Full Press Release Details
TORONTO, Aug. 14, 2025 (GLOBE NEWSWIRE) --Profound Medical Corp.(NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, today reported unaudited financial results for the second quarter ended June 30, 2025. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepted accounting principles (U.S. GAAP).
Business Highlights
“The second quarter was characterized by some unfortunate timing, as we experienced what we believe are short-term delays in completing a few TULSA-PRO®capital sales,” said Arun Menawat, Profound’s CEO and Chairman. “Had these occurred in the quarter, total revenues would have been over $3 million. With this, combined with our large and growing TULSA-PRO®system capital sales pipeline, and the strong TULSA procedure volume growth we are seeing, we continue to work towards achieving total year-over-year revenue growth at an approximate range of 70% to 75% in 2025.”
Summary Second Quarter 2025 Results
For the quarter ended June 30, 2025, Profound recorded revenue of approximately $2.2 million, with $1.6 million from recurring - non-capital revenue, which consists of the sale of TULSA-PRO®consumables, lease of capital equipment and services associated with extended warranties, and $650,000 from the one-time sale of capital equipment. Second quarter 2025 revenue was essentially unchanged from the same three-month period a year ago.
Gross margin for the second quarter of 2025 was 73%, compared to 64% in the prior year period. Gross margin expansion in the 2025 second quarter was primarily due to manufacturing operating at higher efficiency rates based on improvements that have been implemented.
Total operating expenses in the second quarter of 2025 were approximately $15.4 million, compared with $9.3 million in the prior year period. The increase in operating expenses was primarily due to increased headcount, increased enrolment for the CAPTAIN trial, treatments and recruitment efforts, increased sales force, commission payments, and increased travel and infrastructure costs to support the Company’s growth.
Second quarter 2025 net loss was approximately $15.7 million, or $0.52 per common share, compared to approximately $6.9 million, or $0.28 per common share, in the three months ended June 30, 2024.
Liquidity and Outstanding Share Capital
As at June 30, 2025, Profound had cash of approximately $35.2 million.
As at August 14, 2025, Profound had 30,053,142 common shares issued and outstanding.
For complete financial results, please see Profound’s filings, which will be made available under Profound’s profile atwww.sedarplus.com,www.sec.govand on Profound’s website atwww.profoundmedical.comunder “Financial” in the Investors section. A hard copy of Profound’s annual report can also be requested free of charge at the bottom of the Investors section of its website.
Conference Call Details
Profound Medical is pleased to invite all interested parties to participate in a conference call today at 4:30 pm ET during which time the results will be discussed.
To participate in the conference call by telephone, please pre-register via thislinkto receive the dial-in number and your unique PIN.
The call will also be broadcast live and archived on Profound's website atwww.profoundmedical.comunder "Webcasts" in the Investors section.
About Profound Medical Corp.
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, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA procedure, performed using the TULSA-PRO®system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. TULSA employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO®is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).
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 China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve®where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
Forward-Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO®system sales from its qualified sales pipeline; Profound’s full year 2025 revenue growth; and the success of Profound’s U.S. commercialization strategy and activities for TULSA-PRO®. 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. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound's Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available atwww.sedarplus.caandwww.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
| Profound Medical Corp.CONDENSED CONSOLIDATED BALANCE SHEETS(USD in thousands, except per share data)(unaudited) | ||||
| June 30,2025$ | December 31,2024$ | |||
| Assets | ||||
| Current assets: | ||||
| Cash | 35,195 | 54,912 | ||
| Trade and other receivables, net | 4,898 | 7,045 | ||
| Inventory | 8,353 | 5,801 | ||
| Prepaid expenses and deposits | 365 | 1,307 | ||
| Total current assets | 48,811 | 69,065 | ||
| Property and equipment, net | 278 | 425 | ||
| Intangible assets, net | 175 | 261 | ||
| Right-of-use assets, net | 303 | 396 | ||
| Deferred tax assets, net | 101 | 87 | ||
| Total assets | 49,668 | 70,234 | ||
| Liabilities | ||||
| Current liabilities: | ||||
| Accounts payable | 949 | 1,317 | ||
| Accrued expenses and other current liabilities | 3,802 | 2,835 | ||
| Deferred revenue | 694 | 419 | ||
| Long-term debt | - | 1,737 | ||
| Lease liabilities | 279 | 257 | ||
| Total current liabilities | 5,724 | 6,565 | ||
| Deferred revenue | 74 | 49 | ||
| Long-term debt | 4,462 | 2,924 | ||
| Lease liabilities | 72 | 203 | ||
| Other non-current liabilities | 77 | 71 | ||
| Total liabilities | 10,409 | 9,812 | ||
| Shareholders’ equity | ||||
| Common shares, no par value, unlimited shares authorized, 30,053,142 and 30,039,809 issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 281,641 | 281,552 | ||
| Additional paid-in capital | 23,649 | 21,298 | ||
| Accumulated other comprehensive income | 5,558 | 2,742 | ||
| Accumulated deficit | (271,589) | (245,170) | ||
| Total shareholders’ equity | 39,259 | 60,422 | ||
| Total liabilities and shareholders’ equity | 49,668 | 70,234 | ||
| Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHESIVE LOSS(USD in thousands, except per share data)(unaudited) | |||||||||
| Three Months EndedJune 30, | Six Months EndedJune 30, | ||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||
| $ | $ | $ | $ | ||||||
| Revenue | |||||||||
| Recurring - non-capital | 1,561 | 1,460 | 3,362 | 2,899 | |||||
| Capital equipment | 650 | 773 | 1,470 | 773 | |||||
| 2,211 | 2,233 | 4,832 | 3,672 | ||||||
| Cost of sales | 593 | 812 | 1,361 | 1,385 | |||||
| Gross profit | 1,618 | 1,421 | 3,471 | 2,287 | |||||
| Operating expenses | |||||||||
| Research and development | 6,098 | 4,205 | 10,906 | 8,150 | |||||
| Selling, general and administrative | 9,326 | 5,058 | 17,537 | 9,856 | |||||
| Total operating expenses | 15,424 | 9,263 | 28,443 | 18,006 | |||||
| Operating loss | 13,806 | 7,842 | 24,972 | 15,719 | |||||
| Other (income) expenses | |||||||||
| Net finance (income) expense | (343 | ) | (422 | ) | (788 | ) | (884 | ) | |
| Net foreign exchange (gain) loss | 2,168 | (520 | ) | 2,130 | (1,390 | ) | |||
| Total other (income) expenses | 1,825 | (942 | ) | 1,342 | (2,274 | ) | |||
| Net loss before income taxes | 15,631 | 6,900 | 26,314 | 13,445 | |||||
| Income tax expense | 78 | 19 | 119 | 59 | |||||
| Deferred tax recovery | (14 | ) | - | (14 | ) | - | |||
| Total income tax expense | 64 | 19 | 105 | 59 | |||||
| Net loss attributed to shareholders for the period | 15,695 | 6,919 | 26,419 | 13,504 | |||||
| Other comprehensive (income) loss | |||||||||
| Item that may be reclassified to (income) loss | |||||||||
| Foreign currency translation adjustment | (2,713 | ) | 470 | (2,816 | ) | 1,439 | |||
| Net loss and other comprehensive loss for the period | 12,982 | 7,389 | 23,603 | 14,943 | |||||
| Loss per share | |||||||||
| Basic and diluted net loss per common share | 0.52 | 0.28 | 0.88 | 0.55 | |||||
| Basic and diluted weighted average common shares outstanding | 30,053,142 | 24,440,444 | 30,055,047 | 24,373,869 | |||||
| Profound Medical Corp.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS(USD in thousands, except per share data)(unaudited) | |||||
| Six Months Ended June 30, | |||||
| 2025 | 2024 | ||||
| $ | $ | ||||
| Cash flows from operating activities | |||||
| Net loss for the period | (26,419) | (13,504) | |||
| Adjustments to reconcile net loss to net cash provided by operating activities: | |||||
| Depreciation of property and equipment | 218 | 383 | |||
| Amortization of intangible assets | 86 | 101 | |||
| Non-cash lease expense adjustment | (19) | (21) | |||
| Share-based compensation | 2,440 | 1,535 | |||
| Interest and accretion expense | 51 | 323 | |||
| Change in amortized cost of trade and other receivables | - | (167) | |||
| Changes in operating assets and liabilities: | |||||
| Trade and other receivables | 2,449 | 484 | |||
| Inventory | (2,723) | (168) | |||
| Prepaid expenses and deposits | 1,042 | 773 | |||
| Accounts payable, accrued expenses and other liabilities | 545 | (507) | |||
| Deferred revenue | 317 | 18 | |||
| Deferred tax liabilities | (14) | 2 | |||
| Net cash used in operating activities | (22,027) | (10,748) | |||
| Cash flows from financing activities | |||||
| Repayments of long-term debt | (290) | (1,227) | |||
| Issuance of commons shares | - | 22,938 | |||
| Payments of financing costs | - | (1,859) | |||
| Proceeds from the exercise of stock options | - | 1 | |||
| Net cash provided by (used in) financing activities | (290) | 19,853 | |||
| Net increase (decrease) in cash and cash equivalents | (22,317) | 9,105 | |||
| Effect of exchange rate changes on cash | 2,600 | (1,239) | |||
| Cash, beginning of period | 54,912 | 26,213 | |||
| Cash, end of period | 35,195 | 34,079 | |||