PHARM - PHARM STOCK NEWS

Pharming Group reported strong Q3 2024 financial results with total revenues increasing 12% to US$74.8 million. RUCONEST® revenue grew 6% to US$63.6 million, while Joenja® revenue jumped 72% to US$11.2 million. First nine months revenues rose 25% to US$204.5 million. Operating profit increased to US$4.1 million from US$1.9 million in Q3 2023. The company maintains its 2024 revenue guidance of US$280-295 million. CEO Sijmen de Vries announced he will not seek reappointment at the May 2025 AGM. The company also announced the start of a Phase II trial evaluating leniolisib in primary immunodeficiencies.

Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced that it will release its preliminary (unaudited) third quarter 2024 financial results on Thursday, October 24, 2024. The results will cover the period ended September 30. The company will host a presentation for analysts and investors at 13:30 CEST/07:30 am EDT on the same day.

To participate in the conference call, interested parties must register in advance using the provided link. Upon registration, dial-in information and a unique PIN will be provided for call access. The company will only take questions from dial-in attendees. Additionally, a live webcast of the presentation will be available, with a separate registration link provided for those who wish to watch online.

Pharming Group (EURONEXT Amsterdam: PHARM/Nasdaq: PHAR) has initiated a Phase II clinical trial to evaluate leniolisib in primary immunodeficiencies (PIDs) with immune dysregulation linked to altered PI3Kẟ signaling in lymphocytes. The trial will include patients with ALPS-FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency, and PTEN deficiency, among others. These PIDs have a prevalence of approximately seven patients per million, compared to one to two per million for APDS.

The study, conducted at the National Institutes of Health (NIH), is a single arm, open-label, dose range-finding study with approximately 12 patients. It aims to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and explore clinical efficacy of leniolisib in the targeted PID population. This trial represents Pharming's second PID clinical program for leniolisib, expanding beyond its current approved use for APDS in adults and pediatric patients 12 years and older.

Pharming Group N.V. announces that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Joenja® (leniolisib) for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

Leniolisib is the first treatment approved in the U.K. specifically for APDS, a rare and progressive primary immunodeficiency. It is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.

The MHRA evaluated the Marketing Authorisation Application (MAA) for leniolisib through the International Recognition Procedure (IRP) pathway based on the U.S. Food and Drug Administration (FDA) approval received in March 2023. This marks Pharming's third country approval for APDS.

Pharming Group (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced its participation in two major investor conferences in September 2024. The company will be present at the 2024 Wells Fargo Healthcare Conference in Boston from September 4-6, where CEO Sijmen de Vries will engage in a fireside chat on September 6 at 08:45 AM ET. Additionally, Pharming will attend the H.C. Wainwright 26th Annual Global Investment Conference in New York from September 9-11, with de Vries presenting on September 9 at 10:30 AM ET.

Both presentations will be available via live webcast and replay on Pharming's website. Investors interested in one-to-one meetings with Pharming's management team can contact the company's Investor Relations team or their Wells Fargo or H.C. Wainwright representatives.

Pharming Group reported a 35% increase in Q2 2024 revenues to US$74.1 million, driven by strong sales of RUCONEST® and Joenja®. RUCONEST® revenues rose 23% to US$63 million, while Joenja® increased 16% to US$11.1 million from Q1 2024. First half 2024 revenues reached US$129.7 million, up 33% from 1H 2023. The company is on track to meet its 2024 revenue guidance of US$280 million - US$295 million.

However, cash and marketable securities dropped to US$161.8 million due to convertible bond refinancing. Pharming's operating loss narrowed, but net loss was US$1.2 million in Q2 2024, down from a US$1.3 million profit in Q2 2023. The company continues to expand Joenja® availability and expects a decision from the UK MHRA in Q4 2024.

Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) has announced it will report its preliminary (unaudited) second quarter and first half 2024 financial results on Thursday, August 1, 2024. The report will cover the period ended June 30. The company will host a presentation for analysts and investors at 13:30 CEST/07:30 am EDT on the same day.

Interested parties can participate in the conference call by registering in advance. Upon registration, dial-in information and a unique PIN will be provided for call access. The company will only take questions from dial-in attendees. Additionally, a live webcast of the presentation will be available for those who prefer to watch online. Both the conference call and webcast require pre-registration through the provided links.

Pharming Group N.V. (Euronext Amsterdam: PHARM/Nasdaq: PHAR) announced its participation in three key investor conferences in June 2024. CEO Sijmen de Vries will present at the Jefferies Healthcare Conference in New York on June 5. CMO Anurag Relan will join a panel at the Oppenheimer Novel Targets in Immunology Summit on June 24. Additionally, Pharming will attend the Oppenheimer 2024 Montauk Life Sciences Summit from June 26-28. These events aim to provide investors with insights into the company's progress and future plans. Live webcasts and replays will be available on Pharming's website.

Pharming Group has provided an update on the regulatory review of leniolisib for treating APDS in the EU. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has affirmed the clinical benefit and safety of leniolisib but requested further clarification on manufacturing controls before approval.

Pharming has been granted an extension to January 2026 to fulfill these requirements. Despite the delay, leniolisib has shown positive efficacy and safety in clinical trials, meeting co-primary endpoints and benefiting patients in long-term studies. The drug is already approved in the US since March 2023. Pharming maintains its 2024 revenue guidance.