Sign in

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

AI

ATHERSYS, INC / NEW (ATHX)·Q1 2022 Earnings Summary

Executive Summary

  • Revenues of $2.9M, driven by Healios collaboration services, contrasted with no revenue in Q1 2021; GAAP net loss was $(22.2)M and diluted EPS $(0.09), with operating cash burn of $20.2M .
  • No earnings call was held for Q1; management deferred the call to follow the imminent release of topline TREASURE stroke data from Healios in May, positioning the stock’s near-term catalyst squarely around clinical results rather than quarterly financials .
  • R&D spending rose to $20.9M (+$3.4M YoY) on clinical trial and bioreactor process work; G&A fell to $4.1M (from $8.8M in Q1 2021) due to prior-year legal/separation costs, improving opex mix but leaving losses elevated .
  • Liquidity tightened: cash fell to $21.8M (from $37.4M at year-end), and stockholders’ equity dropped to $0.3M at March 31, 2022 (from $16.4M at December 31, 2021), underscoring capital needs and going-concern risk highlighted in forward-looking statements .
  • Strategic progress: FDA approval to use bioreactor-manufactured MultiStem in ARDS/trauma trials and strengthened Healios collaboration; TREASURE one-year follow-up completed, with topline data expected in May .

What Went Well and What Went Wrong

What Went Well

  • FDA approved use of bioreactor-manufactured MultiStem in MACOVIA and MATRICS studies, a key scale/cost milestone supporting potential commercialization; management emphasized the competitive advantage of large-scale 3D manufacturing .
  • TREASURE (ischemic stroke) reached one-year completion for the last patient, enabling data lock and topline disclosure in May; management planned an investor call immediately after the data release .
  • New CEO Dan Camardo communicated confidence in strategy and execution: “With thoughtful and timely execution, we will be well-positioned to meet our long-term goals” .

What Went Wrong

  • Cash burn increased (operating cash use $20.2M vs $17.1M in Q1 2021) and cash on hand declined to $21.8M, intensifying funding pressure .
  • Stockholders’ equity collapsed to $0.3M at quarter-end (from $16.4M at YE’21), reflecting liabilities growth and limited assets, elevating balance sheet and compliance risks .
  • R&D expenses rose to $20.9M on clinical/manufacturing costs; while strategically necessary, the rise contributed to sustained net losses (Q1 net loss $(22.2)M) .

Financial Results

MetricQ1 2021Q3 2021Q4 2021Q1 2022
Revenue ($USD Millions)$0.0 $4.792 $0.722 $2.912
Net Loss ($USD Millions)$(26.468) $(16.177) $(21.711) $(22.216)
Diluted EPS ($USD)$(0.13) $(0.07) $(0.09) $(0.09)
R&D Expense ($USD Millions)$17.508 $17.162 $18.719 $20.944
G&A Expense ($USD Millions)$8.837 $3.632 $3.438 $4.099
Weighted Avg Shares (Millions)208.192 229.218 236.882 244.197

Balance Sheet Snapshot

MetricQ4 2021Q1 2022
Cash and Equivalents ($USD Millions)$37.407 $21.797
Accounts Receivable from Healios ($USD Millions)$4.414 $4.643
Deferred Revenue - Healios ($USD Millions)$3.340 $2.202
Operating Lease Liabilities ($USD Millions)$9.766 $9.519
Total Stockholders’ Equity ($USD Millions)$16.369 $0.307

Operating Cash Flow KPIs

MetricQ1 2021Q1 2022
Net Cash Used in Operating Activities ($USD Millions)$17.1 $20.2

Notes:

  • No gross margin or segment revenue breakdowns are applicable; revenues derive from Healios collaboration, not product sales .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Company financial guidanceFY/Q2 2022None provided None provided; Q1 call deferred until TREASURE topline Maintained (no guidance)
Event timing (TREASURE topline)May 2022Data expected Q2’22 Topline data in May; investor call to follow Clarified timing

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2021)Previous Mentions (Q4 2021)Current Period (Q1 2022)Trend
Bioreactor manufacturing scale-upProgress toward commercial manufacturing capability Tech transfer of second-gen large-scale bioreactor to CMO FDA approved use of bioreactor-made product in MACOVIA/MATRICS; patent filed on process Positive acceleration in manufacturing readiness
Ischemic stroke (MASTERS-2/TREASURE)TREASURE enrollment complete; data to follow one-year visit in Mar’22; steady MASTERS-2 progress Aiming to finish MASTERS-2 enrollment by end of 2022 or as soon as possible TREASURE one-year follow-up complete; topline May; MASTERS-2 enrolling in US/EU/Asia, sites initiated Near-term TREASURE catalyst; continued Phase 3 enrollment
ARDS programONE-BRIDGE topline positive; pooled analyses with MUST-ARDS show benefit trends Supporting Healios’ potential PMDA submission; MUST-ARDS publication Bioreactor product approved for ARDS trials; MACOVIA ongoing Steady regulatory/clinical advancement
Partnerships/Healios collaborationRelationship realigned with Healios; commercialization prep in Japan New Cooperation and Manufacturing Framework Agreements Strengthening partnership; planning commercialization supply for Japan Strengthened collaboration framework
Regulatory planning (pediatrics)Deferral agreements in pediatric plan noted Pediatric plan deferral agreement reaffirmed Pediatric development plan agreements with FDA/EMA for stroke Continued alignment with regulators

Management Commentary

  • CEO Dan Camardo: “I’m confident that we have the right strategy in place. With thoughtful and timely execution, we will be well-positioned to meet our long-term goals.”
  • CSO Dr. John Harrington: “Receiving FDA approval to use the bioreactor manufactured product gives us confidence as we further scale our third-generation bioreactor manufacturing process… This represents a significant competitive advantage in the cell therapy field.”
  • President/COO B.J. Lehmann (prior quarter context): highlighted “positive topline data for… ARDS” and completion of TREASURE enrollment as milestones toward potential commercialization .
  • Q1 positioning: “Athersys will host its next investor conference call after the data are released” for TREASURE, emphasizing data-dependent communications cadence .

Q&A Highlights

  • No Q1 2022 earnings call or Q&A session was held; management deferred the call to immediately follow TREASURE topline data release in May for detailed discussion .

Estimates Context

  • Wall Street consensus (S&P Global) for Q1 2022 revenue and EPS was unavailable for ATHX at the time of analysis; therefore, no estimate comparison is provided.
  • As a result, no beat/miss analysis versus consensus can be presented; focus remains on operational progress and near-term clinical catalysts .

Key Takeaways for Investors

  • Liquidity and equity compression are acute: cash declined to $21.8M and equity to $0.3M, implying near-term financing needs and heightened going-concern/compliance risks; monitor funding actions closely .
  • The near-term stock catalyst is TREASURE ischemic stroke topline data in May; management’s communications and next call hinge on this event—expect volatility around readout .
  • Manufacturing scale-up de-risks commercialization readiness: FDA-cleared bioreactor product use, patent filing, and CMO tech transfer provide a path to lower COGS and scalable supply, a potential competitive edge if efficacy/regulatory outcomes are positive .
  • ARDS program remains a strategic pillar with supportive pooled data and ongoing trials; Japan’s regulatory path via Healios could offer an early regional commercialization route .
  • Operating discipline mixed: G&A normalized post prior-year one-time costs, but R&D elevated with clinical/manufacturing spend, maintaining sizable losses; cash burn accelerated YoY .
  • Without guidance or consensus estimates, frame positioning through clinical/regulatory milestones rather than quarterly financials; TREASURE/MASTERS-2 trajectory will shape medium-term value creation .
  • Risk disclosures explicitly flag capital access and Nasdaq bid-price compliance; traders should account for financing and compliance headlines alongside clinical data flows .