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

GAITHERSBURG, Md., Jan. 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.”

Business Updates

YSJA™ Rabies Vaccine

YS Biopharma’s marketed vaccine product, YSJA 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 YSJA 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.

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 increases 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.

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.

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: [email protected]

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.

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.

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.

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


SOURCE YS Biopharma Co., Ltd.


Go to Source