10 April 2013 -- Vernalis plc (LSE: VER) today announces its audited results for the year ended 31 December 2012.
Financial Highlights
• Revenue up 20 per cent to £14.6 million (2011: £12.2 million) driven by 65 per cent increase in research collaboration income
• Research collaboration income was £8.7 million (2011: £5.3 million) including milestone income of £2.6 million (2011: £1.1 million)
• Frovatriptan royalty income was £5.7 million (2011: £6.5 million) down 11% primarily due to exchange rates with underlying sales made by Menarini flat
• Operating costs remain in-line with 2011
• Pre-exceptional loss for the year reduced by 19 per cent
• Balance sheet strengthened through £68.5 million of new equity financing (March 2012)
• Underlying net cash burn reduced to £4.5 million (2011: £6.0 million)
Operational Highlights
Cough Cold Commercial Pipeline:
• Collaboration commenced March 2012
• CCP-01 proof-of-concept achieved and milestone paid to Tris in March 2013
• First NDA filing anticipated mid-2014
• Four further programmes now in active development at Tris, with 505(b)(2) pathway based on comparative bioavailability confirmed on all five with FDA
• 2012-13 prescription cough cold season up substantially on 2011-12 with approximately 33.2 million prescriptions written in the 12 months to February 2013
NCE Development Pipeline:
Frovatriptan (marketed) (Migraine):
• Underlying Menarini sales €26.5 million (2011: €27.1 million)
• Menarini outlook for 2013 is for flat underlying sales vs 2012
V81444 (CNS diseases)
• Positive Phase I and Receptor Occupancy studies completed (May and Dec 2012 respectively)
• Plans underway to initiate Phase Ib/II POC study in H1 2013
V158866 (Pain)
• Positive results from Phase I study published at 14th World Congress on Pain (August 2012)
• Announced today, patients being recruited into a Phase II POC study (April 2013)
AUY922 (Cancer)
• Continues in multiple Phase I and Phase II studies with Novartis in a variety of cancers including breast, non-small-cell lung, gastric, colon and colorectal cancers
Tosedostat - CHR2797 (Cancer)
• Phase II trials in AML and MDS continue through Chroma/Cell Therapeutics, Inc
RPL554
• Anti-inflammatory study results announced by Verona Pharma (March 2013)
• Future development focussing on bronchodilator properties of RPL554
Servier
• Addition to pre-clinical NCE pipeline of first product candidate from collaboration
Research Collaborations:
• New collaborations with Genentech and Servier (January 2012)
• Ongoing collaboration with Servier extended again (March 2013)
• Genentech milestones of $4.0 million in cash already earned in 2013
Expected Newsflow:
• Achieve multiple proofs-of-concept in cough cold pipeline
• Progress CCP-01 towards NDA filing
• AUY922 (Cancer) – Multiple Phase I and II study results (Novartis) (timing not disclosed)
• V81444 (CNS diseases)
• Initiate Phase Ib/II POC study (H1 2013)
• Complete Phase II POC study (H1 2014)
• V158866 (Pain) – Complete Phase II POC study (H1 2014)
• Tosedostat - CHR2797 (Cancer)– Phase II study results (Chroma) (undisclosed)
• Achieve milestones under existing collaborations (undisclosed)
• Secure new research collaborations (undisclosed)
Ian Garland, Chief Executive Officer, commented, “We performed very strongly in 2012, both financially and operationally, with significant progress in all three elements of our strategy. Revenues were up sharply and our loss and underlying cash burn were both reduced. We delivered proof-of-concept in the most advanced of our cough cold programmes and now have five active cough cold programmes in development with a first NDA submission planned for the middle of next year. We had a record 12 months in our research business, growing revenue for the fifth consecutive year, and reported positive results from two V81444 studies in our NCE pipeline. The outlook for 2013 and beyond is strong as we continue to build our self-sustaining pharmaceutical company.”
Presentation & Conference Call
Vernalis management will host a presentation at 09.00am (UK) at Brunswick’s offices, 16 Lincoln’s Inn Fields, London WC2A 3ED today. It will also be available via webcast at http://www.vernalis.com/investor-centre/presentations-and-webcasts and www.cantos.com and via conference call, which can be joined by dialling: +44 (0) 20 3139 4830, Passcode 13117720#.
Enquiries:
Vernalis Contacts:
Ian Garland, Chief Executive Officer +44 (0) 118 938 0015
David Mackney, Chief Financial Officer
Nomura Code Securities Limited: +44 (0) 20 7776 1200
Juliet Thompson
Jonathan Senior
Brunswick Group: +44 (0) 20 7404 5959
Jon Coles
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 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 are endorsed by collaborations with Endo, 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 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.
