Shionogi TSE:4507 Stock Report

First quarter 2023 earnings: EPS and revenues exceed analyst expectations

First quarter 2023 results: EPS: JP¥115 (up from JP¥107 in 1Q 2022). Revenue: JP¥71.8b (up 4.2% from 1Q 2022). Net income: JP¥34.7b (up 7.7% from 1Q 2022). Profit margin: 48% (up from 47% in 1Q 2022). The increase in margin was driven by higher revenue. Revenue exceeded analyst estimates by 6.1%. Earnings per share (EPS) also surpassed analyst estimates by 39%. Over the next year, revenue is forecast to grow 16%, compared to a 5.1% growth forecast for the industry in Japan. Over the last 3 years on average, earnings per share has fallen by 4% per year but the company’s share price has increased by 5% per year, which means it is well ahead of earnings.

Shionogi & Co., Ltd. Provides Year-End Dividend Guidance for the Year Ending March 31, 2023

Shionogi & Co., Ltd. Initiates Fourth Vaccination Trail

Shionogi & Co., Ltd. announced that it has initiated a fourth vaccination trial, in subjects aged 60 years and over, for its vaccine (S-268019) against COVID-19, caused by the novel coronavirus (SARS-CoV-2) infection. The primary objective of this clinical trial is to evaluate the non-inferiority of immunogenicity after the fourth vaccination with S-268019 versus COMIRNATY. The subjects are individuals aged 60 years and over who have previously been vaccinated with the SARS-CoV-2 vaccine COMIRNATY three times. Advanced age is considered the most important risk factor for aggravation in COVID-19. Since it has been suggested that the effect of vaccination gradually declines over time, implementation of a fourth vaccination for people aged 60 and over and other high-risk persons was started in June 2022 in Japan. On the other hand, at present, the vaccines that can be used for the fourth vaccination in Japan are limited, and new options are needed. The Phase 1/2 clinical trial is a double-blind and placebo-controlled study to evaluate safety, tolerability andimmunogenicity of two doses of the vaccine. 60 adults are enrolled in the trial. For more information about this clinical trial, please refer to jRCT No.:2031210269. Subject registration for this trial has been completed. In the evaluation up to 28 days after two doses of the vaccine, tolerability and safety were confirmed, as was a neutralizing antibody titer equal to or higher than that of convalescent serum. The Phase 2/3 clinical trial is an open-label study to evaluate safety, tolerability and immunogenicity of S-268019 in 3,100 adults and elderly people. For more information about this clinical trial, please refer to jRCT No.:2031210383. Subject registration for this trial has been completed. In the evaluation up to 28 days afterthe second inoculation, tolerability and safety, and the increase in neutralizing antibody titer, were all confirmed. This clinical trial is a randomized, active controlled, double-blind trial. In this trial, the efficacy and safety of an additional dose of COMIRNATY or S-268019 in 200 adults, 6 months or more after receiving a primary series of COMIRNATY, will be compared. For more information about this clinical trial, please refer to jRCT No.:2031210470. Subject registration for this trial has been completed and the primary endpoint (neutralizing antibody titer against SARS-CoV-2 28 days after the additional dose) was achieved. This clinical trial is an open-label trial. This trial is to assess the safety and immunogenicity of an additionaldose of S-268019 in 150 adults aged 20 to 64 years who received 2 inoculations of Spikevax intramuscular injection (hereafter "Spikevax"), and elderly people aged 65 years or older who received 2 inoculations of a primary series of COMIRNATY or Spikevax (in each case, between 6 months and 8 months after the second vaccination). For more information about this clinical trial, please refer to jRCT No.:2031210613. Subject registration for this trial has been completed. This clinical trial is a double-blind randomized active controlled trial to evaluate the neutralizing antibody titer after the primary series of Vaxzevria or S-268019 in 1,000 adults and elderly. For more information about this clinical trial, please refer to jRCT No.:2051210151.

Shionogi & Co., Ltd. Announces Initiation of A Clinical Trial in Japanese Pediatric Subjects of the COVID-19 Recombinant Protein-Based Vaccine, S-268019

Shionogi & Co., Ltd. announced that it has initiated a Phase 1/2/3 clinical trial (part1) in Japanese pediatric subjects of its vaccine (code No. S-268019), against COVID-19, caused by the novel coronavirus (SARS-CoV-2) infection. The primary objective of this clinical trial is to evaluate the safety and tolerability of the primary series of S- 268019 injections in the 5 to 11 year old pediatric population and to define the correct dose of S-268019. The risk of COVID-19 exacerbation has been reported in pediatric patients, and vaccination is expected to prevent such exacerbations. In Japan, the options for vaccines that can be given to younger age groups are limited, and, as with adults, there is a need for vaccination options. Starting in February 2022, they have been in prior consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) in preparation for the approval application in Japan. They will continue to consult closely with the Ministry of Health, Labor and Welfare, PMDA and other organizations based on the results from multiple pivotal clinical trials.