inspire

Durham, N.C.-Based Inspire Pharmaceuticals Cuts Back on Spending  
 
DURHAM, N.C., Jan 30, 2002 (The News & Observer - Knight Ridder/Tribune Business News via COMTEX) -- Inspire Pharmaceuticals is placing two of its drug-development programs on hold in an effort to reduce operating expenses by 25 percent this year.

The spending cuts planned by the Durham-based company are deeper than initially expected. Two weeks ago, the company announced disappointing test results for its lead drug candidate, a treatment for dry-eye disease. The company reiterated, however, that its cost-cutting won't involve layoffs among its 58-person work force.

Instead, Inspire will shift employees who were working on the experimental drugs that were put on the back burner into developing the company's priority projects: four experimental drugs that are in clinical trials.

"We want to move these good opportunities forward," spokeswoman Mary Bennett said. "We do need our people to do that."

Bennett didn't rule out cutting back on the company's 10 contract workers, most of whom work full time. But no such decision has been made yet. "Right now, we're putting them to very hard work," she said.

The two programs put on hold are "longer-term opportunities" that wouldn't generate revenue as soon as the drugs that remain in active development, Bennett said. "We can go back to these other programs. They are still good programs."

The drugs put on hold for now are treatments for chronic bronchitis and vaginal dryness. Patient enrollment in Phase II tests of the chronic bronchitis treatment was suspended last spring because of concerns about the trial's design, but Inspire had planned to restart the study this year. The company hadn't yet begun clinical trials for its vaginal-dryness medication but had expected to do so this year.

Inspire shares fell 73 percent Jan. 16 when the company disclosed that its leading drug candidate didn't work any better than a placebo in the latest tests. The Phase III tests found that the drug was in fact effective in treating the disease -- but so were the saline drops used as a placebo.

Inspire hasn't abandoned the drug. Instead, the company is continuing to analyze the data before determining what its next step should be.

In addition to the dry-eye treatment, Inspire is continuing development of a diagnostic for lung cancer and treatments for cystic fibrosis, sinusitis and cystic fibrosis. In addition, the company intends to complete a Phase I/II trial now under way of a treatment for retinal detachment before determining whether it, too, should be a priority.

Inspire shares closed Tuesday at $3.16, down 10 cents for the day, and 80 percent off the 52-week high Jan. 9.

By David Ranii
To see more of The News & Observer, or to subscribe to the newspaper, go to www.newsobserver.com.


(c) 2002, The News & Observer, Raleigh, N.C. Distributed by Knight Ridder/Tribune Business News.

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STOCK SYMBOLS: [(isph)]






 





 

 

DURHAM, N.C., Feb 6, 2002 /PRNewswire-FirstCall via COMTEX/ -- In conjunction with Inspire's Fourth Quarter/Year-End earnings release, you are invited to listen to its conference call which will be broadcast live over the Internet on Friday, February 15th at 9:00 a.m. EST, with Christy Shaffer, Ph.D., President and Chief Executive Officer, and Greg Mossinghoff, Senior Vice President and Chief Business Officer.


What: Inspire - Fourth Quarter/Year-End Earnings Announcement

When: Friday, February 15th, 2002 at 9:00 a.m. EST

Where: www.videonewswire.com/INSPIRE/021502/

How: Live over the Internet -- Simply log on to the Web at the
address above.

Contact: Donald Murphy, Noonan/Russo Communications, 212-696-4455, x257

Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has six product candidates in clinical development, and has development and commercialization alliances with Allergan, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on proprietary technology relating to P2Y receptors. Inspire is exploring other target diseases where it believes P2Y receptors play important biological roles.

(Minimum Requirements to listen to broadcast: The RealPlayer software, downloadable free from www.real.com/products/player/index.html, or The Windows Media Player, downloadable free from www.microsoft.com and at least a 14.4Kbps connection to the Internet. If you experience problems listening to the broadcast, send an email to webmaster@vdat.com.)



 

Inspire Pharmaceuticals, Inc. Reports Fourth Quarter and Year End 2001Financial Results

DURHAM, N.C., Feb 15, 2002 /PRNewswire-FirstCall via COMTEX/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today reported financial results for the fourth quarter and year ended December 31, 2001.Total revenues for the fourth quarter of 2001 increased to $2.2 million from $1.9 million for the same period in 2000. For the year ended December 31, 2001, revenues increased to $7.3 million from $5.4 million for the comparable period in 2000. The increase in revenue during the fourth quarter and year ended December 31, 2001 resulted from revenues that relate to licensing fees and milestone payments received from collaborative partners in 1999, 2000 and 2001.Net loss for the fourth quarter of 2001 was $7.1 million, or $0.28 per common share, as compared to a net loss of $4.8 million, or $0.19 per common share, for the fourth quarter of 2000. For the year ended December 31, 2001, the Company reported a net loss of $23.1 million, or $0.90 per common share, as compared to a net loss of $14.6 million, or $1.23 per common share, for the same period in 2000. Pro forma net loss for the year ended December 31, 2000 was $0.68 per common share. The pro forma net loss amount for 2000 assumes the conversion of all outstanding shares of preferred stock and accrued preferred stock dividends into common stock at the date of their original issuance or beginning of the reporting period, if later. The Company's IPO in the third quarter of 2000 resulted in an increase of 6.3 million shares of common stock outstanding.The increase in net loss for the full year 2001 compared to 2000 was primarily the result of an increase in drug development activities in launching and advancing various clinical programs, as well as increased expenditure on preclinical testing, toxicology studies and costs related to patent activities. The net loss for the full year 2001 was less than that provided in financial guidance for the year, issued by the Company in August 2001."We achieved all of our major corporate objectives in 2001, including advancing our multiple product candidates, securing a new corporate partner and identifying new non-P2Y2 targets," stated Christy L. Shaffer, Ph.D., President and Chief Executive Officer of Inspire. "Our top priority in the near term is to complete a thorough analysis of the results of INS365 Ophthalmic dry eye study 104, the first Phase III trial, and to build on what we learn to determine the best way forward for this important program. We are also moving forward aggressively with our other high-priority programs."Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on proprietary technology relating to P2Y receptors. Inspire is exploring other target diseases where it believes P2Y receptors play important biological roles.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 and earnings expectations, intellectual property rights and 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. 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 to reflect the occurrence of unanticipated events.A live webcast of our conference call on February 15, 9:00 AM Eastern and a replay will be available at www.videonewswire.com/INSPIRE/021502. The webcast and information on dial-in and replay numbers for the conference call are available from Inspire's website at http://www.inspirepharm.com/.Editor's Note: This release is also available at: http://www.noonanrusso.com/ INSPIRE PHARMACEUTICALS, INC. (A Development Stage Company) BALANCE SHEETS (In thousands, except share and per share amounts) December 31, 2001 2000 Assets Current assets: Cash and cash equivalents $29,959 $35,109 Short-term investments 22,395 44,026 Other receivables 104 209 Interest receivable 102 364 Prepaid expenses 531 415 Total current assets 53,091 80,123 Property and equipment, net 1,471 1,214 Other assets 5,525 1,656 Total assets $60,087 $82,993 Liabilities and stockholders' equity Current liabilities: Accounts payable $1,141 $430 Accrued expenses 1,367 852 Notes payable, current portion -- 26 Capital leases, current portion 376 289 Deferred revenue, current portion 4,083 5,618 Total current liabilities 6,967 7,215 Capital leases, excluding current portion 525 523 Deferred revenue, excluding current portion -- 750 Total liabilities 7,492 8,488 Stockholders' equity: Common stock, $0.001 par value, 60,000,000 shares authorized; 25,751,468 and 25,515,087 shares issued and outstanding at December 31, 2001 and 2000, respectively 26 26 Additional paid-in capital 125,099 126,081 Other comprehensive income 1 51 Deferred compensation (1,525) (3,782) Deficit accumulated during the development stage (71,006) (47,871) Total stockholders' equity 52,595 74,505 Total liabilities and stockholders' equity $60,087 $82,993 INSPIRE PHARMACEUTICALS, INC. (A Development Stage Company) STATEMENTS OF OPERATIONS (In thousands, except share and per share amounts) THREE MONTHS ENDED YEAR ENDED Cumulative from Inception (October 28, 1993) to December December December December December 31, 31, 31, 31, 31, 2001 2000 2001 2000 2001 Revenues: Collaborative research agreements $2,238 $1,905 $7,285 $5,368 $14,117 Operating expenses: Research and development (excludes $125, $141, $519, $838 and $1,940, respectively, of stock based compensation) 8,000 5,796 28,190 16,353 70,144 General and administrative expenses (excludes $179, $169, $687, $678 and $1,930, respectively, of stock based compensation) 1,789 1,326 5,882 3,694 18,359 Total operating expenses 9,789 7,122 34,072 20,047 88,503 Operating loss (7,551) (5,217) (26,787) (14,679) (74,386) Other income (expense), net: Interest income 482 871 3,787 2,120 7,016 Interest expense (2) (439) (132) (994) (1,791) Loss on disposal of property and equipment (3) -- (3) (37) (369) Other income (expense), net 477 432 3,652 1,089 4,856 Loss before provision for income taxes (7,074) (4,785) (23,135) (13,590) (69,530) Provision for income taxes -- 50 -- 400 820 Net loss (7,074) (4,835) (23,135) (13,990) (70,350) Preferred stock dividends -- -- -- (594) (656) Net loss available to common stockholders $(7,074) $(4,835) $(23,135) $(14,584) (71,006) Net loss per common share -- basic and diluted $(0.28) $(0.19) $(0.90) $(1.23) Weighted average common shares outstanding -- basic and diluted 25,745,430 25,488,688 25,702,274 11,870,521 Contact: Inspire Pharmaceuticals, Inc. Greg Mossinghoff Senior Vice President and Chief Business Officer (919) 941-9777, Extension 236 Noonan/Russo Media Contact: Robert Stanislaro (212) 696-4455, Extension 337 MAKE YOUR OPINION COUNT - Click Here tbutton.prnewswire.com/prn/11690X10410664SOURCE Inspire Pharmaceuticals, Inc.CONTACT: Greg Mossinghoff, Senior Vice President and Chief Business Officer, Inspire Pharmaceuticals, Inc., +1-919-941-9777, Ext. 236; or Robert Stanislaro, Noonan-Russo, +1-212-696-4455, ext. 337, for Inspire Pharmaceuticals, Inc. /Audio: www.videonewswire.com/INSPIRE/021502 URL: http://www.inspirepharm.com/ http://www.prnewswire.com/Copyright (C) 2002 PR Newswire. All rights reserved.-0-KEYWORD: North Carolina INDUSTRY KEYWORD: ADV SUBJECT CODE: ERN CCASTOCK SYMBOLS: [(isph)]

 

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Inspire Pharmaceuticals, Inc. Announces Completion of Phase I ClinicalTrial For INS37217 Intranasal  
 
DURHAM, N.C., Mar 6, 2002 /PRNewswire-FirstCall via COMTEX/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today announced completion of a Phase I clinical trial for INS37217 Intranasal, being developed as a nasal spray for the potential treatment of upper respiratory disorders involving impaired mucociliary clearance. Results of this trial demonstrated that INS37217 Intranasal was well tolerated across a wide range of doses. In addition, the data showed consistent evidence of pharmacological effect across the study population following single-dose administration, based on a standard measure of mucociliary clearance and transport.

"We are pleased to see evidence of pharmacological activity in this Phase I study, which was designed primarily to assess the safety and tolerability of INS37217 Intranasal," stated Christy L. Shaffer, Ph.D., President and CEO of Inspire. "Based on these results, we are moving forward to design and launch the Phase II program."

The trial was a single-center, randomized, double-blind, placebo-controlled, ascending-dose safety and tolerability study conducted in 60 subjects. One-half of the study subjects were normal, healthy volunteers; the other half were subjects having a history of chronic rhinitis.

"The safety data from this trial indicate that INS37217 Intranasal appears to be well tolerated by patients," stated Eli Meltzer, M.D., Co-Director for the Allergy & Asthma Medical Group and Research Center in San Diego, and principal investigator for the Phase I study. "The novel mechanism of action of this compound could prove valuable in treating a broad array of upper respiratory disorders."

INS37217 Intranasal is a P2Y2 agonist designed to enhance mucosal hydration and mucociliary clearance in airway tissues. Originally targeted for the potential treatment of sinusitis, it is now believed to be potentially useful across a wide variety of upper respiratory disorders involving impaired clearance including rhinosinusitis, allergic rhinitis and upper respiratory viral infections.

Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on proprietary technology relating to P2Y receptors. Inspire is exploring other target diseases where it believes P2Y receptors play important biological roles.

 

des kurses im jänner, durfte jetzt nach einer positiv verlaufenen phase I studie das papier sich einigermassen erhohlen.  

10-K: INSPIRE PHARMACEUTICALS INC  
 
(EDGAR Online via COMTEX) -- Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations.

The discussion below contains forward-looking statements regarding our financial condition and results of operations that are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted within the United States. The preparation of these financial statements requires Inspire management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. Inspire evaluates its estimates on an on-going basis. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Our future results, performance or achievements could differ materially from those expressed in, or implied by, any such forward-looking statements as a result of certain factors, including, but not limited to, those discussed in this section as well as in the section entitled "Risk Factors."

Significant Accounting Policies

Revenue Recognition

We recognize revenue under our collaborative research and development agreements when we have performed services under such agreements or when we or our collaborative partner has met a contractual milestone triggering a payment to us. Non-refundable fees received at the initiation of collaborative agreements for which we have an ongoing research and development commitment are deferred and recognized ratably over the period of ongoing research and clinical development commitment. We are also entitled to receive milestone payments under our collaborative research and development agreements based upon achievement of development milestones by us or our collaborative partners. We recognize milestone payments as revenues ratably over the remaining period of our research and clinical development commitment. The recognition period begins at the date the milestone is achieved and acknowledged by the collaborative partner, which is generally at the date payment is received from the collaborative partner, and ends on the date that we have fulfilled our research and clinical development commitment. This period is based on estimates by management and the progress towards milestones in our collaborative agreements. The estimate is subject to revision as our development efforts progress and we gain knowledge regarding required additional development. Revisions in the commitment period are made in the period that the facts related to the change first become known. This may cause our revenue to fluctuate from period to period.

Taxes

Significant management judgment is required in determining our provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. We have recorded a valuation allowance of $30.0 million as of December 31, 2001, due to uncertainties related to our ability to utilize deferred tax assets, primarily consisting of certain net operating losses carried forward, before they expire. The valuation allowance is based on estimates of taxable income in each of the jurisdictions in which we operate and the period over which our deferred tax assets will be recoverable. In the event the actual results differ from these estimates or we adjust these estimates in future periods we may need to establish an additional valuation allowance which could materially impact our financial position and results of operations.

Overview

We were incorporated in October 1993 and commenced operations in March 1995 following our first substantial financing. Since that time, we have been engaged in the discovery and development of novel pharmaceutical products that treat diseases which are characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance as well as other diseases. Our technologies are based in part on exclusive license agreements with The University of North Carolina at Chapel Hill for rights to certain developments from the founders' laboratories.

To date, we have devoted substantially all of our efforts to discovery and clinical development of our product candidates as well as establishing strategic partnerships for the development and potential marketing of our products when approved. Currently, we have six product candidates in clinical development. We have not derived any commercial revenues from product sales and we do not expect to receive sales revenues for at least the next several years.

We have incurred significant operating losses since our inception and, as of December 31, 2001, we had an accumulated deficit of $71.0 million. We have primarily financed our operations through proceeds received from the sale of equity securities including private sales of preferred stock and the sale of common stock in our initial public offering, as well as revenues received under corporate collaborations. We operate in a single business segment and do not have any foreign operations.

In June 2001, we entered into a joint license, development and marketing agreement with Allergan to develop and commercialize INS365 Ophthalmic and Allergan's Restasis(R). Under the agreement, we may receive up to $39 million in up-front and milestone payments. We will also receive royalty payments on sales, if any, of INS365 Ophthalmic in the United States and on Allergan's Restasis(R) worldwide, excluding most Asian markets. The agreement also provides for potential co-promotion by Inspire of INS365 Ophthalmic and Restasis(R) and one or more of Allergan's other marketed products in the United States.

In September 2000, we entered into a License Agreement with Kirin for the development and commercialization of INS316 Diagnostic. Under the agreement we granted Kirin an exclusive license to commercialize INS316 Diagnostic in most of Asia. Under the terms of the agreement, we received an upfront payment in cash and may receive milestone payments based on clinical success and approval.

In December 1999, we entered into a collaboration with Genentech to develop treatments for respiratory disorders, pursuant to which we received in excess of $16 million in equity and cash payments prior to the termination of the agreement in November 2001. Upon termination, Genentech returned to us all rights for the use of INS365 Respiratory and our other related P2Y2 agonist at no charge.

In December 1998, we entered into a Development, License and Supply Agreement with Santen for the development of INS365 Ophthalmic for the therapeutic treatment of ocular surface diseases. We are obligated to supply Santen with its requirements of INS365 Ophthalmic in bulk drug substance form for all preclinical studies, clinical trials and commercial requirements at agreed-upon prices. Under the agreement, we received an up-front equity investment of $1.5 million for shares of our stock. In addition, if all milestones are met, we could receive additional payments of up to $4.75 million, as well as royalties on net sales of licensed products. We have not received any milestone payments to date under the agreement.

In September 1998, we entered into a Joint Development, License and Supply Agreement with Kissei for the development of INS365 Respiratory for therapeutic lower respiratory applications in Japan. Pursuant to the agreement with Kissei, we received an up-front payment of $4.5 million, which included the purchase of shares of our stock. In addition, if all milestones under the agreement are met, we would receive additional payments of up to $13.0 million. We will also receive royalties on net sales, if any, of licensed products. To date, we have received $2.1 million in milestone payments.

Results of Operations

Years Ended December 31, 2001, 2000 and 1999

Revenues

Our revenues for the year ended December 31, 2001 were $7.3 million compared to $5.4 million in 2000 and $1.1 million in 1999. Revenues in each year were derived primarily from collaborative research and development agreements with strategic partners. Under these agreements we received payments based both on our achievement, and our partners' achievement, of defined development milestones. Milestone payments from our collaborative partners are recognized over the period of ongoing research and development commitment under the applicable collaborative research and development agreements with the respective companies.

The increase in 2001 revenues relate to milestone payments received pursuant to the execution of a License, Development and Marketing Agreement with Allergan in the third quarter of 2001. The increase in revenues in 2000 over 1999 relate to milestone payments received from Genentech and Kissei in the fourth quarter of 1999 and the milestone payments received from Genentech, Kissei and Kirin during 2000.

Costs and Expenses

Research and development expenses include all direct costs, including salaries for our research and development personnel, consulting fees, clinical trial costs, sponsored research and clinical trials insurance, and other fees and costs related to the development of product candidates. Costs associated with obtaining and maintaining patents on our drug compounds, and license initiation and continuation fees, are evaluated based on the stage of development of the related drug compound and whether the underlying compound has an alternative use. Costs of these types incurred for drug compounds not yet approved by the FDA and for which no alternative use exists are recorded as research and development expense. In the event the drug compound has been approved by the FDA or an alternative use exists for the drug compound, patent costs and license costs are capitalized and amortized over the expected life of the related drug compound. Milestone payments are recognized when the underlying requirement is met by us.

Research and development expenses for the year ended December 31, 2001 were $28.2 million, compared to $16.4 million in 2000 and $7.7 million in 1999. The increase in research and development expenses from year to year reflect the continued advancement of our drug candidates through progressive clinical development phases. We expect expenditures to decrease in 2002 as we focus our development efforts on our higher priority programs.

The increase in research and development expense for 2001 over 2000 was primarily due to increased external costs related to patent activities, research costs, preclinical testing, toxicology studies, clinical development activities, including the enrollment of Phase III clinical trials, and increased internal costs associated with additional personnel necessary to perform or manage these

activities. The increase in research and development expense for 2000 over 1999 relates to increased preclinical testing, costs related to patent activities, toxicology studies, increased clinical development activities and associated increases in personnel costs.

Our research and development expense from inception through December 31, 2001 was $70.1 million. Of this amount, we have spent the following amounts on the pre-clinical and clinical development of the indicated product candidates: $2.3 million on INS316 Diagnostic; $12.1 million on INS365 Ophthalmic; $5.5 million on INS365 Respiratory; $2.3 million on INS37217 Respiratory for cystic fibrosis; $0.7 million on INS37217 Intranasal and $1.5 million on INS37217 Ophthalmic. The balance of our historic research and development expenses, $45.7 million, was spent on various discovery programs and other development programs. We cannot reasonably predict future research and development expense for these programs.

General and administrative costs for the year ended December 31, 2001 were $5.9 million, compared to $3.7 million in 2000 and $2.4 million in 1999. Our general and administrative expenses consist primarily of personnel and related costs for general corporate functions, including business development, finance, accounting, legal, human resources, facilities and information systems. The increase in general and administrative expenses from year to year resulted primarily from increases in administrative personnel costs, and increases in insurance and additional professional services, including legal, accounting and public relations services, to support the Company's strategic business collaborations and operations as a publicly traded company.

Other Income (Expense)

Other income (expense), net totaled $3.7 million for the year ended December 31, 2001, compared to $1.1 million for 2000 and $0.1 million for 1999. The increase in 2001 over 2000, and in 2000 over 1999, was due to higher interest income earned from larger average cash and investment balances partially offset by increased interest expense related to leased equipment and amortization of debt issuance costs.

Income Taxes

The provision for income taxes for the year ended December 31, 2001 was $0, compared to $400,000 in 2000 and $60,000 in 1999. The fluctuations in the provision for income taxes are directly attributable to Japanese withholding taxes paid on milestone payments received from Japanese collaborative partners.

Liquidity and Capital Resources

Historically, we have financed our operations through the sale of equity securities, including private sales of preferred stock and the sale of common stock in our initial public offering.

As of December 31, 2001, our cash and cash equivalents totaled $30.0 million, a decrease of $5.2 million as compared to December 31, 2000. The decrease in cash and cash equivalents resulted from approximately $20.5 million in cash used by operations, purchase of property, plant and equipment of $496,000, the payments of notes payable of $20,000 and the payments of capital lease obligations of $312,000, which was partially offset by the proceeds of net investments in investment grade securities of $16.1 million and the issuance of common stock of $69,000.

Cash used by operations of $20.5 million for the year ended December 31, 2001, represented the net loss of $23.1 million, non-cash expenses of $3.4 million, an increase of $711,000 in accounts payable, an increase of $509,000 in accrued expenses, a decrease of $367,000 in receivables and a decrease in other assets of $59,000, partially offset by decreases of $116,000 in prepaid expenses and $2.3 million in deferred revenue.

Cash used in our investing activities for the year ended December 31, 2001 was comprised of the proceeds of investment grade securities, net of maturities, of $16.1 million and the purchase of property and equipment totaling $496,000.

Cash from our financing activities for the year ended December 31, 2001 was comprised of proceeds in the amount of $69,000 from the issuance of common stock partially offset by the payments of notes payable of $20,000 and the payment of capital lease obligations of $312,000.

We do not expect to generate revenues, other than possible license and milestone payments, from the commercial sale of our products unless and until we or our licensees receive marketing clearance from the FDA and appropriate regulatory agencies in other countries. We cannot predict the timing of any potential marketing clearance nor can assurances be given that the FDA or other such agencies will approve any of our product candidates.

The Company has contractual commitments or purchase arrangements with various clinical research organizations, manufacturers of drug product and others. Most of these arrangements are for a period of less than 12 months. The amount of the Company's financial commitments under these arrangements totals approximately $7.7 at December 31, 2001. This estimate is dependent upon the results of the underlying studies and certain other variable components that may yield a result that differs from management's estimate.

Impact of Recently Issued Accounting Pronouncements

In July 2001, the Financial Accounting Standards Board ("FASB") issued FASB Statements Nos. 141 ("SFAS 141"), "Business Combinations" and 142 ("SFAS 142"), "Goodwill and Other Intangible Assets." SFAS 141 eliminates pooling-of-interests accounting prospectively and provides guidance on purchase accounting related to the recognition of intangible assets and accounting for negative goodwill. SFAS 142 changes the accounting for goodwill from an amortization method to an impairment-only approach. SFAS 141 and SFAS 142 are effective for all business combinations completed after June 30, 2001. We have adopted SFAS 142 as of January 1, 2002, as required, and as of July 1, 2001 for goodwill and intangible assets acquired after June 30, 2001. We do not expect that the adoption of SFAS 141 and 142 will have any impact on our financial position or results of operations.

In August 2001, the FASB issued FASB Statement No. 143 ("SFAS 143"), "Accounting for Asset Retirement Obligations." The objectives of SFAS 143 are to establish accounting standards for the recognition and measurement of an asset retirement obligation and its associated asset retirement cost. SFAS 143 is effective for fiscal years beginning after June 15, 2002. We do not expect the adoption of SFAS 143 to have any impact on our financial position or results of operations.

In October 2001, the FASB issued FASB Statement No. 144 ("SFAS 144"), "Accounting for the Impairment or Disposal of Long-Lived Assets." The Statement supersedes FASB Statement No. 121 ("SFAS 121"), "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of" and APB 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions." The provisions of SFAS 144 are required to be applied to fiscal years beginning after December 15, 2001. We do not expect the adoption of SFAS 144 to have any impact on our financial position or results of operations.



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Received by Edgar Online Mar 26, 2002


CIK Code: 0001040416
Accession Number: 0001021408-02-004144

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STOCK SYMBOLS: [(isph)]

 

Inspire Pharmaceuticals, Inc. Announces Receipt Of Milestone Payment fromAllergan  
 
DURHAM, N.C., Mar 29, 2002 /PRNewswire-FirstCall via COMTEX/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today announced achievement of a milestone under Inspire's agreement with Allergan for INS365 Ophthalmic for dry eye, triggering a payment by Allergan. The payment is for the completion of the first Phase III clinical study for INS365 Ophthalmic, and submission of the study data to Allergan. Payment of the milestone was not dependent on study outcome. The amount of the payment was not disclosed.

Inspire and Allergan entered into a development and commercialization partnership in June 2001 for Inspire's INS365 Ophthalmic and Allergan's Restasis(TM), both for the treatment of dry eye. Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. It is one of the most frequent patient complaints reported to ophthalmologists, and there are currently no FDA-approved, pharmacologically active treatments for this common condition.

Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on proprietary technology relating to P2Y receptors. Inspire is exploring other target diseases where it believes P2Y receptors play important biological roles.

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 and earnings expectations, intellectual property rights and 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. 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 to reflect the occurrence of unanticipated events.


Contacts: Inspire Pharmaceuticals, Inc.
Mary Bennett
Vice President, Operations and Communications
919-941-9777, Extension 245

Noonan Russo - Presence Media Contact:
Emily Poe 212-696-4455, Extension 221

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SOURCE Inspire Pharmaceuticals, Inc.


CONTACT: Mary Bennett, Vice President, Operations and Communications of
Inspire Pharmaceuticals, +1-919-941-9777, ext. 245; or Media, Emily Poe of
Noonan Russo, +1-212-696-4455, ext. 221, for Inspire Pharmaceuticals

URL: www.noonanrusso.com/index.html
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Inspire Pharmaceuticals, Inc. Initiates New Phase III Clinical Trial InDry Eye Program  
 
DURHAM, N.C., Apr 3, 2002 /PRNewswire-FirstCall via COMTEX/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today announced that enrollment has begun in a third Phase III clinical trial of INS365 Ophthalmic for dry eye. The study was initiated based on findings from the first Phase III trial and recent discussions with the U.S. Food and Drug Administration (FDA). The FDA has confirmed that results from this new trial may be used to support a New Drug Application for INS365 Ophthalmic for dry eye.

Inspire announced in January 2002 that while patients in study 104, the first of two planned Phase III clinical trials, did show improvement, the product did not demonstrate statistically significant improvement over placebo in the study's primary endpoints. Inspire has conducted a thorough review of the study 104 data, methods and materials. Based on these analyses, Inspire has launched a new, highly focused Phase III trial.

The new trial, study 108, is designed as a placebo-controlled, double-masked comparison of the safety and efficacy of 2% INS365 Ophthalmic eye drops to placebo in 200 dry eye patients. The study is being conducted in a Controlled Adverse Environment (CAE), which controls for temperature, humidity, and other factors. Endpoints for the study are similar to those studied in the Phase II and III trials conducted to date. However, the CAE provides a well-controlled environment and more precise measurement of patients' signs and symptoms of dry eye. The CAE is expected to enable consistent measurement of patient responses to INS365 Ophthalmic compared to placebo. Controlled environments have been in use for many years in the study of other types of ophthalmic disorders including allergic conjunctivitis, and such studies have supported more than a dozen U.S. New Drug Applications. The study is being conducted by ORA Clinical Research and Development of North Andover, Massachusetts.

Inspire's second Phase III trial in INS365 Ophthalmic, study 105, is ongoing. Inspire plans to meet with the FDA in the second quarter of this year to discuss detailed findings from the analyses of study 104 and to agree on an analysis plan for study 105.

"Based on our in-depth analyses of study 104, we believe that the factors that may have contributed to the unexpected placebo effect can be minimized by use of this new trial design," stated Christy Shaffer, Ph.D., President and CEO of Inspire. "In addition, we are continuing to build a large and important safety database from studies 104 and 105."

INS365 Ophthalmic is a P2Y2 agonist that activates receptors on the surface and inner lining of the eyelid to release water, salt, mucin and lipids -- the key components of natural tears. INS365 Ophthalmic's novel mechanism of action represents a potential breakthrough in the treatment of dry eye. Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. Approximately 10 million Americans suffer from dry eye, and the incidence increases markedly with age and after menopause in women. There are currently no FDA-approved pharmacologically active treatments for dry eye.

Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on proprietary technology relating to P2Y receptors. Inspire is exploring other target diseases where it believes P2Y receptors play important biological roles.

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 and earnings expectations, intellectual property rights and 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. 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 to reflect the occurrence of unanticipated events.

Editor's Note: This release is also available at: www.noonanrusso.com




 

Inspire Pharmaceuticals, Inc. Initiates New Phase III Clinical Trial InDry Eye Program  
 
DURHAM, N.C., Apr 3, 2002 /PRNewswire-FirstCall via COMTEX/ -- Inspire Pharmaceuticals, Inc. (Nasdaq: ISPH) today announced that enrollment has begun in a third Phase III clinical trial of INS365 Ophthalmic for dry eye. The study was initiated based on findings from the first Phase III trial and recent discussions with the U.S. Food and Drug Administration (FDA). The FDA has confirmed that results from this new trial may be used to support a New Drug Application for INS365 Ophthalmic for dry eye.

Inspire announced in January 2002 that while patients in study 104, the first of two planned Phase III clinical trials, did show improvement, the product did not demonstrate statistically significant improvement over placebo in the study's primary endpoints. Inspire has conducted a thorough review of the study 104 data, methods and materials. Based on these analyses, Inspire has launched a new, highly focused Phase III trial.

The new trial, study 108, is designed as a placebo-controlled, double-masked comparison of the safety and efficacy of 2% INS365 Ophthalmic eye drops to placebo in 200 dry eye patients. The study is being conducted in a Controlled Adverse Environment (CAE), which controls for temperature, humidity, and other factors. Endpoints for the study are similar to those studied in the Phase II and III trials conducted to date. However, the CAE provides a well-controlled environment and more precise measurement of patients' signs and symptoms of dry eye. The CAE is expected to enable consistent measurement of patient responses to INS365 Ophthalmic compared to placebo. Controlled environments have been in use for many years in the study of other types of ophthalmic disorders including allergic conjunctivitis, and such studies have supported more than a dozen U.S. New Drug Applications. The study is being conducted by ORA Clinical Research and Development of North Andover, Massachusetts.

Inspire's second Phase III trial in INS365 Ophthalmic, study 105, is ongoing. Inspire plans to meet with the FDA in the second quarter of this year to discuss detailed findings from the analyses of study 104 and to agree on an analysis plan for study 105.

"Based on our in-depth analyses of study 104, we believe that the factors that may have contributed to the unexpected placebo effect can be minimized by use of this new trial design," stated Christy Shaffer, Ph.D., President and CEO of Inspire. "In addition, we are continuing to build a large and important safety database from studies 104 and 105."

INS365 Ophthalmic is a P2Y2 agonist that activates receptors on the surface and inner lining of the eyelid to release water, salt, mucin and lipids -- the key components of natural tears. INS365 Ophthalmic's novel mechanism of action represents a potential breakthrough in the treatment of dry eye. Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. Approximately 10 million Americans suffer from dry eye, and the incidence increases markedly with age and after menopause in women. There are currently no FDA-approved pharmacologically active treatments for dry eye.

Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Kissei Pharmaceutical Co., Ltd., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd. Inspire's products are based on proprietary technology relating to P2Y receptors. Inspire is exploring other target diseases where it believes P2Y receptors play important biological roles.

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 and earnings expectations, intellectual property rights and 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. 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 to reflect the occurrence of unanticipated events.

Editor's Note: This release is also available at: www.noonanrusso.com




 

Synthematix, Inc. to Collaborate with Inspire Pharmaceuticals on use ofNew Chem-Informatics Software  
 
RESEARCH TRIANGLE PARK, N.C., Apr 9, 2002 /PRNewswire via COMTEX/ -- Synthematix, Inc. announced today that they have initiated a collaboration with Inspire Pharmaceuticals to provide Synthematix's new chem-informatics software for storing and searching databases of useful chemical procedures. Access to the types of synthetic chemistry procedures in Synthematix's database allows chemists to find and synthesize molecules more efficiently. Inspire's medicinal chemists will contribute useful synthetic procedures to Synthematix's Arthur(TM) database and will also be able to access the system for detailed chemical, reagent, equipment and procedural information.

"We have a small, focused group of medicinal chemists at Inspire. We want to enable them with new technology to enhance their creativity and effectiveness," said Dr. Ben Yerxa, Vice President, Discovery at Inspire. "The information supplied by Synthematix's system will allow our chemists to easily access detailed synthetic chemical knowledge and will increase reaction planning efficiency."

"We are very pleased to have Inspire Pharmaceuticals as the third customer for our software solution," said Clay B. Thorp, President and CEO, Synthematix, Inc. "Our close interaction with Dr. Yerxa and his staff will ensure that Inspire chemists get maximum power out of our chem-informatics tools. Synthematix will benefit from the feedback and advice of an outstanding group of medicinal chemists."

The Arthur software suite for synthetic chemistry will be demonstrated at the American Chemical Society meeting, April 8-10 in Orlando, Florida. Synthematix will also be a presenter at Venture 2002 on April 30 in Research Triangle Park, NC.

About Synthematix

Synthematix, Inc. (www.synthematix.com), an early stage company based in Research Triangle Park, NC, creates informatics products and databases for research chemists who design, synthesize and characterize novel molecules. These products and databases increase the effectiveness and efficiency of research chemists while permitting enhanced access to a company's chemical R&D assets. Synthematix's also builds searchable databases that store legacy and current synthetic reaction procedures. Synthematix's tools are currently in use at Cubist Pharmaceuticals, Duke University, GlaxoSmithKline, and Inspire Pharmaceuticals, Inc.

For more information, contact Tom Laundon at 919-474-0742, ext. 105 or email at tom.laundon@synthematix.com.


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SOURCE Synthematix, Inc.


CONTACT: Tom Laundon of Synthematix, Inc., +1-919-474-0742, ext. 105, or
e-mail, tom.laundon@synthematix.com

URL: www.synthematix.com
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10-Q: INSPIRE PHARMACEUTICALS INC  
 
(EDGAR Online via COMTEX) -- Item 2. Management's Discussion and Analysis of Financial Condition and Results - of Operations -


CAUTIONARY STATEMENT

The discussion below contains forward-looking statements regarding our financial condition and results of operations that are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted within the United States. The preparation of these financial statements requires Inspire management to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. Inspire evaluates its estimates on an ongoing basis. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances. The results of these estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.

We operate in a highly competitive environment that involves a number of risks, some of which are beyond our control. Statements contained in Management's Discussion and Analysis of Financial Conditions and Results of Operations which are not historical facts are, or may constitute, forward looking statements. Forward looking statements involve known and unknown risks that could cause our actual results to differ materially from expected results. These risks are discussed in the section entitled "Other Information - Risk Factors" as well as in our Annual Report on Form 10-K for the year ended December 31, 2001. Although we believe the expectations reflected in the forward looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.


Inspire Pharmaceuticals, Inc.
(a development stage company)


OVERVIEW

We were incorporated in October 1993 and commenced operations in March 1995 following our first substantial financing. Since that time, we have been engaged in the discovery and development of novel pharmaceutical products that treat diseases which are characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance as well as other diseases. Our technologies are based in part on exclusive license agreements with The University of North Carolina at Chapel Hill for rights to certain developments from the founders' laboratories.

To date, we have devoted substantially all of our efforts to discovery and clinical development of our product candidates as well as establishing strategic partnerships for the development and potential marketing of our products when approved. Currently, we have six product candidates in clinical development. We have not derived any commercial revenues from product sales and we do not expect to receive sales revenues for at least the next several years.

We have incurred significant operating losses since our inception and, as of March 31, 2002, we had an accumulated deficit of $75.8 million. We have primarily financed our operations through proceeds received from the sale of equity securities including private sales of preferred stock and the sale of common stock in our initial public offering, as well as revenues received under corporate collaborations. We operate in a single business segment and do not have any foreign operations.

In June 2001, we entered into a joint license, development and marketing agreement with Allergan, Inc. ("Allergan") to develop and commercialize INS365 Ophthalmic and Allergan's Restasis(R). Under the agreement, we may receive up to $39 million in up-front and milestone payments. We will also receive royalty payments on sales, if any, of INS365 Ophthalmic in the United States and on Allergan's Restasis(R) worldwide, excluding most Asian markets. The agreement also provides for potential co-promotion by Inspire of INS365 Ophthalmic and Restasis(R) and one or more of Allergan's other marketed products in the United States.

In September 2000, we entered into a License Agreement with Kirin Brewing Co., Ltd. Pharmaceutical Division ("Kirin") for the development and commercialization of INS316 Diagnostic. Under the agreement we granted Kirin an exclusive license to commercialize INS316 Diagnostic in most of Asia. Under the terms of the agreement, we received an upfront payment in cash and may receive milestone payments based on clinical success and regulatory approval. We may also receive royalties on net sales of licensed products.

In December 1999, we entered into a collaboration with Genentech, Inc. to develop treatments for respiratory disorders, pursuant to which we received in excess of $16 million in equity and cash payments prior to the termination of the agreement in November 2001. Upon termination, Genentech, Inc. returned to us all rights for the use of INS365 Respiratory and our other related P2Y2 agonists at no charge.

In December 1998, we entered into a Development, License and Supply Agreement with Santen Pharmaceutical Co., Ltd. ("Santen") for the development of INS365 Ophthalmic for the therapeutic treatment of ocular surface diseases. We are obligated to supply Santen with its requirements of INS365 Ophthalmic in bulk drug substance form for all preclinical studies, clinical trials and commercial requirements at agreed-upon prices. Under the agreement, we received an up-front equity investment of $1.5 million for shares of our stock. In addition, if all milestones are met, we could receive additional payments of up to $4.75 million, as well as royalties on net sales of licensed products. We have not received any milestone payments to date under the agreement.

In September 1998, we entered into a Joint Development, License and Supply Agreement with Kissei Pharmaceutical Co., Ltd. ("Kissei") for the development of INS365 Respiratory for therapeutic lower respiratory applications in Japan. Pursuant to the agreement with Kissei, we received an up-front payment of $4.5 million, which included the purchase of shares of our stock. In addition, if all milestones under the agreement are met, we would receive additional payments of up to $13 million. We will also receive royalties on net sales of licensed products. To date, we have received $2.1 million in milestone payments.


Inspire Pharmaceuticals, Inc.
(a development stage company)


SIGNIFICANT ACCOUNTING POLICIES

-

Revenue Recognition

We recognize revenue under our collaborative research and development agreements when we have performed services under such agreements or when we or our collaborative partner has met a contractual milestone triggering a payment to us. Non-refundable fees received at the initiation of collaborative agreements for which we have an ongoing research and development commitment are deferred and recognized ratably over the period of ongoing research and clinical development commitment. We are also entitled to receive milestone payments under our collaborative research and development agreements based upon achievement of development milestones by us or our collaborative partners. We recognize milestone payments as revenues ratably over the remaining period of our research and clinical development commitment. The recognition period begins at the date the milestone is achieved and acknowledged by the collaborative partner, which is generally at the date payment is received from the collaborative partner, and ends on the date that we have fulfilled our research and clinical development commitment. This period is based on estimates by management and the progress towards milestones in our collaborative agreements. The estimate is subject to revision as our development efforts progress and we gain knowledge regarding required additional development. Revisions in the commitment period are made in the period that the facts related to the change first become known. This may cause our revenue to fluctuate from period to period.

Taxes

Significant management judgment is required in determining our provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. We record valuation allowances because of uncertainties related to our ability to utilize deferred tax assets, primarily consisting of certain net operating losses carried forward, before they expire. The valuation allowance is based on estimates of taxable income in each of the jurisdictions in which we operate and the period over which our deferred tax assets will be recoverable. In the event the actual results differ from these estimates or we adjust these estimates in future periods we may need to establish an additional valuation allowance which could materially impact our financial position and results of operations.


RESULTS OF OPERATIONS

-

Three Months Ended March 31, 2002 and 2001

Revenues

Our revenues were derived from collaborative research and development agreements with strategic partners. Revenues were $1.1 million for the three months ended March 31, 2002, compared to $1.4 million for the same period in 2001, a decrease of 21%. Revenues in each year are primarily derived from collaborative research and development agreements with strategic partners. During the three months ended March 31, 2002, revenues were related to an upfront payment received from Allergan, Inc. in the third quarter of 2001 and the upfront payment received from Kirin Brewery Co., Ltd. in the fourth quarter of 2000. Revenues in the same period in 2001 were related to milestone payments received from Kirin Brewery Co., Ltd., Kissei Pharmaceuticals and Genentech, Inc. Milestone payments from our collaborative partners are recognized over the period of ongoing research and development commitment period under the applicable collaborative research and development agreements with the respective company.

Research and Development Expenses

Research and development expenses include all direct costs, including salaries for our research and development personnel, consulting fees, clinical trial costs, sponsored research and clinical trials insurance, and other fees and costs related to the development of product candidates. Costs associated with obtaining and maintaining patents on our drug compounds, and license initiation and continuation fees, are evaluated based on the stage of development of the


Inspire Pharmaceuticals, Inc.
(a development stage company)


related drug compound and whether the underlying compound has an alternative
use. Costs of these types incurred for drug compounds not yet approved by the
FDA and for which no alternative use exists are recorded as research and
development expense. In the event the drug compound has been approved by the FDA
or an alternative use exists for the drug compound, patent costs and license
costs are capitalized and amortized over the expected life of the related drug
compound. Milestone payments are recognized when the underlying requirement is
met by us.

Research and development expenses were $4.7 million for the three months ended March 31, 2002, compared to $6.8 million for the same period in 2001, a decrease of 31%. The decrease in research and development expenses was due to our efforts to focus resources on our higher priority programs. On January 29, 2002, we announced that we would refocus our efforts on our higher priority clinical programs in the ophthalmology and respiratory areas. The programs of primary focus were indications for dry eye, lung cancer diagnostics, upper respiratory disorders and cystic fibrosis.

For the three months ended March 31, 2002, the research and development costs were related to patent activities, research costs, preclinical testing, toxicology studies, clinical supplies, clinical development activities, and personnel costs necessary to perform and/or manage these activities. We expect to incur increases in expenses in future periods as later phases of development typically involve an increase in the scope of studies and the number of patients treated.

Our research and development expenses from inception through March 31, 2002 were $74.9 million. Of this amount, we have spent the following amounts on external pre-clinical and clinical development of the indicated product candidates: $2.8 million on INS316 Diagnostic; $13.2 million on INS365 Ophthalmic; $5.8 million on INS365 Respiratory; $3.3 million on INS37217 Respiratory for cystic fibrosis; $1.2 million on INS37217 Intranasal and $1.6 million on INS37217 Ophthalmic. The balance of our historic research and development expenses, $47 million, includes internal personnel costs of our discovery and development programs, internal and external general research related to the development of our technology, and internal and external expenses of other drug discovery programs and development programs. We cannot reasonably predict future research and development expenses for these programs; however, historical trends indicate that expenses tend to increase in later phases of development.

General and Administrative Expenses

General and administrative expenses consist primarily of personnel costs, facilities costs, business development costs and professional expenses, such as legal and accounting fees. General and administrative expenses were $1.4 million for the three month ended March 31, 2002, compared to $1.2 for the same period in 2001, an increase of 17%. Our general and administrative expenses consist primarily of personnel and related costs for general corporate functions, including business development, finance, accounting, legal, human resources, facilities and information systems. The increase in general and administrative expenses from year to year resulted primarily from increases in administrative personnel costs, and increases in insurance and additional professional services, including legal, accounting and public relations services, to support our strategic business collaborations and operations as a publicly traded company.

Other Income (Expense), Net

Other income (expense), net consists of interest income earned on cash deposits and short-term investments, reduced by interest expense on notes payable, capital lease obligations, losses on sales of property and equipment and amortization of debt issuance costs. Other income (expense), net was $254,000 for the period ended March 31, 2002, compared to $1.4 million for the same period in 2001, a decrease of 82%. The decrease was due to lower interest income earned from lower average cash and investment balances partially offset by interest expense related to leased equipment.


LIQUIDITY AND CAPITAL RESOURCES

-

Historically, we have financed our operations through the sale of equity securities, including private sales of preferred stock and the sale of common stock in our initial public offering.


Inspire Pharmaceuticals, Inc.
(a development stage company)


As of March 31, 2002, cash and cash equivalents totaled $34.6 million, an
increase of $4.6 million as compared to December 31, 2001. The increase in cash
and cash equivalents resulted from the net proceeds of investment grade
securities of $8.3 million, the issuance of common stock of $12,000, partially
offset by $3.5 million in cash used by operations, purchase of property, plant
and equipment of $135,000 and the payment of capital lease obligations of
$101,000.

Cash used by operations of $3.5 million in the three months ended March 31, 2002, represented a net loss of $4.8 million, non-cash expenses of $483,000, a decrease in other receivables of $76,000 and a decrease in prepaid expenses of $80,000, partially offset by, an increase in interest receivable of $5,000, an increase in other assets of $16,000, a decrease in accounts payable of $425,000 and a decrease in accrued expenses of $803,000, and an increase in deferred revenue of $1.9 million.

Cash provided by investing activities for the three months ended March 31, 2002 consisted of the proceeds of investment grade securities, net of purchases totaling $8.3 million and the purchase of property and equipment totaling $135,000.

Cash used from financing activities for the three months ended March 31, 2002 was comprised of the issuance of common stock of $12,000 offset by the payment of lease obligations of $101,000.

We will not generate revenues, other than license and milestone payments, from the sale of our products unless or until we or our licensees receive marketing clearance from the FDA and appropriate governmental agencies in other countries. We cannot predict the timing of any potential marketing clearance nor can assurances be given that the FDA or such agencies will approve any of our products.


IMPACT OF INFLATION

-

Although it is difficult to predict the impact of inflation on our costs and revenues in connection with our products, we do not anticipate that inflation will materially impact our cost of operation or the profitability of our products when marketed.


IMPACT OF RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS

-

In July 2001, the Financial Accounting Standards Board ("FASB") issued FASB Statements Nos. 141 ("SFAS 141"), "Business Combinations" and 142 ("SFAS 142"), "Goodwill and Other Intangible Assets." SFAS 141 eliminates pooling-of-interests accounting prospectively and provides guidance on purchase accounting related to the recognition of intangible assets and accounting for negative goodwill. SFAS 142 changes the accounting for goodwill from an amortization method to an impairment-only approach. SFAS 141 and SFAS 142 are effective for all business combinations completed after June 30, 2001. The Company adopted SFAS 142 as of January 1, 2002, as required, and as of July 1, 2001 for goodwill and intangible assets acquired after June 30, 2001. Adoption of SFAS 141 and SFAS 142 has not had any impact on the Company's financial position or results of operations

In August 2001, the FASB issued FASB Statement 143 ("SFAS 143"), "Accounting for Asset Retirement Obligations." The objectives of SFAS 143 are to establish accounting standards for the recognition and measurement of an asset retirement obligation and its associated asset retirement cost. SFAS 143 is effective for fiscal years beginning after June 15, 2002. The adoption of SFAS 143 is not expected to have any impact on the Company's financial position or results of operations.

In October 2001, the FASB issued FASB Statement No. 144 ("SFAS 144"), "Accounting for the Impairment or Disposal of Long-Lived Assets." The Statement supersedes FASB Statement No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of" and Accounting Principles Board Opinion No. 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of Business, and


Inspire Pharmaceuticals, Inc.
(a development stage company)


Extraordinary, Unusual and Infrequently Occurring Events and Transactions." The
provisions of SFAS 144 are required to be applied to fiscal years beginning
after December 15, 2001. The adoption of SFAS 144 has not had any impact on the
Company's financial position or results of operations.


(c) 1995-2002 Cybernet Data Systems, Inc. All Rights Reserved


Received by Edgar Online May 14, 2002


CIK Code: 0001040416
Accession Number: 0001021408-02-006893

-0-




STOCK SYMBOLS: [(isph)]






 




 

lohnenswert. Inspire explodiert seit 3 Wochen.

N8 Eskimato  

Liest sich nicht so gut,

Inspire Pharmaceuticals (ISPH: news, chart, profile) lost more than 14 percent after the company said a recent trial of its treatment for perennial allergic rhinitis was well-tolerated but it missed its primary endpoint of "significantly reducing the total nasal symptom score over the 28-day treatment period versus placebo." The company plans to conduct secondary analyses to determine future plans for the INS37217 intranasal compound.

Gruss E.

http://chart.bigcharts.com/bc3/quickchart/...65&mocktick=1&rand=5584"  

Von 16 runter auf 11, soweit so gut.

Mal sehen wie es nach den News weitergeht.

Gruss E.

Inspire Pharmaceuticals Submits New Drug Application For Diquafosol For The Treatment of Dry Eye  
       FRIDAY, JUNE 27, 2003 11:45 AM
- PR Newswire

DURHAM, N.C., Jun 27, 2003 /PRNewswire-FirstCall via COMTEX/ -- Inspire Pharmaceuticals, Inc. (ISPH) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval to market diquafosol tetrasodium (INS365) eye drops in a 2% preservative-free solution. Diquafosol represents a new approach to the treatment of dry eye. By stimulating P2Y2 receptors located on the ocular surface and inner lining of the eyelid, diquafosol enhances the secretion of water, salt, mucin and lipids -- key components of natural tears. This increase in the major components of the tear film is believed to result in improved tear volume and tear composition.

The diquafosol NDA submission includes data from one Phase II and two Phase III studies involving over 1,200 dry eye patients. Key data from the studies will be presented at the European Association for Vision and Eye Research (EVER) meeting in Alicante, Spain in October 2003.

"This NDA, Inspire's first, is a major achievement and is the result of nearly six years of focused and dedicated effort on the part of our employees, with valuable support from our partners and guidance from the FDA," stated Christy L. Shaffer, Ph.D., CEO of Inspire. "This milestone marks an important transition for our business as we begin building commercial capabilities."

The NDA submission triggers a milestone payment from Inspire's partner Allergan.

The FDA customarily accepts or refuses to file NDAs and designates review status within 60 days of submission.

About Dry Eye

Dry eye is a painful, burning and irritating condition involving abnormalities and deficiencies in the tear film due to a variety of causes. It affects approximately 10 million North Americans and is one of the most frequent patient complaints reported to ophthalmologists and optometrists. The majority of dry eye patients rely on artificial tears to relieve symptoms. Allergan's Restasis(TM) is the first and only pharmacologically active prescription product approved for patients with chronic dry eye disease.

About Inspire

Inspire Pharmaceuticals, Inc. discovers and develops new drugs to treat diseases characterized by deficiencies in the body's innate defense mechanisms of mucosal hydration and mucociliary clearance, as well as other non-mucosal disorders. Mucosal defense mechanisms are the natural way that the body defends its mucosal surfaces against dust, pollutants, bacteria and viruses. Inspire's lead product candidates target ophthalmic and respiratory diseases with inadequate current treatments and which represent large therapeutic market opportunities. Inspire has development and commercialization alliances with Allergan, Inc., Santen Pharmaceutical Co., Ltd. and Kirin Brewery Co., Ltd., and has a collaboration with Cystic Fibrosis Foundation Therapeutics, Inc. Inspire's products are based on proprietary technology relating to P2Y2 receptors and to non-P2Y2 receptors that show therapeutic promise, including P2Y12.

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 and earnings expectations, intellectual property rights and 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. 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.




 

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