BeiGene Reports First Quarter 2024 Financial Results and Business Updates

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced results from the first quarter 2024 and business highlights.

“We are pleased to present another quarter of strong financial results. Supported by our tremendous global growth in revenue, we have now ascended into the top 15 of global oncology innovators based on total oncology sales. We also continue to make significant improvement in our operating leverage as we progress to sustainable profitability,” said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. “We strengthened our hematology leadership with BRUKINSA, now the BTK inhibitor with the broadest label in the class, as we advance our innovative pipeline of therapies for hematologic malignancies. With TEVIMBRA now approved for use in the U.S. and Europe, we look forward to rapidly advancing our deep pipeline of solid tumor therapies to match our leadership in hematology and continue to solidify our reputation as a global oncology innovator.”

Financial Highlights

(Amounts in thousands of U.S. dollars)

Key Business Updates

BRUKINSA^® (zanubrutinib)

• U.S. sales of BRUKINSA totaled $351 million in the first quarter of 2024, representing growth of 153% over the prior-year period, as BRUKINSA gained share in treatment-naïve (TN) chronic lymphocytic leukemia (CLL), and emerged as the BTKi class leader in new-patient share in relapsed or refractory (R/R) CLL; BRUKINSA sales in Europe totaled $67 million in the first quarter of 2024, representing growth of 243%, driven by continued gains in market share and additional reimbursements including France, which implemented reimbursement for BRUKINSA within CLL, Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma for the first time;
• Presented a new matching adjusted indirect comparison of the efficacy of BRUKINSA versus acalabrutinib in R/R CLL based on data from the Phase 3 ALPINE and Phase 3 ASCEND trials demonstrating a progression-free survival and Complete Response (CR) advantage for BRUKINSA versus acalabrutinib, as well as potentially improved overall survival; and
• Received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with R/R follicular lymphoma, in combination with the anti-CD20 monoclonal antibody obinutuzumab, after two or more lines of systemic therapy.

TEVIMBRA^® (tislelizumab)

• Sales of tislelizumab totaled $145 million in the first quarter of 2024, representing growth of 26% compared to the prior-year period;
• Announced European Commission approval as a treatment for non-small cell lung cancer (NSCLC) across three indications, including first- and second-line use;
• Received FDA approval for the treatment of second-line esophageal squamous cell carcinoma (ESCC) after prior chemotherapy;
• Received FDA acceptance of BLA for the treatment of first-line gastric or gastroesophageal junction cancers; and
• The pending FDA approval for tislelizumab in first-line unresectable, recurrent, locally advanced, or metastatic ESCC with a target PDUFA action date of July 2024 may be deferred on account of a potential delay in scheduling clinical site inspections.

Key Pipeline Highlights

Hematology

Sonrotoclax (BCL2 inhibitor)

• Received FDA fast track designation for R/R mantle cell lymphoma (MCL); and
• Continued enrollment in R/R MCL and WM with registrational intent as well as Phase 3 in TN CLL in combination with BRUKINSA; more than 850 patients enrolled to date across the program.

BGB-16673 (BTK CDAC)

• Initiated expansion cohorts in R/R MCL (potential registrational intent) and R/R CLL; more than 220 patients enrolled to date across the program; and
• Expect to initiate Phase 3 clinical trial in R/R CLL by the end of 2024.

Solid Tumors

Lung Cancer

• Enrolled last subject in a Phase 3 clinical trial for ociperlimab (anti-TIGIT) for first-line PD-L1 high NSCLC;
• Multiple tislelizumab lung cancer combination cohorts with BGB-A445 (anti-OX40), LBL-007 (anti-LAG3) and BGB-15025 (HPK1 inhibitor) expected to read out in 2024; and
• Pan-KRAS and MTA-cooperative PRMT5 inhibitors and EGFR CDAC on track to enter the clinic in the second half of 2024.

Breast Cancer

• BGB-43395 (CDK4 inhibitor): Initiated fourth dose level of monotherapy, which is in the efficacious dose range with no dose limiting toxicities observed; and initiated dosing of combination with fulvestrant just over four months from first monotherapy dose.
• BG-68501 (CDK2 inhibitor): Initiated second dose level of monotherapy in first-in-human study, with clinical pharmacokinetics as expected and no dose limiting toxicities observed.
• BG-C9074 (B7H4 ADC): First patient dosed in Australia in global first-in-human Phase 1 study.

Gastrointestinal Cancers

• Multiple tislelizumab combination cohorts with LBL-007 (anti-LAG3) and BGB-A445 (anti-OX40) reading out in 2024;
• Plan to submit a BLA with the NMPA for zanidatamab for the treatment of second-line biliary tract cancer; and
• CEA-ADC and FGFR2b-ADC on track to enter the clinic in the second half of 2024.

Other Business Highlights

• The U.S. Patent and Trademark Office (USPTO) granted the Company’s petition for post-grant review of the Pharmacyclics’ patent asserted against the Company in a patent infringement suit, stating that the Company has shown that it is more likely than not that the patent is invalid; The USPTO is expected to issue a final decision on the validity of the patent within 12 months;
• Published the 2023 Responsible Business & Sustainability Report which details the Company’s commitment to providing equitable benefit to patients, business and society; and
• Anticipate opening of state-of-the-art biologics manufacturing facility and clinical R&D center at the Princeton West Innovation Campus in Hopewell, New Jersey, in July.

First Quarter 2024 Financial Highlights

Revenue for the three months ended March 31, 2024, was $752 million, compared to $448 million in the same period of 2023, driven primarily by growth in BRUKINSA product sales in the U.S. and Europe of 153% and 243% respectively.

Product Revenue for the three months ended March 31, 2024, was $747 million, compared to $410 million in the same period of 2023, representing an increase of 82%. The increase in product revenue was attributable to increased sales of our internally developed products, BRUKINSA and tislelizumab. For the three months ended March 31, 2024, the U.S. was the Company’s largest market, with product revenue of $351 million, compared to $139 million in the prior year period.

Gross Margin as a percentage of global product revenue for the first quarter of 2024 was 83%, compared to 80% in the prior-year period. The gross margin percentage increased primarily due to proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio.

Operating Expenses

Research and Development (R&D) Expenses increased for the first 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 $35 million in the first quarter of 2024, compared to nil in the prior-year period.

Selling, General and Administrative (SG&A) Expenses increased for the first quarter of 2024 compared to the prior-year period on both a GAAP and adjusted basis due to continued investment in the global commercial launch of BRUKINSA, primarily in the U.S. and Europe. SG&A expenses as a percentage of product sales were 57% for the first quarter of 2024 compared to 80% in the prior year period.

Loss from Operations in the first quarter of 2024 decreased 30% on a GAAP basis and 47% on an adjusted basis compared to the prior-year period. The decrease is driven by significantly improved operating leverage associated with substantial revenue growth and expense discipline as we make significant progress on the path to sustainable profitability.

GAAP Net Loss improved for the quarter ended March 31, 2024, compared to the prior-year period, as our product revenue growth and management of expenses is driving increased operating leverage.

For the quarter ended March 31, 2024, net loss per share was $(0.19) and $(2.41) per American Depositary Share (ADS), compared to $(0.26) per share and $(3.34) per ADS in the prior year period.

Cash Used in Operations for the quarter ended March 31, 2024, totaled $309 million compared to $564 million in the prior-year period, driven by improved operating leverage.

For further details on BeiGene’s First Quarter 2024 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the first quarter of 2024 filed with the U.S. Securities and Exchange Commission.