Telix 2023 Half-Year Results: Revenue and Earnings Growth Marks Transition to a Sustainable Commercial-Stage Company
MELBOURNE, Australia, Aug. 23, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its financial results for the half-year ended 30 June 2023. All figures are in AUD$ unless otherwise stated.[1]
Financial highlights
- Total Group revenue $220.8M - a nine-fold increase on H1 2022 ($24.0M) reflecting continued growth in sales of its prostate cancer imaging agent, Illuccix (kit for the preparation of Ga 68 gozetotide injection), since U.S. commercial launch in April 2022 (H1 2022)
- Net loss after tax $14.3M, an 80% reduction on H1 2022 (net loss $70.9M) including a non-cash adjustment of$36.6M (H1 2022: $5.7M) reflecting the strong commercial performance of Illuccix. The contingent consideration liability reflects future variable payments based on percentages of Illuccix sales
- Adjusted earnings before interest, tax, depreciation, amortisation and research and development (Adjusted EBITDAR) was $82.4M (H1 2022: loss of $28.0M), demonstrating the profitability of the commercial organisation
- Gross margin was 64% (compared to 56% in H1 2022) reflecting normalised operating expenditure
- Transition to positive operating cash flow was driven by growth in commercial sales and expenditure control
- Closing cash balance was $131.7M at 30 June 2023 (31 December 2022: $116.3M)
Operationalhighlights
- Positive growth outlook for Illuccix in the U.S. and globally as market adoption increases
- Supplemental new drug application (sNDA) for Illuccix approved by the U.S. Food and Drug Administration (FDA), label expanded in the U.S. to include selection of patients for PSMA[2]-directed 177Lu radioligand therapy[3]
- Operational focus on preparation of regulatory submissions and commercial launch readiness for renal (TLX250-CDx) and glioma (TLX101-CDx) imaging candidates
- Completion of the ProstACT SELECT study of TLX591 for prostate cancer therapy,[4] with first data readout expected Q4 2023. ProstACT GLOBAL study on track to begin patient dosing at Australian sites imminently
- New studies initiated exploring the carbonic anhydrase IX (CAIX) program in indications beyond kidney cancer, including STARBURST,[5] a 'basket' study exploring multiple theranostic targets and STARSTRUCK,[6] a study of TLX250 investigational therapy in combination with a DNA damage repair inhibitor candidate
- Multiple studies of TLX101 glioblastoma therapy candidate progressing, including dosing of first patients in IPAX-2 in newly diagnosed patients[7]
- Multiple studies progressing with Grand Pharmaceutical Group Limited in China, including bridging studies to support regulatory filings for Illuccix[8] and TLX250-CDx,[9] and approval to commence the Phase I IPAX-China study of TLX101 investigational therapy[10]
- Completed stage one of the buildout of Telix Manufacturing Solutions, our European radiopharmaceutical production facility located in Brussels South, Belgium[11]
- Agreements to acquire Lightpoint Medical and its SENSEI radio-guided surgery business,[12] and Dedicaid GmbH[13] and its artificial intelligence-based platform enhance Telix's product offering
Dr Christian Behrenbruch, Managing Director and Group Chief Executive Officer commented on the result: "Telix has deliveredanexcellentresultacrossallkeyfinancialmetrics.Thebusiness hasdemonstrateditsabilitytocommercialise successfully,deliveringanimpressive$218.3M intotalrevenue fromIlluccixsales[14]inH12023,withsustainedgrowth in demand since launch.
"Importantly,Telixhastransitionedtopositiveearnings onanadjustedEBITDARbasissignallingtheprofitabilityofour commercial organisation.
"Wehaveapositiveoutlook forcontinuedgrowth incommercialsalesofIlluccix,basedonanexpandingglobalPSMA PET imaging market, and expect to see Telix launch two new products in 2024 for brain and kidney cancer imaging, subject to regulatory approval.
"The business is making great progress across its therapeutic programs and, with a number of exciting clinical milestones ahead, will further demonstrate the value and differentiation of its industry-leading pipeline."
InvestorCall
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Participantscanregister forthewebcastandfindaudiocalldetailsatthefollowing link:https://edge.media- server.com/mmc/p/2sr9bunm
AboutTelixPharmaceuticalsLimited
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 stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).
Visitwww.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telixon LinkedIn.
Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[15] by the Australian Therapeutic Goods Administration (TGA),[16] and by Health Canada.[17] Telix is also progressing Marketing Authorisation Applications for 68Ga-PSMA-11 in the United Kingdom and the European Union.[18]
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, 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 are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, 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, manufacturing activities and product marketing activities; the commercialisation of Telix's product 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'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 be adverse. Accordingly, you should not place undue reliance on these forward-looking statements.
Exceptasrequired byapplicablelawsorregulations,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 onourwebsite.
2023TelixPharmaceuticalsLimited.TheTelixPharmaceuticalsandIlluccixnameandlogoaretrademarksofTelix Pharmaceuticals Limited and its affiliates (all rights reserved).
[1] Conversion toAUD$isattheactualexchange rateontransactiondate.Theaverage exchangeraterealised duringtheperiod ofAUD$1=US$0.67;AUD$1=0.62. |
[2] Prostate-specificmembraneantigen. |
[3] TelixASXdisclosure16March2023. Illuccixisnowapprovedforusefortheselectionofpatientswithmetastaticprostate cancer,forwhomlutetium-177(177Lu)PSMA-directedtherapy is indicated,specificallylutetium Lu 177vipivotide tetraxetan PSMA-directedtherapy,marketed as Pluvicto (Pluvictois aregisteredtrademarkofNovartis AGand/oritsaffiliates). |
[4] TelixASXdisclosure19July2023. |
[5] TelixASXdisclosure19June2023. |
[6] Telixmediarelease19July2023. |
[7] Telixmedia release8August 2023. |
[8] TelixASXdisclosure11August2023. |
[9] TelixASXdisclosure19July2023. |
[10] Telixmedia release11April2023. |
[11] Telixmediarelease8June2023. |
[12] TelixASXdisclosure21June2023.Subjecttocompletion. |
[13] TelixASXdisclosure27April2023. |
[14] Includespre-commercialsalesfrominvestigational,clinicaltrial,magisterialandcompassionateuseinaccordancewithlocallawsandregulations(notasacommercialdiagnosticimaging product sold for routine clinical practice). |
[15] TelixASXdisclosure20December2021. |
[16] TelixASXdisclosure2November2021. |
[17] TelixASXdisclosure14October2022. |
[18] TelixASXdisclosure3April2023. |
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