On October 26, 2023 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported financial results for the third quarter ended September 30, 2023 and provided a business update (Press release, Insmed, OCT 26, 2023, View Source [SID1234636373]).
"Insmed made tremendous progress in the third quarter of 2023, punctuated by positive topline results from the ARISE study, encouraging blinded data from the Phase 2 trials of TPIP in PH-ILD and PAH, and the strongest quarter of ARIKAYCE revenues to date," said Will Lewis, Chair and Chief Executive Officer of Insmed. "Each of our mid- to late-stage pipeline assets continue to demonstrate strong performance in the clinic and Insmed’s enormous potential. We are extremely excited about the robust series of clinical, regulatory, and commercial catalysts that lie ahead as we strive to bring forward first-in-class or best-in-class medicines to patients in need."
Recent Pillar Highlights
Pillar 1: ARIKAYCE
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ARIKAYCE global revenue grew 17% in the third quarter of 2023 compared with the third quarter of 2022, reflecting the strongest quarter of sales since commercial launch and continued sequential quarterly revenue growth in the U.S. and Japan.
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Insmed continues to execute on its post-marketing, confirmatory trial program for ARIKAYCE, including the recently completed ARISE study and the ongoing ENCORE study in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung infection who have not started antibiotics.
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The Company announced positive topline efficacy and safety data from the ARISE trial in September of 2023. The study met its primary objective of validating a patient-reported outcome (PRO) instrument in patients with MAC lung disease. In addition, ARIKAYCE-treated patients had nominally statistically significantly higher culture conversion rates at Month 7 versus the comparator arm. Based on the results of ARISE, Insmed plans to explore with global regulators accelerating the filing for approval of ARIKAYCE in newly infected patients with MAC lung disease.
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The Company remains on track to enroll 250 patients in the registrational ENCORE study by the end of 2023. Enrollment is expected to continue into 2024, pending additional discussions with the U.S. Food and Drug Administration (FDA). Insmed anticipates reporting topline data from the ENCORE study in 2025.
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Pillar 2: Brensocatib
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Insmed continues to expect topline data from the ASPEN study, a global Phase 3 trial designed to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis, in the second quarter of 2024.
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The Company has opened several study sites in the Phase 2b BiRCh trial of brensocatib in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and is nearing randomization of the study’s first patients.
Pillar 3: TPIP
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Insmed continues to enroll patients in a Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and a Phase 2 study in pulmonary arterial hypertension (PAH).
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In the ongoing studies, 80% of the first 10 PH-ILD patients and 83% of the first 24 PAH patients who reached the Week 5 visit, which is the last possible point at which the dose can be increased in the trial, were able to titrate up to the maximum dose of 640 micrograms or matching placebo.
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Adverse events observed to date in these trials have been consistent with the events commonly seen in patients with PAH or PH-ILD and with the known effects of inhaled prostacyclin therapies. In addition, adverse events related to cough have been mostly mild and there have been no instances of throat irritation or pain to date. A meeting of the Data Safety and Monitoring Board was held in October of 2023, where it was recommended that both studies continue as planned.
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Based on a review of 22 patients who had completed 16 weeks of treatment in the ongoing PAH study, including patients receiving placebo, the average reduction in PVR from baseline was 21.5%. The average PVR reduction among the 64% of patients who had an improvement in PVR was 47%.
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Insmed remains on track to report topline results from the Phase 2 study of TPIP in PH-ILD in the first half of 2024.
Pillar 4: Early-Stage Research
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Insmed’s early-stage research efforts include more than 30 identified pre-clinical programs in development, all of which have the potential to become first-in-class or best-in-class therapies.
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The Company is continuing to advance its gene therapy program in Duchenne muscular dystrophy (DMD), including additional pre-clinical studies to further characterize its novel intrathecal route of gene therapy administration. Pending completion of this work, the Company expects to initiate clinical trials in patients. In parallel, the Company continues to advance its mid-length dystrophin DMD gene therapy program using its proprietary RNA-end-joining technology.
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The Company continues to anticipate the totality of its early-stage research programs will comprise less than 20% of overall spend.
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Third-Quarter 2023 Financial Results
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Total revenue for the third quarter ended September 30, 2023 was $79.1 million, reflecting the Company’s strongest quarter of sales to date and 17% growth compared to total revenue of $67.7 million for the third quarter of 2022.
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Total revenue for the third quarter of 2023 was comprised of ARIKAYCE net sales of $59.2 million in the U.S., $16.0 million in Japan, and $3.8 million in Europe and rest of world. Third-quarter sales reflect year-over-year growth of 20% and 11% in the U.S. and Japan, respectively, as well as the highest quarter of sales to date in these two regions.
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Cost of product revenues (excluding amortization of intangibles) was $16.7 million for the third quarter of 2023, compared to $13.5 million for the third quarter of 2022, reflecting increased sales volumes of ARIKAYCE.
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Research and development (R&D) expenses were $109.1 million for the third quarter of 2023, compared to $99.9 million for the third quarter of 2022 and $197.0 million for the second quarter of 2023. R&D expenses in third-quarter 2023 reflected continued investment in the Company’s early and mid- to late-stage pipelines.
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Selling, general and administrative (SG&A) expenses for the third quarter of 2023 were $90.6 million, compared to $75.6 million for the third quarter of 2022 and $84.4 million for the second quarter of 2023. The year-over-year increase in SG&A expenses resulted primarily from an increase in compensation and benefit-related expenses and stock-based compensation costs due to an increase in headcount, as well as increased fees and expenses driven by commercial readiness activities for brensocatib.
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Insmed reported a net loss of $158.9 million, or $1.11 per share, for the third quarter of 2023, compared to a net loss of $131.1 million, or $1.09 per share, for the third quarter of 2022, and a net loss of $244.8 million, or $1.78 per share, for the second quarter of 2023.
Balance Sheet, Financial Guidance, and Planned Investments
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As of September 30, 2023, Insmed had cash, cash equivalents, and marketable securities totaling $786 million, down from $918 million as of June 30, 2023, reflecting the ongoing support of the ARIKAYCE franchise, commercial readiness activities for brensocatib, and clinical operations for its mid- to late-stage pipeline programs.
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Insmed is reiterating its sales guidance for full-year 2023 global revenues for ARIKAYCE in the range of $295 million to $305 million.
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Insmed continues to anticipate that over 80% of total expenditures will be on its mid- to late-stage and commercial programs (ARIKAYCE, brensocatib, and TPIP), and that less than 20% of overall spend will be on its early-stage research programs, reflecting the Company’s historical approach to spending.
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The Company plans to continue to invest in the following key activities during the remainder of 2023:
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commercialization and expansion of ARIKAYCE globally;
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advancement of brensocatib, including the Phase 3 ASPEN study in patients with bronchiectasis, which is expected to be completed in the second quarter of 2024, and commercial launch readiness activities, as well as the Phase 2 trial in patients with CRSsNP, which is nearing randomization;
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advancement of the clinical trial program for ARIKAYCE (ARISE and ENCORE), which is intended to satisfy the post-marketing requirement for full approval of its current indication and potentially support label expansion to include all patients with a MAC lung infection;
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advancement of its Phase 2 clinical development programs for TPIP; and
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development of its early-stage research platforms.
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Conference Call
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 (888) 210-2654 (U.S. and international) and referencing access code 7862189. 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 1 hour after its completion through November 25, 2023, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. 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.