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In Brief This Week: MDxHealth, Biodesix, FIND, Alverno Labs, Ibex Medical Analytics

NEW YORK –  MDxHealth said this week that its fourth quarter revenues increased 114 percent year over year to $12.9 million versus $6.0 million in the same period last year. Billable test volume during the three months ended Dec. 31 was 4,339 for the company's Confirm MDx assay, and 3,129 for Select MDx, up 21 percent and down 6 percent, respectively, compared to Q4 2021. 

The firm's full-year 2022 revenues increased by 67 percent to $37.1 million from $22.2 million for 2021. This included $21.8 million from Confirm MDx, $9.3 million from the Genomic Prostate Score, $4.9 million from Resolve MDx, and the remainder from Select MDx and other assays. 

MDxHealth's full-year net loss was $44.0 million, or $.28 per share, compared to $29.0 million, or $.24 per share in 2021. The company ended the year with cash and cash equivalents totaling $15.5 million. It is maintaining its previously issued 2023 revenue guidance of $65 million to $70 million. 

Separately, MDxHealth also said this week that underwriters of a previously announced registered public offering have exercised the option to purchase additional American Depositary Shares (each representing 10 ordinary shares of the company without nominal value) on the same terms and conditions as in the offering. 

The option being exercised is for 750,000 ADSs at a price of $4.00 each, which amounts to gross proceeds of $3.0 million before deducting commissions and estimated offering expenses. Coupled with the initial offering's proceeds, MDx Health will gross $43.0 million.  

Cowen and Company and William Blair & Company acted as joint bookrunning managers, BTIG acted as lead manager, and KBC Securities USA acted as co-manager. The closing of the exercise is expected to occur on March 8. 

Biodesix this week said that its fourth quarter revenues grew 33 percent year over year to $9.6 million from $7.2 million. It missed the consensus Wall Street estimate of $10.8 million, however. COVID-19 revenues plunged to $16,000 in the recently completed quarter from $425,000 a year ago, while lung diagnostic revenues rose to $8.2 million from $5.4 million. Total diagnostic revenues grew to $8.3 million from $5.9 million a year ago, and biopharma service revenues were flat at $1.4 million. 

The Boulder, Colorado-based firm had a net loss of $20.3 million, or $.35 per share, in Q4 2022 compared to net loss of $13.3 million, or $.49 per share, in Q4 2021. It missed the consensus Wall Street estimate of a loss per share of $.28 for Q4 2022. 

For full-year 2022, Biodesix's revenues slid to $38.2 million from $54.5 million in 2021, a 30 percent decline. The analysts' average estimate was $39.3 million in revenues for 2022. COVID-19 revenues dropped to $5.2 million from $30.2 million a year ago, and lung diagnostic revenues rose to $29.2 million from $18.7 million. Total diagnostic revenues fell to $34.5 million from $48.9 million, and biopharma service revenues fell to $3.7 million from $5.6 million. The firm had a net loss of $65.4 million, or $1.55 per share, in 2022 compared to a net loss of $43.2 million, or $1.58 per share, in 2021. It fell short of the analysts' average estimate of a per share loss of $1.44 for 2022. 

Biodesix finished 2022 with $43.1 million in cash and cash equivalents. 

The company guided to $52 million to $55 million in total revenues for 2023. 

FIND and Kilele Health Association said this week that they have launched a coalition to increase cervical cancer screening in sub-Saharan Africa. The coalition comprises community and civil society organizations who will identify obstacles to screening for the disease. They also will raise awareness of preventive measures, press to accelerate progress toward national elimination targets by 2030, and provide user-led feedback and preferences to inform the development and scale-up of new testing technology and strategies, the partners said. Insight from the coalition will shape FIND's goal to increase access to cervical cancer screening and hasten the elimination of cervical cancer, they added. Kilele Health is a grassroots, nonprofit organization based in Nairobi, Kenya, with a goal to reduce the burden, severity, and impact of cancer and other noncommunicable diseases. 

Alverno Laboratories will make Ibex Medical Analytics AI-powered cancer diagnostics available to all pathologists in Alverno's network as part of a deal announced this week. Specifically, Ibex's Galen suite of products will be made available to practitioners in Alverno's network, which includes 30 hospital labs in Indiana and Illinois. Ibex's products include the Galen Breast and Galen Prostate tests. The Israel-based firm announced this week that the UK National Health Service is making the company's tests available to 25 NHS trusts. 

 In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.