Stock Markets

Theraclion Announces Major Advances and Reports First-Half Financial Results

Published

3 weeks ago

October 31, 2024

On the strength of its progress on its 2023 and 2024 priorities (access to the US market, R&D and China), Theraclion is planning its commercial ramp-up for 2025 and 2026.

Pivotal study for access to the important US market: treatments completed in June 2024 as planned;
R&D and product development: the SONOVEIN is reaching a new level of maturity in clinical effectiveness, as recently highlighted by numerous KOLs;
Preparing for the commercialization of SONOVEIN in Europe and the Middle East.

MALAKOFF, France–(BUSINESS WIRE)–Regulatory News:

THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a robotic platform for non-invasive high-intensity focused ultrasound (HIFU) therapy for the treatment of varicose veins, reports on the implementation of its strategy for the first half of 2024 and the start of its commercial ramp-up.

Martin Deterre, Theraclion’s Chief Executive Officer, states, “During the first half of 2024, we achieved major milestones in Theraclion’s strategy based on access to the US and Chinese markets and on advances in SONOVEIN ® technology and clinical performance. This strategy is paying off: with over 2,700 veins treated and clinical efficacy demonstrated in the daily practice of numerous KOLs across Europe and publicly presented, SONOVEIN has reached a new level of maturity. Theraclion intends to pursue its efforts in these strategic areas, with further concrete advances expected in 2025 in regulatory and product development aspects.

In parallel, and given the product’s current performance level, the company is already preparing the next stages of its development, with commercialization ramp-up set to begin in 2025. This gradual targeted commercialization, with measured resources, will begin in Europe, where we are focusing on recurring revenues thanks to our installed base (sale of consumables), and in the Middle East, a buoyant market for system sales. We are aiming for a turnover of €2.5 million in 2025 and €5 million in 2026. After 2026, once FDA approval has been obtained, we expect sales to accelerate in particular through the search for a strategic partnership in the United States.

Access to the US market: a key stage in the FDA approval process for SONOVEIN ® achieved on schedule

In the United States, treatments in the pivotal FDA (Food and Drug Administration) approved study for SONOVEIN ® ended on schedule in mid-June, marking a key stage in the approval process. A total of 70 patients took part in the clinical trial, conducted at four leading centers in the United States and Europe. A 12-month follow-up period has thus begun, and final results should be available in summer 2025. The marketing authorization application should be submitted to the FDA in the second half of 2025, with approval expected in early 2026. These steps will pave the way to the largest market in the world and to high-impact strategic partnerships.

The maturity of SONOVEIN ®’s clinical performance has been highlighted at leading medical conferences and in scientific journals:

Professor Paolo Casoni and his team reported a 98.3% efficacy rate for SONOVEIN ® on 188 treated limbs followed up for 12 months. Their results were published last April in Phlebology, The Journal of Venous Disease, a leading vascular pathology journal.
Last June saw SONOVEIN ®’s inclusion in the American Venous Forum guidelines, thanks to an article by Dr. Steve Elias in the prestigious Handbook of Venous and Lymphatic Disorders, Guidelines of the American Venous Forum.
During the first half of 2024, 12 presentations by 10 opinion leaders practicing in 5 different countries took place during international conferences in several countries (USA, UK, Italy, Spain, Greece and Canada), based on follow-ups of up to 3 years with success rates in the order of 90 to 100% on cohorts comprising up to several hundred patients treated in routine activity1.

A strong commitment to R&D and product development

Major progress has been made in recent months on specific SONOVEIN ® functionalities, particularly in Artificial Intelligence, acoustics and 3D robotics, aimed primarily at significantly increasing treatment speed. These improvements will enable greater adoption by treatment centers and a sharp increase in the addressable market, ensuring that Theraclion’s long-term growth prospects are both significant and sustainable.

Subject to the timely granting of new regulatory approvals, the deployment of these technological improvements in the field is scheduled for 2025 and 2026, underpinning the commercial development expected over this period.

First-half 2024 results

In €K	30/06/2024	30/06/2023	Var. %
Turnover	442	981
from equipment sales	108	597	-82%
from sales of consumables	287	314	-9%
from sales of services	46	69	-33%
Subsidies	138	0
Other products	38	0
Write-back of depreciation and provisions	11	0
Total operating income	628	981	-36%
Purchases of goods and stock variation	170	532	-68%
Gross margin	271	449	-40%
% Gross margin	61 %	45%
Other purchases and external expenses	1 640	1 115	47%
Purchases of goods and external charges	1810	1647	10%
Salaries and social charges	1 661	1 957	-15%
Depreciation expenses	102	103	-1%
Allocations to provisions	41	424	-90%
Other expenses		30
Other operating expenses	1 805	2 514	-28%

Operating income	-2 987	-3 179	-6%
Financial result	84	-65	228%
Extraordinary result	16	263	-94%
Research tax credits	525	504	4%
Net income	-2 363	-2 476	-5%

Average headcount (FTE)	28	30

These accounts have been subject to a limited review by the auditors.

Turnover for the first half of 2024

In the first half of 2024, sales of consumables to existing customers remained stable, while sales of new systems, which were not a priority, fell by 82% in the first half.

Operating income came to 628K €, including an operating subsidy of 138K € received in the first half.

Until now, Theraclion has focused on supporting centers equipped with SONOVEIN ® in order to improve their experience, rather than on prospecting for new customers. In the first half of the year, the company focused its resources on improving products and treatment protocols, as well as on clinical trials with a view to ensuring the success of the US clinical trial.

From 2025 onwards, given the progress made in clinical trials and R&D, the Company will gradually be devoting resources to its commercial roll-out, with priority given to Europe and the Middle East.

Operating expenses

The increase in gross margin reflects a favorable product mix, with margin-generating services and consumables accounting for 75.3% of sales as against 39.1% in the first half of 2023.

External expenses of 1,640K €, compared to 1,115K € at end June 2023 reflect expenditures linked to the clinical study in the United States (333K €). This increase is partly offset by a 15.1% reduction in compensation and benefits compared to prior year period.

After taking account of allocations to the provisions to the tune of 41.5K €, operating income came to a loss of 2,987K €, down 6% compared with the first-half 2023.

The financial result amounted to €84K due to interest gained from long term bank savings.

After taking account of the Research Tax Credit (CrÃ©dit ImpÃ´t Recherche – CIR), amounting to 525K €, the net loss comes to 2,363K €, down 4.6% year-over- year.

Evolution of cash flow and going concern

On June 30, 2024, Theraclion had a cash balance of €5.9 million. This cash position will cover Theraclion’s needs until the end of the first quarter of 2025.

Future short-term cash inflows include:

Short-term cash inflows include payment of the 2023 Research Tax Credit amounting to 1,049K €.
Second-half turnover forecast up on first-half.

The Company has already taken steps to secure the financing it needs to pursue its strategy and begin its commercial expansion.

About Theraclion

Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.

High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room, leaves no scars, and enables patients to return to their daily activities immediately. The HIFU treatment method concentrates therapeutic ultrasounds on an internal focal point from outside the body.

Theraclion develops the HIFU, CE-marked, platform for varicose veins treatment SONOVEIN ®, which has the potential to replace millions of surgical procedures every year. In the United States, SONOVEIN ® is an investigational device limited to investigational use; it is not available for sale in the U.S.

Based in Malakoff (Paris), the Theraclion team is made up of some 30 people, most of them involved in technological and clinical development.

For more information, please visit www.theraclion.com and follow the LinkedIn account.

Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE – ISIN code: FR0010120402
LEI: 9695007X7HA7A1GCYD29

_________
1 References available on www.theraclion.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20241030713291/en/

Theraclion contact
Martin Deterre
Chief Executive Officer
contact@theraclion.com

Source: Theraclion

Stock Markets

Needham initiates coverage on On Holding with buy rating

Published

57 mins ago

November 23, 2024

Investing.com — Needham on Friday initiated its coverage on On Holding AG (NYSE:) with a “buy” rating and a target price of $64.

Brokerage said On has shown industry-leading growth, with impressive revenue increases and healthy margin expansion. The company is likely to keep growing as it increases brand awareness and gains space with top sneaker retailers worldwide.

“We believe the company has a continued runway for strong growth, as they increase brand awareness and gain shelf space with the biggest and best sneaker retailers in the world,” analyst Tom Nikic wrote in the note.

Needham analyst noted that Roger Federer-backed On was valued at 5 times its expected 2025 revenues, which make stock may seem expensive but strong fundamentals could support continued stock momentum.

“Although valuation metrics are lofty, we believe the shares can continue to exhibit momentum as long as fundamentals”

ON is the fastest growing company in Needham’s coverage, with expected 32% revenue growth in 2024. Its Direct-to-Consumer (DTC) growing 43% year-to-date, compared to 24% growth for wholesale sales.

Brokerage highlighted despite this growth, the brand’s awareness is still relatively low. In major markets like the U.S., U.K., France, and Australia, awareness was under 10% a year ago. However, it’s increasing rapidly, with U.S. awareness doubling to around 20%, and tripling in France.

Stock Markets

Toll Brothers Announces Final Opportunity at Verona Estates Community in Chatsworth, California

Published

57 mins ago

November 23, 2024

CHATSWORTH, Calif., Nov. 22, 2024 (GLOBE NEWSWIRE) — Toll Brothers , Inc. (NYSE:), the nation’s leading builder of luxury homes, today announced the final opportunity to own a new home at Verona Estates, an exclusive gated community in Chatsworth, California. Only a few homes remain available for sale in this prestigious community, including the professionally decorated Siena Modern Farmhouse model home.

The intimate gated enclave of Verona Estates is a rare find showcasing award-winning architecture and innovative home designs. Nestled in an established Chatsworth neighborhood south of the Santa Susana Mountains and adjacent to the Vineyards at Porter Ranch, this exceptional community offers a serene and relaxed atmosphere with the convenience of nearby shopping and easy access to freeways, entertainment, and recreation.

Toll Brothers residents in Verona Estates will enjoy distinctive architecture, quality craftsmanship, luxurious home designs with open floor plans, expansive home sites, and proximity to the future 50-acre Porter Ranch community park. Verona Estates offers generous two-story home designs ranging from 4,700 to 6,000+ square feet, with 5 to 6 bedrooms, 4.5 to 6.5 bathrooms, and 3-car garages. The homes also feature popular floor plan options including prep kitchens, guest suites, floating staircases, indoor and outdoor fireplaces, and more. Move-in ready homes in the community are priced from $1,979,995.

We are thrilled to offer the final opportunity to own a home in the exclusive Verona Estates community, said Nick Norvilas, Division President of Toll Brothers in Los Angeles. The Siena model home is a showcase of luxury and design, and we encourage interested home buyers to visit and experience this exceptional home along with the final few quick move-in homes remaining in the community firsthand.

The Siena Modern Farmhouse model home features designer upgrades throughout, including fully landscaped and furnished interiors, offering an unparalleled living experience. The professionally decorated model home is priced at $2,999,995.

For more information, call 844-700-8655 or visit TollBrothers.com/LA. The Sales Center for Verona Estates is located at 20508 Edgewood Court in Chatsworth and is open by appointment only.

About Toll Brothers

Toll Brothers, Inc., a Fortune 500 Company, is the nation’s leading builder of luxury homes. The Company was founded 57 years ago in 1967 and became a public company in 1986. Its common stock is listed on the New York Stock Exchange under the symbol TOL. The Company serves first-time, move-up, empty-nester, active-adult, and second-home buyers, as well as urban and suburban renters. Toll Brothers builds in over 60 markets in 24 states: Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Indiana, Maryland, Massachusetts, Michigan, Nevada, New Jersey, New York, North Carolina, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, and Washington, as well as in the District of Columbia. The Company operates its own architectural, engineering, mortgage, title, land development, smart home technology, and landscape subsidiaries. The Company also develops master-planned and golf course communities as well as operates its own lumber distribution, house component assembly, and manufacturing operations.

In 2024, Toll Brothers marked 10 years in a row being named to the Fortune World’s Most Admired Companies™ list and the Company’s Chairman and CEO Douglas C. Yearley, Jr. was named one of 25 Top CEOs by Barron’s magazine. Toll Brothers has also been named Builder of the Year by Builder magazine and is the first two-time recipient of Builder of the Year from Professional Builder magazine. For more information visit TollBrothers.com.

Contact: Andrea Meck | Toll Brothers, Director, Public Relations & Social Media | 215-938-8169 | ameck@tollbrothers.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cbb8cf4a-a018-4df0-955e-3cf4ab63edeb

Sent by Toll Brothers via Regional Globe Newswire (TOLL-REG)

Verona Estates by Toll Brothers

Toll Brothers announced the final opportunity to own a new home at Verona Estates, including the designer-decorated Siena model home, in Chatsworth, California.

Source: Toll Brothers, Inc.

Stock Markets

Northvolt crisis may be make or break for Europe’s EV battery ambitions

Published

57 mins ago

November 23, 2024

By Marie Mannes, Alessandro Parodi and Stine Jacobsen

STOCKHOLM/GDANSK (Reuters) – Northvolt’s financial collapse deals a blow to Europe’s plan to set up its own battery industry to power electric cars, stirring a debate about whether it needs to do more to attract investment as startups struggle to catch up with Chinese rivals.

Europe’s biggest hope for an electric vehicle battery champion filed for U.S. Chapter 11 bankruptcy protection on Thursday after talks with investors and creditors including Volkswagen (ETR:) and Goldman Sachs for funding failed.

The Swedish company, whose motto is “make oil history”, has received more than $10 billion in equity, debt and public financing since its 2016 start-up. Volkswagen and Goldman Sachs each own about one fifth of its shares.

Northvolt said on Friday it needed $1.0-$1.2 billion in new funds under the restructuring process, which it hopes will end by the end of March.

In recent months, it has shrunk the business and cut jobs in a bid to shore up its finances. But it has struggled to produce sufficient volumes of high-quality batteries, and lost a 2 billion euro ($2.1 billion) contract from BMW (ETR:) in June.

That has left Europe’s ambitions to build its own battery industry looking a distant dream.

In recent years, Northvolt led a wave of European startups investing tens of billions of dollars to serve the continent’s automakers as they switch from internal combustion engines to electric vehicles.

But growth in EV demand is moving at a slower pace than many in the industry projected, and China has taken a huge lead in powering EVs, controlling 85% of global battery cell production, International Energy Agency data shows.

Making batteries and cells, the units that store and convert chemical energy into electricity, is a delicate process and doing so at scale is a challenge for any battery maker.

Northvolt has missed some in-house targets and curtailed production at its battery cells plant in northern Sweden, underscoring the difficulties, Reuters reported on Monday.

“The biggest issue is that batteries are not easy to make and Northvolt haven’t satisfied the supply demands of their customers – that is a management issue,” said Andy Palmer, founder of consultancy Palmer Automotive said.

“The Chinese are technologically 10 years ahead of the West in batteries. That’s a fact,” he said.

At least eight companies have postponed or abandoned EV battery projects in Europe this year, including China’s Svolt and joint venture ACC (NS:), led by Stellantis (NYSE:) and Mercedes-Benz (OTC:).

In 2024, Europe’s battery pipeline capacity out to 2030 has fallen by 176 gigawatt-hours, according to data firm Benchmark Minerals. That’s equivalent to almost all the current installed capacity in Europe, according to Reuters calculations.

RETHINK

Some executives say Europe should do more to attract and support home-grown projects so they can compete with Chinese rivals such as CATL and BYD (SZ:).

“Europe needs to rethink how it supports a nascent sector before China eats up the entire value chain, which is due to smart planning,” said James Frith, European head of Volta Energy Technologies, which specialises in battery and energy storage technology.

Among its $5.8 billion in debts, Northvolt owes the European Investment Bank (EIB) some $313 million.

EIB vice president Thomas Östros said it had been a constructive partner to Northvolt, but it needed to safeguard the EIB and EU’s interests.

“It remains the case that Europe has a strategic interest in a European battery industry for electric cars and we will follow developments very closely. But it is much to early to say what the outcome will be,” he said.

The Swedish government has repeatedly said it does not plan to take a stake in Northvolt.

On Friday, Northvolt’s outgoing CEO and co-founder Peter Carlsson said he was a “little worried” Europe is giving up on its dream of competing with China.

He said Europe would regret it in 20 years time if it retreated.

“It’s not a straight journey and right now, we’re all in a bit of a down in that journey where there’s more hesitations, there’s more questions on the speed of the transition from the carmakers, from policymakers, from the investor community,” he told reporters in a call.