Vernalis plc Trading and Corporate Update

28 February 2018

Vernalis plc ("Vernalis", the "Company", or the "Group")

Trading and Corporate Update

Vernalis plc (LSE: VER) today provides an update to its guidance for the total number of Tuzistra® XR prescriptions for the financial year ending 30 June 2018 and the impact on its business strategy.  

Prescriptions of Tuzistra® XR in the current cough cold season have grown steadily over the prior year (+74% YoY for the first 33 weeks of 2017-18). A number of commercial initiatives to accelerate prescription growth have been introduced, with most recently an enhanced coupon programme rolled out at the beginning of February. The Board has been monitoring closely the week-on-week data and whilst some initial acceleration in growth has been seen, there would need to be further acceleration to achieve our guidance of 105,000-115,000 prescriptions for 2017-18. This guidance was provided at the time of the Company's full year ended 30 June 2017 results announcement in September 2017, ahead of the start of the current cough cold season. With c. 65% of the current cough cold season complete, the Board now believes that such a further acceleration in prescription growth is unlikely and therefore the total number of Tuzistra® XR prescriptions for the current financial year is expected to be below the guided range of 105,000-115,000. There have also been no significant updates from Tris on either addressing the CCP-07 or CCP-08 complete response letters, or achieving proof-of-concept for CCP-06.

In light of the Tuzistra® XR performance described above and slower than hoped for progress with the cough cold pipeline, the Board has been considering alternative strategies for the US business and strategic options for the Group. Although not finalised today, plans are well developed which will significantly reduce the cash burn of the business and a more detailed update will be provided in the coming weeks.

The Group remains in a strong financial position with an unaudited cash balance of £44.0 million at 31 January 2018. It also has a new chemical entity clinical pipeline of nine programmes and a strong collaboration-based research business.

The information contained within this announcement is deemed to constitute inside information as stipulated under the Market Abuse Regulations (EU) No. 596/2014. Upon the publication of this announcement, this inside information is now considered to be in the public domain.

-- ends --

Enquiries:

Notes to Editors

About Vernalis

Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has three approved products: Tuzistra® XR targeting the US prescription cough-cold market; Moxatag®, a once-daily formulation of the antibiotic, amoxicillin, indicated for the treatment of tonsillitis and/or pharyngitis secondary to Streptococcus pyogenes in adults and pediatric patients 12 years and older; and frovatriptan for the acute treatment of migraine. It has an exclusive licensing agreement to develop and commercialise multiple novel products focused on the US prescription cough-cold market as well as eight programmes in its NCE development pipeline. Vernalis has also significant expertise in fragment and structure based drug discovery which it leverages to enter into collaborations with larger pharmaceutical companies. The Company's technologies, capabilities and products have been endorsed over the last five years by collaborations with leading pharmaceutical companies, including Asahi Kasei Pharma, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier and Tris.

For further information about Vernalis, please visit www.vernalis.com 

Vernalis Forward-Looking Statement

This news release may contain forward-looking statements that reflect the Company's current expectations regarding future events including the clinical development and regulatory clearance of the Company's products, the Company's ability to find partners for the development and commercialisation of its NCE pipeline, the Company's ability to successfully commercialise its cough-cold products and Moxatag® through its own sales force, as well as the Company's future capital raising activities. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, the uncertainties related to the regulatory process, the ability of the Company to identify and agree beneficial terms with suitable partners for the commercialisation and/or development of its products, as well as the achievement of expected synergies from such transactions, the acceptance of Tuzistra® XR, Moxatag®, frovatriptan and other products by consumers and medical professionals, the successful integration of completed mergers and acquisitions and achievement of expected synergies from such transactions, and the ability of the Company to identify and consummate suitable strategic and business combination transactions.