Jazz Pharmaceuticals Announces Third Quarter 2024 Financial Results
Jazz Pharmaceuticals announced its Q3 2024 financial results, reporting a 14% year-over-year revenue increase driven by key products Xywav, Epidiolex, and Rylaze. The company affirmed its 2024 total revenue guidance of $4.0 to $4.1 billion.
Key highlights include:
- Record revenues of over $1.05 billion.
- Strong demand for Xywav with 400 net patient additions.
- Anticipated launch of Zanidatamab for BTC in Q4 2024.
- Plan to submit sNDA for Zepzelca in 1H 2025.
Financial highlights show a GAAP net income of $215.1 million and a non-GAAP adjusted net income of $416.9 million. The company completed a $1 billion senior notes offering and repurchased $150 million of its shares.
Jazz Pharmaceuticals ha annunciato i risultati finanziari del terzo trimestre 2024, riportando un aumento del fatturato del 14% rispetto all'anno precedente, sostenuto dai prodotti chiave Xywav, Epidiolex e Rylaze. L'azienda ha confermato la sua previsione di fatturato totale per il 2024 di $4,0 - $4,1 miliardi.
I punti salienti includono:
- Fatturati record superiori a $1,05 miliardi.
- Alta domanda per Xywav con 400 nuovi pazienti netti.
- Atteso lancio di Zanidatamab per BTC nel quarto trimestre 2024.
- Piano di presentare sNDA per Zepzelca nella prima metà del 2025.
I punti finanziari mostrano un reddito netto GAAP di $215,1 milioni e un reddito netto rettificato non GAAP di $416,9 milioni. L'azienda ha completato un'offerta di note senior da $1 miliardo e ha riacquistato azioni per $150 milioni.
Jazz Pharmaceuticals anunció sus resultados financieros del tercer trimestre de 2024, reportando un aumento del 14% en los ingresos interanuales impulsado por los productos clave Xywav, Epidiolex y Rylaze. La compañía reafirmó su perspectiva de ingresos totales de $4.0 a $4.1 mil millones para 2024.
Los aspectos destacados incluyen:
- Ingresos récord de más de $1.05 mil millones.
- Fuerte demanda de Xywav con 400 nuevos pacientes netos.
- Lanzamiento anticipado de Zanidatamab para BTC en el cuarto trimestre de 2024.
- Plan para presentar sNDA para Zepzelca en la primera mitad de 2025.
Los aspectos financieros muestran un ingreso neto GAAP de $215.1 millones y un ingreso neto ajustado no GAAP de $416.9 millones. La compañía completó una oferta de notas senior por $1 mil millones y recompró acciones por $150 millones.
재즈 제약회사(Jazz Pharmaceuticals)는 2024년 3분기 재무 결과를 발표하며 전년 대비 14%의 매출 증가를 보고했습니다. 이는 주요 제품인 Xywav, Epidiolex, Rylaze에 의해 주도되었습니다. 회사는 2024년 총 매출 가이던스를 40억 달러에서 41억 달러로 설정했다고 확인했습니다.
주요 사항은 다음과 같습니다:
- 사상 최대 매출 10억 5천만 달러 이상.
- Xywav에 대한 강력한 수요로 400명의 순 환자 증가.
- 2024년 4분기에 BTC 용 잔니다탐맙(Zanidatamab) 출시 예정.
- 2025년 상반기에 Zepzelca에 대한 sNDA 제출 계획.
재무 하이라이트는 GAAP 기준 순이익 2억 1천5백만 달러 및 비GAAP 조정 순이익 4억 1천6백90만 달러를 보여줍니다. 회사는 10억 달러 규모의 시니어 노트 공모를 완료하고 1억 5천만 달러의 자사주를 재매입했습니다.
Jazz Pharmaceuticals a annoncé ses résultats financiers du troisième trimestre 2024, rapportant une augmentation des revenus de 14% par rapport à l'année précédente, soutenue par les produits clés Xywav, Epidiolex et Rylaze. L'entreprise a confirmé son objectif de revenus totaux de 4,0 à 4,1 milliards de dollars pour 2024.
Les points saillants incluent :
- Revenus record de plus de 1,05 milliard de dollars.
- Demande élevée pour Xywav avec 400 nouveaux patients nets.
- Lancement anticipé de Zanidatamab pour BTC au quatrième trimestre 2024.
- Prévision de soumission d'un sNDA pour Zepzelca dans la première moitié de 2025.
Les faits financiers montrent un revenu net GAAP de 215,1 millions de dollars et un revenu net ajusté non GAAP de 416,9 millions de dollars. L'entreprise a réalisé une offre de billets senior d'un milliard de dollars et a racheté pour 150 millions de dollars de ses actions.
Jazz Pharmaceuticals hat seine Finanzzahlen für das dritte Quartal 2024 bekannt gegeben und berichtet von einem Umsatzanstieg von 14% im Vergleich zum Vorjahr, getrieben von den Schlüsselprodukten Xywav, Epidiolex und Rylaze. Das Unternehmen bestätigte seine Gesamtumsatzprognose für 2024 von 4,0 bis 4,1 Milliarden US-Dollar.
Wichtige Highlights sind:
- Rekordumsätze von über 1,05 Milliarden US-Dollar.
- Starke Nachfrage nach Xywav mit 400 neuen Patienten.
- Vorgesehene Markteinführung von Zanidatamab für BTC im vierten Quartal 2024.
- Plan, ein sNDA für Zepzelca in der ersten Hälfte von 2025 einzureichen.
Die finanziellen Höhepunkte zeigen ein GAAP-Nettoeinkommen von 215,1 Millionen US-Dollar und ein bereinigtes Nettoeinkommen nach Non-GAAP von 416,9 Millionen US-Dollar. Das Unternehmen hat ein Angebot über 1 Milliarde US-Dollar an vorrangigen Anleihen abgeschlossen und Aktien im Wert von 150 Millionen US-Dollar zurückgekauft.
- 14% year-over-year revenue increase from key products.
- 2024 total revenue guidance affirmed at $4.0 to $4.1 billion.
- Record revenues of over $1.05 billion.
- Strong demand for Xywav with 400 net patient additions.
- GAAP net income of $215.1 million, up from $146.8 million.
- Non-GAAP adjusted net income of $416.9 million, up from $340.1 million.
- Completed $1 billion senior notes offering.
- Repurchased $150 million of shares.
- Lowering oncology revenue guidance to $1.08 to $1.13 billion.
- Rylaze net product sales decreased by 6% year-over-year.
- Xyrem net product sales decreased by 54% year-over-year.
Insights
A robust quarter for Jazz Pharmaceuticals with several positive indicators. Total revenues reached
Notable financial strengths include:
- Xywav sales up
17% to$388.5 million with ~400 new patients - Epidiolex sales increased
18% to$251.6 million - Strong cash position of
$2.6 billion with$997.3 million operating cash flow YTD
The raised EPS guidance and strategic debt refinancing through
The clinical pipeline shows significant progress that could drive future growth. Key developments include:
- Positive Phase 3 IMforte trial results for Zepzelca in 1L ES-SCLC, supporting potential label expansion
- Zanidatamab approaching potential FDA approval in biliary tract cancer with PDUFA date November 29
- Strong Phase 2 data for zanidatamab in GEA with
84% response rate and 18.7 month duration of response
The expansion into new indications and positive clinical data strengthens Jazz's oncology portfolio. The company's strategic focus on rare/specialty diseases with high unmet needs positions it well for sustainable growth. The pipeline progress in both neuroscience and oncology provides multiple potential value drivers.
–
Xywav®, Epidiolex® and Rylaze® –
– 2024 total revenue guidance affirmed at
– Zanidatamab 2L BTC PDUFA date of November 29, 2024 –
– Plan to submit sNDA for Zepzelca® in 1L ES-SCLC in 1H25 –
"Jazz once again delivered record revenues of more than
Key Highlights
- Key growth drivers grew
14% combined year-over-year. - Combination of Zepzelca and atezolizumab demonstrated statistically significant and clinically meaningful improvement in OS and PFS primary endpoints, demonstrating the potential of the regimen to delay disease progression in ES-SCLC and extend survival for patients.
- Zanidatamab:
- PDUFA date of November 29; expect 2L BTC commercial launch in 4Q24, following approval.
- Top-line PFS data from zanidatamab in Phase 3 1L GEA estimated to be 2Q25.
- Initiated a Phase 2 pan-tumor trial to evaluate HER2-positive solid tumors.
- 2024 Financial Guidance:
- Affirming 2024 total revenue guidance of
to$4.0 .$4.1 billion - Affirming neuroscience revenue guidance of
to$2.82 5 .$2.92 5 billion - Lowering oncology revenue guidance to
to$1.08 .$1.13 billion - Lowering GAAP R&D expense guidance to
to$862 and non-GAAP R&D expense guidance to$908 million to$790 ,2 primarily driven by strategic pipeline prioritization.$830 million - Raising GAAP EPS guidance range to
to$6.70 and non-GAAP EPS guidance range to$8.50 to$19.50 .2$20.60
- Affirming 2024 total revenue guidance of
1 | Total Sleep revenue includes: Xywav, branded Xyrem and high-sodium oxybate authorized generic royalty revenues. |
2 | See "Non-GAAP Financial Measures." |
Business Updates
Commercial Updates
Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution:
- Xywav net product sales were
.5 million in 3Q24, an increase of$388 17% compared to the same period in 2023. - There were approximately 400 net patient adds for a total of approximately 13,625 active Xywav patients exiting 3Q24 comprised of:
- Approximately 10,075 narcolepsy patients.
- Approximately 3,550 idiopathic hypersomnia (IH) patients, with 250 net patient adds.
- As the only low-sodium oxybate and the only therapy approved to treat IH, expect Xywav to remain the oxybate of choice.
- Presented top-line results from the Phase 4 DUET (Develop hypersomnia Understanding by Evaluating low-sodium oxybate Treatment) trial at the Psych Congress 2024, which demonstrated efficacy and safety consistent with narcolepsy and IH Phase 3 data. The prospective trial assesses the effect of Xywav treatment on excessive daytime sleepiness, polysomnography parameters and functional outcomes in adults with narcolepsy or IH.
Xyrem® (sodium oxybate) oral solution and high-sodium oxybate authorized generic (AG) royalties:
- Xyrem net product sales were
in 3Q24, a decrease of$58.1 million 54% compared to the same period in 2023. - Royalties from high-sodium oxybate AGs were
.2 million in 3Q24, an increase of$58 .2 million compared to the same period in 2023.$29
Epidiolex/Epidyolex (cannabidiol):
- Epidiolex/Epidyolex net product sales were
in 3Q24, an increase of$251.6 million 18% compared to the same period in 2023. - Outside of the U.S., Epidyolex is approved in more than 35 countries.
- Presented data at the European Epilepsy Congress 2024 demonstrating clinically meaningful reductions in drop seizures in patients with Lennox-Gastaut syndrome and subgroup analyses from the BECOME Caregiver Survey showing most caregivers reported patient improvements in seizure and non-seizure outcomes.
- Ongoing data generation of the seizure and non-seizure benefits of Epidiolex, including from the EpiCom study in tuberous sclerosis complex, to be presented at American Epilepsy Society 2024.
Rylaze/Enrylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
- Rylaze/Enrylaze net product sales were
.8 million in 3Q24, a decrease of$98 6% compared to the same period in 2023. - There is a temporary impact to Rylaze revenue due to a recent update to pediatric acute lymphoblastic leukemia (ALL) protocols regarding timing of asparaginase administration. The Company does not expect this impact will affect ongoing demand and expects revenue will normalize by early 2025.
Zepzelca (lurbinectedin):
- Zepzelca net product sales were
.8 million in 3Q24, an increase of$85 10% compared to the same period in 2023. - The Company announced statistically significant and clinically meaningful overall survival (OS) and progression-free survival (PFS) results from the Phase 3 clinical trial, conducted in partnership with Roche, evaluating Zepzelca in combination with Tecentriq® (atezolizumab) in first-line (1L) extensive-stage (ES) small cell lung cancer (SCLC). Based on positive results from the trial, the Company plans to submit a supplemental New Drug Application (sNDA) for Zepzelca in 1L ES-SCLC in the first half of 2025.
Key Pipeline Highlights
Zanidatamab:
- In 2Q24, the
U.S. FDA accepted and granted Priority Review of the Biologics License Application for zanidatamab with a target action date of November 29, 2024. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for biliary tract cancer (BTC) in theU.S. A confirmatory trial in 1L metastatic BTC is ongoing. - The pivotal HERIZON-GEA-01 trial, evaluating zanidatamab in 1L gastroesophageal adenocarcinoma (GEA), is expected to read out in 2Q25.
- Data presented at ESMO 2024 demonstrated sustained clinical antitumor activity in HER2-positive metastatic GEA. Updated results from the Phase 2 trial included a confirmed objective response rate of
84% , duration of response of 18.7 months, median PFS of 15.2 months and a Kaplan-Meier–estimated OS of59% at 30 months. - The Phase 3 EmpowHER-BC-303 trial to evaluate zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients with HER2-positive breast cancer whose disease has progressed on previous trastuzumab deruxtecan (T-DXd) treatment is enrolling patients.
- The Company initiated a Phase 2 DiscovHER-Pan-206 pan-tumor trial in HER2-positive solid tumors.
Senior Notes Offering and Concurrent Share Repurchases
In the third quarter of 2024, the Company completed a private placement of
Financial Highlights
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
(In thousands, except per share amounts) | 2024 | 2023 | 2024 | 2023 | |||
Total revenues | $ 1,054,969 | $ 972,140 | $ 2,980,777 | $ 2,822,269 | |||
GAAP net income | $ 215,055 | $ 146,820 | $ 369,005 | $ 320,678 | |||
Non-GAAP adjusted net income | $ 416,924 | $ 340,148 | $ 963,866 | $ 950,538 | |||
GAAP earnings per share | $ 3.42 | $ 2.14 | $ 5.63 | $ 4.67 | |||
Non-GAAP adjusted EPS | $ 6.61 | $ 4.84 | $ 14.42 | $ 13.29 |
GAAP net income for 3Q24 was
Non-GAAP adjusted net income for 3Q24 was
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) | 2024 | 2023 | 2024 | 2023 | |||
Xywav | $ 388,466 | $ 331,633 | $ 1,072,238 | $ 935,958 | |||
Xyrem | 58,114 | 125,110 | 184,526 | 463,009 | |||
Epidiolex/Epidyolex | 251,558 | 213,711 | 697,376 | 604,846 | |||
Sativex | 4,586 | 4,627 | 13,704 | 14,531 | |||
Total Neuroscience | 702,724 | 675,081 | 1,967,844 | 2,018,344 | |||
Rylaze/Enrylaze | 98,780 | 104,859 | 309,359 | 292,479 | |||
Zepzelca | 85,843 | 77,994 | 241,990 | 215,523 | |||
Defitelio/defibrotide | 65,818 | 47,730 | 158,915 | 132,917 | |||
Vyxeos | 34,313 | 29,827 | 109,348 | 100,583 | |||
Total Oncology | 284,754 | 260,410 | 819,612 | 741,502 | |||
Other | 2,229 | 2,907 | 8,497 | 9,758 | |||
Product sales, net | 989,707 | 938,398 | 2,795,953 | 2,769,604 | |||
High-sodium oxybate AG royalty revenue | 58,157 | 28,921 | 162,268 | 36,531 | |||
Other royalty and contract revenues | 7,105 | 4,821 | 22,556 | 16,134 | |||
Total revenues | $ 1,054,969 | $ 972,140 | $ 2,980,777 | $ 2,822,269 |
Total revenues increased
Total neuroscience revenue, including high-sodium oxybate AG royalty revenue, was
Oncology net product sales were
Operating Expenses and Effective Tax Rate
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
(In thousands, except percentages) | 2024 | 2023 | 2024 | 2023 | |||
GAAP: | |||||||
Cost of product sales | $ 111,611 | $ 102,153 | $ 317,000 | $ 328,334 | |||
Gross margin | 88.7 % | 89.1 % | 88.7 % | 88.1 % | |||
Selling, general and administrative | $ 325,772 | $ 308,310 | $ 1,016,007 | $ 947,071 | |||
% of total revenues | 30.9 % | 31.7 % | 34.1 % | 33.6 % | |||
Research and development | $ 199,919 | $ 234,402 | $ 643,500 | $ 633,050 | |||
% of total revenues | 19.0 % | 24.1 % | 21.6 % | 22.4 % | |||
Acquired in-process research and development | $ — | $ — | $ 10,000 | $ 1,000 | |||
Income tax benefit1 | $ (14,533) | $ (47,176) | $ (33,517) | $ (86,823) | |||
Effective tax rate 1 | (7.2) % | (47.4) % | (9.9) % | (36.7) % |
_________________________
1. | The GAAP income tax benefit decreased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, due to the change in income mix across our jurisdictions. The nine months ended September 30, 2024 were also impacted by tax shortfalls from share-based compensation. |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
(In thousands, except percentages) | 2024 | 2023 | 2024 | 2023 | |||
Non-GAAP adjusted: | |||||||
Cost of product sales | $ 72,844 | $ 67,119 | $ 209,405 | $ 197,841 | |||
Gross margin | 92.6 % | 92.8 % | 92.5 % | 92.9 % | |||
Selling, general and administrative | $ 288,672 | $ 273,042 | $ 903,557 | $ 810,428 | |||
% of total revenues | 27.4 % | 28.1 % | 30.3 % | 28.7 % | |||
Research and development | $ 180,992 | $ 217,767 | $ 588,470 | $ 583,704 | |||
% of total revenues | 17.2 % | 22.4 % | 19.7 % | 20.7 % | |||
Acquired in-process research and development | $ — | $ — | $ 10,000 | $ 1,000 | |||
Income tax expense1 | $ 41,683 | $ 7,378 | $ 130,999 | $ 72,785 | |||
Effective tax rate1 | 9.1 % | 2.1 % | 11.9 % | 7.1 % |
_________________________
1. | The non-GAAP income tax expense increased in the three and nine months ended September 30, 2024, compared to the same periods in 2023, due to the change in income mix across our jurisdictions. The nine months ended September 30, 2024 were also impacted by tax shortfalls from share-based compensation. |
Changes in operating expenses in 3Q24 over the prior year period are primarily due to the following:
- Cost of product sales, on a GAAP basis, increased in 3Q24 compared to the same period in 2023, primarily due to higher product sales, net and higher acquisition accounting inventory fair value step-up expense. Cost of product sales, on a non-GAAP adjusted basis, increased in 3Q24 compared to the same period in 2023, primarily due to higher product sales, net.
- Selling, general and administrative (SG&A) expenses, on a GAAP and on a non-GAAP adjusted basis, increased in 3Q24 compared to the same period in 2023, primarily due to increased compensation-related expenses driven by higher headcount in support of our key growth drivers.
- Research and development (R&D) expenses, on a GAAP and on a non-GAAP adjusted basis, decreased in 3Q24 compared to the same period in 2023, primarily due to lower clinical program costs as a result of JZP150 costs incurred in 3Q23 and lower zanidatamab costs.
Cash Flow and Balance Sheet
As of September 30, 2024, cash, cash equivalents and investments were
2024 Financial Guidance
The Company is updating its full year 2024 financial guidance as follows:
(In millions) | November 6, 2024 | July 31, 2024 | |
Revenues | |||
–Neuroscience (includes royalties from high-sodium oxybate AG) | |||
–Oncology |
GAAP:
(In millions, except per share amounts and percentages) | November 6, 2024 | July 31, 2024 | |
Gross margin % | 89 % | 89 % | |
SG&A expenses | |||
SG&A expenses as % of total revenues | |||
R&D expenses | |||
R&D expenses as % of total revenues | |||
Effective tax rate | (17)% - (2)% | (22)% - (3)% | |
Net income | |||
Net income per diluted share5 | |||
Weighted-average ordinary shares used in per share calculations | 66 | 67 |
Non-GAAP:
(In millions, except per share amounts and percentages) | November 6, 2024 | July 31, 2024 | |
Gross margin % | 93 % | ||
SG&A expenses | |||
SG&A expenses as % of total revenues | |||
R&D expenses | |||
R&D expenses as % of total revenues | |||
Effective tax rate | |||
Net income | |||
Net income per diluted share5 | |||
Weighted-average ordinary shares used in per share calculations | 66 | 67 |
___________________________
1. | Excludes |
2. | Excludes |
3. | Excludes |
4. | Excludes |
5. | Diluted EPS calculations for 2024 include an estimated 3.5 million shares related to the assumed conversion of the |
6. | See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to non-GAAP Adjusted 2024 Net Income 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. ET (9:30 p.m. GMT) to provide a business and financial update and discuss its 2024 third quarter results.
Audio webcast/conference call:
Ireland Dial-In Number: +353 1800 943 926
Additional global dial-in numbers are available here.
Passcode: 5080203
Interested parties may access the live audio webcast 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. 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 2024 financial guidance and the Company's expectations related thereto and anticipated catalysts; expectations that Xywav will remain the oxybate of choice; expectations of high-sodium oxybate AG royalty revenue in 2024; the ability to generate long-term sustainable growth and value; the Company's advancement of pipeline programs and the timing of development activities, regulatory activities and submissions related thereto, including plans to submit a sNDA for Zepzelca in 1L ES-SCLC in the first half of 2025 and the anticipated launch of zanidatamab in 2L BTC; 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, plans to initiate a Phase 1b trial of JZP441 in type 1 narcolepsy patients; and the Company's development, regulatory and commercialization strategy, including the Company's expectations to executing multiple Epidyolex launches through 2024; 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; 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 the conflict between
JAZZ PHARMACEUTICALS PLC | |||||||
CONDENSED CONSOLIDATED STATEMENTS OF INCOME | |||||||
(In thousands, except per share amounts) | |||||||
(Unaudited) | |||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||
2024 | 2023 | 2024 | 2023 | ||||
Revenues: | |||||||
Product sales, net | $ 989,707 | $ 938,398 | $ 2,795,953 | $ 2,769,604 | |||
Royalties and contract revenues | 65,262 | 33,742 | 184,824 | 52,665 | |||
Total revenues | 1,054,969 | 972,140 | 2,980,777 | 2,822,269 | |||
Operating expenses: | |||||||
Cost of product sales (excluding amortization | 111,611 | 102,153 | 317,000 | 328,334 | |||
Selling, general and administrative | 325,772 | 308,310 | 1,016,007 | 947,071 | |||
Research and development | 199,919 | 234,402 | 643,500 | 633,050 | |||
Intangible asset amortization | 157,457 | 154,883 | 468,410 | 456,731 | |||
Acquired in-process research and development | — | — | 10,000 | 1,000 | |||
Total operating expenses | 794,759 | 799,748 | 2,454,917 | 2,366,186 | |||
Income from operations | 260,210 | 172,392 | 525,860 | 456,083 | |||
Interest expense, net | (58,702) | (71,497) | (186,841) | (219,114) | |||
Foreign exchange loss | (701) | (1,377) | (1,887) | (566) | |||
Income before income tax benefit and equity in loss | 200,807 | 99,518 | 337,132 | 236,403 | |||
Income tax benefit | (14,533) | (47,176) | (33,517) | (86,823) | |||
Equity in loss (gain) of investees | 285 | (126) | 1,644 | 2,548 | |||
Net income | $ 215,055 | $ 146,820 | $ 369,005 | $ 320,678 | |||
Net income per ordinary share: | |||||||
Basic | $ 3.50 | $ 2.33 | $ 5.93 | $ 5.05 | |||
Diluted | $ 3.42 | $ 2.14 | $ 5.63 | $ 4.67 | |||
Weighted-average ordinary shares used in per share | 61,414 | 63,114 | 62,275 | 63,532 | |||
Weighted-average ordinary shares used in per share | 63,174 | 71,293 | 67,511 | 72,866 |
JAZZ PHARMACEUTICALS PLC | |||
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
(In thousands) | |||
(Unaudited) | |||
September 30, | December 31, | ||
ASSETS | |||
Current assets: | |||
Cash and cash equivalents | $ 2,218,135 | $ 1,506,310 | |
Investments | 400,000 | 120,000 | |
Accounts receivable, net of allowances | 723,639 | 705,794 | |
Inventories | 539,302 | 597,039 | |
Prepaid expenses | 155,132 | 185,476 | |
Other current assets | 354,215 | 320,809 | |
Total current assets | 4,390,423 | 3,435,428 | |
Property, plant and equipment, net | 176,422 | 169,646 | |
Operating lease assets | 77,164 | 65,340 | |
Intangible assets, net | 5,144,217 | 5,418,039 | |
Goodwill | 1,804,646 | 1,753,130 | |
Deferred tax assets, net | 583,218 | 477,834 | |
Deferred financing costs | 4,395 | 6,478 | |
Other non-current assets | 75,231 | 67,464 | |
Total assets | $ 12,255,716 | $ 11,393,359 | |
LIABILITIES AND SHAREHOLDERS' EQUITY | |||
Current liabilities: | |||
Accounts payable | $ 85,425 | $ 102,750 | |
Accrued liabilities | 858,578 | 793,914 | |
Current portion of long-term debt | 31,000 | 604,954 | |
Income taxes payable | 54,974 | 35,074 | |
Total current liabilities | 1,029,977 | 1,536,692 | |
Long-term debt, less current portion | 6,080,802 | 5,107,988 | |
Operating lease liabilities, less current portion | 71,115 | 59,225 | |
Deferred tax liabilities, net | 791,784 | 847,706 | |
Other non-current liabilities | 110,971 | 104,751 | |
Total shareholders' equity | 4,171,067 | 3,736,997 | |
Total liabilities and shareholders' equity | $ 12,255,716 | $ 11,393,359 |
JAZZ PHARMACEUTICALS PLC | |||
SUMMARY OF CASH FLOWS | |||
(In thousands) | |||
(Unaudited) | |||
Nine Months Ended September 30, | |||
2024 | 2023 | ||
Net cash provided by operating activities | $ 997,328 | $ 924,668 | |
Net cash used in investing activities | (314,908) | (264,860) | |
Net cash provided by (used in) financing activities | 28,791 | (204,948) | |
Effect of exchange rates on cash and cash equivalents | 614 | (652) | |
Net increase in cash and cash equivalents | $ 711,825 | $ 454,208 |
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, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Net | Diluted | Net | Diluted | Net | Diluted | Net | Diluted | ||||||||
GAAP reported | $ 215,055 | $ 3.42 | $ 146,820 | $ 2.14 | $ 369,005 | $ 5.63 | $ 320,678 | $ 4.67 | |||||||
Intangible asset amortization | 157,457 | 2.49 | 154,883 | 2.17 | 468,410 | 6.94 | 456,731 | 6.27 | |||||||
Share-based compensation | 59,760 | 0.95 | 56,115 | 0.79 | 177,855 | 2.63 | 173,900 | 2.39 | |||||||
Acquisition accounting | 35,034 | 0.55 | 30,822 | 0.43 | 97,220 | 1.44 | 119,094 | 1.63 | |||||||
Other costs2 | — | — | — | — | — | — | 23,488 | 0.32 | |||||||
Non-cash interest expense3 | 5,834 | 0.09 | 6,062 | 0.09 | 15,892 | 0.24 | 16,255 | 0.23 | |||||||
Income tax effect of above | (56,216) | (0.89) | (54,554) | (0.77) | (164,516) | (2.44) | (159,608) | (2.19) | |||||||
Effect of assumed conversion | — | — | — | (0.01) | — | (0.02) | — | (0.03) | |||||||
Non-GAAP adjusted | $ 416,924 | $ 6.61 | $ 340,148 | $ 4.84 | $ 963,866 | $ 14.42 | $ 950,538 | $ 13.29 | |||||||
Weighted-average ordinary | 63,174 | 71,293 | 67,511 | 72,866 |
________________________________________________
Explanation of Adjustments and Certain Line Items: | |
1. | Diluted EPS was calculated using the "if-converted" method in relation to the 2024 Notes and the 2026 Notes, which we refer to collectively as the Exchangeable Senior Notes. In August 2023 and July 2024, we made irrevocable elections to net share settle the 2024 Notes and the 2026 Notes, respectively. As a result, the assumed issuance of ordinary shares upon exchange of the Exchangeable Senior Notes has only been included in the calculation of diluted net income per ordinary share, on a GAAP and on a non-GAAP adjusted basis, in each period up to the date each irrevocable election was made. Net income per diluted share, on a GAAP and a non-GAAP adjusted basis, for the three and nine months ended September 30, 2024 included 1.3 million shares and 4.7 million shares, respectively, related to the assumed conversion of the 2026 Notes and the associated interest expense, net of tax, add-back to GAAP reported net income of |
2. | Costs related to program terminations. |
3. | Non-cash interest expense associated with debt issuance costs. |
JAZZ PHARMACEUTICALS PLC | |||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||
CERTAIN LINE ITEMS - FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 | |||||||||||||
(In thousands, except percentages) | |||||||||||||
(Unaudited) | |||||||||||||
Three months ended September 30, 2024 | |||||||||||||
Cost of | Gross | Selling, | Research | Intangible | Interest | Income tax | |||||||
GAAP Reported | 88.7 % | $ 325,772 | $ 199,919 | $ 58,702 | $ (14,533) | ||||||||
Non-GAAP Adjustments: | |||||||||||||
Intangible asset amortization | — | — | — | — | (157,457) | — | — | ||||||
Share-based compensation expense | (3,733) | 0.4 | (37,100) | (18,927) | — | — | — | ||||||
Acquisition accounting inventory fair value | (35,034) | 3.5 | — | — | — | — | — | ||||||
Non-cash interest expense | — | — | — | — | — | (5,834) | — | ||||||
Income tax effect of above adjustments | — | — | — | — | — | — | 56,216 | ||||||
Total of non-GAAP adjustments | (38,767) | 3.9 | (37,100) | (18,927) | (157,457) | (5,834) | 56,216 | ||||||
Non-GAAP Adjusted | $ 72,844 | 92.6 % | $ 288,672 | $ 180,992 | $ — | $ 52,868 | $ 41,683 | ||||||
Three months ended September 30, 2023 | |||||||||||||
Cost of | Gross | Selling, | Research | Intangible | Interest | Income | |||||||
GAAP Reported | 89.1 % | $ 308,310 | $ 234,402 | $ 71,497 | $ (47,176) | ||||||||
Non-GAAP Adjustments: | |||||||||||||
Intangible asset amortization | — | — | — | — | (154,883) | — | — | ||||||
Share-based compensation expense | (4,212) | 0.5 | (35,268) | (16,635) | — | — | — | ||||||
Non-cash interest expense | — | — | — | — | — | (6,062) | — | ||||||
Acquisition accounting inventory fair value | (30,822) | 3.2 | — | — | — | — | — | ||||||
Income tax effect of above adjustments | — | — | — | — | — | — | 54,554 | ||||||
Total of non-GAAP adjustments | (35,034) | 3.7 | (35,268) | (16,635) | (154,883) | (6,062) | 54,554 | ||||||
Non-GAAP Adjusted | $ 67,119 | 92.8 % | $ 273,042 | $ 217,767 | $ — | $ 65,435 | $ 7,378 |
JAZZ PHARMACEUTICALS PLC | |||||||||||||||
RECONCILIATIONS OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION | |||||||||||||||
CERTAIN LINE ITEMS - FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023 | |||||||||||||||
(In thousands, except percentages) | |||||||||||||||
(Unaudited) | |||||||||||||||
Nine months ended September 30, 2024 | |||||||||||||||
Cost of | Gross | Selling, | Research | Intangible | Acquired | Interest | Income tax | ||||||||
GAAP Reported | 88.7 % | $ 643,500 | $ 10,000 | $ 186,841 | $ (33,517) | ||||||||||
Non-GAAP Adjustments: | |||||||||||||||
Intangible asset amortization | — | — | — | — | (468,410) | — | — | — | |||||||
Share-based compensation expense | (10,375) | 0.4 | (112,450) | (55,030) | — | — | — | — | |||||||
Non-cash interest expense | — | — | — | — | — | — | (15,892) | — | |||||||
Acquisition accounting inventory fair | (97,220) | 3.4 | — | — | — | — | — | — | |||||||
Income tax effect of above | — | — | — | — | — | — | — | 164,516 | |||||||
Total of non-GAAP adjustments | (107,595) | 3.8 | (112,450) | (55,030) | (468,410) | — | (15,892) | 164,516 | |||||||
Non-GAAP Adjusted | 92.5 % | $ 903,557 | $ 588,470 | $ — | $ 10,000 | $ 170,949 | |||||||||
Nine months ended September 30, 2023 | |||||||||||||||
Cost of | Gross | Selling, | Research | Intangible | Acquired | Interest | Income tax | ||||||||
GAAP Reported | 88.1 % | $ 947,071 | $ 633,050 | $ 456,731 | $ 1,000 | $ 219,114 | $ (86,823) | ||||||||
Non-GAAP Adjustments: | |||||||||||||||
Intangible asset amortization | — | — | — | — | (456,731) | — | — | — | |||||||
Share-based compensation expense | (11,399) | 0.4 | (113,155) | (49,346) | — | — | — | — | |||||||
Other costs | — | — | (23,488) | — | — | — | — | — | |||||||
Non-cash interest expense | — | — | — | — | — | — | (16,255) | — | |||||||
Acquisition accounting inventory fair | (119,094) | 4.4 | — | — | — | — | — | — | |||||||
Income tax effect of above adjustments | — | — | — | — | — | — | — | 159,608 | |||||||
Total of non-GAAP adjustments | (130,493) | 4.8 | (136,643) | (49,346) | (456,731) | — | (16,255) | 159,608 | |||||||
Non-GAAP Adjusted | 92.9 % | $ 810,428 | $ 583,704 | $ — | $ 1,000 | $ 202,859 | $ 72,785 |
JAZZ PHARMACEUTICALS PLC | |||
RECONCILIATION OF GAAP TO NON-GAAP ADJUSTED 2024 NET INCOME AND DILUTED EPS GUIDANCE | |||
(In millions, except per share amounts) | |||
(Unaudited) | |||
Net Income | Diluted EPS | ||
GAAP guidance | |||
Intangible asset amortization | 605 - 645 | 9.10 - 9.85 | |
Acquisition accounting inventory fair value step-up | 125 - 145 | 1.90 - 2.20 | |
Share-based compensation expense | 235 - 255 | 3.55 - 3.90 | |
Non-cash interest expense | 20 - 30 | 0.30 - 0.45 | |
Income tax effect of above adjustments | (210) - (220) | (3.15) - (3.35) | |
Non-GAAP guidance | |||
Weighted-average ordinary shares used in per share calculations - GAAP and | 66 |
Contacts:
Investors:
Andrea N. Flynn, Ph.D.
Vice President, Head, 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
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