Item 2.02. Results of Operations and Financial Condition.
As described below, on
The estimated cash figure is preliminary and unaudited, represents management's estimate as of the date of this Form 8-K and is subject to completion of the Company's financial closing procedures. The Company's independent registered public accounting firm has not conducted an audit or review of, and does not express an opinion or any other form of assurance with respect to, the estimated cash figure.
The information in this Item 2.02 is furnished under Item 2.02 of Form 8-K, and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the "Securities Act"), or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 7.01. Regulation FD Disclosure.
On
The information in this Item 7.01, including Exhibit 99.1 attached hereto, is furnished under Item 7.01 of Form 8-K, and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01. Other Events.
On
EYSUVISTM Important Safety Information
EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.
The initial prescription and each renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining.
Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP.
Use of corticosteroids may result in posterior subcapsular cataract formation.
Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection.
Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).
Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use.
The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients.
Please see full Prescribing Information at www.eysuvis.com
Cash Runway
The Company anticipates that its existing cash, cash equivalents and short-term investments, along with sales of INVELTYS, will enable it to fund its operations into at least the third quarter of 2022, with additional cash runway expected based on revenues from sales of EYSUVIS. The Company has based this estimate on assumptions that may prove to be wrong, and it could use its capital resources sooner than it currently expects.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, that involve substantial risks
and uncertainties, including statements regarding the Company's goal of
establishing EYSUVIS as the preferred, first-line prescription therapy for dry
eye disease; expectations regarding potential EYSUVIS launch timing,
expectations regarding the potential demand for EYSUVIS and the company's
expectations regarding its use of cash, cash runway and projected revenues. All
statements, other than statements of historical facts, contained in this press
release, including statements regarding the Company's strategy, future
operations, future financial position, future revenue, projected costs,
prospects, plans and objectives of management, are forward-looking statements.
The words "anticipate," "believe," "continue" "could," "estimate," "expect,"
"intend," "may," "plan," "potential," "predict," "project," "should," "target,"
"will," "would," and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain
these identifying words. The Company may not actually achieve the plans,
intentions or expectations disclosed in its forward-looking statements, and you
should not place undue reliance on such forward-looking statements. Actual
results or events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements as a result of various
risks and uncertainties including, but not limited to: the impact of
extraordinary external events, such as the current pandemic health event
resulting from the novel coronavirus (COVID-19), and their collateral
consequences, including disruption of the activities of our sales force and the
market for EYSUVIS and INVELTYS; whether the Company will be able to
successfully implement its commercialization plans for EYSUVIS and INVELTYS;
whether the market opportunity for EYSUVIS and INVELTYS is consistent with the
Company's expectations and market research; the Company's ability execute on the
commercial launch of EYSUVIS on the timeline expected, or at all; whether the
Company will be able to generate its projected net product revenue on the
timeline expected, or at all; whether the Company's cash resources will be
sufficient to fund the Company's foreseeable and unforeseeable operating
expenses and capital expenditure requirements for the Company's expected
timeline; other matters that could affect the availability or commercial
potential of EYSUVIS, INVELTYS and the Company's product candidates; and other
important factors, any of which could cause the Company's actual results to
differ from those contained in the forward-looking statements, discussed in the
"Risk Factors" section of the Company's Annual Report on Form 10-K, most
recently filed Quarterly Report on Form 10-Q and other filings the Company makes
with the
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
99.1 Press Release of
(furnished herewith) 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
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