Organogenesis Holdings Inc. · NASDAQ:ORGO
Organogenesis — Investor Presentation (March 2019)
53 slides from Organogenesis's investor presentation, Mar 20, 2019
Slide 1: Corporate Presentation March 2019
Corporate Presentation March 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, Pro Forma Adjusted EBITDA, Adjusted Revenue and the related pro forma information. EBITDA, Pro Forma Adjusted EBITDA and Adjust
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 1H 2018. 2016 revenue pro forma for the acquisition of NuTech. 2019 based on mid-point of 2019E guidance Experienced Leadership with Track Record of Execu
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 is a 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 Broad and Innovative Relative to Peers: Advanced Wound Care
Our Product Offering is Broad and Innovative Relative to Peers: Advanced Wound Care Products Skin Sub Skin Sub Skin Sub Honey TCC (cast) Dressings NPWT Collagen Dressing Skin Graft Device Skin Sub Skin Sub Skin Sub Skin Sub Skin Sub Enzymatic Debrider, PDGF, Dressings Human Cellular Bioengineered Gr
Slide 13: Continued Penetration of Surgical & Sports Medicine Market Since NuTech
Organogenesis has Continued to Penetrate Surgical & Sports Medicine Market Since NuTech Acquisition Addressing a ~$4.7bn market, growing ~10% annually Product set includes orthobiologics that support the healing of musculoskeletal injuries, including chronic degenerative conditions such as OA and te
Slide 14: Product Offering Relative to 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 15: Proven R&D Engine Supporting Recent and Near-term 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 2019E 2019E 2020E 2020E Product Market AWC
Slide 16: TransCyte – Approved Product in an 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 17: ReNu – Expected BLA Approval Opens Large Market Opportunity
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 18: 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 19: Robust Clinical Data Supporting Products: Advanced Wound Care
Robust Clinical Data Supporting Products: Advanced Wound Care Product Indication Design Anticipated Completion Acute and Chronic Wounds 40 patient, Single Center Controlled Prospective Evaluation Completed, Accepted for Publication Acute and Chronic Wounds 100 patient, Single Center Controlled Prosp
Slide 20: Robust Clinical Data Supporting Products: Surgical & Sports Medicine
Robust Clinical Data Supporting Products: Surgical & Sports Medicine Product Indication Design Anticipated Completion Lumbar Spine Vertebral Fusion 60 patient Prospective, Efficacy Study of NuCel in patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine Q2 20
Slide 21: 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 ~215 Experienced Direct Sales Reps Nationwide Opportunity
Slide 22: Supported by High-Quality Manufacturing Facilities
… Supported by High-Quality Manufacturing Facilities Canton, MA Birmingham, AL La Jolla, CA 65 85 150 275 Organogenesis has three facilities, including two manufacturing facilities (Canton, MA and La Jolla, CA) which produce its non-amniotic products Proven large-scale commercial cell manufacturing
Slide 23: 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 24: Financial Overview
Financial Overview i NSIS 23 Organoger esis:
Slide 25: Fiscal 2019 Guidance
Fiscal 2019 Guidance Fiscal Year 2019 Revenue Guidance: he Company year ions which were introduced on January 7, 2019. For ing December 31, 2019, the Company © Netrevenue of| ili ili i 28% to 34% as compared $193.4 million for ded December 31, y thea 2019 net revenue forecast assumes: Advanced Wound
Slide 26: Detailed Historical P&L
Detailed Historical P&L – Organogenesis Holdings Inc. Audited Financials (in thousands)
Slide 27: Quarterly Statements of Operations
Quarterly Statements of Operations – Organogenesis Holdings Inc. Audited Financials
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 8 – 9% Mid-to-high 60’s Breakeven Interim
Slide 29: Pro Forma Balance Sheet Highlights
Pro Forma Balance Sheet Highlights Notes: PF cash adjustment is net of $3.4mm in fees and interest paid to retire the Notes Payable (Eastward) and fund the SVB/MidCap Term Loan. The Company entered a new credit facility to increase the commitment on the Revolver to $40mm. The balance shown reflects
Slide 30: Capitalization Summary
Capitalization Summary Notes: As of 12/31/18. Capitalization Summary(1) Percent (shares in mm) Shares Ownership Common Shares Outstanding 92.0 79.1% Stock Options 6.6 5.7% Warrants (common equivalents) 17.7 15.2% Total 116.3 100.0%
Slide 31: Detailed Historical Balance Sheet
Detailed Historical Balance Sheet – Organogenesis Holdings Inc. Audited Financials (in thousands)
Slide 32: Detailed Historical Cash Flow
Detailed Historical Cash Flow – Organogenesis Holdings Inc. Audited Financials (in thousands)
Slide 33: Detailed Historical Cash Flow
Detailed Historical Cash Flow – Organogenesis Holdings Inc. Audited Financials (in thousands)
Slide 34: 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 35: Appendix: Technologies, Reimbursement, & Customer Support
Appendix: Technologies, Reimbursement, & Customer Support
Slide 36: 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 37: 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 38: 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 39: 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 40: 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 41: 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 42: 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 43: 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 44: Appendix: Product Details
Appendix Product Details Organogenesis.
Slide 45: Apligraf Advanced Wound Care
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 46: 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 47: Dermagraft Advanced Wound Care
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 48: Dermagraft Phase III Pivotal Trial
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 49: 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 50: Affinity
Affinity 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 amniotic membrane containing
Slide 51: 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 52: NuCel Surgical & Sports Medicine
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 53: 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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