Welcome!

News Feed Item

Interim results for the six months ended 30 June 2014

WINNERSH, UNITED KINGDOM -- (Marketwired) -- 08/05/14 -- Vernalis PLC (LSE: VER) (PINKSHEETS: VNLPY)

Vernalis plc (LSE: VER) today announces its results for the six months ended 30 June 2014.

Financial Highlights

  • Continued strong financial performance ahead of market expectations
  • Revenue was £ 6.2 million (H1 2013: £ 7.6 million)
  • Frovatriptan royalty income at £ 1.8 million (H1 2013: £ 2.6 million) was in line with market expectations, with one 12.5 kg batch of API delivered to Menarini
  • Collaboration income was £ 4.4 million (H1 2013: £ 5.0 million) with £ 1.1 million of milestones earned (H1 2013: £ 2.5 million) and the remaining income derived from FTE funding
  • Operating costs (including R&D) before exceptional items marginally higher at £ 9.5 million (2013: £ 9.1 million)
  • R&D spend remains largely flat at £ 6.9 million (H1 2013: £ 6.5 million)
  • External R&D expenditure increased to £ 1.4 million (H1 2013: £ 1.0 million) due to investment in V158866, V81444 and increased activity on Tris related projects
  • Operating loss before exceptional items was £ 3.9 million (H1 2013: £ 2.6 million)
  • Loss for the period after exceptional items was £ 4.6 million (H1 2013: profit of £ 4.2 million) including a £ 1.7 million unrealised foreign exchange loss (H1 2013: £ 4.4 million gain) due to the strength of Sterling

  • Balance sheet remains strong with £ 70.3 million of cash resources (including cash, cash equivalents and held-to-maturity financial assets) and debt free
  • Net decrease in cash resources of £ 6.6 million for the first six months of 2014
  • Large proportion of cash still denominated in US dollars, with a £ 1.7 million unrealised foreign exchange loss reported for the period
  • Proof-of-Concept (POC) payment on CCP-07 of £ 1.8 million paid to Tris in April 2014
  • Underlying cash burn increased to £ 3.8 million (2013: £ 2.6 million) resulting from decline in revenue and small increase in operating costs

Operational Highlights
Cough Cold Commercial Pipeline:

  • NDA for Tuzistra™ XR (CCP-01) submitted to the FDA at the end of June as expected
  • POC achieved for both CCP-07 and CCP-08 triggering milestone payments to Tris in April and July 2014 respectively
  • Two further programmes continue in active development at Tris and are targeted to achieve POC before the end of 2014

NCE Development Pipeline:
Frovatriptan (marketed) (Migraine):

  • H1 2014 Menarini frovatriptan sales were in line with the same period in 2013 (EUR 13.2 million vs EUR 13.1million)

V81444 (CNS diseases):

  • Results of the Phase Ib/II POC study in Attention Deficit Hyperactivity Disorder (ADHD) (April 2014) were promising and the goal is now to partner this programme for further development in ADHD, PD or other CNS disorders where A2A receptor antagonists show potential patient benefit

V158866 (Pain):

  • The Phase II POC study in spinal cord injury neuropathic pain continues with data now expected in 2015, due to slower than anticipated patient recruitment

AUY922 (Cancer):

  • Multiple Phase I and Phase II studies with Novartis continue in a variety of cancers with a focus on non-small-cell lung cancers

Tosedostat - CHR2797 (Cancer):

  • The partial clinical hold on investigator led trials was removed by the FDA in January 2014 enabling studies to resume
  • CTI Biopharma Corp. (previously Cell Therapeutics Inc.) is hoping that data from these trials in acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) may inform the appropriate design of a Phase III study
  • CTI Biopharma also announced in June, the initiation of an international co-operation group Phase II study of tosedostat in combination with low dose cytarabine in older patients with AML or MDS

Servier 1 (Cancer):

  • Servier signed a global strategic agreement with Novartis to develop and commercialise drug candidates from this collaboration (May 2014)
  • The lead molecule from this collaboration with Servier, a selective BCL-2 inhibitor, has progressed into Phase I (June 2014) triggering a £ 0.8 million (EUR 1 million) milestone receipt

Research Collaborations:

  • Milestone achieved in collaboration with Asahi Kasei Pharma triggering a £ 0.3 million payment to Vernalis (March 2014)
  • Winner of Queen's Award for Enterprise (April 2014)
  • Two milestones achieved in our collaborations with Servier triggering, in total, a EUR 0.75 million payment to Vernalis (August 2014)

Potential Newsflow

  • Tuzistra™ XR NDA filing acceptance by FDA (Q3 2014)
  • Achieve POC for remaining two cough cold pipeline programmes (before year end 2014)
  • V158866 (Pain) - Completion of Phase II POC study (2015)
  • AUY922 (Cancer) - Multiple Phase I and II study results (Novartis, timing not disclosed)
  • Achieve further milestones under existing research collaborations
  • Secure new research collaborations

Ian Garland, Chief Executive Officer, commented, "We have made excellent progress across all aspects of our business during the first half of this year.

The cough cold commercial pipeline has advanced significantly with submission of the Tuzistra™ XR NDA to the FDA and proof-of-concept achieved for both CCP-07 and CCP-08. We aim to achieve proof-of-concept on the two remaining cough cold products before the end of 2014.

We also announced positive news from the NCE pipeline with promising results from V81444's phase Ib/II study in ADHD. We now aim to partner this programme having significantly enhanced the data package. In the period we also announced that Servier 1, a selective BCL-2 inhibitor had entered Phase 1.

Research continues to perform well and remains self-funding with more milestones earned and five collaborations active during the period. Our financial results overall continue to be strong and we are well positioned for the launch of our first cough cold product into the US market in 2015."

Presentation & Conference Call

Vernalis management will host a presentation at 09.00 am (UK) today (5 August 2014) 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.
Please contact Valerie Mugridge at Brunswick on +44 (0) 207 396 5325 for details.

-- ends --
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.

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.

Click on, or paste the following link into your web browser, to view the associated PDF document.
http://www.rns-pdf.londonstockexchange.com/rns/2356O_1-2014-8-5.pdf

This information is provided by RNS
The company news service from the London Stock Exchange

Contact:
RNS
Customer Services
0044-207797-4400
[email protected]
http://www.rns.com

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
Amazon is pursuing new markets and disrupting industries at an incredible pace. Almost every industry seems to be in its crosshairs. Companies and industries that once thought they were safe are now worried about being “Amazoned.”. The new watch word should be “Be afraid. Be very afraid.” In his session 21st Cloud Expo, Chris Kocher, a co-founder of Grey Heron, will address questions such as: What new areas is Amazon disrupting? How are they doing this? Where are they likely to go? What are th...
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.
We all know that end users experience the Internet primarily with mobile devices. From an app development perspective, we know that successfully responding to the needs of mobile customers depends on rapid DevOps – failing fast, in short, until the right solution evolves in your customers' relationship to your business. Whether you’re decomposing an SOA monolith, or developing a new application cloud natively, it’s not a question of using microservices – not doing so will be a path to eventual b...
In his session at 21st Cloud Expo, Michael Burley, a Senior Business Development Executive in IT Services at NetApp, will describe how NetApp designed a three-year program of work to migrate 25PB of a major telco's enterprise data to a new STaaS platform, and then secured a long-term contract to manage and operate the platform. This significant program blended the best of NetApp’s solutions and services capabilities to enable this telco’s successful adoption of private cloud storage and launchi...
Infoblox delivers Actionable Network Intelligence to enterprise, government, and service provider customers around the world. They are the industry leader in DNS, DHCP, and IP address management, the category known as DDI. We empower thousands of organizations to control and secure their networks from the core-enabling them to increase efficiency and visibility, improve customer service, and meet compliance requirements.
In his general session at 21st Cloud Expo, Greg Dumas, Calligo’s Vice President and G.M. of US operations, will go over the new Global Data Protection Regulation and how Calligo can help business stay compliant in digitally globalized world. Greg Dumas is Calligo's Vice President and G.M. of US operations. Calligo is an established service provider that provides an innovative platform for trusted cloud solutions. Calligo’s customers are typically most concerned about GDPR compliance, applicatio...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
Join IBM November 1 at 21st Cloud Expo at the Santa Clara Convention Center in Santa Clara, CA, and learn how IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Cognitive analysis impacts today’s systems with unparalleled ability that were previously available only to manned, back-end operations. Thanks to cloud processing, IBM Watson can bring cognitive services and AI to intelligent, unmanned systems. Imagine a robot vacuum that becomes your personal assistant tha...
Cloud Expo, Inc. has announced today that Andi Mann and Aruna Ravichandran have been named Co-Chairs of @DevOpsSummit at Cloud Expo Silicon Valley which will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. "DevOps is at the intersection of technology and business-optimizing tools, organizations and processes to bring measurable improvements in productivity and profitability," said Aruna Ravichandran, vice president, DevOps product and solutions marketing...
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous a...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, will lead you through the exciting evolution of the cloud. He'll look at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering ...
SYS-CON Events announced today that IBM has been named “Diamond Sponsor” of SYS-CON's 21st Cloud Expo, which will take place on October 31 through November 2nd 2017 at the Santa Clara Convention Center in Santa Clara, California.
SYS-CON Events announced today that N3N will exhibit at SYS-CON's @ThingsExpo, which will take place on Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. N3N’s solutions increase the effectiveness of operations and control centers, increase the value of IoT investments, and facilitate real-time operational decision making. N3N enables operations teams with a four dimensional digital “big board” that consolidates real-time live video feeds alongside IoT sensor data a...
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
In a recent survey, Sumo Logic surveyed 1,500 customers who employ cloud services such as Amazon Web Services (AWS), Microsoft Azure, and Google Cloud Platform (GCP). According to the survey, a quarter of the respondents have already deployed Docker containers and nearly as many (23 percent) are employing the AWS Lambda serverless computing framework. It’s clear: serverless is here to stay. The adoption does come with some needed changes, within both application development and operations. Tha...