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

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
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
SYS-CON Events announced today that LeaseWeb USA, a cloud Infrastructure-as-a-Service (IaaS) provider, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. LeaseWeb is one of the world's largest hosting brands. The company helps customers define, develop and deploy IT infrastructure tailored to their exact business needs, by combining various kinds cloud solutions.
As companies gain momentum, the need to maintain high quality products can outstrip their development team’s bandwidth for QA. Building out a large QA team (whether in-house or outsourced) can slow down development and significantly increases costs. This eBook takes QA profiles from 5 companies who successfully scaled up production without building a large QA team and includes: What to consider when choosing CI/CD tools How culture and communication can make or break implementation
Adding public cloud resources to an existing application can be a daunting process. The tools that you currently use to manage the software and hardware outside the cloud aren’t always the best tools to efficiently grow into the cloud. All of the major configuration management tools have cloud orchestration plugins that can be leveraged, but there are also cloud-native tools that can dramatically improve the efficiency of managing your application lifecycle. In his session at 18th Cloud Expo, ...
The best-practices for building IoT applications with Go Code that attendees can use to build their own IoT applications. In his session at @ThingsExpo, Indraneel Mitra, Senior Solutions Architect & Technology Evangelist at Cognizant, provided valuable information and resources for both novice and experienced developers on how to get started with IoT and Golang in a day. He also provided information on how to use Intel Arduino Kit, Go Robotics API and AWS IoT stack to build an application tha...
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
It’s 2016: buildings are smart, connected and the IoT is fundamentally altering how control and operating systems work and speak to each other. Platforms across the enterprise are networked via inexpensive sensors to collect massive amounts of data for analytics, information management, and insights that can be used to continuously improve operations. In his session at @ThingsExpo, Brian Chemel, Co-Founder and CTO of Digital Lumens, will explore: The benefits sensor-networked systems bring to ...
"Tintri was started in 2008 with the express purpose of building a storage appliance that is ideal for virtualized environments. We support a lot of different hypervisor platforms from VMware to OpenStack to Hyper-V," explained Dan Florea, Director of Product Management at Tintri, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
SaaS companies can greatly expand revenue potential by pushing beyond their own borders. The challenge is how to do this without degrading service quality. In his session at 18th Cloud Expo, Adam Rogers, Managing Director at Anexia, discussed how IaaS providers with a global presence and both virtual and dedicated infrastructure can help companies expand their service footprint with low “go-to-market” costs.
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Is your aging software platform suffering from technical debt while the market changes and demands new solutions at a faster clip? It’s a bold move, but you might consider walking away from your core platform and starting fresh. ReadyTalk did exactly that. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, will discuss why and how ReadyTalk diverted from healthy revenue and over a decade of audio conferencing product development to start an innovati...