Detailed Narrative
Applicator Business Strength
The company reported strong performance in its recurring applicator business, setting new all-time records for both unit volumes and revenues. Applicator unit volumes increased 13% sequentially from Q1 and 27% year-on-year, while applicator revenues grew 8% sequentially from Q1 and 13% year-over-year. This performance is seen as a positive indicator of customer confidence in the Ultramist product, especially given the difficult market conditions in wound care.
System Sales Headwinds
Q2 saw a significant divergence from plan in system sales, which declined 34% year-over-year to $2.3 million. This was primarily attributed to an 'unprecedented🌐 market for used Ultramis devices,' which created profound cannibalization effects. Management estimates that used systems accounted for 40 to 60 system sales in the quarter, impacting new system placements. The active system count at the end of Q2 was 1,411, up 29 from Q1.
CMS Reimbursement Uncertainty
The company highlighted significant uncertainty regarding CMS reimbursement. While a proposed rule for the Calendar Year 2027 Hospital Outpatient Prospective Payment System suggests a 14% increase for Ultramist in hospital outpatient settings, another proposed rule for the physician fee schedule indicates a potential drop in reimbursement for Ultramist (code 97.610) from $397 to approximately $316 in 2027, with further reductions in 2028. This follows previous drastic cuts to skin substitute reimbursement, which led to many wound care provider closures.
Advocacy for Ultramist Reimbursement
SANUWAVE Health, along with Ultramist users, plans to actively participate in the CMS comment period, which runs through September 14th. The goal is to ensure that the data driving reimbursement decisions is accurate and complete, reflecting full practitioner costs and the systemic benefits of Ultramist treatment, particularly its role in preventing amputations and providing significant savings to the healthcare system. The final rule is expected around the first week of November.
Strategic Expansion and Diversification
The company continues its longer-term push into new indications and care settings, including burn, hospital-acquired pressure injury, post-acute, hospital inpatient, hospital outpatient, pediatric, and long-term care facilities. This strategy aims to expand the product's reach and secure sticky, long-term customers with high usage rates, with groundwork laid over the past 9-12 months starting to yield results.
Financial Performance and Cost Management
Overall revenue decreased 3% year-over-year to $9.7 million. The company reported an operating loss of $0.3 million and a net loss of $0.7 million, primarily due to lower gross margin from the shift to consumables and higher operating expenses. Operating expenses increased by $1.3 million, driven by investments in headcount, R&D, and commercial capabilities, partially offset by a $0.9 million favorable swing from sales tax resolutions. Adjusted EBITDA was $1.2 million, down from $3.2 million in the prior year.