LEIDEN, NETHERLANDS--(Marketwire - Mar 7, 2013) - Biotech company Pharming Group NV
("Pharming" or "the Company") (NYSE Euronext: PHARM) today
published its
preliminary (unaudited) financial results for the year ended December 31,
2012.
FINANCIAL HIGHLIGHTS
* Revenues and other income increased to EUR10.9 million (2011: EUR3.2
million)
following the Q4 2012 receipt of US$10.0 million (EUR7.9 million) from
our US
partner Santarus in relation to the successful completion of Study 1310
for
Ruconest®.
* Operating costs from continuing operations increased to EUR24.1 million
(2011:
EUR18.2 million).
* Total net loss from continuing operations increased to EUR24.1 million
(2011:
EUR17.8 million) mainly as a result of non-cash charges, such as
EUR5.8 million
in costs associated with financing activities and impairment charges of
EUR1.2
million in relation to the closure of the US-based cattle operations.
* Net cash outflows from operations decreased to EUR10.3 million (2011:
EUR16.9
million) with net cash inflows from financing activities amounting to
EUR11.6
million (including EUR8.0 million in relation to the issue of
convertible
bonds) and net cash inflows from investing activities amounting to
EUR0.1
million (EUR0.7 million in cash was received due to sale of the US-
based
cattle operations, which offset investment payments of EUR0.6 million).
* Cash at the end of 2012 increased to EUR6.3 million (2011: EUR5.1
million). The
negative equity position of EUR1.2 million at year end 2011 increased
to a
negative equity position of EUR7.7 million.
OPERATIONAL UPDATE
* Successful completion of the Ruconest US Phase III pivotal study (Study
1310) followed by receipt of an associated US$10.0 million milestone
payment
from our US partner Santarus.
* Ruconest continues roll-out across Europe:
* Roll-out progressing slower than expected as a result of
challenging
market access conditions in the EU during 2012.
* To address these issues, our partner Sobi has recently re-aligned
their
commercial organisation and have initiated specific in-market
actions.
* First production validation runs completed and initiation of the
certification process with the European Medicines Agency (EMA) and Food
and
Drug Authority (FDA) for new downstream manufacturing site for
Ruconest,
which will enable significant future reductions in the cost of
manufacturing.
* Restructuring to reduce cash-burn initiated in the second half of 2012;
sale
of the US facility and the downsizing of the Netherlands organization.
The
latter is expected to be completed in the first half of 2013.
* New positive data published showing that Ruconest was not observed to
have a
prothrombotic effect when used to treat acute HAE attacks
* study published by Relan et al in the peer-reviewed journal
Biodrugs
* competitive drugs have shown to be prothrombotic
* Expansion of the geographical coverage for Ruconest through new
agreements
with Singapore based Transmedic Pte for Brunei, Indonesia, Malaysia,
Philippines, Singapore, as well as Thailand and Seoul based Hypjin Corp
for
South Korea.
* Initiated an open-label Phase II clinical study evaluating Ruconest for
the
treatment of acute attacks of angioedema in paediatric patients with
HAE.
* Data published showing that Ruconest has a protective effect in a
preclinical animal model of severe blood loss designed to simulate
battlefield injuries.
Sijmen de Vries, CEO, commented: "2012 was a challenging and volatile
year for
Pharming, largely due to an unforeseen delay in Study 1310 which
negatively
impacted on our cash resources. However, this early challenge was
followed by
the arrangement of an Equity Working Capital Facility for financing
and the
successful completion of Study 1310, which triggered the payment of a
US$10.0
million milestone by our US partner Santarus. This in turn provided the
platform
for the January 2013 EUR16.35 million financing, by means of a
short term
convertible bond, and hence a strong ending to the year. In sharp
contrast to
only some months ago, Pharming is now well prepared and funded to enter
the US
regulatory review process for the treatment of acute HAE with
Ruconest.
Furthermore, in the second half of the year, assuming that the Ruconest BLA
will
have been accepted for review, together with our US partner Santarus we
plan to
request separate meetings with the FDA to discuss the pathway for
other
potential indications for Ruconest such as the treatment of acute
pancreatitis
and the prophylactic treatment of HAE. As we near potential approval
and a
subsequent launch for Ruconest in the US, the world's largest
pharmaceutical
market, Pharming is in a strong position to capitalise on this
significant
commercial opportunity."
FINANCIAL RESULTS
In the year 2012 the Company generated revenue from continuing
operations of
EUR10.6 million (2011: EUR3.0 million). This increase stems from the Q4
2012 receipt
of US$10.0 million (EUR7.9 million) from our US partner Santarus in
relation to
successful completion of Study 1310. Costs of revenues amounted to EUR4.3
million
(2011: EUR3.5 million) with impairments on inventories previously
reserved for
sales amounting to EUR3.1 million (2011: EUR1.7 million). Other income
related to
grants exclusively and increased from EUR0.2 million in 2011 to EUR0.3
million in
2012.
Total operating costs from continuing operations increased by EUR5.9
million from
EUR18.2 million in 2011 to EUR24.1 million in the same period of 2012. The
increase
in part reflects items such as impairment charges related to the US-based
cattle
platform operations (EUR1.2 million), a restructuring provision
expense in
relation to the Dutch operations and the US-based cattle platform
operations
(EUR1.4 million) as well as the Company's activities in relation to
Study 1310
required for US regulatory approval for Ruconest.
Early in 2012 the Company finalized a transaction announced in December
2011
under which it issued EUR8.4 million convertible bonds plus 38,717,484
warrants.
The bonds had to be repaid in six monthly installments and could be
settled in
cash and/or in shares. The bonds have been fully repaid in
2012; all
installments plus interest were in shares with the number of shares
based on
volume weighted average price, a reference period minus a discount. With
regard
to these pay-backs, the Company issued a total of 210,181,995 shares. Total
non-
cash costs associated with these bonds amounted to EUR5.1 million,
which in
addition to the one-time recycling expense of an equity translation
reserve of
EUR1.4 million and EUR1.3 million profit posted on financial derivatives
and various
other expense items totaling EUR1.4 million, accounted for a net loss on
financial
income and expenses of EUR6.6 million as compared to a EUR0.7 million net
profit on
financial income and expenses in 2011.
As a result of the above items, the net loss from continuing
operations
increased by EUR6.3 million to EUR24.1 million in 2012 (2011: EUR17.8
million). Due to
a one-time EUR0.6 million profit on discontinued operations in 2011,
total net
loss increased from EUR17.2 million to EUR24.1 million. The net loss per
share for
2012 amounted to EUR0.03 (2011: EUR0.04).
FINANCIAL POSITION
Total cash and cash equivalents (including restricted cash) increased by
EUR1.2
million from EUR5.1 million at year end 2011 to EUR6.3 million at the end
of 2012.
The increase follows from net cash outflows from operations of EUR10.3
million
with net cash inflows from financing activities amounting to EUR11.6
million and
net cash inflows from investing activities amounting to EUR0.1 million.
Net cash
flows used in operating activities decreased from EUR16.9 million in 2011
to EUR10.3
million in 2012, which largely reflects receipt of US$10.0 million from
our US
partner Santarus following the successful completion of Study 1310.
Financing cash flows followed the early 2012 issue of convertible bonds
which
raised EUR8.0 million in cash (fully repaid in 210,181,995 shares in
2012), EUR4.9
million through the issue of 258,768,453 shares under a EUR10.0 million
equity
working capital facility concluded in August 2012 and EUR0.4 million
through the
issue of 24,051,258 shares following the exercise of warrants; financing
cash
outflows of EUR1.8 million in 2012 related to finance lease payments
and costs
associated with the issue of convertible bonds and shares. Investing cash
flows
included EUR0.6 million in payments related to investments; these were
offset with
EUR0.7 million received in relation to the closure and subsequent sale of
the US-
based cattle operations.
Pharming continues to seek improvement in its financial position and at
December
31, 2012 had a remaining amount available under the EUR10.0 million equity
working
capital facility of EUR5.1 million. In January 2013 the Company announced
it had
entered into a EUR16.35 million convertible bond agreement (net proceeds
of EUR15.3
million); the transaction was subject to shareholder approval,
which was
obtained at the Extraordinary General Meeting of Shareholders held on
February
28, 2013.
In addition, the Company anticipates receiving US$5.0 million from Santarus
when
the US Food and Drug Administration accepts the BLA filing for review.
Receipt
of this milestone is expected to further improve the Company's cash and
equity
position.
NEGATIVE EQUITY
In December 2011 the Company announced that it had entered negative equity.
This
negative equity position of EUR1.2 million at year end 2011 increased
by EUR6.5
million to EUR7.7 million and mainly reflects the EUR24.1 million net
loss for the
year 2012, net of EUR12.5 million posted for shares issued as a
repayment of
convertible bonds (EUR9.9 million), shares issued in relation to the
equity
working capital facility (EUR4.7 million), shares issued in relation
to the
exercise of warrants (EUR0.9 million) and other payments in shares (EUR0.3
million).
In addition, following the closure of the US-based cattle platform
operations
Pharming restated a negative equity translation reserve of EUR1.4 million
to the
statement of income; this restatement impacted the EUR24.1 million net
loss for
the year 2012 but in itself did not affect equity.
The negative equity position has in itself no immediate impact on the
execution
of Pharming's business plan, nor does it imply that the Company is
legally
required to issue new share capital. However, the Company is considering
various
options in order to reduce the negative equity and return to a positive
equity
position.
Pharming is continuously reviewing its financial and liquidity position
and has
various options to improve its equity standing under International
Financial
Reporting Standards (IFRS). Notably, the Company reports that the
negative
equity position was mainly caused by the inability to recognize the
EUR19.7
million upfront payments and milestones received from Sobi and
Santarus as
equity (at December 31, 2012 the deferred license fees income amounted to
EUR15.4
million; if release to the statement of income would have been permitted
under
IFRS, the Company would have reported a positive equity position of
EUR7.7
million). Anticipated receipt of the development milestone associated
with the
acceptance of the BLA filing by the FDA (US$5.0 million) will, under
IFRS, be
recognized immediately and thus augment the equity position.
Conference call information
Today, Chief Executive Officer Sijmen de Vries will discuss the full year
2012
results in a conference call at 10:00am (CET). To participate, please
call one
of the following numbers 10 minutes prior to the call:
From the Netherlands: 31 (0) 45 631 6902
From the UK: 44 (0) 207 153 2027
About Pharming Group N.V.
Pharming Group N.V. is developing innovative products for the treatment of
unmet
medical needs. RUCONEST® is a recombinant human C1 inhibitor
approved for the
treatment of angioedema attacks in patients with HAE in all 27 EU countries
plus
Norway, Iceland and Liechtenstein, and is distributed in the EU by
Swedish
Orphan Biovitrum. RUCONEST® is partnered with Santarus Inc
(NASDAQ: SNTS) in
North America where the drug has completed Phase III clinical
development. The
product is also being evaluated for various follow-on indications.
Pharming has
a unique GMP compliant, validated rabbit platform for the
production of
recombinant human proteins that, with the EU approval of Pharming's
rhC1
inhibitor, has proven capable of producing industrial volumes of high
quality
recombinant human protein in a significantly more economical way
through low
upfront capital investment and manufacturing costs, compared to current
cell
based technologies. Pharming now plans to utilise this platform
for the
development of rhFVIII for the treatment of Haemophilia A.
Additional information is available on the Pharming website,
www.pharming.com.
This press release contains forward looking statements that involve
known and
unknown risks, uncertainties and other factors, which may cause the
actual
results, performance or achievements of the Company to be materially
different
from the results, performance or achievements expressed or implied by
these
forward looking statements.
The full report including tables can be downloaded from the following link:
Q4 Report 2012:
http://hugin.info/132866/R/1683570/551032.pdf
This announcement is distributed by Thomson Reuters on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Pharming Group N.V. via Thomson Reuters ONE
[HUG#1683570]