Voyageur Pharmaceuticals advances barium product pipeline
Year end Nov 30 · 2021 · 2022 · 2023 · 2024
Revenue (C$mln) · 0.0 · 0.0 · 0.0 · 1.4
EBITDA (CA$m) · (1.3) · (1.6) · (4.2) · (4.3)
Contrast media come in three main product types: barium sulfate for gastrointestinal (GI) X-ray and CT; iodine for CT and X-ray; and other agents, e.g. for MRI. Voyageur management assesses that both barium and iodine agents are required to interest distributors and to tender for hospital supply.
Voyageur is developing barium products for the radiology pharmaceutical market. Of these, five are approved by Health Canada as “natural products”, for example, the smoothies are Natural Product Number (NPN): 80108081.
SmoothX, a radiographic barium contrast suspension smoothie and now HDXBa, dry powder high-density barium sulfate, have been successfully formulated for use. The remaining suspension and powder products with Health Canada-approved licenses are MultiX-thick, MultiX-thin, and LDX. AVL is helping to formulate these remaining products so Voyageur can offer a full suite of barium contrast products. This should allow clients to fully transition to Voyageur's product line. All will need FDA authorization before sales in the US, with the company planning to utilize the 505(b)(2) approval pathway.
Full barium contrast suite
Market entry in barium is planned early using a Chinese supply of barium with products produced by a Canadian third party. This will enable Voyager to develop a distribution chain. From 2025, Voyageur plans to have its own Canadian barium supply from its mining facility at Frances Creek and its own manufacturing plant. The company estimates this could reduce the cost of ingredients tenfold.
Alongside it in 2025 to improve the distributor offer and enable purchasing order tendering, Voyageur plans to bottle and sell an Asian generic iodine agent (after FDA approval). Own production is scheduled for 2028 onwards. By 2028, Voyageur's own iodine supply and agent manufacturing facility could be on-stream enabling fully integrated production and high gross profits. We also expect the company to develop international sales of barium and iodine products; this requires separate regulatory approvals and diverse distribution systems.
Value chain development
Exhibit 1 - Voyageur long-term product pipeline
Source: Voyageur
Barium, Iodine, Fullerene
Due to vertical integration, Voyageur intends to be the most price-competitive producer. Currently, high-grade barium sulfate is purified using an energy-intensive chemical process. The Voyageur advantage is a quarry that gives high-grade material that can be simply processed and ground to give 97.5%+ pure barium sulfate for direct blending into medical smoothies and powders.Management research suggests that their key competitor Bracco uses 2,000 tonnes of barite each year for their contrast products which they believe would indicate a barite contrast market value of a minimum of US$500mln.
Recent supply shortages in iodinated agents exacerbated by high current iodine raw material prices and limited supply make this an attractive second market. Voyageur will build new iodine extraction facilities from brine sources in the US, add a GMP manufacturing facility, and gain FDA approvals. The iodine US market is possibly worth about US$1bln but accurate figures are not available. From 2028, Voyageur aims to have its own US iodine extraction and pharmaceutical manufacturing facility. Iodine agents are about a US$1bln current NA market limited by global iodine supply.
In addition, a deal with the technology innovator, Rain Cage, has been signed to develop and manufacture nanocarbon/fullerene-based contrast agents for medical imaging. These agents will use Rain Cage’s EDEN system, which captures and transforms CO2 emissions into advanced engineered carbon material. These can be used to develop advanced imaging agents.