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Natera, Inc. (Symbol: NTRA) is a leading diagnostic and research company based in San Carlos, CA, driven by a commitment to advance the science and application of prenatal testing. In the information age, medical diagnostics have lagged behind in adopting new technologies, but Natera is changing that narrative. The company specializes in preconception and prenatal genetic testing services, providing couples with crucial information throughout the pregnancy journey.
Natera offers a comprehensive range of tests, including Preimplantation Genetic Diagnosis (PGD) for IVF and Non-Invasive Prenatal Testing (NIPT). Their Panorama NIPT is particularly notable for its ability to screen for chromosomal abnormalities in a fetus, even in twin pregnancies, typically through a simple blood draw from the mother. Another significant product is the Horizon Carrier Screening (HCS), which determines carrier status for numerous severe genetic diseases that could be passed on to offspring.
The company's innovative approach leverages advances from the Human Genome Project and is powered by proprietary bioinformatics algorithms. This technology enables highly accurate genetic testing results. Natera's portfolio also includes the Signatera Molecular Residual Disease (MRD) Test, designed to detect circulating tumor DNA in cancer patients, helping to assess molecular residual disease and monitor recurrence. Additionally, the Prospera test assesses organ transplant rejection.
Through its pioneering genetic testing services and experienced genetic counseling, Natera provides valuable insights that help in informed decision-making for pregnancies and medical conditions. The company continues to make significant strides in the field of medical diagnostics, driven by a passion for innovation and excellence.
Natera (NASDAQ: NTRA) announced its upcoming presentation of new SignateraTM data at the San Antonio Breast Cancer Symposium (SABCS), December 10-13. The company will present six abstracts, including significant findings from the ZEST clinical trial, which showed improved disease-free survival with niraparib treatment in ctDNA-positive breast cancer patients (11.4 months vs 5.4 months for placebo).
Key highlights include a clinical genomics study revealing 44% of Signatera-positive patients had targetable genomic alterations, with 34.5% showing PIK3CA mutations. Additionally, four abstracts will present patient-reported outcomes indicating that ctDNA testing provides valuable treatment planning information without increasing patient anxiety.
A federal court jury unanimously ruled in favor of Guardant Health in its lawsuit against Natera for false advertising and unfair competition. The jury awarded $292.5 million to Guardant Health, including $175.5 million in punitive damages, making it one of the largest false advertising verdicts in history. The case, filed in May 2021, centered on Natera's deliberate campaign to mislead cancer clinicians about Guardant Reveal™, a tissue-free minimal residual disease test for early-stage colorectal cancer. The jury rejected all of Natera's counterclaims.
Natera has responded to a jury decision favoring Guardant Health in a false advertising case from 2021. The litigation involved mutual claims regarding statements about Guardant's Reveal test. Natera disagrees with the verdict and plans to appeal. The company emphasizes that the case focused solely on comparative advertisements from 2021 and does not affect their Signatera test, which has become the leading MRD test in the U.S., supported by over 100 peer-reviewed publications.
Natera co-founder and executive chairman Matthew Rabinowitz has been named 2024 R&D Leader of the Year by R&D World. The organization recognized his pioneering work in genetic testing and precision medicine, particularly highlighting the development of transformational products including: Panorama™ for prenatal screening, Signatera™ for cancer recurrence detection, and Prospera™ for transplant rejection risk assessment. Dr. Rabinowitz, who served as CEO from 2005 to 2019, has authored numerous publications in prestigious journals and holds multiple patents in the field.
Natera has achieved a significant milestone with over 100 peer-reviewed publications on Signatera, its personalized molecular residual disease (MRD) test. The studies, published in prestigious journals like Nature and Journal of Clinical Oncology, demonstrate excellent clinical performance and utility. Signatera, the most widely used MRD test in the U.S., has served more than 200,000 cancer patients. The company continues to expand its research pipeline with several phase III randomized clinical trials across various cancer types.
Natera (NASDAQ: NTRA) reported Q3 2024 financial results, highlighting a 63.9% revenue increase to $439.8 million compared to Q3 2023. Product revenues surged by 64.4%. The company achieved a gross margin of 61.8%, up from 45.1% in the prior year. Natera processed approximately 775,800 tests, a 23.9% increase, and performed around 137,100 oncology tests, a 54.4% rise. The company reported a positive cash flow of $34.5 million and raised its annual guidance to $1.61-$1.64 billion in total revenue, 58%-61% gross margin, and $50-$75 million in net cash inflow.
Natera reported a net loss of $31.6 million ($0.26 per diluted share), an improvement from a $109.0 million net loss ($0.95 per diluted share) in Q3 2023. Total operating expenses increased by 34% to $311.1 million. The company held $922.3 million in cash and equivalents as of September 30, 2024, with total debt at $367.0 million. All convertible senior notes were redeemed or converted on October 11, 2024.
Natera (NASDAQ: NTRA) announced the completion of a study using Signatera from the CALGB (Alliance)/SWOG 80702 randomized, phase III clinical trial. This study evaluated the benefit of adding celecoxib to standard postoperative treatment FOLFOX in stage III colorectal cancer (CRC) patients. The analysis included 1,011 patients with post-surgical plasma samples, focusing on Signatera’s ability to identify a subgroup of patients who may benefit from celecoxib addition. Primary and secondary endpoints were disease-free survival (DFS) and overall survival (OS), respectively. Although celecoxib addition did not significantly improve DFS, NSAIDs like celecoxib have shown promise in benefiting certain CRC subpopulations. Results will be presented at the ASCO GI symposium in January 2024.
Natera (NASDAQ: NTRA), a leader in cell-free DNA and genetic testing, has announced its participation in three major healthcare investor conferences. The company will present at the UBS Global Healthcare Conference on November 14, the Wolfe Research Healthcare Conference on November 19, and the 36th Annual Piper Sandler Healthcare Conference on December 3. All presentations will be accessible via live webcast through Natera's investor relations website, with replays available after each event.
Natera, a global leader in cell-free DNA and genetic testing, has announced it will release its third quarter 2024 financial results on November 12, 2024, after market close. The company will host a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET) on the same day. Investors can access the call through domestic (1-888-770-7321) or international (1-929-201-7107) dial-in numbers using conference ID 7684785.
Natera (NASDAQ: NTRA) will present new data on its 385-gene kidney genetic test, Renasight™, at the American Society of Nephrology (ASN) Kidney Week 2024 in San Diego from Oct. 23-27. The company and collaborators will present 7 abstracts focused on comprehensive genetic testing for patients with chronic kidney disease (CKD).
This includes an updated analysis from the prospective RenaCARE study and additional data on the utility of genetic testing for CKD patients. The presentations align with recent support for renal genetic testing from organizations like NKF, KDIGO, and The New England Journal of Medicine.
Dr. Anthony Bleyer of Wake Forest University School of Medicine highlighted that 25% of dialysis patients don't know their kidney disease cause, emphasizing the importance of genetic testing. Natera's presentations will cover topics such as patient satisfaction with genetic counseling, genetic testing results in African American patients, and the genetic landscape of glomerular disease and FSGS.
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