Dave Henry
Analyst · AGP. Please go ahead
Thank you, Paul and good afternoon, everyone. Let me start my remarks, with a review of our second quarter financial results. Revenue for the second quarter of 2024 was $7.5 million. This consists of entirely product revenue and was up 77% over the prior year quarter's product revenue. Total revenue was up 26%, over last year's second quarter, which included a license payment from our joint venture partner in China. Product revenue growth was driven by a higher number of revenue units, which were up 63% year-over-year and by a higher average selling price as Medicare and certain Medicare Advantage payers reimburse for the MyoPro in line, with the fees published by CMS that became effective as of April 1, 2024. Revenue came in higher than our initial guidance due to a higher-than-expected velocity of Medicare payments and hence revenue. 40% -- 47% of revenue in the second quarter came from Medicare Part B patients. As a result, ASP was approximately $47,500, up 9% year-over-year. Revenue from patients with Medicare Advantage plans represented 26% of second quarter revenue, which was down 26% year-over-year. This decrease came in part from a more challenging reimbursement environment. It appears that utilization management initiatives are underway at key Medicare Advantage payers and a higher proportion of initial claims are being denied than we'd seen in prior quarters. Of the 158 revenue units in the second quarter, approximately 20% resulted from fill, which is our term for authorizations and orders received and converted to revenue in the same quarter. Driven by revenue from Medicare Part B patients 78% of our revenue in the second quarter came from the direct billing channel, which is similar to the prior year quarter. 14% of second quarter revenue came from international markets primarily Germany. Given our success in being paid by CMS for Medicare Part B claims effective as of July 1, 2024, we are recording revenue upon product delivery and the filing of claims with CMS. In the second quarter of 2024, both pipeline additions and total pipeline, reached new records. The pipeline was 1,179 patients at the end of the second quarter, an increase of 22% year-over-year. There were 550 additions to the pipeline in the second quarter, an increase of 35% year-over-year. 19% of the pipeline at the end of the second quarter was Medicare Part B patients. Of the pipeline additions in the second quarter, 167 were Medicare Part B patients. Reported backlog represents insurance authorizations and orders received, but not yet converted to revenue. And in the case of Medicare Part B patients, those patients for whom we've collected medical records and deemed qualified for delivery based on our inclusion criteria. Our backlog at the end of the second quarter of 2024 was a record 282 patients, up 58% from our backlog at the end of second quarter 2023. Ending second quarter backlog includes 96 Medicare Part B patients that have either been qualified for delivery with appropriate Medicare documentation or have received a MyoPro and claims have been filed, but payment has not yet been received. The Medicare portion of the backlog increased 16% sequentially. Contributing to our record backlog was a record 213 authorizations and orders, an increase of 70% year-over-year. Gross margin for the second quarter of 2024 coming entirely from product sales was 70.8% compared with 71.8% for the prior year quarter. The decrease was driven primarily by the impact of 100% margin license revenue in the prior year, offset by a higher ASP, I mentioned earlier. Excluding the license revenue, gross margin on product sales was 60.5% in the second quarter of 2023. Operating expenses for the second quarter of 2024 were $6.4 million, an increase of 20% compared with the second quarter of 2023. This increase was driven primarily by higher head count, as we added clinical and reimbursement capacity in order to grow revenue in the second half of the year and beyond, and higher engineering head count to accelerate completion of certain sustaining engineering projects and new product development, offset by lower stock-based compensation expense. Advertising expense of $800,000 was unchanged year-over-year, but cost per pipeline ad was $1,545, which is down 26% compared to the prior year quarter. Operating loss for the second quarter of 2024 was $1.1 million, unchanged from the second quarter of 2023, which included the license revenue at 100% margin. Net loss for the second quarter of 2024 was $1.1 million, or $0.03 per share. This compares with a net loss of $1 million, or $0.04 per share for the second quarter of 2023. Approximately $770,000 prefunded warrants were exercised during the second quarter, and approximately $7.7 million prefunded warrants are still outstanding from our offerings in 2023 and January 2024. These prefunded warrants are considered common stock equivalents under GAAP and are included in our weighted average shares outstanding. Adjusted EBITDA for the second quarter of 2024 was a negative $1.2 million, compared with a negative $800,000 in the second quarter of 2023. Looking at our year-to-date financial results. Revenue for the six months ended June 30, 2024, was $11.3 million, up 20% compared with the same period a year ago. Product revenue, which excludes licensing revenue was up 47% over the first half of 2023. Year-to-date gross margin was 67.6% compared with 70.1% in the year ago period. Excluding license revenue, gross margin on product revenue was 63.4% in the year ago period. Operating expenses for the first half of 2024 were $12.6 million, an increase of 22%, compared with the same period a year ago. Operating loss for the first six months of 2024 was $5 million compared with an operating loss of $3.8 million for the same period a year ago. Net loss for the first six months of 2024 was $5 million or $0.13 per share, compared with a net loss of $3.7 million or $0.14 per share for the same period a year ago. Adjusted EBITDA was a negative $4.7 million for the first half of 2024, compared with a negative $3.2 million for the year ago period. Turning now to our cash position. Cash, cash equivalents and short-term investments as of June 30, 2024 were $9.0 million. Cash used in operating activities was $1.9 million for the second quarter of 2024, compared with $0.3 million for the second quarter of 2023. On July 11, 2024, we entered into a accounts receivable line of credit with Silicon Valley Bank, which provides a borrowing capacity of $4 million based on 80% of eligible receivables as defined in the agreement. As of today, we have not drawn on the credit line. We believe our cash, cash equivalents and short-term investments are sufficient to fund our operations for at least the next 12 months. In May 2024, our shelf registration statement on Form S-3 expired. We believe it is a good corporate housekeeping to have a valid shelf registration statement on file. So a new shelf registration statement is expected to be filed shortly resizing consistent with our prior shelf. Turning to our financial guidance. Given our backlog and the expected higher velocity of revenue being able to -- were able to record for Medicare Part B patients upon product delivery, we believe we are positioned to grow revenue modestly on a sequential basis in the third quarter and we expect revenue in the range of $8.0 million to $8.5 million. While a modest sequential increase, this represents between 58% and 67% year-over-year growth. We intend to increase our advertising spending in the third quarter and second half of the year to educate more patients and generate more volume at the top of the patient funnel. We believe we have the capacity to process a higher volume of patient leads that our additional advertising may generate. This increased spend is aimed at positioning the company for continued growth in the first half of 2025, but we may see some incremental revenue from these efforts in the fourth quarter as well. We continue to believe our full year revenue expectation of $28 million to $30 million is achievable as the required clinical reimbursement and manufacturing capacity is now in place. Our full year revenue expectation and third quarter guidance imply fourth quarter revenue approaching $10 million. We continue to believe that operating cash flow is achievable in the fourth quarter. However, our ability to compensate for higher advertising spending in the second half of the year, may impact achieving this objective. With that financial overview, I'll turn the call back to Paul.