Elutia, Inc. · NASDAQ:ELUT
Elutia — Q3 2023 Earnings Presentation
25 slides from Elutia's earnings presentation, Nov 13, 2023
Slide 1: Elutia Q3 2023 Earnings Presentation
C. Randal Mills PhD Chief Executive Officer Matt Ferguson Chief Financial Officer November 13, 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation of Elutia Inc. (“Elutia,” “we,” “us,” “our” or the “Company”) (together with any other statements or information that we may make or discuss in connection herewith) contains forward-looking statements. All statements other than statements of historical fa
Slide 3: 3Q23 Highlights
3Q23 Highlights Launched company focused on developing and marketing proprietary drug eluting biomatrices Record Financial CanGaroo RM Strategic Performance FDA Update Transactions 26% YoY growth from proprietary products Completed validation of an Gross proceeds Mission accelerated in vitro elution
Slide 4: Leadership - The Right Experience
Leadership - The Right Experience C. Randal Mills, PhD Matt Ferguson Courtney Guyer Kimberly Mulligan, PhD Co-Founder & CEO Chief Financial Officer GM of SimpliDerm GM of BioEnvelope Kevin Rakin Michelle Williams, PhD Jeff Hamet Sonali Fonseca, PhD Co-Founder & Chair Chief Scientific Officer SVP Fin
Slide 5: Introducing medicine so patients can thrive without compromise
Introducing • Elutia is a commercial-stage company with product platforms in CIED and breast reconstruction o CanGaroo o SimpliDerm medicine • We are pioneering the drug-eluting biomatrix (DEB), which solves problems unaddressed by available alternatives so patients can o We expect to launch CanGaro
Slide 6: Serious challenges can arise from device implantation
Serious challenges can arise from device implantation EROSION HEMATOMA INFECTION MIGRATION FIBROSIS / CONTRACTURE 7-11% 12-20% pacemakers breast recon 5
Slide 7: Elutia is breaking silos to develop great solutions
Elutia is breaking silos to develop great solutions Biologic Remodeling Pharmaceutical Device Activity Structure 6
Slide 8: Creating a Compelling Combination
Creating a Compelling Combination Therapeutic Payload Specific activity (antibiotic, etc.) The Drug-Eluting BioMatrix Sustained release Durable structural integrity Enhanced surgical site healing Targeted therapeutic delivery Remodels into patient’s own healthy tissue Biologic Material
Slide 9: A Protected Platform
A Protected Platform • 40 issued U.S. patents • Exclusive licensing agreement for SIS-based ECM • Specialized manufacturing facilities • Proprietary product release assays 8
Slide 10: Two Biologic Platforms
Two Biologic Platforms BIOMATRIX BIOENVELOPE Breast Reconstruction Cardiac Implantable Devices 9
Slide 11: BIOMATRIX - SimpliDerm
SimpliDerm BIOMATRIX
Slide 12: Role of biomatrices in breast reconstruction
Role of biomatrices in breast reconstruction • About 13% (1 in 8) of women will develop invasive breast cancer in their lifetimes • This leads to approximately 151,000 mastectomies requiring reconstruction in the U.S. • Alloderm is the market leader ‒ Acquired by AbbVie as part of Allergan in 2020 ‒
Slide 13: A $1.6B opportunity to improve outcomes in breast recon
A $1.6B opportunity to improve outcomes in breast recon SimpliDerm – simply a great product Superior handling characteristics SimpliDerm Financial Performance Prehydrated and sterile Lower pro-inflammatory M1 macrophage (TNF-α) 44% response $2.6 Lower fibrotic response $1.8 Results surgeons
Slide 14: Drug-Eluting Biomatrix CanGaroo RM
CEMEET OW) CanGaroo RM DRUG-ELUTING BIOMATRIX
Slide 15: CanGaroo – the only biologic CIED envelope
BIOENVELOPE CanGaroo CanGaroo – the only biologic CIED envelope Financial Performance • Biologic material supports wound healing 11% • Decreased inflammatory & fibrotic response $2.6 • Only envelope available for larger SCID devices $2.3 Market Dynamics and Distribution • $600M market with only one
Slide 16: Next Generation CanGaroo RM
Next Generation CanGaroo RM Feature TYRX CanGaroo CanGarooRM Introducing Primary Placement Change Out RM Standard Incision Drug Eluting BioEnvelope Erosion/Thin Skinned with Rifampin and Minocycline Fibrosis and Inflammation A more complete option Defibrillation Threshold for a $600M market Antibiot
Slide 17: Favorable Market Dynamics
Favorable Market Dynamics RM TYRX only other antibiotic pouch on the market Boston Scientific Medtronic ~$250M-300M Abbott (global est.) Biotronik 17
Slide 18: Obtaining FDA Approval for CanGarooRM
Obtaining FDA Approval for CanGarooRM Received ‘Not Substantially Equivalent’ (NSE) Letter from FDA in March • Review was satisfactory except for four items • Two were administrative; other two were QC test-related: 1) FDA wanted an accelerated in vitro elution test 2) Demonstration of consistent el
Slide 19: Generating the Data FDA Requested
Generating the Data FDA Requested 100% Threshold – 80% 80% % Drug Release 60% Old: 75% Eluted 40% 20% 0 0 8 16 24 32 40 Hours 19
Slide 20: Generating the Data FDA Requested
Generating the Data FDA Requested 100% NEW: 93% Eluted Threshold – 80% New Methodology 80% • pH • Surfactant • Agitation % Drug Release 60% Old: 75% Eluted • Temperature 40% 20% 0 0 8 16 24 32 40 48 Hours 20
Slide 21: Focused Pathway to FDA Clearance of CanGarooRM
Focused Pathway to FDA Clearance of CanGarooRM Developed and validated a new accelerated in vitro elution method responsive to FDA requests • Based on original method, with changes to later stages to accelerate release Successful pre-submission meeting with FDA, paving the way for 510(k) submission
Slide 22: Financial Update
Financial Update Matt Ferguson Chief Financial Officer 14
Slide 23: Financial Update
Financial Update Matt Ferguson, Chief Financial Officer • Two major strategic transactions significantly strengthen balance sheet • PIPE financing, up to $26M total proceeds • Orthobiologics divestiture, up to $35M total proceeds • Net sales of $6.1 million vs. $5.8 million in 3Q22 • SimpliDerm net
Slide 24: Positioned for Growth
Positioned for Growth • Commercial-stage company with two established biomatrix product platforms growing at 26% YoY • Pioneering the drug-eluting biomatrix (DEB) technology platform that solves real problems medicine • CanGarooRM – Expected to be the first drug-eluting biologic so patients can o $6
Slide 25: Thank you
Thank you *) ELUTIA Medicine Humanized”