BWX Technologies anticipates regulatory approval and initial revenue in the first quarter of 2021 on its generators for the medical isotope technetium-99m, according to its latest financial presentation.
The Lynchburg, Va., company, better known as a contractor for the Departments of Defense and Energy, in 2018 began seeking a slice of the global business for the isotope, which is used extensively in medical procedures including diagnosing cancers and heart disease.
In May, BWXT announced development of a new neutron-capture approach for generating molybdenum-99, which decays into technetium-99m, along with new generators for the daughter isotope. In July, the company closed its $213 million acquisition of the medical isotopes business of Canadian health company Nordion. That deal brought about 150 employees and two isotope production facilities, in Kanata, Ontario, and Vancouver, British Columbia, under the umbrella of BWXT’s Nuclear Power business.
The isotopes business has largely been integrated into BWXT’s operations, the company said, without discussing details.
“We … remain focused on bringing our proprietary radioisotope technology to market as medical radioisotopes become the first major product line addition to BWXT in more than 25 years,” CEO Rex Geveden said on Feb. 26 during BWXT’s quarterly earnings call with financial analysts.
The technetium-99m generator market is worth about $400 million, according to BWXT. Management plans first to focus on the North American market, which Geveden valued at about $160 million.
The broader worldwide market for the isotope is worth roughly $2.8 billion, according to BWXT.
BWXT’s generator program will require regulatory approvals from the U.S. Nuclear Regulatory Commission, the U.S. Food and Drug Administration, Health Canada, and the Canadian Nuclear Safety Commission.
The company met with officials from the U.S. Food and Drug Administration in October to discuss the content and process for the application, which it expects to file in 2020.
In 2019, BWXT plans to complete design and production of access equipment that will enable insertion and extraction of molybdenum-99 targets in CANDU reactors at the Darlington Nuclear Generating Station in Ontario, where they will be irradiated for use in the technetium-99m generators. The equipment is scheduled to be placed in the plant in the first and second quarters of 2020, according to the presentation. Irradiation of test batches is planned for the third quarter of the year.
The generators themselves will be produced at the Kanata facility, where modifications are due to be completed by the end of this year.
There was no word this week from BWXT regarding potential production figures for the generators and how much revenue it anticipates.
The newly acquired isotopes business is already bringing in roughly $40 million in annualized sales, BWXT said in its earnings presentation. That is derived from existing businesses encompassing cyclotron isotopes and contract manufacturing.
BWXT is one of several companies seeking to provide the United States with a domestic source for molybdenum-99, which has been largely absent since 1989. This has left the nation reliant on sometimes-unreliable foreign sources.
The Department of Energy’s semiautonomous National Nuclear Security Administration has committed $160 million in two tranches of funding to help develop this U.S. capability. The agency’s aim is both to advance U.S. manufacturing that does not involve highly enriched uranium, which could be used to produce nuclear weapons.
BWXT was not among the companies the NNSA said in February it would negotiate with on new cooperative agreements for a total of $60 million in cost-sharing funds. However, the company declined to say whether it had bid on the funding.
The agency tentatively anticipates providing $15 million each to NorthStar Medical Radioisotopes, of Beloit, Wis.; SHINE Medical Technologies, of Janesville, Wis.; Northwest Medical Isotopes, of Corvallis, Ore.; and Niowave, of Lansing, Mich.
