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

January 22, 2024 | Last Trade: US$2.16 0.42 -16.28

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: This email address is being protected from spambots. You need JavaScript enabled to view it.

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

 

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