Beta Bionics, Inc. (BBNX) AI Stock Analysis

• Market Cap: $603.14M
• Dividend Yield: N/A
• Average Volume (3M): 917.05K
• Price to Earnings (P/E): ―
• Beta (1Y): 1.23
• Revenue Growth: 67.01%
• EPS Growth: -39.19%
• Country: US
• Employees: 352
• Sector: Healthcare
• Sector Strength: 45
• Industry: Medical - Equipment & Services
• EPS (TTM): -0.33
• Shares Outstanding: 44,024,630
• 10 Day Avg. Volume: 410,323
• 30 Day Avg. Volume: 917,055
• PEG Ratio: -0.79
• Price to Book (P/B): 1.98
• Price to Sales (P/S): 2.31
• P/FCF Ratio: -2.91
• Enterprise Value/Market Cap: 1.00
• Enterprise Value/Revenue: 6.84
• Enterprise Value/Gross Profit: 12.55
• Enterprise Value/Ebitda: -9.27
• 1Y Price Target: $27.50
• Price Target Upside: 90.18% Upside
• Rating Consensus: Moderate Buy
• Number of Analyst Covering: 8
• EPS Forecast (FY): N/A
• Revenue Forecast (FY): N/A

• Rating: 47 Neutral
• Price Target: $14.50 ▲(0.28% Upside)

The score is held down primarily by weak financial quality (ongoing losses and negative free cash flow) and bearish technicals (price below major moving averages with negative MACD). Positives from the earnings call—rapid revenue growth, margin improvement, and raised revenue guidance—provide support, but are tempered by sharply higher operating expenses and added regulatory risk from the FDA warning letter.

Positive Factors

Revenue Growth

Sustained 60%+ YoY revenue growth indicates accelerating commercial adoption of the iLet platform and successful patient acquisition. Durable top-line momentum expands recurring consumable sales, improves unit economics with scale, and underpins a credible path to long-term margin expansion.

Improving Gross Margins

A mid-50s gross margin demonstrates a high-margin product mix driven by recurring consumables and services. Sustained gross margin strength increases room to invest in sales and R&D while moving toward operating leverage, improving the company's long-term profitability prospects as revenue scales.

Pharmacy/Reimbursement Coverage

Broad PBM formulary coverage materially improves commercial access and reduces friction for ongoing reimbursement. Structural payor coverage supports recurring pharmacy-channel demand, higher retention, and more predictable revenue, enhancing the durability of the company’s commercial model.

Negative Factors

Ongoing Unprofitability and Negative Free Cash Flow

Persistent operating losses and negative free cash flow create reliance on external financing. Continued cash burn can shorten runway, force dilution, or necessitate cost cuts that constrain growth. This structural cash-flow weakness is a core risk to sustainable execution.

Rapid Operating Expense Growth

A 62% jump in operating expenses outpacing revenue growth elevates the break-even threshold and delays durable profitability. If SG&A and R&D scaling do not convert to sustainable customer economics, elevated OPEX will erode cash reserves and limit strategic flexibility.

Regulatory / Quality Compliance Risk

A Form 483 tied to complaint-handling and higher reportable complaints signals structural quality and compliance gaps. Remediation can be costly and time-consuming, potentially slowing approvals, constraining market expansion, and increasing long-term operating and reputational risk.

Beta Bionics, Inc. Business Overview & Revenue Model

Company Description

Beta Bionics, Inc., a commercial-stage medical device company, engages in the design, development, and commercialization of solutions to enhance the health and quality of life of insulin-requiring people with diabetes. It offers iLet Bionic Pancreas, an insulin delivery device for the treatment of type 1 diabetes in adults and children six years of age and older. The company is also developing Patch Pump, an insulin pump that is designed to adhere directly to the skin and administer insulin without the need for tubing; Bihormonal iLet, which combines automated delivery of insulin and glucagon; and iLet to treat people with insulin-dependent type-2 diabetes. It has collaboration and license agreement with Xeris Pharmaceuticals, Inc. (Xeris) to develop and commercialize a pump-compatible glucagon formulation; and development and commercialization agreement with Abbott Diabetes Care Inc. to develop and commercialize an automated insulin delivery system. The company was incorporated in 2015 and is based in Irvine, California.

How the Company Makes Money

Beta Bionics generates revenue primarily through the sales of its flagship product, the iLet Bionic Pancreas, which is expected to be marketed to hospitals, healthcare providers, and directly to consumers. The company may also explore partnerships with healthcare organizations and insurance companies to facilitate reimbursement models for their products. Additionally, Beta Bionics may pursue grants and funding from research institutions or government initiatives targeted at diabetes management solutions, contributing to their overall revenue streams.

Beta Bionics, Inc. Financial Statement Overview

Summary

Strong revenue growth is offset by ongoing unprofitability (negative EBIT/EBITDA and net margins) and unfavorable cash generation (negative free cash flow). The balance sheet is relatively stable with low leverage, but persistent losses and cash burn remain key risks.

Income Statement

Beta Bionics, Inc. shows strong revenue growth with a significant increase from previous years. However, the company is currently unprofitable, with negative EBIT, EBITDA, and net profit margins, indicating challenges in achieving operational efficiency and cost control.

Balance Sheet

The company's balance sheet reflects moderate leverage with a low debt-to-equity ratio and a healthy equity ratio, showcasing financial stability. However, the negative net income impacts the return on equity, which remains a concern for investors seeking profitability.

Cash Flow

Beta Bionics, Inc. faces challenges with negative free cash flow, indicative of high operational costs. Although there is a positive financing cash flow, indicating external funding, the operating cash flow to net income and free cash flow ratios are unfavorable, highlighting cash management issues.

Breakdown	TTM	Dec 2024	Dec 2023	Dec 2022
Income Statement
Total Revenue	88.57M	65.12M	11.99M	179.00K
Gross Profit	48.28M	35.89M	6.31M	179.00K
EBITDA	-65.36M	-44.10M	-34.62M	-63.40M
Net Income	-77.84M	-54.76M	-44.10M	-64.75M
Balance Sheet
Total Assets	330.05M	149.65M	110.04M	35.53M
Cash, Cash Equivalents and Short-Term Investments	228.69M	103.58M	96.75M	27.68M
Total Debt	7.69M	7.25M	4.22M	4.13M
Total Liabilities	35.29M	73.63M	51.43M	22.53M
Stockholders Equity	294.76M	76.01M	58.61M	13.00M
Cash Flow
Free Cash Flow	-60.53M	-51.67M	-32.85M	-60.98M
Operating Cash Flow	-56.58M	-48.27M	-32.45M	-60.21M
Investing Cash Flow	-193.13M	-3.48M	-69.69M	-769.00K
Financing Cash Flow	270.71M	55.62M	101.03M	56.78M

Beta Bionics, Inc. Technical Analysis

• Technical Analysis Sentiment: Positive
• Last Price: 14.46
• 50DMA: Positive
• 100DMA: Positive
• MACD: Negative
• RSI: Neutral
• STOCH: Neutral

Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For BBNX, the sentiment is Positive. The current price of 14.46 is below the 20-day moving average (MA) of 24.82, below the 50-day MA of 23.34, and equal to the 200-day MA of ―, indicating a neutral trend. The MACD of 1.55 indicates Negative momentum. The RSI at 55.71 is Neutral, neither overbought nor oversold. The STOCH value of 64.89 is Neutral, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive sentiment for BBNX.

Beta Bionics, Inc. Peers Comparison

Name	Overall Rating	Market Cap	P/E Ratio	ROE	Dividend Yield	Revenue Growth	EPS Growth
LH	72 Outperform	$22.41B	26.54	10.14%	1.14%	8.28%	97.24%
NVST	69 Neutral	$3.82B	274.04	0.50%	―	4.73%	―
TNDM	61 Neutral	$1.36B	-6.38	-109.73%	―	17.87%	-57.03%
FTRE	56 Neutral	$1.56B	-1.44	-98.13%	―	-0.54%	-259.57%
Sector *	51 Neutral	$7.86B	-0.30	-43.30%	2.27%	22.53%	-2.21%
SANA	51 Neutral	$1.22B	-4.54	-96.11%	―	―	31.16%
BBNX	47 Neutral	$603.14M	-8.07	-47.52%	―	67.01%	-39.19%

Beta Bionics, Inc. Corporate Events

Beta Bionics Receives FDA Warning Letter, Begins Remediation

On January 29, 2026, Beta Bionics, Inc. disclosed that it received an FDA warning letter following a June 9–26, 2025 inspection of its Irvine, California facility, in which regulators cited deficiencies in the company’s responses to a prior Form 483 and highlighted non-conformities in its quality management system, medical device reporting, and correction and removals processes. While the warning letter does not currently limit the company’s ability to manufacture, market, distribute existing products or seek 510(k) clearance for new devices, the company is implementing corrective actions and engaging with the FDA, acknowledging that unresolved issues could lead to additional regulatory action, though it does not expect a material impact on its previously stated goal to launch Mint by the end of 2027.

The most recent analyst rating on (BBNX) stock is a Hold with a $14.50 price target. To see the full list of analyst forecasts on Beta Bionics, Inc. stock, see the BBNX Stock Forecast page.