Hello, everyone, and thank you for joining Japan Lifeline's second quarter and first half earnings call for the fiscal year ending March 31st, 2027. I'm Takeyoshi Egawa, Director and CFO. Before we dive into the numbers, I want to take a moment to express my sincere appreciation to our dedicated employees. Their relentless commitment on the medical front lines and agility in meeting clinical needs have driven our strong commercial execution, enabling us to achieve record-breaking first half net sales. Now, let's get right into the financial results. Please turn to slide four for our first half highlights. During the first half, we maintained exceptionally strong momentum across our business, driving net sales to a record high for an interim period of JPY 31.35 billion, up 7.1% from a year ago. Because we prioritized upfront growth investments like R&D, operating profit landed at JPY 5.46 billion, down 17.4%, and net income came in at JPY 4.43 billion, down 7.2%. Let's break down the key drivers into external and internal factors. On the external front, as a positive dynamic, procedure volumes for atrial fibrillation, or AF, grew by roughly 10%. As a headwind, we absorbed the impact of the reimbursement price cuts implemented in June of this year. Internally, on the commercial side, our core product lineup and new therapeutic areas both expanded robustly, driving our top-line growth. On the profit side, we saw higher raw material costs, as well as increased SG&A expenses, particularly for personnel and R&D. Additionally, one-off items weighed on profitability, specifically M&A expenses tied to the acquisition of U.S.-based Cross Vascular, along with the absence of the bad debt reversal we recorded in the same period last year. Our full-year earnings guidance and dividend forecast remain unchanged. As announced in Q1, we have decided to pay an interim commemorative dividend of JPY 25 per share, as planned. Please turn to slide five for our consolidated profit and loss statement. As mentioned, while net sales hit an all-time high, operating profit declined. Our proprietary sales mix rose by 210 basis points to 57.2%. Conversely, gross margin narrowed by 250 basis points to 57.5%. While our new proprietary RF transseptal wire performed exceptionally well, this margin compression was driven by higher manufacturing costs, including raw materials and labor, as well as lower average selling prices resulting from promotional activities for new products. SG&A expenses increased 14.8% over the previous year, driven by higher personnel and R&D investments on top of the one-off M&A costs and the absence of the prior year bad debt reversal. As a result, operating profit declined 17.4% to JPY 5.46 billion, with the operating margin down 520 basis points to 17.4%. Net income came in at JPY 4.43 billion, down 7.2%, showing a milder decline than operating profit, thanks to non-operating and extraordinary items, including valuation gains and gains on the sale of investment securities. Additionally, our international sales mix stood at 2.5%, and basic EPS was JPY 63.15. Slide six provides the bridge analysis for our JPY 1.15 billion decline in operating profit. Looking first at sales and cost factors, a powerful volume effect from robust domestic sales delivered a JPY 1.52 billion positive contribution. Both our existing therapeutic areas, adding JPY 1.07 billion, and new therapeutic areas, adding JPY 452 million, demonstrated well-balanced expansion. On the other hand, the net price effect created a JPY 1.05 billion drag. This was driven by a JPY 493 million negative impact from higher unit manufacturing costs, alongside a JPY 454 million hit to selling prices from new product promotions and reimbursement price cuts. Turning to SG&A, recurring operating expenses like personnel and outsourcing rose by JPY 586 million. On top of that, growth investments added JPY 637 million in expenses, led by active R&D programs and setting up the OEM line at our Malaysia factory. One-off factors totaled JPY 390 million, mainly for aforementioned bad debt-related and M&A-related fees. To sum up, while sales volume grew strongly, operating profit was impacted by price pressures and our conscious choice to prioritize upfront investments for long-term growth. Moving to slide seven, which tracks our progress against full-year guidance. We achieved 49.6% of our net sales target, 51.1% of operating profit, and 55.4% of net income, tracking ahead of plan, particularly on profitability. However, this upside was mainly due to the timing of expenses, such as delayed R&D spending. Because we expect these costs to be incurred during the second half, we have kept our full-year guidance unchanged across all lines. Skipping ahead to slide 10, let's look at net sales by therapeutic area. Total net sales grew by JPY 2.06 billion over the prior year. Existing cardiac areas contributed JPY 1.28 billion, and new therapeutic areas added JPY 820 million, showing balanced growth across the entire business. Top-line expansion was led by gains of about JPY 1.5 billion in EP ablation, around JPY 500 million in neurovascular, and roughly JPY 300 million in gastrointestinal. Starting from slide 11, I'll provide some color on our individual business lines. In cardiac rhythm management, or CRM, net sales declined 7% compared to last year. The competitive landscape intensified from Q1 into Q2, leading to increased pressure from rival offerings. Our core S-ICD line posted a 7.1% decrease, impacted by a competitor's newly launched product gaining ground in de novo implants. Pacemakers also remained under pressure, down 10.5%, as competitor leadless devices continued to capture share. While we expect these competitive dynamics to persist for some time, we anticipate an increase in S-ICD battery replacement cases. For pacemakers, we expect this year-over-year pressure to gradually ease and run its course through the second half. Please turn to slide 12 for EP ablation. This segment delivered robust double-digit growth, with sales up 10.3%. Our core intracardiac defibrillation catheters grew 6.4%, backed by solid expansion in AF procedure volumes. While unit volume jumped roughly 10%, revenue growth was slightly moderated due to promotional bundling discounts with our new XEROstar wire. Vascular closure maintained strong momentum, climbing 21.8%, as penetration across target accounts is now largely complete. We expect another leg of growth in the third quarter, thanks to the indication expansion for large-bore sheaths. On the contract side, our exclusive distribution agreement for vascular closure runs through March 2027, followed by a one-year automatic renewal. We are actively aiming to extend this partnership further and are currently in constructive, forward-looking discussions with Haemonetics. And excitingly, our new proprietary RF transseptal wire, XEROstar, is penetrating the market faster than expected, reaching a 50% market share by the end of September. With the number two player at around 40%, we successfully captured the top spot just six months after launch. Turning to slide 13 for cardiovascular. Sales grew 4.1% in a stable market environment. Our core Frozen Elephant Trunk, or FET, achieved a 4% increase, driven by a continuous product mix shift toward higher ASP integrated graft models. Abdominal stent grafts, or EVAR, also performed solidly, up 7%, supported by a rebound from last year's procedure volume decline. Slide 14 covers neurovascular. This area continued its rapid growth trajectory, surging 42.9% year-over-year. Embolic coils expanded by 42.5%, led by our new peripheral vascular embolization model and the continued success of our pre-procedural simulation initiatives. Aspiration catheters recorded a 29.6% jump, overcoming reimbursement price cuts through stronger customer engagement and market share gains amid intensifying competition. Stent retrievers doubled compared to last year, tracking right in line with our plan. From Q3 onward, we will shift our commercial focus from deepening penetration in existing accounts to opening new hospital accounts. Moving to slide 15 for gastrointestinal. Sales expanded significantly, jumping 41.6%. The primary growth engine was our biliary tube stents, which surged by 76.7%. In addition to steady adoption of our new model across newly targeted facilities, we captured temporary demand tailwinds resulting from competitor supply shortages. Endoscopic guidewires and GI stents also posted steady growth across the board. Please turn to slide 17. From here, I'll provide an update on our global expansion initiatives. This slide illustrates our overall global roadmap. In phase I, running through fiscal 2028 under our medium-term plan, we are expanding sales of proprietary products through local distributors, primarily across the Middle East and Asia, leveraging our Japanese approvals. For fiscal 2028, our target is an overseas sales ratio of 5%, or about JPY 2 billion- JPY 3 billion in revenue. Concurrently, we are optimizing our domestic products to meet global standards. In phase II, over the medium to long term, we aim to secure regulatory approvals and enter the massive U.S. and European markets. Longer term, our vision is to elevate our international sales ratio to 30%, generating tens of billions of JPY in overseas revenue, and establish ourselves as a true global med tech company. Slide 18 highlights our recent progress. As shown, we are advancing phase I expansion in the Middle East and Asia simultaneously with our groundwork for phase II entry into the U.S. and Europe. In the Middle East and Asia, we have actively pursued local regulatory clearances with country coverage expansion as our primary KPI. As a result, our distributor agreements reached 25 countries as of late September. We also established a representative office in Bangkok this past May, strengthening on-the-ground distributor support and market intelligence. Going forward, we will pivot from adding countries to deepening local penetration and driving market share. At the same time, for the U.S. market, while adapting our proprietary portfolio to overseas regulatory standards, we established our wholly owned subsidiary, JLL Med USA Inc., in California this August, followed by the acquisition of Cross Vascular in October. Looking ahead, we will focus on building our U.S. operating infrastructure and steadily broadening our commercial product lineup. Please turn to slide 19 for details on the acquisition of Cross Vascular. Through our U.S. subsidiary, we fully acquired Cross Vascular, a medical device company with an FDA-cleared RF transseptal system, for a total transaction value of approximately JPY 974 million, including an earn-out of up to $4 million. Using Cross Vascular's transseptal platform as our initial spearhead, we will kick off our full-fledged entry into the U.S., the world's largest medical device market. Slide 20 outlines the strong growth potential of the U.S. EP market. Driven by volume factors such as an aging population, the expansion of ambulatory surgical centers, or ASCs, and procedural efficiency gains facilitated by PFA, the number of U.S. atrial fibrillation procedures is projected to grow from 365,000 cases in 2024 to 1.43 million cases by 2034. That is a 15% CAGR, reaching seven to eight times the size of Japan. On top of this, unit price dynamics will serve as a powerful catalyst, supported by the rising penetration of premium devices like PFA catheters, steerable sheaths, and transseptal wires. Consequently, the total U.S. EP market is projected to expand from $6 billion in 2024 to $25 billion by 2034, also at a 15% CAGR. Within this space, we have identified diagnostic catheters and accessories as our primary target market. The accessories segment, in particular, is expected to grow at a rapid 20% CAGR, bringing our combined target market to $11.5 billion by 2034, over 10 x the size of Japan. Furthermore, hospital prices in the U.S. are substantially higher than in Japan. We see this as an exceptionally compelling growth opportunity that aligns perfectly with our proprietary catheter technologies and core manufacturing strengths. Please turn to slide 21 for our operational roadmap in the United States. We aim to capture this massive market by establishing a focused portfolio centered on AF accessories and diagnostic catheters. First, during the startup phase, running through roughly 2028, we will focus on establishing our local commercial infrastructure, deepening engagement with key opinion leaders, and initiating sales of our transseptal system at select medical centers. At this stage, we target proprietary sales of approximately JPY 500 million. Next, in the lineup expansion phase, we will systematically expand our proprietary product offering by adding steerable sheaths and broadening our lineup of standard EP diagnostic catheters. Diagnostic catheters represent a domain where our core technologies shine, and we intend to roll out a comprehensive lineup of catheter variations. Finally, in the scale-up phase, around 2032, we will launch our flagship intracardiac defibrillation catheters and expand distribution nationwide across U.S. healthcare institutions. This concludes our presentation for the first half of FY 2027. Thank you very much for your time today.
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