InterMune Announces Fourth Quarter 2000 Financial Results and Conference Call
- Sales of ACTIMMUNE(R) Increase by 161% -
BURLINGAME, Calif., Feb. 15 /PRNewswire/ -- InterMune (Nasdaq: ITMN - news) today announced financial results for the fourth quarter ended December 31, 2000. InterMune reported a net loss of $6.3 million, or $0.27 per share on a pro forma basis, compared to a net loss of $2.1 million, or $0.23 per share on a pro forma basis for the same period in 1999. For the year ended December 31, 2000, InterMune reported a net loss of $52.0 million, or $2.61 per share on a pro forma basis, compared to a net loss of $6.3 million, or $0.82 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 year ended December 31, 2000 would have been $1.22 per share. Pro forma net loss per share amounts assume conversion of preferred stock to common stock at the time of the preferred stock's original issue. Pro forma net loss per share for fiscal year 1999 also reflects the common and preferred stock issued on April 27, 1999 in connection with the reorganization as though they had been outstanding for the entire year.
Sales of ACTIMMUNE® for the fourth quarter were $4.2 million compared to $1.6 million in the fourth quarter of 1999, an increase of 161%. Sales of ACTIMMUNE® for the year ended December 31, 2000 were $13.0 million compared to $5.4 million for the same period in 1999, an increase of 142%. 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.
``We are very pleased with the continued growth in sales of ACTIMMUNE® for the quarter, especially since this growth occurred in parallel with the enrollment of our Phase III trial for ACTIMMUNE® in idiopathic pulmonary fibrosis (IPF),'' said W. Scott Harkonen, M.D., President and CEO of InterMune. ``We are also excited to have hired and placed 26 immunology specialists into the field in January. As we add additional immunology specialists in June, for a total of 60 field specialists, and complete enrollment of our Phase III trial for IPF in mid-2001, we expect to see strong continued growth for ACTIMMUNE®. We exceeded our 2000 revenue goal by over $1 million and we reiterate our 2001 revenue goal for ACTIMMUNE® of $24 million, or 100% growth over our 2000 revenue goal of $12 million. In addition, we will have three ongoing Phase III trials and multiple Phase II trials for ACTIMMUNE® this year, which will produce a steady stream of clinical results over the next 12 to 36 months,'' stated Dr. Harkonen.
Amortization expense of $1.8 million was incurred for the year ended December 31, 2000, relating to product revenue rights for ACTIMMUNE® acquired from Connetics Corporation. Research and development expenses were $18.1 million for the year ended December 31, 2000, compared to $2.9 million 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 $12.1 million and $2.4 million for the year ended December 31, 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 December 31, 2000, the Company's cash, cash equivalents and short-term investments totaled $194.5 million.
Highlights from the Fourth Quarter of 2000
-- Initiated enrollment in Phase III clinical trial evaluating the safety
and efficacy of ACTIMMUNE® for the treatment of IPF.
-- Commenced arrangement with Protein Design Labs, Inc. (Nasdaq: PDLI - news) to
humanize an InterMune monoclonal antibody targeted to the bacteria
Pseudomonas aeruginosa.
-- Filed a New Drug Submission (NDS) with the Therapeutic Products
Programme of Health Canada to market ACTIMMUNE® in Canada for chronic
granulomatous disease (CGD) and severe, malignant osteopetrosis.
-- Initiated enrollment in Phase II clinical trial evaluating the safety
and efficacy of inhaled ACTIMMUNE® for the treatment of pulmonary
atypical mycobacterial infections.
-- Completed acquisition of Amphotec®, an FDA-approved lipid-complexed
form of amphotericin B, from ALZA Corporation (NYSE: AZA - news). (Jan. 2001)
-- Appointed James E. Pennington, M.D. to the position of Executive Vice
President of Medical and Scientific Affairs. (Jan. 2001)
-- Trained and placed into the field 26 immunology specialists to support
physicians regarding the safe and appropriate use of ACTIMMUNE® and
Amphotec®. (Jan. 2001)
InterMune's 2001 Financial Outlook
-- Net revenue goal for ACTIMMUNE® of $24 million in 2001. Quarterly
goals for ACTIMMUNE® of $4.6 million in the first quarter,
$5.2 million in the second quarter, $6.4 million in the third quarter,
and $7.8 million in the fourth quarter of 2001.
-- In addition to its quarterly revenue goals, the Company also plans to
complete enrollment in its 260-patient trial in IPF by mid-2001.
-- Net revenue for Amphotec® is expected to be approximately
$2-4 million in 2001. The Company plans to re-launch Amphotec® in
the second quarter and is exploring the potential for additional
studies, including studies in combination with ACTIMMUNE®.
-- Research and development expenses are expected to be approximately
$32 million in 2001. The figure reflects the expansion of InterMune's
development programs for ACTIMMUNE®, such as programs for ovarian
cancer and cystic fibrosis, and the advancement of our monoclonal
antibody program targeting Pseudomonas aeruginosa.
-- Selling, general and administrative expenses are expected to be
approximately $24 million in 2001. The figure reflects the
acceleration of the Company's sales and marketing plans and the lease
of a 55,000 square foot headquarters and pre-clinical development
facility.
-- Net loss for 2001 is expected to be approximately $36 million.
The Company will hold a conference call with research analysts at 11:00 a.m. Eastern Time on Friday, February 16, 2001. 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. |
