2024 Q4 Form 10-Q Financial Statement

#000121390024095397 Filed on November 07, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3
Revenue
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $847.0K
YoY Change -56.25%
% of Gross Profit
Research & Development $2.242M
YoY Change 134.27%
% of Gross Profit
Depreciation & Amortization $52.00K
YoY Change 4.0%
% of Gross Profit
Operating Expenses $2.242M
YoY Change -22.5%
Operating Profit -$3.089M
YoY Change 6.77%
Interest Expense -$15.42M
YoY Change -1966.83%
% of Operating Profit
Other Income/Expense, Net -$15.42M
YoY Change -3644.83%
Pretax Income -$18.51M
YoY Change 463.61%
Income Tax $1.133M
% Of Pretax Income
Net Earnings -$19.62M
YoY Change 508.91%
Net Earnings / Revenue
Basic Earnings Per Share -$0.48
Diluted Earnings Per Share -$0.48
COMMON SHARES
Basic Shares Outstanding 40.31M shares 40.77M shares
Diluted Shares Outstanding 40.90M shares

Balance Sheet

Concept 2024 Q4 2024 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $142.3M
YoY Change -18.69%
Cash & Equivalents $42.10M
Short-Term Investments $100.2M
Other Short-Term Assets $474.0K
YoY Change -32.29%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $142.8M
YoY Change -18.74%
LONG-TERM ASSETS
Property, Plant & Equipment $718.0K
YoY Change -22.21%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $21.07M
YoY Change -60.61%
Other Assets $30.00K
YoY Change
Total Long-Term Assets $22.31M
YoY Change -59.58%
TOTAL ASSETS
Total Short-Term Assets $142.8M
Total Long-Term Assets $22.31M
Total Assets $165.1M
YoY Change -28.5%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.995M
YoY Change 92.12%
Accrued Expenses $243.0K
YoY Change -19.0%
Deferred Revenue
YoY Change
Short-Term Debt
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $5.273M
YoY Change -93.25%
LONG-TERM LIABILITIES
Long-Term Debt $0.00
YoY Change
Other Long-Term Liabilities $60.00K
YoY Change -98.67%
Total Long-Term Liabilities $4.286M
YoY Change -4.5%
TOTAL LIABILITIES
Total Short-Term Liabilities $5.273M
Total Long-Term Liabilities $4.286M
Total Liabilities $9.559M
YoY Change -88.44%
SHAREHOLDERS EQUITY
Retained Earnings -$166.4M
YoY Change -2.61%
Common Stock $322.9M
YoY Change 0.89%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $156.4M
YoY Change
Total Liabilities & Shareholders Equity $165.1M
YoY Change -28.5%

Cashflow Statement

Concept 2024 Q4 2024 Q3
OPERATING ACTIVITIES
Net Income -$19.62M
YoY Change 508.91%
Depreciation, Depletion And Amortization $52.00K
YoY Change 4.0%
Cash From Operating Activities -$7.101M
YoY Change 914.43%
INVESTING ACTIVITIES
Capital Expenditures $5.000K
YoY Change -83.33%
Acquisitions
YoY Change
Other Investing Activities -$34.25M
YoY Change -54.38%
Cash From Investing Activities -$34.26M
YoY Change -54.4%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -1.291M
YoY Change -101.73%
NET CHANGE
Cash From Operating Activities -7.101M
Cash From Investing Activities -34.26M
Cash From Financing Activities -1.291M
Net Change In Cash -42.65M
YoY Change 3232.19%
FREE CASH FLOW
Cash From Operating Activities -$7.101M
Capital Expenditures $5.000K
Free Cash Flow -$7.106M
YoY Change 873.42%

Facts In Submission

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<p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif"><b>NOTE 1 - GENERAL:</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify; text-indent: 165.9pt"><span style="font-family: Times New Roman, Times, Serif"><b> </b></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 72px"><span style="font-family: Times New Roman, Times, Serif"> </span></td> <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>a.</b></span></td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Incorporation and Operations</b></span></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 99.1pt"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Oramed Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company”, unless the context indicates otherwise), a Delaware corporation, was incorporated on April 12, 2002.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">On March 18, 2021, Oravax Medical Inc. (“Oravax”) was established by the Company and others. The Company holds a 63% interest in Oravax. Consequently, the Company consolidates Oravax in its consolidated financial statements since that time. </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. As a result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. As these results are considered a triggering event, the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use assets in the first quarter of 2023 and concluded that no impairment was required. The Company completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin (ORMD-0801). These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, the Company submitted a new Phase 3 clinical trial protocol (ORA-D-013-3) to the U.S. Food and Drug Administration (the “FDA”).</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">On January 22, 2024, the Company and its wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement (the “JV Agreement”), with Hefei Tianhui Biotech Co., Ltd. (“HTIT Biotech”) and Technowl Limited, a wholly-owned indirect subsidiary of HTIT Biotech (“HTIT Sub” and together with HTIT Biotech, “HTIT”), pursuant to which, subject to the terms and conditions set forth in the JV Agreement, the parties will establish a joint venture (the “JV”), based on the Company’s oral drug delivery technology.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify">The JV will focus on the development and worldwide commercialization of innovative products based on the Company’s oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies. The JV expects to conduct a Phase 3 oral insulin clinical trial in the United States.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify">The Company and HTIT will initially hold equal shares in the JV, with each owning 50% of the equity. The board of directors will initially consist of equal representation from HTIT and the Company. HTIT will contribute to the JV cash and credit to purchase materials, while the Company will contribute cash and shares of the Company’s common stock (that will be subject to certain registration rights) and will transfer intellectual property related to its oral insulin and POD™ technology, as well as other assets in the Company’s pipeline.</p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The consummation of the JV Agreement is subject to and contingent upon the parties entering into additional agreements pursuant to the JV Agreement. There is no assurance that the parties will complete and sign these additional agreements.  </span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif"> </span></p><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="vertical-align: top"> <td style="width: 72px"><span style="font-family: Times New Roman, Times, Serif"> </span></td> <td style="width: 24px"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>b.</b></span></td> <td><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Development and Liquidity Risks</b></span></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">The Company is engaged in research and development in the biotechnology field for innovative pharmaceutical solutions, including an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules for delivery of other polypeptides, and has not generated significant revenues from its operations. Following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials, the Company’s research and development activities have been significantly reduced while it conducts a strategic review process. As a result, the Company is currently incurring lower research and development and sales and marketing expenses.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif">Based on the Company’s current cash resources and commitments, the Company believes it will be able to maintain its current planned activities and the corresponding level of expenditures for at least the next 12 months.</span></p>
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