ReWalk Robotics Ltd.

Welcome to the Q4 2021 Rewalk Robotics Earnings Conference Call. My name is Vanessa, and I will be your operator for today's call. At this time, all participants are in a listen-only mode. Later, we will conduct our question and answer session. To queue up with your question, you can press star, then 1 on your touchtone phone, and these instructions will be repeated for you. I will now turn the call over to your host, Ori Ghan.

Thank you, Vanessa. Good morning and welcome to Rework Robotics' fourth quarter 2021 earnings call. This is Oregon Rework Chief Financial Officer and with me on today's call is Larry Jasinski, our Chief Executive Officer. Today, the company issued a press release detailing financial results for the three and 12 months ended December 31st, 2021. This press release and a webcast of this call can be accessed through the investor relations section of the Rework website at www.rework.com. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, focus, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Rework Management as of today and involve risks and uncertainties. including those noted in our press release and reworks filing with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Reworks specifically disclaims any intent or obligation to update these forward-looking statements, except as required by law. Our earnings press release and this call will include discussion of certain non-GAAP information. You can find our earnings press release, including relevant non-gap reconciliations, on our corporate website at rewalk.com. A telephone replay of the call will be available shortly after completion of this call. You will find the dialing information in today's press release. The archived webcast will be available on the company's website at rewalk.com. For the benefit of those who may be listening to the replay or the archived webcast, this call was held and recorded on February 24, 2022. Since then, Rewalk may have made announcements related to the topics discussed, so please reference the company's most recent press releases and SEC findings. And with that, I'll turn the call over to Rewalk CEO, Larry Jasinski. Larry?

Thank you, Ori. Rewalk completed 2021 in a positive position to achieve our vision of creating a meaningful and sustainable market for personal use of robotic technologies to change people's lives. The key measurements for the year are progress in creating systemic reimbursement payment pathways to build a business, technical developments that can expand our markets and allow more effective market penetration under coverage programs achieved, and a financial position that supports achieving our goals. During a year when the pandemic continued longer than expected and the significant spike in the fourth quarter with the Omnicon variant, The company grew revenue for the year ended December 31st, 2021 to 5.97 million, a 36% increase year over year. We had 1.24 million in Q4 sales, which was a 2% increase over the prior year quarter. During 2021, the COVID-19 pandemic continued to impact our sales activities. Three key factors were one, Reduction in incoming leads over much of 2021 as trade shows and in-person demonstrations were very limited by COVID-19 restrictions. Two, our inability to train patients as many clinics remain closed, which prevented the six months plus cycle of moving patients through the system for Q4 conversion due to the ongoing pandemic. And three, further limitation of conversion of the trainings that were achieved to date due to the Omicron variant spike in Q4. These levels of revenues are not sufficient for a sustainable business. Significant expansion of market penetration and revenue is reliant on success with reimbursement and our ability to implement this in the marketplace. I'd like to review three categories of focus that we believe will support this future. our continued progress in establishing reimbursement payment programs. Second, the technical developments with respect to our products that we believe will support growth. Third, developing and putting in place structures with respect to training, service, reimbursement assistance, and sales coverage to grow effectively. To add detail to these three categories, starting with reimbursement, Our results will be driven by German definitions through the legal process and through the completion of benefit category pricing and coverage by CMS, the Center for Medicaid and Medicaid Services. In Germany, the Federal Social Court, the highest court in the country to define social programs, continues to progress on a court case that will define for all insurers whether direct compensation for a spinal cord injury is a requirement in the German system. The case initiated in 2017 and has progressed to this final point of determination over the past five years. The court does not provide specific information on the timing for ruling on an accepted case. But in the publicly published court docket on January 7, 2022, Rewalk is the third case on the docket out of 24 listed. While we have no guidance in the sequence the court will hear or address cases, we have been advised that a Q1 determination is a reasonable expectation. In the United States for CMS, we significantly expanded our resources and talents to support completion of coverage based on the new code we applied for and achieved in 2020. We have focused on expanding the evidence documentation providing information and engaging with CMS regarding the decision on a benefit category and for pricing, and in preparing our initial cases for submission to CMS. The current dossier is being enhanced to articulate clinical, economic, and humanistic value in relevant stakeholders' language. On the evidence-based documentation, we have expanded the materials to meet the standards for all submissions, and are providing new scientific support for the economic value and in modeling for payers. On December 21st, 2021, CMS issued a final rule on DEMPOS. That's durable medical equipment, prosthetics, orthotics, and supplies. This rule provides methodologies for benefit categories and payment determinations for new items. This directly applies to exoskeletons, and our code that was created in late 2020. This final rule provides us a clear path forward with respect to CMS. We anticipate our benefit category and pricing will be addressed at CMS sessions occurring mid-year with conclusions on or before their fall sessions. We intend to process our first Medicare, Medicaid cases in 2022 and expect a coverage path they will be defined by year end or early 2023 for patients to pursue exoskeletons. We further expect that this progress with CMS will allow our expansion to the private sector afterwards. A reliable, systematic method to identify the proper patients and supply those that meet all the requirements to achieve a way to walk once again is our end goal. Moving now to technical developments and achievements to support market growth. In 2021, we have worked on features for the spinal cord injury designs which will expand the ability to use the system in more places in the United States and have focused on meaningful technological improvements for easier operation and expansion of the data provided to users and all stakeholders on a global basis. We anticipate two FDA submissions in 2022 for the different design improvements we have developed. Rewalk is the most used personal exoskeleton in the world and proceeding to a seventh generation design. We are also taking early research for an eighth generation that we believe will continue to make the system easier to use. Now, regarding infrastructure for the implementation of coverage, we are focused on ensuring that we have the training, service, reimbursement assistance, and sales coverage to achieve a market development and growth. We have learned a great deal from our success in Germany in how to expand and support our customers. This has provided a model for our US plans as reimbursement is determined. In addition to maintaining and expanding the US and German teams, we have added a contract with a company called Robotics Technology in the UK, where we have transferred one of our employees and they are providing the full infrastructure needed to support expansion in the UK. As a company, our capital position is suitable to achieve these goals and allow the company to move from an establishment phase to a growth phase. It has taken longer and has been harder than expected, but the stage is set as a pivotal year, which is built on a long period of gaining understanding of the potential of these technologies and in having systems and support from all stakeholders to move forward. I'd like to ask Ori to cover the specifics of your end financials and our overall financial position.