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Qiagen Beats Q4 Estimates, Guidance; Details Oncology IVD Plans for Digital PCR Platform

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This story has been updated from a previous version to include comments made by Qiagen executives in an earnings call and follow-up interview.

NEW YORK – Qiagen reported on Tuesday that its fourth quarter sales declined 14 percent with an expected decrease in COVID-related sales offset by increased sales in the firm's non-COVID portfolio.

For the quarter ended December 31, 2022, Qiagen had net sales of $498.0 million compared to $582.4 million in the year-ago period and beating analysts' average estimate of $486.9 million. At constant exchange rates (CER), sales declined 9 percent to $531 million, coming in ahead of prior guidance for at least $520 million in CER sales.

In Q4 and 2022, Qiagen reported growth across its main business categories, namely sample preparation technologies, diagnostic solutions, PCR, and NGS. In a Wednesday conference call recapping the company's financial results, CEO Thierry Bernard noted that instrument placements across these businesses continued to trend well in 2022, particularly in sample prep and diagnostics.  

"This is a very positive signal about the value of our portfolio and should support future consumable trends," Bernard said.

Cumulatively within sample prep, Qiagen has placed approximately 3,200 QIASymphony systems, 14,000 QiaCube systems, and 5,000 EZ1 and EZ2 systems, Bernard said.

Among its clinical systems, Qiagen's NeuMoDx system for core labs is "making good progress [in its] transition to non-COVID use," Bernard said, especially ex-US where it has 16 CE IVD assays. The firm has placed approximately 300 NeuMoDx systems cumulatively worldwide, he said, adding that this equates to more than 10 percent of the market share of the leading competitor just two years since launching the system.

Qiagen has also placed more than 3,500 QIAStatDx syndromic testing systems since launch and also saw good demand for respiratory testing at the end of 2022, Bernard said. The firm has launched respiratory, gastrointestinal, and meningitis panels in Europe on the QIAStat. A respiratory panel is available in the US, and Qiagen now expects the GI panel to be cleared by the US Food and Drug Administration in the second half of the year, while it will submit the meningitis panel before the end of 2023, Bernard said. Qiagen's planned QIAStat menu for the coming two years includes a panel for positive blood cultures and one for complicated urinary tract infections.

For the QIACuity digital PCR system, Bernard said the firm has placed more that 1,300 systems in two years. "This is a very strong base for future consumables growth as we focus on expansion with research and biopharma," he said. Development may also draw on Qiagen's more than 30 master collaboration agreements with global pharma and biotech companies related to companion diagnostics.

When the QIACuity system was first disclosed, Qiagen said it would ultimately bring it to clinical labs with regulated in vitro diagnostic assays. On Wednesday's call, Bernard said that the firm now expects a regulatory submission by the end of 2023 aiming initially at the oncology market.

In a follow-up interview, Bernard specified that the firm will pursue CE marking and FDA clearance in parallel for a BCR-ABL assay and that Qiagen expects its first sales of digital PCR clinical tests in 2024. Qiagen will first pursue an oncology menu, he said, as that is an area of expertise for the firm, but it will also consider infectious disease applications and possibly non-invasive prenatal testing applications, as well.

Within the digital PCR space, Bio-Rad Laboratories has also branched into clinical IVD testing with its QXDx BCR-ABL %IS Kit cleared in 2019. The firm said last year that it is also developing digital PCR diagnostics for reproductive health, infectious disease, and transplant monitoring while also focusing on biopharma customers.

Bernard said Qiagen has confidence that there is a market for its dPCR clinical solutions, in part because there has already been demand from its customers.

Q4 and FY2022 Results

Qiagen's Q4 results were driven by a 64 percent decline in COVID-only sales to $66 million from $183 million. This was offset by 8 percent growth in non-COVID product sales to $432 million from $400 million.

Fourth quarter sales in the firm's molecular diagnostics business unit fell 18 percent to $258 million from $313 million. Sales in the life sciences unit, meanwhile, declined 11 percent to $240 million from $269 million. 

Qiagen reported Q4 net income of $88.8 million, or $.39 per share, compared to $129.2 million, or $.56 per share, a year ago. Qiagen's adjusted diluted earnings per share in the quarter were $.53, or $.55 at CER, ahead of the firm's outlook for at least $0.50 CER and beating analysts' average estimate of $.47.

For full-year 2022, Qiagen's net sales declined 5 percent to $2.14 billion from $2.25 billion in 2021. At constant exchange rates, year-over-year sales were flat. The firm saw a 33 percent decline in COVID-related sales to $470 million from $704 million, offset by 8 percent growth in its non-COVID portfolio to $1.67 billion from $1.55 billion.

Full-year sales in the firm's molecular diagnostics business unit dipped 2 percent to $1.13 billion from $1.14 billion. Sales in the life sciences unit, meanwhile, declined 8 percent to $1.02 billion from $1.11 billion. 

Qiagen recently launched the EZ2 Connect MDx system, NeuMoDx MPXV monkeypox test for research use only, and the therascreen KRAS RGQ PCR kit as a companion diagnostic test to aid in identifying non-small cell lung cancer patients eligible for treatment with Krazati (adagrasib) from Mirati Therapeutics. It also launched a new cell line database called ATCC Cell Line Land.

In the quarter Qiagen and Helix also entered into an exclusive strategic partnership to advance companion diagnostics for hereditary diseases and Qiagen acquired NGS-based forensics firm Verogen.

Qiagen also disclosed that it has appointed Rick Bright, former director of the Biomedical Advanced Research and Development Authority and former CEO of the Rockefeller Foundation's Pandemic Prevention Initiative, to its scientific advisory board.

Qiagen reported full year net income of $423.2 million, or $1.84 per share, compared to $512.6 million, or $2.21 per share, in 2021. Qiagen's adjusted diluted earnings per share for 2022 were $2.38, or $2.46 at CER, ahead of the firm's outlook for at least $2.40 CER and above analysts' average estimate of $2.32.

The firm guided for full-year 2023 net sales of at least $2.05 billion CER and adjusted diluted EPS of at least $2.10 CER based on expectations for ongoing double-digit CER growth in the non-COVID products and a continued decline in COVID-19 product sales.

Qiagen ended the year with $730.7 million in cash and cash equivalents and $687.6 million in short-term investments.

Qiagen's stock on the New York Stock Exchange was down a fraction of a percent on Wednesday afternoon to $49.57.

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