Kelyniam Global Announces Q3 2025 Financial Results
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.
Kelyniam Global (OTC: KLYG) ha riportato i risultati del Q3 2025 per il trimestre chiuso al 30 settembre 2025. Ricavi YTD erano 2.186.491 $, in calo del 12,3% rispetto a 2.492.607 $ nel 2024; utile lordo è sceso a 1.695.496 $, in calo del 13,3%. L'azienda ha registrato una perdita operativa di 162.373 $ rispetto a un reddito operativo di 273.248 $ un anno prima, citando costi superiori di supporto alle vendite e di conformità regolatoria legati al prodotto Vestakeep®.
Principali sviluppi: autorizzazione FDA 510(k) per Vestakeep®, un impianto bi-calcio fosfato riassorbibile; sei importanti ospedali negli Stati Uniti sono in revisione da Value Analytics; e KLYG è stato elevato a OTCID su OTC Markets.
Kelyniam Global (OTC: KLYG) informó los resultados del tercer trimestre de 2025 para el trimestre terminado el 30 de septiembre de 2025. Los ingresos acumulados del año fueron 2.186.491 $, con una disminución de 12,3% frente a 2.492.607 $ en 2024; la utilidad bruta cayó a 1.695.496 $, con una disminución de 13,3%. La compañía registró una pérdida operativa de 162.373 $ frente a un ingreso operativo de 273.248 $ un año antes, citando mayores costos de apoyo a ventas y de cumplimiento normativo vinculados al producto Vestakeep®.
Desarrollos clave: autorización 510(k) de la FDA para Vestakeep®, un implante de fosfato de calcio bi-cálcico reabsorbible; seis grandes hospitales de EE. UU. están en revisión de Value Analytics; y KLYG fue elevado a OTCID en OTC Markets.
Kelyniam Global (OTC: KLYG)은 2025년 9월 30일 종료된 2025년 3분기 실적을 발표했다. 연간 누적 매출은 2,186,491달러로 2024년의 2,492,607달러 대비 12.3% 하락했다; 총이익은 1,695,496달러로 13.3% 하락했다. 회사는 운영손실 162,373달러를 기록했으며 이는 작년 동기간의 영업이익 273,248달러 대비 하락한 것으로, Vestakeep® 제품과 관련된 더 높은 판매지원 및 규제비용을 이유로 들었다.
주요 발전: Vestakeep®에 대한 FDA 510(k) 승인, 생흡수성 이중 칼슘 인산염 임플란트; Value Analytics 검토 중인 미국 주요 병원 6곳; 그리고 KLYG가 OTC Markets의 OTCID로 상향 조정되었다.
Kelyniam Global (OTC: KLYG) a publié les résultats du T3 2025 pour le trimestre se terminant le 30 septembre 2025. Les revenus YTD étaient de 2 186 491 $, en baisse de 12,3% par rapport à 2 492 607 $ en 2024; le bénéfice brut est tombé à 1 695 496 $, en baisse de 13,3%. L'entreprise a enregistré une perte opérationnelle de 162 373 $ contre un résultat opérationnel de 273 248 $ l'année précédente, citant des coûts accrus de support des ventes et de conformité réglementaire liés au produit Vestakeep®.
Évolutions clés: autorisation FDA 510(k) pour Vestakeep®, un implant en phosphate de calcium bi-calcique résorbable; six grands hôpitaux américains sont en revue par Value Analytics; et KLYG a été relevé au OTCID sur OTC Markets.
Kelyniam Global (OTC: KLYG) berichtete die Ergebnisse des Q3 2025 für das Quartal zum 30. September 2025. Jahresumsatz bis dato betrug 2.186.491 $, gegenüber 2.492.607 $ im Jahr 2024; Bruttogewinn fiel auf 1.695.496 $, ein Rückgang von 13,3%. Das Unternehmen verzeichnete einen operativen Verlust von 162.373 $ gegenüber einem operativen Einkommen von 273.248 $ im Vorjahr, und führte höhere Kosten für Vertriebsunterstützung und regulatorische Aufwendungen im Zusammenhang mit dem Vestakeep®-Produkt an.
Kernentwicklungen: FDA 510(k)-Freigabe für Vestakeep®, ein resorbierbares Bi-Calciumphosphat-Implantat; sechs große US-Krankenhäuser befinden sich in der Value Analytics-Überprüfung; und KLYG wurde auf OTCID bei OTC Markets hochgestuft.
Kelyniam Global (OTC: KLYG) أعلنت عن نتائج الربع الثالث من 2025 للربع المنتهي في 30 سبتمبر 2025. إيرادات YTD بلغت 2,186,491 دولار، بانخفاض 12.3% مقارنة بـ 2,492,607 دولار في 2024؛ الربح الإجمالي انخفض إلى 1,695,496 دولار، بانخفاض 13.3%. سجلت الشركة خسارة تشغيلية قدرها 162,373 دولار مقابل دخل تشغيلي قدره 273,248 دولار قبل عام، معلنة أن ذلك بسبب ارتفاع تكاليف دعم المبيعات والتكاليف التنظيمية المرتبطة بمنتج Vestakeep®.
التطورات الرئيسية: تصريح FDA 510(k) لـ Vestakeep®، زرعة فوسفات الكالسيوم ثنائية الكالسيوم القابلة للامتصاص؛ ستة مستشفيات أميركية كبرى قيد مراجعة Value Analytics؛ وترقية KLYG إلى OTCID في OTC Markets.
- Received FDA 510(k) clearance for Vestakeep
- Uplisted to OTCID on OTC Markets, improving disclosure status
- 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
Q3 2025 Financial Highlights (Compared to Q3 2024)
- Year-to-date revenue of
$2,186,491 $2,492,607 12.3% . - Gross profit of
$1,695,496 $1,956,714 13.3% , primarily due to the revenue headwinds offset by stable material costs. - Operating loss of
$(162,373) $273,248
"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
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 - 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)?
What caused Kelyniam's operating loss in Q3 2025 for KLYG?
What is Vestakeep and what regulatory progress did Kelyniam (KLYG) announce on Nov 10, 2025?
How could hospital reviews affect Kelyniam Global (KLYG) revenue?
What does Kelyniam's uplist to OTCID mean for KLYG investors?
