Pharming Group Release: Interim Report January - September 2015
Leiden, The Netherlands, 28 October 2015, Biotech company Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM) presents its (unaudited) financial report for the first nine months ended 30 September 2015.
CEO’s Commentary
The third quarter of 2015 has been a very active period for Pharming. In July, we completed a straight debt financing of $17 million (€15.6 million) with Oxford Finance and Silicon Valley Bank. This non-dilutive financing is a milestone for a biotech company as it reflects recognition of the strengthening cash flows from sales and license deals in the company and allows us to secure working capital for our growing sales activity without calling on shareholders for their support.
The acquisition of our US partner Salix by Valeant Pharmaceuticals International (Valeant) in the first half of 2015 has led to a revision in the way our lead product, RUCONEST®, is being marketed in the US. Valeant is concentrating sales effort on larger HAE clinics, which deal with significant numbers of patients with acute attacks of Hereditary Angioedema, the indication for which RUCONEST® is approved. During the quarter, the number of prescriptions for RUCONEST® increased by 29%, which indicates that more patients are finding RUCONEST® effective to deal with their HAE attacks. Pharming recognizes revenue from RUCONEST® sales immediately when those sales are incurred, and Pharming is paid by its partner 60 days after the end of the relevant quarter. We expect to see the effect of this increase in prescriptions continuing through the fourth quarter.
Also in July, we went live with the “HAEi GAP” (the Hereditary Angioedema International Patient Organization’s Global Access Program) in collaboration with Clinigen Group PLC, to provide patients with access to RUCONEST® in countries where the drug is not yet commercial available. On behalf of their patients, physicians may request RUCONEST® through an ethically and regulation-compliant ”Named Patient Program” mechanism. The first requests under this program have already been received by Clinigen.
In September, we proposed Robin Wright as our new Chief Financial Officer (CFO) and statutory director. Robin is a Fellow of the Institute of Chartered Accountants in England & Wales, he has a strong background in finance and investor relations as well as business development and licensing. He has extensive senior level experience as a CFO of public companies in both the pharmaceutical and biotechnology industries. Robin’s experience, both as an operational CFO for public companies and as a former investment banker brings important additional strengths, experience and perspectives to Pharming’s Board of Management and we look forward to confirming his appointment in the EGM later today.
In addition, we have stepped up our research and development activities, with two of our ongoing studies, a randomised, double-blind placebo controlled Phase II study for RUCONEST® in prophylaxis of HAE and a Phase II pediatric study for treatment of HAE in young children (2-13 years of age), progressing during the quarter. These studies are expected to finish during the first half of 2016. We have also begun work on new programs for Pompe and Fabry disease with leads for relevant protein therapeutic molecules through our rabbit founder technology platform. We will provide more details on these new programs once we have preliminary data and clarity on the development pathways and expected timelines.
After the quarter end, we received notification from the US Food and Drug Administration (FDA) that they have granted RUCONEST® extended data exclusivity (from 7 years to 12 years), which means that no bio-similar version of RUCONEST® can be approved in the US before July 2026. This should enable Pharming to develop its current pipeline of products to full commercialisation before revenues from RUCONEST® come under generic competition.
Sijmen De Vries
Chief Executive Officer
Contact
Sijmen de Vries, CEO: T: +31 71 524 7400
FTI Consulting
Julia Phillips/ Victoria Foster Mitchell, T: +44 203 727 1136
ABOUT PHARMING GROUP N.V.
Pharming Group N.V. is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the US, Israel, all 28 EU countries plus Norway, Iceland and Liechtenstein. RUCONEST® is commercialised by Pharming in Austria, Germany and the Netherlands.
RUCONEST® is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine.
RUCONEST® is partnered with Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX), through its subsidiary Salix Pharmaceuticals, Ltd. in North America.
RUCONEST is also being investigated in a randomized Phase II clinical trial for prophylaxis of HAE and in a Phase II clinical trial for the treatment of HAE in young children (2-13 years of age). RUCONEST® is also being evaluated for various additional follow-on indications unrelated to HAE.
Pharming has a unique GMP-compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell-based technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe and Fabry’s diseases are under early evaluation. The platform is partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre-clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilise this platform for the development of recombinant human Factor VIII for the treatment of Haemophilia A.
Additional information is available on the Pharming website: www.pharming.com.
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CEO’s Commentary
The third quarter of 2015 has been a very active period for Pharming. In July, we completed a straight debt financing of $17 million (€15.6 million) with Oxford Finance and Silicon Valley Bank. This non-dilutive financing is a milestone for a biotech company as it reflects recognition of the strengthening cash flows from sales and license deals in the company and allows us to secure working capital for our growing sales activity without calling on shareholders for their support.
The acquisition of our US partner Salix by Valeant Pharmaceuticals International (Valeant) in the first half of 2015 has led to a revision in the way our lead product, RUCONEST®, is being marketed in the US. Valeant is concentrating sales effort on larger HAE clinics, which deal with significant numbers of patients with acute attacks of Hereditary Angioedema, the indication for which RUCONEST® is approved. During the quarter, the number of prescriptions for RUCONEST® increased by 29%, which indicates that more patients are finding RUCONEST® effective to deal with their HAE attacks. Pharming recognizes revenue from RUCONEST® sales immediately when those sales are incurred, and Pharming is paid by its partner 60 days after the end of the relevant quarter. We expect to see the effect of this increase in prescriptions continuing through the fourth quarter.
Also in July, we went live with the “HAEi GAP” (the Hereditary Angioedema International Patient Organization’s Global Access Program) in collaboration with Clinigen Group PLC, to provide patients with access to RUCONEST® in countries where the drug is not yet commercial available. On behalf of their patients, physicians may request RUCONEST® through an ethically and regulation-compliant ”Named Patient Program” mechanism. The first requests under this program have already been received by Clinigen.
In September, we proposed Robin Wright as our new Chief Financial Officer (CFO) and statutory director. Robin is a Fellow of the Institute of Chartered Accountants in England & Wales, he has a strong background in finance and investor relations as well as business development and licensing. He has extensive senior level experience as a CFO of public companies in both the pharmaceutical and biotechnology industries. Robin’s experience, both as an operational CFO for public companies and as a former investment banker brings important additional strengths, experience and perspectives to Pharming’s Board of Management and we look forward to confirming his appointment in the EGM later today.
In addition, we have stepped up our research and development activities, with two of our ongoing studies, a randomised, double-blind placebo controlled Phase II study for RUCONEST® in prophylaxis of HAE and a Phase II pediatric study for treatment of HAE in young children (2-13 years of age), progressing during the quarter. These studies are expected to finish during the first half of 2016. We have also begun work on new programs for Pompe and Fabry disease with leads for relevant protein therapeutic molecules through our rabbit founder technology platform. We will provide more details on these new programs once we have preliminary data and clarity on the development pathways and expected timelines.
After the quarter end, we received notification from the US Food and Drug Administration (FDA) that they have granted RUCONEST® extended data exclusivity (from 7 years to 12 years), which means that no bio-similar version of RUCONEST® can be approved in the US before July 2026. This should enable Pharming to develop its current pipeline of products to full commercialisation before revenues from RUCONEST® come under generic competition.
Sijmen De Vries
Chief Executive Officer
Contact
Sijmen de Vries, CEO: T: +31 71 524 7400
FTI Consulting
Julia Phillips/ Victoria Foster Mitchell, T: +44 203 727 1136
ABOUT PHARMING GROUP N.V.
Pharming Group N.V. is developing innovative products for the treatment of unmet medical needs. RUCONEST® (conestat alfa) is a recombinant human C1 esterase inhibitor approved for the treatment of angioedema attacks in patients with HAE in the US, Israel, all 28 EU countries plus Norway, Iceland and Liechtenstein. RUCONEST® is commercialised by Pharming in Austria, Germany and the Netherlands.
RUCONEST® is distributed by Swedish Orphan Biovitrum AB (publ) (SS: SOBI) in the other EU countries and in Azerbaijan, Belarus, Georgia, Iceland, Kazakhstan, Liechtenstein, Norway, Russia, Serbia and Ukraine.
RUCONEST® is partnered with Valeant Pharmaceuticals International, Inc. (NYSE: VRX/TSX: VRX), through its subsidiary Salix Pharmaceuticals, Ltd. in North America.
RUCONEST is also being investigated in a randomized Phase II clinical trial for prophylaxis of HAE and in a Phase II clinical trial for the treatment of HAE in young children (2-13 years of age). RUCONEST® is also being evaluated for various additional follow-on indications unrelated to HAE.
Pharming has a unique GMP-compliant, validated platform for the production of recombinant human proteins that has proven capable of producing industrial volumes of high quality recombinant human protein in a more economical way compared to current cell-based technologies. Leads for Enzyme Replacement Therapy (ERT) in Pompe and Fabry’s diseases are under early evaluation. The platform is partnered with Shanghai Institute of Pharmaceutical Industry (SIPI), a Sinopharm Company, for joint global development of new products. Pre-clinical development and manufacturing will take place at SIPI and are funded by SIPI. Pharming and SIPI initially plan to utilise this platform for the development of recombinant human Factor VIII for the treatment of Haemophilia A.
Additional information is available on the Pharming website: www.pharming.com.
Help employers find you! Check out all the jobs and post your resume.