Musculoskeletal News Roundup 10-Nov-17

November 10, 2017 | Blake Mossy

EARNINGS

ConforMIS reported financial results for 3Q:17. Total revenue was $18.4 million in 3Q:17, beating consensus estimates by 5% and representing a decrease of 1% compared to $18.6 million in 3Q:16. Gross margin for 3Q:17 increased to 40%, from 37% in 3Q:16. Domestic revenues decreased by 1% related to recent hurricanes, largely attributable to deferred procedures and international revenues increased by 7% respectively in 3Q:17.

CONMED Corporation reported financial results for 3Q:17. Total revenue was $190.1 million in 3Q:17, beating consensus estimates by 2% and representing an increase of 2.4% compared to $184.8 million in 3Q:16. Adjusted EBITDA was $31.9 million in 3Q:17, increasing 0.1% on a reported basis from $31.2 million in 3Q:16. Adjusted EBITDA margin decreased to 16.8% in 3Q:17 from 16.9% in 3Q:16. Gross margin for 3Q:17 decreased to 54.7% from 54.8% in 3Q:16. The company's segments grew by: Orthopedic Surgery (2%), General Surgery +7%, Single-use Products +4% and Capital Products (4%) respectively in 3Q:17. All growth rates are on a constant currency basis, unless stated otherwise.

Exactech reported financial results for 4Q:17. Total revenue was $61.4 million in 3Q:17, missing consensus estimates by 1% and representing an increase of 2% compared to $66.2 million in 3Q:16. Gross margin for 3Q:17 increased to 70.3%, from 68.7% in 3Q:16. The company’s segments grew by: Extremities +19%, Knee +0%, and Hip (2%) in 3Q:17. All growth rates are on a constant currency basis.

Globus Medical reported financial results for 3Q:17. Total revenue was $151.7 million in 3Q:17, beating consensus estimates by 1.0% and representing an 11.9% compared to $135.7 million in 3Q:16. Adjusted EBITDA was $53.4 million and the company exhibited an adjusted EBITDA margin of 35.2% in 3Q:17.Gross margin for 3Q:17 decreased to 75.7% from 77.1% in 3Q:16. All growth rates are on a constant currency basis.

K2M reported financial results of 3Q:17. Total revenue was $62.7 million in 3Q:17, in-line with consensus estimates and representing an increase of 5% compared to $59.3 million in 3Q:16. Gross margin for 3Q:17 increased to 67.4%, from 67.1% in 3Q:16. The company’s segments grew by: Complex Spine +2.7%, Minimally Invasive +13.7%, and Degenerative and Other +5.4% om 3Q:17. All growth rates are on a constant currency basis.   

Mazor Robotics reported financial results for 3Q:17. Total revenue was $17.2 million in 3Q:17, increasing 126% compared to $7.6 million in 3Q:16. Revenue generated in the U.S. increased from $5.7 million in 3Q:16 to $17.2 million in 3Q:17, selling seventeen of its Mazor X systems. International non-U.S. revenue decreased from $1.9 million in 3Q:16 to $1.8 million in3Q:17. Revenue from system kit sales, services & other was $7.0 million in 3Q:17, representing a 63% increase compared to $4.3 million in 3Q:16. Gross margin for 3Q:17 increased to 69.2%, from 65.7% in 3Q:17. All growth rates are on a reported basis.

Orthofix International reported financial results for 3Q:17. Total revenue was $105.2 million in 3Q:17, beating consensus estimates by 5% and representing an increase of 6% compared to $98.5 million in 3Q:16. Adjusted EBITDA was $21.1 million in 3Q:17, decreasing from $23.5 million in 3Q:16. Adjusted EBITDA margin decreased to 20.1% in 3Q:17 from 23.9% in 3Q:16. Gross margin for 3Q:17 decreased to 77.5% compared to 79.8% in 3Q:16. The company's segments grew by: BioStim +3%, Biologics +6%, Extremity Fixation +1% and Spine Fixation +19% in 3Q:17. All growth rates on a constant currency basis.

SeaSpine Holdings reported financial results for 3Q:17. Total revenue was $31.7 million in 3Q:17, unchanged compared to $31.7 million in 3Q:16. Gross margin for 3Q:17 increased to 61.6%, from 56.3% in 3Q:16. The company's segments increased by: Orthobiologics +1% and Spinal Fusion Hardware (1%) in 3Q:17 respectively. Overall, U.S. revenue increased 2% to $34.2 million in 3Q:17. All growth rates are on a reported basis.

Smith & Nephew reported financial results for 3Q:17. Total revenue was $1,152 million in 3Q:17, in-line consensus estimates and compared to $1,119 million in 3Q:16. The company's segments grew at: Knee +6%, Hip +1%, Sports Medicine / Joint Repair +8%, Arthroscopic Enabling Technologies (3%), Trauma & Extremities (2%) and Other Surgical +16% respectively in 3Q:17. All growth rates are on a constant currency basis.

Stryker reported financial results for 3Q:17. Total revenue was $3.01 billion in 3Q:17, beating consensus estimates by 1% and representing an increase of 6% compared to $2.84 billion in 3Q:16. Gross margin for 3Q:17 increased to 66%, from 65.9% in 3Q:16. The company's segments grew by: Knees +4%, Hips +1%, Trauma & Extremities +7%, Other Orthopedics +16%, Instruments +6%,Endoscopy +14%, Medical (1%), Sustainability +7%, Spine (4%) and Neurotechnology +14%respectively in 3Q:17. International revenues increased by 5% and represented 38% of total revenue in 3Q:17. All growth rates are on a constant currency basis.

Wright Medical reported financial results for 3Q:17. Total revenue was $170.5 million in 3Q:17, below consensus estimates by 1% and representing an increase of 6% compared to 157.3 million in 3Q:16. Adjusted EBITDA was $19.8 million in 3Q:17 increasing from $12.2 million in 3Q:16. The adjusted EBITDA margin in 3Q:17 was 7.3% increasing from 3.6% in 3Q:16. Gross margin for 3Q:17 was 78.2% consistent with from 78.2% in 3Q:16. The company's segments grew by: Lower Extremities (0.3%), Upper Extremities +18.6%, Biologics +2.2% and Sports Medicine & Other (0.3%) in 3Q:17 respectively. All growth rates are on a pro forma, constant currency basis.

Zimmer Biomet reported financial results for 3Q:17. Total revenue was $1.82 billion in 3Q:17, slightly below consensus estimates and representing a decrease of 1.3% compared to $1.83 billion in 3Q:16. Gross margin for 3Q:17 decreased to 72.5%, from 77.1% in 3Q:16. The company's segments grew at: Knees (4%), Hips (5%), Surgical, Sports Medicine, Foot & Ankle, Extremities & Trauma+1%, Dental (4%), Spine & CMF +0.3% and Other (5.3%) respectively in 3Q:17. Geographically, the company grew: Americas (+3%), EMEA (0.4%) and Asia-Pacific +5% respectively in 3Q:17. All growth rates are on a constant currency basis

REGULATORY

Amedica announced its 510(k) submission to the FDA for its Valeo C+CSC with Lumen spinal implant based a similar cancellous structured ceramic cervical implant. The device intends to increase implant surface area and participates in fusion, while retaining other benefits of silicon nitride materials.

DT MedTech received 510(k) clearance from the FDA for its Hintermann Series H2 Total Ankle Replacement System, a semi-constrained, total ankle replacement prosthesis indicated for use with bone cement to treat ankle arthritis in primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle. The system is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis.

Medacta received 510(k) clearance from the FDA for its 3DMetal Tibial Cones, designed to provide structural support in areas of bone deficiencies that may compromise revision implant fixation. The system aims to allow structural and functional connection with the bone through an interconnecting pore structure similar to the cancellous bone structure.