Product revenue for the fourth quarter of 2021 was $196.8 million, up 96.6% from $100.1 million in the year-ago quarter;
Full-year product revenue was $634.0 million, up 105.3% from $308.9 million in the previous year
BEIJING, USA, Feb. 25, 2022 /PRNewswire/ -- BeiGene (NASDAQ: BGNE; HKEx: 06160; SSE: 688235) is a science-based, global biotechnology company focused on developing innovative, affordable medicines to improve outcomes and accessibility for patients around the world. The Company today announced its fourth quarter and full year 2021 financial results, recent business highlights and anticipated milestones.
Mr. John V. Oyler, Co-Founder, Chairman and CEO of BeiGene, said, "2021 is a transformative year for BeiGene, and the strategic competitive advantage we have built will further help us achieve our company mission to bring more accessible and affordable innovative medicines to patients around the world. This year, with the approval of Baiyueze ® in 45 markets, the coverage of our products in the global market has increased significantly; in China, we have 16 approved drugs, including Bai Zean ®, which has been approved for 6 indications, and 5 approved anti-tumor drugs that are licensed from Novartis to begin commercialization in designated regions in China after completing the business transition with Novartis. With multiple core medicines, we have built a strong portfolio of products that will support us in further developing more potential innovative therapies in the future." Among them, the pace of globalization of Baiyueze ® is breaking through, and its application for marketing authorization for the most common adult leukemia, chronic lymphocytic leukemia (CLL), has been accepted in the United States and the European Union. In addition, we continue to deepen our fruitful collaboration with Novartis to further enter into options, collaborations and licensing agreements to advance the development and commercialization of one of the most advanced anti-TIGIT antibodies, ociperlimab. ”
Ms. Wang Aijun, Chief Financial Officer of BeiGene, said: "In the context of rising costs of capital across the industry, we have established a strong and robust financial performance and advantageous position. In 2021, we added more than $4 billion in cash reserves, mainly from the initial public offering of shares on the Star Market, the advance payment with Novartis on Bai Zean ®, and the additional $300 million in advance payment from our partnership with Novartis on TIGIT in early 2022. This cooperation with Novartis also once again validates our R&D capabilities. Our commercialization team also continues to make efforts to achieve a significant increase in product revenue through the commercialization of independently developed products and cooperatively introduced products. With the approval of listing applications and the promotion of milestones, we expect the company's revenue to increase further significantly. We continue to build up our in-house clinical development and production capabilities to bring cost advantages to the company and manage expenses through an efficient internal system. ”
Cash, cash equivalents, restricted funds and short-term investments : $6.62 billion as of December 31, 2021, compared to $3.92 billion as of September 30, 2021 and $4.66 billion as of December 31, 2020. Cash and cash equivalents as of December 31, 2021 do not include an advance payment of $300 million received from Novartis in January 2022 for the opt-in, cooperation and licensing agreement for Osperiblor.- Total cash and short-term investments increased by US$2.7 billion in the fourth quarter of 2021, cash expenditure from operating activities was US$507.8 million, capital expenditure was US$115 million, and cash raised from financing activities was US$3.4 billion, almost all from net proceeds raised from the sci-tech innovation board offering on December 15, 2021.
- For the full year 2021, total cash and short-term investments increased by $2 billion, cash expenditure from operating activities was $1.3 billion, capital expenditure was $262.9 million, and cash raised from financing activities was $3.6 billion, mainly from net proceeds from the sci-tech board issuance on December 15, 2021.
Revenue for the fourth quarter of 2021 was $214 million and full-year revenue was $1.2 billion. Revenue for the year-ago quarter was $100.1 million and $308.9 million, respectively. Compared to the same period last year, the increase in total revenue in the fourth quarter was mainly due to sales revenue from the company's self-developed products, sales revenue from the authorized introduction of products by Amgen and Bristol-Myers Squibb, and revenue from the cooperation agreement with Novartis.
- Total product revenue for the fourth quarter of 2021 was $196.8 million and full-year product revenue was $634.0 million. Total product revenue for the year-ago quarter was $100.1 million and $308.9 million, respectively. Product revenue includes:
– Baiyueze's ® global sales for the fourth quarter and full year of 2021 were US$87.6 million and US$218.0 million, respectively. Sales for the year-ago quarter were $18.3 million and $41.7 million, respectively. Of the full year 2020 revenue, the revenue from Baiyueze ® consists of its sales since its listing in China in June 2020, as well as its annual sales in the United States;
– Bai Zean's ® sales in China for the fourth quarter and full year of 2021 were US$54.4 million and US$255.1 million, respectively. In the year-ago quarter, sales were $63.5 million and $163.4 million, respectively. Bai Zean's sales in the fourth quarter were affected by the 2022 price reduction of China's ® National Medicare Drug List (NRDL), resulting in a negative adjustment of $25.4 million. As some of the products sold at pre-Medicare prices were still in the distribution channel during the quarter, we compensated distributors for existing products sold at pre-Medicare prices in the distribution channels in accordance with PRC policy requirements. As a result of Bai zean being ® listed in NRDL twice in March 2021 and January 2022, Bai Zean's ® full-year sales for 2021 include two negative adjustments totaling $45.6 million for distributor inventory compensation. Bai Zean's ® full-year 2020 revenue is composed of its sales after its listing in China in March 2020;
– Bristol-Myers Squibb Authorized to Sell Products in China generated sales of $29.9 million and $89.7 million for the fourth quarter and full year of 2021, respectively. In comparison, sales for the same period last year were $12.6 million and $95.1 million, respectively;
– Amgen authorized to sell products in China generated sales of US$20.3 million and US$58.8 million for the fourth quarter and full year of 2021, respectively. In comparison, sales for the same period last year were $5.4 million and $8.5 million, respectively. BeiGene began selling Amgen's Agave ® (dishuzumab) and Bellito (Berintoo monoclonal ®) products in July 2020 and August 2021, respectively.
- Partnership revenue for the fourth quarter and full year 2021 was $17.2 million and $542.3 million, respectively, primarily from revenue recognition of $650 million in cooperative advances with Novartis for Broadeyam ® in the first quarter of 2021 and $300 million in advances for Osperlimonasumab in the fourth quarter of 2021. In 2020, the company has no revenue from cooperative projects.
Expenses for the fourth quarter and full year 2021 were $785.7 million and $2.6 billion, respectively, compared to expenses of $585 million and $2 billion for the same period last year, respectively.
- Cost of Sales: Cost of sales was $48.5 million and $164.9 million for the fourth quarter and full year 2021, compared to $21.1 million and $70.7 million for the same period last year, respectively. The increase in cost of sales was mainly due to the increase in the scale of product sales of Bai ZeAn ®, Bai Yue Ze ® and An jia Wei ®, as well as expenses arising from the sale of Belito ® that began in August 2021.
- R&D expenses : R&D expenses were $430.5 million and $1.5 billion for the fourth quarter and full year 2021, compared to $355.5 million and $1.3 billion for the same period last year, respectively. The increase in R&D expenses was primarily due to an increase in the number of employees and an increase in investment in drug discovery and clinical development, including continued investment in internal research and clinical development activities; some of the increase in R&D expenses was offset by lower costs for related clinical trials in Therawig ®, Bai zean ® and Bahui ze ® clinical trials, as well as by the decrease in upfront costs associated with ongoing R&D projects. In the fourth quarter and full year of 2021, ongoing advance payments related to the authorized introduction of drug candidates for R&D were $30 million and $83.5 million, respectively, compared to $0 and $109.5 million for the same period last year. In addition, R&D-related equity award expenses have also led to an overall increase in R&D expenses. R&D-related equity-based compensation expense was $30.6 million and $114.4 million, respectively, for the fourth quarter and full year 2021, compared to $23.5 million and $93 million for the same period last year, with the increase in expense attributable to increased headcount and share price.
- Sales, General & Administration ( SG&A Cost: SG&A expenses were $306.5 million and $990.1 million for the fourth quarter and full year 2021, compared to $208.2 million and $600.2 million for the same period last year, respectively. The increase in SG&A expenses was primarily attributable to the increase in the number of employees, much of which came from continued expansion of the commercial team size, higher professional services fees, and increased external commercial expenses including sales and marketing, market access research and promotional activities. The increase in SG&A-related equity-based compensation expense also led to an overall increase in SG&A expenses. SG&A-related share-based compensation expense was $32.4 million and $126.4 million, respectively, for the fourth quarter and full year 2021, compared to $26 million and $90.5 million for the same period last year, and the increase in this expense was attributable to increased headcount and share price.
- Net loss : Net losses for the fourth quarter and full year 2021 were $585.7 million and $1.4 billion, respectively, losses of $0.47 and $1.17 per share, or losses of $6.16 and $15.23 per American Depositary Shares (ADS), compared to $472.7 million and $1.6 billion, or losses per share, or $0.40 and $19.13 per share, respectively, for the year-ago quarter.
- Compared with the same period of the previous year, product sales in the fourth quarter of 2021 increased by 96.6%, and product sales increased by 105.3% for the whole year, mainly due to the sales growth of the company's self-developed products and amgen authorized products;
- For the fourth quarter and full year of 2021, Baiyueze's ® global sales were $87.6 million and $218.0 million, respectively, an increase of 378% and 423% compared to the same period last year. In the U.S., Baiyueze ® had fourth-quarter sales of $55.9 million and full-year sales of $115.7 million, up 539% and 535%, respectively, from the same period last year. Continued sales growth in the U.S. during the quarter was driven by continued penetration of the sleeve cell lymphoma (MCL) market and recent FDA approval for Fahrenhet macroglobulinemia (WM) and marginal lymphoma (MZL) indications. In China, Baiyueze's ® fourth-quarter sales were $30.6 million, compared to $101.2 million for the full year, representing growth of 219% and 331%, respectively, compared to the same period last year, driven by significant increases in sales in a number of approved indication areas, including chronic lymphocytic leukemia (CLL), and $4.4 million and $7.9 million in accrued compensation to distributors in March 2021 and January 2022 due to price changes resulting from the inclusion of NRDL , which had a certain negative impact on Baiyueze's ® sales in China in the fourth quarter and full year of 2021;
- In the fourth quarter of 2021, Bai Zean's ® sales in China were US$54.4 million, down 14% from the same period last year, and Bai Zean's ® sales in China for the whole of 2021 were US$255.1 million, an increase of 56% compared to the same period of the previous year. In the fourth quarter, the increase in patient demand, the further expansion of the sales team and the increase in the number of drug admissions brought about by the expansion of the scope of medical insurance reimbursement continued to promote the increase in market penetration and market share of Bai Zean ®;
- Continue to build commercialization capabilities in designated areas in China ("broad markets") to meet the growing demand for medicines. We entered into a new cooperation agreement with Novartis, whereby BeiGene obtained authorization to promote and sell five anti-tumor products that Novartis has approved and qualified for national health insurance reimbursement. These products include: Teflon ® (darafenib), meginen ® (trimetinib), Vinquante ® (Pazopanib), fetil ® (everolimus) and Zaanda ® (seritinib);
- Promote the declaration of eligible drugs/indications and successfully include them in the National Medical Insurance Drug Catalogue (NRDL) of China, including Bai Zean ® for the treatment of first-line non-squamous non-small cell lung cancer (NSCLC), first-line squamous NSCLC, second- or third-line therapy for hepatocellular carcinoma (HCC), Baiyueze ® for the treatment of Fahrenheit macroglobulinemia (WM); and Parkway Ze ® for the treatment of advanced ovarian cancer with germline BRCA (gBRCA) mutations that have received at least second-line chemotherapy in the past, Tubal or primary peritoneal cancer;
- Our China commercialization team continues to focus on bringing new products to market, achieving successful launches of Kaiserbay ® and Pubexi ® in the fourth quarter.
Zebutinib ®: A small molecule Bruton's tyrosine kinase (BTK) inhibitor designed to maximize BTK share and minimize off-target effects, has been approved for multiple indications in 45 markets including the United States, China, the European Union, the United Kingdom, Canada and Australia, and is currently undergoing further clinical development to obtain additional market approvals worldwide. Baiyueze's ® global clinical development program has enrolled nearly 4,000 participants in more than 25 countries and regions.
- Announcing that the U.S. FDA has accepted a marketing application for a new indication for the treatment of ® adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), based on data from two key randomized trials: data from the ALPINE Phase 3 trial (NCT03734016) presented at the 26th Annual Meeting of the European Association of Haematology (EHA 2021) network in June 2021, and data from the SEQUOIA Phase 3 trial (NCT03336333) presented at the 63rd Annual Meeting of the American Society of Hematology (ASH) in December 2021;
- Announced that the European Medicines Agency (EMA) has accepted the marketing application for two new indications from Baiyueze ® for the treatment of patients with CLL and MZL;
- Approved in Korea for the treatment of adult patients with MCL who have previously received one treatment and adult patients with WM with Fahrenheit macroglobulinemia who have received at least one therapy;
- Approved in the Eu for the treatment of adult patients with Fahrenheit macroglobulinemia (WM) who have previously received at least one therapy, or as a first-line treatment option for patients with WM who are not candidates for chemotherapoimmunotherapy. The ratification applies to all 27 EU member states, as well as Iceland, Liechtenstein and Norway. BeiGene has begun to promote Baiyueze ® in the European Union;
- Approved for the treatment of patients with WM in the United Kingdom and Switzerland, approved for the treatment of patients with MCL in Saudi Arabia and Ecuador, approved for the treatment of patients with MZL in Canada, and covered by national health insurance reimbursement in Israel. At present, more than 40 listing applications for multiple indications submitted by Baiyueze ® worldwide are under review;
- It was included in the National Comprehensive Cancer Network ® (NCCN) Clinical Practice Guidelines for Oncology (NCCN Guidelines ®2022.2) as the first- and second-line category 2A treatment recommendations for patients with or without del(17p)/TP53 mutations in CLL/SLL. Baiyueze ® has not yet obtained approval in the CLL/SLL indication outside of China;
- Announced that the State Drug Administration of China (NMPA) has accepted new indications for the treatment of adult WM patients (sNDA) and sNDA for the treatment of adult patients with primary chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), which has been recognized as breakthrough therapy (BTD).
Bezean ® (Terelizumab): A humanized IgG4 anti-PD-1 monoclonal antibody designed to minimize binding to Fcγ receptors in macrophages. Bai Zean ® has been approved for use in a number of indications in China and is currently being further developed to obtain more marketing approvals worldwide. The Beizean ® Global Clinical Development Program has enrolled more than 9,000 participants in more than 35 countries and territories.
- Approved in China for the sixth indication for second- or third-line treatment of locally advanced or metastatic NSCLC;
- Positive results were announced in the Global Phase 3 RATIONALE 305 trial (NCT03777657). The clinical trial is a Combination of Bai Zean ® chemotherapy versus placebo combination chemotherapy for the efficacy and safety of first-line treatment in patients with locally advanced, unresectable or metastatic gastric or PD-L1-positive gastroesophageal-conjunctive (G/GEJ) adenocarcinoma. At the time of the interim analysis, The Bazean ® combined chemotherapy achieved the primary endpoint of overall survival (OS) in PD-L1-positive patients and further follow-up was needed to assess OS benefit in the intentional therapy (ITT) population. The safety characteristics of Bai Zean ® are consistent with the observations in previous trials, and no new safety warnings appear after the addition of chemotherapy;
- The results of The Phase 3 trial OF ® RATIONALE 309 (NCT03924986) for the first-line treatment of patients with nasopharyngeal carcinoma were presented at the 2021 Congress of the Immuno-Oncology Society of the European Society of Oncology. In this trial, Bai Zean significantly prolonged the patient's ® progression-free survival, and the safety profile of the combination therapy was consistent with the known risks of each treatment drug.
Osperibalizumab (BGB-A1217): A monoclonal antibody under investigation with perfect Fc function. The global development of Osperliumab has enrolled nearly 800 participants in 25 countries and territories.
- Announced an option, cooperation and licensing agreement with Novartis to jointly develop, produce and commercialize Osperli maclizumab in North America, Europe and Japan. BeiGene has received an advance payment of $300 million and granted Novartis an exclusive, time-based option that Novartis can decide whether to exercise by the end of 2023. If Novartis decides to exercise that option, BeiGene could receive an additional payment of $600 million or $700 million after obtaining antitrust approval. During the effective period of the option, Novartis will fund and initiate a new global clinical trial of Osperibliumab and Bai Zean ® in specific tumor types;
- The BeiGene Global Phase 2 AdvanTIG-205 Trial (NCT05014815) for the treatment of patients with initial treatment of metastatic NSCLC has initiated patient enrolment.
- Continue to advance dose-escalation phase studies of self-developed drug candidates in early clinical pipelines, including BGB-A445 (a non-ligand competitive anti-OX40 monoclonal antibody for the treatment of solid tumors as a single agent or in combination with Bai Zean ®), BGB-15025 (an inhibitor of hematopoietic stem cell kinase 1 [HPK1] as a single agent or in combination with Bai Zean ® for the treatment of solid tumors), BGB-10188 (a single drug or in combination with Bai Yue Ze for ® the treatment of hematological tumors or in combination with Bai ZeAn ®). PI3Kδ inhibitors in research for the treatment of solid tumors);
- The first Phase 1 clinical trial (NCT05093270) has been initiated for BGB-23339, a high-potent tyrosine kinase 2 (TYK2) allosteric inhibitor for inflammation and immunity.
- Successfully launched a new generation of proteasome inhibitor Kailos ® (carfizomib for injection) in China for the treatment of patients with relapsed or refractory multiple myeloma.
- Approved for marketing in ® China for the treatment of patients with advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. The product was authorized to be introduced by BIOTECH Biopharmaceutical Co., Ltd.;
- Approved by Sawinko ® (stuximab for injection) in China for the treatment of adult patients with human immunodeficiency virus (HIV)-negative and human herpesvirus type 8 (HHV-8)-negative multicenter Type Castleman disease (MCD), i.e. idiopathic MCD (iMCD). The product was introduced with the authorization of EUSA Pharma (UK), Ltd.;
- Kaysersbaeu ® (datuximab β) is listed in China for the treatment of patients with high-risk neuroblastoma aged 12 months and older who have previously achieved at least partial remission (PR) after induction chemotherapy and have subsequently undergone myeloablative therapy and stem cell transplantation, and can also be used in patients with relapsed or refractory (R/R) neuroblastoma with or without residual lesions. The product was introduced with the authorization of EUSA Pharma (UK), Ltd.;
- Signed a global licensing and cooperation agreement with Nanjing Weili Zhibo, obtained a global R&D and production license for LBL-007( a new research-under-development antibody targeting the LAG-3 channel), and exclusive commercialization rights outside of China.
Zanidatamab is a bispecific antibody under investigation against the HER2 target that is currently in the late stages of clinical development at Zymeworks.
- Awarded the "Breakthrough Therapy" designation by the Drug Evaluation Center (CDE) of the State Drug Administration of China (NMPA) for the treatment of patients with biliary cancer who have previously undergone systematic chemotherapy failure;
- A phase 3 CLINICAL trial of HERIZON-GEA-01 (NCT05152147) has been initiated for zanidatamab plus chemotherapy with or without Bai Zean ® versus standard therapy (trastuzumab plus chemotherapy) for the first-line treatment of metastatic HER2-positive gastroesophageal adenocarcinoma (GEA).
- Completed the initial public offering of RMB ordinary shares on the Science and Technology Innovation Board of the Shanghai Stock Exchange with the stock code of "688235", raising net proceeds of approximately US$3.4 billion;
- The opening ceremony of the BeiGene Bio-Island Innovation Center was held in Guangzhou to help scientists and entrepreneurs accelerate the achievement of highly differentiated cutting-edge medical innovations. The Beinje Bio-Island Innovation Center is an innovator-centric incubator built on The Vision of BeiGene and will support innovators in exploring new ways to meet the needs of patients around the world;
- Announced the appointment of Dr. Margaret Dugan and Dr. Alessandro Riva as members of the Board; Mr. Sam Su resigned as a member of the Board after 4 years in office.
- The Company includes the following new members in the Executive Committee:
– Mark Lanasa, MD, Senior Vice President, Chief Medical Officer for Solid Tumors – Kyu-Sung Lee ("Q"), Senior Vice President, Head of Global Technology Operations and Production – Kevin Mannix, Senior Vice President of Investor Relations – Jurij Petrin, Head of New Market Development – Min Yin, Chief Commercial Officer for Greater China
Production operations- The acquisition of land for the Princeton West Innovation Campus in Hopewell, New Jersey, has been completed, and BeiGene plans to use it for a new commercial phase of production and clinical R&D facility covering 42 acres (approximately 170,000 square meters). Initial construction is expected to start in 2022. In addition, the site has set aside more than 1 million square feet (about 93,000 square meters) of developable real estate for further expansion in the future;
- Continue to build a new small molecule innovative drug industrialization base in Suzhou, China. The first phase of construction will cover an area of more than 52,000 square meters, with a solid dosage capacity of up to 600 million tablets (granules), and is expected to be completed in 2023. After the completion of the base construction, acceptance and approval, it is expected that the company's production capacity of small molecule drugs in China will be increased to 6 times the current level;
- Continue construction of a world-class biopharmaceutical production site in Guangzhou, China, which currently has an approved biopharmaceutical capacity of 8,000 litres, and a new phase of construction is expected to be completed by the end of 2022 and meet GMP standards, when the total capacity will reach 64,000 litres.
Joyze ® (Zebutinib)
- The latest key results of the Phase 3 ALPINE trial (NCT03734016) for R/R CLL/SLL will be announced in the second quarter of 2022;
- Clinical data from the Global Phase 2 ROSEWOOD Trial (NCT03332017) for R/R follicular lymphoma will be published in 2022;
- Continued support for CLL/SLL New Drug Approval Applications (BAs) that are under FDA review. Under the Prescription Drug User Fee Act (PDUFA), the target date for FDA's decision on the listing request is October 22, 2022;
- Continued support for CLL/MZL applications for new indications under EMA review;
- Continue to promote Therap ® global expansion of new regions and new indications registration, and is expected to be approved for listing in more than 10 other markets by 2022.
Bai Zean ® (Terelizumab)
- Three new applications for marketing authorization for new indications currently submitted in China are under review and are expected to be approved in 2022, including for the first-line treatment of nasopharyngeal carcinoma (NPC), the second-line treatment of patients with esophageal squamous cell carcinoma (ESCC) and second-line highly microsatellite unstable (MSI-High) solid tumors;
- Partnering with Novartis to continue support for new drug marketing authorization (BLA) applications for second-line treatments ESCC that are under FDA review. Under the Prescription Drug User Fee Act (PDUFA), the target date for FDA's decision on the listing request is July 12, 2022;
- Continue to work with Novartis in 2022 to support first-tier NPCs in the U.S., NSCLC listing applications in the U.S. and the European Union;
- The main results of a global Phase 3 clinical trial (NCT03412773) for first-line treatment of HCC patients will be published in 2022.
Osperizumab (Ociperlimab)
- New critical clinical trials will be launched in 2022;
- Data from the Phase 1 trial (NCT04047862) for multiple solid tumor cohorts will be published in the second half of 2022.
Parkway Ze ® (Pami Pali)
- The main results of The Phase 3 trial (NCT03519230) of Parkway for ® maintenance therapy in platinum-sensitive recurrent ovarian cancer patients in China will be announced in the first half of 2022.
BGB-11417 (BCL-2 inhibitor)
- Key trials will be launched in 2022.
- A Phase 1 dose-escalation clinical study (NCT04215978) of BGB-A445 (OX-40) in patients with advanced solid tumors will be initiated in the first half of 2022.
- The Company expects that the world health crisis caused by the COVID-19 pandemic will continue to have a negative impact on its business, including commercial sales, pharmaceutical communication, inspection and declaration, production, clinical trial patient enrollment, participation and data release. The impact of the pandemic on the future remains uncertain. The company is working to reduce work delays and disruptions due to the pandemic and continues to work in line with the commercialization, pharmaceutical affairs, manufacturing and clinical development goals set globally.
| Concise consolidated balance sheet summary data (US GAAP) | ||
| (in $1,000) | ||
| (Audited) | ||
| up to | ||
| 2021 year 12 month 31 day | 2020 | |
| asset: | ||
| Cash, cash equivalents, restricted funds and short-term investments | $ 6,624,849 | $ 4,658,730 |
| Net accounts receivable | 483,113 | 60,403 |
| Property and equipment, net | 587,605 | 357,686 |
| Total assets | $ 8,645,949 | $ 5,600,757 |
| Liabilities and owner's equity: | ||
| Accounts Payable | $ 262,400 | $ 231,957 |
| Accrued costs and other amounts payable | 558,055 | 346,144 |
| Deferred earnings | 407,703 | — |
| R&D cost-sharing liabilities | 390,362 | 502,848 |
| debt | 629,678 | 518,652 |
| Total liabilities | 2,402,962 | 1,731,514 |
| Total owner's equity | $ 6,242,987 | $ 3,869,243 |
| Concise Consolidated Operating Statements (U.S. GAAP) | ||||
| (In addition to the number of common shares, the number of ADS, the common stock per share and the ADS data per share, the unit is $1000) | ||||
| Day 3 Months | ||||
| (Unaudited) | ||||
| Net product revenue | $ 196,785 | $ 100,100 | $ 633,987 | $ 308,874 |
| Cooperative income | 17,194 | 542,296 | ||
| gross income | 213,979 | 100,100 | 1,176,283 | 308,874 |
| Cost of product sales | 48,545 | 21,078 | 164,906 | 70,657 |
| R&D expenses[1] | 430,485 | 355,537 | 1,459,239 | 1,294,877 |
| Sales, general and administrative expenses | 306,501 | 208,209 | 990,123 | 600,176 |
| Amortization of intangible assets | 187 | 188 | 750 | 846 |
| Total cost | 785,718 | 585,012 | 2,615,018 | 1,966,556 |
| Operational losses | (571,739) | (484,912) | (1,438,735) | (1,657,682) |
| Net interest income (expense). | (4,482) | (5,186) | (15,757) | 1,998 |
| Net other income (expenses). | (10,583) | 8,122 | 15,904 | 37,490 |
| Pre-tax losses | (586,804) | (481,976) | (1,438,588) | (1,618,194) |
| Income tax expense (income) | (1,151) | (9,327) | (25,234) | (17,671) |
| (585,653) | (472,649) | (1,413,354) | (1,600,523) | |
| Deducted: Net income (loss) attributable to minority shareholders' equity | 96 | (3,617) | ||
| Net loss attributable to BeiGene | $ (585,653) | $ (472,745) | $ (1,413,354) | $ (1,596,906) |
| Net loss per share attributable to BeiGene, underlying and diluted share price | $ (0.47) | $ (0.40) | $ (1.17) | $ (1.47) |
| Weighted average of outstanding shares: basic and diluted share price | 1,235,346,414 | 1,181,005,180 | 1,206,210,049 | 1,085,131,783 |
| ADS net loss per share attributable to BeiGene: underlying and diluted share price | $ (6.16) | $ (5.20) | $ (15.23) | $ (19.13) |
| Weighted average of circulating ADS: basic and diluted share price | 95,026,647 | 90,846,552 | 92,785,388 | 83,471,676 |
[1] R&D expenditure for the fourth quarter and full year of 2021, including advance payments for ongoing R&D projects and authorized introduction of products, totalled $30 million and $83.5 million, respectively, compared to $00 and $109.5 million for the same period last year.
About BeiGeneBeiGene is a global biotechnology company based on science focused on developing innovative, affordable medicines that aim to improve outcomes and access to medicines for patients worldwide. The company's extensive drug portfolio currently includes more than 40 clinical drug candidates. By strengthening its independent R&D capabilities and cooperation, the company has accelerated the development of diversified and innovative drug pipelines. We are committed to improving access to medicines across the board for more than 2 billion people worldwide by 2030. BeiGene has built a team of more than 8,000 people on five continents. For more information, please visit.
Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding clinical data and approval information for BeiGene drug candidates; publication of conduct and expected data results for later clinical trials; and approval and listing of other planned products ;expected clinical development, regulatory approvals, other milestones and commercialization processes for Marketed Products and Drug Candidates in BeiGene; commercial progress and revenue growth in BeiGene; expected capacity and completion times of the Company's manufacturing sites under construction; impact of the COVID-19 pandemic on the Company's clinical development, pharmaceutical administration, commercialization, production, and other businesses; Plans and Expected Events and Milestones under the headings "Recent Business Highlights" and "Expected Milestones" in BeiGene; and About BeiGene", the plans, commitments, ambitions and goals mentioned under the subtitle "About BeiGene". Actual results may differ materially from forward-looking statements due to a variety of important factors. These factors include the risk of BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical outcomes of drug candidates that may not support further development or marketing approval; the actions of the Pharmaceutical Administration that may affect the initiation, timeline, and progress of clinical trials and drug listing approvals; BeiGene's ability to commercially succeed in marketing drugs and drug candidates (if approved); and BeiGene's ability to obtain and maintain intellectual property protection for its drugs and technologies ; BeiGene's reliance on third parties for drug development, production, commercialization and other services; BeiGene's limited experience in regulatory approvals and commercialization of pharmaceutical products and its ability to obtain further working capital to complete drug candidate development and realization and remain profitable; the impact of the COVID-19 pandemic on BeiGene's clinical development, regulation, commercial operations, production, and other businesses; and BeiGene's "risk factors" in Form 10-Q in its most recent quarterly report The various types of risks discussed more comprehensively in the chapters, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's post-period submission to the SEC. All information in this press release is limited to the date of publication of this press release and BeiGene has no obligation to update such information except as required by law.
Teflon ®, Meginen ®, Vincent ®, Fenito ® and Zanda are ® registered trademarks of Novartis Pharmaceutical Group.
Agavi ® and Belitto ® are registered trademarks of Amgen.
Pubexi ® is a registered trademark of BIOPHARMACEUTICAL CO., Ltd.
Savinko ® and Kaiser Bai ® are registered trademarks of EUSA Pharma (UK), Ltd.