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<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Item 2.02.</b><b style="font-family:'Arial','Helvetica','sans-serif';font-weight:bold;">&#160;&#160;&#160;&#160;&#160;&#160;</b><b style="font-weight:bold;">Results of Operations and Financial Condition.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">As described below, on October 27, 2020, Kala Pharmaceuticals, Inc. (the <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span>), issued a press release announcing that the U.S. Food and Drug Administration (the <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>FDA<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span>) approved its New Drug Application (<span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>NDA<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span>) for EYSUVIS<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM </sup>(loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. Although the Company has not finalized its full financial results for the three and nine months ended September 30, 2020, the Company disclosed in the press release that it expects to report cash, cash equivalents and short-term investments of approximately $159.1 million as of September 30, 2020.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The estimated cash figure is preliminary and unaudited, represents management<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s estimate as of the date of this Form 8-K and is subject to completion of the Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s financial closing procedures. The Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">The information in this Item 2.02 is furnished under Item 2.02 of Form 8-K, and shall not be deemed <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>filed<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>Exchange Act<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span>) 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 <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>Securities Act<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span>), or the Exchange Act, except as expressly set forth by specific reference in such a filing.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Item 7.01.</b><b style="font-family:'Arial','Helvetica','sans-serif';font-weight:bold;">&#160;&#160;&#160;&#160;&#160;&#160;</b><b style="font-weight:bold;">Regulation FD Disclosure.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">On October 27, 2020, the Company issued a press release announcing that the FDA approved its NDA for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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 <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>filed<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> 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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Item 8.01.</b><b style="font-family:'Arial','Helvetica','sans-serif';font-weight:bold;">&#160;&#160;&#160;&#160;&#160;&#160;</b><b style="font-weight:bold;">Other Events.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">On October 27, 2020, the Company announced that the FDA approved its NDA for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">EYSUVIS</b><sup style="font-size:7.5pt;font-weight:bold;line-height:100%;top:0pt;vertical-align:top;">TM</sup><b style="font-weight:bold;"> Important Safety Information</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Use of corticosteroids may result in posterior subcapsular cataract formation.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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).</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Please see full Prescribing Information at www.eysuvis.com</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Cash Runway</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;"><b style="font-weight:bold;">Forward-Looking Statements</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">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<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>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<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>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<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>anticipate,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>believe,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>continue<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>could,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>estimate,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>expect,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>intend,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>may,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>plan,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>potential,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>predict,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>project,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>should,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>target,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>will,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>would,<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> 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<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s expectations and market research; the Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>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&#39;s cash resources will be sufficient to fund the Company&#39;s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company&#39;s expected timeline; other matters that could affect the availability or commercial potential of EYSUVIS, INVELTYS and the Company&#39;s product candidates; and other important factors, any of which could cause the Company&#39;s actual results to differ from those contained in the forward-looking statements, discussed in the <span style="font-family:'Arial','Helvetica','sans-serif';">&#8220;</span>Risk Factors<span style="font-family:'Arial','Helvetica','sans-serif';">&#8221;</span> section of the Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings the Company makes with the<span style="font-family:'Arial','Helvetica','sans-serif';">&#8239;</span>Securities and Exchange Commission. These forward-looking statements represent the Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s views as of the date of this Form 8-K and should not be relied upon as representing the Company<span style="font-family:'Arial','Helvetica','sans-serif';">&#8217;</span>s views as of any date subsequent to the date hereof. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-weight:bold;visibility:hidden;">&#8203;</span></p><a id="_53dc5da8_c3d6_41d1_b039_157d4ce22435"></a></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 6pt 0pt;"><b style="font-weight:bold;">Item 9.01. Financial Statements and Exhibits.</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">(d)&#160;Exhibits:</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><div style="padding-left:28.8pt;"><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0.5pt;padding-right:0.5pt;width:94%;"><tr><td style="vertical-align:top;width:5.84%;margin:0pt;padding:0pt 0.5pt 0pt 0.5pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">99.1</p></td><td style="vertical-align:top;width:94.16%;margin:0pt;padding:0pt 0.5pt 0pt 0.5pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><a style="-sec-extract:exhibit;" href="kala-20201027xex99d1.htm"><span style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:normal;font-weight:normal;text-align:left;">Press Release of Kala Pharmaceuticals, Inc., dated October 27, 2020 (furnished herewith)</span></a></p></td></tr><tr><td style="vertical-align:top;width:5.84%;margin:0pt;padding:0pt 0.5pt 0pt 0.5pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">104</p></td><td style="vertical-align:top;width:94.16%;margin:0pt;padding:0pt 0.5pt 0pt 0.5pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Cover Page Interactive Data File (embedded within the Inline XBRL document)</p></td></tr></table></div><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><a id="_360473ae_8d8f_4042_b0b3_abc4199042cd"></a></div></div>
<div style="background-color:#000000;clear:both;height:2pt;page-break-after:always;width:79.3%;border:0;margin:30pt 10.35% 30pt 10.35%;"></div><div style="max-width:100%;padding-left:10.35%;padding-right:10.35%;position:relative;"><div style="clear:both;max-width:100%;position:relative;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:center;margin:0pt 0pt 6pt 0pt;"><b style="font-weight:bold;">SIGNATURES</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:22.3pt;margin:0pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><table style="border-collapse:collapse;font-size:16pt;height:max-content;padding-left:0pt;padding-right:0pt;width:100%;"><tr style="height:1pt;"><td style="vertical-align:top;width:48.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td colspan="2" style="vertical-align:top;width:51.3%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">KALA PHARMACEUTICALS, INC.</p></td></tr><tr style="height:1pt;"><td style="vertical-align:top;width:48.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td style="vertical-align:top;width:3.54%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td style="vertical-align:top;width:47.76%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td></tr><tr style="height:1pt;"><td style="vertical-align:top;width:48.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Date: October 27, 2020</p></td><td style="vertical-align:top;width:3.54%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">By:</p></td><td style="vertical-align:top;width:47.76%;border-bottom:1px solid #000000;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">/s/ Eric L. Trachtenberg</p></td></tr><tr style="height:1pt;"><td style="vertical-align:top;width:48.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td style="vertical-align:top;width:3.54%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td style="vertical-align:top;width:47.76%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Name: Eric L. Trachtenberg</p></td></tr><tr style="height:1pt;"><td style="vertical-align:top;width:48.69%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td style="vertical-align:top;width:3.54%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">&#160;</p></td><td style="vertical-align:top;width:47.76%;margin:0pt;padding:0pt;"><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;">Title: General Counsel, Chief Compliance Officer &amp; Corporate Secretary</p></td></tr></table><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="font-size:1pt;visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt;"><span style="visibility:hidden;">&#8203;</span></p></div></div>
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​
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 27, 2020
Kala Pharmaceuticals, Inc.
(Exact Name of Company as Specified in its Charter)
​
​
​
​
Delaware
001-38150
27-0604595
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
​
490 Arsenal Way
,
Suite 120
Watertown
,
MA
02472
(Address of Principal Executive Offices) (Zip Code)
Company's telephone number, including area code:
(
781
)
996-5252
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
​
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
​
​
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
​
​
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
​
​
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
​
Securities registered pursuant to Section 12(b) of the Act:
​
​
​
​
Title of each class
Trading symbol(s)
Name of each exchange on which registered
Common Stock, $0.001 par value per share
KALA
The Nasdaq Global Select Market
​
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☒
​
​
Item 2.02.
Results of Operations and Financial Condition.
As described below, on October 27, 2020, Kala Pharmaceuticals, Inc. (the
"
Company
"
), issued a press release announcing that the U.S. Food and Drug Administration (the
"
FDA
"
) approved its New Drug Application (
"
NDA
"
) for EYSUVIS
TM
(loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. Although the Company has not finalized its full financial results for the three and nine months ended September 30, 2020, the Company disclosed in the press release that it expects to report cash, cash equivalents and short-term investments of approximately $159.1 million as of September 30, 2020.
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 October 27, 2020, the Company issued a press release announcing that the FDA approved its NDA for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K and is incorporated herein by reference.
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 October 27, 2020, the Company announced that the FDA approved its NDA for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease.
EYSUVIS
TM
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
Securities and Exchange Commission. These forward-looking statements represent the Company
'
s views as of the date of this Form 8-K and should not be relied upon as representing the Company
'
s views as of any date subsequent to the date hereof. The Company does not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
​
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits:
​
99.1
Press Release of Kala Pharmaceuticals, Inc., dated October 27, 2020 (furnished herewith)
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
​
​
​
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
​
KALA PHARMACEUTICALS, INC.
Date: October 27, 2020
By:
/s/ Eric L. Trachtenberg
Name: Eric L. Trachtenberg
Title: General Counsel, Chief Compliance Officer & Corporate Secretary
​
​
​
​