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TI

TALPHERA, INC. (ACRX)·Q1 2024 Earnings Summary

Executive Summary

  • Q1 2024 was a transition quarter: no revenue reported in continuing operations, operating expenses declined year over year, and diluted EPS was $(0.16) as the company focused resources on NEPHRO (Niyad) trial initiation .
  • NEPHRO enrollment slipped to Q2 2024 and management withdrew prior top-line data timing (previously “by September 30, 2024”), saying updated timelines will be provided after enrollment begins—an explicit guidance revision and a near-term stock catalyst once enrollment is announced .
  • Liquidity improved sequentially with cash and investments of $18.6M (from $9.4M at year-end), aided by $8M monetization of DSUVIA receivables and $6M first-tranche equity; however, the 10-Q includes a going-concern warning, signaling the need for additional capital within 12 months absent further financing or milestones .
  • S&P Global consensus estimates for Q1 2024 revenue and EPS were unavailable via our feed; accordingly, we cannot provide a vs-consensus comparison for this quarter (see Estimates Context) [Functions GetEstimates error; TLPH request limit exceeded].

What Went Well and What Went Wrong

What Went Well

  • Reduced operating spend: Combined R&D+SG&A fell to $4.2M vs $5.3M YoY; non-GAAP operating expenses (ex-stock comp) were $3.9M vs $4.8M YoY, reflecting headcount reductions post-DSUVIA divestiture .
  • Strengthened liquidity: Cash, cash equivalents and investments rose to $18.6M at March 31, 2024 (from $9.4M at Dec 31, 2023), boosted by $8.0M XOMA monetization and a $6.0M equity tranche closing in January .
  • Portfolio/leadership progress: NEPHRO CRRT has central IRB approval and contracts finalized at five academic centers; Dr. Shakil Aslam (renal diseases) joined as CDO to bolster nephrology expertise .
    • “We are eager to have the first patient enrolled in the NEPHRO study so we can complete this pivotal trial and demonstrate the efficacy and safety of this unique anticoagulant.” — Vince Angotti, CEO .

What Went Wrong

  • Clinical timeline slippage and guidance withdrawn: Initial site activation “took longer than expected”; first patients now expected in Q2 2024 and prior top-line data timing (by Sept 30, 2024) will be revised—injecting timeline risk .
  • Going concern highlighted: Management noted substantial doubt about the company’s ability to continue as a going concern without additional capital within 12 months, underscoring financing dependency .
  • Earnings optics: No revenue recognized in continuing ops and diluted EPS of $(0.16); change in fair value of warrant liability (non-cash) negatively impacted the quarter .

Financial Results

MetricQ3 2023Q4 2023Q1 2024
Revenue ($USD Millions)$0.117 $0.281 $0.000 (no revenues reported in continuing ops)
R&D Expense ($USD Millions)$1.178 $1.769 $1.433
SG&A Expense ($USD Millions)$2.248 $2.795 $2.804
Total Operating Expenses ($USD Millions)$3.426 $4.564 $4.237
Loss from Operations ($USD Millions)$(3.309) $(4.283) $(4.237)
Net (Loss) from Continuing Ops ($USD Millions)$(1.418) $(4.505) $(3.954)
Diluted EPS ($USD)$(0.08) $(0.25) $(0.16)
Shares Used (Millions)16.758 18.369 24.722

Balance sheet snapshot:

MetricDec 31, 2023Mar 31, 2024
Cash, Cash Equivalents and Investments ($USD Millions)$9.381 $18.584
Total Assets ($USD Millions)$20.395 $28.772
Total Liabilities ($USD Millions)$6.290 $12.438
Total Stockholders’ Equity ($USD Millions)$14.105 $16.334

Non-GAAP and other KPIs:

KPIQ1 2023Q1 2024
Operating Expenses (non-GAAP: OpEx less stock-based comp) ($USD Millions)$4.778 $3.935
Cash Operating Expenses commentary (FY 2024)—Management indicated FY24 cash OpEx expected toward the low-to-mid end of $21–$23M range (call)

Notes: DSUVIA-related revenues in 2023 periods are presented within continuing operations post-divestiture as disclosed; Q1 2024 recognized no revenue in continuing operations .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent Guidance (Q1 2024)Change
NEPHRO enrollment start2024Start “this quarter” (Q4: expected Q1 2024) First patients expected to be enrolled in Q2 2024 Delayed
NEPHRO top-line timing2024Top-line data “by September 30, 2024” (stated prior) Previous guidance will be revised; updated timeline to be provided after enrollment begins Withdrawn/revised (timing under review)
PMA submission for Niyad2024PMA submission projected by end of 2024 Plan to submit PMA upon trial completion; timeline to be updated post-enrollment Under review (not reaffirmed)
FY 2024 cash operating expenses2024Not quantified in Q4 press release Expected low-to-mid end of $21–$23M (call) New detail from call

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2023, Q4 2023)Current Period (Q1 2024)Trend
NEPHRO (Niyad) enrollment and timelineIDE and central IRB approvals; start this quarter (Q3’23), first patient enrollment expected Q1’24; PMA planned by end-2024 First patients now expected Q2’24; prior top-line by 9/30/24 to be revised; updated completion date after enrollment begins Slipped timeline; guidance under review
Financing/runwayQ4: $9.4M YE cash; January 2024 $26M commitments; runway projected to potential Niyad approval in H1/Q2’25 Cash/investments $18.6M; $8M XOMA monetization; $6M equity; but going-concern disclosed—more capital needed within 12 months Liquidity up but higher financing risk
Regulatory path (PMA)PMA targeted by end-2024 PMA “upon trial completion”; timeline contingent on enrollment/completion Timing less specific
Market opportunityCRRT market engagement; KOL events (Dec’23) Call Q&A discussed ~165k CRRT patients and ~$100M peak sales potential for CRRT use case (management commentary) Reiterated
Operating spend outlookCost reductions post-DSUVIA, OpEx declines YoY FY24 cash OpEx guided to low–mid $21–$23M (call) More specific
Supply chain/manufacturingGeneral supply chain and single-source risk noted Risks reiterated in 10-Q; no acute disruptions disclosed Stable; caution maintained

Management Commentary

  • “We are eager to have the first patient enrolled in the NEPHRO study… While the initial site activation has taken longer than expected… we expect the trial will complete quickly given the primary endpoint is measured at 24 hours… we expect that our previous guidance of having top-line data available by September 30 will be revised.” — Vince Angotti, CEO (press release) .
  • Leadership additions: “The addition of Dr. Aslam… will provide significant nephrology expertise to the team and further support the development and commercial preparation of Niyad.” — Vince Angotti, CEO .
  • Spend discipline and FY24 outlook: Management indicated FY24 cash operating expenses are expected at the low-to-mid end of $21–$23M (earnings call) .

Q&A Highlights

  • Timeline and data: Management acknowledged delays in initial enrollment and indicated better timing specificity would follow next quarter; investors probed whether top-line could still be achieved in 2024 (company deferred until after enrollment starts) .
  • Market sizing and adoption: Discussion of ~165k CRRT patients in the U.S. and potential ~$100M peak sales in CRRT, with positioning vs. citrate/heparin based on safety/simplicity .
  • Economics and spend: Analysts asked about Niyad cost positioning vs citrate and the OpEx ramp as the trial progresses; management reiterated FY24 cash OpEx expectations (low-to-mid $21–$23M) .

Estimates Context

  • S&P Global consensus for Q1 2024 EPS and revenue was unavailable through our feed for Talphera (TLPH) at the time of analysis; therefore, we cannot present a vs-consensus comparison for the quarter. We attempted retrieval via ACRX/TLPH but were blocked by mapping/limit errors (tool errors documented). Where estimates are cited in future periods, we will default to S&P Global data and annotate accordingly.

Key Takeaways for Investors

  • Near-term catalyst: NEPHRO enrollment start (expected Q2 2024) and subsequent updated guidance for top-line timing—these events will likely drive the stock near term .
  • Timeline risk now elevated: Prior top-line guidance was withdrawn; PMA timing is now contingent on actual enrollment/throughput—expect heightened sensitivity to operational updates .
  • Liquidity improved but financing risk remains: Despite $18.6M cash/investments and recent monetization/equity proceeds, the going-concern disclosure signals additional capital will be needed within 12 months absent new funding or milestone receipts .
  • Cost discipline provides runway extension: Non-GAAP OpEx fell YoY; management signaled FY24 cash OpEx at the low-to-mid end of $21–$23M, implying continued spend control while trial activity ramps .
  • Strategic focus on Niyad remains intact: Regulatory path (IDE, Breakthrough Device) and KOL engagement continue to support the lead indication; leadership additions strengthen clinical execution capabilities .
  • Optionality from DSUVIA monetization structure: The XOMA agreement front-loaded cash but retains potential future economics post-threshold; not a near-term revenue driver, but could re-rate if DoD sales/milestones accelerate .
  • Risk-reward: Shares are likely to be event-driven around trial operations and funding. Execution on site activation/enrollment can reset timelines positively; delays or financing overhang could pressure the stock .

Sources:

  • Q1 2024 8-K and press release with financial tables and corporate update .
  • Q1 2024 10-Q for detailed financials, liquidity, going concern, and program updates .
  • Q4 2023 and Q3 2023 8-Ks for trend analysis .
  • Earnings call transcript summaries and Q&A highlights (external) .