SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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|Item 7.01|| |
Regulation FD Disclosure.
Sight Sciences, Inc. (the “Company”) reaffirms its revenue guidance for the year ending December 31, 2023 of $89.0 million to $94.0 million, which represents growth of approximately 25% to 32% compared to the year ended December 31, 2022. The Company also reaffirms its expectation for average adjusted operating expense on a quarterly basis of approximately $30.5 million.
|Item 8.01|| |
On June 1, 2023, WPS Government Health Administrators (“WPS”), a Medicare Administrative Contractor (“MAC”), filed a proposed local coverage determination (“LCD”) on micro-invasive glaucoma surgery (“MIGS”) (DL39620). WPS administers Part B Medicare benefits in Kansas, Nebraska, Missouri, Iowa, Indiana, and Michigan. The proposed LCD identifies non-implantable MIGS procedures as investigational. If finalized, this determination would lead to non-implantable MIGS procedures being non-covered in these states for Medicare beneficiaries. The WPS-served states accounted for approximately 8% of the Company’s Surgical Glaucoma revenue in 2022.
The Company strongly disagrees with the proposed LCD’s characterization of the procedures involving the OMNI technology as investigational. Based on the Company’s preliminary review of the proposed LCD, the Company is concerned that the assessment process appears not to have taken into account meaningful and current clinical and real-world evidence illustrating the proven benefits of the OMNI® Surgical System. The Company believes the clinical evidence demonstrating the OMNI technology’s safety and efficacy, as well as OMNI’s broad Food and Drug Administration (“FDA”) clearance for lowering intraocular pressure in all adults with primary open-angle glaucoma, strongly support continued Medicare coverage in the WPS states.
WPS should develop coverage criteria based on existing clinical literature, proven clinical efficacy, and FDA clearance. To help inform WPS’ review, the Company plans to present peer-reviewed, published clinical evidence establishing that procedures involving the OMNI technology are reasonable and necessary based on Medicare coverage standards at the upcoming open WPS meeting on June 14, 2023 and in the comment period through July 15, 2023.
Previously in 2020, another MAC, Palmetto GBA (“Palmetto”), also proposed an LCD that outlined non-coverage of non-implantable MIGS. The ophthalmic community, comprising leading surgeons, medical societies, and patient advocacy groups, was successful in providing information that led to Palmetto withdrawing their proposed policy.
Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K, together with other statements and information publicly disseminated by the Company, contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which statements are subject to considerable risks and uncertainties. The Company intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 and includes this statement for purposes of complying with these safe harbor provisions. Any statements made in this Current Report on Form 8-K that are not statements of historical fact, including statements about our beliefs and estimates, are forward-looking statements and should be evaluated as such. Such statements often include words such as “anticipate,” “expect,” “suggests,” “plan,” “believe,” “intend,” “estimates,” “targets,” “projects,” “should,” “could,” “would,” “may,” “will,” “forecast” and other similar expressions. We base these forward-looking statements on our current expectations, plans and assumptions that we have made in light of our experience in the industry, as well as our perceptions of historical trends, current conditions, expected future developments and other factors we believe are appropriate under the circumstances at such time. Although we believe these forward-looking statements are based upon reasonable assumptions at the time they are made, we cannot guarantee their accuracy or completeness. Forward-looking statements are subject to and involve risks, uncertainties and assumptions that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance, or achievements predicted, assumed or implied by such forward-looking statements, including the important factors discussed under the caption “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission, as may be updated from time to time in subsequent filings. These forward-looking statements include, but are not limited to, statements regarding estimates of our future revenue and operating expenses, the outcome of proposed LCDs on non-implantable MIGS procedures and related Medicare coverage, WPS’ MIGS assessment process, the Company’s plans to present WPS with evidence regarding MIGS procedures and the use of OMNI technology, and the strength of the Company’s business and products. These cautionary statements should not be construed by you to be exhaustive and are made only as of the date of this Current Report on Form 8-K. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
The information in Item 7.01 and Item 8.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
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.|
|Date: June 2, 2023||By:|
|President and Chief Executive Officer|