BioCardia, Inc. (BCDA)·Q4 2024 Earnings Summary

Executive Summary

• Q4 2024 was primarily a clinical/regulatory catalyst quarter: BioCardia presented two-year CardiAMP HF data with strong Tier 1 and Tier 2 benefits (mortality and MACE reductions), though the composite primary endpoint was not met due to 6-minute walk outcomes; management emphasized significance in the NT‑proBNP-elevated subgroup and plans FDA/PMDA consultations .
• Financially, Q4 revenue was $0 while net loss increased sequentially to $2.296M (derived from FY and 9M), reflecting continued operating investment into programs despite lower quarterly activity .
• Management guided to modest R&D increases and moderate cash burn growth in 2025, with SG&A near 2024 levels, and expects “significant news flow” from CardiAMP HF II site activations and enrollment .
• Versus Wall Street consensus, Q4 revenue missed (consensus $22,500 vs actual $0) while EPS beat (consensus -$0.625 vs actual -$0.25), with the ACC late-breaking presentation and regulatory pathway in Japan as key stock-reaction catalysts—management noted market response was “a bit of a surprise” despite data aligning with prior expectations .

What Went Well and What Went Wrong

What Went Well

• CardiAMP HF two-year data showed a 47% relative risk reduction in heart death equivalents and 16% reduction in major adverse cardiac events; quality of life improved meaningfully and six-minute walk improved modestly, with stronger statistical significance in NT‑proBNP-elevated patients (p=0.02 using QoL as Tier 3) .
• Management reported signals of reduced arrhythmias and improved cardiac remodeling trends (LVEF and reduced volumes), supporting safety and potential efficacy in a high-need population; FDA Breakthrough Device designation provides a constructive regulatory context .
• PMDA invited the next consultation after submission of two-year data and indicated openness to sufficiency of CardiAMP HF and prior trials for registration; management views this as a potential pathway to Japanese approval without new local trials .
  • “This data readout has potential to significantly de-risk development… and may serve as the primary evidence to support product registration for market release.” — CEO Peter Altman .

What Went Wrong

• The composite primary endpoint was not met due to Tier 3 six-minute walk outcomes across the full trial population, although quality of life trends were favorable; management highlighted this non-success in Tier 3 as the offset .
• Q4 revenue was $0 and quarterly net loss increased sequentially to $2.296M despite year-over-year expense reductions, underscoring ongoing reliance on external financing and disciplined cash management amid low near-term commercialization revenue .
• Limited near-term revenue expected from Morph DNA and partnering activities; management acknowledged no significant revenue visibility yet, emphasizing clinical, regulatory, and partnering milestones over immediate monetization .

Financial Results

Quarterly P&L and Operating Metrics

Note: Q4 2024 values are calculated as FY 2024 minus 9M 2024 where applicable.

Cash and Balance Sheet Trend

Full-Year YoY (Context)

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• Strategic focus: Advance CardiAMP HF with strong two-year data signals, align with FDA/PMDA, and drive HF II enrollment; leverage Morph DNA and Helix platforms for optional strategic monetization and partnerships .
• “We have long known that this trial would not meet its primary endpoint… and are delighted that the two-year outcomes are so strong across all patients and reach statistical significance in NT‑proBNP-elevated patients.” — Peter Altman .
• “The CardiAMP HF2 trial is active… we expect significant news flow ahead as we progress in this study in parallel to ongoing regulatory discussions.” — Peter Altman .
• CFO: “Total expense decreased 35% YoY… R&D down 43%… SG&A down 16%… We expect cash burn will increase moderately in 2025… SG&A to remain close to 2024 levels.” — David McClung .

Q&A Highlights

• Regulatory pathway: PMDA timeline contingent on compiling a robust 2-year data package; possibility of conditional or full approval discussed; FDA meeting anticipated with potential creative approaches given Breakthrough status .
• Trial design and enrollment: HF II uses composite endpoint with QoL in Tier 3 and elevated NT‑proBNP inclusion; protocol allows personalized dosing to improve eligibility; management expects faster enrollment leveraging best-performing sites .
• Efficacy durability: Discussion emphasized robust Tier 1 and Tier 2 signals at two years; management will detail survival and MACE statistics in manuscripts; arrhythmia reduction noted .
• Commercial strategy: Morph DNA open for business, physician usage first; evaluating distribution vs divestiture; Helix delivery partnerships continue, but near-term revenue minimal .

Estimates Context

Values retrieved from S&P Global.*
Q4 2024 vs consensus: Revenue missed materially; EPS beat relative to consensus (less negative than expected). The revenue miss reflects limited near-term commercialization and partnering revenue, while the EPS beat likely reflects lower operating expenses and modest other income vs expectations .

Key Takeaways for Investors

• CardiAMP HF two-year data strengthens the clinical narrative in NT‑proBNP-elevated patients; expect near-term regulatory engagement with FDA/PMDA and potential pathways to Japanese approval without local trials .
• Near-term trading catalyst: Manuscripts and further regulatory updates; HF II site activation and initial enrollment momentum should be monitored closely for operational execution .
• Financial profile: Q4 revenue $0 and net loss widened sequentially; 2024 expenses reduced YoY, but 2025 burn guided modestly higher—watch funding runway and potential non-dilutive options from Morph DNA monetization/partnerships .
• Morph DNA: FDA-cleared device family now commercially available; while not a near-term revenue engine, it offers strategic optionality (distribution or divestiture) to support core therapeutics .
• Competitive context: Peer MSC approvals/conditional approvals could lift interest in BioCardia’s CardiALLO program and partnering discussions; DSMB low-dose cohort review is an upcoming safety milestone .
• Risk framework: Primary endpoint miss underscores dependence on subgroup definition and composite endpoint selection; execution risk in HF II enrollment and funding remains central to the medium-term thesis .
• Estimate path: Consensus likely revisits revenue assumptions down and EPS loss assumptions modestly, calibrating for expense discipline and lack of near-term product revenue; track revisions around HF II progress and regulatory milestones (S&P Global data).*

Appendix: Source Highlights

• Q4 2024 8-K 2.02 earnings press release and exhibit 99.1 with FY 2024 financials and business updates .
• Q4 2024 earnings call transcript (03/31/2025) — full transcript, clinical results discussion, CFO commentary, and Q&A .
• Prior quarters: Q3 2024 8-K and call (11/13/2024); Q2 2024 8-K and call (08/13/2024) .
• Additional Q4-period press releases (PMDA consultation; Morph DNA commercial availability) .