Cash and cash equivalents were $47.7 million as of March 31, 2024. This compares to cash and cash equivalents of $59.7 million as of December 31, 2023.
FDA Clearance as a First-Line Add-On Treatment for Adolescents with Depression
In late March, Neuronetics received U.S. Food and Drug Administration (“FDA”) clearance for its NeuroStar Advanced Therapy as the first and only transcranial magnetic stimulation (“TMS”) treatment cleared as a first line, adjunct for major depressive disorder (“MDD”) in adolescents aged 15-21. The FDA clearance was supported by real-world data from our TrakStar database showing 78% of adolescent patients treated with NeuroStar achieved clinically meaningful improvement in their depression severity. This clearance opened up a new treatment option for the large adolescent MDD patient population that had extremely limited FDA-approved treatment options available previously. With the addition of the adolescent indication, Neuronetics’ total addressable market for MDD increased by approximately 35%. NeuroStar is now FDA-cleared to treat MDD patients aged 15 and older.
Launched Second Cohort of Customers within the Better Me Guarantee Provider Pilot Program
Following its initial pilot launch during late 2023, the Company enrolled its second pilot cohort within the Better Me Guarantee Provider (“BMGP”) pilot program, which consisted of approximately 100 customer sites in January of 2024. The BMGP program creates a nationwide group of accounts that are committed to meeting certain standards of patient care and responsiveness developed in collaboration with medical experts. Regardless of practice size or tenure, this program aims to address reported responsiveness issues and lack of knowledge of TMS therapy that have negatively impacted patient access to care. Participating providers agree to attend advanced training at NeuroStar University, ensure that office phones are answered during business hours, advise patients of the benefits of treating to the full course of 36 sessions when medically appropriate, assign medical personnel to promptly respond to PHQ-10 assessments, and update websites and social media platforms to educate potential patients about the benefits of NeuroStar TMS therapy and its availability as a potential treatment option. In April 2024, the Company launched the third cohort of 100 customer sites. The Company currently has over 200 customer sites participating in the pilot program. The Company plans to continue its measured pilot roll-out with the next cohort of providers slated for inclusion in May 2024.
5-Year Exclusive Partnership with Transformations Care Network
Neuronetics announced an expanded five-year exclusive commercial partnership with Transformations Care Network, one of the nation’s largest mental health care providers. Under the new agreement, Neuronetics will be the exclusive supplier of new TMS equipment to Transformations Care Network, increasing the availability of Neuronetics’ NeuroStar TMS therapy to patients across Transformations Care Network’s facilities in six states. As part of the detail, Transformations agreed to convert from its prior fixed price treatment sessions to our consumable purchase model.
Business Outlook
For the second quarter of 2024, the Company expects total worldwide revenue between $18.0 million and $19.0 million.
For the full year 2024, the Company expects total worldwide revenue to be between $78.0 million and $80.0 million.
For the full year 2024, the Company expects total operating expenses to be between $80.0 million and $84.0 million.
Webcast and Conference Call Information
Neuronetics’ management team will host a conference call on May 7, 2024, beginning at 8:30 a.m. Eastern Time.
The conference call will be broadcast live in listen-only mode via webcast at https://edge.media-server.com/mmc/p/i3t5h9gs. To listen to the conference call on your telephone, you may register for the call here. While it is not required, it is recommended you join 10 minutes prior to the event start. To access the live audio webcast or subsequent archived recording, visit the Investor Relations section of Neuronetics’ website at ir.neuronetics.com.