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Sera Prognostics Q4, Full-Year Net Loss Swells

NEW YORK — Sera Prognostics reported after the close of market on Tuesday that its fourth quarter and full-year net loss swelled as the company worked to drive adoption of its PreTRM proteomic test for predicting risk of preterm birth.

The firm's net loss during the fourth quarter was $12.5 million, or $.41 per share, compared to $5.4 million, or $3.29 per share, in Q4 2020, missing analysts' average estimate for a loss of $.29 per share. Sera used approximately 30.7 million shares to calculate its per-share loss in the recently completed quarter compared to about 1.6 million shares in the year-ago period.

Last July, Sera went public on the Nasdaq and completed a $75 million initial public offering.

For the three months ended Dec. 31, 2021, the Salt Lake City-based diagnostics firm posted revenues of $26,000 compared to $6,000 in Q4 2020.

Sera Chairman and CEO Gregory Critchfield said in a statement that the firm has seen "a slow initial rate of adoption" for its PreTRM proteomic test for predicting risk of preterm birth.

However, the firm expects "to see growth during 2022 and beyond as COVID headwinds continue to wind down, as our sales staff make market inroads, and we accelerate our commercial activities," he said.

Sera said that the Centers for Medicare & Medicaid Services has established a Medicare payment rate of $750 for the unique Proprietary Laboratory Analysis code, 0247U, for PreTRM, and noted that it recently announced an agreement to participate in preferred provider organization MultiPlan's PHCS and MultiPlan networks, expanding access to the PreTRM test.

The company's Q4 R&D expenses rose 48 percent year over year to $3.1 million from $2.1 million, while its SG&A expenses rose more than threefold year over year to $9.4 million from $2.7 million.

Sera's 2021 net loss was $35.0 million, or $2.33 per share, compared to $19.8 million, or $12.76 per share, in 2021, and missed analysts' average estimate for a loss of $1.55 per share. The firm used approximately 15.0 million shares to calculate its per-share loss in 2021 compared to about 1.6 million shares in 2020.

Sera's 2021 revenues increased more than threefold to $82,000 from $25,000 in 2020.

Its 2021 R&D expenses rose 41 percent year over year to $11.0 million from $7.8 million, while its SG&A expenses more than doubled to $24.4 million from $10.2 million.

The company ended Q4 with $58.9 million in cash and cash equivalents and $46.2 million in marketable securities.

Oppenheimer analyst Kevin DeGeeter said in a research note on Tuesday that the investment bank expects that interim data from the PRIME study — which Sera is conducting in partnership with health insurer Anthem — will support reimbursement discussions and commercial adoption of PreTRM in 2024 and beyond.

In the near term, however, Sera said that its 2022 revenues are expected to be approximately $500,000, while Oppenheimer's prior estimate was $6.0 million, DeGeeter said.

In midmorning trading on the Nasdaq, Sera's shares were down nearly 10 percent at $3.66.