Vernalis — H1 2016 Earnings Presentation
33 slides from Vernalis's earnings presentation, Mar 17, 2016
Slide 1: Slide 1
Slide 2: Vernalis plc Interim Results Presentation
Vernalis plc 6 months ended 31 December 2015 Interim Results Presentation Ian Garland, CEO David Mackney, CFO 17 March 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 17 Mar '16 Interim Results Presentation
Slide 5: Highlights
Highlights 5 17 Mar '16 Interim Results Presentation
Slide 6: Highlights
Highlights Significant progress in our commercial business: • US commercial infrastructure: Cough cold focused primary care field sales force established • Tuzistra® XR: US launch in early September 2015, ahead of the 2015-16 cough cold season • Moxatag®: US rights acquired October 2015, re-launch e
Slide 7: Highlights (continued)
Highlights (continued) Other operational highlights: • No further in-house investment in NCE pipeline V158866 – pain study completed, primary endpoint missed V81444 – Corvus disclosed as partner, focused on immuno-oncology • Research business remains self financing Revenue maintained at £3.8m
Slide 8: Strategy
Strategy 8 | 17 Mar '16 | Interim Results Presentation
Slide 9: 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 9 17 Mar '16 Interim Results Presentation
Slide 10: Commercial update
Commercial update • Tuzistra® XR • Moxatag® 10 | 17 Mar '16 | Interim Results Presentation
Slide 11: Commercial business: 2015-16 Overview and priorities
Commercial business | 2015-16 Overview and priorities Focus is on the launch of Tuzistra® XR and re-launch of Moxatag® • Routine supply from Tris • Trade & samples Ongoing Supply • Add to 3PL operations • Routine 3PL operations • Wholesaler contracts • Update w’saler contracts Trade • Nati
Slide 12: Commercial business: 2015-16 Overview and priorities
Commercial business | 2015-16 Overview and priorities Tuzistra® XR launch metrics indicate steady progress across all of these priorities Measures of launch progress • Routine supply from Tris Supply • Ex-factory unit sales to wholesalers • Routine 3PL operations • Pull through from wholesalers
Slide 13: Narcotic cough cold market
Commercial business | Narcotic cough cold market Milder and later 2015-16 season compared to prior year Source: IMS weekly TRx, CDC FluView report, Vernalis analysis • Very mild early cough cold season: Weekly TRx down ~25% on prior year through January 2016 • Season following 2010-11 trend but mild
Slide 14: Early launch performance
Commercial business | Early launch performance Steady prescription growth since launch, reflecting increased awareness and growing sales force effectiveness Source: IMS weekly TRx, summarised Monthly Source: IMS TRx, Mckesson & Relay coupon data weekly, Vernalis analysis • TRx growing steadily: both
Slide 15: Early launch performance
Commercial business | Early launch performance Initial stocking of wholesalers has been followed by increasing ex-factory volumes and increasing wholesaler pull through Source: Vernalis 3PL records Source: Wholesaler 852 daily sales reports • Ex-factory unit sales: initial volumes reflect launch sto
Slide 16: Early launch performance
Commercial business | Early launch performance Initial wholesaler launch stocks being distributed to pharmacies, where estimated stocking is growing steadily Source: Wholesaler 852 daily inventory reports Source: IMS TRx and 852 weekly sales reports, Vernalis analysis • Wholesaler inventory: After i
Slide 17: Early launch performance
Commercial business | Early launch performance Growing numbers of new prescribers are being added each week and increasing number of physicians are prescribing each week Source: Vernalis analysis of IMS Xponent data Source: Vernalis analysis of IMS Xponent data • New Tuzistra prescribers: the field
Slide 18: Early launch performance
Commercial business | Early launch performance FIA (IMS) data indicates we are losing prescriptions due to insurance rejection and patient abandonment Source: IMS FIA data, Vernalis analysis Source: IMS FIA data, Vernalis analysis • FIA data: Indicates we are losing approximately 40-50% of prescript
Slide 19: Early launch performance
Commercial business | Early launch performance McKesson and Relay coupon data is consistent with FIA data on abandoned prescriptions Source: Relay data, Vernalis analysis Source: McKesson data, Vernalis analysis • McKesson coupon cards (~41% of claims): Distributed to physicians or download from w
Slide 20: Early launch performance
Commercial business | Early launch performance Some regions and territories have progressed more rapidly than others Source: IMS TRx since launch, Vernalis analysis Source: IMS TRx since launch, Vernalis analysis • Regional performance: Four (of eight) regions already out-performing the others • Ter
Slide 21: Early launch performance
Commercial business | Early launch performance Data on average Rx size, co-pay assistance cost and sales mix is starting to clarify the expected 2015-16 average $ per Rx value Received (Paid) Payer Patient Pharmacy Vernalis $ $ $ $ WAC price per Rx (avg. 168 mL) (177) 177 Patient Tier 3 co-pay xx xx
Slide 22: Launch update
Commercial business | Launch update Trade launch will occur as soon as trade supply received from manufacturer • Trade launch: Moxatag supplier is at final stages of releasing trade supply for commercial use Expect to launch to wholesalers and pharmacies in Q2 2016 (CY), assuming trade supplies
Slide 23: Cough cold pipeline: Summary of status
Cough cold pipeline| Summary of status CCP-07 and CCP-08 continue their progress towards NDA filings in 2016 • CCP-07 and CCP-08 on track for 2016 submission • CCP-07: Successful pivotal single-dose bioavailability study completed • CCP-08: Successful completion of submission batches • Next mileston
Slide 24: Financial results 6 months ended 31 December 2015
Financial results 6 months ended 31 December 2015 24 17 Mar '16 Interim Results Presentation
Slide 25: Financial highlights
6 months ended 31 December 2015 - Financial highlights H1 H1 to Dec 15 to Dec 14 % Change £m £m Total revenues 6.1 5.7 +7% Tuzistra® XR revenue 0.6 - Research collaboration income 3.8 3.8 Frovatriptan royalty 1.6 1.7 Other Collaboration income 0.1 0.2 Operating costs (19.0) (9.9) -91% Operating loss
Slide 26: Key cash flow movements
6 months to 31 December 2015 - Key cash flow movements £m 70.0 60.0 £1.9 £0.2 £2.5 £1.1 50.0 £10.6 £2.4 Underlying net cash burn £8.7m 40.0 Cash utilised in business £4.8m 30.0 £61.3 Reduction in reported cash £7.3m £54.0 20.0 10.0 0.0 Opening cash 1 Cash utilised by Tax interest and Collaboration M
Slide 27: Impact of currency movements
Impact of currency movements for 6 months to 31 December 2015 Cash holding by currency 31 December 2015 • Majority of cash remains denominated in GBP 24% USD GBP • £2.7 million unrealised fx gain on 30% EUR 4% retranslation of cash balances during the USD 72% year to 31 December 2015 US$ • 13% movem
Slide 28: Financial guidance for 12 months to 30 June 2016
Financial guidance for 12 months to 30 June 2016 • Revenue • Frovatriptan royalties – 2 batches of API now projected by Menarini (one further batch) • patent expiry will likely impact volume and pricing for second batch • Research collaboration income • Tuzistra® XR sales on a ‘delivered to wholesal
Slide 29: Newsflow
Newsflow 29 17 Mar '16 Interim Results Presentation
Slide 30: 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 2016 (CY) NDA submission 2016 (CY) CCP-08: Completion of submission batches Single 2016 (CY) Multi-dose PK study results 2016 (CY) NDA submission 2016
Slide 31: Potential Newsflow: NCE and Research
Potential Newsflow | NCE and Research Event Expected Timing Frovatriptan: • Expiry of composition of matter patent Partnered: • Tosedostat: Potential partner newsflow Undisclosed • RPL554: Potential partner newsflow Undisclosed • Research: Potential milestones & new collaborations Undisclosed 31 1
Slide 32: Summary and outlook
Summary and outlook • Continued significant progress in our critical US commercial business • Financial performance remains strong, whilst reflecting increased investment in US infrastructure • Cough cold pipeline maturing well • Tuzistra® XR launched and growing steadily • CCP-07 & CCP-08 on-track
Slide 33: Slide 33