Form 8-K

8-K — SHOULDER INNOVATIONS, INC.

Accession: 0001699350-26-000050

Filed: 2026-08-06

Period: 2026-08-06

CIK: 0001699350

SIC: 3841 (SURGICAL & MEDICAL INSTRUMENTS & APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — si-20260806.htm (Primary)

EX-99.1 (ex-991earningsreleaseq22026.htm)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K

8-K (Primary)

Filename: si-20260806.htm · Sequence: 1

si-20260806

0001699350false00016993502026-08-062026-08-06

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): August 6, 2026

___________________________________________

SHOULDER INNOVATIONS, INC.

(Exact name of registrant as specified in its charter)

Delaware 001-42771 27-0538764

(State or other jurisdiction of

incorporation) (Commission File Number) (IRS Employer

Identification No.)

1535 Steele Avenue SW, Suite B

Grand Rapids, Michigan

49507

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (616) 294-1026

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 (see General Instruction A.2. below):

☐ 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 Name of each exchange on which registered

Common Stock, $0.001 par value per share SI 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 x

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 August 6, 2026, Shoulder Innovations, Inc. (the “Company”) issued a press release announcing financial results for the second quarter ended June 30, 2026. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Current Report on Form 8-K (including Exhibit 99.1 hereto) shall not be deemed “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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits:

99.1

Press Release of the Company, dated August 6, 2026.

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

SIGNATURES

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

Dated: August 6, 2026 SHOULDER INNOVATIONS, INC.

(Registrant)

/s/ Jeffrey Points

Jeffrey Points

Chief Financial Officer

EX-99.1

Filename: ex-991earningsreleaseq22026.htm · Sequence: 2

Document

Exhibit 99.1

Shoulder Innovations Reports Second Quarter 2026 Financial Results and Raises Full Year Outlook

Generates First Half 2026 Revenue Growth of 60%

Grand Rapids, MI – August 6, 2026 – Shoulder Innovations, Inc. (Shoulder Innovations, or the company) (NYSE: SI), a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, today reported financial results for the second quarter ended June 30, 2026.

Second Quarter Financial Highlights

•Generated net revenue of $17.2 million in the second quarter, a 56% increase over the second quarter of 2025

•Achieved gross margin of 78.3% for the second quarter compared to 76.2% for the second quarter of 2025

•Increased average selling price of our implant systems to $7,674 in the second quarter, a 5% increase over the second quarter of 2025

•Increased full year 2026 net revenue guidance to $67 million to $69 million, representing growth of approximately 42% to 46% over full year 2025 net revenue

Recent Business Highlights

•Sold 2,238 total implant systems in the second quarter, an approximate 50% increase over the second quarter of 2025

•Initiated full commercial launch of the N-22 glenosphere for patients with metal hypersensitivity

•Initiated full commercial launch of a new titanium plasma spray (TPS) baseplate line extension for reverse procedures

•Closed two new credit facilities for an aggregate amount of up to $50 million with Stifel Venture Banking, refinancing existing debt and adding undrawn working capital capacity

•Expanded commercial organization in the second quarter to support increased business scale

"Our second quarter results build on a strong start to the year and reflect remarkable momentum across every dimension of our business,” said Rob Ball, CEO of Shoulder Innovations. “We continued to rapidly onboard new surgeons against a large, underpenetrated market opportunity, deepened utilization within our existing surgeon base, and advanced a broad and increasingly differentiated product pipeline. This performance resulted in net revenue growth of 56% and implant volume growth of approximately 50%, enabling us to increase our outlook for the full year.”

Mr. Ball continued, “Our confidence in what lies ahead has never been stronger. The commercial organization we’ve built continues to perform, our innovation pipeline is growing, and our conviction in the team’s ability to execute is high. With a strengthened financial foundation following our recent debt refinancing, we believe Shoulder Innovations remains in the early stages of what we can accomplish in transforming shoulder surgical care, and we look forward to demonstrating that in the back half of 2026 and beyond.”

Second Quarter 2026 Financial Results

Net revenue in the second quarter of 2026 increased 56% to $17.2 million, compared to $11.0 million in the second quarter of 2025. The increase was due to an increase in the number of implant systems sold, as well as an increase in the number of customers.

Gross margin in the second quarter of 2026 was 78.3%, compared to 76.2% in the second quarter of 2025. The increase was was due to increases in the average selling price of implant systems, as well as benefits from negotiated cost reduction programs.

Selling, general and administrative expenses in the second quarter of 2026 increased 56% to $20.1 million, compared to $12.8 million in the second quarter of 2025. The increase was primarily due to investments in the commercial organization, higher variable selling expenses, and increased costs associated with becoming a public company.

Research and development expenses in the second quarter of 2026 increased 141% to $3.4 million, compared to $1.4 million in the second quarter of 2025. The increase was due to investment in new product development efforts, including development related to the robotic platform strategic partnership.

Operating loss in the second quarter of 2026 was $10.0 million, compared to a loss of $5.9 million in the second quarter of 2025. Net loss in the second quarter of 2026 was $10.2 million, compared to a net loss of $19.2 million in the second quarter of 2025. The increase in operating loss was primarily related to increased operating expenses, while the decrease in net loss was primarily due to a significant prior year charge related to changes in the fair value of the company's preferred stock warrant liability and Series E purchase option.

Adjusted EBITDA in the second quarter of 2026 was a loss of $8.0 million, compared to a loss of $18.1 million in the second quarter of 2025. The decrease in loss was primarily due to a significant prior year charge related to changes in the fair value of the company's preferred stock warrant liability and Series E purchase option.

As of June 30, 2026, cash and cash equivalents, and marketable securities totaled $99.0 million.

2026 Financial Outlook

Shoulder Innovations expects net revenue for the full year 2026 to be in the range of $67 million to $69 million, representing growth of approximately 42% to 46% over full year 2025 net revenue. This compares to prior guidance of $65 million to $68 million, representing growth of approximately 37% to 44% over full year 2025 net revenue.

Conference Call

Management will host a conference call today, August 6, 2026, at 4:30 p.m. ET / 1:30 p.m. PT to discuss the company’s second quarter 2026 financial results. Those interested in listening to the conference call may do so by dialing (877) 407-8216 for domestic callers or (412) 902-1015 for international callers and providing access code 13761097. A live and archived webcast of the event will be available in the "Investor Relations" section of the Shoulder Innovations website at https://ir.shoulderinnovations.com.

Use of Non-GAAP Financial Measures and Key Business Metrics

In addition to our results and measures of performance determined in accordance with U.S. GAAP, we believe that non-GAAP financial measures can be useful in evaluating and comparing our financial and operational performance over multiple periods, identifying trends affecting our business, formulating business plans and making strategic decisions. We use

and present Adjusted EBITDA for this purpose. We define Adjusted EBITDA as net loss before interest (income) expense, net, income tax expense, loss on extinguishment of debt, depreciation and amortization, and stock-based compensation expense. We have reconciled our historic non-GAAP financial measures to the applicable most comparable GAAP measures in this press release.

We believe that Adjusted EBITDA, together with a reconciliation to net loss, provides meaningful supplemental information regarding our performance by excluding certain items that may not be indicative of our business, results of operations, or outlook. However, Adjusted EBITDA has limitations as an analytical tool, and you should not consider this measure in isolation or as a substitute for analysis of our financial results as reported under U.S. GAAP. Some of these potential limitations include: (i) other companies, including companies in our industry which have similar business arrangements, may report Adjusted EBITDA, or similarly titled measures but calculate them differently, which reduces their usefulness as comparative measures; (ii) although depreciation and amortization expenses are non-cash charges, the assets being depreciated and amortized may have to be replaced in the future, and Adjusted EBITDA does not reflect cash capital expenditures for such replacements or for new capital expenditure requirements; (iii) Adjusted EBITDA also does not reflect changes in, or cash requirements for, our working capital needs or the potentially dilutive impact of stock-based compensation; and (iv) Adjusted EBITDA does not reflect the interest (income) expense, net, or the cash requirements necessary to service interest or principal payments, on existing or future debt that we may incur. Because of these and other limitations, you should consider Adjusted EBITDA only as supplemental to other GAAP-based financial measures.

In addition, we believe that the number of implant systems sold is a key business metric and a useful indicator of our ability to drive demand for our implant systems, generate net revenue and expand our business. We regularly review a number of operating and financial metrics to evaluate our business, measure our performance, identify trends affecting our business, formulate our business plan and make strategic decisions.

About Shoulder Innovations

Shoulder Innovations is a commercial-stage medical technology company exclusively focused on transforming the shoulder surgical care market, with a current offering of advanced implant systems for shoulder arthroplasty. These systems are a core element of Shoulder Innovations’ ecosystem, which is designed to improve core components of shoulder surgical care – preoperative planning, implant design and procedural efficiency – to benefit each stakeholder in the care chain. Shoulder Innovations’ ecosystem is also comprised of enabling technologies, efficient instrument systems, specialized support and surgeon-to-surgeon collaboration. Together, these elements seek to address the long-standing clinical and operational challenges in the shoulder surgical care market by delivering predictable outcomes, procedural simplicity, and efficiency across all sites of care.

Forward-Looking Statements

This press release contains, and other communications of the company may contain, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the fact that they do not relate strictly to historical or current facts. Forward-looking statements often use words such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “outlook,” “forecast,” “target,” “trend,”

“plan,” “goal,” or other words of comparable meaning or future-tense or conditional verbs such as “may,” “will,” “should,” “would,” or “could.”

Statements concerning the company’s future are forward-looking statements, and are based on management’s current expectations, assumptions and beliefs about the company’s business, financial performance, creation of long-term shareholder value, operating results, the industry in which we operate and possible future events. These statements include, but are not limited to, statements regarding the company’s anticipated growth prospects and future operating and financial performance. Forward-looking statements convey the company’s expectations, intentions, or forecasts about future events, circumstances, results, or aspirations. Forward-looking statements are not guarantees of future results and are subject to risks, uncertainties, assumptions and other important factors, which may change over time and many of which are beyond the company’s control, and which could cause the company’s actual results to materially and adversely differ from those expressed in any forward-looking statement, including (i) our history of significant net losses; (ii) failure to manage the growth of our business; (iii) our inability to compete successfully against our existing or potential competitors; (iv) failure to develop, retain, or expand an effective dedicated commercial leadership team; (v) risks associated with litigation; (vi) our dependence upon the adoption of our implant systems by hospitals, ambulatory surgery centers, surgeons and patients; (vii) our ability to enhance our implant systems, expand our indications and develop and commercialize additional products in a timely manner; (viii) risks associated with our third-party manufacturers and suppliers; (ix) demand forecasts for our implant systems; (x) our ability to demonstrate to shoulder specialists or key opinion leaders the merits of our implant systems; (xi) federal and state healthcare laws and government regulation and oversight over our devices and operations; (xii) our ability to obtain and maintain patent and other intellectual property protection over our products; (xiii) risks associated with our common stock; and (xiv) the other important factors described in our most recently filed Annual Report on Form 10-K and subsequent other filings with the Securities and Exchange Commission.

These documents are available in the Investor Relations section of the company’s website at www.shoulderinnovations.com (information on the website is not incorporated by reference into this press release and should not be considered part of this document).

You should not place undue reliance on forward-looking statements. The information in this press release is provided as of today’s date only, and, except as required by federal securities law, we do not undertake to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changing circumstances or for any other reason after today.

Contact

Brian Johnston or Sam Bentzinger

Gilmartin Group LLC

ir@shoulderinnovations.com

Shoulder Innovations, Inc.

Condensed Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share amounts)

Three Months Ended

Six Months Ended

June 30, 2026 June 30, 2025 June 30, 2026 June 30, 2025

Net revenue

$ 17,175 $ 11,013 $ 33,883 $ 21,145

Cost of goods sold

3,734 2,620 7,456 4,961

Gross profit

13,441 8,393 26,427 16,184

Selling, general, and administrative expenses

20,086 12,849 38,294 23,351

Research and development expenses

3,391 1,406 7,145 2,989

Operating loss

(10,036) (5,862) (19,012) (10,156)

Other (income) expense

Interest (income) expense, net

(673) 216 (1,109) 583

Change in fair value of Series E purchase option

— 11,719 — 11,719

Loss on extinguishment of debt 589 — 589 —

Other expense, net

201 1,399 40 1,400

Total other (income) expense

117 13,334 (480) 13,702

Loss before income tax expense

(10,153) (19,196) (18,532) (23,858)

Income tax expense

— — — —

Net loss

$ (10,153) $ (19,196) $ (18,532) $ (23,858)

Other comprehensive loss, net

Unrealized gain (loss) on marketable securities

(40) 1 (221) (115)

Total other comprehensive gain (loss), net

(40) 1 (221) (115)

Comprehensive loss

$ (10,193) $ (19,195) $ (18,753) $ (23,973)

Net loss per share attributed to common stock – basic and diluted:

Net loss per share

$ (0.49) $ (165.53) $ (0.90) $ (232.13)

Weighted average shares outstanding:

Weighted average common shares outstanding – basic and diluted

20,735,694 115,965 20,694,593 102,775

Shoulder Innovations, Inc.

Condensed Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)

June 30, 2026 December 31, 2025

Assets

Current assets

Cash and cash equivalents

$ 24,460 $ 26,871

Marketable securities

74,533 97,434

Trade accounts receivable, net of allowance for credit losses

10,873 8,268

Inventories, net

22,920 21,591

Prepaid expenses

2,329 1,518

Other current assets

2,292 1,483

Total current assets

137,407 157,165

Property and equipment, net

14,498 12,532

Operating lease right-of-use asset

69 110

Other assets 33 —

Intangible assets, net

— 100

Total assets

$ 152,007 $ 169,907

Liabilities, convertible preferred stock, and stockholders’ equity

Current liabilities

Accounts payable

$ 5,931 $ 8,874

Current operating lease obligations

37 62

Accrued liabilities

6,864 5,259

Total current liabilities

12,832 14,195

Long-term liabilities

Long-term debt

14,813 14,911

Other long-term liabilities

34 51

Total long-term liabilities

14,847 14,962

Total liabilities

$ 27,679 $ 29,157

Commitments and contingencies

Stockholders’ equity

Common stock, $0.001 par value, 730,000,000 shares authorized and 20,822,472 and 20,623,457 shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

$ 21 21

Preferred stock, $0.001 par value, 20,000,000 shares authorized and no shares issued and outstanding as of June 30, 2026 and December 31, 2025, respectively

— —

Additional paid-in capital

240,343 238,012

Accumulated deficit

(115,932) (97,400)

Accumulated other comprehensive income (loss)

(104) 117

Total stockholders’ equity

124,328 140,750

Total liabilities, convertible preferred stock, and stockholders’ equity

$ 152,007 $ 169,907

Shoulder Innovations, Inc.

Reconciliation of Reported Net Loss to Adjusted EBITDA

(Unaudited)

(in thousands, except share and per share amounts)

Three Months Ended

June 30, Six Months Ended

June 30,

2026 2025 2026 2025

Net loss

$ (10,153) $ (19,196) $ (18,532) $ (23,858)

Interest (income) expense, net

(673) 216 (1,109) 583

Income tax expense

— — — —

Loss on extinguishment of debt 589 — 589 —

Depreciation and amortization expense

1,133 717 2,265 1,385

Stock-based compensation expense

1,081 190 1,807 317

Adjusted EBITDA

$ (8,023) $ (18,073) $ (14,980) $ (21,573)

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Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration