Business Highlights
- The TULSA-PRO® systems installed base grew from 47 at the end of 2023 to 53 as of the end of Q1-2024; Profound continues to expect that to grow to 75 TULSA-PRO® systems this year.
- Profound continued to see a wide variety of prostate disease patients treated by its TULSA-PRO® customers in the first quarter of 2024:
- Approximately 71% were treated for prostate cancer, 21% were hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”), 6% were salvage, and 2% were men with BPH only;
- For cancer grade, approximately 15% were GG1, 47% were GG2, 27% were GG3, and 13% were GG4 & GG5;
- In terms of ablation, approximately 53% were whole gland; 26% were sub-total but more than half the gland; 10% were hemi-ablations; and 12% were focal therapy; and
- For prostate size, approximately 4% were < 20cc; 29% were 20 – 40cc; 40% were 40-60cc; 23% were 60-100cc; and 4% were over 100cc.
- Profound’s next TULSA AI module, Contouring Assistant, which has been designed to enable the creation of a suggested treatment design based upon the specific prostate anatomy of each patient, is currently under
U.S. Food and Drug Administration (FDA) review. - In or around
late-July 2024 , the Company anticipates that theU.S. Centers for Medicare & Medicaid Services (CMS) will issue its proposed outpatient prospective payment system (OPPS) reimbursement rule for the three new CPT® Category 1 codes and their descriptors covering the TULSA procedure, with the final rule anticipated inNovember 2024 , which will become effective onJanuary 1, 2025 . - The ongoing Level 1 CAPTAIN trial comparing the TULSA procedure to radical prostatectomy in men with localized prostate cancer remains on track to complete patient enrollment by the end of this year.
- Earlier this week, Profound announced that 25 TULSA-related scientific research presentations have already been delivered at major medical meetings around the world thus far in 2024.
- Today, the Company is providing annual revenue guidance for the first time.
“Concurrent with growing awareness of the TULSA procedure’s potential to become a mainstream treatment modality for prostate disease among urologists via our sales, marketing and clinical education programs, our preparations continue for the permanent CPT® Category 1 codes for TULSA going into effect at the beginning of 2025,” said
Summary First Quarter 2024 Results
For the quarter ended
Total operating expenses, which consist of research and development (“R&D”), general and administrative (“G&A”), and selling and distribution (“S&D”) expenses, were approximately
Expenditures for R&D for the three months ended
G&A expenses for the 2024 first quarter increased by 13% to approximately
First quarter 2024 S&D expenses increased by 15% to approximately
Net finance income for the three months ended
First quarter 2024 net loss was approximately
2024 Financial Outlook
Based on the Company’s current business planning and budgeting activities, it expects total revenue for full-year 2024 to be in the range of
Liquidity and Outstanding Share Capital
As at
As at
For complete financial results, please see Profound’s filings at www.sedarplus.ca, www.sec.gov and on the Company’s website at www.profoundmedical.com under “Financial” in the Investors section.
Conference Call Details
To participate in the conference call by telephone, please pre-register via this link to receive the dial-in number and your unique PIN.
The call will also be broadcast live and archived on the Company's website at www.profoundmedical.com under "Webcasts" in the Investors section.
About
Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® has the potential to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (“BPH”). TULSA-PRO® is CE marked,
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the
Forward-Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, any express or implied statements or guidance regarding current or future financial performance and position, including the Company’s year 2024 financial guidance and related assumptions; the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; and its future revenues/financial results. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition, statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and Profound’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management's expected ranges. For additional risks, please see the Company’s annual information form for the year ended
Financial Outlook
This press release contains a financial outlook within the meaning of applicable securities laws. The financial outlook has been prepared by management of the Company to provide an outlook for the Company’s forecasted revenue for the 12 months to be ended
For further information, please contact:
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849
Interim Condensed Consolidated Balance Sheets
(Unaudited)
2024 $ | 2023 $ | ||||
Assets | |||||
Current assets | |||||
Cash | 41,180 | 26,213 | |||
Trade and other receivables | 6,510 | 7,288 | |||
Inventory | 6,976 | 6,989 | |||
Prepaid expenses and deposits | 875 | 1,406 | |||
Total current assets | 55,541 | 41,896 | |||
Property and equipment | 866 | 909 | |||
Intangible assets | 428 | 490 | |||
Right-of-use assets | 547 | 616 | |||
Total assets | 57,382 | 43,911 | |||
Liabilities | |||||
Current liabilities | |||||
Accounts payable and accrued liabilities | 2,875 | 3,282 | |||
Deferred revenue | 644 | 721 | |||
Long-term debt | 6,482 | 2,104 | |||
Lease liabilities | 253 | 259 | |||
Income taxes payable | 13 | - | |||
Total current liabilities | 10,267 | 6,366 | |||
Deferred tax liability | 59 | 59 | |||
Long-term debt | - | 5,000 | |||
Deferred revenue | 697 | 728 | |||
Lease liabilities | 501 | 578 | |||
Total liabilities | 11,524 | 12,731 | |||
Shareholders’ Equity | |||||
Share capital | 232,763 | 217,393 | |||
Contributed surplus | 19,985 | 19,687 | |||
Accumulated other comprehensive income | 17,240 | 12,031 | |||
Deficit | (224,130 | ) | (217,931 | ) | |
Total Shareholders’ Equity | 45,858 | 31,180 | |||
Total Liabilities and Shareholders’ Equity | 57,382 | 43,911 |
Interim Condensed Consolidated Statements of Loss and Comprehensive Loss
(Unaudited)
Three months ended 2024 $ | Three months ended 2023 $ | ||||
Revenue | |||||
Recurring - non-capital | 1,482 | 1,467 | |||
Capital equipment | 428 | 393 | |||
1,910 | 1,860 | ||||
Cost of sales | 641 | 647 | |||
Gross profit | 1,269 | 1,213 | |||
Operating expenses | |||||
Research and development | 3,933 | 3,840 | |||
General and administrative | 2,387 | 2,106 | |||
Selling and distribution | 2,431 | 2,105 | |||
Total operating expenses | 8,751 | 8,051 | |||
Operating loss | 7,482 | 6,838 | |||
Net finance expense (income) | (1,322 | ) | (145 | ) | |
Loss before income taxes | 6,160 | 6,693 | |||
Income tax expense | 39 | 48 | |||
Net loss attributed to shareholders for the period | 6,199 | 6,741 | |||
Other comprehensive (income) loss | |||||
Item that may be reclassified to loss | |||||
Foreign currency translation adjustment - net of tax | (5,209 | ) | 47 | ||
Net loss and comprehensive loss for the period | 990 | 6,788 | |||
Loss per share | |||||
Basic and diluted loss per common share | 0.26 | 0.32 |
Interim Condensed Consolidated Statements of Cash Flows
(Unaudited)
Three months ended 2024 $ | Three months ended 2023 $ | |||
Operating activities | ||||
Net loss for the period | (6,199 | ) | (6,741 | ) |
Adjustments to reconcile net loss to net cash flows from operating activities: | ||||
Depreciation of property and equipment | 199 | 179 | ||
Amortization of intangible assets | 51 | 50 | ||
Depreciation of right-of-use assets | 55 | 54 | ||
Share-based compensation | 767 | 941 | ||
Interest and accretion expense | 177 | 192 | ||
Deferred revenue | (107 | ) | 212 | |
Change in fair value of derivative financial instrument | - | (121 | ) | |
Net change in amortized cost of trade and other receivables | (69 | ) | (39 | ) |
Changes in non-cash working capital balances | ||||
Trade and other receivables | 854 | (600 | ) | |
Prepaid expenses and deposits | 553 | 364 | ||
Inventory | (180 | ) | (330 | ) |
Accounts payable and accrued liabilities | (570 | ) | (21 | ) |
Provisions | - | 6 | ||
Income taxes payable | 13 | 48 | ||
Foreign exchange on cash | (642 | ) | (17 | ) |
Net cash flow used in operating activities | (5,098 | ) | (5,823 | ) |
Financing activities | ||||
Issuance of common shares | 22,938 | - | ||
Transactions costs paid | (1,859 | ) | - | |
Payment of long-term debt | (623 | ) | (206 | ) |
Proceeds from warrants exercised | - | 2,423 | ||
Payment of lease liabilities | (73 | ) | (73 | ) |
Total cash flow from financing activities | 20,383 | 2,144 | ||
Net change in cash during the period | 15,285 | (3,679 | ) | |
Foreign exchange on cash | (318 | ) | 146 | |
Cash – Beginning of period | 26,213 | 46,517 | ||
Cash – End of period | 41,180 | 42,984 |
Source:
2024 GlobeNewswire, Inc., source