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    Carl Byrnes • Northland Capital Markets

    Carl Byrnes's questions to Alvotech SA (ALVO) leadership

    Carl Byrnes's questions to Alvotech SA (ALVO) leadership • Q2 2025

    Question

    Carl Byrnes of Northland Capital Markets questioned the company's confidence in achieving its year-end BLA approvals without any delays into 2026. He also asked for clarification on the implied second-half run-rate for product sales and milestone revenues required to meet the full-year guidance, given the expected softness in Q3.

    Answer

    CEO Róbert Wessman expressed high confidence in meeting the targeted PDUFA dates for BLA approvals, noting that slippage is not typical. He reiterated that the guidance is back-end loaded, with significant milestones and related product shipments expected in Q4 following anticipated approvals, similar to the pattern observed in the previous year.

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    Carl Byrnes's questions to Alvotech SA (ALVO) leadership • Q1 2025

    Question

    Carl Byrnes from Northland Capital Markets asked for quantification of the initial stocking impact for the Stelara biosimilar within the Q1 net product sales of $110 million.

    Answer

    Joel Morales, Chief Financial Officer, clarified that he would not characterize the sales as 'stocking.' He emphasized Alvotech's B2B model, where shipments are based on purchase orders from commercial partners. Morales attributed the sales figures to the timing of these orders rather than inventory stocking, highlighting the potential for quarter-over-quarter lumpiness inherent in their business model.

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    Carl Byrnes's questions to Alvotech SA (ALVO) leadership • Q3 2024

    Question

    Carl Byrnes from Northland Capital Markets asked about the company's gross profit margin expectations for the next 12-18 months, considering sales ramp-ups and efficiencies. He also requested a breakout of U.S. product sales for the third quarter and the first nine months of the year.

    Answer

    CFO Joel Morales noted that product gross margin expanded significantly from 17% in Q2 to 37% in Q3 and is expected to continue expanding, but he declined to provide specific 2025 guidance. Morales and Chief Strategy Officer Ming Li stated that the company does not currently provide a geographic sales breakout but highlighted that ex-U.S. revenue is expected to contribute up to one-third of total revenue in 2024, with more granular reporting planned as the business matures.

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    Carl Byrnes's questions to Brainsway Ltd (BWAY) leadership

    Carl Byrnes's questions to Brainsway Ltd (BWAY) leadership • Q2 2025

    Question

    Carl Byrnes from Northland Capital Markets asked for clarification on the composition of the revenue backlog, specifically its relation to enterprise customers, and requested the number of OCD system placements during the quarter.

    Answer

    CEO Hadar Levy confirmed that the backlog is primarily driven by multi-year lease agreements with enterprise accounts, which enhances revenue visibility. He also disclosed that the company shipped 30 Deep TMS systems for OCD treatment during the second quarter.

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    Carl Byrnes's questions to Indivior PLC (INDV) leadership

    Carl Byrnes's questions to Indivior PLC (INDV) leadership • Q2 2025

    Question

    Carl Byrnes of Northland Capital Markets asked about the long-term potential for SUBLOCADE's commercial channel penetration, seeking to understand what a realistic target would be, given that commercial patients represent 60% of covered lives but only 25% of current volume.

    Answer

    CEO Joe Ciaffoni clarified that while Indivior expects the contribution from the commercial business to become 'meaningfully higher' than the current 25%, he would not set an expectation that it would ever be on par with or near the level of the Medicaid business, which will remain the primary contributor.

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    Carl Byrnes's questions to MiMedx Group Inc (MDXG) leadership

    Carl Byrnes's questions to MiMedx Group Inc (MDXG) leadership • Q2 2025

    Question

    Carl Byrnes of Northland Capital Markets inquired about the potential for CMS to be flexible on the proposed $125.38 fixed reimbursement rate, the risk of stocking anomalies ahead of new LCDs taking effect, and the timeline for the Vaprox partnership to contribute materially to revenue.

    Answer

    CEO Joseph Capper stated he could not handicap CMS's flexibility on the price point but confirmed Mimetics would submit comments and recommendations. On inventory, he noted the company is experienced in managing stock levels and will monitor the situation closely, with CFO Doug Rice adding they are well-prepared due to their strong balance sheet. Regarding the Vaprox partnership, Capper clarified that a material revenue contribution is not expected in the near term and would likely not be seen until next year.

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    Carl Byrnes's questions to MiMedx Group Inc (MDXG) leadership • Q1 2025

    Question

    Carl Byrnes from Northland Capital Markets inquired about the discrepancy between the strong Q1 adjusted gross margin of 84% and the full-year guidance of 82-83%, asking if product mix was the driver. He also requested a progress update on EPIFIX sales in Japan.

    Answer

    CFO Doug Rice confirmed that the expected moderation in gross margin throughout the year is indeed due to product mix, as some product ASPs have decreased. CEO Joe Capper added that EPIFIX in Japan is performing as expected and growing on track, but its overall revenue contribution is not yet material enough to be disclosed separately.

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    Carl Byrnes's questions to MiMedx Group Inc (MDXG) leadership • Q4 2024

    Question

    Carl Byrnes of Northland Capital Markets asked for more detail on the drivers behind the significant year-over-year growth for EpiFix in Japan.

    Answer

    CEO Joe Capper explained that the high growth is off a very low base, as MiMedx was the first to introduce human tissue products to the Japanese market. The growth is driven by the successful targeting of key opinion leaders and top wound care doctors who are now seeing positive results and reordering the product. CFO Doug Rice clarified that while international sales were a key driver, the 'other' revenue category's growth was not solely attributable to Japan.

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    Carl Byrnes's questions to MiMedx Group Inc (MDXG) leadership • Q3 2024

    Question

    Carl Byrnes asked about the likelihood of CMS adopting a price-per-square-centimeter reimbursement model and how the HELIOGEN launch process differs from previous product introductions.

    Answer

    CEO Joseph Capper confirmed that MiMedx has advocated for a price-per-square-centimeter model but believes such a change is unlikely before the 2025 physician fee schedule at the earliest. He stated the HELIOGEN launch is similar to past surgical rollouts, while Executive Matthew Notarianni added the key difference is the need to navigate the hospital-by-hospital value analysis committee process, which is not a factor in physician office settings.

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    Carl Byrnes's questions to BioLife Solutions Inc (BLFS) leadership

    Carl Byrnes's questions to BioLife Solutions Inc (BLFS) leadership • Q1 2025

    Question

    Carl Byrnes asked for clarification on the expected incremental operating expense from the PanTHERA acquisition for the remainder of the year.

    Answer

    CFO Troy Wichterman confirmed that the acquisition is expected to add approximately $1 million in incremental R&D-related operating expenses for the remaining nine months of 2025.

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