Edison Investment Research - Vernalis PLC (VER) Investing in the commercial platform

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Edison Investment Research

Lala Gregorek

Investing in the commercial platform

Vernalis marked its transition into a commercial-stage speciality pharma company with the September 2015 US launch of Tuzistra XR, the first product from its extended release (ER) prescription only (Rx) cough cold pipeline. First year (FY16) Tuzistra XR net sales were £1.1m. The £38.9m (net) raised in May provides sufficient funds to invest in operational initiatives (pharmacy stocking, patient access) to support stronger sales growth into the 2016/17 cough cold season and beyond. Successful execution will lay important foundations for the launch of CCP-07 in the following season (PDUFA date: 20 April 2017), and potentially CCP-08 soon after (NDA filing by year-end 2016). This increased investment in FY17, offset by weaker sterling, decreases our valuation to £376m (72p/share).

21/10/2016 12 EN

Underlying

Vernalis PLC

Vernalis is a holding company. Through its subsidiaries, Co. is a commercial stage pharmaceutical company focused on drug development. Co. has three marketed products: Tuzistra® XR, in the U.S. prescription cough cold market; Moxatag®, the only once-daily amoxicillin approved in the U.S. for tonsillitis and pharyngitis; and frovatriptan, an acute treatment for migraine. In addition, Co.'s nine programs in its new chemical entity development pipeline are: V158866 for central nervous system indications; CP1-444 and V2006 for immuno-oncology indications; AUY922, Tosedostat, Bcl-2, Mcl-1, and V158411 for cancer indications; and RPL554 for chronic obstructive pulmonary disease indications.

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GB00B3Y5L754 United Kingdom

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Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts

Lala Gregorek

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Tuzistra XR prescriptions (Rx) grew threefold to ~35k in FY16/17 (2nd year on the market) vs ~12k in FY15/16. Investment into addressing the barriers to higher Tuzistra XR prescribing is translating into higher Rx rates, although this has not been matched by revenue growth due to higher inventory stocking in the same period last year. In H217 FDA issued partner Tris with two complete response letters to Vernalisâ€™s CCP-07 and CCP-08 NDAs and we now model launch during the 2018/19 cough cold season. Our updated forecasts reflect this and lower Tuzistra XR revenues due to a slower than anticipa...

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Investing in the commercial platform

CMD showcases expertise and strategy

Vernalis - Operational initiatives in place, execution is key

Tuzistra XR steady growth in Rx run rate

Basilea Pharmaceutica - Cresemba milestone payments continue to roll in

AAC Clyde Space - Solid start to the year with further order growth

Tinexta - Typical seasonality in Q124

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