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6-K 1 ea191942-6k_ysbiopharma.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

 PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

 THE SECURITIES EXCHANGE ACT OF 1934

 

For the month of January 2024

 

Commission File Number: 001-41598

 

YS BIOPHARMA CO., LTD.

 (Exact name of registrant as specified in its charter)

 

Building No. 2, 38 Yongda Road

Daxing Biomedical Industry Park

Daxing District, Beijing, PRC

Tel: 010-89202086

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F ☒ Form 40-F ☐

 

 

 

 


 

EXHIBITS

 

Exhibit No.   Description
     
99.1   Press Release

 

1


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  YS Biopharma Co., Ltd.
   

Date: January 22, 2024

By: /s/ Hui Shao
  Name:  Hui Shao
  Title: Director and Chief Executive Officer

 

 

2

 

 

EX-99.1 2 ea191942ex99-1_ysbiopharma.htm PRESS RELEASE

Exhibit 99.1

 

YS Biopharma Announces Unaudited Financial Results for the First Half of Fiscal Year 2024

 

GAITHERSBURG, MD., January 22, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ: YS) (“YS Biopharma”) along with its subsidiaries (“YS Group” or the “Company”), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced its unaudited consolidated financial results for the first half of the fiscal year ended March 31, 2024 (the “first half of fiscal year 2024”).

 

Dr. David Shao, Director, President, and CEO of the Company, commented, “During the first half of fiscal year 2024, though we continued to experience the lingering impact of inventory issues from previous COVID-related disruptions at our YSJA rabies vaccine manufacturing facilities, we executed various operational enhancements to overcome past setbacks. By improving our raw material supply, refining our inventory management, and optimizing the production throughput, our vaccine production operation has returned to normal, and our inventory situation is improving. With higher production throughput and a healthier inventory level of finished products, we expect that the second quarter of our fiscal year 2024 will be the last to be impacted by the previously incurred production delays. Meanwhile, we expect YSJA rabies vaccine revenues in the third quarter, ended December 31, 2023, to increase approximately 50% sequentially from the second quarter, ended September 30, 2023. Our promising array of product candidates are advancing in the development, and we are optimistic about the potential of our PIKA rabies vaccine to provide us with an important new advantage.”

 

“At the same time, we are fortifying our corporate governance and streamlining our decision-making process to bolster our foundation for long-term and sustainable growth,” Dr. Shao continued. “We have taken steps to diversify our Board composition with the addition of global pharmaceutical industry leadership and US capital market expertise to our company, a move which has thus far been lauded by our shareholders. Under the stewardship of our board of directors, we will continue to innovate and capitalize on resurgent demand from the market.”

 

Ms. Brenda Wu, CFO of the Company, added, “For the first half of fiscal year 2024, our revenues were RMB273.1 million, mainly due to COVID-related disruptions affecting raw material supply chains, manufacturing operations, and production output at our YSJA rabies vaccine production facilities. Our gross profit for the period was RMB220.9 million, and we expanded our gross profit margin by 4.3 percentage points to 80.9%. Our cash and cash equivalents totaled RMB259.9 million at the end of the period. Looking ahead, we will continue to strategically enhance our business and capitalize on growth opportunities as we strive to deliver long-term value for our shareholders.”

 

1


 

Business Updates

 

YSJATM Rabies Vaccine

 

YS Biopharma’s marketed vaccine product, YSJATM rabies vaccine, was the first aluminum-free lyophilized rabies vaccine launched in China. Since the Company commenced production at its current GMP-compliant facilities in February 2020, and, since it commenced the product’s commercialization in late 2020, market intake of the Company’s YSJA rabies vaccine has been consistent and strong. As of September 30, 2023, YS Biopharma had sold more than 23.5 million doses of YSJATM rabies vaccines to approximately 1,718 Chinese Center(s) for Disease Control and Prevention (“CDC”) customers, which represents over 59.6% of CDC customers in China since October 2020.

 

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, PIKA YS-ON-001, and PIKA YS-HBV-002.

 

PIKA Rabies Vaccine

 

On October 31, 2023, the Company announced that it had completed the enrollment of subjects in its Phase III clinical trial of the PIKA rabies vaccine. The trial includes a total of 4,500 participants from Pakistan and the Philippines, and will assess the safety, immunogenicity, and lot-to-lot consistency of the PIKA rabies vaccine. Interim results are expected in the first half of 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 the UAE. 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 that the results from the Phase III clinical trials will be released during the first half of 2024.
     
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 Phase I clinical trial of PIKA YS-ON-001 in China.

 

2


 

PIKA YS-HBV-002

 

On September 15, 2023, the Company announced that the United States Patent and Trademark Office had issued it a patent covering its PIKA YS-HBV-002, an immunotherapeutic vaccine designed to treat patients suffering from chronic hepatitis B virus (HBV) infection.
     
The Company expects to complete an Investigational New Drug (IND) application and commence the clinical development of PIKA YS-HBV-002 as a novel immunotherapy for the treatment of chronic HBV infection in 2024. 

 

First Half of Fiscal Year 2024 Financial Results

 

Total Revenues

 

Total revenues were RMB273.1 million (US$38.0 million) in the first half of fiscal year 2024, compared to RMB399.5 million in the same period of fiscal year 2023, representing a decrease of 31.6%. This was primarily due to COVID-related disruptions affecting the Company’s manufacturing operations and production, which reduced batch approvals and doses available for sale; offset by the increases in product price by approximately RMB3.0 per dose.

 

Gross Profit

 

Gross profit was RMB220.9 million (US$30.8 million), representing an 80.9% gross margin, compared to RMB305.8 million, or a 76.5% gross margin, in the same period of fiscal year 2023.

 

Selling and Marketing Expenses

 

Selling and marketing expenses in the first half of fiscal year 2024 were RMB157.7 million (US$22.0 million), compared to RMB150.2 million in the same period of fiscal year 2023. This increase was primarily attributable to an increase in promotional and marketing services fees as the Company continued to promote its YSJA rabies vaccine.

 

General and Administrative Expenses

 

General and administrative expenses in the first half of fiscal year 2024 were RMB67.6 million (US$9.4 million), compared to RMB49.6 million in the same period of fiscal 2023. This change was primarily attributable to increase in 1) professional service fees, due to the Company’s status as a publicly-listed entity, 2) management salaries, and 3) provision for trade receivables and inventories.

 

Research and Development Expenses

 

Research and development expenses were RMB178.9 million (US$24.9 million) in the first half of fiscal year 2024, compared to RMB123.9 million in the same period of fiscal 2023. The increase was primarily driven by an increase in testing and clinical trial fees associated with the Company’s COVID-19 vaccine, PIKA rabies vaccine, and hepatitis B vaccines.

 

3


 

Net Loss

 

Net loss for the first half of fiscal year 2024 was RMB174.5 million (US$24.3 million), compared with RMB11.1 million in the same period of 2023.

 

Balance Sheet

 

As of September 30, 2023, the Company had cash and cash equivalents of RMB259.9 million (US$36.2 million), compared with RMB370.4 million as of March 31, 2023.

 

About YS Group

 

YS Group 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 Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visit investor.ysbiopharm.com.

 

Exchange Rate Information

 

This announcement contains translations of certain RMB amounts into U.S. dollars at a specified rate solely for the convenience of the reader. Unless otherwise noted, all translations from RMB to U.S. dollars are made at a rate of RMB7.1798 to US$1.00, the exchange rate set forth in the central parity rate release of the People’s Bank of China on September 30, 2023.

 

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 the Company, the development progress of all product candidates, the progress and results of all clinical trials, the Company’s ability to source and retain talent, and the cash position of the Company 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.

 

4


 

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 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 Contact

 

Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com

 

5


 

YS BIOPHARMA CO., LTD AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

    March 31,     September 30,     September 30,  
    2023     2023     2023  
    (RMB)     (RMB)     (US$)  
          (Unaudited)     (Unaudited)  
ASSETS                  
Current assets                  
Cash     370,108,059       259,905,532     $ 36,199,550  
Restricted cash     261,766       -       -  
Accounts receivable, net     463,051,792       429,368,934       59,802,353  
Advance to suppliers, net     6,763,326       21,168,706       2,948,370  
Inventories, net     185,380,952       212,820,371       29,641,546  
Prepaid expenses and other current assets     10,412,769       11,341,675       1,579,664  
Total current assets     1,035,978,664       934,605,218       130,171,483  
Non-current assets                        
Property, plant and equipment, net     571,756,443       561,678,490       78,230,381  
Operating lease right-of-use assets, net     11,132,428       9,607,109       1,338,075  
Deferred tax assets, net     1,905,581       2,725,934       379,667  
Intangible assets, net     78,056,792       74,638,356       10,395,604  
Other assets, non-current     20,923,703       28,027,997       3,903,729  
Total non-current assets     683,774,947       676,677,886       94,247,456  
Total assets     1,719,753,611       1,611,283,104     $ 224,418,939  
                         
LIABILITIES AND SHAREHOLDERS’ EQUITY                        
Current liabilities                        
Bank loans and other borrowings - current     193,736,563       182,741,935     $ 25,452,232  
Accounts payable     80,439,489       84,978,140       11,835,725  
Accrued expenses and other liabilities     377,536,644       388,071,992       54,050,530  
Operating lease liabilities - current     4,753,547       5,027,649       700,249  
Deferred government grants - current     2,295,701       2,295,701       319,744  
Total current liabilities     658,761,944       663,115,417       92,358,480  
                         
Non-current liabilities                        
Bank loans and other borrowings – non-current     293,790,596       361,965,073       50,414,367  
Operating lease liabilities - non-current     6,348,890       4,462,505       621,536  
Deferred government grants - non-current     23,606,507       22,458,657       3,128,034  
Warrants liability     8,792,389       2,185,122       304,343  
Total non-current liabilities     332,538,382       391,071,357       54,468,280  
Total liabilities     991,300,326       1,054,186,774       146,826,760  
                         
Shareholders’ equity                        
Ordinary shares, par value US$0.00002 per share; 9,950,000,000 shares authorized; 93,058,197 shares issued and outstanding;     12,297       12,297       1,713  
Additional paid-in capital     2,656,891,036       2,656,891,036       370,050,842  
Accumulated deficit     (1,874,037,965 )     (2,048,560,763 )     (285,322,817 )
Accumulated other comprehensive loss     (54,412,083 )     (51,246,240 )     (7,137,559 )
Total shareholders’ equity     728,453,285       557,096,330       77,592,179  
Total liabilities and shareholders’ equity     1,719,753,611       1,611,283,104     $ 224,418,939  

 

* Gives retroactive effect to reflect the reorganization in February 2021 and business combination in March 2023.

 

6


 

YS BIOPHARMA CO., LTD AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

    Six Months Ended September 30,  
    2022     2023     2023  
    (RMB)     (RMB)     (US$)  
Revenues     399,534,723       273,092,454     $ 38,036,220  
Cost of revenues     93,700,779       52,187,142       7,268,607  
Gross profit     305,833,944       220,905,312       30,767,613  
                         
Operating expenses:                        
Selling and marketing     150,228,079       157,700,204       21,964,429  
General and administrative     49,587,013       67,610,523       9,416,770  
Research and development     123,861,107       178,853,200       24,910,610  
Total operating expenses     323,676,199       404,163,927       56,291,809  
                         
Loss from operations     (17,842,255 )     (183,258,615 )     (25,524,196 )
                         
Other income (expenses):                        
Late fees for social security insurance     (299,417 )     (446,176 )     (62,143 )
Government grants     22,456,691       14,627,559       2,037,321  
Interest income     266,433       1,957,620       272,657  
Interest expense     (15,215,867 )     (14,926,098 )     (2,078,902 )
Fair value changes of warrant liability     -       6,851,308       954,248  
Other income (expense), net     74,675       (148,749 )     (20,718 )
Total other expense, net     7,282,515       7,915,464       1,102,463  
                         
Loss before income taxes     (10,559,740 )     (175,343,151 )     (24,421,733 )
                         
Income tax (expense) benefit     (565,625 )     820,353       114,258  
                         
Net loss     (11,125,365 )     (174,522,798 )     (24,307,475 )
Accretion to redemption value of convertible redeemable preferred shares     (72,083,238 )     -       -  
Net loss attributable to YS Group     (83,208,603 )     (174,522,798 )   $ (24,307,475 )
                         
Net loss     (11,125,365 )     (174,522,798 )   $ (24,307,475 )
Other comprehensive (loss) income: foreign currency translation adjustment     (168,653,952 )     3,165,843       440,937  
Total comprehensive loss     (179,779,317 )     (171,356,955 )   $ (23,866,538 )
                         
Loss per share*:                        
– Basic and Diluted     (0.18 )     (1.88 )   $ (0.26 )
Weighted average number of ordinary shares outstanding*:                        
– Basic and Diluted     61,785,466       93,058,197       93,058,197  

 

* Gives retroactive effect to reflect the reorganization in February 2021 and business combination in March 2023.

 

7


 

YS BIOPHARMA CO., LTD AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ (DEFICIT)/EQUITY

 

    Six Months Ended September 30,  
    Ordinary shares     Additional
 paid-in
    Accumulated     Accumulated
 other 
comprehensive
    Total
stockholders’
 
    Shares     Amount     capital     Deficit     loss     equity  
          (RMB)     (RMB)     (RMB)     (RMB)     (RMB)  
Balance as of March 31, 2023     93,058,197       12,297       2,656,891,036       (1,874,037,965 )     (54,412,083 )     728,453,285  
Net loss                             (174,522,798 )             (174,522,798 )
Foreign currency translation adjustment                                     3,165,843       3,165,843  
Balance as of September 30, 2023 (in RMB) (unaudited)     93,058,197       12,297       2,656,891,036       (2,048,560,763 )     (51,246,240 )     557,096,330  
Balance as of September 30, 2023 (In US$) (unaudited)     93,058,197       1,713       370,050,842       (285,322,817 )     (7,137,559 )     77,592,179  

 

    Six Months Ended September 30,  
    Ordinary shares*     Additional
 paid-in
    Accumulated     Accumulated
 other 
comprehensive
    Total
stockholders’
 
    Shares     Amount     capital     Deficit     income/(loss)     deficit  
          (RMB)     (RMB)     (RMB)     (RMB)     (RMB)  
Balance as of March 31, 2022     61,827,884       7,978       808,502,018       (1,590,567,163 )     83,087,979       (698,969,188 )
Accretion to redemption value of convertible redeemable preferred shares     -       -       -       (72,083,238 )     -       (72,083,238 )
Net loss     -       -       -       (11,125,365 )     -       (11,125,365 )
Share-based compensation     (143,750 )     -       (85,316 )     -       -       (85,316 )
Foreign currency translation adjustment     -       -       231,807       -       (168,653,952 )     (168,422,145 )
Balance as of September 30, 2022 (in RMB) (unaudited)     61,684,134       7,978       808,648,509       (1,673,775,766 )     (85,565,973 )     (950,685,252 )
Balance as of September 30, 2022 (In US$) (unaudited)     61,684,134       1,124       113,897,365       (235,749,706 )     (12,051,884 )     (133,903,101 )

 

* Gives retroactive effect to reflect the reorganization in February 2021 and business combination in March 2023.

 

 

8


 

YS BIOPHARMA CO., LTD AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

 

    Six Months Ended September 30,  
    2022     2023     2023  
    (RMB)     (RMB)     (US$)  
Cash flows from operating activities:                  
Net loss     (11,125,365 )     (174,522,798 )   $ (24,307,475 )
Adjustments to reconcile net loss to net cash used in operating activities:                        
Deferred income taxes     565,625       (820,353 )     (114,258 )
Depreciation of property, plant and equipment     13,818,386       16,514,915       2,300,192  
Amortization of intangible assets     3,409,643       3,418,436       476,119  
Loss on disposal of property, plant and equipment     64,179       -       -  
Share-based compensation     (85,316 )     -       -  
Bad debt provision of accounts receivable     6,447,109       5,341,696       743,990  
Write-down of inventories to net realizable value     -       10,678,694       1,487,325  
Non-cash lease expense     2,409,286       2,452,349       341,562  
Fair value changes of warrant liability     -       (6,851,308 )     (954,248 )
Changes in operating assets and liabilities:                        
Inventories     4,838,379       (38,118,113 )     (5,309,077 )
Accounts receivable     (166,251,393 )     28,341,162       3,947,347  
Prepaid expenses and other current assets     4,102,924       (22,438,580 )     (3,125,237 )
Accounts payable     6,583,078       4,538,651       632,142  
Accrued expenses and other liabilities     37,289,942       29,330,997       4,085,211  
Deferred government grants     (8,026,551 )     (1,147,850 )     (159,872 )
Operating lease liabilities     (1,435,079 )     (2,549,633 )     (355,112 )
Net cash used in operating activities     (107,395,153 )     (145,831,735 )     (20,311,391 )
                         
Cash flows from investing activities:                        
Proceeds from disposal of property, plant and equipment     -       155,191       21,615  
Purchases of property, plant and equipment     (15,017,753 )     (23,576,885 )     (3,283,780 )
Purchases of intangible assets     (4,006,598 )     -       -  
Net cash used in investing activities     (19,024,351 )     (23,421,694 )     (3,262,165 )
                         
Cash flows from financing activities:                        
Proceeds from bank loans and other borrowings     102,513,927       201,211,920       28,024,725  
Repayment of bank loans and other borrowings     (50,606,602 )     (156,356,071 )     (21,777,218 )
Net cash provided by financing activities     51,907,325       44,855,849       6,247,507  
                         
Effect of foreign exchange rate on cash     30,471,942       13,933,287       1,940,621  
Net decrease in cash     (44,040,237 )     (110,464,293 )     (15,385,428 )
Cash at the beginning of the period     271,067,503       370,369,825       51,584,978  
Cash at the end of the period     227,027,266       259,905,532     $ 36,199,550  
                         
Reconciliation of cash and restricted cash                        
Cash     226,765,500       259,905,532       36,199,550  
Restricted cash     261,766       -       -  
Total cash and restricted cash shown in the statements of cash flows     227,027,266       259,905,532       36,199,550  
Supplemental disclosures of cash flow information:                        
Interest paid     12,723,051       10,132,047     $ 1,411,188  
                         
Non-cash transactions:                        
Accretion to redemption value of convertible redeemable preferred shares     72,083,238       -     $ -  
Operating right-of-use assets recognized for related operating lease liabilities     -       811,094     $ 112,969  

 

 

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