LEIDEN, The Netherlands,
August 23, 2016 /PRNewswire/ --
Pharming Group N.V. (the "Company") (Euronext: PHARM) announces
today that it will hold an Extraordinary General Meeting (EGM) of
shareholders to discuss the Company's definitive agreement to
acquire all North American commercialisation rights to its 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)
(the "Transaction, announced on 09 August
2016"), and to seek approval to increase the Company's
authorized share capital. The EGM will be held at Holiday Inn
Leiden, Haagse Schouwweg 10, 2332 KG Leiden, the Netherlands on Wednesday 05 October 2016 at 14:00
CET.
- The acquisition is anticipated to be accretive to earnings
from day one on a consolidated level and (based on the expected
range of the equity issue) will also be accretive on a per share
level immediately.
- The anticipated additional sales revenues, less the current
costs and the increase in the cost base required to accelerate
RUCONEST® in the USA, are expected
to enable the Company to transform and reach profitability during
2017.
- To finance the Transaction and (mainly)
investments in commercialization, the Company plans to raise
between €73m and €90m as a
combination of straight debt and equity. Out of
this, the Company seeks to raise between €35m and €60m in
equity financing.
- Out of the current Authorized
Capital of 650 million, the Company holds 184 million shares in
treasury.
- To ensure that sufficient share capital is available, the
Company seeks approval from
shareholders for an increase in the
authorized share capital of 150 million shares, such
that up to a total of 334 million shares become available to
enable the Transaction to close, although the
Company expects that not all of this
increase may be needed for
issuance.
- Based on preliminary discussions, the Company
expects to need between 120 and 240 million
shares to complete the equity
financing.
The Board of Management believe that the time is now right for
Pharming to take back these rights and accelerate the sales of
RUCONEST® with additional investment in sales force, medical
science liaison personnel, involvement of patient advocacy groups,
support for the patient associations and centers of excellence and
increased key opinion leader involvement in the legitimate
development of RUCONEST® going forward.
THE TRANSACTION AND USE OF FUNDS
In order to be able to be able to pay the US$60 million upfront payment (approximately €54
million) to Valeant and (i) to invest in the additional
commercialization efforts in the USA, (ii) to invest in additional
commercialization efforts in the EU, (iii) to ensure the
availability of sufficient working capital and (iv) pay for the
costs of the acquisition and financing transactions, the Company
seeks to raise a total amount of between €73 million and €90
million in a mixture of straight debt and new equity.
The equity part of this total amount is to be offered to
existing shareholders first in a rights issue, to avoid concerns
over dilution of existing shareholders by new shareholders ("The
Rights Offering"). To the extent that shareholders do not wish to
take up their rights and subscribe for the new shares, the rights
shares not taken up will be offered to institutional investors in
the EU and the USA at the same
price.
We expect the approximate size of the equity component of the
fundraising to be between €35m and €60m (the "Financing").
The final amount will depend on, inter alia, the Company's
stock price at the time of pricing and announcement of the Rights
Offering, the size and terms of the debt offers received, the
percentage uptake of the rights shares by existing shareholders and
the appetite amongst new equity investors for any balance. A full
prospectus including additional information and financial
statements as at 31 August 2016 will
be prepared and published following the EGM.
The pricing of the Rights Offering will be determined on the
basis of a discount to the Volume Weighted Average Price ("VWAP")
of the Pharming shares over a period to be defined, which period
will close no later than the date of the EGM (Wednesday 5 October).
At the moment, out of our authorized share capital of 650
million shares, 184 million shares are available for issue for the
Financing. On the basis of Pharming's recent share price, it is
possible that Management may not have sufficient headroom with
these shares alone to complete the financing:
Accordingly, the Board of Management is proposing that the
Authorised Share Capital be increased by 150 million new shares to
ensure to enable the Financing to succeed.
For clarity, this requested increase in the authorized
capital does NOT mean that all of the increase or available
headroom shares will be issued.
It is possible and expected on the basis of preliminary
discussions with debt providers and institutional equity investors
that Pharming could complete the Transaction by issuing
significantly less stock than the full headroom allocation within
the increased authorized capital, and the Board of Management is
committed to and will do all things necessary to minimize the
actual number of shares issued, so as to preserve the rights and
value for existing shareholders.
Based on the preliminary discussions, the Board of Management
expects to issue a number of shares in the range of between 120
million and 240 million shares to complete the Financing.
The Notice to Convene, the Explanatory Notes and a Form of Proxy
can be found on our website http://www.pharming.com
Board of Management
Pharming Group N.V.
Leiden
23 August 2016
About RUCONEST®
RUCONEST® (recombinant C1 esterase inhibitor ) is an orphan drug
indicated for the treatment of hereditary angioedema (HAE).
RUCONEST contains C1 esterase inhibitor for delivery at 50
IU/kg
HAE is caused by a deficiency of the C1 esterase inhibitor
protein, which is present in blood and helps control inflammation
(swelling) and parts of the immune system. A shortage of C1
esterase inhibitor can lead to repeated attacks of swelling, pain
in the abdomen, difficulty breathing and other symptoms..
When administered at the onset of HAE attack symptoms at the
recommended dose, RUCONEST helps to return a patient's C1 esterase
inhibitor levels to normal range and to relieve the symptoms of an
HAE attack, with a low recurrence of symptoms within 24 hours.
RUCONEST is the only recombinant C1 esterase inhibitor approved
by the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA) and was approved in July 2014 by the FDA and in October 2010 by the EMA.
Under the Biologics Price Competition and Innovation Act of
2009, RUCONEST was granted data exclusivity in the USA until July
2026.
Important Safety Information for
RUCONEST®
RUCONEST® is a recombinant C1 esterase inhibitor
indicated for the treatment of acute attacks in adult and
adolescent patients with hereditary angioedema (HAE). Effectiveness
in clinical studies was not established in HAE patients with
laryngeal attacks.
RUCONEST (C1 esterase inhibitor [recombinant]) is
contraindicated in patients with a history of allergy to rabbits or
rabbit-derived products, and patients with a history of
life-threatening immediate hypersensitivity reactions to C1
esterase inhibitor preparations, including anaphylaxis.
Severe hypersensitivity reactions may occur. The signs and
symptoms of hypersensitivity reactions may include hives,
generalized urticaria, tightness of the chest, wheezing,
hypotension, and/or anaphylaxis during or after injection of
RUCONEST. Should symptoms occur, discontinue RUCONEST and
administer appropriate treatment. Because hypersensitivity
reactions may have symptoms similar to HAE attacks, treatment
methods should be carefully considered.
Serious arterial and venous thromboembolic (TE) events have been
reported at the recommended dose of plasma-derived C1 esterase
inhibitor products in patients with risk factors. Risk factors may
include the presence of an implanted venous catheter/access device,
prior history of thrombosis, underlying atherosclerosis, use of
oral contraceptives or certain androgens, morbid obesity, and
immobility. Monitor patients with known risk factors for TE
events during and after RUCONEST administration.
RUCONEST has not been studied in pregnant women; therefore, it
should only be used during pregnancy if clearly needed.
The most common adverse reactions (incidence ≥2%) were headache,
nausea, and diarrhea. The serious adverse reaction in clinical
studies of RUCONEST was anaphylaxis.
Please see complete Prescribing Information for RUCONEST.
About HAE
Hereditary Angioedema (HAE) is a rare genetic disorder. It is
characterized by spontaneous and recurrent episodes of swelling
(edema attacks) of the skin in different parts of the body, as well
as in the airways and internal organs. Edema of the skin usually
affects the extremities, the face, and the genitals. Patients
suffering from this kind of edema often withdraw from their social
lives because of the disfiguration, discomfort and pain these
symptoms may cause. Almost all HAE patients suffer from bouts of
severe abdominal pain, nausea, vomiting and diarrhea caused by
swelling of the intestinal wall.
Edema of the throat, nose or tongue is particularly dangerous
and potentially life-threatening and can lead to obstruction of the
airway passages. Although there is currently no known cure for HAE,
it is possible to treat the symptoms associated with edema attacks.
HAE affects about 1 in 10,000 to 1 in 50,000 people worldwide.
Experts believe that a lot of patients are still seeking the right
diagnosis: although HAE is (in principle) easy to diagnose, it is
frequently identified very late or not discovered at all. The
reason HAE is often misdiagnosed is because the symptoms are
similar to those of many other common conditions such as allergies
or appendicitis. By the time it is diagnosed correctly, the patient
has often been through a long lasting ordeal.
About Pharming Group N.V.
Pharming is a specialty pharmaceutical company developing
innovative products for the safe, effective treatment of rare
diseases and unmet medical needs. Pharming's lead product,
RUCONEST® (conestat alfa) is a recombinant human C1 esterase
inhibitor approved for the treatment of acute Hereditary Angioedema
("HAE") attacks in patients in Europe, the US and rest of the world. The
product is available on a named-patient basis in other territories
where it has not yet obtained marketing authorization.
RUCONEST® is commercialized 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 distributed in North
America, Canada and
Mexico by Valeant Pharmaceuticals
International, Inc. (NYSE: VRX/TSX: VRX), following Valeant's
acquisition of Salix Pharmaceuticals, Ltd.
RUCONEST® is distributed in Argentina, Colombia, Costa
Rica, the Dominican
Republic, Panama and
Venezuela, by Cytobioteck.
RUCONEST® is distributed in South
Korea by HyupJin Corporation and in Israel by Megapharm.
RUCONEST® achieved primary and secondary endpoints in a Phase II
randomized, double blind placebo-controlled clinical trial for
prophylactic treatment of HAE and is being evaluated for other
indications as well. The Phase II study was fully recruited shortly
after the year-end, and is expected to report preliminary results
around the middle of 2016.
RUCONEST® is also being investigated in a Phase II clinical
trial for the treatment of HAE in young children (2-13 years of
age) and evaluated for various additional follow-on
indications.
Pharming's technology platform includes a unique, GMP-compliant,
validated process for the production of pure recombinant human
proteins that has proven capable of producing industrial quantities
of high quality recombinant human proteins in a more economical and
less immunogenetic way compared with current cell-line based
methods. Leads for enzyme replacement therapy ("ERT") for Pompe and
Fabry's diseases are being optimized at present, with additional
programs not involving ERT also being explored at an early
stage.
Pharming has a long term partnership with the Shanghai Institute
of Pharmaceutical Industry ("SIPI"), a Sinopharm company, for joint
global development of new products, starting with RUCONEST® and
recombinant human Factor VIII for the treatment of Haemophilia A.
Pre-clinical development and manufacturing will take place to
global standards at SIPI and are funded by SIPI. Clinical
development will be shared between the partners with each partner
taking the costs for their territories under the partnership.
Additional information is available on the Pharming website:
http://www.pharming.com .
Forward-looking Statements
This press release of Pharming Group N.V. and its
subsidiaries ("Pharming", the
"Company" or the
"Group") may contain forward-looking
statements including without limitation those regarding
Pharming's financial projections, market
expectations, developments, partnerships, plans, strategies and
capital expenditures.
The Company cautions that such forward-looking statements may
involve certain risks and uncertainties, and actual results may
differ. Risks and uncertainties include without limitation the
effect of competitive, political and economic factors, legal
claims, the Company's ability to protect
intellectual property, fluctuations in exchange and interest rates,
changes in taxation laws or rates, changes in legislation or
accountancy practices and the Company's ability to
identify, develop and successfully commercialise new products,
markets or technologies.
As a result, the Company's actual performance,
position and financial results and statements may differ materially
from the plans, goals and expectations set forth in such
forward-looking statements. The Company assumes no obligation to
update any forward-looking statements or information, which should
be taken as of their respective dates of issue, unless required by
laws or regulations.
Contact
Sijmen de Vries, CEO: T: +31-71-524-7400
Robin Wright, CFO : T:
+31-71-524-7432
FTI Consulting
Julia Phillips/ Victoria Foster Mitchell, T:
+44-203-727-1136
PRN NLD