Company: CSCIF
Filing Date: 2025-04-09
Form Type: 20-F
Source: 0001641172-25-003456
Chunk: 49

Company: COSCIENS Biopharma Inc.
Filing Date: 2025-04-09
Form: 20-F
Item: Item 5
Chunk 49
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 Commercialization Program

Macrilen™ (macimorelin), is the first and only
U. S. Food and Drug Administration (“ FDA”) and European Medicines Agency (“ EMA”) approved oral test indicated
for the diagnosis of patients with adult growth hormone deficiency (“ AGHD”). Macimorelin is currently marketed under the
tradename Ghryvelin® in the European Economic Area and the United Kingdom through an exclusive licensing agreement with Pharmanovia.
To date the product has been launched in the United Kingdom, Sweden, Denmark, Finland, Germany, Netherlands and Austria. In Republic of Korea, Macrilen™ (macimorelin) was approved on September 7, 2023.
The Company’s partner NK Meditech plans to commence the commercialization after re-imbursement negotiations are finalized. While the Company is actively pursuing business development opportunities
for the commercialization of macimorelin, it is also reviewing strategic alternatives
including the potential to divest this asset.

Geographic Areas

A description of the principal geographic areas in
which we compete, including a geographical and categorical breakdown of our revenues in the past three years, is presented in note 25
(Segment information) to our consolidated financial statements included in this Annual Report on Form 20-F at Item 18.

Seasonality

Demand for the Company’s products varies from
year to year and there is no seasonality or cyclical trend that can be specifically derived from the last decade.

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Raw Materials

The Company is involved in the development of proprietary
extraction technology and the application of this technology to the production of extracts and “active ingredients” from
oats and other renewable plant resources. The Company adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical
and therapeutics products for humans and animals. The Company has historically been able to source the direct raw materials required
for the specific formulation of its products, including grain and grain-derived materials, at varying prices which allowed it to produce
finished goods. The raw materials that the Company purchases in the ordinary course may be subject to variation due to the season’s
output in grain quality.

We will be dependent on third-party manufacturers
for the pharmaceutical products that we or our licensees will market. An interruption in the availability of certain raw materials or
ingredients, or significant increases in the prices paid by us for them, could have a material adverse effect on our business, financial
condition, liquidity and operating results.

Economic Depend