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Sight Sciences, Inc. - Quarter Report: 2023 September (Form 10-Q)

10-Q

 

 

 

 

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 September 30, 2023

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from __________ to ____________

Commission File Number: 001-40587

 

SIGHT SCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

80-0625749

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

4040 Campbell Ave, Suite 100

Menlo Park, CA

94025

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (877) 266-1144

N/A

(Former name, former address and former fiscal year, if changed since last report)

 

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 $0.001 per share

 

SGHT

 

The Nasdaq Global Select Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

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.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

 

As of the close of business on November 1, 2023, the registrant had 48,749,876 shares of Common Stock, par value $0.001 per share, outstanding.

 


 

 

 

 

 


 

Table of Contents

 

 

 

Page

 

Special Note Regarding Forward-Looking Statements

4

 

 

 

PART I.

FINANCIAL INFORMATION

6

 

 

 

Item 1.

Financial Statements

6

 

Condensed Consolidated Balance Sheets (Unaudited)

6

 

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

7

 

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

8

 

Condensed Consolidated Statements of Cash Flows (Unaudited)

10

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

11

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

 

 

 

PART II.

OTHER INFORMATION

35

 

 

 

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

43

Item 3.

Defaults Upon Senior Securities

43

Item 4.

Mine Safety Disclosures

43

Item 5.

Other Information

43

Item 6.

Exhibits

44

 

Signatures

45

 

 

3


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

Unless the context otherwise requires, references in this Quarterly Report on Form 10-Q to the “Company,” “Sight Sciences,” “we,” “us” and “our” refer to Sight Sciences, Inc.

This Quarterly Report on Form 10-Q for the fiscal period ended September 30, 2023 (this "Quarterly Report") contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements other than statements of historical facts contained in this Quarterly Report, including statements regarding our future results of operations or financial condition, business strategy and plans, and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “hope,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. These forward-looking statements include, but are not limited to, statements concerning the following:

our ability to obtain and maintain sufficient reimbursement for our products, including our ability to successfully protect reimbursement for our Surgical Glaucoma products in light of draft and final local coverage determinations recently published by certain Medicare Administrative Contractors;
estimates of our total addressable market, future revenue, expenses, capital requirements, and our needs for additional financing;
our ability to enter into and compete in new markets;
our ability to compete effectively with existing competitors and new market entrants;
the impact of the strategic realignment of our operations, including our reduction in workforce and related cost- savings initiatives;
our ability to maintain compliance with, and retain favorable payment terms under, our current secured credit facility;
our ability to grow or contract our infrastructure as required to meet our business objectives;
our ability to manage and grow our business by expanding our sales to existing customers or introducing our products to new customers;
our ability to establish and maintain intellectual property protection for our products, successfully protect and scale our intellectual property portfolio, or avoid claims of infringement;
potential effects of extensive government regulation;
our ability to hire and retain key personnel;
our ability to obtain financing in future offerings;
the impact of incidence of disease or other epidemics on our business, our customers' and suppliers' businesses, and on our industry and the economy;
the volatility of the trading price of our common stock;
our expectation regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act (the “JOBS Act”); and
our ability to maintain proper and effective internal controls.

Actual events or results may differ from those expressed in forward-looking statements. As such, you should not rely on forward-looking statements as predictions of future events. We have based the forward-looking statements contained in this Quarterly Report primarily on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, operating results, prospects, strategy, and financial needs. The outcome of the events described in these forward-looking statements is subject to risks,

 

4


 

uncertainties, assumptions, and other factors described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (the "SEC") on March 16, 2023 (our "Annual Report"), our Quarterly Report on Form 10-Q for the second quarter ended June 30, 2023 filed with the SEC on August 7, 2023 (our "Q2 Quarterly Report"), and elsewhere in this Quarterly Report. Moreover, we operate in a highly competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this Quarterly Report. The results, events and circumstances reflected in the forward-looking statements may not be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements in this Quarterly Report are based upon information available to us as of the date of this Quarterly Report. While we believe that such information provides a reasonable basis for these statements, such information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.

You should read this Quarterly Report and the documents that we reference in this Quarterly Report and have filed as exhibits to this Quarterly Report with the understanding that our actual future results, performance and achievements may be materially different from what we expect. We qualify all of our forward-looking statements by these cautionary statements. The forward-looking statements made in this Quarterly Report relate only to events as of the date on which the statements are made. We undertake no obligation to update any forward-looking statements made in this Quarterly Report to reflect events or circumstances after the date of this Quarterly Report or to reflect new information, actual results, revised expectations, or the occurrence of unanticipated events, except as required by law. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements.

 

 

5


 

PART 1. FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

SIGHT SCIENCES, INC.

Condensed Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share data)

 

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

144,501

 

 

$

185,000

 

Accounts receivable, net of allowance for credit losses of $1,405 and $1,024 at September 30, 2023 and December 31, 2022, respectively

 

 

16,919

 

 

 

15,148

 

Inventory, net

 

 

9,240

 

 

 

6,114

 

Prepaid expenses and other current assets

 

 

2,899

 

 

 

3,415

 

Total current assets

 

 

173,559

 

 

 

209,677

 

Property and equipment, net

 

 

1,556

 

 

 

1,571

 

Operating lease right-of-use assets

 

 

871

 

 

 

1,614

 

Other noncurrent assets

 

 

655

 

 

 

211

 

Total assets

 

$

176,641

 

 

$

213,073

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,535

 

 

$

2,688

 

Accrued compensation

 

 

5,501

 

 

 

7,352

 

Accrued and other current liabilities

 

 

5,295

 

 

 

7,777

 

Total current liabilities

 

 

14,331

 

 

 

17,817

 

Long-term debt

 

 

33,765

 

 

 

33,313

 

Other noncurrent liabilities

 

 

1,476

 

 

 

1,867

 

Total liabilities

 

 

49,572

 

 

 

52,997

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, par value $0.001 per share; 10,000,000 shares authorized; no shares issued and outstanding as of September 30, 2023 and December 31, 2022

 

 

 

 

 

 

Common stock, par value $0.001 per share; 200,000,000 shares authorized; 48,722,219 and 48,298,138 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively

 

 

49

 

 

 

48

 

Additional paid-in-capital

 

 

411,119

 

 

 

399,271

 

Accumulated deficit

 

 

(284,099

)

 

 

(239,243

)

Total stockholders’ equity

 

 

127,069

 

 

 

160,076

 

Total liabilities and stockholders’ equity

 

$

176,641

 

 

$

213,073

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

6


 

SIGHT SCIENCES, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share data)

 

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue

 

$

20,009

 

 

$

18,677

 

 

$

62,305

 

 

$

50,788

 

Cost of goods sold

 

 

2,677

 

 

 

2,928

 

 

 

9,105

 

 

 

8,696

 

Gross profit

 

 

17,332

 

 

 

15,749

 

 

 

53,200

 

 

 

42,092

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,239

 

 

 

6,053

 

 

 

14,129

 

 

 

17,626

 

Selling, general and administrative

 

 

26,504

 

 

 

31,541

 

 

 

85,235

 

 

 

91,367

 

Total operating expenses

 

 

30,743

 

 

 

37,594

 

 

 

99,364

 

 

 

108,993

 

Loss from operations

 

 

(13,411

)

 

 

(21,845

)

 

 

(46,164

)

 

 

(66,901

)

Interest expense

 

 

(1,432

)

 

 

(1,131

)

 

 

(4,057

)

 

 

(3,243

)

Other income, net

 

 

1,886

 

 

 

766

 

 

 

5,465

 

 

 

846

 

Loss before income taxes

 

 

(12,957

)

 

 

(22,210

)

 

 

(44,756

)

 

 

(69,298

)

Provision for income taxes

 

 

78

 

 

 

19

 

 

 

100

 

 

 

37

 

Net loss and comprehensive loss

 

$

(13,035

)

 

$

(22,229

)

 

$

(44,856

)

 

$

(69,335

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.27

)

 

$

(0.46

)

 

$

(0.92

)

 

$

(1.45

)

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

48,671,049

 

 

 

47,910,541

 

 

 

48,538,517

 

 

 

47,728,845

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

7


 

SIGHT SCIENCES, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(in thousands, except share data)

 

 

 

Three Months Ended September 30, 2023

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at June 30, 2023

 

 

48,649,343

 

 

$

49

 

 

$

407,146

 

 

$

(271,064

)

 

$

136,131

 

Issuance of common stock upon exercise of stock options

 

 

60,738

 

 

 

 

 

 

117

 

 

 

 

 

 

117

 

Issuance of common stock upon vesting of restricted stock units

 

 

12,138

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,856

 

 

 

 

 

 

3,856

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(13,035

)

 

 

(13,035

)

Balance at September 30, 2023

 

 

48,722,219

 

 

 

49

 

 

 

411,119

 

 

 

(284,099

)

 

 

127,069

 

 

 

 

 

Nine Months Ended September 30, 2023

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2022

 

 

48,298,138

 

 

$

48

 

 

$

399,271

 

 

$

(239,243

)

 

$

160,076

 

Issuance of common stock upon exercise of stock options

 

 

163,940

 

 

 

 

 

 

288

 

 

 

 

 

 

288

 

Issuance of common stock upon vesting of restricted stock units

 

 

181,607

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Withholding taxes on net share settlement of restricted stock units

 

 

 

 

 

 

 

 

(222

)

 

 

 

 

 

(222

)

Employee stock purchase plan purchases

 

 

78,534

 

 

 

 

 

 

661

 

 

 

 

 

 

661

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

11,121

 

 

 

 

 

 

11,121

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(44,856

)

 

 

(44,856

)

Balance at September 30, 2023

 

 

48,722,219

 

 

 

49

 

 

 

411,119

 

 

 

(284,099

)

 

 

127,069

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

8


 

SIGHT SCIENCES, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Unaudited)

(in thousands, except share data)

(continued)

 

 

 

Three Months Ended September 30, 2022

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at June 30, 2022

 

 

47,819,706

 

 

$

48

 

 

$

391,818

 

 

$

(200,107

)

 

$

191,759

 

Issuance of common stock upon exercise of stock options

 

 

258,871

 

 

 

 

 

 

186

 

 

 

 

 

 

186

 

Issuance of common stock upon vesting of restricted stock units

 

 

4,715

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

3,223

 

 

 

 

 

 

3,223

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(22,229

)

 

 

(22,229

)

Balance at September 30, 2022

 

 

48,083,292

 

 

 

48

 

 

 

395,227

 

 

 

(222,336

)

 

 

172,939

 

 

 

 

 

Nine Months Ended September 30, 2022

 

 

 

Common Stock

 

 

Additional
Paid-In

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Equity

 

Balance at December 31, 2021

 

 

47,504,704

 

 

$

48

 

 

$

385,060

 

 

$

(153,001

)

 

$

232,107

 

Issuance of common stock upon exercise of stock options

 

 

573,873

 

 

 

 

 

 

438

 

 

 

 

 

 

438

 

Issuance of common stock upon vesting of restricted stock units

 

 

4,715

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

9,729

 

 

 

 

 

 

9,729

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

(69,335

)

 

 

(69,335

)

Balance at September 30, 2022

 

 

48,083,292

 

 

 

48

 

 

 

395,227

 

 

 

(222,336

)

 

 

172,939

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

9


 

SIGHT SCIENCES, INC.

Condensed Consolidated Statements of Cash Flows (Unaudited)

(in thousands)

 

 

 

Nine Months Ended

 

 

 

September 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(44,856

)

 

$

(69,335

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Depreciation

 

 

455

 

 

 

557

 

Accretion of debt discount and amortization of debt issuance costs

 

 

452

 

 

 

502

 

Stock-based compensation expense

 

 

11,121

 

 

 

9,729

 

Provision for credit losses

 

 

416

 

 

 

395

 

Provision for excess and obsolete inventories

 

 

219

 

 

 

124

 

Noncash operating lease expense

 

 

743

 

 

 

374

 

Loss on disposal of property and equipment

 

 

66

 

 

 

55

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Accounts receivable

 

 

(2,187

)

 

 

(4,280

)

Inventory

 

 

(3,345

)

 

 

(2,169

)

Prepaid expenses and other current assets

 

 

517

 

 

 

(245

)

Other noncurrent assets

 

 

(444

)

 

 

 

Accounts payable

 

 

841

 

 

 

(77

)

Accrued compensation

 

 

(1,851

)

 

 

2,006

 

Accrued and other current liabilities

 

 

(3,089

)

 

 

1,631

 

Other noncurrent liabilities

 

 

242

 

 

 

270

 

Net cash used in operating activities

 

 

(40,700

)

 

 

(60,463

)

Cash flows from investing activities

 

 

 

 

 

 

Purchases of property and equipment

 

 

(527

)

 

 

(841

)

Net cash used in investing activities

 

 

(527

)

 

 

(841

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from exercise of common stock options

 

 

289

 

 

 

436

 

Taxes paid on the net share settlement of restricted stock units

 

 

(222

)

 

 

 

Proceeds from employee stock purchase plan purchases

 

 

661

 

 

 

 

Net cash provided by financing activities

 

 

728

 

 

 

436

 

Net change in cash and cash equivalents

 

 

(40,499

)

 

 

(60,868

)

Cash and cash equivalents at beginning of period

 

 

185,000

 

 

 

260,687

 

Cash and cash equivalents at end of period

 

$

144,501

 

 

$

199,819

 

 

 

 

 

 

 

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Cash paid for interest

 

$

3,167

 

 

$

2,350

 

Supplemental noncash disclosure

 

 

 

 

 

 

Acquisition of property and equipment included in accounts payable and accrued liabilities

 

$

81

 

 

$

46

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

10


 

SIGHT SCIENCES, INC.

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

Note 1. Company and Nature of Business

 

Description of Business

Sight Sciences, Inc. (the “Company”) was incorporated in the State of Delaware in 2010 and is headquartered in Menlo Park, California. The Company is an ophthalmic medical device company focused on the development and commercialization of surgical and nonsurgical technologies for the treatment of prevalent eye diseases.

The Company's product portfolio aligns with its two reportable operating segments: Surgical Glaucoma and Dry Eye. The products for the Surgical Glaucoma segment include the OMNI® Surgical System ("OMNI"), which is an implant-free glaucoma surgery technology indicated to reduce intraocular pressure in adult patients with primary open-angle glaucoma, the world's leading cause of irreversible blindness, and the SION™ Surgical Instrument ("SION"), a manually operated device used in ophthalmic surgical procedures to excise trabecular meshwork. The product portfolio for the Dry Eye segment consists of the TearCare® System ("TearCare") for ophthalmologists and optometrists. TearCare is a wearable eyelid technology for adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD) when used in conjunction with manual expression of the meibomian glands, enabling clearance of gland obstructions by physicians to address the leading cause of dry eye disease.

Significant Risks and Uncertainties

Since inception, the Company has incurred losses and negative cash flows from operations. As of September 30, 2023, the Company had an accumulated deficit of $284.1 million and recorded a net loss of $44.9 million for the nine months then ended and expects to incur additional losses in the future. If the Company’s revenue levels from its products are not sufficient or if the Company is unable to secure additional funding when desired, the Company may need to delay the development of its products, scale back its business and operations, or change its business strategy.

The Company believes that its existing sources of liquidity will satisfy its working capital and capital requirements for at least 12 months from the issuance of its financial statements. Any failure to generate increased revenue, achieve improved gross margins, or control operating costs could require the Company to raise additional capital through equity or debt financing. Such additional financing may not be available on acceptable terms, or at all, and could require the Company to modify, delay, or abandon some of its planned future expansion or expenditures or reduce some of its ongoing operating costs, which could harm its business, operating results, financial condition, and ability to achieve its intended business objectives.

Note 2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) applicable to interim periods and pursuant to the instructions to Form 10-Q and Article 10 of Regulation S-X.

The unaudited condensed consolidated financial statements have been prepared on a basis consistent with the audited consolidated financial statements. In the opinion of management, the unaudited condensed consolidated financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for the fair presentation of the Company's financial information contained herein. The condensed consolidated balance sheet as of December 31, 2022 is derived from the Company's consolidated audited financial statements as of that date. These interim condensed consolidated financial statements do not include all disclosures required by GAAP and should be read in conjunction with the Company's audited consolidated financial statements and the accompanying notes thereto for the fiscal year ended December 31, 2022, which are contained in the Annual Report. The Company's results of operations for the nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or for any other interim period.

 

11


 

The accompanying condensed consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of the Company's unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent liabilities as of the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. The most significant areas requiring the use of management estimates and assumptions relate to the provision for credit losses, inventory excess and obsolescence, the selection of useful lives of property and equipment, determination of the fair value of stock option grants, and provisions for income taxes and contingencies. Management evaluates its estimates and assumptions on an ongoing basis using historical experience, existing and known circumstances, authoritative accounting pronouncements, and other factors that management believes to be reasonable, including the current macroeconomic environment, and makes adjustments when facts and circumstances dictate. Although the full impact of these factors is unknown and cannot be reasonably estimated, the Company believes it has made appropriate accounting estimates and assumptions based on information available as of the date of the unaudited condensed consolidated financial statements. Actual results could differ from these estimates and such differences could be material to the Company’s financial position and results of operations.

New Accounting Pronouncements

Accounting Standards Adopted

In June 2016, the Financial Accounting Standards Board (the "FASB") issued Accounting Standards Updated ("ASU") No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities. The guidance was effective for the Company beginning in the first quarter of 2023. The amendments in ASU 2016-13 were adopted with no material impact on the Company's consolidated financial statements.

Accounting Standards Not Yet Adopted

As of September 30, 2023, there are no significant ASUs issued and not yet adopted that are expected to have a material impact on the Company's financial statements and related disclosures.

Note 3. Fair Value Measurements

The Company reports all financial assets and liabilities and nonfinancial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The authoritative guidance establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to measurements involving significant unobservable inputs (Level 3 measurements). The three levels of the fair value hierarchy are as follows:

Level 1—Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.

Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

Level 3—Inputs are unobservable inputs for the asset or liability. The level in the fair value hierarchy within which a fair value measurement in its entirety is based on the lowest-level input that is significant to the fair value measurement in its entirety.

 

12


 

The Company's cash and cash equivalents included $136.3 million of treasury bills as of September 30, 2023. These securities are classified as held-to-maturity and all have been purchased with original maturities of 90 days or less. Held-to-maturity debt securities are recorded at amortized cost in the financial statements. The following table summarizes the amortized cost and fair value of held-to-maturity securities (in thousands):

 

 

 

September 30, 2023

 

 

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Aggregate Fair Value

 

U.S. treasury securities

 

$

136,256

 

 

$

29

 

 

$

 

 

$

136,285

 

The Company measures the fair value of outstanding debt for disclosure purposes on a recurring basis. As of September 30, 2023 and December 31, 2022, total debt of $33.8 million and $33.3 million is reported at amortized cost, respectively. This outstanding debt is classified as Level 2 as it is not actively traded. The amortized cost of the outstanding debt approximates the fair value.

The financial statements as of September 30, 2023 and December 31, 2022 do not include any assets or liabilities that are measured at fair value on a nonrecurring basis.

Note 4. Balance Sheet Components

Property and Equipment, Net

Property and equipment, net consist of the following (in thousands):

 

 

 

As of September 30,

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

Tools and equipment

 

$

2,001

 

 

$

2,173

 

Computer equipment and software

 

 

37

 

 

 

37

 

Furniture and fixtures

 

 

323

 

 

 

282

 

Leasehold improvements

 

 

38

 

 

 

38

 

Construction in process

 

 

624

 

 

 

475

 

 

 

3,023

 

 

 

3,005

 

Less: Accumulated depreciation

 

 

(1,467

)

 

 

(1,434

)

Property and equipment, net

 

$

1,556

 

 

$

1,571

 

 

Depreciation expense was $0.2 million and $0.2 million for the three months ended September 30, 2023 and 2022, respectively. Depreciation expense was $0.5 million and $0.6 million for the nine months ended September 30, 2023 and 2022.

Accrued and Other Current Liabilities

Accrued and other current liabilities consist of the following (in thousands):

 

 

 

As of September 30,

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

Accrued expenses

 

$

2,550

 

 

$

5,307

 

Current portion of lease liabilities

 

 

910

 

 

 

1,033

 

Short term interest payable

 

 

376

 

 

 

348

 

Other accrued liabilities

 

 

1,459

 

 

 

1,087

 

Total accrued and other current liabilities

 

$

5,295

 

 

$

7,775

 

 

Other Noncurrent Liabilities

 

13


 

Other noncurrent liabilities consist of the following (in thousands):

 

 

 

As of September 30,

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

Long term interest payable

 

$

1,437

 

 

$

1,194

 

Noncurrent portion of lease liabilities

 

 

 

 

 

635

 

Other noncurrent liabilities

 

 

39

 

 

 

38

 

Total other noncurrent liabilities

 

$

1,476

 

 

$

1,867

 

 

Note 5. Debt

As of September 30, 2023, the Company had a credit and security agreement with certain entities affiliated with MidCap Financial Services (such entities collectively, the "Lender"), memorializing the terms of a $35.0 million senior secured term loan (the "Term Loan").

The obligations under the Term Loan agreement are guaranteed by the Company's current and future subsidiaries, subject to exceptions for certain foreign subsidiaries, and secured by substantially all assets of the Company, including material intellectual property. Additionally, the Company is subject to customary affirmative and negative covenants as defined in the Term Loan agreement, including minimum revenue and cash covenants, as well as covenants that limit or restrict the ability to, among other things, incur indebtedness, grant liens, merge or consolidate, make investments, dispose of assets, make acquisitions, pay dividends or make distributions, repurchase stock and enter into certain transactions with affiliates, in each case subject to certain exceptions. As of September 30, 2023, the Company was in compliance with all financial and non-financial covenants under the Term Loan agreement. The Term Loan agreement includes a maturity date of November 1, 2025, and principal payments under the Term Loan are expected to commence in December 2023. However, if certain conditions are met, principal payments may instead commence in December 2024.

The Term Loan agreement contains events of default that include, among others, non-payment of principal, interest or fees, breach of covenants, inaccuracy of representations and warranties, cross-defaults and bankruptcy and insolvency events. In addition, the Term Loan agreement includes a stated floating interest rate that is reserve-adjusted Secured Overnight Finance Rate, plus 7.00%, and a provision for a final payment fee of 6.0% of the $35.0 million Term Loan balance, which has been partially accrued and recorded as a long-term interest payable in other noncurrent liabilities of $1.4 million as of September 30, 2023 and $1.2 million as of December 31, 2022.

Long-term and short-term debt as of September 30, 2023 and December 31, 2022, respectively, was as follows (in thousands):

 

 

 

As of September 30,

 

 

As of December 31,

 

 

 

2023

 

 

2022

 

Term Loan

 

$

35,000

 

 

$

35,000

 

Total principal payments due

 

 

35,000

 

 

 

35,000

 

Less: debt discount related to warrant liability and issuance costs

 

 

(1,235

)

 

 

(1,687

)

Total amounts outstanding

 

 

33,765

 

 

 

33,313

 

Less: current portion

 

 

 

 

 

 

Total accrued and other current liabilities

 

$

33,765

 

 

$

33,313

 

 

 

14


 

The repayment schedule relating to the Term Loan as of September 30, 2023, is as follows (in thousands):

 

 

 

Amount

 

2023 (remainder)

 

 

 

2024

 

 

2,917

 

2025

 

 

32,083

 

Thereafter

 

 

 

Total repayments

 

$

35,000

 

 

Note 6. Commitments and Contingencies

Operating Lease Obligations

The Company’s leases include facility leases and storage leases. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date if the rate implicit in the lease is not readily determinable. The Company estimates its incremental borrowing rate based on qualitative factors including company specific credit offers, lease term, general economics, and the interest rate environment. In determining the lease term, the Company includes all renewal options that are reasonably probable to be executed.

During the first quarter of 2021, the Company renewed its lease on its corporate headquarters in Menlo Park, California. The lease commenced in August 2021 and has a term of 37 months from the commencement date. The Company recorded an aggregate right-of-use ("ROU") asset and lease liability of $1.5 million. The ROU asset and corresponding lease liability were estimated using a weighted-average incremental borrowing rate of 13.59%. Total base rent is approximately $1.6 million under the lease agreement.

During the fourth quarter of 2022, the Company entered into a supply agreement with an expected term of 18 months. The supply agreement contains provisions that indicate an embedded lease is present within the agreement. The agreement commenced in early December 2022 and the Company recorded an aggregate ROU asset and lease liability of $0.7 million. The ROU asset and corresponding lease liability were estimated using a weighted-average incremental borrowing rate of 10.75%. Total base rent under the agreement is approximately $0.7 million.

The Company recognizes rent expense on a straight-line basis over the noncancelable lease term. The Company’s rent expense was $0.9 million and $0.5 million for the nine months ended September 30, 2023 and 2022, respectively. The Company’s rent expense was $0.3 million and $0.2 million for the three months ended September 30, 2023 and 2022, respectively. As of September 30, 2023, the weighted average remaining lease term for the leases was 0.8 years.

Operating lease expense and supplemental cash flow information related to operating leases for the three and nine months ended September 30, 2023 and 2022 were as follows (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating lease expense

 

$

288

 

 

$

168

 

 

$

869

 

 

$

514

 

Cash paid for operating leases

 

 

295

 

 

 

168

 

 

 

885

 

 

 

509

 

 

Aggregate future minimum lease payments at September 30, 2023, under these noncancelable operating leases were as follows (in thousands):

 

 

15


 

 

 

As of September 30,

 

 

 

 

2023

 

 

2023 (remainder)

 

 

299

 

 

2024

 

 

662

 

 

Total future minimum lease payments

 

$

961

 

 

Less: imputed interest

 

 

(51

)

 

Present value of future minimum lease payments

 

$

910

 

 

Less: current portion of operating lease liability

 

 

(910

)

 

Operating lease liabilities – noncurrent

 

$

 

 

 

Legal Proceedings

On September 16, 2021, the Company filed suit in the U.S. District Court for the District of Delaware (C.A. No. 1:21-cv-01317) alleging that Ivantis, Inc. ("Ivantis") directly and indirectly infringes the Company's U.S. Patent Nos. 8,287,482, 9,370,443, 9,486,361, and 10,314,742 by making, using, selling, and offering for sale the Hydrus® Microstent. The Company’s complaint seeks money damages and injunctive relief. On January 24, 2022, Ivantis asserted counterclaims requesting declaratory judgments that the Company's asserted patents-in-suit are not infringed and/or are invalid. On August 1, 2022, the Company filed an amended complaint alleging that Alcon Inc., Alcon Vision, LLC and Alcon Research, LLC (collectively, "Alcon") infringe the four originally asserted patents by making, using, selling, and offering for sale the Hydrus® Microstent, and that all defendants also infringe U.S. Patent No. 11,389,328. The defendants asserted counterclaims requesting declaratory judgments that the Company’s asserted patents-in-suit are not infringed and/or are invalid. A five-day jury trial is scheduled to commence on April 8, 2024. Ivantis and Alcon filed petitions with the U.S. Patent Office seeking inter partes review of U.S. Patent Nos. 8,287,482, 9,370,443, 9,486,361, and 10,314,742 (IPR2022-01529, IPR2022-01530, IPR2022-01533, IPR2022-01540), each of which the U.S. Patent Office denied for raising prior art reference and invalidity arguments that were cumulative of those previously considered by the office. The Company is presently unable to predict the outcome of this lawsuit or to reasonably estimate the potential financial impact of the lawsuit on the Company, if any.

The Company is subject to legal, regulatory, and other claims and assessments from time to time in the ordinary course of business. Accruals for litigation and contingencies are reflected in the financial statements based on management’s assessment, including the advice of legal counsel, of the expected outcome of litigation or other dispute resolution proceedings, and/or the expected resolution of contingencies. Liabilities for estimated losses are accrued if the potential losses from any claims or legal proceedings are considered probable and the amounts can be reasonably estimated. Significant judgment is required in both the determination of probability of loss and the determination as to whether the amount can be reasonably estimated. Accruals are based only on information available at the time of the assessment due to the uncertain nature of such matters. As additional information becomes available, management reassesses potential liabilities related to pending claims and litigation and may revise its previous estimates, which could materially affect the Company’s results of operations in a given period. As of September 30, 2023 the Company does not believe it was a party to any legal proceedings, regulatory matters, or other disputes or claims which, if determined adversely, would, individually or taken together, have a material adverse effect on its business, financial condition, operating results, liquidity or future prospects. However, regardless of the merits of the claims raised or the outcome, legal proceedings and claims may have an adverse impact on the Company as a result of defense and settlement costs, diversion of management time and resources, and other factors.

Indemnification

In the normal course of business, the Company enters into contracts and agreements that contain a variety of representations and warranties and provide for general indemnifications. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future, but that have not yet been made. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. However, the Company may record charges in the future as a result of these indemnification obligations.

The Company indemnifies each of its directors and officers for certain events or occurrences, subject to certain limits, while the director is or was serving at the Company’s request in such capacity, as permitted under

 

16


 

Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the indemnification period lasts as long as an indemnitee may be subject to any proceeding arising out of acts or omissions of such indemnitee in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company currently holds director and officer liability insurance. This insurance allows the transfer of risk associated with the Company’s exposure and may enable it to recover a portion of any future amounts paid. The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations as of September 30, 2023 or December 31, 2022.

 

Note 7. Stockholders' Equity

Common Stock

In connection with the initial public offering of the Company's common stock (the "IPO"), the Company’s certificate of incorporation was amended and restated to provide for 200,000,000 authorized shares of common stock with a par value of $0.001 per share and 10,000,000 authorized shares of preferred stock with a par value of $0.001 per share. The holders of common stock are entitled to receive dividends whenever funds are legally available, when and if declared by the board of directors. As of September 30, 2023, no dividends have been declared to date. Each share of common stock is entitled to one vote.

At September 30, 2023 and December 31, 2022, the Company had reserved common stock for future issuances as follows:

 

 

September 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Common stock available for future grant

 

 

7,442,482

 

 

 

6,099,584

 

Common stock options issued and outstanding

 

 

4,705,390

 

 

 

4,819,906

 

Restricted stock units outstanding

 

 

1,853,657

 

 

 

1,014,123

 

Shares available for future purchase under ESPP

 

 

1,630,570

 

 

 

1,226,123

 

Total

 

 

15,632,099

 

 

 

13,159,736

 

 

Note 8. Equity Incentive Plans

2011 Stock Option Plan and 2021 Incentive Award Plan

In 2011, the Company established its 2011 Stock Option Plan (the “2011 Plan”), which provided for the granting of stock options to employees and certain nonemployees of the Company.

In July 2021, the board of directors and stockholders adopted and approved the 2021 Incentive Award Plan, (the “2021 Plan”). Under the 2021 Plan, the Company has the ability to issue incentive stock options ("ISOs"), nonqualified stock options ("NSOs"), stock appreciation rights, dividend equivalent rights, restricted stock awards, and restricted stock unit awards ("RSUs"). Options under the 2021 Plan can typically be granted for periods of up to ten years. For stock options granted to a grantee who, at the time the option is granted, owned stock representing more than 10% of the voting power of all classes of stock of the Company (or any parent or subsidiary of the Company), the term of the stock option may be granted for periods of up to five years. The ISOs and NSOs will be granted at a price per share not less than the fair value at the date of grant. The exercise price of a stock option granted to a 10% stockholder shall be not less than 110% of the grant date fair value of the shares. Options granted to new hires generally vest over a four-year period, with 25% of the shares vesting on the first anniversary of the grant date and the remaining shares vesting in 36 equal monthly installments thereafter; options granted as merit awards generally vest in 48 equal monthly installments following the grant date. RSUs granted generally vest over a four-year period with straight-line vesting in equal amounts on an annual basis.

The Company initially reserved 5,200,000 shares of common stock for future issuance under the 2021 Plan. Pursuant to the evergreen provision in the 2021 Plan, this initial reserve was increased by 2,414,907 and 2,375,235 shares on January 1, 2023 and 2022, respectively. These annual increases under the evergreen provision are equal to the lesser of (i) 5% of the aggregate number of shares of common stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the Board, subject to certain limitations.

 

17


 

The 2011 Plan was superseded by the 2021 Plan at the time of the IPO and no further grants have been made under the 2011 Plan from the date the 2021 Plan became effective. The terms under the 2011 Plan are consistent with those described above for the 2021 Plan.

At September 30, 2023 and December 31, 2022 there were 7,442,482 and 6,099,584 shares, respectively, of common stock available for issuance under the 2021 Plan.

Stock Option Awards

The following table summarizes stock option activity under the 2021 Plan during the periods presented:

 

 

 

Number of
Shares

 

 

Weighted-Average Exercise Price

 

 

Weighted-Average
Contractual
 Term (in years)

 

 

Average Intrinsic Value
(in thousands)

 

Balances as of December 31, 2022

 

 

4,819,906

 

 

$

9.67

 

 

 

7.7

 

 

$

19,463

 

Grants

 

 

755,499

 

 

 

9.79

 

 

 

 

 

 

 

Forfeited/cancelled

 

 

(704,631

)

 

 

12.45

 

 

 

 

 

 

 

Exercised/released

 

 

(165,384

)

 

 

1.68

 

 

 

 

 

 

 

Balances as of September 30, 2023

 

 

4,705,390

 

 

$

9.57

 

 

 

7.2

 

 

$

2,810

 

Vested and exercisable as of September 30, 2023

 

 

2,671,146

 

 

$

7.79

 

 

 

6.3

 

 

$

2,627

 

Vested and expected to vest as of September 30, 2023

 

 

4,705,390

 

 

$

9.57

 

 

 

7.2

 

 

$

2,810

 

 

During the three and nine months ended September 30, 2023, the Company recorded stock-based compensation expense of $2.1 million and $6.6 million related to stock option awards, respectively. During the three and nine months ended September 30, 2022, the Company recorded stock-based compensation expense of $2.4 million and $7.5 million related to stock option awards, respectively. The weighted-average grant-date fair values of options granted during the nine months ended September 30, 2023 and 2022 was $6.92 and $9.58 per share, respectively.

 

The aggregate intrinsic value of options exercised was $0.1 million and $1.2 million during the three and nine months ended September 30, 2023, respectively. The aggregate intrinsic value was calculated as the difference between the exercise prices of the underlying options and the estimated fair value of the common stock on the date of exercise. As of September 30, 2023, the unrecognized stock-based compensation expense relating to unvested options was $17.0 million, which is expected to be recognized over a weighted-average period of 2.0 years.

 

Determination of Fair Value

The Company estimated the grant date fair value of stock options using the Black-Scholes option-pricing model. The fair value of stock options is recognized on a straight-line basis over the requisite service periods of the awards. The fair value of stock options was estimated using the following weighted-average assumptions:

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

2023

 

2022

 

2023

 

2022

Expected term (in years)

 

5.99 – 6.01

 

5.91 – 6.06

 

5.60 – 6.07

 

5.38 – 6.94

Expected volatility

 

79.82%

 

64.12% – 64.61%

 

78.53% – 79.82%

 

58.74% – 64.61%

Risk-free interest rate

 

4.04%

 

3.25% – 3.97%

 

3.48% – 4.04%

 

1.34% – 3.97%

Dividend yield

 

 

 

 

 

Expected Term

The expected term is calculated using the simplified method, which is available if there is insufficient historical data about exercise patterns and post vesting employment termination behavior. The simplified method is based on the vesting period and the contractual term for each grant or for each vesting tranche for awards with

 

18


 

graded vesting. The midpoint of the vesting date and the maximum contractual expiration date is used as the expected term under this method. For awards with multiple vesting tranches, the time from grant until the midpoints for each of the tranches may be averaged to provide an overall expected term.

Expected Volatility

The Company used an average historical stock price volatility of a peer group of publicly traded companies to be representative of its expected future stock price volatility, as the Company's trading history for its common stock does not cover the expected term of granted awards. For purposes of identifying these peer companies, the Company considered the industry, stage of development, size, and financial leverage of potential comparable companies. For each grant, the Company measured historical volatility over a period equivalent to the expected term.

Risk-Free Interest Rate

The risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of a stock award.

Expected Dividend Rate

The Company has not paid, and does not anticipate paying, any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be 0%.

Restricted Stock Units

RSUs are share awards that entitle the holder to receive freely tradeable shares of the Company’s common stock upon vesting. The RSUs cannot be transferred, and the awards are subject to forfeiture if the holder’s employment terminates prior to the release of the vesting restrictions. The RSUs generally vest over a four-year period with straight-line vesting in equal amounts on an annual basis, provided the employee remains continuously employed with the Company. The fair value of the RSUs is equal to the closing price of the Company’s common stock on the grant date.

The following table summarizes restricted share award activity under the 2021 Plan:

 

 

Number of
Shares

 

 

Weighted-Average Grant Date Fair Value Per Share

 

Outstanding, December 31, 2022

 

 

1,014,123

 

 

$

14.25

 

Grants

 

 

1,319,033

 

 

 

9.69

 

Forfeited/cancelled

 

 

(297,892

)

 

 

12.37

 

Vested

 

 

(181,607

)

 

 

14.41

 

Outstanding, September 30, 2023

 

 

1,853,657

 

 

$

11.27

 

During the three and nine months ended September 30, 2023, the Company recorded stock-based compensation expense of $1.6 million and $4.2 million, respectively, related to the RSUs. During the three and nine months ended September 30, 2022, the Company recorded stock-based compensation expense of $0.7 million and $2.0 million, respectively, related to the RSUs. As of September 30, 2023, there was $17.0 million of total unrecognized stock-based compensation expense relating to the RSUs that is expected to be recognized over a weighted-average period of 3.0 years.

Employee Stock Purchase Plan

In July 2021, the board of directors and stockholders adopted and approved the 2021 Employee Stock Purchase Plan (the “ESPP”). The Company initially reserved 850,000 shares of common stock for future issuance under the ESPP. Pursuant to the evergreen provision under the ESPP, this initial reserve was increased by 482,981 and 475,047 shares on January 1, 2023 and 2022, respectively. These annual increases were effected pursuant to an evergreen provision in the ESPP, and are equal to the lesser of (i) 1% of the aggregate number of shares of common

 

19


 

stock outstanding on the final day of the immediately preceding calendar year and (ii) such smaller number of shares of common stock as determined by the board of directors, subject to certain limitations.

The Company has two offering periods annually, running for six-months, with the first offering period beginning in the second quarter, and the second offering period beginning in the fourth quarter. The purchase of shares for participants in the ESPP occurs at the conclusion of each offering period.

For the nine months ended September 30, 2023, participants in the ESPP purchased 78,534 shares for a total of $0.7 million. As of September 30, 2023, the Company has collected payroll withholdings of $0.4 million in the current offering period for the purchase of shares under the ESPP. The Company recorded stock-based compensation expense associated with the ESPP of $0.1 million and $0.4 million for the three and nine months ended September 30, 2023, respectively. The Company recorded stock-based compensation expense associated with the ESPP of $0.1 million and $0.2 million for the three and nine months ended September 30, 2022, respectively.

As of September 30, 2023, there were 1,630,570 shares of common stock available for issuance under the ESPP.

The fair value of shares to be issued under the Company's 2021 ESPP was estimated using the Black-Scholes valuation model with the following assumptions for the three and nine months ended September 30, 2023:

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

 

2023

 

2022

 

2023

 

2022

Expected term (in years)

 

0.48 – 0.50

 

0.50

 

0.48 – 0.50

 

0.50

Expected volatility

 

66.72% – 97.38%

 

76.50%

 

66.72% – 97.38%

 

76.50%

Risk-free interest rate

 

4.62% – 5.32%

 

1.51%

 

4.62% – 5.32%

 

1.51%

Dividend yield

 

 

 

 

Stock-Based Compensation

The following is a summary of stock-based compensation expense by function (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Cost of goods sold

 

$

77

 

 

$

39

 

 

$

206

 

 

$

117

 

Research and development

 

 

549

 

 

 

259

 

 

 

1,664

 

 

 

1,012

 

Selling, general and administrative

 

 

3,231

 

 

 

2,925

 

 

 

9,251

 

 

 

8,600

 

Total stock-based compensation expense

 

$

3,856

 

 

$

3,223

 

 

$

11,121

 

 

$

9,729

 

 

Note 9. Net Loss per Share Attributable to Common Stockholders

Basic net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period. As the Company reported a net loss for the three and nine months ended September 30, 2023 and 2022, basic net loss per share is the same as diluted net loss per share for each of the reported periods.

 

20


 

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders for the periods presented (in thousands, except share and per share data):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Numerator:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss attributable to common stockholders

 

$

(13,035

)

 

$

(22,229

)

 

$

(44,856

)

 

$

(69,335

)

Denominator:

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average shares of common stock
   outstanding—basic and diluted

 

 

48,671,049

 

 

 

47,910,541

 

 

 

48,538,517

 

 

 

47,728,845

 

Net loss per share attributable to common
   stockholders—basic and diluted

 

$

(0.27

)

 

$

(0.46

)

 

$

(0.92

)

 

$

(1.45

)

 

The following potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the period presented because including them would have been antidilutive as a result of the net loss position:

 

 

 

September 30,

 

 

 

2023

 

 

2022

 

Stock option awards

 

 

4,705,390

 

 

 

5,028,066

 

Restricted stock units

 

 

1,853,657

 

 

 

700,873

 

Total

 

 

6,559,047

 

 

 

5,728,939

 

 

Note 10. Segment Information

The Company has two reportable operating segments which are determined on the basis of the product portfolio: Surgical Glaucoma and Dry Eye. The operating and reportable segments were determined based on how the Company’s Chief Executive Officer, its Chief Operating Decision Maker (“CODM”), views and evaluates the Company’s operations. The CODM allocates resources to and evaluates the financial performance of each operating segment primarily based on gross profit and gross profit margin.

Surgical Glaucoma segment includes sales of OMNI and SION for use in minimally invasive glaucoma procedures. Dry Eye segment includes sales of TearCare and related components and accessories for use in the treatment of dry eye disease.

 

21


 

The following table summarizes select operating results information for each reportable segment (in thousands):

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

$

18,425

 

 

$

17,072

 

 

$

57,158

 

 

$

46,842

 

Dry Eye

 

 

1,584

 

 

 

1,605

 

 

 

5,147

 

 

 

3,946

 

Total

 

 

20,009

 

 

 

18,677

 

 

 

62,305

 

 

 

50,788

 

Cost of goods sold

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

2,002

 

 

 

1,932

 

 

 

6,808

 

 

 

5,372

 

Dry Eye

 

 

675

 

 

 

996

 

 

 

2,297

 

 

 

3,324

 

Total

 

 

2,677

 

 

 

2,928

 

 

 

9,105

 

 

 

8,696

 

Gross profit

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

16,423

 

 

 

15,140

 

 

 

50,350

 

 

 

41,470

 

Dry Eye

 

 

909

 

 

 

609

 

 

 

2,850

 

 

 

622

 

Total

 

 

17,332

 

 

 

15,749

 

 

 

53,200

 

 

 

42,092

 

Operating expense

 

 

30,743

 

 

 

37,594

 

 

 

99,364

 

 

 

108,993

 

Loss from operations

 

 

(13,411

)

 

 

(21,845

)

 

 

(46,164

)

 

 

(66,901

)

Interest expense

 

 

(1,432

)

 

 

(1,131

)

 

 

(4,057

)

 

 

(3,243

)

Other income, net

 

 

1,886

 

 

 

766

 

 

 

5,465

 

 

 

846

 

Loss before income tax

 

$

(12,957

)

 

$

(22,210

)

 

$

(44,756

)

 

$

(69,298

)

 

The Company does not allocate any components of income and expenses beyond revenue and cost of goods sold to the reportable operating segments in its reporting to the CODM. No asset information is provided for reportable operating segments because that information is not reviewed by the CODM on a segment basis. Substantially all of the Company’s revenue is generated from sales in the United States.

 

Note 11. Subsequent Events

The Company evaluated subsequent events through November 7, 2023, the date on which the condensed consolidated financial statements were issued.

On October 17, 2023, the Company initiated a strategic realignment of its operations, including approximately a 10% reduction in its workforce, intended to reduce operating expenses, improve cost efficiencies, better align its operating structure for long-term, profitable growth, and further extend its cash runway, as the Company navigates the proposed local coverage determinations (the “Draft LCDs”) published by five of the seven Medicare Administrative Contractors (“MACs”) in the second quarter of 2023. These efforts are designed to help protect the Company’s cash position, drive enhanced focus on the Company’s key strategic priorities, and maintain its path to breakeven without the need for any additional equity capital. As a result of implementing the realignment, the Company expects to record a cash restructuring charge of approximately $1.3 million in the fourth quarter of 2023, consisting primarily of one-time employee severance and benefits contribution costs. The estimates of the charges the Company expects to incur, and the timing thereof, are subject to a number of assumptions and actual results may differ materially. In addition, the Company may incur other charges, costs, or cash expenditures not currently contemplated due to unanticipated events that may occur as a result of, or in connection with, the implementation of this strategic realignment.

On October 26, 2023, one of the five MACs that published Draft LCDs, WPS Government Health Administrators (“WPS”), published LCD L39620 Micro-Invasive Glaucoma Surgery (MIGS), with a future effective date of December 24, 2023 (the “Final LCD”). The Final LCD identifies certain procedures as investigational in patients over the age of 18 for glaucoma management, including canaloplasty in combination with trabeculotomy ab interno, which is the procedure performed by the Company’s OMNI® Surgical System. The WPS-served states accounted for approximately 8% of the Company’s Surgical Glaucoma revenue during the year ended December 31, 2022.

 

22


 

On November 6, 2023, the Company entered into an amendment (the “Fourth Amendment”) to its Amended and Restated Credit and Security Agreement (Term Loan), dated as of November 23, 2020, as amended (the “Credit Agreement”). The Fourth Amendment requires that the Company maintain at all times at least $50 million dollars in unrestricted cash and also provides for certain adjustments to the amortization schedule such that payments on the principal amount of the Term Loan shall commence on the earlier of (a) December 1, 2024, (b) the first day of the calendar month immediately succeeding the date on which a Reimbursement Trigger Event occurs, as determined by Agent in its reasonable discretion, and (c) the first day of the calendar month immediately succeeding any date on which Agent provides notice to Borrowers that an Event of Default has occurred and is continuing, and continuing on the first day of each calendar month thereafter, Borrower shall pay to Agent as a principal payment on the Term Loan an amount equal to the total principal amount of the Term Loan(s) made to Borrower divided by the total number of months remaining at such time prior to the Maturity Date for a straight-line amortization of equal monthly principal payments . A “Reimbursement Trigger Event” means, three (3) or more Medicare Administrative Contractors shall have issued final local coverage determinations in respect of the OMNI® Surgical System (“OMNI”) and/or other similar medical devices that would have the effect of classifying OMNI as an investigational device.

 

23


 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the related notes and other financial information included in this Quarterly Report and our audited consolidated financial statements and related notes disclosed in our Annual Report. Certain statements included in this discussion and analysis constitute “forward-looking statements” that are subject to considerable risks and uncertainties. Please see the information under the heading “Special Note Regarding Forward-Looking Statements” in this Quarterly Report.

Overview

Sight Sciences’ mission is to transform ophthalmology and optometry through the development and commercialization of proprietary devices that target the underlying causes of the world’s most prevalent eye diseases. We are passionate about improving patients’ lives. Our objective is to develop and market products for use in new treatment paradigms and to create an interventional mindset in eyecare whereby our products may be used in procedures which supplant conventional outdated approaches. Our business philosophy is grounded in the following principles:

comprehensively understand disease physiology;
develop products that are intended to restore natural physiological functionality to diseased eyes;
develop and market products that achieve superior effectiveness versus current treatment paradigms while minimizing complications or side effects;
provide intuitive, patient friendly solutions to ophthalmologists and optometrists; and
deliver compelling economic value to all stakeholders, including patients, providers and third-party payors such as Medicare and commercial insurers.

Our initial product development has focused on the treatment of two of the world’s most prevalent and underserved eye diseases, glaucoma and dry eye disease. We have commercialized products in each of our two reportable segments, Surgical Glaucoma and Dry Eye. Our Surgical Glaucoma segment consists of sales of the OMNI® Surgical System ("OMNI") and the SION™ Surgical Instrument ("SION"), while our Dry Eye segment includes sales of the TearCare® System ("TearCare"), and related components and accessories. Each product is primarily sold through a highly-involved direct sales model that offers intensive education, training and customer service. We believe this philosophy and model not only enables us to differentiate our products and company from competitors, but also to expand our addressable market by educating ophthalmologists and optometrists (together, "ECPs"), patients and other stakeholders on our products and evolving treatment paradigms. Outside of the U.S., we have established direct commercial operations in the United Kingdom and Germany. We sell OMNI in several other countries through distributors.

We sell OMNI and SION to facilities where ophthalmic surgeons perform outpatient procedures, such as ambulatory service centers ("ASCs") and hospital outpatient departments ("HOPDs"), which are typically reimbursed by Medicare or private payors for procedures using our products. We sell TearCare to ECPs. Currently, there is no meaningful reimbursement coverage by Medicare or private payors for meibomian gland disease ("MGD") procedures, including TearCare, and patients typically pay out-of-pocket for TearCare. We are continuing our controlled commercial launch and are focused on our comprehensive, clinical data-driven long-term market development plan that aims to improve awareness and patient access to TearCare. We have dedicated meaningful resources to execute our commercial strategy and as we reduce operating expenses and improve cost efficiencies to better align our operating structure for long-term, profitable growth. The overall success of our approach to eyecare to date is evidenced by over 200,000 estimated uses of Surgical Glaucoma products and their predicates in over 1,900 hospitals and ASCs in the U.S. and Europe, and over 45,000 estimated uses of TearCare in over 1,400 eyecare facilities in the U.S. through September 30, 2023.

We do not currently operate any manufacturing facilities and instead contract with third parties for our production requirements. We believe our suppliers will be able to meet our current and anticipated manufacturing needs across all our products. We plan to continue to utilize third party contract manufacturers for our products and any related components.

 

24


 

Revenue in our Surgical Glaucoma segment for the nine months ended September 30, 2023 and 2022 was $57.2 million and $46.8 million, respectively, with gross margins for the same periods of 88.1% and 88.5%, respectively. Revenue in our Dry Eye segment for the nine months ended September 30, 2023 and 2022 was $5.1 million and $3.9 million, respectively, with gross margins for the same periods of 55.4% and 15.8%, respectively. Given the earlier stage of TearCare’s commercial development, we expect our Dry Eye segment’s gross margins to be lower than our Surgical Glaucoma segment’s gross margins for the near- and medium-term due to the allocation of fixed labor and overhead costs to the segment's cost of goods sold.

We believe in the importance of continued strategic investment in initiatives that: further demonstrate our products’ clinical effectiveness and safety to potential customers, patients, payors and regulators; enhance our commercial capabilities, including resources dedicated to sales, marketing and education; ensure the broadest possible patient access to the treatment alternatives that our products are cleared to offer; enhance and improve upon our existing product technologies; and allow us to innovate new products, devices or drugs, in glaucoma and ocular surface disease or in new eye disease areas. As a result, we intend to continue to invest in clinical studies, sales and marketing, education initiatives, market access, and product development. However, we are also focused on disciplined expenditures, and seek to grow our operating expenses at a lower rate than revenue. Because of these and other factors, we expect to continue to incur net losses for at least the next several years, and we may seek additional debt and equity financing to fund our operations and planned growth.

To date, our primary sources of capital have been private placements of redeemable convertible preferred stock, debt financing agreements, the sale of common stock in our IPO, and revenue from the sale of our products. As of September 30, 2023, we had an outstanding term loan balance of $35.0 million (excluding debt discount and amortized debt issuance costs), cash and cash equivalents of $144.5 million and an accumulated deficit of $284.1 million.

Recent Developments

On October 26, 2023, WPS Government Health Administrators (“WPS”), one of seven Medicare Administrative Contractors (“MACs”), published local coverage determination (“LCD”) L39620 Micro-Invasive Glaucoma Surgery (MIGS), with a future effective date of December 24, 2023 (the “Final LCD”). WPS administers Part B Medicare benefits in Kansas, Nebraska, Missouri, Iowa, Indiana, and Michigan. The Final LCD identifies certain procedures as investigational in patients over the age of 18 for glaucoma management, including adult canaloplasty in combination with trabeculotomy ab interno, which is a procedure performed by the OMNI Surgical System. We are also seeking clarity whether the provisions of the Final LCD would result in the characterization of our SION Surgical Instrument as investigational . This Final LCD, if not withdrawn before it becomes effective on December 23, 2023, would result in canaloplasty in combination with trabeculotomy (ab interno), and potentially goniotomy procedures performed by our SION Surgical Instrument, being non-covered for Medicare beneficiaries in the states in which WPS administers Medicare Part B benefits, The WPS-served states accounted for approximately 8% of our Surgical Glaucoma revenue in 2022. We expect the adoption of the Final LCD will have an adverse impact on our revenue, results of operations, and financial condition, the full extent of which is not known at this time.

In addition, in June 2023, four other MACs issued draft LCDs (the “Remaining Draft LCDs”), which propose to establish or update Medicare coverage policies for micro-invasive glaucoma surgery (“MIGS”). Specifically, the Remaining Draft LCDs propose to identify certain non-implantable MIGS procedures as investigational and not reasonable and necessary in the jurisdictions where these MACs administer Medicare Part B benefits, including adult canaloplasty in combination with trabeculotomy ab interno, a procedure performed with the OMNI technology, and goniotomy procedures that may be performed with SION. If these four MACs ultimately adopt coverage policies similar to that included in the Final LCD, or adopt those policies contemplated by the Draft LCDs, the determinations would establish a policy of Medicare non-coverage for these procedures and other non-implantable MIGS procedures performed with our OMNI technology (and potentially our SION technology) in these Medicare jurisdictions. The states served by these four MACs accounted for approximately 55% of our Surgical Glaucoma revenue in 2022. If we are not successful in reversing the Remaining Draft LCDs, or if these MACs or other third-party payors that currently cover or reimburse procedures in which our products are used

 

25


 

reverse or limit their coverage in the future, or other third-party payors issue similar policies, our business, financial condition, and results of operations will be materially and adversely affected.

Factors Affecting Our Business and Results of Operations

We believe there are several important factors that have impacted and that will continue to impact our business and results of operations. Except as described above and in Part II, Item 1A, "Risk Factors," of this Quarterly Report and our Q2 Quarterly Report, as well as in the section titled "Risk Factors" in our Annual Report, we are not aware of any material changes to those factors described in our Annual Report under the heading "Factors Affecting Our Business and Results of Operations."

Components of Our Results of Operations

Revenue

We currently derive the majority of our U.S. revenue from the sale of our OMNI and SION products to ASCs and HOPDs and our TearCare products to ECPs. During the nine months ended September 30, 2023 and 2022, the revenue from our Surgical Glaucoma segment accounted for over 90% of our total revenue. Substantially all of our revenue for both periods were generated from sales within the U.S. Our Surgical Glaucoma customers place orders based on their expected procedure volume and reorder as needed, typically on a biweekly, monthly or bimonthly basis. Our TearCare customers typically purchase a TearCare System which consists of one or more SmartHubs, multiple single-use TearCare SmartLids® ("SmartLids") and other accessories. After utilizing their initial inventory, customers can reorder SmartLids as needed. No single customer accounted for 10% or more of our revenue for either the three or nine months ended September 30, 2023 and 2022.

The growth in our revenue is driven by the demand for elective surgery and treatment utilizing our products. Such demand is often lower during summer months because of ECP vacations and in winter months in certain parts of the world because of fewer business or surgery days due to holidays and adverse weather conditions.

Cost of Goods Sold and Gross Margin

Our products are produced by third-party manufacturers. Our cost of goods sold consists primarily of amounts paid for our products to third-party manufacturers, and our manufacturing overhead costs, which consist primarily of personnel expenses, including salaries, benefits and stock-based compensation, and reserves for excess, obsolete and non-sellable inventory. Cost of goods sold also includes depreciation expenses for production equipment which we provide to our third-party manufacturers and certain direct costs, such as shipping and handling costs.

We calculate gross margin as gross profit divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, including differences in segment gross margins, changes in average selling prices, product sales mix, production and ordering volumes, manufacturing costs, product yields, and headcount. In general, we expect our gross margins to increase over the long-term to the extent our production and ordering volumes increase and as we spread the fixed portion of our overhead costs over a larger number of units produced. We intend to use our design, engineering and manufacturing know-how and capabilities to further advance and improve the efficiency of our suppliers’ manufacturing processes, which we believe will reduce costs and increase our gross margins. Our gross margins could fluctuate from quarter to quarter as we transition to new suppliers, introduce new products, and adopt new manufacturing processes and technologies.

Research and Development Expenses

Research and development ("R&D") expenses consist primarily of costs associated with engineering, product development, clinical studies to develop and support our products, including clinical trial design, clinical trial site initiation and study costs, internal and external costs associated with our regulatory compliance and quality assurance functions, medical affairs, cost of products used for clinical trials and other costs associated with products and technologies – either new or enhancements of existing platforms – that are in development. These expenses also include personnel expenses, including salaries, benefits and stock-based compensation, supplies, consulting, prototyping, testing, materials, travel expenses, depreciation expenses for equipment and an allocation of

 

26


 

information technology ("IT") and facility overhead expenses. Our R&D expenses as a percentage of revenue may vary over time depending on the level and timing of new product development efforts, as well as clinical development, clinical trial and other related activities. We expect our R&D expenses to increase for the next several years as we continue to invest in our active clinical trial program, develop new products, and improve our existing products.

Selling, General and Administrative Expenses

Selling, general and administrative ("SG&A") expenses consist primarily of personnel expenses, including salaries, benefits and stock-based compensation related to selling, marketing and corporate functions, allocation of IT and facility overhead expenses, bad debt expense, finance, legal and human resource costs. Other SG&A expenses include training, travel expenses, promotional activities, marketing initiatives, market research and analysis, conferences and trade shows, professional services fees (including external legal, audit, consulting and tax fees), insurance costs, and general corporate expenses.

Interest Expense

Interest expense consists primarily of interest incurred on our outstanding indebtedness and non-cash interest related to the accretion of debt discount and amortization of debt issuance costs associated with our Term Loan agreement.

Other Income, Net

Other income, net primarily consists of interest and amortization on held-to-maturity investments in treasury securities.

 

27


 

Results of Operations

Comparison of the Three Months Ended September 30, 2023 and 2022 (dollars in thousands)

 

 

 

Three Months Ended September 30,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

 

(unaudited)

 

 

 

 

 

 

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

$

18,425

 

 

$

17,072

 

 

$

1,353

 

 

 

7.9

%

Percentage of total revenue

 

 

92.1

%

 

 

91.4

%

 

 

 

 

 

 

Dry Eye

 

 

1,584

 

 

 

1,605

 

 

 

(21

)

 

 

(1.3

)

Percentage of total revenue

 

 

7.9

%

 

 

8.6

%

 

 

 

 

 

 

Total

 

 

20,009

 

 

 

18,677

 

 

 

1,332

 

 

 

7.1

 

Cost of goods sold

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

2,002

 

 

 

1,932

 

 

 

70

 

 

 

3.6

 

Dry Eye

 

 

675

 

 

 

996

 

 

 

(321

)

 

 

(32.2

)

Total

 

 

2,677

 

 

 

2,928

 

 

 

(251

)

 

 

(8.6

)

Gross profit

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

16,423

 

 

 

15,140

 

 

 

1,283

 

 

 

8.5

 

Dry Eye

 

 

909

 

 

 

609

 

 

 

300

 

 

 

(49.3

)

Total

 

 

17,332

 

 

 

15,749

 

 

 

1,583

 

 

 

10.1

 

Gross margin

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

89.1

%

 

 

88.7

%

 

 

 

 

 

 

Dry Eye

 

 

57.4

%

 

 

37.9

%

 

 

 

 

 

 

Total

 

 

86.6

%

 

 

84.3

%

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

4,239

 

 

 

6,053

 

 

 

(1,814

)

 

 

(30.0

)

Selling, general and administrative

 

 

26,504

 

 

 

31,541

 

 

 

(5,037

)

 

 

(16.0

)

Total operating expenses

 

 

30,743

 

 

 

37,594

 

 

 

(6,851

)

 

 

(18.2

)

Loss from operations

 

 

(13,411

)

 

 

(21,845

)

 

 

8,434

 

 

 

38.6

 

Interest expense

 

 

(1,432

)

 

 

(1,131

)

 

 

(301

)

 

 

(26.6

)

Other income, net

 

 

1,886

 

 

 

766

 

 

 

1,120

 

 

 

(146.2

)

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax

 

 

(12,957

)

 

 

(22,210

)

 

 

9,253

 

 

 

41.7

 

Provision for income tax

 

 

78

 

 

 

19

 

 

 

59

 

 

 

310.5

 

Net loss and comprehensive loss

 

$

(13,035

)

 

$

(22,229

)

 

$

9,194

 

 

 

41.4

%

 

Revenue. Revenue for the three months ended September 30, 2023 was $20.0 million, an increase of $1.3 million, or 7.1%, from the prior year comparable period. The overall increase in Surgical Glaucoma revenue was primarily attributable to an increase in the number of OMNI and SION units sold in the three months ended September 30, 2023. This growth in units was driven by a growth in the number of facilities ordering OMNI and SION with flat unit utilization per ordering facility. Our Dry Eye revenue decreased 1.3% in the three months ended September 30, 2023 versus the comparable period in 2022 primarily due to fewer new customers added in the period, which led to lower SmartHub revenue. Surgical Glaucoma sales represented 92.1% and 91.4% of our total revenue generated in the three months ended September 30, 2023 and 2022, respectively.

Cost of Goods Sold and Gross Profit. Cost of goods sold was $2.7 million during the three months ended September 30, 2023, a decrease of $0.3 million from $2.9 million in the prior year comparable period. Our Surgical Glaucoma cost of goods sold increased $0.1 million as compared to the comparable period in 2022. The increase was driven by increased sales activity, partially offset by lower per unit production costs as a result of continued manufacturing efficiencies. Dry Eye cost of goods sold decreased $0.3 million in the three months ended September 30, 2023 compared to the comparable period in 2022 primarily driven by lower sales volumes, product mix, and cost efficiencies.

 

28


 

Our total gross profit was $17.3 million in the three months ended September 30, 2023, an increase of $1.6 million from the comparable period in 2022. Our total gross margin for the three months ended September 30, 2023 increased to 86.6%, up from 84.3% in the prior year comparable period. Gross margin in our Surgical Glaucoma segment was 89.1% for the quarter ended September 30, 2023, an increase from 88.7% for the prior year comparable period, primarily due to manufacturing efficiencies generated as a result of higher OMNI production volumes, partially offset by lower average selling price due to product mix. In our Dry Eye segment, gross margin increased from 37.9% in the third quarter of 2022 to 57.4% for the quarter ended September 30, 2023, primarily due to lower manufacturing costs, an increased mix of SmartLids, which has a higher gross margin than SmartHubs and higher average selling price of SmartHubs.

Research and Development Expenses. The $1.8 million decrease in R&D expenses during the three months ended September 30, 2023 compared to the three months ended September 30, 2022 was primarily attributable to a $1.2 million decrease in clinical studies expenses and a $0.3 million decrease in legal expenses.

Selling, General, and Administrative Expenses. SG&A expenses were $26.5 million for the three months ended September 30, 2023, a decrease of $5.0 million from the prior year comparable period. The decrease was primarily driven by a $3.6 million decrease in personnel expenses, including lower commissions and incentive compensation during the current year. In addition, the Company saw a $1.3 million decrease in marketing expenses, a $0.6 million decrease in consulting expenses and a $0.4 million decrease in sales training, events, and demo expenses. These decreases were partially offset by a $0.9 million increase in legal expenses.

Interest Expense. Interest expense increased $0.3 million, due to an increase in lending rates during the three months ended September 30, 2023 compared to the three months ended September 30, 2022.

Other Income, Net. Other income, net was $1.9 million for the three months ended September 30, 2023 as compared to $0.8 million in the three months ended September 30, 2022. The income is attributable to the amortization of purchase discounts on held-to-maturity cash-equivalent investments.

 

29


 

Comparison of the Nine Months Ended September 30, 2023 and 2022 (dollars in thousands)

 

 

 

Nine Months Ended September 30,

 

 

Change

 

 

 

2023

 

 

2022

 

 

$

 

 

%

 

 

 

(unaudited)

 

 

 

 

 

 

 

Revenue

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

$

57,158

 

 

$

46,842

 

 

$

10,316

 

 

 

22.0

%

Percentage of total revenue

 

 

91.7

%

 

 

92.2

%

 

 

 

 

 

 

Dry Eye

 

 

5,147

 

 

 

3,946

 

 

 

1,201

 

 

 

30.4

 

Percentage of total revenue

 

 

8.3

%

 

 

7.8

%

 

 

 

 

 

 

Total

 

 

62,305

 

 

 

50,788

 

 

 

11,517

 

 

 

22.7

 

Cost of goods sold

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

6,808

 

 

 

5,372

 

 

 

1,436

 

 

 

26.7

 

Dry Eye

 

 

2,297

 

 

 

3,324

 

 

 

(1,027

)

 

 

(30.9

)

Total

 

 

9,105

 

 

 

8,696

 

 

 

409

 

 

 

4.7

 

Gross profit

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

50,350

 

 

 

41,470

 

 

 

8,880

 

 

 

21.4

 

Dry Eye

 

 

2,850

 

 

 

622

 

 

 

2,228

 

 

 

358.2

 

Total

 

 

53,200

 

 

 

42,092

 

 

 

11,108

 

 

 

26.4

 

Gross margin

 

 

 

 

 

 

 

 

 

 

 

 

Surgical Glaucoma

 

 

88.1

%

 

 

88.5

%

 

 

 

 

 

 

Dry Eye

 

 

55.4

%

 

 

15.8

%

 

 

 

 

 

 

Total

 

 

85.4

%

 

 

82.9

%

 

 

 

 

 

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

14,129

 

 

 

17,626

 

 

 

(3,497

)

 

 

(19.8

)

Selling, general and administrative

 

 

85,235

 

 

 

91,367

 

 

 

(6,132

)

 

 

(6.7

)

Total operating expenses

 

 

99,364

 

 

 

108,993

 

 

 

(9,629

)

 

 

(8.8

)

Loss from operations

 

 

(46,164

)

 

 

(66,901

)

 

 

20,737

 

 

 

(31.0

)

Interest expense

 

 

(4,057

)

 

 

(3,243

)

 

 

(814

)

 

 

25.1

 

Other income, net

 

 

5,465

 

 

 

846

 

 

 

4,619

 

 

 

546.0

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income tax

 

 

(44,756

)

 

 

(69,298

)

 

 

24,542

 

 

 

(35.4

)

Provision for income tax

 

$

100

 

 

$

37

 

 

 

63

 

 

 

170.3

 

Net loss and comprehensive loss

 

 

(44,856

)

 

 

(69,335

)

 

$

24,479

 

 

 

-35.3

%

 

Revenue. Revenue for the nine months ended September 30, 2023 was $62.3 million, an increase of $11.5 million, or 22.7%, from the prior year comparable period. The overall increase in Surgical Glaucoma revenue was primarily attributable to an increase in the number of OMNI and SION units sold in the nine months ended September 30, 2023. This growth in units was driven by both a growth in the number of facilities ordering OMNI and SION, as well as an increase in unit utilization per ordering facility. Our Dry Eye revenue increased in the nine months ended September 30, 2023 versus the comparable period in 2022 due to the continued growth in our customer base and an increase in total TearCare procedures performed. Surgical Glaucoma sales represented 91.7% and 92.2% of our total revenue generated in the nine months ended September 30, 2023 and 2022, respectively.

Cost of Goods Sold and Gross Profit. Cost of goods sold increased $0.4 million during the nine months September 30, 2023 compared to the prior year comparable period. Our Surgical Glaucoma cost of goods sold increased $1.4 million as compared to the comparable period in 2022. The increase was driven by increased sales activity, and product mix, partially offset by lower per unit production costs as a result of continued manufacturing efficiencies. Dry Eye cost of goods sold decreased $1.0 million in the nine months ended September 30, 2023 over the comparable period in 2022 driven primarily by prior year charges associated with the voluntary recall of our SmartHub 1.0 devices, as well as increased efficiencies driven by increased volumes and higher average selling price of our SmartHubs.

Our total gross profit was $53.2 million in the nine months ended September 30, 2023, an increase of $11.1 million from the comparable period in 2022. Our total gross margin for the nine months ended September 30, 2023,

 

30


 

increased to 85.4%, up from 82.9% in the prior year comparable period primarily related to charges from the voluntary recall in our Dry Eye segment mentioned above. Gross margin in our Surgical Glaucoma segment was 88.1% for the nine months ended September 30, 2023, a decrease from 88.5% for the prior year comparable period primarily driven by product mix . In our Dry Eye segment, gross margin increased from 15.8% in the nine months ended September 30, 2022, to 55.4% for the nine months ended September 30, 2023, primarily driven by the impact of the previously announced voluntary recall of SmartHub 1.0 devices in the first quarter of 2022, lower manufacturing costs, an increased mix of SmartLids, which has a higher gross margin than SmartHubs and higher average selling price of SmartHubs.

Research and Development Expenses. The $3.5 million decrease in R&D expenses during the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022 was primarily attributable to a $1.6 million decrease in costs associated with clinical studies and general R&D. In addition, the Company saw a $0.7 million decrease in consulting, legal, and professional services.

Selling, General, and Administrative Expenses. SG&A expenses were $85.2 million for the nine months ended September 30, 2023, a decrease of $6.1 million from the prior year comparable period. The decrease was primarily attributable to a $2.9 million decrease in marketing expenses, a $2.2 million decrease in consulting expenses, a $2.4 million decrease in personnel expenses, including payroll and related benefits, commissions, and incentive compensation. These decreases were offset by a $1.5 million increase in legal, accounting and related expenses, and a $0.7 million increase in stock-based compensation expense.

Interest Expense. Interest expense increased $0.8 million, due to an increase in lending rates during the nine months ended September 30, 2023 compared to the nine months ended September 30, 2022.

Other Income, Net. Other income, net was $5.5 million for the nine months ended September 30, 2023 as compared to $0.8 million in the nine months ended September 30, 2022. The income is attributable to the amortization of purchase discounts on held-to-maturity cash-equivalent investments. The Company began investing in treasury securities in June 2022.

Cash Flows

The following table summarizes our cash flows for the periods indicated (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

 

 

 

 

 

 

Net cash used in operating activities

 

$

(40,700

)

 

$

(60,463

)

Net cash used in investing activities

 

$

(527

)

 

$

(841

)

Net cash provided by financing activities

 

$

728

 

 

$

436

 

Net (decrease) increase in cash

 

$

(40,499

)

 

$

(60,868

)

 

Net Cash Used in Operating Activities.

Net cash used in operating activities for the nine months ended September 30, 2023 was $40.7 million, consisting primarily of a net loss of $44.9 million and a net change in our operating assets and liabilities of $9.3 million, partially offset by non-cash charges of $13.5 million. The net change in our operating assets and liabilities was primarily due to a $2.2 million increase in accounts receivable and a $3.3 million increase in inventory to support the continued growth of our operations and increase stocking levels. We had a $0.9 million increase in accounts payable, while accrued compensation and accrued and other current liabilities decreased by an aggregate of $4.9 million, primarily driven by the timing of payments on invoices and bonuses. The non-cash charges primarily consisted of $11.1 million related to stock-based compensation, $0.7 million of noncash operating lease expense, $0.5 million of depreciation, and $0.5 million of accretion of debt discount and amortization of debt issuance costs.

Net cash used in operating activities for the nine months ended September 30, 2022 was $60.5 million, consisting primarily of a net loss of $69.3 million and a net change in our operating assets and liabilities of $2.9

 

31


 

million, partially offset by non-cash charges of $11.7 million. The change in our net operating assets and liabilities was primarily due to a $4.3 million increase in accounts receivable and a $2.2 million increase in inventory to support the continued growth of our operations. The Company had a $0.1 million decrease in accounts payable, while accrued compensation, as well as accrued and other current liabilities, increased $3.6 million, driven by the timing of payments on invoices and bonuses. The non-cash charges primarily consisted of $9.7 million related to stock-based compensation, $0.6 million of depreciation, $0.5 of accretion of debt discount and amortization of debt issuance costs, and $0.4 million of noncash operating lease expense.

Net Cash Used in Investing Activities.

Net cash used in investing activities in the nine months ended September 30, 2023 and 2022 was $0.5 million and $0.8 million, respectively, in both cases for purchases of property and equipment.

Net Cash Provided by Financing Activities.

Net cash provided by financing activities in the nine months ended September 30, 2023 of $0.7 million primarily relates to the exercise of common stock options and proceeds from ESPP purchases, partially offset by taxes paid on the net share settlement of RSUs.

Net cash provided by financing activities in the nine months ended September 30, 2022 related to proceeds from stock option exercises.

Liquidity and Capital Resources

Sources of Liquidity

To date, our primary sources of capital have been private placements of redeemable convertible preferred stock, debt financing agreements, the sale of common stock in our IPO, and revenue from the sale of our products. Since our inception, we have raised an aggregate of approximately $402.4 million in net proceeds from sales of our redeemable convertible preferred stock and common stock and borrowed $32.9 million of net proceeds under our term loans.

As of September 30, 2023, we had cash and cash equivalents of $144.5 million, an accumulated deficit of $284.1 million and $35.0 million outstanding under our Term Loan agreement (before debt discount and amortized debt issuance costs). Based on our current planned operations, we expect revenue from sales of our products and our cash and cash equivalents will enable us to fund our operations for at least the next 12 months and the foreseeable future thereafter.

MidCap Term Loan

As of September 30, 2023, we had a credit and security agreement with certain entities affiliated with MidCap Financial Services (such entities collectively, the "Lender"), which provides a $35.0 million senior secured term loan (the "Term Loan").

Our obligations under the Term Loan agreement are guaranteed by us and our future subsidiaries, subject to exceptions for certain foreign subsidiaries and secured by substantially all of our assets, including our material intellectual property. Additionally, we are subject to affirmative and negative covenants, including certain minimum revenue and cash covenants as well as covenants that limit or restrict the ability of us to, among other things, incur indebtedness, grant liens, merge or consolidate, make investments, dispose of assets, make acquisitions, pay dividends or make distributions, repurchase stock and enter into certain transactions with affiliates, in each case subject to certain exceptions. As of September 30, 2023, we were in compliance with all financial and non-financial covenants under the Term Loan agreement.

The Term Loan agreement contains events of default that include, among others, non-payment of principal, interest or fees, breach of covenants, inaccuracy of representations and warranties, cross-defaults and bankruptcy and insolvency events.

 

32


 

We incurred $0.7 million of issuance costs in conjunction with the Term Loan which were netted against the borrowed funds in the balance sheets and are being accreted using the effective interest method as interest expense over the contractual period of the Term Loan.

The Term Loan agreement includes a maturity date of November 1, 2025 and includes a stated floating interest rate that is reserve-adjusted Secured Overnight Finance Rate ("SOFR"), plus 7.00%. Principal payments under the Term Loan are scheduled to begin in December 2023. However, we currently expect to meet certain conditions, which, if satisfied, will delay the commencement of principal payments to December 2024. In addition, the Term Loan contains a provision for a final payment fee of 6.0% of the $35.0 million Term Loan balance, which has been partially accrued and recorded as a long-term interest payable in other noncurrent liabilities of $1.4 million as of September 30, 2023 and $1.2 million as of December 31, 2022.

In conjunction with the initial funding of the Term Loan in 2020, we issued a ten-year warrant to the Lender to purchase 300,000 shares of our Series F redeemable convertible preferred stock at an exercise price of $21.88 per share, (the "MidCap Warrant"), with the estimated fair value of $1.8 million. The MidCap Warrant was recorded at the fair value as a debt discount and as a warrant liability. The debt discount is being accreted using the effective interest method as interest expense over the contractual period of the Term Loan. The MidCap Warrant was automatically converted into a common stock warrant in connection with the IPO and subsequently exercised in the third quarter of fiscal year 2021. Accordingly, the MidCap Warrant no longer remains outstanding.

Lease Agreements

Our corporate headquarters are located in Menlo Park, California, where we lease approximately 11,000 square feet of office, research and development, engineering and laboratory space pursuant to a lease that commenced on August 1, 2021, and expires on August 31, 2024. We also lease approximately 2,040 square feet of office space, which is primarily used by our commercial leadership team, in Southlake, Texas, pursuant to a lease that commenced on April 30, 2019 and expires on May 15, 2024.

Critical Accounting Policies and Estimates

Our condensed consolidated financial statements included elsewhere in this Quarterly Report are prepared in accordance with GAAP. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and related disclosures. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

An accounting policy is deemed to be critical if it requires an accounting estimate to be made based on assumptions about matters that are highly uncertain at the time the estimate is made, if different estimates reasonably could have been used, or if changes in the estimate that are reasonably possible could materially impact the financial statements. We believe that the assumptions and estimates associated with stock-based compensation has the greatest potential impact on our condensed consolidated financial statements. Therefore, we consider this to be a critical accounting estimate.

There have been no material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates described in our audited consolidated financial statements for the year ended December 31, 2022, included under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Estimates” in our Annual Report and in Note 2 to our condensed consolidated financial statements in this Quarterly Report.

JOBS Act Accounting Election

The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We have elected to use this extended transition period under the JOBS Act. As a result, our financial statements may not be comparable to

 

33


 

the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make comparison of our financial statements to those of other public companies more difficult.

Recently Issued Accounting Pronouncements

As of September 30, 2023, there are no significant ASUs issued and not yet adopted, that are expected to have a material impact on the Company's financial statements and related disclosures.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

We are exposed to market risks in the ordinary course of our business. These risks primarily include interest rate risk and foreign currency exchange rate risk. There have been no material changes to such risks from those described in our Annual Report under the heading "Quantitative and Qualitative Disclosures About Market Risk."

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation and supervision of our principal executive officer and our principal financial and accounting officer, evaluated our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act). The term "disclosure controls and procedures," means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the Company's management, including its principal executive officer, principal financial officer and principal accounting officer, as appropriate to allow timely decisions regarding required disclosure.

Based on this evaluation, our principal executive officer and our principal financial and accounting officer concluded that, as a result of the material weakness in our internal control over financial reporting described below, as of the end of the period covered by this Quarterly Report, our disclosure controls and procedures were not effective. However, our management, including our principal executive officer and our principal financial and accounting officer, has concluded that, notwithstanding the identified material weakness in our internal control over financial reporting, the condensed consolidated financial statements in this Quarterly Report fairly present, in all material respects, our financial position, results of operations, and cash flows for the periods presented in conformity with GAAP.

Remediation Efforts on Previously Reported Material Weaknesses

In connection with the preparation of our financial statements in connection with our IPO, we identified a material weakness in our internal control over financial reporting. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. The material weakness related to a lack of sufficient full-time accounting personnel with requisite experience and deep technical accounting knowledge to (i) identify and resolve complex accounting issues under GAAP, and (ii) enable appropriate segregation of duties and reviews over the financial close and reporting process.

During the year ended December 31, 2022, our management, with the oversight of the Audit Committee of our board of directors, designed and implemented measures to remediate the control deficiencies contributing to the material weakness and completed testing of internal controls. These remediation efforts, which continued initiatives that began during the year ended December 31, 2021, included the following:

significantly increased our accounting and financial reporting personnel, including the hiring of certified public accountants, and technical accounting and SEC reporting resources with requisite technical accounting knowledge; and

 

34


 

designed and implemented controls to formalize review procedures around the financial close and reporting process with appropriate segregation of duties and to improve the completeness, timeliness and accuracy of our financial reporting and disclosures including the assessment of more judgmental areas of accounting.

While significant progress has been made to improve our internal control over financial reporting, not all aspects of our past material weakness have been sufficiently remediated. The remaining aspect of the material weakness relates to the lack of sufficient accounting resources with deep technical accounting knowledge to identify and resolve complex accounting issues in a timely manner. Remediation of the material weakness will require further validation and testing of the operating effectiveness of the applicable remedial controls over a sustained period of financial reporting cycles.

Changes in Internal Control Over Financial Reporting

Other than the changes intended to remediate the material weakness noted above, there were no changes in our internal control over financial reporting during the most recently completed fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

Except as set forth in Note 6, Commitments and Contingencies, in the notes to the unaudited condensed consolidated financial statements in this Quarterly Report, we do not believe we are currently a party to any legal proceedings, regulatory matters, or other disputes or claims which, if determined adversely to us, would, individually or taken together, have a material adverse effect on our business, financial condition, operating results, liquidity or future prospects. However, regardless of the merits of the claims raised or the outcome, legal proceedings, regulatory matters, and other disputes and claims may have an adverse impact on us as a result of defense and settlement costs, diversion of management time and resources, and other factors.

Item 1A. Risk Factors.

 

Except as set forth below, we are not aware of any material changes to the risk factors set forth under the heading "Risk Factors" in our 2022 Form 10-K or Q2 Quarterly Report, which are incorporated herein by reference. The risks described in the 2022 Form 10-K are not the only ones we face. Additional risks we currently do not know about or that we currently believe to be immaterial may also impair our business, financial condition, operating results, liquidity, and future prospects.

 

Risks Related to Our Business

We may not be able to incrementally secure or maintain adequate levels of third-party coverage and reimbursement for procedures in which our Surgical Glaucoma or TearCare products are used, and third parties have recently rescinded, and others in the future may rescind or modify, their coverage or delay payments related to these products, which will adversely affect our business, financial condition, and results of operations.

We derive revenue from sales of OMNI and SION to physicians, ASCs, and HOPDs, which typically bill all or a portion of the costs and fees associated with our products to various third-party payors, including Medicare, Medicaid, private commercial insurance companies, health maintenance organizations, and other healthcare-related organizations, and then bill patients for any applicable deductibles or co-payments. Internationally, medical reimbursement systems vary significantly from country to country, with some countries limiting medical centers’ spending through fixed budgets, regardless of levels of patient treatment, and other countries requiring application for, and approval of, government or third-party reimbursement. As a result, access to adequate coverage and reimbursement for procedures in which our Surgical Glaucoma products are used by third-party payors is essential to their acceptance and adoption by patients and ECPs.

 

These third-party payors continually review new and existing technologies for possible coverage and can deny or reverse coverage for new or existing products and procedures, and there can be no assurance that third-party payor

 

35


 

policies provide coverage, or will continue to provide coverage, for procedures in which OMNI or our other products are used. For example, CMS, MACs or commercial payors could issue coverage policies that could restrict or eliminate coverage for the patient populations eligible for treatment with our products or that are otherwise unfavorable to our business. In June 2023, for instance, five MACs issued the Draft LCDs, which propose to establish or update Medicare coverage policies for MIGS. The Draft LCDs propose to identify certain non-implantable MIGS procedures as investigational and not reasonable and necessary in the jurisdictions where these MACS administer Medicare Part B benefits, including but not limited to adult canaloplasty in combination with trabeculotomy ab interno, a procedure performed with OMNI and for which it is indicated. The Draft LCDs may also categorize our SION technology as investigational and thus non-covered with respect to goniotomy procedures. On October 26, 2023, one of the five MACs released the Final LCD, identifying certain procedures as investigational, including adult canaloplasty in combination with trabeculotomy ab interno. The states served by that MAC accounted for approximately 8% of our Surgical Glaucoma revenue in 2022. We expect that if the Final LCD is not withdrawn before it becomes effective on December 24, 2023, it will have an adverse impact on our revenue, results of operations, and financial condition, the full extent of which is not known at this time. Further, if the remaining MACs ultimately adopt similar coverage policies, or adopt policies as contemplated by the Draft LCDs, the determinations would establish a policy of Medicare non-coverage for these procedures and other non-implantable MIGS procedures in these Medicare jurisdictions. The states served by all five of these MACs accounted for approximately 63% of our Surgical Glaucoma revenue in 2022. If these five LCDs are not withdrawn, or modified or clarified before they become effective so as to provide for continued coverage of adult canaloplasty in combination with trabeculotomy ab interno (and potentially use of our SION technology in goniotomy procedures), or if these MACS or other third-party payors that currently cover or reimburse procedures in which our products are used reverse or limit their coverage in the future, or if the remaining two MACs or other third-party payors issue similar policies, there will be a material adverse effect on our business, financial condition and results of operations.

We also derive revenue from sales of TearCare to ECPs and eye care clinics, which bill all or a portion of the costs and fees associated with treatments and products to patients or, on a limited basis, to third-party payors. We believe access to adequate coverage and reimbursement for procedures in which TearCare is used by third-party payors is important to the broad acceptance and adoption of TearCare. Currently, no MACs have formal policies establishing coverage for the TearCare procedure; however, MACs from time to time may include, and we are currently aware of three MACs that have included, low payment rates for TearCare procedures in their fee schedules that, if not removed or increased to what we believe is an appropriate reimbursement level, could adversely impact our efforts to achieve reimbursement for TearCare that is sufficient to support its broad commercial growth and adoption. Further, commercial payers may from time to time make “no coverage” or similar determinations with respect to our TearCare product that could hamper our efforts to drive broad commercial adoption of TearCare. We are pursuing a comprehensive long-term market development and patient access plan for TearCare and focusing our efforts on partnering with key strategic accounts to pursue prior authorization approvals and reimbursement claims for procedures in which TearCare is used, but there is no guarantee that we will be successful. If patients are not willing to pay for procedures in which TearCare is used, or if third-party payors continue to refuse to provide coverage and reimbursement, or provide insufficient levels of coverage and reimbursement, it could have a negative impact on ECPs’ adoption of TearCare and sales of TearCare, which could adversely affect our business.

Third-party payors, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, no uniform policy of coverage and reimbursement for procedures using our products exists among third-party payors. Therefore, coverage and reimbursement for procedures using our products can differ significantly from payor to payor. Obtaining and maintaining coverage and reimbursement can be a time-consuming process that could require us to provide supporting scientific, clinical and cost-effectiveness data for the use of our products. We may not be able to provide data sufficient to satisfy governmental and third-party payors that procedures using our products should be covered and reimbursed. With regard to our international sales efforts, even if and as we succeed in bringing our products to market in foreign countries, uncertainties regarding future healthcare policy, legislation and regulation, as well as private market practices, could affect our ability to sell our products in commercially acceptable quantities at acceptable prices.

In the United States, the American Medical Association (“AMA”) generally assigns specific billing codes for procedures under a coding system known as Current Procedure Terminology (“CPT”), which surgeons use to bill third-party payors and receive reimbursement. Once a permanent CPT code (“Category I CPT code”) is established

 

36


 

for a service, CMS establishes payment levels under Medicare, while other payors may establish rates and coverage rules independently. Canaloplasty followed by trabeculotomy procedures using OMNI are typically billed using the Category I CPT code 66174, which describes canaloplasty. Coding for ophthalmic surgical procedures is complex, and changes to the codes used to report services performed with our products may result in significant changes in reimbursement, which could negatively impact our revenue. For example, in 2021 the RVS Update Committee (“RUC”) of the AMA reevaluated the physician work associated with CPT code 66174. As a result of this RUC review, CMS reduced the Medicare Physician Fee Schedule amount associated with this service from approximately $950 in 2021 to $761 in 2022 and approximately $607 in 2023.

The AMA maintains a subset of temporary CPT codes (“Category III CPT codes”) used for new and emerging technologies. For example, TearCare was assigned a Category III CPT code effective beginning January 1, 2020. Coverage for Category III CPT codes is often limited. Medicare does not generally establish national payment rates for Category III CPT codes on the Medicare Physician Fee Schedule. As a result, individual Medicare contractors and private payors may establish their own payment rates for services described by Category III CPT codes, as has been the case with TearCare, which payment rates are subject to change, may be variable across Medicare contractors, may be materially below the final reimbursement rates that we are currently targeting, or may determine not to reimburse services described by Category III CPT codes.

Further, we believe that future coverage and reimbursement may be subject to increased restrictions, such as additional prior authorization requirements, both in the United States and in international markets. Third-party coverage and reimbursement for procedures using our products or any of our products in development for which we may receive regulatory clearance, certification or approval may not be available or adequate in either the United States or international markets. Further, other devices or treatments that compete with our products may be more widely covered or subject to different co-pay policies and requirements, which could impact demand for our products. If hospital, surgical center, ECP and/or patient demand for our products is adversely affected by third-party reimbursement policies and decisions, it could have a material adverse effect on our business, financial condition and results of operations.

Our strategic realignment and cost saving initiatives could result in higher than expected costs, fail to achieve the anticipated cost savings, and cause disruptions in our business that could make it difficult to achieve our strategic objectives.

On October 17, 2023, we initiated a strategic realignment of our operations, including approximately a 10% reduction in our workforce, which is intended to reduce operating expenses, improve cost efficiencies, and further extend our cash runway. However, these initiatives may not result in the anticipated benefits, and may result in unexpected difficulties or costs.

We expect to record a cash restructuring charge of approximately $1.3 million in the fourth quarter of 2023. However, this estimate is subject to assumptions, and actual costs and charges may be higher than anticipated. In addition, we may fail to accurately estimate the level of cost savings and improvements to our cost structure associated with our initiatives, in which case our future operating results may be worse than expected. Further, our workforce reduction may be disruptive to our business and have unanticipated consequences, such as attrition beyond planned staff reductions, reduced employee morale, and decreased operational capabilities primarily within our Dry Eye business. Our workforce reductions could also harm our ability to attract and retain qualified personnel, which could adversely affect our business and results of operation. Our strategic initiatives may also have a negative effect on our existing relationships within our Dry Eye business segment, including with respect to business partners, customers, and other constituents. For example, we intend to amend or terminate certain contractual relationships with existing partners, which could harm our business relationships and result in unexpected costs.

We have limited experience implementing similar strategic initiatives and, as a result, we may fail to achieve the associated benefits, or fail to anticipate the associated costs or manage any expected difficulties. If we are unable to successfully manage these realignment activities, or any similar activities in the future, our financial performance, results of operations, and prospects could be negatively affected. In addition, the impact of these initiatives could result in variations in our financial results from period to period, which could make comparisons of our financial performance more difficult.

 

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We are an early-stage company with a history of significant losses, we expect to incur losses in the future, and we may not be able to achieve or sustain profitability.

We have incurred annual net losses since our formation in 2010. For the years ended December 31, 2022 and 2021, we had net losses of $86.2 million and $63.0 million, respectively. As of December 31, 2022, we had an accumulated a deficit of $239.2 million. To date, we have financed our operations primarily through equity and debt financings and from the sales of our products, which include OMNI, a device that enables canaloplasty followed by trabeculotomy for the reduction of intraocular pressure in adult patients with primary open-angle glaucoma, and TearCare, which is indicated for the application of localized heat therapy in adult patients with dry eye disease due to MGD, when used in conjunction with manual expression of the meibomian glands. Starting in the second half of 2022, we commenced sales of SION, a manually operated device indicated for use in ophthalmic surgical procedures to excise trabecular meshwork. The losses and accumulated deficit have primarily been due to the substantial investments we have made to develop our products, costs related to our sales and marketing efforts, general research and development expenses, including costs related to clinical trials and regulatory initiatives to obtain marketing clearance, and infrastructure improvements. In addition, as a public company, we incur significant legal, accounting, and other expenses that we did not incur as a private company.

Accordingly, we expect to continue to incur losses for the foreseeable future and we cannot assure you that we will ever achieve profitability or that, if we do become profitable, we will sustain profitability. In addition, we expect the publication of the Final LCD to have a material adverse effect on our OMNI sales in the states served by WPS if it becomes effective in December 2023 in its current form. Further, if the other four MACs that published the Remaining Draft LCDs adopt similar coverage policies, determinations of Medicare non-coverage may be made for non-implantable MIGS procedures, which are performed with our Surgical Glaucoma products. The states served by WPS and these four other MACs accounted for approximately 63% of our Surgical Glaucoma revenue during 2022, and additional final LCDs from these other four MACs that reverse or limit coverage for procedures in which our products are used would have a material adverse effect on our revenue and results of operations. Our failure to achieve and sustain profitability in the future would make it more difficult to finance our business and accomplish our strategic objectives, which would have a material adverse effect on our business, financial condition and results of operations. In addition, failure of our products to significantly penetrate our target markets would negatively affect our business, financial condition, and results of operations.

We are highly dependent on revenue from the sales of our products, and our inability to successfully execute our growth strategy could negatively affect our results of operations and financial condition.

We began selling VISCO360 and TRAB360, commercial predicate devices to OMNI, in 2015, TearCare in 2019 and SION in the second half of 2022, and therefore do not have a long history operating as a commercial company. Currently, we are highly dependent on the success of our OMNI and SION technologies, which comprise our Surgical Glaucoma products, and TearCare, and we expect substantially all of our product revenues in at least the next 12 months to be derived from these products. We are particularly dependent on the success of OMNI and SION, which accounted for >90% of our total revenues for the year ended December 31, 2022. We expect that if the Final LCD becomes effective in December 2023 in its current form, it will have a material adverse effect on our OMNI sales in the states served by WPS, and if other four MACs that published Draft LCDs adopt similar coverage policies, determinations of Medicare non-coverage may be made for non-implantable MIGS procedures, which are performed with our OMNI technology (and may also include procedures performed with our SION technology), in states accounting for approximately 63% of our Surgical Glaucoma revenue in 2022. Because we devote substantially all of our resources to these products and rely on them as our sole source of revenue, any factors that negatively impact our products, and particularly OMNI, or result in a decrease in sales, could have a material adverse effect on our business, financial condition and results of operations.

Over the next several years, we expect to continue to devote substantial resources to expand our commercialization efforts, drive increased adoption of our products and continue to develop new and improved products. Our limited commercialization experience and number of products make it difficult to evaluate our current business and predict our future prospects. For example, we believe that OMNI can be used as a Standalone procedure to help effectively reduce IOP in adult POAG patients, but we have limited commercial experience with this Standalone market segment, and the extent to which we are able to penetrate and grow this market is unknown.

 

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In addition, a number of factors, including some outside of our control, may render our products economically impracticable or obsolete and contribute to fluctuations in our financial results, including:

our ability to obtain and maintain reimbursement coverage for procedures in which our products are used, and to successfully engage with MACs to obtain or retain favorable coverage determinations;
changes in reimbursement rates by government or commercial payors;
the results of our clinical trials or investigations;
positive or negative media coverage, or public, patient and/or physician perception, of our products or competing products and treatments;
any safety or effectiveness concerns that arise regarding our products for either their currently authorized uses or the uses for which we are developing our products;
the effectiveness of our marketing and sales efforts, including our ability to have a sufficient number of qualified sales representatives to sell our products;
unanticipated delays in product development or launches;
our ability to raise additional capital on acceptable terms, or at all, if needed to support the commercialization of our products and operations;
our ability to achieve and maintain compliance with all legal and regulatory requirements applicable to our products;
our ability to obtain, maintain, protect, and enforce our intellectual property rights;
our third-party manufacturers’ ability to supply our products in a timely manner, in accordance with our specifications, and in compliance with applicable regulatory requirements; and
introduction of new products or alternative treatments that compete with our products.

Our business is dependent upon the broad adoption of our products by eyecare professionals and patients.

ECPs, including ophthalmologists and optometrists, have limited awareness of, and experience with, our products and brand. Our future growth and profitability largely depend on our ability to increase ECP and patient awareness of our products and on the willingness of ECPs and patients to adopt our products. ECPs may not adopt our products unless they believe they will receive appropriate compensation for such use and are able to determine, based on experience, clinical data, medical society and association recommendations and other analyses, that our products are clinically differentiated from, or otherwise preferable to, available alternatives. Even if we are able to raise awareness among ECPs, they may be slow to change their medical treatment practices and may be hesitant to select our products for a variety of reasons, including:

lack of experience with our products and concerns that we are relatively new to market;
lack of availability of adequate third-party payor coverage or reimbursement, or changes in (or new) third-party payor coverage or reimbursement policies that are materially adverse to our interest, including the publication of the Final LCD by WPS and the potential publication of substantively similar final LCDs by other MACs;
perceived liability risk generally associated with the use of new products and treatment options;
lack, or perceived lack, of sufficient clinical evidence, including long-term data, supporting clinical benefits or the cost-effectiveness of our products over existing treatments;
the failure of key ophthalmologist and optometrist leaders to support and recommend our products;
perceptions that our products are unproven;
ECPs’ long-standing relationships with companies, distributors and salespeople that sell competing products;

 

39


 

competitive response, including new product introduction and negative selling efforts from providers of alternative treatments;
challenges of integrating TearCare into established ophthalmologic and optometric practices; and
perceptions regarding the time commitment and skill development that may be required to gain familiarity and proficiency with our products.

To effectively market and sell our products, we will need to continue to educate the medical community about the safety, efficacy, necessity and efficiency of our products and about the patient populations that would potentially benefit from the use of our products. For example, if first-line ECPs or primary care physicians that serve as the early point of contact for patients are not made aware of our OMNI products, they may not refer patients to ECPs who utilize our products, and those patients may be treated with alternative procedures or treatments. In addition, some physicians may choose to utilize our products on only a subset of their total patient population or may not adopt our products at all. Further, if we are unable to obtain or maintain favorable third-party reimbursement coverage of procedures in which our products are used, particularly as compared to competitive products, adoption of our products by ECPs and patients will suffer. We cannot assure you that our products will achieve broad market acceptance among payors, physicians and patients. Any failure of our products to satisfy demand or to achieve meaningful market acceptance and penetration will harm our future prospects and have a material adverse effect on our business, financial condition and results of operations.

We have a significant amount of debt, which may affect our ability to operate our business and secure additional financing in the future.

As of September 30, 2023, we had a credit and security agreement with the Lender, which provides for a $35.0 million Term Loan. The Term Loan agreement includes a maturity date of November 1, 2025 and includes a stated floating interest rate that is reserve-adjusted SOFR, plus 7.00%. Principal payments under the Term Loan are scheduled to begin in December 2023. However, we currently expect to meet certain conditions, which, if satisfied, will delay the commencement of principal payments to December 2024. In addition, the Term Loan contains a provision for a final payment fee of 6.0% of the $35.0 million Term Loan balance, which has been partially accrued and recorded as a long-term interest payable in other noncurrent liabilities of $1.4 million as of September 30, 2023 and $1.2 million as of December 31, 2022.

Our obligations under the Term Loan agreement are collateralized by a security interest in substantially all of our assets, and we are subject to customary financial and operating covenants limiting our ability to, among other things, relocate or dispose of assets, undergo a change in control, merge or consolidate, enter into certain transactions with affiliates, make acquisitions, incur debt, pay dividends, grant liens, store certain amounts of inventory or equipment with third parties and make investments, in each case subject to certain exceptions. We are also subject to minimum trailing revenue targets that are evaluated on a monthly basis and a $50 million minimum unrestricted cash requirement. While we are currently in compliance with the covenants, trailing revenue targets and minimum cash requirements set forth in the Term Loan agreement, we expect the publication of the Final LCD to adversely affect our OMNI revenue generated in the states served by WPS, which states accounted for approximately 8% of our Surgical Glaucoma revenue in 2022. In addition, the states served by the other four MACs that have published the Remaining Draft LCDs accounted for approximately 55% of our Surgical Glaucoma revenue in 2022. If those other MACs adopt similar coverage policies, the determinations would establish a policy of Medicare non-coverage for adult canaloplasty followed by trabeculotomy ab interno, a procedure performed with our OMNI technology in these Medicare jurisdictions, and may also result in Medicare non-coverage for our SION technology in these jurisdictions. Any such non-coverage would materially adversely affect our revenue. Our failure to comply with the minimum trailing revenue targets or the minimum unrestricted cash requirement would lead to an event of default under the Term Loan agreement, and the Lender could accelerate payments due under the Term Loan. In addition, the covenants related to the Term Loan agreement, as well as any future financing agreements into which we may enter, may restrict our ability to finance our operations and engage in, expand, or otherwise pursue our business activities and strategies.

While we believe that we have not previously breached and are not currently in breach of these or any other covenants contained in the Term Loan agreement, there can be no guarantee that we will not breach these covenants

 

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in the future. Our ability to comply with these covenants may be affected by events beyond our control, and future breaches of any of these covenants could result in a default under the Term Loan agreement. If not waived, future defaults could cause all of the outstanding indebtedness under the Term Loan agreement to become immediately due and payable and terminate commitments to extend further credit and foreclose on the collateral granted to it to collateralize such indebtedness. If we do not have or are unable to generate sufficient cash available to repay our debt obligations when they become due and payable, either upon maturity or in the event of a default, our assets could be foreclosed upon and we may not be able to obtain additional debt or equity financing on favorable terms, if at all, which may negatively impact our ability to operate and continue our business as a going concern.

In order to service this indebtedness and any additional indebtedness we may incur in the future, we need to generate cash from our operating activities. Our ability to generate cash is subject, in part, to our ability to successfully execute our business strategy, as well as general economic, financial, competitive, regulatory and other factors beyond our control. We cannot assure you that our business will be able to generate sufficient cash flow from operations or that future borrowings or other financings will be available to us in an amount sufficient to enable us to service our indebtedness and fund our other liquidity needs. To the extent we are required to use cash from operations or the proceeds of any future financing to service our indebtedness instead of funding working capital, capital expenditures or other general corporate purposes, we will be less able to plan for, or react to, changes in our business, industry and in the economy generally. This may place us at a competitive disadvantage compared to our competitors that have less indebtedness or greater financial resources to service their debt.

Risks Related to Our Common Stock

The price of our common stock may fluctuate substantially or may decline regardless of our operating performance and you could lose all or part of your investment.

The market price of our common stock may be highly volatile and may fluctuate or decline substantially as a result of a variety of factors, some of which are beyond our control or are related in complex ways, including:

changes in analysts’ estimates, investors’ perceptions, recommendations by securities analysts or our failure to achieve analysts’ estimates;
actual or anticipated quarterly variations in our or our competitors’ results of operations;
periodic fluctuations in our revenue, which could be due in part to the way in which we recognize revenue;
the trading volume of our common stock;
general market conditions and other factors unrelated to our operating performance or the operating performance of our competitors;
changes in reimbursement by current or potential payors, and coverage determinations published by MACs;
changes in operating performance and stock market valuations of other technology companies generally, or those in the medical device industry in particular;
actual or anticipated changes in regulatory oversight of our products;
the results of our clinical trials;
the loss of key personnel, including changes in our board of directors or management;
product recalls or other problems associated with our products;
legislation or regulation of our market;
lawsuits threatened or filed against us;
the announcement of new products or product enhancements by us or our competitors;
announced or completed acquisitions of businesses or technologies by us or our competitors;
announcements related to patents issued to us or our competitors and related litigation; and

 

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developments in our industry.

In recent years, including as the result of the COVID-19 pandemic, the stock markets generally have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of listed companies. Broad market and industry factors may significantly affect the market price of our common stock, regardless of our actual operating performance. In addition, the recent publication of the Final LCD, as well as the possibility the MACs that published the Draft LCDs may adopt similar coverage policies, has resulted in a substantial decline in the market price of our common stock, and future determinations may similarly impact our stock price.

In addition, in the past, stockholders have instituted securities class action litigation following periods of market volatility. If we were to become involved in securities litigation, it could subject us to substantial costs, divert resources and the attention of management from our business and harm our business, results of operations, financial condition and reputation. These factors may materially and adversely affect the market price of our common stock.

 

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

Use of Proceeds

In July 2021, we completed our IPO. All shares sold were registered pursuant to a registration statement on Form S-1 (File No. 333-257320), as amended (the "Registration Statement"), declared effective by the SEC on July 14, 2021.

There has been no material change in the intended use of proceeds from the IPO as described in the Registration Statement.

Recent Sales of Unregistered Securities

None.

Issuer Purchases of Equity Securities

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

None.

 

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Item 6. Exhibits.

The following exhibits are filed or furnished as a part of, or incorporated by reference into, this Quarterly Report.

 

 

 

 

 

Incorporated by Reference

 

 

 

 

 

 

 

 

Exhibit Number

 

Exhibit Description

 

Form

 

File No.

 

Exhibit

 

Filing Date

 

Filed/Furnished Herewith

3.1

 

Restated Certificate of Incorporation of Sight Sciences, Inc.

 

8-K

 

001-40587

 

3.1

 

7/19/21

 

 

3.2

 

Amended and Restated Bylaws of Sight Sciences, Inc.

 

8-K

 

001-40587

 

3.2

 

7/19/21

 

 

10.1#

 

Employment Agreement between Sight Sciences, Inc. and Alison Bauerlein, dated April 3, 2023

 

10-Q

 

001-40587

 

10.1

 

5/8/23

 

 

10.2#

 

Employment Agreement between Sight Sciences, Inc. and Matthew Link, dated September 11, 2023

 

 

 

 

 

 

 

 

 

*

10.3

 

Fourth Amendment to the Amended and Restated Credit and Security Agreement (Term Loan) between Sight Sciences, Inc. and Midcap Financial Trust, dated November 6, 2023

 

 

 

 

 

 

 

 

 

*

31.1

Certification of the Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act

 

 

 

 

 

 

 

 

 

*

31.2

Certification of the Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act

 

 

 

 

 

 

 

 

 

*

32.1

Certification of the Chief Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

 

 

**

32.2

Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

 

 

 

 

 

 

 

**

101.INS

Inline XBRL Instance Document

 

 

 

 

 

 

 

*

101.SCH

Inline XBRL Taxonomy Extension Schema Document

 

 

 

 

 

 

 

*

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

 

 

 

 

*

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

 

 

 

 

*

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

 

 

 

 

 

 

 

*

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

 

 

 

 

*

104

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

 

 

 

 

 

 

*

 

* Filed herewith.

** Furnished herewith.

# Indicates a management or compensatory plan

 

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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 thereunto duly authorized.

 

SIGHT SCIENCES, INC

November 7, 2023

By:

/s/ Alison Bauerlein

 

Alison Bauerlein

Chief Financial Officer

 

 

 

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