Insmed's Q3 2025 Earnings Call: Contradictions Emerge on Payer Criteria, Patient Access, and Market Strategy

Date of Call: October 30, 2025

Financials Results

• Revenue: BRINSUPRI net sales $28.0M (partial quarter, ~6 weeks); ARIKAYCE 2025 guidance raised to $420M–$430M (from $405M–$425M); ARIKAYCE Q3 revenue +22% YOY (U.S. +11%; international >50%)
• Gross Margin: Cost of product revenues $29.4M (20.6% of revenues) in Q3 → implied gross margin ~79.4%; percentage lower than historical performance (BRINSUPRI improved margin profile)

Guidance:

• ARIKAYCE 2025 full-year net revenue guidance raised to $420M–$430M (from $405M–$425M).
• BRINSUPRI: first full quarter (Q4 2025) expected to provide clearer launch trajectory; early launch sales $28M in ~6 weeks.
• EMA decision on brensocatib expected by year-end; potential EU launch early 2026; U.K. and Japan filings progressing (Japan accepted).
• BiRCh top-line results no later than early January 2026; CEDAR top-line (214 patients) expected H1 2026 (interim futility forgone).
• TPIP: Phase III PAH trial initiation expected early 2026; additional registrational TPIP trials likely in H2 2026.
• Gross-to-net analogs at launch ~25%–35% (company notes ~half reflects IRA impact).

Business Commentary:

• BRINSUPRI Launch Success:
• Insmed's BRINSUPRI achieved $28 million in net sales during its first partial quarter of launch.

• The positive reception from treating communities and physicians, and the broad prescriber base, contributed to this successful launch.

• ** ARIKAYCE Sales Growth:**

• ARIKAYCE, despite being on the market since 2017, posted its largest quarter of revenue to date, up 22% compared to the same quarter last year.

• Growth was driven by strong execution across multiple geographic regions, particularly in the U.S. and international markets.

• Strong Commercial and Clinical Pipeline:

• Insmed's pipeline is poised to deliver more catalysts over the next 18 months than in the previous period, with multiple commercial launches and clinical drivers expected.

• This robust pipeline includes the continued launch of BRINSUPRI in the U.S. and potential launches in the EU, U.K., and Japan, along with significant clinical trials in PH-ILD, PAH, and other indications.

• BiRCh Study Progress:

• The BiRCh trial of brensocatib in patients with CRS without nasal polyps is on track to complete by the end of 2025, with top-line results expected by early January 2026.
• The study aims to demonstrate a placebo-adjusted treatment effect of 0.97, which, if achieved, would be a significant success for brensocatib as a potential treatment for this condition.

Sentiment Analysis:

Overall Tone: Positive

• CEO: 'enormously pleased' with being multi-product commercial company; BRINSUPRI achieved $28M in net sales in ~6 weeks; CFO raised ARIKAYCE guidance to $420M–$430M and stated cash ≈ $1.7B; management repeatedly emphasized broad prescribing, positive payer reception and multiple near-term catalysts.

Q&A:

• Question from Jessica Fye (JPMorgan): Early field feedback on physician experience with BRINSUPRI and reimbursement process?
  Response: Field feedback is positive with broad trial prescribing; reimbursement has generally been straightforward so far but it's early.

• Question from Ritu Baral (TD Cowen): Will you set payer coverage bogeys (covered lives/time to fill) and what criteria for prior authorizations/reauthorizations?
  Response: Objective is 'frictionless' access with clear, not overly burdensome criteria—practical focus on physicians attesting to diagnosis and ≥2 exacerbations rather than heavy documentation or formulary targets.

• Question from Joseph Schwartz (Leerink): How frictionless has launch been regarding documentation physicians must provide to payers?
  Response: Documentation requirements vary (some payers request CT scans and exacerbation evidence); overall manageable so far and discounts are constrained by IRA impact.

• Question from Jason Zemansky (BofA): Has DTC driven patient awareness vs. prescriber-driven uptake?
  Response: Clear patient enthusiasm observed (social media posts); too early to quantify impact on prescribing patterns.

• Question from Andrea Tan (Goldman Sachs): What investments are needed for EU commercialization and what was BRINSUPRI gross-to-net this quarter?
  Response: Europe investments will be cautious pending reimbursement outcomes; Japan sales force already expanded; gross-to-net not disclosed by quarter but launch analogs ~25%–35% (≈50% of that due to IRA).

• Question from Vamil Divan (Guggenheim): How will you design IPF/PPF trials to address potential orphan exclusivity hurdles?
  Response: Company expects it can overcome orphan exclusivity via trial design and by demonstrating superiority in efficacy, safety or patient-care impact; ramping manufacturing and planning registrational strategies.

• Question from Gavin Clark-Gartner (Evercore ISI): Expectations for control arm TSS reduction and baseline characteristics/eosinophil stratification in BiRCh?
  Response: Baseline sTSS entry ≥5 (scale max 9); trial enrolled patients both <300 and ≥300 eosinophils; primary ITT analysis uses entire population.

• Question from Yuxi Dong (Jefferies): Any seasonality expected for BRINSUPRI patient flow (holidays/CT availability)?
  Response: No major CT access limitations seen; holiday slowdowns possible but main monitoring will be Medicare deductible reset and reauthorization impacts.

• Question from Ashwani Verma (UBS): Do you already have BiRCh data in-house?
  Response: Most data are in-house and in the cleaning process; final database lock and top-line timing targeted for early January.

• Question from Benjamin Burnett (Wells Fargo): Appetite to use BRINSUPRI in more moderate patients or those with only one exacerbation?
  Response: Initial focus and physician uptake target patients with ≥2 exacerbations (moderate–severe); potential to expand populations over time as experience grows.

• Question from Leonid Timashev (RBC): Which CRS subgroups might you analyze beyond eosinophils and is that commercially driven?
  Response: No predefined subgroup identified; company will follow data signals (including eosinophils) to determine responsive subpopulations—driven by science and potential commercial opportunity.

• Question from Olivia Brayer (Cantor Fitzgerald): Why match EU list price to U.S., payer feedback, EU gross-to-net expectations, and prescriber mix split academic vs community?
  Response: EU list price will match U.S. by company practice; payer negotiations will determine net; prescribers include both centers of excellence and broad community; gross-to-net will vary by market and negotiations.

• Question from Stephen Willey (Stifel): Will the single Phase III PAH trial mirror Phase II population and what label expectations exist?
  Response: Phase III will align with Phase II population but allow titration up to 1,280 mcg per patient; label scope will depend on Phase III results.

• Question from Matthew Phipps (William Blair): Which BRINSUPRI dose is being prescribed more often (10 mg vs 25 mg)?
  Response: Majority of early prescriptions are 25 mg, though some physicians start at 10 mg and may up-titrate.

• Question from Maxwell Skor (Morgan Stanley): How does BRINSUPRI's performance compare to provided launch analogs and expectations for upcoming quarters?
  Response: No formal guidance; management benchmarks to strong respiratory launches (high double-digit millions across first two full quarters) but remains cautious until full-quarter data (Q4) are available.

• Question from Samuel Lee (Mizuho): Have payers started restricting BRINSUPRI to patients with ≥2 exacerbations?
  Response: Focus is on ≥2 exacerbations out of the gate; expect payers to mirror clinical trial entry criteria as they formalize coverage.

• Question from Brandon Frith (Wolfe Research): Will HiSCR data be shared at HS top-line and how will brensocatib fit into HS landscape?
  Response: Top-line will include HiSCR50/75 at 16 weeks; 52-week HiSCR will be key for Phase III decisions; brensocatib positioned as an oral treatment option if efficacy is meaningful.

Contradiction Point 1

Payer Criteria and Access Ease

It involves expectations and strategies regarding payer criteria and access ease for patients, which are critical for market adoption and revenue.

What threshold should we target for payer coverage? What criteria are you targeting for prior authorizations and reauthorizations? - Ritu Baral (TD Cowen, Research Division)

2025Q3: Our objective is a frictionless launch with clear and not overly burdensome criteria for physicians. We're willing to offer modest discounts to achieve this. - William Lewis(CEO), Roger Adsett(COO)

Can you elaborate on Insmed's approach and profile that received positive payer feedback for patients with a CT diagnosis and two exacerbations? - Ritu Baral (TD Cowen)

2025Q2: Our strategy is to ensure a frictionless launch with a smooth prior authorization process. We aim to have an attestation for bronchiectasis diagnosis through a CT scan and 2 exacerbations in the past year as criteria. - Roger Adsett(COO)

Contradiction Point 2

Patient Population Size and Access

It involves estimates and expectations regarding the patient population size and access, which impacts market potential and revenue projections.

What factors are driving patient awareness and interest in BRINSUPRI? What impact has DTC had on patient awareness? - Jason Zemansky (BofA Securities, Research Division)

2025Q3: There is significant enthusiasm among patients for BRINSUPRI. Physicians also seem aware of the medicine's arrival due to marketing efforts. - William Lewis(CEO)

How do you plan to identify and reach eligible bronchiectasis patients? - Dingding Shi (Jefferies)

2025Q2: We have identified around 500,000 patients with bronchiectasis and 250,000 with 2 or more exacerbations. - William Lewis(CEO)

Contradiction Point 3

Payer Support and Reimbursement Process

It highlights differing perspectives on the ease and nature of the reimbursement process for BRINSUPRI, which can affect market access and patient treatment.

Can you share early feedback from physicians regarding patient outcomes and reimbursement experience with BRINSUPRI? - Jessica Fye(JPMorgan Chase & Co, Research Division)

2025Q3: The word from the field is positive, with enthusiasm from physicians who see potential in BRINSUPRI. There is broad prescribing, and payers have been supportive, making treatment decisions best for patients. The reimbursement process has been straightforward so far but will likely become more formalized over time. - William Lewis(CEO)

What is your view on pricing and gross-to-net considerations for brensocatib's launch? - Graig Suvannavejh(Mizuho Securities)

2025Q1: Our price range for brensocatib is $40,000 to $96,000, with expectations to price in the upper half. We anticipate a gross-to-net of 25% to 35% based on specialty launch precedents, including a 12% reduction for Medicare patients. - Sara Bonstein(CFO)

Contradiction Point 4

BRINSUPRI's Payer Criteria and Market Access Strategy

It involves differing statements on the payers' criteria and market access strategy for BRINSUPRI, which impacts physician prescribing and patient access.

What threshold for payer coverage should we consider for future guidance? What criteria are you targeting for prior authorizations and reauthorizations? - Ritu Baral (TD Cowen, Research Division)

2025Q3: Our objective is a frictionless launch with clear and not overly burdensome criteria for physicians. We're willing to offer modest discounts to achieve this. - William Lewis(CEO) and Roger Adsett(COO)

What factors are within your control to ensure a successful launch of brensocatib for bronchiectasis? - Joe Schwartz (Leerink Partners)

2024Q4: The key factors in our control are market access and ensuring a frictionless launch. This involves proper pricing, minimal contracting, and a simple prior authorization process. We have high confidence in our strategy and are well-positioned to work with the market access world to achieve this. - Will Lewis(CEO)

Contradiction Point 5

Patient Awareness and Market Access Strategy

It involves differing expectations about the level of patient awareness and the strategy to promote BRINSUPRI, which can impact market access and adoption.

What factors are driving patient awareness and interest in BRINSUPRI's launch? How has DTC impacted awareness? - Jason Zemansky(BofA Securities, Research Division)

2025Q3: There is significant enthusiasm among patients for BRINSUPRI. Physicians also seem aware of the medicine's arrival due to marketing efforts. The qualitative aspect of awareness is harder to discern in these early days, and we'll learn more over the next few quarters. - William Lewis(CEO)

Can you discuss trends in patient motivation to seek treatment related to the bronchiectasis disease awareness website? - Andrea Newkirk(Goldman Sachs)

2025Q1: The website shows favorable engagement, with patients and physicians demonstrating interest and enthusiasm. We are targeting a frictionless launch, aiming for smooth patient identification and physician engagement. - William Lewis(CEO)