2024-10-22 02:50:02
Author: Telix Pharmaceuticals Limited / 2023-07-24 01:24 / Source: Telix Pharmaceuticals Limited

Telix Reports Fourth Quarter 2022 Financial Results

Telix Reports Fourth Quarter 2022 Financial Results

MELBOURNE,Australia,Jan. 18,2023 -- 18 January 2023. 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). All figures are in AUD$ unless otherwise stated1and provided on an unaudited basis.

Financial Summary

Telixachieved positivecashflowfromoperatingactivities:netoperating cashflowimproved by$6.9million overthe 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)

CommercialActivityReport

U.S.commercialupdate

InQ42022,thethird quarterofcommercialsales,Telix generated $76.8 million (US$50.5 million) revenue from sales of its prostate cancer positron emissiontomography(PET)imagingagent,Illuccix®.Thisrepresentsa43%increase ontheprior quarter ($53.7 million,Q3 2022). Sales momentum continues to build,due to active reimbursement and growth across three majorsegments ofhospitalcustomers,independent imaging centres andgovernment (Veterans Affairs)customers.

TheCompany'sdistributionnetworknowconsists of190nuclearpharmaciesnationwide,facilitatingindustry-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."

Prostateimaging worldwiderevenue

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.

Netcashfromoperatingactivities

Telixreports itsmaidenquarter ofnetoperatingcashinflow,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.

1. ConversiontoAUDisattheaverageexchange ratefortheperiod.AUD$1 =US$0.66;AUD$1=€0.64

2. 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.

Paymentsforproduct manufacturingandrelated costsreflecthigher volumeofsalesandtiming ofsupplierpayments,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.

Illuccixglobalregulatoryupdate

Duringthequarter,HealthCanadaapproved IlluccixforusewithPETofprostate specificmembraneantigen (PSMA) positive lesions in men with prostate cancer:

1. withsuspected metastasiswhoaresuitableforinitialdefinitivetherapy;and

2. withsuspected recurrencewithelevated serumprostatespecific antigen(PSA)level.

TelixispreparingforcommerciallaunchinCanada inH12023throughitspartner,Isologic Innovative Radiopharmaceuticals,whose distribution network services 265 hospitals and clinics nationwide.

TelixismakingprogressontheregulatoryrefilinginEurope andistargetingtohavetheupdated dossierfinalised by the end of Q1 2023,for resubmission to the Danish Medicines Agency (DKMA). TheDKMA will advise the revised review timeline upon formal acceptance of the updated dossier. Telix is also progressing marketing authorisationapplicationsin Brazil and South Korea together with its partners.

ClinicalPrograms Update

Telix continues to progress its core clinical pipeline,with a focus on prostate cancer,renal (kidney) cancer,brain cancer (glioblastoma)andrarediseases(bonemarrowconditioning).TheCompanyhasover20clinicaltrials underway,including collaborative investigator-initiated studies. Notable updates are included in this section of the activities report.

Renal(kidney)cancer /carbonicanhydraseIX(CAIX)program

TheCompanyreported highlypositivetop-line datafromtheZIRCON(NCT03849118)PhaseIIIstudy ofTLX250-CDx (89Zr-DFO-girentuximab),an investigational product for the PET imaging of clear cell renal cell carcinoma (ccRCC).1

Thestudymetallofitsprimary andsecondaryendpoints:

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 <4cm ("T1a" classification),was also delivered,with 85% sensitivity and 89% specificity achieved.

Theseresultsmeanthat,forthefirsttime,theremaybeanon-invasivewaytocharacteriseanddiagnoseccRCC,themost aggressive and common form of renal malignancy,which if approved would deliver on a major unmet medical need.

DetailedresultsfromtheZIRCONstudywillbepresentedforthefirsttimeattheAmerican SocietyofClinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (ASCO GU) on 18 February 2023 in an oral presentation format.2

DrColinHayward,ChiefMedicalOfficer atTelixsaid:"TheexcellentresultsfromtheZIRCONstudyvalidatethattheCAIX target is potentially as ground-breaking in ccRCC as PSMA has been for prostate cancer,and that TLX250-CDx could changethestandard ofcareinthediagnosis andmanagementofrenalmasses. Weareexcitedtopresent furtherclinical data at ASCO-GU next month,the leading specialised event for genitourinary cancer care worldwide,and to advance towards the preparation of a Biologics License Application for submission to the FDA."

1. ASXdisclosure7November2022.

2. ASXdisclosure22December2022.

TLX250-CDxpotentialforindicationexpansion

Beyond ccRCC,CAIX is also expressed by a number of other solid tumours including bladder or urothelial,breast,brain,cervix,colon,oesophagus,head and neck,lung,ovarian,pancreatic and vulval cancers. It is often expressed in hypoxic (oxygenated)tumour cells,characteristic of advanced disease with typically poor treatment outcomes. Hypoxictumours are typically more aggressive and less responsive to current treatments,particularly immunotherapies.1

Based on this potential to target multiple tumour types,investigator-led studies are in progress using TLX250-CDx in imaging of urothelial carcinoma or bladder cancer (ZiP-UP,NCT05046665),metastatic triple negative breast cancer (OPALESCENCE,NCT04758780),andnon-muscleinvasive bladdercancer(PERTINENCE,NCT04897763),andasproof- of-concept for stand-alone and combination therapies. OPALESENCE and PERTINENCE studies reported positive preliminary data during the quarter at the European Association of Nuclear Medicine (EANM) Annual Congress.2

Also during the quarter,Telix announced STARBURST (NCT05563272),a prospective,open-label,Phase II study to explore CAIX expression through TLX250-CDx PET/CT imaging in patients with various solid tumours for diagnostic and therapeutic applications.3 An investigationalnewdrugapplication(IND) hasbeensubmitted totheFDAwithfirstpatients expected to be enrolled in the study during Q1 2023.

Prostatecancer/PSMAtherapy program

Telix's PSMA-targeting ProstACT therapeutic program is evaluating the efficacy of Telix's lutetium-177 (177Lu)-labelled therapeuticantibody (TLX591)invarious stagesofprostate cancer,fromfirstrecurrencetoadvancedmetastaticdisease.4

TheProstACTSELECT study(NCT04786847),a"theranostic"(imagingandtherapy) PhaseIradiogenomicsstudyto demonstrate the utility of Illuccix to select TLX591 patients for therapy,continues to recruit well with top-line data expected in H1 2023. During the quarter,a first patient was dosed in the Phase II ProstACTTARGET studyofTLX591 (NCT05146973),inpatientsexperiencingafirstrecurrenceofprostate-specificantigen (PSA)afterinitial therapyfor prostate cancer.5

TheCompanyisprogressingmanufacturingscaleupandregulatorysubmissionsfortheProstACT GLOBALPhaseIIIstudy (NCT04876651) in preparation to commence dosing patients in Australia and New Zealand,the U.S. and Europe,subject to the requisite regulatory approvals. The study will be a global randomised controlled trial in patients progressing on novel hormonal therapy in the metastatic setting. Patients will be randomised 2:1 to TLX591 with a total of ~392 patients expected to be enrolled. An interim analysis for safety and efficacy is planned at approximately 120 patients.

Glioblastoma (braincancer)/LAT-1program

During the quarter,a first patient was dosed in IPAX-Linz (IPAX-L),a Phase II investigator-initiated study of TLX101 in combinationwithexternal beamradiationtherapy (EBRT)inpatients withrecurrenthigh-gradegliomas(HGG),including glioblastomamultiforme(GBM).6 TLX101(4-L-[131I]iodo-phenylalanine,or131I-IPA)isoneofTelix'sleadtherapeuticclinical programs and has been granted orphan drug designation in the U.S. and Europe. TLX101 targets L-type amino acid transporter 1 (LAT-1),typically over-expressed in many malignant tumours,including HGG/GBM.

The IPAX-Linz study,led by Professor Josef Pichler at Kepler University Hospital in Linz,Austria,builds on encouraging safetyandpreliminaryefficacy datageneratedintheIPAX-1 study.7IPAX-Linzwillcontinue tostudythebenefitofTLX101 topatientsinthesecond line(refractory)setting atthisleading neuro-oncologysiteinEurope.Thegoalofthisstudyisto gather additional data on clinical utility.

IPAX-Linz will run concurrently with IPAX-2(NCT05450744),which is evaluating TLX101 in combination with post-surgical standardofcarecomprised ofEBRTandtemozolomideinnewlydiagnosed (firstline)GBMpatients.Itisexpected thatthe combinationofthe IPAX-1,IPAX-2and IPAX-L studies willinform apivotaltrial strategy forthisasset byend-2023.

1. Huizing,F.J.etal.SciRep92019.

2. ASXdisclosure18October2022.

3. ASXdisclosure7November2022.

4. ASXdisclosure27January2022.

5. ASXdisclosure12April2022.

6. Telixmediarelease 22November2022.

7. ASXdisclosure21September2022.

Research,InnovationandManufacturing

In November 2022,Telix entered into a collaboration with UniQuest Pty Ltd (UniQuest),the commercialisation companyof The University of Queensland (UQ),to develop a radiolabelled molecule targeting an immune checkpoint protein.1The goalisthatanimmune targetingpeptidecould beusedasanimaging agenttodeterminethepresenceofcertainimmune checkpoint proteins in metastatic tumours,in order to guide patient selection for immunotherapy.

The Company also announced its acquisition of Optimal Tracers,a Sacramento (California)-based radiochemistry development company,that provides radiochemistry process development services and research tracers for use in clinical trials.2The acquisition of Optimal Tracers expands Telix's translational radiochemistry capability and offers a unique environment for pharma partnerships and collaborations.

In December 2022,Telix published that it has been granted an updated radiation licence by the Belgian Federal Agency forNuclear Control(FANC)foritsEuropean radiopharmaceuticalproductionfacility inBrusselsSouth.3Thislicence paves the way for the Company to activate the site for production H2 2023 subject to the requisite regulatory inspectionsandapprovals.

ExecutiveLeadershipChanges

AlsoinDecember2022,Telixannounced severalkeyexecutiveleadershipappointmentsandpromotions.

RichardValeix,ChiefExecutiveOfficer fortheEurope,MiddleEastandAfrica(EMEA) operatingregionsincejoiningTelixin May 2021,was appointed to the newly created role of Group Chief Commercial Officer.

RaphaelOrtiz,ChiefOperatingOfficer –EMEAsincejoininginJanuary2022,succeedsRichardasChiefExecutive Officer – EMEA.

GenevieveRyanalsojoinedtheCompanyasGroupCompany Secretary,replacingMelanie Farriswhohasretiredfromthe role to take on a broader portfolio as Senior Vice President Global Governance,Risk and Compliance (GRC).

These appointments reflect an increased commercial focus of the Company and ongoing succession planning to ensure Telixhasanoptimal mixofskillsandexperienceastheCompany preparestoenteranewphasewithaportfolioofmultiple commercial products.

PaymentstoRelated Parties

Telix confirms that payments noted under section 6.1 of the accompanying Appendix 4C include payments of $1.3 million toABX-CRO advancedpharmaceuticalservices (ofwhichNon-ExecutiveDirectorDr.Andreas KlugeisManaging Director) for the provision of clinical and analytical services for the Company's development programs. Payments of $0.2 million to Directors were for Director fees and Managing Director salary.

InvestorCall

An investor conference call and webcast was held at 9.00am on Wednesday 18 January AEDT(5.00pm,Tuesday 17 January,EST).

<ENDS>

1. Telix mediarelease27October2022.

2. ASXdisclosure14November2022.

3. Telixsocialmedia21December 2022.

AboutTelix PharmaceuticalsLimited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals.TelixisheadquarteredinMelbourne,Australia withinternationaloperationsinUnitedStates,Europe (Belgium and Switzerland) and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.comand follow Telix on LinkedIn.

TLX250-CDx(89Zr-DFO-girentuximab)hasnotreceived amarketingauthorisationinanyjurisdiction.Telix'sleadproduct,Illuccix®orkitforpreparationofgallium-68(68Ga)gozetotide(also knownas68GaPSMA-11)injection,hasbeenapproved by the U.S. Food and Drug Administration (FDA),1 by the Australian Therapeutic Goods Administration (TGA),2 and by Health Canada.3

TelixInvestor Relations

Ms.KyahnWilliamson


TelixPharmaceuticalsLimited


SVPCorporateCommunicationsandInvestorRelations Email: kyahn.williamson@telixpharma.com

ThisannouncementhasbeenauthorisedforreleasebytheTelix PharmaceuticalsLimitedDisclosureCommitteeonbehalf of the Board.

Legal Notices

Thisannouncementisnotintended aspromotionoradvertisingdirected toanyhealthcareprofessionalorotheraudience 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",orothersimilar 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'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 assumptions will prove to be correct. In the context of Telix's business,forward-looking statements may include,but arenotlimitedto,statementsabout: theinitiation,timing,progressandresults ofTelix'spreclinicalandclinicalstudies,

andTelix's researchanddevelopmentprograms;Telix'sability toadvanceproduct candidatesinto,enrol andsuccessfully complete,clinical studies,includingmulti-nationalclinicaltrials;thetimingorlikelihoodofregulatoryfilings andapprovals,manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates,if or when theyhavebeenapproved;estimatesofTelix's expenses,futurerevenuesandcapitalrequirements; Telix's financial performance; developments relating to Telix's competitors and industry; 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 beadverse.Accordingly,youshouldnotplaceunduerelianceontheseforward-lookingstatements.Youshould read this announcement together with our risk factors,as disclosed in our most recently filed reports with the ASX or on our website.

To the maximum extent permitted by law,Telix disclaims any obligation or undertaking to publicly update or revise any forward-lookingstatementscontained inthisannouncement,whetherasaresult ofnewinformation,futuredevelopments or a change in expectations or assumptions.

TheTelix PharmaceuticalsandtheIlluccixnameandlogoaretrademarksofTelixPharmaceuticalsLimitedanditsaffiliates – all rights reserved.

1. ASXdisclosure20December2021.

2. ASXdisclosure2November2021.

3. ASXdisclosure14October2022

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