Form 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

_________________

FORM 8-K

_________________

CURRENT REPORT

Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported):  August 14, 2025

_______________________________

PROFOUND MEDICAL CORP.

(Exact name of registrant as specified in its charter)

_______________________________

Ontario, Canada001-39032Not Applicable
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

2400 Skymark Avenue, Unit 6

Mississauga, Ontario, Canada L4W 5K5

(Address of Principal Executive Offices) (Zip Code)

Registrant's Telephone Number, Including Area Code: 647-476-1350

 

 

(Former name or former address, if changed since last report)

_______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common SharesPROFThe Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 
 
Item 2.02. Results of Operations and Financial Condition.

 

       On August 14, 2025, the Company issued a press release to announce its unaudited financial results for the three and six months ended June 30, 2025 and provided a business update. A copy of the press release is furnished as Exhibit 99.1. 

 

       The information in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18, of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, and shall not be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
   
99.1 Press Release dated August 14, 2025
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 PROFOUND MEDICAL CORP.
   
  
Date: August 14, 2025By: /s/ Rashed Dewan        
  Rashed Dewan
  Chief Financial Officer
  

 

EXHIBIT 99.1

Profound Medical Announces Second Quarter 2025 Financial Results

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 at www.sedarplus.com, www.sec.gov and on Profound’s website at www.profoundmedical.com under “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 this link to receive the dial-in number and your unique PIN.

The call will also be broadcast live and archived on Profound's website at www.profoundmedical.com under "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 at www.sedarplus.ca and www.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.

For further information, please contact:

Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849

     
Profound Medical Corp.
CONDENSED CONSOLIDATED BALANCE SHEETS
(USD in thousands, except per share data)
(unaudited)
     
  June 30,
2025
$
December 31,
2024
$
 
     
 Assets   
     
 Current assets:   
 Cash35,19554,912 
 Trade and other receivables, net4,8987,045 
 Inventory8,3535,801 
 Prepaid expenses and deposits3651,307 
 Total current assets48,81169,065 
     
 Property and equipment, net278425 
 Intangible assets, net175261 
 Right-of-use assets, net303396 
 Deferred tax assets, net10187 
 Total assets49,66870,234 
     
 Liabilities   
     
 Current liabilities:   
 Accounts payable9491,317 
 Accrued expenses and other current liabilities3,8022,835 
 Deferred revenue694419 
 Long-term debt-1,737 
 Lease liabilities279257 
 Total current liabilities5,7246,565 
     
 Deferred revenue7449 
 Long-term debt4,4622,924 
 Lease liabilities72203 
 Other non-current liabilities7771 
 Total liabilities10,4099,812 
     
 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, respectively281,641281,552 
 Additional paid-in capital23,64921,298 
 Accumulated other comprehensive income5,5582,742 
 Accumulated deficit(271,589)(245,170) 
 Total shareholders’ equity39,25960,422 
     
 Total liabilities and shareholders’ equity49,66870,234 
     


Profound Medical Corp.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHESIVE LOSS
(USD in thousands, except per share data)
(unaudited)
          
  Three Months Ended
June 30,
 Six Months Ended
June 30,
 
  2025202420252024
  $$$$
      
 Revenue     
 Recurring - non-capital1,561 1,460 3,362 2,899 
 Capital equipment650 773 1,470 773 
  2,211 2,233 4,832 3,672 
 Cost of sales593 812 1,361 1,385 
 Gross profit1,618 1,421 3,471 2,287 
      
 Operating expenses    
 Research and development6,098 4,205 10,906 8,150 
 Selling, general and administrative9,326 5,058 17,537 9,856 
 Total operating expenses15,424 9,263 28,443 18,006 
      
 Operating loss13,806 7,842 24,972 15,719 
      
 Other (income) expenses    
 Net finance (income) expense(343)(422)(788)(884)
 Net foreign exchange (gain) loss2,168 (520)2,130 (1,390)
 Total other (income) expenses1,825 (942)1,342 (2,274)
      
 Net loss before income taxes15,631 6,900 26,314 13,445 
      
 Income tax expense 78 19 119 59 
 Deferred tax recovery(14)- (14)- 
 Total income tax expense64 19 105 59 
      
 Net loss attributed to shareholders for the period15,695 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 period12,982 7,389 23,603 14,943 
      
 Loss per share     
 Basic and diluted net loss per common share0.52 0.28 0.88 0.55 
 Basic and diluted weighted average common shares outstanding30,053,142 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,
  20252024
  $$
      
 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 equipment218 383 
 Amortization of intangible assets86 101 
 Non-cash lease expense adjustment(19) (21) 
 Share-based compensation2,440 1,535 
 Interest and accretion expense51 323 
 Change in amortized cost of trade and other receivables- (167) 
 Changes in operating assets and liabilities:  
 Trade and other receivables2,449 484 
 Inventory(2,723) (168) 
 Prepaid expenses and deposits1,042 773 
 Accounts payable, accrued expenses and other liabilities545 (507) 
 Deferred revenue317 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 cash2,600 (1,239) 
 Cash, beginning of period54,912 26,213 
 Cash, end of period35,195 34,079