PHGUF Pharming Group NV Leiden (PK)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 20-F

(Mark One)

☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

OR

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2020

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

OR

☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Date of event requiring this shell company report__________

Commission file number 001-39822

Darwinweg 24

2333 CR Leiden

The Netherlands

Tel: +31 (0)71 5247 400

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Securities registered or to be registered pursuant to Section 12(g) of the Act. None

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the Annual Report

638,821,619 ordinary shares, nominal value €0.01 per share as of December 31, 2020.

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days ☒ Yes ☐ No

Indicate by check mark whether the registrant has submitted electronically, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Emerging growth company ☒

If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☒

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.

Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18 If this is an Annual Report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No

.

TABLE OF CONTENTS
						PAGE
			GENERAL INFORMATION REGARDING FORWARD-LOOKING STATEMENTS			5
Part I
Item 1.			IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS			6
Item 2.			OFFER STATISTICS AND EXPECTED TIMETABLE			6
Item 3.			KEY INFORMATION			6
			A. SELECTED FINANCIAL DATA			6
			B. CAPITALIZATION AND INDEBTEDNESS			6
			C. REASONS FOR THE OFFER AND USE OF PROCEEDS			6
			D. RISK FACTORS			6
Item 4.			INFORMATION OF THE COMPANY			43
			A. HISTORY AND DEVELOPMENT OF THE COMPANY			43
			B. BUSINESS OVERVIEW			43
			C. ORGANIZATIONAL STRUCTURE			67
			D. PROPERTY, PLANT AND EQUIPMENT			67
Item 4 A.			UNRESOLVED STAFF COMMENTS			68
Item 5.			OPERATING AND FINANCIAL REVIEW AND PROSPECTS			68
			A. OPERATING RESULTS			69
			B. LIQUIDITY AND CAPITAL RESOURCES			82
			C. RESEARCH AND DEVELOPMENT, PATENT AND LICENSES, ETC			85
			D. TREND INFORMATION			85
			E. OFF-BALANCE SHEET ARRANGEMENTS			85
			G. SAFE HARBOR			85
Item 6.			DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES			85
			A. DIRECTORS AND SENIOR MANAGEMENT			85
			B. COMPENSATION			88
			C. BOARD PRACTICES			97
			D. EMPLOYEES			98
			E. SHARE OWNERSHIP			98
Item 7.			MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS			99
			A. MAJOR SHAREHOLDERS			99
			B. RELATED PARTY TRANSACTIONS			100
			C. INTERESTS OF EXPERTS AND COUNSEL			101
Item 8.			FINANCIAL INFORMATION			101
			A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION			101
			B. SIGNIFICANT CHANGES			101
Item 9.			THE OFFER AND LISTING			102
			A. OFFER AND LISTING DETAILS			102
			B. PLAN OF DISTRIBUTION			102
			C. MARKETS			102
			D. SELLING SHAREHOLDERS			102
			E. DILUTION			102

			F. EXPENSE OF THE ISSUE			102
Item 10.			ADDITIONAL INFORMATION			102
			A. SHARE CAPITAL			102
			B. ARTICLES OF ASSOCIATION			102
			C. MATERIAL CONTRACTS			118
			D. EXCHANGE CONTROLS			119
			E. TAXATION			119
			F. DIVIDENDS AND PAYING AGENTS			127
			G. STATEMENT BY EXPERTS			127
			H. DOCUMENTS ON DISPLAY			127
			I. SUBSIDIARY INFORMATION			128
Item 11.			QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK			128
Item 12.			DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES			128
			A. DEBT SECURITIES			128
			B. WARRANTS AND RIGHTS			128
			C. OTHER SECURITIES			128
			D. AMERICAN DEPOSITARY SHARES			128
Part II
Item 13.			DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES			131
Item 14.			MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS			131
Item 15.			CONTROLS AND PROCEDURES			131
Item 16.			A. AUDIT COMMITTEE FINANCIAL EXPERT			132
			B. CODE OF ETHICS			132
			C. PRINCIPAL ACCOUNTANT FEES AND SERVICES			133
			D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES			134
			E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS			134
			F.CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT			134
			G. CORPORATE GOVERNANCE			134
			H. MINE SAFETY DISCLOSURE			135
Part III
Item 17.			FINANCIAL STATEMENTS			135
Item 18.			FINANCIAL STATEMENTS			135
Item 19.			EXHIBITS			136

GENERAL INFORMATION REGARDING FORWARD-LOOKING STATEMENTS

In this Annual Report on Form 20-F (“Annual Report”) the terms “Pharming,” “Pharming Group,” “Pharming Group N.V.,” “Pharming Healthcare Inc.,” “the company,” “we,” “us” and “our” refer to Pharming Group N.V. together with its subsidiaries. except where the context otherwise requires.

This Annual Report on Form 20-F contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward- looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this Annual Report on Form 20-F are based upon information available to us as of the date of this Annual Report on Form 20-F and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Forward-looking statements include statements about:

•the development of our product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;

• our ability to obtain and maintain regulatory approval of our product candidates in the indications for which we plan to develop them, and any related restrictions, limitations or warnings in the label of an approved drug or therapy;

• our plans to collaborate, or statements regarding the ongoing collaborations, with third parties;

• our plans to research, develop, manufacture and commercialize our product candidates;

•the timing of our regulatory filings for our product candidates;

•the size and growth potential of the markets for our product candidates;

•our ability to raise additional capital;

•our commercialization, marketing and manufacturing capabilities and strategy;

•our expectations regarding our ability to obtain and maintain intellectual property protection;

•our ability to attract and retain qualified employees and key personnel;

•our ability to contract with third-party suppliers and manufacturers and their ability to perform adequately;

•our estimates regarding future revenues, expenses and needs for additional financing;

•our belief that our existing cash, cash equivalents and term deposits will be sufficient to fund our operating expenses and capital expenditure requirements through as we currently expect;

•our ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of our business; and

•regulatory developments in the United States, the Netherlands, EU and other jurisdictions including tax matters.

You should refer to the section of this Annual Report on Form 20-F titled "Item 3.D—Risk Factors" for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Annual Report on Form 20-F will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Forward-looking statements speak only as of the date they are made, and we do not undertake any obligation to update them in light of new information or future developments or to release publicly any revisions to these statements in order to reflect later events or circumstances or to reflect the occurrence of unanticipated events.

You should read this Annual Report on Form 20-F and the documents that we reference in this Annual Report on Form 20-F and have filed as exhibits to this Annual Report on Form 20-F completely and with the

understanding that our actual future results may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements.

This Annual Report on Form 20-F contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties such as investment banking analysts, industry, medical and general publications, government data and similar sources. In addition, assumptions and estimates of our and our industry's future performance are necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled "Item 3.D—Risk Factors. "These and other factors could cause our future performance to differ materially from our assumptions and estimates.

APPLICATION OF INTERNATIONAL FINANCIAL REPORTING STANDARDS

We adopted International Financial Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board. Unless otherwise stated, all information presented herein has been prepared in accordance with IFRS and all prior period amounts have been prepared in accordance with IFRS.

CURRENCY

Unless otherwise stated, “€”, when used in this Annual Report on Form 20-F, refers to Euros and “$” refers to United States dollars.