Mobius Tx, Company Overview, 2017
Transcript of Mobius Tx, Company Overview, 2017
therapeutics™
Mobius Therapeutics, LLC
Company Overview
therapeutics™ What Mobius™ Looks for In a Molecule
1. Standard of care, as documented in the literature, but off label a. Creates potential for 505b2 – purely literature submission
2. In place economics, benchmarking pricing a. The "Goldliocks Price"
3. Problems with the clinical use of the agent: a. Resolution creates inherent value proposition b. Resolution creates defensible IP estate
Vancomycin Ceftazidime Mitomycin-C
The Team
therapeutics™ Executive Management
1. Ed Timm – Founder, President, and CEO a. +30 years life science: Sales, Marketing, R&D, RA/QA, International b. American Hospital Supply, Given Imaging, Storz, Synergetics c. 15 US patents, 10 international patents
2. Mark Wright – Chief Financial Officer a. CPA: PWC, Maybelline b. Everest Biomedical (sold to Stryker)
3. Owen Bishop – Vice President, Sales and Marketing a. R&D, Sales, Sales Analytics, Sales Management, National Accounts b. DuPont, Alcon, Roche
4. Christina Patullo – Vice President, Regulatory, Quality, and Compliance
a. +30 years pharmaceutical RA/QA experience b. Analytical chemistry, microbiology background c. RA/QA, R&D and compliance responsibilities
therapeutics™ Field Execution
1. Sales Management a. Owen Bishop
2. Sales Representatives
a. 25 US territories covering all 50 states + Puerto Rico
3. Medical Affairs a. Louis Schwartz, MD • Medical Director • Emeritus Clinical Professor of Ophthalmology: Thomas Jefferson University • Emeritus Attending Surgeon on the Glaucoma Service: Wills Eye Hospital
b. Linda Kalata, RN, BSN, CNOR • Clinical Applications • + 30 years ophthalmic OR experience • OR Manager, educator, staff • 2 years with ORBIS
The Products
therapeutics™ The Mitosol® Kit System: 2017
therapeutics™
vs. Compounding Compounding
Assured Sterility No Yes Assured Potency No Yes Assured Dosing No Yes AORN Compliant Sterile Transfer No Yes cGMP Manufacturing Controls No Yes Directions for Use No Yes Shelf Life 5 - 14 days 24 months "Black Box Warning" Removed No Yes Room Temp Storage No Yes Closed Fluid Transfer No Yes NIOSH Compliant Disposal No Yes
Clinical Indications
therapeutics™ Mitosol® in MIGS
Market Opportunity
■SLT
■Medically Non-Compliant
■Ex-PRESS®
¹ MarketScope
Addressable market¹ - USA
588,000
664,187
804,000
908,174
1,392,000
2013E 2017E
SLT MEDs
1
2
Indications
Players ■AqueSys 2017 ■ Allergan
■Transcend 2017 ■ Alcon/Novartis
■ InnFocus 2018 ■ Santen
1
2
3
1,572,361
3
therapeutics™ Mitosol® in Pterygium Surgery
MMC usage today
■Used to reduce recurrence
■ Inhibits pathogenesis subsequent to excision
■First published use in ophthalmology
Addressable market¹
¹ Management developed figures based upon a combination of CMS data and State of California data
79,200 87,443
237,600 262,330
316,800 349,773
2011E 2016E
US OUS
therapeutics™ Mitosol® in Keratorefractive Surgery
MMC usage today
■PRK (photorefractive keratectomy)
■Epi-LASIK
■LASEK
■PTK (phototherapeutic keratectomy)
■LASIK enhancement
■Refractive IOL enhancement
■PRK over PKP
Addressable market¹
1
2
3
4
5
Used to minimize haze
6
7 96,288
160,484
503,658
514,584
599,946
675,068
2011E 2016E
US OUS
Franchise Protection
therapeutics™ Six Issued US Patents
■US Patent #: 7,806,265
■US Patent #: 8,186,511
■US Patent #: D685,962
■US Patent #: D685,963
■US Patent #: 9,205,075
■US Patent #: 9,539,241
■US Pat App #: 14/933,513 (Allowed, 30 January 2017)
■Expiration: 2029
Mobius Eye-BX™
therapeutics™ Endophthalmitis
Acute, prolific intraocular infection
≈60% post-intraocular surgery/injection
2.4 million penetrating eye injury annually USA
ED Treatment: Tap + Injection of ABX
Poor prognosis
Endophthalmitis, Day 8 (VA = NLP) Common Penetrating Eye Injury
therapeutics™ ABX in Endophthalmitis: Problems with Use
Ordering from outside pharmacy
Unstable: Refrigeration required – Max shelf life of 14 days
MD Clinic Time: A "Clinic Buster"
Inefficient: Vast majority of compounded product is wasted
Profound risk of overdose, dosing irregularities
therapeutics™ The Solution: Mobius™ Eye-BX™ Tap and Injection Kit
Mobius Eye-BX™ Procedure Kit
Prep components
Tap/Injection components
Antibiotics
Prefilled WFI
therapeutics™ Mobius™ Eye-BX™: Status
PIND Filed and Reviewed
Clear path to literature based approval
IRIS Database = Study Group
Three proprietary databases = Control
End Point: Non-Inferiority
therapeutics™ Mobius Therapeutics™: Strategic Plan
Sterile, injectable products in the ophthalmic OR
Surround surgical devices with high margin injectables
A portfolio of compatible products
Access to comprehensive ophthalmology
Access to multiple sub-specialties
Selected to attack vulnerable competition and compounded essential copies
Selected such that two or more products might apply to a single procedure
All focused upon a single call point
1. Mitomycin-c (Mitosol®): Glaucoma, Ocular Surface, Refractive Surgery
2. Vancomycin and Ceftazidime (Eye-Bx™): Vitreoretinal Surgery
therapeutics™ Mobius Therapeutics™: Pipeline
Intraoperative Mydriatic: Cataract and Vitreoretinal Surgery
Hyaluronidase: Vitreoretinal, Oculoplastic, Pediatric, Cataract Surgery
Intraoperative Miotic: Cataract, Glaucoma, Cornea Surgery