
13!
Infant Bacterial Therapeutics AB
(publ)
Annual Report 2024
Medical Need and Market
There has been little or no progress in recent years in improving outcomes for infants affected
by NEC or complications such as sepsis or bronchopulmonary dysplasia once the disease has
already broken out. In addition, none of the current standard treatments can address the
underlying risk factors. About 20 to 40% of NEC patients need surgery. Thus, the preventive
strategies are important and the need urgent. However, so far, no such strategy has been
successful or adopted as standard treatment. Therefore, there is still a great medical need for a
preventive treatment of NEC.
NEC patients require medical care and, in many cases, surgical procedures that increase
healthcare costs and prolong hospitalization. Healthcare costs have been estimated at nearly
20% of the total cost of caring for all newborns in the United States. Infants who survive NEC are
at risk of serious lifelong secondary diseases that further impair their quality of life and impose
additional costs on the patient and society. In light of the above, preventive treatment of NEC
could be expected to reduce healthcare costs. IBT intends to demonstrate these benefits in order
to obtain support from healthcare providers, insurance companies and drug-subsidizing
authorities, to contribute to the reimbursement and subsidization of IBP-9414 for the preventive
treatment of NEC.
In 2021, an independent consulting firm was engaged to evaluate the market potential for IBP-
9414. The report showed that there is a great need for improved preventive care of NEC to
alleviate both the clinical and economic burdens. The report showed that estimated peak sales
revenue was USD 630 million per year in the US, plus Europe and the rest of the world. IBT plans
to conduct new market research in 2025 to best prepare for the launch of IBP-9414. The results
of these will guide future distribution and sales activities for IBP-9414, in addition, the commercial
production needs will be influenced by how the market receives our product and how quickly we
reach expected peak sales.
IBT's strategy for distribution partners is that the company itself will be responsible for sales and
marketing in the US while the idea is to work with partners for areas outside the US.
Intellectual Property
IBP-9414 has already granted been patents covering the active substance L. reuteri held by
BioGaia. BioGaia has granted IBT an exclusive, royalty-free license to use L. reuteri in IBT's
field of interest for the duration of the patent.
IBT has applied, and intends to apply, for patent protection for its innovations in order to
ensure adequate and effective protection of IBT's existing and future commercial position and
interests. Patent applications are typically filed in the US, EU, Japan and China, but also in
other markets where it is commercially justified for the company.
The term of patent protection for IBP-9414, which has been granted in the US, extends
through 2026 and in Europe, China and Japan through 2027, after which the patent term may
be extended in certain areas of the world, which may provide the innovation with additional
patent protection.