Telix reports fourth consecutive quarter of positive operating cash flow

MELBOURNE, Australia, Oct. 18, 2023 /PRNewswire/ -- TelixPharmaceuticalsLimited (ASX:TLX,Telix, the Company) today issues its Appendix 4C quarterly cash flow report and accompanying Activities Report for the quarter ended 30 September 2023 (Q3 2023). All figures are inAUD$ unless otherwise stated^[1]and provided on an unaudited basis.

Summary

• Total revenue of $133.6M, up from $120.7M (Q2 2023)
• Fourth consecutive quarter of positive operating cash flow ($21.4M, up $10.6M on the prior quarter)
• Cash receipts from customers up 16% to $130.7M ($112.2M in the prior quarter)
• Closing cash balance of $137.4M (compared to $131.7M at prior quarter end)

Managing Director and Group CEO, Dr Christian Behrenbruch commented, "The achievement of a fourth consecutive quarterofpositiveoperating cashflowisamajormilestonethatreflectstheCompany'smaturationasitdelivers onits commercial goals and progresses the development of its industry-leading pipeline.

"Wehaveposted anotherquarterofdouble-digitrevenue growthforIlluccix intheU.S.withaverage dailydemand for doses continuing to grow month-on-month. Just as importantly we have a number of near-term value drivers onthehorizon, beingthecommencement of theProstACT GLOBAL study and advancing the U.S. regulatory filing and commercial launch preparations for our renal (kidney) and brain cancer imaging agents. This is reflected inour investment during the quarter in research and development and commercial launch preparation, in line with our stated plans."

CommercialActivitiesReport

Americasregion: UnitedStates(U.S.) andCanada

RevenuefromU.S.salesofIlluccix (kitforthepreparationofgalliumGa68gozetotide injection) improved 13% to $130.6M(US$85.2M),upfrom$116.0M inQ22023.

Worldwiderevenue

Total revenue of $133.6M was generated during the quarter (including commercial sales of Illuccix in the U.S.). Ex-U.S. revenue (including compassionate use availability of Illuccix / TLX591-CDx)^[2]was $3.0M.^[3]

Netcashfromoperating activities

Telix delivered its fourth consecutive quarter of positive net operating cash inflow. The net operating cash inflow for the quarter was $21.4M, a $10.6M improvement on the prior quarter (Q2 2023, net operating cash inflow $10.8M). In line with increased revenue and improved collections, cash receipts from customers improved 16% to $130.7M, up from $112.2M in the prior quarter.

Theclosingcashbalanceat30September2023was$137.4M ($131.7M30June2023).Thenetoperating cashinflow was partially offset by cash outflows from investing activities which included an annual payment of $17.8M for thefirst instalment of the contingent consideration payable to former Telix Innovations (ANMI) shareholders, based on Illuccix sales.

Increased product manufacturing and related costs reflect higher volume of sales activity and preparation for future productlaunches. Grossmarginisbroadlyinlinewiththeprevious quarterat63%andreflects stablesellingprices and manufacturing costs.

R&D expenditure^[4]is in line with plan and reflects the momentum in the key near-term value drivers for the Company beingthecommencementoftheProstACT GLOBALstudyandadvancingtheU.S.regulatoryfilingsfortheTLX250-CDx Biologics License Application (BLA) and TLX101-CDx New Drug Application (NDA).

Illuccixglobalregulatoryupdate

Telix is progressing new marketing authorisations for Illuccix in a number of jurisdictions, including the United Kingdom (U.K.),European Union(E.U.)^[5] and Brazil. As previously reported, these respective applications are currently undergoing assessment and the Company will provide an update on any material changes to status. A Phase III study intended to bridge to the marketingauthorisation granted to Illuccix by the United States Food and Drug Administration (FDA) is in progress and recruiting well in China.^[6]

During the quarter the Company participated in a formal pre-NDA meeting with the Japanese regulator, the Pharmaceuticals and Medical Devices Agency (PMDA)aspartofitspreparationtowardsaregulatoryfilingforIlluccix in Japan. The outcome was clear and helpful feedback to support a regulatory submission ofIlluccix in Japan in 2024.

ClinicalPrograms Update

Telix has an industry leading pipeline of late-stageradiopharmaceutical therapeutics and associated diagnostic imagingagents, underpinning its commitment to targeted, precision oncology. The core pipeline is focused on prostate cancer, renal cancer, brain cancer (glioma) and rare diseases (hematologic cancers and bone marrow conditioning). The Company has over 20 clinical studies underway worldwide, includingTelix-sponsored and collaborative investigator- initiated trials.

During the quarter, notable updates were published in the news section of the Company's website(www.telixpharma.com/news-views) and are summarised in this section of the Activities Report.

Priorityfocusareasfortheclinicalpipeline:

• Progression of the prostate cancer therapy program (TLX591, Lutetium (177Lu) rosopatamab tetraxetan):
  The Phase III ProstACT GLOBAL study (ClinicalTrials.gov ID: NCT04876651) is now open for enrolment in Australia, with additional sites in the Asia Pacific region currently being onboarded.Thestudyisexpectedtoopenforenrolment in the U.S. following acceptance of an investigational new drug (IND) application, scheduled for filing in Q4 2023.
  
  
• Preparation of a BLA submission and commercialisation of TLX250-CDx (89Zr-DFO-girentuximab), Telix's investigational kidney cancer imaging agent: As supported under the Breakthrough Therapy designation, the Company is actively engaging with the FDA as it prepares its regulatory filing. The Company has received a formal acceptance letterfromtheFDAinresponsetoarequest forarollingreviewoftheBLA.Thisisanimportantpositive development, which allows the applicant to submit portions of a BLA or NDA separately, when corresponding data becomes available. This enables the FDA to consider reviewing key modules in advance of receiving the entire application, making the review process more efficient and potentially shortening the overall review period. The Company continues to progress its BLA submission in 2023 as planned.
  
  Telix has obtained clearance to commence its Expanded Access Program (EAP) in the U.S. with multiple sites now actively screening patients. Compassionate use access programs are active in Europe and Australia, to provide TLX250-CDx to patients and physicians in areas of unmet need, prior to obtaining marketing authorisation in accordancewiththeapplicablepermittedregulatorypathways. TheCompanyisalsoconductingnewresearchand clinical studies to explore the theranostic utility of this investigational asset in other cancers expressing carbonic anhydrase IX (CAIX), where there are currently high unmet medical needs.
  
  
• Preparation of a NDA submission for TLX101-CDx (18F-FET), Telix's investigational brain cancer imaging agent: Telix has significantly progressed the NDA filing for TLX101-CDx, including formal consultation with the FDA around the final proposed clinical package. Based on this feedback, the NDA submission will occur in Q1 2024 in order to enable Telix to include additional clinical data (already in possession). In addition to this, the Company has filed an applicationtocommenceanEAPintheU.S.thatisexpected toopenforpatientaccess inNovember2023,subjectto regulatory clearance.

CAIXprogram (TLX250-CDx/TLX250): Multiplestudiesunderway tosupporttheranostic indication expansion

Telix has multiple clinical studies in its CAIX program, exploring the potential of this target in combination with immunotherapy for the treatment ofccRCC and also its potential across a broad range of cancer indications.CAIXisaproteinoverexpressed on the surface ofccRCC,thecancertarget inTelix's successful Phase III ZIRCON study. It is also expressed to varying degrees in many other advanced-stage solidtumours with poor prognoses.

The first patients have now been dosed in the STARSTRUCKtherapeuticstudy(ClinicalTrials.govID:NCT05868174)of TLX250 (177Lu-DOTA-girentuximab) in combination with a Merck KGaA,Darmstadt,GermanyDNA-dependentprotein kinase (DNA-PK) inhibitor candidate, peposertib (M3814).^[7]The open label, single-arm, multi-centre dose escalation and dose expansion study is evaluating safety profile, dosing and activity and will enrol up to 80 patients with CAIX- expressing solid tumours.

ThePhaseIIOPALESCENCEinvestigator-initiatedtrial(IIT)ofTLX250-CDxintriple-negativebreast cancer (ClinicalTrials.gov ID: NCT04758780) has completed enrolment with top-line data anticipated shortly.

TLX101braincancer(glioblastoma)therapy programupdate

Dosing of the first cohort of patients has been completed in the Phase I IPAX-2 study of TLX101 (4-L-[131I] iodo- phenylalanine, or 131I-IPA), running at sites across Australia, New Zealand and Europe. IPAX-2 (ClinicalTrials.gov ID: NCT05450744)seekstoconfirmthesafetyprofile ofTLX101asafront-linetherapyincombinationwithstandardofcare (SoC) treatment, ahead of progressing to a label-indicating Phase II/III study in a larger patient population, IPAX-3.

In parallel, building on the success of Telix's Phase I/II IPAX-1 study (ClinicalTrials.gov ID: NCT03849105),^[8]TLX101 is beingfurtherinvestigatedintherecurrentsetting inthePhaseIIIPAX-LinzIIT,whichisprogressingwellandhasnow exceeded 70% of the patient enrolment target.

GrandPharma partnership:Firstpatients dosedinChinese imagingstudies

Two studies are being conducted in collaboration with the Company's strategic partner for the Greater China region,Grand Pharmaceutical Group Limited to demonstrate that the diagnostic utility of TLX591-CDx and TLX250-CDx isequivalentinChinese andWesternpopulations.Thedatagenerated willsupportfuture marketingauthorisation applications for the Company's prostate and renal cancer imaging agents in China.

During the quarter, patient dosing commenced in the Phase III registration study of TLX591-CDx (Illuccix) (ClinicalTrials.gov ID: NCT05847348)^[9]and additional sites were opened.

RelatedParty Transactions

Telix confirms that payments noted under section 6.1 of the accompanying Appendix 4C include payments of $0.3M to ABX-CRO advanced pharmaceutical services (of which Non-Executive Director Dr Andreas Kluge is Managing Director) for the provision of clinical and analytical services for the Company's development programs. Payments of $0.3M were made to Directors for Director fees and Managing Director salary.

InvestorCall

Aninvestor webcastwillbeheldat8.30amAEDT on Thursday 19 October (Wednesday 18 October, 5.30pm EDT)

Participants can register for the webcast and find audio call details at the following link:https://edge.media- server.com/mmc/p/b3jsi4g4

AboutTelix PharmaceuticalsLimited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of clinical- stageproductsthataimstoaddresssignificantunmetmedicalneedsinoncology andrarediseases. Telixislisted onthe Australian Securities Exchange (ASX: TLX).

Visitwww.telixpharma.comforfurther informationaboutTelix, including details of the latest share price, announcements made to the ASX,investorandanalystpresentations,newsreleases,eventdetailsandotherpublicationsthatmaybeof interest. You can also follow Telix on LinkedIn.

Telix's lead product, Illuccix or kit for preparation of gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the FDA,^[10] by the Australian Therapeutic Goods Administration (TGA), ^[11] and by Health Canada.^[12]Telix is also progressing Marketing Authorisation Applications for 68Ga PSMA-11 in the United Kingdom, the European Union,^[13] and Brazil. With the exception ofIlluccixasnotedabove, noTelixproduct hasreceivedamarketing authorisation in any jurisdiction.

TelixInvestorRelations

Ms.Kyahn Williamson
Telix PharmaceuticalsLimited
SVPInvestorRelationsandCorporateCommunications Email: kyahn.williamson@telixpharma.com

ThisannouncementhasbeenauthorisedforreleasebytheTelixPharmaceuticalsLimited DisclosureCommitteeon behalf of the Board.

LegalNotices

This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements 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", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levelsof 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's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptionswillprovetobecorrect. InthecontextofTelix's business,forward-lookingstatementsmayinclude,butare not limited to,statements about: theinitiation,timing, progress and results of Telix's preclinicaland clinicalstudies,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 andapprovals,manufacturingactivitiesandproductmarketing activities;thecommercialisationofTelix'sproduct candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix'sproductcandidates,ifandaftertheyhavebeenapproved.Telix'sactualresults, performanceorachievementsmay 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.

Except as required by applicable laws or regulations, Telixdoesnotundertaketopubliclyupdate orreviewanyforward- looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on ourwebsite.

2023TelixPharmaceuticalsLimited.TheTelixPharmaceuticalsandIlluccixnameandlogoaretrademarksofTelix Pharmaceuticals Limited and its affiliates (all rights reserved).

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SOURCE Telix Pharmaceuticals Limited