EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

For Immediate Release    

Investor Contact:

Inspire Pharmaceuticals, Inc.

Jenny Kobin

VP, Investor Relations and Corporate Communications

(919) 941-9777, Extension 219

   

Media Contact:

Inspire Pharmaceuticals, Inc.

Cara Amoroso

Assoc. Director, Corporate Communications

(919) 941-9777, Extension 266

INSPIRE REPORTS SECOND QUARTER 2010 FINANCIAL RESULTS

- Second Quarter 2010 AZASITE® Revenue Increased 27% from Second Quarter 2009 -

DURHAM, NC - August 5, 2010 - Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today financial results for the second quarter ended June 30, 2010, reporting a net loss of $8.8 million or ($0.11) per share, an improvement from the second quarter of 2009 during which the Company incurred a net loss of $9.5 million or ($0.17) per share.

Total revenue for the second quarter of 2010 was $27.3 million, as compared to $23.1 million for the second quarter of 2009, reflecting an increase of 18%. Revenue from AZASITE® (azithromycin ophthalmic solution) 1% totaled $9.6 million in the second quarter of 2010, an increase of 27% compared to $7.6 million recognized in the second quarter of 2009.

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 $17.7 million for the second quarter of 2010 compared to $15.5 million in the second quarter of 2009, reflecting an increase of 14%. Royalty revenue for the second quarter of 2010 from RESTASIS was $11.2 million as compared to $8.9 million in the second quarter of 2009. Co-promotion revenue from ELESTAT in the second quarter of 2010 was $6.5 million as compared to $6.6 million in the second quarter of 2009.

Total revenue for the six months ended June 30, 2010 was $49.3 million, which represented a 32% increase over total revenue of $37.4 million for the same period in 2009. Total revenue for the six months ended June 30, 2010 was comprised of $31.0 million of co-promotion and royalty revenue on net sales of RESTASIS and ELESTAT and $18.3 million of AZASITE revenue, as compared to $23.6 million and $13.8 million, respectively, recognized for the six months ended June 30, 2009.

Operating expenses for the second quarter of 2010 totaled $35.9 million, as compared to $31.9 million for the same period in 2009, reflecting an increase of 12.5%. The increase in second quarter 2010 operating expenses, as compared to 2009, was primarily due to management changes and the related compensation charges, as well as an increase in cost of sales, primarily associated with increased AZASITE sales volume.

 

LOGO

 

4222 Emperor Boulevard, Suite 200        Durham, North Carolina 27703
Telephone 919.941.9777        Fax 919.941.9797


Page 2

 

Operating expenses for the six months ended June 30, 2010 were $72.4 million, as compared to $64.9 million for the same period in 2009. The increase in six month 2010 operating expenses, as compared to 2009, relates to increased administrative expenses associated with management changes and the related compensation charges, including CEO transition costs of approximately $5 million, as well as an increase in cost of sales primarily resulting from increased AZASITE sales volume.

For the second quarter ended June 30, 2010, the Company reported a net loss of $8.8 million, or ($0.11) per common share, as compared to a net loss of $9.5 million, or ($0.17) per common share, for the same period in 2009. The net loss for the six months ended June 30, 2010 was $23.6 million, or ($0.29) per common share, as compared to a net loss of $28.9 million, or ($0.51) per common share for the same period in 2009. Cash, cash equivalents and investments totaled $106.2 million at June 30, 2010, reflecting a $9.0 million utilization of cash and investments during the second quarter of 2010 and a $22.9 million utilization of cash and investments during the first half of 2010.

“We are pleased to be able to deliver another solid quarter from an overall financial perspective and remain focused on executing with excellence against our core 2010 objectives, in particular in the Commercial and Research and Development areas,” said Adrian Adams, President and CEO of Inspire. “We are continuing to make measured investments in important areas of the business and, with recent organizational changes, we are structuring the organization with a view toward success and shareholder value creation as we journey toward potentially exciting and transformational milestones, in particular related to our denufosol cystic fibrosis program.”

Recent Updates Include (May 3, 2010 through August 5, 2010):

Ophthalmic Research & Development

 

 

Amended the Development, License and Supply Agreement with Santen Pharmaceutical Co., Ltd., related to diquafosol in the Japanese market and nine other Asian countries; Inspire will now be relieved of its supply obligations and will be entitled to receive payments based upon a tiered royalty rate on net sales of DIQUAS™ Ophthalmic Solution 3% (diquafosol tetrasodium) in Japan, with a minimum rate in the high single digits and a maximum rate in the low double digits.

Pulmonary Research & Development

 

 

Initiated a small safety and tolerability clinical trial of denufosol tetrasodium in cystic fibrosis (CF) patients ages 2-4 years old (Trial 08-116);

 

 

Presented data at the American Thoracic Society (ATS) 2010 International Conference suggesting that denufosol, based on its potential to reach the small airways in the lungs, may hold promise as an early intervention treatment for CF; and

 

 

Presented data at the 33rd Annual European Cystic Fibrosis Society (ECFS) Conference discussing denufosol’s potential benefit to adolescent CF patients and patients on minimal

 

LOGO

 

4222 Emperor Boulevard, Suite 200        Durham, North Carolina 27703
Telephone 919.941.9777        Fax 919.941.9797


Page 3

 

 

pharmacotherapies.

Commercial Operations

 

 

Increased second quarter 2010 AZASITE prescription volume by approximately 32% over the second quarter of 2009.

Corporate

 

 

Initiated a series of planned organizational changes, including revised job responsibilities, and the addition of experienced senior leadership positions in key areas that are designed to position the organization for short, medium and long-term success; and

 

 

Entered into a lease for a new corporate headquarters in Raleigh, North Carolina.

Revised Financial Outlook for 2010

 

 

Inspire expects to record 2010 aggregate revenue in the range of $100-$111 million, which is unchanged from previous guidance.

 

 

Total 2010 operating expenses are now expected to be within the narrower range of $145-$159 million, reflecting a reduction from previous guidance, which was $145-$169 million. Specific operating expense category guidance is expected to be as follows: cost of sales of $13-$18 million, which is unchanged from previous guidance; research and development of $48-$60 million, which was previously $60-$70 million; selling and marketing of $48-$53 million, which is unchanged from previous guidance; and general and administrative expenses of $27-$32 million, which is unchanged from previous guidance. Included within this operating expense guidance are projected stock-based compensation costs of approximately $8-$12 million, which is unchanged from previous guidance.

 

 

Cash utilization is now expected to be in the range of $53-$65 million, reflecting a reduction from previous guidance, which was $58-$73 million. Cash utilization guidance continues to incorporate $20 million of principal debt repayment.

Inspire will host a conference call and live webcast with an accompanying slide presentation to discuss its second quarter 2010 financial results on Thursday, August 5, 2010 at 8:00 a.m. ET. The live webcast, slide presentation and replay will be available on Inspire’s website at www.inspirepharm.com. The webcast will include audio of the conference call and a slide presentation to be reviewed during the call. 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 88702441. A telephone replay of the conference call will be available until August 12, 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 88702441.

About Inspire

Inspire is a biopharmaceutical company focused on researching, developing and commercializing prescription pharmaceutical products for ophthalmic and pulmonary diseases. Inspire’s goal is to build and commercialize a sustainable portfolio of innovative new products based on its technical, scientific and commercial expertise. The most advanced compounds in

 

LOGO

 

4222 Emperor Boulevard, Suite 200        Durham, North Carolina 27703
Telephone 919.941.9777        Fax 919.941.9797


Page 4

 

Inspire’s clinical pipeline are denufosol tetrasodium for cystic fibrosis and PROLACRIA™ (diquafosol tetrasodium ophthalmic solution) 2% for dry eye, which are both in Phase 3 development, and AZASITE® (azithromycin ophthalmic solution) 1% for blepharitis, which is in Phase 2 development. Inspire receives revenues related to the promotion of AZASITE for bacterial conjunctivitis, the co-promotion of ELESTAT® (epinastine HCl ophthalmic solution) 0.05% for allergic conjunctivitis and royalties based on net sales of RESTASIS® (cyclosporine ophthalmic emulsion) 0.05% for dry eye. For more information, visit www.inspirepharm.com.

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. Specifically, no assurances can be made with respect to: the ability of the Company to move towards profitability; whether or not 2010 will be productive; the ability of the Company to remain focused on executing with excellence against its core 2010 objectives, in particular in the Commercial and Research and Development areas; that the Company will succeed and create shareholder value; the Company achieving any exciting and transformational milestones, including those relating to its denufosol cystic fibrosis program; the amount of royalties, if any, received in relation to net sales of DIQUAS; the timing or outcome of the denufosol trial studying 2-4 year olds; the potential of denufosol to reach the small airways in the lungs and act as an early intervention treatment for cystic fibrosis; the potential of denufosol tetrasodium to benefit adolescent CF patients and patients on minimal pharmacotherapies; the ability of the Company’s organizations changes, including planned future changes, to position the organization for short, medium or long-term success; the timing associated with the Company’s move to new corporate headquarters; the amount of revenues to be recorded by the Company in 2010; 2010 total operating expenses; 2010 cost of sales; 2010 selling and marketing expenses; 2010 general and administrative expenses; 2010 research and development expenses; 2010 stock-based compensation costs; cash utilization by the Company in 2010, including the amount of principal repayment on the Company’s outstanding debt; and the Company’s ability to build and commercialize a sustainable portfolio of innovative new products based on its technical and scientific expertise. Such forward-looking statements are subject to a wide range of risks and uncertainties that could cause results to differ in material respects, including those relating to product development, revenue, expense and earnings expectations, the introduction of a generic form of epinastine, 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.

— Financial tables follow —

 

LOGO

 

4222 Emperor Boulevard, Suite 200        Durham, North Carolina 27703
Telephone 919.941.9777        Fax 919.941.9797


Page 5

 

INSPIRE PHARMACEUTICALS, INC.

Condensed Statements of Operations

(in thousands, except per share amounts)

(Unaudited)

 

     Three Months
Ended June 30,
    Six Months
Ended June 30,
 
     2010     2009     2010     2009  

Revenues:

        

Product sales, net

   $ 9,621      $ 7,587      $ 18,317      $ 13,773   

Product co-promotion and royalty

     17,651        15,464        31,023        23,609   
                                

Total revenue

     27,272        23,051        49,340        37,382   

Operating expenses:

        

Cost of sales

     3,694        2,284        6,709        4,245   

Research and development

     11,799        13,557        21,392        25,824   

Selling and marketing

     12,342        11,789        26,036        24,809   

General and administrative

     8,064        4,233        18,300        8,053   

Restructuring

     —          48        —          1,979   
                                

Total operating expenses

     35,899        31,911        72,437        64,910   
                                

Loss from operations

     (8,627     (8,860     (23,097     (27,528

Other income/(expense):

        

Interest income

     156        159        325        319   

Interest expense

     (382     (810     (868     (1,709

Gain on investments

     5        —          5        —     
                                

Other income/(expense), net

     (221     (651     (538     (1,390
                                

Net loss

   $ (8,848   $ (9,511   $ (23,635   $ (28,918
                                

Basic and diluted net loss per common share

   $ (0.11   $ (0.17   $ (0.29   $ (0.51
                                

Weighted average common shares used in computing basic and diluted net loss per common share

     82,733        56,687        82,568        56,683   
                                

 

LOGO

 

4222 Emperor Boulevard, Suite 200        Durham, North Carolina 27703
Telephone 919.941.9777        Fax 919.941.9797


Page 6

 

INSPIRE PHARMACEUTICALS, INC.

Selected Balance Sheet Information

(in thousands)

 

     June 30,
2010
   December 31,
2009

Cash, cash equivalents and investments

   $ 106,165    $ 129,099

Trade receivables

     22,305      22,682

Inventories, net

     904      1,717

Total assets

     151,906      178,770

Working capital

     83,123      85,412

Debt, including current portion

     15,400      25,175

Total stockholders’ equity

     102,927      119,168

Shares of common stock outstanding

     82,822      82,346

# # #

 

LOGO

 

4222 Emperor Boulevard, Suite 200        Durham, North Carolina 27703
Telephone 919.941.9777        Fax 919.941.9797