NEW YORK ─ For its recently completed fourth quarter, Hologic reported its revenues declined 2 percent year over year, but the firm expects higher revenue growth going forward on the back of a diverse product portfolio that can help it withstand the effects of the ongoing pandemic.
The drop in revenues for Q4 2021 was due in part to lower year-over-year sales related to its COVID-19 molecular diagnostic tests and related products. However, in its prior-year fiscal fourth quarter, COVID-19 testing volumes were near their peak, offering a difficult year-over-year comparison, Karleen Oberton, the firm's CFO, said on a conference call Monday to discuss the firm's financial results.
This quarter's numbers also masked a strong recovery in Hologic's base businesses, Oberton said.
The firm grew at 12 percent year over year for the recently completed quarter when revenues from Q4 COVID-19 assays and related products were removed from Hologic's current and prior-year quarter revenues. That "compares favorably with the 5 to 7 percent long-term guidance" it provided last quarter for revenue growth without COVID-19 test and related product sales, Oberton said.
"Although COVID testing revenue declined compared to the prior year, it still far exceeded our expectations as the Delta variant surged throughout the quarter," she said.
In Q4 2021, Hologic shipped about 21 million COVID tests to customers, generating assay revenue of $443 million globally. By comparison, in Q4 2020, the firm announced it shipped about 25 million COVID tests to customers, generating revenue of $601 million globally.
In an analyst note, JP Morgan's Tycho Peterson said that despite a slowdown in COVID-19 testing, Hologic's base business remains strong enough that "investors can look toward clear momentum."
The Marlborough, Massachusetts-based company's expectation for between 5 percent and 7 percent growth without COVID-related sales is "achievable based on the bolus of Panther placements installed globally, recent acquisitions, and a dominant position in women’s health," he added.
Stephen MacMillan, Hologic's chairman, president, and CEO, said on the conference call he believes Hologic is "well positioned for success regardless of the future direction of the pandemic. … We benefit from our invaluable testing contributions if the pandemic drags on, or from a strong base business when it wanes."
MacMillan added that Hologic's Q4 revenue growth was "driven by resilience across all our divisions, despite utilization pressure from the Delta variant and customer staffing shortages."
In diagnostics, the firm has seen a two-thirds increase in its total installed base of Panther molecular diagnostic instruments during the pandemic, providing a basis for future growth in assay sales with a larger number of customers expected to add tests unrelated to SARS-CoV-2, MacMillan said.
"Looking forward to 2022, we continue to see strong demand for additional placements globally," MacMillan said. "Utilization of this growing footprint and leveraging our robust portfolio of 19 assays will be key to driving the business forward in a post-COVID world."
In Q4, the company recorded more new non-COVID-related assay sales in the US than it had ever sold there in one quarter. "While our legacy women's health assays are leading the way, we also expect newer assays to make material contributions," he said. "For example, sales of our vaginosis panel almost doubled to nearly $30 million in 2021. We expect significant growth in 2022 as well, which would make this product our most successful diagnostics [product] launch ever, aside from COVID."
MacMillan noted that Hologic completed its acquisitions of Biotheranostics, Diagenode, and Mobidiag in 2021, representing its first diagnostic company acquisitions in about a decade.
"These deals are broadening our product offering and customer base, and strengthening our R&D capabilities around the world," he said.
During Q4, Biotheranostics exceeded expectations with sales of more than $16 million while "the broad European launch of the [Mobidiag] Novodiag system represented a meaningful, early achievement in our integration process," MacMillan said.
With an installed base of 200 instruments, Mobidiag contributed $7 million to Hologic's Q4 revenue, and the company anticipates accelerated growth, initially in European markets, from the Novodiag MDx system, which it is selling to smaller labs.
In 2021, Hologic also purchased Louisville, Colorado-based Bolder Surgical, a provider of advanced energy vessel sealing surgical devices; Austin, Texas-based Acessa Health, which markets a laparoscopic system that enables physicians to treat women with symptomatic, benign uterine fibroids; and Berlin-based Somatex Medical Technologies, which develops and manufactures minimally invasive devices used in the field of tumor diagnostics, biopsy, and interventional specialties. In fiscal 2022, Hologic anticipates about $150 million in revenues from all of its new acquisitions this year.
MacMillan also added during the conference call that the company has launched the Hologic Global Women's Health Index, which shines a light on the global disparity in women’s preventive care. He said that about 60 percent of surveyed women and girls, totaling about 1.5 billion people, had not been tested in the last year for four common diseases that affect women's health — cancer, diabetes, high blood pressure, and sexually transmitted infections.
Looking ahead, Oberton noted the effects of the pandemic on its businesses remains highly unpredictable, and the firm is not immune from supply chain challenges. However, Hologic believes it has "good visibility into the recovery of our base businesses, as well as a valuable hedge to COVID-19 outbreaks with our testing revenue," she said.
Molecular diagnostics is expected to continue to drive revenue growth within its diagnostics segment, given the "larger Panther installed base, uptake of new assays like our vaginosis panel, and international expansion opportunities," Oberton said. "Demand remains unpredictable, and a lot can change between now and the end of our fiscal , so we continue to forecast conservatively and view COVID as upside to our strong base business."
The company expects COVID-19 assay sales to be at least $200 million in the first quarter of 2022, and at least $300 million for full-year 2022. Associated COVID-19-related diagnostic products are expected to be approximately $45 million in the first quarter and at least $120 million for the full year, Oberton added.