Full Press Release Details
LakeShore Biopharma Reports Unaudited Financial
Results for the First Half of Fiscal Year 2025 and Updates Full-Year Guidance
LakeShore Biopharma Co., Ltd. (Nasdaq:
LSB) ("LakeShore" 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 first six months ended September 30, 2024 ("FY2025H1").
"We are thrilled with the outstanding
financial performance achieved in the first half of FY2025 under the leadership of our new management team," said Xu Wang, Chief
Executive Officer. "Despite the challenging macroeconomic conditions in China, heightened competition, and the disruptive attempts
against our company by former Chairman Yi Zhang, we have made a historical leap by achieving a net income of RMB 20.6 million - the first
time we recorded net income since 2013. Moreover, we believe our revenue growth in the first half of FY2025 far outpaced most vaccine
companies in China during the same period."
Mr. Wang continued, "Our financial
turnaround is a testament to our successful strategies to enhance operational efficiency and profitability, coupled with our effective
execution on cost reduction, organizational restructuring, internal control improvement, optimized resource allocation, and enhanced cash
flow management. Looking ahead, we remain committed to our corporate strategy, which aims to maximize value from our existing product
portfolio and drive new business development, positioning us for a robust financial performance in FY2025 and beyond, thereby safeguarding
and enhancing value for our shareholders."
YSJA Rabies Vaccine Phase III Clinical
Trial Approval for Simplified Regimen
On October 25, 2024, the Company received
approval from the National Medical Products Administration (NMPA) in China to conduct a phase III clinical trial evaluating the immunogenicity
and safety of a simplified four-dose regimen for its YSJA rabies vaccine. The trial, scheduled to commence in late December 2024, will
enroll 2,380 participants and compare the immunogenicity and safety of the YSJA rabies vaccine across two distinct four-dose immunization
schedules against the existing Essen regimen (1-1-1-1-1). This randomized, double-blind, controlled study is expected to conclude by the
third quarter of 2025.
The study aims to strengthen the competitiveness
of the YSJA rabies vaccine in the rapidly growing rabies vaccine market, demonstrate its clinical superiority, and garner broader recognition
and support from hospitals, academic institutions, and industry stakeholders in China and globally.
First Half of Fiscal Year 2025
Total revenues reached RMB 371.9 million,
compared to RMB 273.1 million in the same period of FY2024, representing a year-over-year growth of 36.2%. This increase was primarily
driven by higher sales volume, attributable to increased batch approvals and doses available for sale, as well as the targeted and effective
marketing initiatives.
Gross profit was RMB 307.3 million,
with a gross margin of 82.6%, compared to RMB 220.9 million and an 80.9% gross margin in the same period of FY2024. The improvement in
gross margin was primarily driven by a reduction in unit production cost.
Selling and Marketing Expenses
Selling and marketing expenses totaled
RMB 137.1 million, compared to RMB 157.7 million in the same period of FY2024, reflecting a 13.1% decrease. This reduction was attributed
to cost reduction initiatives during the first half of FY2025.
General and Administrative Expenses
General and administrative expenses
were RMB 70.8 million, up from RMB 67.6 million in the same period of FY2024. The increase was mainly driven by costs associated with
workforce reduction.
Research and Development Expenses
Research and development expenses were
RMB 68.5 million, compared to RMB 178.9 million in the same period of FY2024, representing a 61.7% decrease. This decline was primarily
driven by reductions in testing fees, clinical trial fees, and consulting service fees following the conclusion of the Covid-19 vaccine
EBITDA and Adjusted EBITDA
EBITDA2 (Non-GAAP) and Adjusted EBITDA3
(Non-GAAP) was RMB 53.8 million and RMB 57.9 million, compared to negative EBITDA of RMB 138.6 million and negative
adjusted EBITDA of RMB 159.5 million (Non-GAAP) respectively, in the same period of FY2024.
Operating income was RMB 30.9 million,
compared to an operating loss of RMB 183.3 million in the same period of FY2024.
Net Income and Adjusted Net Income
Net income was RMB 20.6 million, and adjusted net
income (Non-GAAP) was RMB 30.4 million, in contrast to net loss of RMB 174.5 million and adjusted net loss (Non-GAAP) of RMB 174.5 million,
respectively, in the same period of FY2024.
As of September 30, 2024, the Company
had cash and cash equivalents of RMB 112.5 million, compared to RMB 246.6 million as of March 31, 2024.
FY2025 Guidance Update
For the full FY2025, the Company expects
total revenues to be between RMB 665 million and RMB 700 million, indicating a growth of 16% to 22% year-over-year. The Company also projects
Adjusted EBITDA to range between RMB 76 million and RMB 89 million. These projections reflect the Company's positive outlook for
the current fiscal year, which would establish significant foundation for fiscal year 2026.
The above outlook is based on information
available as of the date of this press release and reflects the Company's current and preliminary views regarding its business situation
and market conditions, which are subject to change.
About LakeShore Biopharma
LakeShore Biopharma, previously known as 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 immunemodulating technology platform
and a new generation of preventive and therapeutic biologics targeting Rabies, Coronavirus, Hepatitis B, Influenza, Shingles, and other
virus infections. The Company 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.lakeshorebio.com.
| 2 | EBITDA is a non-GAAP financial measure, which is defined as net income (loss) before income tax expense (benefit), financial expenses - net and depreciation and amortization. See "Use of Non-GAAP Financial Measures" below. | |
| 3 | Adjusted EBITDA is a non-GAAP financial measure, which is defined as net income/(loss) before income tax expense (benefit), financial expenses - net, and depreciation and amortization ("EBITDA") adjusted to exclude share-based compensation expenses, late fees related to social security insurance, other income (expense) - net, fair value changes of warrant liability, and government grants. See "Use of Non-GAAP Financial Measures" below. |
Use of Non-GAAP Financial Measures
In evaluating the business, the Company
considers and uses certain non-GAAP measures, including Adjusted EBITDA and adjusted net income (loss), as supplemental measures to
review and assess its operating performance. The presentation of the non-GAAP financial measure is not intended to be considered in
isolation or as a substitute for the financial information prepared and presented in accordance with U.S. GAAP. The Company defines
EBITDA as net income (loss) before income tax expense (benefit), financial expenses - net and depreciation and amortization. The
Company defines Adjusted EBITDA as net income (loss) before income tax expense (benefit), financial expenses - net, and depreciation
and amortization ("EBITDA") adjusted to exclude share-based compensation expenses, late fees related to social security
insurance, other income (expense) - net, fair value changes of warrant liability, and government grants. The Company defines
adjusted net income (loss) as net income (loss) excluding share-based compensation expenses and loss on disposal of property, plant
and equipment. The Company presents the non-GAAP financial measures because they are used by the management to evaluate the
operating performance and formulate business plans. The Company also believes that the use of the non-GAAP measures facilitates
investors' assessment of its operating performance as this measure excludes certain finance or non-cash items that the Company
does not believe directly reflect its core operations. The Company believes that excluding these items enables us to evaluate our
performance period-over-period more effectively and relative to our competitors.
The non-GAAP financial measures are not
defined under U.S. GAAP and are not presented in accordance with U.S. GAAP. The non-GAAP financial measures have limitations as
analytical tools. One of the key limitations of using Adjusted EBITDA is that it does not reflect all items of income and expenses
that affect the Company's operations. Share-based compensation and loss on disposal of property, plant and equipment have been
and may continue to be incurred in the business. Further, the non-GAAP measures may differ from the non-GAAP information used by
other companies, including peer companies, and therefore their comparability may be limited.
The Company compensates for these limitations
by reconciling the non-GAAP financial measure to the nearest U.S. GAAP performance measure, all of which should be considered when evaluating