Pharming Group reports financial results for the first nine months of 2021

Continued strong positive cash flow from operations enable increasing investment in the pipeline to support long-term growth Continued strong positive cash flow from operations enable increasing investment in the pipeline to support long-term growth LEIDEN,The Netherlands,Oct. 28, 2021/PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM/NASDAQ: PHAR) presents its preliminary (unaudited) financial report for the first nine months ended...

Continued strong positive cash flow from operations enable increasing investment in the pipeline to support long-term growth

LEIDEN, The Netherlands, Oct. 28, 2021 /PRNewswire/ -- Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM/NASDAQ: PHAR) presents its preliminary (unaudited) financial report for the first nine months ended September 30, 2021.

Chief Executive Officer, Sijmen de Vries, commented
"We are pleased to deliver continued quarter-on-quarter revenue growth for the year to date, as expected, following the impact of COVID-19 on sales earlier in 2021, as a result of ongoing patient enrollment and increasing product demand. Supported by the strength of the underlying business; we are continuing to invest in future growth in line with our strategy to develop and expand our pipeline through leverage of our in-house expertise. This investment includes licensing of OTL-105, an investigational gene therapy for the potentially curative treatment of hereditary angioedema, from Orchard Therapeutics in July 2021.We are also investing significant and increasing amounts in preparation for the potential launch of leniolisib in Q4 2022, subject to regulatory approval.

I look forward to the read-out of the registration enabling study for leniolisib, expected early in the new year, as a product with transformational potential for APDS patient's lives and also transformational commercial potential for Pharming."

Operational highlights (Q3 2021)

Financial Summary

Financial highlights

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.

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
The risks outlined in the 2020 Annual Report continued to apply in the first nine months of 2021 and are expected to apply for the rest of the financial year.

We continue to closely monitor the key risks and opportunities, and will respond appropriately to any emerging risk.

Related party transactions
There are no material changes in the nature, scope, and (relative) scale in this reporting period compared to last year.

Auditor's involvement
The Condensed Consolidated Interim Financial Statements have not been audited by the Company's statutory auditor.

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: [email protected]
FTI Consulting, London, UK
Victoria Foster Mitchell/ Alex Shaw
T: +44 203 727 1000
FTI Consulting, USA
Jim Polson
T: +1 (312) 553-6730
LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: [email protected]

Conference call dial-in information
Thursday October, 28, 2021 13:30CET/07:30ET
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

United States (Local)       1 646 664 1960

All other locations          +44 20 3936 2999

Access code: 147906

Webcast Link:
https://webcast.openbriefing.com/pharming-q321/

Pharming Group N.V.

Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)

For the period ended 30 September 2021

Appendix: Main condensed consolidated Interim Financial Statements reported in Euros (unaudited)

(This appendix is not part of the Condensed Consolidated Financial Statements)

 

 

 

 

 

Appendix: Main Condensed Consolidated Financial Statements reported in Euro's

These statements are not part of the original Interim Financial Statements. The original Interim Financial Statements are reported in US Dollars. In case of differences of interpretation between the Financial Statements in US dollars and the Financial Statements in Euros, the Financial Statements in US Dollars will prevail.

 

 

 

 

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