NEWS RELEASE – REGULATED INFORMATION 3 MARCH 2021, 07:00 A.M. CET Conference call with Q&A today at 08:00 CET / 07:00 GMT, details provided below IRVINE, CA, and HERSTAL, BELGIUM – March 3, 2021 – MDxHealth SA (Euronext: MDXH.BR), a commercial-stage innovative molecular diagnostics company, today announced its financial results for the year ended December 31, 2020 and provided a business update and outlook for 2021. Michael K. McGarrity, CEO of MDxHealth, commented: “While 2020 has indeed presented challenges due to the COVID-19 pandemic and the impact on the market, we have made significant progress based on our commitment to execute on our stated goals of advancing our turnaround of every operating discipline within the business. “We believe this progress is evidenced by the following: Infusion of $14 million in growth capital in 2020 from funds managed by MVM Partners LLP, followed by our January 2021 successful financing of $30 million, with broad support from U.S. and European investors including continued support from our Reference shareholders, MVM, Valiance and BioVest;SelectMDx for Prostate Cancer test included in the 2020 National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer Early Detection;Completed the fourth quarter with the second consecutive sequential increase in billable volume for both its ConfirmMDx® and SelectMDx® tests;Continued focus on operating discipline resulting in an improvement in collections and capital allocation; andInitiation and advancement of our best-in-class Prostate Cancer menu expansion into Active Surveillance with our renewed engagement and focus on research and development. “We believe these results represent clear validation that the fundamental growth drivers and value that were communicated prior to the pandemic have been instilled in our organization. Furthermore, the redesigned approach of our salesforce to remain highly engaged and utilize our advanced digital marketing strategy with the urology community, will become evident as the pandemic lifts and patient flow returns.” Highlights for the quarter and full year ended December 31, 2020 ConfirmMDx ·For the fourth quarter ended December 31, 2020, billable test volume was up 3% to 3,704 versus 3,579 for the third quarter ended September 30, 2020 For the year ended December 31, 2020, billable test volume was down 18% to 14,945 versus 18,195 for 2019 SelectMDx SelectMDx for Prostate Cancer test has been included in the 2020 National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer Early DetectionFor the fourth quarter ended December 31, 2020, billable test volume was up 6% to 3,472 versus 3,267 for the third quarter ended September 30, 2020 For the year ended December 31, 2020, billable test volume was down 39% to 13,201 versus 21,699 for 2019 Summary of Billable Test Volume by Product Product Year Ended December 31,20202019% ChangeConfirmMDx 14,94518,195(18)%SelectMDx13,20121,699(39)% Product Quarter Ended December 31,20202019% ChangeConfirmMDx 3,7045,158(28)%SelectMDx3,4724,898(29)% Financial Highlights for the year ended December 31, 2020 Total revenue for 2020 of $18.5 million, down 16% from pro-forma 2019 revenues of $21.9 million and up 57% from 2019 reported revenues of $11.8 million (refer to press release issued on February 26, 2020 for details on prior year one-time adjustment)Operating expenses for 2020 were $35.2 million, an improvement of $8.0 million compared to operating expenses of $43.2 million for 2019. Excluding non-cash expenses such as depreciation, amortization and stock-based compensation, operating expenses for 2020 were $30.3 million, an improvement of $2.4 million, or 7%, over 2019Cash and cash equivalents of $16.0 million as of December 31, 2020. In January 2021, the Company successfully completed a EUR 25 million (approximately $30.4 million) capital increase, bringing pro-forma year-end cash and cash equivalents to $46.4 million Financial review for the year ended December 31, 2020 USD in thousands (except per share data) UnauditedYear Ended December 31,20202019 Pro-forma120192020 vs. 2019 Pro-forma12020 vs. 2019Product revenue 18,064 21,52111,443(16)%58%Royalties, patents and other income39634234216%16%Total Revenue18,46021,86311,785(16)%57% Cost of goods(10,416)(11,755)(11,755)(11)%(11)%Gross Profit8,04410,10830(20)%–Operating expenses(35,167)(43,199)(43,199)(19)%(19)%Operating loss(27,123)(33,091)(43,169)(18)%(37)%Net loss(28,662)(33,022)(43,100)(13)%(33)%Basic and diluted loss per share(0.34)(0.53)(0.69)(35)%(50)% 1Excluding the effect of change of estimate of $10.1 million (refer to February 26, 2020 press release for details) Total revenue for 2020 was $18.5 million compared to total revenue of $11.8 million for 2019. Revenues for 2019 were impacted by a one-time adjustment of $10.1 million, which was primarily related to management’s decision to reduce the amount of time it carries accounts receivable from 24 months to 12 months. This adjustment is further detailed in the 2019 year-end results press release dated February 26, 2020. Excluding this one-time adjustment, 2020 revenues would have declined 16% compared to 2019 pro-forma revenues of $21.9 million, due to the COVID-19 pandemic. Gross profit on products and services for 2020 was $8.0 million versus a gross profit of $0 for 2019. Excluding the 2019 one-time adjustment, gross profit on products and services for 2020 decreased 20% compared to pro-forma 2019 gross profit. This decline was primarily the result of the decline in revenues. Total operating expenses in 2020 were $35.2 million, an improvement of $8.0 million over 2019. Excluding non-cash expenses such as depreciation, amortization and stock-based compensation, operating expenses for 2020 were $30.3 million, an improvement of $2.4 million, or 7%, over 2019. Operating loss for 2020 was $27.1 million, a decrease of $16.0 million compared to an operating loss of $43.2 million for 2019. Excluding the 2019 one-time adjustment, operating loss for 2020 decreased 18% compared to 2019 pro-forma operating loss, primarily the result of strong operating discipline as well as a decrease in non-cash expenses of depreciation and amortization. Cash collections from ConfirmMDx and SelectMDx amounted to $21.0 million, a decrease of 12% compared to 2019, despite larger decreases in billable volume due to COVID-19. Total cash burn for 2020 was $22.9 million, representing a reduction of $0.6 million in cash burn compared to $23.5 million in 2019. Cash and cash equivalents as of December 31, 2020 were $16.0 million. Outlook for 2021 Michael K. McGarrity, CEO of MDxHealth, commented: “While the dynamics of the pandemic make it difficult to provide guidance at this time, we are confident that we have advanced adoption of our menu of SelectMDx and ConfirmMDx into the urology market, and that adoption of our product menu as the standard of care in the diagnostic pathway of patients being worked up and suspected of prostate cancer, is taking hold and will drive long term growth beyond 2021. “In addition, we are now focused on advancing our menu into Active Surveillance (AS) of prostate cancer with the development of our AS-MDx and MonitorMDx tests. These two menu additions would provide clinically actionable results for clinicians evaluating patients for active surveillance. This is a well characterized market opportunity to monitor patients in active surveillance where the standard of care is an annual biopsy. We are confident that we can deliver a less invasive actionable solution. “We believe these initiatives, coupled with our current menu, will allow MDxHealth to be the only company in the space that affords clinicians a menu of advanced tests to take a patient from positive PSA screen all the way through the diagnostic pathway continuum of care with clinical confidence. “We are committed to continue to advance the diagnosis and treatment of prostate cancer and our commitment to growth and value creation for all of our stakeholders, including patients, customers, employees and shareholders.” Subsequent Events On January 21, 2021, the Company announced the successful pricing of its capital increase with the offering of new ordinary shares. The Company raised EUR 25.0 million (approximately USD 30.4 million) in gross proceeds by means of a private placement of 27,777,777 new shares (being approximately 30.63% of the Company’s outstanding shares) at an issue price of EUR 0.90 per share through an accelerated bookbuild offering. The net proceeds of this capital increase will be used to drive further commercial focus and execution, to advance the Company’s corporate strategy and for general corporate purposes. Conference Call Michael K. McGarrity, Chief Executive Officer and Ron Kalfus, Chief Financial Officer, will host a conference call and Q&A session today at 08:00am CET / 07:00am GMT. The call will be conducted in English and a replay will be available for 30 days. To participate in the conference call, please select your phone number below and use the Conference ID: 7873716. UK / International: 0800 358 6377 / 323-289-6576 Belgium: 0800 58228 The Netherlands: 0800 023 1436 US: 800-437-2398 Webcast: http://public.viavid.com/index.php?id=143771 To ensure a timely connection, it is recommended that users register at least 10 minutes prior to the scheduledstart time. 2021 Reporting Calendar April 21: Q1-2021 business updateApril 28: Online publication of Annual Report 2020May 27: Annual General MeetingAugust 26: Publication of H1-2021 resultsOctober 21: Q3-2021 business update About MDxHealth MDxHealth is a commercial-stage, innovative healthcare company that provides actionable molecular diagnostic information to personalize the diagnosis and treatment of cancer. The Company’s tests are based on proprietary genetic, epigenetic (methylation) and other molecular technologies and assist physicians with the diagnosis of urologic cancers, prognosis of recurrence risk, and prediction of response to a specific therapy. The Company’s European headquarters are in Herstal, Belgium, with laboratory operations in Nijmegen, The Netherlands, and US headquarters and laboratory operations based in Irvine, California. For more information, visit mdxhealth.com and follow us on social media at: twitter.com/mdxhealth, facebook.com/mdxhealth and linkedin.com/company/mdxhealth. Financial statements and auditor review The Company’s statutory auditor, BDO Bedrijfsrevisoren CVBA, has confirmed that its audit procedures with respect to the Company’s consolidated financial statements, prepared in accordance with the International Financial Reporting Standards as adopted in the European Union, have been substantially completed, that the procedures completed to date have not revealed any material adjustments that would have to be made to the accounting information derived from the Company’s consolidated financial information that is included in this press release. The condensed Consolidated Statement of Comprehensive Income may be found on the Company’s website at www.mdxhealth.com. The full Annual Report is expected to be made available to the public via the Company’s website in April 2021. For more information: MDxHealth info@mdxhealth.com LifeSci Advisors (IR & PR)US: +1 949 271 9223 ir@mdxhealth.com This press release contains forward-looking statements and estimates with respect to the anticipated future performance of MDxHealth and the market in which it operates. Such statements and estimates are based on assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable but may not prove to be correct. Actual events are difficult to predict, may depend upon factors that are beyond the company’s control, and may turn out to be materially different. MDxHealth expressly disclaims any obligation to update any such forward-looking statements in this release to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based unless required by law or regulation. This press release does not constitute an offer or invitation for the sale or purchase of securities or assets of MDxHealth in any jurisdiction. No securities of MDxHealth may be offered or sold within the United States without registration under the U.S. Securities Act of 1933, as amended, or in compliance with an exemption therefrom, and in accordance with any applicable U.S. securities laws. NOTE: The MDxHealth logo, MDxHealth, ConfirmMDx, SelectMDx, AS-MDx and MonitorMDx are trademarks or registered trademarks of MDxHealth SA. All other trademarks and service marks are the property of their respective owners. Attachment English
More than 40 trillion gallons of rain drenched the Southeast United States in the last week from Hurricane Helene and a run-of-the-mill rainstorm that sloshed in ahead of it — an unheard of amount of water that has stunned experts.
That’s enough to fill the Dallas Cowboys’ stadium 51,000 times, or Lake Tahoe just once. If it was concentrated just on the state of North Carolina that much water would be 3.5 feet deep (more than 1 meter). It’s enough to fill more than 60 million Olympic-size swimming pools.
“That’s an astronomical amount of precipitation,” said Ed Clark, head of the National Oceanic and Atmospheric Administration’s National Water Center in Tuscaloosa, Alabama. “I have not seen something in my 25 years of working at the weather service that is this geographically large of an extent and the sheer volume of water that fell from the sky.”
The flood damage from the rain is apocalyptic, meteorologists said. More than 100 people are dead, according to officials.
Private meteorologist Ryan Maue, a former NOAA chief scientist, calculated the amount of rain, using precipitation measurements made in 2.5-mile-by-2.5 mile grids as measured by satellites and ground observations. He came up with 40 trillion gallons through Sunday for the eastern United States, with 20 trillion gallons of that hitting just Georgia, Tennessee, the Carolinas and Florida from Hurricane Helene.
Clark did the calculations independently and said the 40 trillion gallon figure (151 trillion liters) is about right and, if anything, conservative. Maue said maybe 1 to 2 trillion more gallons of rain had fallen, much if it in Virginia, since his calculations.
Clark, who spends much of his work on issues of shrinking western water supplies, said to put the amount of rain in perspective, it’s more than twice the combined amount of water stored by two key Colorado River basin reservoirs: Lake Powell and Lake Mead.
Several meteorologists said this was a combination of two, maybe three storm systems. Before Helene struck, rain had fallen heavily for days because a low pressure system had “cut off” from the jet stream — which moves weather systems along west to east — and stalled over the Southeast. That funneled plenty of warm water from the Gulf of Mexico. And a storm that fell just short of named status parked along North Carolina’s Atlantic coast, dumping as much as 20 inches of rain, said North Carolina state climatologist Kathie Dello.
Then add Helene, one of the largest storms in the last couple decades and one that held plenty of rain because it was young and moved fast before it hit the Appalachians, said University of Albany hurricane expert Kristen Corbosiero.
“It was not just a perfect storm, but it was a combination of multiple storms that that led to the enormous amount of rain,” Maue said. “That collected at high elevation, we’re talking 3,000 to 6000 feet. And when you drop trillions of gallons on a mountain, that has to go down.”
The fact that these storms hit the mountains made everything worse, and not just because of runoff. The interaction between the mountains and the storm systems wrings more moisture out of the air, Clark, Maue and Corbosiero said.
North Carolina weather officials said their top measurement total was 31.33 inches in the tiny town of Busick. Mount Mitchell also got more than 2 feet of rainfall.
Before 2017’s Hurricane Harvey, “I said to our colleagues, you know, I never thought in my career that we would measure rainfall in feet,” Clark said. “And after Harvey, Florence, the more isolated events in eastern Kentucky, portions of South Dakota. We’re seeing events year in and year out where we are measuring rainfall in feet.”
Storms are getting wetter as the climate change s, said Corbosiero and Dello. A basic law of physics says the air holds nearly 4% more moisture for every degree Fahrenheit warmer (7% for every degree Celsius) and the world has warmed more than 2 degrees (1.2 degrees Celsius) since pre-industrial times.
Corbosiero said meteorologists are vigorously debating how much of Helene is due to worsening climate change and how much is random.
For Dello, the “fingerprints of climate change” were clear.
“We’ve seen tropical storm impacts in western North Carolina. But these storms are wetter and these storms are warmer. And there would have been a time when a tropical storm would have been heading toward North Carolina and would have caused some rain and some damage, but not apocalyptic destruction. ”
Associated Press climate and environmental coverage receives support from several private foundations. See more about AP’s climate initiative here. The AP is solely responsible for all content.
It’s a dinosaur that roamed Alberta’s badlands more than 70 million years ago, sporting a big, bumpy, bony head the size of a baby elephant.
On Wednesday, paleontologists near Grande Prairie pulled its 272-kilogram skull from the ground.
They call it “Big Sam.”
The adult Pachyrhinosaurus is the second plant-eating dinosaur to be unearthed from a dense bonebed belonging to a herd that died together on the edge of a valley that now sits 450 kilometres northwest of Edmonton.
It didn’t die alone.
“We have hundreds of juvenile bones in the bonebed, so we know that there are many babies and some adults among all of the big adults,” Emily Bamforth, a paleontologist with the nearby Philip J. Currie Dinosaur Museum, said in an interview on the way to the dig site.
She described the horned Pachyrhinosaurus as “the smaller, older cousin of the triceratops.”
“This species of dinosaur is endemic to the Grand Prairie area, so it’s found here and nowhere else in the world. They are … kind of about the size of an Indian elephant and a rhino,” she added.
The head alone, she said, is about the size of a baby elephant.
The discovery was a long time coming.
The bonebed was first discovered by a high school teacher out for a walk about 50 years ago. It took the teacher a decade to get anyone from southern Alberta to come to take a look.
“At the time, sort of in the ’70s and ’80s, paleontology in northern Alberta was virtually unknown,” said Bamforth.
When paleontogists eventually got to the site, Bamforth said, they learned “it’s actually one of the densest dinosaur bonebeds in North America.”
“It contains about 100 to 300 bones per square metre,” she said.
Paleontologists have been at the site sporadically ever since, combing through bones belonging to turtles, dinosaurs and lizards. Sixteen years ago, they discovered a large skull of an approximately 30-year-old Pachyrhinosaurus, which is now at the museum.
About a year ago, they found the second adult: Big Sam.
Bamforth said both dinosaurs are believed to have been the elders in the herd.
“Their distinguishing feature is that, instead of having a horn on their nose like a triceratops, they had this big, bony bump called a boss. And they have big, bony bumps over their eyes as well,” she said.
“It makes them look a little strange. It’s the one dinosaur that if you find it, it’s the only possible thing it can be.”
The genders of the two adults are unknown.
Bamforth said the extraction was difficult because Big Sam was intertwined in a cluster of about 300 other bones.
The skull was found upside down, “as if the animal was lying on its back,” but was well preserved, she said.
She said the excavation process involved putting plaster on the skull and wooden planks around if for stability. From there, it was lifted out — very carefully — with a crane, and was to be shipped on a trolley to the museum for study.
“I have extracted skulls in the past. This is probably the biggest one I’ve ever done though,” said Bamforth.
“It’s pretty exciting.”
This report by The Canadian Press was first published Sept. 25, 2024.
TEL AVIV, Israel (AP) — A rare Bronze-Era jar accidentally smashed by a 4-year-old visiting a museum was back on display Wednesday after restoration experts were able to carefully piece the artifact back together.
Last month, a family from northern Israel was visiting the museum when their youngest son tipped over the jar, which smashed into pieces.
Alex Geller, the boy’s father, said his son — the youngest of three — is exceptionally curious, and that the moment he heard the crash, “please let that not be my child” was the first thought that raced through his head.
The jar has been on display at the Hecht Museum in Haifa for 35 years. It was one of the only containers of its size and from that period still complete when it was discovered.
The Bronze Age jar is one of many artifacts exhibited out in the open, part of the Hecht Museum’s vision of letting visitors explore history without glass barriers, said Inbal Rivlin, the director of the museum, which is associated with Haifa University in northern Israel.
It was likely used to hold wine or oil, and dates back to between 2200 and 1500 B.C.
Rivlin and the museum decided to turn the moment, which captured international attention, into a teaching moment, inviting the Geller family back for a special visit and hands-on activity to illustrate the restoration process.
Rivlin added that the incident provided a welcome distraction from the ongoing war in Gaza. “Well, he’s just a kid. So I think that somehow it touches the heart of the people in Israel and around the world,“ said Rivlin.
Roee Shafir, a restoration expert at the museum, said the repairs would be fairly simple, as the pieces were from a single, complete jar. Archaeologists often face the more daunting task of sifting through piles of shards from multiple objects and trying to piece them together.
Experts used 3D technology, hi-resolution videos, and special glue to painstakingly reconstruct the large jar.
Less than two weeks after it broke, the jar went back on display at the museum. The gluing process left small hairline cracks, and a few pieces are missing, but the jar’s impressive size remains.
The only noticeable difference in the exhibit was a new sign reading “please don’t touch.”
