Aegerion Pharmaceuticals (AEGR) Offers Robus Prelim. Q4, FY14 Sales Outlook

Aegerion Pharmaceuticals (NASDAQ: AEGR) reported preliminary unaudited 2014 net product sales, its outlook for 2015 and other business updates. Marc Beer, chief executive officer, plans to discuss these topics during a live presentation at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco scheduled for Monday, January 12, 2015 at 4:30 p.m. PST (7:30 p.m. EST). The presentation will be webcast live and accessible through the "Investors" section of Aegerion's website, www.aegerion.com.

2014 Preliminary Results & Business Update

• Fourth Quarter 2014: Aegerion expects fourth quarter 2014 preliminary, unaudited net product sales to be between $49.3 and $51.3 million (consensus sees $47.7 million), which represents growth of approximately:
  • 105 percent over the fourth quarter of 2013; and
  • 15 percent sequentially over the third quarter of 2014.
• Full-Year 2014: Aegerion expects preliminary, unaudited net product sales for full year 2014 to be between $156 and $158 million (the Street is at $154.4 million). These results:
  • align with the Company's most recent guidance of between $150 and $160 million; and
  • represent approximately 220 percent growth over full-year 2013 net product sales.
• The Company announced completion of the acquisition of MYALEPT®.

At December 31, 2014 there were approximately 745 active commercial patients on JUXTAPID therapy globally, approximately 632 of whom are U.S. patients. The cumulative dropout from launch in January of 2013 to year-end 2014 in the U.S. was approximately 41 percent. Cumulative drop-out is defined as the total number of patients who have definitively determined to discontinue therapy from the date of initial launch to the end of 2014 as a percentage of all patients who have received at least one shipment during that period. Compliance rates remain steady in the 80 to 90 percent range.

Marc Beer, chief executive officer of Aegerion, commented: "Our 2014 results reflect progress in reaching HoFH patients, with meaningful top-line and prescription growth over 2013. 2014 was a year of strategic investments in our commercial organization designed to support a positive patient experience with JUXTAPID, and we believe that these were the right investments both for JUXTAPID and future products. We are focused on strong execution in our patient services as we work with healthcare providers and patients to support adherence to therapy.

"We are also pleased to have shipped an order of JUXTAPID to the state of São Paulo, Brazil in December for both newly prescribed HoFH patients and previous JUXTAPID-treated HoFH patients from that state. This represented the first JUXTAPID order for HoFH patients in São Paolo in over one year."

The Company announced that it has entered into an amendment to its Loan and Security Agreement with Silicon Valley Bank (SVB) to borrow $25 million in senior term debt, and to provide for the availability of up to $15 million in a working capital line of credit for general corporate purposes. The Company used part of the proceeds of the senior term debt to repay its existing SVB debt of $3.9 million.

MYALEPT® Acquisition

As previously announced, Aegerion has completed the acquisition of MYALEPT (metreleptin) for injection, an orphan drug product that is indicated, as an adjunct therapy along with diet, to treat complications of leptin deficiency in patients with generalized lipodystrophy (GLD). Since the initial launch of MYALEPT, over 35 GLD patients have initiated commercial therapy.

Mr. Beer commented, "Our team is excited about the opportunity to build upon AstraZeneca's progress in delivering MYALEPT to GLD patients, with a continuing commitment to excellence in patient support. MYALEPT's expected synergistic fit with Aegerion's existing operations should help us in our efforts to achieve this objective. We are also focused on the potential to expand commercial opportunities for MYALEPT globally through additional regulatory filings for marketing approval."

Aegerion acquired global rights to develop, manufacture, and commercialize MYALEPT, subject to an existing distributor license with Shionogi covering Japan, South Korea and Taiwan. MYALEPT is a recombinant analogue of human leptin, indicated in the U.S. as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. MYALEPT has orphan drug designation in the U.S., European Union (EU) and Japan.

2015 Outlook

• With global value dossiers for lomitapide submitted for consideration in key markets in the EU, the Company anticipates reimbursement decisions in several EU countries in 2015.
• The Company continues to expect to submit a New Drug Application for lomitapide in Japan for the treatment of adult HoFH following anticipated completion of the 26-week efficacy phase of the ongoing Phase 3 study in Japan in mid-2015.
• The Company now plans to initiate a therapeutic study of lomitapide in pediatric HoFH patients in the first half of 2015. Discussions with both the U.S. Food and Drug Administration and European Medicines Agency to finalize the trial protocol design are ongoing.

2015 Financial Guidance

• Aegerion expects full-year 2015 global net product sales of JUXTAPID to be between $195 million and $215 million.
• Aegerion expects full-year 2015 global net products sales of MYALEPT to be between $10 million and $20 million.
• Total full-year 2015 global net product sales expectations represent an annual growth rate of approximately 30-50% over 2014 net product sales.
• Aegerion expects full-year total non-GAAP operating expenses of between $195 million and $205 million.
• Aegerion expects to generate cash from operations for the full-year of 2015.

Mr. Beer commented, "We expect 2015 to be a pivotal year, which should provide clarity on the growth trajectory of JUXTAPID, particularly in light of the anticipated introduction of the PCSK-9 inhibitors. While we expect disruption of new-patient starts as a result of PCSK-9 inhibitor launches, and have factored this disruption, and some attrition of our existing patients, into our 2015 financial guidance, our market research supports the belief that over the long-term there is meaningful potential upside from possible increased diagnosis of HoFH as a result of the greater disease awareness likely to follow the introduction of PCSK-9 inhibitors. With JUXTAPID as our cornerstone product, we are building a global rare disease company with a goal of meaningful revenue growth and positive cash flow."

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