Pharming Group reports financial results for the first half of 2021
Recovery continued into Q2 2021 as patient enrollment and product demand increases
LEIDEN, The Netherlands, Aug. 5, 2021 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM/NASDAQ: PHAR) presents its preliminary (unaudited) financial report for the first six months of 2021 ended June 30, 2021.
- The Company will hold an analyst conference call at 13.00 CET/07.00 ET today. Dial in details can be found on page 7 of this report
- The Company will also hold a webinar at 19:00CET. Registration details can be found on the Company's website: www.pharming.com
Financial Summary
Amounts in US$m except per share data | H1 2021 | H1 2020 | % Change |
Income Statement | |||
Revenues | 93.2 | 97.8 | (5)% |
Gross profit | 83.8 | 86.9 | (4)% |
Operating profit | 17.2 | 35.7 | (52)% |
Profit for the year | 14.4 | 20.3 | (29)% |
Balance Sheet | |||
Cash & marketable securities | 189.8 | 173.8 | 9% |
Share Information | |||
Basic earnings per share (US$) | 0.022 | 0.032 | (31)% |
Diluted earnings per share (US$) | 0.019 | 0.028 | (32)% |
Financial highlights
- Total revenues for the first half of 2021 came to US$93.2 million, a 5% decrease from the first half of 2020 US$97.8 million. However, revenues in Q2 2021 increased by 15% to US$49.7 million, compared to US$43.4 million in Q2 2020. Revenues in Q2 2021 also increased by 14% compared to US$43.6 million in Q1 2021. As previously noted in our Q1 2021 financial release, Q1 2021 saw the US healthcare economy significantly affected by the second wave of COVID 19 to hit the US. In Q2 2021 doctors' offices reopened and diagnostic and routine patient appointments initiated a recovery across the pharmaceutical sector and for RUCONEST® (recombinant human C1 esterase inhibitor, or "rhC1INH") sales.
- The start of the RUCONEST® recovery in the US during Q2 2021 was driven by an increase in new patients and product demand. For the first half of 2021 revenue from US sales amounted to US$90.1 million a 4% decrease from US$93.9 million in the first half of 2020. However, US sales revenues in Q2 2021 increased by 16% to US$48.4 million fromUS$41.6 million in Q1 2021.
- Sales revenues in Europe and Rest of World (RoW) decreased to US$3.2 million in the first half of 2021 (H1 2020: US$4.0 million) In Q2 2021 revenue from Europe and RoW sales was US$1.2 million a decrease of 36% on Q1 2021 $1.96 million, mainly as a result of phasing of ordering.
- Gross profit for first half year of 2021 amounted to US$83.8 million a decrease of 4% in comparison to H1 2020 (US$86.9 million). However, gross profit for Q2 2021 increased by 17% to US$45.0 million compared to US$38.4 million in Q2 2020 and by 16% compared to Q1 2021, in line with the increased revenues.
- Operating profit for the first half of 2021 amounted to US$17.2 million, a 52% decrease from H1 2020 (US$35.7 million). Operating profit for Q2 2021 decreased by 23% to US$10.9 million compared to Q2 2020 (US$14.2 million) but increased by 73% compared to Q1 2021 (US$6.3 million).
- Other operating costs increased to US$68.0 million compared to US$51.8 million in the first half year of 2020. The increase was a combination of increased R&D expenditure, investments in launch preparation and manufacturing cost for leniolisib, an increase in employee numbers supporting company growth, a significant increase in cost of insurances, an increase in share-based compensation and increased compliance and control costs.
- Net profit for H1 2021 came to US$14.4 million a 29% decrease in comparison to H1 2020 (US$20.3 million), as a result of lower operating profit offset by currency results and lower funding costs.
- Cash and cash equivalents, together with restricted cash decreased from US$206.7 million at the end of 2020 to US$189.8 million at the end of Q2 2021. This was as a result of positive cash flow from operating activities (US$16.4 million) reduced by investments and the payment of the final $25 million milestone payment in Q2 2021 to Bausch Health Inc. relating to the re-acquisition of the North American RUCONEST® commercialization rights in 2016.
Operational highlights
- Reimbursement of RUCONEST® agreed with the Spanish Ministry of Health for the treatment of acute hereditary angioedema (HAE) attacks in Spain.
- Announced the successful completion of patient enrollment in the pivotal Phase 2/3 triple-blind, randomized, placebo-controlled study of leniolisib for the treatment of activated phosphoinositide 3-kinase delta (PI3K?) syndrome (APDS). The anticipated launch of leniolisib is in Q4 2022, subject to regulatory approval.
- Announced the launch of navigateAPDS, a sponsored genetic testing program in collaboration with Invitae Corporation (NYSE: NVTA) designed to assist clinicians in identifying patients and their family members with activated PI3K delta syndrome (APDS), which may lead to earlier diagnosis.
- The first patient was enrolled in a Phase IIb double-blind, randomized, controlled study to assess the efficacy of RUCONEST®, for the prevention of acute kidney injury after non-ST elevation myocardial infarction at the University Hospital Basel, Switzerland.
- Upon nomination by the Board of Directors, the Company's Annual General Meeting of Shareholders that was held on 19 May 2021 appointed Steven Baert, Leon Kruimer and Jabine van der Meijs as Non-Executive Directors to the Board.
- Appointed Anurag Relan as Chief Medical Officer and Robert Friesen as Chief Scientific Officer.
Post-period operational highlights
- Entered into an exclusive license agreement with NewBridge Pharmaceuticals for the distribution of RUCONEST® in the Middle East and North Africa.
- Announced a strategic collaboration with Orchard Therapeutics, a global gene therapy leader, 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. OTL-105 is designed to increase C1 esterase inhibitor (C1INH) in HAE patient serum to prevent HAE attacks.
Chief Executive Officer, Sijmen de Vries, commented:
"As expected, revenue growth during Q2 2021 has continued to recover, following the impact of COVID-19 on Q1 2021, as underlying demand and patients benefiting from RUCONEST® treatments for their HAE increases. We are confident this positive trend will continue for the remainder of the year and, supported by our strong cash position, will enable us to continue our planned investment in R&D and the ongoing preparations for the launch of leniolisib, which, subject to regulatory approval, is on track for the end of 2022 following the completion of patient enrollment in the potentially registration enabling study in APDS.
In our earlier pipeline, we initiated enrollment of patients in a multi-center Phase IIb clinical trial of rhC1INH for the prevention of acute kidney injury after myocardial infarction. In addition, post period, we delivered on one of our strategic objectives to strengthen our longer-term HAE pipeline, through a collaboration with Orchard Therapeutics, to develop and commercialize the pre-clinical ex-vivo autologous hematopoietic stem cell therapy product OTL-105, which has the potential to become a curative treatment for HAE. We remain focused on the positive progress against our three-pillar strategy of sales, R&D and acquisitive growth."
Outlook
For the remainder of 2021, we expect:
- Continued increase in revenues from the sales of RUCONEST®, as a result of the pharmaceutical market continuing to normalize and return to its pre-COVID 19 state. We will though continue to monitor the situation in all markets and continue to expect some periodic disruptions.
- Maintenance of positive net earnings during the year.
- Investments in acquisitions and in-licensing of new development opportunities and assets.
- Continued investment in the expansion of production facilities, both for RUCONEST® and leniolisib.
- Investment in launch-critical medical affairs and pre-marketing activities for leniolisib and the registration-enabling study for APDS, as well as our ongoing clinical trials for rhC1INH and other development activities, including OTL-105.
No further specific financial guidance for 2021 is provided.
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, in a registration enabling Phase 2/3 study in the United States and Europe.
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.
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 2020 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, 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.
For further public information, contact:
Pharming Group, Leiden, The Netherlands
Sijmen de Vries, CEO: T: +31 71 524 7400
Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: investor@pharming.com
FTI Consulting, London, UK
Victoria Foster Mitchell/Alex Shaw
T: +44 203 727 1000
LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: pharming@lifespring.nl
Conference call dial-in information
Thursday August 5, 2021 13:00CET/07:00ET
Please note, the Company will only take questions from dial-in attendees.
Dial-in details:
Netherlands (Local) 085 888 7233
United Kingdom 0800 640 6441
United Kingdom (Local) 020 3936 2999
All other locations +44 20 3936 2999
Access code: 914296
Webcast Link:
https://webcast.openbriefing.com/pharming-aug21/
Pharming Group N.V.
Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)
For the period ended 30 June 2021
- Condensed consolidated statement of profit and loss
- Condensed consolidated statement of comprehensive income
- Condensed consolidated balance sheet
- Condensed consolidated statement of changes in equity
- Condensed consolidated statement of cash flow
Appendix: Main condensed consolidated Interim Financial Statements reported in Euros
(This appendix is not part of the Condensed Consolidated Financial Statements)
- Condensed consolidated statement of profit and loss in Euros
- Condensed consolidated statement balance sheet in Euros
- Condensed consolidated statement of cash flows in Euros
CONDENSED CONSOLIDATED STATEMENT OF PROFIT AND LOSS | |||||
For the 6-month period ended 30 June | |||||
Amounts in $ '000 | notes | HY2021 | HY 2020 | ||
Revenues | 7 | 93,237 | 97,827 | ||
Costs of sales | 8 | (9,487) | (10,885) | ||
Gross profit | 83,750 | 86,942 | |||
Other income | 1,354 | 525 | |||
Research and development | (24,206) | (17,658) | |||
General and administrative | (15,060) | (9,846) | |||
Marketing and sales | (28,686) | (24,283) | |||
Other Operating Costs | 8 | (67,952) | (51,787) | ||
Operating profit | 17,152 | 35,680 | |||
Fair value gain (loss) on revaluation derivatives | 44 | 93 | |||
Other finance income | 9 | 5,398 | 1,237 | ||
Other finance expenses | 9 | (2,958) | (8,252) | ||
Finance gain (cost) net | 2,484 | (6,922) | |||
Share of net profits in associates using the equity method | 10 | 388 | 134 | ||
Profit before tax | 20,024 | 28,892 | |||
Income tax credit (expense) | (5,672) | (8,561) | |||
Profit for the year | 14,352 | 20,331 | |||
Basic earnings per share (US$) | 17 | 0.022 | 0.032 | ||
Diluted earnings per share (US$) | 17 | 0.019 | 0.028 |
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME | ||||
For the 6-month period ended 30 June | ||||
Amounts in US$ '000 | HY 2021 | HY 2020 | ||
Profit for the year | 14,352 | 20,331 | ||
Currency translation differences | (5,582) | 39 | ||
Items that may be subsequently reclassified to profit or loss | (5,582) | 39 | ||
Other comprehensive income (loss), net of tax | (5,582) | 39 | ||
Total comprehensive income (loss) for the year | 8,770 | 20,370 |
CONDENSED CONSOLIDATED BALANCE SHEET | |||||||||||||||||
as at 30 June
| |||||||||||||||||
Amounts in $ '000 | notes | June 30, 2021 | 31 December 2020 | ||||||||||||||
Non-current assets | |||||||||||||||||
Intangible assets | 91,386 | 94,083 | |||||||||||||||
Property, plant and equipment | 11 | 15,588 | 12,226 | ||||||||||||||
Right-of-use assets | 12 | 22,043 | 9,427 | ||||||||||||||
Deferred tax assets | 13 | 23,925 | 31,877 | ||||||||||||||
Investments accounted for using the equity method | 10 | 7,261 | 7,118 | ||||||||||||||
Restricted cash | 493 | 510 | |||||||||||||||
Total non-current assets | 160,696 | 155,241 | |||||||||||||||
Current assets | |||||||||||||||||
Inventories | 14 | 24,307 | 21,157 | ||||||||||||||
Trade and other receivables | 37,550 | 35,902 | |||||||||||||||
Restricted cash | 987 | 995 | |||||||||||||||
Cash and cash equivalents | 188,303 | 205,159 | |||||||||||||||
Total current assets | 251,147 | 263,213 | |||||||||||||||
Total assets | 411,843 | 418,453 | |||||||||||||||
Equity | |||||||||||||||||
Share capital | 7,251 | 7,163 | |||||||||||||||
Share premium | 453,014 | 444,940 | |||||||||||||||
Legal reserves | 14,665 | 19,859 | |||||||||||||||
Accumulated deficit | (276,858) | (288,527) | |||||||||||||||
Shareholders' equity | 15 | 198,072 | 183,435 | ||||||||||||||
Non-current liabilities | |||||||||||||||||
Convertible bonds | 16 | 145,437 | 149,727 | ||||||||||||||
Lease liabilities | 12 | 20,328 | 8,230 | ||||||||||||||
Other financial liabilities | 189 | 212 | |||||||||||||||
Total non-current liabilities | 165,954 | 158,169 | |||||||||||||||
Current liabilities | |||||||||||||||||
Convertible bonds | 16 | 1,972 | 2,040 | ||||||||||||||
Derivative financial liabilities | 71 | 181 | |||||||||||||||
Trade and other payables | 43,123 | 47,666 | |||||||||||||||
Lease liabilities | 2,651 | 1,962 | |||||||||||||||
Other financial liabilities | — | 25,000 | |||||||||||||||
Total current liabilities | 47,817 | 76,849 | |||||||||||||||
Total equity and liabilities | 411,843 | 418,453 | |||||||||||||||
CONDENSED CONSOLIDATED STATEMENT CHANGES IN EQUITY | |||||||||||||||||
For the period ended 30 June | |||||||||||||||||
Attributable to owners of the parent | |||||||||||||||||
Amounts in $ '000 | notes | Number of shares | Share capital | Share premium | |||||||||||||
Balance at 1 January 2020 as reported in HY report | 631,323 | 7,079 | 439,887 | ||||||||||||||
Result for the half-year | — | — | — | ||||||||||||||
Other comprehensive income (loss) for the half-year | — | — | — | ||||||||||||||
Total comprehensive income (loss) for the half-year | — | — | — | ||||||||||||||
Legal reserves development expenses | — | — | — | ||||||||||||||
Share-based compensation | — | — | — | ||||||||||||||
Bonuses settled in shares | — | — | — | ||||||||||||||
Value of conversion rights on convertible bonds | — | — | — | ||||||||||||||
Shares issued for cash | 2,061 | 23 | 1,534 | ||||||||||||||
Warrants exercised/ issued | — | — | — | ||||||||||||||
Options exercised | 4,319 | 47 | 2,626 | ||||||||||||||
Total transactions with owners, recognized directly in | 6,380 | 70 | 4,160 | ||||||||||||||
Balance at 30 June 2020 | 637,703 | 7,149 | 444,047 | ||||||||||||||
Balance at 1 January 2021 | 17 | 638,822 | 7,163 | 444,940 | |||||||||||||
Result for the year | — | — | — | ||||||||||||||
Other comprehensive income (loss) for the half-year | — | — | — | ||||||||||||||
Total comprehensive income (loss) for the half-year | — | — | — | ||||||||||||||
Legal reserves development expenses | — | — | — | ||||||||||||||
Income Tax expense from excess tax deductions related to Share-based payments | — | — | — | ||||||||||||||
Share-based compensation | 176 | 2 | 264 | ||||||||||||||
Bonuses settled in shares | — | — | — | ||||||||||||||
Shares issued for cash | — | — | — | ||||||||||||||
Warrants exercised/ issued | 61 | 1 | 20 | ||||||||||||||
Options exercised | 7,064 | 85 | 7,790 | ||||||||||||||
Total transactions with owners, recognized directly in equity | 17 | 7,301 | 88 | 8,074 | |||||||||||||
Balance at 30 June 2021 | 17 | 646,123 | 7,251 | 453,014 | |||||||||||||
CONDENSED CONSOLIDATED STATEMENT CHANGES IN EQUITY | ||||||||||||
For the period ended 30 June | ||||||||||||
Attributable to owners of the parent | ||||||||||||
Amounts in $ '000 |
By: PR Newswire Association LLC.
- 05 Aug 2021
Return to news
Upcoming Life Sciences Events
|