In another sign of consolidation in the radiopharmaceutical sector, Telix Pharmaceuticals is set to acquire radiopharmaceutical developer and producer ITM Isotope Technologies Munich SE in a deal valued at $1.65 billion.
The deal would bring ITM’s radioisotope manufacturing capabilities, global distribution network, and therapeutic radiopharmaceutical development pipeline together with Telix’s commercially available diagnostic radiopharmaceuticals and pipeline of complementary therapeutic radiopharmaceutical candidates.
Founded in 2004 and based in Munich, Germany, ITM produces lutetium-177 (Lu-177), actinium (Ac-225), and terbium-161 (Tb-161) for use in commercially available and future therapeutic radiopharmaceuticals. It has two Good Manufacturing Practice (GMP) manufacturing sites and a global distribution network spanning 65 countries, according to the firms.
Via an agreement with Isogen, ITM also has 15 years of exclusive access to Bruce Power’s nuclear reactors in Canada for the irradiation services required to manufacture Lu-177, which is used in commercially available radionuclide therapies such as Pluvicto (Lu-177 vipivotide tetraxetan, Novartis) in prostate cancer and Lutathera (Lu-177 dotatate, Novartis) for treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
It is also developing its own therapeutic candidates. ITM company Lumara Bio Oncologics has successfully completed a Phase 3 study for ITM-11 (Lu-177-edotreotide), a somatostatin receptor (SSTR)-targeted treatment of its own for GEP-NETs. It has also fully enrolled a second indication expansion Phase 3 study, with an interim analysis expected in the first half of 2027. If approved, ITM-11 could accelerate Telix’s entry into the commercial therapeutic market and expand its presence and financial opportunity in the clinically significant market for neuroendocrine tumors, according to the vendors.
Theranostics focus
With a focus on theranostics, Telix has brought three diagnostic radiopharmaceuticals to market, including Illuccix (preparation kit for gallium-68 gozetotide injection, Gozellix (preparation kit for gallium–68 gozetotide injection), and Pixclara (floretyrosine F-18). Illuccix is commercially available in 22 countries, including the U.S. Gozellix has been approved by the U.S. Food and Drug Administration (FDA) for prostate imaging, and Pixclara has received FDA approval for glioma imaging.
Meanwhile, its therapeutic pipeline includes three investigational candidates in pivotal-stage trials, including rials: TLX591-Tx (Lu-177-rosopatamab tetraxetan) in prostate cancer, TLX101-Tx (I-131 iodofalan) in recurrent glioblastoma, and TLX250-Tx (Lu-177-girentuximab tetraxetan) in kidney cancer. The Sydney, Australia-based company said it’s also developing a pipeline of next-generation candidates.
“We have enjoyed a close working relationship with ITM for many years and there is strong management alignment for the rationale behind this transaction,” said Telix Managing Group Director and Group CEO Dr. Christian Behrenbruch in a statement. “By combining our complementary strengths, we will create a company with commercial scale, world-leading supply and the most exciting theranostic drug portfolio in the sector. Importantly, this combination further expands our late-stage therapeutic pipeline with two completed Phase 3 trials and deepens radioisotope security, while bringing together the mission-critical capabilities needed to deliver radiopharmaceutical treatments to patients around the world.”
ITM unit Lumara Bio is also developing a range of radiopharmaceuticals for treatment of prostate cancer, glioblastomas, folate receptor α-positive tumors, such as ovarian cancer, or non-small cell lung adenocarcinoma and clear-cell renal cell carcinoma. ITM CEO Dr. Andrew Cavey highlighted the breadth and depth a combined company would have across the radiopharmaceutical value chain.
“Our management teams have a track record of working together and a nuanced understanding of our respective commercial strengths and customer relationships,” Cavey said. “Together, we believe Telix and ITM will be uniquely positioned to capitalize on rapidly growing global demand for radiopharmaceuticals to the benefit of both shareholders and patients.”
Financial matters
Under the terms of the deal, Telix will acquire all of ITM’s shares for $1.65 billion upfront, including $1.25 billion in the form of 105.8 million Telix shares that will be released to sellers as Nasdaq-listed American Depositary Receipts (ADRs) at the end of their respective escrow periods. Telix will also take on $302 million in net debt from ITM and $96 million of management equity rollover and transaction expenses paid by the sellers.
Furthermore, Telix will pay up to $700 million upon achievement of certain milestones, including $100 million upon FDA approval for expected first indication in G1-G2 GEP-NETs no later than December 31, 2027; $100 million upon FDA approval for G2-G3 GEP-NETs no later than December 31, 2030; and $50 million upon FDA approval for Lung NETs no later than December 31, 2021. Also, it will pay up to $450 million based on ITM-11 net global sales in fiscal year 2030 greater than $150 million. Telix can elect to make these payments in the form of cash or stock.
Telix shareholders will own approximately 76.3% of the new company’s available shares and ITM shareholders will own about 23.7%, according to the firm. Telix expects the transaction will be completed by the end of the 2026 fiscal year, subject to Telix shareholder and regulatory approvals, as well as other customary closing conditions.
ITM produced $273 million in revenue in 2025 and achieved a compound annual growth rate of 40% from 2021 to 2025.
Management estimates the combined company will generate unaudited pro forma 2026 revenue and income of more than $1.3 billion. It also noted that ITM’s radioisotope business is profitable and generates cash flow. Additionally, it expects that continued growth from manufacturing, cost savings, and further targeted synergies and pipeline optimization are expected to support a positive EBITDA contribution in 2027.