Orchestra BioMed Holdings (OBIO) AI Stock Analysis

• Market Cap: $215.13M
• Dividend Yield: N/A
• Average Volume (3M): 323.04K
• Price to Earnings (P/E): ―
• Beta (1Y): 2.33
• Revenue Growth: 6.46%
• EPS Growth: -14.32%
• Country: US
• Employees: 70
• Sector: Healthcare
• Sector Strength: 45
• Industry: Biotechnology
• EPS (TTM): -0.40
• Shares Outstanding: 56,464,730
• 10 Day Avg. Volume: 266,849
• 30 Day Avg. Volume: 323,035
• PEG Ratio: -0.20
• Price to Book (P/B): 4.47
• Price to Sales (P/S): 55.83
• P/FCF Ratio: -2.90
• Enterprise Value/Market Cap: 0.40
• Enterprise Value/Revenue: 30.28
• Enterprise Value/Gross Profit: 32.55
• Enterprise Value/Ebitda: -1.14
• 1Y Price Target: $12.50
• Price Target Upside: 276.51% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 3
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 55 Neutral
• Price Target: $4.50 ▲(35.54% Upside)

Orchestra BioMed's overall stock score is primarily impacted by its weak financial performance, characterized by high leverage and negative profit margins. However, positive corporate events, including strategic partnerships and significant financing, provide a strong foundation for future growth. The technical analysis presents a mixed outlook, while valuation remains a concern due to unprofitability.

Positive Factors

Strategic Partnerships

The strategic agreement with Terumo Corporation, including a $30 million investment, enhances OBIO's market position and provides capital for advancing pivotal programs, indicating long-term growth potential.

FDA Breakthrough Designation

FDA Breakthrough Designation for AVIM Therapy enhances OBIO's market position by facilitating faster regulatory approval, potentially accelerating revenue growth and market penetration.

Significant Financing

The $147 million financing supports OBIO's operations and clinical advancements through key milestones, ensuring financial stability and enabling strategic growth in the cardiovascular sector.

Negative Factors

High Leverage

High leverage indicates financial risk, potentially limiting OBIO's ability to invest in growth opportunities and increasing vulnerability to economic downturns.

Negative Profit Margins

Negative profit margins highlight operational inefficiencies and ongoing losses, which could hinder OBIO's ability to achieve sustainable profitability and long-term financial health.

Declining Revenue Trend

A declining revenue trend suggests challenges in market expansion and product adoption, potentially impacting OBIO's ability to improve financial performance and achieve growth targets.

Orchestra BioMed Holdings Business Overview & Revenue Model

Company Description

Orchestra BioMed Holdings (OBIO) is a biomedical company focused on developing and commercializing innovative solutions to address significant unmet medical needs in the fields of cardiovascular disease and other chronic conditions. The company leverages its proprietary technology platforms to create advanced therapeutic devices, with a core emphasis on enhancing the efficacy and safety of existing treatments. OBIO's flagship products include the Virtue® Sirolimus-Eluting Balloon, aimed at treating peripheral artery disease, and various other devices designed to improve patient outcomes through minimally invasive procedures.

How the Company Makes Money

Orchestra BioMed generates revenue primarily through the commercialization of its medical devices and therapeutic solutions. The company earns money by selling its proprietary products, such as the Virtue® Sirolimus-Eluting Balloon, to healthcare providers and hospitals. Additionally, OBIO may engage in strategic partnerships with larger healthcare companies to co-develop or market its products, which can also provide financial support through upfront payments, milestone payments, and royalties on future sales. The company focuses on expanding its market reach and enhancing its product offerings, which are significant factors contributing to its earnings potential.

Orchestra BioMed Holdings Financial Statement Overview

Summary

Orchestra BioMed Holdings faces challenges with declining revenues and significant losses, as reflected in negative profit margins and high leverage. While the gross profit margin remains strong, indicating cost efficiency, the company struggles with operational inefficiencies and financial risks due to high debt levels. Cash flow metrics show slight improvements, but overall, the financial health of the company is concerning, with a need for strategic improvements to enhance profitability and reduce leverage.

Income Statement

Orchestra BioMed Holdings shows a declining revenue trend with a negative revenue growth rate of -4.28% in TTM. The company has a strong gross profit margin of 92.66%, indicating efficient cost management. However, the net profit margin is significantly negative at -23.67%, reflecting substantial losses. EBIT and EBITDA margins are also negative, highlighting operational inefficiencies.

Balance Sheet

The balance sheet reveals a high debt-to-equity ratio of 6.68 in TTM, indicating high leverage and potential financial risk. The return on equity is negative, suggesting that the company is not generating profit from shareholders' equity. The equity ratio is relatively low, pointing to a reliance on debt financing.

Cash Flow

The cash flow statement shows a slight improvement in free cash flow growth at 1.83% in TTM. However, the operating cash flow to net income ratio is negative, indicating that the company is not generating sufficient cash from operations to cover its net losses. The free cash flow to net income ratio is slightly above 1, suggesting that free cash flow is marginally covering net losses.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement
Total Revenue	2.82M	2.64M	2.76M	3.53M	-782.00K	5.70M
Gross Profit	2.62M	2.43M	2.57M	3.21M	-981.00K	5.56M
EBITDA	-74.74M	-63.99M	-51.22M	-32.44M	-21.62M	-18.61M
Net Income	-75.10M	-61.02M	-49.12M	-33.61M	-23.01M	-21.36M
Balance Sheet
Total Assets	104.81M	76.17M	95.21M	95.57M	13.53M	38.09M
Cash, Cash Equivalents and Short-Term Investments	95.82M	66.81M	87.59M	83.78M	10.90M	35.79M
Total Debt	1.83M	16.53M	1.69M	11.87M	5.67M	9.46M
Total Liabilities	61.07M	43.22M	27.17M	43.04M	84.76M	86.63M
Stockholders Equity	43.74M	32.96M	68.04M	52.53M	-71.23M	-48.54M
Cash Flow
Free Cash Flow	-60.79M	-50.85M	-46.20M	-29.88M	-19.70M	-26.72M
Operating Cash Flow	-60.23M	-50.56M	-46.13M	-29.29M	-19.43M	-26.18M
Investing Cash Flow	-12.98M	13.09M	10.69M	-64.12M	13.02M	26.97M
Financing Cash Flow	89.62M	29.17M	46.22M	103.26M	-3.99M	10.00M

Orchestra BioMed Holdings Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 3.32
• 50DMA: Positive
• 100DMA: Positive
• 200DMA: Positive
• MACD: Positive
• RSI: Neutral
• STOCH: Positive

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For OBIO, the sentiment is Positive. The current price of 3.32 is below the 20-day moving average (MA) of 4.61, below the 50-day MA of 3.95, and above the 200-day MA of 3.29, indicating a bullish trend. The MACD of 0.18 indicates Positive momentum. The RSI at 54.85 is Neutral, neither overbought nor oversold. The STOCH value of 14.54 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for OBIO.

Orchestra BioMed Holdings Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
OBIO	55 Neutral	$215.13M	―	-166.97%	―	6.46%	-14.32%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
CRDF	47 Neutral	$142.13M	-2.66	-102.71%	―	-27.29%	16.40%
PYXS	47 Neutral	$262.75M	―	-87.28%	―	-82.53%	-52.00%
CLYM	41 Neutral	$127.40M	-2.71	-25.65%	―	―	64.81%
CGTX	41 Neutral	$152.71M	-3.64	-109.73%	―	―	50.39%

Orchestra BioMed Holdings Corporate Events

Orchestra BioMed Secures FDA Breakthrough Designation

On November 12, 2025, Orchestra BioMed Holdings held a conference call to discuss significant business updates, including clinical, strategic, and financing developments. The company highlighted its recent achievements, such as raising nearly $150 million in capital, strengthening collaborations with Medtronic, and securing FDA Breakthrough Device Designation for AVIM Therapy. These developments position Orchestra BioMed optimally to complete pivotal trials and advance its therapies towards regulatory approvals, enhancing its market position and potential profitability.

Orchestra BioMed Secures $147M for Therapy Advancements

In October 2025, Orchestra BioMed Holdings announced securing over $147 million in strategic-driven financing since August 2025, aimed at advancing their high-impact therapies like AVIM Therapy and Virtue SAB. The company is leveraging partnerships to accelerate clinical development and expects this funding to support operations through key milestones into Q4 2027, indicating a strong future market position and potential profitability in the cardiovascular treatment sector.

Orchestra BioMed Announces Strategic Agreement with Terumo

On October 28, 2025, Orchestra BioMed Holdings announced a new strategic agreement with Terumo Corporation, which includes a $30 million investment and grants Terumo a right of first refusal for the Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) for coronary artery disease treatment. This agreement supersedes a prior distribution agreement and highlights the clinical and commercial potential of Virtue SAB, as well as providing Orchestra BioMed with additional capital to advance its pivotal stage programs. The company also initiated patient enrollment for its Virtue Trial in the U.S., aiming to support regulatory approval for the Virtue SAB, which has shown promising results in previous studies and has FDA Breakthrough Device Designation.