Year-End Trading Update and Notice of Full Year Results
Continued steady growth of Tuzistra® 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® 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 £61 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® XR and the cough cold franchise
Tuzistra® 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® 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.
Since the closure in 2016 of Moxatag® 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® in September 2017, across the entire 100 person sales force.
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.
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.
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Notes to Editors
Vernalis is a revenue generating, commercial stage pharmaceutical company with significant expertise in drug development. The Group has three approved products: Tuzistra® XR targeting the US prescription cough cold market; Moxatag®, 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® 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® XR, Moxatag®, 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.