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.

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

Operational highlights

Post-period operational highlights

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:

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 NetherlandsSijmen de Vries, CEO: T: +31 71 524 7400 Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: [emailprotected]

FTI Consulting, London, UKVictoria Foster Mitchell/Alex Shaw T: +44 203 727 1000

LifeSpring Life Sciences Communication, Amsterdam, The NetherlandsLeon Melens T: +31 6 53 81 64 27 E: [emailprotected]

Conference call dial-in informationThursday August 5, 2021 13:00CET/07:00ETPlease 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

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

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)

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Pharming Group reports financial results for the first half of 2021 - PRNewswire