Pharming Reports on Financial Results for the First Six Months of 2016
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Leiden, The Netherlands, 28 July 2016: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) announces its (unaudited) financial report for the six months ended 30 June 2016.
The Company will hold a conference call at 10:00 CET today, dial-in details can be found on page 7.
Highlights
Sales of RUCONEST® up 63% overall in second quarter relative to first quarter, so that sales in the first half of 2016 sales were slightly ahead of the first half of 2015
Sales in the USA up by approximately 33% in the second quarter compared with the first quarter
Gross Profit increased by 14% for the half year compared with the first half of 2015
Strongly Positive Results from Phase II study of RUCONEST® for prophylaxis of HAE
Pharming agrees to market RUCONEST directly in 21 more EU and Middle East countries in amendment with SOBI
CEO’s Commentary
After a relatively modest start to sales of RUCONEST® (recombinant C1 esterase inhibitor, 50 IU/kg) in 2016, sales trends during the second quarter improved again. More consistent sales efforts in the US, recovering from the impact of a significant reorganization of the Valeant sales force in Q4 2015, and a modest expansion in our EU direct commercialization efforts drove these improvements. Pharming is continually looking for ways to improve sales performance in the USA and the rest of the world in cooperation with our partners.
Income from sales increased 63% from €1.6 million in the first quarter to €2.6 million in the second quarter, with sales in the USA up from €1.5 million in the first quarter to €2.0 million in the second quarter. This represents a good half year, and exceeds the first half of 2015 when the major wholesalers in the USA were ramping up their stocking levels of RUCONEST® to meet increasing demand. Gross profits from sales continue to increase as well; from €1.6 million in the first quarter to €1.7 million in the second quarter of 2016 as result of the changing mix between US sales and sales in the EU by Swedish Orphan Biovitrum (“SOBI”) and by Pharming. We continued to keep pressure on cash expenditure despite the improvement, resulting in resource management improvement in the first half of 2016 compared with the first half of 2015.
During March, the European Commission adopted the CHMP recommendation to include the treatment of hereditary angioedema (“HAE”) attacks in adolescents and to remove the requirements for rabbit IgE testing that previously formed part of the EU label for RUCONEST®. The CHMP also noted that the importance of favorable effects of RUCONEST® is further supported by the continued availability of supply of RUCONEST® (produced by recombinant technology) in comparison to supply from blood donor plasma that may vary, and that as it is not a blood derived product RUCONEST® carries no potential risk of exposure to blood-borne pathogens.
We continue to make good progress in developing our pipeline to produce the next generation of therapies from our platform. Our first program lead for Pompe disease is now entering its next stage of pre-clinical testing and process development with the second program for Fabry Disease following by approximately six months. We will be announcing details of these programs and the timetable of their clinical development later this year.
After the end of the period we updated our distribution agreement with SOBI. As of 1 October this year, Pharming will commercialize RUCONEST® directly in a further 21 countries. SOBI had not yet begun significant sales efforts in most of these countries. The countries include the major EU markets of the UK, France and Spain, and a number of countries across Europe and the Middle East which do not yet have optimal access to therapies for HAE. In some of these countries we will continue to act in partnership with the HAEi Global Access Program.
Earlier this month we also announced positive results from a Phase 2 clinical study of RUCONEST® for prophylaxis in patients with HAE. In the study, RUCONEST® showed a clinically relevant and statistically significant reduction in attack frequency for both the twice-weekly (p-value <0.0001) and once-weekly (p-value = 0.0004) treatment regimens as compared with placebo. The secondary endpoint showed a response rate of up to 96% in the twice weekly treated per protocol group of patients, corroborating reports from day-to-day use of RUCONEST. At present, there is only one product formally approved for treatment of prophylaxis of HAE in the USA, and the market is expected to be around $800 million in 2017. This represents a huge potential market for RUCONEST®, which if approved would be the only product approved for both acute attacks and prophylactic therapy. More detail is given below.
Based on our financial results for the first half of 2016, we expect that both sales and gross profits will continue to improve during the remainder of the year and that investments in R&D will continue to increase gradually, following the sales trends.
No further financial guidance is provided
Sijmen de Vries
Chief Executive Officer