Inspire Reports Third Quarter 2005 Financial Results; Third Quarter 2005 Revenue Up 73%, Company Raises 2005 Revenue 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 third quarter ended September 30, 2005. Total revenue for the third quarter of 2005 was $6.6 million compared to $3.8 million for the third quarter of 2004, reflecting a 73% increase in total co-promotion revenue. This increase is attributed to the continued market penetration Noun 1. market penetration - the extent to which a product is recognized and bought by customers in a particular market penetration - the act of entering into or through something; "the penetration of upper management by women" 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% and 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% 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. , accompanied by an increase in the Company's entitled percentage of net sales Net SalesThe 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 Restasis. Co-promotion revenue from net sales of Elestat for the third quarter of 2005 was $4.5 million, as compared to $3.3 million of co-promotion revenue from Elestat recognized in the third quarter of 2004. Co-promotion revenue on net sales of Restasis for the third quarter of 2005 was $2.1 million, as compared to $0.5 million recognized in the third quarter of 2004. Total co-promotion revenue for the nine months ending September 30, 2005 was $18.0 million, as compared to $7.3 million for the same period in 2004. For the quarter ended September 30, 2005, the Company reported a net loss of $6.8 million, or ($0.16) per share, as compared to a net loss of $10.2 million, or ($0.28) per share, for the same period in 2004. The net loss for the nine months ended September 30, 2005 was $24.8 million, or ($0.59) per share, as compared to a net loss of $32.3 million, or ($0.96) per share 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 third quarter of 2005 totaled $14.4 million, as compared to $14.3 million for the same period in 2004. Operating expenses for the nine months ended September 30, 2005 were $45.8 million, as compared to $40.4 million for the same period in 2004. Cash, cash equivalents and investments totaled $125.9 million at September 30, 2005, reflecting a $6.1 million utilization of cash, cash equivalents and investments during the third quarter of 2005. Based upon results and revenue trends for both Elestat and Restasis, the Company is increasing its previously issued 2005 operating guidance for co-promotion revenue to a new range of $22-26 million from the previous range of $19-23 million and is reaffirming its operating expenses guidance for 2005 to be in the $59-65 million range. 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, "Our commercial organization continues to drive excellent revenue growth for Elestat and provide co-promotion support for Restasis. Elestat is now 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 in the United States, based on recent market data. In research and development, we made progress in 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. program, as previously announced, by completing two long-term animal toxicology studies and an additional Phase 2 safety clinical trial in cystic fibrosis patients. Based on the cumulative pre-clinical and clinical data in our CF program, we have requested and been granted an End-of-Phase 2 meeting 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. in late January 2006 to discuss next steps." Recent Updates Include (July 1, 2005 through November 8, 2005): Research & Development -- Completed two six-month animal toxicology studies in denufosol tetrasodium for the treatment of cystic fibrosis; -- Announced top-line results of a Phase 2 safety clinical trial of denufosol for the treatment of cystic fibrosis; -- Submitted an application to the European Medicines Evaluation Agency (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) to receive orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the status for denufosol in cystic fibrosis in Europe; -- Presented scientific data at two poster sessions and one Early Bird Short Course at the 2005 North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. Cystic Fibrosis Conference; and -- Discontinued enrollment in a pilot Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. of diquafosol for corneal corneal pertaining to the cornea. See also keratitis, keratopathy. corneal anomaly includes microcornea, coloboma, megalocornea, dermoid, congenital opacity. corneal black body see corneal sequestrum (below). epithelial wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by since the single clinical trial site, located in New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded , was seriously impacted by Hurricane Katrina Sales and Marketing -- Succeeded in making Elestat the second most prescribed allergic conjunctivitis product in the United States, achieving over 9% in total weekly prescription volume, and achieving approximately 8% of total year-to-date 2005 prescription volume based upon 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. , as measured for the week ending October 14, 2005; and -- In collaboration with Allergan, increased prescription volume of Restasis, which is the only approved prescription treatment for dry eye in the United States; Allergan reported aggregate third quarter 2005 net sales of Restasis of $54 million, representing a 124% increase over the third quarter of 2004. Inspire will host a conference call and live webcast to discuss its third quarter 2005 financial results on Tuesday, November 8th 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 November 22, 2005. To access this replay, U.S. participants may call (877) 519-4471 and international participants may call (973) 341-3080. The conference pass code is 6584278. 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 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 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, 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, expense and earnings expectations, the seasonality of Elestat, 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, adverse developments in the U.S. Securities and Exchange Commission (SEC) investigation, 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 U.S. Food and Drug Administration. Inspire's revenues, and the rate of revenue growth, for the three and nine month periods ended September 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 or Restasis for any future periods. Further information regarding factors that could affect Inspire's results is included in Inspire's filings with the SEC. 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 Nine Months
Ended September Ended September
30, 30,
-----------------------------------
2005 2004 2005 2004
------- -------- -------- --------
Revenues:
Revenue from product co-promotion $ 6,562 $ 3,791 $ 18,020 $ 7,348
------- -------- -------- --------
Total revenue 6,562 3,791 18,020 7,348
Operating expenses:
Research and development 6,672 6,762 19,463 17,318
Selling and marketing 5,063 5,529 18,160 16,665
General and administrative 2,672 2,035 8,163 6,369
------- -------- -------- --------
Total operating expenses 14,407 14,326 45,786 40,352
------- -------- -------- --------
Loss from operations (7,845) (10,535) (27,766) (33,004)
Other income (expense):
Interest income 1,129 422 3,130 1,010
Interest expense (36) (37) (114) (78)
Loss on investments - - - (198)
------- -------- -------- --------
Other income, net 1,093 385 3,016 734
------- -------- -------- --------
Net loss $(6,752)$(10,150)$(24,750)$(32,270)
======= ======== ======== ========
Basic and diluted net loss per
common share $ (0.16)$ (0.28)$ (0.59)$ (0.96)
======= ======== ======== ========
Weighted average common shares used
in computing basic and diluted net
loss per common share 42,188 36,767 42,066 33,566
======= ======== ======== ========
INSPIRE PHARMACEUTICALS, INC.
Selected Balance Sheet Information
(in thousands)
September December
30, 31,
2005 2004
---------- ----------
Cash, cash equivalents and investments $125,885 $156,796
Receivable from Allergan 6,497 3,501
Working capital 101,925 134,559
Total assets 137,428 165,696
Total stockholders' equity 125,328 149,598
Shares of common stock outstanding 42,203 41,845
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