Vernalis — FY2016 Earnings Presentation
28 slides from Vernalis's earnings presentation, Sep 29, 2016
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Slide 2: Vernalis plc Year ended 30 June 2016 Results Presentation
Vernalis plc Year ended 30 June 2016 Results Presentation Ian Garland, CEO David Mackney, CFO 29 September 2016
Slide 3: Important Disclaimer
Important Disclaimer The distribution of this presentation in certain jurisdictions may be restricted by law, and persons into whose possession this presentation comes should inform themselves about, and observe, any such restrictions. Although reasonable care has been taken to ensure that the facts
Slide 4: Agenda for today's presentation
Agenda for today’s presentation 1. Highlights 2. Strategy 3. Commercial update • Tuzistra® XR • Moxatag® 4. Financial results 5. Newsflow 6. Summary 4 29 Sep '16 2015-16 Annual Results Presentation
Slide 5: Highlights
Highlights 5 29 Sep '16 2015-16 Annual Results Presentation
Slide 6: Highlights
Highlights Significant progress in our US commercial business: • Tuzistra® XR: US launch in early September 2015, ahead of the 2015-16 cough cold season • US commercial infrastructure: Cough cold focused primary care field sales force established • Moxatag®: US rights acquired October 2015, re-launc
Slide 7: Highlights (continued)
Highlights (continued) Other operational highlights: • NCE pipeline CPI-444 (formerly V81444) – Corvus announced as partner and has started Phase I/Ib study focused on immuno-oncology as single agent and in combination Vipadenant (V2006) – our partner RedoxTherapies acquired by Juno, a leader in
Slide 8: Highlights (continued)
Highlights (continued) Financial performance: • Total revenue of £12.0 million (2015: £13.7 million): £1.1 million of Tuzistra® XR sales, recorded on a ‘delivered to wholesaler’ basis £8.0 million of Research collaboration income (2015: £7.9 million) £2.9 million of frovatriptan sales (2015: £
Slide 9: Strategy
Strategy 9 | 29 Sep '16 2015-16 Annual Results Presentation
Slide 10: Strategy
Strategy 2) Realise value from NCE pipeline 1) Develop, acquire and commercialise low development risk late stage products 3) Continue balanced investment in research 10 29 Sep '16 2015-16 Annual Results Presentation
Slide 11: Commercial update
Commercial update • Tuzistra® XR • Moxatag® 11 | 29 Sep '16 2015-16 Annual Results Presentation
Slide 12: Commercial business | Narcotic cough cold market
Commercial business | Narcotic cough cold market Milder and later 2015-16 season compared to prior years Source: IMS weekly TRx, CDC FluView report, Vernalis analysis • Very mild early narcotic cough cold season: Weekly TRx down ~25% on prior year through January 2016 • CDC data showed similar mild
Slide 13: Commercial business | Total prescription cough cold market
Commercial business | Total prescription cough cold market 2015-16 was a moderate season with 33.5 million TRx Source: IMS NPA TRx data, Vernalis analysis • 33.5 million TRx in 2015-16: Although the narcotic market was down 12% on 2014-15, the total market was only down 3.5% • Narcotic market share
Slide 14: Commercial business | 2015-16 performance
Commercial business | 2015-16 performance The key focus for 2015-16 was the launch of Tuzistra® XR First season achievements • Routine supply from Tris • Multiple batches manufactured & Supply delivered to 3PL warehouse • Routine 3PL operations • Wholesaler contracts • Contracts with the top w
Slide 15: Commercial business | 2015-16 performance
Commercial business | 2015-16 performance Approximately 10,000 Tuzistra® XR TRx in 2015-16 financial year Source: IMS weekly TRx data, Vernalis analysis 15 29 Sep '16 2015-16 Annual Results Presentation
Slide 16: Commercial business | 2016-17 priorities
Commercial business | 2016-17 priorities In 2016-17 we will focus on patient access & affordability and brand awareness & usage 2016-17 priorities Supply & • Tris, 3PL and wholesale • Maintain routine supply through to Wholesaler distribution wholesalers • New pharmacy incentives to boost stocking •
Slide 17: Commercial business | 2016-17 priorities
Commercial business | 2016-17 priorities New positioning and samples for patients 17 29 Sep '16 2015-16 Annual Results Presentation
Slide 18: Commercial business | Moxatag Launch update
Commercial business | Moxatag® Launch update Trade launch is happening now • Trade launch: Suir Pharma Limited (Suir) has supplied launch stocks of Moxatag® which are available for supply to wholesaler customers Suir was placed into provisional liquidation on 17 May 2016 Suir will not continue
Slide 19: Cough cold pipeline | Summary of status
Cough cold pipeline| Summary of status CCP-07 and CCP-08 continue their progress towards potential 2017-18 season launches • Excellent progress made on both CCP-07 & CCP-08 during the year: • CCP-07: Development completed and NDA under review at FDA following submission in June 2016 – PDUFA date 20
Slide 20: Financial results 12 months ended 30 June 2016
Financial results 12 months ended 30 June 2016 20 29 Sep '16 2015-16 Annual Results Presentation
Slide 21: 12 months ended 30 June 2016 - Financial highlights
12 months ended 30 June 2016 - Financial highlights Year to Year to June 16 June 15 £m £m Total revenues 12.0 13.7 Tuzistra® XR revenue 1.1 - Research collaboration income 8.0 7.9 Frovatriptan royalty 2.9 4.9 Other Collaboration income - 0.9 Operating costs (36.6) (21.7) Operating loss (26.2) (8.2)
Slide 22: 12 months to 30 June 2016 - Key cash flow movements
12 months to 30 June 2016 - Key cash flow movements 90.0 £8.0 80.0 £38.9 70.0 60.0 50.0 £1.9 £0.2 £84.0 40.0 £1.1 £m £23.7 £3.7 30.0 £61.3 Underlying net cash burn £21.8m Cash utilised in business £24.2m 20.0 Increase in reported cash £22.7m 10.0 0.0 Opening cash Cash utilised Tax, interest Collabor
Slide 23: Impact of currency movements for 12 months to 30 June 2016
Impact of currency movements for 12 months to 30 June 2016 Cash holding by currency 30 June 2016 • Majority of cash remains denominated in USD GBP • £8.0 million unrealised fx gain on 25% retranslation of cash balances during the year to 30 June 2016 • 15% movement in USD and euro rates 2% Euro vers
Slide 24: Financial guidance for 12 months to 30 June 2017
Financial guidance for 12 months to 30 June 2017 • Revenue • Tuzistra®XR and Moxatag® sales on a ‘delivered to wholesaler’ basis • Lower net $ per Rx in year to 30 June 2017 • Moxatag® launch on a restricted basis for 2017 • Frovatriptan royalties – 2 batches of API projected by Menarini • Volume an
Slide 25: Newsflow
Newsflow 25 29 Sep '16 2015-16 Annual Results Presentation
Slide 26: Potential Newsflow | Cough Cold and Moxatag
Potential Newsflow | Cough Cold and Moxatag Event Expected Timing CCP-07: Single -dose PK study results Multi-dose PK study results NDA submission & acceptance for review PDUFA date 20 April 2017 CCP-08: Completion of submission batches Single -dose PK study results Multi-dos
Slide 27: Summary and outlook
Summary and outlook • Our transition from development stage to full commercial company has started with the launch of Tuzistra® XR • 2016-17 will see further significant investment in US infrastructure while we build operational effectiveness and grow US commercial sales • A targeted Moxatag® launch
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