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Outlook Therapeutics (OTLK)
:OTLK
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Outlook Therapeutics
(NASDAQ:OTLK)
28Underperform
Positive Factors
Market Authorization and Launch Plans
The company received EU and UK Marketing Authorization for LYTENAVA for the treatment of wet AMD, with commercial launches in Europe planned to start in the first half of 2025.
Strategic Collaboration
Outlook has entered into a strategic collaboration with Cencora to support the global commercial launch of Lytenava.
Negative Factors
Clinical Trial Challenges
ONS-5010 missed the primary endpoint of non-inferiority at week 8 set forth in the special protocol assessment with the FDA.
Outlook Therapeutics (OTLK) vs. S&P 500 (SPY)
Market Cap
$48.03M
Dividend YieldN/A
Average Volume (3M)562.50K
Price to Earnings (P/E)―
Beta (1Y)-0.54
Revenue GrowthN/A
EPS Growth-29.01%
CountryUS
Employees23
SectorHealthcare
Sector Strength78
IndustryBiotechnology
Share Statistics
EPS (TTM)-7.94
Shares Outstanding32,017,178
10 Day Avg. Volume443,882
30 Day Avg. Volume562,499
Financial Highlights & Ratios
PEG RatioN/A
Price to Book (P/B)N/A
Price to Sales (P/S)N/A
Price to Cash Flow (P/CF)-1.10
P/FCF Ratio0.00
Enterprise Value/Market CapN/A
Enterprise Value/RevenueN/A
Enterprise Value/Gross ProfitN/A
Enterprise Value/EbitdaN/A
Forecast
1Y Price Target
$10.00Price Target Upside549.35% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering4
Outlook Therapeutics Business Overview & Revenue Model
Company DescriptionOutlook Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The firm engages in the identification, development, manufacture, and commercialization of complex biosimilar therapeutics. It focuses on monoclonal antibodies, in the disease areas of immunology and oncology. The company was founded by Pankaj Mohan on January 5, 2010 and is headquartered in Cranbury, NJ.
How the Company Makes MoneyOutlook Therapeutics makes money primarily through the development and commercialization of its ophthalmic therapies. The company's revenue model is focused on the successful clinical development, regulatory approval, and eventual commercialization of its lead product candidate, ONS-5010/Lytenava. Revenue is expected to be generated through direct sales to healthcare providers, licensing agreements, and potential partnerships with pharmaceutical companies for distribution and co-development. The company's earnings are significantly influenced by its ability to navigate regulatory pathways, secure market approval, and establish strategic partnerships for production and distribution. Additionally, Outlook Therapeutics may engage in collaborations with other firms to expand its market reach and enhance its product pipeline.
Outlook Therapeutics Financial Statement Overview
Summary
Outlook Therapeutics faces substantial financial challenges, with no revenue generation and high net losses historically. The balance sheet shows high leverage and negative equity, posing significant financial risk. Cash flow metrics indicate reliance on external financing to sustain operations, highlighting financial instability.Income Statement
The company has consistently reported zero revenue over the analyzed periods, indicating a lack of sales activity. The net income for TTM showed a significant positive figure due to a reversal or adjustment, but historical data shows substantial losses. EBIT and EBITDA are negative, suggesting ongoing operational challenges.5
Very Negative
Balance Sheet
The balance sheet reveals negative stockholders' equity, indicating a deficit that exceeds assets. The company is highly leveraged, with liabilities far surpassing assets. This financial structure suggests potential solvency issues and high financial risk.3
Very Negative
Cash Flow
The company exhibits negative operating and free cash flows, indicating cash outflows from operations and lack of free cash for reinvestment. Financing cash flows are positive due to capital raising activities, which may not be sustainable long-term.4
Very Negative
| Breakdown | |||||
| TTM | Sep 2024 | Sep 2023 | Sep 2022 | Sep 2021 | Sep 2020 |
|---|---|---|---|---|---|
| Income Statement | Total Revenue | ||||
| 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | Gross Profit |
| 0.00 | 0.00 | 0.00 | -204.69K | -262.14K | -554.07K | EBIT |
| -82.99M | -71.70M | -53.13M | -63.07M | -51.73M | -36.84M | EBITDA |
| 9.67M | -71.59M | -56.85M | -62.87M | -51.46M | -35.76M | Net Income Common Stockholders |
| -46.81M | -75.37M | -58.98M | -66.05M | -53.16M | -35.24M |
| Balance Sheet | Cash, Cash Equivalents and Short-Term Investments | ||||
| 43.63M | 14.93T | 23.39M | 17.40M | 14.48M | 12.54M | Total Assets |
| 54.02M | 28.82T | 32.30M | 28.53M | 22.81M | 19.73M | Total Debt |
| 31.84M | 29.74M | 35.56M | 10.96M | 11.90M | 8.80M | Net Debt |
| -11.79M | 14.81M | 12.16M | -6.44M | -2.57M | -3.74M | Total Liabilities |
| 43.54M | 10.00T> | 46.74M | 19.79M | 18.20M | 16.91M | Stockholders Equity |
| 10.49M | -73.08T | -14.44M | 8.74M | 4.61M | 2.83M |
| Cash Flow | Free Cash Flow | ||||
| -10.97T | -68.79T | -42.97M | -56.67M | -54.25M | -31.79M | Operating Cash Flow |
| -10.97T | -68.79T | -42.97M | -56.67M | -54.25M | -31.79M | Investing Cash Flow |
| 3.00 | 0.00 | 0.00 | 0.00 | 0.00 | -900.00K | Financing Cash Flow |
| 1.74T | 60.33T | 48.97M | 59.59M | 56.19M | 37.21M |
Outlook Therapeutics Technical Analysis
Negative
1.54
Price Trends
1.85
Negative
2.93
Negative
5.01
Negative
Market Momentum
-0.11
Negative
44.50
Neutral
60.49
Neutral
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For OTLK, the sentiment is Negative. The current price of 1.54 is below the 20-day moving average (MA) of 1.56, below the 50-day MA of 1.85, and below the 200-day MA of 5.01, indicating a bearish trend. The MACD of -0.11 indicates Negative momentum. The RSI at 44.50 is Neutral, neither overbought nor oversold. The STOCH value of 60.49 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for OTLK.
Outlook Therapeutics Risk Analysis
Outlook Therapeutics disclosed 74 risk factors in its most recent earnings report. Outlook Therapeutics reported the most risks in the “Tech & Innovation” category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Outlook Therapeutics Peers Comparison
Overall Rating
UnderperformOutperform
Sector (49)
Financial Indicators
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
68 Neutral | $10.69B | 33.14 | 14.16% | ― | 24.81% | 33.67% | |
52 Neutral | $1.35B | ― | -95.21% | ― | 9.03% | -25.00% | |
49 Neutral | $6.90B | 0.02 | -54.05% | 2.46% | 24.91% | -3.14% | |
48 Neutral | $505.16M | ― | -43.42% | ― | -5.97% | -25.87% | |
42 Neutral | $42.06M | ― | -430.96% | ― | ― | 70.70% | |
28 Underperform | $48.03M | ― | <0.01% | ― | ― | -29.01% |
* Healthcare Sector Average
Performance Comparison
OTLK
Outlook Therapeutics
1.54
-4.19
-73.12%
NBIX
Neurocrine
109.07
-30.09
-21.62%
EYPT
EyePoint Pharmaceuticals
7.33
-14.41
-66.28%
OCUL
Ocular Therapeutix
8.43
-0.83
-8.96%
KALA
Kala Pharmaceuticals
6.95
-0.68
-8.91%
Outlook Therapeutics Earnings Call Summary
Earnings Call Date: Feb 14, 2025 | % Change Since: -16.30% | Next Earnings Date: May 14, 2025
Earnings Call Sentiment Positive
The earnings call highlighted significant progress in regulatory approvals and clinical trials, along with a strong financial position. However, there were delays in the BLA resubmission timeline and increased expenses. Overall, the positive developments and strategic advancements outweigh the challenges noted.Highlights
Regulatory Approvals in the EU and UK
Outlook Therapeutics received marketing authorization for an ophthalmic formulation of bevacizumab for the treatment of retina diseases in the European Union and the United Kingdom.
NORSE EIGHT Clinical Trial Progress
NORSE EIGHT clinical trial in the U.S. is progressing well with 359 of the planned 400 subjects enrolled, with expected enrollment completion before the end of the third quarter.
Positive FDA Interactions
Completed Type C and D meetings with the FDA addressing open CMC items, indicating positive discussions and progress towards resubmitting the BLA in Q1 2025.
Strong Financial Position
Cash position of $32 million and expected $107 million from the exercise of warrants should support operations through calendar 2025.
Reduction in Convertible Notes
Outstanding convertible notes reduced to approximately $30.3 million, indicating improved financial health.
Lowlights
Delay in BLA Resubmission
BLA resubmission with the FDA has been pushed to the first calendar quarter of 2025 due to enrollment timelines not being met as initially anticipated.
Increased G&A Expenses
General and Administrative expenses increased in fiscal Q3 compared to Q2 due to prelaunch expenses for Europe.
Company Guidance
During the Q3 2024 earnings call, Outlook Therapeutics provided several key updates and guidance metrics. The company announced it has received marketing authorization for its ophthalmic formulation of bevacizumab in the European Union and the United Kingdom. They are preparing for commercial launch in these regions in the first half of 2025, with ongoing market access work and inventory planning. In the United States, the NORSE EIGHT clinical trial is progressing, with 359 of the planned 400 subjects enrolled, and completion expected by the end of Q3 2024. Outlook Therapeutics anticipates top-line results from NORSE EIGHT in Q4 2024 and plans to resubmit the Biologics License Application (BLA) to the FDA in Q1 2025. Financially, the company reported a reduction in adjusted net loss and R&D expenses from the previous quarter, with a cash position of $32 million as of June 30, 2024, and expected proceeds of $107 million from the exercise of warrants, supporting operations through 2025.Outlook Therapeutics Corporate Events
Executive/Board ChangesPrivate Placements and Financing
Outlook Therapeutics Secures Funding and Board Restructures
Neutral
Jan 31, 2025
On January 31, 2025, Outlook Therapeutics entered into a Securities Purchase Agreement with Avondale Capital for a $33.1 million unsecured convertible promissory note. The proceeds are intended to repay existing debts and support the development of ONS-5010, alongside general corporate purposes. This financial maneuver aims to streamline the company’s debt obligations and bolster its developmental programs. Additionally, a reclassification of board member Lawrence A. Kenyon took place on January 30, 2025, to maintain balance among the board’s classes, ensuring consistent governance.
Glossary
OutperformA stock rated as "Outperform" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock is likely to deliver higher returns compared to the average returns of other stocks in the same sector or market index. Investors might consider this stock a good buying opportunity.
NeutralA stock rated as "Neutral" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly attractive nor unattractive for investment. Investors may consider holding onto the stock, as it is not expected to either significantly outperform or underperform the market.
UnderperformA stock rated as "Underperform" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests that the stock may deliver lower returns compared to the average returns of other stocks in the same sector or market index. Investors might consider selling the stock or avoiding it as an investment.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.