TIDMVER
RNS Number : 2825L
Vernalis PLC
18 July 2017
18 July 2017
LSE: VER
Year-End Trading Update and Notice of Full Year Results
Continued steady growth of Tuzistra(R) XR annualised
prescription run rate through drug's second cough cold season;
similar growth rate expected for 2017/18 season
Plan to resume full promotion of Moxatag(R) in September
Continued to advance cough cold development pipeline
Vernalis plc ("Vernalis" or the "Company") today announces a
trading and operational update for the financial year ended 30 June
2017, ahead of the publication of its audited financial results for
the year on 12 September 2017.
Total revenues are expected to be ahead of current market
expectations, principally as a result of larger than expected
research collaboration milestones, already announced to the market.
With better than expected total operating costs due to careful cost
control, the resulting operating loss is expected to be smaller
than consensus.
The Company's unaudited cash position (including cash and cash
equivalents and held-to-maturity assets), at 30 June 2017, is
expected to be GBP61 million. This results from the relatively
smaller operating loss as well as the delay to the CCP-07 approval
milestone payment to development partner Tris, and the favourable
impact of foreign exchange on the Company's US dollar cash
holdings.
Tuzistra(R) XR and the cough cold franchise
Tuzistra(R) XR
Tuzistra(R) XR prescriptions grew three-fold in the year to 30
June 2017, the drug's second year on the market, to approximately
35,000, (year to 30 June 2016: c. 11,000). Tuzistra XR reported net
revenues for the year will depend on the impact of rebates and
vouchers on gross revenues and will be finalised in the coming
weeks as part of the year end reporting process. The annualised
prescription run rate for Tuzistra XR has continued to grow
steadily, reaching a peak of approximately 55,000 prescriptions,
approximately three times the run rate at the same stage in June
2016.
Growing the number of Tuzistra XR prescriptions and improving
the level of performance across the whole salesforce remain top
priorities. In May 2017, the Company made a strategic decision to
bring in-house its inVentiv outsourced 100 person cough cold
focused salesforce and completed this transition in early July 2017
at no incremental cost. Vernalis is targeting a similar rate of
growth in Tuzistra(R) XR prescriptions and run-rate during the
2017/18 financial year, which would equate to total prescriptions
of approximately 105,000 to 115,000, with a closing annualised
run-rate of approximately 155,000 to 175,000 prescriptions.
The US prescription narcotic cough cold market remains
significant with 13.1 million codeine or hydrocodone-based
prescriptions in the year to 30 June 2017, although the market is
approximately 7% lower than the year to 30 June 2016. Codeine-
based prescriptions, which continue to account for approximately
80% of the total narcotic cough cold market, were down
approximately 6% and hydrocodone prescriptions were down
approximately 11%, when compared to the year to 30 June 2016.
Moxatag(R)
Since the closure in 2016 of Moxatag(R) supplier Suir Pharma,
our commercial promotion of this product has been limited. Based on
levels of in-house inventories and progress in securing a new
supplier, which is expected to come on-stream in 2018, Vernalis
plans to begin active promotion of Moxatag(R) in September 2017,
across the entire 100 person sales force.
Development Pipeline
There is no further information to announce on the resubmission
of CCP-07 to FDA or the wider cough cold development pipeline, but
the Company will provide an update as soon as we are able.
Research Collaborations
Total revenues include income from research collaborations with
partners. As previously announced during the year, the Company
received a number of milestones from its collaborators. A new,
additional research collaboration with Servier was also initiated
just prior to the financial year end.
The information contained within this announcement is deemed to
constitute inside information as stipulated under the Market Abuse
Regulations (EU) No. 596/2014. Upon the publication of this
announcement this inside information is now considered to be in the
public domain.
-- ends --
Enquiries:
Vernalis plc:
Ian Garland, Chief Executive
Officer
David Mackney, Chief Financial +44 (0) 118 938
Officer 0015
Canaccord Genuity Limited (Nominated +44 (0) 20 7523
Adviser and Joint Broker) 8000
Henry Fitzgerald-O'Connor
Emma Gabriel
+44 (0) 20 7408
Shore Capital (Joint Broker): 4090
Bidhi Bhoma
Toby Gibbs
+44 (0) 20 3727
FTI Consulting: 1000
Ben Atwell
Simon Conway
Stephanie Cuthbert
Stern Investor Relations, Inc + 1 212 362 1200
Stephanie Ascher
Carl Mauch
Notes to Editors
About Vernalis
Vernalis is a revenue generating, commercial stage
pharmaceutical company with significant expertise in drug
development. The Group has three approved products: Tuzistra(R) XR
targeting the US prescription cough cold market; Moxatag(R) , a
once-daily formulation of the antibiotic, amoxicillin, indicated
for the treatment of tonsillitis and/or pharyngitis secondary to
Streptococcus pyogenes in adults and pediatric patients 12 years
and older; and frovatriptan for the acute treatment of migraine. It
has an exclusive licensing agreement to develop and commercialise
multiple novel products focused on the US prescription cough cold
market as well as eight 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 Asahi Kasei Pharma, 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 NCE pipeline, the
Company's ability to successfully commercialise its cough cold
products and Moxatag(R) through its own sales force, 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 Tuzistra(R) XR, Moxatag(R) ,
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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