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Orthocell Ltd (AU:OCC)
:OCC
Australian Market

Orthocell Ltd (OCC) AI Stock Analysis

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AU

Orthocell Ltd

(Sydney:OCC)

59Neutral
Orthocell Ltd presents a mixed outlook with strong revenue growth but significant profitability issues, impacting its financial performance score. Positive technical indicators suggest current market confidence, yet the lack of valuation appeal due to negative earnings tempers the overall score.

Orthocell Ltd (OCC) vs. S&P 500 (SPY)

Orthocell Ltd Business Overview & Revenue Model

Company DescriptionOrthocell Ltd (OCC) is an Australian-based regenerative medicine company specializing in the development and commercialization of innovative products for the repair and regeneration of soft tissue injuries. The company operates in the biotechnology and healthcare sectors, focusing on advanced tissue engineering and regenerative medicine solutions. Its core products include CelGro™, a collagen medical device designed to facilitate tissue repair and healing, and Ortho-ATI®, an autologous cell therapy for treating tendon injuries.
How the Company Makes MoneyOrthocell Ltd generates revenue primarily through the commercialization of its regenerative medicine products. The company earns money by selling its products, such as CelGro™ and Ortho-ATI®, to healthcare providers, including hospitals and clinics, which utilize these solutions for patients with soft tissue injuries. Additionally, Orthocell may engage in strategic partnerships and licensing agreements to enhance the distribution and adoption of its technologies, potentially leading to milestone payments and royalties. The company's revenue is influenced by the success of its clinical trials, regulatory approvals, and market adoption of its innovative solutions.

Orthocell Ltd Financial Statement Overview

Summary
Orthocell Ltd shows promising revenue growth, yet faces significant profitability challenges with consistent net losses. The balance sheet remains under pressure as equity decreases, though leverage is conservative. Cash flow management reflects volatility, highlighting operational cash flow issues despite adequate cash reserves. The company must address profitability to improve its financial health.
Income Statement
45
Neutral
Orthocell Ltd has shown consistent revenue growth, with a 25.3% increase in revenue from 2023 to 2024. However, the company has been struggling with negative profitability, as evidenced by a negative EBIT and net income across the years, reflecting challenges in achieving operational efficiency. The gross profit margin is relatively healthy at 69.38% in 2024, but the net profit margin remains negative at -135.1%, highlighting significant cost challenges.
Balance Sheet
55
Neutral
The company maintains a low debt-to-equity ratio of 0.15, indicating conservative leverage practices. However, stockholders' equity has decreased over the years, from $10.7M in 2019 to $4.5M in 2024, showing potential risks in financial stability. The equity ratio has also declined, suggesting a weakening financial position. Despite these concerns, the company has maintained a substantial cash position.
Cash Flow
50
Neutral
Orthocell Ltd experienced a significant drop in free cash flow, from $13.9M in 2023 to -$7.4M in 2024. The operating cash flow to net income ratio is negative, indicating cash flow challenges relative to net losses. Despite this, the company has historically shown strong cash positions and has managed financing activities effectively to support operations.
Breakdown
Jun 2024Jun 2023Jun 2022Jun 2021Jun 2020
Income StatementTotal Revenue
5.32M4.24M1.53M1.02M719.52K
Gross Profit
3.69M3.06M832.52K299.88K-6.40K
EBIT
-11.68M-10.31M-11.52M-11.67M-9.47M
EBITDA
-10.91M-9.93M-11.52M-11.67M-9.25M
Net Income Common Stockholders
-7.18M-6.25M-9.11M-9.04M-6.15M
Balance SheetCash, Cash Equivalents and Short-Term Investments
20.61M24.82M11.02M16.33M20.44M
Total Assets
26.62M29.61M37.90M19.33M23.17M
Total Debt
689.69K562.30K507.56K621.72K500.89K
Net Debt
-19.92M-24.26M-10.51M-15.71M-19.94M
Total Liabilities
22.08M23.46M27.99M2.46M2.27M
Stockholders Equity
4.53M6.15M9.90M16.87M20.90M
Cash FlowFree Cash Flow
-7.45M13.96M-6.80M-4.82M-5.31M
Operating Cash Flow
-6.51M14.59M-6.26M-4.63M-5.26M
Investing Cash Flow
-942.02K-631.56K-535.02K-188.52K-55.20K
Financing Cash Flow
3.24M-164.61K1.49M709.15K14.52M

Orthocell Ltd Technical Analysis

Technical Analysis Sentiment
Positive
Last Price1.58
Price Trends
50DMA
1.39
Positive
100DMA
1.39
Positive
200DMA
0.95
Positive
Market Momentum
MACD
0.03
Negative
RSI
60.21
Neutral
STOCH
80.25
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AU:OCC, the sentiment is Positive. The current price of 1.58 is above the 20-day moving average (MA) of 1.40, above the 50-day MA of 1.39, and above the 200-day MA of 0.95, indicating a bullish trend. The MACD of 0.03 indicates Negative momentum. The RSI at 60.21 is Neutral, neither overbought nor oversold. The STOCH value of 80.25 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AU:OCC.

Orthocell Ltd Peers Comparison

Overall Rating
UnderperformOutperform
Sector (52)
Financial Indicators
Name
Overall Rating
Market Cap
P/E Ratio
ROE
Dividend Yield
Revenue Growth
EPS Growth
AUOCC
59
Neutral
AU$387.16M-29.77%6.07%59.09%
AURAC
54
Neutral
AU$210.20M-37.20%32.02%
52
Neutral
$5.35B3.96-42.60%2.86%17.58%1.27%
AUPYC
50
Neutral
AU$714.49M-112.97%-84.82%
AUPIQ
44
Neutral
AU$53.89M-131.55%12.53%-11.04%
AUCBL
38
Underperform
AU$11.49M-98.08%-7.44%30.34%
AUBIT
36
Underperform
$3.98M-119.28%64.10%
* Healthcare Sector Average
Performance Comparison
Ticker
Company Name
Price
Change
% Change
AU:OCC
Orthocell Ltd
1.60
1.21
310.26%
AU:BIT
Biotron
0.01
-0.05
-80.36%
AU:PYC
PYC Therapeutics Limited
1.22
0.13
11.93%
AU:RAC
Race Oncology Ltd.
1.21
0.02
1.68%
AU:PIQ
Proteomics International Laboratories Ltd.
0.38
-0.71
-65.14%
AU:CBL
Control Bionics Ltd.
0.04
0.00
0.00%

Orthocell Ltd Corporate Events

Orthocell Gains Health Canada Approval for Nerve Repair Product Remplir
Apr 30, 2025

Orthocell Limited has received regulatory approval from Health Canada to sell its nerve repair product, Remplir™, in the Canadian market, which is valued at US$75 million. This approval expands the total addressable market for Remplir to US$1.8 billion, following recent approvals in the US and Thailand, and existing approvals in Australia, New Zealand, and Singapore. The company plans to appoint local distributors in Canada to drive sales, with first sales expected in the second half of 2025. Orthocell is well-funded with A$31.7 million in cash reserves, positioning it to capitalize on these new market opportunities and continue its global expansion strategy.

Orthocell Limited Requests Trading Halt for Pending Announcement
Apr 29, 2025

Orthocell Limited has requested a trading halt on its securities pending an announcement about a new regulatory approval for its product, Remplir. This move indicates a significant development that could impact the company’s market positioning and stakeholder interests, as regulatory approvals are crucial for product commercialization and market expansion.

Orthocell Limited Initiates Trading Halt Ahead of Major Announcement
Apr 29, 2025

Orthocell Limited has requested a trading halt on its securities pending an announcement about a new regulatory approval for its product, Remplir. This move indicates a significant development for the company, potentially impacting its market position and stakeholder interests as it awaits the formal announcement.

Orthocell Expands into Thai Market with Remplir™ Approval
Apr 28, 2025

Orthocell Ltd has received regulatory approval from the Thai FDA to commence sales of its nerve repair product Remplir™ in Thailand, a market valued at US$84 million. This approval, achieved through an expedited registration pathway, significantly enhances Orthocell’s presence in the Asia Pacific region and is expected to drive revenue growth. The company plans to partner with a local distributor and anticipates first sales in the second half of 2025. With a strong cash reserve and no debt, Orthocell is well-positioned to expand its global footprint and capitalize on the growing demand for nerve repair solutions.

Orthocell Expands into US Nerve Repair Market with New Distributors
Apr 23, 2025

Orthocell Limited has appointed its first four US distributors for its nerve repair product, Remplir™, following its recent FDA 510(k) clearance. This strategic move allows Orthocell to enter the US$1.6 billion US nerve repair market, with initial sales expected soon. The company plans to expand its distributor network to approximately 10 by mid-2025, covering around 25 states, to accelerate market penetration and revenue growth. Orthocell’s strong financial position and existing inventory support its US rollout, positioning it well for success in the competitive nerve repair industry.

Orthocell Secures FDA Clearance for Remplir™, Eyes US Market Expansion
Apr 14, 2025

Orthocell Limited has achieved a significant milestone with the US FDA 510(k) clearance for its nerve repair product, Remplir™, positioning the company to enter the lucrative US$1.6 billion nerve repair market. This clearance is expected to drive a substantial increase in revenue as the company has prepared logistics and sales pathways for its US launch. Additionally, Orthocell reported strong quarterly revenue growth, maintaining a robust cash position, and is expanding its market reach with regulatory applications in Canada and Thailand. The company’s inclusion in the S&P/ASX All Ordinaries Index further underscores its growing market presence.

Orthocell Gains ANVISA Approval for Striate+ in Brazil, Expanding Latin American Reach
Apr 9, 2025

Orthocell Limited has received regulatory approval from Brazil’s ANVISA for its dental regeneration product, Striate+, marking its first market authorization in Latin America. This approval is a strategic milestone for Orthocell, as Brazil represents a significant market opportunity and serves as a gateway for further expansion into Latin American countries. The approval follows the recent US FDA clearance for another product, Remplir, highlighting the company’s successful global commercialization efforts. With a strong balance sheet and a robust distribution partnership with BioHorizons, Orthocell is well-positioned to capitalize on the estimated US$735 million global market opportunity for Striate+, targeting a 20% market share.

Orthocell Secures US FDA Clearance for Remplir Nerve Repair Product
Apr 3, 2025

Orthocell Limited announced the US FDA 510(k) clearance for its Remplir nerve repair product, marking a significant milestone for the company. This clearance is expected to enhance Orthocell’s market positioning in regenerative medicine, potentially benefiting stakeholders by expanding the product’s availability and application in the US market.

Orthocell Secures FDA Clearance for Remplir, Targets US Nerve Repair Market
Apr 3, 2025

Orthocell Ltd has received US FDA 510(k) clearance for its nerve repair product, Remplir, allowing it to enter the US$1.6 billion US nerve repair market. This regulatory milestone is expected to significantly boost the company’s revenue and drive it towards profitability. Orthocell has prepared for this expansion with established logistics and sales pathways, a manufacturing facility capable of producing 100,000 units annually, and a strong cash reserve to support its US rollout and further market growth. The company aims to capture a meaningful market share without needing to displace existing dominant products, leveraging its proprietary manufacturing technology and strategic US commercial strategy.

Orthocell Limited Requests Trading Halt Pending FDA Clearance Announcement
Apr 2, 2025

Orthocell Limited has requested a trading halt on its securities pending an announcement regarding the results of its US FDA 510(k) clearance application. This clearance is crucial for the company as it seeks to commence commercial distribution in the US market, potentially impacting its market positioning and stakeholder interests.

Orthocell to Present at HealthInvest 2025, Updates on FDA Application
Apr 2, 2025

Orthocell Limited announced that its CEO, Paul Anderson, will present at the HealthInvest 2025 conference in Sydney, highlighting the company’s progress and strategic initiatives. The presentation will include an update on the US FDA application for the Remplir nerve repair product, which signifies a critical step in Orthocell’s expansion efforts and could enhance its market positioning in regenerative medicine.

Orthocell Expands Striate+ Sales in Key European Markets
Mar 26, 2025

Orthocell Limited has announced the successful launch and first sales of its dental guided bone and tissue regeneration product, Striate+™, in Germany, Austria, and Switzerland, marking a significant step in its European market expansion. This move, facilitated by their distribution partner BioHorizons, is expected to rapidly increase sales and revenue, with the company targeting a 20% share of the over A$1 billion global market. The product’s strong performance, backed by a 98.6% success rate in clinical studies, and positive feedback from dental surgeons, positions Orthocell for further growth, particularly with anticipated regulatory approval in Brazil within three months.

Orthocell Secures Singapore Regulatory Approval for Striate+
Mar 18, 2025

Orthocell Limited has received regulatory approval from Singapore’s Health Sciences Authority for its dental membrane product, Striate+, marking a significant milestone in its global expansion strategy. This approval not only validates the quality of Orthocell’s products but also positions the company to capitalize on Singapore as a strategic hub for further ASEAN market penetration. With a strong balance sheet and robust sales growth driven by positive clinical feedback, Orthocell is well-positioned to increase its market share in the AU$1 billion global market opportunity, targeting a 20% share.

Orthocell Ltd Issues Unquoted Securities to Bolster Employee Retention
Mar 17, 2025

Orthocell Ltd has announced the issuance of 26,783 unquoted securities under an employee incentive scheme. This move is part of the company’s strategy to retain key talent and align employee interests with organizational goals, potentially strengthening its position in the competitive biotechnology market.

Orthocell Ltd Issues Unquoted Equity Securities to Boost Employee Incentives
Mar 4, 2025

Orthocell Ltd announced the issuance of unquoted equity securities, including retention and performance rights, as part of an employee incentive scheme. This strategic move aims to align employee interests with company goals, potentially enhancing operational performance and strengthening its position in the regenerative medicine sector.

Orthocell Issues Shares Under Employee Incentive Plan
Mar 3, 2025

Orthocell Limited has issued 100,000 fully paid shares under its Employee Incentive Plan, in compliance with the Corporations Act. This move reflects the company’s ongoing efforts to incentivize its workforce and align employee interests with corporate goals, potentially impacting its operational dynamics and market positioning.

Orthocell Ltd Issues New Shares Under Employee Incentive Plan
Mar 3, 2025

Orthocell Ltd announced the issuance of 100,000 ordinary fully paid shares under its Employee Incentive Plan, with the shares set to be quoted on the Australian Securities Exchange (ASX) on March 3, 2025. This move is part of the company’s strategy to incentivize employees, potentially enhancing its operational performance and industry positioning.

Orthocell Ltd Announces Quotation of New Securities on ASX
Feb 28, 2025

Orthocell Ltd announced the issuance of 625,000 ordinary fully paid securities, which will be quoted on the Australian Securities Exchange (ASX) under the code OCC. This move is part of the company’s strategy to enhance its market presence and provide additional value to its stakeholders by leveraging its position in the regenerative medicine sector.

Orthocell Announces Global Expansion of Remplir™
Feb 26, 2025

Orthocell Limited announced a webinar presentation by CEO Paul Anderson to discuss the global expansion of their product Remplir™, which has recently received approval in Australia, New Zealand, and Singapore. This expansion is part of Orthocell’s strategy to enhance its market positioning and accelerate the development of its tendon cell therapy in the US, aiming to engage with the FDA and prepare for partnering discussions.

Orthocell Accelerates Global Expansion with U.S. Market Entry
Feb 25, 2025

Orthocell Limited is accelerating its global expansion following strong sales of Remplir™ in Australia, New Zealand, and Singapore. The company has submitted a 510(k) application to the U.S. FDA, aiming to enter the $1.6 billion U.S. nerve repair market, with approval anticipated by March or April 2025. This move is part of Orthocell’s broader strategy to enhance its market positioning and engage in partnering discussions in the U.S.

Orthocell Limited Reports Improved Financial Results for Half-Year 2024
Feb 24, 2025

Orthocell Limited reported a significant improvement in its financial performance for the half-year ended December 31, 2024. The company’s revenue increased by 31% compared to the previous period, and its loss after tax decreased by 75.2%, reflecting enhanced operational efficiencies and growth in market reach. Despite the positive trends, the company did not declare any dividends for the period, focusing instead on reinvestment for further growth and development.

Orthocell Expands Global Reach with Thai FDA Application for Remplir™
Feb 20, 2025

Orthocell Limited has submitted a regulatory application to the Thai Food and Drug Administration to sell its nerve repair product, Remplir™, in Thailand’s US$84 million market. The company is actively expanding its global reach, targeting significant markets such as the US, Canada, and various Asia-Pacific countries, with approvals expected in 2025. This strategic move aims to capture a substantial portion of the US$3.2 billion global market for nerve repair, enhancing Orthocell’s revenue potential and market presence.

Orthocell Limited Issues Over One Million New Shares
Feb 18, 2025

Orthocell Limited has issued 1,273,363 fully paid ordinary shares following the exercise of various unlisted options. This issuance was conducted without disclosure to investors under the relevant sections of the Corporations Act, and the company has confirmed compliance with necessary legal provisions. The announcement reflects Orthocell’s strategic moves to strengthen its financial position, potentially impacting its capability to advance its product development and market reach.

Orthocell Announces New Securities Quotation on ASX
Feb 18, 2025

Orthocell Limited has announced a new issuance of 1,273,363 ordinary fully paid securities, which will be quoted on the Australian Securities Exchange (ASX) under the code OCC. This move is part of the company’s strategic actions following the exercise of options or conversion of other convertible securities, potentially impacting its market operations and investor relations by increasing the available shares in the market.

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.