On February 27, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported financial results for the fourth quarter and full year 2022, recent business highlights, and upcoming milestones (Press release, BeiGene, FEB 27, 2023, View Source [SID1234627715]).

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"We had an outstanding fourth quarter and 2022, with revenues from our two cornerstone medicines, BRUKINSA and tislelizumab, dramatically increasing as our global team continues to bring these innovative therapies to more patients and their caregivers," said John V. Oyler, Co-Founder, Chairman and Chief Executive Officer at BeiGene. "The final progression-free survival (PFS) analysis of the ALPINE trial demonstrating superior efficacy and a favorable cardiac safety profile compared to IMBRUVICA in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and the recent U.S. FDA approval for BRUKINSA in adult patients with CLL/SLL were the most impactful of many recent milestones for our company and a testament to our commitment to following the science."

"Our fourth quarter results continue to demonstrate BeiGene’s commercial capability as well as our commitment to driving operational and financial excellence," said Julia Wang, Chief Financial Officer at BeiGene. "With our strong cash position and total product revenue reaching $1.3 billion in 2022, BeiGene is well positioned to leverage its global scale and financial strength for long-term growth."

Fourth Quarter and Full Year 2022 Financial Results

Revenue for the fourth quarter and full year 2022 was $380.1 million and $1.4 billion, respectively, compared to $214.0 million and $1.2 billion in the prior-year periods. The increase in total revenue in the quarter compared to the prior year is primarily attributable to sales of our internally developed products, BRUKINSA and tislelizumab; sales of in-licensed products from Amgen; and collaboration revenue from the Novartis agreements.

Product revenues totaled $339.0 million and $1.3 billion for the fourth quarter and full year 2022, respectively, compared to $196.8 million and $634.0 million in the prior-year periods, and include:
Global sales of BRUKINSA of $176.1 million and $564.7 million for the fourth quarter and full year 2022, respectively, compared to $87.6 million and $218.0 million in the prior-year periods;
Sales of tislelizumab in China of $102.2 million and $422.9 million for the fourth quarter and full year 2022, respectively, compared to $54.4 million and $255.1 million in the prior-year periods;
Sales of Amgen in-licensed products in China of $27.7 million and $114.6 million for the fourth quarter and full year 2022, respectively, compared to $20.3 million and $58.8 million in the prior-year periods. We began selling Amgen’s BLINCYTO (blinatumomab) in August 2021. Additionally, prior-year period sales do not include sales of KYPROLIS (carfilzomib), which was launched in China in January 2022;
Sales of BMS in-licensed products in China of $21.4 million and $94.3 million for the fourth quarter and full year 2022, respectively, compared to $29.9 million and $89.7 million in the prior-year periods; and
Collaboration revenue totaled $41.1 million and $161.3 million for the fourth quarter and full year 2022, respectively, resulting from the partial recognition of the upfront payments from Novartis related to the tislelizumab and ociperlimab agreements, which were entered into in the first and fourth quarters of 2021. This compared to $17.2 million and $542.3 million in the prior-year periods. Full year 2021 collaboration revenue benefited from the timing of revenue recognition from the upfront license payment from Novartis under the tislelizumab agreement.
Cost of Sales for the fourth quarter and full year 2022 were $73.5 million and $286.5 million, respectively, compared to $48.5 million and $164.9 million in the prior-year periods. Cost of sales increased primarily due to increased product sales of BRUKINSA and tislelizumab, as well as sales of BLINCYTO, which commenced in August 2021, and KYPROLIS and POBEVCY, which commenced in January 2022;

Gross Margin as a percentage of global product sales for the fourth quarter and full year 2022 was 78.3% and 77.2%, respectively, compared to 75.3% and 74.0% in the prior-year periods. The gross margin percentage increased in both the quarter-over-quarter and year-over year periods primarily due to a proportionally higher sales mix of global BRUKINSA sales compared to other products in our portfolio and compared to lower margin sales of in-licensed products, as well as lower costs per unit for both BRUKINSA and tislelizumab, partially offset by lower average selling prices in China for both BRUKINSA and tislelizumab.

Operating Expenses for the fourth quarter and full year 2022 were $775.2 million and $2.9 billion, respectively, compared to $737.2 million and $2.5 billion in the prior-year periods.

R&D Expenses for the fourth quarter and full year 2022 were $446.0 million and $1.6 billion, respectively, compared to $430.5 million and $1.5 billion in the prior-year periods. The increase in R&D expenses was primarily attributable to increases in headcount and costs related to investment in our discovery and development activities, including our continued efforts to internalize research and clinical development activities, partially offset by lower fees paid to clinical research organizations (CROs) for clinical trials. Upfront fees related to in-process R&D for in-licensed assets totaled $48.7 million and $68.7 million in the fourth quarter and full year 2022, respectively, compared to $30.0 million and $83.5 million in the prior-year periods. Employee share-based compensation expense was $35.0 million and $139.3 million for the fourth quarter and full year 2022, respectively, compared to $30.6 million and $114.4 million in the prior-year periods; and
SG&A Expenses for the fourth quarter and full year 2022 were $329.0 million and $1.3 billion, respectively, compared to $306.5 million and $990.1 million in the prior-year periods. The increase in SG&A expenses was primarily attributable to increased headcount, largely related to continued expansion of our commercial teams, and higher external commercial expenses, including market access studies and promotional activities. Employee share-based compensation expense was $43.2 million and $163.8 million for the fourth quarter and full year 2022, respectively, compared to $32.4 million and $126.4 million for the prior-year periods.
Net Loss for the fourth quarter of 2022 was $445.3 million, or $0.33 per share and $4.29 per ADS, compared to $590.7 million, or $0.48 per share and $6.22 per ADS in the prior year period. The decrease in net loss is primarily attributable to improved operating leverage due to growing product revenues exceeding operating expense growth. The company expects this trend to continue into 2023. Net loss for full year 2022 was $2.0 billion, or $1.49 per share and $19.43 per ADS, compared to $1.5 billion, or $1.21 per share and $15.71 per ADS in the prior-year period. Net loss for 2022 was unfavorably impacted by other non-operating expenses of $223.9 million, primarily related to foreign exchange losses resulting from the strengthening of the U.S. dollar and the revaluation impact of foreign currencies held in U.S. functional currency subsidiaries. Net loss for the full year 2021 was positively impacted by the timing of revenue recognition related to the Novartis tislelizumab collaboration agreement. The company recognized $484.6 million in the full year 2021 of the $650.0 million upfront payment received.

Cash, Cash Equivalents, Restricted Cash and Short-Term Investments were $4.5 billion as of December 31, 2022, compared to $6.6 billion as of December 31, 2021.

In the fourth quarter of 2022, cash used in operating activities was $318.2 million, primarily due to our net loss of $445.3 million, offset by non-cash charges of $127.3 million; capital expenditures were $121.4 million; and cash used in financing activities was $110.4 million;

In the fourth quarter of the prior year, cash used in operating activities was $507.8 million, primarily due to our net loss of $590.7 million, offset by non-cash charges of $92.7 million; capital expenditures were $115.0 million; and cash provided by financing activities was $3.4 billion, primarily due to the STAR Market offering in December of 2021; and

For the full year 2022, cash used in operating activities was $1.5 billion, primarily due to our net loss of $2.0 billion, inclusive of $223.9 million of other losses due primarily to the strengthening of the U.S. dollar and the related revaluation of foreign currencies held by U.S. functional currency subsidiaries, non-cash charges of $374.8 million and a decrease in our net operating assets and liabilities of $132.4 million.

For the full year 2021, cash used in operating activities was $1.3 billion, primarily due to our net loss of $1.5 billion and an increase in our net operating assets and liabilities of $118.3 million, partially offset by non-cash charges of $277.4 million; capital expenditures were $262.9 million; and cash provided by financing activities was $3.6 billion, primarily due to the net proceeds from the STAR Market offering in December of 2021.
Recent Business Highlights

Commercial Operations

Product sales increased 72.3% and 97.9% in the fourth quarter and full year of 2022, respectively, compared to the prior-year periods, primarily due to increased sales of our internally developed products, as well as increased sales of in-licensed products from Amgen and Bio-Thera;
Global sales of BRUKINSA totaled $176.1 million and $564.7 million in the fourth quarter and full year 2022, representing growth of 101% and 159%, respectively, compared to the prior-year periods; U.S. sales of BRUKINSA totaled $125.3 million and $389.7 million in the fourth quarter and full year 2022, respectively, representing growth of 124% and 237%, compared to the prior-year periods. U.S. sales growth continued in the quarter, driven again by increasing uptake in mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), and marginal zone lymphoma (MZL). BRUKINSA sales in China totaled $40.9 million and $150.3 million in the fourth quarter and full year 2022, respectively, representing growth of 33% and 49% compared to the prior-year periods, driven by increases in all approved indications;
Sales of tislelizumab in China totaled $102.2 million and $422.9 million in the fourth quarter and full year 2022, respectively, representing growth of 88% and 66% compared to the prior-year periods. Continued increase in new patient demand from broader reimbursement and further expansion of our salesforce and hospital listings continued to drive increased market penetration and market share for tislelizumab;
Secured National Reimbursement Drug List (NRDL) inclusion of four additional indications in China, with nine approved tislelizumab indications now included. New indications covered as of March 1, 2023, are for:
Certain adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);
Adult patients with advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and certain patients with advanced colorectal cancer (CRC);
Adult patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have progressed after or are intolerant of prior first-line standard chemotherapy; and
As a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC); and
KYPROLIS was included in the NRDL for the first time for the treatment of adult patients with R/R multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. XGEVA was successfully renewed for NRDL inclusion for the treatment of patients with giant cell tumor of the bone (GCTB) that is unresectable or where surgical resection is likely to result in severe morbidity.
Regulatory Progress and Development Programs

BRUKINSA (zanubrutinib), a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects, approved in more than 65 markets including the U.S., China, European Union (EU), Great Britain, Canada, Australia, South Korea and Switzerland in selected indications and under development for additional approvals globally. The global BRUKINSA development program includes more than 4,800 subjects enrolled to-date in 29 countries and regions.

In January 2023, announced U.S. FDA approval for the treatment of adult patients with R/R and first-line CLL/SLL;
Announced European Commission (EC) approval for the treatment of adult patients with treatment-naïve (TN) or R/R CLL;
Presented results from a final analysis of the Phase 3 ALPINE trial demonstrating superior PFS versus IMBRUVICA in adult patients with R/R CLL/SLL, as assessed by an independent review committee (IRC) and investigator, as part of a late breaking abstract session at the 64th American Hematology Society (ASH) (Free ASH Whitepaper) Annual Meeting, with simultaneous publication in The New England Journal of Medicine;
Presented other key data from the BRUKINSA clinical development programs at ASH (Free ASH Whitepaper) 2022, including an oral presentation of results from the MAGNOLIA trial in MZL and a poster with updated results in acalabrutinib-intolerant patients with B-cell malignancies;
Announced approvals in Brazil for the treatment of adult patients with WM and adult patients with R/R MZL who have received at least one anti-CD20-based regimen;
Received marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain for the treatment of adult patients with CLL, and those with MZL who have received at least one prior anti-CD20-based therapy; and
Expanded BRUKINSA’s registration program globally, including 34 launches in 20 markets since January 1, 2022.
Tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages; approved in China in 10 indications and under development for additional approvals globally. The global tislelizumab clinical development program includes more than 11,800 subjects enrolled to-date in 31 countries and regions.

Announced China National Medical Products Administration (NMPA) approval of BLA application for tislelizumab in combination with chemotherapy as a first-line treatment for patients with locally advanced unresectable or metastatic G/GEJ adenocarcinoma with high PD-L1 expression, which is the tenth approved indication in China for tislelizumab;
Announced acceptance by the NMPA of a supplemental biologics license application (sBLA) in patients with first-line unresectable or metastatic hepatocellular carcinoma (HCC);
Filed new drug application for tislelizumab in Brazil seeking marketing authorization for use in first- and second-line NSCLC and second-line esophageal cancer, marking BeiGene’s first application for tislelizumab in Latin America; and
Presented results from the RATIONALE-301 (NCT03412773), RATIONALE-305 (NCT03777657) and RATIONALE-306 (NCT03783442) trials at the 2023 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium, including positive interim overall survival (OS) data for a combination of tislelizumab and chemotherapy in first-line gastric or gastroesophageal junction (G/GEJ) cancer patients whose tumors express PD-L1.
Ociperlimab (BGB-A1217), an investigational anti-TIGIT monoclonal antibody with competent Fc function. The global ociperlimab development program includes 17 countries and regions, and more than 1,600 subjects have been enrolled.

Presented Phase 1 clinical data for checkpoint inhibitor-experienced advanced NSCLC and extensive-stage small cell lung cancer (SCLC) (NCT04047862) at ESMO (Free ESMO Whitepaper)-IO 2022.
BGB-11417, an investigational highly selective and highly potent inhibitor of BCL-2, being developed as monotherapy or in combination with zanubrutinib +/- obinutuzumab in B-cell malignancies, in combination with azacytidine in AML and MDS and as monotherapy and in combination with dexamethasone and in combination with carfilzomib in multiple myeloma. The global BGB-11417 development program includes six countries and regions, and more than 350 subjects have been enrolled.

Presented Phase 1 clinical data for non-Hodgkin’s lymphoma, CLL, acute myeloid leukemia (AML) and multiple myeloma (MM) (NCT04883957, NCT04277637, NCT04771130, and NCT04973605) at ASH (Free ASH Whitepaper) 2022.
BGB-A445, an investigational non-ligand competing OX40 monoclonal antibody, being developed as monotherapy or in combination with tislelizumab.

Initiated patient dosing in a Phase 2 basket trial as monotherapy and in combination with tislelizumab in melanoma, renal cell cancer (RCC) and bladder cancer (NCT05661955).
Early-Stage Programs

Continued to advance our early-stage clinical pipeline of internally developed product candidates at dose escalation stage, including:
BGB-B167: an investigational first-in-class CEA x 4-1BB bispecific antibody, as a monotherapy and in combination with tislelizumab in patients with selected CEA-expressing advanced or metastatic solid tumors, including colorectal cancer (CRC);
BGB-A425: an investigational TIM-3 antibody, in combination with tislelizumab in patients with head and neck squamous cell carcinoma (HNSCC), NSCLC and RCC;
BGB-15025: an investigational, first-in-class hematopoietic progenitor kinase 1 (HPK1) inhibitor as monotherapy or in combination with tislelizumab in solid tumors;
BGB-16673: an investigational Chimeric Degradation Activating Compound (CDAC), targeting BTK protein degradation as monotherapy in B cell malignancies;
BGB-24714: an investigational Second Mitochondrial-derived Activator of Caspase, or SMAC, mimetic as monotherapy or in combination with paclitaxel in advanced solid tumors;
BGB-10188: an investigational PI3Kδ inhibitor as monotherapy or in combination with BRUKINSA in hematology malignancies, or in combination with tislelizumab in solid tumors; and
BGB-23339: a potent, allosteric investigational tyrosine kinase 2 (TYK2) inhibitor.
Collaboration Programs

In collaboration with Zymeworks, announced positive topline results for a Phase 2b clinical trial of zanidatamab in advanced or metastatic HER2-amplified biliary tract cancers (NCT04466891); and
In collaboration with Mirati, initiated patient enrollment for a Phase 2 clinical trial of sitravatinib in combination with tislelizumab in locally advanced unresectable or metastatic ESCC that progressed on or after anti-PD-(L)1 antibody therapy (NCT05461794).
Manufacturing Operations

Construction continues on the U.S. flagship manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, N.J. The property has more than one million square feet total of developable real estate, allowing for future expansion;
Completed expansion and Good Manufacturing Practices (GMP) certification of our state-of-the-art biologics facility in Guangzhou, China, bringing total capacity to 54,000 liters with an additional expansion of 10,000 liters expected in the second quarter of 2023; and
Continued construction on our new small molecule manufacturing campus in Suzhou, China. Phase 1 of construction is expected to add more than 559,000 square feet and expand production capacity to 600 million tablets/capsules, and to be completed in 2023. Once completed, qualified and approved, the total production capacity is expected to increase our small molecule manufacturing capability in China by up to 10 times current capacity.
Corporate Developments

Announced the launch of the Talk About It: Cancer and Mental Health program, designed to elevate the important intersection of mental health and cancer care to help improve health outcomes for cancer patients.
Expected Milestones

BRUKINSA

Submit supplemental New Drug Applications (sNDA) in the U.S. and EU in the first half of 2023 for PFS superiority versus IMBRUVICA in R/R CLL/SLL, as demonstrated in the Phase 3 ALPINE trial;
Continue to support NMPA review of sNDA for first-line CLL/SLL and WM in China, with a decision expected in the first half of 2023;
Continue to support Health Canada and Australian Therapeutic Goods Administration (TGA) reviews of sNDAs for CLL, with decisions expected in 2023; and
Continue to expand BRUKINSA’s registration program globally in new geographies and indications.
Tislelizumab

Continue to support NMPA review of BLA applications for tislelizumab in combination with chemotherapy as a first-line treatment in patients with unresectable locally advanced, recurrent or metastatic ESCC, with a decision expected in the first half of 2023; and for tislelizumab as a treatment for first-line hepatocellular carcinoma, with a decision expected in the second half of 2023;
Continue to support review by regulatory authorities of BeiGene’s applications for tislelizumab, including:
Australia’s TGA review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in the second half of 2023, as well as New Zealand’s Medsafe review of BLA for tislelizumab in first- and second-line NSCLC and second-line ESCC; and
South Korea’s MFDS review of BLA for tislelizumab in second-line ESCC;
In collaboration with Novartis, continue to support review of marketing applications, including:
Ongoing FDA review of the BLA submission in second-line ESCC, including facilitating the scheduling of required inspections as soon as possible, with a decision expected in 2023;
European Medicines Agency (EMA) review of marketing authorization applications for tislelizumab in first- and second-line NSCLC and second-line ESCC, with a decision expected in 2023;
MHRA review of tislelizumab for treatment of first- and second-line NSCLC and second-line ESCC in Great Britain;
Swissmedic review of marketing authorization applications for tislelizumab in second-line ESCC and second-line NSCLC;
Support U.S. FDA regulatory submission by Novartis in 2023 for first-line gastric cancer and first-line unresectable ESCC;
Submit BLA to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in 2023 for first- and second-line ESCC; and
Announce final analysis data from pivotal trials in extensive-stage small cell lung cancer and first-line gastric cancer in 2023.
BGB-11417 (BCL-2)

Initiate global pivotal trial in first-line CLL in combination with BRUKINSA in the second half of 2023; and
Announce readouts from ongoing studies.
Ociperlimab (TIGIT)

Announce readouts for multiple Phase 2 studies in 2023, including:
For second-line ESCC in patients whose tumors express PD-(L)1 (NCT04732494);
For first-line HCC (NCT04948697);
For first-line NSCLC (NCT05014815); and
Complete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in 2023.
BGB-16673 (BTK CDAC)

Initial data readouts for Phase 1 studies in B cell malignancies (NCT05006716, NCT05294731) in 2023.
BGB-A445 (OX 40)

Initial data readout for Phase 1 study in solid tumors (NCT04215978) in 2023.
BGB-15025 (HPK 1)

Initiate dose expansion in combination with tislelizumab in solid tumors (NCT04649385) in 2023.
Collaboration Programs

In collaboration with Leads Biolabs, initiate patient dosing of LBL-007, a novel investigational antibody targeting the LAG-3 pathway, in combination with tislelizumab, in umbrella studies comparing different tislelizumab combination regimens, including with BGB-A445 and ociperlimab (NCT05635708, NCT05577702), in 2023.
COVID-19 Impact and Response

We expect that the worldwide health crisis of COVID-19 will continue to have a negative impact on our operations, including commercial sales, regulatory interactions, inspections, filings, manufacturing, and clinical trial recruitment, participation, and data readouts. There remains uncertainty regarding the future impact of the pandemic both globally and specifically in China due to outbreaks and restrictions and potential impact on clinical, manufacturing and commercial operations. We are striving to minimize delays and disruptions, have put protocols and procedures in place, and continue to execute on our commercial, regulatory, manufacturing, and clinical development goals globally.

Financial Summary

Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)

(Amounts in thousands of U.S. Dollars)

As of

December 31,

December 31,

2022

2021 1

(audited)

Assets:

Cash, cash equivalents, restricted cash and short-term investments

$

4,540,288

$

6,624,849

Accounts receivable

173,168

483,113

Property and equipment, net

845,946

587,605

Total assets

$

6,379,290

$

8,535,525

Liabilities and equity:

Accounts payable

$

294,781

$

262,400

Accrued expenses and other payables

467,352

558,055

Deferred revenue

255,887

407,703

R&D cost share liability

293,960

390,362

Debt

538,117

629,678

Total liabilities

1,995,935

2,402,962

Total equity

$

4,383,355

$

6,132,563

Condensed Consolidated Statements of Operations (U.S. GAAP)

(Amounts in thousands of U.S. dollars, except for shares, American Depositary Shares (ADSs), per share and per ADS data)

Three Months Ended

December 31,

Twelve Months Ended

December 31,

2022

2021 1

2022

2021 1

(unaudited)

(audited)

Revenue:

Product revenue, net

$

339,022

$

196,785

$

1,254,612

$

633,987

Collaboration revenue

41,073

17,194

161,309

542,296

Total revenues

380,095

213,979

1,415,921

1,176,283

Expenses:

Cost of sales – products

73,522

48,545

286,475

164,906

Research and development

446,023

430,485

1,640,508

1,459,239

Selling, general and administrative

328,984

306,501

1,277,852

990,123

Amortization of intangible assets

188

187

751

750

Total expenses

848,717

785,718

3,205,586

2,615,018

Loss from operations

(468,622

)

(571,739

)

(1,789,665

)

(1,438,735

)

Interest (expense) income, net

18,219

(4,482

)

52,480

(15,757

)

Other (expense) income, net

19,438

(10,583

)

(223,852

)

15,904

Loss before income taxes

(430,965

)

(586,804

)

(1,961,037

)

(1,438,588

)

Income tax expense

14,370

3,874

42,778

19,228

Net loss

(445,335

)

(590,678

)

(2,003,815

)

(1,457,816

)

Less: Net loss attributable to noncontrolling interest

—

—

—

—

Net loss attributable to BeiGene, Ltd.

$

(445,335

)

$

(590,678

)

$

(2,003,815

)

$

(1,457,816

)

Net loss per share attributable to BeiGene, Ltd., basic and diluted

$

(0.33

)

$

(0.48

)

$

(1.49

)

$

(1.21

)

Weighted-average shares outstanding, basic and diluted

1,348,916,108

1,235,346,414

1,340,729,572

1,206,210,049

Net loss per ADS attributable to BeiGene, Ltd., basic and diluted

$

(4.29

)

$

(6.22

)

$

(19.43

)

$

(15.71

)

Weighted-average ADSs outstanding, basic and diluted

103,762,778

95,026,647

103,133,044

92,785,388

[1] We revised certain prior period financial statements for an error related to the valuation of net deferred tax assets, the impact of which was immaterial to our previously filed financial statements in the first and second quarter of 2022 and the quarterly and annual periods of fiscal 2021 (see "Notes to the Consolidated Financial Statements, Note. 2 Summary of Significant Accounting Policies" and "Note 3. Revision of Prior Period Financial Statements" included in our Annual Report on Form 10-K for the fiscal year ended 2022).

BeiGene is a global biotechnology company that is developing and commercializing innovative and affordable oncology medicines to improve treatment outcomes and access for far more 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 more than 9,000 colleagues spans five continents, with administrative offices in Basel; Beijing; and Cambridge, U.S. To learn more about BeiGene, please visit www.beigene.com and follow us on Twitter at @BeiGeneGloba

On February 27, 2023 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance broadening protection of Anixa’s novel breast cancer vaccine technology (Press release, Anixa Biosciences, FEB 27, 2023, View Source [SID1234627713]). This technology was invented and developed at Cleveland Clinic and Anixa is the exclusive worldwide licensee.

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The patent is titled, "Vaccine Adjuvants and Formulations," and the lead inventor is the late Dr. Vincent Tuohy, of Cleveland Clinic. This patent covers additional intellectual property related to the formulation of Anixa’s breast cancer vaccine.

"We are pleased to receive this notice of allowance from the USPTO, confirming additional protection of our breast cancer vaccine technology," stated Dr. Amit Kumar, Chairman and CEO of Anixa. "This breast cancer vaccine has the potential to prevent Triple Negative Breast Cancer ("TNBC"), the deadliest form of breast cancer, and perhaps other forms of breast cancer that express alpha-lactalbumin. With our partners at Cleveland Clinic, we are currently performing clinical trials of this vaccine, and plan to present data from the trial at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April."

About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

About Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences.

On February 27, 2023 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the fourth quarter and year ended December 31, 2022 and provided corporate updates (Press release, Chinook Therapeutics, FEB 27, 2023, View Source [SID1234627712]).

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"During 2022, we made excellent progress across our pipeline, including driving strong enrollment of our phase 3 ALIGN, phase 2 AFFINITY and phase 1/2 BION-1301 clinical trials, generating compelling clinical data from our atrasentan and BION-1301 programs for IgA nephropathy (IgAN), initiating our phase 1 clinical trial of CHK-336 in healthy volunteers and continuing to advance our preclinical programs for rare, severe chronic kidney diseases," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "Our mission at Chinook is to change the course of kidney care by developing therapies that make dialysis and transplant unnecessary for patients living with kidney disease. With our strong financial position and growing team, we look forward to an exciting 2023 when we will be presenting data from all three of our clinical programs at medical conferences, commencing a phase 3 study of BION-1301 in patients with IgAN mid-year and reporting topline proteinuria data from the ongoing phase 3 ALIGN study of atrasentan."

2022 and Recent Accomplishments

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has potential therapeutic benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial is evaluating atrasentan in patients with IgAN and the phase 2 AFFINITY basket trial is evaluating atrasentan in patients with proteinuric glomerular diseases.

Enrollment in the phase 3 ALIGN trial of atrasentan now exceeds 270 patients. The interim proteinuria endpoint analysis will be performed on the first 270 patients enrolled.

In response to review of the statistical analysis plan for the ALIGN trial, Chinook received correspondence from the U.S. Food and Drug Administration (FDA) last week recommending that evaluation of the interim proteinuria endpoint analysis for accelerated approval in the ALIGN trial be delayed from week 24 to week 36. The FDA referenced the likelihood that the later timepoint would allow for a greater amount of eGFR data to be evaluated at the time of accelerated approval. Chinook plans to engage with the FDA as soon as possible to discuss their advice. If Chinook shifts the interim proteinuria endpoint analysis of the ALIGN trial to 36 weeks, topline proteinuria data would be expected in the fourth quarter of 2023. Therefore, Chinook is updating its timing to report topline proteinuria data from the ALIGN trial to the second half of 2023.

Chinook has completed enrollment of the IgAN patient cohort of the AFFINITY trial, and continues to enroll the other cohorts, including patients with focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors. Chinook plans to report additional data from cohorts of the AFFINITY trial in the second half of 2023.

In November 2022, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,491,137, titled, "Methods of Improving Renal Function," which is directed to methods of treating patients with IgAN with atrasentan, and expires in 2040 absent any patent term extensions.

Several presentations on atrasentan were delivered at nephrology conferences throughout 2022, including:

Updated interim data from the IgAN patient cohort of the phase 2 AFFINITY trial demonstrated consistent and clinically meaningful proteinuria reductions in patients with IgAN already on a maximally tolerated and stable dose of a RAS inhibitor. Specifically, atrasentan demonstrated mean reductions in 24-hour urine protein creatinine ratio (UPCR) of 38.1% at six weeks of treatment, 48.3% at 12 weeks of treatment and 54.7% at 24 weeks of treatment. After 24 weeks of treatment, 15 of the 19 patients (79%) who had completed this visit had greater than a 40% reduction in UPCR. There were no meaningful changes in blood pressure or acute eGFR effects, suggesting proteinuria reductions were not primarily due to hemodynamic effects of atrasentan, and there were no increases in BNP or mean bodyweight, suggesting minimal fluid retention. Atrasentan was well-tolerated, with no treatment-related serious adverse events. (ASN Kidney Week 2022)

Preclinical research on single-cell RNA-seq of a mouse model of IgAN, revealing a prominent expansion of failed repair proximal tubular epithelial cells, which was reversed by atrasentan but not by ACE inhibition. (ASN Kidney Week 2022)

Preclinical mechanistic data describing atrasentan’s effect to block mesangial cell injury and the pathogenic transcriptional networks driving IgAN progression in a model system. (59th ERA Congress)

BION-1301

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) has been demonstrated clinically in both healthy volunteers and patients with IgAN.

Chinook has finalized trial design, is conducting site and country feasibility and completing global regulatory interactions to enable initiation of a phase 3 trial of BION-1301 in mid-2023.

Chinook has completed enrollment of 30 patients in Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301. Patients in Cohort 2 receive a subcutaneous (SC) dose of 600 mg of BION-1301 every two weeks. Chinook plans to report additional data from Cohorts 1 and 2 in the first and second half of 2023.

Chinook presented interim data from Cohorts 1 and 2 in a poster presentation at ASN Kidney Week 2022 in November, further demonstrating BION-1301’s disease-modifying potential in IgAN by generating rapid and durable reductions in mechanistic biomarkers and corresponding clinically meaningful proteinuria reductions within three months of initiating treatment, which was consistent across both cohorts.

In Cohort 1, patients transitioned from intravenous (IV) dosing at 450 mg every two weeks to SC dosing at 600 mg every two weeks after at least 24 weeks of treatment. Reductions in IgA and Gd-IgA1 were maintained beyond 52 weeks of treatment. Reductions in IgM, and to a lesser extent IgG, were also observed. BION-1301 demonstrated mean reductions in 24-hour UPCR of 30.4% in seven patients at 12 weeks of treatment, 48.8% in eight patients at 24 weeks of treatment, 66.9% in eight patients at 52 weeks of treatment, 67.4% in four patients at 76 weeks of treatment and 71.0% in two patients at 100 weeks of treatment.

In Cohort 2, SC BION-1301 treatment resulted in rapid and sustained reductions in IgA and Gd-IgA1, IgM, and to a lesser extent IgG, through 24 weeks of treatment, highly consistent with Cohort 1. BION-1301 demonstrated mean reductions in 24-hour UPCR of 28.7% in 15 patients at 12 weeks of treatment and 53.8% in 9 patients at 24 weeks of treatment, similar to reductions observed at the same timepoints in Cohort 1.

In both cohorts, BION-1301 was well-tolerated, with no serious adverse events or treatment discontinuations due to adverse events, and no anti-drug antibodies observed.

BION-1301 was granted orphan drug designation for the treatment of primary IgAN by the European Commission in July 2022.

CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria (PH) and other kidney stone disorders driven by endogenous overproduction of oxalate.

The phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial evaluating CHK-336 in healthy volunteers is ongoing, and initial data from this trial is expected in the first half of 2023.

Chinook presented a poster on CHK-336 at ASN Kidney Week 2022, demonstrating preclinical efficacy in PH1 and PH2 mouse models, and the potential for benefit in non-genetic hyperoxalurias caused by oxalate overproduction was also described.

Precision Medicine Research & Discovery
Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths. Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates. Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.

Chinook delivered an oral presentation at ASN Kidney Week 2022 in November on a multi-omics approach to the characterization of IgAN in the NURTuRE cohort, integrating clinical, histological, transcriptomic and serum proteomic data to gain deeper insights into patient stratification and IgAN disease pathogenesis. Also at ASN, Chinook presented a poster in collaboration with Evotec on a human data-driven, patient-centric and multi-omics-enabled target identification framework focused on common cellular and molecular mechanisms of CKD by leveraging the NURTuRE and QUOD patient cohorts.

Chinook delivered an oral presentation at the 59th ERA Congress in May 2022 on the approach used in collaboration with Evotec to leverage the NURTuRE CKD biobank to generate mechanistic disease understanding for patient-centric, integrated target and biomarker discovery that will enable the development of novel precision treatments for CKD patient subsets.

Corporate

Chinook recently announced the appointment of Andrew Oxtoby as Chief Commercial Officer. Under Andrew’s leadership, Chinook will develop its go-to-market strategy and build a commercial organization in preparation

for the potential launch of atrasentan and future pipeline products. Andrew brings to Chinook over 20 years of experience in marketing, sales, finance and commercial leadership roles at Aimmune Therapeutics and Eli Lilly and Company.

Sairopa B.V. (Sairopa) entered into an exclusive agreement with Exelixis, Inc. in November 2022 for the development of ADU-1805, a monoclonal antibody targeting SIRPα, and received an upfront payment of $40.0 million. The U.S. Food and Drug Administration (FDA) recently cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors, which triggers a $35.0 million milestone payment that will be paid to Sairopa in the first quarter of 2023. Under the terms of the agreement, Sairopa is eligible to receive additional payments if Exelixis exercises its option and upon achievement of specified development, commercial and net sales milestones, as well as tiered royalties on net sales worldwide. As of December 31, 2022, Chinook owned approximately a 36% interest in Sairopa and has one seat on its board of directors. Chinook will hold its shares in Sairopa until there is a liquidation event, at which time, in accordance with the CVR agreement, 50% of any net proceeds will accrue to the benefit of the CVR holders, net of deductions permitted, including taxes and certain other expenses.

Chinook closed a $120.7 million public offering in May 2022, which included the exercise in full of the underwriters’ option to purchase additional shares of common stock.

Chinook announced an outreach initiative in collaboration with the IgA Nephropathy Foundation and Komodo Health in April 2022, leveraging data and technology to drive awareness of IgAN and engage key medical providers at nephrology practices across the U.S., with the goal of ensuring patients have access to optimal support and treatment options earlier in their disease journey.

Fourth Quarter and Full Year Ended December 31, 2022 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $385.3 million as of December 31, 2022, compared to $355.1 million as of December 31, 2021.

Revenue – Revenue for the quarter and year ended December 31, 2022 was $0.5 million and $6.1 million, respectively, compared to $51.2 million and $51.6 million for the same periods in 2021. The higher revenue amounts in 2021 were primarily due to $41.2 million non-cash revenue recognized under Chinook’s license agreement with SanReno Therapeutics and a $10.0 million milestone payment earned under the collaboration agreement with Merck.

Expenses –

Research and development expenses for the quarter and year ended December 31, 2022 were $43.0 million and $141.2 million, respectively, compared to $24.9 million and $97.0 million, respectively, for the same periods in 2021. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, an increase in licensing and contract research and manufacturing costs, consulting and outside services fees, as well as facilities and other costs to continue the progression of our research and clinical programs.

General and administrative expenses for the quarter and year ended December 31, 2022 were $9.8 million and $36.3 million, respectively, compared to $7.7 million and $31.9 million, respectively, for the same periods in 2021. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, higher consulting and outside services costs to support our operations, and other costs. These increases were partially offset by a decrease in facilities costs.

The change in fair value of contingent consideration and contingent value rights liabilities for the quarter and year ended December 31, 2022 resulted in expenses of $7.3 million and $12.0 million, respectively, compared to expenses of $5.8 million and $27.3 million, respectively, for the same periods in 2021. The increase in these non-cash expenses in the quarter ended December 31, 2022 was primarily due to an increase in the fair value of the contingent value rights liability related to the preferred shares in Sairopa mainly as a result of Sairopa entering into a license agreement with Exelixis in November 2022. The decrease in the year ended December 31, 2022 was primarily due to a higher fair value in 2021 that included the impact of earning a milestone payment under the license agreement with Merck.

Net Loss – Net loss for the quarter ended December 31, 2022 was $62.6 million, or $0.90 per share, compared to net income of $7.5 million, or $0.15 per basic share for the same period in 2021. Net loss for the year ended December 31, 2022 was $187.9 million, or $2.92 per share, compared to $102.9 million, or $2.26 per share for the same period in 2021.

On February 26, 2023 Amgen reported the company and BeiGene entered into a Second Amendment to the Collaboration Agreement ("Amendment") (Filing, Amgen, FEB 26, 2023, View Source [SID1234648536]). This Amendment amends that certain Collaboration Agreement, entered into as of October 31, 2019 (as amended from time to time, the "Agreement"), by and between Amgen and BeiGene and, solely with respect to Section 13.6 thereof, BeiGene Parent. Capitalized terms used but not defined herein have the meanings given to them in the Agreement.
RECITALS
WHEREAS, pursuant to the Agreement, Amgen and BeiGene collaborate on the commercialization of certain Products (as defined in the Agreement) in the Collaboration Territory (as defined in the Agreement) and the global development funding and clinical development and commercialization of certain clinical-stage pipeline Products in the Collaboration Territory; and
WHEREAS, the Parties desire to enter into this Amendment, upon the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties, intending to be legally bound hereby, do agree as follows:

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1.Amendment to Section 1.13. Section 1.13 of the Agreement is hereby amended by adding the following language at the end of the existing Section 1.13:
"Amgen Pipeline Product Global Development Costs shall not include Costs incurred by Amgen during the period starting on January 1, 2023 and ending on August 31, 2023 to the extent such Costs are attributable to AMG 510 (also known as sotorasib or LUMAKRAS)."
2.Amendment to Section 1.28. Section 1.28 of the Agreement is hereby amended by adding the following language at the end of the existing Section 1.28:
"BeiGene Pipeline Product Development Costs shall not include Costs incurred by BeiGene during the period starting on January 1, 2023 and ending on August 31, 2023 to the extent such Costs are attributable to AMG 510 (also known as sotorasib or LUMAKRAS)."
3.New Section 1.174. The following is hereby inserted as a new Section 1.174 of the Agreement:
"Section 1.174 "Tianjin" means the Pilot Zone in the Tianjin province."
4.New Section 1.175. The following is hereby inserted as a new Section 1.175 of the Agreement:
"Section 1.175 "Tianjin Support Costs" means all actual and, if reasonably practicable, [*]
5.Amendment to Section 5.1.4. Section 5.1.4 of the Agreement is hereby amended and restated in its entirety as follows:
"Section 5.1.4 Reversion of In-Line Products and Pipeline Products. In order to memorialize and effectuate the reversion of Product rights to Amgen pursuant to Sections 5.1.2 and 5.1.3 and Sections 14.6 and 14.9, the Parties shall, within forty-five (45) months following the Effective Date, enter into, execute and deliver a Master Reverse Transition Services Agreement with Product-specific addendums to be entered into at least twenty-four (24) months prior to the expected Product Reversion date (each a "Reverse Transition Services Agreement"), consistent with the scope of the Product Reversion Transition Services Schedule attached hereto, with such changes, if any, as may be mutually agreed by the Parties, including any changes to the Product Reversion Transition Services Schedule as each Party, using its reasonable best efforts, shall negotiate and supplement or finalize. The Parties shall begin good faith negotiations regarding each Reverse Transition Services Agreement at least thirty (30) months prior to the expected Product Reversion Date for the applicable Product."
6.Amendment to Section 7.2.3(b). Section 7.2.3(b) of the Agreement is hereby amended by adding the following to the end of the existing Section 7.2.3(b):
"The table below sets out the 2022 and 2023 baseline budget for Product Team/Work Package Team strategy FTEs based on the Pipeline Product portfolio as of the Second Amendment Effective Date: [*]
7.Amendment to Section 7.2.3(c). Section 7.2.3(c) of the Agreement is hereby amended and restated in its entirety as follows:
"(c) The Product Team and Work Package Team FTE allocation for Pipeline Products will be adjusted by Amgen [*] based on relevant factors, [*]. Such adjusted allocations shall be reflected in the records of the JSC or other governance committee or team."
8.Amendment to Section 7.2.8. Section 7.2.8 (Hainan Bo Ao Cost-Share Matters) of the Agreement is hereby amended and restated in its entirety as follows:

"Section 7.2.8 Early Access Program Cost-Share Matters. Notwithstanding anything to the contrary in this Agreement, with respect to the AMG 510 (also known as sotorasib or LUMAKRAS) Product (as applicable, the "Bo Ao Product," the "Tianjin Product" or, the "Early Access Product"), the Parties desire to initiate the Profit-sharing arrangement set forth in Section 7.2 prior to applicable Initiation Date, subject to the following terms and conditions:
(a) Commercialization and Related Costs. Prior to the applicable Initiation Date, costs (including Costs for outside services and expenses (e.g., consultants, agency fees, etc.)) for the following activities shall be considered "Commercialization and Related Costs" for purposes of determining "Amgen Costs" or "BeiGene Costs," as applicable:
(i) [*];
(ii) Medical Affairs Activities Costs incurred in connection with Hainan Bo Ao and Tianjin in or for the Collaboration Territory prior to commercialization and during commercialization;
(iii) all Costs incurred by the Parties or their respective Affiliates associated with any recalls of the Early Access Product in the Collaboration Scope and in or for the Collaboration Territory;
(iv) all Costs incurred by the Parties or their respective Affiliates with respect to product liability claims for the Early Access Product in the Collaboration Scope in the Collaboration Territory;
(v) all Costs incurred by the Parties or their respective Affiliates associated with any returns and withdrawals of the Early Access Product in the Collaboration Scope in the Collaboration Territory;
(vi) any Third Party IP Payments to the extent not already included in Manufacturing Actual Costs; and
(viii) all unrecovered Indirect taxes, including, for the avoidance of doubt, unrecovered VAT surcharge, incurred by either Party arising with respect to payments to be made under Section 7.2.7 (Calculation of Collaboration Profits).
[*]
Commercialization and Related Costs for purposes of this Section 7.2.8 shall not include [*] or any Cost subject to an indemnification obligation under Article XIII.
(b) Manufacturing Actual Costs. The Manufacturing Actual Costs incurred with respect to the Early Access Product in connection with Hainan Bo Ao or Tianjin, as applicable, shall be deemed "Amgen Costs" for purposes of the calculations set forth under Section 7.2 (Profit Sharing).
(c) Net Revenues. Net Revenues from the sale or transfer for value of the Early Access Product in Hainan Bo Ao or Tianjin, as applicable, shall be considered "Net Revenues" for purpose of Section 7.2 (Profit Sharing).
(d) Support Costs. Bo Ao Support Costs and Tianjin Support Costs incurred with respect to the applicable Early Access Product in connection with Hainan Bo Ao or Tianjin, as

applicable, shall be deemed "Amgen Costs" for purposes of the calculations set forth under Section 7.2 (Profit Sharing)."
9.New Section 7.2.9. The following is hereby inserted as a new Section 7.2.9 of the Agreement:
10.Amendment to Section 7.2. Section 7.2 (Profit Sharing) of the Agreement is hereby amended and restated by adding a new Section 7.2(d):
"Section 7.2.9 Adjustments. Notwithstanding anything to the contrary in this Agreement, within fifty (50) days following December 31, 2023, BeiGene shall deliver to Amgen a statement setting forth, in reasonable detail, [*] (the "Restated Operating Income") [*]. Amgen shall review the calculations delivered by BeiGene and Amgen shall notify BeiGene of any disagreement with the calculations. In the event of a disagreement between the Parties with respect to the Restated Operating Income, the Parties shall cooperate in good faith to resolve such disagreement, and any unresolved disagreements shall be addressed through Section 15.4 of this Agreement. If the agreed-upon Restated Operating Income is a negative number, Amgen shall deliver an invoice to BeiGene setting forth the amount (the "Adjustment Amount") equal to [*] of the absolute value of the Restated Operating Income and BeiGene shall make a payment to Amgen in the amount of the Adjustment Amount, which payment shall be made in accordance with the provisions of Article VIII (Payments)."
11.New Section 11.8. The following is hereby inserted as a new Section 11.8 of the Agreement:
"Section 11.8 Additional Restrictions. With respect to clinical and regulatory information or data belonging to Amgen or a Third Party pertaining to the development of one or more Products in combination with pembrolizumab (such information, the "Amgen Proprietary Information"), the following shall apply:
11.8.1 Designated Personnel.
(a) BeiGene hereby designates the regulatory, clinical, commercial and other personnel (including relevant personnel of its Affiliates and Third Party consultants and contractors) listed on the Designated Personnel Schedule, attached hereto and incorporated herein by this reference, as the designated personnel ("Designated Personnel" and, each, a "Designated Person") to receive Amgen Proprietary Information. Amgen shall ensure storage and use of personal information contained in the Designated Personnel Schedule strictly in observance of and in compliance with Applicable Law on data protection and privacy, consistent with the obligations set out in Section 12.5 (Privacy and Data Protection). BeiGene may, at any time upon written notice to Amgen, revise the Designated Personnel Schedule as reasonably necessary to add Designated Personnel who will be responsible for conducting regulatory activities under the Collaboration Agreement on behalf of BeiGene and to remove Designated Personnel who are no longer responsible for conducting regulatory activities under the Collaboration Agreement on behalf of BeiGene; provided, however, that BeiGene may not disclose any Amgen Proprietary Information to any such new Designated Personnel prior to updating such Designated Personnel Schedule listing such new Designated Personnel and delivering such revised Designated Personnel Schedule to Amgen. BeiGene shall provide Amgen with an updated Designated Personnel Schedule at the end of each semi-annual period ending June 30 and December 31 and at such earlier times as personnel are assigned to receive Amgen Proprietary Information (e.g., upon new employees joining BeiGene in a relevant capacity) and such Designated Personnel Schedule shall cumulatively set out all updates of Designated Personnel Schedule made by BeiGene in such semi-annual period.

(b) BeiGene shall be bound by, and shall ensure that each Designated Person is bound by, restrictions on use and disclosure of any Amgen Proprietary Information it receives consistent with the confidentiality obligations under Article XI (Confidentiality) (including, without limitation, Section 11.1 (Confidentiality; Exceptions)), and BeiGene shall be responsible for each Designated Person’s compliance with such restrictions, as follows:
i.During the Term and for [*] thereafter, each Designated Person (regardless of the date such Designated Person was removed from the list of Designated Personnel) shall keep confidential all Amgen Proprietary Information and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Section 11.8 any Amgen Proprietary Information.
ii.Each Designated Person may use and access such Amgen Proprietary Information solely for the purposes of carrying out the applicable responsibilities of BeiGene under this Agreement, including disclosing such information to the extent reasonably necessary to other Designated Personnel and the relevant Governmental Authority, and, except as permitted under this Section 11.8.1(b)(ii), such Designated Personnel shall not disclose such Amgen Proprietary Information to any other personnel of BeiGene or its Affiliates, including, without limitation, its or their respective Representatives or any Third Party (including any partner or collaborator), for any purpose. For the avoidance of doubt, each Designated Person may not disclose Amgen Proprietary Information to any Third Party Collaboration Personnel (as defined below).
iii.The obligations of nondisclosure and the limitations upon the right to use such Amgen Proprietary Information under this Section 11.8 will not apply to the extent that BeiGene can demonstrate that such Amgen Proprietary Information: (A) was obtained or was already known by BeiGene or its Affiliates without obligation of confidentiality as a result of disclosure from a Third Party that BeiGene did not know, after due inquiry, was under an obligation of confidentiality to Amgen with respect to such information, (B) was generally available to the public or otherwise part of the public domain at the time of its disclosure to BeiGene through no act or omission of BeiGene or its Affiliates or Representatives in breach of this Agreement, (C) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of BeiGene or its Affiliates or Representatives in breach of this Agreement or (D) was independently discovered or developed by BeiGene or its Affiliates (without reference to or use of Amgen Proprietary Information or Confidential Information of Amgen).
11.8.2 Third Party Collaborations.
(a) BeiGene agrees that individuals that will receive information from and engage with [*] or any of its Affiliates pursuant to [*], by and between BeiGene and [*], with respect to any proposed and/or approved [*] (as defined in the [*] Agreement) involving a proprietary product that would be a Distracting Product under this Agreement if developed by BeiGene (such individuals, the "Third Party Collaboration Personnel" and, each, a "Third Party Collaboration Person", and such [*], a "Restricted Study") shall not have access to any Amgen Proprietary Information or Confidential Information of Amgen without Amgen’s prior written consent. In no event shall any individual that is or has been a Designated Person or any BeiGene personnel that

have had access to Amgen proprietary clinical, regulatory, and strategic information or data pertaining to Amgen’s global development and commercialization of the Products be classified as a Third Party Collaboration Person.
(b) BeiGene shall not provide any input, advice, feedback, comments, or guidance to [*] or its Affiliates in connection with any Restricted Study; provided, however, that the foregoing shall not restrict the Third Party Collaboration Personnel’s ability to provide comments to a proposed protocol for a Restricted Study to the extent such comments relate solely to patient safety.
11.8.3 Compliance with Section 11.8.
(a) On or before January 15 and July 15 of each calendar year, BeiGene will certify its compliance with the terms of this Section 11.8, including, but not limited to, confirmation that each Designated Person has been made aware of the requirements and restrictions applicable to such Designated Person under this Agreement and that the Designated Personnel Schedule attached hereto are accurate as of such certification date, by providing written confirmation to Amgen in a form acceptable to Amgen.
(b) Upon the written request and reasonable notice of Amgen and not more than once in each calendar year, Amgen shall have the right, at its own expense, to have access (directly or through a Third Party consultant) during normal business hours to records and related systems that are reasonably necessary to assess BeiGene’ compliance with this Section 11.8 to review such records and related systems of BeiGene and any relevant Affiliates solely for the purpose of assessing BeiGene’s compliance with the terms of this Section 11.8."
12.Amendment to Section 12.5: Section 12.5 (Privacy and Data Protection) of the Agreement is hereby amended and restated in its entirety as follows:
"12.5 Data Protection and Privacy.
(a) Generally. Each Party agrees that it determines the purpose and means of processing Personal Data, and, as such, each Party is: (i) acting as a "controller" (as defined under the GDPR and other Applicable Law) of such information and shall be responsible for its own "processing" activities and the activities of its "processors" (as defined under GDPR and other Applicable Law), and (ii) shall comply with GDPR and all applicable Data Protection Laws applicable to a controller, which shall include without limitation employing and maintaining appropriate Security to protect such data. "Security" means technological, physical and administrative controls, including, but not limited to, policies, procedures, organizational structures, hardware and software functions, as well as physical security measures, the purpose of which is, in whole or part, to ensure the confidentiality, integrity or availability of Personal Data. For purposes of this Agreement, (1) "Data Protection Laws" means, as in effect from time to time, with respect to the processing of Personal Data, the applicable data privacy laws of the applicable jurisdiction, including without limitation the European Union General Data Protection Regulation (Regulation (EU) 2016/679) ("GDPR"), together with any national implementing laws in any Member State of the European Union or, to the extent applicable, in any other country, as amended, repealed, consolidated or replaced from time to time and all data breach notification and information security laws and regulations specific thereto and (2) "Personal Data" means any information that relates to, describes or is capable of being associated with or linked to an individual, by direct or indirect means, including without limitation classes, categories and other types of information that may identify an individual as specified by Applicable Law.
(b) Data Transfers. If, in connection with this Agreement or the Safety Agreement, either Party is required to transfer or otherwise disclose to the other Party Personal Data that has not been de-identified or anonymized in accordance with applicable Data Protection Laws (e.g., in connection with the Safety Agreement), the Parties agree to comply with the following:

i.In the event of the actual or reasonably suspected unauthorized access, acquisition, alteration, and/or deletion of Personal Data, collected or otherwise processed under this Agreement, resulting from a breach or violation of Security, each Party shall notify the other, in accordance with the Information Security Schedule, of such incident without undue delay (but in no event later than [*] after discovery). In such event, each Party shall be responsible for fulfilling any reporting and notification obligations required under GDPR and other Applicable Law (inclusive of Data Protection Laws) with regard to the data processing operations it carries out.
ii.The Parties hereby incorporate the EU Standard Contractual Clauses necessary to effectuate the compliant transfer of EU/EEA/UK/Swiss Personal Data outside of EU/EEA/UK/Switzerland to any jurisdiction that does not ensure an adequate level of data protection within the meaning of Data Protection Laws, which Clauses are attached hereto as the Schedule titled "Privacy and Data Protection." In addition, the Parties agree to cooperate with each to effectuate the compliant transfer of Personal Data applicable to other jurisdictions, which may include executing additional data transfer agreements.
iii.The Parties shall notify each other without undue delay (but in no event later [*] after receipt) in the event a data subject included in the Data asserts one of his/her rights under GDPR and Applicable Law (inclusive of Data Protection Laws). Any such notifications shall be made in a pseudonymous form using the subject’s trial-specific identification number only. If necessary and appropriate, the Parties shall reasonably cooperate with each other by providing the necessary information to ensure full and effective implementation of the rights of the data subject. Notification required under this Section shall be made as follows:
Amgen: [*]
BeiGene: [*]
iv.To the extent required under GDPR and Applicable Law (inclusive of Data Protection Laws) and upon a Party’s reasonable request, the other Party shall make available to the requesting Party documentation reasonably necessary to demonstrate the other Party’s compliance with its obligations under GDPR and Applicable Law (inclusive of Data Protection Laws) and such Party’s obligations set out in this Agreement."
13.Amendment to Schedule: The Schedule to the Agreement titled "Privacy and Data Protection" is amended and restated in its entirety in the form attached to this Amendment as Exhibit A and is deemed entered into as of the date of this Amendment.
14.Addition of New Schedules.
(a)A new schedule titled "Designated Personnel Schedule" in the form attached to this Amendment as Exhibit B is hereby added to the Agreement.
15.Select Products.
a.The Parties agree that AMG 701 shall be deemed terminated from the Agreement effective as of December 4, 2022.

b.The Parties shall cooperate with one another in good faith to prepare a transition plan by [*] and such other documentation as may be necessary or useful in connection with the anticipated termination of AMG 510 (also known as sotorasib or LUMAKRAS) from the Agreement; provided, however, that if a further amendment to the Agreement is required in connection with such termination, the Parties shall cooperate with one another in good faith to finalize such amendment by June 30, 2023. The Parties anticipate terminating AMG 510 (also known as sotorasib or LUMAKRAS) from the Agreement by [*].
16.Miscellaneous.
(a)Except as specifically amended above, the Agreement shall continue to be in full force and effect.
(b)This Amendment and its effect are subject to and shall be construed and enforced in accordance with the laws of the State of New York, U.S.A.
(c)This Amendment may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Amendment may be exchanged by facsimile or other electronic means without affecting the validity thereof.

On February 25, 2023, Wuhan Binhui Biotechnology reported its first oncolytic virus candidate drug recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection (Vero cells) was approved by the State Drug Administration (Press release, Binhui Biotechnology, FEB 25, 2023, View Source [SID1234633513]). Approved by the Center for Evaluation (CDE), included in breakthrough therapy varieties.

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01 "High-speed channel" for drug listing

On July 1, 2020, the newly revised "Measures for the Administration of Drug Registration" was officially implemented. In particular, a chapter on accelerated drug market registration procedures was added, and four fast-track drug reviews were established: breakthrough therapy drugs, conditional approval, priority review and approval, and special approval. Channels to encourage innovation and meet urgent clinical needs. The "Breakthrough Therapy Drug Review Work Procedures (Trial)" also clarified: the Center for Drug Evaluation shall communicate and exchange resources for the priority allocation of drugs included in the breakthrough therapy drug program, strengthen guidance and promote drug research and development; applicants that meet the relevant conditions after evaluation , and may also submit a conditional approval application and a priority review application when applying for a drug marketing authorization.

02 Approved gold standard | Outstanding clinical data

The general idea of ​​the breakthrough therapy drug review process is in line with international standards, and it is benchmarked against FDA Fast Track (FastTrack) and Breakthrough Therapy (Breakthrough Therapy). It is suitable for the prevention and treatment of diseases that are seriously life-threatening or seriously affect the quality of life, and there is no effective treatment Methods or innovative drugs or improved new drugs that have sufficient evidence to show that they have obvious clinical advantages compared with existing treatments. Drugs in clinical trials must have obvious clinical advantages and significant improvement in one or more clinically meaningful endpoints before they can apply for the breakthrough therapy drug program.

03 OH2 Injection | The first oncolytic virus breakthrough treatment product

Owning independent intellectual property rights, the industry-leading Binhui Bio-oncolytic virus (oHSV2) immunotherapy platform is the only industry-university-research integrated research platform in China that develops oncolytic virus products in a fully closed loop. OH2 injection, as the first candidate drug developed by the platform, is the first oncolytic virus independently developed in China to obtain FDA orphan drug designation; it is the first national major new drug creation project of oncolytic virus to enter confirmatory phase III clinical research and the first oncolytic virus to be included in a breakthrough therapy category.