Clinuvel Pharmaceuticals (CLVLF) AI Stock Analysis

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Clinuvel Pharmaceuticals (CLVLF) vs. SPDR S&P 500 ETF (SPY)

Market Cap

$336.21M

Dividend Yield0.45%

Average Volume (3M)26.00

Price to Earnings (P/E)14.4

Beta (1Y)0.38

Revenue GrowthN/A

EPS GrowthN/A

CountryUS

Employees16

SectorHealthcare

Sector Strength41

IndustryBiotechnology

Share Statistics

EPS (TTM)0.18

Shares Outstanding50,123,630

10 Day Avg. Volume20

30 Day Avg. Volume26

Financial Highlights & Ratios

PEG Ratio1.74

Price to Book (P/B)2.62

Price to Sales (P/S)0.00

P/FCF Ratio24.15

Enterprise Value/Market CapN/A

Enterprise Value/RevenueN/A

Enterprise Value/Gross ProfitN/A

Enterprise Value/EbitdaN/A

Forecast

1Y Price Target

$25.48

Price Target Upside247.61% Upside

Rating ConsensusModerate Buy

Number of Analyst Covering0

Clinuvel Pharmaceuticals Business Overview & Revenue Model

Company DescriptionClinuvel 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 Earnings Call Summary

Earnings Call Date:Feb 26, 2025

(Q2-2025)

% Change Since: 5.47%|

Next Earnings Date:Sep 02, 2025

Earnings Call Sentiment Positive

The earnings call highlighted strong financial performance with significant revenue growth and operational successes, such as expansion in treatment networks and ongoing development in the vitiligo program. However, rising expenses and challenges in drug development and regulatory approvals present some concerns. Despite these challenges, the company remains optimistic about future growth and market recognition.

Q2-2025 Updates

Positive Updates

Strong Financial Performance

Sales grew by 10.5% to $36 million, total revenues increased by 21% to $43 million, and profit before tax rose by 48% to just under $22 million. Profit after tax increased by almost 30% to $14 million.

Earnings Per Share and Cash Reserves

Earnings per share rose by 27% from $0.22 to $0.28, and cash reserves increased by 8% to $198 million.

Operational Success

The company remains debt-free for the 20th consecutive year with an increase of 7% in net assets. The company's model has allowed expansion without needing dilutive capital raises or external debt funding.

Expansion in Treatment Network

Increase in revenues due to more patients being treated and a more frequent dosing of patients across the U.S. and Europe. Successful engagement with physicians who are building a network of treatment centers.

Ongoing Development in Vitiligo Program

Visible repigmentation in trials with plans to expand clinical and nonclinical development. New sites and patients being incorporated into the program.

Negative Updates

Rising Expenses

Personnel expenses increased by 34%, clinical and nonclinical expenses up 22%, and commercial distribution expenditure up 25% as a direct result of larger sales figures.

Challenges and Risks in Drug Development

Drug development is risky with competition for clinic and patient recruitment in trials. The company faces challenges in competing with immunosuppressants and other competing clinical trials for vitiligo.

Regulatory and Market Challenges

Ongoing dialogue with regulators for approval of afamelanotide for adolescent patients. There is market resistance to new treatments and delays in regulatory approvals.

Company Guidance

In the recent investor call, CLINUVEL presented impressive financial metrics for the half-year ending December 31, 2024. Their sales increased by 10.5% to $36 million, while total revenues rose by 21% to $43 million. The company managed to keep expenses growth to a modest 2%, leading to a 48% increase in profit before tax, reaching nearly $22 million. Profit after tax grew by almost 30% to $14 million, and earnings per share increased by 27% from $0.22 to $0.28. The balance sheet showed a 7% rise in net assets, with cash reserves climbing by 8% to $198 million. This strong financial performance was accompanied by strategic operational highlights, including expansion in the U.S. and Europe and advancements in their vitiligo program, reflecting CLINUVEL's ongoing commitment to sustainable growth and shareholder value.

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

Very Positive

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

Positive

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

Positive

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.

TTM	Jun 2024	Jun 2023	Jun 2022	Jun 2021	Jun 2020
Breakdown
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
	EBIT
49.10M	48.01M	40.91M	33.08M	26.70M	10.20M
	EBITDA
51.73M	51.86M	46.37M	35.08M	26.57M	11.99M
	Net Income Common Stockholders
38.78M	35.64M	30.60M	20.88M	24.73M	16.65M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
198.22M	183.87M	156.81M	121.51M	82.69M	66.75M
	Total Assets
236.20M	231.12M	194.52M	144.81M	108.57M	81.54M
	Total Debt
715.38K	879.78K	999.87K	1.26M	1.30M	1.32M
	Net Debt
-16.11M	-182.99M	-22.87M	-26.15M	-35.84M	-24.33M
	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 Peers Comparison

Overall Rating

UnderperformOutperform

Sector (54)

Financial Indicators

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
CLVLF		$336.21M	14.36	19.93%	0.45%	―	―
Sector *	54 Neutral	$5.31B	3.26	-45.10%	2.79%	16.76%	0.02%
CKDXF		$481.10M	―		―	―	―
PRRUF		$256.80M	―	-31.16%	―	―	―
PYC	53 Neutral	AU$699.91M	―	-112.97%	―	―	-84.82%
CU6	53 Neutral	AU$723.04M	―	-53.99%	―	―	-40.19%
BOT	53 Neutral	AU$647.09M	―	-56.99%	―	10.76%	-195.89%

* Healthcare Sector Average

Performance Comparison

CLVLF

Clinuvel Pharmaceuticals

7.33

-2.51

-25.51%

CKDXF

Opthea Limited

0.48

0.19

65.52%

PRRUF

Immutep Ltd

0.19

-0.09

-32.14%

AU:PYC

PYC Therapeutics Limited

1.20

0.16

15.38%

AU:CU6

Clarity Pharmaceuticals Ltd.

2.25

-2.94

-56.65%

AU:BOT

Botanix Pharmaceuticals Limited

0.33

0.05

17.86%

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.