Full Press Release Details
Corporate Presentation May 2019 Exhibit
Unless the context indicates otherwise,
the terms "Organogenesis," "Company," "we," "us" and "our" refer to Organogenesis Holdings Inc. (formerly known as Avista Healthcare Public Acquisition Corp.), a Delaware corporation.
References in this prospectus to the "Business Combination" refer to the consummation of the transactions contemplated by that certain Agreement and Plan of Merger, dated as of August 17, 2018, which transactions were consummated on
December 10, 2018. This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events.
Forward-looking statements may be identified by the use of words such as "forecast," "intend," "seek," "target," "anticipate," "believe," "expect,"
"estimate," "plan," "outlook," and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking
statements include statements relating to the Company's expected revenue for fiscal 2019 and the breakdown of such revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories as well as the estimated revenue
contribution of its PuraPly products and non-PuraPly products and statements related to the expected launch dates for new products. Forward-looking statements with respect to the operations of the Company, strategies, prospects and other aspects of
the business of the Company are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such
forward-looking statements. These factors include, but are not limited to: (1) the Company has incurred significant losses since inception and anticipates that it will incur substantial losses for the foreseeable future; (2) the Company faces
significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company's products to become obsolete and if the Company does not
enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to
existing treatments and that its products should be used in their procedures; (5) the Company's ability to raise funds to expand its business; (6) the impact of any changes to the reimbursement levels for the Company's products and the
impact to the Company of the loss of preferred "pass through" status for PuraPly AM and PuraPly on October 1, 2020; (7) the Company's ability to maintain compliance with applicable Nasdaq listing standards; (8) changes in
applicable laws or regulations; (9) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; and (10) other risks and uncertainties described in the Company's filings with the
Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company's Form 10-K for the year ended December 31, 2018. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the
date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by
applicable securities laws. Unless otherwise noted, the forecasted industry and market data contained herein are based upon management estimates and industry and market publications and surveys. The information from industry and market publications
has been obtained from sources believed to be reliable, but there can be no assurance as to the accuracy or completeness of the included information. The Company has not independently verified any of the data from third-party sources, nor has the
Company ascertained the underlying economic assumptions relied upon therein. While such information is believed to be reliable for the purposes used herein, the Company makes no representation or warranty with respect to the accuracy of such
information. Forward-Looking Statements / Industry and Market Data
This Company has presented the
following measures that are not measures of performance under accounting principles generally accepted in the United States ("GAAP"): EBITDA and Adjusted EBITDA. EBITDA and Adjusted EBITDA are not measurements of our financial
performance under GAAP and these measures should not be considered as an alternative to net income, operating income or any other performance measures derived in accordance with GAAP or as an alternative to cash flows from operating activities as a
measure of our liquidity. EBITDA as used herein is defined as net income (loss) attributable to Organogenesis Holdings Inc. before depreciation and amortization, net interest expense and income taxes and the Company defines Adjusted EBITDA as
EBITDA, further adjusted for the impact of certain items that the Company does not consider indicative of its core operating performance. These items include non-cash equity compensation, mark to market adjustments on the Company's warrant
liabilities, change in fair value of interest rate swaps and its contingent asset and liabilities, write-off of deferred offering costs, merger transaction costs related to the Business Combination and a loss on the extinguishment of debt. The
Company presented Adjusted EBITDA in this presentation because it is a key measure used by the Company's management and Board of Directors to understand and evaluate the Company's operating performance, generate future operating plans and make
strategic decisions regarding the allocation of capital. In particular, the Company's management believes that the exclusion of certain items in calculating Adjusted EBITDA can produce a useful measure for period-to-period comparisons of the
Company's business. The Company's management does not consider these non-GAAP measures in isolation or as an alternative to financial measures determined in accordance with GAAP. Other companies may calculate EBITDA, Pro Forma Adjusted
EBITDA and Pro Forma Adjusted EBITDA Margin and other non-GAAP measures differently, and therefore The Company's EBITDA, Pro Forma Adjusted EBITDA and Pro Forma Adjusted EBITDA Margin and other non-GAAP measures may not be directly comparable
to similarly titled measures of other companies. A reconciliation of Non-GAAP measures used in this presentation to the most closely comparable GAAP measure is set forth in the Appendix. Use of Non-GAAP Financial Measures
Key Company Highlights Notes: Includes
studies yet to publish data and retrospective projects. Number of facilities that have ordered products in 2018. Experienced Leadership with Track Record of Execution Differentiated and Comprehensive Suite of Products ~245 Direct Sales
Representatives 450,000+ Square feet across 4 dedicated facilities 200+ Publications reviewing Organogenesis products 14 Ongoing studies(1) 3,000+ Healthcare facilities served in 2018(2) ~155 Independent Agencies 1 2 3 4 5 6 Attractive End Markets
Rapidly Scaling Business with Multiple Levers for Growth Established and Scalable Infrastructure Robust Clinical Data Supporting Products Proven R&D Engine with Deep Pipeline $4.7Bn+ Surgical & Sports Medicine Market (S&SM) $7Bn+
Advanced Wound Care Market (AWC) Pipeline products expected to be launched in next 2 years 5 Low-to-mid Teens Revenue Growth CAGR Interim Financial Target (2019 through 2022)
Experienced Management Team Name/Title
Background Information Howard Walthall EVP, Strategy and Market Development Gary Gillheeney, Sr President & Chief Executive Officer Tim Cunningham Chief Financial Officer Patrick Bilbo Chief Operating Officer Brian Grow Chief Commercial Officer
6 years as President and CEO of NuTech Medical Previously served as partner at Burr & Forman, specializing in technology law and litigation 25+ years in senior leadership positions in both public and private organizations Served as President and
CEO of Organogenesis since 2014 16 years at Organogenesis; also served as COO and CFO Recognized as one of Ernst & Young's 2009 "Entrepreneur of the Year" Earlier career in public accounting with Big 4 accounting firms followed
by 20+ years leading Finance in private equity and venture backed companies to an IPO or a sale Certified Public Accountant 2 years at Organogenesis 24 years with Organogenesis Previously held management and research positions at Hologic, Stryker,
and Harvard Medical School 14 years with Organogenesis Previously spent 3 years at Novartis / Innovex and 1 year at Bristol-Myers Squibb Innovative Clinical Solutions Lori Freedman VP and General Counsel 15+ years as general counsel and business
development executive - 14 years for public companies Most recently VP Corporate Affairs, General Counsel & Secretary of pSivida Corp. with earlier career at McDermott, Will & Emery Antonio Montecalvo VP, Health Policy and Contracting
15 years with Organogenesis 6 years experience of Provider contracting with UnitedHealth and 7 years public accounting experience with large local public accounting firms
Who We Are Leading regenerative
medicine company Technology spun out of MIT; HQ in Canton, MA Diversified commercialized product portfolio and robust new product development pipeline Operates in two large, attractive markets Advanced Wound Care Surgical & Sports Medicine
Strong commercial infrastructure ~750+ employees ~245 direct sales representatives ~155 independent agencies 3 manufacturing facilities & 2 contract manufacturers Robust financial profile $255.5 million of Revenue 2019E(1) 70.3% Q1 2019 gross
margin Several catalysts for double-digit topline growth & gross margin improvements Low-to-mid Teens Revenue Growth CAGR Interim Financial Target (2019 through 2022) Low-to-mid 70s Gross Margin Interim Financial Target (2019 through 2022)
Adjusted EBITDA of break-even Interim Financial Target Product Portfolio Overview Company Overview Commercialized Products Pipeline Notes: Based on mid-point of updated 2019 revenue guidance provided on 5/10/19 Affinity production suspended
Comprehensive and Differentiated
Product Portfolio Product Product Description Regulatory Pathway Clinical Application Bioengineered living cell therapy that contains keratinocyte and fibroblast living cells PMA Venous leg ulcers Diabetic foot ulcers Bioengineered product with
living human fibroblasts, which are seeded on a bioabsorbable scaffold PMA Diabetic foot ulcers Purified native collagen matrix with broad-spectrum antimicrobial agent Designed to address challenges posed by bioburden and excessive inflammation of
the wound 510(k) Chronic and acute wounds (except 3rd degree burns) Surgical treatment of open wounds Dehydrated placental tissue graft preserved to retain all layers of the native tissue 361 HCT/P Chronic and acute wounds Tendon, ligament and other
soft tissue injuries Fresh amniotic membrane containing many types of viable cells, growth factors/cytokines, and extracellular matrix (ECM) proteins 361 HCT/P Chronic and acute wounds Tendon, ligament and other soft tissue injuries Cellular
suspension, stem cell-containing allograft derived from human amnion tissue and amniotic fluid 361 HCT/P (Potential BLA applications) Orthopedic surgical procedures including bony fusion Cryopreserved suspension of amniotic fluid cells and
morselized amnion from the same donor 361 HCT/P (Potential BLA applications) Chronic inflammatory and degenerative conditions; soft tissue injuries such as tendinosis and fasciitis Advanced Wound Care Surgical & Sports Medicine AWC / S&SM
Product portfolio protected by a range of barriers, including IP, know-how, trade-secrets, clinical data, market reputation, supply chain, manufacturing complexity, and robust commercialization infrastructure and relationships (1) Notes: Affinity
production suspended in Q1 2019 Minimal sales in AWC (VA) (2)
Attractive End Markets Benefitting from
Secular Tailwinds Market Overview Organogenesis Product Offering Advanced Wound Care ~$7.3bn market growing at a ~8% CAGR through 2024(1) ~80mm people globally suffer from chronic or acute wounds Components Include: Chronic wounds include venous leg
ulcers (VLUs), diabetic foot ulcers (DFUs), pressure ulcers, and surgical wounds(2) Acute wounds include burns, trauma wounds and surgical wounds Product portfolio addresses patient needs across the continuum of care Surgical and Sports Medicine
~$4.7bn market, growing ~10% annually Components Include: Bone fusion (e.g., spine fusion surgery): ~$1.7bn market(3) ~667K spine fusion surgeries in the US annually Tendon and ligament injuries; ~$1bn market(4) ~250K rotator cuff repairs and ~40K
outpatient achilles tendon repairs in the US annually Chronic Inflammatory and degeneration conditions (e.g., osteoarthritis (OA), tendonitis, plantar fasciitis: ~$2bn market)(3) OA affects ~30mm individuals in the US Product portfolio includes
regenerative orthobiologics addressing a wide variety of musculoskeletal injuries Key drivers of market growth include: Aging population Greater incidence of co-morbidities such as diabetes, obesity, cardiovascular and peripheral vascular disease
Increasing acceptance of advanced technologies to treat complex wounds Based on MedMarket Diligence. Excludes surgical incisions. Technavio (2015), Global Orthobiologics Market Report, retrieved September 25, 2017, from EMIS Professional Database,
excluding demineralized bone matrix, or DBM, and conventional allograft. Technavio (2015), Global Regenerative Medicine Market Report, retrieved September 26, 2017, from EMIS Professional Database. 1 Commercial Products Pipeline Products Commercial
Products Pipeline Products
Skin Substitutes is a Fast-growing,
Under-penetrated Sub-Market of the Advanced Wound Care Market AWC Product Categories Skin Substitute Sub-Market(1) Organogenesis' products are generally considered "skin substitutes" Sub-market has experienced double digit growth
but is still highly underpenetrated Less than 5% of addressable wounds are treated with skin substitutes(2) Organogenesis is well positioned as a key player in the skin substitute sub-market Key Drivers of Skin Substitute Market Include: Physician
and payer education about the effectiveness and benefits of these products Clinical data Overall growth of Advanced Wound Care market Skin Substitute Notes: Technavio (2016), Global Bioactive Wound Care Market Report, retrieved September 13, 2017,
from EMIS Professional Database. BioMed GPS SmartTrak 1 CAGR: 14.3% CAGR: 14.5%
Bacterial bioburden &
contamination Protease activity (e.g., MMPs(2)) Inflammatory cells & cytokine activity Impaired cellular signaling Incidence of chronic wounds is on the rise due to an aging US population and increasing co-morbidities (e.g., obesity, diabetes,
cardiovascular and peripheral vascular disease) Standard of Care (SoC) Alone Is Not Enough SoC Healing Rates at 12 Weeks Controls in RCTs(1) (3) USWR-Real World(1) Pressure Ulcers 40.0% (2 trials) 29.6% (66,577) VLUs 42.7% (20 trials) 44.1% (97,420)
DFUs 37.9% (26 trials) 30.5% (62,964) Inflammatory Proliferative Remodeling Organogenesis has a broad portfolio of skin substitutes to address wounds across the wound care continuum, which we believe results in better patient outcomes Why Wounds
Stall in the Inflammatory Phase: 2 Notes: Fife, CE. How Should Outpatient Wound Clinics Honestly Measure Success? Today's Wound Clinic. 2018; 12(4). Matrix metalloproteinases. RCT = randomized controlled trial. 1 2 3 1 2 3 Our Advanced Wound
Care Products Address Patient Needs Across the Continuum of Care
And Now Cover the Full
Spectrum of Addressable Wounds Addressable Wounds Type Distribution(2) Ability to Treat a Wide Range of Wounds Chronic Wounds: VLUs, DFUs and Pressure Ulcers Acute Wounds: Traumatic Wounds and Burns 2 % Wound type Distribution In WCC(2) Prior
to PuraPly AM launch (2016)(1) and NuTech acquisition (2017), Organogenesis' product portfolio only covered ~17% of addressable wounds Apligraf (VLUs and DFUs) and Dermagraft (DFUs) are PMA-approved, supported by robust clinical data, and
well-regarded by physicians, but priced at a premium and focused on "stalled" (more severe) VLUs and DFUs Competitors with lower-priced, non-PMA approved products hold considerable share "Bundled" reimbursement dynamics
favored smaller, lower-cost products in less severe addressable wounds Today, Organogenesis portfolio contains solutions for the full spectrum of addressable wounds PuraPly AM addresses biofilm earlier in treatment regimen, while Affinity and
NuShield provides additional treatment options at lower price points versus Apilgraf and Dermagraft Additional Product Offering Post PuraPly & NuTech(3) Product Offering Pre-PuraPly & Pre-NuTech PuraPly AM was launched in 2016, while PuraPly
was launched in 2015. Management Estimates (References: MEDICAL, DRUG, AND WORK-LOSS COSTS OF VENOUS LEG ULCERS Rice JB1 et al, e (2013); Gillespie DL, et al. J Vasc Surg. 2010;52(5 suppl):8S-14S; Healogics WCAW Infographic; Including pipeline
products of Novachor, PuraPly MZ, and PuraPly XT.
Our Product Offering is Broad and
Innovative Relative to Peers: Advanced Wound Care Products Skin Sub Skin Sub-Sheet/Flowable Skin Sub Honey ,TCC (cast), Dressings Skin Sub, NPWT, Skin Graft Device, Dressings Skin Sub, Enzymatic Debrider, PDGF, NPWT, Dressings Skin Sub, Ultrasonic
Debrider Skin Sub-Sheet/Flowable Skin Sub-Sheet/Flowable Human Cellular Bioengineered Graft Xenograft / Antimicrobial Xenograft Allograft PMA / BLA
Approved Products 4 0 1 0 1 0 0 0 2
Our Product Offering is Broad and
Innovative Relative to Peers: Surgical & Sports Medicine Products Amniotic Membrane, Amniotic Suspension, Xenograft Amniotic Membrane, Amniotic Suspension Dermal Template, Amniotic Membrane, Amniotic Suspension, Tendon Reinforcement, Collagen
Sheets and Powders Amniotic Membrane, Tendon Reinforcement Orthobiologics Orthobiologics Orthobiologics, Tendon Reinforcement, Amniotic Suspension, Amniotic Membrane Platelet Rich, Plasma Solutions Hyaluronic Acid Injections Spine Fusion
Extremity Fusion Tendon Repair OA Degenerative Acute Surgical Wound 2 Multiple Multiple
1998 - 2013 2014 2016 2017
2019E+ Proven R&D Engine Supporting Several Recent and Expected Near-term Product Launches Additional growth drivers BLA approval BLA approval Year introduced to portfolio 1998 2014(1) 2016(2) 2017(3) 2017(3) 2017(3) 2017(3) 2019E 2020E 2020E
2020E 2020E Product Market AWC SS&M Pipeline 3 Notes: Acquired through Shire in 2014; Dermagraft originally
launched in 2001. PuraPly AM was launched in 2016, while PuraPly was launched in 2015. Acquired from NuTech in 2017; products originally launched in 2009 (NuCel), 2010 (NuShield), 2014 (Affinity) and 2015 (ReNu). 12+ Key Products