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CEO Antony Koblish stated the company ended the quarter with 69 territory managers and 25 account specialists and plans to reach its target of 76 territory managers. President Jeffrey Blizard confirmed active recruiting is underway. CFO & COO Roberto Cuca outlined the expected revenue cadence, noting a typical step-up from Q1 to Q2, flatter growth into Q3 due to summer holidays, and a larger increase from Q3 to Q4. He added that OpEx is expected to remain largely flat quarter-over-quarter.

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CEO Antony Koblish described the strategy as 'basic blocking and tackling,' focused on increasing the number of surgeons using TELA products within each facility to gain leverage. He highlighted that the new Territory Manager (TM) and Account Specialist (AS) sales structure is crucial for this, enabling TMs to open new accounts while ASs deepen penetration and ensure continuous coverage. This provides both an offensive and defensive capability to manage GPO dynamics more effectively.

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CFO Roberto Cuca projected a standard seasonal revenue cadence for 2025, with growth accelerating in Q2 and Q4. CEO Antony Koblish detailed a new enhanced compensation plan and a 'team selling' model with Account Specialists to improve retention. Koblish emphasized that the primary driver of the Q4 shortfall was the unexpected loss of sales reps late in the quarter, which had a greater impact than external factors like the hurricane or IV fluid shortages.

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Executive Roberto Cuca explained the OpEx savings are primarily from sustainable headcount reductions in the sales organization as reps became more efficient, reducing the need for clinical specialists. Both Cuca and executive Antony Koblish clarified they did not see a significant backlog from Q2 flow into Q3, stating that procedure volumes at affected hospitals simply returned to normal pre-disruption levels rather than surging.

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President & CEO Keith Pfeil clarified that manufacturing initiatives are multifaceted and ongoing, with output expected to increase as staff become more efficient with new machinery. He noted the main remaining integration task is consolidating international businesses. Regarding Enabling Tech, Pfeil stated that the company offers a full suite of financing options and believes the current focus should be on closing deals within the strong existing pipeline, as there is no shortage of offerings.

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CEO Dan Scavilla noted he lacked hard data on market growth but shared anecdotal surgeon feedback of a slowdown. He confirmed Modulus approval for Excelsius is 'in the works' and that they are already seeing a 'decent impact' from placing robots and the fully integrated ReLine system into legacy NuVasive accounts.

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CEO Dan Scavilla stated that Nevro's SI joint portfolio was not a driving factor in the acquisition decision, viewing it as a minor enhancement to Globus's existing offerings. CFO Keith Pfeil commented that the ExcelsiusFlex launch is in a 'crawl, walk, run' phase and is not expected to be a meaningful revenue contributor until 2026, as the focus remains on building a holistic procedural solution with supporting implants.

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President & CEO Dan Scavilla highlighted the ortho robot's small footprint, modern design, smooth movements, and flexible workflow that doesn't require pre-planning. For the freehand navigation system, he stated that it opens the largest segment of the navigation market for Globus and has seen strong early excitement and procedures across all settings (hospitals, outpatient, ASCs), positioning it to be a meaningful contributor in 2025.

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CEO Damien McDonald described the surgeon reaction to ARVIS for shoulder as 'tremendous,' highlighting its portability and scalability. He noted significant excitement for the next-gen version's lighter headset and improved software. CFO Ben Berry clarified that the EMDR costs are related to remediating tech files for existing products to maintain market access in Europe, not for new product approvals, and that this is the last significant year of that spend.

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CEO Matthew Trerotola stated the Arvis shoulder launch is proceeding 'really well' in a controlled phase, generating extremely positive surgeon feedback and creating significant buzz. He then detailed a full pipeline of launches for the year, including knee revision products, the ARG in shoulder, a new hip stem, and enabling technologies, as well as spine braces and the Manafuse product in P&R.

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CFO Phillip Berry outlined that year two (2025) of the Lima integration should yield 10-20 basis points of margin impact, with the remainder of the $40M+ cost synergy goal realized in 2026 from larger operational projects. He also noted that Q4 extremities growth was driven by both shoulder, which returned to at/above market growth, and foot & ankle, which delivered strong double-digit growth.

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CEO Matthew Trerotola described the Foot & Ankle market as a high-single-digit grower with significant innovation opportunities, though it can have more variability than large joints. For the U.S. Hip business, he expects new products launching around year-end to have a meaningful impact by Q2 2025 and a more substantial impact in the second half of the year.

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Chairman, President & CEO Ivan Tornos noted that while the category's reported revenue declined due to a mix shift from outright sales to placements, installations remain on track. He confirmed the exclusive partnership with Think Surgical was recently extended, citing a large deal pipeline. He also highlighted a next-gen ROSA Knee launch in late 2025 as a future accelerator.

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President and CEO Ivan Tornos reported that the integration is proceeding 'far better than expected.' He highlighted key successes, including the retention of the entire Paragon 28 senior commercial leadership team and its U.S. sales force, which ensures minimal disruption. He also confirmed the plan to preserve Paragon 28's innovation engine and culture.

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CFO Suketu Upadhyay explained that the third consecutive quarter of positive pricing was driven by a better structural market, improved internal governance, and opportunistic price increases. This performance led to the updated full-year guidance of flat to +50 basis points. He noted the U.S. was down only modestly, an improvement over historical trends.

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President & CEO Linda Tharby explained the next-gen pump is critical for international growth as it accommodates all pre-filled syringe sizes, simplifying infusions. She anticipates an EU filing about one quarter after the US submission. CFO Tom Adams quantified the tariff impact at approximately 90 basis points, which is being mitigated by operational efficiencies. Both executives expressed confidence the distributor issue is a one-time Q3 event, based on strong end-user demand data.

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Executive Linda Tharby reported that U.S. prefilled syringe penetration has surpassed 65%. She highlighted the international tender win as a key milestone, as KORU's system can use prefills directly while dominant e-pumps in Europe cannot, creating a significant opportunity. Executive Tom Adams clarified the tariff impact, stating that after a full supply chain analysis, the effect is under 100 basis points and is already incorporated into the reaffirmed 61% to 63% gross margin guidance for the year.

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CFO Tom Adams confirmed there was no impact from macro issues, as the company proactively increased inventory to mitigate risks, with levels expected to normalize in Q4. President and CEO Linda Tharby added that the SCHOTT partnership is progressing well, with teams meeting regularly to optimize the device-syringe combination and collaborate on new pipeline opportunities.

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CEO Robert Claypoole outlined a limited PNS launch in H2 2025, followed by a rapid ramp in 2026, noting the new PNS and PRP platforms could add 200 basis points to company growth next year. SVP & CFO Mark Singleton explained the expected tariff impact has risen to $3 million for the year. He emphasized that this, along with a $2 million FX headwind, has been absorbed within the reaffirmed full-year guidance, showcasing the P&L's strength.

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CEO Rob Claypoole stated that the primary focus for capital deployment is reducing leverage to below 2.0x, given the strength of the current portfolio and new growth drivers like PRP. However, he affirmed they will pursue synergistic deals that align with their mission, citing the recent PRP distribution agreement as an example. He also confirmed the new international leader started in the current month and will focus on driving a disciplined growth strategy by prioritizing specific countries and products and improving commercial execution.

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SVP and CFO Mark Singleton explained that within Pain Treatments, DUROLANE is the primary growth driver, SUPARTZ is stable, and GELSYN is declining as the market and company efforts shift toward single-injection therapies. President and CEO Robert Claypoole added that OUS expansion will be a targeted, high-ROI effort under new leadership. For Ultrasonics, he clarified that while the portfolio covers neuro and general surgery, the primary focus remains on spine, with a more significant expansion into other areas expected in 2026 and beyond.

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CEO Robert Claypoole expressed confidence in the HA business, citing strong clinical differentiation, a dedicated sales force, and robust payer contracts as key drivers of market share gains. He noted that while they are in the early stages with Ultrasonics, they have world-class technology and will increase R&D investment for future innovation. Claypoole also stated he remains very optimistic about the long-term growth potential of the international business, though foundational work is still required.

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President and CEO Massimo Calafiore stated that the distributor transition is progressing well and is expected to positively impact growth from Q3 onward, helping the company achieve its three-year plan CAGR. He also confirmed AccelStim 2.0 was FDA approved and will launch in H2, with its seamless connectivity to the post-op platform generating significant surgeon interest.

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CFO Julie Andrews stated the NGO business impact will be seen in the international Orthopedics segment and that the company is not updating its long-term guidance at this time, with an update planned for the Q4 call. She also mentioned that progress continues with the 7D system, with a focus on earn-out placements to drive pull-through for the spine business, but offered no specific updates on the broader capital environment.

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CEO Massimo Calafiore explained that the M6 exit was a strategic decision to reallocate investment towards more profitable, high-growth areas like spine deformities, given the disc's decreasing demand. He noted that while M&A is not an immediate focus, the company's improved balance sheet allows them to be opportunistic. Regarding the 7D system, he stated 2024 was a record year with a 150% year-over-year increase in earn-out agreements, which are exceeding performance expectations and successfully driving implant pull-through with new customers.

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President and CEO Michael Dale described the FDA interactions as professional and cooperative, noting that final clarity on requirements typically comes at the very end of the process. He stated that while there is no change to the current OpEx guidance, the company is evaluating the possibility of accelerating hiring plans due to the significant market opportunity for nerve care.

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CEO Michael Dale confirmed that existing inventory produced under the tissue designation will still be available for sale after BLA approval. CFO Nir Naor noted that OpEx is expected to grow gradually due to strategic hiring, with some costs rolling off after the BLA approval in September. Regarding headcount, Michael Dale stated the company plans to add a net of approximately 20 salespeople by year-end.

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CEO Michael Dale stated that for 2025, the focus is on getting through the BLA process, which limits dramatic process changes, making the current guidance prudent. He expects incremental improvements longer-term. Regarding the BLA, Dale reported no signs of delay, noting that communication with the FDA remains active and consistent.

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CEO Michael Dale speculated that the FDA's decision for a standard review was not concerning and that the lack of an advisory committee could reflect confidence in the product's long history and safety profile. He also stated that the company will no longer report on 'core accounts' or 'direct reps,' instead focusing on 'high potential accounts.'

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CEO Laura Francis confirmed that while SI joint fusion remains the cornerstone, some new surgeons, particularly adult deformity specialists, are now entering the ecosystem through Granite, creating a 'halo effect' for cross-selling. CFO Anshul Maheshwari clarified that the anticipated second-half cash use is primarily for building surgical capacity and inventory in preparation for Q4 and the new product launch in 2026.

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CEO Laura Francis declined to specify a reimbursement code for the new SI joint product, emphasizing the strategy is to offer a comprehensive portfolio for all physician needs. She described the third breakthrough device as a novel implant leveraging core technology for a pressing need in spine surgery. Francis clarified that while surgeons are the majority, interventionalists are an additive and growing segment, with a record number performing procedures in Q1.

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CEO Laura Francis stated that the Globus/Nevro deal substantiates SI-BONE's platform strategy and does not change their approach, expressing confidence in their market leadership. Regarding the new BDD product, she noted it is in early development with no revenue contribution expected in 2025, and details will be shared closer to launch.

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CFO Anshul Maheshwari explained that Granite 9.5 conveniently uses the same instrument sets as the 10.5 version, driving higher asset utilization, though overall capacity is still being added to meet strong demand. For the new TNT product, he confirmed it requires a new tray and that capacity is being added thoughtfully to support strong early demand from surgeons and new regional agencies, all within the company's asset-light CapEx model of $7-8 million annually.

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Chair & CEO Kevin Lobo stated that both hip and knee robotic procedure penetration continue to climb, driven by new software and the Insignia hip stem. He emphasized focusing on Stryker's own commercial offense rather than competitors. He confirmed the strength in navigation is directly related to the Q Guidance system, which is a core component of the Mako 4 platform and is also used with the CoPilot haptic burr, driving a strong system-based performance.

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CEO Kevin Lobo reported that all seven acquisitions from last year are performing at or ahead of plan, with the Artelon and Vertos deals off to a particularly fast start. VP Jason Beach added that the shift of procedures to ASCs continues to be a tailwind, with the percentage of Stryker's hips and knees performed in that setting increasing every quarter.

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CEO Kevin Lobo responded that it is still early days for the new Mako applications, which are in limited launch, but the brand is generating excitement. He noted that while the Foot & Ankle market improved in Q4, the standout growth in Trauma & Extremities was driven by the Shoulder and Core Trauma businesses.

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CEO Dominick Colangelo noted it's difficult to parse specific 'Arthro' biopsies but highlighted accelerating overall biopsy growth and a 40% increase in small femoral condyle defects. He detailed the sales force expansion plan, aiming for new reps to be supporting territories by Q4 2025. He also confirmed the trend of dormant Epicel accounts reactivating has continued.

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CEO Nick Colangelo stated that while plans are not finalized, the sales force expansion would likely involve a 'couple of dozen' territories to support growth into 2026. He confirmed that the 'low-hanging fruit' of current MACI users constitutes the vast majority of the 400 surgeons trained on Arthro so far. Regarding Epicel, he clarified that the lower graft-per-patient in Q1 was a quarterly fluctuation, not a systemic trend, and that underlying patient metrics remain unchanged.

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CEO Dominick Colangelo confirmed the MACI Arthro launch is a high priority for the sales force in 2025 and that a sales force sizing analysis will be refreshed this year, with any major changes likely implemented in 2026. Regarding OUS expansion, he clarified that while the new facility will be ready in 2026, commercial launches are more likely a 2027-2028 opportunity due to regulatory timelines.

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CEO Nick Colangelo stated that Vericel has historically reached about 50% penetration of its target surgeon base before expanding it and expects a similar dynamic with the new 7,000-surgeon base. Regarding Epicel, he noted that while there is opportunity, the number of actively treating centers (40-50 annually) has not markedly changed yet, though 70-80 centers typically provide biopsies.

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CEO Moshe Mizrahy clarified that the urology platform is launching with indications for blood circulation and pain relief while awaiting a key FDA indication for erectile dysfunction. CFO Yair Malca confirmed that the guidance incorporates a revised geographic mix, with the historical 65% U.S. share now closer to a 50/50 split between U.S. and OUS sales for the remainder of the year.

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CFO Yair Malca confirmed that InMode will proceed with all planned investments, including team expansions. He noted that the geographic revenue mix shifting away from the U.S. is expected to negatively impact profitability by approximately 4% to 5%. CEO Moshe Mizrahy added that he is still serving as the acting President of North America and travels to the U.S. monthly, with no new hire yet announced.

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CEO Moshe Mizrahy clarified that the approximate 20% revenue decline in 2024 was consistent across all territories, including North America. CFO Yair Malca and CEO Moshe Mizrahy explained that the newly announced 10% share repurchase is structured to be tax-efficient, similar to past programs. They noted that any additional, significant capital return is still being evaluated with advisors to maximize tax efficiency, referencing Israeli tax laws on buybacks.

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CEO Moshe Mizrahy corrected that U.S. consumable sales had decreased, not grown, attributing it to a 40% drop in high-cost minimally invasive procedures due to macroeconomic pressures. Regarding manufacturing, he explained that despite exploring options in Europe, they found no alternative facilities with the required regulatory approvals to handle their products, and therefore, operations will remain in Israel.

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Patrick Miles (Executive) stated that an inflection is expected, but the timing is the main challenge. He noted the reception to EOS Insight has been outstanding, but the company is in the early phase of its rollout. J. Koning (Executive) added context, explaining the $75 million guide is a step towards the long-range plan of $100 million in 2027, and he expects interest and placements to grow as EOS Insight gains adoption, driving more implant pull-through.

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Executive Patrick Miles confirmed the orders reflect great enthusiasm for EOS Insight and are primarily from new institutions, which provides access for implant pull-through. Executive J. Koning clarified that while the order book is strong, revenue recognition has a lead time. He noted the implied Q4 EOS revenue of $18 million is a step-up from the consistent ~$15 million in recent quarters, reflecting confidence backed by the strong order book.

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The CFO confirmed the $8 million annualized savings from the restructuring are on track, with the main impact in Q4, supplemented by ongoing cost optimization efforts like zero-based budgeting. Regarding 2025 EBITDA, he noted that while seasonality will affect quarterly results (with higher expenses in H1), they expect significant year-over-year improvement and are confident in achieving full-year positivity.

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Management attributed the 'choppiness' to a return to normal seasonality with summer vacations, which may linger into Q3, rather than a specific economic issue. Regarding Smart 28, they are excited about the pilot launch, highlighting its ease of use and FDA clearance for both CT and X-ray. A more fulsome launch is expected in the second half of 2024, with the long-term goal of expanding the technology across the entire foot and ankle portfolio.

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The company views preoperative planning technology as a positive for the market and aligned with their Smart28 goals. They expect adjusted EBITDA to scale with revenue throughout 2024, with continued operating leverage.

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