ICOS Reports Results for First Quarter of 2002
BOTHELL, Wash.--(BUSINESS WIRE)--April 23, 2002--ICOS Corporation (Nasdaq:ICOS - news; the ``Company'') today summarized recent events and released its financial results for the three months ended March 31, 2002.
During the first quarter of 2002, clinical data was presented on Cialis(TM), a potential treatment for erectile dysfunction (ED), at two medical meetings--the European Association of Urology meeting, in Birmingham, U.K., in February, and the American College of Cardiology meeting, in Atlanta, Georgia, in March. Additional clinical data will be available at the American Urology Association meeting, in Orlando, Florida, in May. Cialis(TM) is being developed by Lilly ICOS LLC, a collaboration with Eli Lilly and Company.
The U.S. Food and Drug Administration (``FDA'') is currently in the process of reviewing Eli Lilly and Company's bulk manufacturing and dry products facilities where Cialis(TM) is manufactured. In addition to the manufacturing inspections that are ongoing, Lilly ICOS LLC must complete all regulatory steps required for product approval, including conducting label discussions with the FDA.
The U.S. New Drug Application (``NDA'') and European Market Authorization Application, seeking market approval of Cialis(TM) for the treatment of ED, were submitted on June 28, 2001. The Company continues to plan for a commercial launch of Cialis in the second half of 2002.
In the Phase 3 clinical trial with Pafase® for the treatment of severe sepsis, the first interim analysis has been completed ahead of schedule due to faster than expected patient enrollment. As expected, the independent data monitoring committee has recommended that the trial proceed. The trial is designed to enroll up to 2,500 patients. The second interim analysis is expected to occur in the first half of 2003. Interim data will not be made available to the Company or the public unless the trial is terminated early. Pafase® is being developed by Suncos Corporation, a 50/50-owned corporation formed with Suntory Limited.
The Phase 2b/3 clinical trial with sitaxsentan, for the potential treatment of pulmonary arterial hypertension, is expected to complete patient enrollment during the second quarter of 2002. Sitaxsentan is being developed by ICOS-Texas Biotechnology L.P., a limited partnership formed with Texas Biotechnology.
During the first quarter of 2002, progress also was made in early-stage programs, including the completion of Phase 1 trials with IC747. ICOS and Biogen, Inc. together plan to initiate patient enrollment in a Phase 2 trial with IC747, for the potential treatment of psoriasis, in the third quarter of 2002. Other clinical trials that are scheduled to begin this year include Phase 2 trials with IC14, in community-acquired pneumonia and sepsis, and RTX(TM) in interstitial cystitis.
For the first quarter of 2002, ICOS reported a net loss of $39.2 million ($0.65 per share), compared to a net loss of $15.2 million ($0.29 per share) for the first quarter of 2001.
Total revenue was $22.5 million in the first quarter of 2002, compared to $18.9 million in the first quarter of 2001.
First quarter 2002 collaboration revenue from affiliates (``cost reimbursement revenue'') was $19.4 million, compared to $11.7 million in the first quarter of 2001. The increase in cost reimbursement revenue primarily relates to the Pafase® Phase 3 clinical trial for severe sepsis. That increase was partially offset by a decrease in cost reimbursement revenue related to Cialis(TM), as certain clinical activities were completed prior to the submission of the NDA to the FDA in June 2001. Revenue from ICOS Clinical Partners, L.P. also declined, as funding under the related services agreement ended in the first quarter of 2001.
Revenue from licenses of technology was $1.4 million in the first quarter of 2002, compared to $6.6 million in the first quarter of 2001. The decrease was primarily due to the completion of Cialis(TM) development activities required to file the NDA in June 2001.
During the first quarter of 2002, the Company recognized $1.8 million in revenue related to the development and manufacture of third party clinical materials, compared to $0.6 million in the prior year. The Company began offering contract manufacturing services in the fourth quarter of 2000.
Total operating expenses were $40.4 million in the first quarter of 2002, compared to $24.5 million in the first quarter of 2001.
Research and development expenses increased $12.4 million, to $35.4 million in the first quarter of 2002, mainly due to the progression of development activities for Pafase® and sitaxsentan. These increases were partially offset by lower Cialis(TM) clinical program costs, compared to the first quarter of 2001.
Selling, general and administrative costs increased $3.5 million, to $5.0 million in the first quarter of 2002, reflecting growth of the Company's corporate sales and marketing functions to support the anticipated commercial launch of Cialis(TM).
During the first quarter of 2002, the Company recognized $24.7 million in losses related to its equity interests in affiliates, an increase of $11.7 million compared to the first quarter of 2001. The increase reflects higher operating losses from Lilly ICOS LLC and Suncos Corporation, due to marketing costs associated with the anticipated commercial launch of Cialis(TM) and the progression of development activities for Pafase®, respectively.
At March 31, 2002, the Company had cash, cash equivalents, investment securities available-for-sale and interest receivable of $433.7 million.
The Company's results of operations may vary significantly from period to period. Operating results will depend on, among other factors, the timing of expenses, continued funding from our collaborative partners, and the timing and progress of our research, development, marketing and sales activities. The Company may experience significant fluctuations in cost reimbursement revenue and revenue from licenses of technology. Revenue from licenses of technology will vary as a result of the timing of milestone payments and changes in estimated total development costs, which depend on the success of clinical trial and development efforts. In addition, significant changes in joint venture collaboration activities, including those associated with the anticipated commercial launch of Cialis(TM), could cause the amount of affiliate losses to fluctuate from period to period.
ICOS is a product-driven company that has expertise in both protein-based and small molecule therapeutics. The Company combines its capabilities in molecular, cellular and structural biology, high throughput drug screening, medicinal chemistry and gene expression profiling to develop highly innovative products with significant commercial potential. The Company applies its integrated approach to erectile dysfunction and other urologic disorders, sepsis, pulmonary arterial hypertension and other cardiovascular diseases, and inflammatory diseases. ICOS' strategy targets multiple therapeutic areas with drugs that act through distinct molecular mechanisms, increasing the Company's opportunities to market breakthrough products.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements involve risks and uncertainties that may cause the Company's results and the timing and outcome of events to differ materially from those expressed in or implied by the forward-looking statements, including risks associated with clinical development, regulatory approvals, product commercialization, intellectual property claims and litigation and other risks detailed in the Company's latest Annual Report on Form 10-K and its other public filings with the Securities and Exchange Commission.
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ICOS Corporation and Subsidiaries
SELECTED CONSOLIDATED FINANCIAL DATA
(in thousands, except per share data)
(unaudited)
Three months ended
March 31,
2002 2001
Condensed Consolidated Statement of Operations:
Revenue:
Collaboration revenue from affiliates $ 19,356 $ 11,726
Licenses of technology 1,380 6,614
Other 1,800 560
-------- -------
Total revenue 22,536 18,900
-------- -------
Operating expenses:
Research and development 35,398 23,025
Selling, general and administrative 4,967 1,487
-------- -------
Total operating expenses 40,365 24,512
-------- -------
Operating loss (17,829) (5,612)
Other income (expense):
Equity in losses of affiliates (24,724) (12,993)
Interest and other income 3,333 3,452
-------- -------
Net loss $ (39,220) $ (15,153)
======== =======
Net loss per common share -
basic and diluted $ (0.65) $ (0.29)
======== =======
Weighted average common shares outstanding -
basic and diluted 60,017 52,531
======== =======
Condensed Consolidated Balance Sheet: March 31, December 31,
2002 2001
Cash, cash equivalents, investment
securities and interest receivable $ 433,670 $ 470,707
Receivables from affiliates 24,156 11,405
Property and equipment, net 20,356 19,754
Other 6,100 5,721
--------- ---------
Total assets $ 484,282 $ 507,587
========= =========
Due to affiliates $ 26,970 $ 18,132
Other current liabilities 25,247 21,079
Deferred revenue 13,920 14,626
Stockholders' equity 418,145 453,750
--------- ---------
Total liabilities and
stockholders' equity $ 484,282 $ 507,587
========= =========
ICOS Corporation and Subsidiaries
SUPPLEMENTARY FINANCIAL DATA
(in thousands)
(unaudited)
The following table summarizes our revenue from collaborations and
licenses of technology, and equity in losses of affiliates.
2002 2001
------ --------------------------------------
Q1 Q1 Q2 Q3 Q4 TOTAL
Collaboration revenue from affiliates:
Lilly ICOS LLC $ 1,361 $ 3,694 $ 2,426 $ 2,444 $ 1,401 $ 9,965
Suncos
Corporation 13,889 4,231 6,737 8,397 11,008 30,373
ICOS-Texas
Biotechnology
L.P. 4,106 2,061 3,236 3,043 4,336 12,676
ICOS Clinical
Partners, L.P. -- 1,740 -- -- -- 1,740
------- ------- ------- ------- ------- -------
$19,356 $11,726 $12,399 $13,884 $16,745 $54,754
======== ======== ======= ======= ======= =======
Licenses of technology:
Lilly ICOS LLC $ 623 $ 6,410 $20,021 $ 2,011 $ 974 $29,416
ICOS-Clinical
Partners, L.P. 427 204 280 183 314 981
Biogen, Inc. 330 -- -- 100 349 449
------- ------- ------- ------- ------- -------
$ 1,380 $ 6,614 $20,301 $ 2,294 $ 1,637 $30,846
======== ======== ======= ======= ======= =======
Equity in losses of affiliates:
Lilly ICOS LLC $(14,230) $(9,181) $(7,229) $(9,894)$(11,915)$(38,219)
Suncos
Corporation (7,984) (2,134) (3,372) (4,198) (5,496) (15,200)
ICOS-Texas
Biotechnology
L.P. (2,510) (1,656) (2,854) (4,345) (2,606) (11,461)
ICOS Clinical
Partners, L.P. -- (22) -- -- -- (22)
------- ------- ------- ------- ------- -------
$(24,724)$(12,993)$(13,455)$(18,437)$(20,017)$(64,902)
======== ======== ======= ======= ======= =======
ICOS Corporation and Subsidiaries
SUMMARIZED OPERATING RESULTS OF AFFILIATES
(in thousands)
(unaudited)
2002 2001
------ ----------------------------------------
Q1 Q1 Q2 Q3 Q4 TOTAL
Lilly ICOS LLC:
Research and
development
expenses $(12,023) $(13,367) $(10,023) $(9,609) $(6,353) $(39,352)
Contributed
technology
license(a) -- -- (30,000) -- -- (30,000)
Selling, general
and administrative
expenses (16,437) (4,995) (4,435) (10,179) (17,671) (37,280)
Interest
income -- -- -- -- 196 196
-------- -------- -------- ------- ------- --------
Net loss $(28,460) $(18,362) $(44,458)$(19,788)$(23,828) $(106,436)
======== ======== ======== ======== ======== =========
Suncos Corporation:
Research and
development
expenses(b)$(15,818) $(4,283) $(6,767) $(8,440) $(10,828) $(30,318)
General and
administrative
expenses(b) (164) -- (31) -- (190) (221)
Interest income 13 15 54 44 27 140
-------- -------- -------- ------- ------- --------
Net loss $(15,969) $ (4,268) $ (6,744) $(8,396)$(10,991) $(30,399)
======== ======== ======== ======== ======== =========
ICOS-Texas Biotechnology L.P.:
Research and
development
expenses $ (5,008) $ (3,294) $ (5,698) $(4,687) $(5,194) $(18,873)
Contributed
technology
license -- -- -- (4,000) -- (4,000)
General and
administrative
expenses (12) (18) (10) (3) 4 (27)
-------- -------- -------- ------- ------- --------
Net loss $ (5,020) $ (3,312) $ (5,708) $(8,690) $(5,190) $ (22,900)
======== ======== ======== ======== ======== =========
NOTES:
(a)
ICOS Corporation does not recognize any Lilly ICOS LLC expenses
associated with the valuation of contributed technology, as those
expenses are solely applicable to Eli Lilly and Company.
(b)
Certain amounts for 2001 have been reclassified to conform to the
2002 presentation.
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Contact:
ICOS Corporation
Lacy Fitzpatrick, 425/415-2207 |
