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0001964979false0001964979alur:WarrantsToPurchase1420455SharesOfCommonStockEachAtAnExercisePriceOf810PerShareOfCommonStockMember2024-11-132024-11-1300019649792024-11-132024-11-130001964979alur:CommonStockParValue00001PerShareMember2024-11-132024-11-13

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 13, 2024

 

 

Allurion Technologies, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-41767

92-2182207

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

11 Huron Drive

 

Natick, Massachusetts

 

01760

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (508) 647-4000

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common stock, par value $0.0001 per share

 

ALUR

 

The New York Stock Exchange

Warrants to purchase 1.420455 shares of common stock, each at an exercise price of $8.10 per share of common stock

 

ALUR WS

 

The New York Stock Exchange

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 


Item 2.02 Results of Operations and Financial Condition.

On November 13, 2024, Allurion Technologies, Inc. issued a press release announcing its financial results for the three and nine months ended September 30, 2024. The full text of that press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

The information contained in this Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

Exhibit

Description

99.1

Press Release issued by the registrant on November 13, 2024 furnished herewith.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

Allurion Technologies, Inc.

 

 

 

 

Date:

November 13, 2024

By:

/s/ Chris Geberth

 

 

Name:

Title:

Chris Geberth
Chief Financial Officer

 


EX-99.1 2 alur-ex99_1.htm EX-99.1 EX-99.1

Exhibit 99.1

Allurion Reports Third Quarter 2024 Financial Results and Provides Business Update

NATICK, Mass.-- November 13, 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 third quarter ended September 30, 2024 and provided a business update.

 

Recent Company Highlights

 

Revenue of $5.4 million, which includes a reduction of $1.2 million for product recalled from France during the third quarter
AI product revenue in the third quarter from the Virtual Care Suite (VCS) grew by 82% versus prior year as first patients in the United States treated with GLP-1s were on-boarded
Last patient in AUDACITY FDA clinical trial successfully exited, putting top-line readout on track for the end of the year
Worked collaboratively with ANSM to prepare remediation plan for France, which was submitted in August and completed in September
Updating full-year 2024 revenue guidance to between $30 million and $35 million
Initiated business restructuring which is expected to reduce operating expense by 50% in 2025 and achieve profitability by end of 2025
Completed submissions to the FDA of three out of four modules required for the Pre-Market Approval (PMA) application for the Allurion Balloon
Announced appointment of Adrian Wild as SVP International Commercial and plans to restructure commercial operations and strategy

“We observed robust growth in procedure volume in the third quarter in regions previously impacted by GLP-1s like the Middle East and in parts of Latin America where the macro headwinds we have faced previously appear to be subsiding,” said Dr. Shantanu Gaur, Chief Executive Officer. “Our results were adversely affected by the suspension of sales in France, destocking in certain markets, and the availability of compounded GLP-1s in the UK. Overall, our performance validates the need for considerable change at Allurion. As part of our restructuring, we have installed new leadership in the commercial team and are implementing a new sales strategy that strengthens the sales force in number and focus, shifting them away from less efficient direct-to-consumer approaches and toward what we expect to be more profitable and predictable business-to-business-to-consumer sales strategies with a specific focus on direct markets. With our new plan going into 2025, I have clarity and excitement about our path forward.

“We remain committed to achieving profitability by the end of next year, and we are optimistic about future catalysts, including the AUDACITY read-out expected before the end of this year. We are also optimistic about resuming commercialization in France following the completion of our remediation plan in September. In parallel, we have been pleased to see a steady stream of research articles on the Allurion Balloon published in peer-reviewed journals that validate the balloon’s safety and efficacy,” Dr. Gaur continued.

 

“We have also observed robust growth in our AI product revenue, especially as providers expand their practices with GLP-1s. With revenues increasing at this pace, we believe we can expand this business further and plan on testing Coach Iris—our verticalized, conversational AI agent for weight loss—in different use cases in the coming months.”


 

 

The Company is updating its full-year 2024 revenue guidance to between $30 million and $35 million and expects growth in procedure volume to be flat year-over-year.

In early November 2024, the Company began implementing a worldwide restructuring plan (the “2024 Restructuring Plan”). The 2024 Restructuring Plan was designed to align the Company’s operating expenses with its current sales forecast and strategic plan with a focus on sales and marketing outside of the United States. This restructuring included a worldwide reduction in both workforce and operating expenses of approximately 50% to reduce future operating cash burn. These actions are intended to increase operational and financial flexibility, position the Company to navigate an evolving economic landscape, and extend its financial runway for sustained future growth in 2025 and beyond. The Company anticipates recording restructuring charges of approximately $3.5 million in the fourth quarter of 2024.

 

Third Quarter Financial Results

 

Total revenue for the quarter ended September 30, 2024 was $5.4 million, compared to $18.2 million for the same period in 2023. The year-over-year decrease in revenue reflected de-stocking, macroeconomic headwinds in certain markets leading to lower re-order rates during the period, the temporary suspension of sales in France and the resulting reduction to revenue in the period for product recalled in the third quarter of 2024 from France, and reductions in sales to certain accounts to manage credit risk.

 

Gross profit for the third quarter was 58%, compared to 77% for the same period in 2023, negatively impacted by the reduction to revenue in the period related to the product recalled in France, and lower production volumes, which resulted in less manufacturing labor and overhead being absorbed into inventory costs.

 

Sales and marketing expenses for the third quarter decreased by approximately $8.8 million to $5.2m million, compared to $14.0 million for the same period in 2023, driven largely by increased operating efficiency and our previous cost reduction initiatives implemented in the fourth quarter of 2023.

 

Research and development expenses decreased by $4.0 million to $3.2 million in the quarter driven by reduced costs related to our AUDACITY clinical trial.

 

General and administrative expenses of $7.0 million decreased by $11.9 million, driven by $10.0 million of transaction-related expenses and stock-based compensation expense related to the business combination with Compute Health recognized in the third quarter of 2023 and less bad debts expense recognized in the third quarter of 2024 compared to the third quarter of 2023.

 

Loss from operations for the third quarter decreased by $13.8 million to $12.3 million, compared to $26.2 million in the same period in 2023. The decrease in loss from operations was driven by $10.0 million of transaction-related expenses and stock-based compensation expense related to the business combination with Compute Health recognized in the third quarter of 2023 and less bad debts expense recognized in the third quarter of 2024 compared to the third quarter of 2023 as well as our efforts to reduce operating costs.

 

Cash balance on September 30, 2024 was $28.7 million.


 

Conference Call and Webcast Details

 

Company management will host a conference call to discuss financial results and provide a business update on November 13, 2024 at 8:30 AM ET.

 

To access the conference call by telephone, please dial (888) 330-3417 (domestic) or +1 646 960 0804 (international) and use Conference ID 1905455. To listen to the conference call via live audio webcast, please visit the Events section of Allurion’s Investor Relations website at Allurion - Events & Presentations. The archived webcast will also be available on Allurion’s Investor Relations website mentioned above shortly after the completion of the call.

 

About Allurion

 

Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less(TM) intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.

 

For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com.

 

Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.

 

Forward-Looking Statements

 

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although Allurion believes that it has a reasonable basis for each forward-looking statement contained in this press release, Allurion cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain.

 

Forward-looking statements in this press release include, but are not limited to, statements regarding: the Company’s financial outlook for 2024 and future years, including the anticipated impact of the 2024 Restructuring Plan on the Company’s operating expenses and its ability to achieve profitability by the end of 2025; the Company’s ability, through the implementation of the 2024 Restructuring Plan, to increase operational and financial flexibility, position itself to navigate an evolving economic landscape and extend its financial runway for sustained future growth in 2025 and beyond; the Company’s expectations with respect to the total restructuring charges to be incurred in the fourth quarter of 2024 as part of the 2024 Restructuring Plan; the Company’s beliefs with respect to the shift in number and focus of its sales force strategy; the timing and results of the AUDACITY clinical trial; the performance and market acceptance of products, including VCS and the Coach Iris feature, for patients using different weight loss therapies both outside and within the United States, as well as the Company’s ability to expand these aspects of its business further in 2025; Allurion’s continued engagement with ANSM and its ability to implement remediation efforts sufficient to satisfy ANSM and its expectations regarding the resumption of sales and marketing efforts in France; and the market and demand for our products and weight-loss solutions, including GLP-1 drugs and elective procedures.


 

 

Allurion cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward looking statements are subject to a number of risks and uncertainties, including, among others, general economic, political and business conditions; the ability of Allurion to obtain and maintain regulatory approval for, and successfully commercialize, the Allurion Program; the timing of, and results from, its clinical studies and trials; the evolution of the markets in which Allurion competes; and the impact of GLP-1 drugs; the ability of Allurion to maintain its listing on the New York Stock Exchange; the effect of COVID-19, the Russia and Ukraine war and the Israel-Hamas war on Allurion’s business and financial results; the outcome of any legal proceedings against Allurion; the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion competes; and those factors discussed under the heading “Risk Factors” in the Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 26, 2024, as amended, and other filings with the SEC. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that Allurion will achieve its objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent Allurion’s views as of the date of this press release. Allurion anticipates that subsequent events and developments will cause its views to change. However, while Allurion may elect to update these forward-looking statements at some point in the future, Allurion has no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing Allurion’s views as of any date subsequent to the date of this press release.

 


 

Unaudited Condensed Consolidated Statements of Operations

(dollars in thousands, except per share amounts)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Revenue

 

$

5,367

 

 

$

18,200

 

 

$

26,519

 

 

$

45,232

 

Cost of revenue

 

 

2,256

 

 

 

4,232

 

 

 

7,549

 

 

 

10,165

 

Gross profit

 

 

3,111

 

 

 

13,968

 

 

 

18,970

 

 

 

35,067

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Sales and marketing

 

 

5,197

 

 

 

13,989

 

 

 

18,060

 

 

 

36,127

 

Research and development

 

 

3,212

 

 

 

7,191

 

 

 

13,247

 

 

 

21,623

 

General and administrative

 

 

7,043

 

 

 

18,942

 

 

 

20,746

 

 

 

30,657

 

Total operating expenses:

 

 

15,452

 

 

 

40,122

 

 

 

52,053

 

 

 

88,407

 

Loss from operations

 

 

(12,341

)

 

 

(26,154

)

 

 

(33,083

)

 

 

(53,340

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

 

 

 

 

(2,586

)

 

 

(2,264

)

 

 

(7,331

)

Changes in fair value of warrants

 

 

9,703

 

 

 

3,868

 

 

 

14,210

 

 

 

2,189

 

Changes in fair value of debt

 

 

1,790

 

 

 

(6,008

)

 

 

10,020

 

 

 

(3,751

)

Changes in fair value of Revenue Interest Financing and PIPE Conversion Option

 

 

(11,104

)

 

 

(2,040

)

 

 

(9,608

)

 

 

(2,040

)

Changes in fair value of earn-out liabilities

 

 

2,260

 

 

 

24,330

 

 

 

22,140

 

 

 

24,330

 

Loss on extinguishment of debt

 

 

 

 

 

(3,929

)

 

 

(8,713

)

 

 

(3,929

)

Termination of convertible note side letters

 

 

 

 

 

(9,466

)

 

 

 

 

 

(17,598

)

Other income, net

 

 

757

 

 

 

389

 

 

 

1,928

 

 

 

133

 

Total other income (expense):

 

 

3,406

 

 

 

4,558

 

 

 

27,713

 

 

 

(7,997

)

Loss before income taxes

 

 

(8,935

)

 

 

(21,596

)

 

 

(5,370

)

 

 

(61,337

)

Provision for income taxes

 

 

(69

)

 

 

(34

)

 

 

(210

)

 

 

(90

)

Net loss

 

 

(9,004

)

 

 

(21,630

)

 

 

(5,580

)

 

 

(61,427

)

Cumulative undeclared preferred dividends

 

 

 

 

 

(255

)

 

 

 

 

 

(1,697

)

Net loss attributable to common shareholders

 

$

(9,004

)

 

$

(21,885

)

 

$

(5,580

)

 

$

(63,124

)

Net loss per share

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.14

)

 

$

(0.54

)

 

$

(0.10

)

 

$

(2.00

)

Weighted-average shares outstanding

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted

 

 

64,086,265

 

 

 

40,335,457

 

 

 

53,310,214

 

 

 

31,558,538

 

 


 

Unaudited Condensed Consolidated Balance Sheets

(dollars in thousands)

 

 

 

September 30,
2024

 

 

December 31,
2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

28,654

 

 

$

38,037

 

Accounts receivable, net of allowance of doubtful accounts of $8,243 and
   $12,671, respectively

 

 

9,935

 

 

 

18,194

 

Inventory, net

 

 

4,568

 

 

 

6,171

 

Prepaid expenses and other current assets

 

 

1,672

 

 

 

2,414

 

Total current assets

 

 

44,829

 

 

 

64,816

 

Property and equipment, net

 

 

3,080

 

 

 

3,381

 

Right-of-use asset

 

 

2,283

 

 

 

3,010

 

Other long-term assets

 

 

507

 

 

 

505

 

Total assets

 

$

50,699

 

 

$

71,712

 

Liabilities, Redeemable Convertible Preferred Stock, and Stockholders’ Deficit

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

10,393

 

 

$

10,379

 

Current portion of term loan

 

 

 

 

 

38,643

 

Current portion of lease liabilities

 

 

878

 

 

 

908

 

Accrued expenses and other current liabilities

 

 

7,973

 

 

 

15,495

 

Total current liabilities

 

 

19,244

 

 

 

65,425

 

Warrant liabilities

 

 

7,381

 

 

 

6,765

 

Revenue Interest Financing liability

 

 

38,500

 

 

 

36,200

 

Earn-out liabilities

 

 

1,850

 

 

 

23,990

 

Convertible notes payable, net of discounts and current portion

 

 

36,090

 

 

 

 

Lease liabilities, net of current portion

 

 

1,578

 

 

 

2,306

 

Other liabilities

 

 

9,867

 

 

 

7,513

 

Total liabilities

 

 

114,510

 

 

 

142,199

 

Commitments and Contingencies

 

 

 

 

 

 

Redeemable Convertible Preferred Stock:

 

 

 

 

 

 

Series A redeemable convertible preferred stock, $0.0001 par value — 100,000,000 shares authorized as of September 30, 2024; and 2,260,159 and zero shares issued and outstanding as of September 30, 2024 and December 31, 2023

 

 

979

 

 

 

 

Stockholders’ deficit:

 

 

 

 

 

 

Common stock, $0.0001 par value — 1,000,000,000 shares authorized as of September 30, 2024; and 64,369,381 and 47,688,096 shares issued and outstanding as of September 30, 2024 and December 31, 2023, respectively

 

 

7

 

 

 

5

 

Additional paid-in capital

 

 

150,692

 

 

 

143,007

 

Accumulated other comprehensive loss

 

 

2,890

 

 

 

(700

)

Accumulated deficit

 

 

(218,379

)

 

 

(212,799

)

Total stockholders’ deficit

 

 

(64,790

)

 

 

(70,487

)

Total liabilities, redeemable convertible preferred stock, and stockholders’ deficit

 

$

50,699

 

 

$

71,712

 

 


 

Investors
Mike Cavanaugh, Investor Relations
ICR Westwicke
(617) 877-9641
mike.cavanaugh@westwicke.com

 

Global Media
Cedric Damour
PR Manager
+33 7 84 21 02 20
cdamour@allurion.com
 

Source: Allurion Technologies, Inc.