Full Press Release Details
Gross margin increased to 79.5%; product pipeline continues to advance
Company anticipates double-digit year-over-year revenue growth and bottom line breakeven for Fiscal Year 2025
GAITHERSBURG, Md.,Aug. 15, 2024/PRNewswire/ -- LakeShore Biopharma Co., Ltd. (Nasdaq: LSB) ("LakeShore 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 endedMarch 31, 2024("Fiscal Year 2024").
Mr.Dave Chenn, Chairman and Interim Chief Executive Officer of the Company, commented, "In Fiscal Year 2024, our revenue was affected by a shortage of finished product inventory, resulting from earlier supply chain disruptions at our YSJA rabies vaccine production facilities. Despite these difficulties, we have successfully implemented operational improvements that have normalized production, and our inventory challenges are now resolved as we enter Fiscal Year 2025. We have maintained our position as a leading rabies vaccine producer inChina, and continued to improve our gross margin by emphasizing operational efficiency. We also made significant advancements in our product pipeline during Fiscal Year 2024, progressing our next-generation PIKA rabies vaccine through its ongoing Phase III clinical trial and meeting significant developmental milestones for other pipeline products."
Mr.Dave Chenncontinued, "Looking ahead, our Fiscal Year 2025 strategy will focus on driving revenue growth, controlling expenses, and enhancing profit margins. We are implementing a comprehensive plan that includes cost reductions, organizational restructuring, strengthened internal controls, and strategic resource allocation to key growth areas. Our goal will be to foster innovation, efficiency, stability, and sustainable profitability as we work to build value for our shareholders."
Ms.Rachel Yu, Interim Chief Financial Officer of the Company, added, "For Fiscal Year 2024, we recorded revenues ofRMB573.4 million(US$80.8 million), representing a decrease compared to Fiscal Year 2023 due to persistent supply chain issues affecting raw material availability, manufacturing processes, and overall output capacity which impacted our topline. We recorded a gross profit ofRMB455.7 million(US$64.2 million), and our gross margin increased by 1.8 percentage points to 79.5% compared to Fiscal Year 2023. With cash and cash equivalents ofRMB246.6 million(US$34.7 million), we will maintain our focus on maximizing long-term shareholder returns by refining our business strategies and leveraging new market opportunities. Looking ahead to Fiscal Year 2025, we anticipate double-digit year-over-year growth in revenues, and expect to achieve breakeven on our bottom line by the time our fiscal year concludes onMarch 31, 2025."
Business Updates
YSJATMRabies Vaccine
LakeShore Biopharma's marketed vaccine product, YSJATMrabies vaccine, is the first aluminum-free lyophilized rabies vaccine launched inChina. Since the Company commenced production at its current GMP-compliant facilities inFebruary 2020, and commercialization of the product in late 2020, market intake of the Company's YSJA rabies vaccine has been consistent and strong. As ofMarch 31, 2024, LakeShore Biopharma maintained its leadership position as one of the top rabies vaccine producers inChinaand has sold more than 27.3 million doses of YSJATMrabies vaccines to approximately 1,767 Chinese Center(s) for Disease Control and Prevention ("CDC") customers, which represents 61.3% of CDC customers inChinasinceOctober 2020.
Clinical Pipeline
LakeShore Biopharma continues to prioritize and advance its portfolio of innovative product candidates under various clinical development stages, including PIKA rabies vaccine, PIKA YS-ON-001, and PIKA YS-HBV-002.
PIKA Rabies Vaccine
PIKA YS-ON-001
PIKA YS-HBV-002
Fiscal Year 2024Financial Results
Total Revenue
Total revenue wasRMB573.4 million(US$80.8 million) in Fiscal Year 2024, compared toRMB687.2 millionin the same period of 2023, representing a decrease of 16.6%. 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. This impact was partially offset by an increase in the product price of the YSJA rabies vaccine of approximatelyRMB2.9per dose.
Gross Profit
Gross profit in Fiscal Year 2024 wasRMB455.7 million (US$64.2 million), representing a 79.5% gross margin, compared toRMB533.8 million, or a 77.7% gross margin, in the same period of 2023. The improvement in gross margin was primarily due to the increase in unit price of the YSJA rabies vaccine, and a decrease in unit cost resulting from lowered delivery costs and an increase in production batches.
Selling andMarketing Expenses
Selling and marketing expenses in Fiscal Year 2024 wereRMB301.3 million(US$42.5 million), compared toRMB272.9 millionin the same period of 2023. This change was primarily due to an increase in promoting and marketing service fees to continuously promote the YSJA rabies vaccine.
General and Administrative Expenses
General and administrative expenses in Fiscal Year 2024 wereRMB140.1 million(US$19.7 million), compared toRMB72.9 millionin the same period of 2023. This change was primarily attributable to increases in legal fees, auditing fees, directors & officers liability insurance costs, and employee benefits.
Research and Development Expenses
Research and development expenses in Fiscal Year 2024 wereRMB302.8 million(US$42.7 million), compared toRMB318.7 millionin the same period of 2023. The change was primarily driven by decreases in testing fees, clinical trial fees, and consulting service fees related to the development of the Company's COVID-19 vaccine, and decreases in employee benefits as a result of staffing optimizations.
Impairment Loss on Inventory, Property, Plant and Equipment, and Other Assets
Impairment loss on inventory, property, plant and equipment ("PP&E"), and other assets in Fiscal Year 2024 wasRMB157.4 million(US$22.2 million), compared toRMB8.7 millionin the same period of 2023. The change was primarily attributable to 1) impairment loss on inventory impacted by COVID-related disruptions affecting the Company's manufacturing operations and production and raw materials used in the research and development of the Company's COVID-19 vaccine, and 2) impairment loss on PP&E related to COVID-19 vaccine equipment.
Net Loss
Net loss for Fiscal Year 2024 wasRMB433.5 million(US$61.1 million), compared withRMB145.5 millionin the same period of 2023.
Balance Sheet
As ofMarch 31, 2024, the Company had cash and cash equivalents ofRMB246.6 million(US$34.7 million), compared withRMB370.4 millionas ofMarch 31, 2023.
Business Outlook
The Company anticipates double-digit year-over-year revenue growth and expects to achieve breakeven in Fiscal Year 2025.
The above outlook is based on information available as of the date of this press release and reflects the Company's current and preliminary expectations regarding its business situation and market conditions. The outlook is subject to changes, especially given uncertainties and situations related to market competitive dynamics and regulatory policies, etc.
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® immunomodulating 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 inChina,the United States,Singapore, andthe Philippines, and is led by a management team that combines rich local expertise and global experience in the biopharmaceutical industry. For more information, please visithttps://investor.lakeshorebio.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 ofRMB7.095toUS$1.00, the exchange rate set forth in the central parity rate release of the People's Bank ofChinaonMarch 31, 2024.
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 LakeShore Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, LakeShore Biopharma's ability to source and retain talent, and the cash position of LakeShore Biopharma. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "potential," "forecast," "intend," "will," "expect," "anticipate," "believe," "goal," "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 LakeShore Biopharma's management and are not predictions of actual performance.
LakeShore Biopharma cannot assure you the forward-looking statements in this press release will be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading "Risk Factors" in the company's Annual Report on Form 20-F filed with the Securities and Exchange Commission, or SEC, and other risks described in documents subsequently filed by the company from time to time with the SEC. There may be additional risks that LakeShore Biopharma does not presently know or that LakeShore 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 LakeShore Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while LakeShore 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 LakeShore Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, LakeShore Biopharma does not undertake any duty to update these forward-looking statements.
Investor Relations Contact
Robin YangPartner, ICR, LLCTel: +1 (212) 537-4035Email:[email protected]
SOURCE LakeShore Biopharma Co., Ltd
| LAKESHORE BIOPHARMA CO., LTD AND SUBSIDIARIES | ||||||||||||
| CONSOLIDATED BALANCE SHEET (AUDITED) | ||||||||||||
| As of March 31, | ||||||||||||
| 2023 | 2024 | 2024 | ||||||||||
| (RMB) | (RMB) | (US$) | ||||||||||
| ASSETS | ||||||||||||
| Current assets | ||||||||||||
| Cash | 370,108,059 | 246,351,231 | $ | 34,721,808 | ||||||||
| Restricted cash | 261,766 | 200,000 | 28,189 | |||||||||
| Accounts receivable, net | 463,051,792 | 444,161,291 | 62,602,014 | |||||||||
| Advance to suppliers, net | 6,763,326 | 1,662,739 | 234,354 | |||||||||
| Inventories, net | 185,380,952 | 203,422,602 | 28,671,262 | |||||||||
| Prepaid expenses and other current assets | 10,412,769 | 7,370,089 | 1,038,772 | |||||||||
| Total current assets | 1,035,978,664 | 903,167,952 | 127,296,399 | |||||||||
| Non-current assets | ||||||||||||
| Property, plant and equipment, net | 571,756,443 | 473,348,006 | 66,715,716 | |||||||||
| Operating lease right-of-use assets, net | 11,132,428 | 7,275,367 | 1,025,422 | |||||||||
| Deferred tax assets, net | 1,905,581 | 23,634,189 | 3,331,105 | |||||||||
| Intangible assets, net | 78,056,792 | 71,245,336 | 10,041,626 | |||||||||
| Other assets, non-current | 20,923,703 | 34,356,506 | 4,842,355 | |||||||||
| Total non-current assets | 683,774,947 | 609,859,404 | 85,956,224 | |||||||||
| Total assets | 1,719,753,611 | 1,513,027,356 | $ | 213,252,623 | ||||||||
| LIABILITIES AND SHAREHOLDERS'(DEFICIT)/EQUITY | ||||||||||||
| Current liabilities | ||||||||||||
| Bank loans and other borrowings - current | 193,736,563 | 318,540,732 | $ | 44,896,509 | ||||||||
| Accounts payable | 80,439,489 | 67,774,798 | 9,552,473 | |||||||||
| Accrued expenses and other liabilities | 377,536,644 | 408,737,969 | 57,609,301 | |||||||||
| Operating lease liabilities - current | 4,753,547 | 5,156,540 | 726,785 | |||||||||
| Deferred government grants - current | 2,295,701 | 2,015,693 | 284,100 | |||||||||
| Total current liabilities | 658,761,944 | 802,225,732 | 113,069,168 | |||||||||
| Non-current liabilities | ||||||||||||
| Bank loans and other borrowings – non-current | 293,790,596 | 98,983,780 | 13,951,202 | |||||||||
| Operating lease liabilities - non-current | 6,348,890 | 1,783,593 | 251,387 | |||||||||
| Deferred government grants - non-current | 23,606,507 | 20,279,945 | 2,858,343 | |||||||||
| Warrants liability | 8,792,389 | 4,548,004 | 641,015 | |||||||||
| Total non-current liabilities | 332,538,382 | 125,595,322 | 17,701,947 | |||||||||
| Total liabilities | 991,300,326 | 927,821,054 | 130,771,115 | |||||||||
| Shareholders'(deficit)/equity | ||||||||||||
| Ordinary shares, par value US$0.00002 per share;9,950,000,000 shares authorized; 93,058,197 and190,227,959 shares issued and outstanding as of March 31,2023 and 2024, respectively * | 12,297 | 26,105 | 3,679 | |||||||||
| Additional paid-in capital | 2,656,891,036 | 2,950,862,914 | 415,907,387 | |||||||||
| Accumulated deficit | (1,874,037,965) | (2,307,502,836) | (325,229,434) | |||||||||
| Accumulated other comprehensive loss | (54,412,083) | (58,179,881) | (8,200,124) | |||||||||
| Total shareholders' equity | 728,453,285 | 585,206,302 | 82,481,508 | |||||||||
| Total liabilities and shareholders' equity | 1,719,753,611 | 1,513,027,356 | $ | 213,252,623 | ||||||||
| * Gives retroactive effect to the business combination in March 2023 |
| LAKESHORE BIOPHARMA CO., LTD AND SUBSIDIARIES | ||||||||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (AUDITED) | ||||||||||||||
| Years Ended March 31, | ||||||||||||||
| 2023 | 2024 | 2024 | ||||||||||||
| (RMB) | (RMB) | (US$) | ||||||||||||
| Revenues | 687,201,070 | 573,418,256 | $ | 80,820,050 | ||||||||||
| Cost of revenues | 153,360,262 | 117,688,301 | 16,587,498 | |||||||||||
| Gross profit | 533,840,808 | 455,729,955 | 64,232,552 | |||||||||||
| Operating expenses: | ||||||||||||||
| Selling and marketing | 272,927,356 | 301,259,528 | 42,460,821 | |||||||||||
| General and administrative | 72,939,790 | 140,086,062 | 19,744,336 | |||||||||||
| Impairment loss on inventory, property, plantand equipment and other assets | 8,655,487 | 157,415,875 | 22,186,875 | |||||||||||
| Research and development | 318,700,526 | 302,800,992 | 42,678,082 | |||||||||||
| Total operating expenses | 673,223,159 | 901,562,457 | 127,070,114 | |||||||||||
| Loss from operations | (139,382,351) | (445,832,502) | (62,837,562) | |||||||||||
| Other income (expenses): | ||||||||||||||
| Late fees for taxes other than income tax | (3,603) | - | - | |||||||||||
| Late fees for social security insurance | (747,609) | (756,201) | (106,582) | |||||||||||
| Government grants | 26,072,517 | 20,708,778 | 2,918,785 | |||||||||||
| Financial expenses, net | (30,857,673) | (44,344,808) | (6,250,149) | |||||||||||
| Fair value changes of warrant liability | 21,358 | 4,458,844 | 628,449 | |||||||||||
| Other (expense) income, net | 551,760 | 10,572,411 | 1,490,121 | |||||||||||
| Total other income (expense), net | (4,963,250) | (9,360,976) | (1,319,376) | |||||||||||
| Loss before income taxes | (144,345,601) | (455,193,478) | (64,156,938) | |||||||||||
| Income tax (expense) benefit | (1,133,504) | 21,728,607 | 3,062,524 | |||||||||||
| Net loss | (145,479,105) | (433,464,871) | (61,094,414) | |||||||||||
| Accretion to redemption value of convertibleredeemable preferred shares | (137,991,697) | - | - | |||||||||||
| Net loss attributable to Lakeshore Group | (283,470,802) | (433,464,871) | $ | (61,094,414) | ||||||||||
| Net loss | (145,479,105) | (433,464,871) | $ | (61,094,414) | ||||||||||
| Other comprehensive income (loss): foreigncurrency translation adjustment | (137,500,063) | (3,767,798) | (531,050) | |||||||||||
| Total comprehensive loss | (282,979,168) | (437,232,669) | $ | (61,625,464) | ||||||||||
| Loss per share*: | ||||||||||||||
| – Basic and Diluted | (2.35) | (4.05) | $ | (0.57) | ||||||||||
| Weighted average number of ordinary sharesoutstanding*: | ||||||||||||||
| – Basic and Diluted | 61,785,466 | 106,923,121 | 106,923,121 | |||||||||||
| * Gives retroactive effect to the business combination in March 2023. |