SNPHY Earnings

Peter Sallstig: [Foreign Language] Thank you very much. Good afternoon. I'm Peter Sallstig, Chief Medical Officer. I would like to report the status of pipeline, please see Page 20. [Foreign Language] On the R&D front for the first quarter, we continued to progress in our pipeline. As you can see, we have nine projects in the late phase, coupled with development in new areas: myopia, ptosis, MGD and FECD. [Foreign Language] As announced in June, resubmission for STN1011700 was completed in the U.S. with the PDUFA date set on November 6. In Japan, we kicked off the soft launch [indiscernible] in late July. We also received approval for [indiscernible] which when launched will allow patients to reduce the frequency at which they need to apply eyedrops during their treatment by half from the previous formulation. We're aiming for November price listing. [Foreign Language] [Indiscernible] for the treatment of Vernal keratoconjunctivitis, a rare and recurrent allergic eye condition mainly occurring in children adolescents, was launched in the U.S. and received approval in China. [Foreign Language] Related to China, we also kicked off the Phase 2/3 study of STN1012700, atropine formulations for myopia and we're preparing for the Phase 3 of STN1013800 for Ptosis. As for MGD, we will have the proof of concept data within the second quarter. [Foreign Language] Please move to page 21. [Foreign Language] As you know, the development of ROCK inhibitors for glaucoma is the result of the license agreement Santen has with Aerie covering Japan, China, Asia and Europe. STN1013900 for monotherapy and STN1014000 for combination therapy have been submitted in Asia. In Europe, we're aiming to launch this fiscal year. Meanwhile, Phase 3 studies of STN1013900 are ongoing in Japan and then we'd like to take the opportunity to provide you with an update. [Foreign Language] Please move on to page 22. [Foreign Language] Three Phase 3 studies are required for the submission in Japan. The first study showed superiority to [indiscernible] as previously reported and achieved the primary endpoint. This time, we have the top line results on the adjectives to use with latanoprost, a second study. [Foreign Language] Please move on to page 23. [Foreign Language] The graph shows intraocular pressure lowering from baseline over time. The blue line represent a combination of STN1013900 with statistically significant superiority over the red latanoprost alone group from one week to four weeks. As expected with an add-on therapy, more adverse events were seeing with conjunctival hyperemia being the most frequent. [Foreign Language] We will continue to conduct a third long term study. This concludes my part. [Foreign Language] A - Peter Sallstig: This is Peter Sallstig, Chief Medical Officer. Thank you for the question. What we can say for certainty at this stage is that we are looking into options to move forward as expeditiously as possible not only in Japan, but also as you have seen, we started here the preparations now also for our Phase 1 in China. While I can't go into more specifics with regards to the timelines, what again I can confirm is we're looking forward to moving this forward as quickly as possible here in Japan. Thank you. [Foreign Language] Peter Sallstig: This is Peter Sallstig, Chief Medical Officer. In the complete response letter from the FDA that we received, the issue of non-compliance with regards to the contract manufacturing was clearly mentioned. We have been working together with the agency, with the contract manufacturing to ensure that we're able to address all their requirements. We resubmitted this on May 6. We got the agreement that we had appropriately addressed the requirements in order for them to start the in-depth review and we are looking forward to receiving the PDUFA date by November 6 the latest. Thank you. [Foreign Language]