Pharming Group reports financial results for full year 2020

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Overig advies 04/03/2021 09:02
Leiden, The Netherlands, 4 March 2021: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/Nasdaq: PHAR) presents its preliminary (unaudited) financial report for the full year ended 31 December 2020.
• The Company will hold an analyst conference call at 13.30 CET/07.30 EST today. Dial in details can be found on page 5 of this report
• The Company will also hold a webinar at 19:00CET to review the year in more detail.
Registration details can be found on the Company’s website: www.pharming.com
• In connection with the Company’s recent Nasdaq listing, Pharming’s Annual Report and 20-F filing will be simultaneously published on the 6 April 2021

Financial Summary
Amounts in €m except per share data 2020 2019 % Change
Consolidated Income Statement
Revenues 185.7 169.0 9.9%
Gross profit 165.1 147.7 11.8%
Operating profit 67.4 60.9 10.7%
Finance cost, net (28.5) (14.4) 96.9%
Income tax expense (6.6) (10.5) (36.9%)
Profit for the year 32.7 36.2 (9.8%)
Consolidated Balance Sheet
Cash and cash equivalents (including
restricted cash) 168.3 68.6 145.3%
Share Information
Basic earnings per share (€) 0.051 0.058 (12.1%)
Fully-diluted earnings per share (€) 0.048 0.054 (11.1%)

Financial highlights
• Revenues for the full year increased by 9.9% to €185.7 million (FY2019: €169.0 million), primarily driven by sales growth of RUCONEST® (recombinant human C1 inhibitor) in the US
• Revenues in the US increased €48.1 million in Q4 to €177.4 million (FY2019: €162.7 million) driven by seasonally strong demand and some COVID-19 related additional ordering by patients in Q4 2020, despite significant negative currency effects from the weakened US Dollar versus the Euro
• As result of the strong US sales performance in Q4 2020, the net sales level that triggers the payment of the final $25 million milestone to Bausch Health Inc. has been achieved.

The payment of this final milestone will take place in Q2 2021 and concludes all
obligations under the agreement with Bausch Health Inc.
• Revenues in Europe and RoW increased by 69% to €8.3 million (FY2019: €4.9 million), driven by increasing demand in Q3 and Q4 2020 and as the Company continues to build out its EU commercial infrastructure and expands into new territories following the reacquisition of EU rights for RUCONEST® from Swedish Orphan Biovitrum AB (Sobi).
• Gross profit increased 11.8% to €165.1 million (FY2019: €147.7 million), due to increased sales in the US and EU, coupled with economies of scale in manufacturing, leading to lower cost of sales.
• Operating profit improved strongly to €67.4 million (FY2019: €60.9 million), an increase
of 10.7% despite an increase in clinical and R&D activity
• Net profit of €32.7 million represented a decrease of 9.8% (FY2019: €36.2 million). This despite an increase in operating profit and reflects a significant increase in finance cost of €13.9 million. This was mainly caused by negative currency effects (€12.6 million).
• Cash and cash equivalents, together with restricted cash increased to €168.3 million at the year end, compared with €68.6 million for the year ended 31 December 2019. This was mainly due to strong cash flow from operating activities and proceeds from the issue of a convertible bond which were partly offset by the repayment of loans.

Operational highlights
• Approval of second production facility for RUCONEST® starting material by the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)
• Received European Commission (EC) approval to treat acute HAE attacks in children with RUCONEST®. This followed a positive opinion and recommendation from the EMA’s
Committee for Medicinal Products for Human Use on the extension of the indication for RUCONEST®
• Received EC grant of orphan drug designation for leniolisib for the treatment of APDS, based on a positive opinion from the EMA’s Committee for Orphan Medicinal Products
• Announced positive results from a compassionate use study in patients with confirmed SARS-CoV-2 infections hospitalized with related severe pneumonia that were treated with RUCONEST®. Results were subsequently published in Frontiers in Immunology
• Initiated two studies into the use of RUCONEST® in the prevention of severe SARS-CoV-2
infections in patients hospitalized with related severe pneumonia across Switzerland and the US, as well as in Brazil and Mexico
• Successfully completed a secondary listing of American Depositary Shares (ADS) on the Nasdaq Global Market
• Appointed Jeroen Wakkerman as Chief Financial Officer
• In addition to a corporate governance change from a two-tier board to a one-tier board structure, Barbara Yanni and Mark Pykett were appointed as Non-Executive Directors of the Board, and Deborah Jorn succeeded Juergen Ernst as Vice-Chair of the Board

• Accepted into the Euronext Amsterdam MidKap index (AMX)
Chief Executive Officer, Sijmen de Vries, commented:
“We are pleased to announce continued growth during 2020, especially, having achieved a net sales level that requires the payment of the final $25 million milestone to Bausch Health Inc.
significantly earlier than originally anticipated and despite the impact of the COVID-19 pandemic on sales and marketing activities. Strong growth in our operating result was also achieved, despite a significant decrease in exchange rate of the US dollar versus the Euro.
We have also continued to deliver regulatory and clinical progress, despite the pandemic causing an initial halt in development across our existing pipeline, through the approval of RUCONEST® to treat children with HAE attacks and the grant of orphan drug designation for leniolisib for the treatment of APDS, both by the European Commission, as well as the initiation of two studies into the use of RUCONEST® for the prevention of severe complications of SARSCoV-2 infections.
In addition, we remain focused on building on our solid foundations to deliver long-term growth.
In line with this strategy, we successfully refinanced the Company early in the year, under very favorable terms, received EMA and FDA approval of our second RUCONEST® starting material production facility and implemented plans to expand our in-house processing capability.
Lastly, at the end of the year, we completed a secondary listing of American Depositary Shares on the Nasdaq Global Market, which we believe will enable us to accelerate our growth strategy to deliver significant value to our patients and other stakeholders.”
About Pharming Group N.V.

Pharming Group N.V. is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.
The flagship of our portfolio is our recombinant human C1 esterase inhibitor, or rhC1INH, franchise. C1INH is a naturally occurring protein that down regulates the complement cascade in order to control swelling in affected tissues.
Our lead product, RUCONEST® is the first and only plasma-free rhC1INH protein replacement therapy. It is approved for the treatment of acute hereditary angioedema, or HAE, attacks. We are commercializing RUCONEST® in the United States, the European Union and the United Kingdom through our own sales and marketing organization, and the rest of the world through our distribution network.
We are also developing rhC1INH for subsequent indications, including pre-eclampsia, acute kidney injury and we also investigating the clinical efficacy of rhC1INH in COVID-19.
In addition, we are studying our oral precision medicine, leniolisib (a phosphoinositide 3-kinase
delta, or PI3K delta, inhibitor), for the treatment of activated PI3K delta syndrome, or APDS, in a registration enabling Phase 2/3 study in the United States and Europe.

Furthermore, we are also leveraging our transgenic manufacturing technology to develop nextgeneration protein replacement therapies most notably for Pompe disease, which program is currently in the preclinical stage.

Forward-looking Statements
This press release contains forward-looking statements, including with respect to timing and progress of Pharming’s preclinical studies and clinical trials of its product candidates, Pharming’s clinical and commercial prospects, Pharming’s ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of its business, and Pharming’s expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming’s clinical trials and ramifications for the cost thereof; and clinical,
scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming’s 2019 Annual Report and its report for the nine months ended 30 September 2020, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming’s actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release.

Inside Information
This press release relates to the disclosure of information that qualifies, or may have qualified,
as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

see & read more on
https://www.pharming.com/sites/default/files/imce/Press%20releases/2020%20Full%20Year%20Results%20PR%2004MAR21%20final%20PDF.pdf

tijd 09.12
De Midcap 985,32 -4,01 -0,41% Pharming EUR 1,109 -1,9ct vol. 2,9 miljoen

tijd 13.30
Pharming herstelt licht na het verlies in de morgen, nu EUR 1,1595 +3,15ct vol. 10,5 miljoen.



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