>>BRISBANE, Calif., Oct. 24 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced results from operations for the third quarter and nine months ended September 30, 2002.
For the third quarter of 2002, InterMune recorded total net product sales of $30.2 million, compared to $11.3 million for the third quarter in 2001, an increase of 167%. Actimmune® (interferon gamma-1b) sales for the third quarter of 2002 were $28.5 million, compared to $10.3 million in the same period in 2001.
"Actimmune continues to be the primary driver of our revenue growth, and we anticipate total 2002 sales for this product to reach $95 to $100 million," said Scott Harkonen, President and CEO of InterMune. "Infergen® and Amphotec® sales also continue to grow, keeping us on track to achieve $105 to $110 million in total revenues in 2002. We also continued to make substantial progress with our key clinical development and pre-clinical research programs."
The net loss for the third quarter of 2002 was $43.5 million, or $1.39 per share. This compares to a net loss in the third quarter of 2001 of $15.5 million, or $0.56 per share. The net loss for the third quarter of 2002 included a one-time payment to Eli Lilly and Company of $15.0 million, or $0.48 per share, related to its election to exercise an option to buy-down the royalty on oritavancin. Excluding the one-time payment to Eli Lilly, the pro forma net loss was $28.5 million, or $0.91 per share.
Research and development (R&D) expenses for the third quarter ended September 30, 2002, were $36.7 million, compared to $13.3 million for the same quarter in 2001. The higher spending in the third quarter of 2002 is largely attributable to expenses associated with Phase II and Phase III clinical programs for Actimmune and Phase III clinical and manufacturing technology transfer programs for oritavancin.
Selling, general and administrative (SG&A) expenses for the quarter ended September 30, 2002 were $14.1 million, compared to $9.4 million for the same period of 2001. The additional spending is primarily due to the expansion of the Company's commercial organization in the fourth quarter of 2001 for the re-launch of Infergen® (interferon alfacon-1).
Net interest expense for the third quarter of 2002 was $0.5 million, compared to net interest income of $1.5 million for same quarter in 2001. Lower interest income in the third quarter of 2002 was due to substantially lower market interest rates earned on the Company's portfolio in the quarter.
InterMune also reported results of operations for the nine months ended September 30, 2002. The Company recorded net product sales of $72.6 million for the nine months ended September 30, 2002, an increase of 192% over the same period in 2001. Actimmune sales for the first nine months of 2002 were $68.8 million, compared to $22.5 million for the first nine months of 2001.
The net loss for the nine months ended September 30, 2002 was $118.7 million, or $3.92 per share. This compares to a net loss for the same period last year of $44.2 million, or $1.80 per share. Excluding the one-time payments in 2002 to Eli Lilly related to oritavancin, and the payment to Marnac for the acquisition of pirfenidone in the first quarter, the pro forma net loss for the nine months ended September 30, 2002 was $85.0 million, or $2.80 per share. This compares to a pro forma net loss for the same period in 2001 of $38.8 million, or $1.58 per share, which excludes a one-time payment to Amgen Inc. for the acquisition of rights to develop a pegylated form of Infergen.
R&D expenses for the nine months ended September 30, 2002 were $89.4 million compared to $29.6 million for the same period ended September 30, 2001. The increased spending in 2002 is largely attributable to expenses associated with Phase II and Phase III clinical programs for Actimmune and clinical and manufacturing technology transfer programs for oritavancin.
SG&A expenses were $46.1 million and $22.9 million for the nine-month periods ended September 30, 2002 and 2001, respectively. The increase in spending is primarily due to the expansion of the Company's commercial organization in the fourth quarter of 2001 and the move to new corporate headquarters in July 2001.
Net interest expense for the nine months ended September 30, 2002 was $1.7 million, compared to net interest income of $6.3 million for the same period last year. The increase in net interest expense for 2002 is a result of substantially lower market interest rates earned on the Company's portfolio and higher interest expense due to the issuance of $149.5 million of 5.75% convertible subordinated notes in July 2001.
At September 30, 2002, the Company's cash, cash equivalents and available-for-sale securities totaled $343.2 million.
Third Quarter Product and Pipeline Highlights
Actimmune for IPF
-- The results of the Company's randomized controlled Phase III clinical
trial of Actimmune for the treatment of idiopathic pulmonary fibrosis
(IPF), a fatal lung disorder for which there are no proven effective
treatment options, were presented at the European Respiratory Society
(ERS) Annual Congress 2002 in Stockholm, Sweden.
-- Data from this trial will also be presented at the CHEST meeting on
Tues., Nov. 5, 2002, in San Diego.
-- The Company plans to meet with the U.S. Food and Drug Administration to
discuss the results of the Phase III trial and potential next steps in
the first half of December of this year.
-- In parallel, the Company is planning to follow the patients from this
trial for up to two more years in an open-label extension study, and to
begin another Phase III trial next year.
Actimmune for Liver Fibrosis
-- The Company has completed randomization of its large 500-patient
randomized controlled Phase II trial with Actimmune for the potential
treatment of liver fibrosis, a debilitating disease that affects
millions of patients in the United States alone. Data from this trial
should be available in mid-2004.
Oritavancin for Gram-Positive Hospital Infections
-- The Company has completed enrollment of its second global Phase III
randomized controlled clinical trial with oritavancin for the treatment
of complicated skin and skin structure infections. Data from this
trial should be available in the first half of 2003.
Infergen and PEG-Infergen for Hepatitis C
-- Final data from the Phase IV study comparing the use of Infergen plus
ribavirin to interferon alfa-2b plus ribavirin (Rebetron(R)) will be
presented at the 53rd Annual Meeting of the American Association for
the Study of Liver Diseases (AASLD) on Mon., Nov. 4, 2002, in Boston.
-- InterMune also entered into an agreement with Inhale Therapeutics, Inc.
to develop PEG-Infergen for hepatitis C infections, and plans to begin
clinical trials with this exciting compound in the first half of next
year.
Pirfenidone for IPF
-- Phase II data presented at ERS indicated that pirfenidone, the
Company's orally active agent targeting fibrotic diseases, may also be
a promising new treatment for patients suffering with a variety of
fibrotic diseases including IPF. InterMune is planning additional
Phase II studies with pirfenidone.
Applied Research
-- The Company recently reported on the progress made in its collaboration
with Maxygen to develop a once-weekly formulation of Actimmune.
-- InterMune also announced a drug discovery collaboration with Array
BioPharma focused on creating small molecule therapeutics that target
hepatitis.
Organization
-- In September, the Company appointed Sharon Surrey-Barbari Senior Vice
President and Chief Financial Officer. Ms. Surrey-Barbari joins
InterMune from Gilead Sciences, Inc., where she was Vice President and
Chief Financial Officer.
-- In August, the Company appointed Randall E. Kaye, M.D., Vice President
of Medical Affairs. Dr. Kaye joined InterMune from Pfizer, where he
spent nearly a decade in a variety of medical affairs and marketing
positions.
Conference Call on October 24, 2002
InterMune will host a conference call today at 4:30 p.m. (EDT) to discuss the third quarter financial results. The conference call may be accessed by dialing (888) 799-0528 (U.S.) or (706) 634-0154 (international). A replay of the teleconference will be available approximately three hours after the call through 11:59 p.m. EDT, October 26, 2002. To access the replay, please call 1-800-642-1687 (U.S.) or (706) 645-9291 (international), and enter the conference ID# 5816820.
About InterMune
InterMune is a commercially driven biopharmaceutical company focused on the marketing, development and applied research of life-saving therapies for pulmonary disease, infectious disease and cancer. 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 that involve risks and uncertainties, including without limitation the statements indicating that the Company forecasts $95-$100 million in Actimmune sales in 2002 and expects to achieve $105-$110 million in total revenues in 2002. 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 10-K report filed with the SEC on March 21, 2002, and other periodic reports (i.e., 10-Q and 8-K) filed with the SEC. The risks and other factors that follow, concerning the forward-looking statements in this press release, should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 10-K report and InterMune's other periodic reports filed with the SEC. The forward-looking statement concerning InterMune's $95-$100 million Actimmune sales forecast for 2002 is subject to the uncertainties and risks of a continuing increase in sales of Actimmune for IPF, an indication for which Actimmune has not been approved by the FDA; reimbursement risks associated with third-party payers; and regulation by the FDA with respect to InterMune's communications with physicians concerning Actimmune for the treatment of IPF. The forward-looking statement that InterMune expects to achieve $105-$110 million in total revenues in 2002 is subject to the uncertainties and risks in the preceding sentence and the uncertainties and risks associated with an increase in Infergen and Amphotec/Amphocil sales; significant competition; and InterMune's ability to maintain and enforce patents and other intellectual property; and significant regulatory, supply, intellectual property and competitive barriers to entry in connection with the chronic hepatitis C market.
InterMune, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
Sept. 30, Sept. 30,
2002 2001 2002 2001
Product sales
Actimmune, net $28,531 $10,306 $68,841 $22,513
Other, net 1,706 1,010 3,806 2,373
Total net
sales 30,237 11,316 72,647 24,886
Costs and expenses:
Cost of goods sold 6,095 3,915 16,240 10,514
Amortization of
product rights 1,024 815 2,654 3,990
Research and
development 36,694 13,316 89,358 29,646
Acquired in-process
research and
development 15,000 -- 33,750 5,400
Selling, general and
administrative 14,140 9,438 46,050 22,850
Amortization of
deferred stock
compensation 280 823 1,630 3,068
Total costs
and expenses 73,233 28,307 189,682 75,468
Loss from
operations (42,996) (16,991) (117,035) (50,582)
Interest income 1,942 3,853 5,689 8,691
Interest expense (2,426) (2,316) (7,359) (2,346)
Net loss $(43,480) $(15,454) $(118,705) $(44,237)
Basic and diluted
net loss per share $(1.39) $(0.56) $(3.92) $(1.80)
Shares used in
calculating
basic and diluted
net loss per share 31,261 27,390 30,302 24,532
Comparative amounts excluding acquired in-process research and development
Three Months Ended Nine Months Ended
Sept. 30, Sept. 30,
2002 2001 2002 2001
Net loss $(43,480) $(15,454) $(118,705) $(44,237)
less: Acquired
in-process
research and
development (15,000) -- (33,750) (5,400)
Pro forma net
loss excluding
acquired
in-process
research and
development $(28,480) $(15,454) $(84,955) $(38,837)
Pro forma net
loss per share $(0.91) $(0.56) $(2.80) $(1.58)
Shares used in
calculating
pro forma basic
and diluted
net loss per share 31,261 27,390 30,302 24,532
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
Sept. 30, Dec. 31,
2002 2001
Cash, cash equivalents and
available-for-sale securities $343,178 $332,067
Other assets 63,322 55,179
Total assets $406,500 $387,246
Total liabilities $49,303 $22,687
Convertible subordinated notes 149,500 149,500
Stockholders' equity 207,697 215,059
Total liabilities and
stockholders' equity $406,500 $387,246<<
Cheers, Tuck |
