YS Biopharma Announces Unaudited Financial Results for the First Quarter of Fiscal Year 2024
- Gross margin increases to 80.3%
- Demand for YSJA rabies vaccine remains robust
- YS Biopharma continues to advance its clinical pipeline
- Balance sheet remains strong
- None.
Pipeline makes progress towards commercialization as robust demand for YSJA rabies vaccine continues
Gross margin increases to
Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, "During the first quarter of fiscal year 2024, our top-line came under pressure from tight inventory levels of finished products available for sale, caused by the lingering impacts of COVID-related disruptions at our YSJA rabies vaccine manufacturing facilities. While these disruptions occurred in late 2022 and early 2023, the long and complex nature of the vaccine manufacturing process means that we are experiencing the impact at present. In the first quarter, we took several steps to enhance our operations and ensure future stability, including boosting manufacturing productivity, building out our sales network, and streamlining research and development efforts. Demand for our YSJA rabies vaccine remains robust, and we continue to bring our pipeline of promising product candidates, including our next generation PIKA rabies vaccine, towards commercialization. We are confident that we will overcome the near-term difficulties we have faced, and we believe we are well-positioned for sustainable, long-term success."
Ms. Brenda Wu, CFO of YS Biopharma, added, "In the first quarter of fiscal year 2024, our total revenues were
Business Updates
YSJA™ Rabies Vaccine
YS Biopharma's marketed vaccine product, YSJA™ rabies vaccine, was the first aluminum-free lyophilized rabies vaccine launched in
Clinical Pipeline
YS Biopharma continues to advance its portfolio of innovative product candidates under various clinical development stages, including PIKA rabies vaccine, PIKA recombinant COVID-19 vaccine, and PIKA YS-ON-001.
PIKA Rabies Vaccine
- As of June 1, 2023, the Company had been granted approval by regulatory bodies in
the Philippines ,Singapore , andPakistan to undertake Phase III clinical trials of the vaccine. This multi-country Phase III study is a registration trial and will evaluate the vaccine's ability to induce an immune response and its safety profile. - The Company intends to include a total of 4,500 participants in the Phase III trial, with the recruitment process projected to commence in the fourth quarter of 2023. The Company aims to obtain interim results by early 2024.
PIKA Recombinant COVID-19 Vaccine
- In March 2023, the Company reported positive interim safety and immunogenicity data for the PIKA recombinant COVID-19 vaccine from Phase II of the Phase II/III clinical studies which were completed in
the Philippines and theUAE . The safety and efficacy of the Company's PIKA adjuvant technology was validated in the Phase II/III trial, which involved roughly 6,000 participants. The Company anticipates the findings from the Phase III clinical trials will be released before the end of 2023. - The Company will continue to monitor the evolving global situation surrounding COVID-19, and will utilize appropriate commercialization strategies for the PIKA recombinant COVID-19 vaccine accordingly.
PIKA YS-ON-001
- PIKA YS-ON-001 is designed as an immunological therapeutical agent against cancers. The Company has completed the enrollment of cancer patients for the Phase I clinical trial of PIKA YS-ON-001 in
China . The Company expects the Phase I clinical trial will be completed by December 31, 2023.
First Quarter of Fiscal Year 2024 Financial Results
Total Revenues
Total revenues were
Gross Profit
Gross profit was
Selling and Marketing Expenses
Selling and marketing expenses in the first quarter of fiscal year 2024 were
General and Administrative Expenses
General and administrative expenses in the first quarter of fiscal year 2024 were
Research and Development Expenses
Research and development expenses were
Net Loss
Net loss for the first quarter of fiscal year 2024 was
Balance Sheet
As of June 30, 2023, the Company had cash and cash equivalents of
Corporate Update
As part of its strategy to unlock the commercial potential of its vaccine franchise in underserved markets in
Conference Call Information
The Company's management will hold an earnings conference call on Tuesday, August 15, 2023 at 8:00 P.M. Eastern Time to discuss the financial results. Listeners may access the call by dialing the following numbers:
United States Toll Free: 1-888-346-8982
International: 1-412-902-4272
Mainland China Toll Free: 4001-201203
Canada Toll Free: 1-855-669-9657
Hong Kong: 852-301-84992
The replay will be accessible through August 22, 2023 by dialing the following numbers:
United States Toll Free: 1-877-344-7529
International: 1-412-317-0088
Canada Toll Free: 855-669-9658
Access Code: 8167733
A live and archived webcast of the conference call will also be available at the Company's investor relations website at https://investor.ysbiopharm.com/.
About YS Biopharma
YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other virus infections. YS Biopharma operates in China, the United States, Singapore, and the
Exchange Rate Information
This announcement contains translations of certain RMB amounts into
Cautionary Statement Regarding Forward-Looking Statements
This press release contains "forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma's ability to source and retain talent, and the cash position of YS Biopharma following the closing of the Business Combination. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma's management and are not predictions of actual performance.
These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from those expressed or implied by these forward-looking statements. Although YS Biopharma believes that it has a reasonable basis for each forward-looking statement contained in this press release, YS Biopharma cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. In addition, there are risks and uncertainties described in the final prospectus relating to the proposed Business Combination, and other documents filed by YS Biopharma from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements.
YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including, among others, the ability to recognize the anticipated benefits of the Business Combination, costs related to the transaction, the impact of the global COVID-19 pandemic, the risk that the transaction disrupts current plans and operations as a result of the consummation of the transaction, the outcome of any potential litigation, government or regulatory proceedings, the sales performance of the marketed vaccine product and the clinical trial development results of the product candidates of YS Biopharma, and other risks and uncertainties, including those included under the heading "Risk Factors" in the post-effective amendment No. 1 to Form F-1 filed with the SEC on August 8, 2023 which became effective on August 10, 2023, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements.
Investor Relations Contacts
Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com
Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com
YS Biopharma Co., Ltd. | ||||||
UNAUDITED CONSOLIDATED BALANCE SHEETS | ||||||
(All amounts in thousands, except for share and per share data) | ||||||
As of March 31, | As of June 30, | |||||
2023 | 2023 | 2023 | ||||
RMB | RMB | US$ | ||||
ASSETS | ||||||
Current assets | ||||||
Cash | 370,108 | 94,749 | 13,113 | |||
Restricted cash | 262 | 217,036 | 30,036 | |||
Accounts receivable, net | 463,052 | 495,907 | 68,630 | |||
Advance to suppliers, net | 6,763 | 9,942 | 1,376 | |||
Inventories, net | 185,381 | 182,370 | 25,239 | |||
Prepaid expenses and other current assets | 10,413 | 6,171 | 854 | |||
Total current assets | 1,035,979 | 1,006,175 | 139,248 | |||
Non-current assets | ||||||
Property, plant and equipment, net | 571,756 | 566,872 | 78,451 | |||
Operating lease right-of-use assets, net | 11,132 | 10,934 | 1,513 | |||
Deferred tax assets, net | 1,906 | 2,491 | 345 | |||
Intangible assets, net | 78,057 | 76,335 | 10,564 | |||
Other assets, non-current | 20,924 | 27,069 | 3,746 | |||
Total non-current assets | 683,775 | 683,701 | 94,619 | |||
Total assets | 1,719,754 | 1,689,876 | 233,867 | |||
LIABILITIES AND SHAREHOLDERS' (DEFICIT)/EQUITY | ||||||
Current liabilities | ||||||
Bank loans and other borrowings – current | 193,737 | 171,608 | 23,749 | |||
Accounts payable | 80,439 | 73,868 | 10,223 | |||
Accrued expenses and other liabilities | 377,537 | 398,930 | 55,209 | |||
Operating lease liabilities - current | 4,754 | 5,035 | 697 | |||
Deferred government grants - current | 2,296 | 2,296 | 318 | |||
Total current liabilities | 658,763 | 651,737 | 90,196 | |||
Non-current liabilities | ||||||
Bank loans and other borrowings – non- current | 293,791 | 343,286 | 47,508 | |||
Operating lease liabilities - non-current | 6,349 | 6,683 | 925 | |||
Deferred government grants - non- current | 23,607 | 25,033 | 3,464 | |||
Warrants liability | 8,792 | 2,384 | 330 | |||
Total non-current liabilities | 332,539 | 377,386 | 52,227 | |||
Total liabilities | 991,302 | 1,029,123 | 142,423 | |||
Shareholders'(deficit)/equity | ||||||
Ordinary shares, par value | 12 | 12 | 2 | |||
Additional paid-in capital | 2,656,891 | 2,656,891 | 367,695 | |||
Accumulated deficit | (1,874,039) | (1,943,579) | (268,978) | |||
Accumulated other comprehensive loss | (54,412) | (52,571) | (7,275) | |||
Total shareholders' equity | 728,452 | 660,753 | 91,444 | |||
Total liabilities and shareholders' equity | 1,719,754 | 1,689,876 | 233,867 |
YS Biopharma Co., Ltd. | ||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||
(All amounts in thousands, except for share and per share data) | ||||||
For the three months ended June 30, | ||||||
2022 | 2023 | 2023 | ||||
RMB | RMB | US$ | ||||
Revenues | 205,476 | 176,274 | 24,395 | |||
Cost of revenues | 51,134 | 34,680 | 4,799 | |||
Gross profit | 154,342 | 141,594 | 19,596 | |||
Operating expenses: | ||||||
Selling and marketing | 70,493 | 79,195 | 10,960 | |||
General and administrative | 25,509 | 31,813 | 4,403 | |||
Research and development | 70,288 | 100,640 | 13,928 | |||
Total operating expenses | 166,290 | 211,648 | 29,291 | |||
Loss from operations | (11,948) | (70,054) | (9,695) | |||
Other income (expenses): | ||||||
Late fees related to social security insurance | (228) | (154) | (21) | |||
Government grants | 210 | 1,474 | 204 | |||
Financial expenses, net | (7,375) | (8,028) | (1,111) | |||
Fair value changes of warrant liability | - | 6,693 | 926 | |||
Other income (expense), net | 360 | (59) | (8) | |||
Total other income (expense), net | (7,033) | (74) | (10) | |||
Loss before income taxes | (18,981) | (70,128) | (9,705) | |||
Income tax expense | (612) | 586 | 81 | |||
Net loss | (19,593) | (69,542) | (9,624) | |||
Accretion to redemption value of convertible redeemable preferred shares | (34,473) | - | - | |||
Net loss attributable to YS Group | (54,066) | (69,542) | (9,624) | |||
Net loss | (19,593) | (69,542) | (9,624) | |||
Other comprehensive income (loss): foreign currency translation adjustment | (79,358) | 1,841 | 255 | |||
Total comprehensive loss | (98,951) | (67,701) | (9,369) | |||
Loss per share: | ||||||
– Basic and Diluted | (0.32) | (0.75) | (0.10) | |||
Weighted average number of ordinary shares | ||||||
– Basic and Diluted | 61,827,883 | 93,058,197 | 93,058,197 |
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SOURCE YS Biopharma Co., Ltd.
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