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SpringWorks Therapeutics, Inc. (SWTX)·Q1 2024 Earnings Summary

Executive Summary

  • Strong first full quarter of OGSIVEO commercialization: revenue grew to $21.0M ($21.006M per financials), with GAAP net loss of $87.4M (–$1.18 EPS) and cash/cash equivalents/marketable securities of $573.0M as of March 31, 2024 .
  • Launch momentum underpinned by breadth/depth of prescribers (77% of centers-of-excellence have prescribed), broad payer access (reimbursed by payers covering 98% of commercially insured lives), and demand-driven revenues with minimal distributor inventory/real-time physician ordering .
  • Pipeline/regulatory catalysts: rolling NDA for mirdametinib initiated in March with expected completion in Q2 2024; EMA validation of OGSIVEO MAA; ASCO presentations for DeFi and ReNeu datasets in late May/early June 2024 .
  • Wall Street consensus (S&P Global) was unavailable via our estimates tool for Q1 2024; as a result, we cannot assess beat/miss versus consensus this quarter (see Estimates Context) [SpgiEstimatesError].

What Went Well and What Went Wrong

  • What Went Well

    • Commercial launch execution: OGSIVEO net product revenue reached $21.0M in the first full quarter, with management underscoring “strong adoption” and focus on making OGSIVEO “the standard of care” for desmoid tumors .
    • Access/uptake fundamentals: 77% of sarcoma centers-of-excellence have prescribed; reimbursement spans 98% of commercially covered lives, plus Medicare/Medicaid; physicians report rapid pain reductions post-initiation, supporting continued utilization and adherence .
    • Financial flexibility and confidence: $573M cash/cash equivalents/marketable securities; CFO highlighted a “clear path to profitability” enabling investment across the portfolio .

  • What Went Wrong

    • Losses persist with elevated OpEx to support launch and pipeline: SG&A rose to $60.1M (from $44.2M a year ago) and R&D to $53.6M (from $33.5M), driving a GAAP net loss of $87.4M (–$1.18 EPS) in Q1 2024 .
    • No quantitative revenue/OpEx guidance issued, limiting near-term visibility; management also said it’s early to quantify mix of switches vs. incident patients and any seasonality effects .
    • International contribution pending: EMA validation of OGSIVEO MAA is a step forward, but ex-U.S. commercial impact is still ahead; management emphasized the U.S. launch is early with many more patients to reach .

Financial Results

MetricQ4 2023Q1 2024
Revenue ($USD Millions)$5.4 $21.006
Cost of Product Revenue ($USD Millions)n/a$1.202
R&D Expense ($USD Millions)$43.7 $53.622
SG&A Expense ($USD Millions)$59.8 $60.113
Net Loss ($USD Millions)$(94.3) $(87.385)
Diluted EPS ($)$(1.44) $(1.18)
Cash, Cash Equivalents & Marketable Securities (Period-End, $USD Millions)$662.6 $572.987

Additional context from the prior quarter (for trend analysis):

MetricQ3 2023
Net Loss ($USD Millions)$(79.437)
Diluted EPS ($)$(1.27)
Cash, Cash Equivalents & Marketable Securities (Period-End, $USD Millions)$422.419

KPI highlights for launch execution:

KPIValue
Centers-of-Excellence with OGSIVEO prescriptions77%
Commercial coverage achieved98% of commercially covered lives
Oncologists who have prescribed or plan to prescribe OGSIVEO76%
Oncologists with experience likely to use OGSIVEO frontline98%
Actively managed desmoid patient pool (U.S.)5,500–7,000
Distributor inventory levelsMinimal; revenues primarily demand-driven; real-time physician ordering

Notes:

  • No non-GAAP metrics/EPS were provided by the company for Q1 2024; results reflect GAAP reporting .

Guidance Changes

Metric/TopicPeriodPrevious GuidanceCurrent GuidanceChange
Mirdametinib NDA (NF1-PN) – U.S.1H 2024On track to submit NDA in 1H 2024 Rolling NDA submission initiated Mar 2024; completion expected in Q2 2024 Tightened/advanced (timing specificity)
Mirdametinib MAA – EU2H 2024Plan to submit in 2H 2024 Plan remains to submit in 2H 2024 Maintained
OGSIVEO MAA – EU2024Plan to submit in 1H 2024 EMA validated MAA (Feb 2024) Progressed (validation achieved)
OGSIVEO blister pack availabilityMid-May 2024Not previously specifiedFDA approved supplemental NDA; blister packs expected mid-May 2024 New
SW-682 (pan-TEAD) Phase 1a start1H/Q2 2024IND cleared; plan to initiate 1H 2024 On track to initiate Phase 1a in Q2 2024 Maintained/specified Q2

No quantitative financial guidance (revenue, margins, OpEx, OI&E, tax, dividends) was provided in Q1 2024 materials .

Earnings Call Themes & Trends

TopicQ3 2023 (Q-2)Q4 2023 (Q-1)Q1 2024 (Current)Trend
OGSIVEO product performancePre-approval; preparing for launch, PDUFA 11/27/23 First partial quarter revenue $5.4M; NCCN Category 1; broad access noted First full quarter revenue $21.0M; adoption breadth/depth; strong physician/patient feedback Strong ramp from initial launch to Q1
Reimbursement/accessn/aCoverage aligned with label; >98% commercial coverage noted Broad access across commercial/Medicare/Medicaid; 98% commercial lives Sustained strong access
Prescriber breadth/depthn/aEarly adoption post-approval 77% of COE prescribers; growing community uptake Expanding breadth and depth
Inventory dynamicsn/an/aMinimal distributor inventory; physician real-time ordering Demand-driven revenues
Mirdametinib (NF1-PN) regulatoryTopline ReNeu data expected Q4’23 Positive topline presented; NDA planned 1H’24 Rolling NDA initiated Mar’24; completion expected Q2’24; oral at ASCO Advancing toward approval
EU/Global expansionEMA submission planned 1H’24 (OGSIVEO) EMA MAA submitted Feb’24 (OGSIVEO) EMA validation of OGSIVEO MAA (Feb’24) Progressing in EU
Pipeline (BCMA combos, brimarafenib, SW-682)Multiple early-stage programs advancing IND cleared for SW-682; MapKure combos moving forward SW-682 Phase 1a to start Q2’24; brimarafenib data 2H’24; continued BCMA combo evaluation Multiple 2H’24 catalysts

Management Commentary

  • Strategic focus: “We are…focused on continuing our momentum towards establishing OGSIVEO as the standard of care treatment for adults with desmoid tumors.” – CEO, Saqib Islam .
  • Launch confidence: “We’ve seen robust adoption… with physicians at 77% of [sarcoma centers-of-excellence] already having prescribed OGSIVEO.” – CCO, Bhavesh Ashar .
  • Access breadth: “Since approval, OGSIVEO has been reimbursed by payers representing 98% of commercially covered lives… We have also rapidly secured access for Medicare and Medicaid patients.” – CCO, Bhavesh Ashar .
  • Financial posture: “We continue to maintain a strong financial position with $573 million… on our balance sheet… We have a clear path to profitability…” – CFO, Frank Perier .

Q&A Highlights

  • Inventory/ordering: Distributors hold minimal inventory; revenues primarily reflect new/refill demand with physician real-time ordering; no significant changes expected to this pattern near-term .
  • Patient mix: Early prescriptions include both incident and prevalent-pool switches; management expects frontline use in newly diagnosed patients and steady switching over time, but too early to quantify the mix .
  • Breadth/depth of prescribers: Early strength across COEs and community settings; high awareness, broad label, and robust reimbursement seen as drivers of continued expansion .
  • Blister pack impact: Designed to improve convenience and adherence by reducing pill burden and simplifying dosing; expected to be meaningful as mid-May launch proceeds .
  • Reimbursement/seasonality: Population skews commercial; broad access across all payer segments with no surprises in mix; seasonality impacts not highlighted at this stage .

Estimates Context

  • S&P Global consensus estimates for Q1 2024 (revenue and EPS) were unavailable via our tool due to a company mapping error; therefore, we cannot provide beat/miss analysis this quarter. We will reassess in future periods as access becomes available [SpgiEstimatesError].

Key Takeaways for Investors

  • OGSIVEO’s launch trajectory is robust, with revenue inflecting from $5.4M in Q4 2023 to $21.0M in Q1 2024 amid broad access, strong adoption at COEs (77%), and favorable physician feedback, positioning OGSIVEO to become the systemic standard of care in desmoid tumors .
  • Demand—not channel build—is driving results (minimal distributor inventory, just-in-time physician ordering), which supports quality of revenue and sustainable trends as breadth/depth expand .
  • Significant 2024 catalysts: mirdametinib rolling NDA completion (Q2), ASCO data presentations (DeFi and ReNeu), SW-682 Phase 1a start (Q2), and 2H 2024 data for brimarafenib and nirogacestat ovarian granulosa cell tumor study; EMA MAA validation adds EU optionality .
  • Investment trade-off: continued operating losses as SG&A/R&D remain elevated for launch and pipeline build vs. increasing OGSIVEO revenue and a large actively managed patient pool (5,500–7,000) that supports a multi-quarter adoption curve .
  • Balance sheet strength ($573M) provides runway to drive U.S. OGSIVEO uptake and advance mirdametinib toward potential 2025 approval, while funding broader pipeline assets and combo studies .
  • Lack of quantitative guidance and absence of consensus comparisons this quarter keep near-term visibility modest; watch subsequent quarters for renewal dynamics, breadth outside COEs, and payer policy codification trends [SpgiEstimatesError].

Appendix: Source Documents Reviewed

  • Q1 2024 8-K 2.02 press release and financials (May 2, 2024) .
  • Q1 2024 earnings call transcript (May 2, 2024) –.
  • Prior quarter releases for trend analysis: Q4 2023 (Feb 27, 2024) –; Q3 2023 (Nov 2, 2023) – .