Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today reported financial results for the second quarter ended June 30, 2019 and provided a business update.
“We are very excited about the continued strength of the U.S. launch of ARIKAYCE® (amikacin liposome inhalation suspension), the first and only FDA-approved treatment for patients with refractory MAC lung disease, including the breadth and depth of prescribing, addition of new patients, and positive reception from the payer community throughout the first three quarters of launch,” commented Will Lewis, Chairman and Chief Executive Officer of Insmed. “While the U.S. launch remains our greatest area of focus, we are pleased to have made significant progress on our other strategic priorities this quarter, including filing for regulatory approval of ARIKAYCE in the EU, advancing our planned regulatory filings in Japan, and completing enrollment in the Phase 2 WILLOW study of INS1007. As we move into the second half of the year as a fully operational commercial-stage company, we plan to execute against these priorities with a disciplined approach to investment.”
Second Quarter 2019 Financial Results
- Total revenue for the second quarter ended June 30, 2019 was $30.0 million, comprising U.S. net sales of $29.0 million and ex-U.S. net sales of $1.0 million. The ex-U.S. net product sales include $0.9 million from the Temporary Authorization for Use (Autorisation Temporaire d’Utilisation or ATU) program in France and $0.1 million from the named patient program in Germany, both compassionate use programs.
- Cost of product revenues (excluding amortization of intangible assets) was $4.9 million for the second quarter of 2019.
- Research and development expenses were $33.5 million for the second quarter of 2019, compared with $35.7 million for the second quarter of 2018.
- Selling, general and administrative expenses for the second quarter of 2019 were $52.4 million, compared with $37.2 million for the second quarter of 2018. The increase was primarily due to higher expenses related to commercial activities for ARIKAYCE, including disease awareness, patient support activities, and field operations and, to a lesser extent, an increase in headcount, including non-cash stock-based compensation.
- For the second quarter of 2019, Insmed reported a GAAP net loss of $66.5 million, or $0.81 per share, compared with a GAAP net loss of $76.4 million, or $1.00 per share, for the second quarter of 2018.
- During the second quarter of 2019, Insmed completed a public offering of 10.7 million new shares of common stock that resulted in net cash proceeds of $261.2 million, after deducting underwriting discounts and commissions and other offering-related expenses. – PR Newswire