MELBOURNE, Australia, Oct. 20, 2022 /PRNewswire/ --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 30 September 2022 (Q3 2022). All figures are in AUD$ unless otherwise stated.[1] All figures are provided on an unaudited basis. Financial Summary Telix reports total revenue of $55.3 million from global sales of Illuccix, up 168% on the previous quarter ($20.6 million, Q2 2022) U.S. sales of Illuccix up 178% to $53.7 million (US$36.4 million) in second quarter of commercial sales ($19.3 million, Q2 2022) Cash balance of $117.1 million; provides 21 quarters of cash runway (based on Q3 2022 burn rate) Net operating cash outflow reduced by $20.5 million to $5.3 million, a significant reduction on the prior quarter ($25.8 million net operating cash outflow). Key factors impacting this improvement are: Customer receipts of $44.5 million, up from $5.4 million in the previous quarter, reflecting growth in commercial sales Q3 2022 expenditure to support commercial operations reflecting normalised operations, following one-off launch costs incurred in H1 2022 Ongoing cost-control of research and development (R&D) expenditure, aligned with product earnings growth Capital expenditure included $1.7 million in build-out costs related to Telix's manufacturing facility in Brussels South (Seneffe) Commercial Activity Report U.S. commercial update In Q3 2022, the second quarter of commercial sales, Telix generated $53.7 million (US$36.4 million) revenue from sales of its prostate cancer imaging agent, Illuccix (kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection). This represents a 178% increase on the previous quarter ($19.3 million, Q2 2022). Sales have increased steadily month on month since U.S. reimbursement - HCPCS[2] code and transitional pass-through payment status - became effective on 1 July 2022. Doses were via Telix's distribution network, currently consisting of 179 radiopharmacies. Mr. Kevin Richardson, CEO Telix Americas said, "We are pleased with sales momentum since the U.S. launch. Sales have continued to increase each month, and we have continued to gather pace since reimbursement came into effect on 1 July. We have quickly built a diversified customer base and continue to add new sites. Notably, the commencement of pass-through in July has opened up access to more hospital outpatient accounts, including some of the major academic centres in the U.S. that recognise Illuccix's differentiation in terms of scheduling flexibility and clinical workflow." Illuccix (TLX591-CDx)[3] worldwide revenue A total of $55.3 million in revenue was generated from sales of TLX591-CDx during the quarter. Of this, $1.6 million was generated from rest of world sales, predominantly from pre-commercial sales,[4] primarily in Europe and the United Kingdom. Commercial sales of Illuccix in Australia[5] and New Zealand[6] commenced in September 2022. Net operating cash outflow Net operating cash outflow was $5.3 million, reduced from $25.8 million in the previous quarter. This improvement was driven by an increase in customer receipts, in line with the growth in commercial sales, and a continued focus on cost management. A total of $44.5 million in customer receipts was generated from sales of Illuccix. Net operating cash outflow in Q3 2022 is largely reflective of normalised operations, noting that in H1 2022 one-off costs were incurred for commercial launch in the U.S.. Product manufacturing and operating costs increased to $10.7 million, from $8.6 million in Q2 2022, due to a higher volume of sales, but have reduced as an overall percentage of sales. It should be noted that ongoing manufacturing costs pertain to building medium-term inventory to service both U.S. and global customers. R&D expenditure remained well controlled, with $16.3 million invested in R&D, manufacturing and clinical development activities, compared to $17.4 million in Q2 2022. Illuccix (TLX591-CDx) global regulatory and reimbursement updates During the quarter, the Company announced it had withdrawn its marketing authorisation application (MAA) in Europe.[7] In the late stages of the review the Danish Medicines Agency (DKMA) in consultation with other European regulatory authorities, requested additional Chemistry, Manufacturing and Control (CMC) data. These requests could not be reasonably delivered within the prescribed review timeframe. The Company is assessing alternative regulatory options available for the most streamlined route to approval with a revised submission and will provide an update on anticipated timings when this assessment has been completed. Subsequent to the quarter (14 October 2022), the Company announced that Health Canada had approved Illuccix for use in staging and re-staging intermediate and high-risk prostate cancer and localising tumour tissue in recurrent prostate cancer.[8] Illuccix is the first PSMA PET[9] imaging agent to be granted regulatory approval in Canada. This is the third key market regulatory approval for Illuccix. Illuccix will be made available in Canada to physicians and eligible patients through Telix's partner, Isologic Innovative Radiopharmaceuticals, whose distribution network services 265 hospitals and clinics nationwide. Also subsequent to the quarter (17 October 2022) the Company announced that Telix and its partner Grand Pharmaceutical Group Limited (Grand Pharma), had received approval from the National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) to commence a pivotal Phase III registration study that will bridge to the United States Food and Drug Administration (FDA) approval of Illuccix.[10] The study is expected to commence in Q1 2023. Marketing authorisation applications for TLX591-CDx are under review and progressing in Brazil and South Korea. Telix currently has a temporary use (pre-approval) authorisation in the Czech Republic and Brazil. Clinical Programs Update Telix continues to progress its clinical pipeline, with a core focus on prostate cancer, kidney cancer, brain cancer (glioblastoma) and rare diseases (bone marrow conditioning). The Company has more than 20 clinical trials underway, including collaborative investigator-sponsored studies. Notable updates are included in this section of the activities report. Renal cancer / CAIX program The Company expects to report top line data from the ZIRCON Phase III study of TLX250-CDx (89Zr-DFO-girentuximab), an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with positron emission tomography (PET) around the first week of November 2022. The Company is preparing to launch an Expanded Access Program (EAP) to enable eligible patients to access TLX250- CDx to address unmet need and requests for access under the healthcare professional responsibility prior to marketing authorisation. This is in accordance with Telix's Compassionate Use Policy[11] subject to jurisdictional regulatory requirements in selected countries, dependent on local regulatory requirements. Subsequent to quarter (17 October 2022), Telix announced a collaborative development and reseller agreement with GE Healthcare to supply two of its PET imaging radiotracers (TLX250-CDx and [18F]-FLac (18F-3-fluoro-2-hydroxypropionate)) for use in third party pharmaceutical company clinical research and development activities.[12] The agreement will see these two investigational agents added to GE Healthcare's immuno-diagnostic portfolio. GE Healthcare's Pharmaceutical Diagnostics business is an established global supplier of PET imaging tracers to the global clinical research market. This partnership will enable these investigational imaging agents to be used more widely in third-party clinical trials, separate to Telix's commercialisation of TLX250-CDx. The Company also reported that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) approved a pivotal Phase III registration study that will bridge to Telix