Leiden, The Netherlands, 8 December 2016: Pharming Group N.V. (“Pharming” or “the Company”)
(EURONEXT: PHARM) announces today that it has completed a definitive agreement to acquire all
North American commercialisation rights for its own product, RUCONEST® (recombinant human C1
esterase inhibitor), including all rights in the US, Mexico and Canada, from certain subsidiaries of
Valeant Pharmaceuticals International, Inc. (“Valeant”) (NYSE/TSX: VRX). RUCONEST® is an orphan
drug designated therapy developed by Pharming, already approved for the treatment of acute
Hereditary Angioedema (“HAE”) attacks in patients in the US and EU. This transaction will accelerate
Pharming’s development into a profitable specialty pharmaceutical company with its own
independent commercial infrastructure, which will form the foundation for future growth.
• Transformational acquisition of commercial rights to Pharming’s own product RUCONEST®
• Immediate and substantial positive impact on Pharming’s operational results and near-term profitability; annualised run rate of sales, increased from US$35 million in Q3 2016 to more than US$40 million, based on the average of the most recent two months of sales (October and November).
• US$125 million deal value, with an upfront fee paid to Valeant of US$60 million, and future selffunding sales milestone payments up to a further US$65 million in total
• Funding through a combination of new equity, straight debt and new convertible bonds of €104 million before costs.
• Cash position after closing of deal and payment of all transaction costs strengthenend to €34.3 million
• Additional new investment going into RUCONEST® sales force, medical science liaison personnel and marketing activities in the US and Europe to accelerate sales growth in both the US and Europe
Since the US Food and Drug Administration (“FDA”) approval of RUCONEST® on 16 July, 2014, US net product sales have grown from US$0.3 million in 2014 to an annualised run rate of approximately US$35 million at the end of the third quarter of 2016 and recently, based on average sales over the last two months (October and November) to an annualised run rate of more than US$40 million, within the US acute HAE market of around US$850 million per year.
Recently, RUCONEST® has shown very good positive data in prophylaxis of HAE, meeting its primary endpoints for both once-weekly and twice-weekly dosing regimens in a Phase II clinical trial (announced on July 18, 2016). If approved in this indication, RUCONEST® will be able to enter this additional market, worth around US$700 million per year. RUCONEST® therefore has the potential to be the only recombinant C1 esterase inhibitor approved to target both the acute market and the HAE prophylaxis market.
• Transformational acquisition of commercial rights to Pharming’s own product RUCONEST®
• Immediate and substantial positive impact on Pharming’s operational results and near-term profitability; annualised run rate of sales, increased from US$35 million in Q3 2016 to more than US$40 million, based on the average of the most recent two months of sales (October and November).
• US$125 million deal value, with an upfront fee paid to Valeant of US$60 million, and future selffunding sales milestone payments up to a further US$65 million in total
• Funding through a combination of new equity, straight debt and new convertible bonds of €104 million before costs.
• Cash position after closing of deal and payment of all transaction costs strengthenend to €34.3 million
• Additional new investment going into RUCONEST® sales force, medical science liaison personnel and marketing activities in the US and Europe to accelerate sales growth in both the US and Europe
Since the US Food and Drug Administration (“FDA”) approval of RUCONEST® on 16 July, 2014, US net product sales have grown from US$0.3 million in 2014 to an annualised run rate of approximately US$35 million at the end of the third quarter of 2016 and recently, based on average sales over the last two months (October and November) to an annualised run rate of more than US$40 million, within the US acute HAE market of around US$850 million per year.
Recently, RUCONEST® has shown very good positive data in prophylaxis of HAE, meeting its primary endpoints for both once-weekly and twice-weekly dosing regimens in a Phase II clinical trial (announced on July 18, 2016). If approved in this indication, RUCONEST® will be able to enter this additional market, worth around US$700 million per year. RUCONEST® therefore has the potential to be the only recombinant C1 esterase inhibitor approved to target both the acute market and the HAE prophylaxis market.
