60 Degrees Pharmaceuticals Announces 2024 Annual Results

Rhea-AI Summary

60 Degrees Pharmaceuticals (NASDAQ: SXTP) reported significant financial growth for FY 2024. Net product revenues increased 140% to $607.6 thousand, driven by domestic sales of ARAKODA®. The company achieved a gross profit of $222.8 thousand in 2024, compared to a $221 thousand loss in 2023.

Operating expenses rose to $10.0 million in 2024 from $4.9 million in 2023, primarily due to non-recurring R&D charges and babesiosis clinical trial costs. Net loss widened to $8.43 million ($18.55 per share) from $3.925 million ($59.18 per share) in 2023.

Key developments include:

• FDA approval to import Kodatef® (Australian equivalent of Arakoda) due to increased U.S. demand
• Ongoing babesiosis clinical trials with interim analysis expected in Q1 2026
• Additional Arakoda supply lots scheduled for release in early Q2 2025
• Expansion of clinical studies for babesiosis treatment in various patient groups

Positive

• 140% increase in net product revenues to $607.6K
• Turned $221K gross loss into $222.8K gross profit
• FDA approval for Kodatef importation to meet growing US demand
• Expansion of clinical trial sites and patient recruitment
• Commercial distribution network covering all 50 states

Negative

• Net loss increased by $4.505M to $8.43M in 2024
• Operating expenses doubled to $10.0M
• Non-recurring R&D charges of $2.63M impacting profitability
• Slow patient recruitment in babesiosis trial (only 6 of 24 required patients)

Insights

Financial Analyst

60 Degrees Pharmaceuticals shows a 140% revenue increase to $607.6K for FY 2024, primarily driven by domestic ARAKODA® sales. The company achieved a positive gross profit of $222.8K, a dramatic turnaround from the previous year's $221K gross loss as increased sales volume helped overcome fixed costs associated with regulatory compliance.

Despite this top-line growth, operating expenses doubled to $10M, with the net loss widening to $8.43M from $3.93M. However, 76% of this expense increase came from non-recurring items: a $2.63M non-cash R&D charge, $0.6M for research materials, and $1.36M for the babesiosis clinical program.

The surge in demand for ARAKODA® necessitating FDA approval for importing the Australian equivalent (Kodatef®) signals strengthening market position. This unexpected demand surge could accelerate the path to profitability if managed properly. The company's EPS improved significantly on a per-share basis from -$59.18 to -$18.55, though this likely reflects changes in share count rather than operational improvement.

With a market cap of $2.53M against $607.6K annual revenue, SXTP trades at about 4.2x sales – reasonable for an early-commercial stage pharmaceutical company with clinical programs advancing. The crucial metrics to watch are continued revenue acceleration and whether R&D investments translate to marketable products for babesiosis treatment.

Pharmaceutical Industry Specialist

SXTP's clinical development strategy reveals a focused approach to expanding ARAKODA®'s indications beyond its original malaria prophylaxis use. The babesiosis program represents a strategic pivot toward addressing an underserved parasitic infection market, where few effective treatments exist.

The company's multi-pronged clinical approach is methodical: a randomized controlled trial (currently with 6 of 24 minimum patients enrolled), an open-label study in immunosuppressed patients with relapsing babesiosis, and preparations for evaluating patients with severe fatigue potentially linked to babesiosis. The expansion to Brigham and Women's Hospital as an additional trial site should accelerate recruitment.

The FDA's rapid approval of the regulatory discretion request to import Kodatef® indicates both strong agency relationships and recognition of ARAKODA's clinical importance. This temporary importation solution addresses immediate demand while the company completes validation of additional manufacturing lots, showing regulatory agility.

The epidemiological research with North Carolina State University represents smart resource allocation – using academic partnerships to establish disease prevalence data that could expand the addressable market. Their focus on babesiosis in patients with persistent fatigue and neurological problems could position ARAKODA® in the larger post-infectious syndrome space.

The recent commercial pilot launch (March 17) will be critical to watch, as it will test whether physicians embrace off-label use for babesiosis ahead of formal approvals. This real-world evidence could accelerate regulatory pathways and reduce overall development costs.

• FY 2024 net product revenues increased 140% to $607.6 thousand.
• FY 2024 gross profit increased $443.8 thousand from ($221 thousand) to $222.8 thousand.

WASHINGTON, March 28, 2025 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious diseases, reported today their financial results for the 2024 fiscal year, ended December 31, 2024.

Financial Highlights for the Fiscal Year Ended December 31, 2024:

• Net product revenues increased 140% from $253.6 thousand for fiscal year 2023 to $607.6 thousand for fiscal year 2024; the Company credits growth from domestic commercial sales of ARAKODA^®.
• The Company achieved a gross profit of approximately $222.8 thousand in fiscal year 2024, compared to an approximate gross loss of $221 thousand in fiscal year 2023. Increased sales volume allowed the Company to overcome fixed cost of goods expense associated with the Drug Supply Chain Security Act that previously led to a gross loss.
• Operating expenses were approximately $10.0 million in fiscal year 2024, compared with approximately $4.9 million in fiscal year 2023. The increase in operating expenses was primarily due to a non-recurring non-cash Research and Development charge of $2.63 million, non-recurring non-cash delivery of research materials ($0.6 million) and Research and Development costs associated with the Company’s babesiosis clinical trial program ($1.36 million).
• Net loss attributable to common shareholders in calendar year 2024 was approximately $8.43 million, or $18.55 per share, compared with a net loss of approximately $3.925 million, or $59.18 per share in fiscal year 2023, representing a $4.505 million decline. This decline in profitability is mostly attributed to an increase in non-recurring non-cash Research and Development expenses of $3.23 million.

Recent Business Highlights

• Due to a recent surge in demand for Arakoda^® in the U.S. market, the Company submitted a regulatory discretion request to FDA in December 2024 to allow importation of Kodatef^® (Australian-branded equivalent of Arakoda) to ensure continuous U.S. commercial supply. This was granted in February 2025, and Kodatef was made available for distribution on March 10, 2025, through a specialty pharmacy serving all 50 states.
• The Company is completing validation of two additional lots of Arakoda, to be released into the supply chain by early Q2 2025.
• Preparations for the Company’s commercial pilot are complete. Outreach to physicians commenced on March 17, 2025.
• The Company commenced a randomized evaluation of tafenoquine versus placebo in hospitalized patients with babesiosis in 2024, randomizing N=6 of the minimum 24 patients required to trigger an interim endpoint (all completed the study). The Company recently increased its recruitment capacity for this study by establishing an additional clinical site at Brigham and Women’s Hospital. Interim analysis is expected in Q1 2026.
• We initiated an open label evaluation of Arakoda in immunosuppressed patients who have a diagnosis of relapsing/persistent babesiosis. The first patient was enrolled during Q1, 2025. Up to 15 patients in total will be enrolled.
• The epidemiological study sponsored by the Company, and conducted by North Carolina State University, is complete. The study evaluated the incidence of babesiosis by PCR and DNA sequencing in patients with persistent fatigue and neurological problems. Results of the study will be submitted to a peer-reviewed journal.
• The total prevalence of post-infectious syndromes (severe chronic fatigue, chronic fatigue syndrome, encephalomyelitis, long COVID, and post-treatment Lyme disease syndrome), and the potential contribution of Babesia infection to that burden of disease, is not known. The Company is conducting additional market research to determine the size of these market segments in the U.S., with a view to defining an upper limit on the potential prevalence of chronic babesiosis.
• The Company has secured IRB (ethics) approval for an open label evaluation of Arakoda in patients with severe fatigue and a presumptive diagnosis of babesiosis. The Company is now establishing the feasibility and cost of conducting such a study.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and marketing new medicines for the treatment and prevention of infectious diseases that affect the lives of millions of people. 60 Degrees Pharmaceuticals, Inc. achieved FDA approval of its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research organizations in the U.S., Australia, and Singapore. The 60 Degrees Pharmaceuticals, Inc. mission has been supported through in-kind funding from the U.S. Department of Defense and private institutional investors including Knight Therapeutics Inc., a Canadian-based pan-American specialty pharmaceutical company. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington D.C., with a majority-owned subsidiary in Australia. Learn more at www.60degreespharma.com.

Cautionary Note Regarding Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com
(310) 989-5666

FAQ

What was SXTP's revenue growth in fiscal year 2024?

SXTP's net product revenues grew 140% to $607.6 thousand in FY 2024, up from $253.6 thousand in FY 2023.

How much did SXTP's operating expenses increase in 2024?

Operating expenses increased to $10.0 million in 2024 from $4.9 million in 2023, primarily due to R&D charges and clinical trial costs.

What is the status of SXTP's babesiosis clinical trial program?

SXTP has randomized 6 of 24 required patients and added a site at Brigham and Women's Hospital, with interim analysis expected in Q1 2026.

How is SXTP addressing the increased demand for Arakoda in the US market?

SXTP received FDA approval to import Kodatef (Australian equivalent) and is validating two additional Arakoda lots for Q2 2025 release.

What was SXTP's net loss per share in fiscal year 2024?

SXTP reported a net loss of $18.55 per share in FY 2024, compared to $59.18 per share in FY 2023.