body schreef op 9 augustus 2016 12:06:
PHARMING ANNOUNCES ACQUISITION OF ALL NORTH AMERICAN COMMERCIALISATION RIGHTS TO RUCONEST® FROM VALEANT
Leiden, The Netherlands, 9 August 2016: Pharming Group N.V. (the “Company”) (Euronext: PHARM) announces today that it has entered into a definitive agreement to acquire all North American commercialisation rights to its own product RUCONEST® (recombinant human C1 esterase inhibitor), including all rights in the US, Mexico and Canada, from 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 USA 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 growth in the future.
Today, CEO Sijmen de Vries and CFO Robin Wright, will discuss the transaction in a conference call at 13:30pm (CET). To participate, please see details below.
Transformational acquisition of commercial rights to Pharming’s own product RUCONEST®
RUCONEST® has potential for both acute and prophylaxis treatment in the largest market for HAE (in total $1.4 billion)
Immediate and substantial positive impact on Pharming’s operational results and near-term profitability (see Pro Forma Financial Review below)
$125 million deal value, with an upfront fee for Valeant of US$60 million, and self-funding sales milestone payments up to a further US$65 million in total
Funding through a combination of straight debt and new equity capital of between US$ 80-100 million
Additional new investment in RUCONEST® sales force, medical science liaison personnel and marketing activities in the US and Europe
All new equity capital will be offered to existing shareholders by way of a rights issue
Since the US Food and Drug Administration (“FDA”) approval of RUCONEST® on 16 July, 2014, US net product sales have grown from $0.3m in 2014 to an annualised rate of approximately $25 million at the end of the second quarter of 2016 within the US acute hereditary angioedema (“HAE”) market of around $700 million. Recently RUCONEST® has also shown 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 as announced on July 18, 2016. Once approved in this indication, RUCONEST® will be able to enter this additional market, also worth around $700 million. 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.
Structure of the Deal
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 payments to Valeant on achievement of a small number of specific sales milestones events, totalling a maximum of US$65 million. The specific details of these self-funding additional transaction terms are not disclosed for commercial reasons. The transaction is subject to Pharming obtaining adequate financing. Pharming will carry out a financing round to obtain sufficient new equity capital and debt finance over the coming weeks prior to Closing.
The transaction has already completed pre-notification and clearance procedures under the Hart-Scott-Rodino Antitrust Improvements Act 1976.
Growth of sales force and supplementary marketing efforts crucial for success
To ensure a seamless transition, Pharming is anticipating that Valeant’s dedicated RUCONEST® sales force, a total of 11 people, will accept offers to join Pharming to continue the RUCONEST® sales effort in the USA. The Company also plans to increase the size of the sales force to drive growth in product sales, together with increased investments in medical science liaison personnel and additional marketing activities, including patient advocacy programmes and the provision of significant unconditional support for the HAEA (the US HAE patients association) and its programmes as well as other HAE centers of excellence in the USA. In addition, Pharming is planning further investment in the acceleration of RUCONEST® sales efforts to drive growth in the EU, Middle East and Africa markets which Pharming will take over in October from SOBI, as announced on 14 July 2016, and to make RUCONEST available in Canada and Mexico.
Valeant and Pharming will work closely on the transition for customers and HAE patients under a transition services agreement entered into at the same time as the transaction. This will enable Pharming to replace core functions currently undertaken by Valeant and its contractors in a timely manner.
Pro Forma Financial Review
If this transaction had been completed on January 1, 2016, the highlights of our half year results would have been very different. Sales would have been approximately €12.4m instead of €4.1m for the half year, and all the consequential changes would have been positive. Overall, the Company would have been much nearer profitability even in this half year. Going forward, this transaction will be very positive for Pharming. We illustrate below an approximate pro forma set of numbers for comparison only:
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