Brainsway(BWAY) - 2022 Q1 - Quarterly Report

Financial and Operational Highlights BrainsWay reported strong 2021 financial and operational growth, including 34% revenue increase and 20% Deep TMS installed base expansion Full-Year 2021 Key Metrics | Metric | Value | Change vs 2020 | | :--- | :--- | :--- | | Full-Year Revenue | $29.7 million | +34% | | Q4 Revenue | $8.5 million | +20% | | Total Deep TMS Installed Base | 754 systems | +20% | | Cash and Equivalents (as of Dec 31, 2021) | $57.3 million | N/A | - Achieved final Local Coverage Determination (LCD) from a Medicare Administrative Contractor (Palmetto GBA MAC), providing Deep TMS™ coverage for OCD treatment to over 9 million patients. This brings the total number of covered lives for OCD to approximately 60 million[3][5] - As of year-end 2021, the company had shipped 302 OCD coils as add-on helmets for its Deep TMS systems[3] - The company has demonstrated year-over-year revenue growth for six consecutive quarters, despite challenges from the Omicron surge[4] Financial Results Revenue grew in Q4 and full-year 2021, but increased operating expenses led to higher losses, while an equity offering significantly strengthened cash Fourth Quarter 2021 Financial Results Q4 2021 revenue increased 20% to $8.5 million with stable gross margin, but operating expenses rose, leading to a higher operating loss Q4 2021 vs Q4 2020 Financials | Metric | Q4 2021 | Q4 2020 | | :--- | :--- | :--- | | Total Revenues | $8.5 million | $7.1 million | | Gross Margin | 77% | 77% | | Operating Expenses | $8.0 million | $5.9 million | | Operating Loss | $1.5 million | $0.4 million | Full-Year 2021 Financial Results Full-year 2021 revenue grew 34% to $29.7 million, with positive cash from operations, despite a widened net loss, and a $57.3 million cash balance from an equity offering Full-Year 2021 vs 2020 Financials | Metric | FY 2021 | FY 2020 | | :--- | :--- | :--- | | Total Revenue | $29.7 million | $22.1 million | | Cash from Operations | $0.9 million | ($1.4 million) | | Net Loss | $6.5 million | $5.4 million | | Cash & Equivalents (Year-End) | $57.3 million | $17.2 million | Financial Statements Financial statements reflect increased assets and equity from an offering, strong revenue growth offset by higher expenses leading to a larger net loss, and positive cash from operations Consolidated Statements of Financial Position Total assets more than doubled to $75.7 million by year-end 2021, driven by increased cash and a substantial rise in total equity to $57.3 million due to an equity offering Balance Sheet Highlights (in thousands USD) | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Total Assets | $75,732 | $34,011 | | Cash, cash equivalents & short-term deposits | $57,349 | $17,182 | | Total Liabilities | $18,408 | $14,377 | | Total Equity | $57,324 | $19,634 | Consolidated Statements of Comprehensive Loss Full-year 2021 revenue increased 34% to $29.7 million, but rising operating expenses led to a widened net loss of $6.5 million, or ($0.21) per share Income Statement Summary (in thousands USD, except per share data) | Metric | Full-Year 2021 | Full-Year 2020 | Q4 2021 | Q4 2020 | | :--- | :--- | :--- | :--- | :--- | | Revenues | $29,657 | $22,057 | $8,470 | $7,066 | | Gross Profit | $23,058 | $16,999 | $6,564 | $5,500 | | Operating Loss | ($4,999) | ($4,829) | ($1,452) | ($407) | | Net Loss | ($6,462) | ($5,385) | ($1,347) | ($406) | | Basic and Diluted Net Loss per Share | ($0.21) | ($0.24) | ($0.04) | ($0.02) | Consolidated Statements of Cash Flows In 2021, cash from operations turned positive at $0.9 million, while investing activities used $42.2 million, and financing activities provided $41.5 million from a share issuance Cash Flow Summary (in thousands USD) | Cash Flow Activity | Full-Year 2021 | Full-Year 2020 | | :--- | :--- | :--- | | Net cash provided by (used in) operating activities | $884 | ($1,436) | | Net cash used in investing activities | ($42,216) | ($2,465) | | Net cash provided by (used in) financing activities | $41,516 | ($1,030) | | Cash and cash equivalents at end of year | $16,921 | $16,961 | Company Overview and Forward-Looking Statements BrainsWay, a leader in Deep TMS™, holds three FDA-cleared indications, but faces future risks including market acceptance, regulatory approvals, competition, and reimbursement challenges - BrainsWay is the only TMS company with three FDA-cleared indications backed by pivotal studies: major depressive disorder (including anxious depression), obsessive-compulsive disorder, and smoking addiction[11] - The company is conducting additional clinical trials to expand the use of Deep TMS for other psychiatric, neurological, and addiction disorders[11] - Key risks include changes in technology, delays in clinical trials, failure to obtain regulatory approvals, competition, and inadequate reimbursement from third-party payers[12] Conference Call and Webcast Information BrainsWay management will host a conference call and webcast on Wednesday, March 9, 2022, at 8:30 AM Eastern Time, to discuss Q4 and full-year 2021 results - Event: Discussion of Q4 and Full-Year 2021 Results[8] - Date and Time: Wednesday, March 9, 2022, at 8:30 AM Eastern Time[8][9] - Access: Available via webcast at the company's investor relations website or by phone using Conference ID 13727217[9][10]