Interpace Biosciences Releases Preliminary Record Second Quarter 2023 Business Results; Updates Status of PancraGEN® Reimbursement
- Q2 Revenue of $11 million; a 49.1% increase year-over-year and 12.2% better than Q1; highest quarter in history
- 1st Half Revenue $20.9 million; 36.1% improvement over 1st Half 2022
- Q2 Test volume up 15.2% year-over-year to record levels; 1st Half volume up 16.5% year-over-year
- Novitas announces that LCD L39365 has been rescinded and will NOT go into effect July 17, 2023
PARSIPPANY, NJ, July 10, 2023 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG) today announced preliminary business results for the second quarter ending June 30, 2023, and provided an update on recent activities. Final Q2 financial results are expected to be released no later than August 11, 2023.
Second quarter Net Revenue was $11 million, fueled by significant volume growth for ThyGeNEXT® + ThyraMIR®v2 and PancraGEN®. First half revenue was $20.9 million resulting in a 36.1% increase over 2022. Overall, volume grew 15.2% and 16.5% for Q2 and 1st Half YOY, respectively.. The two franchises grew 13.2% and 18.7% for thyroid and pancreatic testing, respectively. Volume and revenue both surpassed the prior records set in Q1 2023. According to Tom Burnell, President and CEO of Interpace, “We continue to be pleased with the adoption and utilization of the Company’s molecular diagnostic tests and their role in supporting physicians in the diagnosis and treatment of patients.”
On July 6, 2023, Novitas Solutions, Inc. announced that it was rescinding implementation of the Genetic Testing for Oncology LCD (L39365) so that it will not become effective on July 17, 2023. As a result, Interpace is able to continue offering PancraGEN and the related Point2® fluid chemistry tests for amylase, CEA, and glucose.
According to Tom Burnell, “We are very pleased that this revised policy decision allows Interpace to continue offering PancraGEN – a widely used molecular test that aids physicians in their diagnosis of pancreatic cancer when first-line tests and procedures are inconclusive.” Dr. Burnell further added, “Pancreatic cancer primarily strikes the Medicare-aged population and has the highest mortality rate of all major cancers. This new decision by the Medicare Administrative Contractor (MAC), Novitas Solutions, Inc. allows continued physician access to important molecular insights that can help inform optimal patient management – including the reduction of unnecessary surgeries.”
About Interpace Biosciences
Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.
Clinical services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA®, a “molecular only” version of PancraGEN that provides physicians a snapshot of a limited number of factors; ThyGeNEXT® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR®v2, used in combination with ThyGeNEXT®, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification; and RespriDX®, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN®, a molecular-based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.
For more information, please visit Interpace Biosciences’ website at www.interpace.com.
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to the Company’s future financial and operating performance. The Company has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statements, including, but not limited to, the reimbursement of the Company’s tests being subject to review by CMS, the Company’s ability to continue to perform, bill and receive reimbursement for our PancraGEN® molecular test under the existing local coverage determination (“LCD”), given that such LCD is currently under review by Novitas Solutions, Inc., the Company’s Medicare administrative contractor, the possibility that the Company’s estimates of future revenue, cash flows and adjusted EBITDA may prove to be materially inaccurate, the Company’s history of operating losses, the Company’s ability to adequately finance its business and seek alternative sources of financing, the Company’s ability to repay borrowings with Comerica Bank and BroadOak, the Company’s dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect, and the possible removal of the Company’s common stock from trading on the OTCQX®.
Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Interpace Biosciences, Inc.
Released July 10, 2023