Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today reported financial results for the quarter ended March 31, 2011. The Company reported total revenue of $152.7 million for the quarter ended March 31, 2011, which includes net product sales of $150.8 million and revenues under collaborative agreements of $1.9 million. Non-GAAP operating loss was $3.2 million for the quarter ended March 31, 2011, compared to $3.8 million for the same period in 2010. GAAP net loss was $37.3 million, or $0.26 per share, for the quarter ended March 31, 2011, compared to $38.2 million, or $0.27 per share, for the same period in 2010. Net loss excluding restructuring charges was $34.5 million, or $0.24 per share for the quarter ended March 31, 2011, compared to $38.2 million, or $0.27 per share for the same period in 2010.
At March 31, 2011 the Company held cash, cash equivalents, short-term investments and restricted cash of $475.2 million. The Company’s $200 million of 2.5% convertible senior notes were repaid subsequent to the end of the quarter on April 15, 2011. During the first quarter, the Company also notified its partner Eli Lilly and Company of its intent to draw a $165 million line of credit available from Lilly. These funds may be drawn in May of 2011, and, if drawn, the loan would be due in May 2014.
"We continue to manage the business with operational discipline and ended the quarter in a strong financial position that led to reduced expenses and improved gross margins," said Mark G. Foletta, senior vice president of finance and chief financial officer at Amylin Pharmaceuticals. "We remain focused on our longer-term target of generating sustainable positive operating cash flow and, we believe, that the significant cost-savings we have realized over the past two years reflect our ability to efficiently manage our business and achieve this goal."
Highlights of Amylin's First Quarter and Recent Activities
- Initiated a thorough QT study to address questions raised by the U.S. Food and Drug Administration (FDA) in their complete response letter regarding the BYDUREON™ (exenatide extended-release for injectable suspension) New Drug Application.
- Announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of BYDUREON in the European Union for the treatment of type 2 diabetes in combination with certain oral therapies.
- Communicated top-line results from DURATION-6, the sixth DURATION study that showed weekly BYDUREON significantly improved glucose control from baseline. These results reinforce the important role of GLP-1 receptor agonists in the treatment of type 2 diabetes, although BYDUREON did not meet the pre-specified primary endpoint of non-inferiority to daily Victoza® (liraglutide (rDNA origin) injection) in this study.
- Announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes. The investigational GLP-1 treatment improved glucose control with just one dose per month. After 20 weeks of treatment (five injections), patients randomized to the exenatide once monthly treatment arms experienced average reductions in A1C ranging between 1.3 and 1.5 percentage points from baseline. We are proceeding with regulatory interactions to outline the next steps for this important program within the exenatide franchise.
- Lilly received approval in Mexico for an expanded indication of BYETTA® (exenatide) injection as an add-on therapy to basal insulin.
- Voluntarily suspended clinical activities in an ongoing phase 2 study of pramlintide/metreleptin for the treatment of obesity to investigate an antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity. The Company, with partner Takeda Pharmaceutical Company Limited, is committed to working closely with clinical investigators, regulators and outside experts to determine the best path forward.
"We are pleased with the CHMP's recent recommendation to approve BYDUREON in Europe. This therapy could offer millions of people living with diabetes the benefits of a GLP-1 receptor agonist in just one dose per week," said Daniel M. Bradbury, president and chief executive officer at Amylin Pharmaceuticals. "In the coming quarters, we will continue to advance other key development programs to address the needs of the patients we serve. This includes submitting our reply to the BYDUREON complete response letter, as well as completing our regulatory application for the use of metreleptin in patients with lipodystrophy."
Net product sales of $150.8 million for the quarter ended March 31, 2011 include net sales of $128.0 million for BYETTA and $22.8 million for SYMLIN® (pramlintide acetate) injection. This compares to net product sales of $172.3 million, consisting of $149.8 million for BYETTA and $22.5 million for SYMLIN for the same period in 2010.
Revenues under collaborative agreements were $1.9 million for the quarter ended March 31, 2011, unchanged from the same period in 2010, and consist of the amortization of upfront fees received under the Company's collaboration agreement with Takeda.
Selling, general and administrative expenses decreased to $64.6 million for the quarter ended March 31, 2011 from $73.3 million for the same period in 2010. The decrease reflects reduced expenses associated with BYDUREON pre-launch activities and lower business infrastructure spending resulting from continued efforts to drive efficiencies in our business.
Research and development expenses decreased to $41.9 million for the quarter ended March 31, 2011, compared to $45.3 million for the same period in 2010. The decrease reflects our reduced cost structure partially offset by increased development spending on our lipodystrophy development program.
Collaborative profit sharing, which represents Lilly's share of the gross margin for BYETTA, was $59.9 million for the quarter ended March 31, 2011, compared to $67.9 million for the same period in 2010.
Non-GAAP operating loss was $3.2 million for the quarter ended March 31, 2011, compared to non-GAAP operating loss of $3.8 million for the same period in 2010. GAAP net loss was $37.3 million, or $0.26 per share for the quarter ended March 31, 2011, compared to $38.2 million, or $0.27 per share for the same period in 2010. Net loss excluding restructuring charges was $34.5 million, or $0.24 per share for the quarter ended March 31, 2011, compared to $38.2 million, or $0.27 per share for the same period in 2010.
Amylin Pharmaceuticals, Inc.