surf1944
15年前
Inspire Reports First Quarter 2010 Financial Results
- First Quarter 2010 Revenue Increased 54% from First Quarter 2009 -
Press Release Source: Inspire Pharmaceuticals, Inc. On Monday May 3, 2010, 6:30 am EDT
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today financial results for the first quarter ended March 31, 2010, reporting a net loss of $14.8 million or ($0.18) per share.
Total revenue for the first quarter of 2010 was $22.1 million, as compared to $14.3 million for the first quarter of 2009, reflecting an increase of 54%. Revenue from AZASITE® (azithromycin ophthalmic solution) 1% totaled $8.7 million in the first quarter of 2010, an increase of 41% compared to $6.2 million recognized in the first quarter of 2009. Inspire estimates that approximately $1 million of first quarter 2010 AZASITE revenue was associated with hospital usage of AZASITE as a substitute therapy during a supply shortage of erythromycin ophthalmic ointment (0.5%). The supply shortage of erythromycin ophthalmic ointment (0.5%) has been resolved and accordingly, the Company does not expect any future revenue in 2010 associated with the supply shortage.
Total product co-promotion and royalty revenue, comprised of royalty revenue from net sales of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% and co-promotion revenue from net sales of ELESTAT® (epinastine HCl ophthalmic solution) 0.05% was $13.4 million for the first quarter of 2010 compared to $8.1 million in 2009. Royalty revenue for the first quarter of 2010 from RESTASIS was $9.8 million compared to $8.1 million in the first quarter of 2009. Co-promotion revenue from ELESTAT in the first quarter of 2010 was $3.6 million as compared to no revenue recognized in the first quarter of 2009. All first quarter 2009 co-promotion revenue from ELESTAT was deferred and recognized later in 2009 due to not achieving contractual minimum target levels during the first quarter of 2009.
Operating expenses for the first quarter of 2010 totaled $36.5 million, as compared to $33.0 million for the same period in 2009. The increase in first quarter 2010 operating expenses was primarily due to an increase in general and administrative expenses of approximately $5 million associated with the CEO transition, for which the majority of the expense was non-cash, as well as an increase in cost of sales resulting from increased AZASITE sales volume. These increases were partially offset by a decrease in research and development expenses due to the elimination of preclinical and drug discovery activities and to focusing resources on late-stage programs as a result of the restructuring initiative that occurred in the first quarter of 2009.
For the first quarter ended March 31, 2010, the Company reported a net loss of $14.8 million, or ($0.18) per common share, as compared to a net loss of $19.4 million, or ($0.34) per common share, for the same period in 2009. Cash, cash equivalents and investments totaled $115.2 million at March 31, 2010, reflecting a $13.9 million utilization of cash and investments during the first quarter.
“During the quarter, we continued our trend of double-digit revenue growth, and through tight management of our operating expenses, continued to successfully reduce our net loss,” said Adrian Adams, President and CEO of Inspire. “We remain focused on completing TIGER-2, our second pivotal Phase 3 trial of denufosol tetrasodium for cystic fibrosis, expanding the denufosol franchise and preparing for a potential 2012 U.S. launch. We remain intent on executing on our core objectives of leveraging our commercial infrastructure, driving excellence in research and development, pursuing strategically aligned corporate development and licensing opportunities and continuing to deliver strong financial performance.”
Recent Updates Include (March 5, 2010 through May 3, 2010):
Ophthalmic Research & Development
•Announced that the Japanese Ministry of Health, Labour and Welfare granted approval on April 16, 2010 to Santen Pharmaceutical Co., Ltd. (“Santen”) for DIQUAS™ Ophthalmic Solution 3% (diquafosol tetrasodium) for the treatment of dry eye, which is related to an exclusive license from Inspire to Santen to develop and market diquafosol for ocular surface diseases in Japan and nine other Asian countries; and
•Announced results from two Phase 2 clinical trials with AZASITE for the treatment of blepharitis; the next step in the program will be refining the clinical trial design for subsequent trials, including some additional Phase 2 trial work expected to begin in late 2010.
Pulmonary Research & Development
•Extended the length of the TIGER-2 follow-on, open-label denufosol only trial (Trial 08-114) enabling patients who complete TIGER-2 to receive denufosol for up to three years in this trial; and
•Entered into a Technical Transfer & Development Services Agreement with Finorga S.A.S., or Novasep, to enable Novasep to become a qualified commercial manufacturer of the active pharmaceutical ingredient (“API”) for denufosol.
Sales and Marketing
•Increased first quarter 2010 AZASITE prescription volume by approximately 39% over the first quarter of 2009.
Corporate
•Appointed Andrew I. Koven to the newly created position of Executive Vice President and Chief Administrative and Legal Officer, effective May 10, 2010.
Financial Outlook for 2010
•Based upon current trends and assumptions, Inspire expects to record 2010 aggregate revenue in the range of $100-$111 million. Co-promotion revenue from ELESTAT will be dependent on the timing of a launch of a generic form of epinastine, which is expected to occur in the second half of 2010;
•Total 2010 operating expenses are expected to be in the range of $145-$169 million. Cost of sales, which includes the amortization of the AZASITE approval milestone and royalty obligations to InSite Vision Incorporated, is expected to be in the range of $13-$18 million. Total estimated selling and marketing and general and administrative expenses are estimated to be in the range of $48-$53 million and $27-$32 million, respectively. Research and development expenses are estimated to be in the range of $60-$70 million. Included within this operating expense guidance are projected stock-based compensation costs of approximately $8-$12 million; and
•Operating cash utilization in 2010 is expected to be in the range of $58-$73 million, which incorporates $20 million of principal repayment on the Company’s outstanding debt.
Inspire will host a conference call and live webcast with an accompanying slide presentation to discuss first quarter 2010 financial results on Monday, May 3, 2010 at 10:00 a.m. ET. To access the conference call, U.S. participants may call (877) 648-7970 and international participants may call (706) 902-0415. The conference ID number is 70118815. A live webcast and replay of the call will be available on Inspire's website at http://us.lrd.yahoo.com/_ylt=AvAUnqXqUVQte8K1.XiO3Vbjba9_;_ylu=X3oDMTE2dDdkbXM2BHBvcwMxBHNlYwNuZXdzYXJ0Ym9keQRzbGsDd3d3aW5zcGlyZXBo/SIG=16fqt2sr5/**http%3A//cts.businesswire.com/ct/CT%3Fid=smartlink%26url=http%253A%252F%252Fwww.inspirepharm.com%26esheet=6273511%26lan=en_US%26anchor=www.inspirepharm.com%26index=1%26md5=45b6eb81f84e92fad7e2d0a7a793a780. The webcast will include audio of the conference call and a slide presentation to be reviewed during the call. A telephone replay of the conference call will be available until May 17, 2010. To access this replay, U.S. participants may call (800) 642-1687 and international participants may call (706) 645-9291. The conference ID number is 70118815.
surf1944
15年前
Inspire Completes Patient Enrollment in Three Late-Stage Clinical Trials in Cystic Fibrosis, Dry Eye and Blepharitis
Press Release
Source: Inspire Pharmaceuticals, Inc.
On 7:00 am EST, Wednesday November 4, 2009
Companies:Inspire Pharmaceuticals, Inc.
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today patient enrollment is complete in three of its late-stage clinical trials.
“We are pleased to be executing on our strategic plan with the achievement of these patient enrollment milestones in the clinical development programs for denufosol, PROLACRIA™ and AZASITE®, as this places us in a position to have top-line results from all our late-stage clinical programs within 18 months. We would like to thank the dedicated clinical investigators, study coordinators and patients who participated in our trials as well as the Cystic Fibrosis Foundation and its affiliates for raising awareness of the importance of participating in clinical trials,” stated Benjamin R. Yerxa, Ph.D., Executive Vice President and Chief, Research and Development.
Denufosol Tetrasodium for Cystic Fibrosis
Inspire announced today that TIGER-2, the Company’s second Phase 3 pivotal clinical trial (Trial 08-110) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF), has completed patient enrollment. TIGER-2 is a 48-week trial comparing 60 mg of denufosol to placebo, administered three-times daily by jet nebulizer, in a targeted 450 CF patients. The Company expects to have top-line results from TIGER-2 in the first quarter of 2011.
“We are excited that patient enrollment in TIGER-2 is complete. This is an important step toward bringing this potential new treatment to cystic fibrosis patients,” said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. “Denufosol’s novel approach to treating the underlying ion channel defect in CF lung disease makes it a promising therapy, and we look forward to the results from this trial.”
PROLACRIA™ for Dry Eye
Inspire also announced today that patient enrollment is complete in its Phase 3 clinical trial (Trial 03-113) with PROLACRIA, the proposed U.S. tradename for diquafosol tetrasodium ophthalmic solution 2%, for the treatment of dry eye disease. This is a six-week trial comparing PROLACRIA to placebo, administered four-times daily as eye drops, in a targeted 450 dry eye patients. The trial is based on a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The Company expects to have top-line results from this trial in the first quarter of 2010.
Gary N. Foulks, M.D., F.A.C.S., Professor of Ophthalmology and Visual Science and Director of Corneal/External Disease at Kentucky Lions Eye Center, University of Louisville, and principal investigator of Trial 03-113, stated, “There is a significant need for new therapeutic treatments for dry eye disease. With its novel mechanism of action of stimulating the production of natural tear components, PROLACRIA could be of significant benefit to patients suffering from dry eye.”
AZASITE® for Blepharitis
The AZASITE (azithromycin ophthalmic solution) 1% for blepharitis Phase 2 program is targeted to enroll approximately 600 patients in two trials. One trial (Trial 044-101) includes a two-week treatment period with a two-week follow-up period and the other trial (Trial 044-102) includes a four-week treatment period with a four-week follow-up period. Inspire announced today that enrollment is complete in the four-week trial and enrollment in the two-week trial is progressing well with 250 out of a targeted 300 patients enrolled. The Company expects to have enrollment completed in the two-week trial in the first quarter of 2010.
About Denufosol Tetrasodium
Denufosol tetrasodium is a first-in-class receptor-mediated chloride channel activator that addresses the underlying ion transport defect in the lungs of patients with cystic fibrosis (CF). Denufosol is designed to enhance airway hydration and mucociliary clearance through receptor-mediated mechanisms that increase chloride secretion, inhibit sodium absorption and increase ciliary beat frequency. These integrated pharmacological actions are important to restoring airway clearance, maintaining lung function, and potentially delaying the progression of CF lung disease. Denufosol is targeted as an early intervention therapy for CF lung disease. This product candidate has been granted orphan drug and fast-track review status by the U.S. Food and Drug Administration (FDA) and orphan drug status by the European Medicines Agency (EMEA).
About PROLACRIA™
PROLACRIA, the proposed U.S. tradename for diquafosol tetrasodium ophthalmic solution 2%, is a proprietary and selective P2Y2 agonist Inspire is developing for the treatment of dry eye disease. PROLACRIA is designed to stimulate the release of the three natural tear components involved in tear secretion - mucin, lipids and fluid.
About AZASITE®
AZASITE (azithromycin ophthalmic solution) 1% is a prescription medicine approved by the U.S. Food and Drug Administration for the treatment of bacterial conjunctivitis in adults and children 1 year of age and older. AZASITE is for topical ophthalmic use only. In clinical trials, the most frequently reported ocular adverse event was eye irritation, which occurred in 1% - 2% of patients. Please see full Prescribing Information for AZASITE at www.azasite.com. Inspire is pursuing an additional potential indication for AZASITE for the treatment of blepharitis.
surf1944
15年前
Inspire Announces Pricing of $100 Million Common Stock Offering
Press Release
Source: Inspire Pharmaceuticals, Inc.
On Wednesday August 5, 2009, 9:05 am EDT
Companies:Inspire Pharmaceuticals, Inc.
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH - News) announced today the pricing of its previously announced public offering of its common stock at a price to the public of $4.50 per share and an increase in the offering size to 22.2 million shares. Inspire has granted Deutsche Bank Securities Inc., the sole underwriter of the offering, an option to purchase up to an additional 3.3 million shares of common stock to cover over-allotments, if any. All of the shares in the offering are being offered by Inspire. Inspire expects the offering to close on August 10, 2009.
Inspire has filed a registration statement, as well as a prospectus supplement and an accompanying prospectus, with the Securities and Exchange Commission (SEC) for the offering to which this communication relates. The prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, by sending a request to Deutsche Bank Securities Inc., Attn: Prospectus Department, 100 Plaza One, Jersey City, NJ 07311, Telephone number: +1-800-503-4611, Email: prospectusrequest@list.db.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
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. These statements are based upon the current beliefs and expectations of Inspire’s management and are subject to significant risks and uncertainties. Specifically, no assurances can be made with respect to: Inspire’s successful closing of the offering and the underwriter’s exercise of its over-allotment option. 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, intellectual property rights, 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. 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.
Contact:
Investor Contact:Inspire Pharmaceuticals, Inc.Jenny Kobin, VP, Investor Relations andCorporate Communications, 919-941-9777, Ext. 219orThomas R. Staab, II, Chief Financial Officer andTreasurer, 919-941-9777, Ext. 267orMedia Contact:Inspire Pharmaceuticals, Inc.
surf1944
16年前
Inspire Initiates Special Protocol Assessment Process for Prolacria(TM) Trial for Dry Eye
Tuesday September 23, 9:00 am ET
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today it has submitted a clinical protocol and request for Special Protocol Assessment (SPA) to the U.S. Food and Drug Administration (FDA) for a pivotal Phase 3 environmental trial with Prolacria™ (diquafosol tetrasodium ophthalmic solution) for the treatment of dry eye disease.
The protocol is based on information from a detailed analysis of the overall Prolacria clinical trial data to date, including Inspire’s Phase 3 trials and recently completed pilot trial, and consultation with the FDA, Allergan, Inspire’s corporate partner, and other dry eye experts. After detailed analysis, Inspire determined that designing and conducting a further environmental trial was a more appropriate course than further studies of Prolacria in a controlled adverse environment (dry eye chamber). The proposed environmental trial focuses on evaluating the effects of Prolacria on the central region of the cornea measured using the fluorescein staining technique. Once a final SPA agreement is in place, additional details on the trial design will be provided.
“We have taken a methodical approach to identify the appropriate clinical trial design for an additional Phase 3 dry eye trial with Prolacria. In consultation with the FDA, we believe requesting an SPA is a prudent step forward prior to initiating this additional trial,” stated Christy L. Shaffer, Ph.D., President and CEO of Inspire.
About Prolacria™ and Dry Eye
Prolacria is an internally developed P2Y2 receptor agonist being developed by Inspire as an eye drop that stimulates release of the three natural tear components involved in tear secretion - mucin, lipids and fluid. Inspire estimates, based on an extrapolation from U.S. data, that dry eye disease affects over 30 million people in the eight major international prescription pharmaceutical markets, of which over nine million are in North America. Inspire filed an NDA with the FDA in 2003 for Prolacria for the treatment of dry eye disease and has received two approvable letters from the FDA.
surf1944
16年前
Inspire Announces Plans for Clinical Testing of New Compound INS117548 for the Treatment of Glaucoma
Thursday September 11, 7:30 am ET
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today that the standard 30-day review period by the U.S. Food and Drug Administration (FDA) relating to Inspire’s Investigational New Drug Application (IND) for INS117548 Ophthalmic Solution for the treatment of glaucoma has concluded and clinical testing can proceed.
Inspire is currently targeting the initiation of a Phase 1 clinical trial by the end of 2008 to evaluate the tolerability and efficacy of this product candidate in subjects with early stage glaucoma or ocular hypertension.
INS117548 is a rho kinase inhibitor designed to lower intraocular pressure (IOP) in glaucoma patients by disrupting the actin cytoskeleton (cellular skeleton) of the trabecular meshwork, an ocular tissue responsible for most of the outflow of aqueous humor. The elevated IOP commonly associated with glaucoma is believed to arise from impairment in the function of the trabecular meshwork. Currently, none of the FDA-approved, IOP-lowering medications directly target this tissue, so INS117548 may provide a novel approach for lowering IOP by directly enhancing the physiologic function of the trabecular meshwork.
The technology platform that led to the discovery of INS117548 is based on a license agreement with the Wisconsin Alumni Research Foundation (WARF) for use in developing and commercializing new therapies to treat glaucoma. The related patents are based upon research conducted by Paul Kaufman, M.D., Professor and Chair, Department of Ophthalmology and Visual Sciences of the University of Wisconsin-Madison, and Benjamin Geiger, Ph.D., Professor of Molecular Cell and Tumor Biology, and Dean of Biology at the Weizmann Institute of Science in Israel. Inspire has an additional compound, INS115644, related to this platform that is also in Phase 1 clinical testing.
Dr. Kaufman stated, “There remains an important need to identify new treatments for glaucoma, a leading cause of blindness affecting nearly 70 million people worldwide. For many patients, current treatments have limited benefit or multiple eye drops must be used to keep the disease under control. Inspire has made excellent progress in moving this program from the preclinical stage to human clinical testing with multiple compounds being studied to provide critical information about this targeted approach.”
surf1944
16年前
Inspire Reports Second Quarter 2008 Financial Results
Monday August 11, 7:30 am ET
- Q2 2008 Revenue Increased by 43% over Q2 2007 -
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ:ISPH - News) announced today financial results for the second quarter ended June 30, 2008, reporting a net loss of $6.4 million, or ($0.11) per share.
Total revenue for the second quarter of 2008 was $22.0 million, as compared to $15.4 million for the second quarter of 2007. Revenue from AzaSite® (azithromycin ophthalmic solution) 1%, a bacterial conjunctivitis treatment launched in August 2007, totaled $4.1 million in the second quarter of 2008.
Total co-promotion revenue for the second quarter of 2008 of $16.7 million, comprised of co-promotion revenue from net sales of Restasis® (cyclosporine ophthalmic emulsion) 0.05% and Elestat (epinastine HCl ophthalmic solution) 0.05%, increased approximately 8%, as compared to the second quarter of 2007. Co-promotion revenue from Restasis was $8.9 million and from Elestat® was $7.8 million, as compared to $5.7 million and $9.7 million, respectively, recognized in the second quarter of 2007. In addition, the Company has deferred $2.6 million of revenue from net sales of Elestat that occurred in the first six months of 2008. Under the co-promotion agreement for Elestat, Inspire is entitled to a percentage of net sales based upon predetermined calendar year net sales target levels. As the 2008 annual minimum has not been achieved in the second quarter of 2008, a portion of Elestat co-promotion revenue has been recorded as deferred revenue. This deferred revenue is expected to be recognized in 2008 when the annual minimum net sales target level is achieved.
The Company also recognized $1.25 million in collaborative research and development revenue in the second quarter of 2008 received pursuant to a collaborative research agreement with Santen Pharmaceutical Co., Ltd. related to Santen’s completion of Phase 3 development of diquafosol tetrasodium for dry eye disease in Japan.
Total revenue for the six months ended June 30, 2008 was $31.7 million and represented a 40% increase over the total revenue of $22.6 million for the same period in 2007. Total revenue for the six months ended June 30, 2008 was comprised of $24.1 million of co-promotion revenue on net sales of Restasis and Elestat, $6.4 million of net AzaSite revenue and $1.25 million of collaborative and research development revenue. In comparison, total revenue for the six months ended June 30, 2007 was comprised solely of co-promotion revenue on net sales of Restasis and Elestat.
Operating expenses for the second quarter of 2008 totaled $27.9 million, a 30% increase compared to $21.4 million for the same period in 2007. The increase in second quarter 2008 operating expenses, compared to 2007, was primarily due to the expansion of the Company’s sales force and other costs associated with the commercialization of AzaSite, including AzaSite cost of sales of $1.6 million.
Operating expenses for the six months ended June 30, 2008 were $63.4 million, as compared to $55.4 million for the same period in 2007. The increase in six month 2008 operating expenses, as compared to 2007, was primarily due to the increased sales and marketing expenses partially offset by a decrease in research and development expenses associated with a $13 million upfront AzaSite licensing fee paid in the first quarter of 2007.
Total stock-based compensation expenses were $1.1 million and $2.1 million for the second quarter and six months ended June 30, 2008, as compared to $642,000 and $1.1 million, respectively, for the same periods in 2007.
For the second quarter ended June 30, 2008, the Company reported a net loss of $6.4 million, or ($0.11) per share, as compared to a net loss of $5.9 million, or ($0.14) per share, for the same period in 2007. The net loss for the six months ended June 30, 2008 was $32.3 million, or ($0.57) per share, as compared to a net loss of $32.0 million, or ($0.76) per share for the same period in 2007. Cash, cash equivalents and investments totaled $94.4 million at June 30, 2008, reflecting a $45.3 million utilization of cash and investments during the first half of 2008.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, “The second quarter was productive, with positive Phase 3 results in our CF program, a regulatory filing in Japan by our Asian dry eye partner, Santen, and growing product revenues. The recent success of our Phase 3 cystic fibrosis trial, TIGER-1, validates our novel approach of addressing the underlying ion channel defect. We are building on this success both by refining our clinical development program based on the extensive data set from TIGER-1 and by moving forward aggressively with plans to maximize the future potential of denufosol.”
Recent Updates Include (April 1, 2008 through August 11, 2008):
Ophthalmology Research & Development
* Completed and confirmed positive results in three small, open-label Phase 4 trials designed to provide additional information on AzaSite related to pharmacokinetic profile and lid margin disease;
* Received $1.25 million milestone payment from our Asian dry eye partner, Santen Pharmaceutical Co., Ltd, related to the completion of Santen’s Phase 3 testing of diquafosol for the treatment of dry eye; Santen filed an application for manufacturing and marketing approval of the compound with Japanese regulators in May 2008; and
* Presented poster presentations at the Association for Research in Vision and Ophthalmology and the American Society of Cataract and Refractive Surgery Symposium in April 2008.
Pulmonary Research & Development
* Announced top-line results from the first Phase 3 trial (TIGER-1) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF);
* Modified second Phase 3 CF trial (TIGER-2) based on analysis of TIGER-1 data; and
* Discontinued development of epinastine nasal spray for the treatment of seasonal allergic rhinitis.
Sales and Marketing
* In collaboration with Allergan, Inc., increased prescription volume of Restasis, whereby Allergan reported net sales of Restasis of $120 million for the three months ended June 30, 2008, representing a 55% increase in revenue over the same period in 2007. On July 30, 2008, Allergan revised its 2008 guidance to reflect an increase in net sales of Restasis to be in the range of $420-$440 million as compared to the previous guidance range of $375-$405 million; and
* Increased second quarter 2008 prescription volume and associated net revenues of AzaSite by 59% and 79%, respectively, over the first quarter of 2008.
Corporate
* Ranked second overall in the "Best Places to Work in Industry" annual survey conducted by The Scientist magazine, received a Gold-level award by the American Heart Association as a Start! Fit-Friendly Company and was recognized by Business Leader magazine as one of the "2008 Healthiest Companies" in the Research Triangle Park.
Financial Outlook for 2008
Inspire’s 2008 financial results will be highly dependent on the clinical developments and corporate plans for the denufosol, Prolacria, and glaucoma programs as well as revenue from product sales, including sales of AzaSite. Based upon current AzaSite, Restasis and Elestat trends, Inspire expects to record 2008 aggregate revenue in the range of $62-$76 million and expects 2008 total operating expenses to be in the range of $109-$129 million. Cost of sales, which includes the amortization of the AzaSite approval milestone and royalty obligations to InSite Vision, is expected to be in the range of $5-$8 million and is included as a component of total operating expense in 2008. Total estimated selling and marketing and general and administrative expenses are estimated to be in the ranges of $50-$57 million and $14-$18 million, respectively, in 2008. Research and development expenses are estimated to be in the range of $42-$54 million in 2008. Included within this operating expense guidance are projected stock-based compensation costs of approximately $5 million. Cash utilization in 2008 is expected to be in the range of $50-$80 million, which incorporates $14 million of principal repayment on the Company’s outstanding debt. Based on current operating plans, the Company expects its cash and investments to provide liquidity through 2009.
Inspire will host a conference call and live webcast to discuss its second quarter 2008 financial results on Monday, August 11, 2008 at 10:00 a.m. ET. To access the conference call, U.S. participants may call 877-648-7970 and international participants may call 706-902-0415. The conference ID number is 56982011. A live webcast 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 25, 2008. To access this replay, U.S. participants may call 800-642-1687 and international participants may call 706-645-9291. The conference ID number is 56982011.
About Inspire
Inspire is a biopharmaceutical company dedicated to discovering, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire employs a U.S. sales force for the promotion of AzaSite® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat® (epinastine HCI ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is currently developing products for dry eye, cystic fibrosis and glaucoma. Elestat, Restasis and Prolacria are trademarks owned by Allergan, Inc. AzaSite is a trademark owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.
surf1944
16年前
Inspire Announces Achievement of Primary Endpoint in Phase 3 Trial with Denufosol for Cystic Fibrosis
Friday June 6, 7:00 am ET
Conference Call Scheduled for 9:00 AM ET on June 6, 2008
Detailed Results to Be Presented at North American Cystic Fibrosis Conference in October 2008
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today top-line results from the 352-patient, double-blind, 24-week placebo-controlled portion of its Phase 3 trial (TIGER-1) with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF).
The trial demonstrated statistical significance for its primary efficacy endpoint, which was the change in FEV1 (Forced Expiratory Volume in One Second) from baseline at the trial endpoint (at 24 weeks or last observation carried forward). Patients treated with denufosol had a statistically significant improvement in FEV1 compared to placebo (45 milliliter treatment group difference, p = 0.047). On average, patients on denufosol improved relative to baseline whereas patients on placebo remained essentially unchanged. The treatment effect of denufosol increased over the 24-week placebo-controlled period, and available preliminary data from approximately 210 patients who have completed the ongoing open-label safety extension (including the placebo patients switched to denufosol) suggest that FEV1 continued to improve during the extension period from weeks 24 to 48.
Secondary endpoints were also evaluated in the trial. There was a trend in differences in FEF (25%-75%) (Forced Expiratory Flow 25%-75%), a measure of small airway function, favoring denufosol over placebo (p = 0.072). There were no statistically significant differences between denufosol and placebo relative to pulmonary exacerbations. Data analysis is ongoing for various other pre-specified secondary endpoints and sub-groups.
For the 352 subjects randomized, the treatment groups were balanced with respect to key demographic and background characteristics: the mean age was approximately 14.6 years old, the mean lung function at baseline was 92% of the predicted normal value of FEV1, and the use of concomitant medications included inhaled antibiotics (37%), dornase alfa (Pulmozyme®) (77%) and oral macrolide antibiotics (40%). Approximately one-half of patients were receiving three or more pulmonary medications for the treatment of their disease during the course of this trial. This trial demonstrated that the effects of denufosol on FEV1 were beneficial in this population of patients taking multiple commonly-prescribed CF pulmonary medications.
Denufosol was well-tolerated and had a favorable safety profile in the trial. Patient retention rates were high and similar between treatment groups with approximately 90% of patients completing the 24-week placebo-controlled portion. The incidence of adverse events in the denufosol group was comparable to placebo. As in previous trials, the most common adverse event was cough, which was similar in both groups. There were no apparent treatment effects with respect to height, weight or body mass index. The clinical laboratory profiles were similar between the groups. Seven patients withdrew due to adverse events (five denufosol and two placebo recipients).
Following the 24-week placebo-controlled period, approximately 315 patients continued into the open-label safety extension portion of the trial and approximately 213 of those patients have now completed the full trial for a total of 48 weeks. The patient discontinuation rate in the open-label safety extension is currently less than 4%.
Frank J. Accurso, M.D., Professor of Pediatrics and Cystic Fibrosis Center Director, University of Colorado and The Children’s Hospital Denver, and lead principal investigator of TIGER-1, stated “The results from this trial are exciting because they demonstrate that denufosol’s novel mechanism of action, activation of an alternative chloride channel that is treating the underlying defect, had a clinically-meaningful impact on lung function that progressively increased over time. The improvement in FEV1 was achieved on top of aggressive use of multiple concomitant medications, such as inhaled antibiotics, dornase alfa and oral macrolide antibiotics. The benefit in lung function observed in these relatively young patients, with a mean age of around 14 years, was encouraging. In particular, adolescence is an especially vulnerable time for these patients, where lung function generally declines. In this trial, denufosol had a favorable safety profile and provided benefit to CF patients.”
Robert J. Beall, Ph.D., President and CEO, Cystic Fibrosis Foundation, commented, “The data from this Phase 3 trial with denufosol are encouraging for the cystic fibrosis community because it brings us one step closer to a novel treatment that addresses the basic cystic fibrosis defect. There remains a high unmet medical need in the area of CF treatments and denufosol could be an important addition to the treatment regimen. The Foundation has worked closely with Inspire from the beginning of this program and provided funding for a key Phase 2 clinical trial. This validates our business model to support highly innovative potential new treatments for CF.”
“We are pleased that denufosol met the primary efficacy endpoint in TIGER-1 and we will continue to work toward bringing this new treatment to the cystic fibrosis community,” stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. “We would like to thank the Cystic Fibrosis Foundation, the Therapeutics Development Network and all of the dedicated patients, investigators, and study coordinators who participated in TIGER-1. We also want to thank the patients’ families for their support and interest in denufosol. We plan to use the valuable information generated in this trial to further optimize TIGER-2 which began enrolling patients a few months ago.”
Next Steps
Additional analyses are ongoing and next steps in the program will be discussed with key advisors from the CF medical community and the U.S. Food and Drug Administration (FDA). Data from this trial have yet to be reviewed by the FDA. The Company continues to expect that results from the ongoing development work including the TIGER-1 open-label safety extension, TIGER-2 (the second pivotal Phase 3 trial), and a two-year pre-clinical carcinogenicity study, will be necessary for filing a new drug application (NDA) for denufosol. Detailed data from TIGER-1 will be presented at the North American Cystic Fibrosis (NACF) conference scheduled for October 23-25, 2008 in Orlando, Florida. The results from the ongoing open-label extension phase of TIGER-1, in which all patients are receiving denufosol, are expected to be available in the first quarter of 2009.
Conference Call
Inspire will host a conference call and live webcast to discuss the TIGER-1 results today, June 6, 2008 at 9:00 a.m. ET. To access the conference call, U.S. participants may call (877) 648-7970 and international participants may call (706) 902-0415. The conference ID number is 50926500. A live webcast 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 June 20, 2008. To access this replay, U.S. participants may call (800) 642-1687 and international participants may call (706) 645-9291. The conference ID number for the replay is also 50926500.
surf1944
17年前
Inspire Reports First Quarter 2008 Financial Results
Thursday May 8, 7:30 am ET
- Q1 2008 Revenue Increased by 35% over Q1 2007 -
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today financial results for the first quarter ended March 31, 2008, reporting a net loss of $25.9 million, or ($0.46) per share.
Total revenue for the first quarter of 2008 was $9.7 million, as compared to $7.2 million for the first quarter of 2007, reflecting an increase of 35%. Revenue from AzaSite® (azithromycin ophthalmic solution) 1%, a bacterial conjunctivitis treatment launched in August 2007, totaled $2.3 million in the first quarter of 2008 as compared to no revenue in the first quarter of 2007. Co-promotion revenue from net sales of Restasis® (cyclosporine ophthalmic emulsion) 0.05% for the first quarter of 2008 was $7.4 million, an increase of 54% compared to $4.8 million recognized in the first quarter of 2007. All of the co-promotion revenue from net sales of Elestat® (epinastine HCl ophthalmic solution) 0.05% for the first quarter of 2008 was deferred, as compared to $2.4 million recognized in the first quarter of 2007. The Company had $3.8 million and $2.4 million of deferred revenue from sales of Elestat as of the end of March 31, 2008 and 2007, respectively. Under the co-promotion agreement for Elestat, Inspire is entitled to a percentage of net sales based upon pre-set calendar year net sales target levels. As the annual minimum was not achieved in the first quarter of 2008, all Elestat co-promotion revenue has been recorded as deferred revenue. This deferred revenue will be recognized in subsequent quarters of 2008 when, and to the extent, 2008 net sales target levels for Elestat are achieved.
Operating expenses for the first quarter of 2008 totaled $35.6 million, as compared to $33.9 million for the same period in 2007, reflecting an increase of 5%. The increase in first quarter 2008 operating expenses, as compared to 2007, was primarily due to increased sales and marketing expenses of $8.7 million due to the expansion of the Company’s sales force and other costs associated with the commercialization of AzaSite, including cost of sales of $1.0 million. These increases were partially offset by a decrease in research and development expenses of $8.0 million, primarily due to a $13 million upfront licensing fee paid to InSite Vision in the first quarter of 2007 to acquire the exclusive rights to commercialize AzaSite.
For the first quarter ended March 31, 2008, the Company reported a net loss of $25.9 million, or ($0.46) per share, as compared to a net loss of $26.1 million, or ($0.62) per share, for the same period in 2007. Cash, cash equivalents and investments totaled $109.1 million at March 31, 2008, reflecting a $30.6 million utilization of cash and investments during the first quarter.
Christy L. Shaffer, Ph.D., President and CEO of Inspire, stated, “We have multiple value drivers on which we are focused, including three marketed products and three innovative clinical development programs. During the first quarter of 2008, we enhanced these programs through the initiation of the second pivotal cystic fibrosis trial for denufosol, a pilot trial for Prolacria, and several Phase 4 trials for AzaSite. Importantly, we remain on track to have important data points later this year in our key Phase 3 programs in cystic fibrosis and dry eye.”
Recent Updates Include (January 1, 2008 through May 8, 2008):
Ophthalmology Research & Development
* Initiated five Phase 4 trials to expand the scientific database on AzaSite;
* Initiated and completed patient enrollment in a pilot clinical trial studying Prolacria in a proprietary dry eye model; and
* Presented poster presentations at the Association for Research in Vision and Ophthalmology and the American Society of Cataract and Refractive Surgery Symposium in April 2008.
Respiratory/Allergy Research & Development
* Initiated the second pivotal Phase 3 clinical trial with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis, TIGER-2;
* Discontinued development of epinastine nasal spray and oral bilastine for the treatment of allergic rhinitis; and
* Presented poster presentations at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual meeting in March 2008.
Sales and Marketing
* In collaboration with Allergan, Inc., increased prescription volume of Restasis, whereby Allergan reported first quarter 2008 net sales of Restasis of $100 million, representing a 28% increase in revenue over the first quarter of 2007. On May 7, 2008, Allergan confirmed 2008 guidance for net sales of Restasis to be in the range of $375-$405 million;
* Maintained approximately 8% market share for Elestat in the total branded U.S. allergic conjunctivitis market for the year-to-date period ended April 18, 2008, based on prescription data from IMS Health; and
* AzaSite surpassed 5,200 in weekly prescriptions for the week ended April 18, 2008, based on prescription data from IMS Health.
Corporate
* Announced William R. Ringo, Jr. will resign from the Board of Directors of the Company at the annual meeting scheduled for June 10, 2008. Mr. Ringo has accepted a position as Senior Vice President of Strategy and Business Development at Pfizer, Inc.
Financial Outlook for 2008
Inspire’s 2008 financial results will be highly dependent on the clinical and regulatory developments and corporate plans for the denufosol, Prolacria, and glaucoma programs as well as revenue from product sales, including sales of AzaSite, for which Inspire has only limited historical sales data and experience. Based upon current AzaSite, Restasis and Elestat trends, Inspire expects to record 2008 aggregate revenue in the range of $62-$76 million and expects 2008 total operating expenses to be in the range of $109-$129 million. Cost of sales, which includes the amortization of the AzaSite approval milestone and royalty obligations to InSite Vision, is expected to be in the range of $5-$8 million and is included as a component of total operating expense in 2008. Total estimated selling and marketing and general and administrative expenses are estimated to be in the ranges of $50-$57 million and $14-$18 million, respectively, in 2008. Research and development expenses are estimated to be in the range of $42-$54 million in 2008. Included within this operating expense guidance are projected stock-based compensation costs of approximately $5 million. Cash utilization in 2008 is expected to be in the range of $50-$80 million, which incorporates $14 million of principal repayment on the Company’s outstanding debt. Based on current operating plans, the Company expects its cash and investments to provide liquidity through 2009.
Inspire will host a conference call and live webcast to discuss its first quarter 2008 financial results on Thursday, May 8, 2008 at 10:00 a.m. ET. To access the conference call, U.S. participants may call (877) 648-7970 and international participants may call (706) 902-0415. The conference ID number is 44700402. A live webcast 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 May 22, 2008. To access this replay, U.S. participants may call (800) 642-1687 and international participants may call (706) 645-9291. The conference ID number for the replay is also 44700402.
http://biz.yahoo.com/bw/080508/20080508005122.html?.v=1
surf1944
17年前
Inspire Announces Poster Presentations at 2008 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting
Friday March 14, 7:30 am ET
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today that Inspire scientists and collaborators will present information in two poster presentations at the 2008 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting being held March 14 - 18, 2008 in Philadelphia.
The poster entitled “Pharmacokinetic Model of Epinastine, an H1 Antagonist, after Nasal Administration” (C. Crean, P. Ratner, M. Widmann, A. Schaberg, D. Kellerman) contains data from Inspire’s Phase 2 trial with epinastine nasal spray for the treatment of Seasonal Allergic Rhinitis (SAR). The poster focuses on modeling the systemic absorption of epinastine when administered nasally and a comparison to oral delivery.
The second poster entitled “The Use of Oral Antihistamines (OA) in Moderate to Severe Dry Eye Patients” (D. Kellerman, T. Durham, A. Schaberg, K. Kuhn, A. Woodring, K. Brazzell, G. Foulks, E. Meltzer) contains data from Inspire’s Phase 3 program with Prolacria™ (diquafosol tetrasodium) for the treatment of dry eye. The poster is related to the incidence of use of oral antihistamines by patients with moderate to severe dry eye from the clinical trials.
The posters will be available following the conference on Inspire’s website, www.inspirepharm.com.
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 employs a U.S. sales force for the promotion of AzaSite® (azithromycin ophthalmic solution) 1% for bacterial conjunctivitis, Elestat® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and Restasis® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. Inspire is focused on the therapeutic areas of ophthalmology and respiratory/allergy, and is developing products for dry eye, cystic fibrosis, allergic rhinitis and glaucoma. Elestat and Restasis are registered trademarks owned by Allergan, Inc. AzaSite is a registered trademark owned by InSite Vision Incorporated. For more information, visit www.inspirepharm.com.
surf1944
17年前
Inspire Initiates Second Phase 3 Cystic Fibrosis Trial
Wednesday February 13, 7:30 am ET
TIGER-2 Targeting Enrollment of 350 Patients with Mild Cystic Fibrosis Lung Disease
DURHAM, N.C.--(BUSINESS WIRE)--Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH - News) announced today the initiation of TIGER-2, its second pivotal Phase 3 clinical trial with denufosol tetrasodium inhalation solution for the treatment of cystic fibrosis (CF).
TIGER-2 (Transport of Ions to Generate Epithelial Rehydration) is a 24-week, double-blind, placebo-controlled, randomized study comparing 60 mg of denufosol inhaled three times daily to placebo in approximately 350 CF patients with FEV1 (Forced Expiratory Volume in one second) greater than or equal to 75% of predicted normal. The trial’s primary efficacy endpoint is change from baseline in FEV1 (liters) at the 24-week timepoint. Secondary endpoints include other lung function parameters, pulmonary exacerbations, requirements for concomitant CF medications and quality of life.
TIGER-2 is beginning with enrollment in U.S. and Canadian sites, to be followed by enrollment in international sites later as the trial proceeds. Patients aged 5 years and older are eligible for enrollment. The use of standard CF maintenance therapies is permitted during the trial.
“Denufosol could be the first early intervention therapy available to CF patients that affects an early step in the progression of the disease,” stated Felix Ratjen, M.D., Ph.D., Professor of Pediatrics and Division Chief, Respiratory Medicine, University of Toronto, and lead principal investigator of TIGER-2. “There is strong interest in the CF community about this novel approach to treating the disease and I look forward to working with Inspire on the development of denufosol.”
“We are excited to take this important next step in the denufosol Phase 3 program,” stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. “We appreciate the collaborative efforts of the CF clinical sites and the Cystic Fibrosis Foundation to increase patient awareness of potential new therapies, such as denufosol.”
TIGER-1, Inspire’s first Phase 3 study with denufosol for cystic fibrosis, completed enrollment in October 2007 and the Company expects to report top-line efficacy results for this initial trial mid-2008.
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