PhaseBio Pharmaceuticals Inc (PHASQ)·Q4 2021 Earnings Summary

Executive Summary

• Q4 2021 delivered minimal revenue and a larger loss as PhaseBio advanced late‑stage development: sublicensing revenue was $0.158M, net loss was $43.1M (EPS: $(0.90)), and cash/cash equivalents were $41.8M .
• Clinical execution was the quarter’s highlight: interim Phase 3 REVERSE‑IT data showed immediate ticagrelor reversal and adjudicated effective hemostasis in 98.4% of eligible patients; thrombotic SAEs occurred in 5.3% with none considered related to bentracimab; results were accepted by NEJM Evidence, providing a strong regulatory narrative catalyst .
• Guidance was reiterated: BLA submission for bentracimab remains targeted for mid‑2022; PPQ manufacturing runs were completed; PB6440 IND submission remains planned for the second half of 2022 .
• Strategic reprioritization created an overhang: the company voluntarily ended the PEMZIVIPTADIL (PB1046) Phase 2b PAH trial due to COVID‑related manufacturing and enrollment impacts, reallocating resources toward bentracimab and PB6440 .
• Wall Street consensus EPS and revenue for Q4 2021 were unavailable via S&P Global, so beat/miss cannot be assessed; traders should focus on regulatory, manufacturing, and publication catalysts as the primary stock drivers [Sp&P Global data unavailable via GetEstimates].

What Went Well and What Went Wrong

What Went Well

• PPQ manufacturing for bentracimab was completed, validating commercial‑scale process consistency and positioning the company to supply global demand at launch upon approval .
• REVERSE‑IT interim Phase 3 data met primary reversal and co‑primary hemostasis endpoints with rapid onset and sustained reversal; “The emerging safety and efficacy profile of bentracimab is quite compelling,” said Deepak L. Bhatt, MD, MPH, underscoring clinical momentum and regulatory de‑risking .
• European licensing with Alfasigma provided non‑dilutive capital and future optionality: $20M upfront, up to $35M pre‑revenue regulatory milestones, up to $190M sales milestones, and double‑digit tiered royalties up to the mid‑twenties .

What Went Wrong

• Operating loss and net loss widened: Q4 loss from operations was $(32.1)M and net loss was $(43.1)M (vs. $(31.9)M in Q3), reflecting heavier other expense and sustained R&D investment .
• R&D expense rose to $27.4M on increased bentracimab clinical and production activities, depreciation of manufacturing equipment, and higher personnel costs; G&A also increased to $4.9M on higher professional services, personnel, and insurance .
• PB1046 program was voluntarily ended early due to COVID‑related manufacturing/drug supply and enrollment issues, eliminating a near‑term second clinical catalyst and reinforcing the single‑asset focus risk .

Financial Results

KPIs and Funding

Notes:

• The quarter’s small revenue was sublicensing recognition; there is no product revenue and no segment reporting .
• Balance sheet highlights include development derivative liability of $114.843M as of 12/31/2021 (reflective of the SFJ collaboration structure) and stockholders’ deficit of $(93.034)M .

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Our team continues to make notable progress in advancing our lead product candidate bentracimab… we remain focused on executing on our strategic business and clinical objectives, including preparing for the expected commercial launch of bentracimab in the U.S. and submitting an IND for PB6440…” — Jonathan Mow, CEO .
• “The emerging safety and efficacy profile of bentracimab is quite compelling… if approved, bentracimab has the potential to become an important tool in the management of patients who could benefit from ticagrelor therapy.” — Deepak L. Bhatt, MD, MPH (AHA presentation) .
• “These interim data continue to support the potential of bentracimab to help address a clear unmet need… We remain on track to submit our planned BLA… in mid‑2022.” — John Lee, MD, PhD, CMO .

Q&A Highlights

• A Q4 2021 earnings call transcript was not available in our document catalog, and we could not locate an official transcript; PhaseBio held an investor webcast associated with the AHA interim analysis on Nov. 15, 2021, but no transcript text is archived in the filings .
• No Q&A themes can be reliably extracted given the absence of a transcript.

Estimates Context

• S&P Global consensus EPS and revenue for Q4 2021 were unavailable for PHASQ via our estimates tool; as a result, we cannot assess beats/misses or consensus variance for this quarter (Values retrieved from S&P Global; unavailable mapping prevents data retrieval).
• Given the company’s pre‑revenue profile and milestone revenue recognition, future sell‑side adjustments likely center on R&D burn, CMC readiness, and regulatory timeline rather than near‑term P&L metrics .

Key Takeaways for Investors

• Bentracimab clinical risk appears reduced after REVERSE‑IT interim success and NEJM Evidence acceptance; near‑term value catalysts are regulatory (BLA submission mid‑2022) and CMC/manufacturing readiness (PPQ completed) .
• Cash of $41.8M at 12/31/21 plus expected SFJ reimbursements/funding ($28.7M) provide a bridge through regulatory milestones, but sustained R&D and other expense drove a $(43.1)M quarterly net loss—monitor runway and financing options .
• EU commercialization optionality via Alfasigma supports ex‑US strategy and could de‑risk launch execution in Europe over time .
• PB1046 program suspension reduces pipeline breadth and increases reliance on bentracimab/PB6440; watch for PB6440 IND submission in 2H 2022 for incremental optionality .
• With consensus data unavailable, trading focus should remain on publication momentum, regulatory interactions, and manufacturing milestones—any delays to mid‑2022 BLA timing or CMC findings would be material .
• Continued emphasis on enrolling bleeding patients post‑interim analysis suggests additional data flow prior to full REVERSE‑IT completion, potentially strengthening the label discussion .
• Balance sheet includes significant development derivative liability ($114.843M) tied to SFJ structure; understand its implications on future financial statements and potential milestone obligations .

Supporting Press Releases and Filings: Q4 2021 8‑K and Exhibits ; Q3 2021 8‑K and Exhibits ; Q2 2021 8‑K and Exhibits ; PB1046 program update .