Kelyniam Global Announces Q3 2025 Financial Results

Rhea-AI Summary

Kelyniam Global (OTC: KLYG) reported Q3 2025 results for the quarter ended Sept 30, 2025. YTD revenue was $2,186,491, down 12.3% versus $2,492,607 in 2024; gross profit fell to $1,695,496, down 13.3%. The company recorded an operating loss of $162,373 versus operating income of $273,248 a year earlier, citing higher sales support and regulatory costs tied to the Vestakeep® product.

Key developments: FDA 510(k) clearance for Vestakeep®, a resorbable bi-calcium phosphate implant; six major U.S. hospitals are in Value Analytics review; and KLYG uplisted to OTCID on OTC Markets.

Positive

• Received FDA 510(k) clearance for Vestakeep
• Uplisted to OTCID on OTC Markets, improving disclosure status

Negative

• Year-to-date revenue declined 12.3% versus prior year
• Gross profit decreased 13.3% versus prior year
• Operating loss of $162,373 vs prior operating income of $273,248

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CANTON, Conn., Nov. 10, 2025 /PRNewswire/ -- Kelyniam Global, Inc. (OTC: KLYG), a leader in custom cranial and craniofacial implants, today reported financial results for the third quarter ended September 30, 2025.

Q3 2025 Financial Highlights (Compared to Q3 2024)

• Year-to-date revenue of $2,186,491, compared to $2,492,607, a decrease of 12.3%.
• Gross profit of $1,695,496, compared to $1,956,714, a decrease of 13.3%, primarily due to the revenue headwinds offset by stable material costs.
• Operating loss of $(162,373), compared to operating income of $273,248, reflecting increased investments in sales support and regulatory costs associated with the new Vestakeep® product.

"Sales have faced headwinds this year from a slow distributor ramp-up and temporary market share shifts, but through Q3, we're steadily catching up to 2024 levels and building a stronger foundation for sustainable growth," said Ross Bjella, CEO of Kelyniam Global. "The cranial implant sector remains robust, with competitors with overall market projections showing expansion from $1.43 billion in 2024 to over $1.5 billion in 2025. We're capitalizing on this by aggressively adding distributors in untapped markets, where we see tremendous opportunity to capture demand for our rapid-turnaround, custom solutions."

Key Strategic Developments in Q3 2025

• FDA Clearance for Vestakeep®: Received 510(k) clearance for this novel resorbable bi-calcium phosphate implant, expanding Kelyniam's portfolio into regenerative applications and addressing unmet needs in craniofacial reconstruction.
• Hospital Approvals Pipeline: The Kelyniam product line is under Value Analytics review approval at six major U.S. hospitals, including two Level 1 trauma centers, potentially adding up to $500,000+ in annual recurring revenue.
• KLYG uplists to OTCID status on OTC Markets Group Platform. This designation underscores Kelyniam's commitment to financial transparency and compliance.

Kelyniam's complete unaudited financial results for Q3 2025, including detailed segment breakdowns and cash flow statements, are available on the company's website at www.kelyniam.com.

About Kelyniam Global, Inc.

Kelyniam Global, Inc. (OTC: KLYG) designs, manufactures, and distributes custom cranial and craniofacial implants using advanced biocompatible materials. Renowned for its industry-leading 24-48 hour delivery, Kelyniam partners with surgeons, hospitals, and payors to optimize clinical outcomes and reduce costs in neurosurgery. For more information, visit www.kelyniam.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements, including projections for 2026 revenue growth, distributor expansion impacts, and the effects of recent partnerships and clearances, involve risks and uncertainties that could cause actual results to differ materially from those anticipated. Such risks include market competition, regulatory delays, distributor performance variability, economic pressures on healthcare spending, and supply chain disruptions, as detailed in Kelyniam's filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Kelyniam undertakes no obligation to update these statements except as required by law.

View original content:https://www.prnewswire.com/news-releases/kelyniam-global-announces-q3-2025-financial-results-302610664.html

SOURCE Kelyniam Global Inc

FAQ

What were Kelyniam Global's reported YTD revenue and change for Q3 2025 (KLYG)?

Kelyniam reported YTD revenue of $2,186,491 for Q3 2025, a 12.3% decline from $2,492,607 in Q3 2024.

What caused Kelyniam's operating loss in Q3 2025 for KLYG?

The company cited increased sales support investments and regulatory costs related to the Vestakeep product, contributing to the operating loss.

What is Vestakeep and what regulatory progress did Kelyniam (KLYG) announce on Nov 10, 2025?

Vestakeep is a resorbable bi-calcium phosphate implant and Kelyniam received FDA 510(k) clearance for the product.

How could hospital reviews affect Kelyniam Global (KLYG) revenue?

Six major U.S. hospitals are in Value Analytics review, which the company says could potentially add up to $500,000+ in annual recurring revenue if approved.

What does Kelyniam's uplist to OTCID mean for KLYG investors?

The OTCID designation indicates the company is meeting higher financial transparency and compliance standards on the OTC Markets platform.