Orthofix预计全年净销售额为8.08亿至8.16亿美元，同时加速美国脊柱分销商转型

Earnings Call Insights: Orthofix Medical Inc. (OFIX) Q2 2025

Management View

• President and CEO Massimo Calafiore stated the company achieved second quarter pro forma net sales of $200.7 million, marking 4% year-over-year constant currency growth, and highlighted the "disciplined approach led to strong adjusted EBITDA margin growth and positive free cash flow generation underscoring our ability to grow the business responsibly."
• Calafiore noted that "strategic initiatives like accelerating spine distributor transition in certain underpenetrated U.S.A. territories are gaining traction and creating a powerful foundation for a stronger, more scalable commercial organization to drive our next phase of growth." He also emphasized, "we continue to gain share in our U.S. Anterior Lumbar and Cervical Fusion portfolios which both grew in excess of 15%, significantly outperforming the market."
• Calafiore reported, "we received FDA clearance and initiated the limited market release of our new VIRATA Spinal Fixation System in the U.S.," and described the early traction from the limited launch as "impressive," with "over 80% of surgeons participating... representing new or incremental business."
• The CEO detailed that "USA orthopedics grew 28% benefiting from strong execution and the launch of our new TrueLok Elevate Transverse Bone Transport System which is now in full market release globally."
• Calafiore stated, "our momentum continues to build in our orthopedic business with the groundbreaking opportunity we have to define the limb reconstruction category."
• CFO Julie B. Andrews commented, "In the second quarter, total global net sales reached $200.7 million, up 4% over the prior year." Andrews added, "pro forma non-GAAP adjusted gross margin... reached 72.7%, representing an approximate 140 basis point increase compared to the reported non-GAAP adjusted gross margin for the second quarter of 2024 of 71.3%."
• Andrews noted, "pro forma non-GAAP adjusted EBITDA, excluding the impact of the discontinuation of M6 was $20.6 million or 10.3% of net sales."

Outlook

• Andrews reiterated, "we maintain our expectation of full year pro forma net sales between $808 million and $816 million, excluding revenue from the discontinued M6 product lines."
• Management expects "third quarter 2025 net sales to be similar to the second quarter with new distributor partners helping to counter usual seasonal declines in procedure volumes."
• Andrews stated, "we continue to expect full year 2025 pro forma non-GAAP adjusted EBITDA of $82 million to $86 million."
• Gross margins are expected to be "approximately 72% for the remainder of the year."
• Operating expenses are anticipated to improve by "approximately 200 basis points this year versus 2024."

Financial Results

• U.S. Spinal Fixation net sales grew 5.4% with procedure volume up 7%, though "this growth was partially offset by an outsized impact from a price decrease at a major account."
• Global Spinal Implants, Biologics and Enabling Technologies net sales reached $104.8 million with year-over-year growth of 2%.
• Bone Growth Therapies (BGT) net sales reached $62.6 million, reflecting 6% growth, with "fracture growth within BGT was 7% attributed to investments in the fracture sales channel."
• Global Orthopedics business grew 5% to $33.3 million in the quarter, with U.S. Orthopedics up 28% and international Orthopedics down 2% due to non-recurring NGO orders.
• The company reported a total cash balance at the end of Q2, including restricted cash, of $68.7 million and positive free cash flow of $4.5 million for the quarter.

Q&A

• Michael John Petusky, Barrington Research: Asked whether U.S. Orthopedics growth was from deeper utilization or new accounts. Calafiore responded, "the driver is both... the introduction of TrueLok Elevate or TBT is helping us to enter on a market where we were not participating."
• Petusky asked about CapEx and free cash flow outlook. Andrews answered, "Q4 will be cash flow positive, and we may see a little slowdown in Q3. We don't have a specific guide for CapEx, but... probably see a little bit heavier in Q3, but overall, approximately flat to last year."
• Caitlin Cronin, Canaccord: Inquired about the U.S. Spine distributor transition and timing. Calafiore said, "I'm very excited about the effect that it's going to have on our company in the -- from Q3 and beyond."
• Cronin followed up on BGT growth and AccelStim 2.0. Calafiore replied, "it was FDA approved and we are planning to launch it in the second half of the year."
• Jeffrey Scott Cohen, Ladenburg: Asked about 7D traction and pricing. Calafiore highlighted, "the 7D unit placement grew 66% in first half of 2025... majority of our placements are, on average, 50% on top over the commitment."
• Cohen asked about pricing changes. Andrews clarified, "there weren't any pricing changes in the quarter compared to our comments in Q1."
• Jason Hart Wittes, ROTH: Queried on growth in specialized ortho and BGT. Calafiore confirmed, "the strategy that we implemented around Orthopedics, especially in United States is paying off." He added, "the growth that we are experiencing in BGT quarter-over-quarter is amazing."
• Wittes followed up on the impact of a large customer on pricing. Andrews responded, "the vast majority of it is due to that customer."

Sentiment Analysis

• Analysts focused on sustainability of growth, pricing pressures, distributor transitions, and new product launches, with a generally positive but probing tone, particularly around execution of new initiatives and margin durability.
• Management maintained a confident tone, with Calafiore stating, "I feel very confident about the business, because all of these initiatives are creating a much stronger foundation." During Q&A, management was transparent about pricing headwinds and optimistic about the impact of new products and commercial strategies.
• Compared to the previous quarter, both management and analysts maintained a constructive but cautious tone, with slightly increased optimism this quarter following strong orthopedics and BGT results and successful product launches.

Quarter-over-Quarter Comparison

• Guidance for full year net sales and EBITDA remained consistent with previous quarter, but management now expects gross margins of approximately 72% for the remainder of the year, up from the previous 71% expectation. Operating expense improvement guidance was reaffirmed at 200 basis points.
• U.S. Orthopedics growth accelerated to 28% from 12% in Q1, driven by the full market release of TrueLok Elevate and new product launches.
• The impact of a major account price decrease in Spine Fixation continued to weigh on margins, as previously outlined.
• Management's tone shifted from emphasizing groundwork and transitions in Q1 to highlighting tangible results from distributor transitions and product launches in Q2.
• Analysts in both quarters pressed on execution and sustainability of growth, but the current quarter featured more questions on specific product launches, cross-selling, and the impact of new technologies on future growth.

Risks and Concerns

• Management cited ongoing impact from a major account price decrease in Spine Fixation, expected to persist through the remainder of the year.
• Variability in international Orthopedics growth was noted due to the timing and volume of NGO and distributor orders.
• Tariff exposure in multiple regions was highlighted, with $3 million to $4 million annual impact managed within current guidance.
• Analysts expressed concern about timing and magnitude of distributor transitions, margin sustainability, and pricing pressures.

Final Takeaway

Orthofix management underscored the company's momentum in orthopedics and bone growth therapies, backed by robust product launches and strategic distributor transitions. The outlook for the remainder of 2025 remains unchanged for net sales and EBITDA, with gross margin guidance raised to 72%. The company highlighted continued execution on innovation, commercial expansion, and operating discipline as keys to delivering long-term shareholder value through the rest of the year and beyond.

Read the full Earnings Call Transcript