$OTLK
Outlook Therapeutics, Inc.

2024 Q4 Form 10-K Financial Statement

#000155837024016491 Filed on December 27, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3 2024 Q1
Revenue $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $5.431M
YoY Change -13.7%
% of Gross Profit
Research & Development $13.51M
YoY Change 2378.94%
% of Gross Profit
Depreciation & Amortization $28.19K
YoY Change 156.27%
% of Gross Profit
Operating Expenses $18.94M
YoY Change 3375.56%
Operating Profit -$18.94M
YoY Change 176.98%
Interest Expense -$3.115M
YoY Change -1923.35%
% of Operating Profit
Other Income/Expense, Net -$92.23M
YoY Change -590570.81%
Pretax Income -$114.3M
YoY Change 1618.2%
Income Tax $2.800K
% Of Pretax Income
Net Earnings -$114.3M
YoY Change 1617.52%
Net Earnings / Revenue
Basic Earnings Per Share -$8.01
Diluted Earnings Per Share -$8.01
COMMON SHARES
Basic Shares Outstanding 24.91M 23.66M 260.3M
Diluted Shares Outstanding 14.27M

Balance Sheet

Concept 2024 Q4 2024 Q3 2024 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $47.23M
YoY Change 8.25%
Cash & Equivalents $14.93M $47.23M
Short-Term Investments
Other Short-Term Assets $10.56M
YoY Change 12.03%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $27.42M $57.79M
YoY Change -11.5% 8.92%
LONG-TERM ASSETS
Property, Plant & Equipment $3.740K
YoY Change -92.3%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments $693.2K $765.9K
YoY Change -12.69% -5.38%
Other Assets $439.3K $473.2K
YoY Change -12.37% 315.67%
Total Long-Term Assets $1.407M $1.243M
YoY Change 6.49% 27.88%
TOTAL ASSETS
Total Short-Term Assets $27.42M $57.79M
Total Long-Term Assets $1.407M $1.243M
Total Assets $28.82M $59.03M
YoY Change -10.77% 9.26%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $7.969M $4.363M
YoY Change 21.21% 20.54%
Accrued Expenses $3.237M $3.115M
YoY Change 17.91% -49.87%
Deferred Revenue
YoY Change
Short-Term Debt $0.00
YoY Change
Long-Term Debt Due $44.75M
YoY Change 40.56%
Total Short-Term Liabilities $42.55M $54.08M
YoY Change -8.94% 24.24%
LONG-TERM LIABILITIES
Long-Term Debt $0.00
YoY Change
Other Long-Term Liabilities $139.2M
YoY Change 1684942.86%
Total Long-Term Liabilities $139.2M
YoY Change 1684942.86%
TOTAL LIABILITIES
Total Short-Term Liabilities $42.55M $54.08M
Total Long-Term Liabilities $139.2M
Total Liabilities $101.9M $193.3M
YoY Change 118.02% 343.92%
SHAREHOLDERS EQUITY
Retained Earnings -$543.3M -$593.4M
YoY Change 16.11% 36.65%
Common Stock $470.2M $459.1M
YoY Change 3.69% 3.24%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$73.08M -$134.2M
YoY Change
Total Liabilities & Shareholders Equity $28.82M $59.03M
YoY Change -10.77% 9.26%

Cashflow Statement

Concept 2024 Q4 2024 Q3 2024 Q1
OPERATING ACTIVITIES
Net Income -$114.3M
YoY Change 1617.52%
Depreciation, Depletion And Amortization $28.19K
YoY Change 156.27%
Cash From Operating Activities -$19.27M
YoY Change 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
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 56.14M
YoY Change -9501.62%
NET CHANGE
Cash From Operating Activities -19.27M
Cash From Investing Activities
Cash From Financing Activities 56.14M
Net Change In Cash 36.87M
YoY Change -523.25%
FREE CASH FLOW
Cash From Operating Activities -$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 12pt 0pt;">1.     Organization and Operations</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Description of the Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin: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/LYTENAVA<span style="background:#ffffff;">™ (</span>bevacizumab-gamma), 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;"><span style="margin-bottom:12pt;visibility:hidden;">​</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">In May 2024, the Company received Marketing Authorization from the European Commission for ONS-5010/LYTENAVA, an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (“AMD”) in the European Union (“EU”).  Additionally, in July 2024 the Company also received marketing authorization for ONS-5010/LYTENAVA in the United Kingdom (“UK”) from the UK Medicines and Healthcare products Regulatory Agency (MHRA). ONS-5010/LYTENAVA is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in the EU and UK.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 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/LYTENAVA. 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/LYTENAVA BLA. In January 2024, the Company received confirmation that the FDA had 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”). 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. In November 2024, the Company reported that  ONS-5010/LYTENAVA did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the SPA. However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025.</p>
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">Use of estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The preparation of the 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 consolidated financial statements, actual results may materially vary from these estimates. Estimates and assumptions are periodically reviewed and the effects of revisions are reflected in the consolidated financial statements in the period they are determined to be necessary.</p>
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