Orchestra BioMed Holdings (OBIO) AI Stock Analysis

• Market Cap: $104.59M
• Dividend Yield: N/A
• Average Volume (3M): 690.06K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.79
• Revenue Growth: 30.23%
• EPS Growth: -21.32%
• Country: US
• Employees: 70
• Sector: Healthcare
• Sector Strength: 43
• Industry: Biotechnology
• EPS (TTM): -0.49
• Shares Outstanding: 38,312,510
• 10 Day Avg. Volume: 191,341
• 30 Day Avg. Volume: 690,059
• PEG Ratio: 0.33
• Price to Book (P/B): 3.06
• Price to Sales (P/S): 0.00
• P/FCF Ratio: -2.00
• Enterprise Value/Market Cap: 0.92
• Enterprise Value/Revenue: 10.00
• Enterprise Value/Gross Profit: 40.59
• Enterprise Value/Ebitda: -0.41
• 1Y Price Target: $12.75
• Price Target Upside: 367.03% Upside
• Rating Consensus: Strong Buy
• Number of Analyst Covering: 4

• Rating: 51 Neutral
• Price Target: $3.00 ▲( 9.89% Upside)

Orchestra BioMed Holdings shows a mixed outlook. The primary concern is its challenging financial performance, with ongoing losses and negative cash flows. However, recent FDA approvals and strategic initiatives present potential growth opportunities. The technical analysis presents a neutral to bearish short-term outlook, while the valuation is hindered by the lack of earnings.

Positive Factors

Clinical Trial Progress

The ongoing BACKBEAT pivotal study of AVIM therapy is expected to complete enrollment with a global, multi-center trial, showing potential for a significant impact on cardiac pacemaker patients with hypertension.

Regulatory Approval

The FDA has granted Breakthrough Device designation for atrioventricular interval modulation (AVIM) therapy, providing accelerated FDA engagement and review process and potentially favorable reimbursement pathways.

Strategic Partnerships

Orchestra BioMed is a MedTech company with a unique business model maximizing its expertise in R&D while partnering with large companies to bring new devices to market.

Negative Factors

Clinical and Regulatory Risks

Risks include failure of product candidates in clinical trials, failure to secure regulatory approval, and potential dilution risk, which could impact the company's future valuation.

Financial Performance

Net loss was $18.8M, or ($0.49) per share, moderately higher than the estimated loss of $15.5M.

Funding Risks

The company may need to raise additional capital within the next 12 months, indicating a potential financial challenge.

Orchestra BioMed Holdings Business Overview & Revenue Model

Company Description

Orchestra BioMed Holdings, Inc. operates as a biomedical innovation company. The company's flagship product candidates include BackBeat Cardiac Neuromodulation Therapy (CNT) for the treatment of hypertension; and Virtue Sirolimus AngioInfusion Balloon (SAB) for the treatment of atherosclerotic artery disease. Its products also comprise FreeHold retractors that are minimally invasive surgical device solutions. The company has a strategic collaboration with Medtronic for the development and commercialization of BackBeat CNT for the treatment of hypertension in pacemaker-indicated patients; and a strategic partnership with Terumo Corporation for the development and commercialization of Virtue SAB for the treatment of artery disease. Orchestra BioMed Holdings, Inc. is based in New Hope, Pennsylvania.

How the Company Makes Money

Orchestra BioMed Holdings makes money primarily through strategic partnerships and licensing agreements with larger healthcare companies. These collaborations often involve milestone payments and royalties, which provide a steady revenue stream as the partnered products move through clinical development and commercialization. Additionally, the company may engage in co-development agreements where both parties share in the costs and potential profits of bringing new therapies to market. Its focus on high-impact therapeutic devices with significant market potential also positions it for substantial revenue growth as these products gain regulatory approval and commercial traction.

Orchestra BioMed Holdings Financial Statement Overview

Summary

Orchestra BioMed Holdings is experiencing financial difficulties with declining revenue, negative cash flows, and ongoing losses. While the balance sheet shows some financial stability, profitability and cash generation need significant improvement.

Income Statement

Orchestra BioMed Holdings has experienced a decline in revenue, with a negative revenue growth rate over the past year. The company is facing significant losses, as indicated by its negative net profit margin and EBIT margin. The gross profit margin remains positive, suggesting some control over production costs, but the overall profitability is severely impacted by high operating expenses.

Balance Sheet

The company's balance sheet shows a moderate level of leverage with a low debt-to-equity ratio. However, the negative return on equity indicates that the company is not generating sufficient returns on shareholders' equity. The equity ratio is positive, suggesting some level of financial stability.

Cash Flow

Orchestra BioMed Holdings has a negative free cash flow, indicating challenges in generating cash from operations. The operating cash flow to net income ratio is negative, reflecting inefficiencies in converting profits into cash. Nonetheless, the company has managed to improve its cash position through financing activities, which may provide short-term liquidity.

Breakdown
Dec 2024	Dec 2023	Dec 2022	Dec 2021	Dec 2020
Income Statement		Total Revenue
2.64M	2.76M	3.53M	-782.00K	5.70M
	Gross Profit
2.43M	2.57M	3.21M	-981.00K	5.56M
	EBIT
-64.30M	-51.51M	-32.66M	-21.80M	-18.75M
	EBITDA
-64.30M	-51.22M	-32.44M	-21.62M	-18.61M
	Net Income Common Stockholders
-61.02M	-49.12M	-33.61M	-23.01M	-21.36M
Balance Sheet		Cash, Cash Equivalents and Short-Term Investments
66.81M	87.59M	83.78M	10.90M	35.79M
	Total Assets
76.17M	95.21M	95.57M	13.53M	38.09M
	Total Debt
16.53M	1.69M	11.87M	5.67M	9.46M
	Net Debt
-5.73M	-28.87M	-7.91M	-4.26M	-10.89M
	Total Liabilities
43.22M	27.17M	43.04M	84.76M	86.63M
	Stockholders Equity
32.96M	68.04M	52.53M	-71.23M	-48.54M
Cash Flow		Free Cash Flow
-50.85M	-46.20M	-29.88M	-19.70M	-26.72M
	Operating Cash Flow
-50.56M	-46.13M	-29.29M	-19.43M	-26.18M
	Investing Cash Flow
13.09M	10.69M	-64.12M	13.02M	26.97M
	Financing Cash Flow
29.17M	46.22M	103.26M	-3.99M	10.00M

Orchestra BioMed Holdings Technical Analysis

• Technical Analysis Sentiment: Negative
• Last Price: 2.73
• 50DMA: Negative
• 100DMA: Negative
• 200DMA: Negative
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For OBIO, the sentiment is Negative. The current price of 2.73 is below the 20-day moving average (MA) of 2.74, below the 50-day MA of 3.20, and below the 200-day MA of 4.86, indicating a bearish trend. The MACD of -0.08 indicates Negative momentum. The RSI at 45.20 is Neutral, neither overbought nor oversold. The STOCH value of 52.19 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for OBIO.

Orchestra BioMed Holdings Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
Sector *	53 Neutral	$5.14B	3.06	-43.57%	2.81%	16.81%	-0.12%
OBIO	51 Neutral	$104.59M	―	-179.12%	―	30.23%	-21.32%
LRMR	49 Neutral	$131.90M	―	-50.77%	―	―	-54.29%
NKTR	46 Neutral	$127.87M	―	-189.46%	―	-3.24%	31.00%
RAPT	39 Underperform	$127.43M	―	-75.60%	―	―	-2.29%
ALDX	37 Underperform	$141.35M	―	-65.19%	―	―	-47.28%
KOD	35 Underperform	$187.05M	―	-108.92%	―	―	32.58%

Orchestra BioMed Holdings Corporate Events

Orchestra BioMed Receives FDA Approval for IDE Amendment

On April 22, 2025, Orchestra BioMed Holdings announced that the FDA granted Breakthrough Device Designation for its AVIM therapy, aimed at treating hypertension in pacemaker-indicated patients. This designation could expedite FDA reviews and enhance reimbursement pathways, potentially benefiting over 7.7 million U.S. patients with uncontrolled hypertension. On April 29, 2025, the company also received FDA approval for an IDE amendment to initiate an updated design of the Virtue Trial for its Virtue Sirolimus Infusion Balloon, targeting coronary in-stent restenosis. This trial will compare Virtue SAB to the Boston Scientific AGENT paclitaxel-coated balloon, with the goal of supporting U.S. regulatory approval.

Orchestra BioMed Highlights Strategic Initiatives and Innovations

Orchestra BioMed Holdings has released a presentation detailing their strategic initiatives and product developments, including the AVIM therapy and Virtue Sirolimus AngioInfusion Balloon. The company emphasizes its partnership-enabled business model aimed at accelerating innovation and improving patient outcomes, with significant market opportunities in hypertension and artery disease treatment.

Orchestra BioMed Updates Executive Compensation Policies

On February 19, 2025, Orchestra BioMed Holdings’ Compensation Committee approved several policies affecting its executive officers. A new policy was established for handling tax liabilities on restricted stock units (RSUs) for Section 16 Officers, allowing tax payments through share withholding instead of selling shares. Additionally, a new cash bonus plan was introduced, setting performance-based goals and stretch targets for 2025, with bonuses tied to achieving these objectives. The Committee also adopted a revised equity award policy and RSU vesting schedule for Vice Presidents and above, aimed at aligning executive incentives with long-term company success.