H1 Results Conference Call Business Progress and H1 Financial results September 6 th, Polyphor Ltd 2018 Half Year Results Presentation

Transcription

1 H1 Results Conference Call Business Progress and H1 Financial results September 6 th,

2 Disclaimer This presentation (the Presentation ) has been prepared by Polyphor Ltd. ( the Company and together with its subsidiary, we, us or the Group ) solely for informational purposes. Certain statements in this Presentation are forward-looking statements, beliefs or opinions, including statements relating to, among other things, the Company's business, financial condition, future performance, results of operation, potential new market opportunities, growth strategies, and expected growth in the markets in which the Group operates. In some cases, these forward-looking statements may be identified by the use of forward-looking terminology, including the terms targets, believes, estimates, anticipates, expects, intends, may, will or should or, in each case, their negative or other variations or similar expressions. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions, intense competition in the markets in which the Group operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting the Group s markets, and other factors beyond the control of the Group). Neither the Company nor any of its respective directors, officers, employees, agents, affiliates, advisors or any other person is under any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this Presentation. Statements contained in this Presentation regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. Some of the information presented herein is based on statements by third parties, and no representation or warranty, express or implied, is made as to, and no reliance should be placed on, the fairness, accuracy, completeness or correctness of this information or any other information or opinions contained herein, for any purpose whatsoever. This Presentation does not constitute or form part of, and should not be construed as, an offer or invitation or inducement to subscribe for, underwrite or otherwise acquire, any securities of the Company, nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of the Group, nor shall it or any part of it form the basis of, or be relied on in connection with, any contract or commitment whatsoever. This Presentation is not a prospectus and is being made available to you solely for your information and background and is not to be used as a basis for an investment decision in securities of the Company or the Group. 2

3 Agenda Financing Key programs progress Murepavadin Balixafortide OMPTA Platform H1 Financials Q and A 3

4 Agenda Financing Key programs progress Murepavadin Balixafortide OMPTA Platform H1 Financials Q and A 4

5 IPO May 15 th, 2018 Significant fund raising - Gross proceeds: CHF 155M Largest in Switzerland since 10 years, one of the top 3 in Europe in the last 3 years Allows Funding of - Development of murepavadin in HAP/VAP towards regulatory approval - Balixafortide pivotal program in Advanced Metastatic Breast Cancer - Initial investment for the development of the inhaled formulation of murepavadin - Continued development of the OMPTA program - General Corporate purposes 5

6 IPO Shareholders structure as of 23 August, % = shares Board & Management 3% Ingro Finanz AG 11% Varuma AG 9% Next 8 investors (avg. 1.8%)* 14% 12 Months lockup for pre- IPO Investors, Board, Management Members and Employees - expiring May 15 th, % Shares registered Remaining investors 62% * Excluding Board and Management Source: Company information as of reflecting stabilized post-ipo shareholder structure 6

7 Agenda Financing Key programs progress Murepavadin Balixafortide OMPTA Platform H1 Financials Q and A 7

8 Murepavadin (MPV) Murepavadin program significantly progressing Two trials - PRISM-MDR (EMA Study) - MPV+SoC vs. 2 SoC in Centers with high MDR incidence - PRISM-UDR (FDA Study) MPV vs. SoC as Pseudomonas aeruginosa monotherapy in UDR Centers (Centers with Low MDR incidence) PRISM MDR substantially progressing - FPFV, March Centers selected in 15 countries, 4 regions - 50% of sites activated including France, Spain, US - Strong communication with Centers and minor protocol adjustments to secure steady recruitment - Confirming timeline as per Prospectus Notes: SoC: Standard of Care FPFV: First Patient First Visit MDR: Multi Drug Resistance UDR: Usual Drug Resistance 8

9 Murepavadin (MPV) Murepavadin program significantly progressing PRISM UDR to start recruitment before YE - Protocol finalized, FDA submission done in July - Approval received from central IRB (Independent Review Board/ Ethics Committee) for the US - Targeting ~100 sites, ~50% already selected - FPFV anticipated by YE - Confirming timelines as per Prospectus Other studies (preclinical, other) as well as MPV inhaled progressing in parallel - Reprotox completed, no unexpected results - MPV Inhaled: stability and Physicochemical parameters under analysis Overall positive progress Supportive reaction of physicians and investigators, strong interest in the community. Timelines confirmed 9

10 Balixafortide (BLX) Study preparation in full swing One pivotal trial: BLX+ Eribulin vs. Eribulin for the treatment of advanced Metastatic Breast Cancer CRO selected PPD FDA discussion progressing - Fast Track designation achieved - EoP2 Meeting requested (foreseen around YE) - Application for Breakthrough designation planned with interim analysis EMA advice received - One study only sufficient - Finalizing protocol, taking into account advice 10

11 Balixafortide (BLX) Study preparation in full swing Steering Committee identified ( Co-chairs: Cortes, Kaufmann) - Kick-off at ESMO, October 2018 Expecting - Study Start Q FPFV by Q US Filing in H Earlier if accelerated approval Preclinical studies in other combination/indications started Overall, significant progress and strong physicians support Start Q1/19, US Filing H1/21 11

12 OMPTA Platform Significant progress in OMPTAs Lead preclinical candidate selected POL Strong activity against all most resistant Gram negative strains including all WHO priority 1 and colistin resistant - Potency confirmed in-vivo Neutropenic murine thigh infection models - Process optimization started to achieve optimal cost - IND planned H1/2020 In addition, backup program launched, to maximize pipeline/ chances of success 12

13 Novo OMPTA financing Up to CHF 11.5M financing of the OMPTA platform Objective and Scope - Support the advancement of the OMPTA program* - Accelerate new OMPTA development and de-risk it (also backup(s)) - OMPTA Preclinical pipeline - Lead preclinical compound (POL7306) and Backup program Novo REPAIR** Impact Fund - Separate business area of Novo Holdings A/S - Holding company of the Novo Group - Strong investment track record - USD165M, established in Feb Strong Scientific Experts Board - Objective of the fund: Back companies that can change the future of the antibiotic resistance battle: innovative science, driven by a clear product vision and a strong management team and comfortable in a changing regulatory environment - Focus: Discovery and early stage development of therapies targeting resistant micro-organisms - Does not preclude further non-dilutive funding from other sources * A previous stage of the program was financed by the Wellcome Trust ** Replenishing and Enabling the Pipeline for Anti-Infective Resistance 13

14 Novo OMPTA financing Up to CHF 11.5M financing of the OMPTA platform Financing structure - Tranche 1: CHF 6.8M equity investment by Novo Holdings A/S - CHF 38/share - Tranche 2: CHF 4.7M royalty-bearing Project financing upon - Achievement of preclinical milestones - Customary closing conditions Execution - Tranche 1 - Shares issued and filed for registration in the next few weeks - Lock-up until May 15, Tranche 2 - After reaching the milestone - Following report submitted to Novo First investment of the Novo REPAIR Impact Fund: a new, important, dedicated fund Strong validation of our technology and of the OMPTA platform Valuable financial support to our OMPTA Research as per our plan Entry of a distinguished member in our already strong shareholders group 14

15 Key Programs Progress Overview Murepavadin EMA 1 Filing EMA approval Preparation Pivotal Program FDA approval Potential for accelerated approval on interim analysis 5 FDA 2 Filing Antibiotics Inhaled formulation Pre-clinical / Formulation Clinical development CF 3 / NCFB 4 OMPTA Pre-clinical Phase I Ph II Select pre-clinical candidate IND 6 PoC 7 Phase II results Immuno-Oncology Balixafortide Eribulin combo Other combo Fast Track 8 Ph. Ib EOP1 FDA Preclin studies US pivotal trial Potential for accelerated approval on interim analysis and Breakthrough application 9/10 FDA Filing FDA approval Other combination studies in parallel Target timeline Potential accelerated timeline Notes: 1 European Medicines Agency 2 Food and Drug Administration 3 Cystic Fibrosis 4 Non-Cystic Fibrosis bronchiectasis 5 Assuming positive outcome for interim results, filing and approval can be accelerated 6 IND-= Investigational New Drug (also called CTA in Europe) 7 PoC = Proof of Concept 8 Conditional approval based on accelerated approval, timelines based on current estimates for recruitment 9 Fast track status granted 10 Being reviewed to take into account EMA advice 15

16 Agenda Financing Key programs progress Murepavadin Balixafortide OMPTA Platform H1 Financials Q and A 16

17 Financial highlights P&L overview Income statement CHFm Diff. (%) Revenue Total revenue Costs and operating expenses Research and development 2 (21.7) (15.3) 42 Marketing and sales (0.6) (1.3) -55 General and administrative 3 (2.8) (2.0) 38 Capitalized costs of Technology Platforms and other income Net operating expenses (24.9) (17.7) 41 Operating loss (18.0) (14.9) 20 Other Income/(expenses) Comments 1 CHF 6.4m received in form of Santhera shares for POL6014 Increase driven by the clinical trials and 2 extraordinary costs: CHF 1.1m related to the IPO CHF 2.8m impairment of technology platforms and leasehold improvements 3 Increase in H1-18 due to IPO costs and change in the allocation key 4 Includes CHF 2.3m loss on Santhera shares, mostly unrealized, interest expense and foreign exchange gains and losses Financial result 4 (2.9) (0.2) n.m. Net loss for the period (20.8) (15.1) 37 17

18 Cash flow and balance sheet overview Selected cash flow items CHFm H1-18 H1-17 Selected balance sheet items CHFm Diff. (%) Net cash from operating activities 1 (17.9) (13.8) 30 Net cash from investing activities (1.0) n.m. Net cash flow from financing activities n.m. Net increase/decrease in cash equivalents (4.5) n.m. Cash and cash equivalents as of June n.m. Average net cash burn* (2.8) (2.5) 14 Diff. (%) Assets Cash equivalents and financial assets n.m. Accounts receivable and prepaid expenses Total current assets n.m. Property, plant and equipment (PPE) Technology Platforms Total non-current assets Total assets n.m. Liabilities and shareholders' equity Total current liabilities Pension liabilities Other non-current liabilities Total non-current liabilities Total shareholders equity n.m. Total liabilities and shareholders equity n.m. Note: * represents the average monthly cash used for operating and investing activities Comments 1 Increase due to higher R&D costs and IPO-related expenses 2 Includes maintenance of infrastructure and IT, capitalized costs of technology platforms in H1-17 and CHF 1.2m proceeds from sale of financial assets in H H1-18 includes CHF144.2m net proceeds from IPO; H1-17 includes CHF9.8m net proceeds from private placement 4 Includes impairment of CHF0.5m in H1-18 due to rebuilding of some laboratories into offices (consolidation in one building) 5 Includes impairment charge on technology platforms of CHF 2.3m in H1-18 and CHF 5.7m per Defined contribution plan under Swiss pension accounting framework. Classified as defined benefit plan under IAS19. The decrease reflects the release of 35 employees 7 H1-17 includes CHF4.8m interest bearing liabilities of which CHF1.3m relate to a convertible loan, which was converted into shares at IPO 18

19 Summary A first half of year of strong progress on many fronts Substantial IPO, allowing the full execution of the plan Murepavadin trials positive progress and strong physicians support Balixafortide in preparation to start pivotal study in Q1/19 OMPTA Platform progressing well - Strong validation with the investment of Novo A/S H1 results showing increase in R&D costs due to trials launch Expected year end cash position substantially in line with consensus*, adjusted for the Novo investment * According to Bloomberg, net cash as at of CHF 126 million 19

20 Questions and Answers 20

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