Full Press Release Details
SCIENCE Raymond James Human Health Innovation Conference June 23, 2021 1Exhibit 99.1 ADVANCING REGENERATIVE MEDICINE TREATMENT THROUGH PLACENTAL SCIENCE Raymond James Human Health Innovation Conference June 23, 2021 1
DISCLAIMER & CAUTIONARY STATEMENTS Important Cautionary Statement
This presentation includes forward-looking statements. 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. Such forward-looking statements include statements regarding: expectations regarding the timing and results of clinical trials, the timing and results of future regulatory filings, the
potential to receive revenue from future products, and the timing and magnitude of such revenue; the results of a clinical trial or trials may have little or no statistical value, or may fail to demonstrate that the product is safe or effective; the
Company may change its plans due to unforeseen circumstances, to conduct additional analyses, or for other reasons, and delay or alter the timeline for future trials, analyses, or public announcements; the future market for such products depends on
regulatory approval of such products, which might not occur at all or when expected, and is based in part on assumptions regarding the number of patients who elect less acute and more acute treatment than the Company's products, market
acceptance of the Company's products, and adequate reimbursement for such therapies; plans for expansion outside of the U.S.; the process of obtaining regulatory clearances or approvals to market a biological product or medical device
from the FDA or similar regulatory authorities outside of the U.S. is costly and time consuming, and such clearances or approvals may not be granted on a timely basis, or at all, and the ability to obtain adequate reimbursement for the use of such
products may not be obtained on a timely basis or at all; the effectiveness of amniotic tissue as a therapy for any particular indication or condition or as a platform for regenerative medicine; the results of a clinical trial or trials may
have little or no statistical value, or may fail to demonstrate that the product is safe or effective; and expectations regarding trends and growth, including expectations for growth in the wound care business, and the future growth
potential and structure of the business; such expectations depend upon most or all of the above factors. Additional forward-looking statements may be identified by words such as believe, expect, may, plan, potential, will, preliminary, and similar
expressions, and are based on management's current beliefs and expectations. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the Securities and
Exchange Commission. Any forward-looking statements speak only as of the date of this presentation or report and the Company assumes no obligation to update any forward-looking statement. 2DISCLAIMER & CAUTIONARY STATEMENTS Important Cautionary
Statement This presentation includes forward-looking statements. 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. Such forward-looking statements include statements regarding: expectations regarding the timing and results of clinical trials, the timing and results of future regulatory
filings, the potential to receive revenue from future products, and the timing and magnitude of such revenue; the results of a clinical trial or trials may have little or no statistical value, or may fail to demonstrate that the product is safe or
effective; the Company may change its plans due to unforeseen circumstances, to conduct additional analyses, or for other reasons, and delay or alter the timeline for future trials, analyses, or public announcements; the future market for such
products depends on regulatory approval of such products, which might not occur at all or when expected, and is based in part on assumptions regarding the number of patients who elect less acute and more acute treatment than the Company's
products, market acceptance of the Company's products, and adequate reimbursement for such therapies; plans for expansion outside of the U.S.; the process of obtaining regulatory clearances or approvals to market a biological product
or medical device from the FDA or similar regulatory authorities outside of the U.S. is costly and time consuming, and such clearances or approvals may not be granted on a timely basis, or at all, and the ability to obtain adequate reimbursement for
the use of such products may not be obtained on a timely basis or at all; the effectiveness of amniotic tissue as a therapy for any particular indication or condition or as a platform for regenerative medicine; the results of a clinical
trial or trials may have little or no statistical value, or may fail to demonstrate that the product is safe or effective; and expectations regarding trends and growth, including expectations for growth in the wound care business, and the
future growth potential and structure of the business; such expectations depend upon most or all of the above factors. Additional forward-looking statements may be identified by words such as believe, expect, may, plan, potential, will, preliminary,
and similar expressions, and are based on management's current beliefs and expectations. The Company describes additional risks and uncertainties in the Risk Factors section of its most recent annual report and quarterly reports filed with the
Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this presentation or report and the Company assumes no obligation to update any forward-looking statement. 2
INDUSTRY LEADER IN UTILIZING AMNIOTIC TISSUE AS A PLATFORM FOR
REGENERATIVE MEDICINE Promising Late- Base Business Stage Pipeline Advanced Wound Care Musculoskeletal Distinct drivers of significant shareholder value with current and future growth potential 3INDUSTRY LEADER IN UTILIZING AMNIOTIC TISSUE AS A
PLATFORM FOR REGENERATIVE MEDICINE Promising Late- Base Business Stage Pipeline Advanced Wound Care Musculoskeletal Distinct drivers of significant shareholder value with current and future growth potential 3
BASE BUSINESS HAS STABILIZED AND IS NOW POSITIONED FOR GROWTH Net Sales
($M) 2,3 Section 361 vs. Section 351 Sales Breakdown (2.9%) 2020 1Q21 $76 $69 $64 $62 $60 13% 14% $54 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 87% 86% 1 Adjusted Net Sales ($M) +4.2% Section 351 Sales Section 361 Sales $68 $68 $63 $60 $57 $52 1Q 2021 TTM Sales
by Care Setting 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 3 In-patient Advanced Wound Care/Section 361 Net Sales 29% Private +6.2% Office 31% $59 Out-patient $56 $55 $52 $49 $46 29% Other 11% 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 (1) Adjusted net sales excludes impact
of Revenue Transition amounts. Adjusted net sales is a non-GAAP measurement. Refer to Appendix for more information and reconciliation to the nearest GAAP measure; (2) Section 361 includes Tissue + Cord sales. Section 351 includes Micronized +
Particulate sales. 4 (3) Non-GAAP. Please refer to slide 23 for a reconciliation to GAAP.BASE BUSINESS HAS STABILIZED AND IS NOW POSITIONED FOR GROWTH Net Sales ($M) 2,3 Section 361 vs. Section 351 Sales Breakdown (2.9%) 2020 1Q21 $76 $69 $64 $62
$60 13% 14% $54 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 87% 86% 1 Adjusted Net Sales ($M) +4.2% Section 351 Sales Section 361 Sales $68 $68 $63 $60 $57 $52 1Q 2021 TTM Sales by Care Setting 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 3 In-patient Advanced Wound
Care/Section 361 Net Sales 29% Private +6.2% Office 31% $59 Out-patient $56 $55 $52 $49 $46 29% Other 11% 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 (1) Adjusted net sales excludes impact of Revenue Transition amounts. Adjusted net sales is a non-GAAP
measurement. Refer to Appendix for more information and reconciliation to the nearest GAAP measure; (2) Section 361 includes Tissue + Cord sales. Section 351 includes Micronized + Particulate sales. 4 (3) Non-GAAP. Please refer to slide 23 for a
reconciliation to GAAP.
CLEAR STRATEGY FOR VALUE CREATION Industry leading base business with
high gross margins provides foundation for long-term, stable growth, fueling late-stage pipeline Targeting 10%+ growth in base advanced wound care business Japan approval received June 2021, providing foundation for further
international expansion Contribution from late-stage pipeline anticipated in 2023; Potential blockbuster drug reaching the market in 2025 / 2026 Long-term view anticipates additional large-scale markets leveraging platform technology
Knee OA Base Business International Outside US Outside US Pipeline Plantar Fasciitis Plantar Fasciitis Plantar Fasciitis Japan Japan Japan Japan Base Business Base Business Base Business Base Business Base Business 2021 2022 2023 2024 2025+ OUS =
Outside United States. Timeline represents current plans and estimates only. Actual results and timing may differ materially. There can be no assurance that clinical trials are conducted or completed on schedule, that trial results are favorable, or
that we obtain regulatory approval for our products and indications. 5CLEAR STRATEGY FOR VALUE CREATION Industry leading base business with high gross margins provides foundation for long-term, stable growth, fueling late-stage pipeline
Targeting 10%+ growth in base advanced wound care business Japan approval received June 2021, providing foundation for further international expansion Contribution from late-stage pipeline anticipated in 2023; Potential blockbuster
drug reaching the market in 2025 / 2026 Long-term view anticipates additional large-scale markets leveraging platform technology Knee OA Base Business International Outside US Outside US Pipeline Plantar Fasciitis Plantar Fasciitis Plantar
Fasciitis Japan Japan Japan Japan Base Business Base Business Base Business Base Business Base Business 2021 2022 2023 2024 2025+ OUS = Outside United States. Timeline represents current plans and estimates only. Actual results and timing may differ
materially. There can be no assurance that clinical trials are conducted or completed on schedule, that trial results are favorable, or that we obtain regulatory approval for our products and indications. 5
THE PLACENTA IS A SOPHISTICATED BIOLOGICAL SYSTEM THAT SUPPORTS GROWTH
AND HEALING 1 Known Properties of Amniotic Tissue 2 Regulator of angiogenesis Modulates inflammation Barrier membrane Inhibitor of fibrosis and scars 3 Promoter of epithelialization Non-immunogenic
material Our library of peer-reviewed literature provides MIMEDX with a critical advantage for the future development of novel therapeutics (1) N. G. Fairbairn, M. A. Randolph, R. W. Redmond, J Plast Reconstr Aesthet Surg. 2014 May; 67(5):
662-675. Published online 2014 Jan 31. doi: 10.1016/j.bjps.2014.01.031; (2) Angiogenesis is the formation of new blood vessels. This process involves the migration, growth, and differentiation of 6 endothelial cells, which line the inside wall
of blood vessels; (3) Epithelialization is an essential component of wound healing used as a defining parameter of a successful wound closure.THE PLACENTA IS A SOPHISTICATED BIOLOGICAL SYSTEM THAT SUPPORTS GROWTH AND HEALING 1 Known Properties of
Amniotic Tissue 2 Regulator of angiogenesis Modulates inflammation Barrier membrane Inhibitor of fibrosis and scars 3 Promoter of epithelialization Non-immunogenic material Our library of peer-reviewed
literature provides MIMEDX with a critical advantage for the future development of novel therapeutics (1) N. G. Fairbairn, M. A. Randolph, R. W. Redmond, J Plast Reconstr Aesthet Surg. 2014 May; 67(5): 662-675. Published online 2014 Jan 31.
doi: 10.1016/j.bjps.2014.01.031; (2) Angiogenesis is the formation of new blood vessels. This process involves the migration, growth, and differentiation of 6 endothelial cells, which line the inside wall of blood vessels; (3) Epithelialization is
an essential component of wound healing used as a defining parameter of a successful wound closure.
PURION PROCESSED DEHYDRATED HUMAN AMNION CHORION MEMBRANE (dHACM)
The Company's early work characterized the core properties of our technology, including the identification of regulatory proteins and basic biological functions, such as cellular proliferation, migration, and biosynthesis 1-3 Non-viable cells
preserved Not acellular' Structurally intact Bioactive 1-3 Extracellular matrix intact Collagens I, III, IV, V, VII Laminin, fibronectin, proteoglycans 1-3 Biological activity preserved
Growth factors, cytokines, chemokines (1) Koob TJ, Lim JJ, Massee M, Zabek N, Denozi re G. Properties of dehydrated human amnion/chorion composite grafts: implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl
Biomater. 2014 Aug;102(6):1353-62. (2) Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013
Oct;10(5):493-500. (3) Koob TJ, Lim JJ, Massee M, Zabek N, Rennert R, Gurtner G, Li 7 WW. Angiogenic properties of dehydrated human amnion/chorion allografts: therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1;
6:10. PURION PROCESSED DEHYDRATED HUMAN AMNION CHORION MEMBRANE (dHACM) The Company's early work characterized the core properties of our technology, including the identification of regulatory proteins and basic biological functions,
such as cellular proliferation, migration, and biosynthesis 1-3 Non-viable cells preserved Not acellular' Structurally intact Bioactive 1-3 Extracellular matrix intact Collagens I, III, IV, V, VII
Laminin, fibronectin, proteoglycans 1-3 Biological activity preserved Growth factors, cytokines, chemokines (1) Koob TJ, Lim JJ, Massee M, Zabek N, Denozi re G. Properties of dehydrated human amnion/chorion composite grafts:
implications for wound repair and soft tissue regeneration. J Biomed Mater Res B Appl Biomater. 2014 Aug;102(6):1353-62. (2) Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human
amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. (3) Koob TJ, Lim JJ, Massee M, Zabek N, Rennert R, Gurtner G, Li 7 WW. Angiogenic properties of dehydrated human amnion/chorion allografts:
therapeutic potential for soft tissue repair and regeneration. Vasc Cell. 2014 May 1; 6:10.
VERSATILE PLATFORM WITH BROAD POTENTIAL ACROSS MULTIPLE APPLICATIONS
Placental Tissue Injectable Amnion/Chorion Umbilical Cord Matrix Amnion/Chorion 1 1 2 2 Applications : Applications : Indications : Indications : Acute & Chronic Acute & Chronic Soft Tissue Defects
Musculoskeletal & Wounds Wounds Sports Medicine: - Knee Osteoarthritis Diabetic Foot Ulcers Diabetic Foot Ulcers - Plantar Fasciitis Venous Leg Ulcers Venous Leg Ulcers Advanced Wound Care:
- Chronic Wounds - Surgical Incisions (1) 361 HCT/Ps (Human Cell Tissue/ Products) for homologous use only; HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the
manufacturer's objective intent. As defined in 21 CFR 1271.3(c), homologous use means the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or
functions in the recipient as in the donor. (2) Clinical trials in planning or underway; Final indication for use to be confirmed at FDA product 8 approval.VERSATILE PLATFORM WITH BROAD POTENTIAL ACROSS MULTIPLE APPLICATIONS Placental Tissue
Injectable Amnion/Chorion Umbilical Cord Matrix Amnion/Chorion 1 1 2 2 Applications : Applications : Indications : Indications : Acute & Chronic Acute & Chronic Soft Tissue Defects Musculoskeletal & Wounds
Wounds Sports Medicine: - Knee Osteoarthritis Diabetic Foot Ulcers Diabetic Foot Ulcers - Plantar Fasciitis Venous Leg Ulcers Venous Leg Ulcers Advanced Wound Care: - Chronic Wounds -
Surgical Incisions (1) 361 HCT/Ps (Human Cell Tissue/ Products) for homologous use only; HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent. As
defined in 21 CFR 1271.3(c), homologous use means the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.
(2) Clinical trials in planning or underway; Final indication for use to be confirmed at FDA product 8 approval.
INVESTING HEAVILY IN PROMISING LATE-STAGE PIPELINE WITH SIGNIFICANT
GROWTH OPPORTUNITIES MUSCULOSKELETAL/SPORTS MEDICINE 1H 2022 PHASE 3 Plantar Fasciitis (PF) Est. BLA filing PHASE 3 Achilles Tendonitis (AT) * 2H 2024 / 1H2025 PHASE 2B Knee Osteoarthritis (OA) Est. BLA filing ADVANCED WOUND CARE Chronic Cutaneous
1H 2021 P R E - CL IN IC A L Ulcers IND allowed to proceed 1H 2021 Surgical Incisions P R E - CL IN IC A L IND allowed to proceed 1H 2021 P R E - CL IN IC A L Soft Tissue Defects Est. IND/IDE filing * The Company does not anticipate pursuing a BLA
for Achilles Tendonitis at this time; Anticipate safety data can be used from the trial to supplement the data package for other clinical indications underway and inform future clinical indications under consideration IDE= Investigational Device
Exemption; According to recently updated FDA guidance, FDA generally intends to exercise enforcement discretion through May 31, 2021, with respect to the IND and the premarket approval requirements for certain HCT/Ps, provided that use of the HCT/P
does not raise reported safety concerns or potential significant safety concerns.; Timeline represents current plans and estimates only. Actual results and timing may differ materially. There can be no assurance that clinical trials are conducted or
completed on schedule, that trial 9 results are favorable, or that we obtain regulatory approval for our products and indications. INVESTING HEAVILY IN PROMISING LATE-STAGE PIPELINE WITH SIGNIFICANT GROWTH OPPORTUNITIES MUSCULOSKELETAL/SPORTS
MEDICINE 1H 2022 PHASE 3 Plantar Fasciitis (PF) Est. BLA filing PHASE 3 Achilles Tendonitis (AT) * 2H 2024 / 1H2025 PHASE 2B Knee Osteoarthritis (OA) Est. BLA filing ADVANCED WOUND CARE Chronic Cutaneous 1H 2021 P R E - CL IN IC A L Ulcers IND
allowed to proceed 1H 2021 Surgical Incisions P R E - CL IN IC A L IND allowed to proceed 1H 2021 P R E - CL IN IC A L Soft Tissue Defects Est. IND/IDE filing * The Company does not anticipate pursuing a BLA for Achilles Tendonitis at this time;
Anticipate safety data can be used from the trial to supplement the data package for other clinical indications underway and inform future clinical indications under consideration IDE= Investigational Device Exemption; According to recently updated
FDA guidance, FDA generally intends to exercise enforcement discretion through May 31, 2021, with respect to the IND and the premarket approval requirements for certain HCT/Ps, provided that use of the HCT/P does not raise reported safety concerns
or potential significant safety concerns.; Timeline represents current plans and estimates only. Actual results and timing may differ materially. There can be no assurance that clinical trials are conducted or completed on schedule, that trial 9
results are favorable, or that we obtain regulatory approval for our products and indications.
MORE THAN 300 REGULATORY FACTORS ARE 1-3 PRESERVED IN PURION
PROCESSED dHACM (1) Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015 Jul;103(5):1133-40.; (2) Koob TJ,
Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. (3) MiMedx 10 Research
Report, MM-RD-00072, Proteome Characterization of MiMedx Placental Tissue Products.MORE THAN 300 REGULATORY FACTORS ARE 1-3 PRESERVED IN PURION PROCESSED dHACM (1) Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion
allografts compared to multilayer amnion/chorion allografts for wound healing. J Biomed Mater Res B Appl Biomater. 2015 Jul;103(5):1133-40.; (2) Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, Temenoff JS, Li WW, Gurtner G. Biological properties of
dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013 Oct;10(5):493-500. (3) MiMedx 10 Research Report, MM-RD-00072, Proteome Characterization of MiMedx Placental Tissue Products.
dHACM CONTAINS A COMPLEX VARIETY OF MATRIX COMPONENTS AND REGULATORY 1