Vernalis — Investor Presentation (May 2015)
23 slides from Vernalis's investor presentation, May 1, 2015
Slide 1: Tuzistra XR – Investor Presentation
Tuzistra™ XR – Investor Presentation Ian Garland & David Mackney 1 May 2015
Slide 2: 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 3: Contents
Contents 1. Tuzistra™ XR 2. The cough cold market 3. Market research & current pricing 4. Value of Tuzistra™ XR potential market 5. Sales force targeting 6. Potential Tuzistra™ XR peak sales 7. Launch timelines and first year goals 8. Summary 9. Q&A 3 1 May 2015 Tuzistra™ XR Investor Presentation
Slide 4: Tuzistra XR Highlights
Tuzistra™ XR Highlights • Tuzistra™ XR NDA was approved by the FDA on 30 April, its PDUFA date • It is a 12-hourly dosed adult narcotic cough cold treatment, combining codeine (the antitussive) and chlorpheniramine (an antihistamine): - a codeine based equivalent of Tussionex® • Market research indi
Slide 5: Tuzistra XR Development timeline
Tuzistra™ XR Development timeline 2013 2014 2015 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 POC Single Multi Filing FDA Approved (Mar 2013) Dose Study Dose study (End Acceptance Results Results 30 April 2015 June (Sept 2014) (Nov 2013) (Feb 2014) 2014) FDA Acceptance 12 months product stability (60 days) NDA Fil
Slide 6: Key aspects of approved label
Tuzistra™ XR Key aspects of approved label • Active ingredients (per 5 mL): - codeine polistirex which contains 14.7 mg of codeine (equivalent to 20 mg codeine phosphate) - chlorpheniramine polistirex which contains 2.8 mg of chlorpheniramine (equivalent to 4 mg chlorpheniramine maleate) • Indicatio
Slide 7: The cough cold market: prescription volume by segment
The cough cold market Prescription volume by segment 2011 2012 2013 2014 Average TRx m TRx m TRx m TRx m TRx m Narcotics 19.1 17.0 19.0 16.3 17.9 Codeine 13.3 11.7 13.2 11.4 12.4 +antihistamines 5.6 4.9 5.3 4.6 5.1 +expectorants 6.8 6.0 7.1 6.2 6.5 Hydrocodone 5.8 5.3 5.8 4.9 5.5 Non-narcotics 16.2
Slide 8: The cough cold market: potential value of extended release products
The cough cold market Potential market value for extended release products, at 2008 pricing 2011 2012 2013 2014 Average Value TRx m TRx m TRx m TRx m TRx m @$65/Rx Narcotics 19.1 17.0 19.0 16.3 17.9 $1,164m Codeine 13.3 11.7 13.2 11.4 12.4 $806m +antihistamines 5.6 4.9 5.3 4.6 5.1 $332m +expectorant
Slide 9: Initial Tuzistra XR positioning in codeine + antihistamine segment
The cough cold market Initial Tuzistra™ XR positioning in the codeine +antihistamine segment, worth $332m at 2008 pricing 2011 2012 2013 2014 Average Value TRx m TRx m TRx m TRx m TRx m @$65/Rx Narcotics 19.1 17.0 19.0 16.3 17.9 $1,164m Codeine 13.3 11.7 13.2 11.4 12.4 $806m Primary +antihistamines
Slide 10: Market research
Market research Summary • Physicians research: - LEK in 2013 with cough cold prescribers - Healogix in 2014 with codeine prescribers - Healogix in 2015 with hydrocodone prescribers • Consistent strong support for Tuzistra™ XR • Key messages arising: - focus on all codeine prescribers, not just the c
Slide 11: Pricing
Pricing Current cough cold brand pricing • Most recent significant brand launch was from Cypress (now Pernix) in 2011: - Zutripro® - immediate release, hydrocodone combination product • Current Wholesale Acquisition Costs (WACs) are as follows: Zutripro® Tussionex® - Bottle size 480mL 115mL (unit of
Slide 12: Initial Tuzistra XR positioning in codeine + antihistamine segment
The cough cold market Initial Tuzistra™ XR positioning in the codeine + antihistamine segment, worth $332m at 2008 pricing 2011 2012 2013 2014 Average Value TRx m TRx m TRx m TRx m TRx m @$65/Rx Narcotics 19.1 17.0 19.0 16.3 17.9 $1,164m Codeine 13.3 11.7 13.2 11.4 12.4 $806m Primary +antihistamines
Slide 13: Value of Tuzistra XR potential market
Value of Tuzistra™ XR potential market At current brand pricing, initial primary market segment for Tuzistra™ XR is worth $510m 2011 2012 2013 2014 Average Value Value TRx m TRx m TRx m TRx m TRx m @$65/Rx @$100/Rx Narcotics 19.1 17.0 19.0 16.3 17.9 $1,164m $1,790m Codeine 13.3 11.7 13.2 11.4 12.4 $
Slide 14: Expanding target segment to all codeine prescribers
Value of Tuzistra™ XR potential market Expanding target segment to all codeine prescribers - revised primary market segment for Tuzistra™ XR is worth $1.2bn at current pricing 2011 2012 2013 2014 Average Value Value TRx m TRx m TRx m TRx m TRx m @$65/Rx @$100/Rx Narcotics 19.1 17.0 19.0 16.3 17.9 $1
Slide 15: Expanding target segments to include hydrocodone prescribers
Value of Tuzistra™ XR potential market Expanding target segments to include hydrocodone prescribers following DEA Schedule change - expanded market for Tuzistra™ XR is worth $1.8bn at current pricing 2011 2012 2013 2014 Average Value Value TRx m TRx m TRx m TRx m TRx m @$65/Rx @$100/Rx Narcotics 19.
Slide 16: Sales force targeting
Sales force targeting Actual targeting will be completed in Q2 2015 • Further physician segmentation work underway • Final targeting will take into account: - Coupons: physician prior adoption & usage - Medicaid: proportion of physicians’ patients in this channel - Formulary coverage: level of antic
Slide 17: Potential peak sales
Potential peak sales Pricing, segment(s) and market share will drive peak sales potential Codeine Codeine Hydrocodone All Narcotics (+antihistamine only) (all) (all) (all) Average Market TRx 5.1m 12.4m 5.5m 17.9m 2008 Net pricing $331.5m $806.0m $357.5m $1,163.5m ($65 per Rx) Peak market share 10% $
Slide 18: Potential peak sales
Potential peak sales Pricing, segment(s) and market share will drive peak sales potential Codeine Codeine Hydrocodone All Narcotics (+antihistamine only) (all) (all) (all) Average Market TRx 5.1m 12.4m 5.5m 17.9m 2008 Net pricing $331.5m $806.0m $357.5m $1,163.5m ($65 per Rx) Peak market share 10% $
Slide 19: Could Tuzistra XR have peak sales potential of $500m?
Potential peak sales Could Tuzistra™ XR have peak sales potential of $500m? Codeine Codeine Hydrocodone All Narcotics (+antihistamine only) (all) (all) (all) Average Market TRx 5.1m 12.4m 5.5m 17.9m 2008 Net pricing $331.5m $806.0m $357.5m $1,163.5m ($65 per Rx) Peak market share 10% $33.2m $80.6m $
Slide 20: Approximate launch timelines and first year goals
Approximate launch timelines and first year goals Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Approval Start of cough cold season 3PL set up Manufacture launch (Cardinal SPS) stock & ongoing supply Payer & pharmacy market research and Implement trade launch plans & develop payer and trade tactic
Slide 21: Launch timelines and first year goals
Launch timelines and first year goals Key goals for first season are to establish US commercial capability and lay the foundation for accelerated growth in future seasons • Supply: - Manufacture launch stocks and establish routine commercial supply - Set-up 3PL and begin operations • Trade distribut
Slide 22: Summary
Summary Tuzistra™ XR – a significant commercial opportunity with the potential to transform Vernalis • Approved labelling in-line with expectations: - 12-hour dosing, with or without food - broad indication for the relief of cough and symptoms associated with upper respiratory allergies or a common
Slide 23: Questions
Questions 23 1 May 2015 Tuzistra™ XR Investor Presentation