Organogenesis Holdings Inc. · NASDAQ:ORGO
Organogenesis — Investor Presentation (May 2019)
50 slides from Organogenesis's investor presentation, May 22, 2019
Slide 1: Corporate Presentation May 2019
Corporate Presentation May 2019 Exhibit 99.1
Slide 2: Forward-looking statements
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 con
Slide 3: Use of Non-GAAP Financial Measures
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
Slide 4: Key Company Highlights
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+
Slide 5: Experienced Management Team
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 Presi
Slide 6: Who We Are
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 infrastru
Slide 7: Comprehensive and Differentiated Product Portfolio
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 fibroblas
Slide 8: Attractive End Markets Benefitting from Secular Tailwinds
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 (VL
Slide 9: Skin Substitutes: Fast-growing, Under-penetrated Sub-Market
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 underpenetrate
Slide 10: Standard of Care Alone Is Not Enough
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 vasc
Slide 11: Now Cover the Full Spectrum of Addressable Wounds
… 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)
Slide 12: Product Offering vs Peers: Advanced Wound Care
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-
Slide 13: Product Offering vs Peers: Surgical & Sports Medicine
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 Amni
Slide 14: Proven R&D Engine Supporting Product Launches
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
Slide 15: TransCyte – Approved Product in Attractive Market
TransCyte – Approved Product in an Attractive Market with Limited Competition Product Description Market Opportunity TransCyte is a bioengineered tissue scaffold that promotes burn healing Provides bioactive dermal components an outer protective barrier Increases re-epithelialization and pain relief
Slide 16: ReNu – Expected BLA Approval Opens Large Market
ReNu™— Expected BLA Approval Opens Up Large and Growing Market Opportunity Surgical & Sports Medicine Product Description Market Opportunity ReNu is a cryopreserved suspension of amniotic fluid cells and morselized amnion tissue from the same donor Formulated for office use (injection) Used to suppo
Slide 17: Additional Products in Near-term Pipeline
Additional Products in Near-term Pipeline Product Product Description Clinical Application Expected Launch Regulatory Pathway Version of PuraPly Antimicrobial with enhanced thickness and PHMB content Allows for sustained presence of the antimicrobial barrier in the wound Chronic and acute wounds (ex
Slide 18: Robust Clinical Data: Advanced Wound Care
Robust Clinical Data Supporting Products: Advanced Wound Care Product Indication Design Est. Completion Date(1) Est. Data Presentation Date(2) Acute and Chronic Wounds 40 patient, Single Center Controlled Prospective Evaluation Completed Accepted for Publication Acute and Chronic Wounds 100 patient,
Slide 19: Robust Clinical Data: Surgical & Sports Medicine
Robust Clinical Data Supporting Products: Surgical & Sports Medicine Product Indication Design Est. Completion Date(1) Est. Data Presentation Date(2) Lumbar Spine Vertebral Fusion 60 patient Prospective, Efficacy Study of NuCel in patients Undergoing Fusion for One, Two or Three Level Degenerative D
Slide 20: Well Established Commercial Capabilities
Well Established Commercial Capabilities… Sales Marketing Additional Support Infrastructure Supports Customer Relationships Across Continuum of Care Hospital Outpatient Wound Care Clinic In-patient Hospital/ASC Veterans Affairs Private Office ~245 Experienced Direct Sales Reps Nationwide Opportunity
Slide 21: High-Quality Manufacturing Facilities
High-Quality Manufacturing Facilities Canton, MA Birmingham, AL La Jolla, CA 65 85 150 275 Organogenesis has six facilities, including three manufacturing facilities (Canton, MA, Norwood, MA, and La Jolla, CA) Proven large-scale commercial cell manufacturing company Multiple levels of quality contro
Slide 22: Historical Evolution and Strategic Plan
Historical Evolution Strategic Plan Product Suite Apilgraf and Dermagraft indicated for only ~17% of addressable wounds, but are supported by robust Advanced Wound Care sales force and commercialization infrastructure PuraPly AM introduced in 2016(1) and amniotic portfolio (NuTech) acquired in 2017
Slide 23: Financial Overview
Financial Overview 22 Organogenesis Organog
Slide 24: Fiscal 2019 Guidance
Fiscal 2019 Guidance Fiscal Year 2019 Revenue Guidance: The Comp: i ar December 31, 2019, the Company expects: % to 35% December 31, 2018. « The 2019 net revenue forecast assumes: 7 ¢ 33% to 39% yt -year as compared. $164.3 million for _ baie months ended December 31, , 2018. © Netrevenue from as co
Slide 25: Detailed Historical P&L (Audited)
Detailed Historical P&L – Organogenesis Holdings Inc. Source: Audited Financials (in thousands)
Slide 26: Detailed Historical P&L (10-Q)
Detailed Historical P&L – Organogenesis Holdings Inc. Source: Form 10-Q (unaudited)
Slide 27: Quarterly Statements of Operations
Quarterly Statements of Operations – Organogenesis Holdings Inc. Source: Company Filings (unaudited)
Slide 28: Interim and Longer-Term Financial Targets
Interim and Longer-Term Financial Targets Revenue Growth Gross Margin R&D (% of Net Revenue) SG&A (% of Net Revenue) Adjusted EBITDA Margin 10%+ 80% 7% 50% 20%+ Longer-Term Goal Low-to-mid teens CAGR Low-to-mid 70’s 7 – 8% Mid-to-high 60’s Breakeven Interim Target
Slide 29: Detailed Historical Balance Sheet
Detailed Historical Balance Sheet – Organogenesis Holdings Inc. (in thousands) Source: Form 10-Q (unaudited)
Slide 30: Detailed Historical Cash Flow
Detailed Historical Cash Flow – Organogenesis Holdings Inc. (in thousands) Source: Form 10-Q (unaudited)
Slide 31: Adjusted EBITDA Reconciliation
Adjusted EBITDA Reconciliation – Organogenesis Holdings Inc. Notes: Amount reflects the change in fair value of the common shares associated with the shares issued in connection with the acquisition of NuTech Medical that are forfeitable by the sole stockholder of NuTech Medical upon the occurrence
Slide 32: Appendix: Technologies, Reimbursement, & Customer Support
Appendix: Technologies, Reimbursement, & Customer Support
Slide 33: Experienced Management Team (Cont.)
Experienced Management Team (Cont.) Name/Title Background Information Tom Pearl VP, Human Resources Shabnam Vaezzadeh VP, Global Medical and Clinical Affairs Zorina Pitkin SVP, Quality Systems Chris O’Reilly VP, Manufacturing Operations Over 21 years in Human Resources in progressive leadership posi
Slide 34: Multiple Product Technology Platforms
Multiple Product Technology Platforms Platform Product Technology Description Products produced from living allogeneic cells Potential wound and surgical regenerative therapies BLA regulatory pathway Porcine collagen biomaterial technology platform Incorporates patented tissue cleaning processes to
Slide 35: Reimbursement Overview – Advanced Wound Care
Reimbursement Overview – Advanced Wound Care Medicare Physician Office Outpatient Hospitals / ASCs Product paid Average Sales Price (ASP) + 6% Not geographically adjusted Payers Have Separate Payment For Advanced Wound Care Products Established reimbursement for Organogenesis Advanced Wound Care pro
Slide 36: PuraPly Reimbursement Dynamics
PuraPly Reimbursement Dynamics PuraPly benefits from a two-year reinstatement of pass-through reimbursement status effective 10/1/18 Management plans to utilize this favorable reimbursement dynamic over the next two years to refine the PuraPly go-to-market strategy in advance of pass-through exit on
Slide 37: PuraPly Reimbursement Background
PuraPly Reimbursement Background PuraPly AM is a purified native porcine type I collagen matrix embedded with polyhexamethylene biguanide, or PHMB, a localized broadspectrum antimicrobial for the management of multiple wound types Product is differentiated in that it helps manage bioburden while als
Slide 38: Reimbursement Overview – Surgical & Sports Medicine
Reimbursement Overview – Surgical & Sports Medicine Most Payers Do Not Reimburse Separately for Surgical Products Most payers (Medicare, Medicaid and commercial) include the payment for surgical products in the overall payment for the procedure Medicare reimburses hospital inpatient stays based on t
Slide 39: Comprehensive In-House Customer Support
Comprehensive In-House Customer Support Benefit verification/ Prior authorization Assurance Program Claims review support Coding, coverage and payment tools Alternative funding program Patient assistance program Provide technical and medical consultation on product use Field support to customers Sup
Slide 40: Comprehensive Healthcare Compliance Program
Comprehensive Healthcare Compliance Program Healthcare Compliance Program To help ensure compliance with the laws and regulations governing the provision of health care goods and services, we have implemented a comprehensive compliance program based on the HHS Office of Inspector General’s Seven Ele
Slide 41: Appendix: Product Details
Appendix Product Details Organogenesis
Slide 42: Apligraf
Apligraf Advanced Wound Care Description / Clinical Application Technology Key Attributes Bioengineered, bi-layered skin substitute Contains two living cell types: human epidermal keratinocytes and human dermal fibroblasts Only product PMA approved for VLUs and DFUs Drives faster healing and more co
Slide 43: Apligraf’s Proven Clinical Efficacy
Apligraf’s Proven Clinical Efficacy Advanced Wound Care Venous Leg Ulcer Clinical Data(1) Diabetic Foot Ulcer Clinical Data(2) Complete Wound Closure Complete Wound Closure (% of patients Closed) (% of patients Closed) Time in Study Time in Study Notes: Falanga V, Sabolinski ML. A bilayered living s
Slide 44: Dermagraft
Dermagraft Advanced Wound Care Description / Clinical Application Technology Key Attributes Dermal substitute grown from human dermal fibroblasts Helps restore the compromised wound bed to facilitate healing PMA approval for DFUs Produces many of the same proteins and growth factors which support th
Slide 45: Dermagraft Phase III Results
Dermagraft Advanced Wound Care In the Phase III pivotal trial, Dermagraft plus conventional therapy resulted in significantly more patients with DFUs >6 weeks duration achieving complete wound closure by 12 weeks vs conventional therapy alone (30% vs 18%, P=0.023)(1,2) Patients reported being ambula
Slide 46: PuraPly Antimicrobial (AM)
PuraPly Antimicrobial (AM) Description / Clinical Application Technology Key Attributes Clinical Update Purified native collagen matrix with broad-spectrum polyhexamethylene biguanide (PHMB) antimicrobial agent 510(k) clearances for management of multiple wound types and surgical treatment of open w
Slide 47: Affinity – Currently Off Market
Affinity – Currently Off Market Description / Clinical Application Two clinical trials currently in process: 100 patient RCT: Affinity vs. standard of care for DFUs 20 patient prospective study: Closure time for chronic VLUs treated with Affinity Technology Key Attributes Clinical Update Fresh amnio
Slide 48: NuShield
NuShield Description / Clinical Application Technology Key Attributes Clinical Update Dehydrated placental tissue graft Topically or surgically applied to the target tissue to support healing of acute and chronic wounds across a range of sizes Regulated as a 361 HCT/P Preserved utilizing proprietary
Slide 49: NuCel
NuCel Surgical & Sports Medicine Description / Clinical Application Technology Key Attributes Clinical Update Surgically implanted allograft derived from human amniotic tissue and amniotic fluid Regulated as a 361 HCT/P Used primarily in spinal and orthopedic surgical applications to support tissue
Slide 50: ReNu
ReNu™ Description / Clinical Application Technology Key Attributes Clinical Update Cryopreserved suspension of amniotic fluid cells and morselized amnion tissue from the same donor Regulated as a 361 HCT/P Used to support healing of soft tissues, particularly in degenerative conditions such as OA an
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