PhaseBio Pharmaceuticals Inc (PHASQ)·Q1 2022 Earnings Summary

Executive Summary

• Q1 2022 focused on regulatory and manufacturing execution for bentracimab: successful Type B pre-BLA meeting aligned on including 25–30 uncontrolled bleeds plus the fully completed surgical cohort; BLA submission targeted for early Q4 2022, pushing from prior “mid-2022” timing .
• Financials improved versus prior year: net loss narrowed to $11.1M and EPS to $(0.23), with R&D down to $14.3M as 2021 manufacturing and trial start-up costs rolled off; cash fell to $18.7M reflecting operating use .
• Manufacturing readiness advanced: PPQ campaign completed, demonstrating commercial-scale consistency; supports supply at launch, contingent on approval .
• Clinical momentum: full Phase 2b results presented at ACC.22 showed immediate and sustained ticagrelor reversal with significant efficacy across assays; primary endpoint achieved .
• Key catalysts: pre-BLA alignment and PPQ completion are positives; timeline shift for BLA submission into early Q4 2022 is a negative surprise versus prior guidance, increasing near-term regulatory path visibility while extending the timeline .

What Went Well and What Went Wrong

What Went Well

• “Successful Type B pre-BLA meeting” with FDA; plan deemed “appeared reasonable” to submit with 25–30 uncontrolled bleeding patients plus completed surgical cohort; consideration of separating indications for accelerated approval if data support only one .
• Completed PPQ manufacturing campaign with multiple commercial-scale runs validating consistency; positions PhaseBio to meet global demand post-approval .
• Positive Phase 2b results: bentracimab “significantly restored platelet function within five minutes” with tight assay correlation; safety consistent with prior studies .
• Management quote: “The first quarter of 2022 was a period of significant momentum… positions us to submit our BLA early in the fourth quarter of this year” — Jonathan Mow, CEO .

What Went Wrong

• Cash and cash equivalents declined to $18.7M from $41.8M at year-end, driven by operating cash usage, compressing runway ahead of the planned BLA filing .
• BLA timing shifted from “mid-2022” (Q4 2021 update) to “early Q4 2022,” extending regulatory timelines and potentially delaying commercialization .
• Revenue remains de minimis ($0.117M sublicense), with continued operating losses despite y/y improvement; other expense rose to $7.1M, impacting net loss cadence .

Financial Results

Notes:

• Margin metrics (Gross/EBITDA/Net margin) are not applicable given de minimis revenue and lack of disclosed margin line items; company reports operating loss and net loss, not gross profit or EBITDA .

Segment breakdown: Not applicable (pre-commercial; no revenue segments disclosed) .

KPIs

Guidance Changes

Earnings Call Themes & Trends

Management Commentary

• “Our progress was driven primarily by the successful completion of a Type B pre-BLA meeting with the FDA, which positions us to submit our BLA early in the fourth quarter of this year.” — Jonathan Mow, CEO .
• FDA “agreed that the company’s plans to submit a BLA with data from 25–30 patients with uncontrolled bleeding, together with data from the fully completed surgical cohort, appeared reasonable” (final label subject to review) .
• PPQ completion “positions PhaseBio to be ready to supply global demand for bentracimab at launch, once approved” .
• Phase 2b “significantly restored platelet function within five minutes,” with reversal “tightly correlated across all assays” .

Q&A Highlights

• No earnings call transcript was available in the document set; the quarter’s narrative is sourced from the 8-K press release and corporate presentation exhibits .

Estimates Context

• Wall Street consensus (S&P Global) for Q1 2022 EPS and revenue was unavailable for PHASQ due to missing S&P Global CIQ mapping; we searched but could not retrieve estimates. As a result, comparison to consensus cannot be provided at this time. Values would be retrieved from S&P Global if available.*

Key Takeaways for Investors

• Regulatory alignment improved: FDA’s pre-BLA feedback clarifies the initial label strategy and provides a path to accelerated approval for one or both indications, increasing probability of a filing with a more complete dataset .
• Timeline negative: BLA submission to early Q4 2022 represents a push from prior mid-2022 expectations; near-term catalysts still include formal BLA acceptance and potential review milestones .
• Manufacturing de-risked: PPQ completion at commercial scale reduces CMC risk at filing and supports launch readiness .
• Clinical evidence strengthened: ACC.22 Phase 2b full data reinforce rapid and sustained reversal; consistency across assays supports biomarker-based endpoints in REVERSE-IT and the accelerated pathway .
• Liquidity watch: Cash at $18.7M declined significantly; SFJ funding expected to cover additional REVERSE-IT and program costs, but financing visibility is a key monitor into the BLA process .
• Trading implications (near term): Expect stock sensitivity to regulatory updates (BLA submission/acceptance) and any incremental REVERSE-IT bleeding cohort enrollment disclosures; timeline slippage may pressure sentiment until filing .
• Medium-term thesis: If approved, bentracimab could differentiate ticagrelor on safety and support broader utilization; initial U.S. launch readiness (manufacturing, clinical data) appears aligned with regulatory requirements .

Appendix: Additional Data Points

• Balance Sheet (selected): Total assets $38.664M (3/31/22), stockholders’ deficit $(102.395)M, development derivative liability $110.944M .
• Operating metrics: R&D $14.336M in Q1 2022 (down vs 2021 y/y due to lower manufacturing/trial start-up), G&A $4.009M (up vs prior-year period) .
• Corporate presentation dated May 2022 attached to the 8-K as Exhibit 99.2 summarizes program status and timelines .

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