Announcement of Preliminary results for the year ended 31 December 2007
25 April 2008
Winnersh, UK, 25 April 2008, Vernalis plc (LSE: VER) today announces its preliminary results for the year ended 31 December 2007.
During 2007, Vernalis made significant progress across its R&D programmes and both marketed products, Frova® and Apokyn®, showed strong sales growth. However, this progress was overshadowed by the receipt of the FDA’s non-approvable letter for the sNDA for Frova® for the short-term prevention of menstrual migraine. As a result, Vernalis is currently implementing a major change in business strategy and will now focus on building value by effectively and rapidly progressing its innovative development pipeline and discovery programmes.
In order to provide a stable financial platform for this R&D-based strategy, the Company is well advanced in implementing an extensive restructuring of its business. In early 2008, Vernalis has substantially strengthened its financial position through the early settlement of its loan from Endo Pharmaceuticals Inc., and by the recently announced financing of its EU frovatriptan revenues. After completion of the restructuring, the Company expects to have funds to pursue its planned R&D programmes for two years.
Under the new strategy Vernalis will pursue its development programmes, up to and including proof of concept clinical studies and then undertake partnerships for later-phase clinical development and commercialisation.
Highlights
Financial
- Revenues from continuing operations increased to £19.8 million (2006: £12.4 million)
- Operating loss from continuing operations before exceptional items reduced to £13.8 million (2006: £29.1 million). Total operating loss reduced to £31.7 million (2006: £40.8 million)
- Utilisation of cash resources reduced to £17.1 million (2006: £30.7 million)
- Cash reserves at 31 December 2007 of £20.5 million (2006: £37.6 million)
- Early settlement of $56 million loan (announced in February 2008)
- €18.4 million financing for European revenues from frovatriptan (announced in April 2008)
Pipeline
- BIIB014 (V2006) started Phase II (Biogen Idec – Parkinson’s disease)
- Positive V3381 Phase IIa results (Neuropathic Pain)
- NVP-AUY 922 started Phase I (Novartis – Oncology)
- Positive V24343 Phase I results (Obesity)
- V10153 Phase IIa recruiting at 7.5 mg/kg dose (Ischaemic stroke)
- New oncology research collaboration with Servier
Forthcoming Newsflow
- Divestment of Apokyn & US operations Q2 08
- V1512: Partner and start Phase III programme H2 08
- V10153: Complete Phase IIa study H2 08
- V3381: Partner/start Phase IIb H2 08
- V24343: Start dose-ranging study H2 08
- BIIB014: V2006: Complete Phase II (Biogen Idec) 2009
- NVP-AUY922: Complete Phase I (Novartis) Undisclosed
Peter Fellner, Executive Chairman, Vernalis commented, “I am very pleased that we have been able to strengthen our balance sheet substantially by utilising our frovatriptan revenues to raise cash and cancel our debt. This, together with our recent restructuring, has significantly reinforced our financial position, enabling us to fund further investment in our pipeline of product candidates. We are confident that we have now created a platform from which to rebuild shareholder value in the mid-term”.
-- ends --
Enquiries:
| Vernalis plc | +44 (0) 118 977 3133 |
| Peter Fellner, Executive Chairman | |
| Tony Weir, Chief Financial Officer | |
| Brunswick Group | +44 (0) 20 7404 5959 |
| Jon Coles | |
| Justine McIlroy | |
| Alex Tweed |
Notes to Editors
About Vernalis
Vernalis is a speciality bio-pharmaceutical company focused on products marketed to specialist neurologists. The company has two marketed products, Frova® and Apokyn®, and a development pipeline focused on neurology and central nervous system disorders. The company has six products in clinical development and collaborations with leading, global pharmaceutical companies including Novartis, Biogen Idec, Endo, Menarini and Chiesi:
| Product |
Indication |
Phase I |
Phase II |
Phase III |
Registration |
Market |
Marketing Rights |
| Frova® | Migraine |
|
x | Endo/Menarini (Royalties) | |||
| Frova® | Menstrual Migraine Prevention | x |
|
Endo/Menarini (Royalties) | |||
| Apokyn® | Parkinson’s Disease |
|
x |
North America | |||
| V1512 | Parkinson’s Disease | x |
|
World Wide (excl. Italy) | |||
| V10153 | Thrombotic Disorders | x |
|
Worldwide | |||
| V3381 | Neuropathic Pain | x |
|
Worldwide | |||
| V2006 | Parkinson’s Disease | x |
|
Biogen Idec (Milestone & Royalties) | |||
| MMPI | Inflammation | x |
|
Worldwide | |||
| V24343 | Obesity | x |
|
Worldwide | |||
| AUY922 | Cancer | x |
|
Novartis (Milestone & Royalties) | |||
| Hsp90-Oral | Cancer | Novartis (Milestone & Royalties) |
For further information about Vernalis, please visit
www.vernalis.com.
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 Frova® and Apokyn® 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.
View the Announcement of Preliminary results for the year ended 31 December 2007 (PDF - 268 KB).
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