Vernalis plc: Interim results for six months ended 30 June 2013

WINNERSH, UK--(Marketwired - Jul 29, 2013) -

29 July 2013
LSE: VER



      Interim results for the six months ended 30 June 2013


Vernalis plc (LSE: VER) today announces its results for the six months
ended 30 June 2013.


Financial Highlights

* Strong financial performance, ahead of market expectations:

  * Revenue up 29%, or GBP1.7 million to GBP7.6 million (2012: GBP5.9
    million) driven by an increase in both collaboration income and
    frovatriptan royalties

    * Collaboration income increased 26% to GBP5.0 million (2012: GBP3.9
      million) including GBP2.5 million of milestone income (2012:
      GBP0.4 million)

    * Frovatriptan income increased 34% to GBP2.6 million (2012: GBP2.0
      million)

  * Operating costs before exceptional items remain unchanged at GBP9.1
    million (2012: GBP9.3 million)

  * Operating loss before exceptional items reduced by 40% to GBP2.6
    million (2012: GBP4.3 million)

  * Profit for the period after exceptional items was GBP4.2 million
    (2012: loss of GBP3.2 million) including a foreign exchange gain of
    GBP4.4 million (2012: GBP0.2 million)

* Strong balance sheet with GBP85.7 million cash resources (including
  cash, cash equivalents and held-to-maturity financial assets) and debt
  free:

  * Net increase in cash resources of GBP4.1 million for the first 6
    months of 2013

  * Large proportion of cash continues to be denominated in non-
    sterling currencies, with a foreign exchange gain of GBP4.4 million
    reported in the period

  * Underlying cash burn remained flat at GBP2.6 million (2012: GBP2.6
    million)

  * R&D tax credits anticipated on payments made to Tris, related to
    development performed on our behalf and will include the upfront
    payment and the first two milestones payable for each product

  * First proof-of-concept (PoC) milestone paid to Tris in March 2013



Operational Highlights

Cough Cold Commercial Pipeline:

  * CCP-01 PoC achieved and milestone paid to Tris in March 2013

  * First NDA remains on-track for filing mid-2014

  * Four further programmes in active development at Tris

  * 505(b)(2) pathway based on comparative bioavailability confirmed
    with FDA for all five programmes



NCE Development Pipeline:

Frovatriptan (marketed) (Migraine):

  * H1 2013 Menarini frovatriptan sales in-line with same period 2012
   (EUR13.1 million vs EUR13.3 million)

  * Positive results from a pilot study sponsored by Menarini
    presented at the International Headache Congress in Boston, showing
    that the combination of frovatriptan with dexketoprofen resulted in
    improved efficacy compared with frovatriptan alone

V81444 (CNS diseases):

  * First subjects dosed in a combined Phase Ib/II PoC, safety and
    pharmacokinetic study (July 2013)

V158866 (Pain):

  * Recruitment of patients continues in the Phase II PoC study in
    spinal cord injury neuropathic pain

AUY922 (Cancer):

  * Continuing in multiple Phase I and Phase II studies with Novartis
    in a variety of cancers including breast, non-small-cell lung and
    gastric cancers

Tosedostat - CHR2797 (Cancer):

  * Investigator led trial placed on partial clinical hold by FDA
    (June 2013). Cell Therapeutics Inc (CTI) are working to provide
    additional data to the FDA


Research Collaborations:

  * Long-term collaboration with Servier extended (March 2013)

  * Genentech milestones of $4.0 million (GBP2.5 million) earned in
    first half of year


Expected Newsflow

  * Achieve multiple PoCs in cough cold pipeline (H2 2013, and 2014)

  * File CCP-01 NDA (mid 2014)

  * Multiple further cough cold NDA filings (late 2014 and 2015)

  * AUY922 (Cancer) - Multiple Phase I and II study results (Novartis,
    timing not disclosed)

  * V81444 (CNS diseases) - Completion of Phase II PoC study (H1 2014)

  * V158866 (Pain) - Completion of Phase I/II PoC study (H1 2014)

  * Achieve milestones under existing research collaborations

  * Secure new research collaborations


Ian Garland, Chief Executive Officer, commented, "We have continued to
make excellent progress with our cough cold programmes with CCP-01
on-track for NDA filing in mid-2014. We also expect to undertake
multiple proof-of-concept studies during 2013 and 2014 on our other
four cough cold candidates and the accelerated nature of these
programmes positions us for further NDA filings during late 2014 and
2015. Our first half 2013 financial results were strong and we remain
in an excellent position to deliver substantial value to our
shareholders."



Presentation & Conference Call

Vernalis management will host a presentation at 09.30 am (UK) today (29
July 2013) at Brunswick's offices, 16 Lincoln's Inn Fields, London WC2A
3ED.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 99824478#.


                               -- ends --

Enquiries:

Vernalis Contacts:                     +44 (0) 118 938 0015
Ian Garland, Chief Executive Officer
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


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 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 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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