INSM

—New Data Explore Efficacy and Safety of BRINSUPRI ® (brensocatib) in Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB) and History of Nontuberculous Mycobacterial (NTM) Lung Disease— —New Research Examines Treprostinil Palmitil Inhalation Powder (TPIP) via COMPERA 2.0 Risk Assessment in Pulmonary Arterial Hypertension (PAH)— BRIDGEWATER, N.J., Sept. 3, 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 five abstracts highlighting data from its respiratory portfolio have been accepted for presentation at the European Respiratory Society (ERS) Congress 2026 taking place Sept. 5–9, 2026, in Barcelona. Presentation highlights include a late-breaking abstract from the Phase 3b ENCORE study, which evaluated 12 months of treatment with ARIKAYCE® (amikacin liposome inhalation suspension) plus multidrug therapy (azithromycin 250 mg and ethambutol 15 mg/kg) in patients diagnosed with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics. The scientific program will also include a post hoc analysis of COMPERA 2.0 risk score data from the Phase 2 study of treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH). Additionally, data will be presented on the psychosocial burden of exacerbations, treatment patterns, and healthcare resource utilization associated with bronchiectasis, as well as from a post hoc analysis of the Phase 3 ASPEN study of BRINSUPRI® (brensocatib), the first and only approved treatment for non-cystic fibrosis bronchiectasis (NCFB). "The data presented at the ERS Congress 2026 reflect our commitment to advancing research and improving outcomes for patients with serious respiratory diseases," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "We are particularly pleased to present findings from our Phase 3b ENCORE study addressing rates of recurrence following treatment for NTM lung disease, an important challenge in long-term disease management. These findings, together with data from our broader respiratory portfolio, contribute to a growing body of evidence that can help shape the future of care for patients who have long faced limited treatment options." Presentations: Oral Session OA1207, Sunday, Sept. 6, 9:30 a.m. CEST to 10:45 a.m. CEST (3:30 a.m. ET to 4:45 a.m. ET) Late-Breaking Abstract: Microbiologic Outcomes and Recurrence in Patients With Newly Diagnosed Mycobacterium avium Complex Lung Disease (MACLD) in the Phase 3b ENCORE Trial Poster Session PA908, Sunday, Sept. 6, 8:00 a.m. CEST to 9:30 a.m. CEST (2:00 a.m. ET to 3:30 a.m. ET) COMPERA 2.0 Risk Assessment of Treprostinil Palmitil Inhalation Powder (TPIP) for Pulmonary Arterial Hypertension (PAH): A Post Hoc Analysis of a Phase 2 Study Poster Session PA1839, Sunday, Sept. 6, 12:30 p.m. CEST to 2:00 p.m. CEST (6:30 a.m. ET to 8:00 a.m. ET) Brensocatib in Patients With Non-Cystic Fibrosis Bronchiectasis (NCFB) and History of Nontuberculous Mycobacteria (NTM) Infection: A Post Hoc Analysis of the ASPEN Trial Poster Session PA1840, Sunday, Sept. 6, 12:30 p.m. CEST to 2:00 p.m. CEST (6:30 a.m. ET to 8:00 a.m. ET) Quantifying the Psychosocial Impact of Exacerbations in Bronchiectasis: A European Patient-Centered Study Poster Session PA2883, Monday, Sept. 7, 8:00 a.m. CEST to 9:00 a.m. CEST (2:00 a.m. ET to 3:00 a.m. ET) Treatment Patterns and Healthcare Resource Utilization Associated With Bronchiectasis and Pulmonary Exacerbations in Spain About ARIKAYCE ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. 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, 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 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 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 to improve patient care. About BRINSUPRI BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. The therapy is approved in the United States as BRINSUPRI (brensocatib 10 mg and 25 mg tablets) and indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union and United Kingdom, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. In Japan, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of patients with non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years and older. About TPIP Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Designed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being developed as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), progressive pulmonary fibrosis (PPF), and idiopathic pulmonary fibrosis (IPF). TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. BOXED WARNING AND IMPORTANT SAFETY INFORMATION FOR ARIKAYCE IN THE U.S. Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate. Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate. Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate. Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures. Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE. Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE. Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions. Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus. Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside. Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%). Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol. Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. U.S. INDICATION LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitation of Use: ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED. Please see Full Prescribing Information. INDICATION AND IMPORTANT SAFETY INFORMATION FOR BRINSUPRI IN THE U.S. U.S. Indication BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. Important Safety Information WARNINGS AND PRECAUTIONS Dermatologic Adverse ReactionsTreatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. Gingival and Periodontal Adverse ReactionsTreatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. Live Attenuated VaccinesIt is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. ADVERSE REACTIONSThe most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions. Less Common Adverse Reactions Liver Function Test ElevationsIn ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin CancersIn ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. AlopeciaIn ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6%, respectively, compared to 0.4% in placebo-treated patients. USE IN SPECIFIC POPULATIONS Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women. Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age. Please see full US Prescribing Information. About Insmed 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 is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines — including two approved therapies to treat chronic, debilitating lung diseases — as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's commercial portfolio and clinical pipeline are organized around three therapeutic areas: Respiratory, Immunology & Inflammation, and Neuro & Other Rare. The Company's research engine is advancing a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, RNA end-joining, and synthetic rescue, in the pursuit of future pipeline candidates. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit www.insmed.com to learn more or follow us on LinkedIn, Instagram, YouTube, and X. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release 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 forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or European approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S. and Europe; and failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for our product candidates, if approved. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Sara Bonstein Chief Financial Officer [email protected] Media:Claire MulhearnVice President, Corporate [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/insmed-to-present-data-across-its-respiratory-portfolio-including-new-late-breaking-arikayce-amikacin-liposome-inhalation-suspension-results-from-phase-3b-encore-study-at-the-european-respiratory-society-congress-2026-302868119.html

Image source: The Motley Fool. Thursday, August 6, 2026 at 8:00 a.m. ET Head of Investor Relations - Bryan Dunn Chair and Chief Executive Officer - William Lewis Chief Financial Officer - Sara Bonstein Chief Medical Officer - Martina Flammer Operator: Thank you for standing by, and welcome to the Insmed Second Quarter 2026 Financial Results Conference Call. [Operator Instructions] I'd now like to turn the call over to Bryan Dunn, Head of Investor Relations. You may begin. Bryan Dunn: Thank you, Rob, and good day, everyone. Welcome to Insmed's Second Quarter 2026 Earnings Conference Call. Before we get started, please note that today's call will include forward-looking statements. These statements represent our judgment as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the projections discussed. Please refer to our most recent filings with the Securities and Exchange Commission for a full description of these risk factors. The information we will discuss on today's call is meant for the benefit of the investment community. It is not intended for promotional purposes and it is not sufficient for prescribing decisions. Today's call will feature prepared comments from Insmed's quarterly performance and financial position by Will Lewis, Chair and Chief Executive Officer; and Sara Bonstein, Chief Financial Officer, respectively. After their remarks, we will welcome Martina Flammer, Chief Medical Officer, for the Q&A session. I will now turn the call over to Will. William Lewis: Good morning. I want to start off today's call by framing what I believe are our 2 key accomplishments this quarter, operational excellence and positioning for our future. Across our commercial, clinical and research efforts, we have demonstrated exceptional operating performance. This has laid the groundwork for Insmed's potential evolution into a reliably consistent revenue and earnings growth story over the next decade and beyond. Let me briefly summarize what I mean. BRINSUPRI's launch continues at a truly historic pace, delivering another quarter of performance that more than doubled the results of the best specialty respiratory launches our industry has ever seen at this stage. With the potential to expand its reach with improved diagnosis of appropriate patients and a projected approval in Japan later this year, we believe the BRINSUPRI story is just getting started. ARIKAYCE continues to perform well in its eighth year of launch, growing globally by high single digits this quarter compared to the second quarter of last year. Beyond the current opportunity, there is also potential to expand the label to include all patients with MAC lung disease in the U.S. and Japan next year. From a commercial readiness perspective, we are on track to serve a broader base of appropriate patients while providing education for physicians as we enable them to use ARIKAYCE earlier in the treatment paradigm for MAC lung disease. TPIP is emerging as a potentially differentiated asset across 4 large indications: PH-ILD, PAH, PPF and IPF. We believe the data from our ongoing open-label extension study of TPIP in patients with PAH shared last month are further evidence of the strength of TPIP's profile, which we believe has the potential to be the prostanoid of choice. In addition to the progress our top 3 assets are making, we are also positioning the company for continued success in the future. We are steadily progressing a broad and diversified early-stage pipeline consisting of multiple potential blockbuster treatments for a wide range of serious diseases. The FDA recently cleared the IND for INS1033, the first of several next-generation DPP1 inhibitors advancing within our pipeline to proceed into the clinic. The first planned indication for INS-1033 will be in patients with rheumatoid arthritis for which we have promising preclinical data. We anticipate following that with additional clinical programs in ulcerative colitis and COPD for which there is also supportive preclinical data. These indications highlight the potential relevance of DPP1 inhibition beyond bronchiectasis in other large neutrophil-mediated inflammatory diseases. We also added new talent to our leadership team with the hiring of Samuele Butera as our Senior Vice President and General Manager of our Global Respiratory Therapeutic area. Samuele brings with him a wealth of commercial experience in U.S. and international markets, having led multiple global launches at Johnson & Johnson and Novartis throughout his career. We view his hiring as a huge win for Insmed and an equally large endorsement of Insmed's future. Finally, it is important to mention that we are making all these strides while maintaining our financial strength. We continue to believe we are sufficiently resourced to fund our business through cash flow positivity next year without raising additional capital. With BRINSUPRI's remarkable performance through nearly 1 full year of launch and the latest results from our ongoing open-label study of TPIP in PAH, our confidence in the future potential of these assets has grown. As a result, we are raising our peak sales estimates for both assets. For BRINSUPRI, we now estimate global peak sales of greater than $7 billion, up from our previous projection of greater than $5 billion. This updated estimate reflects expected growth of the current addressable market driven by earlier and more consistent diagnosis due to increased awareness among physicians and patients. Importantly, this peak sales projection does not include contributions from the potentially meaningful opportunity to identify additional bronchiectasis patients from the comorbid COPD and asthma populations, which would represent upside to this outlook. For TPIP, we believe the peak sales opportunity is greater than $6 billion, up from our previous peak sales projection of greater than $2 billion, which was provided prior to seeing the strength of our Phase II readouts in PH-ILD and PAH and before we chose to pursue PPF and IPF. This assumes clinical and regulatory success in all 4 indications and the TPIP's profile continues to distinguish itself as meaningfully differentiated versus other prostanoids with comparable efficacy to sotatercept while maintaining a favorable tolerability profile, which allows for higher dosing. Along with the reiterated peak sales estimate of greater than $1 billion for ARIKAYCE, the combined peak sales estimates for our 3 lead assets now exceeds USD 14 billion, up 75% from the greater than $8 billion peak sales estimate we previously provided for these 3 products. Let's now move to a deeper discussion of BRINSUPRI's ongoing launch. In its third full quarter of launch, BRINSUPRI produced $309.2 million in revenue. We believe BRINSUPRI is on its way to becoming the most successful launch in the history of specialty respiratory medicine and has the potential to become one of the top 20 medicine launches of all time in any category. This outstanding performance gives us confidence to increase our full year 2026 BRINSUPRI revenue guidance to between $1.25 billion and $1.4 billion from our previous guidance of greater than $1 billion. This quarter's impressive results demonstrate the remarkable momentum of BRINSUPRI's launch and reinforce our confidence in its future. All detailed metrics we monitor, including payer access, patient compliance and continuation rates continue to track ahead of our expectations. BRINSUPRI added approximately 7,000 new patients in the second quarter, exceeding our previous expectation of approximately 6,300 new patient starts. This result demonstrates the robust ongoing demand for the treatment. We now expect approximately 7,000 new patient starts per quarter for the remaining quarters in 2026, which is reflected in our updated revenue guidance. Strong new patient demand was driven by an acceleration in new prescribers and a deepening of prescribing. As of the end of June, we had more than 6,300 cumulative prescribers, which was an increase of approximately 1,300 writers compared to the end of March. We are also making good progress on depth of prescribing. Approximately 30% of BRINSUPRI's writers have prescribed it for at least 5 of their patients, up from around 20% at the end of March. However, there is still significant opportunity here. Many doctors, including some who treat large numbers of patients with bronchiectasis are still trialing the medicine and have considerable capacity to write for more patients if their experience is positive. This quarter, the European Multicenter Bronchiectasis Audit and Research Collaboration or EMBARC, announced its intention to collaborate with us to evaluate brensocatib's 25-milligram dose in a 3-year open-label study of up to 3,000 patients with bronchiectasis in 6 European countries. EMBARC's intention with this study is to shed light on 2 important questions. First, whether long-term use of brensocatib has the potential to modify the course of the disease; and second, whether earlier upstream use of brensocatib is effective in further slowing disease progression. We look forward to collaborating with EMBARC to address these important questions. We also have ongoing plans to support additional long-term data generation through Phase IV and real-world evidence trials in the U.S. to further solidify our position as the leader in bronchiectasis and DPP1 inhibition and to show the long-term benefits of BRINSUPRI. Beyond what we have just discussed, we see a significant opportunity to expand the diagnosed bronchiectasis population by improving diagnosis among patients with comorbid COPD or asthma. This effort to identify patients with comorbid bronchiectasis is being resourced like its own separate launch and is expected to yield increased diagnosis over the next several years. Some of our initial efforts around improving diagnosis, including our support behind an ATS-led initiative to analyze electronic health records across 7 large academic medical systems, the Suspect BE celebrity campaign with Ty Pennington and hosting the inaugural Bronchiectasis and COPD Stakeholder Summit at the World Bronchiectasis Conference, just to name a few. And we are just getting started with other initiatives currently being piloted, which could advance our efforts to support earlier and more accurate diagnosis of appropriate patients. We will track a variety of indicators to look for signals of progress, including monitoring claims data for increased diagnosis rates and high-resolution CT scans. Given the time it takes for this information to become available and the fact that they are trailing indicators, we will have insights from these data in approximately the middle of next year. We look forward to sharing updates as these initiatives progress. We are convinced that the best of this story is yet to come as more patients receive a proper diagnosis and gain access to appropriate treatment. Now let me provide an update on ARIKAYCE. In addition to continued sales growth, we are making progress toward a potential expansion from refractory MAC into all MAC lung disease. Backed by robust clinical evidence and an experienced commercial organization, we believe ARIKAYCE is well positioned to make the transition to this larger opportunity in the U.S. and Japan. We recently submitted the supplemental new drug application to the FDA for ARIKAYCE in newly diagnosed patients with MAC lung disease, and we intend to submit an application to Japanese regulators in the second half of this year in support of potential launches in 2027. This sets the stage for a particularly dynamic time for our Japan team who could be simultaneously launching both the expanded ARIKAYCE indication and BRINSUPRI in bronchiectasis. These products have clear synergies in terms of their call points, which we expect to benefit both launches. Given the impressive results we have seen from that team as they have executed on ARIKAYCE's current indication, we are excited to see the positive impact they can have on patients once presented with this expanded opportunity. We look forward to sharing additional updates on ARIKAYCE's progress as the regulatory process continues. Let's turn to TPIP. Last month, we announced positive 12-month data from our ongoing open-label extension study of TPIP in patients with PAH. To contextualize how unique and impressive those results were, let's begin with a recap of the randomized Phase IIb trial that preceded it. On a placebo-adjusted basis, TPIP demonstrated a 35% reduction in PVR, a 35.5-meter improvement in 6-minute walk distance and a 60% reduction in NT-proBNP at the end of 16 weeks of treatment. Recall, each of these efficacy metrics was measured at trough or approximately 20 hours after the previous dose was administered. The magnitude of these benefits support our belief that TPIP has the potential to become the clear prostanoid of choice. This study also showed good tolerability with a low 10% dropout rate and 95% of completers choosing to continue in the OLE study. Let's move now to the results of the OLE study. At 12 months, patients who remained on TPIP maintained or improved across all efficacy measures. Moreover, patients who had been on placebo in the lead-in study and switched to taking TPIP in the OLE not only improved but fully caught up to the continued TPIP group. This trend is something rarely observed in other open-label extension studies in PAH patients. At month 12, compared to the baseline of the lead-in study, patients in the OLE experienced an approximately 55-meter improvement in 6-minute walk distance and an approximately 60% reduction in NT-proBNP. Like the Phase IIb study, these endpoints were measured at trough. Additionally, about 80% of patients achieved functional Class 1 or 2 with over 25% of all patients achieving functional Class I, meaning these patients no longer have symptoms of PAH. We also looked at REVEAL Light 2.0 scores, which are a validated measure of the risk of morbidity and mortality in patients with PAH. Impressively, the average REVEAL risk status for all OLE patients improved by 2 categories from intermediate risk to refined low-risk status. This improvement in score is associated with moving from a 5% to 10% risk of mortality in the next year to less than 5% risk of mortality in the next 3 years, along with meaningful improvements in the risk of clinical worsening. Remarkably, 65% of all patients achieved refined low-risk status by month 12. Together, these efficacy benefits far exceeded anything we have seen from other inhaled prostanoids in PAH and were comparable to sotatercept. On safety, we identified no new safety signals despite longer duration of use and higher doses in the OLE. Notably, we also saw a low 15% rate of treatment-emergent cough, which was predominantly mild and only one discontinuation due to cough over the first 12 months of the study. In addition, we saw a high continuation rate with 91% of patients remaining on treatment at the 12-month point. Overall, these results add to our confidence in TPIP's potential to be the next major advancement in the treatment of PAH. Our comprehensive Phase III development program is progressing well with both our PH-ILD and PAH studies actively enrolling patients. In the past, we have seen a boost in enrollment after sharing positive data updates from the program. We hope that the strength of the OLE data will once again bolster interest in our trials. We are also pleased to report the first data monitoring committee meeting for the Palm ILD study recently occurred, resulting in a positive recommendation for the study to continue unmodified. Additional Phase III studies in PPF and IPF, 2 additional large indications remain on track to initiate in the second half of 2026 and the first half of 2027, respectively. In the Phase III studies, patients begin with an initial titration phase to a target dose of 640 micrograms once daily. Upon completing titration, investigators may further escalate the dose to a maximum of 1,280 micrograms once daily when clinically appropriate. The decision to escalate is based on individualized clinical judgment, taking into account the patient's treatment tolerability and clinical status, including evidence of disease progression or the potential for additional therapeutic benefit. We believe TPIP's broad dosing range could provide physicians with the flexibility to optimize the balance between efficacy and tolerability while also allowing treatment strength to be adjusted as the patient's clinical needs change. The flexibility to quickly and safely dose to much higher levels than other inhaled treprostinil products could represent a meaningful differentiator within the class and resembles the individualized dosing approach physicians already use with parenteral therapy since patients respond differently across treprostinil dose levels and their dose requirements may increase over time. The ability to continue to dose higher could also expand the duration of time patients spend on inhaled therapy, delaying the need for patients to switch to parenteral options. As I look across our portfolio at BRINSUPRI's historic launch trajectory, ARIKAYCE's steady contributions and TPIP's potential to be the prostanoid of choice in our earlier-stage programs, which are steadily producing encouraging data, I am energized by what the future can hold for Insmed. I believe we are only just scratching the surface of the positive impact this company can have on patients in need. With that, I'll turn the call over to Sara, who will walk you through the financial details of the quarter. Sara Bonstein: Thank you, Will, and good morning, everyone. I'm pleased to share our second quarter 2026 financial results and updated guidance and to provide some commentary to help with your modeling. BRINSUPRI produced $309.2 million in revenue in the second quarter, up 49% sequentially from an already strong first quarter in which we saw sequential growth of 44%. This growth was primarily driven by strength in new and existing patient demand. This quarter also benefited from better-than-expected gross to net dynamics, which brought GTN towards the lower end of our previous guidance range of mid-20s to low 30s. ARIKAYCE produced $116.3 million in revenue this quarter, representing 8% growth compared to the second quarter of 2025. GTN for ARIKAYCE this quarter fell within the guidance range for the year of low to mid-20s. On this slide, you can see our current guidance ranges for BRINSUPRI and ARIKAYCE revenue for full year 2026 as well as our gross to net expectations for each product. As Will mentioned, based on the strong results we have produced in the first half of the year, we are raising our full year 2026 BRINSUPRI revenue from greater than $1 billion to a range of $1.25 billion to $1.4 billion. While we continue to expect a regulatory decision in Japan for BRINSUPRI in the second half of the year, we do not expect a meaningful revenue contribution from Japan in 2026. ARIKAYCE continues to perform as the steady, reliable contributor it has been for nearly 8 years. We are reiterating our full year revenue guidance for ARIKAYCE of $450 million to $470 million. We continue to see potential for expanded label in the U.S. and Japan next year as an upside catalyst for this program. On gross to net, we are updating our 2026 gross to net guidance for BRINSUPRI to mid- to high 20s, which represents an improvement from our previous guidance range of mid-20s to low 30s. Given we are at the midpoint of 2026, we have confidence in this improvement as we do not foresee any large changes in our contracting strategy for the remainder of the year. Therefore, we expect gross to net for BRINSUPRI to remain within this updated guidance range for each of the remaining quarters in 2026. In addition, we are reiterating our GTN guidance for ARIKAYCE of low to mid-20s. Moving now to the other relevant financial metrics for the second quarter, which are displayed on this slide. Cost of product revenues was $67.2 million or 16% of revenues, which is lower on a percentage basis than the 26% we saw in the second quarter of the prior year, reflecting the positive contributions of BRINSUPRI to the company's gross margin profile. As expected, combined research and development and SG&A expenses increased this quarter, up 38% compared to the prior year period due to the necessary investments made to support the U.S. launch of BRINSUPRI and to continue to fund our pipeline. Let me now spend a moment on our cash position and burn rate. As of the end of the second quarter of 2026, we had approximately $1.2 billion in cash, cash equivalents and marketable securities, which represents a meaningfully lower burn rate than we have seen in recent quarters. This is attributed to higher revenue generation as well as appropriate financial discipline. While we continue to expect to increase revenue generation in the second half of the year, we simultaneously expect to invest more in important initiatives to drive future growth, including the Phase III programs for TPIP across 4 indications, the launch and branded direct-to-consumer advertising for BRINSUPRI and incremental investments in Japan to build out an appropriate sales force and other commercial infrastructure to support future launches of both BRINSUPRI and first-line ARIKAYCE. We also anticipate incurring payments totaling $50 million to AstraZeneca related to regulatory and sales-based milestones for BRINSUPRI in the second half of 2026. We believe we are sufficiently funded to support these initiatives and the current operations of the company until we reach cash flow positivity, which we continue to expect to occur in 2027. As a reminder, we do not currently intend to raise additional capital before reaching that milestone. Finally, I want to share our perspective on the long-term financial profile of this company because I believe it is not fully appreciated. Based on the value drivers Will described, we expect our revenue trajectory to continue to grow well into the 2030s. But what makes this growth profile even more compelling is that it is driven by a largely synergistic portfolio of respiratory assets with similar infrastructure and overlapping call points. These synergies set us up to leverage our strong expected revenue CAGR into attractive and persistent EPS growth. Insmed is not simply a revenue growth story. We are building towards a financial profile that we believe will be highly compelling from both a top and bottom line perspective and one that we expect to translate into a period of lasting value creation. With that, we would now like to open the call to questions. Operator, may we take the first question, please? Operator: [Operator Instructions] Your first question comes from the line of Jessica Fye from JPMorgan. Jessica Fye: Congrats on the strong quarter. For the increase to BRINSUPRI's peak potential, can you expand a bit on what underpins that? Anything you can add around the earlier and more consistent diagnosis that you're seeing? William Lewis: So what I would say about the increase in peak sales and our guidance for the year, they're obviously informed by what's now basically our first year under our belt. We launched last year in August. And the data, I would say, I would describe as remarkably consistent, not only in terms of performance because first quarter was strong, this quarter is strong, maybe even stronger. And I would say that, that matches our internal modeling or it exceeds it. And that is what is really the core of our confidence that this is going to continue for some time. Every year at this time, we do not only our Board meeting, but we do an off-site, a strategic review of everything at the company. We take a whole day to do that with our Board. And the completion of that has resulted in our -- obviously assessing everything going on in the company and taking a longer-term view on all of those trends and directions. And as a result of that, we have the latest and greatest thinking surrounding peak sales estimates and year estimates. And that's why we've chosen this time to update everybody. Operator: Your next question comes from the line of Joe Schwartz from Leerink Partners. Joseph Schwartz: Congratulations on the strong performance and outlook. You now have a larger cohort of patients with sufficient time on therapy to begin evaluating refill behavior. What can you share about persistence, refill timing, discontinuations and adherence? And how are those things tracking relative to the assumptions you shared with us previously? William Lewis: Yes. And what I would say is that this is possibly one of the great strengths of this launch. Across all the metrics you just mentioned, we are at or ahead of our internal benchmarks. Not only that, but those elements are both strong and I would say, stable. So again, giving us confidence as we look forward that this is going to continue in this favorable way. One thing I will just say about some of these forward and new numbers, things like the peak sales number, that assumes a very strong DPP1 competitor introduces -- gets introduced into the market. And it also assumes the IRA Health and Human Services price negotiation takes effect in 2035. So this is a real-world assessment of where we're going to go. Operator: Your next question comes from the line of Vamil Divan from Guggenheim Securities. Vamil Divan: Congrats on the impressive results here. So I just have a question on the new patient starts. You mentioned the 7,000 new patient starts this quarter and then sort of the guidance. So I expect around that number remaining quarters of the year. So that's obviously quite a bit higher than the 6,300 that you were expecting just a little bit ago. So I'm curious the confidence you have on that number staying flat and not continuing to rise since we're still relatively early in the launch. If you can just comment, was all of the 7,000 for the so-called organic patients? Or was there still some of that ready and waiting group that you talked about previously? William Lewis: Yes. No, thanks for the question. That is all organic. The 7,000 number is just -- it's an impressive expansion from the 6,300 we thought we were going to get, and it speaks to the strength of the commercial team and the performance they've delivered. I fully expect that, that 7,000 will remain. Is there room for it to increase? Of course. We'll see how that goes, but our current guidance for the year assumes it will be 7,000 every quarter for the remainder of the year. Operator: Your next question comes from the line of Jason Zemansky from Bank of America. Jason Zemansky: Congrats on the stellar quarter. I wanted to dig into prescribing depth for BRINSUPRI a little bit more. I think you said about 30% of prescribers are now writing for at least 5 patients. But what typically gives physicians enough confidence to reach that level? And once they do, do you see prescribing accelerate as they gain experience with the drug? I guess, is there a point at which BRINSUPRI shifts from being evaluated patient by patient to becoming the default treatment within a practice? William Lewis: Thanks for the question. I think your final line conclusion is exactly what we anticipate will ultimately happen, that there will be a point at which this switches from the trialist sort of going patient by patient to this becoming the default for the treatment of bronchiectasis. And I think that is something we see taking place in the future. Right now, we're pleased to see the improvement. Remember that last quarter, we had 20% of physicians who had written more than 5. That's now moved to 30%. And the impressive results this quarter reflect that. However, what I'm particularly excited about is that there's so much more room to run here with only 30% having written more than 5 and remembering that our Tier 1 physicians have over 100 patients each, there is a lot of room for even our Tier 1 physicians who are writing more than 5 to really pick up the pace. And that's something we're focused on very much in terms of our commercial calling effort. Some of the very metrics that we're putting out today actually go into the hands of our therapeutic specialists to inform physicians, hey, look, 26,350 new patient starts since this drug was launched. There are 28,000 physicians of whom we have managed to convince 6,300 to write a prescription. So there is a lot of room to run here, and that's why we see this guidance for the year and the ultimate peak sales number increasing the way we have just reflected. Operator: Your next question comes from the line of Olivia Saunders from Cantor Fitzgerald. Olivia Brayer: You guys noted that the gross to net obviously came in at the lower end of the range this quarter. And I know you've tightened full year guidance to the mid- to high 20s. So as we think about 2027 and beyond, is that steady-state GTN profile, is that how we should assume it will be going forward in that kind of mid- to high 20s? Just trying to think through where that number could eventually settle and whether we're already at that point in the launch. William Lewis: Sara, you want to take that? Thanks for that. Sara, do you want to take that question? Sara Bonstein: Sure. Thanks, Olivia, for the question. Yes, now that we're obviously at the midpoint of the year, we have a clear line of sight. We don't expect any changes for the remainder of this year and expect that the coming quarters this year will be within that range. Payer access has been really favorable, about 90% approval rate, approval in less than a week for a majority of patients. So access sort of top-notch piece of this launch. As you think about '27 and beyond, we're obviously not providing forward-looking guidance, but you should -- naturally, what you expect to see with gross to net is gross to net does naturally go up a little bit each year. Again, not going to provide forward-looking guidance. But for this year, we have confidence in the mid- to high 20s. Operator: Your next question comes from the line of Ritu Baral from TD Cowen. Ritu Baral: And I want to add my congrats on these metrics, too. One of the things that we have been watching on Symphony TRx is seemingly an improved compliance rate or at least fill rate. Can you go over sort of what initiatives you may be conducting to promote compliance? Is it patient focused? Is it insurance focused? Is it doctor focused? And if you could just comment on continuing Symphony TRxs and how accurate they'll be through the end of the year? William Lewis: Yes. So the first and most important point to understand as it relates to persistence, which, again, is both strong and stable, is that the medicine itself, I think, is the greatest form of advertising. Patients, many of them feel better taking this medicine, and so they want to stay on the medicine. The physicians are hearing that. That becomes something that they reflect to future potential patients and that they themselves trial and experiment with. That then dovetails and extends out into our education of the insurance and physician and patient efforts that we undertake in compliant ways. This medicine is -- simply put, it's a good medicine. It has a low dropout rate. It is something that makes many patients feel better and the avoidance of what we refer to as the heart attack for the lung and exacerbation or a flare is a very meaningful thing for these patients. Interestingly, those where there are patients who stop taking the medicine, they are inevitably going to have one of those flares or experiences, and that's going to drive them right back into the physician's office with a question of what can I do about it? And the answer being, you can take BRINSUPRI. So I think we really have a very sort of unique ecosystem around this medicine in terms of its profile and how it's perceived and taken up. And just to address your other question on Symphony TRxs, yes, that continues to track very tightly with what we see internally through its most recent report. Operator: Your next question comes from the line of Gavin Clark-Gartner from Evercore ISI. Gavin Clark-Gartner: Could you just help us understand the 2026 BRINSUPRI guidance a little more? I mean we're sitting here in August, and it's still a fairly wide range for the course of this year. So you noted 7,000 patient adds moving forward. Beyond that, what takes you to the high end or the low end of this BRINSUPRI guidance? William Lewis: Well, I think it's important to remember that at the beginning of the year, we had gone from what was a referenceable indication of what success looked like that was $500 million to $700 million in revenue in the first full year. That was based on other specialty respiratory launches. We then increased guidance to over $1 billion at the beginning of the year. And here we sit with only 3 full quarters under our belt, and we have just raised that guidance by 25% to 40%. So that is a way to capture the journey that we have gone on. We're now more than double what we initially thought we might do in the first full year. We will see what the next quarter holds. But I think the guidance is trying to be responsible in saying there's a lot of opportunity here. We can't assume it's going to fall into our lap. I have tremendous confidence in the commercial team. And I'm convinced that whatever can be accomplished with this medicine, they're going to bring it over the finish line. But I think right now, we feel comfortable raising to this new level of 1.25 to 1.4. And as we move through the rest of the year, we'll certainly provide guidance on how that might -- where we might end up within that and how that might change. That's as much as we can really say at this point. Operator: Your next question comes from the line of Leonid Timashev from RBC Capital Markets. Leonid Timashev: Just wanted to ask on the TPIP guide actually and the $6 billion. I guess, how are you thinking about the components there? And then specifically on IPF, are you assuming that you succeed in breaking orphan designation there? Is it sort of probability adjusted weighted? I'm just trying to understand sort of how you get to that $6 billion across all the components. William Lewis: Yes. So I think it's very important for people to understand, we assume that we will be approved in all 4 of the indications, PAH, PH-ILD, IPF and PPF. We assume we do overcome the orphan status for IPF. And we assume that we have a profile that is not only clearly superior to other prostanoids but is comparable to sotatercept. One of the interesting comments made when we were reviewing our Phase II open-label extension data was the description by the key opinion leader we had invited to join the call that from his point of view, not only does the profile we produced represent the holy grail, to use his words, of data, but it represents something that causes him to rethink the positioning of this prostanoid relative to something like sotatercept. So I'm very excited about where these results, should they continue, where they will take us in each of those 4 indications. We're not breaking down what part of the 6 comes from where. I will just observe that I've seen some published estimates that sotatercept alone in PAH will achieve somewhere in the neighborhood of $7 billion in revenue from that perspective and assuming comparability and hearing the instinct of the KOL that Insmed may be with TPIP in a place to compete there, I think the $6 billion feels pretty comfortable. Operator: Your next question comes from the line of Faisal Khurshid from Jefferies. Faisal Khurshid: I wanted to ask you, you made some comments in the past about the BRINSUPRI ex U.S. launch sort of pending clarity on MFN. Can we just get an update on your latest views on that and also how the Japan launch plays into that potentially? William Lewis: Sure. So MFN is but one component part of the assessment of how to bring the medicine to Europe. It's relevant, but it is not controlling. I would say the bigger issue going on in Europe right now is the lack of apparent willingness or interest on the part of most of the European countries because of budget constraints to really lean in and pay for the innovation that all these years and billions of dollars require. That lack of willingness makes it less attractive to go there with a traditional commercial approach to Europe. But nonetheless, we have tested this drug in the European market. We want to find ways to make sure that the drug can get to patients who are appropriate, and we have some ideas about how we're going to accomplish that. But there's no doubt that the European opportunity is less today than it was in the distant past. And that's true not just for us, but for everybody. In contrast, Japan, where we have just come from the launch meeting for BRINSUPRI in terms of getting ready, the senior team was over there visiting with our team, getting the review of where they are and how they're positioned for both the BRINSUPRI launch when it gets approved and the ARIKAYCE label expansion. And I can reflect my own enthusiasm for the capabilities of that team and what they're going to be able to produce. Overall, international sales and revenue for this kind of a product tend to be in the sort of 10% to 15% range. I would expect the majority of that will come from Japan, and I couldn't be more excited about what that team is able to deliver. And based on their history and the expanded efforts they've made, including increasing the sales force, I think there is a very good reason to believe that Japan is going to deliver starting next year. Faisal Khurshid: Got it. And that implies Japan pricing is comparable to the U.S.? William Lewis: So the assumption is that we get a price from Japan that is acceptable. That is a process that is still underway. And when it's resolved, that's when we'll give full throated support to the launch in Japan and its expected success. Operator: Your next question comes from the line of Matt Phipps from William Blair. Matthew Phipps: Congrats great execution here. Last quarter, there was a lot of talk about ready and wait patients versus organic demand. So just wondering if the 7,000 patients you feel really fits into that organic demand category you described previously and if that should be the assumption for the rest of the year? William Lewis: Yes. It is 100% organic demand. Ready and waiting patients are gone. There are no more. And that was a comment we made last quarter, and we stick to it from now and going forward. So all the 7,000 new patient starts that we saw this quarter and expect to see in future quarters will be organic demand. Operator: Your next question comes from the line of Ben Burnett from Wells Fargo. Benjamin Burnett: I want to ask one on TPIP. And just back to one of your prior comments that the sales potential that you outlined could include IPF among other things. But with regards to IPF, I guess, what gives you the confidence that you would be able to navigate around a potential TYVASO ODE? William Lewis: Yes. And I'll ask Martina to chime in here in a second. I think there are many ways you can -- I guess, the way to say it is to break the orphan status of a particular product. And we feel we have a number of different levers and approaches we can use there. Certainly, the Phase II data, the once-a-day dosing, many different features of this product and what it can do for patients, I think, presents an almost self-evident case for why we're superior. But Martina, do you want to add any comments? Martina Flammer: Yes. I think one thing I would add here is that you've seen that the agency, the FDA here has also recognized the potential and possible hypothesis that TPIP is clinically superior. We don't know, but we assume and we can -- we've seen some of those that there may also be better safety and tolerability that we can show. And the third element is how you might impact patient care. Now a once-daily drug with a better PK profile certainly would be one of them. That's the reason we have received also the PAH orphan drug designation because the agency already recognized the potential for TPIP. Again, I want to emphasize that we are a molecular different design as a prodrug has that potential opportunity for superiority. Operator: Your next question comes from the line of Maxwell Skor from Morgan Stanley. Maxwell Skor: So you reiterated cash flow positivity in 2027, even with increased second half spend on DTC and launching in Japan. Can you just give us a sense of what's the BRINSUPRI level that underpins that? And how much flexibility do you have if you pursue BD? William Lewis: Sara, do you want to take that one? Sara Bonstein: Sure. Happy to. Thanks for the question, Max. Yes, we reiterated cash flow positivity in 2027. I obviously will not comment specifically on what revenue guide that is implying for BRINSUPRI for 2027, but we feel like the trajectory of this launch is going extremely well, as you could see in our revenue guide increase for this year and our peak sales revenue guide overall and that we have confidence in cash flow positivity through 2027 to fund our current business as well as the items that we have in our pipeline without raising additional capital. Operator: Your next question comes from the line of Andy Chen from Wolfe Research. Brandon Frith: This is Brandon on for Andy. So curious to know what was the reason for the lower GTN? Was it Medicare patients fewer than previously anticipated, rebates less stringent than previously anticipated? Curious to know on that front. William Lewis: Sara, over to you. Sara Bonstein: Yes, sure. So we obviously provided a GTN earlier in the launch. Now that we're in the midpoint of the year, and we have a clear line of sight into contracting for the year, we have confidence in being able to narrow that range, tighten that range to the mid- to high 20s. Importantly, access for patients is going great. I commented earlier around 90% payer approval, less than a week for the majority of patients, and that is the most important. So we're able to have this sort of narrow tighten GTN and patient access is exactly where we want it to be. Operator: Your next question comes from the line of Stephen Willey from Stifel. Stephen Willey: Congrats on the execution. So just given what we know about treprostinil dose dependency, can you comment on how you're powering the Phase I TPIP trials might contemplate the percentage of patients that you're expecting to be titrated up to the highest 1280 dose. And are you expecting those percentages to be meaningfully different across the different disease states? William Lewis: Yes. So I'll turn this one over to Martina to talk about it. It's really important that people understand that the objective of the trial is not per se to push people up to the highest possible dose. It's for the physician to know that they have the flexibility that they can increase dose to achieve the ultimate best outcome for that particular patient. Patients respond to these drugs differently. And it's a very unique and unusual disease state where the FDA permits that kind of a dosing regimen. But what we can do with 1,280 micrograms as the upper end is give them that room, that head space to continue to increase the dose should they not be able to achieve the best possible outcome at a lower dose. And if we look at just some of the recent data that we put out for TPIP, 25% of these patients in PAH in the OLE study get to Class I, which means they have no symptoms of the disease. That is a remarkable increase in outcome for what is a fatal condition, and it is facilitated by this medicine and that extra room you have to increase dose. And that is something we want physicians to understand can happen with a modest side effect profile here. And that, too, was one of the remarkable things in the open-label extension study. But let me flip it over to Martina, who can perhaps dive a little deeper. Martina Flammer: Yes. So when you think about how we designed the trial, you designed the trial from a regulatory perspective, what do we need to show functional improvement, and that is the 6-minute walk test. And that's what we are also powering for. We're powering the trial with a very high confidence of 96% to get a treatment difference of 30 meters, and that is at a p-value of 0.05. So what we are looking for is that patients in the trial have the opportunity to reach the dose that they need to be in a better clinical state and to reach a better functional class as well as a risk score because in the real world, that is how physicians decide whether they will change or increase a treatment for patients when it comes to prostanoid treatment. So if you think about what we've looked at in the open-label extension, which is over 12 months, 77% of these patients have not only reached doses of at least 640, but they also maintain that dose. So what's important for us and for these patients are to have a runway that they can increase dose if they need to. That enables patients and physicians to potentially keep patients on a drug like TPIP for longer. They may not have to go on a pump and that of IV or parenteral treprostinil. That is a huge burden. That is what we're really looking for to put patients in a better clinical state, but we're powering for an approvable endpoint that is functional improvement. Operator: Your next question comes from the line of Qize Ding from Rothschild & Co Redburn. Qize Ding: Congrats on the results. I have one on the capital allocation. So given your balance sheet and active internal programs, going forward, how do you balance the development of your internal pipeline assets versus looking now for external opportunities? William Lewis: Yes. I appreciate the question. I think this is always the challenge that every biotech company faces, especially as it progresses. We are in the enviable position that we have 3 very substantial franchises that are in the same therapeutic area in the respiratory field. And we also have, for the last 4 years, a very developed research program across 4 different platforms that are now beginning to yield clinical drug candidates. The criteria for internal development and advancement is that the medicine in question is either first or best-in-class. And next year, we will be able to share with you the clinical trial results of our first programs emerging from this research area, which include a gene therapy for ALS, a gene therapy for Duchenne muscular dystrophy, and as we mentioned today, entering the clinic just now INS1033, a new next-generation DPP1 for the treatment initially of rheumatoid arthritis and then ulcerative colitis and COPD. So there is more to come from this internal research pipeline. However, at the same time, we are constantly evaluating what is out there because we want to make sure that capital gets deployed against the best opportunities available. And so that, too, is a high bar. It must be first or best-in-class that we're bringing aboard, but we will continue to look and evaluate for those opportunities as well. But this is going to be something we're going to return to again and again as we update you on the progress of the programs coming out of our research department and their progress through the clinic set against what we see in the landscape of business development. Operator: Your final question comes from the line of Danielle Brill from Truist. Danielle Brill Bongero: Congrats on the execution. I did have a follow-up on the peak sales assumption. So you noted the high-level rationale, but I'm curious if you could kind of break down what specific assumptions changed to move the needle from $5 billion to $7 billion at peak? Was it expansion of the diagnosed population, penetration, persistence, duration on therapy or anything else? If you could just comment on what assumptions changed the most meaningfully, that would be helpful. William Lewis: Thanks for the question. I think when it comes to BRINSUPRI, yes, we assume that the addressable market will continue to grow over time. And that's going to be driven by not only population growth, but increased diagnosis. We anticipate patients who are in the 1 or fewer exacerbation category to shift to a certain degree into the 2 or more exacerbation category, and that's because of improved awareness and reporting of exacerbations. We also think that over time, as this medicine's reputation continues to expand, that the default will be to turn to bronchiectasis patients and think of BRINSUPRI in their treatment. I would also say that as we look internally at our modeling efforts, what we have seen is remarkable alignment with what our commercial effectiveness team has forecast. And I have to call them out for the exceptional work that they have done associated with this launch. It allows us to be confident in our presentation of today's new and improved numbers, and it is driven by both strong and stable performance across all the main metrics that we track. Operator: And this concludes today's conference call. Thank you for your participation. You may now disconnect. Before you buy stock in Insmed, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Insmed wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $400,209!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,375,393!* Now, it’s worth noting Stock Advisor’s total average return is 964% — a market-crushing outperformance compared to 215% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of August 13, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Insmed (INSM) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. BRINSUPRI's launch is tracking as one of the most successful specialty respiratory launches in history, delivering $309.2 million in its third full quarter and doubling the performance of previous industry benchmarks. Management increased BRINSUPRI's peak sales estimate to greater than $7 billion, citing accelerated physician awareness and more consistent diagnosis of the addressable bronchiectasis population. ARIKAYCE remains a stable revenue driver with high single-digit growth, while the company prepares for a transition from refractory MAC to a broader first-line treatment label in the U.S. and Japan. TPIP's peak sales potential was tripled to greater than $6 billion following Phase II data that demonstrated efficacy comparable to sotatercept while maintaining a favorable tolerability profile that allows for higher dosing. The company is evolving from a single-product story into a diversified respiratory powerhouse, leveraging a synergistic portfolio that shares commercial infrastructure and call points. Operational excellence is being paired with financial discipline, as the company remains on track for cash flow positivity in 2027 without requiring additional capital raises. Strategic leadership was bolstered by hiring Samuele Butera to lead the Global Respiratory Therapeutic area, bringing extensive experience from Johnson & Johnson and Novartis. Full-year 2026 BRINSUPRI revenue guidance was raised to $1.25 billion - $1.4 billion, assuming approximately 7,000 new organic patient starts per quarter for the remainder of the year. Management expects a regulatory decision for BRINSUPRI in Japan in the second half of 2026, with meaningful revenue contributions anticipated to begin in 2027. The TPIP Phase III program is expanding, with studies in PPF and IPF scheduled to initiate in the second half of 2026 and first half of 2027, respectively. Peak sales projections for BRINSUPRI conservatively assume the entry of a DPP1 competitor and the impact of IRA price negotiations beginning in 2035. Future upside to BRINSUPRI guidance exists through the potential identification of bronchiectasis patients within comorbid COPD and asthma populations, an effort currently resourced as a separate launch. Gross-to-net (GTN) guidance for BRINSUPRI was improved to mid-to-high 20s, reflecting favorable payer access and a 90% approval rate for patients. The company anticipates $50 million in milestone payments to AstraZeneca in the second half of 2026 related to BRINSUPRI's regulatory and sales achievements. Management noted a lack of willingness in European markets to pay for innovation due to budget constraints, leading to a more cautious commercial approach in that region compared to Japan. The FDA cleared the IND for INS1033, marking the expansion of the DPP1 inhibitor pipeline into large inflammatory markets like rheumatoid arthritis and ulcerative colitis. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management confirmed that the 7,000 new patient starts this quarter were entirely organic, as the 'ready and waiting' patient pool has been exhausted. Confidence in maintaining this rate stems from a deepening of prescribing, with 30% of writers now prescribing for 5+ patients, up from 20% in March. Management believes TPIP's once-daily dosing and superior PK profile provide a strong case for clinical superiority over existing treprostinil products. The FDA has already recognized the potential for clinical superiority, which management believes will help navigate around existing orphan drug designations. The 1,280 microgram upper dosing limit is designed to give physicians 'head space' to optimize outcomes for patients who do not reach functional Class I at lower doses. In the OLE study, 77% of patients reached and maintained doses of at least 640 micrograms, suggesting the higher dosing range is well-tolerated and clinically useful.

Insmed INSM reported an adjusted loss of 52 cents per share in the second quarter of 2026, narrower than the Zacks Consensus Estimate of a loss of 69 cents. The adjusted figure excluded a non-cash gain of $99.8 million tied to a change in the fair value of contingent consideration liabilities. Including this item, the reported loss was 6 cents per share. The company had incurred a loss of $1.70 per share in the year-ago quarter. Quarterly revenues soared 296% year over year to $425.5 million, entirely from the sales of its two marketed products. The reported figure beat the Zacks Consensus Estimate of $389.7 million. Shares of Insmed jumped 34% yesterday following the earnings announcement. The stock's upside was driven by strong organic patient uptake of Brinsupri during the quarter, prompting management to significantly raise its sales guidance. Year to date, the stock has lost 24% against the industry’s nearly 4% growth. Image Source: Zacks Investment Research Insmed currently has two marketed drugs, Arikayce and Brinsupri, in its portfolio. While Arikayce is approved to treat refractory mycobacterium avium complex (MAC) lung disease in adults with limited or no treatment options, Brinsupri is approved for non-cystic fibrosis bronchiectasis (NCFB). Sales of Arikayce rose 8% year over year to $116.3 million, driven by strong growth across ex-U.S. markets. The metric also beat the Zacks Consensus Estimate of $113.9 million. This was the third full quarter in which Insmed generated revenues from Brinsupri sales since its approval in August 2025. The drug contributed $309.2 million to the top line during the quarter, up from $207.9 million in the previous quarter. The reported figure also surpassed the Zacks Consensus Estimate of $275.8 million. Around 7,000 new patients started Brinsupri during the quarter, ahead of management's prior expectation of approximately 6,300. Importantly, management stated that all these patient starts represented organic demand, with no contribution from the "ready and waiting" patient pool — those who were already aware of the drug before approval and began treatment quickly once it became available. Insmed expects roughly 7,000 new patient starts per quarter through the remainder of 2026. Management also noted favorable payer access for Brinsupri, with an approximately 90% approval rate and approvals taking less than a week for most patients. Persistence and other patient-use metrics remained at or ahead of Insmed's internal benchmarks, supporting confidence in the growth trajectory. Research and development expenses rose 18.5% year over year to $210 million. The increase was primarily caused by higher employee-related costs and increased clinical development expenses. Selling, general and administrative expenses climbed 60% year over year to $247.5 million. Higher professional fees, external costs and employee-related expenses associated with Brinsupri commercial activities led to the increase. As of June 30, 2026, Insmed had cash, cash equivalents and marketable securities of around $1.2 billion, in line with the previous quarter’s level. Following the stronger-than-expected launch, Insmed raised its 2026 Brinsupri revenue guidance to $1.25-$1.40 billion from its previous expectation of at least $1 billion. The company also increased its estimated global peak sales for Brinsupri to more than $7 billion from the previous guidance of over $5 billion. Management cited expectations for growth in the addressable bronchiectasis market through improved diagnosis and greater disease awareness. Insmed maintained its 2026 Arikayce revenue guidance at $450-$470 million. The company continues to expect to reach cash-flow positivity in 2027 without raising additional capital. Last month, Insmed submitted a regulatory filing with the FDA seeking to expand Arikayce's use to newly diagnosed patients with MAC lung disease. The company also plans discussions with Japanese regulators later this year to support a potential label expansion in Japan. Insmed continues to advance its investigational treprostinil palmitil inhalation powder (TPIP) program across multiple pulmonary indications. The company is currently enrolling patients in separate late-stage studies for pulmonary hypertension associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). The company remains on track to initiate two additional late-stage TPIP studies, one in progressive pulmonary fibrosis (PPF) in the second half of 2026 and another in idiopathic pulmonary fibrosis (IPF) in the first half of 2027. Like Brinsupri, Insmed raised its peak sales estimate for TPIP to more than $6 billion from the previous guidance of over $2 billion. This reflects increased confidence following encouraging clinical data and the expansion of the program into additional indications. Insmed currently carries a Zacks Rank #3 (Hold). Insmed, Inc. price | Insmed, Inc. Quote Some better-ranked stocks in the biotech sector are Harmony Biosciences HRMY and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, earnings per share (EPS) estimates for Harmony Biosciences have risen from $3.20 to $3.33 for 2026. Over the same period, EPS estimates have increased from $3.64 to $3.87 for 2027. HRMY shares have risen about 4% year to date. Harmony Biosciences missed on earnings in three of the trailing four quarters and met on one occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen from $4.81 to $5.31. LQDA shares have skyrocketed 159% so far this year. Liquidia’s earnings beat estimates in three of the trailing four quarters and missed on one occasion, with the average surprise being 54.40%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Insmed, Inc. (INSM) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

This article first appeared on GuruFocus. BRINSUPRI Revenue: $309.2 million in Q2 2026, up 49% sequentially. ARIKAYCE Revenue: $116.3 million in Q2 2026, up 8% year-over-year. Cost of Product Revenues: $67.2 million, or 16% of revenues, down from 26% in Q2 2025. R&D and SG&A Expenses: Combined expenses increased 38% year-over-year. Cash Position: Approximately $1.2 billion in cash, cash equivalents, and marketable securities. 2026 BRINSUPRI Revenue Guidance: Raised to $1.25 billion to $1.4 billion. 2026 ARIKAYCE Revenue Guidance: Reiterated at $450 million to $470 million. BRINSUPRI Gross-to-Net Guidance: Updated to mid- to high 20s. ARIKAYCE Gross-to-Net Guidance: Reiterated at low to mid-20s. Warning! GuruFocus has detected 4 Warning Signs with INSM. Is INSM fairly valued? Test your thesis with our free DCF calculator. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BRINSUPRI's launch continues at a historic pace, with Q2 2026 revenue of $309.2 million, more than doubling the best specialty respiratory launches at this stage. BRINSUPRI added approximately 7,000 new patients in Q2, exceeding expectations, with strong payer access (90% approval) and high patient compliance and continuation rates. Insmed raised its full-year 2026 BRINSUPRI revenue guidance to $1.25-$1.4 billion and increased peak sales estimates to >$7 billion, reflecting strong demand and market expansion. TPIP's open-label extension study in PAH showed sustained efficacy at 12 months, with 65% of patients achieving low-risk status and no new safety signals, supporting its potential as a differentiated prostanoid. ARIKAYCE continues to perform well, growing 8% year-over-year, with a supplemental NDA submitted for expansion into all MAC lung disease, potentially opening a larger market. The company maintains a strong cash position of $1.2 billion and expects to reach cash flow positivity in 2027 without raising additional capital. Early-stage pipeline progress includes FDA clearance for INS1033, a next-generation DPP1 inhibitor, for rheumatoid arthritis, with potential in other indications. Combined peak sales estimates for lead assets now exceed $14 billion, up 75% from previous estimates, driven by strong performance and market opportunities. BRINSUPRI's gross-to-net is expected to remain in the mid-to-high 20s, which may limit revenue growth despite strong sales. The company faces uncertainty in European market access for BRINSUPRI due to budget constraints and lack of willingness to pay for innovation, potentially limiting international revenue. TPIP's peak sales estimate of >$6 billion assumes clinical and regulatory success in all four indications, including overcoming orphan drug exclusivity for IPF, which is not guaranteed. The company expects to incur $50 million in milestone payments to AstraZeneca in H2 2026, impacting cash flow. Increased investments in TPIP Phase III programs, BRINSUPRI DTC advertising, and Japan infrastructure will raise expenses in the second half of 2026. BRINSUPRI's peak sales estimate does not include potential upside from comorbid COPD/asthma patients, but this opportunity is still unproven and may take years to materialize. The company's cash flow positivity in 2027 is dependent on continued strong revenue growth, which could be affected by competitive or regulatory challenges. Q: For the increase to BRINSUPRI's peak potential, can you expand a bit on what underpins that? Anything you can add around the earlier and more consistent diagnosis that you're seeing? A: Will Lewis, CEO, stated that the increase is informed by nearly a full year of launch data, which has been "remarkably consistent" and has exceeded internal modeling. The updated peak sales estimate of greater than $7 billion reflects expectations for growth in the current addressable market driven by earlier and more consistent diagnosis due to increased awareness. He noted this projection does not include the potential upside from identifying additional bronchiectasis patients within comorbid COPD and asthma populations. Q: You now have a larger cohort of patients with sufficient time on therapy to begin evaluating refill behavior. What can you share about persistence, refill timing, discontinuations and adherence and how are those things tracking relative to the assumptions you shared with us previously? A: Will Lewis, CEO, highlighted that persistence, refill timing, and adherence are "at or ahead" of internal benchmarks and are both strong and stable. He emphasized that the new peak sales estimates are "real-world assessments" that assume a strong DPP-1 competitor enters the market and that IRA price negotiation takes effect in 2035. Q: You mentioned the 7,000 new patient starts this quarter and then the guidance thing. So I expect around that number remaining quarters of the year. So I'm curious the confidence you have on that number staying flat and not continuing to rise because they're still relatively early in the launch. And if you can just comment, was all of the 7,000 then so-called organic patients or was there still some of that ready and waiting group that you talked about previously? A: Will Lewis, CEO, confirmed that the 7,000 new patient starts are "100% organic demand" and that the "ready and waiting" patient group is gone. He expressed confidence in the commercial team's performance and stated that the current guidance assumes 7,000 new patient starts per quarter for the remainder of 2026, while acknowledging there is room for the number to increase. Q: I wanted to dig into prescribing depth for BRINSUPRI a little bit more. I think you said about 30% of prescribers are now writing for at least five patients, but what typically gives physicians enough confidence to reach that level? And once they do you see prescribing accelerate as they gain experience with the drug? I guess, is there a point at which BRINSUPRI shifts from being evaluated patient by patient to becoming the default treatment within a practice? A: Will Lewis, CEO, stated that the company anticipates a shift where BRINSUPRI becomes the default treatment for bronchiectasis. He noted that while 30% of prescribers have written for at least five patients, up from 20% last quarter, there is significant room for growth, especially among Tier 1 physicians who treat over 100 patients each. He emphasized that the company is using launch metrics to inform physicians of the drug's success and potential. Q: You guys noted that the gross-to-net obviously came in at the lower end of the range this quarter, and I know you've tightened for your guidance to the mid to high 20s. So as we think about 2027 and beyond, is that steady state gross-to-net profile, is that how we should assume it will be going forward in that kind of mid to high 20s? A: Sara Bonstein, CFO, explained that with clear line of sight at the midpoint of the year, the company has confidence in the tightened gross-to-net guidance of mid-to-high 20s for the remainder of 2026. She noted that payer access has been favorable with a 90% approval rate and approvals in less than a week for most patients. While not providing forward-looking guidance for 2027, she indicated that gross-to-net naturally increases a bit each year. Q: One of the things that we have been watching on Symphony TRXs is seemingly an improved compliance rate or at least fill rate. Can you go over sort of what initiatives you may be conducting to promote compliance? Is it patient-focused? Is it insurance-focused? Is it doctor-focused? And if you could just comment on continuing Symphony ERXs and how accurate they'll be through the end of the year. A: Will Lewis, CEO, attributed strong persistence to the medicine itself, as patients feel better and want to stay on it. He described a "unique ecosystem" where patients who stop treatment inevitably experience exacerbations, driving them back to physicians who can prescribe BRINSUPRI. He confirmed that Symphony TRX data continues to track very tightly with internal metrics. Q: Could you just help us understand the 2026 BRINSUPRI guidance a little more? I mean, we're sitting here in August, and it's still a fairly wide range for the course of this year. So you noted 7,000 patient adds moving forward. Beyond that, what takes you to the high end or the low end of this BRINSUPRI guidance? A: Will Lewis, CEO, contextualized the guidance by noting the company started the year with a revenue expectation of over $1 billion, which has now been raised to $1.25 billion to $1.4 billion, more than double initial expectations. He stated the guidance is "trying to be responsible" and reflects confidence in the commercial team while acknowledging the opportunity is significant. He indicated the company will provide updates as the year progresses. Q: Just wanted to ask on the TPIP guide actually and the $6 billion. I guess, how are you thinking about the components there. And then specifically on IPF, are you assuming that you succeed in breaking orphan designation there? Is it sort of probability adjusted weighted? I'm just trying to understand sort of how you get to that $6 billion across all the components. A: Will Lewis, CEO, clarified that the $6 billion peak sales estimate assumes approval in all four indications (PAH, PH-ILD, IPF, and PPF) and assumes the company overcomes orphan designation for IPF. He noted the profile is expected to be clearly superior to other prostanoids and comparable to sotatercept. He referenced published estimates suggesting sotatercept alone could achieve around $7 billion in PAH, making the $6 billion estimate for TPIP across four indications feel comfortable. Q: I wanted to ask you made some comments in the past about the BRINSUPRI ex-US launch sort of pending clarity on MFN. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Insmed, Inc.? Here are five stocks we like better. BRINSUPRI sales accelerated: Second-quarter revenue reached $309.2 million, up 49% sequentially, prompting Insmed to raise 2026 guidance to $1.25 billion–$1.4 billion. The company also increased its global peak-sales estimate to more than $7 billion. ARIKAYCE expansion is advancing: Revenue rose 8% year over year to $116.3 million, while Insmed pursued U.S. approval for newly diagnosed MAC lung disease and plans a Japanese regulatory filing, with potential expanded-indication launches in 2027. Pipeline and financial outlook strengthened: Insmed raised TPIP’s potential peak sales to more than $6 billion based on encouraging extension-study results and ongoing Phase III trials. Despite higher investment in development and commercialization, the company expects cash-flow positivity in 2027 and does not currently plan to raise capital before then. Russell Rebalance: 3 Stocks Ready to Move Higher Insmed (NASDAQ:INSM) reported second-quarter 2026 revenue growth driven by the continued launch of BRINSUPRI and steady sales of ARIKAYCE, while raising its full-year BRINSUPRI revenue outlook and increasing its long-term peak-sales estimates for its leading products. BRINSUPRI generated $309.2 million in second-quarter revenue, up 49% sequentially from the first quarter, Chief Financial Officer Sara Bonstein said. ARIKAYCE revenue totaled $116.3 million, up 8% from the second quarter of 2025. → 3 Drone Stocks That Should Soar After the Summer Slump Stock Rotation is Underway: Here are the Winners Moving Forward The company raised its 2026 BRINSUPRI revenue guidance to $1.25 billion to $1.4 billion, from prior guidance of more than $1 billion. It maintained ARIKAYCE revenue guidance of $450 million to $470 million for the year. Chair and Chief Executive Officer Will Lewis said BRINSUPRI added approximately 7,000 new patients during the second quarter, above the company’s prior expectation of roughly 6,300 starts. Insmed now expects about 7,000 new patient starts in each of the remaining quarters of 2026. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Lewis said the second-quarter patient starts reflected organic demand, adding that the previously discussed group of “ready and waiting” patients had been exhausted. As of the end of June, BRINSUPRI had more than 6,300 cumulative prescribers, an increase of approximately 1,300 from the end of March. The company also reported increasing prescription depth. About 30% of BRINSUPRI prescribers had written prescriptions for at least five patients as of June 30, compared with about 20% at the end of the first quarter. → Jersey Mike's Serves Fresh Gains After IPO Stumble Bonstein said BRINSUPRI’s gross-to-net adjustment benefited from better-than-expected dynamics in the quarter. The company narrowed its full-year gross-to-net guidance for the drug to the mid-to-high 20% range, from a prior range of the mid-20% to low-30% range. She said payer access remained favorable, with an approximately 90% approval rate and approval in less than one week for the majority of patients. Insmed raised its estimate for BRINSUPRI global peak sales to more than $7 billion, from more than $5 billion previously. Lewis said the revised estimate reflects expectations for growth in the addressable market through greater awareness, earlier diagnosis and more consistent diagnosis of bronchiectasis. The forecast does not include a potential opportunity to identify additional bronchiectasis patients among people with chronic obstructive pulmonary disease or asthma, he said. The company said European Multicentre Bronchiectasis Audit and Research Collaboration, or EMBARC, intends to collaborate with Insmed on a three-year open-label study of brensocatib 25 mg in up to 3,000 bronchiectasis patients across six European countries. The study is intended to evaluate whether long-term treatment could modify disease progression and whether earlier use could further slow progression. Lewis said ARIKAYCE continued to grow globally in the high single digits year over year during the quarter. Insmed recently submitted a supplemental new drug application to the FDA seeking to expand ARIKAYCE use to newly diagnosed patients with MAC lung disease, from its current refractory MAC indication. The company plans to submit an application to Japanese regulators in the second half of 2026. Insmed said potential launches tied to the expanded ARIKAYCE indication in the U.S. and Japan could occur in 2027, subject to regulatory decisions. Insmed expects a regulatory decision for BRINSUPRI in Japan during the second half of 2026, though Bonstein said the company does not expect a meaningful contribution from Japan this year. Lewis said the company’s international revenue expectations for a product of this type have generally been in the 10% to 15% range, with Japan expected to account for the majority of that opportunity. Insmed also increased its estimate for TPIP peak sales to more than $6 billion, from more than $2 billion previously. The company said this estimate assumes clinical and regulatory success in pulmonary arterial hypertension, pulmonary hypertension associated with interstitial lung disease, progressive pulmonary fibrosis and idiopathic pulmonary fibrosis. Lewis highlighted 12-month results from an ongoing open-label extension study of TPIP in pulmonary arterial hypertension. According to the company, patients in the extension study experienced an approximately 55-meter improvement in six-minute walk distance and an approximately 60% reduction in NT-proBNP compared with the baseline of the preceding study. Lewis said approximately 80% of patients reached Functional Class 1 or 2 at month 12, while more than 25% reached Functional Class 1. The company also reported that 65% of patients achieved refined low-risk status on the REVEAL Lite 2.0 measure at month 12. Insmed said there were no new safety signals in the extension study, and 91% of patients remained on treatment at 12 months. The company’s Phase III studies in pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease are enrolling patients. Insmed said the first data monitoring committee meeting for the PALM-ILD study recommended that the trial continue without modification. Additional Phase III studies in progressive pulmonary fibrosis and idiopathic pulmonary fibrosis are expected to begin in the second half of 2026 and the first half of 2027, respectively. Insmed ended the second quarter with approximately $1.2 billion in cash, cash equivalents and marketable securities. Cost of product revenue was $67.2 million, or 16% of total revenue, compared with 26% of revenue in the prior-year quarter. Combined research and development and selling, general and administrative expenses rose 38% year over year, reflecting investments in BRINSUPRI’s U.S. launch and pipeline programs. Bonstein said the company expects to increase investment during the second half of 2026 in TPIP Phase III programs, BRINSUPRI direct-to-consumer advertising and commercial infrastructure in Japan. Insmed also expects to make $50 million in regulatory and sales-based milestone payments to AstraZeneca related to BRINSUPRI during the second half. Despite those planned investments, the company reiterated that it expects to reach cash-flow positivity in 2027 and does not currently intend to raise additional capital before then. Separately, Lewis said the FDA cleared the investigational new drug application for INS1033, a next-generation DPP1 inhibitor. Insmed plans to initially study the candidate in rheumatoid arthritis, followed by potential programs in ulcerative colitis and COPD. The company also named Samuele Butera as senior vice president and general manager of its Global Respiratory Therapeutic Area. Insmed Incorporated is a biopharmaceutical company focused on developing and commercializing therapies for patients with rare and serious diseases, with a particular emphasis on difficult-to-treat pulmonary infections. Headquartered in Bridgewater, New Jersey, the company concentrates its research and development efforts on targeted drug delivery technologies and novel formulations intended to improve clinical outcomes for patients who have limited treatment options. The company's principal marketed product is ARIKAYCE (amikacin liposome inhalation suspension), an inhaled liposomal formulation of the antibiotic amikacin that is approved by the U.S. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Insmed Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Insmed (INSM) reported $425.49 million in revenue for the quarter ended June 2026, representing a year-over-year increase of 296.1%. EPS of -$0.52 for the same period compares to -$1.70 a year ago. The reported revenue compares to the Zacks Consensus Estimate of $389.72 million, representing a surprise of +9.18%. The company delivered an EPS surprise of +24.64%, with the consensus EPS estimate being -$0.69. While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- and how they compare to Wall Street expectations to determine their next course of action, some key metrics always provide a better insight into a company's underlying performance. As these metrics influence top- and bottom-line performance, comparing them to the year-ago numbers and what analysts estimated helps investors project a stock's price performance more accurately. Here is how Insmed performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts: Revenues- U.S.: $378.74 million versus the four-analyst average estimate of $334.1 million. The reported number represents a year-over-year change of +451.4%. Revenues- ARIKAYCE- International: $46.13 million compared to the $40.67 million average estimate based on four analysts. Revenues- ARIKAYCE- U.S.: $70.19 million versus $73.5 million estimated by four analysts on average. Revenues- International: $46.75 million compared to the $42.82 million average estimate based on four analysts. The reported number represents a change of +480% year over year. Revenues- ARIKAYCE- Total: $116.32 million compared to the $113.9 million average estimate based on seven analysts. Revenues- BRINSUPRI- Total: $309.17 million versus $275.82 million estimated by seven analysts on average. View all Key Company Metrics for Insmed here>>> Shares of Insmed have returned -15% over the past month versus the Zacks S&P 500 composite's +3.3% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Insmed, Inc. (INSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Arcutis Biotherapeutics, Inc. (ARQT) came out with quarterly earnings of $0.11 per share, beating the Zacks Consensus Estimate of $0.09 per share. This compares to a loss of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +22.22%. A quarter ago, it was expected that this company would post a loss of $0.02 per share when it actually produced a loss of $0.09, delivering a surprise of -350%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Arcutis Biotherapeutics, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $129.86 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.57%. This compares to year-ago revenues of $81.5 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Arcutis Biotherapeutics shares have lost about 10.4% since the beginning of the year versus the S&P 500's gain of 13%. While Arcutis Biotherapeutics has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Arcutis Biotherapeutics was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.05 on $126.8 million in revenues for the coming quarter and $0.16 on $501.85 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Insmed (INSM), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 6. This biopharmaceutical developing inhaled treatments for patients battling rare lung diseases is expected to post quarterly loss of $0.69 per share in its upcoming report, which represents a year-over-year change of +59.4%. The consensus EPS estimate for the quarter has been revised 4.8% lower over the last 30 days to the current level. Insmed's revenues are expected to be $389.72 million, up 262.8% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Arcutis Biotherapeutics, Inc. (ARQT) : Free Stock Analysis Report Insmed, Inc. (INSM) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Insmed (INSM) is expected to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The earnings report, which is expected to be released on August 6, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biopharmaceutical developing inhaled treatments for patients battling rare lung diseases is expected to post quarterly loss of $0.69 per share in its upcoming report, which represents a year-over-year change of +59.4%. Revenues are expected to be $389.72 million, up 262.8% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 4.8% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Insmed, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +22.32%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Insmed will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Insmed would post a loss of$0.9 per share when it actually produced a loss of -$0.76, delivering a surprise of +15.56%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Insmed appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Urogen Pharma (URGN), is soon expected to post loss of $0.38 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +63.8%. Revenues for the quarter are expected to be $62.24 million, up 157% from the year-ago quarter. The consensus EPS estimate for Urogen Pharma has been revised 53.8% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of +30.97%. This Earnings ESP, combined with its Zacks Rank #2 (Buy), suggests that Urogen Pharma will most likely beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates three times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Insmed, Inc. (INSM) : Free Stock Analysis Report Urogen Pharma (URGN) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research