Pipeline makes progress towards commercialization
as robust demand for YSJA rabies vaccine continues
Gross margin increases to 80.3%; balance sheet
remains strong
GAITHERSBURG, Md., Aug. 15,
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 unaudited
financial results for the first quarter of the fiscal year ended
March 31, 2024 (the "first quarter of
fiscal year 2024").
Dr. David Shao, Director,
President, and CEO of YS Biopharma, commented, "During the first
quarter of fiscal year 2024, our top-line came under pressure from
tight inventory levels of finished products available for sale,
caused by the lingering impacts of COVID-related disruptions at our
YSJA rabies vaccine manufacturing facilities. While these
disruptions occurred in late 2022 and early 2023, the long and
complex nature of the vaccine manufacturing process means that we
are experiencing the impact at present. In the first quarter, we
took several steps to enhance our operations and ensure future
stability, including boosting manufacturing productivity, building
out our sales network, and streamlining research and development
efforts. Demand for our YSJA rabies vaccine remains robust, and we
continue to bring our pipeline of promising product candidates,
including our next generation PIKA rabies vaccine, towards
commercialization. We are confident that we will overcome the
near-term difficulties we have faced, and we believe we are
well-positioned for sustainable, long-term success."
Ms. Brenda Wu, CFO of YS
Biopharma, added, "In the first quarter of fiscal year 2024, our
total revenues were RMB176.3 million,
as we continued to deal with the fallout of COVID-related
disruptions on our supply chains and manufacturing operations. Our
gross profit for the quarter was RMB141.6
million, and we recorded a solid gross profit margin of
80.3%. As of the end of the first quarter, our balance sheet
remains strong, and we plan to diligently monitor our expenses in
order to create a stable foundation for our long-term growth. We
are confident in our business model and excited for the
opportunities the future holds."
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
June 30, 2023, YS Biopharma had sold
more than 22.2 million doses of YSJA™ rabies
vaccines to approximately 1,725 CDC customers, which represents
over 60% of CDC customers in China.
Clinical Pipeline
YS Biopharma continues to advance its portfolio of innovative
product candidates under various clinical development stages,
including PIKA rabies vaccine, PIKA recombinant COVID-19 vaccine,
and PIKA YS-ON-001.
PIKA Rabies Vaccine
- As of June 1, 2023, the Company
had been granted approval by regulatory bodies in the Philippines, Singapore, and Pakistan to undertake Phase III clinical
trials of the vaccine. This multi-country Phase III study is a
registration trial and will evaluate the vaccine's ability to
induce an immune response and its safety profile.
- The Company intends to include a total of 4,500 participants in
the Phase III trial, with the recruitment process projected to
commence in the fourth quarter of 2023. The Company aims to obtain
interim results by early 2024.
PIKA Recombinant COVID-19 Vaccine
- In March 2023, the Company
reported positive interim safety and immunogenicity data for
the PIKA recombinant COVID-19 vaccine from Phase II of the Phase
II/III clinical studies which were completed in the Philippines and 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 the findings from the Phase III clinical
trials will be released before the end of 2023.
- The Company will continue to monitor the evolving global
situation surrounding COVID-19, and will utilize appropriate
commercialization strategies for the PIKA recombinant COVID-19
vaccine accordingly.
PIKA YS-ON-001
- PIKA YS-ON-001 is designed as an immunological therapeutical
agent against cancers. The Company has completed the enrollment of
cancer patients for the Phase I clinical trial of PIKA YS-ON-001 in
China. The Company expects the
Phase I clinical trial will be completed by December 31, 2023.
First Quarter of Fiscal Year 2024 Financial
Results
Total Revenues
Total revenues were RMB176.3
million (US$24.4 million) in
the first quarter of fiscal year 2024, compared to RMB205.5 million in the same period of fiscal
year 2023, representing a change of 14.2%. This was primarily due
to COVID-related disruptions affecting raw material supply chains,
manufacturing operations, and production output at the Company's
YSJA rabies vaccine production facilities, which negatively
impacted batch approvals and doses available for sale.
Gross Profit
Gross profit was RMB141.6 million
(US$19.6 million), representing an
80.3% gross margin, compared to RMB154.3
million, or a 75.1% gross margin, in the same period of
fiscal year 2023.
Selling and Marketing Expenses
Selling and marketing expenses in the first quarter of
fiscal year 2024 were RMB79.2 million
(US$11.0 million), compared to
RMB70.5 million in the same period of
fiscal year 2023. The increase in selling and marketing expenses
reflects the Company's ongoing long-term strategies to enhance
promotional and marketing services in order to expand and
strengthen its distribution network of district- and county-level
CDCs and hospitals. This targeted expansion aligns with the
Company's commitment to driving growth in key markets.
General and Administrative Expenses
General and administrative expenses in the first quarter of
fiscal year 2024 were RMB31.8 million
(US$4.4 million), compared to
RMB25.5 million in the same period of
2023. This change was primarily attributable to higher professional
service fees associated with the Company's status as a
publicly-listed entity.
Research and Development Expenses
Research and development expenses were RMB100.6 million (US$13.9
million) in the first quarter of fiscal year 2024, compared
to RMB70.3 million in the same period
of 2023. The change was primarily driven by an increase in
preclinical and clinical development costs associated with the
Company's rabies vaccine pipeline. This increase reflects the
Company's targeted allocation of resources to advance its promising
rabies vaccine candidates through various stages of development, in
line with the Company's commitment to innovation and addressing
unmet medical needs.
Net Loss
Net loss for the first quarter of fiscal year 2024 was
RMB69.5 million (US$9.6 million), compared with RMB19.6 million in the same period of 2023.
Balance Sheet
As of June 30, 2023, the Company
had cash and cash equivalents of RMB311.8
million (US$43.1 million),
compared with RMB370.4 million as of
March 31, 2023.
Corporate Update
As part of its strategy to unlock the commercial potential of
its vaccine franchise in underserved markets in Southeast Asia, the Company recently set up a
new subsidiary in the Philippines
to focus on clinical and regulatory efforts and product
commercialization.
Conference Call Information
The Company's management will hold an earnings conference call
on Tuesday, August 15, 2023 at
8:00 P.M. Eastern Time to discuss the
financial results. Listeners may access the call by dialing the
following numbers:
United States Toll Free:
1-888-346-8982
International:
1-412-902-4272
Mainland China Toll Free:
4001-201203
Canada Toll Free:
1-855-669-9657
Hong Kong:
852-301-84992
The replay will be accessible through August 22, 2023 by dialing the following
numbers:
United States Toll Free:
1-877-344-7529
International:
1-412-317-0088
Canada Toll Free:
855-669-9658
Access Code:
8167733
A live and archived webcast of the conference call will also be
available at the Company's investor relations website at
https://investor.ysbiopharm.com/.
About YS Biopharma
YS Biopharma is a global biopharmaceutical company
dedicated to discovering, developing, manufacturing, and delivering
new generations of vaccines and therapeutic biologics for
infectious diseases and cancer. It has developed a proprietary
PIKA® immunomodulating technology platform and a
new generation of preventive and therapeutic biologics targeting
Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other
virus infections. YS Biopharma operates
in China, the United States, Singapore, and the
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 RMB
7.2258 to US$1.00, the
exchange rate set forth in the central parity rate release of the
People's Bank of China on
June 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 YS Biopharma, the development progress of all product
candidates, the progress and results of all clinical trials, YS
Biopharma's ability to source and retain talent, and the cash
position of YS Biopharma following the closing of the Business
Combination. Forward-looking statements may be identified by the
use of words such as "estimate," "plan," "project," "forecast,"
"intend," "will," "expect," "anticipate," "believe," "seek,"
"target" or other similar expressions that predict or indicate
future events or trends or that are not statements of historical
matters. These statements are based on various assumptions, whether
identified in this press release, and on the current expectations
of YS Biopharma's management and are not predictions of actual
performance.
These statements involve risks, uncertainties and other factors
that may cause actual results, levels of activity, performance, or
achievements to be materially different from those expressed or
implied by these forward-looking statements. Although YS Biopharma
believes that it has a reasonable basis for each forward-looking
statement contained in this press release, YS Biopharma cautions
you that these statements are based on a combination of facts and
factors currently known and projections of the future, which are
inherently uncertain. In addition, there are risks and
uncertainties described in the final prospectus relating to the
proposed Business Combination, and other documents filed by YS
Biopharma from time to time with the SEC. These filings may
identify and address other important risks and uncertainties that
could cause actual events and results to differ materially from
those contained in the forward-looking statements.
YS Biopharma cannot assure you that the
forward-looking statements in this press release will prove to be
accurate. These forward-looking statements are subject to a number
of risks and uncertainties, including, among others, the ability to
recognize the anticipated benefits of the Business Combination,
costs related to the transaction, the impact of the global COVID-19
pandemic, the risk that the transaction disrupts current plans and
operations as a result of the consummation of the transaction, the
outcome of any potential litigation, government or regulatory
proceedings, the sales performance of the marketed vaccine product
and the clinical trial development results of the product
candidates of YS Biopharma, and other risks and uncertainties,
including those included under the heading "Risk Factors" in the
post-effective amendment No. 1 to Form F-1 filed with
the SEC on August 8, 2023 which became effective
on August 10, 2023, and other filings with the SEC. There
may be additional risks that YS Biopharma does not presently know
or that YS Biopharma currently believes are immaterial that could
also cause actual results to differ from those contained in the
forward-looking statements. In light of the significant
uncertainties in these forward-looking statements, nothing in this
press release should be regarded as a representation by any person
that the forward-looking statements set forth herein will be
achieved or that any of the contemplated results of such
forward-looking statements will be achieved. The forward-looking
statements in this press release represent the views of YS
Biopharma as of the date of this press release. Subsequent events
and developments may cause those views to change. However, while YS
Biopharma may update these forward-looking statements in the
future, there is no current intention to do so, except to the
extent required by applicable law. You should, therefore, not rely
on these forward-looking statements as representing the views of YS
Biopharma as of any date subsequent to the date of this press
release. Except as may be required by law, YS Biopharma does not
undertake any duty to update these forward-looking statements.
Investor Relations Contacts
Alyssa Li
Director of Investor Relations
Email: ir@yishengbio.com
Robin Yang
Partner, ICR, LLC
Tel: +1 (212) 537-4035
Email: YSBiopharma.IR@icrinc.com
YS Biopharma Co.,
Ltd.
|
UNAUDITED
CONSOLIDATED BALANCE SHEETS
|
(All amounts in
thousands, except for share and per share data)
|
|
|
|
|
|
|
|
|
|
As of March 31,
|
|
As of June 30,
|
|
|
2023
|
|
2023
|
|
2023
|
|
|
RMB
|
|
RMB
|
|
US$
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash
|
|
370,108
|
|
94,749
|
|
13,113
|
Restricted
cash
|
|
262
|
|
217,036
|
|
30,036
|
Accounts receivable,
net
|
|
463,052
|
|
495,907
|
|
68,630
|
Advance to suppliers,
net
|
|
6,763
|
|
9,942
|
|
1,376
|
Inventories,
net
|
|
185,381
|
|
182,370
|
|
25,239
|
Prepaid expenses and
other current
assets
|
|
10,413
|
|
6,171
|
|
854
|
Total current
assets
|
|
1,035,979
|
|
1,006,175
|
|
139,248
|
|
|
|
|
|
|
|
Non-current
assets
|
|
|
|
|
|
|
Property, plant and
equipment, net
|
|
571,756
|
|
566,872
|
|
78,451
|
Operating lease
right-of-use assets, net
|
|
11,132
|
|
10,934
|
|
1,513
|
Deferred tax assets,
net
|
|
1,906
|
|
2,491
|
|
345
|
Intangible assets,
net
|
|
78,057
|
|
76,335
|
|
10,564
|
Other assets,
non-current
|
|
20,924
|
|
27,069
|
|
3,746
|
Total non-current
assets
|
|
683,775
|
|
683,701
|
|
94,619
|
|
|
|
|
|
|
|
Total
assets
|
|
1,719,754
|
|
1,689,876
|
|
233,867
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS'
(DEFICIT)/EQUITY
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Bank loans and other
borrowings –
current
|
|
193,737
|
|
171,608
|
|
23,749
|
Accounts
payable
|
|
80,439
|
|
73,868
|
|
10,223
|
Accrued expenses and
other liabilities
|
|
377,537
|
|
398,930
|
|
55,209
|
Operating lease
liabilities - current
|
|
4,754
|
|
5,035
|
|
697
|
Deferred government
grants - current
|
|
2,296
|
|
2,296
|
|
318
|
Total current
liabilities
|
|
658,763
|
|
651,737
|
|
90,196
|
|
|
|
|
|
|
|
Non-current
liabilities
|
|
|
|
|
|
|
Bank loans and other
borrowings – non-
current
|
|
293,791
|
|
343,286
|
|
47,508
|
Operating lease
liabilities - non-current
|
|
6,349
|
|
6,683
|
|
925
|
Deferred government
grants - non-
current
|
|
23,607
|
|
25,033
|
|
3,464
|
Warrants
liability
|
|
8,792
|
|
2,384
|
|
330
|
Total non-current
liabilities
|
|
332,539
|
|
377,386
|
|
52,227
|
|
|
|
|
|
|
|
Total
liabilities
|
|
991,302
|
|
1,029,123
|
|
142,423
|
|
|
|
|
|
|
|
Shareholders'(deficit)/equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary shares, par
value US$0.00002 per share;
9,950,000,000 shares authorized; 93,058,197
shares issued and outstanding as of March 31,
2023 and June 30,2023, respectively
|
|
12
|
|
12
|
|
2
|
Additional paid-in
capital
|
|
2,656,891
|
|
2,656,891
|
|
367,695
|
Accumulated
deficit
|
|
(1,874,039)
|
|
(1,943,579)
|
|
(268,978)
|
Accumulated other
comprehensive loss
|
|
(54,412)
|
|
(52,571)
|
|
(7,275)
|
Total shareholders'
equity
|
|
728,452
|
|
660,753
|
|
91,444
|
|
|
|
|
|
|
|
Total liabilities
and shareholders' equity
|
|
1,719,754
|
|
1,689,876
|
|
233,867
|
YS Biopharma Co.,
Ltd.
|
UNAUDITED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
|
(All amounts in
thousands, except for share and per share data)
|
|
|
|
|
|
|
|
|
For the three months
ended June 30,
|
|
|
2022
|
|
2023
|
|
2023
|
|
|
RMB
|
|
RMB
|
|
US$
|
|
|
|
|
|
|
|
Revenues
|
|
205,476
|
|
176,274
|
|
24,395
|
Cost of
revenues
|
|
51,134
|
|
34,680
|
|
4,799
|
Gross
profit
|
|
154,342
|
|
141,594
|
|
19,596
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Selling and
marketing
|
|
70,493
|
|
79,195
|
|
10,960
|
General and
administrative
|
|
25,509
|
|
31,813
|
|
4,403
|
Research and
development
|
|
70,288
|
|
100,640
|
|
13,928
|
Total operating
expenses
|
|
166,290
|
|
211,648
|
|
29,291
|
|
|
|
|
|
|
|
Loss from
operations
|
|
(11,948)
|
|
(70,054)
|
|
(9,695)
|
|
|
|
|
|
|
|
Other income
(expenses):
|
|
|
|
|
|
|
Late fees related to
social security insurance
|
|
(228)
|
|
(154)
|
|
(21)
|
Government
grants
|
|
210
|
|
1,474
|
|
204
|
Financial expenses,
net
|
|
(7,375)
|
|
(8,028)
|
|
(1,111)
|
Fair value changes of
warrant liability
|
|
-
|
|
6,693
|
|
926
|
Other income
(expense), net
|
|
360
|
|
(59)
|
|
(8)
|
Total other income
(expense), net
|
|
(7,033)
|
|
(74)
|
|
(10)
|
|
|
|
|
|
|
|
Loss before income
taxes
|
|
(18,981)
|
|
(70,128)
|
|
(9,705)
|
Income tax
expense
|
|
(612)
|
|
586
|
|
81
|
|
|
|
|
|
|
|
Net
loss
|
|
(19,593)
|
|
(69,542)
|
|
(9,624)
|
Accretion to
redemption value of
convertible redeemable
preferred shares
|
|
(34,473)
|
|
-
|
|
-
|
|
|
|
|
|
|
|
Net loss
attributable to YS Group
|
|
(54,066)
|
|
(69,542)
|
|
(9,624)
|
|
|
|
|
|
|
|
Net
loss
|
|
(19,593)
|
|
(69,542)
|
|
(9,624)
|
Other comprehensive
income (loss): foreign
currency translation
adjustment
|
|
(79,358)
|
|
1,841
|
|
255
|
Total comprehensive
loss
|
|
(98,951)
|
|
(67,701)
|
|
(9,369)
|
|
|
|
|
|
|
|
Loss per
share:
|
|
|
|
|
|
|
– Basic and
Diluted
|
|
(0.32)
|
|
(0.75)
|
|
(0.10)
|
Weighted average
number of ordinary shares
outstanding:
|
|
|
|
|
|
|
– Basic and
Diluted
|
|
61,827,883
|
|
93,058,197
|
|
93,058,197
|
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SOURCE YS Biopharma Co., Ltd.