Cialis Receives Positive Opinion from European Committee for Proprietary Medicinal Products and ICOS Corporation Reports Results for Second Quarter of 2002.Business Editors BOTHELL, Wash.--(BUSINESS WIRE)--July 25, 2002 ICOS Corporation (Nasdaq:ICOS) (the "Company") today announced that Lilly ICOS LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control ("Lilly ICOS"), the Company's collaboration with Eli Lilly and Company Eli Lilly and Company (NYSE: LLY) is a global pharmaceutical company and one of the world's largest corporations. Eli Lilly's global headquarters is located in Indianapolis, Indiana, in the United States. ("Lilly") has received a positive opinion, from the European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. Committee for Proprietary Medicinal Products medicinal product, n a substance administered to humans or animals through injection, application, oral ingestion, inhalation, and so forth, whose purpose is to ultimately restore health or eliminate disease in an individual. (CPMP CPMP Committee for Proprietary Medicinal Products CPMP Core-Plus Mathematics Project CPMP Crew Procedures Management Plan (NASA) CPMP Canadian Project Management Professional CPMP Corporate Planning and Management Practices ) for Cialis Ci·al·is A trademark for the drug tadalafil. tadalafil Cialis Pharmacologic class: Phosphodiesterase type 5 (PDE5) inhibitor Therapeutic class: (TM) (tadalafil ta·da·la·fil n. A phosphodiesterase inhibitor drug used to treat erectile dysfunction for up to several days by increasing the level of cyclic GMP, which increases blood flow to the erectile tissues. ), an investigational PDE5 inhibitor A phosphodiesterase type 5 inhibitor, often shortened to PDE5 inhibitor, is a drug used to block the degradative action of phosphodiesterase type 5 on cyclic GMP in the smooth muscle cells lining the blood vessels supplying the corpus cavernosum of the penis. for the treatment of erectile dysfunction Erectile Dysfunction Definition Erectile dysfunction (ED), formerly known as impotence, is the inability to achieve or maintain an erection long enough to engage in sexual intercourse. . ICOS also summarized other recent events and released its financial results for the quarter ended June 30, 2002. "Based on its clinical profile, we are confident in the value and potential for Cialis(TM)," said Paul Clark Paul Clark may also refer to:
The CPMP, comprised of regulators from the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community countries, based its positive opinion on its review of the comprehensive data package of Cialis(TM). The submission was comprised of more than 60 studies in more than 4,000 humans to characterize the safety and efficacy profile of Cialis(TM). Following the CPMP's positive opinion, the application will be reviewed by the European Commission European Commission, branch of the governing body of the European Union (EU) invested with executive and some legislative powers. Located in Brussels, Belgium, it was founded in 1967 when the three treaty organizations comprising what was then the European Community , which has authority to grant marketing authorization The right or permission to use a system resource; the process of granting access. See access control. for the European Union. This authorization is anticipated for later this year. On April 29, 2002, Lilly ICOS received an approvable letter from the U.S. Food and Drug Administration ("FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ") for Cialis(TM) (tadalafil). An approvable letter indicates that the FDA is prepared to approve an application upon the satisfaction of conditions specified in the letter. The conditions were the successful completion of confirmatory clinical pharmacology Clinical pharmacology is the science of drugs and their clinical use. It is underpinned by the basic science of pharmacology, with added focus on the application of pharmacological principles and methods in the real world. studies, labeling discussions, and successful resolution of issues regarding Lilly's manufacturing facilities. In its 2002 second quarter earnings release and related investor conference call on July 18, 2002, Lilly also provided an update on FDA inspections of its manufacturing facilities. Among other things, during the conference call, representatives of Lilly stated that: -- Cialis(TM) could be launched in the U.S. in the second half of 2003; -- Lilly believes that the FDA observations raised in the pre-approval inspection at the bulk facility are unlikely to stand in the way of Cialis(TM) approval; and, -- The U.S. launch of Cialis(TM) should not be impacted by issues at Lilly's dry product facility due to contingency fill/finish capacity elsewhere that will be coming on line. However, it is not clear whether the FDA will approve any new products, manufactured at any Lilly facilities, while Lilly is under a warning letter for its parenteral facility in Indianapolis. In May 2002, the Company released new clinical data on Cialis(TM) at the American Urology urology Medical specialty dealing with the urinary system and male reproductive organs. It traces its origin to medieval lithologists, itinerant healers who specialized in surgical removal of bladder stones. Association meeting in Orlando, Florida The city of Orlando is a major city in central Florida and is the county seat of Orange County, Florida. According to the 2000 census, the city population was 185,951. A 2006 U.S. . During the second quarter, Lilly ICOS also initiated development efforts on an additional therapeutic indication for Cialis(TM). Further information will be provided as development activities progress. In April 2002, the Company completed the first of three possible interim analyses in the Phase 3 trial with Pafase(R) for the treatment of severe sepsis severe sepsis A condition defined clinically as 'Sepsis associated with organ dysfunction, hypotension, or hypoperfusion abnormalities (which include) …lactic acidosis, oliguria, or an acute alteration in mental status . An independent data monitoring committee evaluated the clinical data and, based on the committee's recommendation, the study is proceeding. Clinical data from the interim analysis remains blinded and will not be available to the Company until the study has been concluded. Patient enrollment in the Phase 2b/3 trial with sitaxsentan, a potential treatment for pulmonary pulmonary /pul·mo·nary/ (pool´mo-nar?e) 1. pertaining to the lungs. 2. pertaining to the pulmonary artery. pul·mo·nar·y adj. Of, relating to, or affecting the lungs. arterial arterial /ar·te·ri·al/ (-al) pertaining to an artery or to the arteries. ar·te·ri·al adj. 1. Of or relating to one or more arteries or to the entire system of arteries. 2. hypertension hypertension or high blood pressure, elevated blood pressure resulting from an increase in the amount of blood pumped by the heart or from increased resistance to the flow of blood through the small arterial blood vessels (arterioles). , was completed during the second quarter. Clinical results from this trial are expected to be available later in the year. On July 22, 2002, ICOS-Texas Biotechnology L.P. announced that it decided to conclude early a sitaxsentan long-term Long-term Three or more years. In the context of accounting, more than 1 year. long-term 1. Of or relating to a gain or loss in the value of a security that has been held over a specific length of time. Compare short-term. safety extension trial. This decision does not impact the ongoing Phase 2b/3 sitaxsentan safety and efficacy clinical trial ("STRIDE STRIDE System to Retrieve Information from Drug Evidence STRIDE Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, Elevation of Privilege (mnemonic for threats to software, used to make threat-modeling scenarios) ") conduct or results. Once the safety and efficacy results for the STRIDE trial are unblinded, additional consideration can be given to the appropriate does for the purpose of assessing long-term safety. The Company continues to make progress with its earlier-stage product candidates. Three product candidates are expected to advance into Phase 2 programs later this year -- IC747, a compound being developed with Biogen, Inc. as a potential treatment for psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the ; IC14, a potential treatment for community-acquired pneumonia community-acquired pneumonia Pneumonia caused by an infection currently present in the community; CAP is the most common cause of infectious death–US, and number 6 killer overall; of the 57% of CAPs in which a pathogen is identified, S pneumoniae and sepsis Sepsis Definition Sepsis refers to a bacterial infection in the bloodstream or body tissues. This is a very broad term covering the presence of many types of microscopic disease-causing organisms. ; and, RTX RTX Russian Traded Index RTX Resiniferatoxin RTX Royal Trux (band) RTX Real Time Executive RTX Re-Transmission RTX Request Retransmission RTX Report Time Crossing (FAA) , a potential treatment for interstitial cystitis interstitial cystitis: see cystitis. . For the second quarter of 2002, ICOS reported a net loss of $40.4 million ($0.66 per share), compared to a net loss of $5.3 million ($0.10 per share) for the second quarter of 2001. Total revenue was $22.0 million in the second quarter of 2002, compared to $33.7 million in the second quarter of 2001. Second quarter 2002 collaboration revenue from affiliates ("cost reimbursement Reimbursement Payment made to someone for out-of-pocket expenses has incurred. revenue") was $17.9 million, compared to $12.4 million in the second quarter of 2001. The increase in cost reimbursement revenue primarily relates to the progression of development activities for the Pafase(R) Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. for severe sepsis, including increased patient enrollment and site initiations. Revenue from licenses of technology was $0.6 million in the second quarter of 2002, compared to $20.3 million in the second quarter of 2001. Prior year results included $14.5 million in license fees earned upon the submission of the Cialis(TM) New Drug Application ("NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ") to the FDA in June 2001. For the three months ended June 30, 2002 and 2001, the Company recognized $0.4 million and $5.8 million, respectively, of revenue collected and deferred in years prior to 2001, to be recognized over product development periods. The $5.4 million decrease was primarily due to the completion, in June 2001, of Cialis(TM) development activities required to file the NDA. During the second quarter of 2002, the Company recognized $3.4 million in revenue related to the development and manufacture of third party clinical materials, compared to $1.0 million in the second quarter of 2001. This increase reflects the growth of the Company's contract manufacturing program since its inception in the fourth quarter of 2000. Total operating expenses Operating expenses The amount paid for asset maintenance or the cost of doing business, excluding depreciation. Earnings are distributed after operating expenses are deducted. were $40.1 million in the second quarter of 2002, compared to $28.7 million in the second quarter of 2001. Research and development expenses increased $8.5 million, to $35.2 million in the second quarter of 2002, primarily due to the progression of development activities for Pafase(R), as noted above, and increased preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. research spending. Selling, general and administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. increased $2.9 million, to $4.9 million in the second quarter of 2002, reflecting growth of the Company's corporate sales and marketing functions to support the anticipated commercial launch of Cialis(TM). Following receipt of the approvable letter from the FDA on April 29, 2002, many Cialis(TM) sales and marketing activities, conducted by the Company and Lilly on behalf of Lilly ICOS, have been postponed. During the second quarter of 2002, the Company recognized $25.3 million in losses related to its equity interests in affiliates, an increase of $11.8 million compared to the second quarter of 2001. The increase primarily reflects higher Lilly ICOS sales and marketing costs associated with the anticipated commercial launch of Cialis(TM). Additionally, Suncos Corporation operating losses operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. increased due to the progression of development activities for Pafase(R). For the six months ended June 30, 2002, ICOS reported a net loss of $79.6 million ($1.31 per share), compared to a net loss of $20.4 million ($0.39 per share) for the six months ended June 30, 2001. At June 30, 2002, the Company had cash, cash equivalents, investment securities and associated interest receivable of $412.2 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 its collaborative partners, and the timing and progression of its 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 trials and other development efforts. In addition, significant changes in joint venture collaboration activities 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 therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. . The Company combines its capabilities in molecular, cellular and structural biology Structural biology is a branch of molecular biology concerned with the study of the architecture and shape of biological macromolecules—proteins and nucleic acids in particular—and what causes them to have the structures they have. , high throughput The speed with which a computer processes data. It is a combination of internal processing speed, peripheral speeds (I/O) and the efficiency of the operating system and other system software all working together. 1. drug screening, medicinal chemistry Medicinal or pharmaceutical chemistry is a scientific discipline at the intersection of chemistry and pharmacology involved with designing, synthesizing and developing pharmaceutical drugs. and gene expression profiling Microarray technology is often used for gene expression profiling. It makes use of the sequence resources created by the genome sequencing projects and other sequencing efforts to answer the question, to develop highly innovative products with significant commercial potential. The Company applies its integrated approach to erectile dysfunction and other urologic disorders urologic disorder Any condition affecting the kidneys, often understood to be of the collecting tubules and southward. Cf Kidney disease. , sepsis, pulmonary arterial hypertension and other cardiovascular diseases Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease , and inflammatory diseases Noun 1. inflammatory disease - a disease characterized by inflammation disease - an impairment of health or a condition of abnormal functioning NEC, necrotizing enterocolitis - an acute inflammatory disease occurring in the intestines of premature infants; . 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 forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. and other risks detailed in the Company's latest Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. and its other public filings with the Securities and Exchange Commission. --Selected financial data follows--
ICOS Corporation and Subsidiaries
SELECTED CONSOLIDATED FINANCIAL DATA
(in thousands, except per share data)
(unaudited)
Three months ended Six months ended
June 30, June 30,
--------------------- ---------------------
2002 2001 2002 2001
---------- ---------- ---------- ----------
Condensed Consolidated
Statement of Operations:
Revenue:
Collaboration revenue
from affiliates $ 17,909 $ 12,399 $ 37,265 $ 24,125
Licenses of technology 634 20,301 2,014 26,915
Contract manufacturing 3,432 1,014 5,232 1,574
-------- -------- -------- --------
Total revenue 21,975 33,714 44,511 52,614
-------- -------- -------- --------
Operating expenses:
Research and development 35,248 26,718 70,646 49,743
Selling, general and
administrative 4,867 1,973 9,834 3,460
-------- -------- -------- --------
Total operating expenses 40,115 28,691 80,480 53,203
-------- -------- -------- --------
Operating income (loss) (18,140) 5,023 (35,969) (589)
Other income (expense):
Equity in losses of
affiliates (25,277) (13,455) (50,001) (26,448)
Interest and other income 3,012 3,165 6,345 6,617
-------- -------- -------- --------
Net loss $(40,405) $ (5,267) $(79,625) $(20,420)
======== ======== ======== ========
Net loss per common share -
basic and diluted $ (0.66) $ (0.10) $ (1.31) $ (0.39)
======== ======== ======== ========
Weighted average common
shares outstanding -
basic and diluted 61,148 53,075 60,586 52,803
======== ======== ======== ========
Condensed Consolidated
Balance Sheet: June 30, Dec. 31,
2002 2001
---------- ----------
Cash, cash equivalents, investment securities
and interest receivable $ 412,247 $ 470,707
Receivables from affiliates 27,025 11,405
Property and equipment, net 21,428 19,754
Other 5,971 5,721
--------- ---------
Total assets $ 466,671 $ 507,587
========= =========
Due to affiliates $ 31,183 $ 18,132
Other current liabilities 25,904 21,079
Deferred revenue 13,761 14,626
Stockholders' equity 395,823 453,750
--------- ---------
Total liabilities and stockholders' equity $ 466,671 $ 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
--------------------------------
Q1 Q2 YTD
--------------------------------
Collaboration revenue from affiliates:
Lilly ICOS LLC $ 1,361 $ 1,579 $ 2,940
Suncos Corporation 13,889 12,918 26,807
ICOS-Texas Biotechnology L.P. 4,106 3,412 7,518
ICOS Clinical Partners, L.P. - - -
-------- -------- --------
$ 19,356 $ 17,909 $ 37,265
======== ======== ========
Licenses of technology:
Lilly ICOS LLC $ 623 $ 83 $ 706
ICOS Clinical Partners, L.P. 427 315 742
Biogen, Inc. 330 236 566
-------- -------- --------
$ 1,380 $ 634 $ 2,014
======== ======== ========
Equity in losses of affiliates:
Lilly ICOS LLC $(14,230) $(17,003) $(31,233)
Suncos Corporation (7,984) (6,317) (14,301)
ICOS-Texas Biotechnology L.P. (2,510) (1,957) (4,467)
ICOS Clinical Partners, L.P. - - -
-------- -------- --------
$(24,724) $(25,277) $(50,001)
======== ======== ========
2001
-----------------------------------------------------
Q1 Q2 Q3 Q4 TOTAL
---------- ---------- ---------- ---------- ---------
Collaboration revenue from affiliates:
Lilly ICOS LLC $ 3,694 $ 2,426 $ 2,444 $ 1,401 $ 9,965
Suncos
Corporation 4,231 6,737 8,397 11,008 30,373
ICOS-Texas
Biotechnology
L.P. 2,061 3,236 3,043 4,336 12,676
ICOS Clinical
Partners, L.P. 1,740 - - - 1,740
-------- -------- -------- -------- --------
$ 11,726 $ 12,399 $ 13,884 $ 16,745 $ 54,754
======== ======== ======== ======== ========
Licenses of technology:
Lilly ICOS LLC $ 6,410 $ 20,021 $ 2,011 $ 974 $ 29,416
ICOS Clinical
Partners, L.P. 204 280 183 314 981
Biogen, Inc. - - 100 349 449
-------- -------- -------- -------- --------
$ 6,614 $ 20,301 $ 2,294 $ 1,637 $ 30,846
======== ======== ======== ======== ========
Equity in losses of affiliates:
Lilly ICOS LLC $ (9,181) $ (7,229) $ (9,894) $ (11,915) $ (38,219)
Suncos
Corporation (2,134) (3,372) (4,198) (5,496) (15,200)
ICOS-Texas
Biotechnology
L.P. (1,656) (2,854) (4,345) (2,606) (11,461)
ICOS Clinical
Partners, L.P. (22) - - - (22)
-------- -------- -------- -------- --------
$(12,993) $(13,455) $(18,437) $(20,017) $(64,902)
======== ======== ======== ======== ========
ICOS Corporation and Subsidiaries
SUMMARIZED OPERATING RESULTS OF AFFILIATES
(in thousands)
(unaudited)
2002
--------------------------------
Q1 Q2 YTD
--------------------------------
Lilly ICOS LLC:
Research and development expenses $ (12,023) $ (12,387) $ (24,410)
Contributed technology license (a) - - -
Selling, general and administrative
expenses (16,437) (21,619) (38,056)
Interest income - - -
--------- --------- ---------
Net loss $ (28,460) $ (34,006) $ (62,466)
========= ========= =========
Suncos Corporation:
Research and development expenses $ (15,818) $ (12,512) $ (28,330)
General and administrative expenses (164) (142) (306)
Interest income 13 20 33
--------- --------- ---------
Net loss $ (15,969) $ (12,634) $ (28,603)
========= ========= =========
ICOS-Texas Biotechnology L.P.:
Research and development expenses $ (5,008) $ (3,827) $ (8,835)
Contributed technology license - - -
General and administrative expenses (12) (88) (100)
--------- --------- ---------
Net loss $ (5,020) $ (3,915) $ (8,935)
========= ========= =========
2001
------------------------------------------------------
Q1 Q2 Q3 Q4 TOTAL
---------- ---------- ---------- ---------- ----------
Lilly ICOS LLC:
Research and
development
expenses $(13,367) $(10,023) $ (9,609) $ (6,353) $ (39,352)
Contributed
technology
license (a) - (30,000) - - (30,000)
Selling,
general and
administrative
expenses (4,995) (4,435) (10,179) (17,671) (37,280)
Interest income - - - 196 196
--------- --------- --------- --------- ---------
Net loss $(18,362) $(44,458) $(19,788) $(23,828) $(106,436)
========= ========= ========= ========= =========
Suncos Corporation:
Research and
development
expenses $ (4,236) $ (6,752) $ (8,405) $(10,828) $ (30,221)
General and
administrative
expenses (47) (46) (35) (190) (318)
Interest income 15 54 44 27 140
-------- -------- -------- -------- ---------
Net loss $ (4,268) $ (6,744) $ (8,396) $(10,991) $ (30,399)
======== ======== ======== ======== =========
ICOS-Texas Biotechnology L.P.:
Research and
development
expenses $ (3,294) $ (5,698) $ (4,687) $ (5,194) $ (18,873)
Contributed
technology
license - - (4,000) - (4,000)
General and
administrative
expenses (18) (10) (3) 4 (27)
-------- --------- --------- --------- ---------
Net loss $ (3,312) $ (5,708) $ (8,690) $ (5,190) $ (22,900)
======== ========= ========= ========= =========
(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.
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