Matthew Taylor

Matthew Taylor inquired about the composition of the 2% order growth in Q4, the outlook for orders and book-to-bill in 2026, and the headwinds and tailwinds impacting future order performance. He also asked for an update on Flyrcado's supply, progress with major partners, and its reception in facilities adopting it into existing rubidium SPECT workflows.

Answer

Jay Saccaro (VP and CFO) and Peter Arduini (President and CEO) highlighted a robust book-to-bill (1.06x in Q4, 1.07x TTM), a record $21.8 billion backlog, and mid-single-digit trailing twelve-month order growth. They noted a challenging Q1 2026 comparison but anticipated acceleration in H2 2026 driven by new product launches post-regulatory approvals. For Flyrcado, Peter Arduini reported positive clinician feedback, consistent 95% on-time dose delivery, and a weekly dose rate of 220 as of January 23rd, with expectations for continued increases and expansion with more CMOs and partners.

Matthew Taylor asked for more color on the 2% order growth, its composition, and the outlook for orders and book-to-bill in 2026, including anticipated headwinds and tailwinds. He also inquired about the current state of Flyrcado supply, progress with major partners, and facility reception when adopting Flyrcado into existing rubidium SPECT workflows.

Answer

Jay Saccaro (VP and CFO) and Peter Arduini (President and CEO) highlighted a robust book-to-bill (1.06x in Q4, 1.07x TTM) and a record $21.8 billion backlog. They noted a challenging Q1 2026 comparison but expect acceleration in H2 2026 from new product launches, with significant sales impact in 2027. For Flyrcado, Peter Arduini confirmed strong clinical feedback and consistent dose delivery (95% on-time), with 220 doses delivered in the week of January 23rd, expecting continued increases and positive partner relationships.

Matthew Taylor asked for color on segment growth expectations for 2025, with a particular focus on the Pharmaceutical Diagnostics (PDx) segment and the Flyrcado launch. He also requested details on the gating factors for Flyrcado's rollout and reimbursement.

Answer

CFO Jay Saccaro stated that PDx growth in 2025 is expected to be broadly in line with 2024, while other segments are anticipated to grow near the corporate average. CEO Peter Arduini elaborated on the Flyrcado launch, confirming the $30 million revenue assumption for 2025 and a methodical rollout through regional contract manufacturing organizations. He noted that reimbursement coding is on track for April and the company is initially targeting centers with existing cardiovascular PET capabilities.

Matthew Taylor followed up on the CHAMPION trial, asking about the range of potential outcomes, specifically if there's a chance of showing superiority on any primary or secondary endpoints. He also inquired if a positive CHAMPION result could boost concomitant procedures within the OPTION indication.

Answer

CMO Kenneth Stein clarified that the bleeding endpoint in CHAMPION is powered for superiority. He stated that showing superiority on stroke is not necessary, as the goal is non-inferiority to drugs combined with superiority on bleeding, similar to the OPTION trial's impact. He believes a positive CHAMPION result would strengthen the current indication, including OPTION, and provide increased impetus for referrers. He noted that building out the new indication (requiring guideline updates and CMS NCD revision) would take time, sustaining Watchman's growth over the long-range plan.

Matt, on behalf of Matthew Taylor, asked a specific question regarding contracting dynamics in the pharmacy channel, inquiring if increased competition is leading to any changes in pricing or contract tenor.

Answer

Ashley McEvoy (President and CEO) stated there were no changes in contracting dynamics. She highlighted Insulet's 8-9 years of leadership in the pay-as-you-go pharmacy model, availability in over 47,000 U.S. pharmacies, coverage for over 300 million lives (90% commercial plans, majority at preferred status for ~$1/day), and efforts to streamline prior authorization for the minority of patients who require it.

Matthew Taylor of Jefferies asked for an update on potential competition and pricing pressure within the pharmacy channel and for management to elaborate on Insulet's defensive moats against these risks.

Answer

President and CEO Jim Hollingshead detailed Insulet's significant advantages in the pharmacy channel. He cited years of experience, established PBM relationships, 95% covered lives, and unique Medicare Part D reimbursement. He argued that Insulet's patch pump form factor and pay-as-you-go model are inherently suited to the pharmacy channel, unlike durable pumps, creating a distinct and difficult-to-replicate moat that protects their position.

Matthew Taylor asked for Insulet's perspective on a competitor's market research suggesting that the intensive Type 2 market could achieve 25% penetration within 3 to 5 years.

Answer

President and CEO Jim Hollingshead expressed strong bullishness on the Type 2 market, stating Insulet has a 'clear right to win' due to Omnipod 5's simplicity and pharmacy access. While not directly endorsing the 25% figure, he reiterated his belief that penetration could 'double or triple' in the next few years, with Insulet leading that market development.

Matthew Taylor requested details on the Diabetes product pipeline, including points of differentiation and upcoming launch timelines.

Answer

Executive Que Dallara outlined a robust pipeline, including the U.S. launch of the Simplera Sync CGM in the fall, a recently submitted ACE pump, and a next-generation durable pump (MiniMed Flex) submission planned by year-end. She highlighted differentiation through improved form factors, enhanced algorithms to reduce patient burden, and the value of a single-company ecosystem for customer support.

Matthew Taylor requested more information on the Diabetes product pipeline, specifically asking about product differentiation and upcoming timelines.

Answer

EVP Que Dallara detailed a robust pipeline, including the U.S. launch of the Simplera Sync sensor in the fall, a pending FDA submission for a pump compatible with an Abbott sensor, and a next-generation durable pump (MiniMed Flex) submission planned by year-end. She highlighted improved form factors, enhanced algorithms, and the customer benefit of a single-company ecosystem.

Matthew Taylor from Jefferies requested clarification on the top-line guidance, noting that it remained unchanged despite the Nevro deal closing a quarter earlier, which implies a change in underlying assumptions. He also asked for more detail on the cause of the enabling tech deal delays.

Answer

COO and CFO Keith Pfeil explained they are being 'conservative on the revenue view' for Nevro to focus on right-sizing the business for profitable growth. CEO Dan Scavilla attributed the enabling tech delays to a longer-than-normal contract redlining process, likely driven by macro challenges at hospitals, rather than any specific customer or deal type.

Matthew Taylor asked about long-term U.S. market penetration, referencing past commentary on achieving 40-70% share in other markets and questioning where the U.S. might land within that range given its early success. He also asked if guidance assumptions for Mia or Preserve had changed.

Answer

CEO Peter Caldini responded that while it is still early in the launch, the company expects to achieve a dominant market share in the United States. He also confirmed that the $8-$10 million revenue guidance for Mia is tracking well and that Preserve's strong early performance was not a significant factor in the initial guidance.

Matthew Taylor asked which incumbent competitor Establishment Labs finds it easier to take market share from in the U.S. He also asked for current thoughts on Mia's potential for market expansion, particularly in Latin America.

Answer

CEO Juan Jose Quiros responded that they are taking share from all competitors who value innovation rather than targeting a specific one, and are not competing in the low-price segment. He reaffirmed confidence in Mia's long-term market expansion potential, highlighting the powerful combination of Mia for new patients and Preserve for the core augmentation market.

Matthew Taylor from Jefferies asked for more details on China's performance against 2024 targets, its potential growth contribution in 2025, and the expected impact of the new $50 million strategic financing for the region.

Answer

CEO Juan Jose Quiros stated the new financing will advance Motiva's growth and accelerate the regulatory pipeline for Ergonomix2 and Mia in China. Executive Rajbir Denhoy confirmed the company is on track to meet its distributor's $10 million commitment for the year, but noted it was too early to provide specific contribution guidance for 2025.

Matthew Taylor followed up on the 2026 outlook, asking for confirmation of the double-digit growth potential and any additional detail on the magnitude of that growth.

Answer

CEO Brian Markison reiterated the company's confidence in achieving double-digit revenue growth in 2026. While he stated it was too early to provide a specific quantum, he listed the key drivers: the potential launches of OCTEVY, PNT2003, and MK-6240, the full-year impact of NEURACEQ, and the continued anchored growth of PYLARIFY and DEFINITY.

Matthew Taylor asked about the likelihood and timing of CMS moving to an ASP-based reimbursement methodology and how such a change would affect PYLARIFY's growth potential in 2026 or 2027.

Answer

CEO Brian Markison characterized a potential move to ASP-based reimbursement as upside to the business. President Paul Blanchfield clarified that the earliest such a change could occur is January 1, 2026, and that the company's current guidance is based on the existing MUC payment policy. He noted that a shift to ASP would further support the payment dynamics for PSMA PET diagnostics.

Matthew Taylor sought confirmation on the specific unit price for PYLARIFY listed in the CMS final addendum and asked about the company's ability to adjust pricing within its long-term strategic contracts if reimbursement rates improve.

Answer

Executive Mark Kinarney stated that the company would not comment on the specifics of its customer partnerships as it is competitive intelligence. President Paul Blanchfield confirmed the reading of the addendum B price but noted CMS reserves the right to make adjustments, while reiterating confidence that PYLARIFY will be paid appropriately in 2025.

Matthew Taylor of Jefferies asked about the potential for further underlying operating margin expansion, the feasibility of mitigating tariff impacts within the current year, and the expected quarterly cadence of the tariff impact.

Answer

CFO Micah Young noted that while the business model has high leverage, the company is balancing margin expansion with strategic investments in sales, marketing, and R&D. He explained that significant tariff mitigation is difficult to achieve in 2025 due to timing but actions are being taken to position well for 2026. Young detailed the tariff impact would be $2M in Q2 and step up each quarter, with a more pronounced increase in Q4 at the high end of the guidance range.

Matthew Taylor questioned the margin progression beyond 2025, asking if the prior cadence of 100 basis points of annual improvement is still a reasonable expectation. He also asked about the future drivers of revenue per driver, specifically the balance between installed base growth and utilization.

Answer

CFO Micah Young stated that post-2025, the company expects at least 100 basis points of annual margin improvement, potentially more. Interim CEO Michelle Brennan added that this is balanced with fully resourcing high-growth opportunities. On revenue per driver, Young emphasized that growth will come more from increasing revenue per patient by upselling to premium technologies and monetizing connectivity platforms, rather than just installed base growth. COO Bilal Muhsin confirmed this focus on expanding platform use within the existing base.

Matthew Taylor requested a follow-up on tariffs, asking for an estimate of the gross headwind before mitigations and more detail on the primary sources of tariff exposure to better understand potential future changes.

Answer

CFO and EVP Suketu Upadhyay clarified that mitigation efforts have centered on optimizing country of origin, transfer pricing, and making strategic sourcing changes. He identified China as the largest area of tariff exposure, both for products shipped into and out of the country. He noted the company took proactive steps, such as building inventory in China ahead of tariffs and evaluating alternative sourcing routes.

Matthew Taylor from Jefferies followed up on the Paragon 28 deal, asking about the potential to exceed growth expectations implied by the CVR earnout and the company's capacity for additional M&A.

Answer

President and CEO Ivan Tornos confirmed that while the deal model includes appropriate synergies, there is further upside potential from ASC cross-selling, leveraging Paragon's channel for ZBH's trauma products, and international expansion. Regarding future deals, he stated that while the financial "firepower" exists, the immediate priority is to successfully integrate Paragon 28 before considering subsequent acquisitions.

Matthew Taylor from Jefferies followed up on the guidance, asking for more specific expectations for Q2 and the phasing for the rest of the year. He also requested details on the source and calculation of the new tariff impact.

Answer

CEO Moshe Mizrahy detailed the guidance calculation, which assumes a seasonal pattern with Q2 being stronger ($102M target) and Q3 being slower. He stated if Q2 revenue falls short, around $90-95M, they will lower the full-year guidance. Regarding tariffs, he explained the calculation is based on the transfer price and U.S. business percentage. A 10% tariff translates to a 2-3% impact on gross margin and the bottom line, but he stressed that there is significant confusion and uncertainty around the rules, even among customs authorities and auditors.

Matthew Taylor from Jefferies asked for clarification on the U.S. growth improvement, questioning if supply issues impacted revenue and seeking details on the narrowing gap between revenue growth and volume growth.

Answer

CFO Jereme Sylvain explained that channel supply levels were normalized by quarter-end, so the reported revenue reflects a true demand pattern. He highlighted a record new patient quarter and suggested volume growth was consistent with the ~25% year-end patient growth rate, confirming the price-to-volume gap is closing as previously guided.

Matthew Taylor inquired about the expected contribution from newly covered non-intensive Type 2 lives in 2025 and the timeline for broader uptake in this population.

Answer

CFO Jereme Sylvain confirmed that the new coverage is factored into the 2025 guidance. He stated the immediate work involves educating the market and working with PBMs and CMS to expand access further. He also noted that the ongoing randomized controlled trial (RCT) for this population should have early readouts by the end of the year, which will be used to strengthen the case for broader coverage.

Matthew Taylor asked for a benchmark of Dexcom's progress against its Q2 commentary, specifically regarding new patient start expectations for Q4 and whether the low end of the 2025 long-range plan is still achievable.

Answer

CFO Jereme Sylvain confirmed they are on the recovery timeline outlined last quarter, evidenced by record new patients in Q3. He stated that based on current business trends, including DME channel stability and international acceleration, Dexcom is 'on track to hit our $4.6 billion' revenue target and corresponding margins for 2025.

Matthew Taylor asked a conceptual question about what would happen if the $200 million tariff impact were to disappear, specifically how much would be reinvested versus flowing to the bottom line.

Answer

CFO Preston Wells and CEO Kevin Lobo confirmed that while some of the savings would be reinvested into the business, a removal of tariffs would certainly result in a raise to the bottom-line earnings guidance. Lobo stated unequivocally that earnings would have been raised if not for the tariffs.

Matthew Taylor asked about the sustainability of positive pricing trends into 2025 and what areas of the business could be a source of upside surprise next year.

Answer

CFO Glenn Boehnlein and VP of Finance and IR Jason Beach both deferred providing specific guidance for 2025. They stated that a full outlook on pricing trends and potential areas of growth outperformance would be shared during the January earnings call.

Matthew Taylor asked for details on the specific mitigation actions BD is taking to counteract tariff impacts, inquiring about levers like pricing, global footprint adjustments, and changes in sourcing for both the short and long term.

Answer

Chairman, CEO and President Thomas Polen outlined a multi-pronged mitigation strategy. Short-term actions include proactively positioning inventory to create a buffer. Longer-term levers involve shifting supply flows, such as sourcing Vacutainers for China from the UK instead of the U.S., and accelerating the ramp-up of its new local Flush facility in China. He also highlighted optimizing raw material sourcing and leveraging the BD Excellence program for margin protection. Polen noted that pricing is a potential third lever if tariffs persist.

Matthew Taylor asked for more color on operational performance, specifically the ongoing headwinds from China and research funding that tempered the guidance raise despite a strong quarter and FX impacts.

Answer

EVP and CFO Chris DelOrefice emphasized the high quality of Q1 results, with strong margin expansion giving confidence to raise operational EPS guidance despite FX headwinds. Life Sciences President Mike Feld addressed the China situation, noting the impact of a U.S. export ban on the high-end FACSDISCOVER platform, which was unplanned. He added that the company is engaging with policymakers and continues to monitor the cautious research spending environment in the U.S. and China.

Matthew Taylor asked for an update on the recently closed Advanced Patient Monitoring (APM) acquisition, inquiring about its long-term growth potential, margin contribution, and integration with BD's broader connected care strategy.

Answer

Chairman, CEO, and President Tom Polen stated that the APM integration is going extremely well and that the business is expected to be a durable 6-7% grower. He reiterated the key strategic rationale of combining APM's hemodynamic monitoring with Alaris infusion data to create closed-loop systems that improve patient outcomes, noting that a project to advance this integration is already funded for fiscal 2025.

Matthew Taylor requested more detail on the early experience with the pharmacy channel and the anticipated timeline for it to become a material part of the business.

Answer

CFO Leigh Vosseller highlighted that U.S. lives covered under pharmacy benefits increased from 20% to 30%. She emphasized that this channel significantly lowers patient out-of-pocket costs, addressing a key adoption barrier. While contracts are profitable, she reiterated it will remain a modest contributor in 2025.

An analyst on behalf of Matthew Taylor from Jefferies asked about the progress of the FreeStyle Libre integration and its potential to drive new pump starts.

Answer

John Sheridan, President and CEO, clarified that Libre 2 is currently integrated and they are working to bring Libre 3 to market soon for both new and existing users. He highlighted the large market opportunity, noting 300,000-400,000 people with Type 1 diabetes in the U.S. use Libre but not pumps, representing a key growth area for collaboration with Abbott.

Matthew Taylor requested more details on the comment about a "high rate" of conversions from patch pumps.

Answer

President and CEO John Sheridan explained that this metric, historically low for years, saw a "meaningful step up" in Q2 which continued into Q3. He attributed this trend to former patch users being attracted to the advanced Control-IQ algorithm in a device that is similarly sized and offers greater wearability.

Matt Taylor asked if the SAPIEN M3 launch was factored into original guidance and how its launch trajectory might compare to EVOQUE's launch in both Europe and the U.S.

Answer

Daveen Chopra, Global Leader of TMTT, confirmed the M3 launch was included in the original guidance. She explained the European launch will be a gradual, controlled rollout focused on training and securing reimbursement. She anticipates the U.S. launch will be slower than EVOQUE's, as M3's indication is for patients unsuitable for TEER or surgery, a more specific population than EVOQUE's broader initial indication.

Matthew Taylor requested a framework for understanding the sources of TMTT growth in 2025, asking for color on the relative contributions from U.S. vs. O.U.S. markets and from mitral vs. tricuspid products, as well as any market share expectations.

Answer

CEO Bernard Zovighian emphasized that the company's focus is on creating and defining a new market, not on taking share, pointing to the long-term goal of a $2 billion TMTT business by 2030. Daveen Chopra, Global Leader of TMTT, added that both geographies (U.S. and Europe) and both key products (PASCAL and EVOQUE) are expected to be large, meaningful growth drivers in 2025.

Matthew Taylor asked how quickly a positive sales lift could be expected for TAVR and TMTT if the upcoming EARLY TAVR and tricuspid trial results at TCT are positive.

Answer

CEO Bernard Zovighian stated that he could not comment on the potential impact of the blinded, embargoed trial data before its presentation next week, and directed the question to the company's upcoming TCT and investor conference events for a detailed discussion.

Matthew Taylor from Jefferies followed up on the tariff issue, asking about any discussions with the government regarding broader medtech exemptions and the potential for success.

Answer

CEO Michael Farrell, speaking as a board member of AdvaMed, stated that while the industry group's goal is a broad exemption for all medtech, he would defer to AdvaMed's CEO on specific negotiations. He stressed that ResMed's own position is secure and the company is prepared to thrive regardless, thanks to its strong balance sheet and operational resilience.

Matthew Taylor from Jefferies sought clarification on the U.S. prescriber count, the expected geographic mix of revenue growth for 2025, and the composition of the current prescriber base.

Answer

Executive Frederick Sullivan clarified that the 2,400 prescriber count was an annual figure, while a smaller number represented prescribers since the recent launch. Executive Tim Goodnow stated that most growth will come from the U.S., with a significant increase expected from Europe in the second half of the year. Brian Hansen of Ascensia described the prescriber base as a distribution, including many new primary care physicians from DTC advertising, mid-tier endocrinologists, and a few high-volume clinics.

Matthew Taylor asked about the level of conservatism in the 2025 guidance, specifically concerning potential future ship holds and ongoing Integra Skin supply issues, to understand how de-risked the forecast is.

Answer

CFO Lea Knight detailed the guidance structure, which includes provisions for potential new shipping holds ranging from $60 million (high end) to $120 million (low end). CEO Mojdeh Poul added that for Integra Skin, planned maintenance and low safety stock will constrain Q1 supply, with improvement expected as the year progresses.

Matthew Taylor sought clarification on the company's debt covenants, asking for details on how much room they have, and inquired about any potential scenarios that would necessitate a capital raise.

Answer

CFO Lea Knight clarified that the current leverage ratio is 4.0x against a covenant threshold of 4.5x, expressing confidence in staying below the limit. She stated that based on the current outlook, which includes potential disruptions, the company does not foresee a need to raise capital.

Matthew Taylor of Jefferies inquired about the expected phasing of revenue and EPS throughout 2025, asking if any volatility or special factors should be considered. He also asked for a timeline on when the company would provide more specific details on its plans for the sleep apnea (OSA) asset, including development, potential partnerships, or monetization.

Answer

CFO Alex Shvartsburg responded that there is nothing unusual about the 2025 phasing, expecting a typical pattern with Q1 as the lowest revenue quarter and a ramp-up to the highest in Q4. CEO Vladimir Makatsaria outlined the key upcoming milestones for OSA, stating that the 12-month OSPREY study results will be announced in Q2, the FDA submission will occur before the end of Q2, and a full commercialization plan and long-term financial outlook will be presented at an Investor Day in Q4.

Matthew Taylor from Jefferies asked about the potential for U.S. revenue in 2025, sought clarity on gross margin expectations for Q4 and 2025, and requested details on the recent restructuring, including the allocation of expense reductions and the strategy for driving growth without significant DTC spending.

Answer

CEO Shantanu Gaur confirmed expectations for U.S. revenue from the VCS product in 2025. CFO Chris Geberth projected Q4 gross margins in the low-to-mid 60s, with an expected return to the mid-70s by the end of 2025 due to restructuring. Geberth explained the cost reductions are across all departments to target profitability by late 2025 and noted that while DTC spend is down, sales headcount has increased to support a B2B2C strategy, with growth expected to be weighted to the second half of 2025.

Sought clarification on the expected timeline for trial recovery, asking if trends will remain weak until the second half of 2025 when the renewed DTC spending is expected to show results. Also asked for the quantum of the DTC spending change.

Answer

The company confirmed that their Q4 guidance assumes trial trends do not improve. They explained the lag time for DTC impact is due to the patient journey, which takes 4-6 months from initial contact to a potential trial. They did not quantify the DTC spend but stated the reinvestment would not negate the overall $30 million in annualized cost savings.

Matthew Taylor asked for more color on the balloon pump forecast, specifically regarding the visibility from order flow. He also inquired about the magnitude and expected duration of the impact from recent hurricanes and IV saline shortages.

Answer

Liam Kelly, Chairman, President and CEO, confirmed that Q4 orders for balloon pumps are in excess of $10 million and that quotation rates have remained strong. Regarding the headwinds, he explained that the hurricane impact was localized to the Southeast, while the saline shortage is viewed as a temporary issue that is already beginning to normalize as suppliers increase imports. The shortage particularly affects urology procedures like UroLift.

Matthew Taylor of Tudor, Pickering, Holt & Co. asked if European customers view LNG as a long-term solution or a short-term bridge away from Russian gas. He also questioned whether Cheniere would consider acquiring or building regasification assets in Europe.

Answer

EVP and CCO Anatol Feygin explained that while Europe is focused on infrastructure, long-term global demand growth remains driven by Asia. He and President and CEO Jack Fusco clarified that with over 60 million tonnes of new European import capacity being developed by others, Cheniere's direct involvement in building regasification assets is not required and has not hindered their growth.