Organogenesis (ORGO) 2024 Cantor Fitzgerald Global Healthcare Conference summary

Leadership and company evolution

• CEO and CFO have extensive experience in life sciences and have led significant organizational growth.

• Company originated from MIT technology in 1985, launching the first FDA-approved living skin substitute in 1998.

• Expanded from a single product to a portfolio of nine commercial products and four technology platforms.

• Acquisitions and product launches increased total addressable market (TAM) from $2 billion to $25 billion.

• Went public again in 2018, now with a robust commercial infrastructure and pipeline.

Product portfolio and market positioning

• Products address all phases of wound healing, with PuraPly as a first-line antimicrobial solution.

• Amniotic and bioengineered skin products target complex cases and comorbidities.

• Portfolio approach allows flexibility in response to reimbursement changes.

• Recent line extension in the surgical space with larger PuraPly AM SKUs to meet OR demand.

Regulatory and reimbursement landscape

• Draft LCDs coordinated by all MACs and CMS approved only 15 products, excluding over 200 others.

• Three products are on the approved list, with ongoing efforts to add more through clinical studies.

• Expectation for PuraPly trial completion in Q2 2025, with potential coverage reinstatement by late Q3 or Q4 2025.

• LCD implementation anticipated for January 2025, with possible delays depending on regulatory timelines.