Elutia : Presentation (ELUT Earning Call 14May26 Final)

Published: 2026-05-14 17:33:27 ET ELUT

Published on 05/14/2026 at 05:33 pm EDT

1St Quarter 2026 Earnings Call

Nasdaq: ELUT

C. Randal Mills PhD

Chief Executive Officer

Matt Ferguson

Chief Financial Officer

May 14, 2026

TODAY'S AGENDA

1Q 2026

Earnings Call

May 14, 2026

C. Randal Mills, PhD

Chief Executive Officer

Matt Ferguson

Chief Financial Officer

Nasdaq: ELUT

1

1Q26 Business Highlights

2

Where We're Headed

3

Strategic Processes Update

4

Financial Results

5

Closing Remarks and Q&A

3

3

Business Highlights

NXT-41 FDA Review Advancing

Productive interactions with FDA on the NXT-41 510(k) submission has increased confidence in the planned NXT-41x submission. Clearance for NXT-41 remains on track for 4Q 2026, and NXT-41x clearance is anticipated in 1H 2027.

Automated Manufacturing Platform Operational

Automated manufacturing platform installed and operating. Process supports target gross margins in excess of 80% at scale while enabling competitive pricing and differentiated product value.

Launch Confidence Building

Direct surgeon engagement by our commercial team confirms a $1.5 billion U.S. market, 15-20% postoperative infection rates, and no meaningful innovation in standard of care.

Strong Balance Sheet: $36.5M

$28.5M cash plus $8.0M in escrow from the BioEnvelope divestiture (release expected in 4Q 2026). Strategic processes underway for SimpliDerm divestiture and inbound acquisition interest received for the Cardiovascular product line.

What are we great at?

Optimal Biologic Matrix

Powerful Antibiotics

Sustained antibiotic release

to prevent bacterial colonization and associated complications.

Sold to Boston Scientific for $88M

Breast Cancer Surgery Is a Transformational Opportunity

A $1.5B U.S. market with no meaningful innovation in the standard of care

$1.5B

U.S. breast cancer surgery TAM

Big Market

15-20%

Post-op infection rate after mastectomy

Big Problem

$88M

Boston Scientific acquired our first-generation product EluPro

Proven Solution

A Large Established Market

Biologics represent a $1.5B US TAM and 65% of reconstruction spend

Approximately 168,000 breast reconstruction procedures are performed annually in the U.S.

Biologic mesh is utilized in more than 85% of implant-based reconstruction procedures

Biologics account for approximately 65% of reconstruction procedural spend

Human biologic mesh ASPs typically range from $7,500-$9,500 per breast

Represents an estimated $1.5 billion U.S. market opportunity

ASPS 2024 Plastic Surgery Statistics Report.

Sorkin M et al. Plast Reconstr Surg. 2017;139:379e-389e.

Korn PT et al. Aesthetic Surg J. 2019;39:NP255-NP263.

Albornoz CR et al. Plast Reconstr Surg. 2013;131:1-10. 7

The Unmet Need Is Severe

Status quo is not addressing post-operative infection in breast reconstruction

Suffer serious

post-reconstruction complications

1 in 3

Experience post-operative

infection

15-20%

Up to 21% result in implant

loss

21%

Average hospital cost of

reconstruction infection

$48,344

Reish RG et al. Plast Reconstr Surg. 2013;132:806e-815e. Spear SL et al. Plast Reconstr Surg. 2011;127:2189-2196.

Vandergrift et al., The economic burden of post-operative infections in implant-based breast

reconstruction. Plastic and Reconstructive Surgery, 2019;143(2):373e-381e.

Drug-Eluting Biomatrix Addresses Surgery's #1 Problem

Not a passive support.

An active partner in recovery.

Easy to Use

Utilizes existing surgeon technique

Cost Neutral for Hospital

Replaces legacy products

Powerful Antibiotic Coverage

Sustained, uniform antibiotic release at the site

Legacy biologic mesh

1Q2026 Business Highlights

FDA review | Manufacturing automation | Commercial readiness | Strategic processes

10

NXT-41 510(k) FDA Review Advancing

Collaborative dialogue with FDA increasing confidence in NXT-41x submission

NXT-41 Submission SUBMITTED

NXT-41 Expected Clearance 4Q 2026

NXT-41x Submission 4Q 2026

NXT-41x Expected Clearance 1H 2027

Manufacturing Automation Online

Supporting gross margin in excess of 80% at scale

1Q26 Manufacturing Progress

Automated platform operational

Production equipment for NXT-41x at scale is now online

Precision robotic coating system

Automated drug-eluting layer optimized for the biologic matrices

Designed for manufacturing advantage

Integrated in-house process supports efficiency, quality, and scalability

Enables a differentiated value proposition

Supports competitive pricing while delivering differentiated functionality

Commercial Launch Confidence Building

Ligotti's first months as CCO is confirming the size and severity of the need as well as the potential to efficiently capture market share

Top 50 Centers account for 38,000 cases ($300M+)

THE INSIGHT: Breast reconstruction is a billion-dollar U.S. market, but most of the volume is concentrated at a few hundred hospitals, enabling efficient commercialization.

Strategic Processes Advancing

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Acquisition interest received from multiple parties

Proprietary, differentiated technology

Strong clinical data

$1.0M revenue 1Q26 85% gross margin

Cardiovascular Product Line

INBOUND INTEREST RECEIVED

Sharpening focus on the NXT-41x opportunity

Previously announced exploration of strategic options is on track

Standalone, EBITDA-accretive human ADM business

$2.1M revenue 1Q26

57% gross margin

•

~100M covered lives across UnitedHealthcare, Anthem,

and 9 regional plans

Patent-protected proprietary manufacturing process

SimpliDerm

PROGRESSING WELL

1Q2026 Financial Results

15

1Q26 Financial Summary

Continuing operations only; excludes divested BioEnvelope business

REVENUE

Total net sales: $3.1M vs. $3.0M in 1Q25 (+6%)

SimpliDerm: $2.1M vs. $2.6M in 1Q25

Cardiovascular: $1.0M vs. $0.3M in 1Q25

Growth driven by return to direct distribution and CV volume

MARGIN & PROFITABILITY

Adj. EBITDA (Non-GAAP): $(4.4M)

vs. $(2.8M)

Net loss: $(7.5M) vs. $(3.9M)

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GAAP gross margin: 57.9% vs. 46.8%

Adj. gross margin (Non-GAAP): 66.5% vs. 55.9%

BALANCE SHEET & CASH

44.2M common shares + 3.2M pre-

funded warrants = 47.4M

Cash + escrow: $36.5M

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Escrowed receivable from

BioEnvelope divestiture (releases 4Q26): $8.0M

Cash on hand (Mar 31): $28.5M

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NET LOSS VARIANCE EXPLANATION

Higher net loss vs. 1Q25 is driven primarily by a $6.7M unfavorable swing in other expense (income), net, comprised largely of a $1.7M non-cash loss on revaluation of warrant liabilities in 1Q26 compared to a $5.2M non-cash gain in 1Q25. Operating loss improved year-over-year.

16

Catalysts Ahead

2026

Bolster the balance sheet with one or more divestitures of non-strategic assets

CV / SimpliDerm Transaction

4Q 2026

Base biologic matrix 510(k) clearance anticipated in 2H 2026

NXT-41 FDA Clearance

4Q 2026

Drug-eluting version submission to FDA

NXT-41x 510(k) Submission

Drug-eluting biomatrix clearance anticipated

NXT-41x FDA Clearance

1H 2027

Targeted launch into $1.5B U.S. market

NXT-41x Commercial Soft Launch

2H 2027

Investment Summary

Validated Platform

We can

Develop it. Clear it.

Commercialize it.

Blockbuster Pipeline

Reconstruction is

$1.5B market.

162,000 surgeries.

15-20% infection rate.

Key Approvals Expected in 2H26 and 1H27

Fully Resourced

We have

Proven team.

Existing GMP facility.

Cash to fund the company through product approval and launch.

Its GO time!

19

Disclaimer

Elutia Inc. published this content on May 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2026 at 21:32 UTC.