{"id":10355,"date":"2022-07-21T00:34:00","date_gmt":"2022-07-21T00:34:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3823184_AE23184_0"},"modified":"2022-07-21T00:34:00","modified_gmt":"2022-07-21T00:34:00","slug":"telix-reports-second-quarter-2022-financial-results","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=10355","title":{"rendered":"Telix Reports Second Quarter 2022 Financial Results"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1775408\/Telix_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"xn-location\">MELBOURNE, Australia<\/span>, <span class=\"xn-chron\">July 21, 2022<\/span> \/PRNewswire\/ &#8212; Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)&nbsp;today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended <span class=\"xn-chron\">30 June 2022<\/span>. All figures are in AUD$ unless otherwise stated. All figures are provided on an unaudited basis.<\/p>\n<p><b>Financial Summary<\/b><\/p>\n<ul type=\"disc\">\n<li>Telix reports total revenue of <span class=\"xn-money\">$22.5 million<\/span> from global sales of Illuccix\u00ae in its first commercial quarter &#8211; more than a ten-fold increase on the previous quarter (<span class=\"xn-money\">$1.9 million<\/span>, Q1 2022). This includes <span class=\"xn-money\">USD$13.6 million<\/span> (AUD$19.3 million) generated from sales of Illuccix in <span class=\"xn-location\">the United States<\/span> in the ten weeks following first commercial sales.<\/li>\n<li>As of <span class=\"xn-chron\">30 June 2022<\/span>, the Company held cash reserves of <span class=\"xn-money\">$122.6 million<\/span>.<\/li>\n<li>Cash inflows for the quarter included <span class=\"xn-money\">$5.4 million<\/span> in customer receipts, up from <span class=\"xn-money\">$1.9 million<\/span> in the previous quarter. Additional (non-product related) cash inflows include <span class=\"xn-money\">$17.2 million<\/span> in government tax incentives for eligible R&amp;D activities undertaken for the year ended <span class=\"xn-chron\">31 December 2021<\/span> and <span class=\"xn-money\">$1.1 million<\/span> of proceeds from options exercised.<\/li>\n<li>Net operating outflows during the quarter were <span class=\"xn-money\">$25.8 million<\/span>, down from <span class=\"xn-money\">$33.6 million<\/span> in the previous quarter. Expenditure included a one-off upfront license fee payment to Eli Lilly and Company (Lilly) of <span class=\"xn-money\">USD$5 million<\/span> (AUD$6.8 million) and <span class=\"xn-money\">$2.1 million<\/span> in build-out costs related to Telix&#8217;s manufacturing facility in Brussels South (Seneffe).<\/li>\n<li><span class=\"xn-money\">$17.4 million<\/span> was invested in R&amp;D, manufacturing and clinical development activities during the quarter, primarily in relation to the Company&#8217;s therapeutic programs.<\/li>\n<li>Per the Appendix 4C, the Company has 5.5 quarters runway based on net cash used in operations in the <span class=\"xn-chron\">June 2022<\/span> quarter. The Company notes that the net operating outflows (used to calculate runway) include only <span class=\"xn-money\">$3.8 million<\/span> from U.S. customer cash receipts compared to the U.S. commercial revenue of <span class=\"xn-money\">$19.3 million<\/span> due to timing differences of revenue recognition and cash payment terms from distributors.<\/li>\n<\/ul>\n<p><b>Operational Highlights<\/b><\/p>\n<ul type=\"disc\">\n<li>Commercial launch of Illuccix in the U.S. and rapid expansion of the distribution network to 140 pharmacies across the Cardinal Health, PharmaLogic, United Pharmacy Partners (UPPI), Jubilant Radiopharma and Radioisotope Life Sciences (RLS) networks.<\/li>\n<li>U.S. reimbursement designations granted and effective from <span class=\"xn-chron\">1 July 2022<\/span>: a dedicated Healthcare Common Procedure Coding System (HCPCS) Level II code and transitional pass-through (TPT) payment status.<\/li>\n<li>ZIRCON Phase III kidney cancer imaging trial enrolment completed, with 300 patients dosed.<\/li>\n<li>Progress across core therapeutic clinical programs for prostate, kidney and brain cancer.<\/li>\n<li>In-licence agreement with Lilly to develop the antibody olaratumab (formerly marketed as Lartruvo\u00ae) as a diagnostic and therapeutic radiopharmaceutical agent.<\/li>\n<li>Co-development and commercialisation agreement with RefleXion Medical to advance Illuccix for biology-guided radiation therapy (BgRT), a future market growth opportunity.<\/li>\n<li>TelixAI\u2122 Artificial Intelligence platform being developed with Invicro; pilot showcased at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) annual meeting held in <span class=\"xn-location\">Vancouver<\/span> in <span class=\"xn-chron\">June 2022<\/span>.<\/li>\n<li>Mr. <span class=\"xn-person\">Darren Smith<\/span> appointed as Group Chief Financial Officer, effective <span class=\"xn-chron\">1 August 2022<\/span>, and Mr. <span class=\"xn-person\">Kevin Richardson<\/span> appointed as CEO of Telix Americas.<\/li>\n<\/ul>\n<p><b>Commercial Activity Report <\/b><\/p>\n<p><b><i>Illuccix U.S. Commercial Launch <\/i><\/b><\/p>\n<p>During the quarter, Telix launched its lead prostate cancer imaging product, Illuccix\u00ae (kit&nbsp;for the&nbsp;preparation of&nbsp;gallium-68&nbsp;(<sup>68<\/sup>Ga)&nbsp;gozetotide&nbsp;(also known as&nbsp;PSMA-11)&nbsp;injection) in the U.S., with first commercial doses being administered from <span class=\"xn-chron\">14 April 2022<\/span>.<sup>[1]&nbsp;<\/sup><\/p>\n<p>Sales revenue from U.S. commercial sales between 14 April and <span class=\"xn-chron\">30 June 2022<\/span> was <span class=\"xn-money\">USD$13.6 million<\/span> (AUD$19.3 million). Sales were primarily generated via Telix&#8217;s nuclear pharmacy distribution partners to imaging centres and hospitals, but also included some luminary academic centres and Veterans&#8217; Affairs (VA) sites directly contracted with Telix. &nbsp;<\/p>\n<p>During the quarter the Illuccix distribution network was progressively expanded from 117 to 140 radiopharmacies. Select Jubilant and RLS pharmacies have been added to the partnership network since launch, which initially comprised Cardinal Health, PharmaLogic and UPPI. The objective of the pharmacy network expansion is to provide broad geographic coverage, boosting capacity in both major metropolitan and regional markets to enable reliable access to PSMA-PET<sup>[2]<\/sup> imaging.<\/p>\n<p><i>Telix Managing Director and Group CEO Dr. <span class=\"xn-person\">Christian Behrenbruch<\/span>, said, &#8220;The U.S. commercial launch of Illuccix is off to a strong start. This result reflects the efficacy of our differentiated business model in a large and growing market. We&#8217;ve delivered doses across the entire country, demonstrating the value of our nationwide pharmacy distribution partnerships and with industry-leading on-time delivery. We are meeting the needs of our customers and patients through reliable service delivery and wide accessibility to PSMA-PET imaging. With reimbursement effective 1 July, we expect to see Illuccix revenues grow considerably.&#8221;<\/i><\/p>\n<p>During the quarter Telix announced it had been granted a Healthcare Common Procedure Coding System (HCPCS) Level II code, A9596 and Transitional Pass-Through Payment Status.<sup>[3]<\/sup> Both reimbursement designations were formally recognised by the U.S. Centers for Medicare and Medicaid Services (CMS) from <span class=\"xn-chron\">1 July 2022<\/span>. Transitional pass-through status enables CMS to provide separate payments for the&nbsp;radiopharmaceutical and the PET-CT scan, when performed with Illuccix in the hospital outpatient setting, for a period of up to three years.<\/p>\n<p><b><i>Illuccix (TLX591-CDx)<sup><b>[4]<\/b> <\/sup>worldwide revenue and customer receipts <\/i><\/b><\/p>\n<p>A total of <span class=\"xn-money\">$22.5 million<\/span> in revenue was generated from sales of TLX591-CDx during the quarter. Of this <span class=\"xn-money\">$3.2 million<\/span> was generated from pre-commercial sales<sup>[5]<\/sup>, primarily in <span class=\"xn-location\">Europe<\/span> and the <span class=\"xn-location\">United Kingdom<\/span>, reflecting 166% growth on the previous corresponding quarter (<span class=\"xn-money\">$1.2 million<\/span>, <span class=\"xn-chron\">June 2021<\/span>). &nbsp;<\/p>\n<p>Of the <span class=\"xn-money\">$5.4 million<\/span> in customer receipts, <span class=\"xn-money\">$3.8 million<\/span> (<span class=\"xn-money\">USD$2.7 million<\/span>) was from U.S. commercial sales. Revenue from commercial sales is recognised when a dose is administered. Payment terms average 45 days from invoicing. &nbsp;<\/p>\n<p>Commercial sales of Illuccix in <span class=\"xn-location\">Australia<\/span> and <span class=\"xn-location\">New Zealand<\/span> is planned to commence in Q3, 2022.<\/p>\n<p><b><i>Illuccix (TLX591-CDx) global regulatory and reimbursement updates <\/i><\/b><\/p>\n<p>Marketing authorisation applications for TLX591-CDx are under review and progressing in 17 countries (13 European Union Member States, <span class=\"xn-location\">United Kingdom<\/span>, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">Brazil<\/span> and <span class=\"xn-location\">South Korea<\/span>). Telix currently has a temporary use (pre-approval) authorisation in the <span class=\"xn-location\">Czech Republic<\/span> and Brazil.&nbsp;<\/p>\n<p>In summary, the key regulatory updates for the quarter are:<\/p>\n<ul type=\"disc\">\n<li><b>U.S.: <\/b>On 17 May Telix filed a supplemental new drug application (sNDA) to the FDA, pursuant to section 505(b)(2) of the of the Federal Food, Drug, and Cosmetic Act (FDCA), for Illuccix. The sNDA relates to an indication expansion for Illuccix&nbsp;for patient selection for radioligand (PSMA) therapy. The sNDA has been accepted for standard review with a Prescription Drug User Fee Act (PDUFA) user fee goal date of <span class=\"xn-chron\">17 March 2023<\/span>.<\/li>\n<li><b>EU: <\/b>The Company&#8217;s Marketing Authorisation Application (MAA) is being evaluated by the Danish Medicines Agency (DKMA) in its capacity as a Reference Member State, on behalf of the 13 European countries selected by Telix. As previously reported, Telix has until <span class=\"xn-chron\">9 August 2022<\/span><sup>[6]<\/sup> to conclude the regulatory review process.<\/li>\n<li><b><span class=\"xn-location\">South Korea<\/span>: <\/b>An imported New Drug Application (NDA) has been submitted by Telix&#8217;s partner in <span class=\"xn-location\">South Korea<\/span>, DuChemBio Co, Ltd. (DuChemBio), to the Ministry of Food and Drug Safety (MFDS).<\/li>\n<li><b><span class=\"xn-location\">New Zealand<\/span>:<\/b> The drug safety regulator Medsafe has confirmed that Illuccix is an exempt product under the NZ Medicines Act 1981 and Radiation Safety Act 2016. Illuccix may now be supplied and used in <span class=\"xn-location\">New Zealand<\/span>.<\/li>\n<\/ul>\n<p>In addition, and subsequent to quarter end, on <span class=\"xn-chron\">1 July 2022<\/span>, PSMA-PET imaging for prostate cancer was listed on the Medicare Benefits Schedule (MBS) in <span class=\"xn-location\">Australia<\/span>. This means that MBS funding now covers the initial staging of intermediate to high-risk patients with prostate cancer and the restaging of patients with recurrent prostate cancer, commensurate with the broad clinical indications granted in <span class=\"xn-location\">Australia<\/span> for Illuccix. Illuccix remains the only Therapeutic Goods Administration (TGA)-approved PET agent for the diagnostic imaging of men with prostate cancer available in <span class=\"xn-location\">Australia<\/span>.<\/p>\n<p><b><i>Illuccix (TLX591-CDx) g<\/i><\/b><b><i>lobal distribution agreements <\/i><\/b><\/p>\n<p>Telix has continued to build out its global distribution network for TLX591-CDx in preparation for regulatory decision notification and commercial launch in countries beyond <span class=\"xn-location\">Australia<\/span> and <span class=\"xn-location\">the United States<\/span>. During the quarter, Telix entered into the following agreements:<\/p>\n<ul type=\"disc\">\n<li><b><span class=\"xn-location\">Canada<\/span>: <\/b>Isologic Innovative Pharmaceuticals (Isologic) and Telix signed a licence and distribution agreement, appointing Isologic as the commercial distributor for Illuccix in <span class=\"xn-location\">Canada<\/span>, once approved.<sup>[7]<\/sup><\/li>\n<li><b><span class=\"xn-location\">Saudi Arabia<\/span>:<\/b> <span class=\"xn-person\">Abdulla Fouad<\/span> for Medical Supplies and Services Company (AFMS) and Telix signed a licence and distribution agreement, appointing AFMS as the commercial distributor for Illuccix in the <span class=\"xn-location\">Kingdom of Saudi Arabia<\/span>, once approved.<\/li>\n<\/ul>\n<p>Telix now has commercial distribution agreements in place in all major European Union markets and the <span class=\"xn-location\">United Kingdom<\/span>. In the APAC region, Telix has distribution agreements in place for <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">New Zealand<\/span>, <span class=\"xn-location\">Greater China<\/span> (including <span class=\"xn-location\">Hong Kong<\/span>, <span class=\"xn-location\">Taiwan<\/span>, <span class=\"xn-location\">Macau<\/span>) and <span class=\"xn-location\">South Korea<\/span>. In the Americas region (ex-U.S.) Telix has agreements in place for <span class=\"xn-location\">Canada<\/span> and <span class=\"xn-location\">Brazil<\/span>.<\/p>\n<p><b>Clinical Programs Update <\/b><\/p>\n<p><b><i>ZIRCON Phase III kidney cancer imaging study completed &nbsp;<\/i><\/b><\/p>\n<p>The Company announced recruitment completion of the ZIRCON Phase III study of TLX250-CDx (<sup>89<\/sup>Zr-DFO-girentuximab), an investigational product for the imaging of clear cell renal cell carcinoma (ccRCC) with PET.<sup>[8]<\/sup>&nbsp;A total of 300 patients were dosed in the study. The Company expects to report the outcome of the ZIRCON study in 2H 2022.<\/p>\n<p><i>&#8220;This is a major clinical milestone and an important validation point for the Company. If the study is successful in meeting its endpoints, it paves the way for us to seek regulatory approval and commercialise a follow-on imaging product for the urologic oncology field in an area of unmet need. Indeterminate renal masses (IDRMs) are being detected at an increasing rate and present a dilemma for physicians. While it is estimated that up to 80% of IDRMs will be malignant, currently the only way to confirm diagnosis is through an invasive biopsy or partial nephrectomy and these procedures are not always necessary and can lead to complications, &#8221; stated Telix Chief Medical Officer, Dr. <span class=\"xn-person\">Colin Hayward<\/span>.<\/i><\/p>\n<p>Following readout of the study, TLX250-CDx is expected to be available in selected countries to eligible patients under an Expanded Access Program (EAP) (also known as early access, pre-approval access or emergency use), in accordance with Telix&#8217;s Compassionate Use Policy and subject to jurisdictional regulatory requirements.<sup>[9]<\/sup><\/p>\n<p><b><i>Clinical Development Highlights <\/i><\/b><\/p>\n<p>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 20 clinical trials underway, including collaborative investigator-sponsored studies. Some key highlights include:<\/p>\n<ul type=\"disc\">\n<li>Telix&#8217;s PSMA-targeting ProstACT therapeutic program is evaluating the efficacy of Telix&#8217;s lutetium-177 (<sup>177<\/sup>Lu)-labelled therapeutic antibody (TLX591) in various stages of prostate cancer, from first recurrence to advanced metastatic disease.<sup>[10]<\/sup> The Company continues to progress its global regulatory submissions for the ProstACT GLOBAL Phase III study.<\/li>\n<li>During the quarter, Human Research Ethics Committee (HREC) approval was granted and patient recruitment commenced in the Phase II ProstACT TARGET study of TLX591, in patients experiencing a first recurrence of prostate-specific antigen (PSA) after initial therapy for prostate cancer.<sup>[11]<\/sup><\/li>\n<li>The ProstACT SELECT study, a &#8220;theranostic&#8221; (imaging and therapy) Phase I radiogenomics study to demonstrate the utility of Illuccix imaging to select TLX591 patients for therapy, is now approaching the halfway point of patient enrolment.<\/li>\n<li>The first patients have been dosed in the STARLITE 2 Phase II study of the Company&#8217;s investigational renal cancer therapy, TLX250 (<sup>177<\/sup>Lu-DOTA-girentuximab), at Memorial Sloan Kettering Cancer Center (MSK) in <span class=\"xn-location\">New York<\/span>.<sup>[12]<\/sup> This study is assessing the efficacy of TLX250 targeted radiation in combination with immunotherapy for ccRCC the most common and aggressive form of kidney cancer. TLX250 targets carbonic anhydrase IX (CA9, a protein that is highly expressed in patients that are likely to be less responsive to cancer immunotherapy.<sup>[13]<\/sup> The clinical hypothesis is that low doses of targeted radiation can potentially overcome immune resistance or immunologically &#8220;prime&#8221; a tumour, making it more susceptible to cancer immunotherapy.<\/li>\n<li>The NOBLE (<u>Nob<\/u>ody <u>Le<\/u>ft Behind) Registry continues to collect clinical data to inform the development of TLX599-CDx (<sup><span class=\"xn-money\">99m<\/span><\/sup>Tc-iPSMA), an investigational prostate cancer imaging agent that targets PSMA using single photon emission computed tomography (SPECT) imaging.<sup>[14] <\/sup>SPECT is the predominant imaging modality in many countries, including remote and rural regions. The NOBLE registry aims to accelerate global access to advanced prostate cancer imaging where PET is not an option and is now active across eight sites globally.<sup>[15]<\/sup> The NOBLE Registry is funded in collaboration with the Oncidium Foundation.<\/li>\n<\/ul>\n<p><b>Research and Innovation Activity<\/b><\/p>\n<p><b><i>Olaratumab in-licence agreement with Eli Lilly and Company (Lilly)<\/i><\/b><\/p>\n<p>In April, Telix announced the signing of a licence agreement with Lilly granting Telix exclusive worldwide rights to develop and commercialise radiolabelled forms of Lilly&#8217;s olaratumab antibody for the diagnosis and treatment of human cancers.<sup>[16]<\/sup> Olaratumab was originally developed by Lilly as a (non-radiolabelled) monoclonal antibody targeting Platelet Derived Growth Factor Receptor Alpha (PDGFR\u03b1). Telix intends to develop radiolabelled olaratumab initially for the diagnosis and treatment of soft tissue sarcoma, a debilitating cancer with a high unmet need for new treatment options.<\/p>\n<p><b><i>Expanded partnership with RefleXion Medical<\/i><\/b><\/p>\n<p>Following a successful preliminary collaboration, the Company announced that it has advanced to a co-development and commercialisation agreement with RefleXion Medical Inc (RefleXion) to evaluate the use of Illuccix as a biological guide in RefleXion&#8217;s BgRT<sup>[17]<\/sup> platform.<sup>[18]<\/sup> Illuccix will be the exclusive kit-based <sup>68<\/sup>Ga PSMA-PET imaging agent used with RefleXion&#8217;s BgRT platform.&nbsp;<\/p>\n<p>BgRT is the first and only cancer treatment designed to integrate PET technology as part of external-beam radiotherapy delivery.&nbsp;It uses PET tracers as biological guides to signal the location of cancer and guide the delivery of radiotherapy to tumors in real-time. Telix and RefleXion will conduct and co-fund a BgRT clinical program using Illuccix as a biological guide, seek regulatory approval and jointly pursue commercialization, initially in <span class=\"xn-location\">the United States<\/span>. If approved, Illuccix for BgRT could potentially open a broad new market opportunity for Illuccix as a therapy guidance agent.<\/p>\n<p><b><i>TelixAI\u2122: Artificial Intelligence Platform <\/i><\/b><\/p>\n<p>Telix progressed its partnership with Invicro LLC (Invicro), a global, industry-leading imaging CRO, and part of REALM IDx, Inc., to develop an artificial intelligence (AI) platform to accompany Illuccix &#8211; dubbed TelixAI<sup>TM<\/sup>.<sup>[19]<\/sup> TelixAI<sup>TM<\/sup> seeks to increase the efficiency and reproducibility of clinicians&#8217; imaging assessments using advanced analysis capabilities with an initial focus on prostate cancer but with the eventual goal of supporting Telix&#8217;s entire diagnostic imaging pipeline.<\/p>\n<p>The commercial objective of the development partnership is the submission to the United States Food and Drug Administration (FDA) 510(K) approval for software as a medical device. A demonstration of the TelixAI<sup>TM<\/sup> was presented to key opinion leaders at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) Annual Meeting, which took place in <span class=\"xn-location\">Vancouver<\/span> (<span class=\"xn-location\">Canada<\/span>) in June of this year.<\/p>\n<p><b>Advanced Manufacturing <\/b><\/p>\n<p>Following the completion of project financing for Telix&#8217;s Brussels South (Seneffe) manufacturing facility in Q1, 2022,<sup>[20] <\/sup>the Company has completed major building and infrastructure works to prepare for the commencement of clean room and hot cell installation for nine GMP manufacturing lines for isotope processing and radiopharmaceutical manufacturing. The Company is currently on track to complete the build-out and commence regulatory inspections by end-2022.<\/p>\n<p>During the quarter, Telix was part of a consortium awarded <span class=\"xn-money\">$23.0 million<\/span> in Federal Government funding to establish the <span class=\"xn-money\">$71.2 million<\/span> Australian Precision Medicine Enterprise Project (APME).<sup>[21]&nbsp;<\/sup>At the heart of APME \u2013 a collaboration with Global Medical Solutions Australia (GMSA) and Monash University \u2013 a new high energy cyclotron will become a source of critical radioisotopes, many of which are currently imported into <span class=\"xn-location\">Australia<\/span> at high cost and variable accessibility. For Telix this will mean increased capacity to develop and manufacture theranostic radiopharmaceuticals in <span class=\"xn-location\">Australia<\/span>, strengthening its global supply chain for both clinical and commercial products.<\/p>\n<p><b>Notable Executive Appointments<\/b><\/p>\n<p>On <span class=\"xn-chron\">1 June 2022<\/span>, the Company announced it had appointed Mr. <span class=\"xn-person\">Darren Smith<\/span> as Group Chief Financial Officer (CFO), effective from <span class=\"xn-chron\">1 August 2022<\/span>. Darren joined the Company in <span class=\"xn-chron\">February 2022<\/span> as part of succession planning for Mr. <span class=\"xn-person\">Douglas Cubbin<\/span>.<sup>[22]<\/sup> Darren brings over 20 years of executive finance and general management experience, including in the nuclear medicine industry. Darren previously served as Global CFO and Company Secretary at Sirtex Medical Limited, acquired by China GrandPharma in 2018.<\/p>\n<p>Mr. <span class=\"xn-person\">Kevin Richardson<\/span> has been appointed to the role of CEO of Telix Americas (U.S.\/<span class=\"xn-location\">Canada<\/span>\/<span class=\"xn-location\">Latin America<\/span>), and commenced employment on <span class=\"xn-chron\">11 July 2022<\/span>.<sup>[23]<\/sup> Kevin brings 25 years of commercial experience in the healthcare industry including senior leadership and sales roles at Sirtex Medical, St Jude Medical, Boston Scientific and most recently as Chief Operating Officer of UroShape Medical.<\/p>\n<p><b>Payments to Related Parties <\/b><\/p>\n<p>Telix confirms that payments noted under section 6.1 of the accompanying Appendix 4C include payments of <span class=\"xn-money\">$0.7 million<\/span> to ABX-CRO advanced pharmaceutical services (of which non-executive director Dr. <span class=\"xn-person\">Andreas Kluge<\/span> is Managing Director) for the provision of clinical and analytical services for the Company&#8217;s development programs.<\/p>\n<p>Payments of <span class=\"xn-money\">$0.3 million<\/span> to Directors were for director fees and Managing Director salary.<\/p>\n<p><b>About <\/b><b>Telix Pharmaceuticals Limited <\/b><\/p>\n<p>Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in <span class=\"xn-location\">Melbourne, Australia<\/span> with international operations in <span class=\"xn-location\">Belgium<\/span>, <span class=\"xn-location\">Japan<\/span>, <span class=\"xn-location\">Switzerland<\/span>, and <span class=\"xn-location\">the United States<\/span>. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit <a href=\"http:\/\/www.telixpharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.telixpharma.com<\/a>&nbsp;and follow Telix on <a href=\"https:\/\/twitter.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow noopener\">Twitter<\/a> (@TelixPharma) and <a href=\"https:\/\/www.linkedin.com\/company\/telixpharma\/\" target=\"_blank\" rel=\"nofollow noopener\">LinkedIn<\/a>.<\/p>\n<p>Telix&#8217;s lead product, Illuccix<sup>\u00ae<\/sup> (kit for preparation of gallium-68 (<sup>68<\/sup>Ga) gozetotide (also known as <sup>68<\/sup>Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),<sup>[24]<\/sup> and by the Australian Therapeutic Goods Administration (TGA).<sup>[25]<\/sup> Telix is also progressing marketing authorisation applications for this investigational candidate in <span class=\"xn-location\">Europe<\/span><sup><sup>[26]<\/sup><\/sup> and <span class=\"xn-location\">Canada<\/span>.<sup><sup>[27]<\/sup><\/sup><\/p>\n<p><b>Telix Investor Relations<\/b><\/p>\n<p>Ms. Kyahn Williamson<br \/>Telix Pharmaceuticals Limited<br \/>SVP Corporate Communications and Investor Relations<br \/>Email: <a href=\"mailto:kyahn.williamson@telixpharma.com\" target=\"_blank\" rel=\"nofollow noopener\">kyahn.williamson@telixpharma.com<\/a><\/p>\n<p><i>This announcement has been authorised for release by the Board of Directors. &nbsp;<\/i><\/p>\n<p>Legal Notices<\/p>\n<p><i>This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments.&nbsp; Forward-looking statements can generally be identified by the use of words such as &#8220;may&#8221;, &#8220;expect&#8221;, &#8220;intend&#8221;, &#8220;plan&#8221;, &#8220;estimate&#8221;, &#8220;anticipate&#8221;, &#8220;outlook&#8221;, &#8220;forecast&#8221; and &#8220;guidance&#8221;, or other similar words. 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 the Company&#8217;s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company&#8217;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&#8217;s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix&#8217;s preclinical and clinical studies, and Telix&#8217;s research and development programs; Telix&#8217;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, manufacturing activities and product marketing activities; the commercialisation of Telix&#8217;s product candidates, if or when they have been approved; estimates of Telix&#8217;s expenses, future revenues and capital requirements; Telix&#8217;s financial performance; developments relating to Telix&#8217;s competitors and industry; and the pricing and reimbursement of Telix&#8217;s product candidates, if and after they have been approved. Telix&#8217;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. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.<\/i><\/p>\n<p><i>To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions. &nbsp;<\/i><\/p>\n<p><i>The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).&nbsp;&nbsp;<\/i><\/p>\n<hr>\n<p>[1]&nbsp;Media release <span class=\"xn-chron\">14 April 2022<\/span>.<\/p>\n<p>[2]&nbsp;Positron emission tomography<\/p>\n<p>[3]&nbsp;ASX disclosure <span class=\"xn-chron\">30 May 2022<\/span>.<\/p>\n<p>[4]&nbsp;For regulatory reasons, Telix refers to its 68 Ga-gozetotide kit as Illuccix in markets where it has received regulatory approval, and TLX-591CDx when referring to its use in both approved and unapproved markets.<\/p>\n<p>[5]&nbsp;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).<\/p>\n<p>[6]&nbsp;ASX disclosure <span class=\"xn-chron\">7 February 2022<\/span>.<\/p>\n<p>[7]&nbsp;ASX disclosure <span class=\"xn-chron\">23 June 2022<\/span>.<\/p>\n<p>[8]&nbsp;ASX disclosure <span class=\"xn-chron\">11 July 2022<\/span>.<\/p>\n<p>[9]&nbsp;Telix Compassionate Use Policy, accessible at: <a href=\"https:\/\/telixpharma.com\/wp-content\/uploads\/Policy-on-Offering-Compassionate-Use-to-Investigational-Medicines.pdf\" rel=\"nofollow\">https:\/\/telixpharma.com\/wp-content\/uploads\/Policy-on-Offering-Compassionate-Use-to-Investigational-Medicines.pdf<\/a><\/p>\n<p>[10]&nbsp;ASX disclosure <span class=\"xn-chron\">27 January 2022<\/span>.<\/p>\n<p>[11]&nbsp;ASX disclosure <span class=\"xn-chron\">12 April 2022<\/span>.<\/p>\n<p>[12]&nbsp;Media release <span class=\"xn-chron\">5 May 2022<\/span>.<\/p>\n<p>[13] Giatromanolaki et al. <i>British Journal of Cancer<\/i>. 2020.&nbsp;<\/p>\n<p>[14]&nbsp;See: <a href=\"http:\/\/www.nobleregistry.org\" target=\"_blank\" rel=\"nofollow noopener\">www.nobleregistry.org<\/a>.<\/p>\n<p>[15]&nbsp;The NOBLE Registry is being conducted at eight sites globally in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Azerbaijan<\/span>, <span class=\"xn-location\">Egypt<\/span>, <span class=\"xn-location\">Indonesia<\/span>, <span class=\"xn-location\">Mexico<\/span>, <span class=\"xn-location\">Nigeria<\/span>, <span class=\"xn-location\">South Africa<\/span>, and the <span class=\"xn-location\">United Arab Emirates<\/span>.<\/p>\n<p>[16]&nbsp;ASX disclosure <span class=\"xn-chron\">11 April 2022<\/span>.<\/p>\n<p>[17]&nbsp;The RefleXion\u00ae&nbsp;X1 is cleared for SBRT\/SRS\/IMRT. BgRT is pending regulatory review and is not commercially available.<\/p>\n<p>[18]&nbsp;ASX disclosure <span class=\"xn-chron\">10 June 2022<\/span>.<\/p>\n<p>[19]&nbsp;Media release <span class=\"xn-chron\">14 June 2022<\/span>.<\/p>\n<p>[20]&nbsp;ASX disclosure <span class=\"xn-chron\">22 March 2022<\/span>.<\/p>\n<p>[21]&nbsp;ASX disclosure <span class=\"xn-chron\">4 April 2022<\/span>.<\/p>\n<p>[22]&nbsp;ASX disclosure <span class=\"xn-chron\">1 June 2022<\/span>.<\/p>\n<p>[23]&nbsp;ASX disclosure <span class=\"xn-chron\">11 July 2022<\/span>.<\/p>\n<p>[24]&nbsp;ASX disclosure <span class=\"xn-chron\">20 December 2021<\/span>.<\/p>\n<p>[25]&nbsp;ASX disclosure <span class=\"xn-chron\">2 November 2021<\/span>.<\/p>\n<p>[26]&nbsp;ASX disclosure <span class=\"xn-chron\">10 December 2021<\/span>.<\/p>\n<p>[27]&nbsp;ASX disclosure <span class=\"xn-chron\">16 December 2020<\/span>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>MELBOURNE, Australia, July 21, 2022 \/PRNewswire\/ &#8212; Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)&nbsp;today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 30 June 2022. All figures are in AUD$ unless otherwise stated. All figures are provided on an unaudited basis. Financial Summary Telix reports total [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-10355","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Telix Reports Second Quarter 2022 Financial Results - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=10355\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Telix Reports Second Quarter 2022 Financial Results - My Blog\" \/>\n<meta property=\"og:description\" content=\"MELBOURNE, Australia, July 21, 2022 \/PRNewswire\/ &#8212; Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company)&nbsp;today issues its Appendix 4C quarterly cash flow statement and accompanying Activities Report for the quarter ended 30 June 2022. 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