MaxCyte

Vertex Pharmaceuticals secures exa-cel SPL

Lighthouse | 29 September 2022

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  • MaxCyte’s latest non-exclusive Strategic Platform Licence (SPL) provides Vertex Pharmaceuticals with the clinical and commercial rights to enable continued use of its proprietary flow electroporation technology and ExPERT platform in development of exa-cel (formerly CTX001). Under the terms of the SPL, MaxCyte is entitled to receive platform licencing fees and programme related revenue. CRISPR Therapeutics initially developed exa-cel using MaxCyte’s technology under an SPL signed in March 2017.
  • Exa-cel (exagamglogene autotemcel), an ex vivo CRISPR gene-edited cell therapy for haemoglobinopathies, is the most advanced asset under an SPL. Execution of this SPL with Vertex comes on the heels of confirmation that regulatory pre-submission meetings in sickle cell disease (SCD) and transfusion dependent ß-thalassemia (TDT) have concluded.
  • Exa-cel will be submitted to the FDA for rolling review, with the start of the BLA submission in November and completion by end-Q123. EMA and MHRA submissions are on track for Q422. These timelines imply a potential approval decision in late-2023 and, if successful, launch(es) in 2024.
  • MaxCyte plans to sign further SPL partnerships in 2022, adding to the 17 current SPLs. As of January 2022, MaxCyte disclosed that its then 16 SPLs represented >$1.25bn in potential pre-commercialisation milestones. There is also the prospect of meaningful downstream economics that could include sales royalties, disposables use, and/or other sales-based payments.
  • SPLs provide a risk/reward asymmetry, in our view, as downside exposure to a single SPL asset or partner is limited by the growing size and diversity of MaxCyte’s SPL portfolio, whereas the success of a single programme could transform its revenue profile. Exa-cel is on track to become the first approved SPL programme and should make a meaningful contribution to MaxCyte’s top line. Our September 2022 Update provides an overview of SPL partners and underlying assets, as well as more detail on exa-cel.

Trinity Delta view: MaxCyte is approaching a landmark with the first regulatory filings for a programme under an SPL. We anticipate a first regulatory decision by year-end 2023 at the earliest. If approved, and pending payor/reimbursement discussions, the first launch of an SPL asset could occur in 2024. Exa-cel approval would have a major impact on MaxCyte’s FY24 revenues given that milestones for BLA/MAA approval are understood to typically be mid-seven figures (potentially per major region), with future revenues also benefiting from post-commercial income. Investment in in-house manufacturing scale up for near-to-mid-term commercialisation of partner products is supported by MaxCyte’s end-June 2022 cash balance of $240.9m. With a robust core cell therapy business and an advancing and growing SPL pipeline, we continue to view MaxCyte as a unique and diversified play on the whole cell engineering field, providing broad exposure across cell types, technologies, indications, and approaches. Our valuation is £980m ($1.27bn) or 964p/$12.53 per share.

Lighthouse

29 September 2022

Price560p
$6.25
Market Cap£569.7m
$635.8m
Primary exchangeAIM London
SectorHealthcare
Company Code
 
MXCT.L
MXCT
Corporate clientYes

Company description

MaxCyte uses its patented flow electroporation platform to transfect a wide array of cells. Revenues arise from sale and lease of equipment, disposables and licence fees; with an impressive client list. Key programmes with several clients are gaining greater visibility and approaching material value-inflections points. These will trigger a stream of milestone fees.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Franc Gregori
fgregori@trinitydelta.org
+44 (0) 20 3637 5041

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