Pharming Group Reports Strong Financial Results for the First Half of 2019

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") 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


2019 2018
%

Amounts in EURm except per share data 1st Half 1st Half Change

*restated

--- ---




Income Statement



Revenues 77.9 59.5 31%



Gross profit 67.0 50.0 34%



Operating result 24.6 16.3 51%



Net result 13.6

8.5* 60%





Balance Sheet

Cash & marketable securities 65.3 66.9 (2%)


Share Information 0.022

Earnings per share (EUR): -Undiluted 0.020

0.014* 57%
- Fully diluted


0.013* 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 EUR77.9 million, from EUR59.5 million for the same period last
year. Comparing the two first quarters of this year, the increase was
approximately 21% to EUR42.7 million in the second quarter compared with
EUR35.2 million during the first quarter of this year.
-- US net product sales increased 33% year-on-year to EUR75.0 million (H1
2018: EUR56.3 million), and 21% quarter on quarter to EUR40.9 million
from EUR33.7 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 EUR2.5 million (H1 2018: EUR2.5 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 EUR24.6 million, compared to EUR16.3
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 EUR12.2 million in Q1 2019 to EUR12.4
million in Q2 2019.
-- Net profit increased by 60% to EUR13.6 million, compared to EUR8.5
million for H1 2018. Quarter on quarter, the increase was in line with
that on operating profit from EUR6.7 million in the first quarter to
EUR6.9 million in the second quarter.
-- Positive cashflows during the quarter were driven by strong revenue,
generating almost EUR10 million above the cash required for operating
costs. This was then reduced by the quarterly instalment of EUR7.7
million of the principal amount of the Company's outstanding loan
including associated fees and the (one-off) strategic investment of
EUR2.5 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 EUR65.3 million, down slightly
from EUR66.5 million at 31 March 2019 (and EUR66.9 million at 30 June
2018).
-- The equity position improved from EUR61.8 million at the end of December
2018 to EUR77.5 million at the end of the first half of 2019 (H1 2018:
EUR39.8 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 [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.

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 [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 [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 [https://mma.prnewswire.com/media/952793/Pharming_Group_H119_Results.pdf]

Web site: https://www.pharming.com/

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