations. At September 30, 2001, cash, cash equivalents and available-for-sale securities totaled $396.2 million.
Highlights From the Third Quarter of 2001:
Acquisition of worldwide rights to oritavancin from Eli Lilly and Company, subject to approval by the U.S. Federal Trade Commission. Oritavancin is a glycopeptide antibiotic in development for the treatment of a broad range of resistant gram-positive bacterial infections. The product is in two Phase III clinical trials for the treatment of complicated skin and skin-structure infections and in a Phase II clinical trial for the treatment of bacteremia. We expect to announce data in the first of the two Phase III clinical trials for the treatment of complicated skin and skin-structure infections in the fourth quarter.
Completion of enrollment in the Phase III trial of Actimmune(R) for the treatment of idiopathic pulmonary fibrosis.
Formation of a collaboration with Maxygen, Inc. to develop and commercialize novel, next-generation interferon gamma products.
FDA approval for the transfer of manufacturing of Actimmune(R) from Genentech, Inc. to Boehringer Ingelheim Austria GmbH.
Completion of the humanization of a monoclonal antibody targeted against the PcrV protein of the bacterium Pseudomonas aeruginosa with Protein Design Labs, Inc. InterMune plans to develop the humanized monoclonal antibody for the treatment and prevention of Pseudomonas infections.
Addition of several key executives to significantly strengthen clinical development expertise in oncology, pulmonary and infectious disease programs.
Revised Full-Year 2001 Guidance:
InterMune also announced today updated full-year 2001 and 2002 product revenue guidance. The Company expects $39 to $40 million in total product revenues in 2001, and $80 million in total product revenues in 2002. Further details regarding the increased revenue guidance will be discussed during the Company's conference call.
The Company will hold a conference call at 4:30 p.m. Eastern Time on Wednesday, October 24, 2001. Interested investors and others may participate in the conference call by dialing 877-709-5341 (domestic) or 212-547-0424 (international) and referencing call number 2587. A telephone replay of the conference call will be available through Tuesday, October 30, 2001. To access the replay, please dial 800-756-8516 (domestic) or 402-998-0460 (international) and reference call number 2587.
The conference call can also be heard live and on a replay basis through an Internet webcast, which may be accessed by visiting InterMune's website at intermune.com and clicking on the "Investor Relations" icon.
InterMune is a commercial-stage biotechnology company dedicated to developing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune has three marketed products, growing product revenues and advanced-stage clinical programs addressing a range of diseases with attractive commercial markets. For additional information about InterMune, please visit www.intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements concerning certain of InterMune's financial, business, and clinical development activities and goals that involve risks and uncertainties. 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. Factors that could cause or contribute to such differences include, but are not limited to those discussed under the heading "Risk Factors" and the risks and factors discussed in InterMune's most recent periodic reports (i.e., 10-K, 10-KA, 10-Q and 8-K) filed with the SEC. In sum, these significant risks include, but are not limited to: the uncertain, lengthy and expensive regulatory process; the uncertainty of success of InterMune's efforts in research, development, commercialization, product acceptance, third-party manufacturing and capital raising; uncertainties associated with: obtaining and enforcing patents important to its business, being an early stage company and relying on third-party payors' reimbursement policies; competition from other products; and product liability lawsuits.
InterMune, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2001 2000 2001 2000
Product sales
Actimmune, net $10,306 $3,831 $22,513 $6,964 (a)
Other, net 1,010 -- 2,373 --
Total net sales 11,316 3,831 24,886 6,964
Costs and expenses:
Cost of goods sold 3,915 1,457 10,514 3,397
Amortization of product
rights 815 557 3,990 1,777
Research and development 13,316 4,696 29,646 11,993
Selling, general and
administrative 9,438 2,992 22,850 7,689
Deferred compensation 823 2,056 3,068 5,127
Acquired in-process research
and development -- -- 5,400 --
Total costs and expenses 28,307 11,758 75,468 29,983
Loss from operations (16,991) (7,927) (50,582) (23,019)
Interest income, net 1,537 2,510 6,345 5,071
Net loss (15,454) (5,417) (44,237) (17,948)
Preferred stock accretion -- -- -- (269)
Redeemable preferred stock
dividend -- -- -- (27,762)
Net loss attributable to
common stockholders $(15,454) $(5,417) $(44,237) $(45,979)
Historical basic and diluted
net loss per share $(0.56) $(0.25) $(1.80) $(3.03)
Shares used in calculating
historical
basic and diluted net loss
per common share 27,390 21,757 24,532 15,169
Pro forma basic and diluted
net loss per share giving effect to
conversion of preferred
stock into common stock on
the Company's IPO $(0.56) $(0.25) $(1.80) $(2.41)
Shares used in calculating pro
forma basic and diluted net loss
per common share 27,390 21,757 24,532 18,944
Pro forma net loss
attributable to common stockholders
excluding acquired
in-process research
and development $(15,454) $(38,837)
Pro forma basic and diluted
net loss per share
excluding acquired
in-process research and
development $(0.56) $(1.58)
Shares used in calculating pro
forma net loss per share 27,390 24,532
(a) Sales of Actimmune(R) up to a contractual threshold of (in
thousands) $1,827 were reported by Connetics Corporation for the
respective period.
InterMune, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
September 30, December 31,
2001 2000
Cash, cash equivalents and
available-for-sale securities $396,190 $194,520
Other assets 54,555 7,129
Total assets $450,745 $201,649
Total liabilities $15,982 $5,848
Convertible subordinated notes 149,500 --
Stockholders' equity 285,263 195,801
Total liabilities and
stockholders' equity $450,745 $201,649
SOURCE InterMune, Inc. |
