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INSMED Inc (INSM)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 delivered record ARIKAYCE revenue of $104.4M (+24.8% YoY) and full‑year 2024 revenue of $363.7M (+19.2% YoY), with strength across the U.S. ($67.8M), Japan ($30.7M), and Europe/ROW ($5.9M) .
  • Management reiterated FY2025 global ARIKAYCE revenue guidance of $405–$425M (11%–17% YoY growth vs. 2024) and ended 2024 with ~$1.4B in cash, cash equivalents and marketable securities, providing ample launch funding runway .
  • Brensocatib NDA in bronchiectasis was accepted for Priority Review with an FDA PDUFA date of Aug 12, 2025; company expects a U.S. launch in 3Q25 if approved; pricing expected “in the upper half” of $40k–$96k list-price range at launch, with a market‑access strategy targeting frictionless prior auth and reauthorization .
  • Stock catalysts: Priority Review/PDUFA visibility, reiterated 2025 ARIKAYCE guidance, and explicit brensocatib pricing/gross‑to‑net framing (25%–35% launch gross‑to‑net) alongside IRA dynamics for ARIKAYCE (2025 gross‑to‑net high‑teens to low‑20s) .

What Went Well and What Went Wrong

  • What Went Well

    • Commercial execution: ARIKAYCE Q4 revenue hit $104.4M (+24.8% YoY), with annual revenue $363.7M (+19.2% YoY), above the top end of 2024 guidance .
    • Regulatory momentum: FDA accepted brensocatib NDA with Priority Review (PDUFA Aug 12, 2025); EU/UK/Japan filings planned in 2025 .
    • Management tone on launch readiness and demand: “tremendous excitement” among patients/physicians; ~90% of surveyed U.S. pulmonologists intend to prescribe to patients with ≥2 exacerbations; company can “call on every single pulmonologist in the United States” with expanded sales force .

  • What Went Wrong

    • Operating loss widened with heavier launch and pipeline investments: Q4 R&D $179.7M and SG&A $142.5M (both up YoY), producing Q4 net loss of $(235.5)M or $(1.32) per share (vs. $(186.1)M/$(1.28) prior-year) .
    • Cost of product revenues rose alongside growth: Q4 cost of product revenues (ex‑amort) $26.2M vs. $18.4M in Q4’23; FY cost $85.7M vs. $65.6M in 2023 .
    • Estimates comparison unavailable: S&P Global consensus could not be retrieved due to API limit; inability to benchmark revenue/EPS vs Street in this recap (to be updated when available).

Financial Results

MetricQ4 2023Q2 2024Q3 2024Q4 2024
ARIKAYCE Revenue ($M)$83.7 $90.3 $93.4 $104.4
YoY Revenue Growth—+17% +18% +24.8%
Cost of Product Revenues (ex‑amort, $M)$18.4 $21.0 $21.2 $26.2
R&D Expense ($M)$137.0 $146.7 $150.8 $179.7
SG&A Expense ($M)$89.5 $106.6 $118.9 $142.5
Net Loss ($M)$(186.1) $(300.6) $(220.5) $(235.5)
Diluted EPS ($)$(1.28) $(1.94) $(1.27) $(1.32)
Weighted Avg Shares (M)144.8 154.7 173.7 179.0

Segment revenue (ARIKAYCE) by region ($M):

RegionQ2 2024Q3 2024Q4 2024
U.S.$63.8 $66.9 $67.8
Japan$21.1 $21.0 $30.7
Europe & ROW$5.4 $5.6 $5.9

Additional KPIs and balance sheet:

  • Cash, cash equivalents and marketable securities at 12/31/24: ~$1.4B .
  • FY2024 U.S. gross‑to‑net for ARIKAYCE: 17%; 2025 expected high‑teens to low‑20s (IRA dynamic) .

Estimates vs. actuals: S&P Global consensus data was unavailable at time of writing due to API limits; we will update when accessible.

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
ARIKAYCE Global RevenueFY2025$405–$425M (prior) $405–$425M Maintained
Brensocatib U.S. Launch Timing3Q 2025 (post‑PDUFA)Mid‑2025 expected PDUFA Aug 12, 2025; U.S. launch expected 3Q25, if approved Narrowed/timed
Brensocatib Pricing (U.S.)LaunchN/AUpper half of $40k–$96k annual list price range expected at launch New detail
ARIKAYCE Gross‑to‑NetFY2025N/AHigh‑teens to low‑20s (IRA) New detail
Brensocatib Gross‑to‑NetLaunchN/A25%–35% at launch (specialty analogs; Medicare catastrophic share) New detail
TPIP PH‑ILD2H 20252H 2025 initiation 2H 2025 Phase 3 initiation affirmed Maintained
TPIP PAHMid‑20252H 2025 topline (prior) Mid‑2025 topline Pulled forward/clarified

Earnings Call Themes & Trends

TopicQ‑2 (Q2’24)Q‑1 (Q3’24)Current (Q4’24)Trend
Brensocatib regulatory pathASPEN topline positive; NDA planned 4Q24 NDA on track for 4Q24; launch mid‑2025 expected NDA accepted; Priority Review; PDUFA 8/12/25; launch 3Q25 if approved Improving visibility
Launch readiness & accessHired 120 specialists for disease‑state education 120 reps deployed; pre‑launch efforts expanded Full pulmonology coverage; focus on frictionless prior auth/reauth; ~90% intent to prescribe in ≥2 PE patients Strengthening
ARIKAYCE trajectoryQ2 revenue $90.3M (+17% YoY) Q3 revenue $93.4M (+18% YoY) Q4 revenue $104.4M (+24.8% YoY); FY25 guidance $405–$425M Accelerating
IRA/Gross‑to‑net dynamics——ARIKAYCE FY24 U.S. GTN 17%; 2025 high‑teens/low‑20s; brenso launch GTN 25%–35% New headwind managed
TPIP developmentPH‑ILD P2 positive topline; P3 planned 2025 P3 PH‑ILD in 2H25; PAH P2 ~90% enrolled PH‑ILD imaging suggests small‑vessel benefit; PAH P2 102 randomized; topline mid‑2025 On track
R&D breadth——Gene therapy IND cleared for DMD (INS1201); trials to initiate 1H25 Broadening

Management Commentary

  • CEO on 2025 setup: “In 2025, the expected U.S. launch of brensocatib in bronchiectasis in the third quarter is going to take center stage... Phase II data for TPIP in PAH in the middle of the year... Phase II data for brensocatib in CRS without nasal polyps... by the end of the year.” .
  • Pricing/access strategy: brensocatib “annual U.S. list price to be in the upper half of our original $40,000 to $96,000 range at launch,” with a strategy to achieve “a simple and straightforward prior authorization” and “seamlessly reauthorized” access .
  • ARIKAYCE execution: “record-setting revenues” in 2024 and 2025 guidance of $405–$425M, “yet another year of strong double-digit growth” in the current indication .

Q&A Highlights

  • Market access focus: Management prioritizes frictionless launch and reauthorization, contemplating “minor contracting” to secure verbal attestation of ≥2 exacerbations; extensive payer dialogues (~90% of covered lives) have been “incredibly encouraging” .
  • IRA impact: ARIKAYCE benefits from “specified small manufacturer” sliding‑scale for catastrophic discounts (1% in 2025 rising to 20% by 2031), but brensocatib will face the full 20% manufacturer responsibility at launch; brensocatib launch gross‑to‑net modeled at 25%–35% .
  • TAM and eligible patients: ~500k diagnosed bronchiectasis patients in the U.S., about half with ≥2 exacerbations (target population); broader addressable pool from COPD/asthma comorbid patients may expand over time .
  • TPIP expectations: PVR reductions above “mid‑teens to low‑20s” seen historically for prostacyclins would be differentiating; mid‑2025 PAH P2 topline expected; PH‑ILD P3 starts 2H25 .

Estimates Context

  • We attempted to retrieve S&P Global consensus (revenue and EPS) for Q4 2024 and near‑term forward quarters; the request failed due to the provider’s daily API limit. As a result, this recap does not benchmark actuals vs. Street. We will update the comparisons once S&P Global data is accessible.

Key Takeaways for Investors

  • Core franchise momentum: ARIKAYCE posted record Q4 and +19% FY growth, and FY2025 guidance of $405–$425M implies continued double‑digit expansion in the refractory MAC niche .
  • Brensocatib visibility and launch readiness improved: Priority Review with an 8/12/25 PDUFA and fully built U.S. field footprint; explicit pricing and access plan suggest a deliberate ramp with a few weeks of 3Q sales if approved .
  • Access/gross‑to‑net framing is realistic: ARIKAYCE GTN stepping up under IRA (high‑teens/low‑20s in 2025); brensocatib launch GTN 25%–35% provides early net pricing guardrails for models .
  • Pipeline catalysts cluster in 2025–2026: TPIP PAH mid‑2025, brensocatib BiRCh (CRSsNP) by YE25, ARIKAYCE ENCORE in 1Q26, with ex‑U.S. brensocatib launches in 2026 if approved .
  • Cash runway supports execution: ~$1.4B cash/securities at 12/31/24 provides flexibility to fund brensocatib launch and pivotal studies while absorbing elevated OpEx .
  • Trading lens: Near‑term stock drivers are brensocatib regulatory news flow/label/access shape, mid‑2025 TPIP PAH data, and ARIKAYCE quarterly cadence vs reiterated FY25 guide .

Appendix: Other Relevant Q4 2024 Press Releases

  • ASPEN subgroup analyses (CHEST 2024): efficacy consistent across most subgroups; brensocatib 25 mg slowed FEV1 decline across prespecified subgroups; safety acceptable .