BeiGene, Ltd. American Depositary Shares - BGNE STOCK NEWS

BeiGene (NASDAQ: BGNE) announced new data for TEVIMBRA® (tislelizumab) to be presented at ESMO 2024. Key highlights include:

1. RATIONALE-315: Significant event-free survival benefit in resectable NSCLC with neoadjuvant tislelizumab plus chemotherapy.

2. RATIONALE-305: Three-year overall survival data showing long-term efficacy in first-line advanced GC/GEJC.

3. RATIONALE-307: Continued OS benefit with promising four-year OS rates in first-line squamous NSCLC.

4. Comparative effectiveness data vs. other anti-PD-1 treatments in second-line ESCC.

TEVIMBRA has been launched in Germany, Austria, and Norway following EU approvals for ESCC and NSCLC indications.

BeiGene, a global oncology company, has announced its participation in the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024. The company, traded as BGNE on NASDAQ, 06160 on HKEX, and 688235 on SSE, will engage in a fireside chat at 10 a.m. EDT.

Investors and interested parties can access a live webcast of the event through BeiGene's investor relations websites. The webcast will be archived and available for 180 days after the event, providing extended access to the company's insights and discussions from the conference.

BeiGene's BGB-16673, an oral BTK-targeting chimeric degradation activation compound (CDAC), has received Fast Track Designation from the U.S. FDA for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have been previously treated with at least two prior lines of therapy. This designation aims to expedite the development and review of drugs for serious conditions with unmet medical needs.

The decision was supported by promising safety and efficacy data from a Phase 1/2 study in heavily pretreated patients. BGB-16673 is the most advanced BTK degrader in clinical trials and is expected to complement BeiGene's BRUKINSA (zanubrutinib). Over 300 patients across 15 countries have been treated with BGB-16673 in its global clinical development program.

BeiGene reported strong Q2 2024 financial results, with total revenues of $929 million, up 56% year-over-year. BRUKINSA global sales reached $637 million, a 107% increase. The company achieved non-GAAP operating income of $48 million, marking a significant milestone. BeiGene advanced its hematology pipeline, including sonrotoclax and BGB-16673, and expanded its solid tumor portfolio. The company opened an $800 million U.S. biologics facility in New Jersey and proposed redomiciling to Switzerland. Key highlights include:

• U.S. BRUKINSA sales of $479 million, up 114%
• European BRUKINSA sales of $81 million, up 209%
• Tislelizumab sales of $158 million, up 6%
• Gross margin improved to 85%
• R&D expenses increased 7% to $454 million
• SG&A expenses rose 12% to $444 million

BeiGene (NASDAQ: BGNE) has opened its flagship U.S. facility in Hopewell, N.J., representing an $800 million investment in biologics manufacturing and clinical R&D capabilities. The 42-acre site features 400,000 square feet of commercial-stage biologic pharmaceutical manufacturing capacity, with room for expansion. This facility enhances BeiGene's ability to produce innovative cancer medicines at scale, reduce costs, and ensure supply chain resiliency.

The company plans to create hundreds of skilled high-tech jobs by the end of 2025. The site includes sustainability measures such as a heating and cooling system using recycled wastewater and is solar-ready. This expansion supports BeiGene's global growth strategy and strengthens its position as a leading oncology innovator with over 30 molecules at clinical or commercial stage.

BeiGene, (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) has appointed Aaron Rosenberg as Chief Financial Officer, effective July 22. Rosenberg, with over 20 years of experience at Merck & Co., replaces Julia Wang, who is departing to pursue external opportunities. This change comes during a transformative year for BeiGene, now a top 15 global oncology innovator by revenue with progress towards profitability and a robust pipeline.

Rosenberg's most recent role was Senior Vice President and Corporate Treasurer at Merck. His experience includes leading enterprise-wide business transformation and heading Financial Planning & Analysis. BeiGene's CEO, John V. Oyler, expressed confidence in Rosenberg's ability to support the company's growth and reinforce its global leadership in hematology and other cancer treatments.

BeiGene presented new data from the SEQUOIA study at EHA2024, evaluating BRUKINSA® (zanubrutinib) with venetoclax in high-risk, treatment-naïve patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) with del(17p) and/or TP53 mutation.

In 65 response-evaluable patients, the overall response rate (ORR) was 100%, with a 48% complete response (CR) and CR with incomplete hematopoietic recovery (CRi). The median follow-up was 31.6 months, with 12- and 24-month progression-free survival (PFS) rates of 95% and 94%, respectively. Safety profiles were consistent with prior studies.

Common adverse effects included infections, COVID-19, and diarrhea. High-risk tumor lysis syndrome (TLS) decreased significantly. The findings support BRUKINSA's efficacy and tolerability in high-risk patients.

BeiGene (NASDAQ: BGNE) and NewBridge Pharmaceuticals have agreed to end their partnership for BRUKINSA® (Zanubrutinib) in the MENA region, effective by March 31, 2025. This decision aligns with BeiGene's strategy to expand its direct operations in the area. The partnership, initiated in 2020, facilitated BRUKINSA's approval and market presence in multiple territories. From June 11, 2024, BeiGene will assume all customer-facing activities, including Medical Affairs, Commercial Operations, and Market Access, using an expanded regional team. The agreement marks a pivotal step in BeiGene's goal to enhance cancer treatment availability and support its global growth aspirations.

BeiGene, a global oncology company, announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024. The event will feature a fireside chat at 1:20 pm EDT, accessible via live webcast through BeiGene's investor relations websites. The replay will be available for 180 days post-event.