Mike Lawless
Analyst · H.C. Wainwright. Please go ahead
Thanks, Larry. Before I review the financial results, I want to remind everyone that our fourth quarter GAAP results include various costs and expenses related to the acquisition of AlterG, which can obscure visibility to the underlying operational performance of Lifeward. In order to facilitate understanding of both the GAAP results and the operational results of Lifeward, I want to discuss our performance in the fourth quarter of 2023 on both a GAAP and non-GAAP basis, which excludes the purchase accounting adjustments, transaction expenses, restructuring charges, rebranding and integration costs, inventory charge and stock compensation expense. The reconciliation of the non-GAAP to GAAP results is provided in today's earnings release, and I encourage you to reference these tables as I discuss the financials. Moving to revenue. Lifeward reported revenue of $6.9 million in the fourth quarter of 2023 compared to $2.2 million in the fourth quarter of 2022, up $4.7 million or over 200%. The increase in revenue is attributable to the acquisition of AlterG. Excluding AlterG sales, the fourth quarter of 2023 revenue was $2.2 million, up $0.7 million sequentially from the third quarter of 2023 and in line with the $2.2 million reported in the fourth quarter of 2022. ReWalk Exoskeleton revenue in Q4 2023 was flat versus Q4 2022 on the same number of units sold, while the revenue from the sale of MyoCycle FES training cycles declined slightly, but was offset with an increase of revenue from ReStore units. Turning to our pipeline metrics. Our pace of active rentals consists of 24 cases, down two from last quarter, which is broken down with 21 in Germany and three VHA rentals. As of December 31, 2023, our overall number of ReWalk cases in process was 70 with 49 in Germany and 21 in the US. We ended the quarter with orders for 46 AlterG systems in backlog, which is lower than the backlog at the end of Q3 2023 due to our internal focus on our commercial reorganization and integration activities. We expect the AlterG backlog to return to higher levels in the coming quarters. As Larry discussed earlier, we expect to have submitted a cumulative 35 claims to Medicare by the end of February for reimbursement of ReWalk systems. To date, one of these claims has been paid, and we expect that more will begin to be processed and paid by the Medicare contractors in the near future. This revenue from Medicare will be additive to the revenue from our traditional pipeline of VHA and workers' compensation cases. Moving to gross profit. In the fourth quarter of 2023, our GAAP gross profit was $2.4 million or 35.5% of revenue as compared to $0.7 million or 30.9% of revenue in the fourth quarter of 2022. On a non-GAAP basis, gross profit was $3.2 million or 47% of revenue for the fourth quarter of 23% as compared to 52.8% for the fourth quarter of 2022. The fourth quarter a year ago had a very favorable mix of product sales and favorable material costs, which contributed to the higher gross margin. In Q4 2023, AlterG gross margin was accretive to the overall LIBOR consolidated gross margin. Moving to operating expenses. GAAP operating expenses were $8.6 million in the first quarter -- in the fourth quarter of 2023, up $2.9 million or 51% compared to $5.7 million in Q4 2022. Within the major OpEx categories, GAAP R&D expenses were $1.3 million in Q4 2023 as compared to $1.1 million in Q4 2022. On a non-GAAP basis, R&D expenses were $1.1 million and flat with the amount in the fourth quarter of 2022. AlterG contributed $0.5 million in the most recent quarter, while the R&D expenses for ReWalk declined due to lower spending on subcontractors and consultants from the conclusion of the Stairs and Curbs project and reduction in spending on the ReWalk 7 project since we are at the final stage before FDA submission. GAAP selling and marketing expenses were $4.8 million in Q4 2023 as compared to $2.7 million in Q4 2022. On a non-GAAP basis, selling and marketing expenses were $4 million, up $1.4 million or 52%. The majority of this increase came from the addition of the AlterG business, which contributed $1.3 million in selling and marketing expenses. The rest of the increase was primarily due to higher consulting and professional service fees associated with CMS reimbursement related activity. GAAP general and administrative expenses were $2.4 million as compared to $1.9 million in the prior year's quarter. On a non-GAAP basis, G&A expenses were $1.9 million, up $0.3 million or 17%. The addition of the AlterG business contributed to all of this increase, while G&A for the ReWalk business declined. Our GAAP operating loss for the fourth quarter was $6.1 million compared to an operating loss of $5 million in the fourth quarter of 2022. The non-GAAP operating loss was $3.8 million in Q4 2023 as compared to $4 million in Q4 2022. The fourth quarter 2023 results also reflect a $1.1 million sequential improvement in the operating loss versus Q3 2023. As was the case last quarter, the AlterG business had a positive operating profit in Q4 and contributed to the improvement in the non-GAAP operating loss. Moving to the balance sheet. We ended the quarter with $28.1 million in cash and cash equivalents and no debt. Cash used in operations was in Q4 was $4.4 million, which includes some transition and integration costs. Next, I want to provide an update on the status of our listing requirements for NASDAQ. As you know, back in October, we were notified by NASDAQ that our second grace period to regain compliance with the $1 bid price requirement had expired. We requested and received extensions from the NASDAQ Hearings Panel through March 31, 2024, based on the anticipated announcement of the final payment rates by CMS for exoskeletons, which we believe would provide the clarity and certainty investors are seeking and positively impact our stock price such that an inverse stock split would not be necessary. At this stage, there are no further extensions available for us under the NASDAQ listing rules. We continue to expect a favorable stock response once the final payment rate is announced by CMS, but the timing of this is uncertain relative to our NASDAQ compliance deadline. We have our contingency plans in place for our Board to authorize a reverse stock split, should the CMS announcement not take place in time for our deadline with NASDAQ. Okay, now, moving to financial guidance. As a reminder, Medicare has still not provided a final payment rate for exoskeletons nor do we have the timetable at which the Medicare claims will begin to be processed and paid by the MAX. These two factors have a significant influence on our potential 2024 results. The following guidance is our attempt to factor in the uncertainty related to these two variables with the appropriate conservatism. For the full year 2024, we expect revenues of between $28 million to $32 million. The growth in revenue is driven by a full year's contribution from the AlterG business augmented by a new product introduction that we expect in mid-2024 of the new entry-level model of the AlterG. Additionally, we expect ReWalk revenue will benefit from the expansion of the market coming to the new benefit category and payment rate by Medicare starting on April 1st. We expect non-GAAP gross margin to expand to the high 40% range, driven by volume leverage from a higher level of shipments of ReWalk devices and product cost improvements in the AlterG Systems. We expect non-GAAP operating expenses to decline from the fourth quarter 2023 run rate level, and our non-GAAP operating loss will be reduced to the low double-digit millions. We expect to exit 2024 with a significantly reduced quarterly operating loss, which provides visibility to achievement of future operating profit. Since we still have low visibility to the timing and pricing of Medicare payments, our guidance does not anticipate any Medicare revenue in Q1 2024. Additionally, the first quarter is seasonally the lowest quarter of revenue for the AlterG Systems and the new combined commercial team, which just came together in January, will also need time to achieve sales traction across the product portfolio. Taking these factors into account, we expect revenue in Q1 2024 to be in the range of $5 million to $5.5 million. In the quarters that follow, we expect revenue will increase sequentially on Medicare claims beginning to be paid and the seasonal increase in AlterG revenue, supplemented by the new AlterG product introduction expected in mid-2024. With that, I'll turn the call back over to Larry for further remarks.