Stock Markets

Theraclion Announces Major Advances and Reports First-Half Financial Results

Published

6 days 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

Truist cuts Editas Medicine target to $8, keeps buy rating

Published

24 hours ago

November 5, 2024

On Monday, Truist Securities revised its price target for Editas Medicine (NASDAQ:), a company specializing in gene editing technology. The firm reduced the target to $8.00 from the previous $12.00 while retaining a Buy rating on the stock.

The adjustment follows the company’s third-quarter report, which did not present any unexpected results following recent announcements. The analyst indicated that Editas Medicine is expected to provide updated data on its reni-cel therapy at the upcoming American Society of Hematology (ASH) meeting, as well as updates on its in vivo program in the first quarter of 2025.

The reassessment of the reni-cel program prompted the analyst to moderate the outlook, leading to the lowered price target. Despite this change, the firm continues to support a Buy rating for Editas Medicine shares, suggesting confidence in the company’s long-term potential.

Editas Medicine is actively engaged in the development of gene-editing therapies, with reni-cel being one of its key investigational treatments. The forthcoming data presentations are anticipated to shed more light on the progress and efficacy of these treatments.

The updated price target of $8.00 reflects a more conservative valuation of Editas Medicine by Truist Securities, while the maintained Buy rating indicates a positive view of the stock’s future performance despite the recent adjustments.

In other recent news, Editas Medicine has been the focus of several analyst adjustments. Wells Fargo reduced its price target for Editas from $27.00 to $9.00, while maintaining an Overweight rating. This adjustment followed Editas Medicine’s disclosure of preclinical data for its in vivo hematopoietic stem and progenitor cell (HSPC) editing program.

The company also announced its intention to partner or out-license its reni-cel therapy. Baird also lowered its target for Editas Medicine to $10 from $18, keeping an Outperform rating.

The company has made significant strides in gene editing treatments for sickle cell disease and beta-thalassemia. It reported high levels of editing in hematopoietic stem and progenitor cells. Additionally, Editas secured an upfront payment of $57 million from a financing agreement with DRI Healthcare Trust. Leerink Partners and Truist Securities maintained their Market Perform and Buy ratings respectively on Editas’ stock.

InvestingPro Insights

Recent financial data from InvestingPro provides additional context to Truist Securities’ revised outlook on Editas Medicine (NASDAQ:EDIT). The company’s market capitalization stands at $245.89 million, reflecting its current valuation in the biotech sector. Editas’ stock has experienced significant volatility, with a 41.8% price decline over the past three months and a 48.68% drop in the last six months, aligning with the analyst’s more cautious stance.

InvestingPro Tips highlight that Editas is quickly burning through cash and is not expected to be profitable this year, factors that likely influenced Truist’s decision to lower the price target. The company’s gross profit margin is weak, with a negative 165.65% for the last twelve months as of Q2 2024, underscoring the challenges in its developmental stage.

Despite these headwinds, Editas maintains a strong liquidity position. An InvestingPro Tip notes that the company’s liquid assets exceed short-term obligations, providing some financial flexibility as it advances its gene-editing therapies. This could be crucial as Editas prepares to present updated data on reni-cel and its in vivo program.

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This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Stock Markets

Cemex stock hits 52-week low at $5.17 amid market challenges

Published

24 hours ago

November 5, 2024

Cemex SAB de CV (NYSE:), a leading materials company in the construction industry, has seen its stock price touch a 52-week low, dipping to $5.17. This price level reflects a significant downturn from its previous positions, marking a challenging period for the company. Over the past year, Cemex’s stock has experienced a notable decline, with a 1-year change showing a decrease of 22.42%. This downturn is indicative of the broader pressures facing the construction sector, including fluctuating demand and cost pressures, which have impacted the company’s market valuation and investor confidence.

In other recent news, CEMEX has reported a year of substantial growth and strategic optimization despite facing natural disasters and undergoing significant divestitures. The company announced divestitures amounting to $2.2 billion, concentrating on operations in the Dominican Republic, Guatemala, and the Philippines. In spite of severe weather conditions, including three major hurricanes in the U.S., CEMEX achieved a net income increase of over 200% year-over-year.

CEMEX’s growth strategy, initiated in 2019, has resulted in a 14% compound annual growth rate (CAGR) since 2020. The company also reported a 3% reduction in Scope 1 emissions and received a €157 million grant from the EU for a carbon capture project in Germany.

Analysts from Thompson Davis and Goldman Sachs questioned the company’s valuation strategies and the impact of Mexican residential demand on CEMEX, respectively. In response, CEMEX executives emphasized careful evaluation of operational changes and positive expectations for significant impact starting in 2025.

These are among the recent developments that underline CEMEX’s resilience and strategic focus, allowing it to navigate a challenging environment while maintaining a positive outlook for growth.

InvestingPro Insights

Cemex’s recent stock performance aligns with several key insights from InvestingPro. The company is currently trading near its 52-week low, as reflected in the article, with InvestingPro data showing the stock price at $5.18 at the previous close. This represents just 56.02% of its 52-week high, underscoring the significant downturn mentioned.

Despite the challenging market conditions, InvestingPro Tips highlight that Cemex remains a prominent player in the Construction Materials industry. The company’s Price to Book ratio of 0.63 suggests it may be undervalued relative to its assets, potentially offering value for investors looking beyond current market sentiment.

Importantly, an InvestingPro Tip indicates that net income is expected to grow this year, which could provide a positive catalyst for the stock. This growth expectation, combined with the company’s low valuation multiples, may present an opportunity for investors willing to weather the current downturn.

For those seeking a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide further insights into Cemex’s financial health and future prospects.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Stock Markets

Jefferies cuts Booz Allen stock rating to Hold, sees slowdown in the long-term

Published

24 hours ago

November 5, 2024

On Monday, Jefferies adjusted its stance on shares of Booz Allen Hamilton (NYSE:), downgrading the stock from Buy to Hold, though the firm increased the price target to $190 from $180. The revision comes despite acknowledging the company’s strong management and share price performance.

The analyst from Jefferies noted that while Booz Allen Hamilton has shown stellar performance, a pause on the stock is suggested as earnings per share (EPS) revisions through the fiscal year 2025 (ending in March 2025) may be limited.

The limited potential for EPS revisions is attributed to margins being range-bound, with the Defense sector—accounting for 48% of sales and approximately 10% margins—outperforming the Civil sector, which makes up 33% of sales and has a 13% margin. The analyst further pointed out that there is an anticipated slowdown in organic growth excluding items, from 11% in the fiscal year 2025 to 8% in fiscal years 2026 to 2027 estimates.

The new price target of $190 is based on a 30% market premium or twice the three-year average, reflecting the analyst’s valuation of the stock. This price target suggests a modest upside from the previous target, indicating a positive outlook on the company’s value despite the rating downgrade.

The downgrade to Hold reflects a cautious approach towards Booz Allen Hamilton’s stock, considering the expected limitations in earnings growth and margin expansion in the upcoming years. The firm’s analysis suggests that while the company has been performing well, future gains might not be as robust as in the previous periods.

In other recent news, Booz Allen Hamilton reported a robust second quarter for fiscal year 2025, with major revenue hikes in its civil, defense, and intelligence sectors.

The company’s VOLT growth strategy, a record $41 billion backlog, a $115 million insurance recovery, and a $200 million boost from payroll modernization were significant contributors to this performance. Adjusted EBITDA reached $364 million, a 25% year-over-year increase, and net income surged by 129% to $390 million.

Despite the loss of the Advana contract and a Department of Veterans Affairs contract to Deloitte, Booz Allen maintains a strong demand environment with a qualified pipeline of over $20 billion.

The firm’s operating model allows for quick adaptation to client needs amid shifting priorities, and recruitment and retention trends remain strong, making Booz Allen an attractive destination for tech talent. These recent developments emphasize Booz Allen’s strong market presence and potential for continued growth.

InvestingPro Insights

While Jefferies has downgraded Booz Allen Hamilton (NYSE:BAH) to Hold, recent data from InvestingPro paints a nuanced picture of the company’s financial health and market performance. BAH’s revenue growth of 13.94% over the last twelve months and a strong 18.01% quarterly growth align with the company’s solid performance noted in the article.

The stock’s P/E ratio of 28.58 and an adjusted P/E ratio of 31.27 for the last twelve months as of Q2 2025 suggest that investors are willing to pay a premium for BAH’s earnings, which could be justified by its consistent growth. This valuation is further supported by the company’s robust EBITDA growth of 30.89% over the same period.

InvestingPro Tips highlight that BAH has raised its dividend for 9 consecutive years and maintained payments for 13 years, indicating a commitment to shareholder returns. This is particularly relevant given the article’s focus on the company’s financial outlook. Additionally, the tip that BAH operates with a moderate level of debt provides context to the company’s financial stability, which could be a factor in its ability to navigate potential growth slowdowns mentioned in the analyst’s report.

For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips that could provide further insights into BAH’s market position and future prospects.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.