Sign in

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

ST

SANGAMO THERAPEUTICS, INC (SGMO)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 delivered $7.6M revenue and -$0.11 EPS, missing Wall Street consensus on both metrics amid a sharp sequential decline from Q3’s Genentech-driven revenue spike; YoY revenue grew on new licenses (Astellas, Genentech) but quarterly profit stayed negative .
  • The company secured pivotal regulatory progress: FDA alignment on an Accelerated Approval pathway for Fabry (ST-920) using 52-week eGFR slope, enabling a potential BLA in 2H 2025, and IND clearance for ST-503 (Nav1.7) in chronic neuropathic pain .
  • Business development remained active: Sangamo licensed its STAC-BBB capsid to Astellas ($20M upfront; up to $1.3B milestones) and reported over $100M raised in 2024 from non-dilutive license/milestone fees plus equity; a third STAC-BBB deal is in late-stage negotiations .
  • 2025 OpEx guidance: GAAP $135–$155M; non-GAAP $125–$145M, reflecting a lean neurology focus while preparing Fabry BLA and pursuing commercialization partnership; cash runway extends into mid-Q2 2025 (inclusive of ATM proceeds and expected Pfizer payment) .
  • Stock reaction catalysts: near-term Fabry partnership timeline, third STAC-BBB license, pre-BLA activities, and ST-503 clinical start mid-2025; risks center on funding, Pfizer collaboration transition (hemophilia A), and execution of Fabry commercialization .

What Went Well and What Went Wrong

  • What Went Well

    • FDA alignment on Accelerated Approval for Fabry using 52-week eGFR slope; BLA submission targeted for 2H 2025. “I strongly believe in the potential for ST-920… delighted to have a clear regulatory pathway” – CEO .
    • IND clearance for ST-503 (Nav1.7) in idiopathic small fiber neuropathy; Phase 1/2 enrollment planned mid-2025, with preliminary efficacy read in Q4 2026 .
    • Capsid licensing momentum: Astellas deal ($20M upfront; up to $1.3B milestones and tiered royalties); negotiations advancing for a third STAC-BBB license .

  • What Went Wrong

    • Q4 2024 missed consensus: revenue $7.6M vs $11.7M*, EPS -$0.11 vs -$0.091*; sequential revenue fell sharply from Q3’s $49.4M .
    • Funding and going-concern risk remain front-and-center; cash and equivalents $41.9M at 12/31/24, with runway into mid-Q2 2025 dependent on capital raises/partnerships .
    • Collaborations ended/transitioning: Pfizer terminated hemophilia A global collaboration; SGMO regains rights and is exploring partner options, adding uncertainty/timing risk .

Financial Results

MetricQ2 2024Q3 2024Q4 2024
Revenue ($USD Millions)$0.356 $49.412 $7.551
Revenue Consensus Mean ($USD Millions)$8.26*$25.07*$11.70*
Revenue vs ConsensusMiss (−$7.90M)*Beat (+$24.34M)*Miss (−$4.15M)*
Diluted EPS ($USD)−$0.18 $0.04 −$0.11
EPS Consensus Mean ($USD)−$0.146*−$0.04*−$0.0909*
EPS vs ConsensusMiss (−$0.034)*Beat (+$0.08)*Miss (−$0.019)*
Net Loss ($USD Millions)$(36.128) $10.672 $(23.396)
GAAP Total Operating Expenses ($USD Millions)$37.440 $38.781 $33.541
Non-GAAP Operating Expenses ($USD Millions)$31.9 $34.2 $29.0
Cash & Equivalents (period-end) ($USD Millions)$27.786 $39.201 $41.918

Note: Values marked with an asterisk (*) retrieved from S&P Global.

Revenue composition (Q4 2024):

ComponentQ4 2024 Contribution
Astellas license revenue$6.5M
Genentech license revenue$0.8M
Other collaborations/licensesNet decrease offsetting above

YoY (Q4 2024 vs Q4 2023): Revenue $7.6M vs $2.0M; EPS −$0.11 vs −$0.34; net loss $23.4M vs $60.3M .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Total Operating Expenses (GAAP)FY 2025N/A~$135–$155MNew FY2025 guide
Total Operating Expenses (Non-GAAP)FY 2025N/A~$125–$145M (excludes ~$7M SBC, ~$3M D&A)New FY2025 guide
Total Operating Expenses (GAAP)FY 2024~$150–$170M ~$150–$170MMaintained in Q3/Q2 PRs
Total Operating Expenses (Non-GAAP)FY 2024~$125–$145M ~$125–$145MMaintained in Q3/Q2 PRs

Cash runway commentary: cash and equivalents of $41.9M at 12/31/24, plus $10.1M ATM raised in 2025 and expected $5.0M Pfizer payment, sufficient into mid-Q2 2025 .

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 2024)Previous Mentions (Q3 2024)Current Period (Q4 2024)Trend
Fabry regulatory pathEMA/CBER joint interactions; preliminary eGFR improvements; 17/18 off ERT FDA Accelerated Approval path using 52-week eGFR; BLA in 2H25; all 18 off ERT Reiterated FDA alignment; plan pre-BLA in summer; BLA 2H25; strong QoL and renal data Strengthening, timeline pulled in
ST-503 (Nav1.7) pain programIND-enabling; animal data; NHP tolerability IND submitted; clinic mid-2025 (pending clearance) IND cleared; Phase 1/2 enrollment mid-2025; Q4 2026 prelim efficacy Advancement to clinical start
STAC-BBB capsid BDGenentech deal validates cargo+capsid; more partners interested Additional BD in progress; capsid as funding source Astellas deal signed; third license in late-stage negotiations Momentum building
Hemophilia A (Pfizer)AFFINE met key endpoints; milestone/royalty potential Pfizer discussing data with regulators; potential 2025 BLA Collaboration terminated; SGMO regaining rights; exploring partner transition; incoming interest Transition risk, but optionality
Financing/runwayNeed non-dilutive capital; Genentech payments extend runway Runway into early Q1/Q1 2025 absent new deals Cash into mid-Q2 2025 incl. ATM and Pfizer payment; priority is Fabry BD and third capsid deal Still tight, but improving with deals

Management Commentary

  • “We have a clear regulatory pathway to Accelerated Approval in Fabry disease, which could reduce the time to potential approval by approximately three years.” – CEO .
  • “Our #1 priority continues to be addressing our financial needs… securing a commercial partner [for Fabry] is our key focus.” – CEO .
  • “We strongly believe in the potential of ST-503 to revolutionize the chronic pain landscape… enrollment and dosing in mid-2025.” – CDO .
  • “We are actively engaged in advanced contract negotiations for a third STAC-BBB license… a logical blue-chip choice.” – CEO .

Q&A Highlights

  • Fabry partnership timing and data: late-stage negotiations with multiple partners; final 52-week eGFR data soon; aim to announce as feasible; partners have seen CMC and broader datasets but not later efficacy beyond WORLD cutoff .
  • Hemophilia A transition: SGMO regaining rights; access to full Pfizer dataset; exploring direct handoff to new partner; incoming interest noted .
  • OpEx discipline: non-GAAP OpEx down nearly half YoY since 2023; FY25 OpEx designed to focus on neurology programs (Nav1.7, prion) .
  • Nav1.7 safety: no hyper/hypotension signals observed in NHP GLP studies; intrathecal delivery emphasized; Phase 1/2 design and inclusion/exclusion to be detailed on clinicaltrials.gov .
  • ST-503 efficacy expectations: plan to observe pain reduction within ~12 weeks; placebo effect likely to wane given one-time therapy; plateau in animal models at 3–4 weeks .

Estimates Context

  • Q4 2024: revenue $7.551M vs $11.70M consensus*; EPS −$0.11 vs −$0.0909 consensus* – both misses. Q3 2024: revenue $49.412M vs $25.07M consensus*; EPS $0.04 vs −$0.04 consensus* – both beats. Q2 2024: revenue $0.356M vs $8.26M consensus*; EPS −$0.18 vs −$0.146 consensus* – both misses .
  • Consensus revisions likely: near-term estimates should reflect volatility tied to licensing revenue timing (Genentech/Astellas), while OpEx guidance and Fabry BLA timeline introduce catalysts for FY25. Note: Values marked with an asterisk (*) retrieved from S&P Global.

Key Takeaways for Investors

  • Near-term stock drivers: Fabry partnership announcement, third STAC-BBB license close, pre-BLA meeting and BLA filing cadence; watch 52-week eGFR dataset release .
  • Fabry derisking: Accelerated Approval pathway and durable multi-domain data (eGFR, QoL, biomarker) support an expedited timeline; commercialization partner is critical for funding and launch .
  • Platform validation: STAC-BBB capsid deals (Genentech, Astellas) and late-stage talks indicate non-dilutive financing potential; these can smooth revenue but will be lumpy quarter to quarter .
  • Execution focus: Maintain lean OpEx while advancing ST-503 into clinic mid-2025 and preparing prion CTA in 2026; funding runway into mid-Q2 2025 underscores urgency of BD .
  • Hemophilia A optionality: Despite Pfizer termination, SGMO has rights and incoming interest; data reportedly near filing-ready, enabling potential re-partner and milestones/royalties if approved .
  • Risk management: Monitor going-concern disclosures, capital markets activity (ATM), and timing/terms of BD agreements; any slippage in Fabry or STAC-BBB deals could pressure runway .
  • Tactical idea: Position around Fabry BLA timeline and partnership newsflow; estimate updates likely to incorporate non-dilutive revenue and structured OpEx guidance.

Additional source documents referenced:

  • Q4 2024 8-K with press release and financials .
  • Q4 2024 earnings call transcript .
  • Q3 2024 press release and call .
  • Q2 2024 press release and call .
  • FDA Accelerated Approval alignment for Fabry (Oct 22, 2024) .
  • IND clearance for ST-503 (Nov 19, 2024) .
  • Astellas capsid license (Dec 19, 2024) .

Note: Values marked with an asterisk (*) retrieved from S&P Global.