Corporate Presentation

Transcription

1 Carriers Injectable to oral Progressive/Practical Innovation Emisphere Products Corporate Presentation November 2015 Patients OTCBB: EMIS

2 Safe Harbor Statement The statements in this presentation or oral statements made by representatives of Emisphere relating to matters that are not historical facts are forward-looking statements that involve risks and uncertainties, including, but not limited to, the sufficiency of the Company s cash position, the Company s ability to enter into strategic partnerships, the Company s ability and/or that of its partners to develop, manufacture and commercialize products using Emisphere s drug delivery technology, and other risks and uncertainties detailed in Emisphere s filings with the Securities and Exchange Commission, including those factors discussed under the caption Risk Factors identified in the documents Emisphere has filed, or will file, with the Securities and Exchange Commission ( SEC ). Copies of Emisphere s filings with the SEC may be obtained from the SEC Internet site at Emisphere expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Emisphere s expectations with regard thereto or any change in events, conditions, or circumstances on which any such statements are based. 2

3 Investment Rationale Commercial-stage, revenue-generating company Two business sectors driving immediate and longterm revenue Commercial Business: Eligen B12 recently launched in the US Carrier Business: Partnerships generating non-dilutive funding Business development Broad range of growth initiatives underway 3

4 Oral prescription medical food Oral prescription Enhanced New Pipeline Product candidate Feasibility/discovery Preclin Phase 1 Phase 2 Phase 3 Registered/ Approved Market Oral semaglutide (GLP-1) Type 2 Diabetes Insulin Diabetes Novo Nordisk 1 Novo Nordisk 1 Phase 3 trials expected to commence 1Q16 Molecule 1 Metabolic indication 1 Novo Nordisk 2 Molecule 2 Metabolic indication 2 Novo Nordisk 2 Molecule 3 Metabolic indication 3 Novo Nordisk 2 Molecule 4 Metabolic indication 4 Novo Nordisk 2 Development / Regulatory Registered/ Approved Market Eligen B12 Vitamin B12 deficiency Eligen B12 Bariatric Nutrition Nutrient deficiency following bariatric surgery Eligen B12 + Folic Acid Folic acid deficiency anemia Novo Nordisk 2008 partnership Novo Nordisk 2015 partnership Developed by Emisphere 1 Based on information publicly disclosed by licensee; current as of August 26, Based on information publicly disclosed by Emisphere on October 15,

5 Eligen Technology Delivery System Mechanism of Action Carrier Transport Delivers API 5

6 Eligen Technology Delivery System Value Proposition Clinically proven: Safety/GRAS Efficacious Progressive alternative to injectables Comparable therapeutic outcomes Demonstrated delivery of newer marketed peptides 6

7 Key Highlights: Eligen Carriers Eligen Technology Applicable to a specific range of NCE s Focus: new/smaller proteins and peptides Strong emphasis on approved NDA s/bla s New oral formulations to replace injections Generated ~$44M in non-dilutive capital since

8 Oral semaglutide (GLP-1) Metabolic candidates Oral insulins Novo Nordisk Partnerships Phase 3 to commence 1Q 2016 Novo Nordisk positioning: first-line oral for Type II diabetes OD oral formulation Uses EMIS s SNAC carrier New license agreement with milestones/royalties Developing oral formulations of four proprietary molecules Targeting metabolic indications, including diabetes and obesity New and expanded feasibility work progressing Global leader in diabetes care 8

9 Oral Semaglutide Opportunity Oral semaglutide has the potential to be the best-in-class tablet Novo Nordisk s injectable for type 2 diabetes Considered current gold standard GLP-1 Dominates GLP-1 market Generated $1.2B in 1H15; 15% of Novo Nordisk sales Analysts project sales to exceed $3.0B in Efficacy expected to equal Victoza 2 Tablet version a game-changer in diabetes 2 Consensus projections: Launch in $270M Year 1 sales 1 Peak sales of $3.4B 2 EMIS entitled to Dev & Sales Milestone Payments + Royalty Stream 1 First Order Analytic, Ltd./Consensus Pipeline 2 UBS Investment Research published 26 August

10 New Multi-molecule Opportunities Signed major new licensing agreement with Novo Nordisk in Oct 2015 For oral formulation of 4+ molecule classes targeting major metabolic disorders (e.g. diabetes, obesity) Emisphere received $5M upfront Eligible for more than $207M in milestones, plus royalties on product sales Novo Nordisk solely responsible for development and commercialization of all product candidates Aggregate market potential over $100B 10

11 11

12 Eligen B12 The first and only high-dose, prescription oral vitamin B12 therapeutic ever launched Once daily; improves compliance Injection-strength B12 without the needle Significantly greater bioavailability than OTC Patent protected through 2029 The first and only prescription oral B12 available 12

13 Vitamin B12 Deficiency Up to 43% of Americans have low levels of vitamin B12 1 The body s ability to absorb dietary B12 declines steadily with age 2. More than 20% of people over 65 suffer from severe clinical B12 deficiency 3 B12 deficiency has been strongly linked to a variety of age-related and neurological and conditions including early dementia, cognitive impairment 4,5, depression 4,5, Parkinson s 6, and Alzheimer s disease 7,8 Widely used drugs to treat diabetes (Glucophage [metformin]) or reduce stomach acid (e.g., Prilosec, Prevacid, Tagamet, Zantac ) may also block B12 absorption 1,9. Inflammatory GI diseases (e.g., Crohn s, IBS, IBD, Celiac) are also strongly linked to B12 deficiency. 1 Prev Med Dec;39(6): QJM Jan;102(1): CMAJ Aug 3;171(3): Z Gerontol Geriatr Apr;37(2): Age Ageing Jul;35(4): Parkinsonism Relat Disord Jan;20(1): Neurology May 8;56(9): J Neurol Sci Sep 15;284(1-2): Rev Prat Sep 15;58(13):

14 Oral Eligen B12 Target Product Profile Physicians want a therapeutic that: Clinically proven Able to achieve 1000 pg/ml plasma levels by ~1 month Clinically meaningful effect on other important biomarkers Provides an easy regimen/better compliance Patients want an oral that: Eliminates painful, inconvenient injections Equally effective to an injection Preferably a once daily; easier to maintain consistent therapy 14

15 Eligen B12 Clinical Study Design Multicenter, randomized, open-label, parallel group study Comparing efficacy and tolerability of Eligen B12 to intermittent intramuscular (IM) vitamin B12 in restoring normal serum B12 Patients aged years; n=48 Primary endpoint: Efficacy at 60 days Secondary endpoints: Efficacy at 90 days and changes in methylmalonic acid (MMA) and homocysteine levels Source: Castelli, et all. Clin Ther Mar;33(3): e2. doi: /j.clinthera

16 B12 (pg/ml) Eligen B12 Clinical Data 3000 Mean B Baseline Day 15 Day 31 Day 61 Day 91 Study days IM Eligen B12 Normal range pg/ml Borderline/low pg/ml (n=48) Eligen B12 enabled 100% of clinically deficient patients achieve normal* B12 levels comparable to intramuscular (IM) injection *Normal level established for clinical trial was >350 pg/ml 16

17 MMA (nmol/l) Homocysteine (umol/l) Eligen B12 Clinical Data Mean Methylmelonic acid (MMA) Homocysteine IM Eligen B12 Eligen B12 also modulated other important biomarkers as well as IM injection Source: Castelli, et al. Clin Ther Mar;33(3): e2. doi: /j.clinthera

18 Prescription B12 Opportunity Injections: 33M Annually Other key figures: Patients receiving B12 treatment per year: 4.7M Average # of injections per year: 7 1% market share = 165K Rx s $ $87M $58M $29M 0.5% 1.0% 1.5% Market penetration potential 18

19 Launch situation analysis Need minimum 5-6 visits by sales force reps for first trial \ Levels checked after 1+ months of treatment to see efficacy vs IM Replacing entrenched standard of care Changing existing MD Rx habits Physician require multiple clinical successes to consistently switch patients from IM to oral Eligen B12 promotionally responsive to SOV 19

20 Eligen B12 Commercial Overview Launch/expansion highlights ~70% of private insurers cover Eligen B12 Highly positive reception from MDs/patients Actual post-launch patient results outstanding No efficacy failures/safety issues reported New and refill rates slow/steady growth Augmenting FF effort with MD/Nurse webinars Developing targeted DTP program Pursuing specialty co-promotion/expanded FF initiatives 20

21 Eligen B12 Commercial Overview Targeted/integrated promotional awareness campaign underway Medical education Pharmacy promotion Public relations DTP advertising/social media 21

22 Leadership Team Alan L. Rubino Chief Executive Officer and President Timothy G. Rothwell Board Chairman Michael R. Garone Vice President & Chief Financial Officer Carl V. Sailer Vice President, Sales & Marketing Peter J. Shaw, MD Chief Medical Officer Carlos de Lecea, M.D., PhD Global Business Development Head Accomplished executive management team; collectively launched and marketed 70+ products across all therapeutic areas 22

23 Carriers Injectable to oral Progressive/Practical Innovation Emisphere Products Thank you! Questions & Answers Patients OTCBB: EMIS