Company to Share Probability Values from its Knee Osteoarthritis (KOA) Study; Analyses Conducted Support Confidence in Initiation of Confirmatory Phase 3 Trials in 2022
Commercial Business Strategy Demonstrates Sustainable Double-digit Growth Potential in Multiple Underpenetrated Markets
MIMEDX Increases 2021 Adjusted Net Sales Outlook to between $253 Million and $258 Million
MiMedx Group, a transformational placental biologics company, will provide new details about near- and long-term growth opportunities for its multimodal placental tissue platform at today’s virtual Investor Day, which begins at 9:00 a.m. ET. The Investor Day will provide updates by Company leadership, third-party experts and key opinion leaders on the musculoskeletal late-stage pipeline and robust commercial business.
Timothy R. Wright, MIMEDX Chief Executive Officer, commented, “The leadership team is excited to share reasons behind our confidence in the Company’s plans to design and execute a Phase 3 clinical trial program that will support approval and commercialization of our KOA candidate as a potential blockbuster biologic opportunity. The underlying mechanism of action and proprietary tissue engineering of MIMEDX dehydrated Human Amnion Chorion Membrane (dHACM) provides an extensive range of transformative platform potential and organic product innovation opportunities across multiple underpenetrated markets. Our commercial business is growing, with strong double-digit growth potential driven by global expansion initiatives and our dedication to product innovation. Our leadership team is talented, experienced in drug development and commercialization, tissue engineering, and resolute in our commitment to advancing the scientific rigor within the industry and bringing innovative solutions to physicians and patients in need across the world.”
Key Insights to Be Shared at MIMEDX 2021 Investor Day Include:
KOA Clinical Program
- Additional analyses from and next steps for the KOA clinical program
- Third-party biostatisticians validated the statistically significant and clinically meaningful improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain at three and six months, respectively (p=0.032 and p=0.009), WOMAC Function (p=0.046 and p=0.009), and WOMAC Total (p=0.038 and p=0.008) for the Pre-Interim Analysis Cohort of 190 patients.
- Root-cause analysis has determined that the potency of the investigational product faded as it aged, which resulted in the study’s failure to meet its primary endpoints. An intense examination of study results identified this factor as the primary difference in clinical responses observed between the Pre-Interim Analysis Cohort of 190 patients and the Post-Interim Analysis Cohort of 256 patients.
- MIMEDX proprietary biochemical and biological tests detected this reduced potency, related to age of the investigational product used in the Phase 2B KOA study. The Company is confident in its manufacturing processes and proprietary tissue engineering know-how and has a clear path forward.
- Based on the clinically meaningful and statistically significant data from the Pre-Interim Analysis Cohort of 190 patients in the Phase 2B trial, published retrospective data, extensive real-world clinical use, and ongoing scientific mechanism of action research, the Company believes that future planned KOA trials have an increased probability of success, benefitted by the learnings gained from the exploratory Phase 2B KOA clinical trial.
- Commencing in 2022, MIMEDX expects to initiate Phase 3 trials for its KOA candidate, with a Biologics License Application (BLA) filing anticipated in late 2025, and will work closely with the U.S. Food & Drug Administration (FDA) in advancing these trials.
Robust Commercial Growth Potential
- MIMEDX anticipates achieving sustainable growth of 11-14% across its vibrant commercial portfolio. This above-market growth rate comprises:
- An increase in its Advanced Wound Care business, driven by broadened product access across multiple underpenetrated markets, along with commercial excellence initiatives.
- An increase in its Surgical Recovery business, driven by market development, product innovation and increased clinical and economic evidence.
- An increase in its international markets, driven in part by its Japanese commercial strategy.
- The Company also has a robust near-term product pipeline, with two new product launches anticipated in the first half of 2022.
Outlook for 2021
The Company now expects that adjusted net sales for fiscal year 2021 will be between $253 million to $258 million, above the previously provided outlook of $245 million to $255 million. The revised 2021 outlook includes $16.7 million of Section 351 products sold in the United States for the six months ended June 30, 2021, prior to the end of the period of Enforcement Discretion. Adjusted net sales for fiscal year 2020 were $240.5 million, including $31.8 million of Section 351 products.
Investor Day speakers and topics include:
- Timothy R. Wright, Chief Executive Officer, MIMEDX
- Peter M. Carlson, EVP, Chief Financial Officer, MIMEDX
KOA Key Findings & Path Forward
- Robert B. Stein, M.D., Ph.D., EVP, Research and Development, MIMEDX
- Michelle Massee, AVP, Product Development, MIMEDX
- Thomas M. Mick, M.D., Medical Director, Clinical Development, MIMEDX
- Vibeke Strand, M.D., Stanford University School of Medicine
- Kris J. Alden, M.D., Ph.D., Orthopaedic Surgeon, Hip, Knee & Shoulder Reconstruction
Growth Strategy & Market Opportunity
- Rohit Kashyap, Ph.D., EVP, Chief Commercial Officer, MIMEDX
- John Harper, Ph.D., SVP, Research & Product Development, Chief Technology Officer, MIMEDX
- William H. Tettelbach, M.D., Principal Medical Officer, Head of Medical Affairs, MIMEDX
- Bidhan B. Das, M.D., Colon, Rectal & General Surgeon
- Caroline Clarke, M.D., Plastic, Reconstructive & Cosmetic Surgeon
- Jonathan Labovitz, D.P.M., Western University of Health Sciences
A live webcast will be available on the Events page of the Investors section of the Company’s website at www.mimedx.com at the time of the event. To register for the webcast, participants must use access code ‘MDXG.’ Participants will have the opportunity to submit written questions to MIMEDX presenters via the webcast. A replay of the webcast will be available on the Company’s website.