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Pharming Group to report second quarter and first half 2024 financial results on August 1
Newsfilter· 2024-07-18 06:00
Conference call registration: To watch the live webcast, please register in advance using the link below. About Pharming Group N.V. For further public information, contact: LifeSpring Life Sciences Communication, Amsterdam, The Netherlands Leon Melens T: +31 6 53 81 64 27 E: pharming@lifespring.nl To participate in the conference call, please register in advance using the link below. Once registered, dial-in information and a unique PIN will be provided, allowing access to the call. https://register.vevent. ...
Pharming Group to participate in June investor conferences
Newsfilter· 2024-06-03 06:00
Leiden, the Netherlands, June 3, 2024: Pharming Group N.V. ("Pharming") (NASDAQ:PHAR) announces that Pharming's management will participate in the following investor conferences in the month of June: Jefferies Healthcare Conference, New York, USA, June 5-6, 2024 Sijmen de Vries, Chief Executive Officer, will present on Wednesday, June 5 at 10:30EDT/16:30CEST. A live webcast and replay of the presentation will be available in the "Upcoming Events" and "News" sections of Pharming's website. Oppenheimer Novel ...
Pharming Group reports on results of the 2024 Annual General Meeting of Shareholders
Newsfilter· 2024-05-21 15:30
A recording of the webcast, presentation slides from today's AGM, and more details regarding agenda items are available on the Company's website in the Investor Relations section. About Pharming Group N.V. Leiden, the Netherlands, May 21, 2024: Pharming Group N.V. ("Pharming" or "the Company") (NASDAQ:PHAR) announces that at its Annual General Meeting of Shareholders (AGM) held today, all proposals were approved. The shareholders approved the proposals to reappoint Ms. Barbara Yanni (agenda item 4.a) and Mr ...
Pharming Group to participate in May investor conference
Newsfilter· 2024-05-20 06:00
About Pharming Group N.V. Pharming Group N.V. (NASDAQ:PHAR) is a global biopharmaceutical company dedicated to transforming the lives of patients with rare, debilitating, and life-threatening diseases. Pharming is commercializing and developing an innovative portfolio of protein replacement therapies and precision medicines, including small molecules and biologics that are in clinical development. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in ...
Pharming N.V.(PHAR) - 2024 Q1 - Earnings Call Presentation
2024-05-12 13:19
Pharming Group N.V. First quarter 2024 financial results and business update May 8, 2024 NASDAQ: PHAR | EURONEXT Amsterdam: PHARM � Pharming® Sijmen de Vries, MD Stephen Toor Chief Executive Officer Chief Commercial Officer SPEAKERS Anurag Relan, MD Jeroen Wakkerman Chief Medical Officer Chief Financial Officer Forward-looking statements This presentation may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management's current expectatio ...
Pharming N.V.(PHAR) - 2023 Q4 - Annual Report
2024-04-04 12:20
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the Month of April 2024 Commission File Number: 001-39822 Pharming Group N.V. (Exact Name of Registrant as Specified in Its Charter) Darwinweg 24 2333 CR Leiden The Netherlands (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of Form ...
Pharming N.V.(PHAR) - 2023 Q4 - Annual Report
2024-04-04 12:03
Part I [Key Information](index=9&type=section&id=Item%203.%20Key%20Information) The company faces significant risks from its reliance on RUCONEST®, competition, and material weaknesses in internal controls [Risk Factors](index=11&type=section&id=D.%20Risk%20Factors) Key risks include commercial dependency on RUCONEST®, new product uncertainties, supplier concentration, and financial control deficiencies - The company is heavily dependent on sales of RUCONEST®, which accounted for approximately **92.6% of total revenues in 2023**[39](index=39&type=chunk) - Joenja®, approved by the FDA in March 2023, is a new drug and could develop unexpected safety or efficacy concerns, which would pose a material risk[40](index=40&type=chunk) - The company experiences significant customer concentration, with two U.S. specialty wholesale companies accounting for **83% of revenues in 2023**[92](index=92&type=chunk) - **Material weaknesses** have been identified in the company's internal control over financial reporting across all five components of the COSO framework[154](index=154&type=chunk)[718](index=718&type=chunk) - RUCONEST® faces intense competition from other approved products for treating Hereditary Angioedema (HAE), including both acute and prophylactic therapies, as well as generic equivalents to competing treatments[34](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) [Information on the Company](index=46&type=section&id=Item%204.%20Information%20on%20the%20Company) The company is a global biopharmaceutical firm focused on rare diseases with two commercial products, RUCONEST® and Joenja® [History and Development of the Company](index=46&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) Pharming Group N.V., incorporated in 1988, trades on Euronext Amsterdam and Nasdaq, with capital expenditures of $1.4 million in 2023 - The company was incorporated in The Netherlands on November 11, 1988[201](index=201&type=chunk) Capital Expenditures (2021-2023) | Year | Capital Expenditures (in millions) | | :--- | :--- | | 2023 | $1.4 | | 2022 | $1.4 | | 2021 | $10.7 | [Business Overview](index=47&type=section&id=B.%20Business%20Overview) The company's portfolio features RUCONEST® and the newly approved Joenja®, supported by a proprietary manufacturing platform - The company's portfolio is led by two commercialized products: **RUCONEST® for HAE and Joenja® for APDS**[206](index=206&type=chunk)[207](index=207&type=chunk)[208](index=208&type=chunk) - Joenja® (leniolisib) received FDA approval on March 24, 2023, for the treatment of APDS in adult and pediatric patients 12 years and older[208](index=208&type=chunk)[221](index=221&type=chunk) - As of December 31, 2023, Pharming has identified over **840 diagnosed APDS patients globally**, including over 200 in the United States, with an estimated total prevalence of approximately 2,000 patients in key markets[239](index=239&type=chunk) - RUCONEST® is manufactured using a proprietary transgenic platform where recombinant proteins are produced in the milk of rabbits[278](index=278&type=chunk)[280](index=280&type=chunk) - The company is subject to extensive pre- and post-market regulation by authorities such as the FDA in the U.S. and the EMA in the EU[310](index=310&type=chunk)[349](index=349&type=chunk) [Organizational Structure](index=82&type=section&id=C.%20Organizational%20Structure) Pharming Group N.V. is the parent company with wholly-owned subsidiaries in The Netherlands and the United States - Pharming Group N.V. is the parent company with multiple wholly-owned subsidiaries in The Netherlands and the United States[419](index=419&type=chunk) [Property, Plant and Equipment](index=84&type=section&id=D.%20Property%2C%20Plant%20and%20Equipment) The company's primary facilities are in The Netherlands, with a capital investment of $1.4 million in 2023 - The company's main facilities, including administrative offices, labs, and production sites, are located in The Netherlands[421](index=421&type=chunk)[422](index=422&type=chunk) - Capital investment in 2023 was **$1.4 million**, primarily for new machinery and lab equipment[427](index=427&type=chunk) [Operating and Financial Review and Prospects](index=84&type=section&id=Item%205.%20Operating%20and%20Financial%20Review%20and%20Prospects) Revenue grew to $245.3 million in 2023, but increased operating expenses for the Joenja® launch resulted in a net loss [Operating Results](index=85&type=section&id=A.%20Operating%20Results) Revenue increased 19.3% to $245.3 million in 2023, but higher launch-related expenses led to a net loss of $10.5 million Consolidated Statement of Income (2021-2023) | Amounts in $'000 | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | **Revenues** | **245,316** | **205,622** | **198,871** | | Gross profit | 220,104 | 188,060 | 177,729 | | **Operating profit / (loss)** | **(5,387)** | **18,233** | **13,561** | | (Loss) / Profit before tax | (12,012) | 14,987 | 23,078 | | **(Loss) / Profit for the year** | **(10,548)** | **13,674** | **15,996** | | Basic (loss) / earnings per share ($) | (0.016) | 0.021 | 0.025 | | Diluted (loss) / earnings per share ($) | (0.016) | 0.019 | 0.023 | Revenues by Product and Geography (2023 vs 2022) | Amounts in US$ '000 | 2023 | 2022 | | :--- | :--- | :--- | | **RUCONEST®** | **227,134** | **205,622** | | - US | 221,213 | 200,082 | | - Europe and RoW | 5,921 | 5,540 | | **Joenja®** | **18,182** | **—** | | - US | 17,894 | — | | - Europe and RoW | 288 | — | | **Total revenues** | **245,316** | **205,622** | - Marketing and sales costs increased by **44.6% to $124.0 million** in 2023, primarily due to the commercial expansion for the launch of Joenja®[463](index=463&type=chunk) - Research and development costs rose by **31.2% to $68.9 million** in 2023, mainly related to leniolisib clinical trials for pediatric APDS patients and research into additional indications[461](index=461&type=chunk) [Liquidity and Capital Resources](index=102&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) The company maintains a strong liquidity position with $213.4 million in cash, despite a net cash outflow from operations - The company held **$213.4 million in cash**, cash equivalents, and marketable securities as of December 31, 2023, which is expected to fund operations for more than 12 months[520](index=520&type=chunk)[521](index=521&type=chunk) Selected Cash Flow Information (2021-2023) | Amounts in $'000 | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Net cash from (used in) operating activities | (17,302) | 22,458 | 37,842 | | Net cash from (used in) investing activities | (129,388) | 5,323 | (21,305) | | Net cash from (used in) financing activities | (1,039) | (4,982) | (27,947) | | **Net change in cash and cash equivalents** | **(145,601)** | **15,418** | **(13,235)** | - The company has **€125 million in 3.00% convertible bonds** due January 21, 2025[534](index=534&type=chunk) [Critical Accounting Estimates](index=106&type=section&id=E.%20Critical%20Accounting%20Estimates) Financial statements rely on critical management judgments and estimates, with details provided in the Annual Financial Statements - The company's financial statements rely on critical accounting estimates and judgments, particularly concerning the value of assets and liabilities, which are reviewed on an ongoing basis[542](index=542&type=chunk) [Directors, Senior Management and Employees](index=106&type=section&id=Item%206.%20Directors%2C%20Senior%20Management%20and%20Employees) The company operates with a one-tier board, and its workforce grew to an average of 382 full-time employees in 2023 [Directors and Senior Management](index=106&type=section&id=A.%20Directors%20and%20Senior%20Management) Pharming has a one-tier board structure led by CEO Sijmen de Vries and seven non-executive directors - The company has a one-tier board structure with a single executive director, CEO Sijmen de Vries, and seven non-executive directors[543](index=543&type=chunk)[546](index=546&type=chunk) - Dr. Richard Peters was appointed Chairman of the Board of Directors on September 25, 2023, succeeding Paul Sekhri[556](index=556&type=chunk) [Compensation](index=111&type=section&id=B.%20Compensation) Executive remuneration includes fixed salary, annual bonuses, and long-term performance-based share incentives CEO Remuneration (2023) | Amounts in $'000 | Fixed Remuneration | Annual Bonus | Share-based Payments | Other | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Dr. Sijmen de Vries | 673 | 615 | 1,371 | 150 | 2,809 | - The executive LTI plan is performance-related, with vesting based on **Total Shareholder Return (40% weight)** and **strategic objectives (60% weight)** over a three-year period[582](index=582&type=chunk) - Non-executive directors receive fixed annual retainers and committee fees, not linked to company performance, to ensure independence[584](index=584&type=chunk)[587](index=587&type=chunk) [Board Practices](index=120&type=section&id=C.%20Board%20Practices) The Board has established Audit, Remuneration, and Corporate Governance committees composed of non-executive members - The Board has three primary committees: Audit, Remuneration, and Corporate Governance, all composed of non-executive directors[600](index=600&type=chunk) [Employees](index=122&type=section&id=D.%20Employees) The company's workforce grew to an average of 382 full-time equivalents in 2023, primarily in The Netherlands and the U.S Average Full-Time Equivalent Employees (2021-2023) | Year | Total Employees | | :--- | :--- | | 2023 | 382 | | 2022 | 332 | | 2021 | 285 | [Major Shareholders and Related Party Transactions](index=123&type=section&id=Item%207.%20Major%20Shareholders%20and%20Related%20Party%20Transactions) No shareholder owns over 5%, and the primary related party transaction is with associate company BioConnection [Major Shareholders](index=123&type=section&id=A.%20Major%20Shareholders) As of March 31, 2024, no shareholder beneficially owned more than 5% of the company's ordinary shares - As of March 31, 2024, there was no known beneficial owner of more than **5%** of the company's issued and outstanding common shares[617](index=617&type=chunk) - Executive officers and directors as a group beneficially owned **2.2%** of ordinary shares as of March 31, 2024[618](index=618&type=chunk) [Related Party Transactions](index=125&type=section&id=B.%20Related%20Party%20Transactions) The company's main related party transactions are with its fill and finish partner BioConnection, in which it holds a 22.98% stake - Pharming holds a **22.98% stake** in its fill and finish partner, BioConnection; in 2023, Pharming paid BioConnection **$4.7 million** for services[623](index=623&type=chunk) - The company has adopted a Related Person Policy requiring board or committee approval for all related party transactions[628](index=628&type=chunk) [Financial Information](index=127&type=section&id=Item%208.%20Financial%20Information) The company has no material legal proceedings and does not anticipate paying dividends, retaining earnings for business use - The company is not currently a party to any material legal or administrative proceedings[634](index=634&type=chunk) - Pharming has never declared or paid dividends and does not anticipate paying them in the foreseeable future, intending to retain earnings for business investment[635](index=635&type=chunk) [Additional Information](index=129&type=section&id=Item%2010.%20Additional%20Information) Key material contracts include license agreements for leniolisib and OTL-105, with details on Dutch and U.S. tax considerations - The license agreement with Novartis for leniolisib includes up to **$200 million** in potential milestone payments, plus tiered royalties[649](index=649&type=chunk) - The collaboration with Orchard for OTL-105 involves an upfront payment of **$17.5 million**, with up to **$189.5 million** in potential milestones and royalties[651](index=651&type=chunk)[652](index=652&type=chunk) - Dividends distributed by the company are generally subject to a **15% Dutch dividend withholding tax**, though exemptions or reductions may apply[681](index=681&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=142&type=section&id=Item%2011.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is primarily exposed to liquidity, market (currency and interest rate), and credit risks, managed by the Board - The company's most significant financial risks are identified as liquidity, market risk (currency and interest rate), and credit risk[702](index=702&type=chunk) [Controls and Procedures](index=145&type=section&id=Item%2015.%20Controls%20and%20Procedures) Disclosure controls were deemed ineffective due to material weaknesses in internal control over financial reporting - Management, including the CEO and CFO, concluded that disclosure controls and procedures were **not effective** as of December 31, 2023[715](index=715&type=chunk) - Material weaknesses were identified across all five components of the COSO framework: Control Environment, Risk Assessment, Control Activities, Information & Communication, and Monitoring[718](index=718&type=chunk)[733](index=733&type=chunk)[737](index=737&type=chunk) - The independent registered public accounting firm issued an **adverse opinion** on the Company's internal control over financial reporting as of December 31, 2023[727](index=727&type=chunk)[784](index=784&type=chunk) - A remediation plan is underway, which includes implementing key controls, strengthening internal teams, and undergoing effectiveness testing in 2024[719](index=719&type=chunk)[720](index=720&type=chunk)[722](index=722&type=chunk) [Corporate Governance and Other Disclosures](index=149&type=section&id=Item%2016.%20Corporate%20Governance%20and%20Other%20Disclosures) As a foreign private issuer, the company follows Dutch governance practices and discloses details on its audit committee and cybersecurity risk management - As a "foreign private issuer," the company complies with its home country (Dutch) governance requirements, exempting it from certain Nasdaq corporate governance standards[753](index=753&type=chunk) - The Board of Directors has determined that Mr. Leonard Kruimer, Chairman of the Audit Committee, qualifies as an "audit committee financial expert"[736](index=736&type=chunk) Principal Accountant Fees (2022-2023) | Amounts in $'000 | 2023 | 2022 | | :--- | :--- | :--- | | Audit Fees | (1,328) | (1,357) | | Total | (1,328) | (1,357) | - The Board of Directors, through its Audit Committee, has oversight responsibility for cybersecurity risks[767](index=767&type=chunk)[768](index=768&type=chunk) Part III [Financial Statements](index=156&type=section&id=Item%2017%20%26%2018.%20Financial%20Statements) The audited IFRS financial statements received an unqualified opinion, but the auditor issued an adverse opinion on internal controls - The consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the IASB[804](index=804&type=chunk) - The independent auditor, Deloitte Accountants B.V., issued an **unqualified opinion** on the financial statements but an **adverse opinion** on the company's internal control over financial reporting due to material weaknesses[783](index=783&type=chunk)[784](index=784&type=chunk) - A critical audit matter was identified related to **U.S. Revenue Rebate Accruals** due to the significant assumptions and judgments involved in their calculation[788](index=788&type=chunk)[789](index=789&type=chunk)[790](index=790&type=chunk)
Pharming N.V.(PHAR) - 2023 Q4 - Earnings Call Transcript
2024-03-14 17:15
Pharming Group N.V. (NASDAQ:PHAR) Q4 2023 Earnings Conference Call March 14, 2024 8:30 AM ET Company Participants Sijmen de Vries - Chief Executive Officer Stephen Toor - Chief Commercial Officer Anurag Relan - Chief Medical Officer Jeroen Wakkerman - Chief Financial Officer Conference Call Participants Christian Glennie - Stifel Alistair Campbell - Royal Bank of Canada Joe Pantginis - H.C. Wainwright Simon Scholes - First Berlin Operator Good day and thank you for standing by. Welcome to the Pharming Group ...
Pharming N.V.(PHAR) - 2023 Q4 - Earnings Call Presentation
2024-03-14 13:06
Pediatric study for 1 to 6 years ongoing First patient dosed November 2023, enrollment continuing as planned 1. Rao VK and Oliveria JB. How I treat autoimmune lymphoproliferative syndrome. Blood 2011; 118(22):5741-51 2. Westerman-Clark et al 2021; Schwab C, Gabrysch A, Olbrich P, Patiño V, Warnatz K, et al. Phenotype, penetrance, and treatment of 133 cytotoxic T-lymphocyte antigen 4-insufficient subjects. J Allergy Clin Immunol. 2018;142(6):1932-1946 3. Eissing M, Ripken L, Schreibelt G, Westdorp H, Ligtenb ...
Pharming N.V.(PHAR) - 2023 Q3 - Earnings Call Transcript
2023-10-27 12:35
Sijmen de Vries - Chief Executive Officer Stephen Toor - Chief Commercial Officer Anurag Relan - Chief Medical Officer Jeroen Wakkerman - Chief Financial Officer Good morning or good afternoon, ladies and gentlemen. Iâm here with my three colleagues, Stephen Toor, our Chief Commercial Officer; Anurag Relan, our Chief Medical Officer; and Jeroen Wakkerman, our Chief Financial Officer and we are delighted to take you through the third quarter results of this year. And then, of course, you move to the middle p ...