Inspire Reports Third Quarter 2004 Financial Results; Company Provides Corporate Update.DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ISPH ISPH Inspire Pharmaceuticals, Inc. ) today reported financial results for the third quarter and nine months ended September 30, 2004. Total revenues for the third quarter of 2004 were $3.8 million compared to no revenue for the third quarter of 2003. Total revenues for the first nine months of 2004, which related to product co-promotion revenue, were $7.3 million as compared to $5.2 million of total revenues from collaborative research agreements in the same 2003 period. Product revenue reflected the Company's third quarter of co-promotion revenue from Elestat(TM) and the second full quarter of co-promotion revenue from Restasis(R). During the third quarter, the Company achieved its 2004 net sales Net Sales The amount a seller receives from the buyer after costs associated with the sale are deducted. Notes: This amount is calculated by subtracting the following items from gross sales: merchandise returned for credit, allowances for damaged or missing goods, freight target for Elestat, as specified in its co-promotion agreement with Allergan (NYSE NYSE See: New York Stock Exchange : AGN AGN Again (Amateur Radio) AGN Active Galactic Nucleus AGN Acute Glomerulonephritis AGN Accountants Global Network AGN Air Gabon (ICAO code) ), and recognized all previously deferred Elestat revenue of $661,000. 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. for the third quarter of 2004 totaled $14.3 million, as compared to $8.3 million for the same period in 2003. The increase in third quarter 2004 operating expenses, as compared to 2003, was primarily due to a $5.1 million increase in selling and marketing expenses to support the marketing and promotion of Elestat and Restasis. Operating expenses for the nine months ended September 30, 2004 were $40.4 million, as compared to $28.0 million for the same period in 2003. For the quarter ended September 30, 2004, the Company reported a net loss of $10.2 million, or ($0.28) per share, as compared to a net loss of $7.9 million, or ($0.25) per share, for the same period in 2003. Net loss for the nine months ended September 30, 2004 was $32.3 million, or ($0.96) per share, as compared to a net loss of $22.3 million, or ($0.74) per share, for the same period in 2003. Cash, cash equivalents and investments totaled $121.0 million at September 30, 2004. Commenting on the results, Christy L. Shaffer, Ph.D., Chief Executive Officer, stated, "Inspire has had a very productive quarter, making significant gains in our commercial operations and progress in our development programs. Our sales force made a positive impact in sales of Restasis and Elestat, making Elestat the second most prescribed allergic conjunctivitis allergic conjunctivitis n. Conjunctivitis caused by an allergic reaction to a substance. Also called atopic conjunctivitis. allergic conjunctivitis product among eye care professionals and allergists that Inspire targets. On the scientific front, we made progress on our Phase 3 study of diquafosol in dry eye patients, moved forward in our additional Phase 2 work on our Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. drug candidate and advanced INS INS abbr. 1. Immigration and Naturalization Service 2. International News Service Noun 1. INS 50589 Cardiovascular toward an Investigational New Drug (IND) filing and initiation of a Phase 1 trial by year end 2004. We are excited about the future of Inspire and believe we have the team and resources to capitalize on Cap´i`tal`ize on` v. t. 1. To turn (an opportunity) to one's advantage; to take advantage of (a situation); to profit from; as, to capitalize on an opponent's mistakes s>. the many opportunities ahead." Recent highlights through November 4, 2004: Corporate --Completed a successful public common stock offering, raising $77.1 million in net proceeds Net Proceeds The amount received after all costs are deducted from the sale of a piece of property or security. Notes: In the case of an investor selling a security, net proceeds represent the proceeds from the sale minus any trading costs (i.e. commissions). ; --Appointed Barry G. Pea as Executive Vice President of Corporate Development and General Counsel; Research & Development --Completed patient enrollment in a confirmatory Phase 3 trial for diquafosol in dry eye patients; --Assisted Allergan in initial meetings with regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. in Europe regarding registration of diquafosol; --Presented additional data at the annual North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. Cystic Fibrosis Conference on Inspire's Phase 2 trial of INS37217 Respiratory; --Met with the 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. to confirm plans for toxicology toxicology, study of poisons, or toxins, from the standpoint of detection, isolation, identification, and determination of their effects on the human body. Toxicology may be considered the branch of pharmacology devoted to the study of the poisonous effects of drugs. and additional Phase 2 work on INS37217 Respiratory; --Conducted a pre-Investigational New Drug (IND) meeting with the FDA for Inspire's platelet aggregation Platelet aggregation The clumping together of blood cells, possibly forming a clot. Mentioned in: Herbalism, Traditional Chinese inhibitor program (INS50589 Cardiovascular); and Sales & Marketing --Continued to increase market share of Elestat, achieving approximately 15% of new prescription volume in Inspire's target universe (the top 200 prescribing eye care professionals and allergists in each of Inspire's 64 U.S. sales territories) for the week ending October 1, 2004, based on National Prescription data from IMS Health IMS Health (NYSE: RX) is an international consulting and data services company that supplies the pharmaceutical industry with sales data and consulting services. IMS Health was founded in 1954 by Bill Frohlich and David Dubow. . Inspire will host a conference call and live webcast to discuss these results on Thursday, November 4th at 10:00 AM ET (revised time). To access the conference call, U.S. participants may call (877) 780-2276. International participants may call (973) 582-2757. A live web cast and replay of the call will be available on Inspire's website at www.inspirepharm.com. A telephone replay of the conference call will be available until November 18, 2004. To access this replay, U.S. participants may call (877) 519-4471. International participants may call (973) 341-3080. The replay pass code is 4609999. About Inspire Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing novel prescription products for diseases with significant unmet medical needs. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology ophthalmology (ŏf'thălmŏl`əjē), branch of medicine specializing in the anatomy, function and diseases of the eye. Ophthalmologists specialize in the medical and surgical treatment of eye disorders, vision measurements for and respiratory and is a leader in the field of P2 receptors which are important drug targets in various therapeutic areas, including ophthalmology, respiratory disease Noun 1. respiratory disease - a disease affecting the respiratory system respiratory disorder, respiratory illness adult respiratory distress syndrome, ARDS, wet lung, white lung - acute lung injury characterized by coughing and rales; inflammation of the , cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease and pain. Inspire's specialty sales force promotes Elestat(TM) and Restasis(R), ophthalmology products developed by Inspire's partner, Allergan, Inc. Forward-Looking Statements The forward-looking statements in this news release relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc management's expectations and beliefs are based on preliminary information and management assumptions. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue and earnings expectations, intellectual property rights 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. , competitive products, results of clinical trials, the need for additional research and testing, delays in manufacturing, funding and the timing and content of decisions made by regulatory authorities, including the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. . Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the Securities and Exchange Commission. Inspire undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof.
INSPIRE PHARMACEUTICALS, INC.
Condensed Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Nine Months
Ended September 30, Ended September 30,
------------------- -------------------
2004 2003 2004 2003
--------- --------- --------- ---------
Revenues:
Revenue from product co-
promotion $3,791 $- $7,348 $-
Collaborative research
agreements - - - 5,200
--------- --------- --------- ---------
Total revenue 3,791 - 7,348 5,200
Operating expenses:
Research and development 6,762 6,225 17,318 22,235
Selling and marketing 5,529 398 16,665 826
General and administrative 2,035 1,652 6,369 4,986
--------- --------- --------- ---------
Total operating expenses 14,326 8,275 40,352 28,047
--------- --------- --------- ---------
Loss from operations (10,535) (8,275) (33,004) (22,847)
Other income (expense):
Interest income 422 386 1,010 916
Interest expense (37) (13) (78) (36)
Loss on investments - (40) (198) (340)
--------- --------- --------- ---------
Other income 385 333 734 540
--------- --------- --------- ---------
Net loss $(10,150) $(7,942) $(32,270) $(22,307)
========= ========= ========= =========
Basic and diluted net loss per
common share $(0.28) $(0.25) $(0.96) $(0.74)
========= ========= ========= =========
Common shares used in computing
basic and diluted net loss per
common share 36,767 31,758 33,566 30,083
========= ========= ========= =========
INSPIRE PHARMACEUTICALS, INC.
Selected Balance Sheet Information
(in thousands)
September 30, December 31,
2004 2003
(Unaudited)
------------- ------------
Cash, cash equivalents and investments $121,018 $75,166
Receivable from Allergan 2,955 -
Working capital 112,955 66,231
Total assets 129,123 79,678
Deferred revenue - -
Total stockholders' equity 116,747 71,052
Shares of common stock outstanding 38,958 31,847
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