Q1 2024 Financial Performance and Product Highlights: BGI Genomics, Roche, Guardant Health, Natera, and More

It is worth noting that,BGI's cash balance at the end of this quarter was 4.464 billion yuan.，Adequate cash flow will help the company further focus on its core business and related R&D, ensuring investment in overseas localization efforts and promoting the globalization of its core business.Currently, with technological innovation and channel expansion, BGI's core businesses have achieved positive results.

The company stated that in the future, it will increase R&D investment in chronic disease populations centered on cardiovascular and cerebrovascular diseases. Building on its existing core businesses of birth defect prevention, cancer control, and infectious disease management, it will leverage tools such as AI and combine the big data advantages generated by its multi-omics platform to further advance genomic development.

In addition, BGI has implemented organizational structure optimization and structural optimization of the R&D department to improve the overall operational efficiency and profitability of the company, optimize R&D processes and resource allocation, accelerate product innovation, better meet market demands, and promote the company's continuous growth and competitiveness enhancement.

Immunoassay (including cardiac, oncology, and thyroid testing) product revenue grew 10% year-over-year in Q1, clinical chemistry revenue increased by 8%, advanced oncology staining product revenue rose 12%, and companion diagnostics revenue surged 47%. Meanwhile, Roche's point-of-care immunoassay revenue dropped 68% year-over-year, while point-of-care molecular diagnostics revenue grew 4%; blood screening business revenue increased by 11%, virology base business revenue rose 9%, and diabetes care revenue declined by 12%.

In the diagnostic business,Core Lab Q1 revenue was CHF 1.93 billion, flat compared to the same period last year, accounting for 55% of total Diagnostics sales.; Molecular Lab sales amounted to 620 million Swiss francs, a year-on-year decrease of 9%, accounting for 18% of total sales; Pathology Lab business sales reached 363 million Swiss francs, a year-on-year increase of 10%, accounting for 10% of total sales; Near-patient care business revenue was 570 million Swiss francs, a year-on-year decrease of 26%, accounting for 16% of total sales.

Roche CEO Thomas Schinecker highlighted the significant developments this quarter,FDA Approves Roche's Cobas Malaria Test, and Elecsys PTau217 for Alzheimer’s Receives FDA Breakthrough Device Designation。

Overall,Roche's Total Sales in Q1 2024 Amounted to 14.04 Billion Swiss Francs, a decrease of 6% year-on-year, but an increase of 2% year-on-year at constant exchange rates;Pharmaceuticals Division Sales Reach CHF 10.92 Billion, a decrease of 6% year-over-year, but an increase of 2% year-over-year based on constant currency. Additionally, for the full year 2024 revenue (based on constant currency), the company expects growth in the single-digit range.

The company stated that the Guardant360 liquid biopsy therapy selection test remains the primary driver of testing volume growth, but the contributions from new products such as the TissueNext tissue sequencing test and the Guardant Response disease monitoring test are increasing.

Guardant Health Q1Development services and other revenues totaled $12.3 million, a year-over-year decrease of approximately 20%.; R&D costs were $83.8 million, a year-on-year decrease of approximately 10%; however, SG&A expenses increased to $119.1 million, a year-on-year increase of 2%.

Guardant Health co-CEO Helmy Eltoukhy said that the research report is expected to be published in 2024.Helps expand the Medicare coverage of the company's MRD test method Guardant Reveal, especially in other indications for colorectal cancer and breast cancer.In 2025, more research will be published to explore the clinical effectiveness of this testing method in lung cancer, pancreatic cancer, and stomach cancer.

In addition,Guardant Health is expected to launch the in vitro diagnostic version of its colorectal cancer screening test, Guardant Shield, in 2024.In particular, the company highlighted the latest research published in March 2024 by researchers at Kaiser Permanente, which found that colorectal cancer screening rates significantly increased when participants opted for the Shield test.

Company Q1 net loss of $115 million, or $94 per share; Gross profit was $103.2 million, an increase of $27.6 million compared to the same period last year, with a gross margin of 61%. The company raised its full-year 2024 revenue forecast, statingFull-year 2024 revenue (excluding screening) is currently expected to be between $675 million and $685 million.。

Exact Sciences CEO Kevin Conroy stated that the company's recent marketing campaign has elevated Cologuard's brand awareness and customer satisfaction to an all-time high.Since the beginning of 2023, 50,000 healthcare providers have chosen Cologuard, becoming new customers of the company.。

Although the company's precision oncology testing growth lags behind its screening business, Exact statedThe Number of People Worldwide Receiving the Oncotype DX Breast Cancer Prognostic Test Hits a Record High This Quarter; The company has also made significant progress in increasing the international adoption rate of Oncotype DX, with the number of ordering suppliers in Q1 increasing by more than 20%.

Conroy stated,Exact Sciences plans to launch a series of new testing projects within the next 18 months., includingOncoDetect, a proprietary minimal residual disease detection method that can identify residual and recurrent cancers earlier than existing imaging systems, as well asOncoLiquid, a blood-based therapeutic option test used to complement the tissue-based OncoExtra test. In addition, the company is expected to release results of the second-generation Cologuard blood-based test later this year.

Exact Sciences Q1 R&D expenditure was $110.6 million, a 17% increase year-over-year; SG&A costs were $435.5 million, an 8% increase year-over-year. The company's net loss was $110.2 million, or $60 per share.Exact Sciences Maintains Full-Year 2024 Revenue Guidance of $2.81 Billion to $2.85 Billion。

This quarter,Natera handled approximately 735,800 tests in total., an increase of 18% year-on-year, with testing volumes in the fields of oncology, organ health, and women's health reaching record highs. In particular,The company handled 114,800 tumor tests, a 62% increase from 71,000 tests in the same period last year.。

The company also launched in Q1Non-Invasive Prenatal Testing (NIPT) for Fetal RhD, aimed at providing assistance to obstetricians and patients during the shortage of Rho(D) immune globulin therapy (RhIG) in the United States. This test can be performed at 9 weeks of pregnancy to determine the fetal RhD status from the blood of pregnant patients, including complex pseudogenes and RhD-ce-d hybrid variants.

Solomon Moshkevich, President of Natera's Clinical Diagnostics Division, said: "The launch of this testing product represents a significant advancement in the field of prenatal care and is truly what sets Natera apart.; It is conducted simultaneously with the company's Panorama prenatal screening test, effectively addressing the current issue of limited drug supply faced by obstetricians and gynecologists." Additionally, a validation study has shown,The test has 100% sensitivity and over 99% specificity.。

In terms of organ health, the company's researchers and academic collaborators in April 2024TransplantationA study published in the journal supports the use of Prospera donor-derived cell-free DNA (dd-cfDNA) testing as a primary indicator for renal transplant rejection.

Natera Q1 R&D expenditure was $88.6 million, an 8% increase year-over-year; SG&A expenditure was $194.3 million, a 30% increase year-over-year; net loss narrowed to $67.6 million, or $0.56 per share. Additionally, due to the continued growth in testing volume and strong contributions from the oncology business,Natera Raises Full-Year 2024 Revenue Guidance from Previous $1.32B-$1.35B to $1.42B-$1.45B。

Myriad President and CEO Paul Diaz said, "There are early signs of growth in market share for Q1 hereditary cancer and prenatal testing, and we expect this trend to accelerate throughout the year."

Q1 prenatal screening business revenue was $171.9 million, a year-over-year increase of 22%; pharmacogenomics business (including GeneSight testing) revenue was $38.9 million, a year-over-year increase of 21%, with testing volume up 13% year-over-year.Myriad's Largest Business Unit — Hereditary Cancer Testing Q1 Revenue of $88.1 Million, Up 16% Year-over-YearDue to a decrease in biopharmaceutical business, the company's oncology analytics revenue fell 17% year-over-year to $30.9 million. Additionally, due to improved payor coverage,The company's Prolaris test revenue increased by 9%.。

Diaz stated that Myriad has recently achieved victories in oncology and women's health business,Currently integrating Precise Tumor and Precise Liquid tests to enhance oncology products., which the company acquired from Intermountain Precision Genomics in February 2024.

The CompanyQ1 net loss of $26 million, or $29 per shareR&D expenses increased by 11% year-over-year, reaching $24.9 million; SG&A costs were $140.6 million, a decrease of approximately 7% year-over-year. Myriad Genetics reaffirmed,Expected full-year revenue for 2024 to be between $820 million and $840 million.。

As part of the European business restructuring,Myriad Genetics, Inc. announced in early May 2024To Sell Its Breast Cancer Test Product EndoPredict to French In Vitro Diagnostic Company Eurobio Scientific, the specific amount has not been disclosed. In addition,The company also granted Eurobio Scientific the rights to sell its Prolaris IVD kit outside the United States.; Within the United States, Myriad will continue to retain the rights to produce and sell EndoPredict as a Laboratory Developed Test (LDT) as part of its precision oncology solutions suite.This transaction is expected to be completed in the second or third quarter of 2024.。

Sophia Genetics CEO Jurgi Camblong stated, "We achieved solid results in Q1, including signing 27 new core genomics customers, officially launching MSK-ACCESS powered by Sophia DDM... and collaborating with biopharmaceutical partners to expand the Sophia DDM network into regions such as Africa for the first time."

The company's growth momentum in the U.S. during Q1 was strong, with the U.S. market accounting for approximately 34% of total sales.Among them, the Mayo Clinic is one of the latest American users of the DDM platform. Recently, Sophia Genetics has also reached deals with institutions in India, South Korea, Europe, and Africa, many of which are for the liquid biopsy product offered in collaboration with MSK.

Camblong stated,The company is a leader in the application of HRD testing for solid tumors and overall solid tumor genomics, with double-digit growth annually.; Hereditary cancer testing showed "strong single-digit growth"; genetic and rare disease testing lagged behind other applications. In biopharmaceuticals, the company more than doubled its product pipeline in 2023, but this business unit is "still in its infancy," making related revenue timing difficult to predict.

Recently, Sophia Genetics has also signed the first breast cancer pilot project with a biopharmaceutical company, aiming to identify multimodal biomarkers and advance personalized treatment for stage 4 breast cancer patients.

Sophia Genetics Q1 Net Loss of $13.7 Million, or $21 per Share; R&D costs increased from $9.3 million in the same period last year to $9.4 million; SG&A expenses also rose slightly to $19.8 million.

Sophia stated that the company will maintain its full-year 2024 revenue growth forecast of 25%-30%.。

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2.https://www.genomeweb.com/business-news/roche-dx-revenues-down-6-percent-q1-lower-covid-test-sales-base-business-rises

3.https://www.genomeweb.com/molecular-diagnostics/guardant-health-raises-full-year-guidance-q1-revenues-rise-31-percent

4.https://www.genomeweb.com/molecular-diagnostics/exact-sciences-q1-revenues-6-percent-colon-cancer-screening-remaining-lead

5.https://www.genomeweb.com/business-news/natera-reports-52-percent-spike-q1-revenues-raises-full-year-guidance

6.https://www.genomeweb.com/business-news/myriad-genetics-revenues-rise-12-percent-q1

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8.https://www.genomeweb.com/business-news/sophia-genetics-q1-revenues-climb-13-percent-missing-wall-street-estimate