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PI

POLARITYTE, INC. (PTEIQ)·Q1 2022 Earnings Summary

Executive Summary

  • Q1 2022 marked a transitional quarter: revenue fell 84% year over year to $0.74M as SkinTE product sales ceased and COVID testing wound down, while GAAP basic EPS improved to $(0.04) from $(0.23) driven by a favorable $5.1M non-cash warrant liability remeasurement and absence of prior-year warrant inducement loss .
  • Strategic/regulatory momentum improved: SkinTE received FDA RMAT designation and the pivotal Phase III DFU trial (COVER DFUs) began enrolling, positioning the program for expedited development interactions with FDA .
  • Portfolio rationalization and liquidity: divested IBEX services and real estate (promissory note $0.4M, net cash proceeds ~$2.6M); cash and equivalents were $18.7M with operating cash burn ~$2.0M/month and runway into 4Q22 .
  • Corporate action: 1-for-25 reverse split effective May 16 to satisfy Nasdaq minimum bid and SPA obligations; outstanding shares reduced from ~100M to ~4M post-split .
  • No S&P Global consensus estimates available for Q1 2022 (SPGI mapping unavailable), so beats/misses to Street cannot be assessed.

What Went Well and What Went Wrong

What Went Well

  • RMAT designation for SkinTE, enabling enhanced FDA engagement to expedite development and review; management expects to coordinate a multidisciplinary FDA discussion to accelerate clinical and CMC plans .
  • Pivotal trial execution: first subject enrolled in Phase III COVER DFUs (up to 100 subjects, 20 sites; primary endpoint: incidence of closure at 24 weeks), signaling operational progress on the lead asset .
  • CEO tone constructive on transition: “RMAT designation will help us advance our development program, efficiently… now with the benefit of an approved IND, actively-enrolling Phase III pivotal study, and RMAT designation” .

What Went Wrong

  • Revenue collapsed with strategic exit from commercial SkinTE and COVID testing: total net revenues down 84% YoY to $0.741M as SkinTE product revenue went to $0 and services revenue fell to $0.741M .
  • Operating loss widened modestly YoY to $(8.873)M (vs. $(8.209)M) as revenue contraction outpaced cost reductions; gross profit declined 90% to $0.250M .
  • Core services trajectory to zero post-divestiture: with IBEX sold end of April, services revenue expected to be nominal in Q2 and absent in 2H22, eliminating a near-term revenue contributor .

Financial Results

Income statement summary (quarterly)

MetricQ2 2021Q3 2021Q1 2022
Total Net Revenues ($M)$2.537 $1.116 $0.741
Gross Profit ($M)$1.613 $0.482 $0.250
Operating Loss ($M)$(8.628) $(7.410) $(8.873)
Net Loss ($M)$(3.188) $(1.021) $(3.771)
GAAP EPS – Basic ($)$(0.04) $(0.01) $(0.04)
GAAP EPS – Diluted ($)$(0.04) $(0.01) $(0.09)

Revenue mix (quarterly)

Revenue Mix ($M)Q2 2021Q3 2021Q1 2022
Products$1.195 $0.000 $0.000
Services$1.342 $1.116 $0.741
Total Net Revenues$2.537 $1.116 $0.741

Non-GAAP (year-over-year Q1)

Non-GAAPQ1 2021Q1 2022
Adjusted Net Loss ($M)$(8.186) $(8.876)
Adjusted EPS – Basic ($)$(0.11) $(0.11)
Adjusted EPS – Diluted ($)$(0.11) $(0.10)

Liquidity and cash burn

Liquidity/KPIsQ2 2021Q3 2021Q1 2022
Cash & Equivalents ($M, period-end)$32.614 $27.351 $18.723
Working Capital ($M)~$30.5 ~$24.9 ~$17.2
Cash Used in Ops ($M)$(4.1) (quarter) $(4.6) (quarter) $(6.041) (quarter)
Avg Monthly Cash Use ($M/month)~$1.4 ~$1.5 ~$2.0
Runway CommentaryInto but not beyond 3Q–4Q22 (Q2 view) Into 4Q22 (Q3 view) Into 4Q22 incl. IBEX proceeds

Drivers and notable items

  • YoY revenue decline reflects cessation of SkinTE sales (end of May 2021) and COVID testing; IBEX services partly offset in 2021 but were de-emphasized ahead of sale .
  • Net loss improved YoY on $5.1M gain from warrant liability remeasurement and absence of 2021 warrant inducement loss ($5.2M) .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash runwayFY 2022“Into 4Q22” (as of 12/31/21) “Into 4Q22,” inclusive of IBEX real estate net proceeds Maintained
Revenue/EPSFY 2022None providedNone provided
Capital actions2022N/A1-for-25 reverse split effective May 16, 2022 New disclosure

Earnings Call Themes & Trends

Note: A full Q1 2022 call transcript was not available in our sources; themes below synthesize company press materials.

TopicPrevious Mentions (Q3 2021 and FY2021)Current Period (Q1 2022)Trend
Regulatory pathway (IND/RMAT)Submitted IND (7/23/21); IND accepted 1/14/22; preparing pivotal study RMAT designation granted; plan comprehensive FDA discussions Improving
Clinical executionReadied sites; ability to start quickly post-IND acceptance First subject enrolled in Phase III COVER DFUs; up to 100 subjects/20 sites Improving
Portfolio rationalizationDeprioritized COVID testing; focus on IBEX services in 2021 Sold IBEX services and related property; $0.4M note, ~$2.57M net cash De-risking/liquidity
IP expansionMultiple patent allowances/grants (US/China/Israel/Philippines) IP estate at 18 allowed/granted utility patents worldwide; further allowances Building
Cash/burnCash $27.4M (9/30/21), burn ~$1.5M/month; runway into 4Q22 Cash $18.7M (3/31/22); burn ~$2.0M/month; runway into 4Q22 incl. IBEX proceeds Tighter liquidity
Capital markets/listing1-for-25 reverse split to satisfy Nasdaq bid price and SPA obligations Compliance-driven

Management Commentary

  • “We are very excited to be underway and enrolling patients in COVER DFUs… FDA designating SkinTE as an RMAT enhances this milestone… advancing our key asset, SkinTE—now with the benefit of an approved IND, actively-enrolling Phase III pivotal study, and RMAT designation.” — Richard Hague, CEO .
  • “We are pleased to have reached the significant milestone of IND acceptance… our confidence in SkinTE’s ability to address wounds… is borne out of our extensive clinical experience.” — Richard Hague, CEO (FY21 release) .
  • “We are encouraged by the feedback… on track to submit our complete [IND] response by year end… executing… while demonstrating good discipline with respect to managing our capital efficiently.” — Richard Hague, CEO (Q3:21) .

Q&A Highlights

  • No Q1 2022 earnings call transcript or detailed Q&A was available in our document set; while the company hosted a call/webcast on May 16, 2022, only access details and replay references were provided, with no transcript captured in this corpus .
  • As such, any granular Q&A clarifications (e.g., enrollment cadence, CMC timelines, or cash runway sensitivities) were not reviewable here.

Estimates Context

  • We attempted to retrieve Wall Street consensus (S&P Global) for Q1 2022 revenue/EPS/EBITDA, but data were unavailable due to missing SPGI mapping for the ticker; therefore, comparison to Street estimates cannot be provided. Any estimate-based beat/miss assessment is unavailable at this time.

Key Takeaways for Investors

  • Near-term story is clinical and regulatory, not revenue: RMAT designation plus active Phase III enrollment meaningfully de-risk the SkinTE path and should anchor the medium-term thesis .
  • Liquidity runway remains the key gating factor into late 2022; with ~$18.7M cash at 3/31 and ~$2.0M/month burn, additional capital likely needed to sustain the Phase III and operating plan beyond 4Q22 .
  • Revenue base will trend to negligible in 2H22 following the IBEX divestiture, sharpening focus on expense discipline and clinical milestones as stock catalysts .
  • Non-cash valuation items (warrant liability remeasurement) can materially swing GAAP EPS; adjusted net loss is the better lens for core operating trajectory (Q1: $(8.88)M vs $(8.19)M YoY) .
  • Reverse split removes Nasdaq compliance overhang and satisfies SPA requirements but does not change fundamentals; trading could be more volatile around liquidity events .
  • Watch for pivotal trial updates (site activations, enrollment pace, interim operational updates) and FDA interactions under RMAT as key inflection points .

Appendix: Additional Detail From Q1 2022 Press Release

  • Selected P&L drivers YoY: Net revenues down $4.0M (84%); COGS down $1.7M (77%); gross profit down $2.3M (90%); opex down $1.6M (15%); operating loss up $0.7M (8%) .
  • Non-operating: +$5.1M gain from change in fair value of warrant liability (vs. $(4.0)M loss in Q1’21); no repeat of $5.2M warrant inducement loss from Q1’21 .
  • Balance sheet: Total assets $30.0M, equity $17.8M at 3/31/22 .

All figures are from company filings and press materials as cited. No S&P Global consensus estimates were available for this ticker at the time of analysis.