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In Brief This Week: Personalis, Biocartis, Opko Health, Berkeley Lights, More

NEW YORK – Personalis said this week that its fourth quarter revenues dropped 19 percent to $16.7 million from $20.7 million a year ago, but beat analysts' average estimate of $15.3 million. The Fremont, California-based cancer genomics company reported $15.8 million in revenue from pharma tests, enterprise, and other customers, up slightly from $15.4 million a year ago. Revenue from enterprise customers included revenue of $8.2 million from an ongoing collaboration with Natera. Fourth quarter net loss swelled to $31.1 million, or $.67 per share, from a net loss of $20.2 million, or $.45 per share, a year ago. On average, analysts had expected a net loss per share of $.64. During the quarter Personalis signed an agreement with Moderna to apply its NeXT biomarker analysis platform to a clinical trial of an mRNA-based cancer vaccine. Also, in January, the company disclosed in a regulatory filing that it was laying off up to 30 percent of its workforce. 

For full-year 2022, Personalis reported revenues of $65.0 million, down 24 percent from $85.5 million in 2021 and beating analysts' average estimate of $63.6 million. Full-year net loss grew to $113.3 million, or $2.48 per share, from $65.2 million, or $1.49 per share, in 2021. On average, analysts were expecting a loss per share of $2.45. Personalis finished the year with $89.1 million in cash and cash equivalents and $78.5 million in short-term investments. 

Belgian molecular diagnostics firm Biocartis said this week that its 2022 revenues grew 19 percent year over year. The company booked €57.5 million ($61.0 million) in revenues in 2022, compared to €48.3 million in 2021. Of those, €45.0 million derived from product sales, mostly cartridges for cancer testing, up from €40.5 million in 2021; €11.1 million came from collaborations, up from €6.1 million the previous year; and €1.4 million were service revenues, down from €1.7 million in 2021. The Mechelen, Belgium-based firm said SARS-CoV-2 testing contributed €3.5 million to 2022 revenues as COVID-19 testing needs were "fading." 

The company's net loss in 2022 was €47.7 million, or €.79 per share, down from a net loss of €71.5 million, or €1.26 per share, in 2021. As of Dec. 31, Biocartis held €26.1 million in cash and cash equivalents. The company installed 173 net new Idylla instruments in 2022, bringing its installed base to 2,085 instruments. For 2023, Biocartis expects product revenues between €55 million and €60 million, reflecting 25 percent to 35 percent growth over 2022 not including SARS-CoV-2 tests, which are expected to further decrease. 

Opko Health reported this week a 54 percent year-over-year drop in revenues for the fourth quarter on lower COVID-19-related revenues. For the three months ended Dec. 31, 2022, the firm reported total revenues of $185.4 million, down from $401.3 million a year ago and short of the consensus Wall Street estimate of $168.2 million. Diagnostics revenues shrank to $139.4 million for Q4 2022 from $362.8 million a year ago, driven by lower COVID-19 testing revenues, Opko said, as its BioReference Laboratories subsidiary processed about 100,000 COVID-19 PCR tests in the recently completed quarter, down from 2.7 million tests a year ago. Meanwhile revenues from the firm's pharmaceuticals business grew to $37.9 million from $35.3 million in Q4 2021. Opko Health had a net loss of $85.2 million, or $.11 per share, in Q4 2022, compared to a net loss of $73.8 million, or $.11 per share, a year ago. The analysts' average estimate for Q4 2022 was a loss per share of $.11. 

For full-year 2022, the company took in total revenues of $1.00 billion compared to $1.77 billion in 2021.The consensus Wall Street estimate was $986.8 million. Diagnostics revenues fell to $755.6 million from $1.61 billion the prior year, while pharmaceuticals revenues inched up to $142.9 million from $141.8 million. Net loss for 2022 widened to $328.4 million, or $.46 per share, from a net loss of $30.1 million, or $.05 per share, in 2022 and matched the consensus Wall Street estimate. 

Opko finished 2022 with $153.2 million in cash and cash equivalents. 

Berkeley Lights reported this week that its fourth quarter revenues decreased 23 percent year over year to $17.8 million from $23.2 million. Net loss for the quarter rose to $29.3 million, or $.41 per share, from $17.7 million, or $.26 per share, a year ago. 

Full-year 2022 revenues fell 8 percent to $78.6 million from $85.4 million in 2021. The company's 2022 net loss grew to $98.0 million, or $1.42 per share, from $71.2 million, or $1.08 per share, in 2021. The Emeryville, California-based digital cell biology company ended the year with approximately $86.5 million in cash and cash equivalents and $46.3 million in short-term marketable securities. 

Berkeley Lights did not provide 2023 revenue guidance, pending the close of its $57.8 million acquisition of IsoPlexis, announced in December. 

Devyser Diagnostics this week reported its Q4 and full-year 2022 financial results. Net sales for the quarter were SEK 34.2 million ($3.3 million), up nearly 40 percent from SEK 24.5 million in the same quarter in 2021 and up 30 percent adjusted for exchange rates. Net loss for the quarter was SEK 16.7 million, or SEK 1.04, compared to a loss of SEK 10.6 million, or SEK .87, in Q4 2021. Net sales for the full year were SEK 126.6 million, up 35 percent compared SEK 93.5 million in 2021 and up 29 percent when adjusted for exchange rates. Net loss for the year was SEK 46.0 million, or SEK 2.89, compared to a loss of SEK 20.7 million, or SEK 1.85, in 2021. 

Centogene this week said it increased the number of trial sites in its EFRONT study, an observational study it announced in 2021 to investigate the genetic makeup of frontotemporal dementia (FTD), a rare and progressive neurodegenerative disease. EFRONT aims to enroll and offer genetic testing to more than 2,500 patients with diagnosed or suspected FTD in Germany, Spain, Italy, Portugal, Belgium, Turkey, and Greece. The study is running with support from immuno-neurology company Alector, and study participants found to have mutations in the GRN gene will have the option to enroll in Alector's Phase III clinical trial for latozinemab, an investigational therapeutic candidate for treating FTD. 

Invivoscribe said this week that its lab in Shanghai has been accredited by the College of American Pathologists. The process includes an inspection of the lab facilities, equipment, personnel, and processes, and an evaluation of its performance and proficiency testing results. Invivoscribe noted it has three companion diagnostic approvals by various regulatory bodies with more CDx being developed. The CAP accreditation, the firm said, will allow it to expand its capability to support pharma and biopharma partners worldwide. 

Danaher announced this week that its board of directors has approved a regular quarterly cash dividend of $.27 per share of its common stock, payable on April 28 to shareholders of record on March 31. The board also approved a quarterly cash dividend of $12.50 per share of its 5 percent Series B Mandatory Convertible Preferred Stock, payable on April 17 to holders of record on March 31. 

Oncocyte said this week that it has completed the previously announced sale of 70 percent of its ownership stake in its subsidiary Razor Genomics and identified the buyer as Dragon Scientific. Financial terms of the deal were not disclosed. Oncocyte retains a 30 percent equity stake in Razor but said it is no longer responsible for an estimated $8 million in annual operating expense and $13 million in future milestone and development payments. The deal involved the transfer of all the assets and liabilities related to the DetermaRx lung cancer prognostic test to Dragon. 

Agilent Technologies said this week that its board of directors has approved a quarterly dividend of $.23 per share of common stock, payable on April 26 to shareholders of record at the close of business on April 4. 

Swiss startup 4D Lifetec said last week that it is preparing to launch its early cancer detection tests in the US market, and it is strengthening its scientific and commercial presence in the US ahead of that launch through a newly opened branch office on the MIT campus in Cambridge, Massachusetts. The company launched in 2022 sales in Europe of its blood-based 4D Lifetest Lung Dx assay for detection of early-stage lung cancer, and it has secured CE-IVD marking for 4D Lifetest assays for breast, prostate, and colon cancers. 

Molecular Designs, a Birmingham, Alabama-based developer and manufacturer of molecular multiplex pathogen assays, said this week that it has received ISO 13485:2016 certification of its quality management system. The certification demonstrates the firm's commitment to design, develop, produce, and deliver PCR assays that meet strict quality standards, according to the firm. 

French veterinary molecular diagnostics company Enalees said this week that it has opened a new subsidiary in Monheim am Rhein in Germany, where it plans to introduce its Epona equine tests as well as its Astéria tests for cats and dogs. The company offers rapid isothermal PCR diagnostic veterinary tests to diagnose various infectious diseases. 

Malaysian Genomics Resource Center said this week that it has signed a strategic collaboration agreement with Divine Genes to collaborate on business opportunities for offering genetic tests for reproductive health. Under the deal, Malaysian Genomics will add Divine Genes' DNA-based fertility test to its portfolio, offering it in Malaysia and overseas. The partners will also collaborate on improving the test. 

Thermo Fisher Scientific said this week that its board of directors has authorized a quarterly cash dividend of $.35 per common share payable on April 14 to stockholders of record as of March 15. This reflects a 17 percent increase over the previous dividend payment of $.30, according to the company. 

Epigenetics firm VolitionRx announced this week that it closed an $8.7 million underwritten public offering of approximately 4.9 million shares of common stock at $1.75 per share. The firm had previously priced 4.3 million shares, with expected gross proceeds of about $7.5 million. 

In its 10-K form filed last week with the US Securities and Exchange Commission, Abbott disclosed that it recorded employee-related severance and other charges of approximately $234 million in 2022. About $59 million was recorded in cost of products sold, approximately $36 million in research and development, and about $139 million in selling, general, and administrative expenses. The company declined to provide further information on the charges. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb. 

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