Hologic Inc - HOLX STOCK NEWS

Hologic (HOLX) has received CE Mark approval for its Affirm® Contrast Biopsy Software, a technology that combines contrast-enhanced diagnostic capabilities with lesion targeting for biopsy procedures. The software, which received FDA clearance in October 2020, integrates with Hologic's Selenia® Dimensions® and 3Dimensions™ systems.

The technology enables clinicians to target and acquire tissue samples in lesions identified through contrast-enhanced mammography (CEM), particularly in cases where correlation may not be found using tomosynthesis or ultrasound. It offers an alternative to MRI-guided biopsy with reduced noise and shorter examination times, potentially improving patient experience while reducing costs.

This software is part of Hologic's comprehensive contrast mammography and biopsy portfolio, which includes the Affirm Upright Biopsy System and I-View® 2.0 Contrast-Enhanced Mammography Software.

Hologic (NASDAQ: HOLX) has received FDA 510(k) clearance for its Aptima SARS-CoV-2 assay, upgrading from its previous Emergency Use Authorization (EUA) status granted in May 2020. The test detects SARS-CoV-2 RNA from nasopharyngeal or nasal swab samples, offering a less invasive testing option through nasal swabs.

The assay utilizes Hologic's transcription-mediated amplification (TMA) chemistry and runs on the Panther system, capable of processing over 1,000 tests daily with initial results in under three hours. The company has also secured FDA clearances for several other respiratory tests, including the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay for various sample types.

Hologic (HOLX) reported Q1 fiscal 2025 financial results with revenue of $1,021.8 million, up 0.9% year-over-year. The company achieved GAAP EPS of $0.87 and Non-GAAP EPS of $1.03, reaching the high end of guidance.

Key performance metrics include: Diagnostics revenue increased 5.1% to $470.6 million, Breast Health revenue decreased 2.3% to $369.1 million, and Surgical revenue grew 2.5% to $166.3 million. The company maintained strong cash flow from operations at $189.3 million and repurchased 6.8 million shares for $517 million.

Due to currency headwinds and weakness in breast health capital sales, Hologic lowered its full-year revenue guidance to $4,050-$4,100 million but maintained its non-GAAP EPS guidance of $4.25-$4.35. The company completed the acquisition of Gynesonics for approximately $350 million on January 2, 2025.

Hologic's Global Women's Health Index reveals concerning trends in women's health worldwide. For the first time, cancer testing among women has declined to just 10%, dropping two percentage points from previous years. The report, based on interviews with over 146,000 people across 142 countries, shows that 38% of women faced food insecurity, while 32% struggled with shelter costs.

The global women's health score remains stagnant at 53 out of 100. Taiwan leads with 68, followed by Kuwait (67), Austria (66), and Switzerland (65). The US scored 60, ranking 37th globally. Key findings include increased rates of worry (42%) and sadness (30%) among women, with 35% feeling unsafe in their communities. The study also revealed low HIV testing rates globally at 6%, with some Middle Eastern and North African countries showing rates below 0.5%.

Hologic (HOLX) reported preliminary Q1 FY2025 revenues of $1,021.8 million, showing a 0.9% increase year-over-year, or 1.0% in constant currency. The company expects GAAP and non-GAAP earnings per share to be near the high end of guidance ranges despite currency headwinds that reduced revenue by approximately $9 million.

Division performance showed mixed results: Diagnostics grew 5.1% to $470.6 million, with organic growth excluding COVID-19 at 9.0%. Breast Health declined 2.3% to $369.1 million, while GYN Surgical increased 2.5% to $166.3 million. Skeletal Health saw a significant decline of 37.8% to $15.8 million. The company plans to provide full financial results and updated guidance for Q2 and full-year FY2025 on February 5, 2025.

Hologic (NASDAQ: HOLX) has announced its upcoming presentation at the 43rd Annual J.P. Morgan Healthcare Conference scheduled for Tuesday, January 14, 2025, at 1:30 p.m. Pacific Time. The event will feature both a presentation and Q&A session, which will be accessible through a live webcast.

Interested parties can access the webcast through a link on the Investors section of Hologic's website at http://investors.hologic.com. The webcast recording will remain available for 30 days after the event. Hologic is known for its focus on improving women's health and well-being through early detection and treatment technologies.

Hologic (NASDAQ: HOLX) has scheduled the release of its first quarter fiscal 2025 financial results for Wednesday, February 5, 2025, after market close. The company will host a conference call at 4:30 p.m. Eastern Time on the same day to discuss the results.

Participants can join the call by dialing (888) 394-8218 in the US and Canada or +1 (773) 305-6853 for international callers, using access code 4103504. A webcast replay will be available on the company's investor relations website for 30 days following the call.

Hologic (HOLX) has completed its previously announced acquisition of Gynesonics, a private medical device company, for approximately $350 million. The acquisition brings the Sonata System into Hologic's portfolio, expanding their range of minimally invasive solutions for heavy periods and fibroids.

The Sonata System is a technology for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. It combines real-time intrauterine ultrasound guidance with targeted radiofrequency ablation in an incisionless procedure. The system has already been used to treat thousands of women, according to Gynesonics' CEO Skip Baldino.

Hologic (NASDAQ: HOLX) has entered into an agreement with the CDC to develop analyte specific reagents (ASRs) for detecting H5N1 bird flu. The development comes as H5N1 continues to spread among wild birds, causing outbreaks in poultry and dairy cows in the U.S. The ASRs will be developed on the Panther Fusion® system, with over 1,700 systems installed across U.S. laboratories.

While Hologic doesn't currently plan to commercialize these ASRs, future commercialization may be considered if rapid H5N1 testing becomes necessary. The Panther systems can generate over 1,000 results in 24 hours and can quickly scale up testing capacity. This initiative builds on Hologic's diagnostic solutions portfolio, including their successful COVID-19 testing programs which shipped over 68 million tests to 40 countries in 2020.