Welcome!

News Feed Item

Vernalis PLC: Announcement of Results for Year Ended 31 Dec 2013

WINNERSH, UNITED KINGDOM -- (Marketwired) -- 04/01/14 --


1 April 2014

LSE: VER

Announcement of Results for the year ended 31 December 2013

Vernalis plc (LSE: VER) today announces its audited results for the year ended 31 December 2013.

Financial Highlights

  • Financial performance ahead of market expectations

  • Revenue was GBP14.1 million (2012: GBP14.6 million)

- Frovatriptan royalty income was up 16 % at GBP6.7 million (2012:
GBP5.7 million) primarily due to a 14% increase in volume of activepharmaceutical ingredient (API) supplied, with underlying in-market sales made by Menarini flat

- Research collaboration income was GBP7.1 million (2012: GBP8.7 million) including GBP2.5 million of milestones payments (2012: GBP2.6 million) allowing our research organisation to remain self-funding

  • Operating costs before exceptional items were GBP19.3 million (2012: GBP18.2 million), up 6% due to preparatory activities for expansion into the US and investment in the NCE pipeline (V158866 and V81444)

  • Pre-exceptional loss for the year was GBP5.6 million (2012: GBP5.2 million) and GBP4.0 million (2012: GBP5.2 million) on a
    post-exceptional basis

  • Cash resources including cash and cash equivalents and held to maturity assets reduced by GBP4.7 million in the year following:

- GBP2.0 million proof-of-concept milestone payment to Tris for CCP-01 and

- GBP0.9 million foreign exchange loss on the conversion of cash held in US dollars into sterling

  • Balance sheet remains strong with GBP76.9 million of cash resources and no debt

Operational Highlights

Cough Cold Commercial Pipeline:

  • CCP-01 proof-of-concept achieved and milestone paid to Tris (March 2013)

  • Successfully completed single and multi-dose pivotal bioavailability studies (November 2013 and February 2014), completing
    the clinical studies required for NDA filing

  • Positive interim six months stability data for CCP-01 has been generated and NDA filing on track for mid-2014

  • Four further programmes in active development at Tris, and we aim to achieve POC on all four of the remaining programmes during 2014

Frovatriptan (marketed) (Migraine):

  • Underlying Menarini sales flat at EUR26.4 million (2012: EUR26.5 million)

  • Menarini outlook for 2014 is for flat underlying sales vs 2013, both in tablet volumes and sales revenue

  • We expect Menarini to reduce stock in 2014 with 2 shipments of API, one in each half of the year

NCE Development Pipeline:

V81444 (CNS diseases)

  • Phase Ib/II POC study initiated (July 2013) with data anticipated in H1 2014

V158866 (Pain)

  • Phase II POC study initiated (April 2013) and progressing well. Of a total of 36 subjects, 16 have completed and a further 4 are enrolled. Data now anticipated around the end of 2014

AUY922 (Cancer)

  • Phase I and Phase II studies in multiple oncology indications including lung and breast continue with Novartis

Tosedostat - CHR2797 (Cancer)

  • Cell Therapeutics reported positive interim results from an investigator-initiated Phase II trial at the 55th American Society of Haematology annual meeting (December 2013)

  • The partial clinical hold on investigator led trials was removed by FDA in January 2014 enabling studies to resume

RPL554

  • Anti-inflammatory study results announced by Verona Pharma (March 2013)

  • Verona announced a successful GBP14 million fundraising in March 2014. Some of the proceeds are intended to be used to develop RPL554 in three clinical studies using a nebulised formulation in patients with severe COPD and additional studies are planned to prepare for a larger Phase IIb study in hospitalised COPD patients. Results are expected in
    2015

Research Collaborations:

  • New collaboration with AKP announced (October 2013) and GBP0.3 million milestone earned (March 2014)

  • First Servier collaboration extended for a further 2 years (March 2013)

  • GBP2.5 million of milestones earned from successful collaboration with Genentech (February and March 2013)

Expected 2014 Newsflow:

  • V81444 (CNS diseases) - Complete Phase Ib/II POC study (Data H1 2014)

  • CCP-01 - Filing of NDA (Mid 2014)

  • Proofs-of-concept on all four remaining programmes in cough cold pipeline (by 2014 year end)

  • V158866 (Pain) - Complete Phase II POC study (Data around 2014 year end)

  • AUY922 (Cancer) - Multiple Phase I and II study results (Novartis) (undisclosed)

  • Tosedostat - CHR2797 (Cancer)- Phase II study results (Chroma) (undisclosed)

  • Achieve milestones under existing collaborations (undisclosed)

  • Secure new research collaborations (undisclosed)

Ian Garland, Chief Executive Officer, commented, "We made significant progress across all three elements of our strategy during 2013 and continued our strong financial and operational performance. Our lead cough cold programme, CCP-01, progressed rapidly achieving proof-of-concept, successfully completing both required pivotal clinical studies and achieving six month accelerated stability. We are on target therefore for an NDA filing in mid-2014. With four further cough cold programmes in development we aim to achieve POC on all four of these programmes in the coming year.

In the NCE pipeline we initiated two POC studies for V81444 and V158866 and expect data from both, during 2014. We also had another positive year in our research business following on from last year's record performance and continue to be self-funding.

The outlook for 2014 and beyond is extremely positive as we get closer to our first NDA filing from the cough cold portfolio and its potential approval in the first half of 2015."

Presentation & Conference Call

Vernalis management will host a presentation at 9.00am (UK) at
Brunswick's offices, 16 Lincoln's Inn Fields, London WC2A 3ED today. 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 #35707904.

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

Click on, or paste the following link into your web browser, to view
the associated PDF document.

http://www.rns-pdf.londonstockexchange.com/rns/6618D_1-2014-3-31.pdf

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

END

Contacts:
RNS
Customer
Services
0044-207797-4400
Email Contact
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
"LinearHub provides smart video conferencing, which is the Roundee service, and we archive all the video conferences and we also provide the transcript," stated Sunghyuk Kim, CEO of LinearHub, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
When you focus on a journey from up-close, you look at your own technical and cultural history and how you changed it for the benefit of the customer. This was our starting point: too many integration issues, 13 SWP days and very long cycles. It was evident that in this fast-paced industry we could no longer afford this reality. We needed something that would take us beyond reducing the development lifecycles, CI and Agile methodologies. We made a fundamental difference, even changed our culture...
Things are changing so quickly in IoT that it would take a wizard to predict which ecosystem will gain the most traction. In order for IoT to reach its potential, smart devices must be able to work together. Today, there are a slew of interoperability standards being promoted by big names to make this happen: HomeKit, Brillo and Alljoyn. In his session at @ThingsExpo, Adam Justice, vice president and general manager of Grid Connect, will review what happens when smart devices don’t work togethe...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
@DevOpsSummit taking place June 6-8, 2017 at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @DevOpsSummit at Cloud Expo New York Call for Papers is now open.
"There's a growing demand from users for things to be faster. When you think about all the transactions or interactions users will have with your product and everything that is between those transactions and interactions - what drives us at Catchpoint Systems is the idea to measure that and to analyze it," explained Leo Vasiliou, Director of Web Performance Engineering at Catchpoint Systems, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York Ci...
SYS-CON Events announced today that Dataloop.IO, an innovator in cloud IT-monitoring whose products help organizations save time and money, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Dataloop.IO is an emerging software company on the cutting edge of major IT-infrastructure trends including cloud computing and microservices. The company, founded in the UK but now based in San Fran...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Discover top technologies and tools all under one roof at April 24–28, 2017, at the Westin San Diego in San Diego, CA. Explore the Mobile Dev + Test and IoT Dev + Test Expo and enjoy all of these unique opportunities: The latest solutions, technologies, and tools in mobile or IoT software development and testing. Meet one-on-one with representatives from some of today's most innovative organizations
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
SYS-CON Events announced today that Super Micro Computer, Inc., a global leader in Embedded and IoT solutions, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 7-9, 2017, at the Javits Center in New York City, NY. Supermicro (NASDAQ: SMCI), the leading innovator in high-performance, high-efficiency server technology, is a premier provider of advanced server Building Block Solutions® for Data Center, Cloud Computing, Enterprise IT, Hadoop/Big Data, HPC and E...
Hardware virtualization and cloud computing allowed us to increase resource utilization and increase our flexibility to respond to business demand. Docker Containers are the next quantum leap - Are they?! Databases always represented an additional set of challenges unique to running workloads requiring a maximum of I/O, network, CPU resources combined with data locality.
Internet of @ThingsExpo, taking place June 6-8, 2017 at the Javits Center in New York City, New York, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. @ThingsExpo New York Call for Papers is now open.
WebRTC sits at the intersection between VoIP and the Web. As such, it poses some interesting challenges for those developing services on top of it, but also for those who need to test and monitor these services. In his session at WebRTC Summit, Tsahi Levent-Levi, co-founder of testRTC, reviewed the various challenges posed by WebRTC when it comes to testing and monitoring and on ways to overcome them.
"This week we're really focusing on scalability, asset preservation and how do you back up to the cloud and in the cloud with object storage, which is really a new way of attacking dealing with your file, your blocked data, where you put it and how you access it," stated Jeff Greenwald, Senior Director of Market Development at HGST, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.