Jazz Pharmaceuticals Announces Third Quarter 2025 Financial Results and Updates 2025 Financial Guidance
Jazz Pharmaceuticals (Nasdaq: JAZZ) reported 3Q25 total revenues of $1.126B, up 7% year‑over‑year, driven by Xywav, Epidiolex and the Modeyso launch. Modeyso received FDA accelerated approval and generated $11.0M in 3Q25 after an August launch. Xywav sales were $431.4M (+11%) and Epidiolex was $302.6M (+20%). GAAP net income for 3Q25 was $251.4M and non‑GAAP adjusted net income was $500.7M. Cash and investments were $2.0B with long‑term debt of $5.4B. Company narrowed 2025 revenue guidance to $4,175–$4,275M and provided updated GAAP and non‑GAAP guidance.
Jazz Pharmaceuticals (Nasdaq: JAZZ) ha riportato ricavi total 3Q25 di 1,126 miliardi di dollari, in aumento del 7% annuo, trainati da Xywav, Epidiolex e dal lancio di Modeyso. Modeyso ha ricevuto l'approvazione accelerata FDA e ha generato 11,0 milioni di dollari nel 3Q25 dopo il lancio di agosto. Xywav vendite sono state 431,4 milioni di dollari (+11%) e Epidiolex è stato 302,6 milioni di dollari (+20%). L'utile netto GAAP per il 3Q25 è stato 251,4 milioni di dollari e l'utile netto rettificato non-GAAP è stato 500,7 milioni di dollari. Cassa e investimenti ammontavano a 2,0 miliardi di dollari con un debito a lungo termine di 5,4 miliardi di dollari. L'azienda ha ridotto le previsioni di ricavi 2025 a 4.175–4.275 milioni di dollari e ha fornito previsioni aggiornate GAAP e non-GAAP.
Jazz Pharmaceuticals (Nasdaq: JAZZ) informó ingresos totales en 3T25 de 1.126 millones de dólares, un aumento del 7% interanual, impulsados por Xywav, Epidiolex y el lanzamiento de Modeyso. Modeyso recibió aprobación acelerada de la FDA y generó 11,0 millones de dólares en 3T25 tras su lanzamiento en agosto. Xywav ventas fueron 431,4 millones de dólares (+11%) y Epidiolex fue 302,6 millones de dólares (+20%). El ingreso neto GAAP para 3T25 fue de 251,4 millones de dólares y el ingreso neto ajustado no GAAP fue de 500,7 millones de dólares. La caja e inversiones fueron 2,0 mil millones de dólares con una deuda a largo plazo de 5,4 mil millones de dólares. La empresa redujo la guía de ingresos para 2025 a 4.175–4.275 millones de dólares y proporcionó guías actualizadas GAAP y no-GAAP.
Jazz Pharmaceuticals (나스닥: JAZZ)는 3Q25 매출 총액 112.6억 달러를 보고했으며, 전년 대비 7% 증가했고 Xywav, Epidiolex 및 Modeyso 출시가 견인했습니다. Modeyso는 FDA의 가속 승인를 받고 8월 출시 이후 11.0백만 달러를 3Q25에 창출했습니다. Xywav 매출은 431.4백만 달러 (+11%)였고 Epidiolex는 302.6백만 달러 (+20%)였습니다. GAAP 순이익은 3Q25에서 251.4백만 달러, 비GAAP 조정 순이익은 500.7백만 달러였습니다. 현금 및 투자자산은 20억 달러였고 장기 부채는 54억 달러였습니다. 회사는 2025년 매출 가이던스를 41.75억~42.75억 달러로 축소했고 GAAP 및 비GAAP 가이던스를 업데이트했습니다.
Jazz Pharmaceuticals (Nasdaq : JAZZ) a publié un chiffre d'affaires total du T3 2025 de 1,126 milliard de dollars, en hausse de 7 % d'une année sur l'autre, tiré par Xywav, Epidiolex et le lancement de Modeyso. Modeyso a obtenu l'approbation accélérée de la FDA et a généré 11,0 millions de dollars au cours du T3 2025 après un lancement en août. Les ventes de Xywav s'élevaient à 431,4 millions de dollars (+11 %) et Epidiolex à 302,6 millions de dollars (+20 %). Le résultat net GAAP du T3 2025 était 251,4 millions de dollars et le résultat net ajusté non-GAAP était 500,7 millions de dollars. La trésorerie et les investissements s'étaient élevés à 2,0 milliards de dollars avec une dette à long terme de 5,4 milliards de dollars. L'entreprise a relevé ses prévisions de revenus pour 2025 à 4,175–4,275 milliards de dollars et a fourni des prévisions GAAP et non-GAAP mises à jour.
Jazz Pharmaceuticals (Nasdaq: JAZZ) berichtete Gesamterlöse im 3Q25 von 1,126 Mrd. USD, ein Anstieg von 7 % gegenüber dem Vorjahr, getrieben durch Xywav, Epidiolex und die Modeyso-Einführung. Modeyso erhielt die beschleunigte FDA-Zulassung und erwirtschaftete 11,0 Mio. USD im 3Q25 nach dem August-Start. Die Xywav-Verkäufe betrugen 431,4 Mio. USD (+11 %) und Epidiolex lag bei 302,6 Mio. USD (+20 %). Das GAAP-Nettoeinkommen für 3Q25 betrug 251,4 Mio. USD und das non-GAAP bereinigte Nettoeinkommen war 500,7 Mio. USD. Cash und Investitionen lagen bei 2,0 Mrd. USD mit einer langfristigen Verschuldung von 5,4 Mrd. USD. Das Unternehmen hat die Umsatzprognose für 2025 auf 4,175–4,275 Mrd. USD eingedampft und aktualisierte GAAP- und non-GAAP-Guidance bereitgestellt.
جيز للأدوية الصيدلانية (ناسداك: JAZZ) ذكرت إجمالي الإيرادات للربع الثالث 2025 بلغ 1.126 مليار دولار، بزيادة 7% على أساس سنوي، مدفوعاً بـ Xywav وEpidiolex وإطلاق Modeyso. Modeyso حصل على موافقة FDA المعجلة وحقق 11.0 مليون دولار في الربع الثالث 2025 بعد الإطلاق في أغسطس. مبيعات Xywav كانت 431.4 مليون دولار (+11%) وEpidiolex بلغ 302.6 مليون دولار (+20%). صافي الدخل المحقق وفق مبادئ المحاسبة المقبولة عمومًا GAAP للربع الثالث 2025 كان 251.4 مليون دولار وصافي الدخل المعدل غير GAAP كان 500.7 مليون دولار. السيولة والاستثمارات كانت 2.0 مليار دولار مع دين طويل الأجل قدره 5.4 مليار دولار. قلّصت الشركة توجيهات الإيرادات لعام 2025 إلى 4,175–4,275 مليون دولار ووفّرت توجيهات GAAP وnon-GAAP المحدثة.
- Total revenues +7% to $1.126B in 3Q25
- Xywav net sales $431.4M (+11%) in 3Q25
- Epidiolex net sales $302.6M (+20%) in 3Q25
- Modeyso launch generated $11.0M in 3Q25
- Non‑GAAP adjusted net income $500.7M in 3Q25
- Generated $993.3M cash from operations YTD through 9M25
- Nine‑month GAAP net loss $(559.6)M through 9M25
- Outstanding long‑term debt $5.4B as of Sept 30, 2025
- SG&A rose due to $90M Avadel and $61.5M Xyrem settlements
- Acquired IPR&D expense $947.9M included in 2025 guidance
Insights
Strong quarter driven by new FDA approvals and product growth; guidance tightened with one-time charges, supporting a constructive outlook.
The business shows clear commercial traction: total revenues rose 7% year-over-year to
Key dependencies and risks include substantial one‑time items and acquired adjustments that materially affect GAAP metrics: the guidance incorporates
Concrete near‑term items to watch are the top‑line PFS readout from zanidatamab Phase 3 HERIZON‑GEA‑01 expected in
– Modeyso™ approved as the first and only treatment for recurrent H3 K27M-mutant DMG –
– Zepzelca® and atezolizumab (Tecentriq®) combination approved as maintenance therapy in 1L ES-SCLC –
– 3Q25 total revenues increased
"Achieving the highest revenue quarter in Jazz's history speaks to the strength of our diversified portfolio and the outstanding performance of our team. We were pleased to once again deliver solid execution across our sleep, epilepsy and oncology portfolios, led by double-digit percentage growth from Epidiolex and Xywav," said Renee Gala, president and chief executive officer of Jazz Pharmaceuticals. "In addition, we achieved several key milestones that will enhance our commercial portfolio, including receiving FDA approvals for Modeyso as well as the Zepzelca and atezolizumab first-line maintenance combination. We remain confident in the opportunity presented by zanidatamab and look forward to sharing the top-line data readout from the Phase 3 HERIZON-GEA-01 trial before the end of the year. With a proven portfolio and strong financial foundation, we are well-positioned to accelerate our evolution and deliver meaningful value for patients and shareholders alike."
Key Highlights
-
Modeyso received accelerated approval from the FDA ahead of its PDUFA date; initiated commercial launch in August 2025 with strong initial uptake and sales of
in 3Q25.$11.0 million - Zepzelca and atezolizumab combination received FDA approval for 1L maintenance treatment of ES-SCLC based on positive data from the Phase 3 IMforte trial.
- Top-line PFS data from zanidatamab in Phase 3 1L GEA expected in 4Q25; updated intent-to-treat population for PFS to include all patients enrolled in the trial.
- Narrowed 2025 total revenue guidance range to
-$4.17 5 from$4.27 5 billion -$4.15 0 .$4.30 0 billion - Announced the appointment of Dr. Ted Love to the Board of Directors.
Business Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
- Net product sales increased
11% to in 3Q25 compared to 3Q24.$431.4 million - Meaningful net patient adds in 3Q25 of approximately 450 patients. There were approximately 15,675 active patients exiting the quarter comprised of approximately 10,725 narcolepsy patients and approximately 4,950 idiopathic hypersomnia (IH) patients.
Epidiolex/Epidyolex® (cannabidiol):
- Net product sales increased
20% to in 3Q25 compared to 3Q24.$302.6 million - In 3Q25, volumes increased by
10% , driven by demand, and net product sales benefitted from lower gross to net deductions in theU.S.
Rylaze®/Enrylaze®(asparaginase erwiniachrysanthemi (recombinant)-rywn):
- Net product sales increased
1% to in 3Q25 compared to 3Q24.$99.9 million
Zepzelca (lurbinectedin):
- Net product sales decreased
8% to in 3Q25 compared to 3Q24.$79.3 million - Zepzelca and atezolizumab combination was included in National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology as a preferred regimen for patients whose disease has not progressed following four cycles of platinum-based chemotherapy and atezolizumab induction.
Ziihera® (zanidatamab-hrii):
- Net product sales were
in 3Q25 following product launch in December 2024.$8.3 million - Updated the intent-to-treat population for the primary PFS (progression-free survival) and interim overall survival analyses of the HERIZON-GEA-01 trial to include the full patient population enrolled in the trial.
Modeyso (dordaviprone):
- Net product sales were
in 3Q25 following product launch in August 2025.$11.0 million - Modeyso was made commercially available quickly following FDA accelerated approval on August 6, ensuring patients with H3 K27M-mutant diffuse midline glioma (DMG) had access to the first and only targeted drug therapy for this ultra-rare and aggressive brain tumor.
- Modeyso was included in the NCCN® Clinical Practice Guidelines in Oncology.
Corporate Development:
- The Company announced a global licensing agreement with Saniona to develop and commercialize SAN2355, a highly differentiated, subtype selective Kv7.2/Kv7.3 activator in preclinical development for epilepsy and other potential indications.
Financial Highlights
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||
|
(In thousands, except per share amounts) |
2025 |
|
2024 |
|
2025 |
|
2024 |
|
Total revenues |
$ 1,126,107 |
|
$ 1,054,969 |
|
$ 3,069,660 |
|
$ 2,980,777 |
|
GAAP net income (loss) |
$ 251,412 |
|
$ 215,055 |
|
$ (559,599) |
|
$ 369,005 |
|
Non-GAAP adjusted net income1 |
$ 500,653 |
|
$ 412,359 |
|
$ 101,037 |
|
$ 951,445 |
|
GAAP earnings (loss) per share |
$ 4.08 |
|
$ 3.42 |
|
$ (9.18) |
|
$ 5.63 |
|
Non-GAAP adjusted earnings per share1 |
$ 8.13 |
|
$ 6.54 |
|
$ 1.63 |
|
$ 14.25 |
____________________________
|
1. |
Commencing with the first quarter of 2025, we are no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures and for the purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. See "Non-GAAP Financial Measures" below. |
Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.
Total Revenues
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||
|
(In thousands) |
2025 |
|
2024 |
|
2025 |
|
2024 |
|
Xywav |
$ 431,410 |
|
$ 388,466 |
|
$ 1,191,535 |
|
$ 1,072,238 |
|
Xyrem |
35,663 |
|
58,114 |
|
108,253 |
|
184,526 |
|
Epidiolex/Epidyolex |
302,608 |
|
251,558 |
|
772,075 |
|
697,376 |
|
Sativex |
4,752 |
|
4,586 |
|
14,774 |
|
13,704 |
|
Total Neuroscience |
774,433 |
|
702,724 |
|
2,086,637 |
|
1,967,844 |
|
Rylaze/Enrylaze |
99,868 |
|
98,780 |
|
294,760 |
|
309,359 |
|
Zepzelca |
79,295 |
|
85,843 |
|
216,869 |
|
241,990 |
|
Defitelio/defibrotide |
51,752 |
|
65,818 |
|
140,520 |
|
158,915 |
|
Vyxeos |
37,583 |
|
34,313 |
|
111,978 |
|
109,348 |
|
Ziihera |
8,306 |
|
— |
|
16,272 |
|
— |
|
Modeyso |
11,032 |
|
— |
|
11,502 |
|
— |
|
Total Oncology |
287,836 |
|
284,754 |
|
791,901 |
|
819,612 |
|
Other |
2,143 |
|
2,229 |
|
10,863 |
|
8,497 |
|
Product sales, net |
1,064,412 |
|
989,707 |
|
2,889,401 |
|
2,795,953 |
|
High-sodium oxybate AG royalty revenue |
52,945 |
|
58,157 |
|
156,029 |
|
162,268 |
|
Other royalty and contract revenues |
8,750 |
|
7,105 |
|
24,230 |
|
22,556 |
|
Total revenues |
$ 1,126,107 |
|
$ 1,054,969 |
|
$ 3,069,660 |
|
$ 2,980,777 |
Total revenues increased
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, increased
Oncology net product sales increased
Operating Expenses and Income Tax (Benefit) Expense
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||
|
(In thousands, except percentages) |
2025 |
|
2024 |
|
2025 |
|
2024 |
|
GAAP: |
|
|
|
|
|
|
|
|
Cost of product sales |
$ 128,880 |
|
$ 111,611 |
|
$ 349,768 |
|
$ 317,000 |
|
Gross margin |
87.9 % |
|
88.7 % |
|
87.9 % |
|
88.7 % |
|
Selling, general and administrative |
$ 530,647 |
|
$ 325,772 |
|
$ 1,403,059 |
|
$ 1,016,007 |
|
% of total revenues |
47.1 % |
|
30.9 % |
|
45.7 % |
|
34.1 % |
|
Research and development |
$ 198,203 |
|
$ 199,919 |
|
$ 568,827 |
|
$ 643,500 |
|
% of total revenues |
17.6 % |
|
19.0 % |
|
18.5 % |
|
21.6 % |
|
Acquired in-process research and development |
$ 42,500 |
|
$ — |
|
$ 947,862 |
|
$ 10,000 |
|
Income tax benefit |
$ (242,424) |
|
$ (14,533) |
|
$ (277,406) |
|
$ (33,517) |
|
Effective tax rate |
N/A(1) |
|
(7.2) % |
|
33.2 % |
|
(9.9) % |
_________________________
|
1. |
Not a meaningful metric due to minimal profit before tax in this period. |
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||
|
(In thousands, except percentages) |
2025 |
|
2024 |
|
2025 |
|
2024 |
|
Non-GAAP adjusted: |
|
|
|
|
|
|
|
|
Cost of product sales |
$ 83,176 |
|
$ 72,844 |
|
$ 229,175 |
|
$ 209,405 |
|
Gross margin |
92.2 % |
|
92.6 % |
|
92.1 % |
|
92.5 % |
|
Selling, general and administrative |
$ 460,061 |
|
$ 288,672 |
|
$ 1,242,722 |
|
$ 903,557 |
|
% of total revenues |
40.9 % |
|
27.4 % |
|
40.5 % |
|
30.3 % |
|
Research and development |
$ 169,977 |
|
$ 180,992 |
|
$ 496,730 |
|
$ 588,470 |
|
% of total revenues |
15.1 % |
|
17.2 % |
|
16.2 % |
|
19.7 % |
|
Acquired in-process research and development |
$ 42,500 |
|
$ — |
|
$ 947,862 |
|
$ 10,000 |
|
Income tax (benefit) expense |
$ (178,781) |
|
$ 40,414 |
|
$ (100,096) |
|
$ 127,528 |
|
Effective tax rate |
(55.5) % |
|
8.9 % |
|
N/A(1) |
|
11.8 % |
_________________________
|
1. |
Not a meaningful metric due to minimal profit before tax in this period. |
Changes in operating expenses and income tax (benefit) expense in 3Q25 over the prior year period are primarily due to the following:
- Cost of product sales, on a GAAP and non-GAAP adjusted basis, increased in 3Q25 compared to 3Q24, primarily due to higher inventory provisions and changes in product mix. Cost of product sales, on a GAAP basis, included higher acquisition accounting inventory fair value step-up expense in 3Q25 as compared to 3Q24.
- Selling, general and administrative (SG&A) expenses, on a GAAP and non-GAAP adjusted basis, increased in 3Q25 compared to 3Q24, primarily due to the Avadel litigation settlement of
.0 million and a Xyrem antitrust litigation settlement of$90 , and, to a lesser extent, higher compensation-related expenses driven by higher headcount along with increased investment in sales and marketing in support of our commercial portfolio. SG&A expenses, on a GAAP basis, also included increased share-based compensation expense.$61.5 million - Research and development (R&D) expenses, on a GAAP and non-GAAP adjusted basis, decreased in 3Q25 compared to 3Q24, primarily due to lower clinical study costs primarily related to zanidatamab as a result of timing of clinical trial activities, JZP385 (essential tremor) following discontinuation of this program, and JZP258 (XYLO/DUET) due to the completion of this trial in the first half of 2025, partially offset by the addition of costs relating to Modeyso following the Chimerix acquisition. R&D expenses, on a GAAP basis, included integration expenses related to the Chimerix acquisition of
.$6.5 million - Acquired in-process research and development (IPR&D) in 3Q25, on a GAAP and non-GAAP adjusted basis, represents the upfront payment made in connection with our global license agreement with Saniona.
- Income tax benefit in 3Q25, on a GAAP and non-GAAP adjusted basis, included a benefit of
on recognition of certain$205.9 million U.S. federal and state deferred tax assets acquired through the Chimerix acquisition.
Cash Flow and Balance Sheet
As of September 30, 2025, cash, cash equivalents and investments were
2025 Financial Guidance
Jazz Pharmaceuticals has updated its full-year 2025 financial guidance as follows:
|
|
Guidance provided as of |
||
|
(In millions) |
November 5, 2025 |
|
August 5, 2025 |
|
Total Revenues |
|
|
|
GAAP:
|
(In millions, except per share amounts and percentages) |
November 5, 2025 |
|
August 5, 2025 |
|
Gross margin % |
88 % |
|
88 % |
|
SG&A expenses |
|
|
|
|
R&D expenses |
|
|
|
|
Acquired IPR&D |
|
|
|
|
Effective tax rate |
|
|
|
|
Net loss |
|
|
|
|
Net loss per diluted share |
|
|
|
|
Weighted-average ordinary shares used in per share calculations |
61 |
|
61 - 62 |
Non-GAAP adjusted:
|
(In millions, except per share amounts and percentages) |
November 5, 2025 |
|
August 5, 2025 |
|
Gross margin % |
|
|
92 % |
|
SG&A expenses |
|
|
|
|
R&D expenses |
|
|
|
|
Acquired IPR&D |
|
|
|
|
Effective tax rate |
(20)% - (15)%5,6 |
|
|
|
Net income |
|
|
|
|
Net income per diluted share |
|
|
|
|
Weighted-average ordinary shares used in per share calculations |
62 |
|
62 - 63 |
___________________________
|
1. |
The projected GAAP net loss and non-GAAP adjusted net income include acquired IPR&D expenses of |
|
2. |
Excludes |
|
3. |
Excludes |
|
4. |
Excludes |
|
5. |
Excludes |
|
6. |
See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of 2025 GAAP Net Loss and Diluted LPS to Non-GAAP Adjusted Net Income and Diluted EPS Guidance" at the end of this press release. |
Conference Call Details
Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EST (9:30 p.m. GMT) to provide a business and financial update and discuss its 2025 third quarter results.
Interested parties may register for the call here or via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.
A replay of the webcast will be available via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in
Non-GAAP Financial Measures
To supplement Jazz Pharmaceuticals' financial results and guidance presented in accordance with
The Company believes that each of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors and analysts and that each of these non-GAAP financial measures, when considered together with the Company's financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare the Company's results from period to period, to its forward-looking guidance, and to identify operating trends in the Company's business. In addition, these non-GAAP financial measures are regularly used by investors and analysts to model and track the Company's financial performance. Jazz Pharmaceuticals' management also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate the Company's business and to make operating decisions, and compensation of executives is based in part on certain of these non-GAAP financial measures. Because these non-GAAP financial measures are important internal measurements for Jazz Pharmaceuticals' management, the Company also believes that these non-GAAP financial measures are useful to investors and analysts since these measures allow for greater transparency with respect to key financial metrics the Company uses in assessing its own operating performance and making operating decisions. These non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable GAAP measures; should be read in conjunction with the Company's consolidated financial statements prepared in accordance with GAAP; have no standardized meaning prescribed by GAAP; and are not prepared under any comprehensive set of accounting rules or principles in the reconciliation tables that follow. In addition, from time to time in the future there may be other items that the Company may exclude for purposes of its non-GAAP financial measures; and the Company has ceased, and may in the future cease, to exclude items that it has historically excluded for purposes of its non-GAAP financial measures. In this regard, commencing with the first quarter of 2025, the Company is no longer including an adjustment for non-cash interest expense in the Company's non-GAAP adjusted financial measures. For purposes of comparability, non-GAAP adjusted financial measures for the 2024 periods have been updated to reflect this change. Likewise, the Company may determine to modify the nature of its adjustments to arrive at its non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measures as used by Jazz Pharmaceuticals in this press release and the accompanying tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies.
Caution Concerning Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to: the Company's growth prospects and future financial and operating results, including the Company's 2025 financial guidance and the Company's expectations related thereto, including with respect to anticipated catalysts; expectations with respect to the transition of the CEO role; anticipated multiple near-term pipeline catalysts that each represent significant opportunities to drive greater revenue and create long-term value; expectations that Epidiolex will achieve blockbuster status in 2025; anticipated benefits and expenses relating to the Company's acquisition of Chimerix; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto; the potential of the ongoing Phase 3 ACTION trial to confirm clinical benefit of Modeyso in recurrent H3 K27M-mutant diffuse glioma and extend to use in first-line patients; planned or anticipated clinical trial events, including with respect to initiations, enrollment and data read-outs, and the anticipated timing thereof, including: top-line PFS data from a Phase 3 trial of zanidatamab in 1L GEA; and the Company's development, regulatory and commercialization strategy; the Company's expectations with respect to its products and product candidates and the potential of the Company's products and product candidates and the potential regulatory path related thereto; including Zepzelca's potential to change current practice as maintenance therapy in 1L ES-SCLC and Modeyso's potential to be a meaningful and durable revenue opportunity; the Company's capital allocation and corporate development strategy; the potential successful future development, manufacturing, regulatory and commercialization activities; the Company's ability to realize the commercial potential of its products; the Company's net product sales and goals for net product sales from new and acquired products; the Company's views and expectations relating to its patent portfolio, including with respect to expected patent protection, as well as expectations with respect to exclusivity; the Company's clinical trials confirming clinical benefit or enabling regulatory submissions; planned or anticipated regulatory submissions and filings, and the anticipated timing thereof; potential regulatory approvals; and other statements that are not historical facts. These forward-looking statements are based on the Company's current plans, objectives, estimates, expectations and intentions and inherently involve significant risks and uncertainties.
Actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with: maintaining or increasing sales of, and revenue from, Xywav, Rylaze and Epidiolex/Epidyolex and other marketed products; the introduction of new products into the U.S. market that compete with, or otherwise disrupt the market for the Company's products and product candidates; effectively launching and commercializing the Company's other products and product candidates; the successful completion of development and regulatory activities with respect to the Company's product candidates; obtaining and maintaining adequate coverage and reimbursement for the Company's products; the time-consuming and uncertain regulatory approval process, including the risk that the Company's current and/or planned regulatory submissions may not be submitted, accepted or approved by applicable regulatory authorities in a timely manner or at all; the costly and time-consuming pharmaceutical product development and the uncertainty of clinical success, including risks related to failure or delays in successfully initiating or completing clinical trials and assessing patients; global economic, financial, and healthcare system disruptions and the current and potential future negative impacts to the Company's business operations and financial results; geopolitical events, including international tariffs and trade restrictions and the conflict between
|
JAZZ PHARMACEUTICALS PLC |
|||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS) |
|||||||
|
(In thousands, except per share amounts) |
|||||||
|
(Unaudited) |
|||||||
|
|
|||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product sales, net |
$ 1,064,412 |
|
$ 989,707 |
|
$ 2,889,401 |
|
$ 2,795,953 |
|
Royalties and contract revenues |
61,695 |
|
65,262 |
|
180,259 |
|
184,824 |
|
Total revenues |
1,126,107 |
|
1,054,969 |
|
3,069,660 |
|
2,980,777 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of product sales (excluding amortization of |
128,880 |
|
111,611 |
|
349,768 |
|
317,000 |
|
Selling, general and administrative |
530,647 |
|
325,772 |
|
1,403,059 |
|
1,016,007 |
|
Research and development |
198,203 |
|
199,919 |
|
568,827 |
|
643,500 |
|
Intangible asset amortization |
168,368 |
|
157,457 |
|
484,919 |
|
468,410 |
|
Acquired in-process research and development |
42,500 |
|
— |
|
947,862 |
|
10,000 |
|
Total operating expenses |
1,068,598 |
|
794,759 |
|
3,754,435 |
|
2,454,917 |
|
Income (loss) from operations |
57,509 |
|
260,210 |
|
(684,775) |
|
525,860 |
|
Interest expense, net |
(48,576) |
|
(58,702) |
|
(149,645) |
|
(186,841) |
|
Foreign exchange gain (loss) |
102 |
|
(701) |
|
(1,910) |
|
(1,887) |
|
Income (loss) before income tax benefit and equity in |
9,035 |
|
200,807 |
|
(836,330) |
|
337,132 |
|
Income tax benefit |
(242,424) |
|
(14,533) |
|
(277,406) |
|
(33,517) |
|
Equity in loss of investees |
47 |
|
285 |
|
675 |
|
1,644 |
|
Net income (loss) |
$ 251,412 |
|
$ 215,055 |
|
$ (559,599) |
|
$ 369,005 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) per ordinary share: |
|
|
|
|
|
|
|
|
Basic |
$ 4.14 |
|
$ 3.50 |
|
$ (9.18) |
|
$ 5.93 |
|
Diluted |
$ 4.08 |
|
$ 3.42 |
|
$ (9.18) |
|
$ 5.63 |
|
Weighted-average ordinary shares used in per share |
60,696 |
|
61,414 |
|
60,955 |
|
62,275 |
|
Weighted-average ordinary shares used in per share |
61,606 |
|
63,174 |
|
60,955 |
|
67,511 |
|
JAZZ PHARMACEUTICALS PLC |
|||
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||
|
(In thousands) |
|||
|
(Unaudited) |
|||
|
|
|||
|
|
September 30,
|
|
December 31,
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ 1,326,070 |
|
$ 2,412,864 |
|
Investments |
720,000 |
|
580,000 |
|
Accounts receivable, net of allowances |
764,364 |
|
716,765 |
|
Inventories |
483,111 |
|
480,445 |
|
Prepaid expenses |
146,892 |
|
177,411 |
|
Other current assets |
315,441 |
|
261,543 |
|
Total current assets |
3,755,878 |
|
4,629,028 |
|
Property, plant and equipment, net |
188,913 |
|
173,413 |
|
Operating lease assets |
61,204 |
|
53,582 |
|
Intangible assets, net |
4,565,737 |
|
4,755,695 |
|
Goodwill |
1,827,483 |
|
1,716,323 |
|
Deferred tax assets, net |
846,168 |
|
560,245 |
|
Deferred financing costs |
8,034 |
|
9,489 |
|
Other non-current assets |
103,068 |
|
114,482 |
|
Total assets |
$ 11,356,485 |
|
$ 12,012,257 |
|
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ 152,227 |
|
$ 77,869 |
|
Accrued liabilities |
1,001,556 |
|
910,947 |
|
Current portion of long-term debt |
1,029,179 |
|
31,000 |
|
Income taxes payable |
91,140 |
|
18,757 |
|
Total current liabilities |
2,274,102 |
|
1,038,573 |
|
Long-term debt, less current portion |
4,331,982 |
|
6,077,640 |
|
Operating lease liabilities, less current portion |
53,426 |
|
38,938 |
|
Deferred tax liabilities, net |
629,033 |
|
676,736 |
|
Other non-current liabilities |
108,912 |
|
86,614 |
|
Total shareholders' equity |
3,959,030 |
|
4,093,756 |
|
Total liabilities and shareholders' equity |
$ 11,356,485 |
|
$ 12,012,257 |
|
JAZZ PHARMACEUTICALS PLC |
|||
|
SUMMARY OF CASH FLOWS |
|||
|
(In thousands) |
|||
|
(Unaudited) |
|||
|
|
|||
|
|
Nine Months Ended September 30, |
||
|
|
2025 |
|
2024 |
|
Net cash provided by operating activities |
$ 993,255 |
|
$ 997,328 |
|
Net cash used in investing activities |
(1,137,751) |
|
(314,908) |
|
Net cash provided by (used in) financing activities |
(948,820) |
|
28,791 |
|
Effect of exchange rates on cash and cash equivalents |
6,522 |
|
614 |
|
Net increase (decrease) in cash and cash equivalents |
$ (1,086,794) |
|
$ 711,825 |
|
JAZZ PHARMACEUTICALS PLC |
|||||||||||||||
|
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION |
|||||||||||||||
|
(In thousands, except per share amounts) |
|||||||||||||||
|
(Unaudited) |
|||||||||||||||
|
|
|||||||||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
2025 |
|
2024 |
|
2025 |
|
2024 |
||||||||
|
|
Net |
|
Diluted |
|
Net |
|
Diluted |
|
Net |
|
Diluted EPS/(Loss) |
|
Net |
|
Diluted |
|
GAAP reported |
$ 251,412 |
|
$ 4.08 |
|
$ 215,055 |
|
$ 3.42 |
|
|
|
$ (9.18) |
|
$ 369,005 |
|
$ 5.63 |
|
Intangible asset |
168,368 |
|
2.73 |
|
157,457 |
|
2.49 |
|
484,919 |
|
7.83 |
|
468,410 |
|
6.94 |
|
Share-based |
88,125 |
|
1.43 |
|
59,760 |
|
0.95 |
|
220,279 |
|
3.56 |
|
177,855 |
|
2.63 |
|
Acquisition accounting |
40,355 |
|
0.66 |
|
35,034 |
|
0.55 |
|
107,344 |
|
1.73 |
|
97,220 |
|
1.44 |
|
Integration related |
16,036 |
|
0.26 |
|
— |
|
— |
|
25,404 |
|
0.41 |
|
— |
|
— |
|
Income tax effect of |
(63,643) |
|
(1.03) |
|
(54,947) |
|
(0.87) |
|
(177,310) |
|
(2.86) |
|
(161,045) |
|
(2.39) |
|
Effect of potentially |
— |
|
— |
|
— |
|
— |
|
— |
|
0.14 |
|
— |
|
— |
|
Non-GAAP adjusted |
$ 500,653 |
|
$ 8.13 |
|
$ 412,359 |
|
$ 6.54 |
|
$ 101,037 |
|
$ 1.63 |
|
$ 951,445 |
|
$ 14.25 |
|
Weighted-average |
61,606 |
|
|
|
63,174 |
|
|
|
60,955 |
|
|
|
67,511 |
|
|
|
Dilutive effect of |
— |
|
|
|
— |
|
|
|
951 |
|
|
|
— |
|
|
|
Weighted-average ordinary |
61,606 |
|
|
|
63,174 |
|
|
|
61,906 |
|
|
|
67,511 |
|
|
________________________________________________
Explanation of Adjustments and Certain Line Items:
|
1. |
Diluted EPS was calculated using the "if-converted" method in relation to the |
|
2. |
Integration related expenses with respect to the Chimerix acquisition. |
|
JAZZ PHARMACEUTICALS PLC |
|||||||||||||||||
|
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION - CERTAIN LINE ITEMS |
|||||||||||||||||
|
(In thousands, except percentages) |
|||||||||||||||||
|
(Unaudited) |
|||||||||||||||||
|
|
|||||||||||||||||
|
|
Three months ended September 30, 2025 |
||||||||||||||||
|
|
Cost of |
|
Gross |
|
SG&A |
|
R&D |
|
Intangible |
|
Acquired |
|
Interest |
|
Income tax |
|
Effective |
|
GAAP Reported |
|
|
87.9 % |
|
$ 530,647 |
|
$ 198,203 |
|
|
|
$ 42,500 |
|
|
|
$ (242,424) |
|
N/A(1) |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset |
— |
|
— |
|
— |
|
— |
|
(168,368) |
|
— |
|
— |
|
— |
|
— |
|
Share-based |
(5,063) |
|
0.5 |
|
(61,295) |
|
(21,767) |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Acquisition accounting |
(40,355) |
|
3.8 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Integration related |
(286) |
|
— |
|
(9,291) |
|
(6,459) |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Income tax effect of |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
63,643 |
|
N/A(1) |
|
Total of non-GAAP |
(45,704) |
|
4.3 |
|
(70,586) |
|
(28,226) |
|
(168,368) |
|
— |
|
— |
|
63,643 |
|
N/A(1) |
|
Non-GAAP Adjusted |
$ 83,176 |
|
92.2 % |
|
$ 460,061 |
|
$ 169,977 |
|
$ — |
|
$ 42,500 |
|
|
|
$ (178,781) |
|
(55.5) % |
_________________________
|
1. |
Not a meaningful metric due to minimal GAAP profit before tax in this period. |
|
|
Three months ended September 30, 2024 |
||||||||||||||
|
|
Cost of |
|
Gross |
|
SG&A |
|
R&D |
|
Intangible |
|
Interest |
|
Income tax |
|
Effective |
|
GAAP Reported |
$ 111,611 |
|
88.7 % |
|
$ 325,772 |
|
$ 199,919 |
|
$ 157,457 |
|
$ 58,702 |
|
$ (14,533) |
|
(7.2) % |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset |
— |
|
— |
|
— |
|
— |
|
(157,457) |
|
— |
|
— |
|
— |
|
Share-based |
(3,733) |
|
0.4 |
|
(37,100) |
|
(18,927) |
|
— |
|
— |
|
— |
|
— |
|
Acquisition accounting |
(35,034) |
|
3.5 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Income tax effect of |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
54,947 |
|
16.1 |
|
Total of non-GAAP |
(38,767) |
|
3.9 |
|
(37,100) |
|
(18,927) |
|
(157,457) |
|
— |
|
54,947 |
|
16.1 |
|
Non-GAAP Adjusted |
$ 72,844 |
|
92.6 % |
|
$ 288,672 |
|
$ 180,992 |
|
$ — |
|
$ 58,702 |
|
$ 40,414 |
|
8.9 % |
|
JAZZ PHARMACEUTICALS PLC |
|||||||||||||||||
|
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION - CERTAIN LINE ITEMS |
|||||||||||||||||
|
(In thousands, except percentages) |
|||||||||||||||||
|
(Unaudited) |
|||||||||||||||||
|
|
|||||||||||||||||
|
|
Nine months ended September 30, 2025 |
||||||||||||||||
|
|
Cost of |
|
Gross |
|
SG&A |
|
R&D |
|
Intangible |
|
Acquired |
|
Interest |
|
Income tax |
|
Effective |
|
GAAP Reported |
|
|
87.9 % |
|
$ 1,403,059 |
|
$ 568,827 |
|
|
|
$ 947,862 |
|
$ 149,645 |
|
$ (277,406) |
|
33.2 % |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset |
— |
|
— |
|
— |
|
— |
|
(484,919) |
|
— |
|
— |
|
— |
|
— |
|
Share-based |
(12,963) |
|
0.5 |
|
(143,968) |
|
(63,348) |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Integration related |
(286) |
|
— |
|
(16,369) |
|
(8,749) |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Acquisition accounting |
(107,344) |
|
3.7 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Income tax effect of |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
177,310 |
|
N/A(1) |
|
Total of non-GAAP |
(120,593) |
|
4.2 |
|
(160,337) |
|
(72,097) |
|
(484,919) |
|
— |
|
— |
|
177,310 |
|
N/A(1) |
|
Non-GAAP Adjusted |
|
|
92.1 % |
|
$ 1,242,722 |
|
$ 496,730 |
|
$ — |
|
$ 947,862 |
|
$ 149,645 |
|
$ (100,096) |
|
N/A(1) |
_________________________
|
1. |
Not a meaningful metric due to minimal non-GAAP profit before tax in this period. |
|
|
Nine months ended September 30, 2024 |
||||||||||||||||
|
|
Cost of |
|
Gross |
|
SG&A |
|
R&D |
|
Intangible |
|
Acquired |
|
Interest |
|
Income tax |
|
Effective |
|
GAAP Reported |
|
|
88.7 % |
|
|
|
$ 643,500 |
|
$ 468,410 |
|
$ 10,000 |
|
|
|
$ (33,517) |
|
(9.9) % |
|
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible asset |
— |
|
— |
|
— |
|
— |
|
(468,410) |
|
— |
|
— |
|
— |
|
— |
|
Share-based |
(10,375) |
|
0.4 |
|
(112,450) |
|
(55,030) |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Acquisition accounting |
(97,220) |
|
3.4 |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
Income tax effect of above |
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
— |
|
161,045 |
|
21.7 |
|
Total of non-GAAP adjustments |
(107,595) |
|
3.8 |
|
(112,450) |
|
(55,030) |
|
(468,410) |
|
— |
|
— |
|
161,045 |
|
21.7 |
|
Non-GAAP Adjusted |
|
|
92.5 % |
|
$ 903,557 |
|
$ 588,470 |
|
$ — |
|
$ 10,000 |
|
|
|
$ 127,528 |
|
11.8 % |
|
JAZZ PHARMACEUTICALS PLC |
|||
|
RECONCILIATION OF 2025 GAAP NET LOSS AND DILUTED LPS TO NON-GAAP ADJUSTED NET INCOME AND DILUTED EPS GUIDANCE |
|||
|
(In millions, except per share amounts) |
|||
|
(Unaudited) |
|||
|
|
Net Income (Loss) |
|
Diluted EPS/(LPS) |
|
GAAP |
|
|
|
|
Intangible asset amortization |
610 - 660 |
|
9.85 - 10.65 |
|
Share-based compensation expense |
280 - 300 |
|
4.50 - 4.85 |
|
Acquisition accounting inventory fair value step-up |
135 - 155 |
|
2.15 - 2.50 |
|
Integration related expenses |
25 - 35 |
|
0.40 - 0.55 |
|
Income tax effect of above adjustments |
(210) - (240) |
|
(3.40) - (3.85) |
|
Effect of potentially dilutive ordinary shares on non-GAAP adjusted EPS |
- |
|
0.10 - 0.15 |
|
Non-GAAP adjusted |
|
|
|
|
|
|
|
|
|
Weighted-average ordinary shares used in per share calculations - GAAP |
61 |
||
|
Weighted-average ordinary shares used in per share calculations - non-GAAP |
62 |
||
Contacts:
Investors:
Jack Spinks
Executive Director, Investor Relations
Jazz Pharmaceuticals plc
InvestorInfo@jazzpharma.com
Media:
Kristin Bhavnani
Head of Global Corporate Communications
Jazz Pharmaceuticals plc
CorporateAffairsMediaInfo@jazzpharma.com
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SOURCE Jazz Pharmaceuticals plc