2024 Q2 Form 10-Q Financial Statement

#000121390024041364 Filed on May 09, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2024 Q1 2023 Q1
Revenue $666.0K
YoY Change 0.0%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.693M $1.783M $1.447M
YoY Change -35.97% 23.22% -76.21%
% of Gross Profit
Research & Development $1.442M $1.179M $4.427M
YoY Change -20.81% -73.37% -24.14%
% of Gross Profit
Depreciation & Amortization $54.00K $56.00K $37.00K
YoY Change 3.85% 51.35% 236.36%
% of Gross Profit
Operating Expenses $1.442M $1.179M $4.427M
YoY Change -67.7% -73.37% -62.85%
Operating Profit -$3.135M -$2.962M -$5.208M
YoY Change -17.3% -43.13% -53.71%
Interest Expense $13.97M $592.0K $1.597M
YoY Change 463.88% -62.93% 193.57%
% of Operating Profit
Other Income/Expense, Net $14.23M $5.088M $1.597M
YoY Change 474.41% 218.6%
Pretax Income $10.84M $1.534M -$3.611M
YoY Change -925.44% -142.48% -66.28%
Income Tax $1.634M
% Of Pretax Income 15.08%
Net Earnings $9.212M $1.536M -$3.611M
YoY Change -871.52% -142.54% -65.36%
Net Earnings / Revenue -542.19%
Basic Earnings Per Share $0.22 $0.04 $0.08
Diluted Earnings Per Share $0.22 $0.04 $0.07
COMMON SHARES
Basic Shares Outstanding 40.63M shares 40.52M shares 39.78M shares
Diluted Shares Outstanding 41.59M shares 41.56M shares 40.04M shares

Balance Sheet

Concept 2024 Q2 2024 Q1 2023 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $152.7M $18.94M $24.47M
YoY Change 2050.92% -22.59% -82.72%
Cash & Equivalents $84.75M $18.58M $24.10M
Short-Term Investments $67.98M $367.0K $366.0K
Other Short-Term Assets $533.0K $501.0K $1.423M
YoY Change -30.69% -64.79% -27.1%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $153.3M $177.1M $155.2M
YoY Change 1.52% 14.14% 8.08%
LONG-TERM ASSETS
Property, Plant & Equipment $765.0K $819.0K $977.0K
YoY Change -19.05% -16.17% -36.23%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $29.59M $25.10M $2.707M
YoY Change 738.12% 827.26% -90.01%
Other Assets $28.00K $29.00K $24.00K
YoY Change 7.69% 20.83% 0.0%
Total Long-Term Assets $30.95M $26.56M $4.623M
YoY Change 479.21% 474.45% -83.87%
TOTAL ASSETS
Total Short-Term Assets $153.3M $177.1M $155.2M
Total Long-Term Assets $30.95M $26.56M $4.623M
Total Assets $184.2M $203.7M $159.8M
YoY Change 17.85% 27.46% -7.23%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.483M $1.267M $4.055M
YoY Change 320.65% -68.75% 22.51%
Accrued Expenses $250.0K $254.0K $242.0K
YoY Change 5.93% 4.96% 2.11%
Deferred Revenue
YoY Change
Short-Term Debt $32.03M $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $3.733M $33.56M $4.972M
YoY Change 249.86% 574.9% -21.38%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $60.00K $4.375M $4.660M
YoY Change -98.69% -6.12% 26.73%
Total Long-Term Liabilities $4.336M $4.375M $4.660M
YoY Change -5.57% -6.12% 26.73%
TOTAL LIABILITIES
Total Short-Term Liabilities $3.733M $33.56M $4.972M
Total Long-Term Liabilities $4.336M $4.375M $4.660M
Total Liabilities $8.069M $37.93M $9.632M
YoY Change 42.59% 293.8% -2.46%
SHAREHOLDERS EQUITY
Retained Earnings -$146.8M -$156.0M -$166.5M
YoY Change -12.44% -6.28%
Common Stock $323.9M $322.7M $481.0K
YoY Change 66815.91% 66980.87%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $177.1M $166.6M $151.0M
YoY Change
Total Liabilities & Shareholders Equity $184.2M $203.7M $159.8M
YoY Change 17.85% 27.46% -7.23%

Cashflow Statement

Concept 2024 Q2 2024 Q1 2023 Q1
OPERATING ACTIVITIES
Net Income $9.212M $1.536M -$3.611M
YoY Change -871.52% -142.54% -65.36%
Depreciation, Depletion And Amortization $54.00K $56.00K $37.00K
YoY Change 3.85% 51.35% 236.36%
Cash From Operating Activities $2.076M -$1.476M -$5.549M
YoY Change -178.82% -73.4% -39.19%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $2.000K $199.0K
YoY Change -100.0% -98.99% -523.4%
Acquisitions
YoY Change
Other Investing Activities $94.66M $30.00M -$13.00M
YoY Change -744.35% -330.7% -275.59%
Cash From Investing Activities $94.66M $30.00M -$13.20M
YoY Change -743.47% -327.21% -279.41%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -30.55M -$19.00M $2.430M
YoY Change -881.89% 6.02%
NET CHANGE
Cash From Operating Activities 2.076M -$1.476M -$5.549M
Cash From Investing Activities 94.66M $30.00M -$13.20M
Cash From Financing Activities -30.55M -$19.00M $2.430M
Net Change In Cash 66.18M $9.521M -$16.36M
YoY Change -481.58% -158.2% -3210.27%
FREE CASH FLOW
Cash From Operating Activities $2.076M -$1.476M -$5.549M
Capital Expenditures $0.00 $2.000K $199.0K
Free Cash Flow $2.076M -$1.478M -$5.748M
YoY Change -178.22% -74.29% -36.68%

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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; font-size: 10pt"><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; font-size: 10pt"><b> </b></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.75in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>a.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><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; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On March 18, 2021, the Company entered into a license agreement (the “Oravax License Agreement”) with Oravax Medical Inc. (“Oravax”) and into a stockholders agreement (the “Stockholders Agreement”) with Akers Biosciences Inc., Premas Biotech Pvt. Ltd., Cutter Mill Capital LLC and Run Ridge LLC. According to the Stockholders Agreement, Oravax issued 1,890,000 shares of its capital stock to the Company, representing 63% of the issued and outstanding share capital of Oravax as of the date of issuance. Consequently, Oramed 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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On November 23, 2021, Oravax incorporated a wholly-owned subsidiary in Israel, Oravax Medical Ltd., which is engaged in research and development. Effective January 1, 2022, Oravax transferred its rights and obligations under the Oravax License Agreement to Oravax Medical Ltd.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, the Company is working on a protocol for a new Phase 3 clinical trial to be submitted to the FDA.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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 parties intend for the JV to use the protocol the Company is currently working on to initiate a Phase 3 oral insulin trial in the United States.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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 $70,000 in cash, while the Company will contribute $20,000 (comprised of $10,000 in cash and $10,000 in 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. HTIT will have an option to invest additional funds into the JV up to an aggregate amount of $20,000, thereby increasing its equity holdings and granting the right to increase its board representation. The Company will be entitled to receive a 3% royalty on gross revenues of the JV generated from Company-related assets.</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; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The consummation of the JV Agreement is subject to and contingent upon the parties entering into additional agreements within a three-month period from the signature of the JV Agreement, including an asset transfer agreement for the transfer of the Company’s intellectual property to the JV, a commercial supply agreement for the manufacture and supply of products by HTIT to the JV, as well as other documents and agreements to regulate the relationship of the parties and the JV to be formed pursuant to the JV Agreement. There is no assurance that the parties will complete and sign these additional agreements within the agreed timeline or at all. If such agreements are not signed within the agreed timeframe, then either party may apply a 30-day extension, after which the JV Agreement may be terminated and voided by either party. The 30-day extension was applied by the Company on April 18, 2024 and will last until May 22, 2024. Thereafter, the consummation of the JV transaction is further subject to the satisfaction or waiver of certain other closing conditions within a three-month period following the completion of the aforesaid ancillary agreements. If the closing conditions are not met within the agreed timeframe, then either party may apply a 30-day extension, after which the JV Agreement may be terminated and voided by either party. In addition, completion of the transactions contemplated under the JV Agreement is subject to the satisfaction or waiver of customary and certain other closing conditions.</span></p><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"> </p><table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.75in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>b.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><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; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">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, although no assurance can be given that the Company will not need additional funds prior to such time. If there are unexpected increases in its operating expenses, the Company may need to seek additional financing during the next 12 months. The Company may also need additional funds to realize the decisions made as part of its strategic review process. The Company cannot predict the outcome of these activities.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On August 7, 2023, the Company entered into a Stock Purchase Agreement, as subsequently amended on August 9, 2023 and August 21, 2023, (the “Sorrento SPA”), with Sorrento Therapeutics, Inc. (“Sorrento”), to acquire certain equity securities of Scilex Holding Company (“Scilex”), owned by Sorrento (the “Purchased Securities”), for a purchase price of $105,000. Sorrento and its affiliated debtor, Scintilla Pharmaceuticals, Inc. (“Scintilla” and together with Sorrento, the “Debtors”) are in Chapter 11 bankruptcy proceedings.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On August 9, 2023, the Company entered into a Senior Secured, Super-Priority Debtor-in-Possession Loan and Security Agreement (the “Senior DIP Loan Agreement”) with the Debtors in the principal amount of $100,000, which included a non-refundable closing fee of $450 paid in full out of the proceeds. This amount was subsequently drawn in full by the Debtors and was intended to be used by the Company as a credit for the consideration for the Purchased Securities, with an additional $5,000 in cash to be paid by the Company at closing. Thereafter, the Company and Sorrento continued discussions and negotiations relating to the sale contemplated under the Sorrento SPA.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On September 21, 2023, the Company entered into and consummated the transactions contemplated by a Securities Purchase Agreement (the “Scilex SPA”) with Scilex and Acquiom Agency Services LLC. Pursuant to the Scilex SPA, in exchange for Scilex assuming outstanding obligations of Sorrento under the Senior DIP Loan Agreement (the “DIP Assumption”) and for the ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento, Scilex (i) issued to the Company (A) a Senior Secured Promissory Note due 18 months from the date of issuance in the principal amount of $101,875 (the “Note”), which includes accrued and unpaid interest of $875 under the Senior DIP Loan Agreement and $1,000 of fees added to the principal amount of the Note, (B) the Closing Penny Warrant (as defined herein), and (C) the Subsequent Penny Warrants (as defined herein), and (ii) caused the Transferred Warrants (as defined herein) to be transferred to the Company. For further details, see note 7.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. For further details, see note 6.</span></p>
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