MARINUS PHARMACEUTICALS, INC. (MRNS)·Q1 2024 Earnings Summary

Executive Summary

• Q1 2024 showed continued commercial traction for ZTALMY with net product revenue of $7.5M (+125% YoY), while total revenue declined YoY due to a sharp drop in BARDA contract revenue; losses narrowed sequentially vs Q4 but remained substantial .
• Management raised FY2024 U.S. ZTALMY net product revenue guidance to $33–$35M from $32–$34M and implemented cost reductions (including ~20% workforce reduction) to extend cash runway into late Q1 2025 .
• Clinical catalysts remain the key stock drivers: RAISE (IV ganaxolone in RSE) topline expected in early summer 2024 (interim did not trigger early stopping), and TrustTSC topline expected in the first half of Q4 2024; sNDA for TSC targeted for April 2025 with priority review expected .
• The company achieved profitability on the ZTALMY commercial investment in Q1 2024 (ahead of the original target), while ex-U.S. partners (Orion, Tenacia) continue preparing launches and milestones, including eligibility for a €10M CDD launch milestone in Europe .

What Went Well and What Went Wrong

• What Went Well

  • ZTALMY momentum: Net product revenue grew 125% YoY in Q1, and management increased FY2024 guidance to $33–$35M; commercial investment reached profitability in Q1 ahead of plan .
  • Pipeline execution: TrustTSC enrollment expected to complete mid‑May with low (~7%) discontinuation rates and topline expected in 1H Q4 2024; management is “optimistic” the Phase 3 design improves tolerability and efficacy versus Phase 2 .
  • Strategic discipline and runway: Cost reductions (20% workforce, deferred IV manufacturing, trial enrollment stops) extend cash runway into Q1 2025, aligning spend with near‑term catalysts .

  Selected quotes:

  • “Our unwavering commitment is to develop innovative treatment options for individuals with seizure disorders…We are actively engaged with the tuberous sclerosis complex community…in preparation for a potential second half 2025 TSC launch.” – CEO Scott Braunstein .
  • “We are optimistic that we can replicate the success of our pivotal CDD trial of ZTALMY in the TrustTSC study…suggest [ing] improved tolerability.” – CMO Joseph Hulihan .

• What Went Wrong

  • Non-product revenue headwind: BARDA revenue fell to $0.2M from $7.0M in Q1 2023 given 2023 base period completion, pressuring total revenue YoY despite product growth .
  • Continued losses and cash burn: Net loss was $38.7M; SG&A rose to $18.6M on commercial spend and headcount; R&D remains elevated with ongoing pivotal programs .
  • RAISE timing slippage: Interim analysis did not meet early stopping criteria; topline moved to early summer 2024 with future IV development to be assessed post‑readout; RAISE II enrollment was stopped in favor of reassessment after topline .

Financial Results

Overall P&L (USD Millions unless noted)

Revenue mix (USD Millions)

Liquidity & Operating KPIs

Implications:

• Product growth is robust and sequential, but the normalization of BARDA revenue created an optics headwind on total revenue YoY; investors should anchor on ZTALMY as the economic driver and watch BARDA as an opportunistic offset .
• SG&A investment in commercial scale-up and rising R&D for pivotal programs continue to pressure P&L until data/label expansions unlock further revenue leverage .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• CEO Scott Braunstein: “With continued commercial success in CDD and a significant unmet need in drug-resistant epilepsies, we believe there is a robust market opportunity for the ZTALMY franchise… We plan to announce the RAISE trial topline results this summer and to then engage the FDA to discuss a potential filing strategy.”
• CMO Joseph Hulihan: “We are optimistic that we can replicate the success of our pivotal CDD trial of ZTALMY in the TrustTSC study… refinements made to the Phase 3 titration schedule and low discontinuation rates… suggest improved tolerability.”
• On business discipline: “The Company has implemented cost reduction plans… stopped clinical trial enrollment in the RAISE and RAISE II trials… reduced the Company's workforce by approximately 20%… [extending] cash runway into the first quarter of 2025.”

Q&A Highlights

Note: A Q1 2024 earnings call transcript was not available in our document set. The closest available is the Q4 2023 call (Mar 5, 2024); highlights below provide context rather than Q1-specific Q&A.

• RAISE interim/stopping criteria: Co-primaries must each hit significance at p=0.0293 with >90% power to detect a 40% delta; management reiterated they would update the Street even if the interim did not meet stopping rules .
• SRSE strategy: Encouraging emergency IND outcomes with a higher daily dosing regimen (~1,050 mg ganaxolone + 63g Captisol); planning a single‑arm proof‑of‑concept trial and pursuing FDA alignment on dosing .
• Reimbursement and off-label context (ZTALMY): Payer approvals nearly universal in CDD; management observed some spontaneous off-label use in refractory epilepsies, while emphasizing on‑label focus .
• Acute care launch readiness: Field access teams, NTAP filing plans, and payer/formulary engagement outlined ahead of potential IV launch .

Estimates Context

• S&P Global (Capital IQ) consensus estimates for MRNS Q1 2024 were unavailable via our data connection at time of analysis; as a result, we cannot present a vs‑consensus comparison for revenue or EPS. Values were not retrievable from S&P Global using our tool mapping.

Key Takeaways for Investors

• ZTALMY is compounding sequentially and drove the quarterly beat vs prior periods; focus on execution vs the raised $33–$35M FY24 guide and durability of new prescribers/patient adds .
• The YoY total revenue decline is optical, driven by BARDA normalization; product revenue is the truer economic indicator and remains on plan/above prior expectations .
• Near‑term binary risk/reward: RAISE topline in early summer 2024 will determine IV ganaxolone’s regulatory path and hospital opportunity; TrustTSC topline in 1H Q4 2024 underpins the 2025 sNDA and potential label expansion .
• Cost actions extend runway into Q1 2025, bridging to both toplines; watch opex cadence vs the $135–$140M FY24 plan and timing of cost realization in 2H 2024 .
• Ex‑U.S. optionality: Orion EU launches and potential €10M CDD milestone offer non‑dilutive upside; Tenacia China and MENA distribution broaden access and future royalties .
• Second‑gen prodrug timeline pushed to 1H 2025 for IND‑enabling; incremental but longer‑dated lever for oral franchise expansion .
• Trading setup: Stock likely driven by RAISE readout and subsequent FDA dialogue; positive data could re-rate the hospital franchise optionality, while negative/ambiguous results elevate reliance on TSC expansion and ongoing ZTALMY growth .

Appendix: Additional Quantitative Detail (YoY within Q1)

Sources: MRNS 8‑K and press release, May 8, 2024 ; MRNS 8‑K and press release, Apr 15, 2024 ; MRNS 8‑K and press release, Mar 5, 2024 ; MRNS 8‑K and press release, Nov 7, 2023 ; Q4 2023 earnings call transcript (Mar 5, 2024) ; Q3 2023 earnings call transcript (Nov 7, 2023) .