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
"My role is working with customers, helping them go through this digital transformation. I spend a lot of time talking to banks, big industries, manufacturers working through how they are integrating and transforming their IT platforms and moving them forward," explained William Morrish, General Manager Product Sales at Interoute, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with budd...
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
SYS-CON Events announced today that Ocean9will exhibit at 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. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
With billions of sensors deployed worldwide, the amount of machine-generated data will soon exceed what our networks can handle. But consumers and businesses will expect seamless experiences and real-time responsiveness. What does this mean for IoT devices and the infrastructure that supports them? More of the data will need to be handled at - or closer to - the devices themselves.
In his session at DevOps Summit, Tapabrata Pal, Director of Enterprise Architecture at Capital One, will tell a story about how Capital One has embraced Agile and DevOps Security practices across the Enterprise – driven by Enterprise Architecture; bringing in Development, Operations and Information Security organizations together. Capital Ones DevOpsSec practice is based upon three "pillars" – Shift-Left, Automate Everything, Dashboard Everything. Within about three years, from 100% waterfall, C...
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.
SYS-CON Events announced today that Juniper Networks (NYSE: JNPR), an industry leader in automated, scalable and secure networks, will exhibit at 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. Juniper Networks challenges the status quo with products, solutions and services that transform the economics of networking. The company co-innovates with customers and partners to deliver automated, scalable and secure network...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
SYS-CON Events announced today that Linux Academy, the foremost online Linux and cloud training platform and community, will exhibit at 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. Linux Academy was founded on the belief that providing high-quality, in-depth training should be available at an affordable price. Industry leaders in quality training, provided services, and student certification passes, its goal is to c...
Some people worry that OpenStack is more flash then substance; however, for many customers this could not be farther from the truth. No other technology equalizes the playing field between vendors while giving your internal teams better access than ever to infrastructure when they need it. In his session at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will talk through some real-world OpenStack deployments and look into the ways this can benefit customers of all sizes....
Deep learning has been very successful in social sciences and specially areas where there is a lot of data. Trading is another field that can be viewed as social science with a lot of data. With the advent of Deep Learning and Big Data technologies for efficient computation, we are finally able to use the same methods in investment management as we would in face recognition or in making chat-bots. In his session at 20th Cloud Expo, Gaurav Chakravorty, co-founder and Head of Strategy Development ...
SYS-CON Events announced today that CA Technologies has been named “Platinum 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, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
Interoute has announced the integration of its Global Cloud Infrastructure platform with Rancher Labs’ container management platform, Rancher. This approach enables enterprises to accelerate their digital transformation and infrastructure investments. Matthew Finnie, Interoute CTO commented “Enterprises developing and building apps in the cloud and those on a path to Digital Transformation need Digital ICT Infrastructure that allows them to build, test and deploy faster than ever before. The int...