February 19, 2026 Fourth-Quarter 2025 Earnings Presentation We're in. For science. Forward Looking Statements The forward-looking statements in this presentation are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated ...

Drug Approvals and Designations - ARIKAYCE received accelerated approval in the US in September 2018 for MAC lung disease, with subsequent approvals in Europe and Japan in October 2020 and March 2021 respectively[21]. - BRINSUPRI was approved in the US in August 2025 and in Europe in November 2025 for non-cystic fibrosis bronchiectasis, with regulatory submissions accepted in the UK and Japan[37]. - The FDA granted orphan drug designation to TPIP for pulmonary arterial hypertension in January 2026, with a Phase 3 study planned for H1 2026[27]. - The FDA granted orphan drug designation for INS1201 in August 2025 for the treatment of DMD, and treprostinil palmitil received the same designation in January 2026 for PAH[135]. - Orphan drug designation provides a seven-year exclusive marketing period in the US upon FDA approval for drugs targeting rare diseases[136]. - The European Commission grants a 10-year orphan exclusivity period for drugs with orphan drug marketing authorization, extendable by two years with an agreed pediatric investigation plan[140]. Clinical Trials and Studies - The Phase 2b CEDAR study of brensocatib for hidradenitis suppurativa completed enrollment in October 2025, with topline data expected in Q2 2026[30]. - The ENCORE trial for ARIKAYCE completed enrollment with 425 patients in Q4 2024, and topline data is anticipated by April 2026[28]. - The ASPEN study of brensocatib demonstrated a 21.1% reduction in the annualized rate of pulmonary exacerbations compared to placebo[44]. - The Phase 2b study of brensocatib in chronic rhinosinusitis was discontinued as it did not meet primary or secondary efficacy endpoints[82]. - The Phase 1 study of TPIP was generally well tolerated, with 88.4% of patients experiencing treatment-emergent adverse events (TEAEs) compared to 75.8% in the placebo group[77]. - The Phase 2a study showed that 79.3% of TPIP patients reached the maximum dose of 640 µg by Week 5, with serious adverse events reported in 20.7% of TPIP patients versus 40.0% in the placebo group[70]. - The Phase 2b study demonstrated a 35% placebo-adjusted reduction in pulmonary vascular resistance (PVR) and a 60% reduction in NT-proBNP concentrations, both statistically significant[75]. Market Potential and Commercialization - The potential addressable market for bronchiectasis is estimated at 500,000 patients in the US, 600,000 in the European 5, and 150,000 in Japan[45]. - The estimated addressable market for TPIP at launch includes approximately 50,000 diagnosed patients with PH-ILD and 35,000 with PAH in the United States[81]. - The company aims to ensure a successful US commercial launch of BRINSUPRI and expand the label for ARIKAYCE[36]. - The company is exploring lifecycle management programs for ARIKAYCE to reach more patients beyond refractory MAC lung disease[63]. Intellectual Property and Patents - The company owns or licenses over 1,400 patents, including more than 400 related to ARIKAYCE, to maintain proprietary protection for its product candidates[93]. - The company has 13 in-force US patents related to ARIKAYCE, with expiration dates ranging from 2026 to 2035, ensuring patent coverage through at least May 15, 2035[97][98]. - The company owns 10 in-force European patents for ARIKAYCE, with expiration dates also extending to 2035, which supports its market position in Europe[99]. - There are 13 in-force US patents for BRINSUPRI, with expiration dates primarily in 2035, which secures the company's intellectual property for this drug[102][103]. Financial and Investment Activities - The company made an upfront payment of $30 million to AstraZeneca for exclusive global rights to develop and commercialize brensocatib, with additional milestone payments totaling up to $42.5 million for further indications[113]. - An asset purchase agreement with Opsidio in December 2025 included an upfront payment of $40.0 million and contingent payments up to $382 million based on development and sales milestones[127]. - The aggregate investment to increase long-term production capacity for ARIKAYCE, including agreements with Patheon, is estimated to be approximately $127.7 million[125]. - The company is focused on controlling spending and prudently deploying capital to support the best return-generating opportunities[36]. Regulatory and Compliance - The FDA's approval process includes extensive regulation and compliance checks, ensuring safety and efficacy before marketing[146]. - The FDA may require substantial post-approval testing, known as Phase 4 studies, to gather additional information on a drug's effects and side effects[157]. - The FDA typically requires post-marketing clinical studies to verify clinical benefits for drugs granted accelerated approval, with the possibility of withdrawal if studies fail[159]. - The FDA's enforcement of promotional regulations includes strict penalties for off-label marketing, which can lead to significant liabilities for companies[189]. Pediatric Considerations - Pediatric assessments are required under the PREA for certain NDAs, BLAs, and supplements to ensure safety and effectiveness in pediatric populations[216]. - The BPCA incentivizes pediatric research with the possibility of six months of pediatric exclusivity for drugs that meet specific criteria[217]. - In the EU, new drugs must undergo mandatory pediatric testing through a pediatric investigation plan (PIP) approved by the EMA[218]. - The MHLW in Japan recommends adequate post-marketing surveillance for pediatric drugs to collect information for proper use[219].

Financial Performance - Insmed reported total revenues of $606.4 million for the full year 2025, with BRINSUPRI revenues of $172.7 million and ARIKAYCE revenues of $433.8 million, reflecting a 19% annual growth for ARIKAYCE[1]. - The company expects full-year 2026 BRINSUPRI revenues to be at least $1 billion and maintains ARIKAYCE revenue guidance of $450 million to $470 million[1]. - ARIKAYCE global revenue grew 19% in 2025 compared to 2024, exceeding the upper end of the 2025 guidance of $420 million to $430 million[7]. - Product revenues for the three months ended December 31, 2025, were $263.843 million, a significant increase from $104.442 million in the same period of 2024, representing a growth of 152%[21]. - Total operating expenses for the twelve months ended December 31, 2025, were $1.853 billion, up from $1.242 billion in 2024, reflecting an increase of 49.1%[21]. - The net loss for the three months ended December 31, 2025, was $328.485 million, compared to a net loss of $235.548 million for the same period in 2024, indicating a 39.3% increase in losses[21]. - The company reported a net loss of $328.5 million, or $1.54 per share, for the fourth quarter of 2025, compared to a net loss of $235.5 million, or $1.32 per share, for the same period in 2024[16]. - Cash and cash equivalents as of December 31, 2025, were $510.445 million, down from $555.030 million as of December 31, 2024, a decrease of 8%[23]. - Total assets increased to $2.265 billion as of December 31, 2025, from $2.025 billion in 2024, marking an increase of 11.8%[23]. - The total liabilities decreased to $1.526 billion as of December 31, 2025, from $1.740 billion in 2024, a reduction of 12.3%[23]. Research and Development - Research and development expenses for the full year 2025 were $771.1 million, up from $598.4 million in 2024, primarily due to increased compensation and the acquisition of INS1148[16]. - Research and development expenses for the twelve months ended December 31, 2025, were $771.093 million, up from $598.367 million in 2024, an increase of 28.9%[21]. - Insmed plans to advance Phase 3 studies for TPIP in patients with pulmonary arterial hypertension (PAH) and interstitial lung disease (ILD) in 2026[19]. - The company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs[19]. - Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS) and expects to report topline data in the second quarter of 2026[9]. - Insmed's early-stage programs include technologies such as gene therapy and AI-driven protein engineering[59]. Product Portfolio and Market Focus - The company is focused on expanding its product portfolio with innovative therapies such as ARIKAYCE and BRINSUPRI, which are already approved for specific indications[24][26]. - ARIKAYCE is indicated for adults with limited or no alternative treatment options for Mycobacterium avium complex (MAC) lung disease, requiring a minimum of 6 consecutive months of multidrug therapy[45]. - The company has developed several investigational products, including INS1201 and INS1202, targeting significant unmet medical needs in respiratory and neurological diseases[30][31]. - Insmed is advancing a diverse portfolio of approved and investigational medicines, focusing on pulmonary and inflammatory conditions[59]. Adverse Reactions and Safety - The most common adverse reactions in patients using ARIKAYCE included dysphonia (47%), cough (39%), and bronchospasm (29%), with significant differences compared to the background regimen alone[42]. - In the ASPEN trial, the incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9% for placebo and BRINSUPRI 10 mg and 25 mg, respectively[53]. - The incidence of skin cancers in patients treated with BRINSUPRI was 0.5% and 1.9% for 10 mg and 25 mg doses, compared to 1.1% in placebo-treated patients[54]. - The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease[46]. Company Recognition and Forward-Looking Statements - The company has been recognized as one of the best employers in the biopharmaceutical industry, including five consecutive years as the No. 1 Science Top Employer[60]. - Forward-looking statements indicate potential risks, including failure to successfully commercialize ARIKAYCE and BRINSUPRI in key markets[61]. - The company cautions that actual results may differ materially from forward-looking statements due to various risks and uncertainties[63].

Core Insights - Insmed reported total revenues of $606.4 million for the full year 2025, with significant contributions from its products BRINSUPRI and ARIKAYCE [1][2] - The company anticipates full-year 2026 revenues for BRINSUPRI to be at least $1 billion and for ARIKAYCE to be between $450 million and $470 million [1][2] - Insmed's net loss for the fourth quarter of 2025 was $328.5 million, compared to a net loss of $235.5 million in the same quarter of 2024 [2][3] Financial Performance - Total revenues for the fourth quarter of 2025 were $263.8 million, a 153% increase compared to $104.4 million in the fourth quarter of 2024 [2] - ARIKAYCE revenues for the fourth quarter of 2025 were $119.2 million, reflecting a 14% growth year-over-year, while full-year revenues reached $433.8 million, a 19% increase from 2024 [2] - BRINSUPRI generated $144.6 million in the fourth quarter and $172.7 million for the full year 2025, marking its successful U.S. commercial launch [1][2] Research and Development Updates - Insmed is advancing its clinical programs, including the Phase 3 ENCORE trial for ARIKAYCE and additional Phase 3 studies for TPIP in patients with pulmonary conditions [1][2] - The company plans to submit a supplementary new drug application for ARIKAYCE in the second half of 2026, pending positive topline data from the ENCORE trial [1][2] - Insmed is also developing INS1148 and INS1201, targeting various respiratory and genetic diseases, with IND filings expected in 2026 [1][2] Cash Position and Future Guidance - As of December 31, 2025, Insmed had approximately $1.4 billion in cash, cash equivalents, and marketable securities, positioning the company for continued investment in its pipeline [1][2] - The company expects to maintain a focus on commercialization and expansion of its product offerings, particularly BRINSUPRI and ARIKAYCE, throughout 2026 [1][2] - Insmed anticipates that pre-clinical research programs will comprise less than 20% of overall expenditures, indicating a strategic focus on advancing clinical development [2]

February 2026 Investor Presentation We're in. For patients. 1 Forward Looking Statements The forward-looking statements in this presentation are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any ...

Industry Overview - The fourth-quarter 2025 reporting season for the Medical sector is nearing its final stretch, with only a few pharma and biotech companies left to report [1] - As of February 11, 73.3% of companies in the Medical sector, representing 91% of the sector's market capitalization, reported quarterly earnings, with 86.4% exceeding both earnings and sales estimates [2][10] - Overall, fourth-quarter earnings in the medical sector are expected to decrease by 0.6%, while sales are projected to rise by 10.4% compared to the previous year [4] Company Performance Johnson & Johnson - Reported strong fourth-quarter results, beating estimates for both earnings and sales [3] Novartis - Beat earnings estimates but faced revenue pressure due to generic competition for key drugs like Entresto and Promacta [3] Bristol Myers Squibb - Beat both earnings and sales estimates and issued encouraging guidance [3] Gilead Sciences - Earnings exceeded both top and bottom lines, supported by higher sales of HIV and Liver Diseases drugs [3] Bausch Health - Mixed performance with two earnings beats and two misses in the last four quarters, delivering a four-quarter average negative surprise of 6.26% [5] - Scheduled to report on February 18, with an Earnings ESP of -8.84% and a Zacks Rank 3 [7] Amicus Therapeutics - Disappointing earnings track record with three misses and one beat in the last four quarters, averaging a negative surprise of 20.21% [8] - Set to be acquired by BioMarin, with its lead drug Galafold showing solid uptake [9] BioMarin Pharmaceutical - Impressive track record, beating earnings estimates in each of the last four quarters with an average surprise of 66.51% [11] - Scheduled to report with an Earnings ESP of -3.23% and a Zacks Rank 3, driven by strong demand for its dwarfism drug Voxzogo [12] Insmed - Poor earnings track record with four consecutive misses, averaging a negative surprise of 20.64% [13] - Scheduled to report on February 19, with an Earnings ESP of +7.01% and a Zacks Rank 3 [14] - Lead drug Arikayce gaining traction, with a new drug approval marking a significant milestone [15] Madrigal Pharmaceuticals - Missed earnings expectations in three of the last four quarters, with an average negative surprise of 17.17% [16] - Scheduled to report on February 19, with an Earnings ESP of -852.37% and a Zacks Rank 4 [16][17]

Core Insights - Maverick Capital Ltd. established long positions in Google C, Applied Materials, Boston Scientific, Visa, and Camden Property during the fourth quarter [1] - The firm increased its holdings in TSMC, NVIDIA, GFL Environment, and Carvana [1] - Maverick Capital completely exited positions in Kenvue, US Bancorp, AMD, Danaher, and Insmed [1] - The company reduced its stakes in Nubank, Disney, Merit Medical, Acadia Health, and Sherwin-Williams [1] - The firm maintains significant positions in NVIDIA, Microsoft, Amazon, TSMC, and Google C [1]

Insmed To Present at March 2026 Investor Conferences [Accessibility Statement] Skip NavigationBRIDGEWATER, N.J., Feb. 13, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that management will present at the following investor conferences:- Leerink Partners Global Healthcare Conference in Miami, on Tuesday, March 10, 2026, a ...

Core Insights - In 2025, Insmed (INSM) experienced significant stock growth, more than doubling in value from January to December, outperforming both the biotech sector and the broader market [1] Company Overview - Insmed gained investor attention following a key approval, which contributed to its stock performance [1] Leadership Background - The company has a co-founder, Brendan, who has a strong academic and professional background, including a Ph.D. from Stanford University and experience at major pharmaceutical and biotech firms [1]

Core Viewpoint - Banco BPM is enhancing the representation of minority shareholders, specifically allowing France's Credit Agricole to have a greater presence on the bank's board by increasing the maximum number of seats from three to six [1] Group 1 - Banco BPM is set to double the maximum number of board seats available to minority shareholders [1] - This change aims to strengthen the influence of minority shareholders in the governance of Banco BPM [1]