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Mineralys Therapeutics, Inc. (MLYS)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered clean execution: net loss of $43.3M and EPS of -$0.66, a clear beat versus Wall Street’s -$0.74 consensus; EBITDA missed modestly versus consensus as spending remained elevated to support pivotal program wrap-up and OSA/CKD efforts . EPS estimate from S&P Global (-$0.74*) and EBITDA estimate (-$45.6M*) vs actual (-$46.7M*) indicate a small EBITDA miss despite the EPS beat; Values retrieved from S&P Global.
  • Balance sheet strengthened: cash, cash equivalents and investments rose to $324.9M at quarter-end (from $343.0M in Q1 after capital raise), providing runway into 2027 and de-risking pre-NDA workstreams and commercialization preparation .
  • Clinical momentum: Launch-HTN and Advance-HTN pivotal data published/presented (JAMA/NEJM), Explore-CKD met primary endpoint with significant SBP and UACR reductions, and a pre-NDA meeting is now scheduled for Q4 2025—key regulatory catalyst .
  • Commercial setup advancing: management reiterated favorable payer feedback (no anticipated step-through spironolactone; likely step through two generics), and physician intent to prescribe is strong (95% likely to prescribe lorundrostat if approved) .
  • Stock reaction catalysts near term: Q4 pre-NDA meeting outcome; competitor readouts (AZ Baxdrostat) and differentiation on hyperkalemia and 24-hour BP control; medium-term: Explore-OSA topline in 1H 2026 and potential partnership(s) .

What Went Well and What Went Wrong

What Went Well

  • Pivotal trial data visibility and validation: Launch-HTN and Advance-HTN results published/presented in top-tier venues (JAMA/NEJM; ACC; ESH), bolstering credibility and clinical narrative .
  • Explore-CKD met primary endpoint and showed meaningful UACR reduction (25.6% placebo-adjusted; p=0.0015), supporting expansion into CKD comorbidity and reinforcing mechanism-driven value .
  • Regulatory path clarity: “Pre-NDA meeting scheduled to take place in 4Q 2025,” confirming execution progress and providing a line-of-sight to NDA submission planning . Quote: “The results from our clinical program have positioned us to move ahead with our NDA strategy, and we have scheduled a pre-NDA meeting with the FDA to take place in the fourth quarter of 2025.”

What Went Wrong

  • EBITDA modestly below consensus as spending cadence remained high post-pivotal completion (R&D $38.3M; G&A $8.5M), reflecting continued investment in pre-commercial and clinical programs . EBITDA estimate (-$45.6M*) vs actual (-$46.7M*) indicates a small miss; Values retrieved from S&P Global.
  • Other income declined YoY ($3.5M vs $4.2M) due to lower average cash balances invested, a small offset to higher operating spend .
  • Competitive overhang: Multiple Q&A threads centered on AZ Baxdrostat hyperkalemia and 24-hour profile; management rightly avoided speculative commentary pending data, but investor uncertainty persists until head-to-head differentiators are clearer .

Financial Results

MetricQ2 2024Q1 2025Q2 2025Q2 2025 Consensus
Cash, Cash Equivalents & Investments ($USD Millions)N/A$343.0 $324.9 —
R&D Expense ($USD Millions)$39.3 $37.9 $38.3 —
G&A Expense ($USD Millions)$5.9 $6.6 $8.5 —
Total Operating Expenses ($USD Millions)$45.2 $44.4 $46.7 —
Loss from Operations ($USD Millions)$(45.2) $(44.4) $(46.7) —
Total Other Income, net ($USD Millions)$4.2 $2.2 $3.5 —
Net Loss ($USD Millions)$(41.0) $(42.2) $(43.3) —
Diluted EPS ($USD)$(0.83) $(0.79) $(0.66) $(0.74)*
EBITDA ($USD Millions)N/AN/A$(46.7)*$(45.6)*

Notes: Asterisk (*) denotes Values retrieved from S&P Global.

Segment breakdown: Not applicable; no commercial revenues reported in period and no segments disclosed .

KPIs:

KPIValueSource
Launch-HTN SBP reduction (AOBP) at week 12 – absolute; placebo-adjusted19.0 mmHg; 11.7 mmHg
Launch-HTN confirmed hyperkalemia (>6.0 mmol/L)0.6% (50 mg arm); 1.1% (50–100 mg arm)
Advance-HTN SBP reduction (24-hr ABPM) at week 12 – absolute; placebo-adjusted15.4 mmHg; 7.9 mmHg
Advance-HTN confirmed hyperkalemia (>6.0 mmol/L)2.1% (50 mg arm)
Explore-CKD SBP reduction (AOBP) – placebo-adjusted7.5 mmHg (p=0.0024)
Explore-CKD UACR reduction – placebo-adjusted25.6% (p=0.0015)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Pre-NDA Meeting TimingQ4 2025Anticipated in Q4 2025 Scheduled in Q4 2025 Maintained/timing firmed
Cash RunwayThrough 2027Into 2027 Into 2027 Maintained
Explore-CKD ToplineQ2 2025Topline anticipated Q2 2025 Positive topline announced June 17, 2025 Achieved
Explore-OSA Topline1H 2026Trial initiated Q1 2025; no prior timing Topline anticipated 1H 2026 New timing disclosure
Transform-HTN OLEOngoingOngoing Ongoing Maintained
Revenue/Margins/OpEx guidanceFY/QuarterNot providedNot providedMaintained (none provided)

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024 and Q1 2025)Current Period (Q2 2025)Trend
Regulatory/NDA pathPivotal readouts imminent; OLE safety key; pre-NDA targeted for Q4 2025 Pre-NDA meeting scheduled for Q4 2025 Visibility improved
CKD programEnrollment completed; topline anticipated Q2 2025 Positive topline with significant SBP and UACR reductions; CKD on SGLT2+ACE/ARB Strengthened
OSA programInitiation planned/started; novel nighttime BP measurement OSA ongoing; topline 1H 2026; nighttime dosing to target aldosterone surge Ongoing; clarity added
Hyperkalemia and safetyTarget-HTN/Advance acceptability; diuretics may offset K+ rise; benefit-risk emphasis Launch-HTN hyperkalemia low; discussion vs AZ Baxdrostat ongoing; safety profile reinforced Consistent, favorable
Payer/access8–10 mmHg SBP effect supports access; targeted 3rd/4th line; payer research positive No step-through spironolactone expected; step-through two generics likely; optimize net price Improving access narrative
PartnershipsIndicated as part of strategy (U.S./ex-U.S.) Active interest; details limited; room for multiple ASIs in market Continues
Competitor AZ BaxdrostatAnticipation of ESC data; cautious on cross-trial comparisons Multiple Q&A on grades of hyperkalemia and 24-hr profile; management defers until data Unchanged uncertainty

Management Commentary

  • “We continue to lead the way in the development of ASIs… We have scheduled a pre-NDA meeting with the FDA to take place in the fourth quarter of 2025.” — Jon Congleton, CEO
  • “We ended the quarter with cash, cash equivalents and investments of $324,900,000… sufficient to fund… into 2027.” — Adam Levy, CFO
  • “Launch HTN… 11.6 mmHg placebo adjusted change, 19 mmHg absolute… hyperkalemia >6 mmol/L of 0.6%.” — Jon Congleton (trial characterization)
  • “We do not anticipate a step through spironolactone… payers will step us through two generic classes… optimize the net price.” — Adam Levy on access
  • “Lorundrostat… highly effective antihypertensive… confident in the twenty four hour blood pressure control… measured in the morning at trough before that day’s dose.” — Jon Congleton

Q&A Highlights

  • Safety vs AZ Baxdrostat: Management emphasized confidence in lorundrostat’s efficacy/safety, low confirmed hyperkalemia in Launch-HTN, and cautioned against speculating ahead of AZ data; the design and background meds influence observed K+ rates .
  • Payer dynamics: Expect no step-through spironolactone; likely step-through two generic classes via electronic edits; focus on prescriber-friendly criteria and net price optimization .
  • Drug-drug interactions: PPI use allowed periodically; if chronic PPIs reduce exposure, monitor BP and consider dose adjustment; confirms morning trough measurements demonstrate 24-hour control .
  • Commercial strategy and partnering: Target key prescribers in 3rd/4th-line with a partner to maximize reach; room for multiple ASIs given ~20M patients uncontrolled on ≥2 meds .
  • OSA endpoints: Trial powered for AHI; novel nighttime BP measurement planned; bedtime dosing to target nocturnal aldosterone surge .

Estimates Context

  • Q2 2025 EPS beat: Actual EPS -$0.66 vs S&P Global consensus -$0.74*, a ~$0.08 beat; Values retrieved from S&P Global. Actual EPS from press release .
  • Q2 2025 EBITDA: Actual -$46.7M* vs consensus -$45.6M*, a modest miss; Values retrieved from S&P Global.
  • Revenue: Consensus $0*, consistent with clinical-stage status; Values retrieved from S&P Global.
MetricQ2 2025 ActualQ2 2025 ConsensusSurprise
Diluted EPS ($USD)-$0.66 -$0.74*+$0.08 (beat)
EBITDA ($USD Millions)-$46.7*-$45.6*-$1.1M (miss)
Revenue ($USD Millions)0 (not reported)0.0*In line

Notes: Asterisk (*) denotes Values retrieved from S&P Global.

Key Takeaways for Investors

  • Execution and credibility are strong: dual pivotal readouts in premier journals/conferences and a scheduled pre-NDA meeting anchor the regulatory path; near-term regulatory feedback is the next key de-risking step .
  • Clinically meaningful efficacy with favorable safety: double-digit SBP reductions and low confirmed hyperkalemia in Launch-HTN support a differentiated benefit-risk profile versus MRAs and speak to demand in later-line hypertension .
  • CKD expansion validated: Explore-CKD’s significant SBP and UACR reductions on top of SGLT2+ACE/ARB broaden the addressable population and support label/package discussions .
  • Access outlook constructive: payer research suggests manageable utilization controls without spironolactone step-through, supporting 3rd/4th-line placement and early uptake if approved .
  • Watch competitor dynamics: AZ Baxdrostat hyperkalemia and 24-hr control data may shape relative positioning; management’s conservative stance is appropriate pending full readouts .
  • Balance sheet supports optionality: runway into 2027 enables pre-commercial build, potential partnership(s), and continued development (OSA/CKD), reducing financing overhang near term .
  • Trading lens: EPS beats despite elevated OpEx signal disciplined execution; upcoming pre-NDA meeting and any partnership updates represent meaningful catalysts that can shift sentiment and estimates.