Gozellix Receives Permanent HCPCS Code

Rhea-AI Summary

Telix Pharmaceuticals (NASDAQ: TLX) has achieved a significant milestone as its prostate cancer imaging agent Gozellix received a permanent Healthcare Common Procedure Coding System (HCPCS) code from CMS. The code A9616, effective October 1, 2025, will facilitate provider billing and reimbursement processes.

Gozellix is a PSMA PET imaging agent used for detecting prostate cancer metastasis in initial therapy candidates and patients with suspected biochemical recurrence. The product features an extended shelf-life and flexible production options, addressing historical logistical barriers in PSMA-PET imaging access.

The HCPCS code represents a crucial step toward obtaining Transitional Pass-Through payment status and expanding commercial accessibility of PSMA PET imaging across the United States.

Positive

• Permanent HCPCS code granted for Gozellix, facilitating billing and reimbursement
• Extended shelf-life and flexible production options overcome logistical barriers
• Product addresses two key medical needs: initial therapy candidate screening and biochemical recurrence detection

Negative

• None.

Insights

Pharmaceutical Reimbursement Specialist

Permanent HCPCS code for Gozellix significantly improves commercial prospects by establishing reliable reimbursement pathway for Telix's cancer imaging agent.

The permanent HCPCS code (A9616) granted to Telix's Gozellix represents a critical regulatory milestone in the commercialization journey. This isn't merely administrative - it's the financial backbone that enables reliable billing and reimbursement from both CMS and commercial insurers starting October 1, 2025.

This development directly addresses one of the most significant barriers in specialty pharmaceutical commercialization - payment uncertainty. Without established reimbursement codes, providers face substantial financial risk when adopting new diagnostics, regardless of clinical value. The permanent code effectively removes this obstacle.

The timing is particularly strategic as it positions Telix for potential Transitional Pass-Through (TPT) payment status, which would provide enhanced reimbursement for a defined period, typically 2-3 years. TPT status is designed specifically to encourage adoption of innovative technologies by temporarily paying above standard rates.

Gozellix offers meaningful advantages over existing PSMA-PET options through its extended shelf-life and flexible production, addressing logistical constraints that have limited PSMA-PET adoption, especially in non-urban settings. The reimbursement certainty provided by the permanent code will likely accelerate market penetration, particularly in community practice settings where financial considerations often outweigh clinical preferences.

For Telix, this represents a clear path to revenue predictability during the critical early commercialization phase when establishing market position is paramount. With prostate cancer remaining one of the most prevalent male cancers, this reimbursement milestone substantially derisks the commercial outlook for this product.

MELBOURNE, Australia and INDIANAPOLIS, July 10, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that its next-generation PSMA¹ PET² imaging agent, Gozellix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection), has been granted a permanent Healthcare Common Procedure Coding System (HCPCS) code by the U.S. Centers for Medicare & Medicaid Services (CMS).

Effective from 1 October 2025, CMS and commercial health insurers will recognise the HCPCS Level II code A9616 assigned for reimbursement of Gozellix. The assignment of the code is a significant milestone supporting provider billing and reimbursement for Gozellix, and a further step toward receiving Transitional Pass-Through (TPT) payment status.

After radiolabelling with ⁶⁸Ga, Gozellix is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected biochemical recurrence (BCR) based on elevated serum prostate-specific antigen (PSA) level.³ With its extended shelf-life and flexible production options, Gozellix overcomes many of the logistical barriers that have historically limited access to PSMA-PET imaging. Telix believes receiving a HCPCS code will support clinical adoption of Gozellix and expanded access to PSMA PET imaging.

Kevin Richardson, Chief Executive Officer, Precision Medicine, Telix, said, “Being granted a HCPCS code marks a significant step forward in Telix’s mission to improve access to precision medicine imaging for prostate cancer patients across the United States, regardless of their location. It is also an important enabler for commercial scale-up and reimbursement of Gozellix in the U.S. as we bring our next-generation PSMA PET imaging agent to market.”

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (⁶⁸Ga) gozetotide injection) has been approved by the U.S. FDA⁴.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)
Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: annie.kasparian@telixpharma.com

Media Contact
Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS

Risk for Misinterpretation
Image interpretation errors can occur with Gozellix PET. A negative image does not rule out the presence of prostate cancer, and a positive image does not confirm the presence of prostate cancer. Gallium Ga-68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget’s disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Imaging Prior to Initial Definitive or Suspected Recurrence Therapy
The performance of Gozellix for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of Gozellix for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score.

Radiation Risks
Gallium Ga-68 gozetotide contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and healthcare providers. Advise patients to hydrate before and after administration and to void frequently after administration.

Hypersensitivity Reactions
Monitor patients for hypersensitivity reactions, particularly patients with a history of allergy to other drugs and foods. Reactions may be delayed. Always have trained staff and resuscitation equipment available.

ADVERSE REACTIONS
The safety of gallium Ga-68 gozetotide was evaluated in 960 patients in the PSMA-PreRP and PSMABCR studies, each receiving one dose of gallium Ga-68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of <1%.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga-68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga-68 gozetotide PET has not been established.

Please note that this information summary is not comprehensive.

Please see the Full Prescribing Information here.

You are encouraged to report suspected adverse reactions of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix Pharmaceuticals (US) by calling 1-844-455-8638 or emailing pharmacovigilance@telixpharma.com.

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

Legal Notices

Cautionary Statement Regarding Forward-Looking Statements

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.

Trademarks and Trade Names
All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties.

©2025 Telix Pharmaceuticals Limited. All rights reserved.

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¹ Prostate-specific membrane antigen.
² Positron emission tomography.
³ Please see full Important Safety Information on corresponding pages.
⁴ Telix ASX disclosure 21 March 2025.

FAQ

What is the new HCPCS code for Telix's Gozellix (TLX) and when is it effective?

The permanent HCPCS Level II code A9616 has been assigned to Gozellix and will be effective from October 1, 2025.

What is Gozellix used for in prostate cancer patients?

Gozellix is used for PET scanning of PSMA positive lesions in men with suspected metastasis who are candidates for initial therapy, and those with suspected biochemical recurrence based on elevated PSA levels.

How does Gozellix (TLX) improve upon existing PSMA-PET imaging solutions?

Gozellix features an extended shelf-life and flexible production options, which help overcome traditional logistical barriers that have limited access to PSMA-PET imaging.

What is the significance of the HCPCS code for Telix Pharmaceuticals (TLX)?

The HCPCS code enables provider billing and reimbursement for Gozellix, supports clinical adoption, and represents a step toward obtaining Transitional Pass-Through payment status.