Q2 results from across the medical device industry

OrthoPediatrics Corp. reports Q2 2019 financial results
Record revenue of $18.2 million, up 20.7% year-over-year

OrthoPediatrics Corp. financial results for the quarter ending June 30, 2019:

• Increased total revenue to $18.2 million for second quarter 2019, up 20.7% from $15.1 million in second quarter 2018
• Deployed $9.3 million of consignment sets during the second quarter 2019
• Acquired Vilex, including its Orthex Hexapod circular fixation technology and proprietary CORA-based x-ray planning software, for $60.2 million
• Increased domestic sales organization to 152 reps, including Orthex, up 22% from the second quarter 2018
• Received FDA 510(k) clearance in July for two new Cannulated Screw Systems for treating younger patients with fractures and fusions
• Received FDA 510(k) clearance in August for PediFoot, the first pediatric-specific to address the most common foot deformities in children
• Updated full year revenue guidance from 21% to 23% growth to 23% to 25%, including Orthex

Teleflex reports Q2 2019 results
Second quarter 2019 net revenues were $652.5 million, an increase of 7% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 9.6% over the year ago period.

• Second quarter 2019 net revenues from sales of Vascular Access products were $153.6 million, an increase of 9.6% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 12% compared to the prior year period.
• Second quarter 2019 net revenues from sales of Interventional products were $104.8 million, an increase of 6.7% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 8.8% compared to the prior year period.
• Second quarter 2019 net revenues from sales of Anesthesia products were $85.7 million, a decrease of 4.0% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues decreased 0.9% compared to the prior year period.
• Second quarter 2019 net revenues from sales of Surgical products were $95.6 million, an increase of 5.6% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 9% compared to the prior year period.
• Second quarter 2019 net revenues from sales of Interventional Urology products were $67.9 million, an increase of 42.5% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 42.7% compared to the prior year period.
• Second quarter 2019 net revenues from sales of OEM products were $56.4 million, an increase of 7.3% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 8.5% compared to the prior year period.
• Second quarter 2019 net revenues from sales of other products were $88.4 million, a decrease of 3.3% compared to the prior year period. Excluding the impact of foreign currency exchange rate fluctuations, second quarter 2019 net revenues increased 0.3% compared to the prior year period.

NuVasive Q2 2019 results
NuVasive reported second quarter 2019 total revenue of $292.1 million, a 3.7% increase compared to $281.6 million for the second quarter 2018.

• On a constant currency basis, second quarter 2019 total revenue increased 4.7% compared to the same period last year.
• For the second quarter 2019, both GAAP and non-GAAP gross profit was $214.5 million and GAAP and non-GAAP gross margin was 73.4%. These results compared to the second quarter 2018 GAAP and non-GAAP gross profit of $204.5 million and $204.9 million, respectively, and GAAP and non-GAAP gross margin of 72.6% and 72.8%, respectively.
• On a GAAP basis, the Company reported net income of $15.0 million, or diluted earnings per share of $0.29, for the second quarter 2019 compared to a net income of $11.5 million, or diluted earnings per share of $0.22, for the second quarter 2018. On a non-GAAP basis, the Company reported net income of $32.8 million, or diluted earnings per share of $0.63 per share, for the second quarter 2019 compared to net income of $30.3 million, or diluted earnings per share of $0.58 per share, for the second quarter 2018.

Silk Road Medical Q2 2019 results
Silk Road Medical Inc., focused on reducing the risk of stroke and its devastating impact, reported financial results for the three months ended June 30, 2019.

Revenue for the second quarter of 2019 was $14.9 million, an increase of $7.2 million or 92%, compared to the second quarter of 2018. The increase was driven primarily by growing adoption of the TCAR procedure across an expanded base of hospital accounts, trained physicians, and active sales territories.

Gross profit for the second quarter of 2019 was $11.2 million compared to $5.4 million for the second quarter of 2018. Gross margin for the second quarter of 2019 increased to 75% compared to 69% in the second quarter of 2018, driven primarily by leveraging manufacturing overhead costs across higher revenue, as well as manufacturing efficiencies and the delayed timing of certain manufacturing engineering projects.

“Our second quarter results demonstrate strong performance as we expand our footprint with TCAR to reduce the risk of stroke and its devastating impact,” said Erica Rogers, Chief Executive Officer. “The recently presented data from ROADSTER-2, taken together with the updated results from the TCAR Surveillance Project, mark a major milestone in our journey demonstrating successful patient outcomes. We are challenging the standard of care with mounting clinical evidence in support of TCAR.”

Stryker reports Q2 2019 operating results
"We are pleased with our second quarter performance, highlighted by 8.5% organic sales growth," said Kevin A. Lobo, chairman and chief executive officer. "The durability of our growth is evidenced by continued strength across our businesses and regions, as well as our revised full-year outlook."

Sales analysis

• Consolidated net sales of $3.7 billion increased 9.9% in the quarter and 11.5% in constant currency. Organic net sales increased 8.5% in the quarter including 9.3% from increased unit volume partially offset by 0.8% from lower prices.
• Orthopaedics net sales of $1.3 billion increased 3.7% in the quarter and 5.6% in constant currency. Organic net sales increased 5.6% in the quarter including 6.9% from increased unit volume partially offset by 1.3% from lower prices.
• MedSurg net sales of $1.6 billion increased 11.1% in the quarter and 12.5% in constant currency. Organic net sales increased 11.5% in the quarter including 11.6% from increased unit volume partially offset by 0.1% from lower prices.
• Neurotechnology and Spine net sales of $0.8 billion increased 18.9% in the quarter and 20.8% in constant currency. Organic net sales increased 7.4% in the quarter including 8.7% from increased unit volume partially offset by 1.3% from lower prices.