Insmed Incorporated , 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, 2021 and provided a business update.
“Insmed made meaningful progress in the second quarter of 2021, with important achievements across our four pillars—ARIKAYCE, brensocatib, TPIP, and translational medicine,” commented Will Lewis, Chair and Chief Executive Officer of Insmed. “With the launch of ARIKAYCE just last month in Japan, the largest market for refractory MAC lung disease that we are pursuing, we’re thrilled that our lead product is now available in three major territories. We continue to enroll patients in both the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis and the ARIKAYCE frontline clinical trial program in patients with NTM lung disease in line with expectations, and we are advancing TPIP to Phase 2 development in both PAH and PH-ILD. As we carry forward learnings from the past year and a half in navigating the pandemic, we have great confidence in our ability to execute on our commercial and clinical activities around the world.”
Recent Corporate Developments & Program Highlights
- ARIKAYCE launched in Japan in July of 2021, following its approval by the Ministry of Health, Labour, and Welfare in March of 2021 for the treatment of patients with nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) who did not sufficiently respond to prior treatment with a multidrug regimen. ARIKAYCE has been priced in Japan in line with list prices in the U.S. and Europe.
- Insmed continues to advance the European launch of ARIKAYCE following its approval by the European Commission in October of 2020 for the treatment of NTM lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis (CF). Consideration should be given to official guidance on the appropriate use of antibacterial agents.
- Enrollment continues in the post-approval confirmatory frontline clinical trial program of ARIKAYCE in patients with NTM lung disease caused by MAC. The program consists of ARISE, an interventional study designed to validate a patient-reported outcome (PRO) tool in MAC lung disease, and ENCORE, a pivotal trial designed to establish, using the PRO tool validated in the ARISE trial, the clinical benefits and evaluate the safety of ARIKAYCE in patients with newly diagnosed MAC lung disease.
- Enrollment continues in the Phase 3 ASPEN study, a global, randomized, double-blind, placebo-controlled trial to assess the efficacy, safety, and tolerability of brensocatib in patients with bronchiectasis. Patients with bronchiectasis due to CF may not be enrolled in the study.
- The CF Therapeutics Development Network has endorsed Insmed’s study protocol for brensocatib in CF and the process for initiating study sites for a Phase 2 pharmacokinetic/pharmacodynamic multiple-dose study is now underway.
- Insmed expects to present data from the Phase 1 healthy volunteer trial of TPIP at the European Society of Cardiology Congress on August 30, 2021. The Company reported positive topline data from this study earlier this year.
- Insmed plans to advance two Phase 2 studies of TPIP in patients with pulmonary arterial hypertension (PAH). The first study will measure the impact of TPIP on pulmonary vascular resistance (PVR) over a 24-hour period. The Company anticipates sharing preliminary data from a small number of patients in this study in the second half of 2021. The second study will evaluate the effect of TPIP on PVR and 6-minute walk distance over a 16-week treatment period. The Company plans to initiate this study in the fourth quarter of 2021.
- Insmed plans to initiate a Phase 2 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) in early 2022.
- In July of 2021, Insmed announced the promotion of Michael Smith to the role of General Counsel, Senior Vice President of Insmed, replacing Christine Pellizzari, who retired from her position as the Company’s Chief Legal Officer. Mike joined Insmed in 2014 and most recently served as the Company’s Senior Vice President, General Counsel – U.S. In his new role, Mike will have responsibility for Insmed’s global legal function, including corporate governance, intellectual property, and contract management.
Second Quarter 2021 Financial Results
- Total revenue for the second quarter ended June 30, 2021 was $45.4 million, compared to total revenue of $42.5 million for the second quarter of 2020.
- Cost of product revenues (excluding amortization of intangible assets) was $10.8 million for the second quarter of 2021, compared to $10.0 million for the second quarter of 2020.
- Research and development (R&D) expenses were $64.7 million for the second quarter of 2021, compared to $35.7 million for the second quarter of 2020.
- Selling, general and administrative (SG&A) expenses for the second quarter of 2021 were $57.2 million, compared to $49.7 million for the second quarter of 2020.
- For the second quarter of 2021, Insmed reported a GAAP net loss of $117.3 million, or $1.07 per share, compared to a GAAP net loss of $61.9 million, or $0.64 per share, for the second quarter of 2020.
- During the second quarter of 2021, Insmed completed a public offering of 11,500,000 shares of common stock, including 1,500,000 shares issued pursuant to the exercise in full of the underwriters’ option to purchase additional shares, as well as a public offering of $575 million aggregate principal amount of its 0.75% convertible senior notes due 2028 (the 2028 Convertible Notes), including $75 million aggregate principal amount of notes purchased pursuant to the exercise in full of the underwriters’ option to purchase additional notes, solely to cover over-allotments. The offerings resulted in net cash proceeds of approximately $270.1 million and $559.0 million, respectively, after deducting underwriting discounts and other offering-related expenses. A portion of the net cash proceeds from the 2028 Convertible Notes was used to repurchase $225.0 million of the Company’s outstanding 1.75% convertible senior notes due 2025 (2025 Convertible Notes). The offerings resulted in net cash proceeds of approximately $590.0 million after the repurchase of a portion of the outstanding 2025 Convertible Notes.
Balance Sheet and Planned Investments
As of June 30, 2021, Insmed had cash and cash equivalents of $928.3 million. The Company’s total operating expenses for the second quarter of 2021 were $133.9 million. Adjusted R&D expenses for the second quarter of 2021 were $58.9 million and adjusted SG&A expenses for the second quarter of 2021 were $48.8 million. Adjusted R&D expenses and adjusted SG&A expenses are non-GAAP measures, which we describe further below.
The Company plans to continue to invest in the following key activities in 2021:
U.S. commercialization of ARIKAYCE;
clinical trial activities, including (a) advancement of the frontline clinical trial program for ARIKAYCE (ARISE and ENCORE), (b) advancement of the Phase 3 ASPEN study of brensocatib in patients with bronchiectasis, (c) advancement of clinical development of TPIP, and (d) advancement of our translational medicine efforts; and
launch activities for ARIKAYCE in initial European countries and in Japan.
Insmed will host a conference call beginning today at 8:30 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (844) 200-6205 (domestic) or +44-208-0682-558 (international) and referencing access code 711350. The call will also be webcast live on the Company’s website at www.insmed.com.
A replay of the conference call will be accessible approximately 45 minutes after its completion through September 6, 2021 by dialing (929) 458-6194 (domestic) or +44-204-525-0658 (international) and referencing access code 984249. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company’s website at www.insmed.com.