SAN MATEO, Calif. - Tuesday, 12. November 2024 AETOSWire
Continued financial progress with $1 billion in quarterly total revenue, reduced GAAP loss and second consecutive quarter of positive non-GAAP operating income
Strengthened franchise leadership in chronic lymphocytic leukemia (CLL) with foundational therapy BRUKINSA global revenue of $690 million, rapidly progressing pivotal programs for late-stage hematology pipeline
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
(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the third quarter of 2024.
“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 U.S., BRUKINSA, with the broadest label of any BTK inhibitor, is now the leader in new patient starts in both frontline and relapsed/refractory (R/R) CLL in addition to all other approved B-cell malignancies. As the cornerstone of our hematology franchise, BRUKINSA shows tremendous promise for patients as a monotherapy and as a backbone for best-in-class combinations with our late-stage BCL2 inhibitor, sonrotoclax, and BTK degrader BGB-16673. In the solid tumor area, we’re expanding access to our PD-1 inhibitor, TEVIMBRA, for patients worldwide and building global commercial capabilities to support our prolific pipeline of exciting potential cancer medicines. We are laying the foundation for future franchises in breast, lung, and gastrointestinal cancers across three signature platform technologies including multi-specific antibodies, protein degraders, and antibody-drug conjugates. This progress not only highlights our achievements but also emphasizes our commitment to positively impacting patients' lives globally, fostering hope and advancements in the fight against cancer.”
Third Quarter 2024 Financial Snapshot
(Amounts in thousands of U.S. dollars and Unaudited)
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 $504 million in the third quarter of 2024, representing growth of 87% over the prior-year period, with more than 60% 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 in Europe totaled $97 million in the third quarter of 2024, representing growth of 217%, driven by increased market share across all major markets, including Germany, Italy, Spain, France and the UK;
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 $163 million in the third quarter of 2024, representing growth of 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) and Israel (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)
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