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Hologic ticks up on raised Q4 outlook

Hologic (NSDQ:HOLX) is up today after its financial outlook for the fourth quarter improved from projections in its third-quarter results from July.

Shares of HOLX were up 3.8% at $62.22 per share in mid-morning trading today.

After reporting a strong third quarter boosted by COVID-19 test sales, the company expected to log adjusted EPS of 95¢ to $1.15 in the fourth quarter, with revenue projected to fall between $925 million and $1.025 billion.

Since the Marlborough, Mass.-based company made those projections on July 29, its diagnostics business has continued to expand its supply chain capacity, boosting revenues with increased production and sales of its COVID-19 tests, Panther instruments and other related products.

Additionally, the company’s breast and skeletal business, along with its surgical segment, have performed slightly above expectations, according to an SEC filing.

With more than 80% of the fiscal fourth quarter complete…

MedTech 100 roundup: Industry reaches new heights again

The past month has seen a resurgence from medtech companies in the markets and last week saw the best performance yet.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 90.78 points at the end of last week (Aug. 28). Overall, medtech stocks saw a 1.3% increase from the 89.6-point total at the same time a week prior (Aug. 21).

While 90.78 points is already the highest total on which the index has ended a week during the COVID-19 pandemic, just the day before, the index hit 91 points even, marking the highest point total since the pandemic took its toll.

The most recent high mark represents just a -1.4% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -1.7% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 3.3% increase from Aug. 14 to Aug. 21, having steadily climbed since reaching record highs on Aug. 18. Meanwhile, the …

Hologic buys Accessa Health for $80M

Hologic (NSDQ:HOLX) announced that it acquired fibroid treatment developer Acessa Health in a deal worth approximately $80 million.

Austin, Texas-based Acessa markets the Acessa ProVu fully integrated laparoscopic system for combining radiofrequency ablation with intra-abdominal ultrasound visualization and guidance mapping for treating women with symptomatic, benign uterine fibroids.

Marlborough, Mass.-based Hologic said in a news release that the Acessa ProVu system will complement its market-leading MyoSure products designed for the hysteroscopic removal of fibroids found in the uterine cavity.

The deal includes $80 million in cash, plus additional contingent payments based on future revenue growth, according to the release. Hologic estimates that Acessa Health will generate approximately $13 million in revenue for fiscal 2021, producing a slightly dilutive impact on Hologic’s non-Gaap earnings per share for the year, then a break-even in 2022, …

MedTech 100 roundup: Up-and-down week for industry

Medtech stocks highlighted the topsy-turvy nature of the market last week, but ultimately finished the seven days nearly unchanged.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.77 points at the end of last week (Aug. 14). Overall, medtech stocks saw a 0.13% increase from the 89.65-point total at the same time a week prior (Aug. 7).

On Aug. 13, the index reached 90.4 points, a total that nearly poked past the previous mid-pandemic high (90.45), which came just last week.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, while the tally at the end of the week marks a -2.8% decrease from that pre-pandemic high.

Meanwhile, the S&P 500 Index saw a 0.64% increase from Aug. 7 to Aug. 14, and the Dow Jones Index fared even better, rising 1.8% over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at …

Hologic applies for pooled COVID-19 testing nod

Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing.

Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July, as did LabCorp, in an EUA reauthorization. Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing the testing method in June.

The FDA is touting pooled-sample testing as more efficient than individual tests, meaning fewer testing supplies are used and more tests can be run at the same time, allowing patients to receive their results more quickly in most cases. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative, according to the agency.

Qu…

Hologic spending more than $50M to expand COVID-19 test production

Hologic (NSDQ:HOLX) is spending $50 million — including $14 million during its most recent quarter — to boost its production of COVID-19 tests.

The U.S. government is providing $7.6 million to support the effort.

The investment, which CEO Stephen MacMillan outlined during a July 29 earnings call, includes installation of new high-speed filling lines and investment in new custom machinery to produce more penetrable caps.

Hologic has been producing around the clock at its facility in San Diego, where employees from areas such as finance are now working packaging lines while the company hires 150 new operations employees to boost the headcount by more than 50%. The company is also expanding capabilities at its Manchester, U.K. diagnostic plant, which started making COVID tests at the end of June

“Overall, these actions have provided the capacity to produce at least 1.5 million COVID tests per week, on average, and should enable COVID sales to i…

Hologic blasts American Cancer Society over new Pap test guidelines

Hologic (NSDQ:HOLX) — a major company in the Pap and human papillomavirus (HPV) testing space — is criticizing the American Cancer Society over new cervical cancer screening recommendations that prefer simply doing HPV tests every five years.

“Although all the screening tests are good at finding cancer and pre-cancer, primary HPV testing is better at finding them than a Pap test done alone. Plus, primary HPV testing does not lead to more follow-up tests for abnormal areas that turn out to not to be pre-cancer,” Sandy McDowell, senior editor of research at ACS, explained in a July 30 blog post.

“In the US, the expectation is that over time fewer people will have a co-test or Pap test alone as the primary HPV test become more widely available.”

Hologic in a July 31 statement said it was “disappointed” by the new guidelines — noting that the cervical cancer rate has fallen by more than 70% since the Pap test was introduce…

MedTech 100 roundup: Industry hits another mid-pandemic high

Despite a minor regression week-over-week, the medtech industry’s stocks hit another milestone as the COVID-19 rebound remains in progress.

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 89.01 points at the end of last week (July 31). Overall, medtech stocks saw a -0.3% increase from the 89.29-point total at the same time a week prior (July 24).

On July 30, the index reached 90.37 points, marking its highest point since that pre-pandemic high, with the previous mid-pandemic high (90.11) coming last week.

The most recent high mark represents just a -2.1% dip from the Feb. 19 high point of 92.32, marking the smallest margin of decline over the past five months.

Meanwhile, the S&P 500 Index saw a 1.7% increase from July 24 to July 31, and the Dow Jones Index posted a -0.2% drop over the same period of time.

Medtech’s lowest point during the COVID-19 pandemic remains at …

DTW: What in the world will Thrive Earlier Detection do with $257 million?

In this week’s podcast, two executives from Thrive Earlier Detection explain how the “turbo-charged” diagnostics company intends to upend how, when and where cancer is diagnosed.

Dr. Isaac Kinde, co-founder and head of research and innovation, walks us through the company’s CancerSEEK test and how the company is marrying new technology with an innovative clinical approach. Meanwhile, CFO Isaac Ro, tells host Tom Salemi how the company closed on $257 million (hint: lots of Zoom) and why he left a career on Wall Street to join this innovative start-up.

Chris Newmarker, executive editor of life sciences at MassDevice, also counts down on the biggest newsmakers in this week’s MassDevice.

Don’t miss an episode! Subscribe to DeviceTalks Weekly on your podcast players. It’s available on Apple Podcasts, Spotify and other podcast channels.

DeviceTalks by MassDevice · What in the world will Thrive Earlier Detection do with $257 million?

The top 5 MassDevice stories of the week — July 31, 2020

The past week has seen a slew of Q2 earnings reports from medical device companies — and the picture overall hasn’t been pretty amid the COVID-19 pandemic.

Still, medtech CEOs during their earnings calls said they’re starting to see some signs of hospital procedures recovering a bit even as the southern U.S. deals with a coronavirus wave. Some of the top MassDevice stories this week actually involved companies providing more solutions to improve management of the pandemic.

Want to hear more about the week’s top news? Executive editor Chris Newmarker and Tom Salemi will discuss during our DeviceTalks Weekly podcast. Without further ado, here’s this week’s MassDevice Top Five:

5. A few bright spots amid the COVID-19 financial toll

Dexcom (NSDQ:DXCM) proved to be one of the few bright spots among medtech Q2 earnings reports, blowing away the Wall Street consensus forecast as it successfully pivoted to making its continuous glucose monitors avail…

Hologic booms on Q3 revenues driven by COVID-19 diagnostics

Hologic (NSDQ:HOLX) shares got a huge boost today on third-quarter results that beat the consensus earnings forecast.

Shares of HOLX were up 10.1% at $70.49 before the market opened today, then remained strong during early-morning trading, registering up 9.3% at $69.98.

The Marlborough, Mass.-based company posted profits of $136.4 million, or 53¢ per share, on sales of $822.9 million for the three months ended June 27, 2020, for a 45.3% bottom-line gain despite a sales decline of 3.5%.

Adjusted to exclude one-time items, earnings per share were 75¢, 37¢ ahead of Wall Street, beating the analysts’ sales projections by 37.11%.

A large part of Hologic’s strong quarter came as a result of its widely-used SARS-CoV-2 assays used for detecting COVID-19 on the company’s Panther and Panther Fusion systems.

Hologic’s molecular diagnostics segment registered revenues of $460.3 million, marking a 169.3% increase year-over-year a…

HHS, DOD invest $7.6m in Hologic COVID-19 test samples

The U.S. Dept. of Health and Human Services (HHS) and Defense Dept. (DoD) announced a $7.6 million contract for COVID-19 testing from Hologic (NSDQ:HOLX).

Marlborough, Mass.-based Hologic will receive the undenifitized contract with a ceiling of $7.6 million so it can expand production of custom sample collection and processing consumables for COVID-19 testing, according to a news release.

Hologic’s tube, cap and multi-tube unit consumables are used to perform molecular diagnostic tests on the company’s Panther Fusion system. With the additional funds from the contract, Hologic is slated to boost its test production from 4.8 million per month to 6.8 million per month, with the increased consumable volume expected to reach the market by January 2021.

The fully automated Panther systems provide initial results from the tests in approximately three hours, processing more than 1,000 coronavirus tests in 24 hours. Hologic already has two approved …