Amounts in US$m except per share data 2021 2020 % Change
Income Statement
Revenues
Gross profit
Operating result
Profit for the year
198.9
177.7
13.6
16.0
212.2
188.6
76.3
37.7
(6)%
(6)%
(82)%
(58)%
Balance Sheet
Cash & marketable securities
193.0
206.7
(7)%
Share Information
Basic earnings per share (US$)
Diluted earnings per share (US$)
0.025
0.023
0.058
0.055
(57)%
(58)%
Financial highlights
Total revenues decreased by 6% to US$198.9 million, mainly due to lower sales of RUCONEST® in the US market. US sales decreased by 5% (US$193.4 million in 2021 compared to US$202.7 million in 2020), following the impact of COVID-19 on the US healthcare economy in Q4 2020 and Q1 2021, in addition to the phasing of ordering from our customers, as previously noted in the Company’s Q1 2021, H1 2021 and Q3 2021 financial reports.
Revenues in Europe decreased to US$4.9 million in 2021 (from US$8.2 million in 2020), mainly caused by phasing of ordering, as stated in the Company’s Q1 2021, H1 2021 and Q3 2021 financial reports. Rest of World revenue (excluding Europe) decreased to US$0.5 million (from US$1.3 million in 2020).
Gross profit was US$177.7 million, a 6% decrease in comparison to the year 2020 (US$188.6 million), which is in line with the decrease in revenues.
Operating profit of US$36.9 million, before US$23.3 million of one-off costs, relating to investment in the pipeline of US$13.1 million to in-license OTL-105 from Orchard Therapeutics and impairment losses on tangible and intangible assets (US$10.2 million) as result of strategic decisions. Operating profit after one-off costs are US$13.6 million. We continued significant investment in Pharming’s long-term growth including increased R&D expenditure, increased pre-launch marketing preparations and manufacturing cost for leniolisib (US$11.6 million), and increased employee numbers to support growth (US$8.2 million). Insurance costs increased due to the Nasdaq listing (US$5.5 million).
Net profit was US$16.0 million, a 58% decrease compared to the year 2020 (US$37.7 million), due to a significant increase in operating expenses. This was offset by favorable foreign currency effects (US$14.9 million).
Cash and cash equivalents, together with restricted cash, decreased from US$206.7 million at the end of 2020 to US$193.0 million at the end 2021, due to positive cash flows from operating activities of US$37.8 million post the US$13.1 million one-off payment to Orchard Therapeutics. These are offset by negative cash flows from investments and financing activities, totaling US$49.3 million. This figure includes the payment of the final US$25.0 million milestone to Bausch Health Inc. in relation to the re-acquisition of the North American RUCONEST® commercialization rights in 2016.
As of 1 January 2021, the Company changed its presentation currency from Euro to US dollar.
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 (rhC1INH) franchise. C1INH is a naturally occurring protein that down regulates the complement and contact cascades in order to control inflammation 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 (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.
In addition, we are investigating the clinical efficacy of rhC1INH in the treatment of further indications, including pre-eclampsia, acute kidney injury and severe pneumonia as a result of COVID-19 infections.
We are also 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. World-wide rights for leniolisib were licensed from Novartis AG in 2019. Leniolisib met both of its primary end points in a registration enabling Phase 2/3 study in the United States and Europe. We are targeting global regulatory filings for leniolisib from Q2 2022 onwards.
Additionally, we entered into a strategic collaboration with Orchard Therapeutics to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex-vivo autologous hematopoietic stem cell (HSC) gene therapy for the treatment of HAE.
Furthermore, we are leveraging our transgenic manufacturing technology to develop next-generation protein replacement therapies, most notably for Pompe disease, which is currently in preclinical development.
Risk profile