Aegerion Announces Fourth Quarter And Full Year 2014 Financial Results

- Company records $158.4 million in net product sales of JUXTAPID® in 2014, representing 226% growth over 2013 -

- Company generates $17.9 million in positive cash flow from operations in the second half of 2014 -

- 2015 total net product sales guidance maintained at between $205 and $235 million -

CAMBRIDGE, Mass., Feb. 26, 2015 (GLOBE NEWSWIRE) -- Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, announced its financial results and business highlights for the fourth quarter and full year of 2014.

Highlights

• Aegerion recorded $51.7 million in net product sales of JUXTAPID® (lomitapide) capsules in the fourth quarter of 2014, representing growth of approximately 111% over the fourth quarter of 2013, and 18% growth sequentially over the third quarter of 2014. 86% of net product sales in the fourth quarter were from prescriptions written in the United States.
• For the full-year of 2014, Aegerion recorded $158.4 million in net product sales of JUXTAPID, representing growth of approximately 226% over 2013. 91% of net product sales in 2014 were from prescriptions written in the United States.
• With the objective of strengthening and diversifying the revenue base, the Company launched MYALEPT® (metreleptin) for injection in late January of 2015 after acquiring the product from AstraZeneca. As of February 20, 2015, 45 generalized lipodystrophy patients were active on commercial therapy.
• The Company reported total non-GAAP operating expenses, excluding stock-based compensation, of $140.8 million in 2014, in line with previously downward revised operating expense guidance of $135 million to $145 million.
• The Company achieved positive cash flow from operations of $9.2 million during the fourth quarter, and $17.9 million in the second half of 2014.
• The schedule for completion of the clinical study evaluating lomitapide in Japanese HoFH patients is on track, and the Company is planning for a Japanese NDA filing in mid-2015.

Chief Executive Officer Marc D. Beer commented, "We entered 2015 with strong momentum and continued confidence in the potential of Aegerion. Through the addition of MYALEPT, we have transformed into a diversified orphan drug company with a continued sharp focus on managing expenses and a goal of achieving full year cash flow positive operations in 2015.

"We continue to believe there is opportunity for growth in the JUXTAPID business. We have calibrated our operations with calculated investments and data-driven focus directed at impacting trends such as early drop-out and patient-elected non-starts. We also believe that we're still in the early stages of our commercial progress with lomitapide globally.

"We believe 2015 will begin to provide clarity on the impact that PCSK-9 inhibitors will have on the growth trajectory of JUXTAPID. We expect disruption of new patient starts as a result of the introduction of PCSK-9 inhibitors, and have factored this disruption and some attrition of our existing patients into our 2015 financial guidance. We believe, over the long term, the greater disease awareness likely to follow introduction of PCSK-9 inhibitors may result in the possible identification of more HoFH patients who may be candidates for JUXTAPID.

"In addition, we expect our growth will be bolstered by support from MYALEPT. We are encouraged by our results to date and the strong synergies that we have experienced with our existing operations. We also look forward to exploring potential geographic and label expansion."

Financial Results

Net product sales for the fourth-quarter ended December 31, 2014 were $51.7 million, compared with $24.5 million in the fourth quarter ended December 31, 2013. Net product sales for the full-year ended December 31, 2014 were $158.4 million, compared with $48.5 million for full year ended December 31, 2013. 86% of net product sales in the fourth quarter of 2014 were from prescriptions written in the U.S., while 14% came from prescriptions written in ex-U.S. countries, primarily named patient sales in Brazil. For the full year of 2014, 91% of net product sales were from prescriptions written in the U.S., while 9% came from prescriptions written in ex-U.S. countries, primarily named patient sales in Brazil. The Company expects net product sales from named patient sales in ex-U.S. countries to fluctuate significantly quarter-over-quarter, and those sales could in any quarter be a significantly smaller or greater percentage of total net product sales than in the previously reported quarter.

For the fourth quarter ended December 31, 2014, GAAP net loss was $8.1 million, or $0.29 per share, compared with a GAAP net loss of $13.9 million, or $0.47 per share, for the same period in 2013. For the full year ended December 31, 2014, GAAP net loss was $39.4 million, or $1.35 per share, compared with a GAAP net loss of $63.4 million, or $2.19 per share, for the same period in 2013.

For the fourth quarter ended December 31, 2014, total operating expenses on a GAAP basis were $47.9 million, compared with $35.7 million for the same period in 2013. For the full year ended December 31, 2014, total operating expenses on a GAAP basis were $170.7 million, compared with $105.9 million for the same period in 2013.

Selling, general and administrative expenses were $37.2 million for the fourth quarter ended December 31, 2014, compared to $27.2 million for the same period in 2013. Selling, general and administrative expenses were $132.7 million for the full year ended December 31, 2014, compared to $76.1 million for the same period in 2013. The increase in selling, general and administrative expenses in the fourth quarter and full year of 2014 over the comparable periods in 2013 was primarily related to the increased headcount in both selling and administrative functions, increased costs associated with outside services required to support the commercial activities related to JUXTAPID in the U.S. and our global expansion, and increased legal fees, primarily related to ongoing investigations.

Research and development expenses were $10.7 million for the quarter ended December 31, 2014 compared to $8.5 million for the same period in 2013. Research and development expenses were $38.0 million for the full year ended December 31, 2014, compared to $29.8 million for the same period in 2013. The increase in research and development expenses for the fourth quarter and full year of 2014 over the comparable periods in 2013 was primarily related to clinical development expenses incurred to support clinical development required for a potential marketing authorization application for lomitapide in Japanese HoFH patients and in connection with preparations for the planned pediatric HoFH study; employee costs associated with increased headcount; and outside service expenses primarily related to contract manufacturing and process development activities associated with new strengths of lomitapide and to meet regulatory requirements in Brazil and Europe.