Financial Data and Key Metrics Changes - For Q1 2025, the company's commercial revenue was $18.5 million, representing a 67% increase compared to the same period in 2024 [24] - The gross profit margin for Q1 was 84.7%, down from 86.4% in the same period of 2024, primarily due to volume discounts and product mix [25] - The net loss for Q1 was $13.9 million, improving from a net loss of $18.7 million in the same period in 2024 [28] Business Line Data and Key Metrics Changes - The launch of ReCell Go Mini and Co Helix is expected to significantly contribute to revenue growth throughout 2025 [24][30] - The company has expanded its product portfolio to include ReCell Go, ReCell Go Mini, Co Helix, and Permuderm, targeting both burn and trauma centers [13][21] Market Data and Key Metrics Changes - The US addressable market for the company has expanded from approximately $500 million to over $3.5 billion annually, marking a seven-fold increase [5] - The trauma market is estimated to have approximately 270,000 cases annually in the US, which the new ReCell Go Mini product aims to address [8] Company Strategy and Development Direction - The company is focusing on acute wound care, stepping back from further commercial investment in the vitiligo indication due to uncertainty in reimbursement [20][52] - A significant shift in the commercial model has been implemented, moving from a service-oriented approach to a more focused selling-oriented approach [15][46] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, expecting to generate free cash flow in the second half of the year and achieve GAAP profitability in Q4 2025 [29][30] - The company is actively engaged in the public comment process for a proposed new technology add-on payment for ReCell, which could take effect on October 1 [20] Other Important Information - The company expects to save approximately $2.5 million per quarter in operating expenses due to recent transformations and operational efficiencies [27][29] - The annual meeting of stockholders is scheduled for June 4, encouraging participation [30] Q&A Session Summary Question: Response and performance of Co Helix during limited commercial launch - Management noted that early feedback from the limited market release of Co Helix was positive, with a notable case demonstrating faster graft readiness compared to other dermal matrices [33][34] Question: Revenue contributions from ReCell Go Mini - Management indicated that ReCell Go Mini is expected to be a material contributor to revenue, with plans to break out non-resale sales by Q3 [41][42] Question: Sales force adequacy to meet revenue targets - Management expressed confidence in the current sales force structure, which has been reconfigured to enhance selling capabilities across the product portfolio [43][46] Question: Revenue cadence expectations for the rest of the year - Management expects steady sequential growth throughout the year, with some weighting towards the back end as new product approvals are anticipated [48][49] Question: Status of the vitiligo initiative and reimbursement discussions - Management clarified that spending on the vitiligo initiative has been paused due to uncertainty in achieving reimbursement, focusing resources on acute wound care instead [52][53]

Financial Data and Key Metrics Changes - Revenue for Q1 was $598 million, reflecting a slight decline of 0.8% year-over-year on a constant currency basis, primarily due to softer enabling technology sales and supply chain disruptions [6][19] - Non-GAAP EPS increased by 9% to $0.68 compared to the prior year, despite a higher diluted share count and a one-time EPS gain not repeated in 2025 [6][20] - Free cash flow reached a record $141 million, up 493% from the previous year, with the company returning to debt-free status after paying off nearly $900 million from the NuVasive merger [7][30] - GAAP net income was $75.5 million, translating to fully diluted GAAP earnings of $0.54 per share, an increase from the prior year quarter [20] Business Line Data and Key Metrics Changes - U.S. Spine revenue grew by 2% in Q1, driven by strong retention rates and product cross-selling, despite temporary supply chain disruptions [8][21] - Enabling Technologies revenue decreased by 31% to $22 million, impacted by a tough prior year comparison and elongated selling cycles [12][19] - The combined trauma and NSO business declined by 8%, although core trauma delivered 34% growth [14][21] - International spine implant business grew by 1% on a constant currency basis, affected by timing of distributor orders and supply chain issues [13][21] Market Data and Key Metrics Changes - U.S. revenue was $483.9 million, essentially flat compared to the prior year, while international revenue decreased by 7.7% [26] - The overall market growth was described as slow, with surgeons noting longer approval times from insurance companies [95] Company Strategy and Development Direction - The company aims to focus on sustained profitable growth, leveraging financial strength to accelerate top-line results while maintaining strong EPS and free cash flow [7][8] - The acquisition of Nevro for $250 million is expected to expand the company's reach into the musculoskeletal market, adding a $3 billion market space [14][15] - The company is committed to integrating Nevro into its existing infrastructure to improve profitability and cash flow [15][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in recovering from Q1 challenges, citing positive trends in U.S. Spine and ongoing remediation of supply chain issues [45][46] - The company reaffirmed its 2025 net sales guidance of $2.8 billion to $2.9 billion but lowered non-GAAP EPS guidance to $3.0 to $3.3 due to additional costs from the Nevro acquisition [36][37] - Management remains optimistic about the second quarter, expecting to see improved results as supply chain disruptions ease [37][38] Other Important Information - The company has completed its share repurchase program, buying back over 20% of the dilution created from the NuVasive merger [30][31] - The company is actively addressing tariff impacts through cost action offsets, including price increases and vendor negotiations [35][112] Q&A Session Summary Question: Confidence in Q2 performance after a challenging Q1 - Management indicated that supply chain disruptions and timing of distributor orders were temporary issues, with confidence in a recovery in Q2 [45][46] Question: Synergies from the Nevro acquisition - Focus will be on reducing operational expenses and improving gross margins, with a commitment to driving profitable sales growth [48][49] Question: Impact of competitors on sales cycles - Management noted that while selling cycles have elongated, they have not seen competitors causing delays in closing deals [53][54] Question: Expectations for cash use post-Nevro acquisition - The company plans to prioritize internal investments and may consider tuck-in acquisitions, with share repurchases remaining part of the capital structure [62][64] Question: Integration status of Nevro and NuVasive - Management reassured that Nevro's integration is separate from ongoing NuVasive activities, with confidence in managing both integrations effectively [86][88] Question: Update on FDA warning letter - Management reported progress with the FDA and is awaiting inspection, expressing readiness to resolve the matter [92] Question: Impact of tariffs on margins - Management stated that tariffs are not expected to materially impact margins due to the company's vertical integration and U.S.-based production [111][112]

Financial Data and Key Metrics Changes - First quarter revenue for 2025 was $41.5 million, a decrease of 7.6% compared to the first quarter of 2024, primarily due to weakness in instrument sales in the U.S. and EMEA regions [8][25] - Service revenue increased by 24% year-over-year, reaching $13.3 million, driven by the expansion of the instrument installed base [8][26] - GAAP gross profit was $20.2 million, a decrease of 12% from $23 million in the prior year, with a GAAP gross margin of 49% compared to 51% a year ago [27][28] Business Line Data and Key Metrics Changes - Product revenue, which includes instruments and reagents, decreased by 18% compared to Q1 of 2024, mainly due to a weaker instrument market in the U.S. and EMEA [25][26] - Aurora cell sorter revenue grew by 15% year-over-year, while Northern Lights revenue increased by 6% year-over-year in the first quarter [18][19] - Trailing twelve-month recurring revenue grew 17% year-over-year, representing 31% of total revenue in the first quarter, up from 26% a year ago [21][56] Market Data and Key Metrics Changes - Total revenue in the Asia Pacific and the rest of the world was $11.4 million, up 35.6% year-over-year, driven by strong demand in China [11][26] - U.S. and EMEA revenue declined by 13% and 24% respectively, due to lower instrument sales influenced by academic funding uncertainties and government budget pressures [26][27] - The company continues to experience growth in the clinical market, particularly in the EU and APAC regions [22][23] Company Strategy and Development Direction - The company is focused on expanding its market leadership in the cell analysis market and has established manufacturing operations in the U.S., China, and Singapore to optimize product flows [13][14] - Strategic investments are being made to advance the product pipeline, including the launch of the SiPET MUSE microsystem to drive adoption in emerging markets [15][18] - The company aims to leverage its established and expanding installed base to drive long-term growth in recurring services and reagent sales [21][24] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenging macroeconomic environment and uncertainties affecting capital equipment spending in the U.S. and EMEA [12][31] - The full-year 2025 revenue outlook has been revised to a range of $196 million to $210 million, reflecting a growth of -2% to +5% over the full year 2024 [31][32] - Management remains confident in the company's positioning and believes it will perform well relative to the overall flow cytometry market [31][32] Other Important Information - The company has a strong balance sheet, allowing for continued investments in growth and share repurchases [30][34] - The company plans to host six user group meetings in 2025 to engage with the scientific community and showcase its products [5][6] Q&A Session Summary Question: Impact of tariffs on gross margin - Management indicated that tariffs are manageable and expect a limited gross margin impact of 1% to 3%, with improvements anticipated as revenues increase [36][41] Question: Academic government end market outlook - Management acknowledged uncertainties in university funding and indicated that more than 50% of revenue comes from outside the U.S., which mitigates the impact of U.S. funding issues [44][46] Question: Growth drivers for AURORA sales orders - Growth in AURORA sales is attributed to the alignment of the SiTeX sorter with existing analyzers and strong performance across all territories [50][51] Question: R&D spending focus - The company continues to allocate 15% to 20% of revenue to R&D, with a focus on imaging and spectral innovations [59][60] Question: Share repurchase versus M&A - Management plans to balance share repurchases with capital available for M&A, indicating a healthy balance sheet [63]

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