Fintech PR

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

Published

8 months ago

February 22, 2024

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®.

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]

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.

[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 PR

Reshaping Finance: Huawei’s Commitment to 4-Zero and Resilient Infrastructure

Published

8 hours ago

October 15, 2024

CISION (PR Newswire)

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DUBAI, UAE, Oct. 15, 2024 /PRNewswire/ — On the first day of GITEX GLOBAL 2024, the Huawei Finance Forum was held under the theme of Boost Resilience, Reshaping Smarter Finance Together. This forum explored how to build resilient financial infrastructure for the future, as well as digital transformation and ecosystem development to help financial institutions gain a new competitive edge.

Over the past 15 years, China’s finance industry has undergone a significant transformation, largely driven by FinTech giants. As Chinese banks embarked on their digital transformation journey, Huawei developed an FSI solution framework, which focuses on reshaping customers’ resilience, agility, and intelligence.

“The value Huawei brings to our customers is not only in our products and solutions, but also in our unique capabilities, such as best practices worldwide, a global ecosystem, and an extensive digital talent system in China. These capabilities are crucial for customers’ successful transformation.” Shared by Alvin Feng, Director of Global Marketing and Solution Sales, Huawei Digital Finance BU.

Huawei has proposed reshaping resilient financial infrastructure with 4 Zeros: Zero Downtime, Zero Wait, Zero Touch, and Zero Trust. To achieve this, we need to coordinate cloud, network, storage, and computing infrastructure to develop an end-to-end resilient system.

Application modernization is vital for reshaping agility. Huawei has successfully supported many banks in transforming their legacy centralized architecture towards a cloud-native distributed architecture.

In terms of reshaping intelligence. Huawei supports banks in enhancing real-time data operations, a fundamental step for data intelligence. Meanwhile, we actively boost Generative AI adoption in banks through joint innovations in various scenarios.

Dr. Jassim Haji, President of the International Group of Artificial Intelligence, Executive Advisor of HH (His Highness) Nasser Artificial Intelligence Research and Development Center.

“Huawei is pioneering the future of intelligent finance, seamlessly blending AI innovation with enduring infrastructure. Their vision for All Intelligence and commitment to building resilient, secure, and efficient financial ecosystems is transforming the industry, creating smarter, more inclusive services for the AI era.” Said Dr. Jassim Haji, President of the International Group of Artificial Intelligence, Executive Advisor of HH (His Highness) Nasser Artificial Intelligence Research and Development Center.

Roger Wang, Director of Partner Development & Sales, Digital Finance BU, Huawei

“Huawei is continuously collaborating with global and local ecosystem partners to deliver value to customers by developing competitive scenario-based solutions”, stated by Roger Wang, Director of Partner Development & Sales, Digital Finance BU, Huawei. We consistently add value to our customers’ success through our global best practices, business and architecture innovation, and excellent service and support.

For more details, please visit: https://e.huawei.com/en/industries/finance

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Fintech PR

Qatari Diar Unveils Exclusive Waterfront Townhouses at The Seef Lusail

Published

11 hours ago

October 15, 2024

CISION (PR Newswire)

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Luxury Living Redefined with Attractive Investment Opportunities Starting from QAR 1.7 Million for apartments and QAR 3.4 Million for townhouses in Downtown Lusail

Flexible Payment Plans with 0% Interest and Direct Financing

Freehold Ownership and Residency in Qatar

DOHA, Qatar, Oct. 15, 2024 /PRNewswire/ — Qatari Diar Real Estate Investment Company announced the launch of exclusive upscale waterfront townhouses at The Seef in Downtown Lusail, offering exceptional investment opportunities with 0% interest, direct financing, and flexible payment plans. Lusail represents a bold step forward in sustainable, smart urban living. Known for its state-of-the-art infrastructure and forward-thinking design, Lusail offers a mix of residential, commercial, and entertainment districts just minutes from Qatar’s newest community.

Situated in the heart of Lusail’s waterfront district, The Seef offers a limited collection of luxurious townhouses starting from QAR 3.4 million and apartments starting from QAR 1.7 million. These residences offer immediate occupancy and are designed to provide residents with a blend of modern elegance and comfort. With breathtaking sea views overlooking Qetaifan Islands and Lusail’s iconic skyline, the townhouses redefine modern living.

Lusail’s thriving real estate market presents significant growth potential for investors. The Seef offers freehold ownership, providing residency in Qatar for foreigners. With mortgage financing options from leading local banks, in addition to direct payment plans with 0% interest extending to 6 years for apartments and 4 years for townhouses, owning a luxury residence in The Seef is more accessible than ever. Situated in a location known for attracting substantial foreign investment, The Seef promises robust returns whether for resale or long-term residence.

Eng. Ali Mohamed Al-Ali, CEO of Qatari Diar, said: “The launch of our exclusive waterfront townhouses at The Seef marks a significant milestone in offering unparalleled luxury living in Qatar. Lusail represents more than just a place to live; it’s a lifestyle destination that combines convenience, sophistication and investment potential. With the recent advancements in the Qatari mortgage law, we are thrilled to extend flexible financing options in partnership with several Qatari banks that make owning a piece of this vibrant community achievable for a broader market.”

The Seef’s townhouses are built to meet the diverse needs of residents, from professionals to families. Each townhouse features spacious layouts with high-end finishes, ensuring comfort and luxury at every turn. Residents will enjoy uninterrupted sea views, offering a tranquil escape within the city, and lush green landscapes that create a serene environment for relaxation. The prime location provides proximity to key attractions, including the Meryal Waterpark—the largest in Qatar—Lusail Marina, and Place Vendôme. Located near transit hubs, major highways, shopping centers, healthcare facilities, and educational institutions, The Seef offers residents unparalleled convenience, placing all the vibrant energy of Lusail right at their doorstep.

The Seef reflects Qatari Diar’s commitment to sustainability, with eco-friendly design elements that include energy-efficient infrastructure and green landscaping. The project’s unique architectural innovations, including sky bridge swimming pools and modern areas amenities, such as kids’ playgrounds, squash courts, gym facilities, retail outlets, and serene promenades, sets it apart from typical residential projects, creating a true lifestyle destination.

Prospective buyers and investors are invited to explore The Seef firsthand at the Cityscape Global in Riyadh, Saudi Arabia from 11 – 14 November. Attendees will have the opportunity to learn more about the development, view its luxury offerings, and discover how The Seef can become part of their future in Lusail, Qatar’s city of the future.

For more information, please visit Qatari Diar’s website to explore The Seef and view the full portfolio of investment opportunities.

About Qatari Diar
Qatari Diar Real Estate Company was established in 2005 by the Qatar Investment Authority, the sovereign wealth fund of the State of Qatar. Headquartered northeast of capital, Doha, in the City of Lusail, on the coast of the Arabian Gulf. Qatari Diar was entrusted to support Qatar’s growing economy and to coordinate the country’s real estate development priorities. For more information, visit qataridiar.com.

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Fintech PR

PharmaMar Announces Positive and Statistically Significant Overall Survival and Progression-Free Survival Results for Zepzelca® (lurbinectedin) and Atezolizumab Combination in First-Line Maintenance Therapy for Extensive-Stage Small Cell Lung Cancer

Published

11 hours ago

October 15, 2024

CISION (PR Newswire)

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Jazz plans to submit supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and PharmaMar will submit Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in first half of the year 2025 for this combination therapy as a first-line maintenance treatment for ES-SCLC.

MADRID, Oct. 15, 2024 /PRNewswire/ — PharmaMar (MSE: PHM) and its partner Jazz Pharmaceuticals plc (Nasdaq: JAZZ) have announced today positive top-line results from the Phase 3 clinical trial evaluating Zepzelca^® (lurbinectedin) in combination with the PD-L1 inhibitor atezolizumab (Tecentriq^®) compared to atezolizumab alone when administered as a maintenance treatment for adults with extensive-stage Small Cell Lung Cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab. The combination of lurbinectedin and atezolizumab demonstrated a statistically significant improvement in the primary endpoints of overall survival (OS) and progression-free survival (PFS), as assessed by an independent review facility (IRF), compared to treatment with atezolizumab alone.

“Each year, approximately 63,000 to 72,000 new cases of Small Cell Lung Cancer (SCLC) are reported in Europe. A majority of these patients are diagnosed with extensive stage disease, which is aggressive and often difficult to treat, with poor prognosis,[i]^,[ii]^,[iii]” said Luis Paz-Ares, M.D., Ph.D., head of medical oncology at the Hospital Universitario 12 de Octubre in Madrid, Spain, and IMforte trial principal investigator. “These trial results demonstrate the efficacy of lurbinectedin, in combination with standard-of-care atezolizumab for patients in first-line maintenance treatment, a much-needed advancement for patients with extensive disease.”

“The results of the Phase 3 IMforte trial are highly encouraging and showed a statistically significant benefit for the lurbinectedin and atezolizumab combination for extensive-stage small cell lung cancer patients receiving this treatment in the first-line maintenance setting. These results demonstrate the potential of this regimen to delay disease progression and extend survival for patients with this aggressive disease,” said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. “We are pleased with these clinically meaningful results and plan to submit an sNDA in the first half of 2025 to support this combination in the first-line maintenance setting. We thank the investigators and patients who are involved in this trial, along with our partners at Roche.“

“Lurbinectedin monotherapy is currently the standard of care in 2L SCLC. In Europe, it is only approved in Switzerland and early access and compassionate use programs have already allowed some European patients to benefit from lurbinectedin,” said Javier Jiménez, Chief Medical Officer of PharmaMar.

The combination was generally well-tolerated. The preliminary safety data in the ongoing trial is consistent with the known safety profiles of lurbinectedin and atezolizumab with no new safety signals observed in the combination arm.

Jazz and Roche plan to submit these data for presentation at a future medical meeting.

PharmaMar will submit a marketing authorisation application (MAA) to the EMA in the first half of 2025 to request regulatory approval in the European Union (EU). Lurbinectedin is available for use in 16 territories around the world.

Legal warning

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

About PharmaMar

PharmaMar is a biopharmaceutical company focused on the research and development of new oncology treatments, whose mission is to improve the healthcare outcomes of patients afflicted by serious diseases with our innovative medicines. The Company is inspired by the sea, driven by science, and motivated by patients with serious diseases to improve their lives by delivering novel medicines to them. PharmaMar intends to continue to be the world leader in marine medicinal discovery, development and innovation.

PharmaMar has developed and now commercializes Yondelis® in Europe by itself, as well as Zepzelca® (lurbinectedin), in the US; and Aplidin® (plitidepsin), in Australia, with different partners. In addition, it has a pipeline of drug candidates and a robust R&D oncology program. PharmaMar has other clinical-stage programs under development for several types of solid cancers: lurbinectedin, ecubectedin, PM534 and PM54. Headquartered in Madrid (Spain), PharmaMar has subsidiaries in Germany, France, Italy, Belgium, Austria, Switzerland and The United States. PharmaMar also wholly owns Sylentis, a company dedicated to researching therapeutic applications of gene silencing (RNAi). To learn more about PharmaMar, please visit us at www.pharmamar.com.

About the IMforte Phase 3 Trial

IMforte (NCT05091567) is an ongoing Phase 3, randomized, multicenter maintenance trial evaluating the efficacy, safety and pharmacokinetics of lurbinectedin plus atezolizumab in adults (≥18 years) with ES-SCLC following induction therapy with carboplatin, etoposide and atezolizumab. The primary endpoints for this study are OS and IRF-assessed PFS.

The trial consists of two phases: an induction phase and a maintenance phase. Participants were required to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after the induction phase of four cycles of carboplatin, etoposide, and atezolizumab to be considered for eligibility screening for the maintenance phase. Eligible participants were randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

The trial is sponsored by Roche and co-funded by Jazz Pharmaceuticals. Additional information about the trial, including eligibility criteria and a list of clinical trial sites, can be found at: https://clinicaltrials.gov (ClinicalTrials.gov Identifier: NCT05091567).

About Zepzelca^®

Zepzelca^® (lurbinectedin), also known as PM1183, is an analog of the marine compound ET-736 isolated from the sea squirt Ecteinascidia turbinata in which a hydrogen atom has been replaced by a methoxy group. It is a selective inhibitor of the oncogenic transcription programs on which many tumors are particularly dependent. Together with its effect on cancer cells, lurbinectedin inhibits oncogenic transcription in tumor-associated macrophages, downregulating the production of cytokines that are essential for the growth of the tumor. Transcriptional addiction is an acknowledged target in those diseases, many of them lacking other actionable targets.

please visit our website at www.pharmamar.com

[i] Cancer today. (s. f.). https://gco.iarc.who.int/today/en/fact-sheets-populations#regions

[ii] Alvarado-Lunda G, Morales-Espinosa D. Treatment for small cell lung cancer, where are we now? – A review. Transl Lung Cancer Res. 2016;5(1):26-38.

[iii] SEER Explorer Lung and Bronchus Cancer, Recent Trends in SEER Incidence Rates, 2000-2016, by Age, https://seer.cancer.gov/explorer Updated June 27, 2024. Accessed October 10, 2024.

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