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PROTHENA CORP PUBLIC LTD CO (PRTA)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 was a relatively quiet financial quarter ahead of multiple 2025 readouts: revenue was $2.1M, net loss was $58.0M ($1.08 per share), and quarter-end cash and restricted cash stood at $472.2M with no debt .
  • 2025 cash burn guidance was set at $168–$175M with an expected year-end cash balance of ~$301M (midpoint), and estimated net loss of $197–$205M (includes ~$41M SBC), positioning the company to fund key milestones, notably birtamimab Phase 3 AFFIRM-AL topline in 2Q25 and PRX012 Phase 1 readouts starting mid-2025 .
  • Narrative and call tone emphasize birtamimab’s potential to address early mortality in Mayo Stage IV AL amyloidosis under an FDA SPA (success at p≤0.10) and to drive the transition to a fully integrated commercial biotech if positive; management reiterated a potential U.S. launch by 2H 2026 on success .
  • Strategic updates include BMS’s $80M global license for PRX019 and the BMS-led Phase 2 TargetTau-1 for BMS-986446 (formerly PRX005); Roche’s Phase 2b PADOVA in early Parkinson’s narrowly missed the primary endpoint but showed consistent positive trends, with next steps to be determined with health authorities .

What Went Well and What Went Wrong

What Went Well

  • Clear 2025 clinical catalysts: AFFIRM-AL topline (2Q25) and PRX012 Phase 1 updates starting mid-2025, with management framing 2025 as “transformative” and indicating a path to BLA submission and potential U.S. launch by 2H 2026 if AFFIRM-AL is positive at p≤0.10 .
  • Strengthened external validation and optionality: BMS paid $80M for PRX019 global rights; Prothena initiated a Phase 1 trial and remains eligible for up to $617.5M in milestones plus tiered royalties .
  • Parkinson’s program signals (prasinezumab): despite missing the primary endpoint, PADOVA showed a hazard ratio of 0.84 (p=0.0657), stronger signals in levodopa subgroup, and consistent positive trends across secondary/exploratory endpoints, supporting continued development discussions with regulators .

Management quotes:

  • “We expect 2025 to be a transformative year for Prothena... topline data next quarter from the confirmatory Phase 3 AFFIRM-AL... at a statistical significance level of 0.10” — Gene Kinney, CEO .
  • “With positive Phase III results for birtamimab, we expect to launch in the U.S. by the second half of 2026” — Brandon Smith, COO .

What Went Wrong

  • Minimal operating revenue and ongoing losses: Q4 revenue was $2.1M, net loss $58.0M (EPS $(1.08)); sequential and YoY results reflect a biotech profile with limited recurring revenue (excluding Q2’s one-time-heavy revenue) .
  • R&D intensity remains high: Q4 R&D of $50.2M (Q4 2023: $61.9M) and FY R&D of $222.5M (FY 2023: $220.6M); the full-year increase driven by higher clinical and personnel costs, underscoring continued cash utilization .
  • Prasinezumab’s PADOVA missed its primary endpoint (despite positive trends); Roche must confer with health authorities regarding next steps, introducing execution/timing uncertainty for this partnered asset .

Financial Results

Quarterly P&L and Cash (GAAP)

Metric (USD, 000s)Q4 2023Q2 2024Q3 2024Q4 2024
Total Revenue316 132,014 970 2,123
Research & Development Expense61,891 57,510 50,723 50,172
General & Administrative Expense16,940 16,127 16,760 16,848
Total Operating Expenses78,831 73,637 67,483 67,020
Loss from Operations(78,515) 58,377 (66,513) (64,897)
Other Income, net7,897 6,470 6,677 5,396
Benefit from Income Taxes(3,142) (2,039) (835) (1,545)
Net Income (Loss)(67,476) 66,886 (59,001) (57,956)
Diluted EPS(1.26) 1.22 (1.10) (1.08)
Net Cash from (used in) Op & Inv Activities—15,800 provided (45,200) used (47,800) used
Cash & Restricted Cash (period-end)—565,000 520,100 472,200

Notes:

  • Q2 2024 revenue was driven by collaboration revenue from BMS, reflecting the PRX019 global license; FY commentary attributes 2024 revenue primarily to PRX019 license and related development services plus lapse of certain material rights, vs. 2023 revenue primarily from BMS’s PRX005 option exercise .

Full-Year Comparison

Metric (USD, 000s)FY 2023FY 2024
Total Revenue91,370 135,157
Research & Development Expense220,571 222,519
General & Administrative Expense61,835 67,199
Total Operating Expenses282,406 289,718
Other Income, net30,556 25,631
Benefit from Income Taxes(13,452) (6,620)
Net Loss(147,028) (122,310)
Diluted EPS(2.76) (2.27)
Cash & Cash Equivalents (12/31)618,830 471,388
Restricted Cash (12/31)2,212 (current+non-current) 860 (non-current)

KPI commentary:

  • Q4 R&D down YoY on lower clinical and manufacturing/other R&D; FY R&D up slightly YoY on higher clinical and personnel costs, partially offset by lower manufacturing/other R&D .
  • Q4/FY G&A up YoY primarily on higher personnel-related expenses .
  • Year-end 2024 cash, cash equivalents and restricted cash were $472.2M; no debt; ~53.8M ordinary shares outstanding (as of Feb 13, 2025) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Net cash used in operating and investing activitiesFY 2025—$168–$175M New
Year-end cash, cash equivalents & restricted cashFY 2025—~$301M (midpoint) New
Net lossFY 2025—$197–$205M (incl. ~$41M SBC) New
Share-based compensation (non-cash)FY 2025—~$41M New

Note: Q3 2024 press release addressed FY 2024 guidance, not FY 2025; the above 2025 framework is newly provided with Q4/FY 2024 results .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q-2 and Q-1)Current Period (Q4 2024)Trend
Birtamimab AFFIRM-AL timing and SPATopline expected between 4Q24–2Q25; SPA with success at p≤0.10 ; Q3 reiterated 1H25 timing Topline expected 2Q25; success threshold p≤0.10 reiterated; if positive, BLA and potential U.S. launch by 2H26 Stable timing; increased commercialization detail
PRX012 (Alzheimer’s)Phase 1 ASCENT ongoing; multiple readouts starting mid-2025 and throughout the year Initial readouts mid-2025 from ASCENT-2 “A” cohorts (~225 pts); additional updates possible later in 2025; emphasis on monthly SC, at-home burden reduction Execution progressing; clearer dataset cadence
PRX123 (dual Aβ/tau vaccine)IND cleared; Fast Track; Phase 1 plan update expected in 2024/2025 Plans to update Phase 1 in 2025; external tau signals (e.g., MTBR) bolster conviction Continued optionality; timing update reiterated
Prasinezumab (PD, Roche)PADOVA topline expected 2H/4Q24 PADOVA narrowly missed primary (HR 0.84; p=0.0657) with positive trends; levodopa subgroup HR 0.79, p=0.0431; next steps with regulators Mixed but supportive for continued eval
Coramitug (ATTR-CM, Novo)Phase 2 in ~99 pts; topline 1H25 Trial completion 1H25; announcement and next steps expected 2H25 Timeline refined
PRX019 (BMS)BMS global license $80M; Phase 1 initiation by YE24 $80M received; Phase 1 initiated; eligible for up to $617.5M milestones and tiered royalties; Phase 1 completion expected 2026 Partnership deepening; execution on plan
Cash/OpEx2024 net cash use expected $148–$160M; YE cash ~$468M (midpoint) 2025 net cash use $168–$175M; YE cash ~$301M (midpoint) Burn increases with clinical execution

Management Commentary

  • Strategic focus: “We expect 2025 to be a transformative year... topline data next quarter from the confirmatory Phase 3 AFFIRM-AL... and multiple clinical readouts starting mid-2025... for PRX012” — Gene Kinney, CEO .
  • Commercial vision: “With positive Phase III results for birtamimab, we expect to launch in the U.S. by the second half of 2026… a very attractive commercial opportunity” — Brandon Smith, COO .
  • Financial posture: “Net cash used in operating and investing activities of $150.3M [2024]… Year-end cash $472.2M… 2025 net cash used of $168–$175M; YE cash ~$301M midpoint” — Tran Nguyen, CFO & CSO .

Q&A Highlights

  • AFFIRM-AL expectations and success criteria: Management reiterated SPA-defined success at p≤0.10 on all-cause mortality; success would underpin BLA plans and potential U.S. launch by 2H26; the control arm behavior is expected to resemble VITAL (median survival ~8.3 months in Stage IV) .
  • Treatment landscape and market sizing: Management estimates ~16,000 diagnosed and treated AL amyloidosis patients in the U.S. (~13,000 with cardiac involvement), with ~5,000 Mayo Stage IV; >20,000 Mayo Stage IV across major global markets, supporting a multi-billion-dollar global peak opportunity if approved .
  • Daratumumab backdrop: ~80% of AFFIRM-AL participants are on daratumumab; ANDROMEDA curves suggest limited impact on early mortality in first ~15 months, supporting birtamimab’s differentiated mechanism aimed at early survival benefit .
  • PRX012 dataset cadence: Initial results around mid-year 2025 (ASCENT-2 “A” cohorts), with potential additional data (APOE4 homozygous “B” cohorts; OLE data) through 2025; program designed for monthly SC, at-home administration to reduce treatment burden .

Estimates Context

  • Wall Street consensus (S&P Global) for Q4 2024 revenue and EPS was unavailable at the time of analysis due to data access limits; as a result, we cannot determine beats/misses versus consensus. We will update estimate comparisons once S&P Global consensus can be retrieved.

Key Takeaways for Investors

  • Binary catalyst in 2Q25: AFFIRM-AL topline (p≤0.10 SPA) is the critical near-term driver; a positive readout could unlock a U.S. launch in 2H26 and reset Prothena’s commercial profile .
  • Diversified pipeline with partnered validation: BMS’s $80M PRX019 license and ongoing BMS-986446 Phase 2, plus Roche’s continued prasinezumab engagement, add depth and validate targets beyond birtamimab .
  • Cash runway aligned to milestones: YE 2024 cash and restricted cash of $472.2M, no debt, and 2025 YE cash guided to ~$301M support execution through key 2025 events without near-term financing signals in disclosures .
  • R&D cadence and OpEx: Elevated spend will persist with multiple clinical programs; investors should expect burn to increase in 2025 per guidance as data sets mature .
  • Alzheimer’s optionality: PRX012 aims to combine risk/benefit parity with reduced treatment burden (monthly SC, at-home), potentially addressing a key barrier to broad uptake if later-stage efficacy is competitive .
  • Parkinson’s risk/reward: PADOVA’s near-miss with supportive signals could still translate to a viable regulatory path pending Roche’s discussions; however, visibility on timing and design of next steps remains limited .
  • Trading setup: The stock is likely to trade on AFFIRM-AL probability-of-success into 2Q25; positioning may also reflect mid-2025 PRX012 readout cadence and updates from Novo (coramitug) in 2H25 .