Vernalis PLC

Unaudited Interim Results for the six months ended 31 December 2016 - Seite 2

• CCP-07 NDA filed and accepted for review by FDA with a PDUFA date of 20 April 2017
• CCP-08 NDA filed and accepted for review by FDA with a PDUFA date of 4 August 2017
• Two further programmes in active development at Tris, with proof-of-concept ("POC") targeted by the end of 2017

Other Operational Highlights:

• Frovatriptan (marketed): Underlying Menarini sales for the six months to 31 December 2016 down 31 per cent at EUR 8.7 million (2015: EUR 12.7 million) due to patent expiry and market entry of generics, as previously highlighted
• NCE Development Pipeline: The Company announced in February 2017 that Corvus Pharmaceuticals Inc had reached the predefined criteria for expansion of the cohort of patients with renal cell carcinoma treated with single-agent CPI-444 in the ongoing Phase 1/1b study. The expansion of this study triggered a $3 million milestone payment to Vernalis under the licensing deal with Corvus. Promising evidence of single-agent activity has also been seen in patients in other disease-specific cohorts, including lung cancer and melanoma
• Research Collaborations: Five active collaborations at 31 December 2016

Expected Newsflow (all dates calendar years):

• CCP-07: potential FDA approval (Q2 2017)
• CCP-08: potential FDA approval (Q3 2017)
• POCs on two remaining programmes in cough cold pipeline (CCP-05 and CCP-06) (by end of 2017)
• End of 2016/17 season Tuzistra^® XR trading update (June/July)
• Receive payments for achieving milestones under existing collaborations
• Secure new research collaborations
• Continue to leverage our US commercial infrastructure with possible complementary new product acquisitions/in-licensing

Ian Garland, Chief Executive Officer, commented,

"We are encouraged with the progress we have made in the last six months as we continued to expand our sales and saw further progress in our cough cold development pipeline.

"Midway through the 2016/17 cough cold season we have seen Tuzistra^® XR prescriptions continue to grow steadily. We believe the emergence of high performing sales representatives in all regions across the US validates the market potential for Tuzistra^® XR. We are, however, still in the early stages of the launch and our focus for the second half of the season is to drive sales-force effectiveness and so further increase the proportion of high performing sales territories. With continued prescription growth expected, the annualised run-rate at the end of June 2017 should provide a more meaningful predictor of sales performance for future years.