NEW YORK – Hologic on Monday said it continues to see rising revenues from its molecular women's health assays that run on the company's base model Panther instrument, while the growing installed base for the firm's PCR-based Panther Fusion module has provided an opening to expand use of the firm's respiratory tests.
During a conference call to review the firm's fiscal fourth quarter financial results, Hologic CEO Steve MacMillan attributed much of the recent jump in the firm's molecular diagnostics revenues to rising utilization of the company's Panther instruments and tests.
"These results should put to rest any concerns regarding Panther utilization in a post-COVID environment," he said.
CFO Karleen Oberton added during the call that the firm now has a global installed base of more than 3,300 Panther instruments, which is up sharply since the height of the COVID-19 pandemic.
The comments reinforce similar statements by Hologic officials earlier this year that sales of the firm's transcription-mediated amplification-based Panther instruments had slowed but sales of its PCR-based Panther Fusion modules were on the rise. The company continued to improve upon its existing transcription-mediated amplification assays for the base model Panther, but it was focused on developing new, innovative tests for the Fusion module. The Panther and Fusion have a combined menu of about 20 assays.
Hologic Chief Operating Officer Essex Mitchell said on Monday that the company continued to expand the global footprint of the Panther Fusion module during fiscal Q4.
The Waltham, Massachusetts-based firm said after the close of the market on Monday that its fiscal fourth quarter revenues rose 5 percent year over year on the strength of the firm's non-COVID-19 molecular diagnostics business and contributions from its breast health and surgical businesses. It also reported that its revenues grew by 4 percent on a constant currency basis.
For the quarter ended Sept. 28, Hologic reported revenues of $987.9 million compared to $945.3 million one year earlier. The firm beat Wall Street's consensus prediction of $976.7 million for the quarter.
The company's overall diagnostics revenues rose about 7 percent year over year to $443.3 million compared to $416.4 million in the year-ago quarter. Organic revenues for the business, excluding COVID-19-related revenues, jumped almost 10 percent on a constant currency basis.
Hologic's molecular diagnostics revenues, including COVID-19 assays, jumped 9 percent to $319.3 million from $291.9 million. The firm cited higher sales of its bacterial vaginosis, Candida vaginitis, and Trichomonas vaginalis assays as well as Biotheranostics lab tests and the company's syndromic respiratory assays for COVID-19, flu A/B, and respiratory syncytial virus. The company also said that its non-COVID-19 molecular diagnostics revenues rose 13 percent year over year on a constant currency basis.
Cytology and perinatal revenues, however, rose 1 percent to $116.5 million from $115.2 million a year earlier. The company secured early this year US Food and Drug Administration de novo marketing authorization for its Genius digital cytology platform that incorporates volumetric imaging technology and algorithm-based recognition of potentially cancerous abnormalities. The system was already available in Europe, Australia, and New Zealand.
Mitchell said that the first US customers for the Genius system began using it during Q4. Hologic has said that the Genius system improves on the sensitivity of microscopy-based assessment of Pap test samples, aiding the detection of cervical cancer as well improving cytology workflows.
The growth in Hologic's diagnostics revenues were partly offset by a 19 percent decline in blood screening revenues to $7.5 million from $9.3 million.
The company reported COVID-19 revenues declined about 12 percent year over year during the quarter. COVID-19 assay revenues were $15.2 million for Q4 2024. Other COVID-19-related revenues, including revenues from discontinued products for the recently completed quarter, were $24.8 million.
Oberton said that the company expects mid-single-digit growth in its diagnostics business in fiscal 2025 driven by a continued rise in use of the firm's women's health assays, the Biotheranostics Breast Cancer Index gene expression assay that is used to aid treatment decisions on extended, adjuvant endocrine therapy, and the continued rollout of the Genius digital cytology system.
Hologic's breast health revenues also rose 6 percent to $375.5 million from $352.8 million in the year-ago quarter on the strength of the firm's breast imaging service and the recent acquisition of breast cancer surgery technology firm Endomagnetics. Revenues for the business also were up by 6 percent on a constant currency basis.
Hologic reported its GYN Surgical business revenues also rose 6 percent to $156.5 million from $148.0 million on strong international performance. Mitchell said that the growth was led by the company's MyoSure and Fluent products, although that growth was partly offset by declines in its NovaSure business.
The firm's skeletal health revenues, however, declined 55 percent year over year to $12.7 million from $28.0 million. The firm noted that it has temporarily halted shipments of its Horizon DXA systems. Hologic issued a recall this year that was related to nonconformance to electromagnetic compatibility requirements and warned against scanning patients who have implanted medical devices including neurostimulators, pacemakers, cardiac defibrillators, and continuous glucose monitors.
Mitchell said that Hologic plans to resume shipments of the DXA systems during fiscal Q1 2025.
Hologic reported net income of $178.6 million, or $.76 per share, compared to $90.6 million, or $.37 per share, in Q4 2023. It also reported a non-GAAP diluted EPS of $1.01 per share, which met the analysts' consensus estimate.
The firm cut its R&D spending by 8 percent year over year to $67.3 million from $72.9 million. Its SG&A spending, meanwhile, went up 7 percent to $249.2 million from $232.4 million.
For the full fiscal year 2024, Hologic's revenues were flat year over year at $4.03 billion. The full-year revenues came in at the top of the company's guidance range of $4.01 billion to $4.03 billion and beat analysts' consensus estimate of $4.02 billion.
The firm's net income was $789.5 million in fiscal 2024, or $3.32 per share, compared to $456 million, or $1.83 per share, in fiscal 2023. Adjusted EPS was $4.08, matching Wall Street's consensus prediction.
Hologic ended the quarter with $2.16 billion in cash and cash equivalents.
Hologic reported that it repurchased $58 million in stock during fiscal Q4 and $808 million in stock during the full fiscal year. The firm announced on Monday that it intends to buy back another $250 million of stock through an accelerated share repurchase agreement to be completed in Q2 2025.
The company recently extended its stock repurchase spending with the authorization of a $1.5 billion stock repurchase program with a five-year term. It had announced two years prior a $1 billion stock repurchase program.
For fiscal Q1 2025, Hologic expects revenues in the range of $1.03 billion to $1.04 billion, which would be a 1 percent to 2 percent increase over Q1 2024. GAAP EPS is expected to be in the range of $.81 to $.84 while non-GAAP EPS is expected to be in the range of $1.00 to $1.03.
For the full fiscal year 2025, Hologic expects revenues in the range of $4.15 billion to $4.20 billion, which would be a 3 percent to 4 percent increase over fiscal 2024. GAAP EPS is expected to be in the range of $3.53 to $3.63 while non-GAAP EPS is expected to be in the range of $4.25 to $4.35.
In early morning Tuesday trading on the Nasdaq, Hologic shares were down 4 percent at $80.56.