MELBOURNE,Australia,Aug. 22,2024 -- Telix PharmaceuticalsLimited (ASX: TLX,Telix,the Company) today announces its financial results for the half-year ended 30 June 2024. All figures are in AU$ unless otherwise stated.[1]
H1 2024 financial highlights
Total Group revenue of $364.0 million,an increase of 65% compared to H1 2023,reflecting continued growth in sales of its prostate cancer imaging agent,Illuccix® in the United States (U.S.),now in its second full year of commercial sales.
Net profit after tax of $29.7 million compared to a net loss of $14.3 million in H1 2023.
Gross margin improved to 66% (compared to 63% in H1 2023),supported by stable selling price of Illuccix® and disciplined cost control.
Adjusted earnings before interest,tax,depreciation,and amortisation (Adjusted EBITDA) of $57.5 million,an increase of $22.8 million or 66%,when compared to $34.7 million in H1 2023.
Adjusted earnings before interest,amortisation and research and development (Adjusted EBITDAR) of $137.1 million,a significant uplift from $81.3 million in H1 2023,demonstrating the profitability of the commercial organisation.
Net cash generated from operating activities of $39.1 million (compared to $13.3 million in H1 2023),primarily from sales of Illuccix®.
Closing cash balance was $118.8 million as at 30 June 2024. Subsequent to the reporting period,Telix completed a convertible bond financing,raising $650.0 million (before costs).
Telix reaffirms its full year 2024 revenue guidance of US$490M to US$510M ($745 million to $776 million at current exchange rates),representing a ~48-54% increase on FY 2023. Telix also confirms previously advised guidance for R&D expenditure remains unchanged[2].
H1 2024 operational highlights
Positive efficacy data generated by the ProstACT SELECT (TLX591) study,and proof-of-concept in the CUPID (TLX592) study reinforce the clinical potential and differentiation of the Company's beta and alpha prostate cancer therapy programs.
For the Phase III ProstACT GLOBAL trial (TLX591),the Investigational New Drug application was cleared by the U.S. Food and Drug Administration (FDA) and site activation commenced in the U.S.
Expansion of the commercial precision medicine (diagnostic imaging) portfolio:
Regulatory filing of a New Drug Application (NDA) for a new PSMA-PET[3] product (TLX007-CDx) accepted by the FDA.
Regulatory filings for two additional new products: TLX101-CDx (Pixclara®[4] for imaging of glioma) and TLX250- CDx (Zircaix®[4] for imaging of kidney cancer) expected in Q3 2024,and Q4 2024[5],respectively.
Illuccix® European Union (EU) and United Kingdom (UK) submissions progressing in line with expectations and in accordance with guidance to industry. All questions raised by the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte,BfArM) as EU competent authority during standard review "clock-stop" period have been addressed. The UK Medicines & Healthcare Products Regulatory Agency (MHRA) regulator's assessment report has been received with no substantive issues raised. Decisions expected in H2 2024.
Illuccix® submission with the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria,ANVISA) in the final stages of review with an approval decision anticipated during Q3 2024 based on current information. Approval is expected,however regulator has been experiencing strike action.
Completion of the ARTMSandIsoTherapeuticsacquisitionsfurtherenhance ongoingverticalintegrationstrategy,delivering greater control over supply chain and additional self-sufficiency and capabilities in manufacturing,particularly for gallium-68 (68Ga) and zirconium-89 (89Zr) to support near-term revenue and margin growth.
DrChristianBehrenbruch,Managing Director and Group Chief Executive Officer,commented on the result:
"Telix continues to grow revenue from Illuccix®,increase gross profit margin and manage costs effectively,while investingforfuturegrowth. Ourachievementsinthefirst halfof2024havecreated valueforshareholdersandpositioned the Company for success on multiple fronts. Building on our commercial success with Illuccix®,we are focused on expanding the near-term opportunity in precision medicine diagnostics with three new products planned for launch in 2025,subject to regulatoryapproval.Atthesametime,newefficacydata fromtheProstACT SELECT trial has reinforced the therapeutic potential of TLX591 – our Phase III asset for prostate cancer therapy,while we have a number of additional significant clinical milestones ahead across our therapeutic pipeline.
"Wealsocontinue tobuildoutourinternal manufacturingcapability,which webelieveisacompetitiveadvantageforour radiopharmaceuticalsupply chainandability todeliverpatient dosesglobally.Telix's successful$650million convertible bond offering will facilitate our ambitions in this regard,while also positioning us to accelerate clinical development on key programs and capitalise on potential strategic M&A opportunities.
"We believe the radiopharmaceutical sector is at an inflection point and Telix has the proven commercial ability,clinical experienceandbalance sheetstrengthtoadvanceourleading-edgetheranosticpipeline.Withaprovenrevenue stream and a clear path to future business growth,Telix is positioned at the vanguard of this fast-growing field."
Investor call
Aninvestor webcastwillbeheldat9.00amAEST onFriday 23August2024(7.00pmEDT,Thursday22August2024).
Participantscanregister forthewebcastandfindaudiocalldetailsatthefollowing link:https://s1.c-conf.com/ diamondpass/10041010-puhyt.html
AboutTelix PharmaceuticalsLimited
Telixisabiopharmaceuticalcompany focusedonthedevelopmentandcommercialisationoftherapeuticanddiagnostic radiopharmaceuticalsandassociatedmedicaldevices.TelixisheadquarteredinMelbourne,withinternational operations in the United States,Europe (Belgium and Switzerland),and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases.
TelixislistedontheAustralianSecuritiesExchange(ASX:TLX).
Telix'sleadimaging product,gallium-68(68Ga)gozetotideinjection,(alsoknownas68GaPSMA-11andmarketed under the brand name Illuccix®),has been approved by the U.S. Food and Drug Administration (FDA)[6],by the Australian Therapeutic Goods Administration (TGA)[7],and by Health Canada[8]. No otherTelix product has received a marketing authorisation in any jurisdiction.
Visitwww.telixpharma.comforfurther informationaboutTelix,includingdetailsofthelatest shareprice,announcements madeto theASX,investor andanalystpresentations,newsreleases,event detailsandother publicationsthatmaybeof interest. You can also follow Telix on X and LinkedIn.
1]. Conversion to AU$ is at the exchange rate on the relevant transaction date. The average exchange rate realised during the period was AU$1 = US$0.66; AU$1 = €0.58.
[2]. TelixASXdisclosures18July2024and22February2024.Revenueguidance isbasedonapprovedproducts injurisdictionswithamarketing authorisation.Illuccix®hasreceivedamarketing authorisation in Australia,Canada and the U.S.
[3]. Imaging of prostate-specific membrane antigen with positron emission tomography.
[4]. Brand name subject to final regulatory approval.
[5]. FDA has requested further validation for the TLX250-CDx Biologics License Application (BLA) filingtoadvance tofullreview. TelixASX disclosure 31 July 2024.
[6]. TelixASX disclosure20December2021.
[7]. TelixASX disclosure2November2021.
[8]. TelixASXdisclosure14October2022.
Telix InvestorRelations
Ms.Kyahn Williamson
Telix PharmaceuticalsLimited
SVPInvestorRelations andCorporateCommunications Email:
ThisannouncementhasbeenauthorisedforreleasebytheTelix PharmaceuticalsLimited BoardofDirectors
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the initiation,timing,progress and results of Telix's preclinical and clinical trials,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 and approvals for Telix's product candidates,manufacturing activities and product marketing activities; Telix's sales,marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates,if or when they have been approved; Telix'sabilitytoobtainanadequatesupply ofrawmaterialsatreasonablecostsforitsproductsandproductcandidates; estimates of Telix's expenses,future revenues and capital requirements; Telix's financial performance; developments relatingtoTelix's competitorsandindustry; andthepricingandreimbursementofTelix'sproduct candidates,ifandafter 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 be adverse. Accordingly,you should not place undue reliance on these forward-looking statements.
Telixusesvarious non-IFRSinformationtoreflectitsunderlyingperformance.Forfurtherinformation,thereconciliation of non-IFRS financial information to Telix's statutory measures,reasons for usefulness and calculation methodology,please refer to the Alternative performance measures section in Telix's Annual Report.
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