LEIDEN, The Netherlands, October 27, 2016 /PRNewswire/ --
Pharming Group N.V. ("Pharming" or "the Company") presents its (unaudited) financial report for the nine months ended 30 September 2016.
- Sales of RUCONEST(R) for the period to 30 September were up 67% overall compared
to the six months to 30 June 2016
- Sales in the US in the first nine months of 2016 were up by approximately 16% compared
to the same period last year, and up 66% compared to the first half year of 2016
- Gross Profit increased by 15% relative to the same period last year, which was
previously Pharming's most successful period, and up 67% compared to the first half
year of 2016
- Transformational acquisition of commercial rights to Pharming's own product RUCONEST(R)
in North America from Valeant Pharmaceuticals International, Inc. for $60m upfront
and sales milestones of up to $65 million
- Statistically significant results from Phase II study of RUCONEST(R) for prophylaxis
- Pharming agrees to market RUCONEST(R) directly in 21 additional EU and Middle Eastern
countries in amendment with SOBI
- The Extraordinary General Meeting of Shareholders, held on 5 October, unanimously
voted to increase authorized share capital by 150 million shares to 800 million shares
For the first nine months ended 30 September:
YTD YTD H1
Amounts in EURm, except
per share data 2016 2015 % Change 2016 % Change
Product sales 7.0 6.8 3% 4.2 67%
License fees 1.7 1.7 - 1.1 55%
Revenue 8.7 8.5 2% 5.3 64%
Gross Profit 5.5 4.8 15% 3.3 67%
income 0.3 0.1 200% 0.2 50%
Operating Costs (15.1) (13.9) (9%) (9.7) (56%)
Operating Result (9.4) (9.1) (3%) (6.2) (52%)
Cash & marketable
securities 17.0 35.1 (52%) 21.7 (22%)
Earnings per share (0.025) (0.014) (78%) (0.016) (56%)
Pro Forma Financial Review
If the Valeant transaction had been completed before January 1, 2016, the highlights of our nine-month results would have been significantly different. Overall, the Company would have been much closer to profitability in this period. We show on the page below an approximate pro forma set of numbers for this hypothetical situation for comparison and illustrative purposes only:
Amounts in EURm
(unaudited) except per Actual Pro Forma % Net Pro Forma % Net
share data YTD 2016 YTD 2016 Change 1H 2016 Change*
Product sales 7.0 20.5 193% 12.4 195%
License fees 1.7 0.7 (59%) 1.1 -
Revenue 8.7 21.2 144% 13.5 155%
Gross Profit 5.5 18.0 228% 11.5 248%
income 0.3 0.3 -
Costs (15.1) (21.4) (42%) (14.7) 52%
Operating Result (9.4) (3.1) 67% (3.1) 50%
Cash & marketable
securities 17.0 23.7 39% 26.3 21%
Earnings per share (0.025) (0.010) 39% (0.013) 19%
*On the basis of the results for the first six months ended 30 June 2016, announced on 28 July 2016.
Please note that this pro forma summary represents Pharming management estimates as well as actual figures and has not been independently verified by the Company's auditors. These numbers may be subject to change if the current financial plans or accounting treatment should change.
- These results show a continued improvement from the 30 June and 31 August pro
forma results, with annualized sales levels based on September of EUR32 million versus
EUR24.8 million based on H1 2016 results.
- At the operating result level, the 30 June pro forma resulted in a loss of EUR3.1
million for H1 2016, exactly the same as the EUR3.1 million loss for the total pro
forma period of nine months to September, showing that the additional profit
contribution from the US business would have resulted in an approximately break-even
position during Q3 2016 at the operating level.
After a relatively modest start to sales of RUCONEST(R) (recombinant C1 esterase inhibitor, 50 IU/kg) in 2016, revenue growth during the third quarter has significantly increased. Sales efforts in the US drove this growth.
We are very pleased with these results, which show Pharming is now growing towards profitability and, together with the transformational acquisition of the North American rights to RUCONEST(R) from Valeant, means that we can achieve profitability on an operational level during 2017.
Income from product sales increased 67% from EUR4.2 million in the first half of 2016 to EUR7.0 million in the nine-month period to 30 September 2016. Sales of RUCONEST(R) in the US was up from EUR1.5 million in the first quarter and EUR2.0 million in the second quarter to EUR2.3 million in the third quarter, which is as predicted in the eight month results announcement 3 October 2016 and represents a strong performance. Gross profit from sales has also continued to increase; from EUR3.3 million in the first half of 2016 to EUR5.5 million in the nine-month period as a result of improving US sales. We maintain pressure on cash expenditure, despite the improvement in gross margins, so that resource management continues to improve even with much greater research and development (R&D) activity.
On 9 August 2016, the Company announced that it has entered into a definitive agreement to acquire all North American commercialization rights to its own product RUCONEST(R) (recombinant human C1 esterase inhibitor), including all rights in the US, Mexico and Canada, from Valeant Pharmaceuticals International, Inc. ("Valeant") . Under the terms of the agreement, Pharming will pay Valeant an upfront fee of US$60 million upon Closing, which is expected during the fourth quarter this year. In addition, over the coming years the Company will make one-time-only self-funding (meaning that no external financial resources should be necessary to finance them) payments to Valeant on the achievement of a small number of specific sales milestones events, totalling a maximum of US$65 million. The specific details of these additional transaction terms are not disclosed for commercial reasons. The transaction is subject to Pharming obtaining adequate financing over the coming weeks.
On 18 July 2016, we also announced compelling data from our Phase II clinical study of RUCONEST(R) for prophylaxis in patients with Hereditary Angioedema ("HAE"). In the study, RUCONEST(R) showed a clinically relevant and statistically significant reduction in attack frequency for both the twice-weekly (p-value