Alkermes reports 38% of year-over-year revenue growth from key products

Alkermes plc (NASDAQ: ALKS) today reported financial results for the quarter ended Sept. 30, 2013. This is the second quarter of the nine-month period ending Dec. 31, 2013, as the company transitions to reporting on a calendar year basis.

"Against a backdrop of another quarter of solid financial performance, Alkermes is advancing one of the most important CNS pipelines in the biopharmaceutical industry," commented Richard Pops, Chief Executive Officer of Alkermes. "During the quarter, we achieved key milestones for our most advanced programs. Looking forward, 2014 will be an important year for this late-stage pipeline as we obtain phase 3 results for aripiprazole lauroxil and prepare for the NDA submission and launch, as well as initiate the phase 3 program for ALKS 5461, which has been granted Fast Track status for the adjunctive treatment of major depressive disorder."

"This quarter's financial results demonstrate the power of our business model to generate substantial cash flows while also providing the resources to invest in our advancing pipeline," commented James Frates, Chief Financial Officer of Alkermes. "Our commercial portfolio demonstrated another strong quarter with 38% year-over-year revenue growth from our key products."

Quarter Ended Sept. 30, 2013 Highlights

• Total revenues for the quarter were $139.8 million, compared to total revenues of $124.0 million for the same period in the prior year.
• Revenues from the company's five key commercial products for the quarter grew 38% to $101.5 million, from $73.8 million for the same period in the prior year.
• Non-GAAP net income for the quarter was $31.8 million, or a non-GAAP diluted earnings per share (EPS) of $0.22. This compared to non-GAAP net income of $23.7 million, or a non-GAAP diluted EPS of $0.17, for the same period in the prior year.
• GAAP net loss for the quarter was $7.8 million, or a basic and diluted GAAP loss per share of $0.06. This compared to GAAP net loss of $16.7 million, or a basic and diluted GAAP loss per share of $0.13, for the same period in the prior year.
• Free cash flow for the quarter was $26.2 million, compared to $19.2 million for the same period in the prior year.

Quarter Ended Sept. 30, 2013 Financial Results

Revenues

• Manufacturing and royalty revenues from the company's long-acting atypical antipsychotic franchise, RISPERDAL^® CONSTA^® and INVEGA^® SUSTENNA^®/XEPLION^®, were $62.6 million, compared to $50.3 million for the same period in the prior year. Worldwide end-market sales of RISPERDAL CONSTA and INVEGA SUSTENNA/XEPLION were approximately $650 million, compared to approximately $563 million in the same period in the prior year.
• Manufacturing and royalty revenues from AMPYRA^®/FAMPYRA^®1 were $12.6 million, compared to $5.0 million for the same period in the prior year.
• Net sales of VIVITROL^® were $19.2 million, compared to $15.2 million for the same period in the prior year, representing an increase of approximately 26% year over year.
• Royalty revenue from BYDUREON^® was $7.0 million, compared to $3.3 million for the same period in the prior year.
• Results for the quarter included RITALIN LA^®/FOCALIN XR^® revenues of $9.2 million, VERELAN^® revenues of $4.4 million and TRICOR^® 145 revenues of $3.5 million. This compared to RITALIN LA/FOCALIN XR revenues of $9.1 million, VERELAN revenues of $5.8 million and TRICOR 145 revenues of $12.5 million for the same period in the prior year.

Costs and Expenses

• Operating expenses were $143.7 million, compared to operating expenses of $118.6 million for the same period in the prior year.
• Net interest expense was $3.2 million, compared to net interest expense of $22.4 million for the same period in the prior year. The reduction was driven by the successful refinancing and repricing of the company's term loans completed in 2012 and 2013, respectively.

Balance Sheet

• At Sept. 30, 2013, Alkermes recorded cash and total investments of $395.2 million, compared to $325.0 million at June 30, 2013, and $304.2 million at March 31, 2013.

Financial Expectations for Nine Months Ending Dec. 31, 2013

• The company reiterated all of its financial expectations for the nine-month period ending Dec. 31, 2013, (originally provided on May 23, 2013) except for Selling, General and Administrative expense, which the company now expects to be in the range of $105 million to $115 million, up from the previous range of $95 million to $105 million, reflecting increased commercial activity in preparation for the aripiprazole lauroxil launch and activities related to the VIVITROL label update.
• The company reiterated its expectations for non-GAAP net income to be in the range of $85 million to $105 million for the nine-month period ending Dec. 31, 2013, and expects to be in the upper end of that range.

Conference Call

Alkermes will host a conference call at 8:00 a.m. EDT (12:00 p.m. GMT) on Thursday, Oct. 31, 2013, to discuss these financial results and provide an update on the company. The conference call may be accessed by dialing +1 888 424 8151 for U.S. callers and +1 847 585 4422 for international callers. The conference call ID number is 6037988. In addition, a replay of the conference call will be available from 11:00 a.m. EDT (3:00 p.m. GMT) on Thursday, Oct. 31, 2013, through 5:00 p.m. EST (10:00 p.m. GMT) on Nov. 7, 2013, and may be accessed by visiting Alkermes' website or by dialing +1 888 843 7419 for U.S. callers and +1 630 652 3042 for international callers. The replay access code is 6037988.