CytoSorbents Corp. (CTSO:NASDAQ) has announced preliminary, unaudited financial results for the fourth quarter and full year of 2024, reflecting strong performance and key advancements. Product revenue for Q4 is estimated between US$9.0 million and US$9.2 million, marking a 22% to 25% increase compared to US$7.35 million in Q4 2023. For the full year, product revenue is expected to reach US$35.4 million to US$35.6 million, up 14% from $31.1 million in 2023. The gross margin for Q4 is projected at approximately 70%, a notable recovery from 61% in Q3 2024, attributed to resolving manufacturing issues and inventory adjustments.
The company's flagship product, CytoSorb®, continues to drive international growth across critical care and cardiac surgery applications, with over 250,000 units utilized globally. CEO Dr. Phillip Chan remarked in the news release, "This strong top-line close to 2024, as well as our return to more normalized product gross margins, positions us well to drive improved efficiencies in our core business as we prepare to enter the North American market with DrugSorb-ATR."
CytoSorbents also highlighted progress in its regulatory pathway for DrugSorb™-ATR, an investigational device designed to mitigate bleeding risks during coronary artery bypass graft (CABG) surgery for patients on antithrombotic drugs like Brilinta® (ticagrelor). The U.S. Food and Drug Administration (FDA) and Health Canada are conducting reviews, with decisions anticipated in 2025. The company is concurrently hosting investor meetings during the upcoming J.P. Morgan Healthcare Conference.
Advancing Medical Technology in Critical Care
The medical device and biotechnology sectors remain pivotal within healthcare, marked by robust innovation and evolving market dynamics. In 2023, the U.S. medical device industry led globally, with exports exceeding US$103 billion, as reported by the International Trade Administration. The industry, encompassing diagnostic, therapeutic, and surgical devices, directly supports over 500,000 jobs and benefits from collaborations across biotechnology, microelectronics, and software development. Advances such as robotic assistance and neuro-stimulators exemplify the sector's commitment to innovation, positioning it for continued growth amid increasing life expectancy and aging populations worldwide.
Analyst Jason Kolbert reaffirmed a "Buy" rating with a 12-month price target of US$10.00, citing the company's operational efficiency and readiness for North American market expansion.
The biotechnology sector similarly demonstrated resilience and potential, particularly in regulatory reform discussions.
These changes were expected to reduce drug development timelines, providing smaller biotech firms with new opportunities for market entry while fostering investor confidence. However, risks included potential safety concerns and disproportionate advantages for established players.
In Türkiye, the medical device and pharmaceutical sectors showed significant growth, as outlined in a Mondaq article on January 3. The Turkish pharmaceutical market, for example, expanded by 90.9% in 2023, reaching 222.5 billion TRY, with domestic production accounting for 90.6% of units sold.
Similarly, Türkiye's medical device exports increased, achieving an export-to-import coverage ratio of 48% by mid-2024, up from 23% in 2017. These advancements reflect the country's strategic push to reduce import dependency, increase efficiency, and enhance competitiveness in international markets.
Regulatory Milestones Drive Momentum for CytoSorbents
CytoSorbents's investor presentation lays out its milestones in 2025, pending regulatory decisions for DrugSorb-ATR expected from both the FDA and Health Canada. This approval could pave the way for the device's commercialization in the North American market, addressing an unmet need for perioperative blood thinner removal. The DrugSorb-ATR system has already received two FDA Breakthrough Device Designations, underscoring its potential impact on improving surgical outcomes.
The company's international presence and adoption of CytoSorb® continue to expand, supported by its compatibility with existing hospital infrastructure and its ability to address critical conditions like sepsis and cytokine storm. In addition, CytoSorbents' new PuriFi pump, launched in 2024, enhances access to treatment in regions lacking established dialysis frameworks, creating further opportunities for market penetration.
Financially, CytoSorbents has demonstrated fiscal discipline, reducing its cash burn and securing a US$20 million loan facility. The company believes that this financial flexibility, combined with a strong product pipeline and regulatory progress, positions the company to achieve operational efficiencies and expand its market share in 2025 and beyond.
Experts Highlight CytoSorbents' Transformative Potential
According to Zacks Investment Research, CytoSorbents' DrugSorb-ATR, designed to reduce perioperative bleeding in cardiac surgery patients, represents a breakthrough in addressing critical unmet medical needs.
In their December 12, 2024 report, Zacks emphasized the company's progress in securing FDA and Health Canada regulatory approvals, which are expected in 2025. The analysts assigned a valuation of US$4.00 per share based on a discounted cash flow (DCF) model, reflecting the device's transformative potential in the North American market.
Zacks also noted the positive impact of a recent rights offering, which is expected to substantially increase liquidity and fund operations through key regulatory milestones.
Streetwise Ownership Overview*In a January 3, 2025 update from D. Boral Capital, CytoSorbents was recognized for its strong preliminary fourth-quarter performance, with estimated product revenue growth of 22%-25% year-over-year and a gross margin rebound to approximately 70%.
Analyst Jason Kolbert reaffirmed a "Buy" rating with a 12-month price target of US$10.00, citing the company's operational efficiency and readiness for North American market expansion. Kolbert highlighted the DrugSorb-ATR's potential to unlock significant value by addressing critical care needs in cardiac surgery and projected its commercialization to drive substantial revenue growth in 2025 and beyond.
Ownership and Share Structure
According to Refinitiv, 3.9% of CytoSorbents is held by management and insiders, with Phillip P. Chan holding the most at 1.35%.
Institutions hold 33.29%. Of those, Avenir Corporation owns 5.43%, Skylands Capital LLC holds 5.03%, Granahan Investment Management has 3.82%, The Banguard Group Inc. owns 3.56%, and Neuberger Berman LLC holds 3.25%.
The rest is retail.
The company's market cap is US$51.35 Million with 52.69 Million Free Float Shares. The 52 week range for CytoSorbents is $US $0.70–$1.59.
| Want to be the first to know about interesting Biotechnology / Pharmaceuticals investment ideas? Sign up to receive the FREE Streetwise Reports' newsletter. | Subscribe |
Important Disclosures:
1) James Guttman wrote this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee.
2) This article does not constitute investment advice and is not a solicitation for any investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Each reader is encouraged to consult with his or her personal financial adviser and perform their own comprehensive investment research. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company.
For additional disclosures, please click here.
