Organogenesis Holdings Inc. · NASDAQ:ORGO
Organogenesis — Investor Presentation (January 2019)
50 slides from Organogenesis's investor presentation, Jan 7, 2019
Slide 1: Corporate Presentation January 2019
Corporate Presentation January 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: 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 ~$7.3bn market growing at a ~8% CAGR through 2024(1) ~80mm people globally suffer from chronic or acute wounds Components Include: Chronic wounds include venous leg ulcers (VL
Slide 9: Skin Substitutes is a Fast-growing, Under-penetrated Segment
Skin Substitutes is a Fast-growing, Under-penetrated Segment of the Advanced Wound Care Market AWC Product Categories Skin Substitute Market(1) Organogenesis’ products are generally considered “skin substitutes” Market has experienced double digit growth but is still highly underpenetrated Less than
Slide 10: Standard of Care Alone Is Not Enough
Bacterial bioburden & contamination Protease activity (e.g., MMPs(2)) Inflammatory cells & cytokine activity Impaired cellular signaling Incidence of chronic wounds is on the rise due to an aging US population and increasing co-morbidities (e.g., obesity, diabetes, cardiovascular and peripheral vasc
Slide 11: Now Cover the Full Spectrum of Addressable Wounds
… And Now Cover the Full Spectrum of Addressable Wounds… Addressable Wounds Type Distribution(2) Ability to Treat a Wide Range of Wounds Chronic Wounds: VLUs, DFUs and Pressure Ulcers Acute Wounds: Traumatic Wounds and Burns 2 % Wound type Distribution In WCC(2) Prior to PuraPly AM launch (2016)(1)
Slide 12: Accelerating Growth of Amniotic Portfolio
… With Accelerating Growth of Amniotic Portfolio… ($ in mm) Amnions from NuTech sold by AWC sales reps – Quarterly Revenue Ability to include acquired products “in the bag” of Advanced Wound Care sales reps is driving robust sales growth 2 NuTech Organogenesis(1) Introduction of amnions to Advanced
Slide 13: Increasing Account Reach and Penetration
A complete product offering enables reps to better reach and penetrate accounts Potential to fully address physician needs; strengthen relationship and drive convenience of “one-stop shop” Active account results demonstrate complete Advanced Wound Care product offering is driving account growth and
Slide 14: Early Wins in Market Share Agreement Opportunity
… And Facilitating Early Wins in Large Market Share Agreement (MSA) Opportunity Organogenesis is continuing to grow its commercial presence, expanding the number of agreements signed with GPOs and IDNs More than 4,000 facilities now covered by contracts(1) The company’s broad product portfolio enabl
Slide 15: Product Offering is Broad and Innovative Relative to Peers
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 16: Continued Penetration of Surgical & Sports Medicine Market
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 17: Broad and Innovative 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 18: Proven R&D Engine Supporting Product Launches
1998 – 2013 2014 2016 2017 2018E+ Proven R&D Engine Supporting Several Recent and Expected Near-term Product Launches Additional growth drivers BLA approval Out-license BLA approval Year introduced to portfolio 1998 2014(1) 2016(2) 2017(3) 2017(3) 2017(3) 2017(3) 2019E 2019E 2019E 2019E 2020E Produc
Slide 19: 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 20: 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 21: 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 22: 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 23: 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 24: 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 ~200 Experienced Direct Sales Reps Nationwide Opportunity
Slide 25: 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 26: 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 27: Financial Overview
Financial Overview Organogenesis
Slide 28: Pro Forma Revenue Growth – Organogenesis Inc.
Pro Forma Revenue Growth – Organogenesis Inc.* Notes: PuraPly was approved for pass-through status on 7/22/2015 and reverted to bundle payment status on 12/31/17. PuraPly pass-through status restored as of 10/1/2018 through 9/30/2020. Pro forma PuraPly calculated by applying 2017A net pricing to Q1
Slide 29: 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 30: Detailed Historical P&L – Organogenesis Inc.
Detailed Historical P&L – Organogenesis Inc.* * Reflects historical financial information for Organogenesis Inc., which became a wholly owned subsidiary of the Company as a result of the Business Combination on December 10, 2018
Slide 31: Appendix: Technologies, Reimbursement, & Customer Support
Appendix: Technologies, Reimbursement, & Customer Support
Slide 32: 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 33: 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 34: Reimbursement Overview – Medicare
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 35: 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 36: 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 37: 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 38: 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 39: Pro Forma Revenue Reconciliation – Organogenesis Inc.
Pro Forma Revenue Reconciliation – Organogenesis Inc.* Notes: Amount reflects the revenue attributable to NuTech Medical prior to the completed acquisition of NuTech Medical on March 24, 2017. Amount reflects adjustment to calculate Pro forma PuraPly Revenue by applying 2017A net pricing to Q1 2018,
Slide 40: Adjusted EBITDA Reconciliation – Organogenesis Inc.
Adjusted EBITDA Reconciliation – Organogenesis Inc.* Notes: Amount reflects the settlement received in 2015 in connection with a 2011 lawsuit filed against a former employee, alleging the breach of an Invention, Non-Disclosure and Non-Competition Agreement. Amount reflects the change in fair value o
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
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
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 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 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 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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