|By Marketwired .||
|April 1, 2014 02:20 AM EDT||
WINNERSH, UNITED KINGDOM -- (Marketwired) -- 04/01/14 --
1 April 2014
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 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
- 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
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
- 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
- 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
- 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
- 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,
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
Dr Julian Feneley
Shore Capital (Joint Broker)
+44 (0)20 7408 4090
+44 (0) 20 7404 5959
Click on, or paste the following link into your web browser, to view
the associated PDF document.
This information is provided by RNS
The company news service from the London Stock Exchange
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 12, 2016 10:00 PM EST Reads: 241
Data-as-a-Service is the complete package for the transformation of raw data into meaningful data assets and the delivery of those data assets. In her session at 18th Cloud Expo, Lakshmi Randall, an industry expert, analyst and strategist, will address: What is DaaS (Data-as-a-Service)? Challenges addressed by DaaS Vendors that are enabling DaaS Architecture options for DaaS
Feb. 12, 2016 09:45 PM EST Reads: 384
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Feb. 12, 2016 09:00 PM EST Reads: 132
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
Feb. 12, 2016 06:00 PM EST
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed...
Feb. 12, 2016 06:00 PM EST Reads: 402
When building large, cloud-based applications that operate at a high scale, it’s important to maintain a high availability and resilience to failures. In order to do that, you must be tolerant of failures, even in light of failures in other areas of your application. “Fly two mistakes high” is an old adage in the radio control airplane hobby. It means, fly high enough so that if you make a mistake, you can continue flying with room to still make mistakes. In his session at 18th Cloud Expo, Lee...
Feb. 12, 2016 04:45 PM EST
With the proliferation of both SQL and NoSQL databases, organizations can now target specific fit-for-purpose database tools for their different application needs regarding scalability, ease of use, ACID support, etc. Platform as a Service offerings make this even easier now, enabling developers to roll out their own database infrastructure in minutes with minimal management overhead. However, this same amount of flexibility also comes with the challenges of picking the right tool, on the right ...
Feb. 12, 2016 04:30 PM EST Reads: 192
DevOps is not just last year’s buzzword. Companies with DevOps practices are 2.5x more likely to exceed profitability, market share, and productivity goals. But how do you enable high performance? What can you do right now to start? Find out from DevOps experts including Gene Kim, co-author of "The Phoenix Project," and the Dynatrace Center of Excellence.
Feb. 12, 2016 04:30 PM EST
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 12, 2016 04:15 PM EST Reads: 428
SYS-CON Events announced today that Column Technologies will exhibit at SYS-CON's @DevOpsSummit at Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a global technology solutions provider with over 400 employees, headquartered in the United States with offices in Canada, India, and the United Kingdom. Column Technologies provides “Best of Breed” technology solutions that automate the key DevOps principal...
Feb. 12, 2016 04:15 PM EST
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
Feb. 12, 2016 03:00 PM EST
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
Feb. 12, 2016 02:15 PM EST Reads: 453
There will be new vendors providing applications, middleware, and connected devices to support the thriving IoT ecosystem. This essentially means that electronic device manufacturers will also be in the software business. Many will be new to building embedded software or robust software. This creates an increased importance on software quality, particularly within the Industrial Internet of Things where business-critical applications are becoming dependent on products controlled by software. Qua...
Feb. 12, 2016 02:15 PM EST
As someone who has been dedicated to automation and Application Release Automation (ARA) technology for almost six years now, one of the most common questions I get asked regards Platform-as-a-Service (PaaS). Specifically, people want to know whether release automation is still needed when a PaaS is in place, and why. Isn't that what a PaaS provides? A solution to the deployment and runtime challenges of an application? Why would anyone using a PaaS then need an automation engine with workflow ...
Feb. 12, 2016 01:45 PM EST Reads: 233
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 12, 2016 01:00 PM EST Reads: 230