Sign in

You're signed outSign in or to get full access.

TI

TALPHERA, INC. (ACRX)·Q4 2023 Earnings Summary

Executive Summary

  • Talphera (formerly AcelRx) delivered a small revenue quarter ($0.28M) with a narrower year-over-year net loss and reduced operating expenses; sequential operating loss widened vs Q3 2023, and discontinued operations were de minimis .
  • The company completed a strategic rebranding to Talphera (Nasdaq: TLPH) and secured $26M in committed capital (royalty monetization and staged equity), extending cash runway toward a potential Niyad approval targeted for Q2 2025 .
  • Execution milestones were reiterated/clarified: first patient in NEPHRO CRRT registration trial expected in Q1 2024, topline by end of Q3 2024, PMA submission by end of 2024; approval targeted Q2 2025, underpinning the stock’s next catalysts .
  • Consensus estimates from S&P Global were unavailable for this quarter; as a result, beat/miss vs Street cannot be assessed at this time (S&P Global data unavailable).

What Went Well and What Went Wrong

What Went Well

  • Corporate transformation and funding: Rebranded to Talphera, divested DSUVIA, and secured $26M in committed capital, including $8M from partial monetization of DSUVIA royalties/milestones and $18M in staged equity, supporting Niyad development through potential approval in Q2 2025 .
  • Regulatory and clinical progress: FDA-approved IDE for Niyad; NEPHRO CRRT registrational study to start imminently, with PMA submission planned by year-end 2024 and topline by end of Q3 2024 .
  • Cost discipline and y/y improvement: Q4 GAAP operating expenses fell to $4.56M from $5.89M in Q4 2022; net loss attributable to shareholders improved to $4.52M ($0.25/share) from $7.48M ($1.00/share) y/y .
    • CEO quote: “This transformation has generated new interest and investments... projected to support the development of Niyad through a potential FDA approval by the middle of next year.”

What Went Wrong

  • Limited revenue base: Q4 revenues were $0.28M, primarily DSUVIA-related royalties post-divestiture; the prior period’s DSUVIA revenue is now reported within discontinued operations, constraining growth optics .
  • Sequential operating pressure: Loss from operations increased sequentially to $(4.28)M from $(3.31)M in Q3, reflecting higher Niyad R&D and corporate transition costs .
  • Cash draw and dependency on milestones: Cash fell to $9.38M at year-end (from $13.39M in Q3), with forward runway relying on milestone-triggered equity commitments and royalty monetization .

Financial Results

Income Statement and EPS (USD Millions, except per-share)

MetricQ2 2023Q3 2023Q4 2023
Revenue ($)$0.253 $0.117 $0.281
Loss from Operations ($)$(3.969) $(3.309) $(4.283)
Net Income (Loss) from Continuing Ops ($)$(4.364) $(1.418) $(4.505)
Net Loss Attributable to Common Shareholders ($)$(4.371) $(1.357) $(4.517)
Basic/Diluted EPS (Net) ($)$(0.40) $(0.08) $(0.25)

Operating Expenses (GAAP and Non-GAAP, USD Millions)

MetricQ2 2023Q3 2023Q4 2023
Total Operating Expenses (GAAP)$4.222 $3.426 $4.564
Operating Expenses (Non-GAAP)$3.751 $3.048 $4.253

Balance Sheet KPIs (USD Millions)

MetricQ2 2023Q3 2023Q4 2023
Cash, Cash Equivalents, Restricted Cash & Investments$7.410 $13.389 $9.381
Total Assets$17.725 $23.261 $20.395
Total Liabilities$7.306 $4.954 $6.290
Stockholders’ Equity$10.419 $18.307 $14.105

Year-over-Year (Q4 2023 vs Q4 2022)

MetricQ4 2022Q4 2023
Total Operating Expenses (GAAP) ($M)$5.886 $4.564
Net Loss Attributable to Common Shareholders ($M)$7.484 $4.517
Net Loss per Share (Basic/Diluted) ($)$(1.00) $(0.25)
Net Loss from Continuing Operations ($M)$(5.936) $(4.505)

Continuing vs Discontinued Operations (USD Millions)

MetricQ2 2023Q3 2023Q4 2023
Net Income (Loss) – Discontinued Ops$0.057 $0.061 $(0.012)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
First Patient Enrollment – NEPHRO CRRTQ1 2024Study “set to start this quarter” (Q4 2023) First patient expected “in coming weeks” (Q1 2024) Slight timing shift to Q1 2024
Topline Data – NEPHRO CRRTBy end of Q3 2024Mid-2024 End of Q3 2024 Clarified window (still mid-’24 timeframe)
PMA Submission – NiyadEnd of 20242H 2024 By end of 2024 Maintained/confirmed
Potential FDA Approval – NiyadQ2 2025Not specifiedTargeted Q2 2025 New explicit target
Cash RunwayThrough potential approvalNot specifiedRunway through potential approval in Q2 2025 New explicit runway
2024 Cash OpExFY 2024Not specifiedExpected cash operating expenses for 2024 discussed, no numeric detail provided Commentary only
Capital Commitments2023–2024Financing up to $26.3M (July ’23) $26M committed: $8M royalty monetization (Xoma), $18M staged equity ($6M closed + $10M/$2M tied to trial/price milestones) Structure updated and partially funded

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 & Q3 2023)Current Period (Q4 2023)Trend
Regulatory/Clinical (IDE, NEPHRO)IDE approved; NEPHRO set to start in Q4; PMA planned 2H 2024 First patient expected Q1 2024; topline end-Q3 2024; PMA by end 2024 Timeline refined; execution imminent
Financing/LiquidityJuly private placement up to $26.3M; debt repaid $26M committed ($8M royalty monetization; $18M staged equity); cash $9.4M YE Capital plan advanced; runway extended
Portfolio FocusDSUVIA divestment; focus on Niyad Rebranding to Talphera; priority on Niyad CRRT anticoagulant Strategy crystallized
Market Education/KOLsEUA discussed; stability data; study planning KOL panel on CRRT anticoagulation; publication in Renal Failure Clinical need validated
Operating DisciplineOpEx reduced vs 2022 Q4 OpEx down y/y; non-GAAP provided Continued cost control

Management Commentary

  • CEO Vince Angotti: “With the divestment of DSUVIA last year and priority focus on our new lead asset, Niyad, we expect a series of significant upcoming milestones… provided us with the capital and commitments projected to support the development of Niyad through a potential FDA approval by the middle of next year.”
  • Study emphasis: “Our priority this year is the successful completion of this trial and the submission of a PMA to the FDA by the end of 2024.”
  • Clinical context: Publication and KOL panel highlighted concerns with heparin/citrate and the consequences of no anticoagulation in CRRT, reinforcing Niyad’s potential role .

Q&A Highlights

  • The Q4 2023 earnings call transcript could not be retrieved due to a system document inconsistency; therefore, detailed Q&A highlights and any clarifications from management are unavailable for inclusion at this time.

Estimates Context

  • S&P Global consensus estimates for Revenue and EPS for Q4 2023 and the prior two quarters were unavailable due to data access/mapping limitations during retrieval; as a result, we cannot assess beat/miss vs Street for this period at this time (S&P Global data unavailable).

Key Takeaways for Investors

  • Funding and runway: New $26M capital commitment plus YE cash provide runway towards pivotal NEPHRO topline (end-Q3 2024), PMA submission (end-2024), and targeted approval in Q2 2025—key stock catalysts over the next 12–18 months .
  • Clinical execution is paramount: First patient enrollment timing (Q1 2024) is a near-term milestone; timely enrollment and delivering topline by end-Q3 2024 are likely to drive narrative and valuation .
  • Cost discipline supports durability: Y/y reductions in GAAP and non-GAAP OpEx and improved y/y EPS indicate tighter operations even as Niyad investment continues .
  • Revenue is modest and royalty-driven: With DSUVIA divested, near-term P&L relies on royalties and milestone monetization; fundamental upside hinges on Niyad clinical/regulatory progress .
  • Watch the conditional equity tranches: Additional $10M/$2M in equity depends on pivotal data and price milestones—outcomes that may influence both funding certainty and stock volatility around data releases .
  • Trading setup: Expect event-driven moves around first patient, topline, PMA submission, and any regulatory interactions; limited Street estimates may exacerbate volatility on data updates (S&P Global data unavailable).
  • Medium-term thesis: If NEPHRO CRRT demonstrates strong efficacy/safety and Niyad achieves approval, Talphera could create first-ever US-approved regional anticoagulant for dialysis circuits, addressing documented clinical gaps in CRRT .