Kelyniam Global, Inc. (OTC:KLYG)

Kelyniam Global, Inc. (OTC:KLYG) ($0.15; $4.60M market cap) announced Q1 2025 results:

• Q1 sales of $0.62 million vs. $0.96 million in the prior year
• Q1 EPS of $(0.00) vs $0.00 in the prior year
• Operating loss of $(140,556) vs. operating profit of $123,599 in Q1 2024
• New three-year U.S. distribution agreement with Osteopore Ltd. (ASX: OSX)

Management Commentary:

“Kelyniam experienced a challenging first quarter due to seasonal variability and the timing of surgical schedules, which delayed revenue recognition,” said Ross Bjella, CEO of Kelyniam. “To address these challenges, we strengthened our sales organization by appointing Alex Rivero as National Sales Director and plan to onboard up to 10 additional distributors in 2025. Our commitment to delivering custom implants within 24-48 hours, combined with strategic partnerships, positions us for improved performance.”

“Our partnerships with Osteopore and Finceramica position Kelyniam as a leader in regenerative medicine in the U.S.,” added Bjella. “Regenerative products are an important part of the future of cranial surgery and will uniquely position Kelyniam in the market along with our commitment to quality and rapid service.”

Desiree Webb, Kelyniam's Chief Operating and Revenue Officer said, “Osteopore's products are exceptional additions for surgeons in need of a biomimetic and bioresorbable option for areas where natural, healthy bone growth are desired. Kelyniam is laser focused on providing the best in cranial and craniofacial regenerative options, and we look forward to making great strides with Osteopore in the United States. Osteopore will complement Kelyniam's culture of providing a high level of service and expertise for the most complex cases by leveraging key opinion leaders in various surgical specialties.”

Osteopore's CEO, Dr. Yujing Lim said, “Kelyniam has demonstrated its ability to manufacture and distribute effectively, as shown by their record performance in 2024. We believe that working directly with Kelyniam allows us to leverage their established access to hospitals and potential customers, thereby accelerating customer access to Osteopore's products.”

Kelyniam Global, Inc. designs, manufactures, and distributes custom cranial and maxillofacial implants using advanced computer-aided design and medical-grade polymers for reconstructive surgical applications.

Kelyniam Global (OOTC:KLYG) ($0.014; $4.4M market cap) announced Q3 2024 results:

• Q3 sales of $790K vs $640K in the prior year
• Q3 operating profit of $101K vs a loss of $100k in the prior year
• Nine month sales of $2.49 million vs $1.34 million
• Nine month operating profit of $273,248 vs a loss of $329,993 

"We are proud of our profitable growth in 2024," said Bjella. "Our team has been invigorated by rising sales, the addition of new surgeons and hospital customers, and a stringent focus on expense management. These results support Kelyniam's capability to generate cash and capitalize on our operating model's leverage. While pricing pressures persist, strategic growth and diligent expense management have driven the significant turnaround in our operating profit."

Other events occurring in the third quarter included: 

• Greater market acceptance for the CustomizedBoneÔ (hydroxyapatite) regenerative implant
• Greater trial and usage of the NEOS Cranial Loop fixation
• Attendance at the College of Neurological Surgeons annual meeting

Kelyniam Inc., specializes in the rapid production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers.  The Company develops, manufactures, and distributes custom cranial and maxillo-facial implants for patients.

Kelyniam Global (OOTC:KLYG) ($0.012; $3.6M market cap) announced Q2 2024 results:

• Q2 sales of $743K vs $544K in the prior year

• Q2 operating profit of $49K vs a loss of $162k in the prior year

• Six month sales of $1.7 million vs $1.1 million

• Six month operating profit of $172,093 vs a loss of $229,345 

“The increase in profitability was primarily due to increased sales, efficiency improvements and reducing software, insurance and consulting expenses. Sales for the first half of the year have remained strong as additional surgeons request implants with Kelyniam's patented integrated fixation in the PEEK implant product line. Sales from the hydroxyapatite CustomizedBone™ implant with NEOS Cranial Loop fixation also increased as the products continue to gain market acceptance.” 

Kelyniam Inc., specializes in the rapid production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers.  The Company develops, manufactures, and distributes custom cranial and maxillo-facial implants for patients.

Kelyniam Global (OOTC:KLYG) ($0.04; $1.2M market cap) announced Q1 2024 results:

• Q4 sales of $957,447 vs $596,455 in the prior year

• Operating profit of $123,599 vs a loss of $67,978 in the prior year

“Profitability was strongly enhanced by a year's long effort in reconfiguring the Company's structural costs and a tight focus on this year's operations.  The Company saw those efforts pay off with decreased consulting fees and information technology costs which positively affected the bottom line.” 

 "Sales momentum from Q4 continued into Q1, resulting in record growth, quarterly revenue and profit.  Surgeons and Distributors using Kelyniam custom cranial and craniofacial implants have increased, in addition to the level of case complexity. This is a result of proven outcomes, a laser focus on customer service and operations, and Kelyniam's ability to deliver RUSH cases within 24-48 hours to any hospital in the United States.  Interest in the CustomizedBoneä hydroxyapatite osteo-integrative cranial implant continues to grow, particularly due to the indication for pediatric patients. Looking forward we expect to see continued interest in this unique cranial implant because of the recent approval of the NEOS Cranial Loop fixation vs. traditional suturing, resulting in decreased OR time."

Kelyniam Inc., specializes in the rapid production of custom prosthetics utilizing computer aided design and computer aided manufacturing of advanced medical grade polymers.  The Company develops, manufactures, and distributes custom cranial and maxillo-facial implants for patients.