Interim results for the six months ended 30 June 2013

29 July 2013

LSE: VER

 

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 £1.7 million to £7.6 million (2012: £5.9 million) driven by an increase in both collaboration income and frovatriptan royalties
    • Collaboration income increased 26% to £5.0 million (2012: £3.9 million) including £2.5 million of milestone income (2012: £0.4 million)
    • Frovatriptan income increased 34% to £2.6 million (2012: £2.0 million)
      • Operating costs before exceptional items remain unchanged at £9.1 million  (2012: £9.3 million)
      • Operating loss before exceptional items reduced by 40% to £2.6 million (2012: £4.3 million)
      • Profit for the period after exceptional items was £4.2 million (2012: loss of £3.2 million) including a foreign exchange gain of £4.4 million (2012: £0.2 million)
  • Strong balance sheet with £85.7 million cash resources (including cash, cash equivalents and held-to-maturity financial assets) and debt free:
    • Net increase in cash resources of £4.1 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 £4.4 million reported in the period
    • Underlying cash burn remained flat at £2.6 million (2012: £2.6 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 (€13.1 million vs €13.3 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 (£2.5 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.

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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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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