Company Overview - BeiGene has over 9,000 colleagues across approximately 40 offices on 5 continents[7] - The company has over 950 oncology research team members[8] - BeiGene has a global commercial team of over 3,500 people[7] - The company has 16 approved products[7] - BeiGene's annual product revenue is over $1 billion, with a 109% product revenue growth[7] - The company's cash balance is over $5 billion[7] Clinical Development and Portfolio - BeiGene has approximately 50 assets in clinical and commercial stages[8] - The company has over 60 pre-clinical programs, with the majority having first-in-class potential[8] - BeiGene has conducted over 15 global phase 3 registration trials[14] - The company has initiated over 110 clinical trials with over 20,000 subjects enrolled[14] - BeiGene expects 10+ INDs (Investigational New Drug applications) per year starting in 2024[11] BRUKINSA (Zanubrutinib) - BRUKINSA demonstrated superior efficacy versus ibrutinib in R/R CLL (Relapsed/Refractory Chronic Lymphocytic Leukemia) in the ALPINE trial, with improved ORR (Overall Response Rate) and PFS (Progression-Free Survival)[17] - In the ALPINE trial, BRUKINSA showed a PFS of 79.5% compared to 67.3% for Ibrutinib[19] - BRUKINSA also demonstrated a favorable safety profile versus ibrutinib, with an improved cardiac profile[17] - Serious cardiac adverse events were reported in 1.9% of patients on BRUKINSA compared to 7.7% on Ibrutinib[46] - BRUKINSA is now approved in over 60 markets[57] Tislelizumab - The global market for PD-1/PD-L1 class drugs is estimated to reach $55 billion by 2026[64] - BeiGene is eligible for $1.5 billion collaboration revenue from Novartis for Tislelizumab in North America, Europe, and Japan[64] Financial Strength - BeiGene had a $5.1 billion cash position as of Q3 2022[65] - The company is eligible for up to $3.6 billion in collaboration revenue[65]

| --- | --- | |-------|-------------------------------------------------------------| | | | | | ___________________________________________________________ | | | FORM 10-Q | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition pe ...

| --- | --- | |-------|-------------------------------------------------------------------------| | | | | | ___________________________________________________________ FORM 10-Q | UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition p ...

[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The company's unaudited statements show a Q1 2022 net loss of $434.3 million and total assets of $8.02 billion Condensed Consolidated Balance Sheet Data (Unaudited) | Account | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 4,347,162 | 4,375,678 | | Short-term investments | 1,897,783 | 2,241,962 | | Total current assets | 6,948,139 | 7,613,880 | | Total assets | 8,021,388 | 8,645,949 | | **Liabilities and Equity** | | | | Total current liabilities | 1,376,306 | 1,599,555 | | Total liabilities | 2,135,888 | 2,402,962 | | Total equity | 5,885,500 | 6,242,987 | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Product revenue, net | 261,573 | 106,117 | | Collaboration revenue | 45,053 | 499,755 | | **Total revenues** | **306,626** | **605,872** | | Research and development | 389,915 | 320,726 | | Selling, general and administrative | 294,573 | 182,106 | | **Total expenses** | **749,913** | **535,705** | | (Loss) income from operations | (443,287) | 70,167 | | **Net (loss) income** | **(434,274)** | **66,495** | | Net (loss) income per ADS - Basic | (4.24) | 0.73 | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Net cash (used in) provided by operating activities | (236,563) | 125,095 | | Net cash provided by investing activities | 210,393 | 291,948 | | Net cash (used in) provided by financing activities | (11,267) | 107,419 | | Net (decrease) increase in cash | (28,437) | 520,401 | [Note 3. Collaborative and Licensing Arrangements](index=15&type=section&id=Note%203.%20Collaborative%20and%20Licensing%20Arrangements) Collaboration revenue decreased significantly due to a large one-time license fee from Novartis in the prior year Collaboration Revenue Breakdown (Q1 2022 vs Q1 2021) | Revenue from Collaborators | Three Months Ended March 31, 2022 ($) | Three Months Ended March 31, 2021 ($) | | :--- | :--- | :--- | | License revenue | — | 484,646 | | Research and development service revenue | 13,427 | 15,109 | | Right to access intellectual property revenue | 26,249 | — | | Other | 5,377 | — | | **Total** | **45,053** | **499,755** | - In January 2021, the company received a **$650 million upfront payment** from Novartis for the tislelizumab collaboration, of which **$484.6 million was recognized as license revenue in Q1 2021**[64](index=64&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) - In December 2021, the company entered an option and collaboration agreement with Novartis for ociperlimab, receiving a **$300 million upfront payment** in January 2022[70](index=70&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk) - Under the Amgen collaboration, BeiGene's portion of co-development funding for pipeline assets was **$44.2 million in Q1 2022**, with a remaining commitment of **$746.8 million**[81](index=81&type=chunk) [Note 11. Product Revenue](index=25&type=section&id=Note%2011.%20Product%20Revenue) Net product revenue grew 146.5% to $261.6 million, driven by strong sales of BRUKINSA® and tislelizumab Net Product Sales by Product (Q1 2022 vs Q1 2021) | Product | Three Months Ended March 31, 2022 ($ thousands) | Three Months Ended March 31, 2021 ($ thousands) | | :--- | :--- | :--- | | BRUKINSA® | 104,325 | 22,090 | | Tislelizumab | 87,643 | 48,879 | | REVLIMID® | 21,660 | 16,629 | | XGEVA® | 13,499 | 14,454 | | BLINCYTO® | 11,866 | — | | **Total product revenue – net** | **261,573** | **106,117** | [Note 17. Commitments and Contingencies](index=29&type=section&id=Note%2017.%20Commitments%20and%20Contingencies) The company holds significant financial commitments of $1.87 billion, primarily for co-development and capital projects Summary of Commitments as of March 31, 2022 | Commitment Type | Amount ($ thousands) | | :--- | :--- | | Co-Development Funding (Amgen) | 746,844 | | Capital Commitments | 239,436 | | Purchase Commitments | 122,485 | | Research and Development Commitment | 26,579 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=32&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Product revenue grew significantly, but a drop in collaboration revenue and rising expenses led to a net loss [Results of Operations](index=39&type=section&id=Results%20of%20Operations) Total revenues fell 49.4% due to lower collaboration revenue, despite a 146.5% increase in product sales Key Operational Results (Q1 2022 vs Q1 2021) | Metric | Q1 2022 ($M) | Q1 2021 ($M) | Change (%) | | :--- | :--- | :--- | :--- | | Total Revenues | 306.6 | 605.9 | (49.4)% | | Product Revenue, net | 261.6 | 106.1 | 146.5% | | Collaboration Revenue | 45.1 | 499.8 | (91.0)% | | Total Expenses | 749.9 | 535.7 | 40.0% | | Net (Loss) Income | (434.3) | 66.5 | (753.1)% | - The increase in R&D expense was primarily due to a **$80.0 million (49.5%) increase in internal costs**, reflecting global expansion[188](index=188&type=chunk)[190](index=190&type=chunk) - The increase in SG&A expense was driven by a **$62.5 million rise in employee costs** and a **$20.8 million increase in external commercial expenses**[191](index=191&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a strong liquidity position sufficient for the next 12 months despite significant future commitments Liquidity Position | Account | March 31, 2022 ($ thousands) | December 31, 2021 ($ thousands) | | :--- | :--- | :--- | | Cash, cash equivalents and restricted cash | 4,354,450 | 4,382,887 | | Short-term investments | 1,897,783 | 2,241,962 | | Total debt | 608,992 | 629,678 | - The company received an upfront cash payment of **$300 million from Novartis** in January 2022 for the ociperlimab collaboration[198](index=198&type=chunk) Material Cash Requirements as of March 31, 2022 | Obligation | Total ($ thousands) | Short Term ($ thousands) | Long Term ($ thousands) | | :--- | :--- | :--- | :--- | | Co-development funding commitment | 746,844 | 245,146 | 501,698 | | Debt obligations | 608,992 | 407,387 | 201,605 | | Capital commitments | 239,436 | 239,436 | — | | Purchase commitments | 122,485 | 64,143 | 58,342 | [Quantitative and Qualitative Disclosures About Market Risk](index=47&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company's primary market risks include interest rates and foreign currency, particularly the Chinese Renminbi - The company is exposed to foreign exchange risk from transactions in currencies like the **RMB, Euro, and Australian dollar**[232](index=232&type=chunk)[233](index=233&type=chunk) - The company's ability to convert RMB is subject to **PRC government controls**, potentially limiting fund remittances[236](index=236&type=chunk)[544](index=544&type=chunk) - A hypothetical **100-basis point change in interest rates** would impact investment value by approximately **$10 million**[229](index=229&type=chunk) [Controls and Procedures](index=48&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the quarter-end - **Disclosure controls and procedures are effective** at a reasonable assurance level as of March 31, 2022[239](index=239&type=chunk) - In Q1 2022, the company implemented **new controls for key financial processes** including order-to-cash and R&D accruals[240](index=240&type=chunk) [PART II. OTHER INFORMATION](index=49&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=49&type=section&id=Item%201.%20Legal%20Proceedings) The company is engaged in an ongoing arbitration with a Bristol Myers Squibb company regarding a supply agreement - The company initiated an arbitration proceeding against BMS-Celgene in June 2020 over the **ABRAXANE® supply agreement in China**[242](index=242&type=chunk) [Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks in commercialization, clinical development, and operations in China [Risks Related to Commercialization](index=49&type=section&id=Risks%20Related%20to%20Commercialization) Key commercialization risks include market acceptance, intense competition, and securing adequate reimbursement - The company's medicines may **fail to achieve market acceptance** from physicians, patients, and payors[244](index=244&type=chunk)[245](index=245&type=chunk) - The company faces **substantial competition** from larger pharmaceutical companies and potential generic therapies[259](index=259&type=chunk)[260](index=260&type=chunk) - Successful commercialization depends on **achieving adequate reimbursement** from government and private payors[269](index=269&type=chunk)[270](index=270&type=chunk) [Risks Related to Clinical Development and Regulatory Approval](index=58&type=section&id=Risks%20Related%20to%20Clinical%20Development%20and%20Regulatory%20Approval) Drug development is subject to lengthy, expensive, and uncertain clinical trials and regulatory approval processes - Business success depends on **successful clinical development and regulatory approval**, a lengthy and uncertain process[290](index=290&type=chunk)[293](index=293&type=chunk) - **Clinical trials may fail or be delayed** due to safety, efficacy, or enrollment issues[296](index=296&type=chunk)[300](index=300&type=chunk) - **Regulatory approvals from the FDA, NMPA, and EMA are unpredictable** and can be delayed by external factors[306](index=306&type=chunk)[312](index=312&type=chunk) [Risks Related to Financial Position and Need for Additional Capital](index=68&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of significant net losses and may require additional capital to fund future operations - The company has an **accumulated deficit of $5.4 billion** and expects to incur further losses[345](index=345&type=chunk)[346](index=346&type=chunk) - The company **may need to obtain additional financing**, and failure to do so could delay or reduce programs[350](index=350&type=chunk)[354](index=354&type=chunk) - The company is exposed to **foreign currency exchange risk**, particularly with the Chinese RMB[357](index=357&type=chunk)[358](index=358&type=chunk)[360](index=360&type=chunk) [Risks Related to Doing Business in the PRC](index=93&type=section&id=Risks%20Related%20to%20Our%20Doing%20Business%20in%20the%20PRC) Operations in China face risks from political uncertainty, U.S.-China relations, and potential delisting under HFCAA - The company's ADSs may be **delisted from U.S. exchanges under the HFCAA** if the PCAOB cannot inspect its China auditor[507](index=507&type=chunk)[508](index=508&type=chunk) - To address HFCAA risk, the company has engaged a **U.S.-based auditor for FY2022** to satisfy PCAOB inspection requirements[510](index=510&type=chunk)[513](index=513&type=chunk) - The potential **AHFCA Act could shorten the delisting timeline** to 2023 if inspection issues are not resolved[515](index=515&type=chunk)[516](index=516&type=chunk)[517](index=517&type=chunk) - Operations are subject to uncertainty from **PRC political policies, U.S.-China relations, and government oversight**[499](index=499&type=chunk)[500](index=500&type=chunk)[501](index=501&type=chunk) - Dividend payments from PRC subsidiaries are **restricted by PRC regulations** and currency exchange controls[529](index=529&type=chunk)[530](index=530&type=chunk)[531](index=531&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=108&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period - None[615](index=615&type=chunk) [Defaults Upon Senior Securities](index=108&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reported no defaults upon senior securities during the period - None[615](index=615&type=chunk) [Mine Safety Disclosures](index=108&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[615](index=615&type=chunk) [Other Information](index=108&type=section&id=Item%205.%20Other%20Information) The company reported no other information required to be disclosed under this item - Not applicable[615](index=615&type=chunk) [Exhibits](index=108&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report, including officer certifications and XBRL data - The report includes a new consulting agreement with Jane Huang, effective April 3, 2022, as an exhibit[617](index=617&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37686 BEIGENE, LTD. (Exact Name of Registrant as Specified in its Charter) Cayman Islands 98-1209416 (State or oth ...

Financial Performance & Growth - BeiGene reported $962 million in Q3 year-to-date revenue from product sales and collaborations[7] - The company's product revenue growth showed a +109% year-over-year increase[58] - Specifically, product revenue in North America grew by +111% year-over-year, reaching $192.5 million in Q3 2021 and $437.2 million for the period of 1Q-3Q 2021[58] - BeiGene has a strong cash position of $7.6 billion, including Q3 2021 cash balance, STAR net proceeds, and Novartis TIGIT upfront payment[7, 63] Pipeline & Clinical Development - BeiGene has approximately 50 assets in clinical and commercial stages[7] - The company has initiated over 100 clinical trials across 45 markets[7, 22] - Zanubrutinib demonstrated a 24-month Progression-Free Survival (PFS) rate of 85.5% compared to 69.5% for Bendamustine + Rituximab (BR) in the SEQUOIA Phase 3 study in 1L CLL[40] - In the ALPINE Phase 3 study of Zanubrutinib vs Ibrutinib in R/R CLL/SLL, Zanubrutinib showed an Overall Response Rate (ORR) of 78.3% compared to 62.5% for Ibrutinib (p < 0.001)[45] Collaborations & Commercialization - BeiGene's PD-1 and TIGIT collaborations with Novartis included nearly $1 billion in upfront payments[16] - The company retains rights to PD-1 and TIGIT to drive broad access for 6.6 billion people in its territories[52, 60] - Brukinsa has been approved in 43 markets by 16 regulatory authorities[7, 57] - BeiGene's global commercial team consists of 3,400+ professionals[7, 9, 58]