Delivered 31% increase in revenue, 51% increase in operating
profit and 60% increase in net profit year-on-year
Delivered 21% increase in revenue, with increases in
operating profit and net profit compared to Q1 2019
Increased investment in pipeline to support long-term
growth
LEIDEN, Netherlands,
July 26, 2019 /PRNewswire/
-- Pharming Group N.V. ("Pharming" or "the Company") (Euronext
Amsterdam: PHARM) presents its (unaudited) interim financial report
for the first half year ended 30 June
2019.
The Company will hold a conference call at 13:00 CET / 07:00
EST today: dial-in details can be found on pages 4 and
5.
Financial
summary
|
|
6 months to 30
June
|
Amounts in €m
except per share data
|
2019
1st
Half
|
2018
1st
Half
*restated
|
%
Change
|
Income
Statement
Revenues
Gross
profit
Operating
result
Net
result
|
77.9
67.0
24.6
13.6
|
59.5
50.0
16.3
8.5*
|
31%
34%
51%
60%
|
Balance
Sheet
Cash &
marketable securities
|
65.3
|
66.9
|
(2%)
|
Share
Information
Earnings per share
(€): - Undiluted
-
Fully diluted
|
0.022
0.020
|
0.014*
0.013*
|
57%
54%
|
* After restatement on the basis set out above and in
Note 4 to the Financial Statements in the Annual Report
2018.
Financial highlights
- The Company made record revenues in the first half year, an
increase of 31% to €77.9 million, from €59.5 million for the same
period last year. Comparing the two first quarters of this year,
the increase was approximately 21% to €42.7 million in the second
quarter compared with €35.2 million during the first quarter of
this year.
- US net product sales increased 33% year-on-year to €75.0
million (H1 2018: €56.3 million), and 21% quarter on quarter to
€40.9 million from €33.7 million in the first quarter of 2019,
reflecting strong growth despite a more competitive
marketplace. In Europe and the rest of the world, product
sales for the first six months of 2019 were flat at €2.5 million
(H1 2018: €2.5 million), mainly due to increased competition in
certain Eastern European markets after competitor product launches,
balanced by limited growth for Pharming direct markets which are
affected by national revenue caps.
- Operating profits rose by 51% to €24.6 million, compared to
€16.3 million in the same period last year, reflecting an
improvement in gross margin and better cost controls. Increased
expenditure on our pre-eclampsia and Acute Kidney Injury studies
relative to the first quarter, on production of our
alpha-glucosidase product for Pompe disease and on capacity
improvements led to lower 2% growth in operating profit quarter on
quarter, from €12.2 million in Q1 2019 to €12.4 million in Q2
2019.
- Net profit increased by 60% to €13.6 million, compared to €8.5
million for H1 2018. Quarter on quarter, the increase was in line
with that on operating profit from €6.7 million in the first
quarter to €6.9 million in the second quarter.
- Positive cashflows during the quarter were driven by strong
revenue, generating almost €10 million above the cash required for
operating costs. This was then reduced by the quarterly
instalment of €7.7 million of the principal amount of the Company's
outstanding loan including associated fees and the (one-off)
strategic investment of €2.5 million in our fill & finish
partner BioConnection, and the costs of capacity
improvements. The net effect of investment and deleveraging
resulted in a stable cash position to €65.3 million, down slightly
from €66.5 million at 31 March 2019
(and €66.9 million at 30 June
2018).
- The equity position improved from €61.8 million at the end of
December 2018 to €77.5 million at the
end of the first half of 2019 (H1 2018: €39.8 million), reflecting
the net result for the period.
- Right-of-use assets in the non-current assets section of the
balance sheet, and lease liabilities under current and non-current
liabilities, show the effects of new disclosures of items acquired
under leases under the new financial standard IFRS 16. These
changes have had no material net effect on operating results during
the quarter.
- Other financial liabilities, which refers to the contingent
consideration for the milestones, reflects the payment of the first
successful sales performance milestone in March 2019 and the revised probability and timing
for paying the last milestone. The next milestone will appear
in current liabilities once it is certain of being incurred, which
is expected to happen later this year.
- Since the last reporting date of 15 May
2019, the Company has issued or reserved for issue a total
of 2,467,074 shares in connection with a number of exercises of
options under the current schemes, and has committed a further
15,414,026 shares under the existing approved employee option and
long term incentive plan programs. The number of issued shares as
at 25 July 2019 is 626,798,839.
The fully diluted number of shares as at 25
July 2019 is 681,535,016.
Sijmen de Vries, Chief Executive Officer, commented:
"We are pleased to report strong results today, demonstrating
continued growth in a period of intense competition.
Pharming's revenue and profit performance confirm our in-market
strategy as we see continued growth from existing and new patients
requesting or being prescribed RUCONEST® as their preferred
breakthrough therapy as well as medication for acute hereditary
angioedema (HAE) attacks. We expect this underlying demand
for the product to continue to drive sales growth as we enter the
second half of the year. As a result of this demand and the
regular need to provide ad hoc supplies in various EU markets
following temporary shortages of plasma derived products, we are
now seeing short term pressure on supplies of product for the
European market. This pressure will be eliminated upon validation
of our new production facility, expected during Q1 next year.
We are doing everything possible in the meantime to minimize this
issue.
In addition, we are making good progress in our pipeline.
Following approval from the Dutch investigating centre's
ethics committee, we are working to commence our clinical study of
the effects of our recombinant human C1 esterase inhibitor
(RUCONEST®) in patients with pre-eclampsia.
We expect to initiate a second major clinical trial with
RUCONEST® in the second half of the year to treat acute kidney
injury in patients undergoing percutaneous coronary interventions
accompanied by contrast-enhanced examinations. An
announcement will be made once this study has been approved to
begin by the relevant authorities.
While the solid growth performance of RUCONEST® in HAE is the
engine room of Pharming's profitable underlying business, we see
very large growth potential in these new indications, each of which
addresses a separate currently-unmet medical need with sales
potential well over $1 billion.
Together with our next protein replacement therapy product for
Pompe disease and a later one for Fabry disease, these offer
prospects for a very bright future for Pharming and all its
stakeholders."
Outlook
For the remainder of 2019, the Company expects:
- Continued growth in revenues from sales of RUCONEST®, mainly
driven by the USA and European
operations.
- Maintenance of positive quarterly net earnings during the
year.
- Continued investment in the expansion of production of
RUCONEST® in order to ensure continuity of supply to the growing
markets in the US, Europe,
China and the Rest of the
World.
- Investment in clinical trials for pre-eclampsia and acute
kidney injury, and support for investigators wishing to explore
additional indications for RUCONEST®
- Re-evaluation of the most advantageous new routes of
administration while we focus on supplying all patients looking to
receive RUCONEST® therapy.
- Investment in development of the new pipeline programs in Pompe
disease and Fabry's disease, and purchase or license of other new
development opportunities and assets.
- Increasing marketing activity where this can be
profit-enhancing for Pharming.
- Supporting all our teams and marketing partners in order to
enable the maximisation of the sales and distribution potential of
RUCONEST® for patients in all territories.
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, Israel and South
Korea. The product is available on a named-patient basis in
other territories where it has not yet obtained marketing
authorization.
RUCONEST® is distributed by Pharming in Austria, France, Germany, Luxembourg, the
Netherlands, the United
Kingdom and the United States of
America. Pharming holds commercialisation rights in
Algeria, Andorra, Bahrain, Belgium, Ireland, Jordan, Kuwait, Lebanon, Morocco, Oman, Portugal, Qatar, Syria,
Spain, Switzerland, Tunisia, United Arab
Emirates and Yemen. In some
of these countries distribution is made in association with the
HAEi Global Access Program (GAP).
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 Argentina, Colombia, Costa
Rica, the Dominican
Republic, Panama, and
Venezuela by Cytobioteck, in
South Korea by HyupJin Corporation
and in Israel by Kamada.
RUCONEST® is also being examined for approval 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 at
present.
Pharming has a long-term partnership with the China State
Institute of Pharmaceutical Industry ("CSIPI"), a Sinopharm
company, for joint global development of new products, starting
with recombinant human Factor VIII for the treatment of Haemophilia
A. Pre-clinical development will take place to global standards at
CSIPI and are funded by CSIPI. Manufacturing for the Chinese market
and to provide additional supply for Pharming will take place at
CSIPI's affiliate, the Chengdu Institute of Biological Products Co.
Ltd. 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:
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.
For further public information, 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
LifeSpring Life Sciences Communication
Leon Melens, Tel: +31 6 53 81 64
27
Conference call information
From the Netherlands: +31 207095189
Toll-Free:
08004050000
From the
UK:
+44 3333000804
Toll-Free:
08003589473
From
Belgium:
+32 24035814
Toll-Free: 080029913
From
France:
+33 170750711
Toll-Free:
0800946608
From Switzerland:
+41 225809034
Toll-Free:
0800721298
From the US:
+1 6319131422
Toll-Free:
+1 855 85 70686
For other numbers, please see:
http://events.arkadin.com/ev/docs/NE_W2_TF_Events_International_Access_List.pdf
Conference call PIN: 63072535#
Presentation link:
https://arkadin-event.webex.com/arkadin-event/onstage/g.php?MTID=e1d8b2e7bd72c6e5d446d5109b80d36e8
Presentation Password: 301295111
Please see link for full Pharming Group N.V. Financial
Results:
PDF:
https://mma.prnewswire.com/media/952793/Pharming_Group_H119_Results.pdf