Oncosil Medical (OSL) CE Mark Virtually Certain Recommendation Buy (unchanged) Price $0.16 Valuation $0.30 (previously $0.20) Risk Speculative Analyst John Hester 612 8224 2871 Tanushree Jain 612 8224 2849 Authorisation TS Lim 612 8224 2810 GICS Sector Healthcare Equipment and Services Expected Return Capital growth 87.5% Dividend yield 0.0% Total expected return 87.5% Company Data & Ratios Enterprise value $91.7m Market cap $100.9m Issued capital 630.7m Free float 100% Avg. daily val. (52wk) $180,000 12 month price range $0.02 - $0.21 Price Performance BELL POTTER SECURITIES LIMITED ACN 25 006 390 7721 AFSL 243480 DISCLAIMER: THIS REPORT MUST BE READ WITH THE DISCLAIMER ON PAGE 7 THAT FORMS PART OF IT. Page 1 (1m) (3m) (12m) Price (A$) 0.07 0.07 0.19 Absolute (%) 127.9 138.5 -16.2 Rel market (%) 125.3 133.8 -31.6 Speculative See key risks on Page 5 and Biotechnology Risk Warning on Page 7. Speculative securities may not be suitable for Retail Clients. BSI Issues Positive CE Mark Status Report Recent announcements by the company regarding its steady progress with the submission of various data points to the European regulator (the British Standards Institute - BSI) are now coming to a head with the likely outcome that the company is virtually certain of receiving the CE Mark for its Oncosil therapy in the coming months. Most recently Oncosil received a positive CE Mark Status report from BSI indicating that all remaining concerns with the external clinical and bio-statistical expert reports had been closed out. We understand this to mean there are no further questions regarding safety, protocol for use, mechanism of action and expected patient survival benefits. We outline the efficacy data in the body of this report, most of which has been previously reported. The CE Mark process now moves to the final phase which is post market clinical follow up and surveillance. The company will shortly present its plans in this regard which is likely to consist of safety data from commercial sales of the device. We expect the company will be awarded a CE Mark in the coming months with a broad indication for treatment of inoperable pancreatic cancer. The company is then likely to commence a limited roll out of the Oncosil therapy to a small number of hospitals in the UK, Europe and Australia. Oncosil had notional cash as at 30 September of $9.2m which is sufficient to fund a limited launch, however, expansion of the sales and marketing function, plus the requirement for further clinical studies (required for registration in the US market) is likely to require a further capital raise which is built into the forecast for FY20. Valuation Raised to $0.30 The valuation is raised to $0.30 and we retain our Buy (Speculative) recommendation. Changes to earnings in FY20 are immaterial. The forecast loss for FY21 is increased by approximately $6m due to the addition of marketing costs and ongoing R&D.
OSL Price at posting:
16.0¢ Sentiment: Buy Disclosure: Held
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