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WATERTOWN, Mass.–(BUSINESS WIRE)–Kala Pharmaceuticals, Inc. (Kala) (NASDAQ:KALA), a biopharmaceutical aggregation focused on the development and commercialization of analysis application its proprietary AMPPLIFY™ mucus-penetrating atom (MPP) Drug Delivery Technology, today appear banking after-effects for the third division concluded September 30, 2019.



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“INVELTYS accustomed growing appeal in the third quarter, with absolute acknowledgment from physicians and a connected uptick in prescriptions and bazaar share. Additionally, we fabricated important advance in accretion payor coverage,” said Mark Iwicki, Chief Executive Officer of Kala. “Our STRIDE 3 Phase 3 analytic balloon for EYSUVISTM (KPI-121 0.25%), our artefact applicant for dry eye disease, continues to accept and we are targeting topline abstracts in the aboriginal division of 2020. We apprehend that abstracts from this balloon will serve as the base for our resubmission of the EYSUVIS New Drug Application to the U.S. Food and Drug Administration.”

If approved, Kala believes EYSUVIS will be the ideal decree analysis for alleviative dry eye flares that affect the all-inclusive majority of dry eye patients.



Third Division and Recent Highlights:



INVELTYS®: INVELTYS (loteprednol etabonate ophthalmic suspension) 1% was launched in January 2019 as the aboriginal and alone twice-daily ocular corticosteroid adumbrated for the analysis of post-operative deepening and affliction afterward ocular surgery. The different aggregate of safety, adeptness and twice-daily dosing of INVELTYS was developed to abode a cogent unmet need. Kala believes these attributes are actuality beheld agreeably by physicians.

EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: On August 7, Kala accustomed a complete acknowledgment letter (CRL) from the U.S. Food and Drug Administration (FDA) apropos its New Drug Application (NDA) for EYSUVIS for the acting abatement of the signs and affection of dry eye disease. The FDA adumbrated that adeptness abstracts from an added analytic balloon will be bare to abutment a resubmission of the NDA. Kala is currently administering the added Phase 3 analytic trial, STRIDE 3 (STRIDE – Short Term Abatement In Dry Eye), which Kala expects will serve as the base of its acknowledgment to the CRL. Kala has articular key factors that contributed to the differences empiric in the after-effects from STRIDE 2 compared to those of STRIDE 1 and the Phase 2 trials, and Kala believes that changes fabricated to the inclusion/exclusion acceptance of STRIDE 3 based on these analyses will advance the anticipation of success of STRIDE 3. Kala is targeting topline abstracts from STRIDE 3 in the aboriginal division of 2020 and resubmission of the NDA in the aboriginal bisected of 2020. The Aggregation believes this resubmission would be accountable to a six-month analysis beneath the Decree Drug User Fee Act (PDUFA).

Financial Results:

The banking after-effects beneath accommodate both GAAP and non-GAAP banking measures. The non-GAAP banking measures exclude banal compensation, abrasion and non-cash absorption expense. See “Non-GAAP Banking Measures” below; for a abounding adaptation of our GAAP to non-GAAP banking measures amuse accredit to the tables at the end of this columnist release.

Cash Position

Third Division 2019 Banking Results

Year-to-Date Banking Results

Conference Alarm Information

Kala will host a alive appointment alarm and webcast today, November 7, 2019 at 8:00 a.m. ET to analysis the third division 2019 banking results. To admission the appointment call, amuse punch 866-300-4091 (domestic callers) or 703-736-7433 (international callers) bristles account above-mentioned to the alpha of the alarm and accommodate the appointment ID: 1955939. To admission a consecutive archived recording of the call, amuse appointment the “Investors & Media” area on the Kala website at Media Kala Pharmaceuticals, Inc.

Kala is a biopharmaceutical aggregation focused on the development and commercialization of analysis application its proprietary AMPPLIFYTM mucus-penetrating atom (MPP) Drug Delivery Technology, with an antecedent focus on the analysis of eye diseases. Kala has activated the AMPPLIFY Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), advised for ocular applications, constant in the August 2018 FDA approval of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the analysis of deepening and affliction afterward ocular surgery, and its advance artefact candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25%, for the acting abatement of the signs and affection of dry eye disease.

Non-GAAP Banking Measures

In this columnist release, the banking after-effects of Kala are provided in accordance with accounting attempt about accustomed in the United States (GAAP) and application assertive non-GAAP banking measures. The items included in GAAP presentations but afar for purposes of free non-GAAP banking measures for the periods presented in the columnist absolution are stock-based advantage expense, non-cash absorption and depreciation. Administration believes this non-GAAP advice is advantageous for investors, taken in affiliation with Kala’s GAAP banking statements, because it provides greater accuracy and period-over-period allegory with account to Kala’s operating performance. These measures are additionally acclimated by administration to appraise the achievement of the business. Investors should accede these non-GAAP measures alone as a supplement to, not as a acting for, or as above to, measures of banking achievement able in accordance with GAAP. In addition, these non-GAAP banking measures are absurd to be commensurable with non-GAAP advice provided by added companies. For a adaptation of these non-GAAP banking measures to the best commensurable GAAP measures, amuse accredit to the table at the end of this columnist release.

Forward-Looking Statements

This columnist absolution contains advanced statements aural the acceptation of the Private Securities Litigation Reform Act of 1995, that absorb abundant risks and uncertainties, including statements apropos INVELTYS for the analysis of deepening and affliction afterward ocular surgery, including advance of bartering launch, cachet of allowance advantage and the availability of reimbursements beneath Medicare Part D, the Company’s advance artefact candidate, EYSUVIS, for the acting abatement of the signs and affection of dry eye disease, including the Company’s acceptance that changes fabricated to the inclusion/exclusion acceptance of STRIDE 3 will advance the anticipation of success, the Aggregation targeting topline after-effects for STRIDE 3 in the aboriginal division of 2020, and the Company’s expectations apropos its use of cash, banknote aerodrome and projected revenues. All statements, added than statements of absolute facts, independent in this Columnist Release, including statements apropos the Company’s strategy, approaching operations, approaching banking position, approaching revenue, projected costs, prospects, affairs and objectives of management, are advanced statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue” and agnate expressions are advised to analyze advanced statements, although not all advanced statements accommodate these anecdotic words. The Aggregation may not absolutely accomplish the plans, intentions or expectations appear in its advanced statements, and you should not abode disproportionate assurance on such advanced statements. Absolute after-effects or contest could alter materially from the plans, intentions and expectations appear in the advanced statements as a aftereffect of assorted risks and uncertainties, including but not bound to: whether the Aggregation will be able to auspiciously apparatus its commercialization affairs for INVELTYS; whether the bazaar befalling for INVELTYS and EYSUVIS is constant with the Company’s expectations and bazaar research; uncertainties inherent in the availability and timing of abstracts from advancing analytic trials, and the after-effects of such trials, including STRIDE 3; whether any added analytic trials will be accomplished or appropriate for EYSUVIS above-mentioned to approval of the NDA, or at all, and whether the NDA will be approved; the Company’s adeptness assassinate on the bartering barrage of EYSUVIS, if and back approved, on the timeline expected, or at all; whether the Aggregation will be able to accomplish its projected net artefact acquirement on the timeline expected, or at all; whether the Company’s banknote assets will be acceptable to armamentarium the Company’s accountable and adventitious operating costs and basic amount requirements for the Company’s accepted timeline; added affairs that could affect the availability or bartering abeyant of INVELTYS and the Company’s artefact candidates, including EYSUVIS; and added important factors, any of which could account the Company’s absolute after-effects to alter from those independent in the advanced statements, discussed in the “Risk Factors” area of the Company’s Annual Report on Form 10-K, best afresh filed Quarterly Report on Form 10-Q and added filings the Aggregation makes with the Securities and Exchange Commission. These advanced statements represent the Company’s angle as of the date of this absolution and should not be relied aloft as apery the Company’s angle as of any date consecutive to the date hereof. The Aggregation does not accept any obligation to amend any advanced statements, whether as a aftereffect of new information, approaching contest or otherwise, except as appropriate by law.

Financial Tables:

2019

2018

$

            97,556

$

          170,898

          161,013

          220,966

            94,490

          160,018

            70,935

            70,226

            29,026

            28,752

            43,056

          104,978

(1) The Aggregation defines alive basic as accepted assets beneath accepted liabilities. See the
Company’s  abridged circumscribed banking statements for added advice regarding
its accepted assets and accepted liabilities.

2019

 

2018

 

2019

 

2018

$

           1,451

$

$

           4,894

$

668

1,261

15,280

8,469

50,523

21,102

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7,070

7,027

21,137

20,051

23,018

15,496

72,921

41,153

(21,567)

(15,496)

(68,027)

(41,153)

571

325

1,973

848

(2,180)

(432)

(6,335)

(1,214)

(23,176)

(15,603)

(72,389)

(41,519)

$

(0.68)

$

(0.63)

$

(2.13)

$

(1.69)

34,168,282

24,600,080

33,977,477

24,570,081

2019

 

2018

 

 

2019

 

2018

$

(23,176)

$

(15,603)

$

(72,389)

$

(41,519)

2,572

2,265

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7,666

6,417

237

75

709

75

226

70

614

243

$

(20,141)

$

(13,193)

$

(63,400)

$

(34,784)

$

668

$

$

1,261

$

60

101

2

2

$

606

$

$

1,158

$

$

15,280

$

8,469

$

50,523

$

21,102

1,599

1,581

5,250

4,353

140

13

376

16

$

13,541

6,875

$

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44,897

$

16,733

$

7,070

$

7,027

$

21,137

$

20,051

913

684

2,315

2,064

84

57

236

227

$

6,073

6,286

$

18,586

$

17,760

$

(21,567)

$

(15,496)

$

(68,027)

$

(41,153)

2,572

2,265

7,666

6,417

226

70

614

243

$

(18,769)

$

(13,161)

$

(59,747)

$

(34,493)

 

Investors:
Hannah Media
212-362-1200

Media:
Kari Media
781-235-3060

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