Thursday July 26, 7:03 am Eastern Time
Press Release
SOURCE: InterMune, Inc.
InterMune Announces Second Quarter 2001 Financial Results and Conference Call
Revenue Growth Driven By 140% Increase in Actimmune(R) Sales
BRISBANE, Calif., July 26 /PRNewswire/ -- InterMune, Inc. (Nasdaq: ITMN - news) today announced financial results for the second quarter ended June 30, 2001. Sales of lead product Actimmune® for the second quarter of 2001 were $7.3 million, compared to $3.0 million in the second quarter of 2000, an increase of 140%. Total InterMune product sales recorded in the second quarter of 2001 were $8.0 million, compared to $3.0 million for the same period in 2000.
InterMune reported a pro forma net loss of $12.8 million, or $0.55 per share, compared to a net loss of $6.9 million, or $0.33 per share for the same period in 2000. The pro forma net loss figure for the second quarter excludes a one-time non-cash charge of $5.4 million for acquired in-process research and development costs relating to the acquisition of product development rights to an early stage pegylated interferon product candidate from Amgen Inc. Including this one-time charge, the net loss for the quarter ended June 30, 2001 was $18.2 million, or $0.79 per share.
``We are very pleased with the continued growth in sales of our lead product, Actimmune,'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``Heightened physician interest in Actimmune® has been a major driver of sales growth. Looking forward, revenue growth should be fueled by new indications for Actimmune®, our international strategic partnership with Boehringer Ingelheim, and the re-launch of Infergen®, which we recently licensed from Amgen. Regarding product development, we have now enrolled over 300 patients in the United States and Europe in our Phase III clinical trial for Actimmune® in the treatment of idiopathic pulmonary fibrosis. We plan to complete enrollment in August and should have results by November 2002.''
``We are also pleased to have priced a major financing this quarter, bringing in $287 million in gross proceeds to the Company. This financing will allow us to aggressively in-license new products and initiate new programs with significant revenue opportunities. With three marketed products, an expanded field force, multiple late-stage clinical programs and over $400 million in cash, InterMune is now operating on all cylinders,'' said Dr. Harkonen.
Total amortization of product rights was $1.1 million in the three-month period ended June 30, 2001. Research and development expenses were $10.1 million for the three months ended June 30, 2001, compared to $3.3 million in the same period in 2000. The increase was due primarily to increased costs of clinical trial expenses for Actimmune® in new disease indications. Research and development expenses for the second quarter of 2001 also included an up-front license fee of $1.5 million paid to MoliChem Medicines, Inc.
Selling, general and administrative expenses were $7.7 million and $3.4 million for the three-month periods ending June 30, 2001 and 2000, respectively. This increase was attributable primarily to increased corporate staffing, the addition of 48 field specialists and related expenses necessary to support the expansion of the Company's operations. For the three-month period ended June 30, 2001, the Company recorded a one-time non-cash charge of $5.4 million for in-process research and development costs relating to the acquisition of product development rights to an early stage pegylated interferon product candidate from Amgen Inc. At June 30, 2001, cash, cash equivalents and available-for-sale securities totaled $144.5 million.
Highlights From the Second Quarter of 2001:
-- Licensed Infergen(R) (Interferon alfacon-1), an FDA-approved product
for the treatment of chronic hepatitis C infections, from Amgen Inc.
The license also included an early stage pegylated interferon product
candidate. There are currently four ongoing Phase IV studies of
Infergen(R) involving more than 1,000 patients.
-- Licensed Moli 1901 (duramycin), a pulmonary molecule currently in a
Phase I clinical trial for the treatment of cystic fibrosis, from
MoliChem Medicines, Inc.
-- Announced plans to develop Actimmune(R) in combination with Rituxan(R)
as second-line therapy for the treatment of non-Hodgkin's lymphoma.
-- Announced plans to develop Actimmune(R) for the treatment of liver
fibrosis (cirrhosis) associated with hepatitis C infections.
-- Completed the training of 22 field specialists in order keep pace with
the growing number of physician inquiries regarding the safe and
appropriate use of Actimmune(R). InterMune now has 60 specialists in
the field.
-- Received top honors from the National Organization for Rare Disorders
(NORD) for the development of Actimmune(R) for the treatment of
osteopetrosis.
-- Priced public offerings of common stock and convertible notes, with
gross proceeds to the Company of $287 million. Net proceeds of
approximately $273 million were received upon the closing of the
transactions on July 5, 2001.
The Company will hold a conference call at 10:30 a.m. Eastern Time on Thursday, July 26, 2001. Interested investors and others may participate in the conference call by dialing 888-209-3911 (domestic) or 415-904-2408 (international) and referencing call number 19360213. A telephone replay of the conference call will be available through Monday, July 30, 2001. To access the replay, please dial 800-633-8284 (domestic) or 858-812-6440 (international) and reference call number 19360213.
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 developing and commercializing innovative products for the treatment of serious pulmonary and infectious diseases and cancer. InterMune markets its lead product, Actimmune®, for the treatment of chronic granulomatous disease (CGD) and severe, malignant osteopetrosis. InterMune is currently conducting a Phase III clinical trial with Actimmune® for the treatment of idiopathic pulmonary fibrosis (IPF). InterMune is also conducting or planning clinical trials of Actimmune® for the treatment of multidrug-resistant tuberculosis (MDR TB), atypical mycobacterial infections, ovarian cancer, cryptococcal meningitis, cystic fibrosis, liver fibrosis and non-Hodgkin's lymphoma. InterMune recently acquired rights to Infergen®, which is marketed in the United States and Canada for the treatment of chronic hepatitis C infections. InterMune also markets Amphotec® worldwide for the treatment of invasive aspergillosis.
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-Q and 8-K) 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; the uncertain, lengthy and expensive regulatory process; 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 STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30, June 30,
2001 2000 2001 2000
Product sales
Actimmune, net $7,278 $3,027 $12,207 $3,133 (a)
Other, net 750 -- 1,363 --
Total net sales 8,028 3,027 13,570 3,133
Costs and expenses:
Cost of goods sold 3,084 1,885 6,599 1,940
Amortization of product
rights 1,057 1,220 3,175 1,220
Research and development 10,050 3,260 16,330 7,297
Selling, general and
administrative 7,702 3,403 13,412 4,698
Deferred compensation 1,007 2,312 2,245 3,070
Acquired in-process research
and development 5,400 -- 5,400 --
Total costs and expenses 28,300 12,080 47,161 18,225
Loss from operations (20,272) (9,053) (33,591) (15,092)
Interest income, net 2,058 2,154 4,808 2,561
Net loss (18,214) (6,899) (28,783) (12,531)
Preferred stock accretion -- -- -- (269)
Redeemable preferred stock
dividend -- - -- (27,762)
Net loss attributable to
common stockholders $(18,214) $(6,899) $(28,783) $(40,562)
Historical basic and diluted
net loss per share $(0.79) $(0.33) $(1.25) $(3.42)
Shares used in calculating
historical basic and diluted
net loss per common share 23,173 20,736 23,102 11,875
Pro forma basic and diluted
net loss per share giving
effect to conversion of
preferred stock into common
stock on the Company's IPO $(0.79) $(0.33) $(1.25) $(2.30)
Shares used in calculating pro
forma basic and diluted net
loss per common share 23,173 20,736 23,102 17,537
Pro forma net loss attributable
to common stockholders
excluding acquired
in-process research $(12,814) $(23,383)
Pro forma basic and diluted
net loss per share excluding
acquired in-process research $(0.55) $(1.01)
Shares used in calculating pro
forma net loss per share 23,173 23,102
(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 BALANCE SHEETS
(unaudited, in thousands)
June 30, December 31,
2001 2000
Cash, cash equivalents and
available-for-sale securities $144,479 $194,520
Other assets 45,517 7,129
Total assets $189,996 $201,649
Total liabilities $20,019 $5,848
Stockholders' equity 169,977 195,801
Total liabilities and
stockholders' equity $189,996 $201,649
SOURCE: InterMune, Inc. |
