$OTLK
Outlook Therapeutics, Inc.

2024 Q2 Form 10-Q Financial Statement

#000155837024008318 Filed on May 15, 2024

View on sec.gov

Income Statement

Concept 2024 Q2 2024 Q1
Revenue $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $8.361M $5.431M
YoY Change 18.76% -13.7%
% of Gross Profit
Research & Development $11.20M $13.51M
YoY Change 0.9% 2378.94%
% of Gross Profit
Depreciation & Amortization $28.66K $28.19K
YoY Change 156.12% 156.27%
% of Gross Profit
Operating Expenses $19.56M $18.94M
YoY Change 76.22% 3375.56%
Operating Profit -$19.56M -$18.94M
YoY Change 7.83% 176.98%
Interest Expense $347.1K -$3.115M
YoY Change -10.56% -1923.35%
% of Operating Profit
Other Income/Expense, Net $63.62M -$92.23M
YoY Change -2277.63% -590570.81%
Pretax Income $44.41M -$114.3M
YoY Change -314.8% 1618.2%
Income Tax $0.00 $2.800K
% Of Pretax Income 0.0%
Net Earnings $44.41M -$114.3M
YoY Change -314.8% 1617.52%
Net Earnings / Revenue
Basic Earnings Per Share $1.91 -$8.01
Diluted Earnings Per Share -$0.89 -$8.01
COMMON SHARES
Basic Shares Outstanding 23.41M 260.3M
Diluted Shares Outstanding 25.48M 14.27M

Balance Sheet

Concept 2024 Q2 2024 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $32.02M $47.23M
YoY Change -5.0% 8.25%
Cash & Equivalents $32.02M $47.23M
Short-Term Investments
Other Short-Term Assets $13.59M $10.56M
YoY Change 46.01% 12.03%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $45.62M $57.79M
YoY Change 6.04% 8.92%
LONG-TERM ASSETS
Property, Plant & Equipment $286.5K $3.740K
YoY Change 616.15% -92.3%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $708.4K $765.9K
YoY Change -11.7% -5.38%
Other Assets $479.2K $473.2K
YoY Change -18.69% 315.67%
Total Long-Term Assets $1.474M $1.243M
YoY Change 3.15% 27.88%
TOTAL ASSETS
Total Short-Term Assets $45.62M $57.79M
Total Long-Term Assets $1.474M $1.243M
Total Assets $47.09M $59.03M
YoY Change 5.95% 9.26%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $5.552M $4.363M
YoY Change 9.83% 20.54%
Accrued Expenses $2.681M $3.115M
YoY Change -67.61% -49.87%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due $32.43M $44.75M
YoY Change -6.64% 40.56%
Total Short-Term Liabilities $42.55M $54.08M
YoY Change -14.77% 24.24%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $88.21M $139.2M
YoY Change 440956.95% 1684942.86%
Total Long-Term Liabilities $88.21M $139.2M
YoY Change 440956.95% 1684942.86%
TOTAL LIABILITIES
Total Short-Term Liabilities $42.55M $54.08M
Total Long-Term Liabilities $88.21M $139.2M
Total Liabilities $130.8M $193.3M
YoY Change 161.79% 343.92%
SHAREHOLDERS EQUITY
Retained Earnings -$549.0M -$593.4M
YoY Change 20.67% 36.65%
Common Stock $465.3M $459.1M
YoY Change 3.53% 3.24%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$83.67M -$134.2M
YoY Change
Total Liabilities & Shareholders Equity $47.09M $59.03M
YoY Change 5.95% 9.26%

Cashflow Statement

Concept 2024 Q2 2024 Q1
OPERATING ACTIVITIES
Net Income $44.41M -$114.3M
YoY Change -314.8% 1617.52%
Depreciation, Depletion And Amortization $28.66K $28.19K
YoY Change 156.12% 156.27%
Cash From Operating Activities -$19.51M -$19.27M
YoY Change 47.64% 137.44%
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $5.000M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 4.308M 56.14M
YoY Change 30.69% -9501.62%
NET CHANGE
Cash From Operating Activities -19.51M -19.27M
Cash From Investing Activities
Cash From Financing Activities 4.308M 56.14M
Net Change In Cash -15.20M 36.87M
YoY Change 53.27% -523.25%
FREE CASH FLOW
Cash From Operating Activities -$19.51M -$19.27M
Capital Expenditures
Free Cash Flow
YoY Change

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 10pt 0pt;">1.     Organization and Description of Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 10pt 0pt;">Outlook Therapeutics, Inc. (“Outlook” or the “Company”) was incorporated in New Jersey on January 5, 2010, started operations in July 2011, reincorporated in Delaware by merging with and into a Delaware corporation in October 2015 and changed its name to “Outlook Therapeutics, Inc.” in November 2018. The Company is a biopharmaceutical company focused on developing and commercializing ONS-5010, an ophthalmic formulation of bevacizumab for use in retinal indications. The Company is based in Iselin, New Jersey. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 10pt 0pt;">In the fourth quarter of calendar 2023, the Company agreed to conduct an additional adequate and well-controlled clinical trial following discussions with the U.S. Food and Drug Administration (“FDA”) in support of the Company’s Biologics License Application (“BLA”) for ONS-5010. In December 2023, the Company submitted a Special Protocol Assessment (“SPA”) to the FDA for this study (NORSE EIGHT) seeking confirmation that, if successful, it will address the FDA’s requirement for a second adequate and well-controlled clinical trial to support its planned resubmission of the ONS-5010 BLA. In January 2024, the Company received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA and that, if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter (“CRL”). The first subject was enrolled in NORSE EIGHT in January 2024.  In addition, through a Type A meeting and additional interactions, the Company has identified the approaches needed to resolve the chemistry, manufacturing and controls (“CMC”) comments in the CRL. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">Separately, in October 2022 the Company submitted a Marketing Authorization Application (“MAA”), for ONS-5010 with the European Medicines Agency (“EMA”). On December 22, 2022, the Company’s MAA was validated for review by the EMA. In March 2024, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) was completed with a positive opinion issued on March 22, 2024. A related positive decision by the European Commission is estimated to be received in the second quarter of calendar 2024. ONS-5010 is the Company’s sole product candidate in active development.</p>
CY2024Q1 us-gaap Retained Earnings Accumulated Deficit
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 10pt 0pt;">Use of estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">The preparation of the unaudited interim consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Due to the uncertainty of factors surrounding the estimates or judgments used in the preparation of the unaudited interim consolidated financial statements, such as the current macroeconomic environment, including as a result of inflation, high interest rates or ongoing overseas conflict, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed, and the </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 10pt 0pt;">effects of revisions are reflected in the unaudited interim consolidated financial statements in the period they are determined to be necessary.</p>
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otlk Finance Lease Cost
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CY2024Q1 us-gaap Weighted Average Number Of Diluted Shares Outstanding
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us-gaap Weighted Average Number Of Diluted Shares Outstanding
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CY2023Q1 us-gaap Earnings Per Share Diluted
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us-gaap Earnings Per Share Diluted
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us-gaap Earnings Per Share Diluted
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CY2024Q1 us-gaap Lease Cost
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