Harrow, Inc. · NASDAQ:HROW
Harrow — Imprimis Pharmaceuticals — Investor Presentation (May 2017)
30 slides from Harrow's investor presentation, May 16, 2017
Slide 1: Corporate Presentation May 2017
elon CORPORATE PRESENTATION MAY 2017
Slide 2: Safe Harbor
phar mia-cee-u tiene | s SAFE HARBOR = This presentation contains express “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995; Yoularé cautioned not to relyon these —~ forward-looking statements. These statements are based on current expectations of future
Slide 3: Abstract
ABSTRACT Eton is a subsidiary of Imprimis Pharmaceuticals, Inc. (NASDAQ: IMMY) Focus on 505(b)(2) patent-pending drug candidates with multiple potential indications in billion dollar markets with single incumbent competition Eton will be funded and managed outside of Imprimis Initial development ass
Slide 4: 505(b)(2) & DESI: Faster Path to Approval
505(B)(2) & DESI: FASTER 505(B)(2) + Potential for lower risk due to reference product approval * Lower cost, accelerated development, fewer studies * Can rely on already completed clinical trials, existing data * May qualify for 3-5 years of exclusivity (extended with IP) + Shorter path to approval
Slide 5: MS Relapse & Infantile Spasms: Synthetic Corticotropin
a i t 4 "MS RELAPSE & INFANTILE SPAS MS SYNTHETIC CORTICOTROPIN (FOR INJECTION)
Slide 6: MS Relapse & Infantile Spasms: Synthetic Corticotropin
a i t 4 "MS RELAPSE & INFANTILE SPAS MS SYNTHETIC CORTICOTROPIN (FOR INJECTION)
Slide 7: Market Analysis: H.P. Acthar Gel
MARKET ANALYSIS HP ACTHARGEL Adrenocorticotropic hormone analogue used for various indications (see slide 9) HP. Acthar® Gel was acquired by Mallinckrodt in 201 4 through $5.8B Questcor acquisition? Questcor’s sole commercial asset was H.P. Acthar® Gel 2016 net annual sales for H.P. Acthar® Gel est.
Slide 8: Corticotropin Formulation
CORTICOTROPIN FORMULATION Eton synthetic formulation mimics amino acid chain of 7 HP. Acthar® Gel j HQ Patent-pending technology stabilizes a known unstable molecule Eton formulation description: + 39-chain amino acid peptide synthetic adrenocorticotrophic hormone + Preservative free and non-gelatin
Slide 9: Competitive Analysis
COMPETITIVE ANALYSIS - = ani i tained RUDE a, ACTHAR GEL CCORTICOTROPIN (ZINC) SYNACTHEN* SYNTHETIC CORTICOTROPIN FDA APPROVED WORKING TOWARDS FIC FORCED LICENSE OF rouse (1952) sNDA SUBMISSION DRUG RIGHTS 505(B)(2) API SOURCE PORCINE PITUITARY PORCINE PITUITARY SYNTHETIC GLANDS GLANDS AMINO ACID PE
Slide 10: Estimated Target Markets
ESTIMATED TARGET MARKETS® FISCAL 2016" || FiscaL 2016* -ATIENTS ACTHA! TREATED W/ |) NOT TREATED ADDRESS. "ACTHAR W/ACTHAR TIENTS. a PROTENIURIA REMISSION IN 12° = DERMATOMYOSTIS, i RHEUMATOID ARTHRITIS 828. iva 318,694 11,227 307,467 “Estimate and based on Mallinckrodt Pharmaceuticals, inc. fiscal
Slide 11: Scenario
SCENARIO 1 SCENARIO 2 FDA agrees that the product is the “same as” the naturally derived product Potential for significant CMC and possibly some immunogenicity work but not sophisticated analytical testing. Must demonstrate we meet current impurity and degradation limits under ICH No additional toxi
Slide 12: Peyronie's Disease: Pentoxifylline (for Injection)
PEYRONIE’S DISEASE PENTOXIFYLLINE (FOR INJECTION}
Slide 13: Disease Profile and Market Analysis
DISEASE PROFILE AND MARKET ANALYSIS PENTOXIFYLLINE Peyrorie’s disease (PD) is the development of fibrous scar tissue (plaque) inside the penis that causes curved, painful erections Symptoms can include: significant bend to and/or shortening of penis, penile pain with or without erection, and erectil
Slide 14: Peyronie's Program Advantages
ETON PHARMACEUTICALS PEYRONIE’S PROGRAM ADVANTAGES Patent-pending formulation of pentoxifylline in solution as an injectable for the treatment of symptoms associated with PD Generic, oral pento: treatment for cert symptoms!¢ ylline is prescribed off-label as first-line patients suffering from PD for
Slide 15: Initial Studies of Eton Pentoxifylline Formulation
INITIAL STUDIES OF ETON PENTOXIFYLLINE FORMULATION Investigator-initiated study conducted at leading university to study up to 10 patients with PD Goal was to determine: + Efficacy of injectable pentoxifylline for treatment of PD; identify ideal patient responders + Gain experience with the formulat
Slide 16: Near Term Opportunities: DESI Drugs
al NEAR TERM OPPORTUNITIES DES! DRUGS
Slide 17: DESI Opportunities
DESI OPPORTUNITIES: COMPETITIVE ANALYSIS + FDA program Drug Efficacy Study Implementation (DES!) for drugs that came to market before 1962 prior to FDA approval for a drug requiring efficacy + FDA can approve a new-drug application for a DESI drug and developer of the new drug may get a new period o
Slide 18: DESI Asset #1
DESI ASSET#1 Current product sales not captured by IMS, ‘opportunity may be undervalued by the market * Product is mostly sold direct to hospitals Scarce API has been secured with long-term exclusive supply agreement Development work is completed, registration batch production to be manufactured in
Slide 19: DESI Asset #2
DESI ASSET#2 Well known to physicians with decades long track record, providing immediate potential demand for product upon launch with no promotional spending + There are no substitute prescription alternatives currently approved by the FDA Finalizing development activities; registration batch prod
Slide 20: Management and Summary
MANAGEMENT AND SUMMARY
Slide 21: Key Team Members
KEY TEAM MEMBERS Chief Executive Officer: Over 20 years of experience in the pharmaceutical industry. Mostly serving as senior executive in corporate development for multi-billion dollar pharma companies; has led over 100 transactions contributing hundreds of millions of dollars of annual revenve. D
Slide 22: Summary
SUMMARY 505(b)(2) sterile injectable development focused Eton is a subsidiary of Imprimis Pharmaceuticals, Inc. Eton will be funded and managed outside of Imprimis as a separate entity Assembling experienced management and Board to carryout strategy Two proprietary assets intended to treat diseases
Slide 23: Appendix
APPENDIX
Slide 24: References
REFERENCES 12. ‘Mallinckrodt Pharmaceuticals: Jefferies London NDR Investor Presentation. (2017, March). Retrieved May 11, 2017. Internal business data, 2017, based on assumptions with respect to pricing, reimbursement, market penetration and other factors. Actual results and future estimates may di
Slide 25: References
REFERENCES 13. 14, 15. 16. 17. 18. 19. 20. Pollack, A. (2013, December 6}. Injections to Treat an Embarrassing Ailment Win U.S. Approval. Retrieved May 11, 2017, from http://www.nytimes.com/201 3/12/07 /business/fda-approves- treatment-for-curved:-penis.html XIAFLEX® Full Prescribing Information. (n
Slide 26: Operational Plan
180 DAY OPERATIONAL PLAN Assemble experienced management team and empanel Board of Directors * Qualified candidates have 505(b)(2) and NDA submission experience Request and prepare package for Pre-IND meeting with FDA regarding synthetic corticotropin asset * Justification and support for 505(b)(2)
Slide 27: Corticotropin Concentration 80U/mL Six Month Stability Study
CORTICOTROPIN CONCENTRATION 80U/ML SIX MONTH STABILITY STUDY 5 0* 140% i 0% LAs 110% HOOs or 80% Vale 60% 108 ©CT17.16 OCT.27.16 NOV.07.16 NOV.16.16 —DEC.16.16 © JAN.16.17 FEB.16.17 APR.I7.17 US. Pharmacopeia monograph for corticotropin ( ; Ina suitable dilvent, of material containing the polypeptid
Slide 28: Pre-IND Meeting Strategy: 505(b)(2)
PRE-IND MEETING STRATEGY: 505(B)(2) KEY QUESTIONS TO ANSWER: * Toxicology studies requirements or other non-clinical studies to support the NDA + Support with predicate data based on products used as Reference Listed Drug (RLD) ing studies requirements be rationalized with predicate data + Examples
Slide 29: H.P. Acthar Gel Indications
P. ACTHARGEL NDICATIONS Treatment di therapy in selected cases of systemic lupus erythematosus ‘Monotherapy for the treatment of infantile spasms ir and children under 2 years of age The treatment of acute exacerbations of mul in adults. Controlled clinical trials have shown HP. Acthar® Gel to be ef
Slide 30: Thank You
Imprimis Pharmaceuticals — Investor Presentation (May 2017) on 6ix