GNI Group FY2021 Annual General Meeting Q&A Summary
(Held on March 25, 2022)
Q1: How do you plan to conduct F351's NASH clinical trials in the US?
A1: We are in the middle of discussions with FDA on how to do the clinical trials. FDA has to agree on indications and protocol / procedures, which may take a while. NASH-induced fibrosis is a major disease, and many firms are testing new drugs for them now, but so far there has been no treatment. There were many expensive failures of other company's drugs in clinical trials in the past, so we are communicating carefully with FDA. In order to avoid risks for our company and our shareholders, we do not intend to rush to the decision.
Q2: What is your business development (BD below) plan in Japan?
A2: All of us in GNI have been working hard to expand our business in Japan and are actively preparing for such expansion. However, unfortunately, we cannot disclose much now.
Q3: What is Cullgen's PROTAC drug pipeline and also IPO status?
A3: You will start seeing more IND's from Cullgen this year. We expect 2-3 IND's every year in the future. Many famous venture capital and private equity funds have invested in Cullgen and are looking for optimal exit strategy. Therefore, we are planning to list Cullgen at some point. NASDAQ is an option, but we have not decided yet. Market conditions change all the time, so we are carefully watching the timing and the listing venue.
Q4: Shouldn't GNI consider dividends to increase stable, large institutional investors such as pension funds?
A4: It is a difficult question on whether to distribute the profits as dividends or invest such profits in further growth. We are one of a rare, small number of biotech companies that are profitable. But we are also still on a fast growth curve. Therefore, we believe it would generate more return to our shareholders if we invest our profits into future growth at this moment. When our profits become much larger, we will consider dividends.
Q5: Why there are different levels of discloser between Japan and Hong Kong regarding Beijing Continent?
A5: If there is discrepancy between the disclosures in Japan and Hong Kong regarding Beijing Continent, please use the data published in A1 filing by Beijing Continent in Hong Kong. Due to Hong Kong Exchange rules, we cannot disclose forecasts of financial results of Beijing Continent, as that is considered as a violation of the listing rules in Hong Kong. In the future we will try to coordinate disclosures between Tokyo and Hong Kong stock exchanges.
Q6: What is your basic business strategy and plan in the US?
A6: We have mainly 2 businesses in the US: Cullgen and Berkeley Advanced Biomaterials (BAB). We would like to see faster growth in our biomaterials business for BAB and target to make it our major pillar. Our goal for Cullgen is to grow it to be a global top-tier biotech firm. We have over 90 staffs in Cullgen, around 30 of who hold PhD, MD, or JD. Several of them were university professors in the US.
Q7: Are you planning to market BAB products in Japan and China?
A7: BAB is actually selling in China and last year we saw a significant growth. We are planning to increase their direct sales in China this year. Japan market is different and more complex, as Japan is strong in biomaterials. We need a reliable partner to help us in Japan.