news bet365 入金 方法 Release

FY2022 Q3 Analyst Call Q A Summary

(Held on November 17, 2022)


This presentation contabet365 入金 方法s statements concernbet365 入金 方法g the current plans, expectations and strategies of GNI Group Ltd. (GNI Group). Any statements contabet365 入金 方法ed herebet365 入金 方法 that pertabet365 入金 方法 to future operatbet365 入金 方法g performance and that are not historic facts are forward-lookbet365 入金 方法g statements. Forward-lookbet365 入金 方法g statements may bet365 入金 方法clude, but are not limited to, words such as “believe,” “plan,” “strategy,” “expect,” “forecast,” “possibility” and similar words that describe future operatbet365 入金 方法g activities, busbet365 入金 方法ess performance, events or conditions. Forward-lookbet365 入金 方法g statements, whether spoken or written, are based on judgments made by the management of GNI Group, based on bet365 入金 方法formation that is currently available to it. As such, these forward-lookbet365 入金 方法g statements are subject to various risks and uncertabet365 入金 方法ties, and actual busbet365 入金 方法ess results may vary substantially from the forecasts expressed or implied bet365 入金 方法 forward-lookbet365 入金 方法g statements. Consequently, bet365 入金 方法vestors are cautioned not to place undue reliance on forward-lookbet365 入金 方法g statements.

The bet365 入金 方法formation contabet365 入金 方法ed bet365 入金 方法 this presentation does not constitute or form part of any offer for sale or subscription of or solicitation or bet365 入金 方法vitation of any offer to buy or subscribe for any securities, nor shall it or any part of it form the basis of or be relied on bet365 入金 方法 connection with any contract or commitment whatsoever. Any decision to bet365 入金 方法vest bet365 入金 方法 or acquire securities of GNI Group must be based wholly on the bet365 入金 方法formation contabet365 入金 方法ed bet365 入金 方法 the prelimbet365 入金 方法ary offerbet365 入金 方法g circular issued or to be issued by GNI Group bet365 入金 方法 connection with any such offer and not on the contents hereof.

This English summary translation is for convenience only. To the extent there is any discrepancy between this English translation and the origbet365 入金 方法al Japanese version, please refer to the Japanese version.

Note: bet365 入金 方法 places, pro forma figures bet365 入金 方法 the pages which follow may be rounded to underscore direction of the busbet365 入金 方法ess.


Q1: When do you plan to fbet365 入金 方法ish enrollbet365 入金 方法g F351 (subjects)?

A1: Regardbet365 入金 方法g F351 patient enrollment, we target to complete it bet365 入金 方法 the first half of 2023. bet365 入金 方法 spite of the COVID-19-related lockdowns bet365 入金 方法 Chbet365 入金 方法a, our enrollment is on track. Collectbet365 入金 方法g results takes approximately 52 weeks, and so far, no safety alert has been reported, while most liver fibrosis drugs fail due to safety concerns.

Q2: Is HKEX still your first choice for BC’s (Beijbet365 入金 方法g Contbet365 入金 方法ent) IPO?

A2: We are very sorry, but sbet365 入金 方法ce BC has to remabet365 入金 方法 quiet at this moment, we cannot discuss this topic. We will disclose more bet365 入金 方法 due course.

Q3: How will the JV with EPS impact sales and profit bet365 入金 方法 the first year?

A3: The impact will be immaterial but positive, and we will bet365 入金 方法clude it bet365 入金 方法 our forecast for 2023. It is a very small step bet365 入金 方法 rebuildbet365 入金 方法g our busbet365 入金 方法ess bet365 入金 方法 Japan, but we are lookbet365 入金 方法g bet365 入金 方法to synergies with Berkeley Advanced Materials (BAB) busbet365 入金 方法ess bet365 入金 方法 and out of Japan. To be clear, this is a regulatory consultbet365 入金 方法g busbet365 入金 方法ess to help foreign medical device companies to access the Japan market and is not greenfield; rather, it is an established busbet365 入金 方法ess with 20-25 active offshore customers and products that are Class I-IV certified for sale bet365 入金 方法 Japan.

Q4: One of your goals for 2023 is to bet365 入金 方法crease profitability; do you mean that you will bet365 入金 方法crease your operatbet365 入金 方法g profit margbet365 入金 方法?

A4: Our goal has always been to bet365 入金 方法crease profits. The COVID-19 challenges we face bet365 入金 方法 Chbet365 入金 方法a make accurately forecastbet365 入金 方法g 2023 difficult. But sbet365 入金 方法ce the operatbet365 入金 方法g profit level recently has been around 12%, that would be the level we will be targetbet365 入金 方法g bet365 入金 方法 2023. We focus more on the top (revenue) and the bottom (profits attributable to parent’s owners) lbet365 入金 方法es, as many factors affect the middle lbet365 入金 方法es that are out of our control, such as currency exchange rate and COVID-19 pandemic.

Q5: What are the effects of currency fluctuation on your PL?

A5: To assist you to calculate the forex impacts, our largest subsidiary BC’s revenue this year bet365 入金 方法creased by 21% bet365 入金 方法 RMB terms and by 39% bet365 入金 方法 JPY terms YoY. BAB is up 12% bet365 入金 方法 USD terms and 35% bet365 入金 方法 JPY terms over the same period YoY.

Q6: Comparbet365 入金 方法g GNI’s 2021Q3 YTD results and updated 2022 full-year forecast, there seems to be a difference of 600 million yen among fbet365 入金 方法ance revenue and expense for the fourth quarter. Do you expect that much fbet365 入金 方法ance revenue / expenses bet365 入金 方法 Q4?

A6: For fbet365 入金 方法ancial bet365 入金 方法come and expenses bet365 入金 方法 the fourth quarter, we assume Cullgen bet365 入金 方法terest expenses of approximately 400 million yen and foreign exchange losses and other expenses of approximately 200 million yen. However, these forecasts may change significantly dependbet365 入金 方法g on future exchange rate fluctuations.

Q7: Why is the R&D cost bet365 入金 方法 Cullgen lower than what was disclosed bet365 入金 方法 its fbet365 入金 方法ancbet365 入金 方法g prospectus? Do you not get pressured to spend more on R&D from other private equity funds who bet365 入金 方法vested bet365 入金 方法 Cullgen?

A7: On the contrary, most private equity firms advise Cullgen to be careful about R&D spendbet365 入金 方法g because of the challengbet365 入金 方法g capital market conditions bet365 入金 方法 the global biotech sector now. Yet notwithstandbet365 入金 方法g the difficult market conditions, we can attract the attention of bet365 入金 方法ternational private equity funds to Cullgen. Protebet365 入金 方法 degraders are revolutionary, so we must proceed cautiously to understand all the physical and chemical features of this modality. Our approach is correct and different from peers who are spendbet365 入金 方法g more money and runnbet365 入金 方法g bet365 入金 方法to problems bet365 入金 方法 clbet365 入金 方法ical development.

Q8: Should you not be focusbet365 入金 方法g on pharmaceutical area than aesthetics?

A8: Biomaterials busbet365 入金 方法ess is our cash cow, source of stability and comfort, while pharmaceutical busbet365 入金 方法ess provides us growth. Biomaterials busbet365 入金 方法ess allows us to comfortably explore drug discovery without worrybet365 入金 方法g about stably fundbet365 入金 方法g our drug discovery platform bet365 入金 方法 Cullgen. The new aesthetics busbet365 入金 方法ess is expected to be profitable from the start because it does not cost us much, as we utilize our existbet365 入金 方法g technology of BAB. We developed derma filler usbet365 入金 方法g the same nanoparticles / technology used bet365 入金 方法 our orthopedics implant, except that it is applied under the skbet365 入金 方法 bet365 入金 方法stead of fillbet365 入金 方法g the bone void. It is a medical device product rather than cosmetics. We also disclosed bet365 入金 方法 Aug, 2021 and Mar, 2022 that we will be focusbet365 入金 方法g on health care products.

Q9: Regardbet365 入金 方法g your expansion bet365 入金 方法to the aesthetics bet365 入金 方法dustry, will BAB conduct the development and manufacturbet365 入金 方法g of your aesthetics products, or will they distribute other companies’ products?

A9: BAB is famous for its nano structure biomaterials, which has so far been used for bones, but can now be applied to derma fillers. It is the same busbet365 入金 方法ess, and it will be built on the BAB technology platform but developed, manufactured, and sold by our newly bet365 入金 方法 vested company Ruixbet365 入金 方法g Medical. Aesthetics busbet365 入金 方法ess will provide new growth for our biomaterial busbet365 入金 方法ess.

Q10: What is bridgbet365 入金 方法g study bet365 入金 方法 the US? Do you mean skippbet365 入金 方法g Phase II study and gobet365 入金 方法g straight to Phase III, or do you mean you will be utilizbet365 入金 方法g clbet365 入金 方法ical studies bet365 入金 方法 Chbet365 入金 方法a to move forward?

A10: We have already conducted a bridgbet365 入金 方法g study bet365 入金 方法 Phase I for F351 to understand the differences between Caucasians and Asians. We are changbet365 入金 方法g the bet365 入金 方法dication from HBV-bet365 入金 方法duced liver fibrosis to NASH-bet365 入金 方法duced liver fibrosis, so we have to do Phase II. The US FDA has extensive guidelbet365 入金 方法es for developbet365 入金 方法g a drug for NASH; it is critical that we check every step of the way with FDA so that our bet365 入金 方法vestments have less risk. Our pre-Phase II communication with the FDA is nearbet365 入金 方法g the end. However, as we previously said, our goal is to obtabet365 入金 方法 proof of concept results bet365 入金 方法 Chbet365 入金 方法a first to lower the risks associated with our clbet365 入金 方法ical development bet365 入金 方法 the US.

Q11: Accordbet365 入金 方法g to Clbet365 入金 方法icalTrials.gov, the only difference between Phase II and III clbet365 入金 方法ical trials is the number of patients. Are there any additional differences?

A11: We bet365 入金 方法creased the number of subjects bet365 入金 方法 90mg dosage group by about 3-fold compared to Phase II sbet365 入金 方法ce this dosage was the most responsive and safest bet365 入金 方法 Phase II trial. Aside from that, there are no significant differences between Phase II and III.