William Grant
Analyst · Laidlaw & Company
Good morning, and thanks, everyone, for joining us on the call today. Before we get into the details of the quarter and the year, I want to start with what we believe is fundamental to the Lifeward investment thesis today. We're executing against a strategy to build a leading, diversified, biomedical innovation company with multiple technology platforms and strong clinical foundations. Importantly, we're establishing a clear line of sight to scale through continued progress in reimbursement, commercial execution and product innovation. Our strategic transaction with Oramed gives us meaningful access to capital to support our growth initiatives, and we remain focused on driving the business toward cash flow positive operations while investing in innovations that will define the future of the company. An important milestone for Lifeward is the pending close of our strategic agreement with Oramed following the receipt of shareholder approval last week. This partnership significantly strengthens our financial foundation and expands our strategic scope. I want to thank our shareholders for approving the transaction. Your support reflects confidence in the strategy we've laid out and the opportunity ahead of us. I also want to acknowledge our outstanding team at Oramed. They've been great partners, and I look forward to building a long-term collaboration that creates meaningful value for patients, partners and shareholders. Personally, this opportunity is particularly exciting for me given my background in diabetes at Medtronic and metabolic health at Bristol-Myers Squibb. One of the more compelling assets in this partnership is ORMP-0801 an advanced clinical-stage oral insulin candidate that has the potential to fundamentally change how insulin therapy is delivered. Because oral insulin is delivered through the gut, it goes to the liver first mimicking the path of natural insulin for the pancreas. For the patient, this can mean better regulation of glucose production by the liver and less circulating through the body, which will reduce weight gain and the risk of hypoglycemia. Multiple studies have shown no increased risk of hypoglycemia compared with placebo. This is an important distinction in the insulin field and if successfully developed, could meaningfully improve both patient safety and treatment adherence. We're excited about the potential of this program and believe it represents meaningful addition to Lifeward's long-term innovation platform. The current plan is to move forward with the new U.S. study. The unique funding structure for the clinical program also allows Lifeward to maintain pinpoint operational focus on profitability and cash generation of our portfolio while simultaneously gaining exposure to the potential substantial upside of a large-scale biotech opportunity. Another major recent step forward for the company is the acquisition of intellectual property and technology from Skelable. This transaction was structured in a very capital-efficient way, and we believe it will prove to be highly accretive as the technology advances to market. The technology we acquired supports development of a powered upper extremity orthotic system with AI capabilities designed to assist functional movement and restore function in individuals with weakened or paralyzed arms and hands, particularly following stroke. The device is intended to enable patients to perform activities of daily living that would otherwise be very difficult or impossible while supporting therapeutic goals such as muscle reeducation and improved range of motion. In the U.S. alone, this upper body neuro rehab system can help an estimated 245 -- 245,000 newly diagnosed stroke survivors annually and an addition of 4.6 million stroke survivors who remain disabled. With plans to develop and launch a product, we are eager to get to this patient population. What makes this acquisition particularly valuable, not only the technology itself, but it's the team that comes with it. As you know, you don't have the opportunity for outside in inflection points that often. So the core Skelable engineering group will be joining Lifeward bringing more than 60 years of combined experience across electrical, software, mechanical and industrial design. That experience is incredibly important as we integrate the technology into our development framework, bring the original engineering team with the platform ensures continuity of knowledge and allows for a disciplined transfer of intellectual property design intent and technical architecture into our broader pipeline. The stellar engineering team will also be a core team working on the advance advancing and the rest of our neuro rehab product portfolio. We believe this platform expands Lifeward's leadership into whole body robotic rehabilitation and opens a significant market opportunity with neuro rehabilitation. In fact, the new platform is highly complementary to our existing ReWalk ecosystem. We will leverage our established clinical relationships, distribution network and reimbursement channels to accelerate the time of commercialization. And I want to underscore here that Lifeward's focus in robotic rehabilitative technologies is exactly that to rehabilitate and help the human return to full function or return to as much function as humanly possible. We are committed to continuous innovation, deploying the most advanced robotics and AI technologies to restore full health and quality of life to a broadening patient population. Now turning to our established core neuro rehab business. We continue to make important progress across reimbursement, clinical partnerships and global distribution during the year. At the same time, revenue for the fourth quarter and for the full year came in lower than estimated, and there were two primary drivers behind that. First, in the United States, we implemented a major change in our sales and distribution infrastructure. As we discussed on our third quarter call, we began a transition toward a hybrid model that combines our internal direct sales efforts with external channel partnerships. Building those partnerships takes time. They don't translate into revenue overnight, so you're not seeing the full impact of those changes in our numbers yet. Within this restructured also our sales organization internally to better align with our business evolving. Today, our commercial efforts operate across three focused areas: First, our direct-to-patient channel, which supports individuals pursuing a personal ReWalk system through the reimbursement process; second, our capital equipment sales team, which focuses on institutional customers, including rehabilitation centers, hospitals and support medicine facilities for AlterG. We believe there are substantial untapped opportunities here that can better be served by our capital equipment sales team; the third is a dedicated reimbursement and payer engagement function that works across all payers to expand coverage and support both our direct and distribution channels. As you know, reimbursement is a critical driver of our long-term growth strategy and building a stronger payer engagement capability is essential to expanding patient access, accelerating adoption of our technologies. It's critical for our patients to be able to access our technologies through their health care benefit in their community. We believe this structure will ultimately improve the overall sales process strengthen payer engagement and drive greater adoption. As those changes mature, we expect to see the positive effects begin to show in the coming quarters. The second factor affecting the revenue was the decline in AlterG sales tied to a specific distributor dynamic. In 2024, one of our distributors made a very large inventory purchase. That distributor had not placed that comparable in 2025. A which created a year-over-year comparison headwind. Based on our discussions with them, we expect that purchasing to normalize again in 2026. Despite those temporary dynamics, the underlying fundamentals of the business remain strong. Reimbursement coverage continues to expand. Clinical demand remains solid, and we're building a growing backlog and qualified pipeline. Recently, we achieved reimbursement for coverage of ReWalk in the three largest Medicare Advantage insurers in the U.S., Aetna, Humana and UnitedHealthcare, which collectively represent over 16 million covered lives in America. We also made meaningful progress expanding international distribution for ReWalk. Following the receipt of the CE Mark in September of last year, we have been accelerating our efforts across Europe. Germany has become our primary international test market and is proving to be valuable insights to reimbursement pathways, clinical adoption and patient demand. International markets represent a significant long-term opportunity for the ReWalk platform, and we're opportunistic about the trajectory we're seeing so far. Through an agreement with Verita Neuro and a partner-led capital-efficient structure, we expanded distribution into Mexico, Thailand and the United Arab Emirates. Our core neuro rehabilitation business serves as a powerful innovation engine for Lifeward. We have multiple next-generation technologies in development. A new version of AlterG should be expected and our next-generation ReWalk is currently targeted. And with the scalable IP and technology acquisition, we expect our upper body exoskeleton platform to reach the market, too. Together, these programs significantly expand our addressable market and strengthen our long-term product pipeline. I will now turn the call over to Almog to review our financial results and provide additional detail on operating performance and liquidity position. Before doing that, please note, given the significant transformation Lifeward has recently undergone and the pending close of our agreement with Oramed, we will not be providing guidance at this time. We remain excited about the long-term prospects and cautiously optimistic about the growth in our core MedTech business, together with continued improvements in operating expenses will help drive the company towards a positive cash flow in the near future.