BeiGene's Revenue Skyrockets on the Back of Successful Therapies BRUKINSA and Tislelizumab
BeiGene Ltd. (BGNE), is a leading biotechnology company that specializes in developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer. The company has a strong pipeline of drug candidates that target several types of cancer, including lung, breast, gastric, and hematologic malignancies.
Headquartered in Beijing, China, BGNE operates in several regions, including the United States, Europe, and Asia-Pacific. The company's primary focus is to bring transformative therapies to patients with cancer, through a strategic combination of internal drug discovery and external collaboration. Subscribers who purchased BGNE stock based on our quarterly AI prediction published every trading for the next 90 days would have made a substantial profit of 26.76%.
The company is an established player in the oncology market and has collaborated with several renowned pharmaceutical companies, including Amgen, Bristol-Myers Squibb, and Celgene. BGNE entered these collaborations to accelerate the development and commercialization of its innovative oncology therapies. Some of the noteworthy collaborations that BGNE has entered into with these companies are as follows:
In 2017, BGNE entered into a global strategic collaboration with Amgen to develop and commercialize four oncology biosimilar drugs in China and other major markets. Under the terms of the agreement, Amgen provided exclusive rights to its biosimilar candidates for the Chinese market, while BGNE was responsible for the development, manufacturing, and commercialization of the biosimilars.
In 2018, BGNE and Bristol-Myers Squibb (BMS) entered into a collaboration to develop and commercialize BeiGene's PD-1 inhibitor, tislelizumab, in China. The collaboration included the co-development and commercialization of tislelizumab in China, with BeiGene leading the commercialization effort, and BMS providing technical expertise and support.
In 2019, BGNE and Celgene, a subsidiary of Bristol-Myers Squibb, entered into a strategic collaboration to develop and commercialize BeiGene's PD-1 inhibitor, tislelizumab, in the United States, Europe, Japan, and other major markets outside of China. Under the terms of the agreement, Celgene made an upfront payment of $263 million to BGNE and agreed to pay additional milestone payments and royalties on future sales of tislelizumab.
Most recently, BGNE has initiated patient enrollment for another 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. The clinical trial, registered under the National Clinical Trials (NCT05461794) database, is being conducted in collaboration with Mirati Therapeutics. Sitravatinib is an orally administered small molecule inhibitor that targets multiple receptor tyrosine kinases, including those associated with immunosuppression, while tislelizumab is a humanized monoclonal antibody that blocks PD-1. The combination of sitravatinib and tislelizumab represents a novel approach to treating ESCC, which is one of the most common types of cancer in China. The clinical trial's success will provide a significant boost to BGNE's presence in the oncology market and further increase the company's revenue stream.
Now you may be wondering, what exactly is "tislelizumab" and why is it important?
Tislelizumab is a monoclonal antibody and a PD-1 inhibitor that is being developed by BeiGene Ltd. (BGNE) for the treatment of various types of cancer, including lung, liver, and gastric cancers, among others. Tislelizumab is designed to block the PD-1 receptor on T-cells, which can help to restore the body's natural immune response against cancer cells.
Tislelizumab is an investigational drug and is currently being evaluated in several clinical trials, both as a monotherapy and in combination with other therapies, for the treatment of various types of cancer. In China, tislelizumab was granted conditional approval by the National Medical Products Administration (NMPA) for the treatment of classical Hodgkin's lymphoma (cHL) in 2019, making it the first PD-1 inhibitor to be approved in China for this indication.
In addition to its potential as a monotherapy, tislelizumab has also demonstrated promising results in combination with other therapies. For example, in a phase 3 trial (RATIONALE 302) for the treatment of advanced non-squamous non-small cell lung cancer (NSCLC), tislelizumab in combination with chemotherapy demonstrated statistically significant improvements in progression-free survival and overall survival compared to chemotherapy alone.
Overall, tislelizumab represents an innovative therapy that has the potential to offer a new treatment option for cancer patients. As BeiGene continues to evaluate the drug in clinical trials and seeks additional regulatory approvals in various regions, it will be interesting to see how tislelizumab impacts the oncology landscape and improves outcomes for patients with cancer.
Now, these collaborations have allowed BGNE to leverage the technical expertise and commercial infrastructure of these companies to accelerate the development and commercialization of its innovative oncology therapies. They have also provided BGNE with access to new markets and expanded its reach beyond China, which has been a key driver of the company's growth in recent years.
Market Risks BeiGene Faces
One of the primary challenges that BGNE faces is the intense competition in the oncology market. The company must constantly innovate and develop novel therapies to remain relevant in the industry. With several established pharmaceutical companies and numerous emerging biotech companies vying for market share BGNE faces intense competition from both established and emerging players, which creates significant challenges for the company to remain relevant in the industry.
To address this challenge, BGNE has focused on developing innovative therapies that target unmet medical needs in the oncology space. For example, we addressed the above tislelizumab as an innovative PD-1 inhibitor that has shown promising results in clinical trials and has the potential to become a leading therapy in the field of immuno-oncology. However, developing innovative therapies is a lengthy and costly process, and there is no guarantee of success. Therefore, BGNE must continue to invest heavily in research and development to maintain its position as an industry leader.
Another challenge that BGNE faces is the regulatory environment in China, which can be unpredictable at times. In recent years, the Chinese government has implemented several regulatory reforms aimed at improving drug safety and accelerating the approval process for new drugs. While these reforms have created new opportunities for companies like BGNE, they have also introduced new challenges, including increased scrutiny and a more complex regulatory environment.
Furthermore, the Chinese regulatory landscape remains highly fragmented, with different agencies responsible for different aspects of drug development and approval. This complexity can make it difficult for companies like BGNE to navigate the regulatory environment and obtain timely approvals for their products.
Despite these challenges, BGNE has had several notable successes in recent years, including the approval of its drug Brukinsa (zanubrutinib) by the U.S. FDA in November 2019 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Brukinsa is a Bruton's tyrosine kinase (BTK) inhibitor, which works by blocking a specific enzyme involved in the growth and spread of cancer cells.
The approval of Brukinsa was a significant milestone for BGNE, as it marked the company's first drug to receive FDA approval. It also represented an important step forward in the company's efforts to develop innovative therapies for patients with cancer.
BGNE has also received approvals for its drugs in other regions, such as Europe and Australia. In 2020, the company received marketing authorization from the European Commission for its drug, Brukinsa, for the treatment of Waldenström's macroglobulinemia (WM), a rare type of non-Hodgkin's lymphoma. Additionally, the company's drug, Pamiparib, received approval from the Australian Therapeutic Goods Administration (TGA) in 2020 for the treatment of ovarian cancer.
BGNE Impressive 4th Quarter Results Announced Feb 27 2023
BeiGene, Ltd. (BGNE) recorded an impressive growth in revenue, driven largely by the success of its innovative therapies, BRUKINSA, and tislelizumab. The company's recent milestones, including the final analysis of the ALPINE trial and the U.S. FDA approval for BRUKINSA in adult patients with CLL/SLL, demonstrate the company's commitment to following the science. With a strong financial position, BeiGene is well-positioned for long-term growth.
The company has recorded a significant increase in revenue, as evidenced by the recently released Q4 2022 report. According to the report, the product revenue recorded in Q4 was $339 million, marking a 72.3% increase from the prior-year period, while the revenue recorded for the full year was $1.3 billion, representing a 97.9% increase from the prior-year period.
Notably, the growth in product revenue was largely driven by two of the company's innovative therapies, BRUKINSA, and tislelizumab, whose product revenue increased significantly by 101% and 88%, respectively, compared to the prior-year period. BRUKINSA was also recently approved in the U.S. to treat adult patients with relapsed/refractory (R/R) and first-line chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), and in the EU to treat CLL. Moreover, the data from the final analysis of the Phase 3 ALPINE trial demonstrated progression-free survival superiority for BRUKINSA versus IMBRUVICA in R/R CLL/SLL, as published in The New England Journal of Medicine.
The company's CEO, John V. Oyler, noted that the recent milestones achieved by the company, such as the final progression-free survival (PFS) analysis of the ALPINE trial and the U.S. FDA approval for BRUKINSA in adult patients with CLL/SLL, demonstrate the company's commitment to following the science.
In addition, the report shows that the total 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 is attributed to the sales of internally developed products, BRUKINSA and tislelizumab, as well as the sales of in-licensed products from Amgen and collaboration revenue from the Novartis agreements.
Furthermore, the report indicates that BeiGene's financial position is strong, with a cash position that enables the company to leverage its global scale and financial strength for long-term growth. The CFO, Julia Wang, also noted that the fourth-quarter results demonstrate the company's commercial capability, as well as its commitment to driving operational and financial excellence.
“Our fourth quarter results continue to demonstrate BeiGene’s commercial capability as well as our commitment to driving operational and financial excellence... 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.”
The company's internally developed products and in-licensed products from Amgen and Bio-Thera contributed significantly to this success. BGNE's innovative therapies, BRUKINSA, and tislelizumab, played a crucial role in driving the company's revenue growth.
BRUKINSA's global sales recorded an impressive 101% growth in the fourth quarter and 159% growth in the full year of 2022, compared to the prior-year periods. The sales growth in the U.S. market was particularly remarkable, with a growth rate of 124% and 237% in the fourth quarter and full year of 2022, respectively. BRUKINSA's continued success in the U.S. market was driven by its increasing uptake in mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), and marginal zone lymphoma (MZL). The sales growth of BRUKINSA in China was also impressive, with a 33% growth rate in the fourth quarter and a 49% growth rate in the full year of 2022, driven by increases in all approved indications.
Sales of tislelizumab in China also showed significant growth, with an 88% growth rate in the fourth quarter and a 66% growth rate in the full year of 2022, compared to the prior-year periods. The increased market penetration and market share for tislelizumab were driven by the continued expansion of the company's salesforce, hospital listings, and broader reimbursement, resulting in new patient demand.
BGNE's NRDL inclusion of four additional indications in China further strengthens the company's market position. The newly approved indications cover certain adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC), advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, and certain patients with advanced colorectal cancer (CRC), locally advanced or metastatic esophageal squamous cell carcinoma (ESCC), and as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC).
Furthermore, BGNE's 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 also 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
Now let's delve into BeiGene's regulatory progress and development programs, including updates on its key drugs, BRUKINSA®, tislelizumab, ociperlimab, BGB-11417, and BGB-A445.
Starting with BRUKINSA, a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to maximize BTK occupancy and minimize off-target effects. BRUKINSA has been approved in more than 65 markets globally, including the US, China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland, for selected indications, and is under development for additional approvals worldwide. The global BRUKINSA development program has more than 4,800 subjects enrolled to date in 29 countries and regions. In January 2023, BeiGene announced that the US FDA had approved BRUKINSA for the treatment of adult patients with relapsed/refractory (R/R) and first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). In addition, the European Commission (EC) approved BRUKINSA for the treatment of adult patients with treatment-naïve (TN) or R/R CLL.
Moreover, the final analysis of the Phase 3 ALPINE trial showed superior progression-free survival (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) Annual Meeting, with simultaneous publication in The New England Journal of Medicine. Other key data from the BRUKINSA clinical development programs at ASH 2022 included an oral presentation of results from the MAGNOLIA trial in marginal zone lymphoma (MZL) and a poster with updated results in acalabrutinib-intolerant patients with B-cell malignancies. BeiGene also announced approvals in Brazil for the treatment of adult patients with Waldenström’s macroglobulinemia (WM) and adult patients with R/R MZL who have received at least one anti-CD20-based regimen. The Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain also authorized BRUKINSA for the treatment of adult patients with CLL and those with MZL who have received at least one prior anti-CD20-based therapy. Furthermore, BeiGene expanded BRUKINSA's registration program globally, including 34 launches in 20 markets since January 1, 2022.
As per tislelizumab, a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages has been approved in China for 10 indications and is under development for additional approvals globally. In the context of FcγR, the "γ" refers to the gamma chain, which is one of the chains that make up the receptor. FcγR stands for "Fc gamma receptor," and it is a type of cell surface receptor that binds to the Fc portion of immunoglobulins (antibodies) with high affinity. The FcγR receptor plays a critical role in the immune response by triggering various cellular processes, including phagocytosis, antibody-dependent cellular cytotoxicity (ADCC), and cytokine release.
The global tislelizumab clinical development program includes more than 11,800 subjects enrolled to date in 31 countries and regions. BeiGene announced that the China National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) 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.
AI Trading
Subscribers who bought BGNE stock based on our AI forecast for the quarterly time horizon on this date generated a significant profit of 26.76%. As a subscriber, when you view your forecasts published daily, you can recognize better opportunities by looking for repetition of certain stock picks repeatedly remaining in the AI forecasts. Another indicator is when you see the stock pick appear in multiple forecasted time frames, especially over multiple forecasts published each morning EST.
Below is our stock prediction from our quarterly stock forecast (90 days) publicly announcing BGNE as a strong buy on December 7th, 2022 to our subscribers getting exclusive market insights based on artificial intelligence. Artificial intelligence for stock market analysis is far more effective than a human studying the market alone because it can study more assets objectively and continually throughout the day by merging big data analytics. When combined with machine learning, these incredibly intricate mathematical functions for statistical programming and modeling are capable of comparing their current coefficients and algorithms to newly added data and then adapting to improve the models' accuracy through a process of validation and reflection. With our AI prediction system, you can improve decision-making, result modeling and forecasting, and market knowledge. This stock prediction has been consistently accessible in numerous predictions during this month as well as in earlier AI forecasts for different time frames. You may spot better possibilities when you review your daily forecasts by monitoring stock picks that appear consistently in the AI stock predictions. Another indicator is stock picks that appear in multiple anticipated time periods, particularly throughout multiple predictions. Based on the historical accuracy of each prior financial asset forecast as well as current market variables important to stock price, the AI system calculates the Signal Confidence (SC), which is stated as a percentage out of 100%. In this stock prediction, the Signal Confidence (SC) is 72%.
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Stock Ticker | Open: Dec 7, 2022 | Close: March 7, 2023 | ROI% |
BeiGene Ltd. (BGNE) | $182.64 | $231.51 | 26.76% |
As previously noted, this stock received several recommendations throughout a range of time intervals. Please remember to always exercise discretion when studying the market. Prior to putting any financial plans into action, you should always conduct your own due diligence and seek assistance from a licensed financial advisor.
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Sources: 1. BeiGene Investor Relations, "BeiGene Reports Fourth Quarter and Full Year 2022 Financial Results" (2023)
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