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Profound Medical Announces Preliminary Unaudited Fourth Quarter and Full Year 2024 Revenues

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Profound Medical (NASDAQ:PROF) announced preliminary unaudited revenues for Q4 and full year 2024. The company expects Q4 2024 revenue between $4.1-4.2 million, representing 105-110% year-over-year growth and 45-48% sequential growth. Full year 2024 revenue is anticipated at $11.1-11.2 million, compared to $7.2 million in 2023.

Starting January 1, 2025, Profound will transition to reporting financial results under U.S. GAAP and file domestic forms with the SEC, while maintaining SEDAR+ filings in Canada. The company recently completed an underwritten public offering of common shares and achieved unique reimbursement for its TULSA procedure at Urology APC Level 7 across multiple treatment settings.

Profound Medical (NASDAQ:PROF) ha annunciato i ricavi preliminari non verificati per il quarto trimestre e l'intero anno 2024. L'azienda prevede ricavi per il quarto trimestre 2024 compresi tra $4.1-4.2 milioni, che rappresentano una crescita del 105-110% rispetto all'anno precedente e una crescita sequenziale del 45-48%. I ricavi totali per l'anno 2024 sono previsti tra $11.1-11.2 milioni, rispetto ai $7.2 milioni del 2023.

A partire dal 1° gennaio 2025, Profound passerà a riportare i risultati finanziari secondo i principi contabili GAAP statunitensi e presenterà modulistica domestica alla SEC, mantenendo però i depositi SEDAR+ in Canada. Recentemente, l'azienda ha completato un'offerta pubblica di azioni ordinarie e ha ottenuto una rimborsabilità unica per la sua procedura TULSA al livello 7 dell'Urologia APC in diversi contesti di trattamento.

Profound Medical (NASDAQ:PROF) anunció ingresos preliminares no auditados para el cuarto trimestre y todo el año 2024. La compañía espera ingresos para el cuarto trimestre de 2024 entre $4.1-4.2 millones, lo que representa un crecimiento del 105-110% interanual y un crecimiento secuencial del 45-48%. Se anticipa que los ingresos totales para 2024 se sitúen entre $11.1-11.2 millones, en comparación con los $7.2 millones de 2023.

A partir del 1 de enero de 2025, Profound comenzará a informar los resultados financieros bajo GAAP de EE. UU. y presentará formularios domésticos ante la SEC, mientras mantiene los depósitos SEDAR+ en Canadá. Recientemente, la empresa completó una oferta pública de acciones comunes y logró un reembolso único para su procedimiento TULSA a nivel 7 del APC Urológico en múltiples entornos de tratamiento.

Profound Medical (NASDAQ:PROF)은 2024년 4분기 및 전체 연도에 대한 잠정적인 감사되지 않은 수익을 발표했습니다. 회사는 2024년 4분기 수익을 $4.1-4.2 백만으로 예상하며, 이는 전년 대비 105-110%의 성장과 전분기 대비 45-48%의 성장을 나타냅니다. 2024년 전체 연도 수익은 $11.1-11.2 백만으로 예상되며, 이는 2023년의 $7.2 백만과 비교됩니다.

2025년 1월 1일부터 Profound는 미국 GAAP에 따라 재무 결과를 보고하고 SEC에 국내 양식을 제출할 예정이며, 캐나다에서는 SEDAR+ 제출을 유지할 것입니다. 회사는 최근 보통주 공모를 완료했으며, 여러 치료 환경에서 비뇨기 APC 수준 7에서 TULSA 절차에 대한 독특한 보험 환급을 성공적으로 획득했습니다.

Profound Medical (NASDAQ:PROF) a annoncé des revenus préliminaires non audités pour le quatrième trimestre et pour l'année 2024. La société prévoit des revenus pour le quatrième trimestre 2024 compris entre $4.1-4.2 millions, représentant une croissance de 105-110% d'une année sur l'autre et une croissance séquentielle de 45-48%. Les revenus totaux pour l'année 2024 sont anticipés entre $11.1-11.2 millions, par rapport à 7.2 millions de dollars en 2023.

À partir du 1er janvier 2025, Profound passera à la présentation des résultats financiers selon les normes GAAP américaines et déposera des formulaires nationaux auprès de la SEC, tout en maintenant les dépôts SEDAR+ au Canada. Récemment, l'entreprise a achevé une offre publique sous garantie d'actions ordinaires et a obtenu un remboursement unique pour sa procédure TULSA au niveau 7 de l'APC en urologie dans différents contextes de traitement.

Profound Medical (NASDAQ:PROF) gab vorläufige, nicht getestete Einnahmen für das vierte Quartal und das gesamte Jahr 2024 bekannt. Das Unternehmen erwartet im vierten Quartal 2024 Einnahmen zwischen $4.1-4.2 Millionen, was einem Wachstum von 105-110% im Vergleich zum Vorjahr und einem sequenziellen Wachstum von 45-48% entspricht. Die Gesamteinnahmen für das Jahr 2024 werden auf $11.1-11.2 Millionen geschätzt, verglichen mit 7.2 Millionen Dollar im Jahr 2023.

Ab dem 1. Januar 2025 wird Profound die Finanzberichte nach US-GAAP erstellen und heimische Formulare bei der SEC einreichen, während gleichzeitig die SEDAR+-Einreichungen in Kanada beibehalten werden. Das Unternehmen hat kürzlich ein unterzeichnetes öffentliches Angebot für Stammaktien abgeschlossen und einzigartige Rückerstattungen für das TULSA-Verfahren auf Urologie APC Niveau 7 in verschiedenen Behandlungssettings erreicht.

Positive
  • Q4 2024 revenue growth of 105-110% year-over-year
  • Sequential Q4 revenue growth of 45-48%
  • Full year 2024 revenue increased to $11.1-11.2M from $7.2M in 2023
  • Secured unique reimbursement for TULSA procedure at Urology APC Level 7
  • Strengthened balance sheet through public offering completion
Negative
  • None.

Insights

The preliminary Q4 2024 results demonstrate remarkable momentum with revenue estimated at $4.1-4.2 million, marking a substantial 105-110% year-over-year growth and 45-48% sequential increase. Full-year revenue projections of $11.1-11.2 million vs $7.2 million in 2023 indicate strong market penetration. Two critical developments enhance growth prospects: 1) The transition from patient-pay to insurance coverage for TULSA procedures, with unique reimbursement at Urology APC Level 7 across multiple treatment settings, should significantly expand market access. 2) The recent capital raise strengthens the balance sheet, providing runway for commercial expansion. The shift to U.S. GAAP reporting aligns with the company's increasing U.S. investor base and enhances financial transparency. These developments position PROF for accelerated growth in 2025.

The transition from self-pay to insurance coverage represents a pivotal inflection point for TULSA-PRO® adoption. Securing APC Level 7 reimbursement is particularly significant as it typically indicates procedures with higher complexity and value, potentially translating to better provider economics. The 105-110% YoY revenue growth suggests strong clinical acceptance of the technology even in a predominantly self-pay environment. With reimbursement barriers now addressed and multiple treatment setting options available, the addressable market should expand substantially. The sequential growth of 45-48% indicates building commercial momentum and growing physician comfort with the technology. These metrics suggest TULSA-PRO® is gaining traction in the competitive prostate treatment landscape.

– Fourth quarter revenue growth estimated at 105% to 110% year-over-year –

– Company to start reporting in accordance with U.S. GAAP and filing with the SEC on U.S. domestic forms –

– Profound reminds investors that it is scheduled to present at JPM 2025 on January 16th at 11:15 a.m. PT –

TORONTO, Jan. 08, 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, incision-free therapies for the ablation of diseased tissue, today announced preliminary unaudited revenues for the fourth quarter and full year 2024.

Profound anticipates total revenue for the fourth quarter of 2024 to be in the approximate range of $4.1 million to $4.2 million, representing year-over-year growth of between 105% and 110%, and sequential quarter-over-quarter growth of between 45% and 48%. Full year 2024 total revenue is expected to be approximately $11.1 million to $11.2 million, compared to approximately $7.2 million in the prior year period. These figures are preliminary and unaudited, and actual revenues may differ.

Profound is providing this information due to planned investment community meetings to be held in connection with, among other investor events, the 43rd Annual J.P. Morgan Healthcare Conference (“JPM 2025”) in San Francisco, CA. Profound is scheduled to present at JPM 2025 on Thursday, January 16th at 11:15 a.m. Pacific Time. The presentation will be broadcast live and archived on the Company's website at www.profoundmedical.com under "Webcasts" in the Investors section.

Profound also announced that, as of January 1, 2025, it will start reporting its financial results in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and its status in the United States transitioned to a foreign private issuer filing via domestic forms (e.g. Forms 10-K, 10-Q, and 8-K) with the U.S. Securities and Exchange Commission (“SEC”). The Company will continue to use the United States dollar as its presentation currency and, in Canada, will also continue to file all required filings under its SEDAR+ profile.

“In light of the fact that 2024 marked the final year in which we were operating in a primarily patient-pay environment for TULSA, we were excited to see adoption of TULSA-PRO® continue to increase,” said Arun Menawat, Profound’s CEO and Chairman. “Now, with the strengthening of our balance sheet via the completion of our underwritten public offering of common shares in December, and, as of last week, the TULSA procedure being uniquely reimbursed both at Urology APC Level 7 and at an unrivalled number of treatment settings, we believe that we are on the cusp of entering into a stage of escalating growth.”

Dr. Menawat continued, “We look forward to updating investors as we progress. To that end, and recognizing that the majority of our shareholders are U.S.-based, we believe changing our financial reporting from IFRS to U.S. GAAP, and starting to file on U.S. domestic forms with the SEC, will make it easier for investors to find, access and analyse our stock regulatory filings.”

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, 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. The Company 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, any express or implied statements or guidance regarding current or future financial performance and position, including the Company’s results for the three and 12 months ended December 31, 2024, 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 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, 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. 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. 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 Canadian 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 three and 12 months to be ended December 31, 2024 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 will likely 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


FAQ

What is Profound Medical's (PROF) expected revenue for Q4 2024?

Profound Medical expects Q4 2024 revenue to be between $4.1-4.2 million, representing 105-110% year-over-year growth.

How much revenue did PROF generate in full year 2024?

Profound Medical anticipates full year 2024 revenue to be approximately $11.1-11.2 million, compared to $7.2 million in 2023.

When will Profound Medical (PROF) transition to U.S. GAAP reporting?

Profound Medical will begin reporting financial results under U.S. GAAP starting January 1, 2025.

What reimbursement level did PROF's TULSA procedure receive?

The TULSA procedure received unique reimbursement at Urology APC Level 7 across multiple treatment settings.

What was PROF's sequential revenue growth in Q4 2024?

Profound Medical's Q4 2024 revenue showed sequential quarter-over-quarter growth of between 45% and 48%.

Profound Medical Corp.

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