Clinuvel Pharmaceuticals (CUV) AI Stock Analysis

• Market Cap: $473.17M
• Dividend Yield: 0.53%
• Average Volume (3M): 73.52K
• Price to Earnings (P/E): 12.2
• Beta (1Y): 0.40
• Revenue Growth: 12.74%
• EPS Growth: 27.56%
• Country: AU
• Employees: 16
• Sector: Healthcare
• Sector Strength: 46
• Industry: Biotechnology
• EPS (TTM): 0.28
• Shares Outstanding: 50,123,630
• 10 Day Avg. Volume: 87,311
• 30 Day Avg. Volume: 73,523
• PEG Ratio: 1.74
• Price to Book (P/B): 2.62
• Price to Sales (P/S): 0.00
• P/FCF Ratio: 24.15
• Enterprise Value/Market Cap: N/A
• Enterprise Value/Revenue: N/A
• Enterprise Value/Gross Profit: N/A
• Enterprise Value/Ebitda: N/A
• 1Y Price Target: $39.32
• Price Target Upside: 292.40% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 0

• Rating: 75 Outperform
• Price Target: AU$11.00 ▲(9.78%Upside)

Clinuvel Pharmaceuticals scores well due to its strong financial performance and positive earnings call results, reflecting significant revenue growth and strategic expansions. Despite bearish technical indicators and some challenges in drug development, the company's stable financial foundation and low valuation make it a potentially attractive investment in the biotechnology sector.

Clinuvel Pharmaceuticals Business Overview & Revenue Model

Company Description

Clinuvel Pharmaceuticals Limited (CUV) is a global biopharmaceutical company focused on developing and delivering innovative treatments for patients with unmet medical needs, primarily in the field of photoprotection and skin disorders. The company's core product, SCENESSE®, is designed to treat erythropoietic protoporphyria (EPP), a rare genetic disorder causing severe phototoxic reactions to sunlight. Clinuvel operates within the pharmaceutical and biotechnology sectors, leveraging its expertise in dermatology to expand its product pipeline and address other skin-related conditions.

How the Company Makes Money

Clinuvel Pharmaceuticals Limited generates revenue primarily through the commercialization of its flagship product, SCENESSE®, which is approved for use in the European Union, the United States, and other regions for the treatment of erythropoietic protoporphyria (EPP). The company makes money by selling SCENESSE® directly to specialized distribution partners, hospitals, and clinics, which then provide the treatment to patients. Clinuvel also focuses on expanding its market reach by obtaining regulatory approvals in additional countries and exploring new indications for SCENESSE®. Strategic partnerships and collaborations with research institutions and healthcare organizations contribute to the company's growth and revenue potential, alongside efforts to develop new products targeting other skin-related disorders.

Clinuvel Pharmaceuticals Financial Statement Overview

Summary

Clinuvel Pharmaceuticals exhibits strong overall financial health, characterized by robust revenue and profit growth, efficient operational management, and a solid equity position. The company maintains low leverage, which reduces financial risk, and demonstrates efficient cash flow management despite some fluctuations in free cash flow growth. Overall, Clinuvel is well-positioned in the biotechnology sector with a stable financial foundation and growth potential.

Income Statement

Clinuvel Pharmaceuticals has demonstrated strong growth in revenue over the years, with a notable increase from 2023 to 2024. The gross profit margin and net profit margin have remained healthy, indicating efficient cost management and profitability. The EBIT and EBITDA margins also reflect strong operational efficiency, contributing to the company's robust financial performance.

Balance Sheet

The balance sheet shows a strong equity position with a low debt-to-equity ratio, indicating financial stability and low leverage risk. The return on equity is impressive, reflecting effective utilization of shareholders’ funds. The equity ratio reinforces the company’s strong financial health, with substantial equity backing its assets.

Cash Flow

The company has consistently generated positive operating cash flow, with a solid free cash flow position that supports ongoing operations and potential investments. However, the free cash flow growth rate has shown some fluctuations, which could indicate variable capital expenditures or changes in cash management strategy. The operating cash flow to net income ratio is healthy, suggesting efficient cash conversion.

Breakdown	TTM	Jun 2024	Jun 2023	Jun 2022	Jun 2021	Jun 2020
Income Statement
Total Revenue	91.02M	88.18M	78.32M	65.72M	47.98M	32.57M
Gross Profit	82.68M	80.45M	50.59M	46.62M	35.20M	18.43M
EBITDA	51.73M	51.86M	46.37M	35.08M	26.57M	11.99M
Net Income	38.78M	35.64M	30.60M	20.88M	24.73M	16.65M
Balance Sheet
Total Assets	236.20M	231.12M	194.52M	144.81M	108.57M	81.54M
Cash, Cash Equivalents and Short-Term Investments	198.22M	183.87M	156.81M	121.51M	82.69M	66.75M
Total Debt	715.38K	879.78K	999.87K	1.26M	1.30M	1.32M
Total Liabilities	18.90M	28.11M	29.89M	19.25M	9.83M	9.48M
Stockholders Equity	217.30M	203.01M	164.63M	125.56M	98.74M	72.07M
Cash Flow
Free Cash Flow	23.49M	31.48M	35.88M	39.44M	18.41M	13.30M
Operating Cash Flow	23.83M	37.05M	36.91M	39.87M	19.26M	14.19M
Investing Cash Flow	-43.02M	-29.03M	-1.03M	-434.44K	-854.33K	-888.83K
Financing Cash Flow	-3.88M	-3.57M	-2.24M	-1.50M	-1.48M	-1.49M

Clinuvel Pharmaceuticals Technical Analysis

• Technical Analysis Sentiment: Neutral
• Last Price: 10.02
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Positive
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For AU:CUV, the sentiment is Neutral. The current price of 10.02 is below the 20-day moving average (MA) of 10.18, below the 50-day MA of 10.64, and below the 200-day MA of 12.18, indicating a bearish trend. The MACD of -0.29 indicates Positive momentum. The RSI at 45.89 is Neutral, neither overbought nor oversold. The STOCH value of 30.16 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Neutral sentiment for AU:CUV.

Clinuvel Pharmaceuticals Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CUV	75 Outperform	$473.17M	12.19	19.93%	0.53%	12.74%	27.56%
CU6	53 Neutral	AU$646.16M	―	-53.99%	―	―	-40.19%
BOT	53 Neutral	AU$588.26M	―	-56.99%	―	10.76%	-195.89%
Sector *	51 Neutral	$7.36B	0.28	-61.07%	2.37%	17.46%	1.71%
PYC	50 Neutral	AU$699.91M	―	-112.97%	―	―	-84.82%
IMM	44 Neutral	AU$328.59M	―	-31.16%	―	―	14.47%
OPT	30 Underperform	$738.77M	―		―	-24.46%	-7.90%

Clinuvel Pharmaceuticals Corporate Events

JPMorgan Chase & Co. Ceases Substantial Holding in Clinuvel Pharmaceuticals

JPMorgan Chase & Co. and its affiliates have ceased to be substantial holders in Clinuvel Pharmaceuticals Ltd as of June 16, 2025. This change involves various transactions and securities lending agreements affecting ordinary shares, indicating a shift in JPMorgan’s investment strategy or portfolio management concerning Clinuvel Pharmaceuticals.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$46.35 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.

CLINUVEL’s Study Highlights Need for Combined Therapy in Vitiligo Treatment

CLINUVEL announced the results of its Phase II pilot study, CUV104, which evaluated SCENESSE® as a monotherapy for vitiligo, demonstrating that it was ineffective in repigmenting skin without adjunct narrowband ultraviolet B (NB-UVB) phototherapy. The study’s findings confirm the necessity of combining afamelanotide with NB-UVB for effective treatment, influencing the company’s future study designs and regulatory submissions. This development underscores CLINUVEL’s commitment to advancing treatment options for vitiligo, particularly for patients with darker skin types, and aligns with its strategic focus on innovative therapies.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$46.35 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.

CLINUVEL Pharmaceuticals Announces Leadership Update

CLINUVEL Pharmaceuticals announced the return of Dr. Philippe Wolgen as Managing Director, who will focus on advancing product development and corporate projects. This leadership update is expected to guide the company through its next critical phase, with Dr. Wolgen dedicating time to key objectives while the executive team maintains management continuity.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$46.35 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.

CLINUVEL Expands SCENESSE® Use to Youngest EPP Patient

CLINUVEL announced the successful administration of SCENESSE® to a 9-year-old girl with severe erythropoietic protoporphyria (EPP), marking the youngest patient treated with the drug. This development highlights the potential for expanding SCENESSE®’s use to younger patients, pending regulatory approval, and underscores the company’s commitment to addressing unmet needs in EPP treatment. The treatment was well tolerated, with no adverse events, and has enabled the patient to resume normal activities, including attending school.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$46.35 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.

Clinuvel Advances Vitiligo Treatment with SCENESSE®

Clinuvel Pharmaceuticals has provided an update on its vitiligo program, highlighting the progress and future plans for SCENESSE®. The company has completed recruitment for its Phase III CUV105 study and is actively engaged in regulatory discussions for the CUV107 protocol. Clinuvel is also expanding its North American infrastructure and engaging over 100 potential new Specialty Centers. The company’s unique approach to treating vitiligo has gained recognition from the medical community, positioning SCENESSE® as a promising treatment option.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$46.35 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.

CLINUVEL Showcases SCENESSE® Efficacy at EADV Symposium

CLINUVEL Pharmaceuticals has presented long-term data on their drug SCENESSE® at the European Academy of Dermatology and Venereology Symposium, highlighting its safety and effectiveness in treating erythropoietic protoporphyria (EPP) and hepatoerythropoietic porphyria (HEP). The presentation underscores the drug’s positive impact on patient quality of life and its consistent safety profile, reinforcing CLINUVEL’s position as a leader in photomedicine. The announcement also emphasizes Italy’s pioneering role in EPP treatment, with SCENESSE® being administered since 2008 and the country having the largest EPP treatment network in Europe.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$46.35 price target. To see the full list of analyst forecasts on Clinuvel Pharmaceuticals stock, see the AU:CUV Stock Forecast page.

JPMorgan Chase & Co. Ceases Substantial Holding in Clinuvel Pharmaceuticals

JPMorgan Chase & Co. and its affiliates have ceased to be substantial holders of Clinuvel Pharmaceuticals Ltd as of May 6, 2025. This change in holding may impact Clinuvel’s market perception and stakeholder confidence, as JPMorgan’s involvement often signals institutional support and stability. The adjustment in holdings was due to securities lending and proprietary trading activities by JPMorgan’s subsidiaries.

Clinuvel Completes Recruitment for Phase III Vitiligo Trial

Clinuvel Pharmaceuticals has successfully recruited over 200 patients for its Phase III trial (CUV105) of SCENESSE® in treating vitiligo, with results expected in the second half of 2026. The trial, conducted across North America, Africa, and Europe, aims to evaluate the efficacy of SCENESSE® as a systemic repigmentation therapy in combination with narrowband ultraviolet B phototherapy. Initial clinical observations have been positive, and the company is preparing for further regulatory discussions and a subsequent trial, CUV107, to expand its market presence.

Clinuvel Pharmaceuticals Ceases 19,000 Performance Rights

Clinuvel Pharmaceuticals Limited announced the cessation of 19,000 performance rights due to the conditions for these securities not being met. This development may impact the company’s capital structure and could have implications for stakeholders, reflecting on the company’s operational adjustments in response to unmet performance conditions.

CLINUVEL PHARMACEUTICALS Issues New Shares to Bolster Market Position

CLINUVEL PHARMACEUTICALS LIMITED announced the issuance of 62,950 fully paid ordinary shares without disclosure under the Corporations Act, confirming compliance with relevant legislative provisions. This move indicates the company’s ongoing strategic financial maneuvers to support its operations and maintain its position in the pharmaceutical industry, potentially impacting stakeholders by reinforcing its market presence and financial stability.

Clinuvel Pharmaceuticals Issues Shares Under Incentive Program

Clinuvel Pharmaceuticals Limited has announced the issuance of 56,700 ordinary fully paid shares to employees as part of a long-term incentive program. This move is expected to enhance employee engagement and align their interests with the company’s growth objectives, potentially impacting its market position positively.

Clinuvel Pharmaceuticals Expands Market Presence with New Securities Quotation

Clinuvel Pharmaceuticals Limited announced the quotation of 6,250 ordinary fully paid securities on the ASX, effective April 3, 2025. This move signifies the company’s ongoing efforts to enhance its market presence and provide liquidity to its stakeholders, potentially impacting its operational strategies and investor relations.

JPMorgan Reduces Stake in Clinuvel Pharmaceuticals

JPMorgan Chase & Co. and its affiliates have reduced their voting power in Clinuvel Pharmaceuticals Ltd, a company in the biotechnology sector, from 6.26% to 5.26%. This change reflects a decrease in the number of ordinary shares held by JPMorgan, which may impact their influence in company decisions.

Clinuvel Pharmaceuticals Announces On-Market Share Buy-Back

Clinuvel Pharmaceuticals Limited has announced an on-market buy-back of its ordinary fully paid shares, as per the notification dated March 27, 2025. This strategic move is likely aimed at enhancing shareholder value and optimizing the company’s capital structure, potentially impacting its market positioning and investor relations.

CLINUVEL Pharmaceuticals Renews Share Buy-Back Program

CLINUVEL Pharmaceuticals Limited has announced the renewal of its share buy-back program for another 12 months, allowing the repurchase of up to 1,500,000 ordinary shares, approximately 3% of its outstanding share capital. This initiative reflects the company’s commitment to prudent cash management amid uncertain macroeconomic conditions and aims to support shareholder value. The buy-back’s timing and extent will depend on market conditions, and the company reserves the right to adjust the program as needed.

Clinuvel Pharmaceuticals Completes Strategic Buy-Back

Clinuvel Pharmaceuticals Limited has completed a buy-back of 66,590 ordinary fully paid securities, with a total consideration of AUD 993,674.15. This final buy-back notification signifies the company’s strategic move to manage its capital structure, potentially enhancing shareholder value and reflecting confidence in its financial health.

Clinuvel Reports Positive Results in Stroke Treatment Study

Clinuvel Pharmaceuticals has announced positive preliminary results from its CUV803 study, which investigates the use of afamelanotide in treating arterial ischaemic stroke (AIS) patients. The study demonstrated that afamelanotide was well tolerated, with mild and transient adverse events, and showed functional improvement in 88.9% of patients and radiological improvement or stability in 66.7% of patients. These findings suggest potential benefits for AIS patients who are ineligible for standard treatments, although Clinuvel has decided to suspend further work in this area to focus on other therapeutic developments.