On May 10, 2018 Novelion Therapeutics Inc. (NASDAQ: NVLN), a biopharmaceutical company dedicated to developing and commercializing therapies for individuals living with rare diseases ("Novelion" or the "Company"), reported financial results for the first quarter ended March 31, 2018 and provided an overview of business activities (Press release, QLT, MAY 10, 2018, View Source [SID1234526492]).
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Chief Operating Officer Jeff Hackman said, "Thus far in 2018 we have executed a number of important initiatives, including finalizing the settlements with the DOJ, reducing costs, strengthening our balance sheet with a $20 million term loan, and reviewing our holding and capital structure with a goal of optimizing our assets for shareholders. We have a strong rare disease product portfolio that carries the opportunity to expand metreleptin into new disease areas, and which we believe will deliver meaningful future sales growth. We remain focused on continuing to market important therapies that will bring value to our patients."
Business Update
JUXTAPID: Novelion reported net revenues of JUXTAPID of $13.4 million in the first quarter of 2018, $8.6 million, or 64%, of which were from prescriptions written in the U.S.
MYALEPT: Novelion reported net revenues of MYALEPT of $14.1 million in the first quarter of 2018, $9.8 million, or 69%, of which were from prescriptions written in the U.S.
Novelion reported total consolidated net revenues of $27.5 million in the first quarter of 2018.
Novelion ended the first quarter of 2018 with $52.0 million in unrestricted cash, compared with $55.4 million at the end of 2017. The $52.0 million includes proceeds from a $20.0 million term loan to Aegerion Pharmaceuticals, Inc. ("Aegerion") provided by affiliates of Sarissa Capital Management and Broadfin Capital LLC, as announced in March 2018.
The Company expects the opinion of the European Medicines Agency’s Committee for Medicinal Products for Human Use ("CHMP") on the metreleptin marketing authorization application in the second quarter of 2018, followed by a mid-2018 European Commission approval decision.
Novelion announced that a poster describing the results of a metreleptin study for weight loss in overweight and obese adults with low leptin levels will be presented at the American Diabetes Association’s 78th Annual Scientific Sessions which is being held from June 22 to June 26, 2018 in Orlando, Florida.
First Quarter 2018 Financial Results
GAAP total net revenues for the first quarter of 2018 were $27.5 million compared to $30.0 million for the same period of 2017. GAAP net revenues for JUXTAPID in the first quarter of 2018 were $13.4 million compared to $16.0 million for the same period in 2017. GAAP net revenues for MYALEPT in the first quarter of 2018 were $14.1 million compared to $14.0 million for the same period in 2017.
GAAP total operating expenses for the first quarter of 2018 were $35.5 million compared to total operating expenses of $35.2 million for the same period in 2017. GAAP SG&A expenses were $23.7 million in the first quarter of 2018 compared to $24.5 million for the same period in 2017. GAAP R&D expenses were $11.8 million in the first quarter of 2018 compared to $9.3 million for the same period in 2017.
On a pro forma basis, during the first quarter of 2018, SG&A expenses were $21.6 million compared to $23.0 million for the same period in 2017. The decrease in pro forma SG&A expenses in the first quarter of 2018 compared with the same period in 2017 was primarily related to a reduction in headcount and legal and consulting fees.
On a pro forma basis, during the first quarter of 2018, R&D expenses were $11.6 million compared to $9.0 million for the same period in 2017. The increase in pro forma R&D expenses in the first quarter of 2018 compared with the same period in 2017 was primarily related to additional spending in certain clinical activities.
GAAP net loss in the first quarter of 2018 was $32.8 million compared to GAAP net loss of $31.0 million during the same period in 2017.
On a pro forma basis, net loss in the first quarter of 2018 was $13.5 million, compared to a loss of $8.7 million for the same period in 2017.
As of March 31, 2018, the Company’s consolidated unrestricted cash balance was $52.0 million, compared to $55.4 million at December 31, 2017. As of March 31, 2018, there were18.7 million shares outstanding. Convertible debt principal is $325.0 million, reflecting the amount of convertible debt, before discount, issued by subsidiary Aegerion. In addition, as described above, in March 2018, Novelion’s subsidiary, Aegerion, entered into a secured financing facility with affiliates of Sarissa Capital Management and Broadfin Capital LLC providing for a $20.0 million term loan to Aegerion.