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 third quarter ended September 30, 2019 and provided a business update.
"We remain very pleased with the continued strong performance of the US launch of ARIKAYCE® (amikacin liposome inhalation suspension). Insmed remains guided by our desire to have a positive impact on patients' lives and is powered by our shared sense of purpose to deliver therapies to small patient populations experiencing big health problems," commented Will Lewis, Chairman and Chief Executive Officer of Insmed. "We are also progressing well with our global expansion efforts including filing for regulatory approval of ARIKAYCE in the EU last quarter and advancing our planned regulatory filings in Japan in first half of 2020. We are also looking forward to the topline results from the WILLOW study which we expect in the first quarter of 2020."
Third Quarter 2019 Financial Results
- Total revenue for the third quarter ended September 30, 2019 was $38.9 million, comprising U.S. net sales of $37.8 million and ex-U.S. net sales of $1.1 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 $0.2 million from the named patient program in Germany, both compassionate use programs.
- Cost of product revenues (excluding amortization of intangible assets) was $6.4 million for the third quarter of 2019.
- Research and development expenses were $34.3 million for the third quarter of 2019, compared with $39.5 million for the third quarter of 2018.
- Selling, general and administrative expenses for the third quarter of 2019 were $53.3 million, compared with $44.4 million for the third quarter of 2018. The increase was primarily due to milestone payments and other external expenses related to ARIKAYCE.
- For the third quarter of 2019, Insmed reported a GAAP net loss of $60.7 million, or $0.68 per share, compared with a GAAP net loss of $87.7 million, or $1.14 per share, for the third quarter of 2018.
Recent Corporate Developments & Program Highlights
WILLOW Study
Insmed completed enrollment in the six-month Phase 2 WILLOW study of INS1007 for patients with non-cystic fibrosis (CF) bronchiectasis during the 2nd quarter of 2019 and continues to expect top-line data in the first quarter of 2020.
ARIKAYCE Launch and Lifecycle Management
Insmed continues to advance the post-approval confirmatory clinical trial for ARIKAYCE and the Company has initiated efforts to develop an appropriate patient reported outcome (PRO) tool that will enable the assessment of therapies for the treatment of NTM lung disease. Insmed plans to conduct the confirmatory study of ARIKAYCE in a frontline setting of patients with MAC lung disease as well as a separate study in patients with NTM lung disease caused by Mycobacterium abscessus.
Insmed Appoints Chief Medical Officer
Martina Flammer, M.D., M.B.A., has been appointed Chief Medical Officer at Insmed, effective mid-December 2019. Dr. Flammer has more than 17 years of experience in both medical and commercial roles. She has launched global brands and managed pipeline portfolios across therapeutic areas and geographies, including the U.S., Europe, Japan and China. Dr. Flammer was most recently Head of Corporate Division Customer Value, Senior Vice President at Boehringer Ingelheim International. She has previously held various roles at Boehringer Ingelheim, including Vice President Clinical Development & Medical Affairs, Specialty Care Business Unit, and Chief Medical Officer, Vice President of Medicine, Regulatory Affairs & Pharmacovigilance, Boehringer Ingelheim Canada. Prior to that, Dr. Flammer held commercial and medical roles at Pfizer. She holds a medical degree from the University of Vienna Medical School, Austria and a Master of Business Administration degree from New York University Stern School of Business.
Financial Guidance and Balance Sheet
As of September 30, 2019, Insmed had cash and cash equivalents of $535.6 million. The Company's total costs and expenses for the third quarter of 2019 were $95.4 million, compared with total costs and expenses for the third quarter of 2018 of $84.0 million. Cash-based operating expenses, as defined below, for the third quarter of 2019 were $72.6 million, compared with cash-based operating expenses for the third quarter of 2018 of $75.1 million.
The Company now expects full-year 2019 total revenue for ARIKAYCE to be in the range of $133 million to $138 million.
The Company plans to continue to invest in the following key activities in 2019:
| (i) | support of the U.S. launch and commercialization of ARIKAYCE; |
| (ii) | clinical trials including (a) the development and verification of a PRO for NTM lung disease as a pivotal step toward initiating a confirmatory clinical study of ARIKAYCE, (b) the six-month Phase 2 WILLOW study of INS1007 in patients with non-CF bronchiectasis, and (c) the advancement of other pipeline programs including INS1009 and our earlier-stage research pipeline; |
| (iii) | global expansion in Europe and Japan to support pre-commercial activities in those regions and potential regulatory filings in Japan; and |
| (iv) | buildout of an additional third-party manufacturing facility to increase long-term production capacity for ARIKAYCE and its new corporate headquarters facility. |
Insmed continues to expect cash-based operating expenses to be in the range of $140 million to $155 million for the second half of 2019. In addition, the Company continues to expect capital expenditures, including those related to its new corporate headquarters facility as well as payments classified within other assets for the future right-of-use asset related to the buildout of an additional third-party manufacturing facility, to be in the range of $20 million to $30 million for the second half of 2019.
About ARIKAYCE® (amikacin liposome inhalation suspension)
ARIKAYCE is the first and only FDA-approved therapy indicated for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides. This approach prolongs the release of amikacin in the lungs while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI).
About PARI Pharma and the Lamira® Nebulizer System
ARIKAYCE® (amikacin liposome inhalation suspension) is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of liquid medications, including liposomal formulations such as ARIKAYCE, via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms and new pharmaceutical formulations that work together to improve patient care.
