Allurion Technologies(ALUR)
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ALUR Stock Declines Despite Submitting PMA for Allurion Balloon
ZACKS· 2024-10-24 17:56
Company Overview - Allurion Technologies, Inc. (ALUR) has submitted the first three modules of its premarket approval application (PMA) to the FDA for the Allurion Balloon, utilizing the FDA's modular submission program to enhance application efficiency. The final module, containing clinical data from the AUDACITY trial, is expected to be filed early next year [1] - The Allurion Gastric Balloon is the first swallowable, procedureless gastric balloon designed for weight loss, which can be placed without surgery, endoscopy, or anesthesia, taking approximately 15 minutes during an outpatient visit [2][3] Product Details - The Allurion Balloon helps control appetite by filling space in the stomach and is designed to empty naturally after approximately four months through a time-activated release valve. It is made from polyurethane, ensuring comfort and a snug fit [3] - The AUDACITY trial, a pivotal controlled study involving 550 patients across 17 sites in the U.S., completed enrollment in fall 2023 and is expected to conclude by the end of 2024 [3] Clinical Data and Efficacy - In a study of 121 individuals treated with two consecutive, four-month courses of Allurion balloon therapy, participants lost an average of 22.1% of their body weight after one year, outperforming traditional endoscopic intragastric balloon therapy, which resulted in weight losses of 15.4% and 16.2% [4] - The Allurion Balloon has shown a lower intolerance rate compared to 12-month endoscopic balloons, with a significantly lower overall serious adverse event rate [4][5] Market Potential - The global weight management market was valued at $142.6 billion in 2022 and is projected to grow at a rate of 9.9% from 2023 to 2030, driven by increasing bariatric surgeries, online weight loss program adoption, and rising obesity rates [6] - Allurion's gastric balloon technology is positioned to capitalize on this market growth, potentially boosting the company's business and revenue [6]
October's 4 Best Penny Stocks: High-Risk, High-Reward Picks
MarketBeat· 2024-10-04 13:27
Group 1: Penny Stocks Overview - The definition of penny stocks has expanded to include companies trading up to $5 per share, characterized as high-risk, high-reward investments [1] - Penny stocks often consist of newly-established firms or those facing bankruptcy, lacking liquidity and being targets for scams [1] - Despite the risks, penny stocks can offer significant rewards at low costs, attracting investors looking for growth opportunities [1] Group 2: Allurion Technologies - Allurion Technologies (ALUR) is focused on weight loss management, with a program that has shown positive results in a recent systematic review [2] - The weight loss management market is projected to exceed $328 billion by 2032, indicating substantial growth potential [2] - Allurion reported a 25% quarter-over-quarter revenue growth, with analysts giving it a Buy rating and an average price target of $2.88, four times its current price [3] Group 3: Lucid Diagnostics - Lucid Diagnostics (LUCD) provides a test for precancer detection in patients with gastroesophageal reflux disease (GERD), affecting about 20% of the U.S. population [4] - The company experienced a 31% quarter-over-quarter increase in tests performed, with revenue growing fivefold year-over-year [4] - Lucid is positioned to capture a significant share of a U.S. market valued at $25 billion [4] Group 4: KULR Technology Group - KULR Technology Group (KULR) specializes in thermal management solutions for batteries and has secured a $2.4 million contract extension with the U.S. Army [6] - The company is emerging as a leader in sustainable energy management and data center cooling technologies [6] - KULR's technology is increasingly relevant in the growing green energy and data center markets [6] Group 5: Gevo Inc. - Gevo Inc. (GEVO) focuses on renewable fuels, particularly aviation fuel, and has benefited from the Inflation Reduction Act, with shares rising over 48% in the past year [7] - The company produced a record-setting 400,000 British thermal units of renewable natural gas (RNG) in the latest quarter [7] - Analysts have set an average price target of $5.68 for Gevo, indicating significant upside potential from its current trading price [7]
Allurion Technologies(ALUR) - 2024 Q2 - Quarterly Report
2024-08-14 20:30
Financial Performance - Allurion generated revenue of $21.2 million for the six months ended June 30, 2024, compared to $27.0 million for the same period in 2023, reflecting a decrease of approximately 21%[159]. - The company incurred a net loss of $39.8 million for the six months ended June 30, 2023, while achieving a net income of $3.4 million for the same period in 2024[159]. - Revenue decreased by $1.2 million, or 9%, to $11.8 million for the three months ended June 30, 2024, and decreased by $5.8 million, or 22%, to $21.2 million for the six months ended June 30, 2024, compared to the same periods in 2023[185]. - Gross profit decreased by $1.0 million, or 10%, to $9.0 million for the three months ended June 30, 2024, and decreased by $5.2 million, or 25%, to $15.9 million for the six months ended June 30, 2024[187]. - The company recorded a loss of $8.7 million on extinguishment of debt for both the three and six months ended June 30, 2024[195]. - As of June 30, 2024, the company had $19.3 million in cash and cash equivalents, with an accumulated deficit of $209.4 million[198]. - Cash outflows from operating activities were $17.6 million for the six months ended June 30, 2024, compared to $20.0 million for the same period in 2023[198]. - The company has substantial doubt about its ability to continue as a going concern for a period of one year from the date of the financial statements due to recurring losses and the need for additional capital[199]. Product Development and Market Presence - Allurion completed the enrollment of 550 patients in the AUDACITY clinical trial across 17 sites in the United States during the third quarter of 2023[158]. - The Allurion VCS was launched in the United States in April 2024 for patients utilizing various weight loss treatments, including anti-obesity medications and bariatric surgery[157]. - The Allurion Program includes the world's first swallowable, procedure-less intragastric balloon for weight loss, along with AI-powered remote patient monitoring tools[155]. - The Allurion App integrates data from the Allurion Connected Scale to monitor various health metrics and is available in 15 languages[156]. - Allurion's products are currently sold in multiple regions, including Europe, the Middle East, Africa, Latin America, Canada, and the Asia-Pacific region[158]. - The company aims to increase market acceptance of its products to drive sales growth and expand its customer base in existing and new markets[171]. - Regulatory approval and timely introduction of new products are critical for the company's sales growth and market presence[172]. Financial Agreements and Capital Structure - The company issued $48 million in convertible senior secured notes with an annual interest rate of 6.0%, maturing on April 16, 2031[163]. - The company has increased the revenue interest payments to be paid to RTW from 6% to 12% for net sales less than or equal to $100 million prior to December 31, 2026[164]. - The public offering on June 28, 2024, resulted in gross proceeds of $17.3 million from the sale of 14,406,508 shares at an offering price of $1.20 per share[167]. - A private placement on June 28, 2024, generated approximately $2.7 million from the sale of 2,260,159 shares of Series A Preferred Stock and accompanying warrants[168]. - The company received $48 million in gross proceeds from the Amended Note Purchase Agreement with RTW on April 16, 2024, which was used to repay the Fortress Term Loan[205]. - The Revenue Interest Financing Agreement with RTW provided $40 million in proceeds, with an increased revenue interest payment rate from 6% to 12% for net sales less than or equal to $100 million prior to December 31, 2026[206]. Operational Expenses - Operating expenses include sales and marketing, research and development, and general and administrative costs, impacting overall financial performance[176][177]. - Sales and marketing expenses decreased by $3.6 million, or 35%, to $6.7 million for the three months ended June 30, 2024, and decreased by $9.3 million, or 42%, to $12.8 million for the six months ended June 30, 2024[188]. - Research and development expenses decreased by $2.3 million, or 35%, to $4.3 million for the three months ended June 30, 2024, and decreased by $4.4 million, or 30%, to $10.0 million for the six months ended June 30, 2024[189]. - General and administrative expenses increased by $0.9 million, or 14%, to $7.3 million for the three months ended June 30, 2024, and increased by $2.0 million, or 17%, to $13.7 million for the six months ended June 30, 2024[190][191]. - Interest expense decreased by $2.2 million, or 86%, to $0.3 million for the three months ended June 30, 2024, and decreased by $2.5 million, or 52%, to $2.3 million for the six months ended June 30, 2024[192]. Regulatory and Compliance Issues - The French regulatory authority suspended sales of the Allurion Balloon, prompting the company to withdraw the device from the French market pending a remediation plan[169]. - The company received a letter from NYSE regarding non-compliance with the minimum share price requirement, with an average closing price below $1.00 for 30 consecutive business days[170]. - The company is classified as an emerging growth company, allowing it to delay adopting new accounting standards[221]. Cash Flow and Investments - Net cash used in investing activities was $0.5 million for the six months ended June 30, 2024, primarily for purchases of property and equipment[212]. - Cash used in financing activities was $0.7 million for the six months ended June 30, 2024, including a $47.7 million repayment of the Fortress Term Loan[213]. - As of June 30, 2024, the company had cash and cash equivalents totaling $19.3 million, primarily invested in money market funds[222]. - A hypothetical 10% change in interest rates would not have a material impact on the value of cash, cash equivalents, net loss, or cash flows[222]. - A 10% adverse change in foreign exchange rates could impact revenues by approximately 7% and net income by approximately 6%[222].
Allurion Technologies(ALUR) - 2024 Q2 - Earnings Call Transcript
2024-08-13 14:18
Financial Data and Key Metrics Changes - Revenue for Q2 2024 was $11.8 million, a sequential increase of $2.4 million or 25% from Q1 2024, but a decrease of $1.2 million from Q2 2023 [6][22] - Gross profit was 76% compared to 77% for the same period a year ago [23] - Loss from operations decreased by $3.9 million or 30% to $9.3 million compared to $13.3 million in the same period in 2023 [24] Business Line Data and Key Metrics Changes - Procedure volume grew by 12% compared to the same period in 2023, equating to over 10,000 Allurion balloon placements for two consecutive quarters [7] - Operating expenses and loss from operations reduced by 21% and 30% respectively compared to the prior year period [9] Market Data and Key Metrics Changes - France represents approximately 15% of the company's business over the past two quarters, with macroeconomic headwinds in Latin America and Asia Pacific leading to slower procedure growth [12] - The company adjusted its full-year procedure volume growth forecast to between 10% and 15% and expects full-year revenue to range between $40 million and $45 million [12] Company Strategy and Development Direction - The company aims to achieve profitability by the end of 2025, focusing on operational efficiencies and cost reduction initiatives [9][10] - Allurion is exploring partnerships with pharmacies and providers to offer its products to patients who have not found success with GLP-1 drugs [14] - The company is advancing its digital platform, including the Allurion Virtual Care Suite, to enhance patient monitoring and support [16] Management's Comments on Operating Environment and Future Outlook - Management noted that the French regulatory authority's actions were not based on new scientific evidence and emphasized ongoing cooperation to resume commercialization in France [11][27] - The company is optimistic about achieving top-line revenue growth next year, despite current challenges [36] Other Important Information - The company raised $22 million in gross proceeds through a public offering and a concurrent private placement of securities [10] - A new Chief Operating Officer, Ojas A. Buch, has been appointed to strengthen the management team [21] Q&A Session Summary Question: What prompted the action by the French regulatory authority? - The French regulatory authority focused on advertising, follow-up programs, and training related to the balloon, but the decision was not based on new scientific evidence [27] Question: How much of the path to profitability is based on lowering operating expenses? - Expense management and extracting efficiencies will be significant contributors to the path to profitability [30] Question: Can you quantify the impact of France inventory and macro headwinds on guidance reduction? - France accounts for approximately 15% of business, and macro headwinds have led to reduced anticipated procedural volume and conservative inventory restocking [34] Question: Will France contribute to revenue next year? - The hope is that France will contribute to revenue next year, and some macro headwinds are expected to improve [36] Question: Are there learnings from France that can be applied to other markets? - There are some learnings that may be incorporated into marketing and follow-up strategies in other parts of Europe, but the issue is largely isolated to France [38]
Allurion Technologies(ALUR) - 2024 Q2 - Quarterly Results
2024-08-13 12:00
Financial Performance - Second quarter revenue reached $11.8 million, a sequential increase of $2.4 million or 25% from Q1 2024[2] - Revenue for Q2 2024 was $11,766,000, a decrease of 9.2% compared to $12,960,000 in Q2 2023[20] - Gross profit for Q2 was 76%, slightly down from 77% in the same period last year[8] - Gross profit for Q2 2024 was $8,993,000, down from $9,968,000 in Q2 2023, representing a decline of 9.8%[20] - Net loss for Q2 2024 was $2,162,000, compared to a net loss of $21,996,000 in Q2 2023, showing significant improvement[20] - The company reported a basic net income (loss) per share of $(0.05) for Q2 2024, compared to $(0.84) for Q2 2023[20] Expenses and Cost Management - Loss from operations decreased by 30% year-over-year, amounting to $9.3 million compared to $13.3 million in Q2 2023[11] - Sales and marketing expenses decreased by approximately $3.6 million to $6.7 million compared to $10.3 million in Q2 2023[8] - Research and development expenses decreased by $2.3 million to $4.3 million, driven by reduced costs related to the AUDACITY clinical trial[9] - Total operating expenses for Q2 2024 were $18,339,000, a decrease of 21.3% from $23,262,000 in Q2 2023[20] - Research and development expenses for Q2 2024 were $4,310,000, down from $6,581,000 in Q2 2023, a reduction of 34.5%[20] Cash and Assets - Cash balance as of June 30, 2024, was $19.3 million, prior to the closing of a public offering generating approximately $22 million in gross proceeds[12] - Cash and cash equivalents decreased to $19,258,000 as of June 30, 2024, down from $38,037,000 at the end of 2023[21] - Total assets decreased to $46,550,000 as of June 30, 2024, from $71,712,000 at the end of 2023[21] - Total liabilities decreased to $117,132,000 as of June 30, 2024, down from $142,199,000 at the end of 2023[21] Operational Highlights - Procedure volume grew by 12% year-over-year, resulting in over 10,000 Allurion balloon placements for the second consecutive quarter[2] - Full-year 2024 revenue guidance updated to between $40 million and $45 million, with expected growth in procedure volume between 10% and 15%[5] - The Company is implementing a remediation plan in response to the suspension of sales of the Allurion Balloon in France[4] - The launch of GLP-1 drug support for Coach Iris aims to enhance patient outcomes in weight loss management[3]
Allurion (ALUR) Unveils Positive Data for Its Balloon Therapy
ZACKS· 2024-06-14 18:46
Company Insights - Allurion Technologies, Inc (ALUR) announced three scientific presentations at the American Society for Metabolic and Bariatric Surgery Annual Meeting, highlighting the success of its gastric balloon technology for weight loss [1] - A study involving 1,313 patient interactions with Coach Iris, an AI-powered weight reduction coach, showed that 84% of respondents were satisfied with integrity, 79% with accuracy, 89% with safety, and 95% with tone [1] - In a study of 121 individuals treated with Allurion balloon therapy, participants lost an average of 22.1% of their body weight after a year, outperforming those who underwent 12-month endoscopic intragastric balloon therapy, which resulted in weight losses of 15.4% and 16.2% [2] - The Allurion Balloon demonstrated a lower intolerance rate compared to 12-month endoscopic balloons, with a significantly lower overall serious adverse event rate [2] - The Allurion gastric balloon is swallowed as a capsule and does not require surgery or endoscopy, making it a less invasive option for weight loss [3] - The balloon is designed to fill the stomach, controlling appetite and facilitating weight loss, and it empties naturally after approximately four months [3] Industry Prospects - The global weight management market was valued at $142.6 billion in 2022 and is projected to grow at a rate of 9.9% from 2023 to 2030 [4] - Market growth is driven by increasing bariatric surgeries, the adoption of online weight loss programs, rising disposable incomes in developing countries, government initiatives for weight management awareness, and growing obesity rates due to sedentary lifestyles [4] - Allurion's gastric balloon technology is expected to enhance the company's business and generate additional revenues due to the market potential [4] Price Performance - Over the past six months, ALUR's shares have decreased by 60.7%, contrasting with a 5.9% rise in the industry and an 8.9% increase in the S&P 500 [5]
Allurion Technologies, Inc. (ALUR) Loses -38.66% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner
ZACKS· 2024-06-11 14:35
Allurion Technologies, Inc. (ALUR) has been beaten down lately with too much selling pressure. While the stock has lost 38.7% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier.How to Determine if a Stock is OversoldWe use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a moment ...
Allurion Technologies(ALUR) - 2024 Q1 - Quarterly Report
2024-05-14 20:39
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-----------------------------------------------------------------------------------|---------------------------------------------| | | | | For the transition period from ______ ...
Allurion Technologies(ALUR) - 2024 Q1 - Earnings Call Transcript
2024-05-14 15:58
Allurion Technologies Inc. (NYSE:ALUR) Q1 2024 Earnings Conference Call May 14, 2024 8:30 AM ET Company Participants Mike Cavanaugh - Investor Relations, ICR Westwicke Shantanu Gaur - Chief Executive Officer Chris Geberth - Chief Financial Officer Conference Call Participants Matthew Taylor - Jefferies Keay Nakae - Chardan Operator Thank you for standing by and welcome to the Allurion First Quarter Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks ...
Allurion Technologies(ALUR) - 2024 Q1 - Quarterly Results
2024-05-14 12:05
ACTIVE/129533855.2 Exhibit 99.1 Allurion Reports First Quarter 2024 Financial Results and Provides Business Update NATICK, Mass.- May 14, 2024 (BUSINESS WIRE)-- Allurion Technologies, Inc. (NYSE: ALUR) ("Allurion" or the "Company"), a company dedicated to ending obesity, today announced its financial results for the first quarter ended March 31, 2024, and provided a business update. Recent Company Highlights • First quarter revenue of $9.4 million, an increase of 14% from the fourth quarter of 2023 and in l ...