18 November 2014
LSE: VER

 

Vernalis plc today announces a change to its accounting reference date and financial year end from 31 December to 30 June and provides an update on its cough cold pipeline since it announced its half year result in August.

Vernalis' Board has taken the decision to change the accounting reference date and financial year-end from 31 December to 30 June to align the external reporting period with the seasonality of the US cough cold market which will become a major component of the Company's future commercial business. As a result of this change, Vernalis' next two financial reporting events will be as follows:

o Unaudited results for the 6 month period to 31 December 2014 to be announced in Q1 2015.
o Audited results for the 18 month period to 30 June 2015 to be announced by the end of September 2015.

Thereafter, Vernalis will revert to a normal biannual reporting calendar based on a 30 June financial year-end.

Preparations for the commercialisation of Vernalis' lead cough cold programme, Tuzistra™ XR, continue to progress well. The Tuzistra™ XR NDA is under review at FDA with a 30 April 2015 PDUFA target action date and a planned launch in Q3 2015 ahead of the start of the 2015/16 cough cold season.

Following proofs-of-concept for CCP-07 and CCP-08 announced earlier this year, our partner Tris is targeting NDA filings around the end of 2015 for CCP-07 and in 2016 for CCP-08. The remaining two Tris programmes, CCP-05 and CCP-06, are now targeted to achieve proof-of-concept in 2015 following positive progress on both programmes during the current year.

 

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Enquiries:

Vernalis plc:

 

Ian Garland, Chief Executive Officer

+44 (0) 118 938 0015

David Mackney, Chief Financial Officer

 

Canaccord Genuity Limited (Nominated Adviser):

+44 (0) 20 7523 8350

Lucy Tilley

 

Dr Julian Feneley

 

Henry Fitzgerald-O’Connor

 

Shore Capital (Joint Broker)

+44 (0)20 7408 4090

Bidhi Bhoma

 

Toby Gibbs

 

Brunswick Group:

+44 (0) 20 7404 5959

Jon Coles

 

 

Notes to Editors

About Vernalis
Vernalis is a revenue generating development stage pharmaceutical company with significant expertise in drug development. The Group has one marketed product, frovatriptan for the acute treatment of migraine, an exclusive licensing agreement to develop and commercialise multiple novel products focussed on the US prescription cough cold market as well as seven 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 AKP, Biogen Idec, Endo, GSK, Genentech, Lundbeck, Menarini, Novartis, Servier and Tris.

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 products, 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 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.

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T: 0118 938 0000
F: 0118 938 0001

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To report SUSPECTED ADVERSE REACTIONS, contact Vernalis Therapeutics, Inc. at 1-855-705-9546 and drugsafety@propharmagroup.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch