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Pharming Group reports third quarter 2024 financial results and provides business update

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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 ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con un incremento del 12% dei ricavi totali, che ammontano a 74,8 milioni di dollari USA. I ricavi di RUCONEST® sono aumentati del 6% a 63,6 milioni di dollari USA, mentre i ricavi di Joenja® sono schizzati del 72% a 11,2 milioni di dollari USA. Nei primi nove mesi, i ricavi sono aumentati del 25%, raggiungendo 204,5 milioni di dollari USA. L'utile operativo è salito a 4,1 milioni di dollari USA, rispetto a 1,9 milioni di dollari USA nel terzo trimestre del 2023. L'azienda mantiene la previsione di fatturato per il 2024 compresa tra 280 e 295 milioni di dollari USA. Il CEO Sijmen de Vries ha annunciato che non cercherà il rinnovo della carica nella riunione annuale del maggio 2025. L'azienda ha inoltre annunciato l'inizio di una sperimentazione di Fase II per valutare il leniolisib nelle immunodeficienze primarie.

Pharming Group informó resultados financieros sólidos para el tercer trimestre de 2024, con un aumento del 12% en los ingresos totales, que alcanzaron 74.8 millones de dólares USA. Los ingresos de RUCONEST® crecieron un 6% hasta alcanzar los 63.6 millones de dólares USA, mientras que los ingresos de Joenja® saltaron un 72% hasta llegar a 11.2 millones de dólares USA. Durante los primeros nueve meses, los ingresos aumentaron un 25% hasta los 204.5 millones de dólares USA. Las ganancias operativas aumentaron a 4.1 millones de dólares USA desde 1.9 millones de dólares USA en el tercer trimestre de 2023. La compañía mantiene su pronóstico de ingresos para 2024 de entre 280 y 295 millones de dólares USA. El CEO Sijmen de Vries anunció que no buscará la reelección en la junta anual de mayo de 2025. La compañía también anunció el inicio de un ensayo de Fase II para evaluar el leniolisib en deficiencias inmunitarias primarias.

파밍 그룹(Pharming Group)은 2024년 3분기 재무 실적이 강세를 보였으며, 총 수익이 12% 증가하여 7480만 달러에 달한다고 보고했습니다. RUCONEST®의 수익은 6% 성장하여 6360만 달러에 이르렀고, Joenja®의 수익은 72% 급등하여 1120만 달러에 달했습니다. 처음 아홉 달 동안의 수익은 25% 증가하여 2억 450만 달러에 달했습니다. 운영 이익은 2023년 3분기에 비해 190만 달러에서 410만 달러로 증가했습니다. 회사는 2024년 수익 지침을 2억 8000만 달러에서 2억 9500만 달러로 유지한다고 밝혔습니다. CEO인 사이먼 드 프리제(Sijmen de Vries)는 2025년 5월 주주총회에서 재임을 추구하지 않을 것이라고 발표했습니다. 또한, 회사는 1차 면역결핍증에서 leniolisib을 평가하는 2상 시험의 시작을 발표했습니다.

Pharming Group a annoncé des résultats financiers solides pour le troisième trimestre 2024, avec des revenus totaux en hausse de 12% à 74,8 millions de dollars US. Les revenus de RUCONEST® ont augmenté de 6% à 63,6 millions de dollars US, tandis que ceux de Joenja® ont bondi de 72% à 11,2 millions de dollars US. Au cours des neuf premiers mois, les revenus ont augmenté de 25% pour atteindre 204,5 millions de dollars US. Le bénéfice d'exploitation a augmenté à 4,1 millions de dollars US contre 1,9 million de dollars US au troisième trimestre 2023. L'entreprise maintient sa prévision de revenus pour 2024, qui se situe entre 280 et 295 millions de dollars US. Le PDG Sijmen de Vries a annoncé qu'il ne cherchera pas à être réélu lors de l'assemblée générale annuelle de mai 2025. L'entreprise a également annoncé le début d'un essai de phase II évaluant le leniolisib dans les immunodéficiences primaires.

Pharming Group berichtete über starke Finanzzahlen im dritten Quartal 2024, mit einem Anstieg der Gesamterlöse um 12% auf 74,8 Millionen US-Dollar. Die Erlöse von RUCONEST® stiegen um 6% auf 63,6 Millionen US-Dollar, während die Erlöse von Joenja® um 72% auf 11,2 Millionen US-Dollar sprangen. In den ersten neun Monaten stiegen die Erlöse um 25% auf 204,5 Millionen US-Dollar. Der Betriebsgewinn erhöhte sich auf 4,1 Millionen US-Dollar von 1,9 Millionen US-Dollar im dritten Quartal 2023. Das Unternehmen hält an seiner Umsatzprognose von 280 bis 295 Millionen US-Dollar für 2024 fest. CEO Sijmen de Vries kündigte an, dass er sich nicht um eine Wiederwahl bei der Hauptversammlung im Mai 2025 bewerben werde. Das Unternehmen kündigte außerdem den Beginn einer Phase-II-Studie zur Bewertung von Leniolisib bei primären Immundefizienzen an.

Positive
  • Q3 2024 revenues increased 12% to US$74.8 million
  • Operating profit rose to US$4.1 million from US$1.9 million in Q3 2023
  • Joenja® revenue grew 72% to US$11.2 million
  • Cash position increased to US$173.3 million from US$161.8 million in Q2 2024
  • On track for 14-20% revenue growth guidance for 2024
Negative
  • Net loss of US$1.0 million in Q3 2024 compared to net profit of US$3.5 million in Q3 2023
  • Operating expenses increased from US$56.8 million to US$64.7 million year-over-year
  • Foreign currency loss of US$1.5 million compared to gain of US$1.7 million in Q3 2023

Insights

The Q3 2024 results showcase strong financial performance with $74.8M in total revenues, up 12% YoY. Key highlights include $63.6M from RUCONEST® (up 6%) and $11.2M from Joenja® (up 72%). The company maintains healthy cash position of $173.3M and projects FY2024 revenue guidance of $280-295M.

Operating profit improved to $4.1M from $1.9M YoY, despite increased operating expenses. The balance sheet remains solid with reduced cash burn and positive operating cash flow of $9.7M. The upcoming CEO transition in May 2025 adds some uncertainty but occurs during a period of financial strength.

The expansion of leniolisib into additional PID indications represents significant upside potential, with a 5x larger patient population than current APDS indication.

The clinical development expansion of leniolisib into broader Primary Immunodeficiencies (PIDs) marks a strategic pivot with substantial market potential. The new Phase II trial targeting conditions like ALPS-FAS and CTLA4 haploinsufficiency addresses a patient population of ~7 per million, compared to 1-2 per million for APDS.

The strong patient adherence rates for Joenja® and continued enrollment growth (93 patients on paid therapy) validate the drug's clinical value. The pediatric trial data readout in Q4 2024 and potential label expansion could further accelerate adoption. The UK approval via the International Recognition Procedure demonstrates regulatory momentum for global expansion.

  • Third quarter 2024 total revenues increased by 12% to US$74.8 million, compared to the third quarter 2023, driven by continued strong RUCONEST® and Joenja® revenue growth
  • RUCONEST® third quarter revenue increased by 6% to US$63.6 million, compared to the third quarter 2023
  • Joenja® (leniolisib) third quarter revenue increased by 72% to US$11.2 million, compared to the third quarter 2023
  • First nine months total revenues increased by 25% to US$204.5 million, compared to the first nine months 2023
  • On track for 2024 total revenue guidance of US$280 million - US$295 million (14 - 20% growth)
  • Third quarter operating profit increased to US$4.1 million from US$1.9 million in the third quarter 2023
  • Overall cash and marketable securities increased to US$173.3 million at the end of the third quarter 2024 from US$161.8 million at the end of the second quarter 2024
  • Sijmen de Vries, our Executive Director/Chief Executive Officer, has informed the Board of Directors that he will not be available for reappointment at the next Annual General Meeting of Shareholders in May 2025
  • Pharming to host a conference call today at 13:30 CEST (7:30 am EDT)

Leiden, the Netherlands, October 24, 2024: Pharming Group N.V. (“Pharming” or “the Company”) (Euronext Amsterdam: PHARM/NASDAQ: PHAR) presents its preliminary, unaudited financial report for the three months ended September 30, 2024.

Chief Executive Officer, Sijmen de Vries, commented:
“Pharming has delivered an excellent third quarter, increasing quarterly revenues by 12% to a record-high US$74.8 million and also achieving record revenues of US$204.5 million for the first nine months of the year. The combination of strong revenue performance, combined with reduced operating expenses compared to the previous quarter, enabled us to realize a positive operating profit in the third quarter. We are firmly on track to meet our 2024 total revenue guidance of US$280 million - US$295 million (14 - 20% growth).

The third quarter demonstrated Pharming’s ability to deliver continued growth for RUCONEST® in the competitive U.S. HAE market, with strength in underlying demand including new patient enrollments. Third quarter revenue for this product increased by 6% compared to the same quarter in 2023.

For Joenja®, we continue to both increase the number of patients on therapy quarter-on-quarter and to maintain high adherence rates for these patients. We received U.K. approval for Joenja® (leniolisib) in September, demonstrating our active efforts with regulatory authorities to make this medicine available to as many patients as possible, and now look forward to the results of the reimbursement evaluation over the coming quarters and to a subsequent commercial launch.

In October 2024, we announced the start of a Phase II, proof of concept, clinical trial evaluating leniolisib in primary immunodeficiencies (PIDs) with immune dysregulation linked to PI3Kẟ signaling. This is an important step for Pharming as this trial will include patients with various PIDs with significant unmet medical need and much higher overall prevalence than APDS, including ALPS-FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency and PTEN deficiency. With prevalence of approximately seven patients per million, these PIDs represent a potential five-fold increase in the commercial opportunity for leniolisib, thereby ensuring Pharming is delivering on its mission to serve the unserved rare disease patient.

I have informed the Board of Directors that I will not be available, after a 16 year tenure at the helm of Pharming, for reappointment as Executive Director/Chief Executive Officer. Our company is in great shape today. So this is the right moment for me to make way for a successor to lead Pharming into the next chapter of its strategy for growth, building on the achievements of the past years. I am proud of all these achievements and grateful for the trust put in me by our patients, employees and investors over the years. I will continue to dedicate myself fully to Pharming until my successor has been appointed and will do everything in my power to ensure a smooth hand-over.”

Chairman of the Board of Directors, Dr. Richard Peters, commented:
“On behalf of the entire Board of Directors, I would like to thank Sijmen de Vries for his high commitment to Pharming over the past 16 years and for the way he has created the company that it is today, serving patients and paving the way for the delivery on the company’s strategy for growth.

The Board of Directors has engaged a leading global executive search firm for the search of a successor. Further announcements will be made when appropriate.

We will of course take time to celebrate Sijmen’s tenure as our CEO in the coming months.”

Third quarter highlights

Commercialized products
RUCONEST® marketed for the treatment of acute HAE attacks

RUCONEST® continued to perform well in the third quarter of 2024, with revenues of US$63.6 million, a 6% increase compared to the third quarter of 2023. Revenue for the first nine months of 2024 was US$172.6 million, a 12% increase compared to the same period in 2023.

The U.S. market contributed 97% of third quarter revenues, while the EU and Rest of World contributed 3%.

In the U.S. market, we saw continued strength in the third quarter in underlying in-market demand, including approximately 100 new patient enrollments. We achieved strong overall performance in the third quarter in other leading key revenue indicators including the number of prescribers, the total number of patients on therapy, and vials shipped to patients. Increasing enrollments helped to drive a sharp increase in unique patient shipments in the third quarter.

Joenja® (leniolisib) marketed for the treatment of APDS

Joenja® revenues increased to US$11.2 million in the third quarter of 2024, a 72% increase compared to the third quarter of 2023. This increase was mostly driven by higher volume from the 50% increase in patients on paid therapy in the U.S. compared to the third quarter of 2023, and revenues from EU and Rest of World which are from product provided on a named patient basis. Revenue for the first nine months of 2024 was US$31.9 million, compared to US$10.3 million for the same period in 2023.

As of September 30, 2024, we have 93 patients on paid therapy in the U.S. and an additional five patients enrolled and pending authorization, representing an increase of both active and pending patients during the third quarter and continued progress enrolling and moving eligible patients to paid therapy.

Joenja® (leniolisib) development updates
Leniolisib for APDS

Pharming made continued progress in the third quarter of 2024 on leniolisib regulatory filings for APDS patients 12 years of age and older in key global markets. Pharming is on track to complete the manufacturing activities requested by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) and submit a response prior to the January 2026 deadline. In addition, Pharming progressed ongoing clinical trials to support regulatory filings for approval in Japan and pediatric label expansion beginning in 2025. Data readout from the clinical trial for children ages 4 to 11 years old is expected in the fourth quarter of 2024.

In total, there are currently 164 patients in a leniolisib Expanded Access Program (compassionate use), an ongoing clinical study, or a named patient program.

United Kingdom

On September 25, 2024, the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Joenja® (leniolisib) for the treatment of APDS in adult and pediatric patients 12 years of age and older. Joenja® was the first new medicine approved by the MHRA via the International Recognition Procedure (IRP) using the U.S. FDA as reference regulator. Leniolisib is currently under evaluation by the National Institute for Health and Care Excellence (NICE) regarding reimbursement within the National Health Service (NHS) in England.

Leniolisib for additional indications (PI3Kδ platform) - Primary immunodeficiencies (PIDs) beyond APDS

On October 10, 2024, Pharming announced the start of a Phase II, proof of concept, clinical trial evaluating leniolisib in PIDs with immune dysregulation linked to PI3Kẟ signaling in lymphocytes, with similar clinical phenotypes and unmet medical needs to APDS. The first patient is expected to be enrolled in the study in the coming weeks. The clinical trial will include PID patients with ALPS-FAS, CTLA4 haploinsufficiency, NFKB1 haploinsufficiency and PTEN deficiency, among others. Epidemiology suggests a prevalence of approximately seven patients per million in this targeted PID population, compared to one to two patients per million for APDS.

The Phase II clinical trial is a single arm, open-label, dose range-finding study to be conducted in approximately 12 patients. The objectives for the trial will be to assess safety and tolerability, pharmacokinetics, pharmacodynamics, and explore clinical efficacy of leniolisib in the targeted PID population. The trial has been designed to inform a subsequent Phase III program.

Pharming has also prioritized development of leniolisib for an additional PID indication. Pharming will provide further updates and details on our plans, including the proposed clinical development plan, later this year.

Organizational update

Sijmen de Vries, our Executive Director/Chief Executive Officer, has informed the Board of Directors that he will not be available for reappointment at the Company’s next Annual General Meeting of Shareholders (AGM) in May 2025. The mandate of Sijmen de Vries is scheduled to expire at the closing of the AGM to be held in May 2025. Further announcements on the search of a successor will be made when appropriate.

Financial Summary

Consolidated Statement of Income 3Q 2024 3Q 2023 9M 2024 9M 2023
Amounts in US$m except per share data        
Total Revenues 74.8 66.7 204.5 164.1
Cost of sales (6.8) (8.3) (23.2) (18.1)
Gross profit 68.0 58.4 181.3 146.0
Other income 0.8 0.3 2.1 22.8
Research and development (20.7) (20.8) (60.8) (57.3)
General and administrative (15.3) (10.9) (46.0) (31.9)
Marketing and sales (28.7) (25.1) (91.9) (86.1)
Other Operating Costs (64.7) (56.8) (198.7) (175.3)
Operating profit (loss) 4.1 1.9 (15.3) (6.5)
Finance income (expense) and share of net profits in associates (2.6) 1.4 0.1 (3.5)
Profit (loss) before tax 1.5 3.3 (15.2) (10.0)
Income tax credit (expense) (2.5) 0.2 0.5 2.6
Profit (loss) for the period (1.0) 3.5 (14.7) (7.4)
Share Information        
Basic earnings per share (US$) (0.002) 0.005 (0.022) (0.011)
Diluted earnings per share (US$) (0.002) 0.005 (0.022) (0.011)


Segment information - Revenues 3Q 2024 3Q 2023 9M 2024 9M 2023
Amounts in US$m        
Revenue - RUCONEST® (US) 62.0 58.4 168.4 149.3
Revenue - RUCONEST® (EU and RoW) 1.6 1.8 4.2 4.5
Total Revenues - RUCONEST® 63.6 60.2 172.6 153.8
Revenue - Joenja® (US) 10.0 6.5 28.7 10.3
Revenue - Joenja® (EU and RoW) 1.2 3.2
Total Revenues - Joenja® 11.2 6.5 31.9 10.3
         
Total Revenues - US 72.0 64.9 197.1 159.6
Total Revenues - EU and RoW 2.8 1.8 7.4 4.5
         
Total Revenues 74.8 66.7 204.5 164.1


Consolidated Balance Sheet September 30, 2024 December 31, 2023
Amounts in US$m    
Cash and cash equivalents, restricted cash and marketable securities 173.3 215.0
Current assets 282.2 316.3
Total assets 425.5 462.9
Current liabilities 79.8 78.0
Equity 225.8 218.8


Financial highlights

Third quarter 2024

For the third quarter of 2024, total revenues increased by US$8.2 million, or 12%, to US$74.8 million, compared to US$66.7 million in the third quarter of 2023. RUCONEST® revenues amounted to US$63.6 million, a 6% increase compared to the third quarter of 2023. The volume increase in the U.S., and a U.S. price increase in line with CPI, were the primary factors behind this increase in RUCONEST® revenues. Joenja® revenues amounted to US$11.2 million in the third quarter of 2024, a 73% increase compared to the third quarter of 2023. This increase was primarily driven by an increase in volume.

Gross profit increased by US$9.7 million or 17% to US$68.0 million (3Q 2023: US$58.4 million), mainly due to the increase in revenues.

The operating profit amounted to US$4.1 million compared to an operating profit of US$1.9 million in the third quarter of 2023. This increase was primarily due to the increase in gross profit mentioned above, offset by the increase in operating expenses from US$56.8 million in the third quarter of 2023 to US$64.7 million. The increase in operating expenses compared to the same quarter in 2023 was caused by a combination of continuing investments in Joenja® in the U.S., launch preparation for leniolisib outside of the U.S., increasing R&D investments to expand the leniolisib franchise and increased payroll expenses due to business growth. Third quarter 2024 operating expenses decreased 8% from US$70.1 million in the second quarter of 2024.

The net finance result amounted to a loss of US$2.2 million compared to a gain of US$1.9 million in the third quarter of 2023. This was primarily driven by unfavorable EUR/USD exchange rate developments, resulting in a foreign currency loss of US$1.5 million compared to a gain of US$1.7 million in the third quarter of 2023. Additionally, interest expense increased by US$1.0 million in the third quarter of 2024 compared to the previous year, following the convertible bond issuance in the second quarter of 2024.

The Company had a net loss of US$1.0 million, compared to a net profit of US$3.5 million in the third quarter of 2023. This change was mainly due to higher finance expense resulting from unfavorable EUR/USD exchange rate developments and higher income tax expenses, despite higher operating profit. While the exchange rate fluctuations resulted in a foreign currency loss in the income statement, currency translation differences in other comprehensive income led to a positive result of US$2.9 million, compared to a negative result of US$5.2 million in the third quarter of 2023. This outcome was driven by the Company’s predominantly euro-denominated assets, including the vast majority of the cash and marketable securities position.

Cash and cash equivalents, including restricted cash and marketable securities, increased from US$161.8 million at the end of second quarter of 2024 to US$173.3 million at the end of the third quarter of 2024. This increase was primarily driven by positive cash flows from operations of US$9.7 million (3Q 2023: US$3.5 million), which includes a deduction of US$9.1 million in paid taxes (3Q 2023: US$0.0 million).

Nine months 2024

Total revenues increased 25% during the first nine months of 2024 to US$204.5 million, versus US$164.1 million during the first nine months of 2023. Total RUCONEST® revenues were 12% higher at US$172.6 million, compared to revenues of US$153.8 million for the first nine months of 2023. Joenja® revenues amounted to US$31.9 million in the first nine months of 2024, a 210% increase compared to the first nine months of 2023 (first sales commenced at the start of the second quarter of 2023). This increase was primarily driven by an increase in volume.

Gross profit increased by US$35.3 million or 24% to US$181.3 million (9M 2023: US$146.0 million), mainly due to the increase in revenues.

Other income decreased to US$2.0 million compared to US$22.8 million in the first nine months of 2023. Other income in the first nine months of 2023 was supported by the sale of the Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis for a pre-agreed, one-time payment of US$21.1 million.

The operating loss amounted to US$15.3 million compared to an operating loss of US$6.5 million in the first nine months of 2023. This change was mainly due to the decrease in other income and the expected increase in operating expenses from US$175.3 million in the first nine months of 2023 to US$198.7 million, offset by the above mentioned increase in gross profit in the first nine months of 2024. The first nine months of 2023 operating expenses included milestone payments for Joenja® of US$10.5 million in the second quarter. The increase in operating expenses in the first nine months of 2024 was caused by a combination of continuing investments in Joenja® in the U.S., launch preparation for leniolisib outside of the U.S., increasing R&D investments to expand the leniolisib franchise and increased payroll expenses due to business growth. Excluding the one time proceeds from the PRV sale and the milestone payment expenses for Joenja® in the first nine months of 2023, the operating loss decreased from US$17.1 million to US$15.3 million in the first nine months of the current year.

The net finance result amounted to a gain of US$1.4 million compared to a loss of US$2.6 million in the first nine months of 2023. This was primarily driven by a fair value gain of US$5.2 million upon the reclassification of the convertible bond-related derivative to equity. This fair value gain was a result of the decrease in value of the option component classified as a derivative from issuance until the physical settlement date of the newly issued convertible bond. In addition, interest income from investments in marketable securities, which commenced in the second quarter of 2023, increased by US$1.7 million. These positive results were partially offset by US$1.1 million higher interest expense on the 2024 issued convertible bond and unfavorable EUR/USD exchange rate developments, which led to a foreign currency loss of US$1.3 million compared to a loss of US$0.1 million in the first nine months of 2023.

The Company had a net loss of US$14.7 million, compared to a net loss of US$7.4 million in the first nine months of 2023. In addition to the support in other income from the PRV and the milestone payments for Joenja® in the first nine months of 2023, the change was mainly due to an increase in gross profit, higher interest income and the fair value gain upon the reclassification of the convertible bond-related derivative to equity, offset by an increase in operating expenses, unfavorable EUR/USD exchange rate developments and higher interest expenses on the 2024 issued convertible bond.

Cash and cash equivalents, including restricted cash and marketable securities, decreased from US$215.0 million at the end of 2023 to US$173.3 million at the end of September 2024. This decrease was primarily driven by the repurchase of the outstanding convertible bonds amounting to US$134.9 million and paid taxes of US$13.9 million, offset by net proceeds of US$104.5 million for newly issued convertible bonds.

On 5 October 2023, Orchard Therapeutics Plc. (Orchard) announced it had entered into a definitive agreement with Japanese company Kyowa Kirin Co. LTD for the acquisition of Orchard. During the first nine months of 2024, Pharming received US$2.0 million in cash for its shares held in Orchard. Pharming has terminated the research collaboration & licensing agreement with Orchard Therapeutics and discontinued the OTL-105 program.

Outlook/Summary

For the remainder of 2024 and the full year, the Company anticipates:

  • Total revenues between US$280 million and US$295 million (14% to 20% growth).
  • Continued progress finding additional APDS patients in the U.S., supported by family testing and VUS validation efforts, and subsequently converting patients to paid Joenja® (leniolisib) therapy.
  • Increasing leniolisib ex-U.S. revenues - through our Named Patient Program and other funded early access programs in key global markets.
  • Completion of leniolisib clinical trials to support regulatory filings for approval in Japan and pediatric label expansion in key global markets.
  • Progress towards regulatory approvals for leniolisib in the EEA, Canada and Australia.
  • Advancing the Phase II clinical trial for leniolisib in PIDs with immune dysregulation linked to PI3Kδ signaling to significantly expand the long-term commercial potential of leniolisib.
  • Continued focus on potential acquisitions and in-licensing of clinical stage opportunities in rare diseases. Financing, if required, would come via a combination of our strong balance sheet and access to capital markets.

No further specific financial guidance for 2024 is provided.

Additional information
Presentation

The conference call presentation is available on the Pharming.com website from 07:30 CEST today.

Conference Call

The conference call will begin at 13:30 CEST/07:30 EDT on Thursday, October 24. A transcript will be made available on the Pharming.com website in the days following the call.

Please note, the Company will only take questions from dial-in attendees.

Webcast Link:

https://edge.media-server.com/mmc/p/yotjk8ib

Conference call dial-in details:

https://register.vevent.com/register/BId118ac68d9124f67b1a83e3769559100

Additional information on how to register for the conference call/webcast can be found on the Pharming.com website.

For further public information, contact:

Pharming Group N.V., Leiden, the Netherlands
Michael Levitan, VP Investor Relations & Corporate Communications
T: +1 (908) 705 1696
E: investor@pharming.com

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

LifeSpring Life Sciences Communication, Amsterdam, the Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: pharming@lifespring.nl

About Pharming Group N.V.

Pharming Group N.V. (EURONEXT Amsterdam: PHARM/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. Pharming is headquartered in Leiden, the Netherlands, and has employees around the globe who serve patients in over 30 markets in North America, Europe, the Middle East, Africa, and Asia-Pacific.

For more information, visit www.pharming.com and find us on LinkedIn.

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 may contain forward-looking statements. Forward-looking statements are statements of future expectations that are based on management’s current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance, or events to differ materially from those expressed or implied in these statements. These forward-looking statements are identified by their use of terms and phrases such as “aim”, “ambition”, ‘‘anticipate’’, ‘‘believe’’, ‘‘could’’, ‘‘estimate’’, ‘‘expect’’, ‘‘goals’’, ‘‘intend’’, ‘‘may’’, “milestones”, ‘‘objectives’’, ‘‘outlook’’, ‘‘plan’’, ‘‘probably’’, ‘‘project’’, ‘‘risks’’, “schedule”, ‘‘seek’’, ‘‘should’’, ‘‘target’’, ‘‘will’’ and similar terms and phrases. Examples of forward-looking statements may include statements with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, 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, commercial, competitive and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that are described in Pharming's 2023 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2023, 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. All forward-looking statements contained in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. Readers should not place undue reliance on forward-looking statements. 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. Pharming does not undertake any obligation to publicly update or revise any forward-looking statement as a result of new information, future events or other information.

Inside Information
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Pharming Group N.V.

Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)

For the period ended September 30, 2024

  • Condensed consolidated interim statement of income
  • Condensed consolidated interim statement of comprehensive income
  • Condensed consolidated interim balance sheet
  • Condensed consolidated interim statement of changes in equity
  • Condensed consolidated interim statement of cash flows

CONDENSED CONSOLIDATED INTERIM STATEMENT OF INCOME
For the period ended September 30
 
Amounts in US$ ‘000 3Q 2024 3Q 2023 9M 2024 9M 2023
Revenues 74,849 66,661 204,528 164,099
Costs of sales (6,819) (8,295) (23,186) (18,094)
Gross profit 68,030 58,366 181,342 146,005
Other income 777 304 2,034 22,811
Research and development (20,721) (20,753) (60,839) (57,287)
General and administrative (15,292) (10,886) (45,999) (31,849)
Marketing and sales (28,686) (25,123) (91,863) (86,136)
Other Operating Costs (64,699) (56,762) (198,701) (175,272)
Operating profit (loss) 4,108 1,908 (15,325) (6,456)
Fair value gain (loss) on revaluation 21 5,159
Other finance income 825 1,251 3,760 2,050
Other finance expenses (2,998) 633 (7,488) (4,621)
Finance result, net (2,152) 1,884 1,431 (2,571)
Share of net profits (loss) in associates using the equity method (442) (485) (1,276) (954)
Profit (loss) before tax 1,514 3,307 (15,170) (9,981)
Income tax credit (expense) (2,548) 157 470 2,556
Profit (loss) for the period (1,034) 3,464 (14,700) (7,425)
Basic earnings per share (US$) (0.002) 0.005 (0.022) (0.011)
Diluted earnings per share (US$) (0.002) 0.005 (0.022) (0.011)


CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE INCOME
For the period ended September 30
 
Amounts in US$ ‘000 3Q 2024 3Q 2023 9M 2024 9M 2023
Profit (loss) for the period (1,034) 3,464 (14,700) (7,425)
Currency translation differences 2,883 (5,158) (1,352) (2,079)
Items that may be subsequently reclassified to profit or loss 2,883 (5,158) (1,352) (2,079)
Fair value remeasurement investments 1 281 79 419
Items that shall not be subsequently reclassified to profit or loss 1 281 79 419
Other comprehensive income (loss), net of tax 2,884 (4,877) (1,273) (1,660)
Total comprehensive income (loss) for the period 1,850 (1,413) (15,973) (9,085)


CONDENSED CONSOLIDATED INTERIM BALANCE SHEET    
     
Amounts in US$ ‘000 September 30, 2024 December 31, 2023
Non-current assets    
Intangible assets 67,096 71,267
Property, plant and equipment 8,692 9,689
Right-of-use assets 21,975 23,777
Long-term prepayments 93 92
Deferred tax assets 36,752 29,761
Investment accounted for using the equity method 1,016 2,285
Investments in equity instruments designated as at FVTOCI 2,020
Investment in debt instruments designated as at FVTPL 6,150 6,093
Restricted cash 1,548 1,528
Total non-current assets 143,322 146,512
Current assets    
Inventories 62,227 56,760
Trade and other receivables 48,199 46,158
Marketable securities 111,104 151,683
Cash and cash equivalents 60,662 61,741
Total current assets 282,192 316,342
Total assets 425,514 462,854
Equity    
Share capital 7,750 7,669
Share premium 487,079 478,431
Other reserves 9,334 (2,057)
Accumulated deficit (278,371) (265,262)
Shareholders’ equity 225,792 218,781
Non-current liabilities    
Convertible bonds 92,099 136,598
Lease liabilities 27,784 29,507
Total non-current liabilities 119,883 166,105
Current liabilities    
Convertible bonds 3,319 1,824
Trade and other payables 72,638 72,528
Lease liabilities 3,882 3,616
Total current liabilities 79,839 77,968
Total equity and liabilities 425,514 462,854


CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN EQUITY
For the period ended September 30
Attributable to owners of the parent
           
Amounts in US$ ‘000 Share capital Share premium Other reserves Accumulated deficit Total equity
Balance at January 1, 2023 7,509 462,297 (8,737) (256,431) 204,638
Profit (loss) for the period (7,425) (7,425)
Reserves
Other comprehensive income (loss) for the period (1,660) (1,660)
Total comprehensive income (loss) for the period (1,660) (7,425) (9,085)
Other reserves (518) 518
Income tax benefit from excess tax deductions related to share-based payments 574 574
Share-based compensation 5,935 5,935
Options exercised / LTIP shares issued 141 13,686 (5,947) 7,880
Value of conversion rights of convertible bonds
Total transactions with owners, recognized directly in equity 141 13,686 (518) 1,080 14,389
Balance at September 30, 2023 7,650 475,983 (10,915) (262,776) 209,942
           
Balance at January 1, 2024 7,669 478,431 (2,057) (265,262) 218,781
Profit (loss) for the period (14,700) (14,700)
Reserves 1,560 (1,560)
Other comprehensive income (loss) for the period (1,273) (1,273)
Total comprehensive income (loss) for the period 287 (16,260) (15,973)
Other reserves (31) 31
Income tax benefit from excess tax deductions related to share-based payments (241) (241)
Share-based compensation 8,605 8,605
Options exercised / LTIP shares issued 81 8,648 (5,244) 3,485
Value of conversion rights of convertible bonds 11,135 11,135
Total transactions with owners, recognized directly in equity 81 8,648 11,104 3,151 22,984
Balance at September 30, 2024 7,750 487,079 9,334 (278,371) 225,792


CONDENSED CONSOLIDATED INTERIM STATEMENT OF CASH FLOWS
For the period ended September 30
 
Amounts in $’000 3Q 2024 3Q 2023 9M 2024 9M 2023
Profit (loss) before tax 1,514 3,307 (15,170) (9,981)
Adjustments to reconcile net profit (loss) to net cash used in operating activities:        
Depreciation, amortization, impairment of non-current assets 2,743 2,902 8,371 8,370
Equity settled share based payments 2,918 1,965 8,605 5,935
Fair value loss (gain) on revaluation (21) (5,159)
Gain on disposal from PRV sale (21,080)
Other finance income (182) (1,251) (3,117) (2,050)
Other finance expenses 2,315 (633) 6,765 4,621
Share of net result in associates using the equity method 442 485 1,276 954
Other 1,055 (1,130)
Operating cash flows before changes in working capital 9,729 7,830 1,571 (14,361)
Changes in working capital:        
Inventories (2,133) (396) (5,248) (11,113)
Trade and other receivables 2,919 (7,363) (2,044) (12,902)
Payables and other current liabilities 6,560 3,242 4,305 8,075
Restricted cash (47) 363
Total changes in working capital 7,346 (4,563) (2,987) (15,577)
         
Interest received 1,784 260 4,154 1,059
Income taxes received (paid) (9,117) (13,864)
Net cash flows generated from (used in) operating activities 9,742 3,527 (11,126) (28,879)
         
Capital expenditure for property, plant and equipment (366) (147) (660) (1,133)
Proceeds on PRV sale 21,080
Investment intangible assets 23 23
Disposal of investment designated as at FVOCI 8 1,972
Purchases of marketable securities (109,796) (144,554) (222,249) (231,901)
Proceeds from sale of marketable securities 114,504 86,451 262,345 86,451
Net cash flows generated from (used in) investing activities 4,350 (58,227) 41,408 (125,480)
         
Payment of lease liabilities (918) (1,007) (2,485) (3,022)
Interests on lease liabilities (258) (270) (784) (825)
Net proceeds of issued convertible bonds (263) 104,539
Repurchase of convertible bonds (9) (134,931)
Interests on convertible bonds (8) (2,029) (2,032) (4,052)
Settlement of share based compensation awards 23 8,546 3,485 7,880
Net cash flows generated from (used in) financing activities (1,433) 5,240 (32,208) (19)
         
Increase (decrease) of cash 12,659 (49,460) (1,926) (154,378)
Exchange rate effects 861 (913) 847 1,689
Cash and cash equivalents at the beginning of the period 47,142 105,026 61,741 207,342
         
Total cash and cash equivalents at September 30 60,662 54,653 60,662 54,653

Attachment


FAQ

What was Pharming Group's (PHARM) revenue growth in Q3 2024?

Pharming Group's total revenues increased by 12% to US$74.8 million in Q3 2024 compared to Q3 2023.

How much did Joenja sales grow for Pharming (PHARM) in Q3 2024?

Joenja revenue increased by 72% to US$11.2 million in Q3 2024 compared to Q3 2023.

What is Pharming's (PHARM) revenue guidance for 2024?

Pharming expects total revenues between US$280 million and US$295 million, representing 14% to 20% growth.

When will Pharming's (PHARM) CEO Sijmen de Vries step down?

CEO Sijmen de Vries will not seek reappointment at the Annual General Meeting in May 2025.

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