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VERTEX PHARMACEUTICALS INC / MA (VRTX)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 revenue was $2.96B (+12% YoY) with non-GAAP diluted EPS of $4.52; both beat consensus (Revenue: $2.91B*, EPS: $4.25*) on stronger CF demand and early contributions from ALYFTREK, JOURNAVX, and CASGEVY .
  • Guidance was reiterated: FY25 revenue $11.85–$12.0B; non-GAAP combined R&D/AIPR&D/SG&A $4.9–$5.0B; non-GAAP tax rate 20.5–21.5% .
  • Commercial KPIs inflected: 110,000 JOURNAVX prescriptions filled, ~150M covered lives (84M unrestricted), >75 CASGEVY ATCs activated, 115 first cell collections, 29 infusions (16 in Q2) .
  • Pipeline clarity: FDA feedback narrows peripheral neuropathic pain to DPN first; two Phase 3 suzetrigine DPN trials to complete enrollment by end of next year, while VX-993 will not advance as monotherapy in acute pain .

What Went Well and What Went Wrong

What Went Well

  • CF leadership sustained; U.S. revenue +14% to $1.85B on demand and favorable gross-to-net, OUS +8% to $1.12B; ALYFTREK EU approval and NHS England reimbursement broaden access .
  • JOURNAVX adoption accelerated: 110,000 scripts, 150M covered lives, 84M unrestricted; >50 targeted healthcare systems and ~500 hospitals added to formularies; management ramping commercial investment given responsiveness .
  • CASGEVY execution improved: >75 ATCs activated; 115 first cell collections; 29 infusions (16 in Q2); expanding reimbursement footprint including Northern Ireland, Scotland, and Denmark .

Quote: “Momentum accelerated… we executed with very strong performance across the board, growing and diversifying revenue with multiple new product launches...” — Reshma Kewalramani .

What Went Wrong

  • VX-993 Phase 2 in acute pain missed SPID48 primary endpoint; company will not advance VX-993 as monotherapy in acute pain, though safety was similar to placebo .
  • FDA does not see a path today to broad PNP label; Vertex will prioritize DPN as first indication and defer LSR Phase 3, implying a stepwise neuropathic pain strategy .
  • Prior quarter (Q1) saw OUS revenue decline due to IP violations in Russia, and non-GAAP EPS missed consensus ($4.06 vs $4.29*), highlighting near-term ex-U.S. pressures and launch ramp timing .

Financial Results

Revenue and EPS vs prior periods and estimates

MetricQ2 2024Q1 2025Q2 2025Consensus Q1 2025*Consensus Q2 2025*
Total Revenue ($USD Billions)$2.646 $2.770 $2.965 $2.861*$2.907*
Diluted EPS (Non-GAAP, $)($12.83) $4.06 $4.52 $4.293*$4.251*
Diluted EPS (GAAP, $)($13.92) $2.49 $3.99 n/an/a

Note: Asterisks indicate values retrieved from S&P Global.

Segment/Product revenue breakdown

ProductQ1 2025 ($USD Millions)Q2 2025 ($USD Millions)
TRIKAFTA/KAFTRIO$2,535.5 $2,551.1
ALYFTREK$53.9 $156.8
Other CF (KALYDECO/ORKAMBI/SYMDEKO)$170.8 $193.7
CASGEVY (Included in Other)$14.2 $30.4
JOURNAVX (Included in Other)Insignificant amount $12.0
Other revenues$10.0 $20.7
Total Revenues$2,770.2 $2,964.7

Margins (S&P Global)

MetricQ4 2024Q1 2025Q2 2025
Gross Profit Margin %51.16%*51.53%*53.25%*
EBIT Margin %38.20%*37.22%*38.93%*
EBITDA Margin %38.93%*38.97%*40.68%*

Note: Asterisks indicate values retrieved from S&P Global.

KPIs

KPIQ1 2025Q2 2025
JOURNAVX prescriptions filled>20,000 (Mar–Apr) >110,000 (to mid-July)
JOURNAVX covered lives~94M covered; ~42M unrestricted ~150M covered; ~84M unrestricted
JOURNAVX formulary adoption>50 systems initiated P&T >50 systems added; ~500 hospitals added
CASGEVY ATCs activated>65 >75
CASGEVY first cell collections~90 ~115
CASGEVY infusionsn/a29 total; 16 in Q2

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total RevenueFY 2025$11.85–$12.0B (low end raised from $11.75 in Q1) $11.85–$12.0B Maintained
Combined GAAP R&D, AIPR&D & SG&AFY 2025$5.55–$5.70B $5.55–$5.70B Maintained
Combined Non-GAAP R&D, AIPR&D & SG&AFY 2025$4.90–$5.00B $4.90–$5.00B Maintained
Non-GAAP Effective Tax RateFY 202520.5%–21.5% 20.5%–21.5% Maintained

Management also noted immaterial tariff cost impact embedded in FY25 guidance .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
CF franchise and ALYFTREK rolloutALYFTREK approved in U.S.; CHMP positive; building access; CF TRIKAFTA label expansion EU approval, NHS England reimbursement; expanding younger-age labels; continued CF demand Strengthening access and uptake
JOURNAVX launch and accessFDA approval; early scripts; 94M covered lives; P&T initiation 110k scripts; ~150M covered lives (84M unrestricted); >50 systems/~500 hospitals added; increased marketing Accelerating adoption and investment
CASGEVY scale-up>50 ATCs; initiation of collections; expanding reimbursement (NHS England) >75 ATCs; 115 collections; 29 infusions; broader reimbursement footprint Building operational cadence
Pain strategy (suzetrigine/VX-993)LSR Ph2 met primary but no separation; planning LSR Ph3; VX-993 programs ongoing VX-993 acute pain Ph2 miss; not advancing monotherapy; FDA PNP feedback — focus on DPN Phase 3×2 Refined strategy; DPN-first
T1D (zimislecel)Pivotal dosing completes in 2025; plan filings in 2026; NEJM and ADA data upcoming NEJM/ADA data show 83% insulin independence at 12 months; submissions targeted in 2026 De-risking; nearer to filings
Renal portfolio (pove/inaxaplin)RAINIER IA cohort enrollment; pMN Phase 2/3 plan; AMPLITUDE IA cohort targets RAINIER full enrollment by YE; accel approval prospects; gMG/wAIHA prioritized; AMPLITUDE IA cohort on track Multiple pivotal paths advancing
Tariffs/macroTariff sensitivity low given supply chain; NOPAIN Act add-on expected FY25 tariffs immaterial; continued watch on sector specifics; NOPAIN Act listing clarification in process Managed exposure

Management Commentary

  • “We delivered $2,960,000,000 in revenue… growing and diversifying revenue with multiple new product launches, driving advancement of programs in pivotal development” — Reshma Kewalramani .
  • “FDA… do not see a path to a broad PNP label at this time… we will prioritize DPN as the first PNP indication and begin a second DPN Phase 3 study” — Reshma Kewalramani .
  • “More than 110,000 prescriptions… nearly 150 million individuals already have covered access… two of the three large national PBMs” — Commercial update .
  • “Approximately 115 patients have had their first cell collection, and 29… have received infusions of CASGEVY, including 16 infused in Q2” .
  • “VX-993… did not result in a statistically significant improvement… we will not be advancing it as monotherapy in acute pain” — CMO statement .

Q&A Highlights

  • JOURNAVX commercialization: Management is augmenting marketing/field support given favorable payer momentum and promotional responsiveness; patient support programs will be retired as coverage normalizes, lifting gross-to-net over 2025 .
  • DPN pathway: First suzetrigine DPN Phase 3 likely to complete enrollment ahead of second; strategy is DPN-first, then broaden indications (e.g., small fiber neuropathy) and potentially NAV1.7+1.8 combinations for broader PNP .
  • Access metrics: Unrestricted access now 84M lives; all negotiated agreements are unrestricted (no PA/step edits) .
  • NOPAIN Act: Clarification underway; management expects JOURNAVX on the final add-on list in the fall .
  • CASGEVY cycle time: ~4–5 months end-to-end; opportunity to improve as ATCs and processes mature; infusions expected to ramp with increased collections .

Estimates Context

  • Q2 2025 beat: Revenue $2.965B vs $2.906B*; non-GAAP EPS $4.52 vs $4.251* — driven by CF demand and launch contributions (ALYFTREK/JOURNAVX/CASGEVY) .
  • Q1 2025 mixed: Revenue $2.770B vs $2.861B* (miss) amid OUS pressure (Russia IP violation); non-GAAP EPS $4.06 vs $4.293* (miss) as launch ramp affected gross-to-net early .

Note: Asterisks indicate values retrieved from S&P Global.

Key Takeaways for Investors

  • Q2 was a clean beat on top-line and non-GAAP EPS vs consensus, with momentum across CF and early launch contributions from ALYFTREK, JOURNAVX, and CASGEVY .
  • JOURNAVX access and utilization are broadening rapidly; increased commercial spend in H2 suggests sustained script growth and improving gross-to-net as PSPs roll off .
  • CASGEVY operational cadence is improving (ATCs, collections, infusions), supporting visibility in H2 revenue trajectories despite quarter-to-quarter variability tied to patient scheduling .
  • Pain strategy is refined: DPN-first for suzetrigine with two Phase 3s; NAV1.7+1.8 combinations are a potential route to broader neuropathic labels; VX-993 acute pain monotherapy discontinued .
  • T1D zimislecel data (NEJM/ADA) de-risk the program; pivotal dosing near completion positions 2026 filings, adding optionality beyond CF .
  • Guidance maintained, tariffs immaterial in 2025; expect H2 to show higher tax rate within guided range and continued investment, particularly behind JOURNAVX .
  • Watch near-term catalysts: NOPAIN Act listing, further payer wins/formulary adds for JOURNAVX, CASGEVY manufacturing/throughput, EU/Canada ALYFTREK reimbursement rollout .

Values retrieved from S&P Global where marked with an asterisk (*).