Profound Medical Corp.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 7 May 2026: press release. Guidance figures: 2 new. The quarter’s numbers.

Key takeaways

Revenue more than doubled year over year: Revenue was $5.3 million, against $2.6 million a year earlier. Capital equipment supplied $2.9 million of it, up from $0.8 million. Source
Operating expenses fell 9%: Total operating expenses were $11.8 million, down from $13.0 million. Management cited lower salaries, sales force, travel, insurance premiums and clinical trial costs after CAPTAIN enrollment completion. Source
Net and operating loss narrowed: Net loss was about $7.0 million, or $0.19 per share, against $10.7 million, or $0.36 per share, in the prior-year quarter. Operating loss was $8.0 million against $11.2 million. Source
Installed base reached 80 systems: The TULSA-PRO installed base was 80 at quarter end. The company also shipped six more systems that had yet to be installed at that date. Source
Same-store procedures up 59%: The new TULSA INDEX20, 20 active commercial sites with at least 12 months of TULSA Procedures, averaged 11.3 procedures a quarter in Q1 2026, up from 7.1 a year earlier. Source
Humana matters for health systems: The company described Humana as one of the largest U.S. commercial payers, and crucial for many health systems given its large Medicare Advantage enrollment. Source
CAPTAIN showed superiority on safety: In March 2026 the company announced superiority on the prespecified primary safety endpoint of the Level 1 post-market CAPTAIN trial, which compares TULSA with robotic radical prostatectomy. Source
Full-year revenue about $25 million: Management projects 2026 total revenue of approximately $25 million, which it describes as 56% growth on prior-year revenue. Source

“We were also pleased to see statistically significant and clinically meaningful benefit from the TULSA Procedure beginning to readout from the randomized post-market CAPTAIN clinical trial”
Arun Menawat, Profound’s CEO and Chairman

Guidance

Area	Period	Figure	Against last quarter
Total revenue Source	Full year 2026	approximately $25 million	New
Gross margin Source	Full year 2026	70% or higher	New

What changed from last quarter

New guidance: Full-year 2026 revenue guidance issued at approximately $25 million, 56% growth on prior-year revenue. Source
New guidance: Full-year 2026 gross margin guidance issued at 70% or higher. Source
New: Humana became the first national U.S. payor to cover the TULSA Procedure. Source
New: TULSA INDEX20 introduced as a supplemental same-store volume measure across 20 sites. Source

Revenue and gross margin

Revenue more than doubled year over year: Revenue was $5.3 million, against $2.6 million a year earlier. Capital equipment supplied $2.9 million of it, up from $0.8 million. Source
Recurring revenue rose to $2.5 million: Recurring non-capital revenue, covering one-time use devices and extended warranty service, was $2.5 million, up from $1.8 million in the prior-year quarter. Source
Gross margin edged up on mix: Gross margin was 72%, up from 71% a year earlier. Management attributed the increase to product mix, with more capital equipment sold, which carries a higher margin. Source

Operating costs and net loss

Operating expenses fell 9%: Total operating expenses were $11.8 million, down from $13.0 million. Management cited lower salaries, sales force, travel, insurance premiums and clinical trial costs after CAPTAIN enrollment completion. Source
Consulting spend rose on R&D work: Consulting expenditures increased, partly offsetting the decline, for R&D initiatives aimed at reducing design costs and improving quality and efficiencies of the company’s products. Source
Net and operating loss narrowed: Net loss was about $7.0 million, or $0.19 per share, against $10.7 million, or $0.36 per share, in the prior-year quarter. Operating loss was $8.0 million against $11.2 million. Source

“These and other anticipated tailwinds, including the expansion of payer coverage for the TULSA Procedure, give us confidence that we are moving closer to a pivotal inflection point in our growth trajectory.”
Arun Menawat, Profound’s CEO and Chairman

Installed base and procedure volume

Installed base reached 80 systems: The TULSA-PRO installed base was 80 at quarter end. The company also shipped six more systems that had yet to be installed at that date. Source
Same-store procedures up 59%: The new TULSA INDEX20, 20 active commercial sites with at least 12 months of TULSA Procedures, averaged 11.3 procedures a quarter in Q1 2026, up from 7.1 a year earlier. Source
Sequential growth in each quarter: Quarter-over-quarter growth in the index was 15%, 5%, 20% and 10% across the four most recent quarters, with annualized average procedures reaching 45.2 in Q1 2026. Source
Index spans U.S. and international sites: The index includes teaching hospitals and private-pay practices. Of its sites, 80% are in the U.S. and 20% are international. Source

Clinical use and site milestones

Malignant tissue ablation was 71%: Ablation of malignant prostate tissue accounted for 71% of cases, with the grade split of 9% GG1, 61% GG2, 21% GG3 and 9% GG4 and GG5. Source
Whole-gland treatment was largest share: By intention-to-treat, whole-gland treatment was 42%, sub-total but more than half the gland 26%, hemi-ablation 23% and focal therapy 9%. Source
Most treated prostates were 20-40 cc: By prostate size, 44% were 20-40 cc, 29% were 40-60 cc, 15% were 60-100 cc, 8% were under 20 cc and 4% were over 100 cc. Source
Texas Prostate milestone in March: The site achieved its 100th TULSA Procedure in March 2026. Its TULSA-PROgram model, launched in September 2025, runs cases in a Dallas Medical Center MRI suite. Source
Presentations at SIR meeting: The TULSA Procedure was highlighted in several presentations at the 2026 Society of Interventional Radiology Annual Scientific Meeting, held in Toronto in April. Source

Payer coverage and CAPTAIN results

Humana matters for health systems: The company described Humana as one of the largest U.S. commercial payers, and crucial for many health systems given its large Medicare Advantage enrollment. Source
Covered lives added in quarter: About 8.5 million covered lives were added in the first quarter, of which 6.9 million came from Humana alone. Source
CAPTAIN showed superiority on safety: In March 2026 the company announced superiority on the prespecified primary safety endpoint of the Level 1 post-market CAPTAIN trial, which compares TULSA with robotic radical prostatectomy. Source

Cash, balance sheet and shares

Cash fell to $50.3 million: Cash was $50.3 million at March 31, 2026, down from $59.7 million at December 31, 2025, after operating cash use and a $0.8 million negative effect from exchange rate changes. Source
Operating cash outflow was $8.6 million: Net cash used in operating activities was $8.6 million, against $8.3 million a year earlier. No long-term debt was repaid in the quarter, versus $0.3 million in the prior-year quarter. Source
Receivables and inventory grew: Trade and other receivables rose to $9.4 million from $7.2 million, and inventory to $9.0 million from $8.2 million, over the quarter. Source
Long-term debt shown as current: Long-term debt of $4.5 million is classified under current liabilities at March 31, 2026, compared with non-current at December 31, 2025. Source
Share count rose to 36.3 million: As of May 7, 2026, the company had 36,337,637 common shares issued and outstanding, against 36,293,640 at December 31, 2025. Source

Full-year 2026 guidance

Full-year revenue about $25 million: Management projects 2026 total revenue of approximately $25 million, which it describes as 56% growth on prior-year revenue. Source
Gross margin of 70% or higher: Full-year 2026 gross margin is expected to be 70% or higher, compared with the 72% reported for the first quarter. Source
2025 revenue base of $16.1 million: Full-year 2025 revenue was $16.1 million, per the prior release, the base against which the 56% growth in the 2026 projection is measured.

Coming up, as management said on 7 May 2026

Further CAPTAIN outcomes due later this year: Management said it will announce additional clinical outcomes from the study when they become available later this year. Source
Payer coverage work continues: The company said it will keep working with payers, providers and health systems to expand coverage and streamline patient access pathways. Source

Figures management reported

Figure	Reported
TULSA-PRO installed base, end of Q1 2026 (systems) Source	80
Systems shipped and not yet installed, Q1 2026 Source	6
TULSA INDEX20 active commercial sites Source	20
TULSA INDEX20 average procedures per quarter, Q1 2026 Source	11.3
TULSA INDEX20 average procedures annualized, Q1 2026 Source	45.2
TULSA INDEX20 year-over-year growth Source	59%

Risks management discussed

Demand: Management said short-term revenue is difficult for investors to predict, and it framed the annual revenue figure as a reasonable bar. Source

Earlier plans management reported on

Not stated: The prior release said the first CAPTAIN clinical outcomes would be presented at the EAU congress. The current release does not state whether that presentation took place.
Not stated: The prior release expected about 120 installs by the end of 2026. The current release does not restate or update that expectation.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.

As filed with the SEC

Open the filing on EDGAR

Profound Medical Reports Strong First Quarter 2026 Financial Results

Quarterly results marked by 104% revenue growth and improved operating performance -
Company issues full-year 2026 revenue guidance -
Announces Humana is now covering the TULSA Procedure™ -

TORONTO, May 07, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets innovative interventional MRI (“iMRI”) procedures, today reported financial results for the first quarter ended March 31, 2026. 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).

“We continued to execute well across our business in the first quarter, delivering triple-digit revenue growth combined with strong gross margin and lower operating expenses. We were also pleased to see statistically significant and clinically meaningful benefit from the TULSA Procedure beginning to readout from the randomized post-market CAPTAIN clinical trial comparing it to robotic radical prostatectomy, the current standard of care,” said Arun Menawat, Profound’s CEO and Chairman. “These and other anticipated tailwinds, including the expansion of payer coverage for the TULSA Procedure, give us confidence that we are moving closer to a pivotal inflection point in our growth trajectory. Nevertheless, it continues to be difficult for the investment community to accurately predict our revenues in the short-term. Accordingly, we are setting what we believe is a reasonable bar for our total annual revenue in 2026.”

Business Highlights

Profound’s TULSA-PRO installed base stood at 80 at the end of Q1-2026, and the Company shipped an additional six (6) systems during the first quarter that had yet to be installed.
In March 2026, Profound announced superiority on the prespecified, primary safety endpoint in the Level 1 post-market CAPTAIN randomized controlled trial comparing the TULSA Procedure with robotic radical prostatectomy in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. The Company looks forward to announcing additional clinical outcomes from this unique, potentially paradigm-changing study when they become available later this year.
Also in March, Texas Prostate achieved its 100 TULSA Procedure. Prior to that, in September 2025, Profound announced the launch of a first-of-its-kind ‘TULSA-PROgram’ under which Texas Prostate began performing TULSA Procedures for men with disease conditions requiring prostate tissue ablation in Dallas Medical Center’s state-of-the-art MRI suite. This model - bridging private-pay practices and Medicare-participating hospitals - is designed to allow more men to benefit from the TULSA Procedure’s versatility across several prostate conditions requiring medical intervention.
In April 2026, the TULSA Procedure was highlighted in several presentations at the 2026 Society of Interventional Radiology (SIR) Annual Scientific Meeting, which was held in Toronto, ON.
Today, Profound is pleased to announce that Humana has become the first national payor in the United States to cover the TULSA Procedure. Humana is one of the largest commercial payers in the U.S., and crucial for many health systems due to its large Medicare Advantage enrollment numbers. The addition of approximately 8.5 million covered lives in the first quarter (6.9 million covered lives with Humana alone) represents meaningful progress toward ensuring more patients have access to the TULSA Procedure. Profound will continue to work collaboratively with payers, providers, and health systems to expand coverage and streamline patient access pathways for the TULSA Procedure.

Q1-2026 Clinical Utilization Trends

Physicians continued to utilize the TULSA Procedure’s customizable prostate tissue ablation capabilities in the first quarter of 2026:

Prostate Condition

Ablation of malignant prostate tissue	Ablation of malignant and benign enlarged prostate tissue	Ablation of recurrent malignant prostate tissue	Ablation of benign enlarged prostate tissue
71% (9% GG1, 61% GG2, 21% GG3, 9% GG4&5)	16%	9%	4%

Intention-to-Treat

Whole-gland	Sub-total but more than half the gland	Hemi-ablation	Focal therapy
42%	26%	23%	9%

Prostate Size

< 20 cc	20-40 cc	40-60 cc	60-100 cc	> 100 cc
8%	44%	29%	15%	4%

TULSA INDEX20

The following table sets out a supplemental ‘same-store’ TULSA Procedure volume analysis designed to assist investors in following the Company’s progress over time. As the name implies, this new TULSA INDEX20 is comprised of 20 active commercial sites that have been performing TULSA Procedures for at least 12-months. The index includes a representative variety of providers, including teaching hospitals and private-pay practices. Geographically, 80% of the index sites are in the U.S. and 20% are international.

TULSA INDEX20	Q1-2025	Q2-2025	Q3-2025	Q4-2025	Q1-2026
# TULSA Sites	20	20	20	20	20
Average Procedures/Quarter	7.1	8.2	8.6	10.3	11.3
Average Procedures Annualized	28.4	32.8	34.4	41.2	45.2
Quarter-Over-Quarter Sequential Growth		15%	5%	20%	10%
Year-Over-Year Growth					59%

Summary First Quarter 2026 Results

For the quarter ended March 31, 2026, Profound recorded revenue of approximately $5.3 million, with $2.5 million from recurring - non-capital revenue, which consists of the sale of one-time use devices and services associated with extended warranties, and $2.9 million from the one-time sale of capital equipment. First quarter 2026 revenue was up 104% from $2.6 million for the same three-month period a year ago.

Gross margin for the first quarter of 2026 was 72%, up marginally from 71% in the prior year period. The increase in first quarter 2026 gross margin was primarily due to product mix whereby more capital equipment was sold which contains a higher margin.

Total operating expenses in the first quarter of 2026 were approximately $11.8 million, down 9% from $13.0 million in the prior year period. The decrease in operating expenses was primarily due to decreases in salaries, sales force, travel expenses, insurance premiums, and clinical trial costs due to CAPTAIN trial enrollment completion, partially offset by increases in consulting expenditures due to spending on R&D initiatives to reduce design costs and improve quality and efficiencies with the Company’s products.

First quarter 2026 net loss was approximately $7.0 million, or $0.19 per common share, a 34% improvement from a net loss of approximately $10.7 million, or $0.36 per common share, in the three months ended March 31, 2025.

Liquidity and Outstanding Share Capital

As at March 31, 2026, Profound had cash of approximately $50.3 million.

As at May 7, 2026, Profound had 36,337,637 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 under “SEC & SEDAR+ Filings.”

Full Year 2026 Financial Outlook

The Company projects total revenue for full-year 2026 to be approximately $25 million, which represents 56% growth compared to its prior year revenue. The Company also expects full year 2026 gross margin to be 70% or higher.

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 dial 1-800-717-1738 (North America) or 1-646-307-1865 (International). The call will also be broadcast live and archived on Profound's website in the Investors section here.

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI (iMRI) procedures. The company’s flagship platform, TULSA-PRO®, enables MRI-guided, incision-free prostate ablation. Physicians use the TULSA Procedure™ to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care - from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound also commercializes Sonalleve®, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumors, and osteoid osteoma, as well as for common gynecologic conditions including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay, and faster recovery - and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies.

Profound Medical’s technologies are approved across major global markets. TULSA-PRO is cleared by the FDA in the United States for transurethral ultrasound ablation (TULSA) of prostate tissue. In addition, TULSA-PRO is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand, and the UAE. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China, and Saudi Arabia.

Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy - expanding access to precise, personalized, and incision-free treatment options worldwide.

Forward-Looking Statements

Forward-looking statements notice

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 technologies for disease conditions requiring MR-Guided ablation procedures for prostate, uterine fibroids, adenomyosis, palliative pain treatment, desmoid tumors, and osteoid osteoma; the extent and timing of Profound’s completion of TULSA-PRO® and Sonalleve® system sales; Profound’s expectations for future revenues/financial results; and the success of Profound’s commercialization strategy and activities for TULSA-PRO and Sonalleve. 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.com 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.

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 December 31, 2026, and may not be appropriate for any other purpose. The financial outlook has been prepared based on a number of assumptions, including the assumptions discussed under the heading “Forward-Looking Statements” herein. The actual results of the Company’s operations for any period may vary from the amounts set forth in these projections, and such variations may be material. The Company and its management believe that the financial outlook has been prepared on a reasonable basis. However, because this information is highly subjective and subject to numerous risks, including the risks discussed under the heading “Forward-Looking Statements” herein, it should not be relied on as necessarily indicative of future results.

For further information, please contact:

Stephen Kilmer Investor Relations skilmer@profoundmedical.com T: 647.872.4849

Profound Medical Corp. CONDENSED CONSOLIDATED BALANCE SHEETS (USD in thousands, except per share data) (unaudited)

	March 31, 2026 $	December 31, 2025 $
Assets
Current assets:
Cash	50,295	59,723
Trade and other receivables, net	9,423	7,200
Inventory	9,001	8,238
Prepaid expenses and deposits	811	928
Total current assets	69,530	76,089
Trade and other receivables, net	150	300
Property and equipment, net	682	698
Intangible assets, net	129	138
Right-of-use assets, net	2,897	184
Deferred tax assets, net	68	66
Total assets	73,456	77,475
Liabilities
Current liabilities:
Accounts payable	2,142	1,563
Accrued expenses and other current liabilities	3,389	3,815
Deferred revenue	464	445
Long-term debt	4,503	-
Lease liabilities	68	213
Income tax payable	41	39
Total current liabilities	10,607	6,075
Deferred revenue	441	388
Long-term debt	-	4,499
Lease liabilities	2,892	-
Other non-current liabilities	92	79
Total liabilities	14,032	11,041
Shareholders’ equity
Common shares, no par value, unlimited shares authorized, 36,337,637 and 36,293,640 issued and outstanding at March 31, 2026 and December 31, 2025, respectively	324,163	323,839
Additional paid-in capital	26,034	25,310
Accumulated other comprehensive income	4,020	5,025
Accumulated deficit	(294,793)	(287,740)
Total shareholders’ equity	59,424	66,434
Total liabilities and shareholders’ equity	73,456	77,475

Profound Medical Corp. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (USD in thousands, except per share data) (unaudited)

	Three Months Ended March 31,
	2026 $	2025 $
Revenue
Recurring - non-capital	2,474	1,801
Capital equipment	2,863	820
	5,337	2,621
Cost of sales	1,505	768
Gross profit	3,832	1,853
Operating expenses
Research and development	5,262	4,808
Selling, general and administrative	6,591	8,211
Total operating expenses	11,853	13,019
Operating loss	8,021	11,166
Other (income) expenses
Net finance (income) expense	(377)	(445)
Net foreign exchange (gain) loss	(616)	(38)
Total other (income) expenses	(993)	(483)
Net loss before income taxes	7,028	10,683
Income tax expense	27	41
Deferred tax expense	(2)	-
Total income tax expense	25	41
Net loss attributed to shareholders for the period	7,053	10,724
Other comprehensive (income) loss
Item that may be reclassified to (income) loss
Foreign currency translation adjustment	1,005	(103)
Net loss and other comprehensive loss for the period	8,058	10,621
Loss per share
Basic and diluted net loss per common share	0.19	0.36
Basic and diluted weighted average common shares outstanding	36,297,684	30,041,735

Profound Medical Corp. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD in thousands, except per share data) (unaudited)

	Three Months Ended March 31,
	2026 $	2025 $
Cash flows from operating activities
Net loss for the period	(7,054)	(10,724)
Adjustments to reconcile net loss to net cash provided by operating activities:
Depreciation of property and equipment	93	116
Amortization of intangible assets	7	47
Non-cash lease expense adjustment	50	(9)
Share-based compensation	1,048	989
Interest and accretion expense	5	48
Changes in operating assets and liabilities:
Trade and other receivables	(2,240)	1,090
Inventory	(996)	(984)
Prepaid expenses and deposits	105	592
Accounts payable, accrued expenses and other liabilities	311	300
Deferred revenue	88	252
Income taxes payable	2	-
Deferred tax asset	(3)	-
Net cash used in operating activities	(8,584)	(8,283)
Cash flows from financing activities
Repayments of long-term debt	-	(290)
Net cash provided by (used in) financing activities	-	(290)
Net increase (decrease) in cash	(8,584)	(8,573)
Effect of exchange rate changes on cash	(844)	94
Cash, beginning of period	59,723	54,912
Cash, end of period	50,295	46,433