Inspire Reports Second Quarter 2005 Financial Results; Second Quarter 2005 Revenue More Than Triple Second Quarter 2004; Company Raises 2005 Guidance.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 second quarter ended June 30, 2005. Total revenue for the second quarter of 2005 was $9.6 million compared to $2.9 million for the second quarter of 2004. Co-promotion revenue from 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 of Elestat(R) (epinastine HCl ophthalmic solution ophthalmic solution n. A sterile solution that is free from foreign particles and is compounded and dispensed for eyedrops. ) 0.05% was $7.9 million, an increase of 205% compared to $2.6 million of co-promotion revenue from Elestat recognized in the second quarter of 2004. During the second quarter of 2005, the Company achieved its 2005 contractual net sales target level for Elestat, thereby allowing the recognition of $1.6 million of previously deferred net sales of Elestat, under Inspire's agreement with Allergan, Inc. (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) ). Co-promotion revenue on net sales of Restasis(R) (cyclosporine ophthalmic emulsion cyclosporine ophthalmic emulsion Sandimmun (UK), Restasis Pharmacologic class: Polypeptide antibiotic Therapeutic class: Immunosuppressant Pregnancy risk category C FDA Boxed Warning) 0.05% for the second quarter of 2005 was $1.7 million, an increase of 370% compared to $0.4 million recognized in the second quarter of 2004. The increases in second quarter 2005 co-promotion revenues, as compared to 2004, were related to the continued market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular marketpenetration - the act of entering into or through something; "the penetration of upper management by women" and patient and physician acceptance of Elestat and Restasis in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , as well as an increase in the percentage of net sales of Restasis to which Inspire is entitled in 2005. Total co-promotion revenue for the six months ended June 30, 2005 was $11.5 million, as compared to $3.6 million for the same period in 2004. 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 second quarter of 2005 totaled $15.3 million, as compared to $12.8 million for the same period in 2004. The increase in second quarter 2005 operating expenses, as compared to 2004, was due to increases in all operating expense Operating Expense The essential things that a company must purchase in order to maintain business. Notes: For example, the payment of employees wages are an operating expense. Also known as OPEX. categories. The increase in research and development expenses of $1.3 million in the second quarter of 2005 was attributable to increased costs for denufosol tetrasodium (INS INS abbr. 1. Immigration and Naturalization Service 2. International News Service Noun 1. INS 37217 Respiratory) for the treatment of 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. associated with toxicology studies and additional Phase 2 clinical trials phase 2 clinical trial Phase 2 study. See Phase study. in preparation for the initiation of a planned Phase 3 program. Operating expenses for the six months ended June 30, 2005 were $31.4 million, as compared to $26.0 million for the same period in 2004. For the quarter ended June 30, 2005, the Company reported a net loss of $4.7 million, or ($0.11) per share, as compared to a net loss of $9.7 million, or ($0.30) per share, for the same period in 2004. The net loss for the six months ended June 30, 2005 was $18.0 million, or ($0.43) per share, as compared to a net loss of $22.1 million, or ($0.69) per share for the same period in 2004. Cash, cash equivalents and investments totaled $132.0 million at June 30, 2005, reflecting a $9.2 million utilization of cash, cash equivalents and investments during the second quarter of 2005. Based upon results and revenue trends for both products, in particular Elestat, the Company is increasing its previously issued 2005 operating guidance for co-promotion revenue from $17-20 million to $19-23 million and is reaffirming its operating expenses guidance of $59-65 million. Christy L. Shaffer, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Inspire, stated, "The second quarter was successful and productive for Inspire on multiple fronts. Our sales force delivered an outstanding quarter, generating strong sales of Elestat and contributing to continued growth in Restasis prescriptions, which prompted us to increase our revenue guidance for the year. We completed and submitted to the 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. ) an amendment to our 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 ) for diquafosol tetrasodium for the treatment of dry eye and expect FDA action on our submission by December 1, 2005. Importantly, we continue to make solid progress in our development pipeline, moving forward in our cystic fibrosis, retinal disease and cardiovascular clinical programs." Recent Updates Include (April 1, 2005 through August 9, 2005): Research and Development --Submitted an amendment to Inspire's NDA for diquafosol for the treatment of dry eye; --Announced top-line results of a Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. of INS50589 Antiplatelet an·ti·plate·let adj. Acting against or destroying blood platelets. antiplatelet directed against or destructive to blood platelets; inhibiting platelet function. , a platelet aggregation Platelet aggregation The clumping together of blood cells, possibly forming a clot. Mentioned in: Herbalism, Traditional Chinese inhibitor; --Completed the dosing phase in two six-month toxicology studies for denufosol for cystic fibrosis; --Completed enrollment in a Phase 2 safety study and initiated a small pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. study for denufosol for cystic fibrosis; --Presented data in three sessions at the 28th European Cystic Fibrosis Society Conference; and --Initiated two Phase 2 pilot clinical trials for denufosol (INS37217 Ophthalmic) in macular edema macular edema Ophthalmology Waxing and waning retinal thickening due to the accumulation of fluid, seen in Pts with diabetic retinopathy, seen with a binocular slit lamp or stereoscopic fundus photography; while ME has no visual consequences, it is often . Sales and Marketing --Achieved market share for Elestat of over 19% 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), making Elestat the second-highest prescribed product in this target universe for the week ended July 15, 2005, 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. . In the total prescription allergic conjunctivitis allergic conjunctivitis n. Conjunctivitis caused by an allergic reaction to a substance. Also called atopic conjunctivitis. allergic conjunctivitis market, Elestat represented over 9% of weekly prescription volume, and was the second most prescribed product, for the week ended July 15, 2005. Elestat represents over 7% of total 2005 year-to-date allergic conjunctivitis U.S. prescription volume through the week ended July 15, 2005; and --Continued to achieve patient and prescriber acceptance of Restasis, the only approved prescription treatment for dry eye in the United States, with second quarter 2005 net sales to Allergan of $46.3 million, representing more than 130% growth over the second quarter of 2004. Corporate --Added M. Lynn Smiley, M.D. as Chief Medical Officer; and --Appointed Alan F. Holmer, former President and CEO of PhRMA, to the Board of Directors. Inspire will host a conference call and live webcast to discuss its second quarter 2005 financial results on Tuesday, August 9th at 10:00 a.m. ET. To access the conference call, U.S. participants may call (877) 780-2276 and 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 August 23, 2005. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The replay pass code is 6281886. About Inspire Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products in disease areas with significant commercial potential and unmet medical needs. Inspire has significant technical and scientific expertise in the therapy areas of ophthalmology 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 and cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . Inspire's U.S. specialty sales force promotes Elestat(R) (epinastine HCl ophthalmic solution) 0.05% and Restasis(R) (cyclosporine ophthalmic emulsion) 0.05%, ophthalmology products developed by Inspire's partner, Allergan, Inc. Elestat and Restasis are trademarks owned by Allergan. Forward-Looking Statements The forward-looking statements in this news release relating to 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, expense and earnings expectations, the seasonality of Elestat(R), intellectual property rights, adverse 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. developments, competitive products, results and timing of clinical trials, success of marketing efforts, 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. . Inspire's revenues, and the rate of revenue growth, for the three and six month periods ended June 30, 2005 are not necessarily indicative of future revenue or the rate of growth, if any, of revenues during the year ending December 31, 2005. Inspire cannot assure the continued growth of revenue from the sale of Elestat(R) or Restasis(R) for any future periods. 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. --Financial tables follow --
INSPIRE PHARMACEUTICALS, INC.
Condensed Statements of Operations
(in thousands, except per share amounts)
(Unaudited)
Three Months Six Months
Ended June 30, Ended June 30,
----------------------------------
2005 2004 2005 2004
------- ------- -------- --------
Revenues:
Revenue from product co-promotion
$ 9,607 $ 2,948 $ 11,458 $ 3,557
------- ------- -------- --------
Total revenue 9,607 2,948 11,458 3,557
Operating expenses:
Research and development 6,739 5,407 12,791 10,556
Selling and marketing 5,728 5,198 13,097 11,136
General and administrative 2,803 2,148 5,491 4,334
------- ------- -------- --------
Total operating expenses 15,270 12,753 31,379 26,026
------- ------- -------- --------
Loss from operations (5,663) (9,805) (19,921) (22,469)
Other income (expense):
Interest income 1,045 254 2,001 588
Interest expense (38) (24) (78) (41)
Loss on investments - (117) - (198)
------- ------- -------- --------
Other income 1,007 113 1,923 349
------- ------- -------- --------
Net loss $(4,656)$(9,692)$(17,998)$(22,120)
======= ======= ======== ========
Basic and diluted net loss per
common share $ (0.11)$ (0.30)$ (0.43)$ (0.69)
======= ======= ======== ========
Weighted average common shares used
in computing basic and diluted net
loss per common share 42,069 31,995 42,003 31,948
======= ======= ======== ========
INSPIRE PHARMACEUTICALS, INC.
Selected Balance Sheet Information
(in thousands)
June 30, Dec. 31,
2005 2004
--------- ---------
Cash, cash equivalents and investments $131,993 $156,796
Receivables from Allergan 7,699 3,501
Working capital 112,974 134,559
Total assets 144,155 165,696
Deferred revenue - -
Total stockholders' equity 131,637 149,598
Shares of common stock outstanding 42,071 41,845
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