Cosmo: the future is NOW

Transcription

1 Cosmo: the future is NOW February 27 th, 2018 CREDIT SUISSE LONDON ONE-ON-ONE HEALTHCARE CONFERENCE

2 Safe Harbor This presentation may include forward-looking statements that are based on our management s beliefs and assumptions and on information currently available to our management. The inclusion of forward-looking statements should not be regarded as a representation by Cosmo that any of its plans will be achieved. Actual results may differ materially from those set forth in this presentation due to the risks and uncertainties inherent in Cosmo s ability to develop and expand its business, successfully complete development of its current product candidates and current and future collaborations for the development and commercialization of its product candidates and reduce costs (including staff costs), the market for drugs to treat IBD diseases, Cosmo s anticipated future revenues, capital expenditures and financial resources and other similar statements, may be forward-looking and as such involve risks and uncertainties and risks related to the collaboration between Partners and Cosmo, including the potential for delays in the development programs for LuMeBlue, and Zemcolo. No assurance can be given that the results anticipated in such forward looking statements will occur. Actual events or results may differ materially from Cosmo s expectations due to factors which include, but are not limited to, increased competition, Cosmo s ability to finance expansion plans, the results of Cosmo s research and development activities, the success of Cosmo s products, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Cosmo assumes no responsibility to update forward-looking statements or to adapt them to future events or developments. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Cosmo undertakes no obligation to revise or update this presentation. 2

3 A unique GI player in the colon space and beyond In USD Mn, 2016: In USD Mn, 2016: products on the US market since, respectively, 2007 and

4 Perfectly positioned to exploit its own pipeline without need of external funding 1H 2017 in EUR Mn: End of October 2017 in EUR Mn: Liquidity at : 136.3M (Cash & Cash Equivalent only) Liquidity at : 263.5M (Including Bonds) Equity Ratio at : 95% Total Equity: 480.7M Total Assets: 507.3M Liquidity at : 141.8M (Cash & Cash Equivalent only) Liquidity at : 252.3M (Including Bonds) Equity Ratio at : 94.3% Total Equity: 471.7M Total Assets: 500.3M 4

5 One new product already on the market New medical device approved in US and EU to remove colonic lesions more safely and quickly 5

6 3 new products in the GI space and beyond Remimazolam Methylene Blue (formerly LuMeBlue): new diagnostic drug to improve lesion detection during colonoscopies Rifamycin SV (formerly Zemcolo): Remimazolam: new sedation agent to new antibiotic to treat colonic which infections have be successfully used in all procedural completed sedations, with same side effects as placebo phase III clinical including trials colonoscopies, safer and faster than available alternatives 6

7 The future is NOW Eleview 2H 2017 highlights US Sales started in June 2017 Aries Inc., Commercial Organization established 45 Sales Reps, 6 Sales managers 10 Medical Science Liasons providing product support Over 1900 accounts targeted by the Aries team 554 accounts who have ordered Eleview to date. Market research conducted in late Sept/early Oct. shows that 74% of physicians are somehow between familiar with Eleview (from 40% right after launch), and that 79% of those familiar with Eleview are either Very Likely or Extremely Likely to use Eleview for polyps removal Signed co-promotion deal with Olympus for US distribution, adding 200 Sales reps, 35 Clinical Education specialists and significantly increasing the number of targeted accounts Signed distribution deal with Fujifilm for EU distribution, retaining 45% of gross revenues 7

8 The future is NOW Methylene Blue (formerly LuMeBlue) 2H 2017 Highlights NDA filed July 2017 NDA accepted by FDA PDUFA date set for May New dedicated plant in Lainate completed in 9 months and already inspected by FDA 8

9 The future is NOW Rifamycin SV (formerly Zemcolo) 2H 2017 Highlights FDA granted both Qualified Infectious Disease Product (QIDP) and Fast Track designation for Rifamycin SV for the treatment of patients with travelers diarrhea IBS-D phase II trial started October 17, 25 sites, 342 patients, first patient treated expected as of November end, trial end expected by end of 2018 New dedicated plant in Lainate completed Dr. Falk Pharma has filed for marketing authorization of Rifafalk 200mg (Rifamycin SV MMX tablets) in Germany as Reference Member State through a de-centralized procedure. The procedure is expected to take approximately 10 months 9

10 The future is NOW Remimazolam 2H 2017 Highlights Remimazolam Remimazolam Successfully completed phase III trial also in bronchoscopy, thus completing the sets of trials required for registration NDA filing expected by the end

11 A unique pipeline whose competing edge goes beyond patent protection Methylene Blue: 3 yrs. regulatory exclusivity, a diagnostic drug acting topically cannot be genericized without evidence of increase in detection n. 3 granted patents in the US, last expiring 2031 Rifamycin SV: 5 yrs. regulatory exclusivity as New Chemical Entity (NCE) + 5 yrs. under the QIPD according to the GAIN Act, for a total of 10 yrs. Additionally, 3 yrs. regulatory exclusivity as a New Molecular Entity (NME) + 5 yrs. under the QIDP for the additional IBS-D indication n. 4 granted patents on the US, last expiring 2025 Remimazolam: 5 yrs. regulatory exclusivity as NCE n. 6 granted patents, last expiring 2033 Eleview (medical device) n. 3 granted patents, last expiring

12 The GI franchise beyond Lialda and Uceris Rifamycin SV (formerly Zemcolo) in a nutshell Provides an effective and innovative treatment option for colonic infections and offers significant anti-infective properties with a unique delivery mechanism for treatment of travelers diarrhea significantly reduces TLUS in Traveller's Diarrhea showed non-inferiority vs Xifaxan in TLUS and treatment success rates in a randomized, double-blind phase II clinical trial TLUS was significantly shorter in Rifamycin SV compared to placebo in a randomized, double-blind phase III clinical trial showed non-inferiority in terms of TLUS and similar efficacy, compared to Ciprofloxacin in a randomized, double-blind phase III clinical trial Compared to Ciprofloxacin, Rifamycin SV has no systemic absorption (very important for resistance) and no warning box issues, thus being way safer in the same context Compared to Xifaxan, Rifamycin SV allows antibiotic to be delivered directly to the colon, avoiding unwanted effects on the beneficial saprophytic bacterial flora living in the upper portions of the gastrointestinal tract; and it enjoys significantly more potent antiinflammatory properties 12

13 Clear edge vs Xifaxan in anti-inflammatory properties Based on the EC50 values, Rifamycin SV is100 times more potent than Rifampicin. Rifamycin SV is at least 1000 times more potent than Rifaximin at stimulating PXR transcriptional activity in a cell line engineered to express a fusion human PXR protein. In terms of the maximum possible stimulation of PXR activity, Rifaximin at 30 µm only activates up to 60% of the maximum activity with Rifamycin SV at 0.3 µm. 13

14 The endoscopy franchise Improve Lesion Detection Improve Lesion Removal Improve Procedure Efficiency Remimazolam 14

15 Exploiting the colonoscopy mass market Number of colonoscopies during 2017 EU: US: Potential ROW:

16 MethyleneBlue Product features Methylene Blue enhances the visualization of abnormalities and the detection of lesions by dying the entire colon prior to a colonoscopy Increases the Adenoma Detection Rate (ADR) substantially beyond the current standard of care HDWL This increase has an important clinical relevance: for each 1% increase in ADR, a 3% decline in incidence of interval cancer and a 5% decline in incidence of fatal colorectal cancer (CRC) has been scientifically attributed PDUFA date set for May 21,

17 MethyleneBlue significantly enhances ADR in the full analysis set FAS HDWL 200 mg ADR 47.81% 56.29% Relative risk increase* 17.7% P-value Odds Ratio 1.41 [1.09, 1.81] *Calculated as (ADRLuMeBlue 200 mg / ADRHDWL)

18 MethyleneBlue FPR is significantly better than HDWL Pts 356 Pts 326 MethyleneBlue decreases FPR by 14,4% vs HDWL FP 97 p-value: < 0,0001 FP FPR MethyleneBlue 23,3% FPR HDWL 29,7% Total MethyleneBlue pts: 485 Total HDWL pts: 479

19 MethyleneBlue efficacy has even greater diagnostic efficacy in largest market segment ADR IN OVERALL PTS POPULATION HDWL MethyleneBlue RRI 17.7% ADR IN PTS WITH EXCISION 3 HDWL 35.9 MethyleneBlue 45.3 RRI 26.2% RRI RRI Pts 485 Pts 479 Pts 362 Pts HDWL HDWL

20 MethyleneBlue shows max diagnostic value increase in the segment with 0-1 excision ADR IN OVERALL PTS POPULATION HDWL MethyleneBlue RRI 17.7% ADR IN PTS WITH EXCISION 0-1 HDWL MethyleneBlue RRI 38.2% RRI Pts 485 Pts 479 HDWL RRI Pts 233 Pts 264 HDWL

21 MethyleneBlue flags more diminutive adenomas than HDWL HDWL 200 mg Patients with diminutive adenomas Percentage overall population 30.06% 36.70% Relative risk increase* 22.1% P-value Odds Ratio 1.35 [1.03, 1.76] 21 Data from FAS *Calculated as (ADRLuMeBlue 200 mg / ADRHDWL) - 1

22 MethyleneBlue flags more subjects with non-polypoid lesions than HDWL HDWL 200 mg Pts with non-polypoid lesions Percentage overall population 35.07% 43.92% Relative risk increase* 25.2% P-value Odds Ratio 1.45 [1.12, 1.88] 22 *Calculated as (ADRLuMeBlue 200 mg / ADRHDWL) - 1

23 Remimazolam Product features Remimazolam Positive Remimazolam data in procedural sedation in U.S. Phase III study during colonoscopy, bronchoscopy and in III/IV ASA patients primary endpoint and important secondary endpoints were achieved with high statistical significance Remimazolam All trial data confirmed Remimazolam s safety profile and tolerability pre-nda meeting with FDA before filing for approval is under planning filing for approval expected n the second half of

24 Minutes Reduces Time to Reach Sedation Remimazolam Medians Remimazolam Placebo Midazolam Start Procedure MOAA/S 3 Peak Sedation 24

25 Minutes Minutes Reduces Time Back to Normal Remimazolam End of procedure to fully alert Time to back to normal (Patient Reported) Remimazolam Placebo Midazolam 0 Remimazolam Placebo Midazolam 25 *R vs. M: Anova F-test for equal means in 2 groups

26 Qolotag Product features Qolotag is a liquid, blue coloured emulsion as an enema formulation to be used for cleansing and simultaneous staining of the sigmoid colon and rectal mucosa to aid visualization of the structure and mucosal lesions by the endoscopist during flexible sigmoidoscopy evaluation Product features allow for a faster and better enhancement of the detection of eventual small lesions or dysplasias Long-term IBD patients generally are monitored with endoscopic system for evaluating the activity of the disease and for dysplasia detection Cosmo intends to license Qolotag for the EU and is currently assessing the regulatory pathway for an approval in the USA 26

27 27

28 Eleview Product features an FDA 510(k)-cleared, ready-to-use submucosal injection composition, that provides an immediate and long-lasting cushion for gastrointestinal endoscopic resections of polyps, adenomas, and other lesions, is ramping up appropriate for challenging polyps, regardless of size, location, or type and the immediate, long-lasting cushion can hold for up to 45 minutes improves margin visibility and helps decrease the risk of gastrointestinal perforation and damage to the external muscular layer, which can lead to gastrointestinal perforation decreases the time and volume needed to resect a lesion while reducing both reinjections required and piecemeal excisions, as compared to saline Addressing the US market with Olympus and EU with Fujifilm 28

29 Unique & Novel Mechanism Upon injection: Eleview : Reconfigures to form a colored cushion 1 Creates an artificial net formed by polymer chains 2 Traps water within to build a colored cushion of optimal shape, height, and duration 1 1 Eleview Instructions for use, Aries Pharmaceuticals, Inc. April Data on File, Aries Pharmaceuticals, Inc. 29

30 Outline of trial primary endpoints all in favor of Eleview Endpoint Statistics Eleview (N=102) (n=102) Reference Comparator (N=109) (n=110) Total injected volume to complete EMR procedure (ml) Total injected volume per lesion size (ml/mm) Mean (±SD) 16.1 (±9.8) 31.6 (±32.1) Range (min-max) P value < Mean (±SD) 0.53 (±0.32) 0.92 (±0.65) Range (min-max) P value <

31 Outline of trial primary endpoints all in favor of Eleview (CONTD) Endpoint Statistics Eleview (N=102) (n=102) Reference Comparator (N=109) (n=110) Mean (±SD) (±16.80) (±69.18) Time to resect the lesion (minutes) Range (min-max) % differenceª -35.5% P value a Eleview vs reference comparator. This can be attributed to the high variability of data, particularly in the reference comparator arm (SD Eleview = m; SD reference comparator =69.18 m 4 times increase) 31 Nevertheless, it is evident that there is a positive trend toward a reduction of the time needed to complete the procedure using Eleview with respect to comparator: reduction of 35.5% (10.6 minutes/procedure). This trend is confirmed by the whole colonoscopy time (one of the secondary end points)

32 Outline of trial Secondary endpoints all in favor of Eleview Endpoint Statistics Eleview (N=102) (n=102) Reference Comparator Eleview n (%) Sidney Resection Quotient (SRQ) Number of resection pieces Injected volume to provide initial lift (ml) Proportion of subjects with en bloc resections N(%) Mean (±SD) 10.3 (±8.1) 8.0 (±5.7) P value Mean (±SD) 5.70 (±6.03) 6.47 (±5.04) P value Mean (±SD) 10.4 (±7.0) 15.3 (±11.7) P value < Mean (±SD) 19 (18.6%) 12 (11.0%) P value

33 Eleview is as safe as the standard saline solution Complication Eleview n (%) Reference Comparator Eleview n (%) Subject with at least one complication 17 (15.0) 17 (15.2) Intraprocedural bleeding Early (<24h) bleeding Delay bleeding ( 24h post EMR) Perforation Postpolypectomy syndrome Hospital admissions for any post procedural clinically relevant complication 8 (7.1) 2 (1.8) 0 (0.0) 0 (0.0) 6 (5.3) 1 (0.9) 11 (9.8) 1 (0.9) 1 (0.9) 1 (0.9) 3 (2.7) 0 (0.0) 33

34 Update on Aries set-up FY17 Operating Expenses of $40m Prelaunch Plans for mid-year launch of MB and Rifamycin SV are being implemented Sales force expansion planned following MB approval likely an additional 110 sales reps plus managers will be added All Sales Reps (~155) are expected to promote all three products (Eleview, MB and Rifamycin SV) Prelaunch planning for a 2019 launch of Remimazolam has begun An additional expansion of the sales force to support Remimazolam is being evaluated 34

35 Next steps: File Rifamycin SV NDA Extend Eleview deals to RoW Start treating patients in Rifamycin SV IBS-D phase II File Remimazolam NDA Further expand pipeline 35

36 Cosmo Pharmaceuticals NV Riverside II Sir John Rogerson s Quay Dublin 2, Ireland media@cosmopharma.com Mr. John Manieri