On August 2, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter and six months ended June 30, 2023 (Press release, Castle Biosciences, AUG 2, 2023, View Source [SID1234633642]).

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"Castle delivered an outstanding second quarter, with strength across our entire test portfolio," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Building on our first quarter momentum and driven by consistent execution across the entire Castle team, we delivered strong test report volume and revenue growth. Based on strong first half 2023 execution and confidence in our business, we are raising our 2023 revenue guidance to at least $180 million.

"In addition, we expanded our body of evidence, further demonstrating the clinical value of our innovative tests and supporting adoption by clinicians and payers. Specifically, two patient outcome studies on our DecisionDx-Melanoma test were published in the second quarter. The first study was from our collaboration with the National Cancer Institute’s SEER Program Registries. Data from this study showed that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. A similar study was published by Dhillon, et al. This independent, multi-center study found that sentinel lymph node negative patients whose follow-up treatment pathway was directed by the DecisionDx-Melanoma test for use of routine imaging in patients with high-risk DecisionDx-Melanoma results led to earlier detection of recurrences, when the tumor burden was lower. At study end, 76% of patients in the tested group who had a melanoma recurrence were alive compared to 50% in the untested group.

"Additionally, during open comment periods, we had the opportunity to present data to a number of Medicare contractors related to one of the treatments that our DecisionDx-SCC test has been shown to inform, adjuvant radiation therapy (ART). These data from a matched control analysis compare patients with high-risk squamous cell carcinoma (SCC) with one or more risk factors who received ART and those who did not. When evaluating this cohort, we observed that the DecisionDx-SCC Class 2B result could identify a group of patients with a significant reduction in metastasis rate after having received ART and that the DecisionDx-SCC Class 1 patients did not receive a benefit from ART.

"Our continued success is a testament to the ongoing dedication of our team to our patient-centric mission. With a track record of delivering on our short- and long-term strategies, combined with a healthy balance sheet and multi-year plan to deliver revenue growth and positive net operating cash flow by year-ending 2025, we are managing the business with a goal of driving near- and long-term shareholder value."
Second Quarter Ended June 30, 2023, Financial and Operational Highlights
•Revenues were $50.1 million, a 44% increase compared to $34.8 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the quarter ended June 30, 2023, were $0.1 million of net negative revenue adjustments, compared to $0.6 million of net positive revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $50.2 million, a 47% increase compared to $34.3 million for the same period in 2022.
•Delivered 16,820 total test reports in the second quarter of 2023, an increase of 52% compared to 11,034 in the same period of 2022:

◦DecisionDx-Melanoma test reports delivered in the quarter were 8,597, compared to 7,125 in the second quarter of 2022, an increase of 21%.
◦DecisionDx-SCC test reports delivered in the quarter were 2,681, compared to 1,344 in the second quarter of 2022, an increase of 99%.
◦MyPath Melanoma test reports delivered in the quarter were 953, compared to 955 MyPath Melanoma and DiffDx-Melanoma aggregate test reports in the second quarter of 2022.
◦DecisionDx-UM test reports delivered in the quarter were 461, compared to 431 in the second quarter of 2022, an increase of 7%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 1,447, compared to 352 in the second quarter of 2022, an increase of 311%.
◦IDgenetix test reports delivered in the quarter were 2,681, compared to 827 in the second quarter of 2022, an increase of 224%.
•Gross margin for the quarter ended June 30, 2023, was 73%, and adjusted gross margin was 78%.
•Net cash used in operations was $3.8 million, compared to $9.0 million for the same period in 2022.
•Net loss for the second quarter, which includes non-cash stock-based compensation expense of $12.8 million, was $(18.8) million, compared to $(1.6) million for the same period in 2022.
•Adjusted EBITDA for the second quarter was $(5.3) million, compared to $(11.2) million for the same period in 2022.

Six Months Ended June 30, 2023, Selected Results
•Revenues were $92.2 million, a 49% increase compared to $61.7 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the six months ended June 30, 2023, were $1.7 million of net negative revenue adjustments, compared to $0.3 million of net negative revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $93.9 million, a 51% increase compared to $62.0 million for the same period in 2022.
•Delivered 31,736 total test reports in the six months ended June 30, 2023, an increase of 61% compared to 19,661 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2023, were 16,180, compared to 13,148 for the same period in 2022, an increase of 23%.
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2023, were 5,092, compared to 2,486 for the same period in 2022, an increase of 105%.
◦MyPath Melanoma and DiffDx-Melanoma test reports delivered in the six months ended June 30, 2023, were 1,933, compared to 1,905 MyPath Melanoma and DiffDx-Melanoma aggregate test reports for the same period in 2022, an increase of 1%.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2023, were 870, compared to 887 for the same period in 2022, a decrease of 2%.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2023, were 2,830, compared to 408 for the same period in 2022, following our initial offering of the test beginning in December 2021.
◦IDgenetix test reports delivered in the six months ended June 30, 2023, were 4,831, compared to 827 for the same period in 2022, following our initial offering of the test beginning in April 2022.
•Gross margin for the six months ended June 30, 2023, was 72%, and adjusted gross margin was 77%.
•Net cash used in operations was $29.2 million, compared to $30.4 million for the same period in 2022.
•Net loss for the six months ended June 30, 2023, which includes non-cash stock-based compensation expense of $26.4 million, was $(48.0) million, compared to $(26.3) million for the same period in 2022.
•Adjusted EBITDA for the six months ended June 30, 2023, was $(20.4) million, compared to $(22.6) million for the same period in 2022.
Cash, Cash Equivalents and Marketable Investment Securities
As of June 30, 2023, the Company’s cash, cash equivalents and marketable investment securities totaled $225.5 million.

2023 Outlook
Castle Biosciences is increasing its guidance for anticipated total revenue in 2023. The Company now anticipates generating at least $180 million in total revenue in 2023 compared to the previously provided guidance of $170-180 million.
Second Quarter and Recent Accomplishments and Highlights
Dermatology
•DecisionDx-Melanoma: In June, the Company announced the initial publication of its collaboration with the National Cancer Institute’s SEER Program Registries. This large study of real-world, unselected patients confirmed prior prospective and retrospective studies showing DecisionDx-Melanoma provided clinically meaningful and significant, independent risk stratification of patients with cutaneous melanoma (CM), beyond American Joint Committee on Cancer Eighth Edition (AJCC8) stage. Additionally, the study showed that testing with DecisionDx-Melanoma was associated with lower melanoma-specific and overall mortality relative to untested patients. The publication can be found here.
•DecisionDx-Melanoma: In May, the Company announced an independent, multi-center study providing a direct chain of evidence that use of DecisionDx-Melanoma test results to guide radiological surveillance could lead to improved patient outcomes. Specifically, this study directly compared the impact of management changes in sentinel lymph node negative patients whose follow-up pathway was directed by the DecisionDx-Melanoma test to patients in the same institution who were not tested and, therefore, did not have their follow-up pathway changed from the institution’s traditional follow-up pathway. The results showed that metastasis was detected earlier, when the tumor burden was smaller, and at study end, 76% of patients in the tested group who had a metastasis were alive compared to 50% in the untested group. The study, authored by Dhillon et al., can be found here.
•DecisionDx-SCC: In June, the Company announced new data demonstrating the ability of the DecisionDx-SCC test to identify cutaneous squamous cell carcinoma (cSCC) tumors at a biologically high risk of metastasis in a subset of patients considered to be at a low risk of metastasis by traditional staging. In the study, the DecisionDx-SCC test was able to significantly stratify three-year metastasis free survival rates within the AJCC8 and Brigham and Women’s Hospital T1 populations of the cSCC cohort. See the Company’s news release from June 12, 2023, for more information.
•DecisionDx-SCC: In June, the Company announced the publication of a paper highlighting a clinician-derived, real-world algorithm that provides a framework to incorporate DecisionDx-SCC test results into clinical practice within National Comprehensive Cancer Network (NCCN) guideline recommendations. This framework for stratifying patients with advanced cSCC includes a treatment algorithm that demonstrates how use of DecisionDx-SCC test results can assist clinicians in identifying personalized, risk-aligned treatment pathway improvements for patients with high-risk cSCC, based on the patient’s tumor biology, which may help improve their disease outcome. The publication can be found here.
Gastroenterology
•In May, the Company announced that its three posters at the recent Digestive Disease Week Annual Meeting were honored as "Posters of Distinction" by the American Gastroenterological Association Institute Council, ranking among the top 10% of the more than 3,100 abstracts showcased during the meeting. See the Company’s news release from May 26, 2023, for more information.
•In May, the Company announced that it had been selected as the winner of the "Best Use of Artificial Intelligence in Healthcare" award in the seventh annual MedTech Breakthrough Awards program for its innovative TissueCypher Barrett’s Esophagus (BE) test. The TissueCypher test provides clinicians with important information about a patient’s individual risk of progression to esophageal cancer based on advanced analysis of biopsied tissue to guide more informed and risk-aligned management of BE patients. See the Company’s news release from May 15, 2023, for more information.
Mental Health
•In June, ECRI, an independent, nonprofit organization improving the safety, quality and cost-effectiveness of care across all healthcare settings, concluded its genetic test assessment of Castle’s

IDgenetix test with a four out of five, or "Somewhat Favorable," rating. Commercial payers utilize ECRI evaluations to assist in making coverage decisions.
•In May, the Company announced real-world study data demonstrating that use of IDgenetix to guide medication management can significantly improve medication response and remission rates in patients diagnosed with moderate to severe depression, compared to current standard-of-care treatment. The study abstract can be found here.
Corporate
•In July, the Company announced that it had earned a second consecutive Arizona Top Workplace award from AZ Central, the digital home of The Arizona Republic newspaper. See the Company’s news release from July 17, 2023, for more information.
•In May, the Company announced that it opened a new state-of-the-art laboratory facility in Pittsburgh. The new 20,000-square-foot facility doubles the size of its previous Pittsburgh laboratory and is expected to have the capacity and ability to process each of its proprietary tests. Additionally, the Company anticipates doubling its workforce in Pittsburgh, creating approximately 35 new jobs by the end of 2023. See the Company’s news release from May 22, 2023, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Wednesday, August 2, 2023, at 4:30 p.m. Eastern time to discuss its second quarter 2023 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until August 23, 2023.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 967509.

There will be a brief Question & Answer session following management commentary.

On August 2, 2023 Eterna Therapeutics presented its investor presentation (Presentation, Brooklyn ImmunoTherapeutics, AUG 2, 2023, View Source [SID1234633641]).

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On August 2, 2023 Blueprint Medicines Corporation (NASDAQ: BPMC) reported financial results and provided a business update for the second quarter ended June 30, 2023 (Press release, Blueprint Medicines, AUG 2, 2023, View Source [SID1234633640]).

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"We have entered a new era at Blueprint with the launch of AYVAKIT in indolent systemic mastocytosis. In the second quarter, we delivered strong growth in AYVAKIT revenue and patients on therapy, reinforcing our belief in the blockbuster potential for AYVAKIT in systemic mastocytosis," said Kate Haviland, Chief Executive Officer of Blueprint Medicines. "We also achieved important regulatory and operational milestones, including multiple readouts from our pipeline at ASCO (Free ASCO Whitepaper) and the nomination of a selective and potent inhibitor of wild-type KIT which leverages our expertise and infrastructure as we build a franchise in mast cell driven diseases. Our year-to-date achievements fortify our strong foundation for near- and long-term growth."

Second Quarter 2023 Highlights and Recent Progress

Systemic mastocytosis (SM) and other mast cell disorders

● Announced that the U.S. Food and Drug Administration (FDA) approved AYVAKIT (avapritinib), the first and only medicine approved for the treatment of adults with indolent systemic mastocytosis (ISM) and the only treatment approved across the spectrum of indolent and advanced SM. Read the press release here.

● Published detailed results from the PIONEER study in New England Journal of Medicine (NEJM) Evidence. Key results demonstrate that AYVAKIT achieved statistically significant and clinically meaningful benefits in overall symptoms and objective measures of mast cell burden compared to placebo at 24 weeks, with improvements deepening through 48 weeks. Data also show meaningful improvements in quality-of-life measurements. AYVAKIT showed a favorable safety profile compared to placebo. Read the press release here.

● Announced nomination of BLU-808, an oral, highly potent and selective wild-type KIT inhibitor with first- and best-in-class potential, as a development candidate for the treatment of mast cell disorders, including chronic urticaria.

Cancers vulnerable to CDK2 inhibition

● Presented monotherapy dose escalation data from the Phase 1/2 VELA trial of BLU-222 in patients with cancers vulnerable to CDK2 inhibition at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The results showed evidence of favorable safety, cell cycle modulation and clinical response, supporting initiation of combination dose escalation of BLU-222 with ribociclib and fulvestrant in patients with hormone receptor-positive/HER2-negative breast cancer. Find the poster here.

EGFR-driven non-small cell lung cancer (NSCLC)

BLU-945

● Presented dose escalation data from the Phase 1/2 SYMPHONY study of BLU-945 in patients with late-line EGFR-driven NSCLC at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. BLU-945 monotherapy and in combination with osimertinib showed evidence of clinical activity and was generally well tolerated, with infrequent adverse events associated with wild-type EGFR inhibition, supporting continued combination dose escalation. Find the poster here.

BLU-451

● Presented dose escalation data from the Phase 1/2 CONCERTO study of BLU-451 in patients with NSCLC driven by EGFR exon 20 insertions and atypical mutations at the 2023 ASCO (Free ASCO Whitepaper) Annual Meeting. Results showed evidence of safety and clinical benefit, including central nervous system activity, supporting continued dose escalation. Find the poster here.

Key Upcoming Milestones

Blueprint Medicines plans to achieve the following milestones by the end of 2023:

● Present data from Part 1 of the HARBOR trial of elenestinib in indolent SM.

● Continue AYVAKIT commercial launch execution in SM.

Second Quarter 2023 Results

● Revenues: Revenues were $57.6 million for the second quarter of 2023, including $39.9 million of net product revenues from sales of AYVAKIT/AYVAKYT and $17.7 million in collaboration revenues. Blueprint Medicines recorded revenues of $36.5 million in the second quarter of 2022, including $28.5 million of net product revenues from sales of AYVAKIT/AYVAKYT and $8.0 million in collaboration revenues.

● Cost of Sales: Cost of sales was $2.3 million for the second quarter of 2023, as compared to $4.9 million for the second quarter of 2022. The decrease was primarily due to a decrease in the cost of collaboration-related sales.

● R&D Expenses: Research and development expenses were $110.1 million for the second quarter of 2023, as compared to $128.5 million for the second quarter of 2022. This decrease was primarily due to continued operational efficiency gains across our portfolio as we execute across our top priority programs and the timing of manufacturing of clinical trial materials. Research and development expenses included $10.2 million in stock-based compensation expenses for the second quarter of 2023.

● SG&A Expenses: Selling, general and administrative expenses were $71.9 million for the second quarter of 2023, as compared to $58.7 million for the second quarter of 2022. This increase was primarily due to an increase in compensation and personnel related costs driven by our first quarter field force expansion to support the AYVAKIT launch in ISM. Selling, general, and administrative expenses included $13.6 million in stock-based compensation expenses for the second quarter of 2023.

● Net Loss: Net loss was $132.8 million for the second quarter of 2023, or a net loss per share of $2.19, as compared to a net loss of $159.7 million for the second quarter of 2022, or a net loss per share of $2.68.

● Cash Position: As of June 30, 2023, cash, cash equivalents and investments were $836.6 million, as compared to $1,078.5 million as of December 31, 2022.

Conference Call Information

Blueprint Medicines will host a live conference call and webcast at 8:00 a.m. ET today to discuss second quarter 2023 financial results and recent business activities. The conference call may be accessed by dialing 833-470-1428 (domestic) or 929-526-1599 (international), and referring to conference ID 669158. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.

Upcoming Investor Conferences

Blueprint Medicines will participate in one upcoming investor conference:

● Morgan Stanley 21st Annual Global Healthcare Conference on Monday, September 11, 2023 at 11:20 a.m. ET.

A live webcast of each presentation will be available by visiting the Investors & Media section of Blueprint Medicines’ website at View Source A replay of the webcasts will be archived on Blueprint Medicines’ website for 30 days following each presentation.

On August 2, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported financial results from the second quarter of 2023 and business highlights (Press release, BeiGene, AUG 2, 2023, View Source [SID1234633639]).

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"Our strong second quarter results highlight the continued execution of our global commercial teams and the success of our two cornerstone medicines, BRUKINSA and tislelizumab. As demonstrated by the growing prescriber use for patients with CLL, BRUKINSA is becoming the BTK inhibitor of choice, driven by compelling efficacy and safety data across indications, including superiority versus IMBRUVICA in relapsed/refractory (R/R) CLL," said John V. Oyler, Co-Founder, Chairman and CEO at BeiGene. "Our robust pipeline, highlighted at our recent investor R&D Day and fueled by one of the largest and most productive oncology research teams in the industry, will continue to drive our short- and long-term growth as a science-based organization, and allow us to fulfill our mission of providing innovative cancer medicines and improving treatment options for more patients around the world."

Key Business and Pipeline Highlights

Received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for tislelizumab as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy;
Announced U.S. Food and Drug Administration (FDA) acceptance of a supplemental new drug application (sNDA) for BRUKINSA in combination with GAZYVA (obinutuzumab) as a treatment for patients with R/R follicular lymphoma (FL) with a target action date in the first quarter of 2024, under the Prescription Drug User Fee Act;
Announced Health Canada approval of BRUKINSA for the treatment of adult patients with CLL, and Australia Therapeutic Goods Administration (TGA) approval of BRUKINSA for the treatment of treatment-naïve (TN) and R/R CLL/small lymphocytic lymphoma (SLL);
Announced new regulatory approvals for BRUKINSA, including China National Medicinal Products Administration (NMPA) approval of two sNDAs for TN adults with CLL or SLL and Waldenström’s macroglobulinemia (WM), and two sNDAs for conversions from conditional approval to regular approval for certain patients with R/R CLL/SLL and R/R WM;
Held investor R&D Day, highlighting the Company’s growing and diverse pipeline of innovative therapies. For webcast replay and more information from the event, visit the investors section of the BeiGene website at View Source; View Source; or View Source;
Announced an agreement with DualityBio for BeiGene to acquire an exclusive option for a global clinical and commercial license to an investigational, preclinical Antibody Drug Conjugate (ADC) therapy for patients with select solid tumors to complement the Company’s initial internally discovered ADC assets, and;
Announced a partnership with The Max Foundation, a global nonprofit organization dedicated to accelerating health equity by delivering medication, technology, and supportive services to patients worldwide, and the BeiGene Foundation, to provide access to BRUKINSA for the treatment of adult patients with CLL in 29 countries over the next three years, enabling the Company’s mission to treat more patients globally.
Second Quarter 2023 Financial Highlights

Product Revenue for the three months ended June 30, 2023, was $553.7 million, compared to $304.5 million in the same period of 2022, representing 81.8% growth;

Product sales increased $249.2 million in the second quarter of 2023 compared to the prior-year period, primarily due to increased sales of our internally developed products, BRUKINSA and tislelizumab, as well as increased sales of in-licensed products from Amgen;
U.S. sales of BRUKINSA totaled $223.5 million in the second quarter, representing growth of 152.9% over the prior-year period, as adoption for adult patients with CLL/SLL accelerated and use across all FDA-approved indications continued to expand. BRUKINSA sales in China totaled $48.5 million, representing growth of 32.2% over the prior-year period, driven by increases in all approved indications as the Company continues to increase market value share as the BTK leader in China;
Sales of tislelizumab in China totaled $149.5 million for the second quarter of 2023, representing growth of 42.5% compared to the prior-year period. Continued increase in new patient demand from reimbursement of new indications and further expansion of our salesforce efficiency and hospital listings continued to drive increased market penetration and leading PD-1 inhibitor market share for tislelizumab, and;
Total product revenues by geographic area are presented as follows (amounts in thousands of U.S. dollars):

Three Months Ended

Six Months Ended

June 30,

June 30,

2023

2022

2023

2022

$

$

$

$

China

293,919

212,429

540,828

403,164

United States

223,540

88,381

362,307

156,269

Rest of world

36,286

3,701

60,901

6,651

Total

553,745

304,511

964,036

566,084

Gross Margin as a percentage of global product revenue for the second quarter of 2023 was 82.7%, compared to 76.6% in the prior-year period. The gross margin percentage increased primarily due to lower costs per unit for both BRUKINSA and tislelizumab, as well as a proportionally higher sales mix of global BRUKINSA compared to other products in the portfolio and compared to lower-margin sales of in-licensed products.

Operating Expenses for the three months ended June 30, 2023, were $818.0 million, compared to $709.8 million in the same period of 2022, representing 15.2% growth in comparison to 81.8% product revenue growth in the quarter, driving significant operating leverage.

Net Loss for the quarter ended June 30, 2023, was $381.1 million, or $0.28 per share, and $3.64 per American Depositary Share (ADS), compared to $565.7 million, or $0.42 per share, and $5.50 per ADS in the same period of 2022. The decrease in net loss is primarily attributable to improved operating leverage due to product revenue growth exceeding operating expense growth. The Company expects this trend to continue through 2023. Net loss for the quarter was negatively impacted by other non-operating expenses of $63.8 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. Non-operating expenses were $129.6 million in the same period of 2022.

Cash, Cash Equivalents, Restricted Cash, and Short-Term Investments were $3.5 billion as of June 30, 2023, and $4.5 billion as of December 31, 2022.

For further details on BeiGene’s Second Quarter 2023 Financial Statements, please see BeiGene’s Quarterly Report on Form 10-Q for the second quarter of 2023 filed with the U.S. Securities and Exchange Commission.

Regulatory Progress and Development Programs

Category

Asset

Recent Milestones

Approvals/Regulatory Updates

BRUKINSA (zanubrutinib)

Health Canada approval for the treatment of adult patients with CLL/SLL
Australia TGA approval for the treatment of TN and R/R CLL/SLL
China NMPA approval of:
sNDA for the treatment of TN adult patients with CLL/SLL
sNDA for the treatment of adult patients with TN WM
sNDA for the conversion from conditional to regular approval for the treatment of adult patients with R/R CLL/SLL
sNDA for the conversion from conditional to regular approval for the treatment of adult patients with R/R WM

Tislelizumab

EU CHMP positive opinion for tislelizumab as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic ESCC after prior platinum-based chemotherapy
China NMPA approval of:
sNDA for the treatment of adult patients with first-line gastric cancer (PD-L1+)
sNDA for the treatment of adult patients with first-line ESCC

BAITUOWEI (Goserelin Microspheres for Injection)

In partnership with Luye Pharma, China NMPA approval for the treatment of patients with prostate cancer requiring androgen deprivation therapy
Regulatory Submissions

BRUKINSA

Received U.S. FDA acceptance of sNDA for the treatment of adult patients with R/R FL
Received EMA acceptance of marketing authorization application for the treatment of adult patients with R/R FL
Clinical Activities

BRUKINSA

First subject enrolled in a Phase 3 clinical trial for primary membranous nephropathy
Anticipated Upcoming Milestones

Category Asset Anticipated Milestone
Approvals/Regulatory Updates

Tislelizumab

In partnership with Novartis, approval for second-line ESCC in U.S.* and EU
Regulatory Submissions

Tislelizumab

First-line extensive stage small cell lung cancer (ES-SCLC) submission in China
In partnership with Novartis for first-line ESCC in U.S. and EU
In partnership with Novartis to first-line gastric cancer in U.S. and EU
In partnership with Novartis for first- and second-line ESCC in Japan
Clinical Activities/Data Readouts

BRUKINSA

Announce additional follow-up data from the Phase 3 ALPINE study versus ibrutinib in R/R CLL

Tislelizumab

Announce results from the Phase 3 RATIONALE-315 trial in neoadjuvant and adjuvant non-small cell lung cancer (NSCLC)

Sonrotoclax (BGB-11417, BCL-2 inhibitor)

Initiate global pivotal trial in combination with BRUKINSA in first-line CLL in the second half of 2023
Initiate global potential registration enabling trial in R/R WM in the second half of 2023
Announce additional data from Phase 1 studies

BTK CDAC (BGB-1663)

Announce updated data readouts from Phase 1 studies in B-cell malignancies

Ociperlimab (Anti-TIGIT)

Complete enrollment in the Phase 3 AdvanTIG-302 trial in first-line NSCLC in 2023
Announce data for multiple Phase 2 studies, including:
For second-line ESCC in patients whose tumors express PD-(L)1
For first-line hepatocellular carcinoma (HCC)
For first-line NSCLC
_________________________________
* Original PDUFA date deferred
Scientific Congress Updates

Present results from the Phase 3 RATIONALE-312 trial investigating tislelizumab with or without chemotherapy as a treatment for extensive-stage small cell lung cancer as an oral presentation at the 2023 World Conference on Lung Cancer in September;
Present eight accepted abstracts, including data from the tislelizumab, ociperlimab and other Solid Tumor programs, at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in October;
Presented clinical results for BRUKINSA at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and European Hematology Association (EHA) (Free EHA Whitepaper) congress, including Phase 1 results in R/R diffuse large B-cell lymphoma (DLBCL) and updated results from the Phase 3 ROSEWOOD study in combination with GAZYVA in R/R FL;
Presented two abstracts for tislelizumab at the ASCO (Free ASCO Whitepaper) Annual Meeting, including additional analyses from the Phase 3 RATIONALE-301 trial versus sorafenib in first-line unresectable HCC;
Presented results from a Phase 1 study of internally discovered OX40 agonist BGB-A445, with or without tislelizumab, in patients with advanced solid tumors at ASCO (Free ASCO Whitepaper); and
In partnership with Zymeworks, presented updated results from the Phase 2b HERIZON-BTC trial of zanidatamab in previously treated, HER2-amplified biliary tract cancer as an oral presentation at ASCO (Free ASCO Whitepaper).
Manufacturing Operations

Continued construction at the $700+ million U.S. flagship manufacturing and clinical R&D facility at the Princeton West Innovation Campus in Hopewell, N.J. The property has more than 1 million square feet of total developable real estate, allowing for future expansion; the site will be ready in 2024;
Continued construction on our state-of-the-art biologics facility in Guangzhou, China, which has a current total capacity of 64,000 liters, including both single-use and stainless-steel technologies; the site continues the construction of an ADC production facility and additional biologics clinical production to be completed in 2024; 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 per year, and to be completed in 2023; once completed, qualified and approved, it is expected to increase the current small molecule manufacturing capacity in China by more than 5 times; the site also started construction of a new R&D center that will improve both clinical and manufacturing capabilities, to be completed in 2024.
Corporate Developments

BeiGene regained full, global rights to develop, manufacture and commercialize investigational TIGIT inhibitor ociperlimab as the result of a mutual decision with Novartis to terminate the Option, Collaboration and License Agreement with Novartis pursuant to which BeiGene granted Novartis an exclusive time-based option to receive such rights in North America, Europe, and Japan, and;
In partnership with Luye Pharma, launched BAITUOWEI (Goserelin Microspheres for Injection) for the treatment of patients with prostate cancer requiring androgen deprivation therapy in China, which broadens our footprint in urological malignancy indications.

Financial Summary
Select Condensed Consolidated Balance Sheet Data (U.S. GAAP)
(Amounts in thousands of U.S. Dollars)

As of

June 30,

December 31,

2023

2022

(unaudited)

(audited)

Assets:

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

$

3,527,267

$

4,540,288

Accounts receivable, net

299,282

173,168

Inventories

321,333

282,346

Property, plant and equipment, net

1,031,938

845,946

Total assets

5,728,736

6,379,290

Liabilities and equity:

Accounts payable

266,975

294,781

Accrued expenses and other payables

454,950

467,352

Deferred revenue

183,310

255,887

R&D cost share liability

271,291

293,960

Debt

628,478

538,117

Total liabilities

1,930,177

1,995,935

Total equity

$

3,798,559

$

4,383,355

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

June 30,

Six Months Ended

June 30,

2023

2022 1

2023

2022 1

(Unaudited)

(Unaudited)

Revenue:

Product revenue, net

$

553,745

$

304,511

$

964,036

$

566,084

Collaboration revenue

41,516

37,061

79,026

82,114

Total revenues

595,261

341,572

1,043,062

648,198

Expenses:

Cost of sales – products

95,990

71,173

177,779

136,410

Research and development

422,764

378,207

831,348

768,122

Selling, general and administrative

395,034

331,403

723,533

625,976

Amortization of intangible assets

188

188

375

376

Total expenses

913,976

780,971

1,733,035

1,530,884

Loss from operations

(318,715

)

(439,399

)

(689,973

)

(882,686

)

Interest income, net

15,070

11,431

31,086

21,502

Other expense, net

(63,818

)

(129,617

)

(45,515

)

(117,650

)

Loss before income taxes

(367,463

)

(557,585

)

(704,402

)

(978,834

)

Income tax expense

13,674

8,141

25,166

22,090

Net loss

(381,137

)

(565,726

)

(729,568

)

(1,000,924

)

Net loss per share attributable to BeiGene, Ltd.:

Basic and diluted

$

(0.28

)

$

(0.42

)

$

(0.54

)

$

(0.75

)

Weighted-average shares outstanding:

Basic and diluted

1,360,224,377

1,336,463,026

1,357,211,308

1,334,252,648

Net loss per ADS attributable to BeiGene, Ltd.:

Basic and diluted

$

(3.64

)

$

(5.50

)

$

(6.99

)

$

(9.75

)

Weighted-average ADSs outstanding:

Basic and diluted

104,632,644

102,804,848

104,400,870

102,634,819

The Company 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 its previously filed financial statements in the second quarter of 2022 (see "Notes to the Condensed Consolidated Financial Statements, Note 1. Description of Business, Basis of Presentation and Consolidation and Significant Accounting Policies" and "Note 2. Revision of Prior Period Financial Statements" included in our Quarterly Report on Form 10-Q for the period ended June 30, 2023, filed with the SEC).

On August 2, 2023 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported that its Phase 3 AXLerate-OC trial evaluating the safety and efficacy of batiraxcept in platinum-resistant ovarian cancer did not meet its primary endpoint of progression-free survival (PFS) in the pre-specified subset of patients naïve to prior bevacizumab treatment (Press release, Aravive, AUG 2, 2023, View Source [SID1234633638]). The trial did not show any difference between the two arms in the overall population (which included patients previously treated with bevacizumab). The Company will continue to evaluate the complete dataset and determine next steps in the development of batiraxcept.

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"We are conducting additional analyses on the AXLerate-OC Phase 3 trial to further evaluate the results of this study and determine the best path forward with our two other planned indications in renal cell carcinoma and pancreatic cancer," said Gail McIntyre, Ph.D., DABT, Aravive’s President and Chief Executive Officer. "We want to thank the patients who participated in this trial, the clinical investigators, and the Aravive team for their hard work, as we continue to pursue our goal of finding innovative cancer treatments for patients in need."

Key Findings from AXLerate-OC Study
AXLerate-OC enrolled 366 patients, and randomization was stratified for prior bevacizumab treatment; 50% of patients received bevacizumab prior to study entry. The statistical analysis plan called for a hierarchical approach for the assessment of PFS first in the bevacizumab-naïve population and then in the overall cohort of patients. In the bevacizumab-naïve population (n=179), the median PFS in the batiraxcept plus paclitaxel arm was 5.4 months, compared to 5.4 months in the paclitaxel arm. In the overall population, the median PFS in the batiraxcept plus paclitaxel arm was 5.1 months, compared to 5.5 months in the paclitaxel arm. None of these differences were statistically different.

The safety profile of batiraxcept was as expected from previous studies. No new safety signals were identified.

"Although AXLerate-OC did not meet the primary endpoint, I look forward to working with Aravive to analyze the Phase 3 data and determine the most appropriate path to bring batiraxcept to those patients who may benefit most," said Dr. Katherine Fuh, Associate Professor, UCSF Division of Gynecologic Oncology.

About the Phase 3 PROC Trial

The global, randomized, double-blind, placebo-controlled adaptive trial (GOG-3059/ENGOT OV-66) is designed to evaluate efficacy and safety of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel. The trial enrolled 366 patients with high-grade serous ovarian cancer who have received one to four prior lines of therapy at approximately 165 sites in the U.S. and Europe. The primary endpoint for the trial is progression free survival and the secondary endpoint is overall survival. Exploratory endpoints include objective response rate, duration of response, quality of life, clinical benefit rate, pharmacokinetic and pharmacodynamic profile, and sAXL/GAS6 ratio. This trial was conducted in partnership with The GOG Foundation, Inc. (GOG-F), through the GOG Partners program in the USA and in partnership with the European Network for Gynecological Oncological Trial (ENGOT) groups in Europe. The Phase 3 trial is listed on clinicaltrials.gov NCT04729608.