Mobius Tx, Company Overview, 2017

21
therapeutics™ Mobius Therapeutics, LLC Company Overview

Transcript of Mobius Tx, Company Overview, 2017

Page 1: Mobius Tx, Company Overview, 2017

therapeutics™

Mobius Therapeutics, LLC

Company Overview

Page 2: Mobius Tx, Company Overview, 2017

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

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The Team

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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

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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

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The Products

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therapeutics™ The Mitosol® Kit System: 2017

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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

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Clinical Indications

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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

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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

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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

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Franchise Protection

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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

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Mobius Eye-BX™

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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

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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

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therapeutics™ The Solution: Mobius™ Eye-BX™ Tap and Injection Kit

Mobius Eye-BX™ Procedure Kit

Prep components

Tap/Injection components

Antibiotics

Prefilled WFI

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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

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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

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therapeutics™ Mobius Therapeutics™: Pipeline

Intraoperative Mydriatic: Cataract and Vitreoretinal Surgery

Hyaluronidase: Vitreoretinal, Oculoplastic, Pediatric, Cataract Surgery

Intraoperative Miotic: Cataract, Glaucoma, Cornea Surgery