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Globe and Mail
5 days ago
- Business
- Globe and Mail
Hologic's Diagnostics Arm Set for Long-Term Upside: What's Behind It?
Hologic 's HOLX Diagnostics unit, the largest by revenues, has been the most impacted by geopolitical headwinds this year. Cuts in USAID funding have affected its HIV testing business in Africa, while a challenging operating environment in China has weighed on its Cytology business. As a result, Diagnostics posted just 0.9% year-over-year reported growth in the third quarter of fiscal 2025. Despite these hurdles, the underlying growth drivers in the segment continue to remain strong. One is the BV, CV/TV assay, which has become Hologic's second-largest assay globally after shifting from a primarily lab-developed test (LDT) approved in 2019 to an in-vitro diagnostics (IVD) test on the high-throughput Panther instrument. The company is working to reach the estimated 60% of U.S. women who are not tested when they experience vaginitis, applying the same approach it uses to expand sexually transmitted infection (STI) testing. Additionally, Panther Fusion, an add-on module to the base Panther platform, is gaining nice traction this year as customers adopt more menus. The system uses PCR chemistry to run Hologic's suite of respiratory assays, including influenza, while offering an expanded IVD menu and Open Access functionality for LDTs. Open Access testing kits contributed to Fusion's solid growth in the fiscal third quarter. Over the next several years, Hologic plans to broaden the menu by launching an IVD test for GI and hospital-acquired infections, positioning the sidecar to play a key role in future Diagnostics growth. The company is also currently in the early stages of its Biotheranostics opportunity. Acquired in 2021, the asset marked Hologic's entry into the lab-based oncology space, an expanding and longtime area of interest. Biotheranostics' Breast Cancer Index test — the only commercially available test validated to inform the decision regarding extended endocrine therapy — continues to see strong adoption. Latest Updates From Hologic's Diagnostics Peers Abbott 's ABT Diagnostics sales declined 1.5% in the second quarter of 2025, mainly due to the year-over-year decrease in COVID-19 testing sales and the impact of volume-based procurement programs in China. Together, these are expected to weigh on ABT's full-year Diagnostics sales growth by around $700 million or 750 basis points. Excluding China, Abbott's Core Lab Diagnostics grew 8%, reflecting strong underlying demand in the global markets. Danaher 's DHR core sales growth in the molecular diagnostics business witnessed growth in the second quarter of 2025, as gains in non-respiratory testing more than offset declines in core sales of respiratory tests. Danaher also announced a new partnership with AstraZeneca to develop diagnostic tools that identify patients most likely to benefit from precision medicine treatments. This collaboration is leveraging the newly launched Danaher Centers to enable precision medicine to streamline the end-to-end development process. HOLX Stock Performance, Valuation and Estimates Year to date, Hologic shares have declined 5.8% compared with the industry's 11.7% fall. Hologic is trading at a forward five-year price-to-earnings of 15.05X, lower than the industry average of 27.49X. The stock carries a Value Score of B at present. Image Source: Zacks Investment Research See how analysts are projecting Hologic's EPS for fiscal 2025 and 2026. HOLX stock currently carries a Zacks Rank #3 (Hold).You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. See our %%CTA_TEXT%% report – free today! 7 Best Stocks for the Next 30 Days Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT): Free Stock Analysis Report Danaher Corporation (DHR): Free Stock Analysis Report Hologic, Inc. (HOLX): Free Stock Analysis Report This article originally published on Zacks Investment Research (
CNBC
06-08-2025
- Business
- CNBC
RBC sees nearly 30% upside for this medical tech stock as headwinds abate
There's a rosy outlook ahead for Hologic , according to RBC Capital Markets. The bank upgraded shares of the medical technology provider to outperform from sector perform. Analyst Conor McNamara accompanied the move by raising his price target to $87 per share from $72. Shares of Hologic have slipped 6% this year, but McNamara's revised price forecast implies an upside ahead of 28%. HOLX YTD mountain HOLX YTD chart "Our new price target assumes HOLX returns to historic multiples seen when the company was growing revenue MSD [mid-single digit] and beating / raising," the analyst wrote. McNamara said he believes that Hologic's organic revenue growth guidance for fiscal year 2026 will exceed current street estimates. This could in turn boost investor confidence, "leading to a period of multiple expansion." Two recent M & A deals could also help increase the company's overall organic growth in fiscal year 2026. "We believe the buyside is discounting HOLX's recent M & A success and over-penalizing the company for recent 1x headwinds; however, we expect upside surprises in coming quarters will convince investors +MSD growth is sustainable," the analyst added. "With a clean balance sheet and multiple end-markets, we think there is ample opportunity for HOLX to continue to exploit this M & A strategy in the medium and long term." McNamara said that two of Hologic's product platforms could begin adding "meaningful growth" beginning late next year — Panther Fusion and the Genius Digital Diagnostics System. Meantime, various headwinds that plagued Hologic in fiscal year 2025 are also set to abate. For instance, China sales declined significantly in fiscal year 2025, but the company believes that these sales have bottomed out. Hologic also faced a year-over-year decline of around $100 million in breast health equipment sales, but RBC does not anticipate this to reoccur. "We think HOLX has enough wiggle room to offset any other headwinds (i.e. - continued declines in HIV testing in Africa via US policy changes)," McNamara added.
Globe and Mail
02-07-2025
- Business
- Globe and Mail
Hologic Faces Molecular Drag, But Here's Why It's Not a Major Concern
Hologic 's HOLX Molecular Diagnostics business posted a 7.8% (excluding COVID-19-related sales) growth in the second quarter of fiscal 2025, although results did not reflect its full performance was impacted by lower HIV testing sales in Africa due to significant funding cuts to USAID programs by the new administration. This $50 million annual revenue stream is now being conservatively excluded from the full fiscal outlook. Management noted that without this setback, molecular revenues would have grown at a low double-digit rate in the second quarter. Even so, the long-term trajectory of the segment remains strong. Molecular Diagnostics continues to be the principal growth driver within Hologic's Diagnostics division, with more than 20 assays running on the Panther and Panther Fusion platforms. The company is focused on driving more utilization of its existing menu, such as the test for Mycoplasma Genitalium (MGen), a prevalent but under-screened sexually transmitted disease (STD). Hologic's revenue growth strategy rests on using both lab-sales force and physician-sales force to team up with lab customers, promote screening guidelines and drive test adoption. Newer innovations, like the BV/CV/TV assay, have meaningfully contributed to growth and still offer room for more expansion. Vaginitis affects nearly 20 million women annually in the United States, yet fewer than 40% are tested. Hologic is addressing this gap by driving awareness and securing reimbursement for this high-throughput test, solidifying its position in this space. Another key asset is Biotheranostics, which Hologic acquired in 2021 to enter the fast-growing oncology adjacency. Biotheranostics' unique Breast Cancer Index test continues to see higher adoption, helping determine the benefits of extended endocrine therapy. Our model projects bullish growth for Hologic's Molecular Diagnostics arm, which is likely to expand at a compound annual growth rate (CAGR) of 7.3% during the 2025-2027 period. The Case for Hologic's Rivals Roche 's RHHBY infectious disease business was also affected by the USAID funding pause for testing, causing a decline of 5% in the first quarter of 2025. Still, without this effect, Roche's Molecular Lab grew more than 6%. The company remains optimistic about the funding pause ending and a rebound in this business. This year, Roche is set to launch the cobas BV/CV assay in CE mark countries for use on the cobas 5800/6800/8800 platforms. Abbott ABT is also exposed to the far-reaching implications of the USAID funding halt, which has disrupted the supply chain for essential medical products in underserved countries. Performance-wise, Abbott's Diagnostics business revenues dropped 5% in the first quarter of 2025 due to weak COVID-19 testing sales. The impact of volume-based procurement programs in China led to low single-digit growth in ABT's Core Laboratory Diagnostics. HOLX Stock Performance, Valuation and Estimates In the last 30 days, Hologic shares have risen 3.6% compared to the industry's 0.7% fall. Hologic is trading at a forward five-year sales multiple of 3.44X compared to the industry average of 4.11X. The stock carries a Value Score of B at present. Consensus estimates for Hologic's fiscal 2025 and 2026 earnings are showing a downward trend. Image Source: Zacks Investment Research HOLX stock currently carries a Zacks Rank #4 (Sell). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Zacks' Research Chief Names "Stock Most Likely to Double" Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest. This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%. Free: See Our Top Stock And 4 Runners Up Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Abbott Laboratories (ABT): Free Stock Analysis Report Roche Holding AG (RHHBY): Free Stock Analysis Report Hologic, Inc. (HOLX): Free Stock Analysis Report
Yahoo
27-05-2025
- Business
- Yahoo
HOLX vs. DGX: Which Women's Health-Focused Stock Is the Better Pick?
With women's health increasingly becoming a global priority, investors are actively targeting companies operating in this space to boost their portfolios. Research and Markets projects the women's health diagnostics market to expand at a compound annual rate of 9.25% through 2030, driven by technological advancements, increasing healthcare expenditures, and initiatives for early detection of women-specific conditions like reproductive health issues, breast cancer, osteoporosis and more. Two U.S. healthcare innovators, Hologic HOLX and Quest Diagnostics DGX, have established a strong foothold in this space, each with its own areas of specialization. Hologic, with a market cap of $12.10 billion, develops products and services across the women's healthcare continuum, such as advanced diagnostics products, medical imaging systems and surgical products. In comparison, Quest Diagnostics, with a market cap of $19.12 billion, provides a comprehensive portfolio of diagnostic tests for all stages of a woman's life — from routine screenings like cervical cancer and sexually transmitted infections (STIs) to pregnancy and fertility testing. Between these two, which one stands out as the smarter pick now? Let's dive deep into their fundamentals, growth drivers and challenges to find out. The Marlborough, MA-based company benefits from its strategy of building multiple durable growth drivers across all its global franchises. Key offerings include Aptima and Panther Fusion assays for sexually transmitted diseases (STDs), vaginitis and respiratory infections. The BV/CV/TV assay shows strong double-digit growth, supported by rising awareness and reimbursement in the U.S. vaginitis market. Molecular growth is further backed by the Biotheranostics business, driven by the rising adoption of the Breast Cancer Index test. However, weaker HIV testing in Africa due to federal funding cuts affected the fiscal 2025 second-quarter performance and is likely to persist. Hologic is seeing strong adoption of the Genius Digital Diagnostics System — the first FDA-cleared digital cytology system for cervical cancer screening, combining novel artificial intelligence (AI) with advanced imaging. However, Q2 International cytology and perinatal sales were impacted by South Korea's physician strike and reduced hospital spending in China. On the MedTech side, the company's mammography products continue to command leading market shares. In the second quarter, recurring service revenues (more than 45% of total Breast Health revenues) rose 12% year over year. The addition of Endomagnetics enhanced its Interventional Breast portfolio, with Hologic now selling its products directly through its U.S. salesforce to tap into wireless localization market opportunities. However, as anticipated, softer capital equipment sales caused the segment's revenues to decline 7.4%. Internationally, the Surgical business continues to be a standout. The company demonstrates sound financial health, with the flexibility to execute both tuck-in M&A and share repurchases. Still, macroeconomic challenges, including the ongoing trade war in China, have affected its 2025 outlook. Tariffs are expected to impact manufacturing costs by $20 million to $25 million per quarter, with two-thirds of it tied to imports from Costa Rica. Based in Secaucus, NJ, Quest Diagnostics is experiencing strong growth in Women's and Reproductive Health, one of its five key clinical areas where it offers Advanced Diagnostics. The growth is largely driven by prenatal and hereditary genetic testing over the past several quarters. In March 2025, the company launched a new solution that allows patients to self-collect a specimen for human papillomavirus (HPV) cervical cancer screening in a physician's office or other healthcare setting. The test uses Roche's RHHBY HPV self-collection solution and builds on Quest Diagnostics' STI-related self-collection option, introduced in October last year. Other clinical areas — advanced cardiometabolic, autoimmune, brain health and oncology — also posted double-digit growth in the first quarter of 2025, contributing to the 12% year-over-year revenue increase. Recent introductions include a laboratory-developed test to confirm Alzheimer's disease (AD) pathology in symptomatic patients and the Haystack MRD — its first circulating tumor DNA (ctDNA) minimal residual disease (MRD) test for assessing early risk of cancer recurrence. The company continues expanding the Advanced Diagnostics portfolio to enable growth across its core channels: Physicians, Hospitals and Consumers. In 2024, Quest Diagnostics completed eight acquisitions, including LifeLabs in Canada, and formed new health plan relationships. These favorably impacted both Q1 Diagnostic Information Services sales and adjusted operating income, translating to 8.3% growth in adjusted earnings per share (EPS). The company also became the first independent lab in the Optum Health preferred network. In February, Quest Diagnostics extended its chronic kidney disease test portfolio to include dialysis-related laboratory and water testing capabilities via a new agreement with Fresenius Medical Care FMS. Operationally, Quest Diagnostics is increasing the use of automation, robotics and AI across the business to drive productivity gains and improve user experience. The company teamed up with Google Cloud to streamline data management using generative AI. Despite broader economic pressures, Quest Diagnostics reaffirmed its 2025 revenue and adjusted EPS guidance. Yet, its escalating debt levels are a concern, ending the first quarter with $5.86 billion in long-term debt and just $188 million in cash and cash equivalents. The Zacks Consensus Estimate for Hologic's fiscal 2025 sales and EPS implies a year-over-year improvement of 1.2% and 3.2%, respectively. The bottom-line estimates have shown mixed movements in the last 30 days. (See the Zacks Earnings Calendar to stay ahead of market-making news.) Image Source: Zacks Investment Research The Zacks Consensus Estimate for DGX's 2025 sales and EPS suggests a year-over-year improvement of 9.2% and 8.6%, respectively. Analysts seem more bullish on Quest Diagnostics, given the upward EPS estimate revisions in the last 30 days. Image Source: Zacks Investment Research In the past six months, Hologic's shares have plunged significantly, down 31.6%, while the benchmark S&P 500 slipped just 3.2%. In contrast, Quest Diagnostics held its ground with a 4.9% gain. Image Source: Zacks Investment Research Hologic is trading at a forward price-to-sales (P/S) multiple of 2.87X, higher than Quest Diagnostics' 1.75X P/S over the last five years. However, both HOLX and DGX appear discounted when compared to their respective industry averages of 4.04X and 2.71X. Each of them has a Value score of B. Image Source: Zacks Investment Research As a pure-play in women's health, Hologic continues to benefit from its diversified revenue model and growth drivers. International prospects are encouraging, while expanding into new areas through M&A activities instills optimism. While near-term headwinds from both internal and external pressures remain, the company's financial strength and a P/S below the industry suggest potential for long-term stability. For now, holding onto HOLX stock seems like a prudent choice. Meanwhile, Quest Diagnostics, as a clinical laboratory services company, sees strong growth opportunities in the women's and reproductive health space. Steady growth from Advanced Diagnostics and contributions from recent acquisitions are highly promising. Further, the stock's recent favorable performance, attractive valuation and upward analyst estimate revisions make it an equally compelling case to stay invested. HOLX and DGX each carry a Zacks Rank #3 (Hold) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Roche Holding AG (RHHBY) : Free Stock Analysis Report Quest Diagnostics Incorporated (DGX) : Free Stock Analysis Report Hologic, Inc. (HOLX) : Free Stock Analysis Report Fresenius Medical Care AG & Co. KGaA (FMS) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-02-2025
- Business
- Yahoo
Hologic Announces FDA Clearance of Aptima SARS-CoV-2 Assay
MARLBOROUGH, Mass., February 18, 2025--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Aptima® SARS-CoV-2 assay, which was first granted Emergency Use Authorization (EUA) status in May 2020. "Our COVID test was instrumental in addressing critical testing needs during the pandemic and offered healthcare providers and laboratories a solution that was highly sensitive and able to help mitigate outbreaks. Nearly five years after the beginning of the pandemic, the test is still widely used," said Hologic Diagnostic Solutions President Jennifer Schneiders, Ph.D. "With the virus now in an endemic state, full FDA clearance will give laboratories and clinicians peace of mind that they can continue to rely on the test to make informed decisions about patient treatment and the management of healthcare resources." The Aptima SARS-CoV-2 Assay is an in vitro diagnostic test that detects SARS-CoV-2 RNA from nasopharyngeal (NP) or nasal swab samples obtained from people exhibiting signs and symptoms of a respiratory tract infection. The nasal swab allows for a simpler, less invasive alternative to NP swab collection, which must be performed by a healthcare practitioner. The nasal swab is minimally inserted into the nostril entrance, which reduces patient discomfort, pain and anxiety during testing compared to the original NP swab method, which is inserted deep into the nasal cavity. The test uses Hologic's transcription-mediated amplification (TMA) chemistry, which can detect and quantify genetic sequences to determine the presence of respiratory viral pathogens. Samples are processed on Hologic's Panther® system, which is used in labs across the U.S. and around the world. Each Panther can provide initial results in less than three hours and process more than 1,000 tests in a 24-hour period. Customers may add a Panther Fusion® module to expand their respiratory testing offerings with the Panther Fusion respiratory assays. FDA clearance for Aptima SARS-CoV-2 underscores Hologic's commitment to emergency preparedness and respiratory diagnostic solutions. In addition to the Aptima SARS-CoV-2 assay, Hologic recently received FDA clearance for several other respiratory tests that detect SARS-CoV-2: In May 2023, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA clearance for use with nasopharyngeal samples. In July 2024, The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay received FDA clearance for use with anterior nasal swabs. In November 2024, the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay was expanded for use with anterior nasal swabs transported via enhanced specimen transport media (eSTM). Development of the Aptima SARS-CoV-2 assay was funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority under contract number 75A50122C00074. About the Panther and Panther Fusion Systems The Panther system is a best-in-class, fully automated, sample-to-result molecular diagnostics platform that can be used in low-, medium- or high-throughput laboratories. With a small footprint, adaptable workflow options and consolidated testing menu, it combines testing for women's health, sexually transmitted infections, respiratory infections, viral load, transplant viruses and other infectious diseases, which can all be done simultaneously. The Panther Fusion module, which is an addition to the Panther system, provides an expanded and growing in vitro diagnostics menu, as well as Open Access™ functionality to run laboratory-developed tests. About Hologic, Inc. Hologic, Inc. is a global leader in women's health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. For more information on Hologic, visit and connect with us on LinkedIn, Facebook, X, Instagram and YouTube. Hologic, The Science of Sure, Aptima, Open Access, Panther and Panther Fusion are all registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. SOURCE: Hologic, Inc. View source version on Contacts Media Contact Bridget PerrySenior Director, Corporate Communications(+1) Investor Contact Michael WattsCorporate Vice President, Investor Relations(+1)
