Clinuvel Pharmaceuticals (CUV) AI Stock Analysis

• Market Cap: $686.69M
• Dividend Yield: 0.4%
• Average Volume (3M): 98.92K
• Price to Earnings (P/E): 17.7
• Beta (1Y): 0.35
• Revenue Growth: 19.42%
• EPS Growth: 1.21%
• Country: AU
• Employees: 16
• Sector: Healthcare
• Sector Strength: 48
• Industry: Biotechnology
• EPS (TTM): 0.42
• Shares Outstanding: 50,123,630
• 10 Day Avg. Volume: 111,432
• 30 Day Avg. Volume: 98,918
• PEG Ratio: N/A
• Price to Book (P/B): N/A
• Price to Sales (P/S): N/A
• P/FCF Ratio: N/A
• Enterprise Value/Market Cap: 0.60
• Enterprise Value/Revenue: 4.49
• Enterprise Value/Gross Profit: 4.94
• Enterprise Value/Ebitda: 7.90
• 1Y Price Target: $21.56
• Price Target Upside: 59.09% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 5

• Rating: 74 Outperform
• Price Target: AU$13.00 ▼(-4.06% Downside)

Clinuvel Pharmaceuticals is well-positioned in the biotechnology sector with strong financial performance and strategic expansion efforts, as highlighted in the recent earnings call. The stock's technical indicators suggest bullish momentum, though caution is warranted due to overbought signals. The company's valuation is attractive, but potential risks from rising expenses and regulatory challenges should be monitored.

Clinuvel Pharmaceuticals Business Overview & Revenue Model

Company Description

Clinuvel Pharmaceuticals Limited, a biopharmaceutical company, focuses on developing and commercializing treatments for patients with genetic, metabolic, and life-threatening disorders in Australia, Europe, the United States, Switzerland, and internationally. Its lead drug candidate is SCENESSE, a systemic photoprotective drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The company's pipeline products include CUV9900, an alpha-melanocyte stimulating hormone analogue; Parvysmelanotide (VLRX001), which provoke prolonged cellular activity; and PRÉNUMBRA, a liquid injectable formulation of afamelanotide. Clinuvel Pharmaceuticals Limited has a collaboration agreement with HK Winhealth Pharma Group Co. Limited t to treat EPP patients with SCENESSE under a named patient program in the People's Republic of China. The company was founded in 1987 and is headquartered in Melbourne, Australia.

How the Company Makes Money

Clinuvel Pharmaceuticals generates revenue primarily through the commercialization of its lead product, SCENESSE®. The company earns money by selling SCENESSE® to healthcare providers, hospitals, and specialty pharmacies, particularly in regions where the product has received regulatory approval, such as Europe and the United States. In addition to direct sales, Clinuvel may engage in licensing agreements and strategic partnerships to expand the reach of its products and pipeline candidates. These partnerships can provide upfront payments, milestone payments, and royalties, contributing to the company's overall revenue. Furthermore, Clinuvel invests in research and development to diversify its product offerings and enter new markets, potentially expanding its revenue streams in the future.

Clinuvel Pharmaceuticals Financial Statement Overview

Summary

Clinuvel Pharmaceuticals exhibits strong overall financial health with robust revenue and profit growth, efficient operational management, and a solid equity position. Despite some fluctuations in free cash flow growth, the company maintains low leverage, reducing financial risk.

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

Clinuvel Pharmaceuticals Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 13.55
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Negative
• 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 Positive. The current price of 13.55 is above the 20-day moving average (MA) of 12.44, above the 50-day MA of 11.53, and above the 200-day MA of 11.56, indicating a bullish trend. The MACD of 0.38 indicates Negative momentum. The RSI at 52.83 is Neutral, neither overbought nor oversold. The STOCH value of 73.78 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for AU:CUV.

Clinuvel Pharmaceuticals Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CUV	74 Outperform	$686.69M	17.69	15.90%	0.40%	19.42%	1.21%
Sector *	51 Neutral	$7.83B	-0.18	-40.10%	2.29%	21.46%	-2.03%
CKDXF	―	$481.10M	―		―	―	―
PRRUF	―	$238.43M	―	-31.16%	―	―	―
CU6	53 Neutral	AU$1.29B	―	-53.99%	―	―	-40.19%
BOT	53 Neutral	AU$313.78M	―	-56.99%	―	10.76%	-195.89%
PYC	51 Neutral	AU$758.24M	―	-112.97%	―	―	-84.82%

Clinuvel Pharmaceuticals Corporate Events

Clinuvel Pharmaceuticals Highlights Risks and Challenges in Product Development

Clinuvel Pharmaceuticals has released a statement highlighting the potential risks and challenges it faces in developing and commercializing its products, including SCENESSE® and other PhotoCosmetic offerings. The company acknowledges the impact of global events, regulatory scrutiny, and competition on its operations, emphasizing the importance of innovative R&D and effective patent protection to maintain its industry position.

The most recent analyst rating on (AU:CUV) stock is a Buy with a A$39.70 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 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.