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Profound Medical Announces Preliminary Unaudited Fourth Quarter and Full Year 2023 Revenues

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Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) announced preliminary unaudited revenues for the fourth quarter and full year 2023, with total revenues for Q4 expected to be in the range of $1.9 million to $2.0 million, representing recurring revenue growth of 51% to 59% year-over-year. Full year 2023 revenues are anticipated to be in the range of $7.1 million to $7.2 million. The company is making progress with the commercialization of TULSA-PRO® in the United States and is focused on increasing the installed base and system utilization of TULSA-PRO® in preparation for the permanent CPT® Category 1 codes for TULSA going into effect at the beginning of 2025.
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The preliminary revenue figures released by Profound Medical Corp. indicate a robust year-over-year and sequential growth in recurring revenue, which is a positive signal to the market. Recurring revenue, being more predictable and stable, is often valued higher by investors as it suggests a sustainable business model. The growth figures, ranging from 51% to 59% year-over-year and 10% to 16% sequentially, are particularly impressive when considering the niche market of incision-free therapies. These numbers not only reflect the company's ability to grow its customer base but also suggest increased utilization of its TULSA-PRO® systems.

Furthermore, the adoption by top-tier cancer hospitals is a testament to the credibility and potential of the TULSA-PRO® technology. Being associated with renowned institutions can serve as a strong endorsement, potentially influencing other hospitals' purchasing decisions. The company's strategic focus on early adopters and teaching hospitals could also drive future growth through peer influence within the medical community. Additionally, the anticipation of permanent CPT® Category 1 codes for TULSA by 2025 may signal a future uptick in adoption rates, as it would likely streamline the reimbursement process for providers.

Profound Medical Corp.'s emphasis on recurring revenue streams through consumables, leasing and extended warranties is a strategic move that aligns well with the current trends in the medical device industry. The company's performance, with a seventh consecutive quarter of recurring revenue growth, indicates a successful penetration and scaling within its market segment. The installation and contracting with 10 of the top 20 cancer hospitals in the United States also underscore the product's acceptance and trust in the clinical community.

The ongoing Level 1 CAPTAIN trial comparing the TULSA procedure to radical prostatectomy is a critical factor in the company's future prospects. Positive trial outcomes could significantly bolster the clinical evidence supporting TULSA-PRO® and potentially increase its adoption for prostate cancer treatment. The development of additional TULSA AI modules is another strategic initiative that could enhance the product's value proposition by improving treatment efficiency and outcomes.

From a financial perspective, the capital raised through recent financing is crucial for Profound Medical Corp. as it aims to expand its commercial organization and prepare for significant milestones such as the implementation of permanent CPT® Category 1 codes. The company's proactive strategy to invest in marketing and sales infrastructure ahead of this anticipated revenue inflection point demonstrates forward-thinking management and positions the company to capitalize on future market opportunities.

It is important to note that the preliminary revenue figures are unaudited and investors should exercise caution until the final numbers are confirmed. However, the strong growth in recurring revenue is a positive indicator of the company's financial health. The strategic investments and clinical trials underway suggest that Profound is positioning itself for long-term growth, although this will likely entail significant operational costs which may impact short-term profitability.

TORONTO, Jan. 03, 2024 (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 2023, and provided an update on the progress it is making with the commercialization of TULSA-PRO® in the United States. Profound is providing this information due to the significant lag time between planned investment community meetings to be held in connection with, among other investor events, the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, and its expected reporting of final 2023 results in March 2024.

Profound anticipates total revenues for the fourth quarter of 2023 to be in the approximate range of $1.9 million to $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO® consumables, lease of medical devices, procedures and services associated with extended warranties. This represents recurring revenue growth of between 51% and 59% year-over-year, and between 10% and 16% sequentially over the 2023 third quarter. For the full year 2023, Profound anticipates total revenues to be in the approximate range of $7.1 million to $7.2 million. These figures are preliminary and unaudited, and actual revenues may differ.

“Our focus on early adopters and teaching hospitals resulted in the adoption of TULSA-PRO® continuing to increase throughout 2023, both in terms of installed base growth and existing system utilization,” said Arun Menawat, Profound’s CEO and Chairman. “Q4-2023 marked the seventh consecutive quarter of recurring revenue growth; and TULSA-PRO® is now installed at, or contracted with, 10 of the top 20 cancer hospitals in the United States as ranked by U.S. News and World Report, including prestigious institutions such as MD Anderson, Mayo Clinic-Rochester, UCLA Medical Center, Brigham and Women's Hospital, Johns Hopkins Hospital, and Cleveland Clinic, among others. The growth capital raised through our recent financing, which closed yesterday, puts us in a stronger position to make the requisite investments, particularly in our commercial organization, to maximize the exciting opportunity for TULSA that we see ahead. In preparation for the permanent CPT® Category 1 codes for TULSA going into effect at the beginning of 2025 -– an anticipated major revenue inflection point for our business – our top priorities for 2024 will be to further increase our TULSA-PRO® installed base, support increased system utilization, complete our ongoing Level 1 CAPTAIN trial comparing the TULSA procedure to radical prostatectomy for the treatment of prostate cancer, and advance additional TULSA AI modules designed to increase both the ease and speed of prostate disease treatment. We look forward to updating investors as we progress.”

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. 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, 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, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, palliative pain treatment and osteoid osteoma; Profound’s preliminary unaudited fourth quarter and full year 2023 revenues; 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. In addition, there is uncertainty about the spread of the COVID-19 virus and the impact it will have on Profound’s operations, the demand for its products, global supply chains and economic activity in general. 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
skilmer@profoundmedical.com
T: 647.872.4849


FAQ

What are Profound Medical Corp.'s preliminary unaudited revenues for the fourth quarter and full year 2023?

Profound Medical Corp. anticipates total revenues for the fourth quarter of 2023 to be in the approximate range of $1.9 million to $2.0 million, with the full amount coming from recurring revenue. For the full year 2023, Profound anticipates total revenues to be in the approximate range of $7.1 million to $7.2 million.

What is the focus of Profound Medical Corp. in terms of commercialization?

Profound Medical Corp. is focused on increasing the installed base and system utilization of TULSA-PRO® in preparation for the permanent CPT® Category 1 codes for TULSA going into effect at the beginning of 2025.

What is the expected revenue growth for Profound Medical Corp. in 2023?

The company anticipates recurring revenue growth of between 51% and 59% year-over-year for the fourth quarter of 2023, and between 10% and 16% sequentially over the 2023 third quarter.

What are the top priorities for Profound Medical Corp. in 2024?

The top priorities for 2024 will be to further increase the TULSA-PRO® installed base, support increased system utilization, complete the ongoing Level 1 CAPTAIN trial comparing the TULSA procedure to radical prostatectomy for the treatment of prostate cancer, and advance additional TULSA AI modules designed to increase both the ease and speed of prostate disease treatment.

Profound Medical Corp.

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Surgical and Medical Instrument Manufacturing
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About PROF

an inside out approach to prostate ablation profound medical is a canadian medical device company that has developed a unique and minimally invasive procedure to ablate the prostate gland in prostate cancer patients. profound’s novel technology combines real-time mr imaging with transurethral therapeutic ultrasound and closed-loop thermal feedback control. it provides a highly precise treatment tailored to patient-specific anatomy and pathology. this method of prostate ablation offers short treatment times and low morbidity, allowing for fast patient recovery. the potential of this technology is currently being demonstrated in clinical trials. for more information, visit profoundmedical.com