Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The company's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The biotechnology and pharmaceutical industries are highly competitive, with competition based on brand recognition, product quality, price, and innovation. Insmed faces potential competitors from many different areas including commercial pharmaceutical, biotechnology and device companies, academic institutions and scientists, other smaller or earlier stage companies and non-profit organizations developing anti-infective drugs and drugs for respiratory, inflammatory, immunology, oncology, and rare diseases. Many of these competitors have greater human and financial resources and may have product candidates in more advanced stages of development.
Insmed's two commercial products, ARIKAYCE and BRINSUPRI, are both part of the Respiratory therapeutic area. The company is not aware of any other approved inhaled therapies specifically indicated to treat MAC lung disease in North America, Europe or Japan. For BRINSUPRI, Insmed is not aware of any approved therapies for treating NCFB in the US, Europe or Japan, other than BRINSUPRI in the US and the EU. The company's major competitors include pharmaceutical and biotechnology companies that have approved therapies or therapies in development for the treatment of chronic lung infections. With regard to ARIKAYCE, the international treatment guidelines, issued by the ATS, ERS, ESCMID and IDSA, strongly recommend the use of ARIKAYCE for the treatment of patients with refractory NTM lung disease caused by MAC as a part of a combination antibacterial drug regiment for adult patients with limited or no alternative treatment options who have failed to convert to a negative sputum culture after at least six months of treatment.
Insmed generates revenue through the sale of its two commercial products, ARIKAYCE and BRINSUPRI. Product revenues, net, consist of net sales of ARIKAYCE and BRINSUPRI. The company's customers in the US include specialty pharmacies and a specialty distributor. Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration the company expects to receive in exchange for the goods or services provided. For all contracts that fall into the scope of ASC 606, the company has identified one performance obligation: the sale of marketed products to its customers. The company's three largest customers as of December 31, 2025 accounted for 74% and 85% of total gross product revenue for the years ended December 31, 2025 and 2024, respectively.
ARIKAYCE is approved in the US as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion and in Japan as ARIKAYCE inhalation 590mg (amikacin sulfate inhalation drug product). ARIKAYCE received accelerated approval in the US in September 2018 for the treatment of MAC lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options in a refractory setting. In October 2020, the European Commission approved ARIKAYCE Liposomal for the treatment of nontuberculous mycobacterial lung infections caused by MAC in adults with limited treatment options who do not have cystic fibrosis. In March 2021, Japan's Ministry of Health, Labour and Welfare approved ARIKAYCE for the treatment of patients with NTM lung disease caused by MAC who did not sufficiently respond to prior treatment with a multidrug regimen. BRINSUPRI (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in patients 12 years of age and older, was approved in the US in August 2025. In November 2025, the EC approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. The Respiratory therapeutic area also includes the clinical-stage programs TPIP and INS1148. TPIP is an inhaled dry powder formulation of the treprostinil prodrug treprostinil palmitil which may offer a differentiated product profile for pulmonary hypertension associated with interstitial lung disease, pulmonary arterial hypertension, progressive pulmonary fibrosis, and idiopathic pulmonary fibrosis. INS1148 is a monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248. The clinical-stage program in the Inflammation & Immunology therapeutic area is brensocatib, a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1, for the treatment of patients with hidradenitis suppurativa. The clinical-stage programs in the Neuro & Other Rare therapeutic area are INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy, and INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis.
In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting SCF248, from Opsidio LLC. At the closing of the transaction, the company owed an upfront payment to Opsidio of $40.0 million 1, subject to a customary holdback. The Opsidio shareholders may also become entitled to receive contingent payments up to an aggregate of $382 million 2 in cash upon the achievement of certain development, regulatory and sales milestones, as well as earnout payments based upon a low to mid single-digit percentage of net sales of certain products. In June 2025, the company completed an underwritten offering of 8,984,375 shares of its common stock at a public offering price of $96.00 per share 3. 1,171,875 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional shares. Net proceeds from the sale of the shares, after deducting the underwriting discounts and offering expenses of $39.2 million 4, were $823.3 million 5. In May 2024, the company completed an underwritten offering of 14,514,562 shares of its common stock at a public offering price of $51.50 per share 6. 1,893,203 of the shares of common stock were issued pursuant to the exercise in full of the underwriters' option to purchase additional shares. Net proceeds from the sale of the shares, after deducting underwriting discounts and offering expenses of $34.3 million 7, were $713.2 million 8. In October 2024, the company entered into an Amended and Restated Loan Agreement, as subsequently amended on July 10, 2025, which provides for a senior secured term loan of $350.0 million 9 (in addition to the accrual and capitalization of $46.8 million 10 of paid-in-kind interest under the Loan Agreement), which was drawn in full in connection with entry into the Loan Agreement (the Tranche A Term Loan). The A&R Loan Agreement adds a new $150.0 million 11 senior secured term loan tranche (the Tranche B Term Loan). The Term Loans bear interest at a fixed rate of 9.60% 12 per annum. The A&R Loan Agreement extends the maturity date of the Term Loans to September 30, 2029 13, subject to acceleration to February 1, 2028 14 on the occurrence of certain prespecified events. Under the Royalty Financing Agreement, OrbiMed paid the company $150.0 million 15 in exchange for the right to receive, on a quarterly basis, royalties in an amount equal to 4.0% 16 of ARIKAYCE global net sales prior to September 1, 2025 and 4.5% 17 of ARIKAYCE global net sales on or after September 1, 2025, as well as 0.75% 18 of brensocatib global net sales, which includes global net sales of BRINSUPRI.
Product revenues, net for the year ended December 31, 2025 were $606.4 million 19 as compared to $363.7 million 20 for the year ended December 31, 2024, an increase of $242.7 million 21, or 66.7% 22. This increase was a result of $172.7 million 23 of US commercial sales of BRINSUPRI following FDA approval in August 2025 and a 19.3% 24 growth in sales of ARIKAYCE, driven primarily by a 40.9% 25 growth in international sales. The consolidated net loss for the year ended December 31, 2025 was $1,276.8 million 26, compared to $913.8 million 27 for the year ended December 31, 2024. As of December 31, 2025, the accumulated deficit was $5.6 billion 28.
Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom and Japan in 2026. The company anticipates reporting topline data from the ENCORE trial by April 2026, with the submission of a US supplementary new drug application for ARIKAYCE in all patients with MAC lung disease projected for the second half of 2026. The company plans to initiate a Phase 3 study of TPIP in patients with PAH in the first half of 2026. Additional Phase 3 studies of TPIP are anticipated to be initiated in patients with PPF and IPF in the second half of 2026. The company anticipates reporting topline data from the Phase 2b CEDAR study of brensocatib in patients with HS in the second quarter of 2026. The company expects to report data from the open-label extension of its Phase 2b study of TPIP in PAH in the second half of 2026.
A key growth vector is the potential label expansion for ARIKAYCE. The ENCORE trial, if data are positive, may support a label expansion to include all MAC lung disease as well as support full approval for the current refractory indication. The company completed enrollment in the ENCORE trial with 425 patients 29 in the fourth quarter of 2024. Another major growth vector is the commercial launch of BRINSUPRI. The company launched BRINSUPRI in the US in the third quarter of 2025 following FDA approval in August 2025. Regulatory submissions for brensocatib in the UK and Japan have been accepted. The company continues to evaluate the potential effect of evolving US policies which will then impact the timing for future potential international commercial launches. The company also plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease and moderate to severe asthma.
The company expects cost of product revenues (excluding amortization of intangible assets) to benefit during 2026 and beyond, as it sells through inventory that was expensed prior to FDA approval of BRINSUPRI. The company expects R&D expenses to increase in 2026 relative to 2025 primarily due to clinical trial activities and related spend, including TPIP and brensocatib clinical trials, and other research efforts for product candidates. The company expects SG&A expenses to continue to increase in 2026 relative to 2025 due, in part, to commercial activities for BRINSUPRI.
The company expects to utilize contract manufacturing organizations to fulfill future manufacturing requirements for TPIP and is evaluating future in-house manufacturing capabilities. The company anticipates increasing its headcount in 2026. As of December 31, 2025, the company had a total of 1,664 30 full-time employees.
The company expects R&D expenses to increase in 2026 relative to 2025 primarily due to clinical trial activities and related spend, including TPIP and brensocatib clinical trials, and other research efforts for product candidates. The aggregate investment to increase the long-term production capacity for ARIKAYCE, including under agreements with Patheon and related agreements or purchase orders with third parties for raw materials and fixed assets, is estimated to be approximately $127.7 million 31. The anticipated future cost of project addenda with PPD for clinical development services is $295.7 million 32.
The company faces risks related to the potential effect of evolving US policies which will impact the timing for future potential international commercial launches. The company also faces risks related to the IRA, which gives HHS the ability to directly negotiate with manufacturers the price that Medicare will pay for certain high-priced drugs. The company believes that ARIKAYCE will be excluded from price negotiation under the IRA due to its orphan drug designation, but BRINSUPRI is likely to be subject to IRA price negotiation in the future. The company also faces risks related to the Trump Administration's proposed most-favored-nation drug pricing policies, including the GUARD model, which if finalized, would require pharmaceutical manufacturers to pay MFN-based rebates on eligible products for 25% 33 of eligible Medicare beneficiaries during the applicable testing period.
Management's key priorities are to ensure successful US commercial launch of BRINSUPRI, continue to provide ARIKAYCE to appropriate patients and expand its label, advance the pipeline and produce topline clinical data readouts in the near and long term, and control spending, prudently deploying capital to support the best return-generating opportunities. The company anticipates reporting topline data from the ENCORE trial by April 2026, with the submission of a US sNDA for ARIKAYCE in all patients with MAC lung disease projected for the second half of 2026. The company plans to initiate a Phase 3 study of TPIP in patients with PAH in the first half of 2026 and anticipates reporting topline data from the Phase 2b CEDAR study of brensocatib in patients with HS in the second quarter of 2026.
For the year ended December 31, 2025, total product revenues, net were $606.4 million 40 compared to $363.7 million 41 for the year ended December 31, 2024. Net loss was $1,276.8 million 42 for 2025 compared to $913.8 million 43 for 2024. Basic and diluted net loss per share was $6.42 44 for 2025 compared to $5.57 45 for 2024. Operating loss was $1,246.8 million 46 for 2025 compared to $878.3 million 47 for 2024. Cost of product revenues (excluding amortization of intangibles) was $122.9 million 48 for 2025 compared to $85.7 million 49 for 2024. Research and development expenses were $771.1 million 50 for 2025 compared to $598.4 million 51 for 2024. Selling, general and administrative expenses were $701.2 million 52 for 2025 compared to $461.1 million 53 for 2024. The change in fair value of deferred and contingent consideration was $252.0 million 54 for 2025 compared to $91.7 million 55 for 2024. Investment income was $60.7 million 56 for 2025 compared to $53.3 million 57 for 2024. Interest expense was $83.8 million 58 for 2025 compared to $84.9 million 59 for 2024. As of December 31, 2025, cash and cash equivalents were $510.4 million 60 and marketable securities were $919.6 million 61. As of December 31, 2025, debt, long-term was $541.0 million 62 and the royalty financing agreement was $162.9 million 63. The company had an accumulated deficit of $5.6 billion 64 as of December 31, 2025.
The company's prospects are highly dependent on the success of its approved products, ARIKAYCE and BRINSUPRI. Full approval of ARIKAYCE in the US is contingent on successful and timely completion of a confirmatory post-marketing clinical trial, the ENCORE trial, which enrolled 425 patients 34. Failure to obtain full approval could have a material adverse effect. The company faces risks related to the IRA, which gives HHS the ability to directly negotiate the price that Medicare will pay for certain high-priced drugs; BRINSUPRI is likely to be subject to IRA price negotiation in the future. The company also faces risks related to the Trump Administration's proposed most-favored-nation drug pricing policies, including the GUARD model, which if finalized, would require pharmaceutical manufacturers to pay MFN-based rebates on eligible products for 25% 35 of eligible Medicare beneficiaries. The company has a history of operating losses, with an accumulated deficit of $5.6 billion 36 as of December 31, 2025, and expects to incur operating losses in the near term. The company has outstanding indebtedness in the form of a term loan and a royalty financing arrangement; the Term Loans bear interest at a fixed rate of 9.60% 37 per annum and the Royalty Financing Agreement requires payments of 4.5% 38 of ARIKAYCE global net sales on or after September 1, 2025 and 0.75% 39 of brensocatib global net sales.
Analysis on 9/28/2026
