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Telix 2023 Full Year Results: Inaugural Profit Achieved, Strong Revenue Growth Underpins Investment in Late-stage Pipeline

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MELBOURNE, Australia, Feb. 22, 2024 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces its results for the financial year ended 31 December 2023. All figures are in AUD$ unless otherwise stated.[1]

2023 highlights

  • Total Group revenue of $502.5M, an increase of 214% from $160.1M in 2022 primarily driven by continued strong growth in sales of Illuccix® in the second year since commercial launch (April 2022)
  • Delivered positive adjusted earnings before interest, tax, depreciation, and amortisation (adjusted EBITDA) of $58.4M an increase of $126.2M, compared to a loss of $67.8M in 2022
  • Inaugural full year profit of $5.2M after tax. A substantial improvement on the net loss after tax of $104.1M in 2022
  • Investment in research and development (R&D) and selling, general and administration (SG&A) reflects progress across the late-stage pipeline and scale-up of the commercial organisation
  • Overall operating costs as a percentage of revenue have reduced to 52% from 105% in 2022
  • Gross margin has improved to 63% (vs. 59% in 2022) reflecting distribution and manufacturing costs optimisation
  • Positive operating cash inflow in line with commercial sales growth, demonstrated through customer receipts of $463.7M (vs. $124.1M in 2022), and
  • Closing cash balance was $123.2M as at 31 December 2023.

Progress across the core pipeline includes:

  • First patients dosed in the ProstACT GLOBAL Phase III clinical trial of TLX591, a first-in-class investigational rADC[2] for prostate cancer therapy
  • Positive interim readout from the ProstACT SELECT Phase I clinical trial reinforcing the differentiation of TLX591, including favourable safety profile and clinical utility of the patient-friendly short dosing regimen
  • Submission of the Biologics License Application (BLA) for TLX250-CDx (Zircaix™[3]) to the United States Food and Drug Administration (U.S. FDA) for kidney cancer imaging on a rolling review basis
  • Patients dosed in multiple clinical trials of Telix’s therapeutic candidate TLX250 for clear cell renal cell carcinoma (ccRCC) and other solid tumours expressing carbonic anhydrase IX (CAIX)
  • First cohort of patients dosed in the IPAX-2 trial investigating Telix’s glioblastoma therapy candidate, TLX101, in newly diagnosed patients
  • Commercialisation plans underway for glioma imaging agent, TLX101-CDx (Pixclara™[3]), ahead of the planned submission of a New Drug Application (NDA) to the U.S. FDA in Q1 2024, and
  • Ethics approval granted to commence biodistribution and safety study of TLX300-CDx, first human study of radiolabelled olaratumab being developed as a therapeutic candidate for soft-tissue sarcoma.

Dr Christian Behrenbruch, Managing Director and Group CEO commented:

“This is an excellent result which demonstrates the strength of the Telix business model. We have achieved profitability while intensively investing in the development of our late-stage assets and the scale-up of our commercial infrastructure and marketing activity. This has resulted in Telix capturing a meaningful market share in the growing urology imaging market whilst laying the foundation for our next commercial products.

“We are highly focused on the development of our theranostic pipeline and vertical integration of supply and manufacturing. This activity is key to diversifying our revenue streams, creates additional value for our therapeutic assets and further differentiates Telix as a fully integrated global radiopharmaceutical company.”

Further details on the Company’s results can be found in the Appendix 4E, the accompanying investor presentation, and 2023 Annual Report lodged with the ASX and also available on the Company’s website.

Guidance

Full year revenue for 2024 expected range of US$445M to US$465M ($675M to $705M at current exchange rates), representing an approximate 35-40% increase on 2023.

Revenue guidance is based on worldwide sales of Illuccix®, with potential upside from Zircaix™[3] (kidney cancer imaging) and Pixclara™[3] (glioma imaging), subject to product regulatory approvals. Guidance will be updated throughout the year, as appropriate, to reflect product approvals.

Expected additional investment of 40-50% in R&D (compared with 2023), including both external and internal costs funded by operating cash flow and broadly in line with revenue growth.

2024 R&D investment activity is expected to include validation of commercial manufacturing and market launch activities in preparation for approval of Zircaix™[3] and Pixclara™[3] a fully operationalised ProstACT GLOBAL therapy trial in prostate cancer, and initiation of additional therapeutic clinical trials, including manufacturing activity, across the broader pipeline. 2024 R&D investment also includes indication expansion and life-cycle management of Illuccix®.

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Investor call

An investor webcast will be held at 9.00am AEDT on Friday 23 February 2024 (Thursday 22 February 2024, 5.00pm EST)

Participants can register for the webcast and find audio call details at the following link: https://event.choruscall.com/mediaframe/webcast.html?webcastid=Y7PkfQhS

About Telix Pharmaceuticals Limited

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 and commercial 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).

Visit www.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 Telix on X and LinkedIn.

Telix’s lead imaging product, gallium-68 (68Ga) gozetotide injection (also known as 68Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA),[4] by the Australian Therapeutic Goods Administration (TGA),[5] and by Health Canada.[6] Telix’s miniaturised surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, has attained a marketing authorisation in the U.S., having been registered with the FDA and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area for the intra-operative detection of sentinel lymph nodes (SLNs). With the exception of Illuccix® and SENSEI® as noted above, no Telix product has received a marketing authorisation in any jurisdiction.

Full United States prescribing information for Illuccix® can be found at: http://illuccixhcp.com/s/illuccix-prescribing-information.pdf

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [email protected]

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This announcement including earnings guidance has been authorised for release by the Telix Pharmaceuticals Limited Board.

Legal Notices

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to shares of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained in this document or opinions expressed in the course of this announcement. The information contained in this announcement is subject to change without notification.

This announcement may contain 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. 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.

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.

Telix uses various non-IFRS information to reflect its underlying performance. For further information, the reconciliation 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.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix®, Pixclara™,[3] Zircaix™[3] and SENSEI® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

[1] Conversion to AUD$ is at the exchange rate on the relevant transaction date. The average exchange rate realised during the period was AUD$1 = US$0.66; AUD$1 = €0.54.

[2] Radio antibody-drug conjugate.

[3] Trade name subject to final regulatory approval.

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[4] Telix ASX disclosure 20 December 2021.

[5] Telix ASX disclosure 2 November 2021.

[6] Telix ASX disclosure 14 October 2022.

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Fintech

Fintech Pulse: A Daily Dive into Industry Innovations and Developments

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The financial technology sector continues to evolve at a rapid pace, offering innovations that disrupt traditional paradigms. Today’s briefing underscores fintech’s diverse growth avenues: from substantial venture capital plays and strategic partnerships to groundbreaking implementations in lending. Here’s a closer look at recent developments shaping the landscape.


Synapse’s Comeback and Andreessen Horowitz’s Strategic Bet

Source: Axios
Synapse, a financial infrastructure company previously embattled by controversy, is staging a remarkable comeback, backed by none other than venture capital heavyweight Andreessen Horowitz (a16z). With this new infusion of funds, Synapse aims to consolidate its position as a premier platform for building financial services tools.

This resurgence demonstrates the resilience of the fintech ecosystem, where innovation often prevails over turbulence. Synapse’s renewed vigor also signals that top-tier investors remain bullish on infrastructural solutions pivotal to the future of digital finance. Andreessen Horowitz’s participation not only validates Synapse’s model but also underscores the VC giant’s enduring interest in fintech infrastructure, even amid global economic uncertainties.

Analysis:
This partnership exemplifies the dynamism within fintech, highlighting the interplay of innovation, capital, and resilience. It also raises questions about the broader implications of giving second chances to firms with turbulent histories. While Synapse’s evolution could inspire others, it also places a spotlight on governance and accountability in high-growth sectors.


Israel’s Fintech Scene Gets a Boost with Investment in Finova Capital

Source: Calcalistech
Israeli fintech startup Finova Capital has raised an impressive $20 million in a funding round led by prominent institutional investors. This marks a significant milestone for the company as it seeks to expand its suite of financial solutions aimed at underserved markets.

Israel’s fintech ecosystem has long been recognized as a hub of innovation, and this latest investment only reinforces its global standing. Finova Capital’s focus on empowering smaller businesses and fostering financial inclusivity aligns with emerging trends where tech-driven solutions bridge critical gaps in financial services.

Analysis:
With this funding, Finova is poised to enhance its technological offerings while contributing to economic inclusion. However, the broader fintech industry will watch closely to see how the company leverages this capital amid increasing competition from regional and global players.


India’s Yubi Plans a Fundraising Push

Source: Bloomberg
Yubi, a prominent Indian fintech platform backed by Insight Partners, is reportedly preparing for a new fundraising round. Having already established itself as a leader in credit infrastructure, Yubi aims to bolster its offerings and expand its market footprint.

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India’s fintech landscape is witnessing explosive growth, with platforms like Yubi playing a critical role in the credit ecosystem. Yubi’s planned fundraising reflects the broader appetite for scaling solutions that streamline credit access, particularly in emerging markets where traditional lending models often fall short.

Analysis:
This development highlights two key trends: the increasing reliance on credit platforms in high-growth economies and the strategic role of international investors like Insight Partners in driving fintech innovation. Yubi’s expansion plans could set a precedent for other regional fintech players seeking to scale amid global economic headwinds.


Provenir and Hastings Financial Services Win Global Recognition

Source: Business Wire
In a testament to the transformative power of digital lending solutions, Provenir and Hastings Financial Services have been jointly recognized for the Best Digital Lending Implementation at the IBSi Global Fintech Innovation Awards. This accolade underscores the success of their collaboration in modernizing the lending process through cutting-edge technology.

Provenir’s advanced decision-making platform and Hastings Financial Services’ lending expertise have delivered a solution that significantly enhances user experience, operational efficiency, and risk management. Such innovations highlight the increasing role of partnerships in advancing fintech’s digital transformation.

Analysis:
This recognition not only validates the efficacy of digital lending but also emphasizes the importance of partnerships in driving innovation. It signals to the industry that collaboration can be a powerful tool for staying ahead in a rapidly evolving marketplace.


Microf and Quantum Financial Technologies Forge New Alliances

Source: PR Newswire
Microf, a financial solutions provider, has announced a strategic partnership with Quantum Financial Technologies. This collaboration aims to expand lending solutions for contractors, providing streamlined access to capital for businesses in need of flexible financing options.

This partnership is a timely response to the growing demand for specialized financial products in niche markets. By leveraging Quantum’s technology, Microf can now offer more tailored solutions, particularly to contractors navigating complex financial requirements.

Analysis:
This development reflects a growing trend: the diversification of fintech offerings to serve specific market segments. As competition in mainstream fintech intensifies, targeting underserved niches could become a defining strategy for success.


Key Takeaways for the Fintech Ecosystem

  1. Resilience in Fintech Funding: Despite economic uncertainties, venture capital continues to fuel innovative fintech players like Synapse and Finova Capital.
  2. Regional Growth Stories: From Israel to India, fintech ecosystems are thriving, attracting global attention and investment.
  3. Collaboration as a Catalyst: The success of partnerships like Provenir-Hastings and Microf-Quantum underscores the importance of strategic alliances.
  4. The Power of Recognition: Awards like the IBSi Fintech Innovation Awards validate industry achievements, inspiring others to push the envelope.
  5. Focus on Inclusion: Whether through credit platforms or lending solutions, fintech is playing a pivotal role in fostering financial inclusivity worldwide.

Looking Ahead: Challenges and Opportunities

The fintech sector’s journey is far from linear. Regulatory complexities, technological disruptions, and market volatility remain persistent challenges. However, as seen in today’s developments, the opportunities far outweigh the risks. By prioritizing innovation, collaboration, and inclusivity, fintech players can navigate the complexities of the global financial landscape.

This moment in fintech history is pivotal. It’s a time for bold decisions, strategic partnerships, and a commitment to bridging financial divides. As industry players rise to the occasion, the road ahead promises a future where technology and finance intertwine to empower individuals and businesses alike.

 

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Fintech PR

BIZCLIK MEDIA LAUNCHES DECEMBER EDITION OF FINTECH MAGAZINE

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The December edition of FinTech Magazine includes interviews with leading experts and executives from Alipay+, Marqeta & Flyfish

LONDON, Nov. 26, 2024 /PRNewswire/ — BizClik, the UK’s fastest-growing publishing company, has released the latest edition of FinTech Magazine.This publication is highly regarded by voices within the Financial Sector for its in-depth reports and interviews with prominent figures in the industry.

FinTech Magazine

This month’s edition features an exclusive lead interview with Flyfish C-Suite, Savvas Pashias, Shay Merary and Michael Zetser on how they have developed a platform for SMEs to access banking services, as traditional infrastructure struggles to meet increasing cross-border needs.

“The UniFi platform is inherently scalable, designed to growin line with a company’s expansion and service requirements” – Michael Zetser, CEO, Flyfish

The edition also contains extensive interviews with key thought leaders from Marqeta, Sidekick, PayU and more. Plus the Top 10: Decacorns

You can visit FinTech Magazine for daily news and analysis of the ever-changing financial industry.

About BizClik

BizClik is one of the fastest-growing digital media companies in the UK, host to a growing portfolio of industry-leading global brands and communities.

BizClik’s expanding portfolio includes Technology, AI, FinTech, InsurTech, Supply Chain, Procurement, Energy, Mining, Manufacturing, Healthcare, Mobile, Data Centre, Cyber, and Sustainability.

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For more information, please visit our website.

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Hakluyt announces new partnership with Orchestras for All

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LONDON, Nov. 26, 2024 /PRNewswire/ — Hakluyt, the global strategic advisory firm for businesses and investors, has today announced a new social impact partnership with Orchestras for All (OFA), on the eve of the charity’s Big Give Campaign launch.

Orchestras for All is a UK-based charity that works with 11-19 year-olds to widen access to music, with a particular focus on those who face challenges such as disability, deprivation or caring responsibilities.

Drawing on its connectivity and in-house expertise, Hakluyt will advise the charity on issues as it seeks to fulfil its mission to ensure that all children, regardless of background or circumstance, are able to share in the benefits of group music-making.

Hakluyt, which has been providing in-kind support to the charity since 2022, has now formalised a partnership with Orchestras for All that will see it provide advice and guidance across a range of strategic challenges in order to help the charity widen its impact and reach more young people.

Kayo Yoshida, who co-leads Hakluyt’s work with Orchestras for All, said: “Orchestras for All does invaluable work sharing the benefits of music with children who have often been shut out of creative opportunities. I am personally delighted to be working with them, and look forward to our partnership flourishing over the coming years.”

Alexandra Davison, who also co-leads Hakluyt’s work with the charity, commented: “The opportunities that Orchestras for All offers can be life-changing for young people. The myriad benefits of musical education to children’s development and educational attainment are well known, and Orchestras for All is an organisation with a proven track record of widening access to music for the children who need it most.”

Nick Thorne, Executive Director of Orchestras for All, added: “We are delighted to have formalised our partnership with Hakluyt, and are incredibly grateful for the support they provide. This relationship is one of our most significant corporate partnerships to date, offering both financial support and advisory services. 

“The funding Hakluyt have provided will not only help OFA continue providing its life-changing musical programmes, but also enable our participation in the Big Give Christmas Challenge 2024. Through this campaign, OFA aims to raise vital funds to ensure that more young people can access inclusive and transformative music-making opportunities.”

Notes to Editors

Hakluyt is a strategic advisory firm that works with corporate leaders and investors around the world on their most important commercial issues. For more information on the firm, please visit www.hakluytandco.com

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Orchestras for All (OFA) is an Arts Council National Portfolio Organisation that breaks down barriers to give all young people the life-changing experience of making music together, regardless of the daily challenges they might be facing. Its inclusive, non-auditioned National Orchestra for All (NOFA) brings together 100 young musicians from across the UK who would otherwise be unable to access musical opportunities – whether due to physical disability, a mental health condition, economic deprivation, or rural isolation.

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