Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 31 December 2022 (Q4 2022).
Financial Summary
Telix achieved positive cash flow from operating activities: net operating cash flow improved by $6.9 million over the prior quarter to a $1.6 million inflow for the quarter
Cash receipts from customers were $72.2 million, up 62% from $44.5 million in the prior quarter
Telix reports Q4 2022 revenue of $78.2 million from global sales of Illuccix, up 41% on the prior quarter ($55.3 million, Q3 2022)
Revenue from sales of Illuccix in the United States up 43% to $76.8 million on the prior quarter (39% on a US dollar basis)
Commercial Activity Report
U.S. commercial update
In Q4 2022, the third quarter of commercial sales, Telix generated $76.8 million (US$50.5 million) revenue from sales of its prostate cancer positron emission tomography (PET) imaging agent, Illuccix. This represents a 43% increase on the prior quarter ($53.7 million, Q3 2022). Sales momentum continues to build, due to active reimbursement and growth across three major segments of hospital customers, independent imaging centres and government (Veterans Affairs) customers.
The Company's distribution network now consists of 190 nuclear pharmacies nationwide, facilitating industry-leading on-time delivery and scheduling flexibility.
Kevin Richardson, CEO Telix Americas said, 'We are pleased to see continued sales momentum nine months after launching in the United States and Puerto Rico. We are continuously adding new sites and growing existing accounts, resulting in a steady increase in demand for doses. In 2023, we look forward to building on the foundations of a successful commercial launch to continue to drive sustainable growth and make a positive impact on more patients' lives.'
Prostate imaging worldwide revenue
Total revenue of $78.2 million was generated from prostate imaging sales (including commercial sales of Illuccix in the U.S.) during the quarter. Of this, $1.4 million was generated from rest of world sales, predominantly being pre-commercial sales2 in Europe and the United Kingdom.
Net cash from operating activities
Telix reports its maiden quarter of net operating cash inflow, being a significant milestone for the business. The $1.6 million inflow for the quarter is a $6.9 million improvement on the prior quarter's net operating cash outflow of $5.3 million and is largely representative of further growth in commercial sales, a continued focus on operating expenditure control and management of customer receivables.
Conversion to AUD is at the average exchange rate for the period. AUD$1 = US$0.66; AUD$1 = EUR0.64
Pre-commercial sales are from investigational, clinical trial, magisterial and compassionate use in accordance with local laws and regulations (not as a commercial diagnostic imaging product sold for routine clinical practice).
Cash receipts from customers improved 62% to $72.2 million, from $44.5 million in the prior quarter.
Payments for product manufacturing and related costs reflect higher volume of sales and timing of supplier payments, with a gross margin achieved of 63%, up 2% on the prior quarter of worldwide sales.
Operating and selling, general and administration costs were lower by $4.7 million compared to the prior quarter, reflecting improved working capital management.
Reasearch and development (R&D) costs remain well controlled, with $19.2 million invested in R&D, manufacturing and clinical development activities, a $2.9 million increase over the prior quarter.
Illuccix global regulatory update
During the quarter, Health Canada approved Illuccix for use with PET of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer: with suspected metastasis who are suitable for initial definitive therapy and with suspected recurrence with elevated serum prostate specific antigen (PSA) level.
Telix is preparing for commercial launch in Canada in H1 2023 through its partner, Isologic Innovative Radiopharmaceuticals, whose distribution network services 265 hospitals and clinics nationwide.
Telix is making progress on the regulatory refiling in Europe and is targeting to have the updated dossier finalised by the end of Q1 2023, for resubmission to the Danish Medicines Agency (DKMA). The DKMA will advise the revised review timeline upon formal acceptance of the updated dossier. Telix is also progressing marketing authorisation applications in Brazil and South Korea together with its partners.
Clinical Programs Update
Telix continues to progress its core clinical pipeline, with a focus on prostate cancer, renal (kidney) cancer, brain cancer (glioblastoma) and rare diseases (bone marrow conditioning). The Company has over 20 clinical trials underway, including collaborative investigator-initiated studies. Notable updates are included in this section of the activities report.
Renal (kidney) cancer / carbonic anhydrase IX (CAIX) program
The Company reported highly positive top-line data from the ZIRCON (NCT03849118) Phase III study of TLX250-CDx (89Zr-DFO-girentuximab), an investigational product for the PET imaging of clear cell renal cell carcinoma (ccRCC).1
The study met all of its primary and secondary endpoints: Co-primary endpoints of 86% sensitivity and 87% specificity were delivered, considerably exceeding the confirmatory trial success target required to demonstrate the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide a non-invasive method of diagnosing the presence and spread of ccRCC.
The key secondary endpoint in detecting ccRCC in tumours
TELIX PHARMACEUTICALS LIMITED 
