Amylin Pharmaceuticals Reports Second Quarter Financial Results

Tag : 100% acetate
Amylin Pharmaceuticals Reports Second Quarter Financial Results
SAN DIEGO, July 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reportedfinancial results for the quarter ended June 30, 2008. The Companyreported total revenue of $222.0 million for the second quarter,including net product sales of $200.3 million. Net loss for thequarter ended June 30, 2008 was $64.8 million, or $0.47 per share.At June 30, 2008, the Company held cash, cash equivalents andshort-term investments of approximately $891.0 million.
"In the second quarter we continued to make substantial progressagainst our goals, with a focus on improving BYETTA and SYMLINsales and supporting the exenatide once weekly regulatorysubmission," said Daniel M. Bradbury , President and Chief Executive Officer of Amylin Pharmaceuticals."SYMLIN sales continued to increase steadily and we implemented anumber of important changes in our sales and marketing approach forBYETTA to drive growth in prescriptions with primary carephysicians."
Bradbury continued, "We are encouraged by the scientificcommunity's strong interest in BYETTA and exenatide once weekly(investigational therapy), as demonstrated by the many prominentdiscussions that centered on both therapies at the AmericanDiabetes Association's 2008 annual meeting. It was apparent thatnot only is glucose control important in managing diabetes; but howglucose control is achieved is being recognized as an importantconsideration. A medicine such as BYETTA, which provides powerful,durable glucose control with progressive weight loss and otherpotential benefits, is uniquely poised to take advantage of themarket's growing appreciation for the benefits of our noveltherapies."
Quarter ended June 30, 2008
Net product sales of $200.3 million for the quarter ended June 30,2008 include $177.5 million for BYETTA(R) (exenatide) injection and$22.8 million for SYMLIN(R) (pramlintide acetate) injection. Thiscompares to net product sales of $167.3 million, consisting of$152.1 million for BYETTA and $15.2 million for SYMLIN for the sameperiod in 2007.
Revenues under collaborative agreements were $21.7 million for thequarter ended June 30, 2008, compared to $29.6 million for the sameperiod in 2007. Collaborative revenues for the quarter ended June30, 2008 consist primarily of cost sharing payments from Eli Lillyand Company, or Lilly, for development expenses associated withexenatide once weekly and BYETTA. Collaborative revenues for thequarter ended June 30, 2007 included $15.0 million in milestones,earned upon Lilly's launch of BYETTA in the European Union.
Selling, general and administrative expenses were $111.1 millionfor the quarter ended June 30, 2008, compared to $93.1 million forthe same period in 2007. The increase reflects expenses associatedwith the recent expansion of the Company's field force, increasedpromotional expenses for BYETTA and SYMLIN, expenses associatedwith exenatide once weekly market development and increases inbusiness infrastructure to support the Company's growth.
Research and development expenses were $75.4 million for thequarter ended June 30, 2008, compared to $71.7 million for the sameperiod in 2007. The increase primarily reflects developmentexpenses for exenatide once weekly and growth in the Company'sresearch capabilities. Research and development expenses for thequarter ended June 30, 2007 included a development milestoneassociated with leptin. Non-GAAP, research and development expensesnet of cost-sharing payments decreased to $54.8 million for thequarter ended June 30, 2008, compared to $58.2 million for the sameperiod in 2007.
Collaborative profit sharing, which represents Lilly's share of thegross margin for BYETTA, was $79.0 million for the quarter endedJune 30, 2008, compared to $70.4 million for the same period in2007.
Net loss for the quarter ended June 30, 2008 was $64.8 million, or$0.47 per share, compared to $45.0 million, or $0.34 per share, forthe same period in 2007.
BYETTA
-- Implemented the expanded and more closely aligned salesorganization with Lilly and initiated the BYETTA-CIALISco-promotion at the end of the quarter.
-- Introduced an expanded program to educate primary carephysicians that BYETTA is a unique solution offering the advantagesof durable glucose control and weight loss.
SYMLIN
-- Announced data showing that the use of mealtime SYMLIN withbasal insulin therapy for 24 weeks resulted in more patients withtype 2 diabetes achieving improved glucose control, without weightgain or hypoglycemia, compared to the use of rapid-acting insulin(RAI) with basal insulin.
Exenatide once weekly
-- Held pre-NDA meeting with the FDA and gained clarity on itsregulatory path forward and remain confident that data from theDURATION-1 clinical study provides the necessary safety andefficacy data for an NDA submission. The Company remains on trackto submit an NDA for exenatide once weekly to the FDA by the end ofthe first half of 2009 with opportunity for acceleration of thefiling.
-- Announced results from a 52-week open-label clinical study thatshowed the durable efficacy of exenatide once weekly. Patientstaking exenatide once weekly experienced an average A1C decline of2.0 percent with 9.5 pound weight loss, and over the course of oneyear, sustained a similar improvement in glucose control comparedto those receiving treatment for 30 weeks.
-- Manufactured and shipped exenatide once weekly at commercialscale for use in ongoing and planned clinical programs during thethird quarter of 2008.
-- Initiated DURATION-3, the second of three planned superiorityclinical trials of exenatide once weekly, comparing exenatide onceweekly to insulin glargine in patients using oral diabetesmedications. Results from this study are expected in the first halfof 2009.
Obesity
-- Initiated a Phase 2B clinical study evaluating various dosingcombinations of pramlintide, an analog of the natural hormoneamylin, and recombinant human leptin (r-metHuLeptin; metreleptin)for the treatment of obesity. The objective of this dose-rangingstudy is to support dose selection for Phase 3, and to guide thedevelopment of a delivery system for this combination regimen.
Six months ended June 30, 2008
Total revenues for the six months ended June 30, 2008 were $419.3million. This includes net product sales of $379.1 million,including $336.0 million for BYETTA and $43.1 million for SYMLIN.This compares to net product sales of $329.3 million, consisting of$298.6 million for BYETTA and $30.7 million for SYMLIN for the sameperiod in 2007.
Revenues under collaborative agreements were $40.2 million for thesix months ended June 30, 2008, compared to $39.6 million for thesame period in 2007. Collaborative revenues for the six monthsended June 30, 2008 consist primarily of cost sharing payments fromLilly for development expenses associated with exenatide onceweekly and BYETTA. Collaborative revenues for the six months endedJune 30, 2007 included $15.0 million in milestones, earned uponLilly's launch of BYETTA in the European Union.
Selling, general and administrative expenses were $209.3 millionfor the six months ended June 30, 2008, compared to $180.9 millionfor the same period in 2007. The increase primarily reflectsincreased promotional expenses for BYETTA and SYMLIN, expensesassociated with exenatide once weekly market development, includingfield force expansion, and increases in business infrastructure tosupport the Company's growth.
Research and development expenses were $152.6 million for the sixmonths ended June 30, 2008, compared to $131.3 million for the sameperiod in 2007. The increase reflects increased developmentexpenses for exenatide once weekly. Non-GAAP, research anddevelopment expenses net of cost-sharing payments increased to$114.6 million for the six months ended June 30, 2008, compared to$108.8 million for the same period in 2007.
Collaborative profit sharing was $148.9 million for the six monthsended June 30, 2008, compared to $137.3 million for the same periodin 2007.
Net loss was $133.6 million, or $0.98 per share for the six monthsended June 30, 2008, compared to $94.4 million, or $0.72 per share,for the same period in 2007.
Conference Call
Amylin will Webcast its Quarterly Update Conference Call today at5:00 p.m. ET/2:00 p.m. PT. The call will be Webcast live throughAmylin's corporate Web site, http://www.amylin.com , and a recording will be made available following the close of thecall.
Daniel M. Bradbury , Amylin's President and Chief Executive Officer, will lead thecall. During the call, the Company plans to provide further detailsunderlying its second quarter financial results, and informationregarding assumptions for the remainder of 2008 operations. Forthose without access to the Internet, the live call may be accessedby phone by calling (866) 244-4530 (U.S./Canada) or (703) 639-1173(international), Conference ID# 1262019. A replay of the call willalso be available by phone beginning approximately two hours afterthe close of the call and can be accessed at (888) 266-2081(U.S./Canada) or (703) 925-2533 (international), Conference ID#1262019.
Note Regarding Use of Non-GAAP Financial Measures
Amylin reports non-GAAP, research and development expenses net ofcost-sharing payments, which is a non-GAAP financial measure. TheCompany believes that investors' understanding of Amylin's netinvestment in research and development activities is enhanced bythis disclosure. In addition, the Company refers to this non-GAAPfinancial information with its analysis of the Company's financialperformance. This non-GAAP financial information should beconsidered in addition to, and not as a substitute for, or superiorto, financial measures calculated in accordance with GAAP. Areconciliation of reported GAAP research and development expensesto non-GAAP research and development expenses, net of cost-sharingpayments, is provided in the table that follows (in thousands,unaudited):
About Amylin
Amylin Pharmaceuticals is a biopharmaceutical company committed toimproving lives through the discovery, development andcommercialization of innovative medicines. Amylin has developed andgained approval for two first-in-class medicines for diabetes,SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide)injection. Amylin's research and development activities leveragethe Company's expertise in metabolism to develop potentialtherapies to treat diabetes and obesity. Amylin is headquartered inSan Diego, California with over 2,000 employees nationwide. Furtherinformation on Amylin Pharmaceuticals is available at http://www.amylin.com .
This press release contains forward-looking statements aboutAmylin, which involve risks and uncertainties. Our actual resultscould differ materially from those discussed herein due to a numberof risks and uncertainties, including risks that BYETTA or SYMLINmay be affected by competition, unexpected new data, technicalissues, or manufacturing and supply issues; risks that ourfinancial results may fluctuate significantly from period to periodand may not meet market expectations; risks that any financialguidance we provide may not be accurate; risks that our clinicaltrials will not be completed when planned or may not replicateprevious results; risks that our preclinical studies may not bepredictive; risks that our NDAs for product candidates or sNDAs forlabel expansion requests, such as exenatide once weekly NDA or theBYETTA monotherapy sNDA, may not be submitted timely or receive FDAapproval; risks that we may not be able to complete ourmanufacturing facility on a timely basis; and other risks inherentin the drug development and commercialization process. Commercialand government reimbursement and pricing decisions and the pace ofmarket acceptance may also affect the potential for BYETTA orSYMLIN. These and additional risks and uncertainties are describedmore fully in the Company's recently filed Form 10-Q. Amylindisclaims any obligation to update these forward-lookingstatements.
SOURCE Amylin Pharmaceuticals Inc.