MIMEDX Primed to Commence Pivotal Phase 3 Clinical Study Program of micronized dehydrated Human Amnion Chorion Membrane (mdHACM) in Knee Osteoarthritis (KOA), Targeting Potential Late-2026 Commercial Launch
Double-Digit Growth Objective in 2022 to be Driven by Treatment Transformation, Global Market Expansion and Ongoing Portfolio Innovation across Multimodal Placental Tissue Platform
Company to Present at 40th Annual
2021 Highlights
- Received regulatory approval of EPIFIX® in
Japan - Authored multiple peer-reviewed clinical, scientific and economic publications
- Filed additional
U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications - Achieved double-digit top-line sales growth of continuing portfolio of products
- Expanded our sales force, putting the right people in the right places
- Furthered our scientific understanding of the significant therapeutic potential of mdHACM in KOA. The Company reviewed Phase 2B KOA clinical trial results, including p-values, additional study analyses, and the proposed path forward at its Investor Day on
December 7, 2021 .
2022 Anticipated Milestones
- Achieve annual growth target across the Company’s vibrant commercial business
- Expand the Company’s international footprint with the initial launch of EPIFIX® in
Japan - Commence Phase 3 KOA program, with two clinical trials
- Implement rigorous Current Good Manufacturing Practice (CGMP) standards throughout entire supply chain as a key market differentiator
- Continue to advance the scientific body of evidence substantiating clinical efficacy, economic viability and underlying mechanism of action for our PURION® processed placental tissue platform through additional peer-reviewed publications, including rigorous scientific research and clinical studies
- Launch two new, organic products in the
U.S. : AMNIOEFFECT™ and Placental Collagen Matrix, facilitating expansion into additional areas of significant unmet clinical need
2022 Outlook
The Company provides the following financial outlook for 2022:
- Annual revenue growth of 11% to 14% in the Company’s continuing portfolio of products
- Base is 2021 Advanced Wound Care (AWC)/Section 361 Adjusted
Net Sales (estimated to range from$236 million to$240 million ) - Contribution from individual drivers varies across quarters and years
- Revenue Transition1 impact complete in fourth quarter of 2021
- We expect 2022 growth rates to be lowest in first quarter, increasing thereafter:
- 1Q22: Mid-single digit percent growth
- 2Q22: High-single digit percent growth
- 3Q22: Mid- to high-teens percent growth
- 4Q22: High-teens to twenty percent growth
- Base is 2021 Advanced Wound Care (AWC)/Section 361 Adjusted
- Research and Development (R&D) spend increasing from expected 2021 level of
$17 million to$22 million - Gross margins slightly lower due to competitive dynamics and product mix
- Expectations for growth assume full access to hospitals and health care provider facilities, as a continuation or escalation of access restrictions or lockdown orders resulting from the ongoing COVID-19 pandemic would adversely affect our results. These expectations additionally anticipate the mid-2022 launch of EPIFIX® in
Japan , following expected reimbursement approval, and the 2022 launch of the Company’s new AMNIOEFFECT™ and Placental Collagen Matrix product lines.
1. For a discussion of the revenue transition and the defined terms, refer to Item 8, Notes to the Consolidated Financial Statements in the
J.P. Morgan Healthcare Conference Presentation
Investors and other interested parties may access the live webcast on the Events page of the Investors section of the Company’s website or by clicking here. A replay of the webcast will be available for 30 days on the Company’s website at www.mimedx.com following the conclusion of the presentation.
Important Cautionary Statement
This press release includes forward-looking statements. Statements regarding: (i) strategic milestones planned for 2022; (ii) our expected 2021 financial results and our 2022 financial outlook; (iii) our expectations regarding the timing of clinical trials; (iv) our expectations regarding the timing of new product launches; and (v) the effectiveness of amniotic tissue as a therapy for any particular indication or condition. Additional forward-looking statements may be identified by words such as "believe," "expect," "may," "plan," “goal,” “outlook,” "potential," "will," "preliminary," and similar expressions, and are based on management's current beliefs and expectations.
Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause actual results to differ from expectations include: (i) future sales are uncertain and are affected by competition, access to customers, patient access to healthcare providers, and many other factors; (ii) the status, timing, results and expected results of the Company’s clinical trials, planned regulatory submissions and regulatory approvals, and our expectations regarding our ability to potentially accelerate the timing of any trial or regulatory submission, depend on a number of factors including favorable trial results, patient access, and our ability to manufacture in accordance with Current Good Manufacturing Practices (CGMP) and appropriate chemistry and manufacturing controls; (iii) the Company may change its plans due to unforeseen circumstances, or delays in analyzing and auditing results, and may delay or alter the timeline for future trials, analyses, or public announcements; (iv) our access to hospitals and health care provider facilities could be restricted as a result of the ongoing COVID-19 pandemic; (v) the results of scientific research are uncertain and may have little or no value; (vi) our ability to sell our products in other countries depends on a number of factors including adequate levels of reimbursement, regulatory approvals, market acceptance of novel therapies, and our ability to build and manage a direct sales force or third party distribution relationship; (vii) the effectiveness of amniotic tissue as a therapy for particular indications or conditions is the subject of further scientific and clinical studies; and (viii) we may alter the timing and amount of planned expenditures for research and development based on the results of clinical trials and other regulatory developments. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the
About
Contacts
Investors:
Investor Relations
404.360.5681
jhowarth@mimedx.com
Media:
404.323.4779
hdixon@mimedx.com
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