Total revenues increase by 36.3% year-over-year;
gross margin improves to 77.7%; balance sheet remains robust
Company's PIKA rabies vaccine approved for Phase
III clinical trials in Singapore,
the Philippines, and Pakistan; interim results expected early next
year
GAITHERSBURG, Md., July 26,
2023 /PRNewswire/ -- YS Biopharma Co., Ltd. (NASDAQ:
YS) ("YS Biopharma" 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 financial
results for the fiscal year ended March 31,
2023 ("Fiscal Year 2023").
Dr. David Shao, Director,
President, and CEO of YS Biopharma, commented, "We are delighted to
announce our first annual results as a Nasdaq-listed company with
significant year-over-year revenue growth, a stable gross margin,
and a strengthened balance sheet. At the same time, we laid the
foundations for our future development as we advanced our
diversified portfolio of innovative product candidates, bringing
them closer to commercialization. Driven by strong demand for our
YSJA rabies vaccine and our strategic execution of sales and
marketing initiatives, we ended fiscal year 2023 standing as one of
the leading human rabies vaccine manufacturers, and we expanded our
market reach to over 60% of CDC customers in China. Meanwhile, we made notable progress in
advancing our rabies vaccine franchise when we received approval to
conduct Phase III clinical trials of our premium, next-generation
PIKA rabies vaccine from regulatory authorities in the Philippines, Singapore, and Pakistan. Looking ahead, we will strategically
unlock the potential of our marketed product and our pipeline
candidates by exploring commercial partnerships, expanding our
infrastructure, entering new markets, and leveraging our deep
experience in vaccine manufacturing, sales, and distribution. With
our first-generation rabies vaccine generating organic cash flows
and our robust product portfolio advancing to the next phase, we
are well-positioned to continue developing transformative vaccines
and therapeutic biologics while creating long-term shareholder
value."
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 as of March 31, 2023, YS Biopharma had sold more than
19.9 million doses of YSJATM rabies vaccines to
approximately 1,687 county-level CDCs in China.
Clinical Pipeline
YS Biopharma is advancing a robust 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
- The Company has completed Phase I and Phase II clinical
trials of its PIKA rabies vaccine in Singapore, and has completed a Phase I
clinical trial in China. As of
June 1, 2023, the Company had
received regulatory approval to conduct Phase III clinical trials
of the vaccine from authorities in the
Philippines, Singapore, and
Pakistan. This multi-country Phase
III study will evaluate lot-to-lot consistency of three lots of the
PIKA rabies vaccine, along with the vaccine's immunogenicity and
safety.
- The Company plans to enroll a total of 4,500 subjects into the
Phase III study, with enrollment expected to begin in the fourth
quarter of 2023. The Company targets to obtain interim results in
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 the UAE. These results
demonstrated the safety profile of the Company's PIKA adjuvant
technology among approximately 6000 subjects in the Phase II/III
trial. The results of the Phase III clinical trials are expected to
be available before the end of 2023.
- As the global situation regarding COVID-19 continues to evolve,
the Company will continue to monitor worldwide health trends and
make appropriate decisions regarding commercialization strategies
for the PIKA recombinant COVID-19 vaccine.
PIKA YS-ON-001
- YS Biopharma is currently enrolling cancer patients for the
Phase I clinical study of PIKA YS-ON-001 in China. The Company expects this Phase I
clinical study to be completed by December
31, 2023.
Fiscal Year 2023 Financial Results
Total Revenues
Total revenues increased by 36.6% to RMB687.2 million (US$100.0
million) in Fiscal Year 2023 from RMB502.9 million in the same period of 2022. The
increase was primarily due to increases in the sales volume and
product unit price of the Company's YSJATM rabies
vaccine.
Gross Profit
Gross profit was RMB533.8
million (US$77.7 million),
representing a 77.7% gross margin, compared to RMB385.9 million, or a 76.7% gross margin, in the
same period of 2022.
Selling Expenses
Selling expenses in Fiscal Year 2023 were RMB272.9 million (US$39.7
million), compared to RMB186.0
million in the same period of 2022. The change in selling
expenses was primarily attributable to an increase in promotional
and marketing services fees to expand the Company's access to
district and county CDCs and hospitals.
General and Administrative Expenses
General and administrative expenses decreased to RMB81.6 million (US$11.9
million) in Fiscal Year 2023, compared to RMB107.6 million in the same period of 2022. The
decrease was mainly due to the reduction in professional service
fees paid by the Company.
Research and Development Expenses
Research and development expenses were RMB318.7 million (US$46.4
million) in Fiscal Year 2023, compared to RMB211.2 million in the same period of 2022. The
increase was primarily driven by an increase in preclinical and
clinical development costs associated with the Company's COVID- 19
and rabies vaccines.
Net Loss
Net loss for Fiscal Year 2023 was RMB145.5 million (US$21.2
million), compared with RMB106.0
million in the same period of 2022.
Balance Sheet
As of March 31, 2023, the Company
had cash and cash equivalents of RMB370.4
million (US$53.9 million),
compared with RMB271.1 million as of
March 31, 2022.
Corporate Update
On March 16, 2023, the Company
announced that it had completed the business combination with
Summit Healthcare Acquisition Corp. and became a publicly listed
company trading on the Nasdaq Capital Market, obtaining
approximately RMB252.5 million
(US$36.7 million) in gross proceeds.
The transaction resulted in approximately 93,058,197 ordinary
shares issued and outstanding as of March
31, 2023.
Conference Call Information
The Company's management will hold an earnings conference call
on Wednesday, July 26, 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:
18556699657
Hong Kong:
852-301-84992
The replay will be accessible through August 2, 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:
8524425
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
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 RMB6.8676 to US$1.00, the exchange rate set forth in the H.10
statistical release of the Federal Reserve Board on March 31, 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 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
final prospectus filed with the SEC on February 8,
2023, as supplemented on February 21, 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. AND SUBSIDIARIES
|
CONSOLIDATED BALANCE
SHEETS
|
|
|
|
As of March
31,
|
|
|
|
2022
|
|
|
2023
|
|
|
2023
|
|
|
|
(RMB)
|
|
|
(RMB)
|
|
|
(US$)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
|
Cash
|
|
|
271,067,503
|
|
|
|
370,108,059
|
|
|
|
53,859,752
|
|
Restricted
cash
|
|
|
-
|
|
|
|
261,766
|
|
|
|
38,093
|
|
Accounts receivable,
net
|
|
|
308,555,105
|
|
|
|
463,051,792
|
|
|
|
67,385,333
|
|
Advance to suppliers,
net
|
|
|
10,648,306
|
|
|
|
6,763,326
|
|
|
|
984,229
|
|
Inventories,
net
|
|
|
166,505,565
|
|
|
|
185,380,952
|
|
|
|
26,977,451
|
|
Prepaid expenses and
other current assets
|
|
|
7,987,914
|
|
|
|
10,412,769
|
|
|
|
1,515,312
|
|
Total current
assets
|
|
|
764,764,393
|
|
|
|
1,035,978,664
|
|
|
|
150,760,170
|
|
Non-current
assets
|
|
|
|
|
|
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
|
550,153,110
|
|
|
|
571,756,443
|
|
|
|
83,204,512
|
|
Operating lease
right-of-use assets, net
|
|
|
14,850,283
|
|
|
|
11,132,428
|
|
|
|
1,620,040
|
|
Deferred tax assets,
net
|
|
|
3,039,084
|
|
|
|
1,905,581
|
|
|
|
277,309
|
|
Intangible assets,
net
|
|
|
80,717,978
|
|
|
|
78,056,792
|
|
|
|
11,359,168
|
|
Other assets,
non-current
|
|
|
28,228,293
|
|
|
|
20,923,703
|
|
|
|
3,044,909
|
|
Total non-current
assets
|
|
|
676,988,748
|
|
|
|
683,774,947
|
|
|
|
99,505,938
|
|
Total
assets
|
|
|
1,441,753,141
|
|
|
|
1,719,753,611
|
|
|
|
250,266,108
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES,
MEZZANINE EQUITY AND SHAREHOLDERS'
(DEFICIT)/EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Bank loans and other
borrowings - current
|
|
|
111,733,754
|
|
|
|
193,736,563
|
|
|
|
28,193,397
|
|
Accounts
payable
|
|
|
30,811,100
|
|
|
|
80,439,489
|
|
|
|
11,705,908
|
|
Accrued expenses and
other liabilities
|
|
|
326,751,353
|
|
|
|
377,536,644
|
|
|
|
54,940,793
|
|
Operating lease
liabilities - current
|
|
|
4,322,252
|
|
|
|
4,753,547
|
|
|
|
691,757
|
|
Deferred government
grants - current
|
|
|
2,295,701
|
|
|
|
2,295,701
|
|
|
|
334,081
|
|
Total current
liabilities
|
|
|
475,914,160
|
|
|
|
658,761,944
|
|
|
|
95,865,936
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Bank loans and other
borrowings – non-current
|
|
|
253,928,000
|
|
|
|
293,790,596
|
|
|
|
42,753,699
|
|
Operating lease
liabilities - non-current
|
|
|
10,605,260
|
|
|
|
6,348,890
|
|
|
|
923,918
|
|
Deferred government
grants - non-current
|
|
|
30,053,517
|
|
|
|
23,606,507
|
|
|
|
3,435,323
|
|
Warrants
liability
|
|
|
-
|
|
|
|
8,792,389
|
|
|
|
1,279,507
|
|
Total non-current
liabilities
|
|
|
294,586,777
|
|
|
|
332,538,382
|
|
|
|
48,392,447
|
|
Total
liabilities
|
|
|
770,500,937
|
|
|
|
991,300,326
|
|
|
|
144,258,383
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mezzanine
equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A and Series
A-1 redeemable convertible preferred
shares (par value US$0.000005 per share, 50,000,000 shares
authorized; 21,548,589 shares issued and outstanding)
|
|
|
458,074,468
|
|
|
|
-
|
|
|
|
-
|
|
Series B redeemable
convertible preferred shares (par value
US$0.000005 per share, 100,000,000 shares authorized;
65,414,858 shares issued and outstanding)
|
|
|
912,146,924
|
|
|
|
-
|
|
|
|
-
|
|
Total mezzanine
equity
|
|
|
1,370,221,392
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'(deficit)/equity
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, par
value US$0.00002 per share;
9,950,000,000 shares authorized; 61,827,883 and 93,058,197
shares issued and outstanding as of March 31, 2022 and 2023,
respectively; *
|
|
|
7,978
|
|
|
|
12,297
|
|
|
|
1,790
|
|
Additional paid-in
capital
|
|
|
808,502,018
|
|
|
|
2,656,891,036
|
|
|
|
386,642,466
|
|
Accumulated
deficit
|
|
|
(1,590,567,163)
|
|
|
|
(1,874,037,965)
|
|
|
|
(272,718,245)
|
|
Accumulated other
comprehensive income/(loss)
|
|
|
83,087,979
|
|
|
|
(54,412,083)
|
|
|
|
(7,918,286)
|
|
Total shareholders'
(deficit)/equity
|
|
|
(698,969,188)
|
|
|
|
728,453,285
|
|
|
|
106,007,725
|
|
Total liabilities,
mezzanine equity and shareholders' (deficit)/equity
|
|
|
1,441,753,141
|
|
|
|
1,719,753,611
|
|
|
|
250,266,108
|
|
*
|
Gives retroactive
effect to reflect the reorganization in February 2021 and business
combination in March 2023.
|
YS BIOPHARMA CO.,
LTD. AND SUBSIDIARIES
|
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
|
|
|
Years Ended March
31,
|
|
|
|
2021
|
|
|
2022
|
|
|
2023
|
|
|
2023
|
|
|
|
(RMB)
|
|
|
(RMB)
|
|
|
(RMB)
|
|
|
(US$)
|
|
Revenues
|
|
|
257,015,929
|
|
|
|
502,949,894
|
|
|
|
687,201,070
|
|
|
|
100,004,521
|
|
Cost of
revenues
|
|
|
59,656,877
|
|
|
|
117,066,090
|
|
|
|
153,360,262
|
|
|
|
22,317,660
|
|
Gross
profit
|
|
|
197,359,052
|
|
|
|
385,883,804
|
|
|
|
533,840,808
|
|
|
|
77,686,861
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling and
marketing
|
|
|
73,485,259
|
|
|
|
185,999,704
|
|
|
|
272,927,356
|
|
|
|
39,717,589
|
|
General and
administrative
|
|
|
155,334,386
|
|
|
|
107,620,500
|
|
|
|
81,595,277
|
|
|
|
11,874,103
|
|
Research and
development
|
|
|
94,387,144
|
|
|
|
211,222,263
|
|
|
|
318,700,526
|
|
|
|
46,378,702
|
|
Total operating
expenses
|
|
|
323,206,789
|
|
|
|
504,842,467
|
|
|
|
673,223,159
|
|
|
|
97,970,394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations
|
|
|
(125,847,737)
|
|
|
|
(118,958,663)
|
|
|
|
(139,382,351)
|
|
|
|
(20,283,533)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expenses):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Late fees related to
income tax
|
|
|
(11,464,741)
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
Late fees related to
taxes other than income tax
|
|
|
(7,261,947)
|
|
|
|
(231,231)
|
|
|
|
(3,603)
|
|
|
|
(524)
|
|
Late fees related to
social security insurance
|
|
|
(7,701,793)
|
|
|
|
(1,852,378)
|
|
|
|
(747,609)
|
|
|
|
(108,795)
|
|
Government
grants
|
|
|
3,530,405
|
|
|
|
23,020,413
|
|
|
|
26,072,517
|
|
|
|
3,794,187
|
|
Financial expenses,
net
|
|
|
(29,689,927)
|
|
|
|
(2,717,433)
|
|
|
|
(30,857,673)
|
|
|
|
(4,490,544)
|
|
Fair value changes of
warrant liability
|
|
|
-
|
|
|
|
-
|
|
|
|
21,358
|
|
|
|
3,108
|
|
Other income
(expense), net
|
|
|
4,063,743
|
|
|
|
(327,987)
|
|
|
|
551,760
|
|
|
|
80,295
|
|
Total other
(expense) income, net
|
|
|
(48,524,260)
|
|
|
|
17,891,384
|
|
|
|
(4,963,250)
|
|
|
|
(722,273)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
|
(174,371,997)
|
|
|
|
(101,067,279)
|
|
|
|
(144,345,601)
|
|
|
|
(21,005,806)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
|
(17,454,245)
|
|
|
|
(4,937,122)
|
|
|
|
(1,133,504)
|
|
|
|
(164,952)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(191,826,242)
|
|
|
|
(106,004,401)
|
|
|
|
(145,479,105)
|
|
|
|
(21,170,758)
|
|
Accretion to
redemption value of convertible redeemable
preferred shares
|
|
|
(16,610,297)
|
|
|
|
(130,662,326)
|
|
|
|
(137,991,697)
|
|
|
|
(20,081,159)
|
|
Net loss
attributable to YS Group
|
|
|
(208,436,539)
|
|
|
|
(236,666,727)
|
|
|
|
(283,470,802)
|
|
|
|
(41,251,917)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss
|
|
|
(191,826,242)
|
|
|
|
(106,004,401)
|
|
|
|
(145,479,105)
|
|
|
$
|
(21,170,758)
|
|
Other comprehensive
income (loss): foreign currency
translation adjustment
|
|
|
22,455,217
|
|
|
|
38,864,606
|
|
|
|
(137,500,062)
|
|
|
|
(20,009,614)
|
|
Total comprehensive
loss
|
|
|
(169,371,025)
|
|
|
|
(67,139,795)
|
|
|
|
(282,979,167)
|
|
|
|
(41,180,372)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per
share*:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
– Basic and
Diluted
|
|
|
(3.10)
|
|
|
|
(1.71)
|
|
|
|
(1.56)
|
|
|
|
(0.23)
|
|
Weighted average
number of ordinary shares
outstanding*:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
– Basic and
Diluted
|
|
|
61,827,883
|
|
|
|
61,827,883
|
|
|
|
93,058,197
|
|
|
|
93,058,197
|
|
|
*
|
Gives retroactive
effect to reflect the reorganization in February 2021 and business
combination in March 2023.
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/ys-biopharma-announces-financial-results-for-fiscal-year-2023-ended-march-31-2023-301886610.html
SOURCE YS Biopharma Co., Ltd.