BeiGene Announces Third Quarter 2024 Financial Results and Corporate Updates
BeiGene reported strong Q3 2024 financial results with $1 billion in quarterly revenue, marking significant growth. BRUKINSA global revenue reached $690 million, with U.S. sales of $504 million (87% growth) and European sales of $97 million (217% growth). The company expanded its oncology pipeline with four new molecular entities entering clinical trials this quarter. Product revenue grew 67% to $993 million, with gross margin at 83%. While operating loss decreased 10%, the company achieved positive non-GAAP operating income of $66 million and generated $188 million in operating cash flow.
BeiGene ha riportato risultati finanziari solidi per il terzo trimestre del 2024, con 1 miliardo di dollari di ricavi trimestrali, segnando una crescita significativa. I ricavi globali di BRUKINSA hanno raggiunto 690 milioni di dollari, con vendite negli Stati Uniti pari a 504 milioni di dollari (crescita del 87%) e vendite in Europa di 97 milioni di dollari (crescita del 217%). L'azienda ha ampliato il suo portafoglio oncologico con quattro nuove entità molecolari che sono entrate in sperimentazione clinica questo trimestre. I ricavi da prodotto sono cresciuti del 67% fino a 993 milioni di dollari, con un margine lordo dell'83%. Sebbene la perdita operativa sia diminuita del 10%, l'azienda ha conseguito un utile operativo non-GAAP positivo di 66 milioni di dollari e ha generato 188 milioni di dollari di flusso di cassa operativo.
BeiGene reportó fuertes resultados financieros en el tercer trimestre de 2024, con 1 mil millones de dólares en ingresos trimestrales, marcando un crecimiento significativo. Los ingresos globales de BRUKINSA alcanzaron 690 millones de dólares, con ventas en EE. UU. de 504 millones de dólares (87% de crecimiento) y ventas en Europa de 97 millones de dólares (217% de crecimiento). La compañía amplió su cartera de oncología con cuatro nuevas entidades moleculares que entraron en ensayos clínicos este trimestre. Los ingresos por productos crecieron un 67% hasta 993 millones de dólares, con un margen bruto del 83%. Aunque la pérdida operativa disminuyó un 10%, la compañía logró un ingreso operativo no-GAAP positivo de 66 millones de dólares y generó 188 millones de dólares en flujo de caja operativo.
BeiGene는 2024년 3분기 재무 결과에 대해 10억 달러의 분기 매출을 보고하며 중요한 성장을 기록했습니다. BRUKINSA의 전 세계 매출은 6억 9천만 달러에 도달했으며, 미국 판매는 5억 4백만 달러로 87% 성장하였고, 유럽 판매는 9천7백만 달러로 217% 성장했습니다. 회사는 이번 분기에 임상 시험에 들어간 네 개의 새로운 분자 단위를 통해 종양학 파이프라인을 확장했습니다. 제품 매출은 67% 성장하여 9억 9천3백만 달러에 달했으며, 총 이익률은 83%였습니다. 운영 손실은 10% 감소했지만, 회사는 6천6백만 달러의 긍정적인 비GAAP 운영 소득을 달성하고 1억8천8백만 달러의 운영 현금 흐름을 생성했습니다.
BeiGene a rapporté de solides résultats financiers pour le troisième trimestre 2024, avec 1 milliard de dollars de revenus trimestriels, marquant une croissance significative. Les revenus mondiaux de BRUKINSA ont atteint 690 millions de dollars, avec des ventes aux États-Unis de 504 millions de dollars (croissance de 87 %) et des ventes européennes de 97 millions de dollars (croissance de 217 %). L'entreprise a élargi son portefeuille en oncologie avec quatre nouvelles entités moléculaires entrant en essais cliniques ce trimestre. Les revenus des produits ont augmenté de 67 % pour atteindre 993 millions de dollars, avec une marge brute de 83 %. Bien que la perte d'exploitation ait diminué de 10 %, l'entreprise a enregistré un bénéfice d'exploitation non-GAAP positif de 66 millions de dollars et a généré 188 millions de dollars de flux de trésorerie opérationnel.
BeiGene hat starke Finanzergebnisse für das dritte Quartal 2024 gemeldet, mit 1 Milliarde Dollar an Quartalsumsatz, was ein signifikantes Wachstum bedeutet. Der globale Umsatz von BRUKINSA erreichte 690 Millionen Dollar, mit Verkäufen in den USA von 504 Millionen Dollar (87% Wachstum) und europäischen Verkäufen von 97 Millionen Dollar (217% Wachstum). Das Unternehmen erweiterte seinen Onkologie-Pipeline mit vier neuen molekularen Einheiten, die in diesem Quartal in klinische Studien eingehen. Der Produktumsatz wuchs um 67% auf 993 Millionen Dollar, bei einer Bruttomarge von 83%. Während der operative Verlust um 10% sank, erzielte das Unternehmen ein positives nicht-GAAP Betriebsergebnis von 66 Millionen Dollar und generierte 188 Millionen Dollar an operativem Cashflow.
- Total revenue reached $1 billion, with product revenue growing 67% to $993 million
- BRUKINSA sales showed exceptional growth: 87% in US ($504M) and 217% in Europe ($97M)
- Gross margin maintained at 83%
- Achieved positive non-GAAP operating income of $66 million
- Operating cash flow improved to $188 million
- Operating loss decreased by 10%
- GAAP net loss of $121 million in Q3 2024
- Collaboration revenue decreased 96% to $8.1 million
- Operating expenses increased 16% to $951 million
Insights
BeiGene delivered strong Q3 results with
The company showed improved operational efficiency with reduced GAAP losses and achieved positive non-GAAP operating income of
BeiGene's pipeline expansion shows remarkable progress with four new molecular entities entering clinical trials this quarter. The company's "Fast to Proof of Concept" strategy demonstrates industry-leading execution speed, particularly evident in the CDK4i and B7H4 ADC programs. Key developments include promising five-year follow-up data for BRUKINSA in CLL treatment, showing
The diversified oncology portfolio spans hematology, breast, lung and gastrointestinal cancers, leveraging three platform technologies: multi-specific antibodies, protein degraders and ADCs. The global clinical development program for BRUKINSA now includes 6,000 patients across 30 countries, while TEVIMBRA's program encompasses 14,000 patients in 66 trials, demonstrating robust clinical development capabilities.
-
Continued financial progress with
in quarterly total revenue, reduced GAAP loss and second consecutive quarter of positive non-GAAP operating income$1 billion -
Strengthened franchise leadership in chronic lymphocytic leukemia (CLL) with foundational therapy BRUKINSA global revenue of
, rapidly progressing pivotal programs for late-stage hematology pipeline$690 million - Expanded oncology pipeline with four new molecular entities (NMEs) entering the clinic this quarter (eight year-to-date); reaffirmed on track to achieve goal to enter 10+ by end of year; in-house innovative “Fast to Proof of Concept” strategy quickly explores the clinical potential of molecules in parallel, with industry leading speed of execution
(Graphic: Business Wire)
“Our exceptional third-quarter results underscore the Company’s global oncology leadership driven by our unique R&D and clinical advantages as well as the tremendous launch trajectory of BRUKINSA,” said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. “In the
Third Quarter 2024 Financial Snapshot
(Amounts in thousands of
|
|
Three Months Ended September 30, |
|
|
|
Nine Months Ended September 30, |
|
|
||||||||||||||
(in thousands, except percentages) |
|
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
||||||||||
Net product revenues |
|
$ |
993,447 |
|
|
$ |
595,290 |
|
|
67 |
% |
|
$ |
2,661,511 |
|
|
$ |
1,559,326 |
|
|
71 |
% |
Net revenue from collaborations |
|
$ |
8,152 |
|
|
$ |
186,018 |
|
|
(96 |
)% |
|
$ |
20,906 |
|
|
$ |
265,044 |
|
|
(92 |
)% |
Total Revenue |
|
$ |
1,001,599 |
|
|
$ |
781,308 |
|
|
28 |
% |
|
$ |
2,682,417 |
|
|
$ |
1,824,370 |
|
|
47 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||
GAAP loss from operations |
|
$ |
(120,265 |
) |
|
$ |
(133,968 |
) |
|
(10 |
)% |
|
$ |
(488,774 |
) |
|
$ |
(823,941 |
) |
|
(41 |
)% |
Adjusted income(loss) from operations* |
|
$ |
65,630 |
|
|
$ |
(16,339 |
) |
|
502 |
% |
|
$ |
(33,247 |
) |
|
$ |
(485,249 |
) |
|
(93 |
)% |
* For an explanation of our use of non-GAAP financial measures refer to the "Use of Non-GAAP Financial Measures" section later in this press release and for a reconciliation of each non-GAAP financial measure to the most comparable GAAP measures, see the table at the end of this press release.
Key Business Updates
BRUKINSA® (zanubrutinib) is an orally available, small molecule inhibitor of BTK designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. The global BRUKINSA clinical development program includes about 6,000 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 70 markets, and more than 100,000 patients have been treated globally.
-
U.S. sales of BRUKINSA totaled in the third quarter of 2024, representing growth of$504 million 87% over the prior-year period, with more than60% of the quarter over quarter demand growth coming from expanded use in CLL as BRUKINSA continued to gain share in CLL new patient starts; BRUKINSA sales inEurope totaled in the third quarter of 2024, representing growth of$97 million 217% , driven by increased market share across all major markets, includingGermany ,Italy ,Spain ,France and theUK ; -
Five-year follow-up results from cohort 1 of the Phase 3 SEQUOIA study showed sustained progression-free survival (PFS) benefit (54-month PFS rate of
80% ) with BRUKINSA in patients with treatment-naïve (TN) CLL or small lymphocytic lymphoma (SLL), with no new safety signals observed; detailed data will be presented at the annual American Society of Hematology (ASH) 2024 conference; and -
Five-year follow-up data of BOVen (zanubrutinib, obinutuzumab, venetoclax) study in TN CLL demonstrates frequent unmeasurable minimal residual disease (uMRD) in peripheral blood (
96% ) and bone marrow (92% ), and uMRD was durable with a median MRD-free survival of 34 months; detailed data will be presented at the ASH 2024 conference.
TEVIMBRA® (tislelizumab) is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1; it is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors. TEVIMBRA is the foundational asset of BeiGene’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 34 counties and regions across 66 trials, including 20 registration-enabling studies. TEVIMBRA is approved in 42 countries and regions, and more than 1.3 million patients have been treated globally.
-
Sales of tislelizumab totaled
in the third quarter of 2024, representing growth of$163 million 13% compared to the prior-year period; -
Announced commercial availability in the
U.S. for second-line esophageal squamous cell carcinoma (ESCC) and in the first European countries for second-line ESCC and first- and second-line non-small cell lung cancer (NSCLC); - Received positive opinions from the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) as a first-line treatment for advanced/metastatic gastric or gastroesophageal junction cancer and ESCC;
- Received China National Medical Products Administration approval for neo-adjuvant/adjuvant NSCLC; and
-
Further expanded global footprint with new approvals in
Brazil (second-line NSCLC, second-line ESCC),Singapore (first- and second-line NSCLC, second-line ESCC),Thailand (first- and second-line NSCLC, first- and second-line ESCC and first-line gastric cancer) andIsrael (second-line ESCC).
Key Pipeline Highlights
BeiGene’s portfolio strategy emphasizes rapid generation of early-stage clinical proof-of-concept data enabled by its speed- and cost-advantaged (“Fast to Proof of Concept”) approach to global clinical operations. The Company’s in-house clinical operations team of 3,600 colleagues conducts trials across five continents, ensuring rigorous data quality through collaborations with regulators and investigators in over 45 countries. This strategic approach maximizes resources by channeling data-gated investments into the most promising clinically differentiated candidates quickly and de-prioritizing others. With one of the largest oncology research teams in the industry, BeiGene has demonstrated strengths in translational small molecule and biologics discovery, including three platform technologies: multi-specific antibodies, chimeric degradation activation compounds (CDACs), and antibody-drug conjugates (ADCs). For NMEs entering the clinic, BeiGene has industry leading preclinical, dose escalation cohort and dose escalation to dose expansion timings. Two examples of the Company’s speed advantage resulting from its internal innovation at scale:
- CDK4i entered the clinic in December 2023; 6.4 weeks on average for dose-escalation cohorts with more than 100 patients;
- B7H4 ADC entered the clinic in April 2024; 6.6 weeks on average for dose-escalation cohorts with 30 patients enrolled.
Hematology
Sonrotoclax (BCL2 inhibitor)
- More than 1,300 patients enrolled to date across the program;
- Continued enrollment in global Phase 2 trial in Waldenström’s macroglobulinemia (WM) and global Phase 3 CELESTIAL trial in combination with BRUKINSA in TN CLL with enrollment completion estimated in the first quarter of 2025;
- Anticipate enrolling first subjects in global Phase 3 programs in R/R CLL and R/R mantle cell lymphoma (MCL) in the first half of 2025; and
- Announced upcoming oral presentation at ASH 2024 of Phase 1 study in combination with BRUKINSA for patients with TN CLL/SLL highlighting continued deep and durable responses and manageable tolerability.
BGB-16673 (BTK CDAC)
- More than 350 patients enrolled to date across the program; continued to enroll potentially registration enabling expansion cohort in R/R CLL;
- Anticipate initiation of Phase 3 trial in R/R CLL in the first half of 2025; and
- Granted US FDA Fast Track Designation for R/R CLL/SLL.
Solid Tumors
Lung Cancer
- BG-T187 (EGFR x MET trispecific antibody): Initiated dose escalation; EGFR and MET dual targeting to address large EGFR-mutated NSCLC population and other EGFR- or MET-driven populations such as colorectal cancer; differentiated MET biparatopic design with optimal MET inhibitory activity to pursue best-in-class opportunity;
-
BGB-58067 (MTA-cooperative PRMT5 inhibitor): on track to enter the clinic in the fourth quarter of 2024; selectively kills MTAP-deletion tumor cells that are present in approximately
15% of all tumor types; designed to avoid on-target hematological toxicity seen with first-generation inhibitors; best-in-class potential with high potency, selectivity, and brain penetrability; and - BG-60366 (EGFR CDAC): on track to enter the clinic in the fourth quarter of 2024: differentiated degrader mechanism to completely abolish EGFR signaling; highly potent across osimertinib-sensitive and resistant EGFR mutations; strong preclinical efficacy data with oral and daily dosing;
Breast and Gynecologic Cancers
- BGB-43395 (CDK4 inhibitor): continued dose escalation in monotherapy and in combination with fulvestrant and letrozole in the anticipated efficacious dose range; more than 100 patients enrolled to date;
- BG-68501 (CDK2 inhibitor) and BG-C9074 (B7H4 ADC): continued monotherapy dose escalation, with pharmacokinetics as expected and no dose-limiting toxicities observed; and
- Four abstracts accepted for presentation at San Antonio Breast Cancer Symposium (SABCS), including preclinical characterization and data from first-in-human Phase 1 dose escalation study of BGB-43395.
Gastrointestinal Cancers
-
NMEs entered into the clinic in the third quarter include:
- BGB-B2033 (GPC3 x 4-1BB bispecific antibody): initiated dose escalation in GPC3 highly expressing tumors; best-in-class potential due to highly potent 4-1BB agonist antibody via simultaneous binding to two 4-1BB molecules for better receptor clustering and T-cell activation;
- BG-C477 (CEA ADC): highly expressed tumor-associated antigen in multiple cancer types; differentiated ADC design enables broad targeting including in patients with medium to low target expression; potent anti-tumor activity in preclinical models of colorectal and gastric cancer and NSCLC; and
- BGB-B3227 (MUC-1 x CD16A bispecific antibody): initiated dose expansion for MUC-1 highly upregulated tumors, including lung, gastrointestinal and breast cancers; differentiated MUC-1 antibody targeting SEA domain to reduce sink effect of soluble MUC-1; potential first-in-class natural killer (NK) cell engager acting through CD16A, an NK activating receptor highly expressed in MUC-1 positive tumors;
-
NMEs on track to enter the clinic in the fourth quarter of 2024:
- BGB-53038 (PanKRAS inhibitor): highly potent and selective with broad activity against KRAS mutations in multiple tumor types; limits toxicity by sparing other RAS proteins; and
- BG-C137 (FGFR2b ADC): potential first-in-class ADC for a validated target in upper gastrointestinal and breast cancers; potential superior efficacy compared to leading monoclonal antibody in both high- and medium-expression models.
Inflammation and Immunology
BGB-45035 (IRAK4 CDAC): Currently in dose escalation in both SAD and MAD cohorts; potent and selective degrader that targets both kinase and scaffold functions of IRAK4 for complete target degradation; deep and fast degradation that leads to stronger cytokine inhibition and superior efficacy in vivo.
Corporate Updates
Strengthened global leadership team with appointments of Matt Shaulis as General Manager of
Third Quarter 2024 Financial Highlights
Revenue for the three months ended September 30, 2024, was
Product Revenue for the three months ended September 30, 2024, was
Gross Margin as a percentage of global product revenue for the third quarter of 2024 was
Operating Expenses
The following table summarizes operating expenses for the third quarter 2024 and 2023, respectively:
|
|
GAAP |
|
|
|
Non-GAAP |
|
|
||||||||||
(unaudited, in thousands, except percentages) |
|
Q3 2024 |
|
Q3 2023 |
|
% Change |
|
Q3 2024 |
|
Q3 2023 |
|
% Change |
||||||
Research and development |
|
$ |
496,179 |
|
$ |
453,259 |
|
9 |
% |
|
$ |
405,545 |
|
$ |
396,146 |
|
2 |
% |
Selling, general and administrative |
|
$ |
455,223 |
|
$ |
365,708 |
|
24 |
% |
|
$ |
380,737 |
|
$ |
308,493 |
|
23 |
% |
Total operating expenses |
|
$ |
951,402 |
|
$ |
818,967 |
|
16 |
% |
|
$ |
786,282 |
|
$ |
704,639 |
|
12 |
% |
The following table summarizes operating expenses for the year-to-date period ended September 30, 2024 and 2023, respectively:
|
|
GAAP |
|
|
|
Non-GAAP |
|
|
||||||||||
(unaudited, in thousands, except percentages) |
|
Q3 YTD 2024 |
|
Q3 YTD 2023 |
|
% Change |
|
Q3 YTD 2024 |
|
Q3 YTD 2023 |
|
% Change |
||||||
Research and development |
|
$ |
1,411,283 |
|
$ |
1,284,607 |
|
10 |
% |
|
$ |
1,193,494 |
|
$ |
1,121,577 |
|
6 |
% |
Selling, general and administrative |
|
$ |
1,326,379 |
|
$ |
1,089,616 |
|
22 |
% |
|
$ |
1,116,805 |
|
$ |
923,254 |
|
21 |
% |
Total operating expenses |
|
$ |
2,737,662 |
|
$ |
2,374,223 |
|
15 |
% |
|
$ |
2,310,299 |
|
$ |
2,044,831 |
|
13 |
% |
Research and Development (R&D) Expenses increased for the third quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis, primarily due to advancing preclinical programs into the clinic and early clinical programs into late stage. Upfront fees and milestone payments related to in-process R&D for in-licensed assets totaled
Selling, General and Administrative (SG&A) Expenses increased for the third quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment to support the global commercial launch of BRUKINSA, primarily in the
GAAP Income (Loss) from Operations in the third quarter of 2024 operating loss decreased
GAAP Net Loss for the quarter ended September 30, 2024 was
For the quarter ended September 30, 2024, net loss per basic ordinary share was
Cash Provided by Operations for the quarter ended September 30, 2024 was
For further details on BeiGene’s Third Quarter 2024 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the third quarter of 2024 filed with the
About BeiGene
BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of nearly 11,000 colleagues spans five continents. To learn more about BeiGene, please visit www.beigene.com and follow us on LinkedIn, X (formerly known as Twitter), Facebook and Instagram.
BeiGene intends to use the Investors section of its website, its X (formerly known as Twitter) account at x.com/BeiGeneGlobal, its LinkedIn account at linkedin.com/company/BeiGene, its Facebook account at facebook.com/BeiGeneGlobal, and its Instagram account at instagram.com/BeiGeneGlobal to disclose material information and to comply with its disclosure obligations under Regulation FD. Accordingly, investors should monitor BeiGene’s website, its X account, its LinkedIn account, its Facebook account, and its Instagram account in addition to BeiGene’s press releases, SEC filings, public conference calls, presentations, and webcasts.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the expansion of TEVIMBRA for patients worldwide; the future and success of BeiGene’s pipeline; and BeiGene’s plans, commitments, aspirations and goals under the caption “About BeiGene”. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and marketing approval; BeiGene’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeiGene's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeiGene’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeiGene’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products; BeiGene’s ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene’s subsequent filings with the
Condensed Consolidated Statements of Operations ( |
||||||||||||||||
(Amounts in thousands of |
||||||||||||||||
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||||||
|
|
|
|
|
|
|
|
|||||||||
|
(Unaudited) |
|
(Unaudited) |
|||||||||||||
Revenues |
|
|
|
|
|
|
|
|||||||||
Product revenue, net |
$ |
993,447 |
|
|
$ |
595,290 |
|
|
$ |
2,661,511 |
|
|
$ |
1,559,326 |
|
|
Collaboration revenue |
|
8,152 |
|
|
|
186,018 |
|
|
|
20,906 |
|
|
|
265,044 |
|
|
Total revenues |
|
1,001,599 |
|
|
|
781,308 |
|
|
|
2,682,417 |
|
|
|
1,824,370 |
|
|
Cost of sales - products |
|
170,462 |
|
|
|
96,309 |
|
|
|
433,529 |
|
|
|
274,088 |
|
|
Gross profit |
|
831,137 |
|
|
|
684,999 |
|
|
|
2,248,888 |
|
|
|
1,550,282 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
|
496,179 |
|
|
|
453,259 |
|
|
|
1,411,283 |
|
|
|
1,284,607 |
|
|
Selling, general and administrative |
|
455,223 |
|
|
|
365,708 |
|
|
|
1,326,379 |
|
|
|
1,089,616 |
|
|
Total operating expenses |
|
951,402 |
|
|
|
818,967 |
|
|
|
2,737,662 |
|
|
|
2,374,223 |
|
|
Loss from operations |
|
(120,265 |
) |
|
|
(133,968 |
) |
|
|
(488,774 |
) |
|
|
(823,941 |
) |
|
Interest income, net |
|
10,643 |
|
|
|
26,649 |
|
|
|
40,028 |
|
|
|
57,735 |
|
|
Other income, net |
|
11,318 |
|
|
|
336,657 |
|
|
|
1,096 |
|
|
|
291,142 |
|
|
(Loss) income before income taxes |
|
(98,304 |
) |
|
|
229,338 |
|
|
|
(447,650 |
) |
|
|
(475,064 |
) |
|
Income tax expense |
|
23,046 |
|
|
|
13,925 |
|
|
|
45,255 |
|
|
|
39,091 |
|
|
Net (loss) income |
|
(121,350 |
) |
|
|
215,413 |
|
|
|
(492,905 |
) |
|
|
(514,155 |
) |
|
|
|
|
|
|
|
|
|
|||||||||
(Loss) earnings per share |
|
|
|
|
|
|
|
|||||||||
Basic |
|
(0.09 |
) |
|
|
0.16 |
|
|
|
(0.36 |
) |
|
|
(0.38 |
) |
|
Diluted |
|
(0.09 |
) |
|
|
0.15 |
|
|
|
(0.36 |
) |
|
|
(0.38 |
) |
|
Weighted-average shares outstanding—basic |
|
1,376,751,873 |
|
|
|
1,360,716,279 |
|
|
|
1,361,216,763 |
|
|
|
1,358,392,470 |
|
|
Weighted-average shares outstanding—diluted |
|
1,376,751,873 |
|
|
|
1,390,331,833 |
|
|
|
1,361,216,763 |
|
|
|
1,358,392,470 |
|
|
|
|
|
|
|
|
|
|
|||||||||
(Loss) earnings per American Depositary Share (“ADS”) |
|
|
|
|
|
|
|
|||||||||
Basic |
|
(1.15 |
) |
|
|
2.06 |
|
|
|
(4.71 |
) |
|
|
(4.92 |
) |
|
Diluted |
|
(1.15 |
) |
|
|
2.01 |
|
|
|
(4.71 |
) |
|
|
(4.92 |
) |
|
Weighted-average ADSs outstanding—basic |
|
105,903,990 |
|
|
|
104,670,483 |
|
|
|
104,708,982 |
|
|
|
104,491,728 |
|
|
Weighted-average ADSs outstanding—diluted |
|
105,903,990 |
|
|
|
106,948,603 |
|
|
|
104,708,982 |
|
|
|
104,491,728 |
|
Select Unaudited Condensed Consolidated Balance Sheet Data ( |
||||||
(Amounts in thousands of |
||||||
|
As of |
|||||
|
September 30, |
|
December 31, |
|||
|
2024 |
|
2023 |
|||
|
(unaudited) |
|
(audited) |
|||
Assets: |
|
|
|
|||
Cash, cash equivalents and restricted cash |
$ |
2,713,428 |
|
$ |
3,185,984 |
|
Accounts receivable, net |
|
569,047 |
|
|
358,027 |
|
Inventories |
|
431,676 |
|
|
416,122 |
|
Property, plant and equipment, net |
|
1,562,965 |
|
|
1,324,154 |
|
Total assets |
|
5,830,860 |
|
|
5,805,275 |
|
Liabilities and equity: |
|
|
|
|||
Accounts payable |
|
307,532 |
|
|
315,111 |
|
Accrued expenses and other payables |
|
717,343 |
|
|
693,731 |
|
R&D cost share liability |
|
187,052 |
|
|
238,666 |
|
Debt |
|
1,051,316 |
|
|
885,984 |
|
Total liabilities |
|
2,394,787 |
|
|
2,267,948 |
|
Total equity |
$ |
3,436,073 |
|
$ |
3,537,327 |
Select Unaudited Condensed Consolidated Statements of Cash Flows ( |
||||||||
(Amounts in thousands of |
||||||||
|
|
Three Months Ended September 30, |
||||||
|
|
2024 |
|
2023 |
||||
|
|
|
|
|
||||
|
|
(unaudited) |
||||||
Cash, cash equivalents and restricted cash at beginning of period |
|
$ |
2,617,931 |
|
|
$ |
3,421,574 |
|
Net cash provided by (used in) operating activities |
|
|
188,369 |
|
|
|
(78,150 |
) |
Net cash used in investing activities |
|
|
(133,882 |
) |
|
|
(186,275 |
) |
Net cash provided by (used in) financing activities |
|
|
12,662 |
|
|
|
(76,782 |
) |
Net effect of foreign exchange rate changes |
|
|
28,348 |
|
|
|
525 |
|
Net increase (decrease) in cash, cash equivalents, and restricted cash |
|
|
95,497 |
|
|
|
(340,682 |
) |
Cash, cash equivalents and restricted cash at end of period |
|
$ |
2,713,428 |
|
|
$ |
3,080,892 |
|
Note Regarding Use of Non-GAAP Financial Measures
BeiGene provides certain non-GAAP financial measures, including Adjusted Operating Expenses and Adjusted Operating Loss and certain other non-GAAP income statement line items, each of which include adjustments to GAAP figures. These non-GAAP financial measures are intended to provide additional information on BeiGene’s operating performance. Adjustments to BeiGene’s GAAP figures exclude, as applicable, non-cash items such as share-based compensation, depreciation and amortization. Certain other special items or substantive events may also be included in the non-GAAP adjustments periodically when their magnitude is significant within the periods incurred. BeiGene maintains an established non-GAAP policy that guides the determination of what costs will be excluded in non-GAAP financial measures and the related protocols, controls and approval with respect to the use of such measures. BeiGene believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of BeiGene’s operating performance. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of the Company’s historical and expected financial results and trends and to facilitate comparisons between periods and with respect to projected information. In addition, these non-GAAP financial measures are among the indicators BeiGene’s management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, non-GAAP financial measures used by other companies.
RECONCILIATION OF SELECTED GAAP MEASURES TO NON-GAAP MEASURES |
||||||||||||||||
(Amounts in thousands of |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
Three Months Ended |
|
Nine Months Ended |
|||||||||||||
|
September 30, |
|
September 30, |
|||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||||||
|
|
|
|
|||||||||||||
Reconciliation of GAAP to adjusted cost of sales - products: |
|
|
|
|
|
|
|
|||||||||
GAAP cost of sales - products |
$ |
170,462 |
|
|
$ |
96,309 |
|
|
$ |
433,529 |
|
|
$ |
274,088 |
|
|
Less: Depreciation |
|
19,589 |
|
|
|
2,320 |
|
|
|
24,618 |
|
|
|
6,680 |
|
|
Less: Amortization of intangibles |
|
1,186 |
|
|
|
981 |
|
|
|
3,546 |
|
|
|
2,620 |
|
|
Adjusted cost of sales - products |
$ |
149,687 |
|
|
$ |
93,008 |
|
|
$ |
405,365 |
|
|
$ |
264,788 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to adjusted research and development: |
|
|
|
|
|
|
|
|||||||||
GAAP research and development |
$ |
496,179 |
|
|
$ |
453,259 |
|
|
$ |
1,411,283 |
|
|
$ |
1,284,607 |
|
|
Less: Share-based compensation cost |
|
47,670 |
|
|
|
44,150 |
|
|
|
141,121 |
|
|
|
124,126 |
|
|
Less: Depreciation |
|
42,964 |
|
|
|
12,963 |
|
|
|
76,668 |
|
|
|
38,904 |
|
|
Adjusted research and development |
$ |
405,545 |
|
|
$ |
396,146 |
|
|
$ |
1,193,494 |
|
|
$ |
1,121,577 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to adjusted selling, general and administrative: |
|
|
|
|
|
|
|
|||||||||
GAAP selling, general and administrative |
$ |
455,223 |
|
|
$ |
365,708 |
|
|
$ |
1,326,379 |
|
|
$ |
1,089,616 |
|
|
Less: Share-based compensation cost |
|
66,933 |
|
|
|
51,969 |
|
|
|
192,890 |
|
|
|
150,710 |
|
|
Less: Depreciation |
|
7,475 |
|
|
|
3,959 |
|
|
|
16,606 |
|
|
|
13,990 |
|
|
Less: Amortization of intangibles |
|
78 |
|
|
|
1,287 |
|
|
|
78 |
|
|
|
1,662 |
|
|
Adjusted selling, general and administrative |
$ |
380,737 |
|
|
$ |
308,493 |
|
|
$ |
1,116,805 |
|
|
$ |
923,254 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to adjusted operating expenses |
|
|
|
|
|
|
|
|||||||||
GAAP operating expenses |
$ |
951,402 |
|
|
$ |
818,967 |
|
|
$ |
2,737,662 |
|
|
$ |
2,374,223 |
|
|
Less: Share-based compensation cost |
|
114,603 |
|
|
|
96,119 |
|
|
|
334,011 |
|
|
|
274,836 |
|
|
Less: Depreciation |
|
50,439 |
|
|
|
16,922 |
|
|
|
93,274 |
|
|
|
52,894 |
|
|
Less: Amortization of intangibles |
|
78 |
|
|
|
1,287 |
|
|
|
78 |
|
|
|
1,662 |
|
|
Adjusted operating expenses |
$ |
786,282 |
|
|
$ |
704,639 |
|
|
$ |
2,310,299 |
|
|
$ |
2,044,831 |
|
|
|
|
|
|
|
|
|
|
|||||||||
Reconciliation of GAAP to adjusted income (loss) from operations: |
|
|
|
|
|
|
|
|||||||||
GAAP loss from operations |
$ |
(120,265 |
) |
|
$ |
(133,968 |
) |
|
$ |
(488,774 |
) |
|
$ |
(823,941 |
) |
|
Plus: Share-based compensation cost |
|
114,603 |
|
|
|
96,119 |
|
|
|
334,011 |
|
|
|
274,836 |
|
|
Plus: Depreciation |
|
70,028 |
|
|
|
19,242 |
|
|
|
117,892 |
|
|
|
59,574 |
|
|
Plus: Amortization of intangibles |
|
1,264 |
|
|
|
2,268 |
|
|
|
3,624 |
|
|
|
4,282 |
|
|
Adjusted income (loss) from operations |
$ |
65,630 |
|
|
$ |
(16,339 |
) |
|
$ |
(33,247 |
) |
|
$ |
(485,249 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112799807/en/
Investors
Liza Heapes
+1 857-302-5663
ir@beigene.com
Media
Kyle Blankenship
+1 667-351-5176
media@beigene.com
Source: BeiGene, Ltd.
FAQ
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