ITMN - Actimmune 149% YOY and 27% sequential growth
Monday October 23, 9:23 pm Eastern Time
Press Release
SOURCE: InterMune Pharmaceuticals, Inc.
InterMune Reports Third Quarter 2000 Financial Results
Sales of ACTIMMUNE(R) Increase by 149%
BURLINGAME, Calif., Oct. 23 /PRNewswire/ -- InterMune (Nasdaq: ITMN - news) today announced financial results for the third quarter, ended September 30, 2000. InterMune reported a net loss of $5.4 million, or $0.25 per share on a pro forma basis, compared to a net loss of $1.3 million, or $0.16 per share on a pro forma basis, in the third quarter of 1999. For the nine months ended September 30, 2000, InterMune reported a net loss of $45.7 million, or $2.41 per share on a pro forma basis, compared to a net loss of $4.3 million, or $0.58 per share on a pro forma basis for the same period in 1999.
In connection with InterMune's initial public offering, the fiscal year 2000 financial results include a deemed dividend of $27.8 million upon the issuance of Series B redeemable convertible preferred stock in the first quarter of 2000. Excluding the effect of this expense item, the pro forma net loss per share for the nine months ended September 30, 2000 would have been $0.95 per share. Pro forma net loss per share amounts assume conversion of preferred stock to common at the time of their original issue.
Sales of ACTIMMUNE® for the third quarter were $3,831,000 compared to $1,537,000 in the third quarter of 1999, an increase of 149%. On June 28, 2000, the Company announced that it had bought all the rights to ACTIMMUNE® revenues from Connetics Corporation (Nasdaq: CNCT - news) that it did not already own and would book all ACTIMMUNE® revenues and related expenses in the United States beginning in the second quarter of 2000. Sales of ACTIMMUNE® for the nine months ended September 30, 2000 were $8,791,000 compared to $3,763,000 for the same nine-month period in 1999, an increase of 134%.
``We are very pleased with the continued growth in sales of ACTIMMUNE® during the third quarter,'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``Because of increased physician use and interest in ACTIMMUNE®, we are accelerating our medical education efforts and plan to place additional medical science liaisons (MSL's) in the field. In addition, our clinical programs for ACTIMMUNE® continue to gain momentum. We are actively enrolling patients in our Phase III trials in idiopathic pulmonary fibrosis (IPF) and multidrug-resistant tuberculosis (MDR-TB), and in our Phase II study for systemic fungal infections. Investors can look forward to our starting a Phase III trial in ovarian cancer and additional Phase II trials as well,'' stated Dr. Harkonen.
Amortization expense of $1,777,000 was incurred for the nine-month period ended September 30, 2000, relating to product revenue rights to ACTIMMUNE® acquired from Connetics Corporation. Research and development expenses were $11,993,000 for the nine months ended September 30, 2000, compared to $1,754,000 in the same period in 1999. The increase was due primarily to increased costs for clinical trial expenses for ACTIMMUNE® in new disease indications and expenses associated with manufacturing transfer costs for ACTIMMUNE® at an additional facility. Selling, general and administrative expenses were $7,689,000 and $1,499,000 for the nine months ended September 30, 2000, and 1999, respectively. This increase is attributable primarily to increased staffing and related expenses necessary to support the expansion of the Company's operations. At September 30, 2000, cash, cash equivalents and short-term investments totaled $197.4 million.
Highlights From the Third Quarter of 2000
-- Initiation of enrollment in phase III trial in multidrug-resistant
tuberculosis.
-- Acquisition of rights to ACTIMMUNE® in Japan from Genentech, Inc. for
infectious diseases, chronic granulomatous disease and osteopetrosis.
-- Completion of private placement of common stock with net proceeds to
the Company of $71.4 million.
-- Announcement of plans to initiate Phase III trial for ACTIMMUNE® in
ovarian cancer.
-- Release of "New Approaches to Managing Idiopathic Pulmonary Fibrosis,"
an educational monograph published by the American Thoracic Society
(ATS).
-- Initiation of enrollment in phase III trial in IPF (October).
The Company will hold a conference call with research analysts at 11:00 a.m. Eastern Time on Tuesday, October 24, 2000. Interested investors and others may listen to the call either live or on a replay basis through our internet webcast, which may be accessed by visiting our website at intermune.com and clicking on the ``Investor Relations'' icon.
InterMune Pharmaceuticals, Inc. is a biotechnology company dedicated to the development and commercialization of innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune currently markets ACTIMMUNE® (Interferon gamma-1b) Injection in the United States for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. For more information about InterMune and ACTIMMUNE®, please visit InterMune's web sites at www.intermune.com and www.actimmune.com, or send e-mail to ir@intermune.com.
Except for the historical information contained herein, this press release contains certain forward-looking statements, concerning the commencement of a Phase III trial in ovarian cancer and additional Phase II trials. These and all other 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 the following: even if InterMune's potential ovarian cancer and other products appear promising at an early stage of development, they may not reach a clinical trial for a number of reasons. Such reasons include, but are not limited to, the possibilities that the potential products will be found to be ineffective during preparation for the clinical trials, difficult to manufacture on a large scale, uneconomical to market, precluded from commercialization by the proprietary rights of third parties, less safe or effective and/or cost more than competitors' products that have been or may be approved by the U.S. FDA. Other 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 Registration Statement on Form S-1, declared effective on September 20, 2000 by the Securities and Exchange Commission (File No. 333-45460), and InterMune's most recent 10-Q filed with the SEC. In sum, these significant risks include, but are not limited to: the uncertainty of success of InterMune's efforts in research, development, commercialization, product acceptance, third-party manufacturing and capital raising; product liability lawsuits; uncertainties associated with: obtaining and enforcing patents important to its business, being an early-stage company and relying on third-party payors' reimbursement policies; the uncertain, lengthy and expensive regulatory process; and competition from other products.
InterMune Pharmaceuticals, Inc.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2000 1999 2000 1999
Product sales, net $3,831 $--(A) $6,964(A) $--(A)
Costs and expenses:
Cost of goods sold 1,457 -- 3,397 --
Amortization of product
revenue rights 557 -- 1,777 --
Research and development 4,696 697 11,993 1,754
Selling, general and
administrative 2,992 603 7,689 1,499
Deferred compensation 2,056 -- 5,127 --
Acquired pre-FDA
approval rights -- -- -- 1,094
Total costs and expenses 11,758 1,300 29,983 4,347
Loss from operations (7,927) (1,300) (23,019) (4,347)
Interest income, net 2,510 (6) 5,071 70
Net loss (5,417) (1,306) (17,948) (4,277)
Preferred stock accretion -- (247) (269) (411)
Redeemable preferred stock
dividend -- -- (27,762) --
Net loss attributable to
common stockholders $(5,417) $(1,553) $(45,979) $(4,688)
Historical basic and
diluted net loss per share $(0.25) $(1.33) $(3.03) $(7.52)
Shares used in calculating
historical basic and
diluted net loss per
common share 21,757 1,165 15,169 623
Pro forma basic and
diluted net loss per share $(0.25) $(0.16) $(2.41) $(0.58)
Shares used in calculating
pro forma basic and diluted
net loss per common share 21,757 8,067 18,944 7,347(B)
(A) Sales of ACTIMMUNE® up to a contractual threshold of (in thousands)
$1,537, $1,827 and $3,763 were reported by Connetics Corporation for
the respective periods.
(B) Does not include shares prior to April 27, 1999 because InterMune was
a wholly owned subsidiary of Connetics Corporation.
InterMune Pharmaceuticals, Inc.
CONDENSED BALANCE SHEETS
(unaudited, in thousands)
September 30, December 31,
2000 1999
Cash, cash equivalents and
short-term investments $197,351 $4,214
Other assets 7,150 1,641
Total assets $204,501 $5,855
Current liabilities $4,361 $4,355
Long-term obligations -- 1,624
Redeemable convertible preferred stock -- 7,416
Stockholders' equity (deficit) 200,140 (7,540)
Total liabilities and
stockholders' equity $204,501 $5,855
SOURCE: InterMune Pharmaceuticals, Inc. |
