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Theraclion Announces Major Advances and Reports First-Half Financial Results

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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 (Crédit Impôt 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

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

Source: Theraclion

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Economic impact of floods in Spain could rise to over 10 billion euros

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By Jesús Aguado

MADRID (Reuters) -Damages to businesses in towns hit by floods in eastern Spain could rise to over 10 billion euros, with banks loan exposure to the area worth alone around 20 billion euros ($21.82 billion), representatives for local firms and a Bank of Spain official said on Tuesday.

On Tuesday, the government earmarked around 10.6 billion euros to help victims of some of Europe’s worst flooding in decades. At least 217 people died and more are still unaccounted for.

Spanish banks’ loans to areas worst hit by floods mainly in Valencia region would rise to around 13 billion euros to households and 7 billion euros to companies, said Angel Estrada, the central bank’s head of financial stability.

In total, the central bank identified 23,000 companies with outstanding loans and 472,000 loan holders in those regions.

Of those 150,000 were mortgage contracts on which the government and banks agreed to offer loan moratoriums. Clients will be spared from paying monthly instalments for the first three months and just pay interests for an additional nine months on their mortgages.

Estrada said it was important to make sure that those moratoriums would not lead to reclassification of credits that might trigger higher provisions.

Jose Vicente Morata, Chairman of Commerce for Valencia region, said that the damage to businesses in the worst affected area of this region would provisionally rise “well over” 10 billion euros.

Estrada said it was still too early to assess the precise economic impact of the floods though he acknowledged that there had been a more “significant destruction of capital” than during the COVID-19 pandemic.

He said the banking sector would be “able to absorb” any impact, though they had laid bare that climate risks were materialising faster than expected and banks should now focus on measuring accelerating physical risks as well as addressing the transition risks of shifting to a lower carbon economy.

Mirenchu del Valle, chairman of Spain’s UNESPA insurance association, said the Valencia floods would represent Spain’s “most significant damages claim for a climate event”, without putting a potential figure on it.

A spokesperson for the Economy Ministry, which oversees the insurance sector, declined to provide a figure for the claims so far.

© Reuters. Cars are seen piled on a street in the aftermath of floods caused by heavy rains in Paiporta, near Valencia, Spain, November 5, 2024. REUTERS/Nacho Doce

So far, the most costly economic event by floods took place in Bilbao in 1983, when claims rose to more than 821 million euros and 1.08bln included associated damage for high winds, according to data from the Spanish insurance consortium.

($1 = 0.9175 euros)

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Albany International’s senior VP Robert Hansen buys $74,826 in stock

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Robert Alan Hansen, the Senior Vice President and Chief Technology Officer of Albany International Corp (NYSE:), recently purchased 1,050 shares of Class A Common Stock. The shares were acquired at an average price of $71.26 per share, amounting to a total transaction value of approximately $74,826. Following this transaction, Hansen’s direct ownership in Albany International stands at 8,387 shares.

In addition to this purchase, Hansen holds various Phantom Stock Units, which are set to be settled and payable in upcoming years. These units entitle Hansen to receive the cash equivalent of Class A Common Stock upon vesting, as part of the company’s Phantom Stock Plan.

In other recent news, Albany International Corp. showcased resilience in its Q3 2024 results. The company reported a 6.1% year-over-year increase in consolidated net sales, totaling $298 million. Despite adjustments in the Engineered Composites segment, free cash flow saw a significant improvement, and the company adjusted its full-year revenue guidance with a slight increase in the adjusted earnings per share (EPS) midpoint.

Machine Clothing sales rose to $183 million, while Engineered Composites sales remained steady at $115 million. Gross profit, however, declined to $90 million due to a $22 million cumulative adjustment in the Engineered Composites segment. Despite this, the company’s year-to-date free cash flow surged to $78 million from $25 million.

The company also announced new leadership appointments and plans for an Investor Day in Spring 2025. Albany International anticipates providing full-year 2025 guidance at the year-end and discussing long-term strategies at the upcoming Investor Day. Despite facing challenges, such as a downward adjustment in production estimates for the LEAP program, the company remains optimistic about future revenue opportunities, particularly in defense classified work.

InvestingPro Insights

Robert Alan Hansen’s recent purchase of Albany International Corp (NYSE:AIN) shares comes at an interesting time for the company. According to InvestingPro data, AIN’s stock is currently trading near its 52-week low, with a significant price drop of 16.44% over the last three months. This insider buying activity could be seen as a vote of confidence in the company’s future prospects.

Despite the recent stock performance, Albany International maintains a strong financial position. InvestingPro Tips highlight that the company has maintained dividend payments for 24 consecutive years and has raised its dividend for 6 consecutive years. This consistent dividend history, coupled with a current dividend yield of 1.48%, may be attractive to income-focused investors.

Furthermore, AIN operates with a moderate level of debt and its liquid assets exceed short-term obligations, indicating a solid balance sheet. The company’s revenue growth of 15.93% over the last twelve months and an EBITDA growth of 8.99% during the same period suggest ongoing business expansion.

It’s worth noting that AIN is trading at a P/E ratio of 22.16, which is considered high relative to its near-term earnings growth. This valuation metric, along with the fact that three analysts have revised their earnings downwards for the upcoming period, may warrant careful consideration by potential investors.

For those interested in a deeper analysis, InvestingPro offers 10 additional tips for Albany International Corp, providing a more comprehensive view of the company’s financial health and market position.

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

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Wells Fargo’s SWOT analysis: stock outlook amid regulatory hurdles

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Wells Fargo & Company (NYSE:), one of the largest banks in the United States, faces a complex landscape of opportunities and challenges as it navigates regulatory scrutiny, operational changes, and market dynamics. This comprehensive analysis examines the company’s current position, future prospects, and the factors influencing its stock performance.

Financial Performance and Outlook

Wells Fargo’s financial performance in recent quarters has been mixed, with some positive indicators offset by ongoing challenges. In the third quarter of 2024, the company reported flat reported profit and loss (RPL) at $2.0 billion. The bank’s net interest income (NII) has been under pressure, with guidance suggesting a decrease of 8-9% year-over-year for the full year 2024.

Expenses remain a concern for investors, with the company projecting full-year expenses around $54 billion. This figure represents an increase from previous estimates, driven by various factors including compensation in Wealth and Investment Management, litigation costs, and regulatory issues.

Loan growth has shown signs of moderation, particularly in the Commercial & Industrial (C&I) and card segments. Deposits have also been on a downward trend, reflecting broader industry challenges in retaining customer funds in a high-interest rate environment.

Despite these headwinds, Wells Fargo has maintained its capital return programs. The company raised its dividend by 14% and continues its share buyback program, with $14.7 billion remaining as of July 2024. These actions signal management’s confidence in the bank’s financial stability and long-term prospects.

Regulatory Challenges and Investigations

Wells Fargo continues to face significant regulatory scrutiny, which has been a persistent theme for the bank in recent years. The company is currently under government investigation concerning its Anti-Money Laundering (AML) and sanctions programs. Additionally, Wells Fargo is in resolution discussions related to the Securities and Exchange Commission’s (SEC) investigation into its cash sweep option.

These regulatory challenges have led to increased expenses and potential reputational risks. The bank has built up reserves, with a recent addition of $0.2 billion bringing the total to $2.0 billion. This reserve build reflects the potential financial impact of ongoing investigations and legal issues.

A key constraint on Wells Fargo’s operations remains the asset cap imposed by the Federal Reserve, which limits the bank’s growth potential. The lifting of this cap could provide a significant boost to earnings, but the timing remains uncertain.

Business Strategy and Operations

Wells Fargo has been actively reshaping its business portfolio and operations. In a notable move, the bank sold most of its commercial mortgage servicing business to Trimont. This decision aligns with a broader trend in the banking industry, where institutions are divesting mortgage businesses to non-banks due to regulatory pressures and the need to streamline operations.

The company maintains a strong market position, ranking second in branch count within the United States. This extensive network provides a solid foundation for customer relationships and deposit gathering, although the banking industry is increasingly shifting towards digital channels.

Wells Fargo is also focusing on growth areas, particularly in its corporate and investment banking divisions. The bank reports market share gains in these segments, which could help diversify revenue streams and reduce reliance on traditional retail banking.

Market Position and Competition

Despite facing challenges, Wells Fargo remains a major player in the U.S. banking sector. Its market capitalization of approximately $215 billion as of November 2024 underscores its significant presence in the industry.

The bank’s valuation metrics suggest potential upside, trading at 1.4x price-to-tangible book value compared to 1.6x for mega bank peers. This discount may reflect ongoing regulatory concerns but could also represent an opportunity if Wells Fargo can successfully navigate its challenges.

Wells Fargo’s competitive position is supported by its strong brand recognition and extensive customer base. However, the bank faces intense competition from both traditional financial institutions and fintech companies that are disrupting various aspects of banking services.

Bear Case

How might ongoing regulatory investigations impact Wells Fargo’s financial performance?

The ongoing regulatory investigations into Wells Fargo’s AML and sanctions programs, as well as the SEC probe into cash sweep options, pose significant risks to the bank’s financial performance. These investigations could result in substantial fines, legal costs, and remediation expenses. The recent reserve build of $0.2 billion, bringing the total to $2.0 billion, indicates the potential scale of financial impact.

Moreover, regulatory issues often lead to increased compliance costs and operational constraints. Wells Fargo has already projected higher expenses of around $54 billion for 2024, partly due to regulatory and litigation-related costs. These elevated expenses could pressure profit margins and limit the bank’s ability to invest in growth initiatives.

The reputational damage from prolonged regulatory scrutiny may also affect customer trust and business relationships, potentially leading to deposit outflows and reduced business opportunities. This could exacerbate the challenges Wells Fargo faces in growing its loan portfolio and maintaining its market share in key segments.

What risks does the asset cap pose to Wells Fargo’s growth potential?

The asset cap imposed by the Federal Reserve continues to be a significant constraint on Wells Fargo’s growth potential. This restriction limits the bank’s ability to expand its balance sheet, effectively capping its asset size at $1.94 trillion as of the third quarter of 2024.

The cap hampers Wells Fargo’s competitiveness, particularly in the markets business, which has been most adversely impacted by this restriction. It prevents the bank from fully capitalizing on market opportunities and expanding into new areas that require significant capital deployment.

Furthermore, the asset cap may force Wells Fargo to make trade-offs in its business mix, potentially foregoing profitable opportunities in favor of maintaining compliance with the restriction. This could lead to suboptimal capital allocation and reduced overall profitability compared to peers who do not face similar constraints.

The uncertainty surrounding the timing of the asset cap’s removal adds another layer of risk. As long as the cap remains in place, Wells Fargo may struggle to keep pace with competitors in terms of growth and innovation, potentially eroding its market position over time.

Bull Case

How could the lifting of the asset cap benefit Wells Fargo’s long-term prospects?

The potential lifting of the asset cap represents a significant opportunity for Wells Fargo to reignite growth and improve its competitive position. Analysts suggest that the removal of this restriction could lead to a multi-year earnings boost for the bank.

Without the asset cap, Wells Fargo would have greater flexibility to expand its balance sheet, potentially leading to increased lending activities and investment opportunities. This could drive revenue growth across various business segments, particularly in areas that have been constrained by the cap, such as the markets business.

The lifting of the asset cap would also signal a resolution of regulatory concerns, potentially improving Wells Fargo’s reputation and reducing the risk premium associated with its stock. This could lead to a re-rating of the bank’s valuation multiples, bringing them more in line with or potentially exceeding those of its peers.

Moreover, the removal of this restriction would allow Wells Fargo to more aggressively pursue strategic initiatives, such as acquisitions or expansions into new markets, which could further enhance its long-term growth prospects and competitive positioning in the banking industry.

What advantages does Wells Fargo’s strong branch network provide in the current banking landscape?

Wells Fargo’s position as the second-largest bank in the U.S. by branch count offers several advantages in the current banking landscape. Despite the trend towards digital banking, physical branches remain important for building customer relationships and trust, particularly for complex financial products and services.

The extensive branch network provides Wells Fargo with a strong foundation for deposit gathering. In an environment where funding costs are increasing, having a large and stable deposit base can be a significant competitive advantage. The branches serve as a key touchpoint for cross-selling various financial products, from mortgages to wealth management services.

Furthermore, the branch network supports Wells Fargo’s community banking strategy, allowing it to maintain a strong presence in local markets. This local presence can be particularly valuable for small business banking and in areas where personal relationships still play a crucial role in financial decision-making.

The branches also serve as a physical manifestation of the bank’s brand, reinforcing its market presence and visibility. This can be especially important in an era where many fintech competitors lack a physical presence, potentially giving Wells Fargo an edge in customer acquisition and retention among certain demographic groups.

SWOT Analysis

Strengths:

  • Extensive branch network and strong market presence
  • Diverse revenue streams across retail, commercial, and investment banking
  • Solid capital position and ongoing share buyback program
  • Strong brand recognition and large customer base

Weaknesses:

  • Ongoing regulatory investigations and compliance issues
  • Asset cap limiting growth potential
  • Higher expenses due to regulatory and operational challenges
  • Underperformance in loan growth and deposit retention

Opportunities:

  • Potential lifting of the asset cap, enabling renewed growth
  • Expansion in investment banking and trading services
  • Monetization of corporate and investment banking components
  • Technological innovations to enhance customer experience and operational efficiency

Threats:

  • Continued regulatory scrutiny and potential fines
  • Increasing competition from fintech companies and traditional banks
  • Macroeconomic uncertainties affecting interest rates and loan demand
  • Reputational risks from past scandals and ongoing investigations

Analysts Targets

  • Barclays (LON:): $75.00 (November 4th, 2024)
  • Barclays: $75.00 (October 17th, 2024)
  • Barclays: $66.00 (October 9th, 2024)
  • Barclays: $66.00 (September 11th, 2024)
  • Deutsche Bank (ETR:): Upgraded to BUY (September 3rd, 2024)
  • Barclays: $66.00 (August 5th, 2024)
  • BMO Capital Markets: $59.00 (July 15th, 2024)
  • Barclays: $66.00 (July 15th, 2024)

This analysis is based on information available up to November 5, 2024, and reflects the complex landscape Wells Fargo navigates as it seeks to overcome regulatory challenges and position itself for future growth in a dynamic banking environment.

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To evaluate WFC further, use InvestingPro’s Fair Value tool for a comprehensive valuation based on various factors. You can also see if WFC appears on our undervalued or overvalued stock lists.

These tools provide a clearer picture of investment opportunities, enabling more informed decisions about where to allocate your funds.

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

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