KALA Kala Pharmaceuticals Inc.

10.61
+0.05  (+0%)
Previous Close 10.56
Open 10.61
52 Week Low 3.24
52 Week High 14.68
Market Cap $591,145,444
Shares 55,715,876
Float 21,647,782
Enterprise Value $291,854,720
Volume 480,799
Av. Daily Volume 1,101,614
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Upcoming Catalysts

Drug Stage Catalyst Date
EYSUVIS (KPI‑121) 0.25%
Dry eye disease
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
KPI‑121 0.25% STRIDE 3
Dry eye disease
Phase 3
Phase 3
Phase 3 data met primary endpoint - March 9, 2020.
INVELTYS
Post‑operative inflammation and pain following cataract surgery
Approved
Approved
FDA approval announced August 23, 2018.
INVELTYS - STRIDE 1
Dry eye disease
Phase 3
Phase 3
Phase 3 data released January 5, 2017 - both primary symptom endpoints met. Primary sign endpoint missed.

Latest News

  1. Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that its 2020 Annual Meeting of Stockholders (including any adjournments or postponements, the "Annual Meeting") has been changed to a virtual-only format. This decision reflects public health and safety concerns related to the novel coronavirus (COVID-19) pandemic and governmental restrictions limiting the number of people who may gather together, and is intended to support the health and well-being of Kala's stockholders, employees and communities.

    As previously announced, the Annual Meeting will be held at 9:00 a.m. Eastern Time, on Thursday, June…

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that its 2020 Annual Meeting of Stockholders (including any adjournments or postponements, the "Annual Meeting") has been changed to a virtual-only format. This decision reflects public health and safety concerns related to the novel coronavirus (COVID-19) pandemic and governmental restrictions limiting the number of people who may gather together, and is intended to support the health and well-being of Kala's stockholders, employees and communities.

    As previously announced, the Annual Meeting will be held at 9:00 a.m. Eastern Time, on Thursday, June 25, 2020. Stockholders will not be able to attend the Annual Meeting in person, but instead will be able to attend virtually. Stockholders will be able to participate in the Annual Meeting, vote shares electronically and submit questions during the live audio webcast of the Annual Meeting by visiting www.virtualshareholdermeeting.com/KALA2020 and entering the 16-digit control number found on the proxy card, voting instruction form or notice previously distributed.

    As described in the proxy materials for the Annual Meeting that were previously distributed, stockholders are entitled to participate in and vote at the Annual Meeting if they were a stockholder of Kala as of the close of business on April 27, 2020, the record date.

    Whether or not a stockholder plans to participate in the live audio webcast of the Annual Meeting, Kala urges all stockholders to vote and submit their proxies in advance of the Annual Meeting by one of the methods described in the proxy materials for the Annual Meeting that were previously provided to the stockholders. The proxy card included with these proxy materials will not be updated to reflect the change in location and may continue to be used to vote stockholder shares in connection with the Annual Meeting.

    A notice regarding this change to a virtual meeting format, additional information regarding the virtual Annual Meeting and this press release are included in a proxy supplement that Kala has filed today with the Securities and Exchange Commission.

    About Kala Pharmaceuticals, Inc.

    Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the January 2019 launch of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25%, for which a New Drug Application (NDA) is under review by the United States Food and Drug Administration (FDA) with a target action date under the Prescription Drug User Fee Act (PDUFA) set for October 30, 2020.

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  2. -- FDA Sets PDUFA Goal Date of October 30, 2020 --

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) resubmission for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30…

    -- FDA Sets PDUFA Goal Date of October 30, 2020 --

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) resubmission for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. The FDA stated that the NDA resubmission is a complete, Class 2 response to the Complete Response Letter (CRL) issued in August 2019, and the FDA set a Prescription Drug User Fee Act (PDUFA) goal date of October 30, 2020 for the completion of its review of the NDA.

    "The FDA's acceptance of our NDA resubmission signifies critical progress toward our goal of delivering EYSUVIS as the first prescription medicine for the short-term treatment of dry eye disease," said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. "We are very appreciative that the Agency set a standard Class 2 review timeline, despite the ongoing pandemic, and we look forward to working together through their review of our NDA submission."

    Kala resubmitted the EYSUVIS NDA in April 2020, in response to the CRL it received from the FDA in August 2019, which indicated that positive data from an additional clinical trial was needed to support a resubmission of the NDA. The positive results from STRIDE 3 for both signs and symptoms of dry eye disease, along with the positive data from the previous clinical trials of EYSUVIS, served as the basis for Kala's NDA resubmission package. As announced in March 2020, STRIDE 3, a Phase 3 clinical trial of EYSUVIS, met both of its primary symptom endpoints, demonstrating a statistically significant improvement in ocular discomfort severity in both the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline. Additionally, statistical significance was achieved in the key secondary endpoints of conjunctival hyperemia at day 15 in the ITT population and ocular discomfort severity at day 8 in the ITT population. Significant results were also observed for total corneal staining at day 15 in the ITT population. Consistent with prior clinical experience, EYSUVIS was well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle.

    About EYSUVIS™

    Kala is developing EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. EYSUVIS utilizes Kala's AMPPLIFY™ mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissues of the eye. Kala has completed one Phase 2 and three Phase 3 clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3 (STRIDE - Short Term Relief In Dry Eye) for EYSUVIS. Kala believes that the broad mechanism of action of EYSUVIS, rapid onset of relief of both signs and symptoms and favorable tolerability and safety profile combine for a strong profile to treat Dry Eye Disease. In addition, the potential for EYSUVIS to be used both as a first line prescription medicine and complementary to existing therapies, could result in a preferred profile for the short-term treatment of dry eye disease, including the management of dry eye flares and other dry eye associated conditions.

    About Kala Pharmaceuticals, Inc.

    Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the January 2019 launch of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25%, for which a New Drug Application (NDA) is under review by the United States Food and Drug Administration (FDA) with a target action date under the Prescription Drug User Fee Act (PDUFA) set for October 30, 2020.

    Forward Looking Statements

    This press release 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 lead product candidate, EYSUVIS, for the short-term relief of the signs and symptoms of dry eye disease. 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 INVELTYS and any delay in timing of regulatory review of the NDA for EYSUVIS; whether the Company will be able to successfully implement its commercialization plans for INVELTYS and EYSUVIS, if approved; whether the market opportunity for INVELTYS and EYSUVIS is consistent with the Company's expectations and market research; whether any additional clinical trials will be initiated or required for EYSUVIS prior to approval of the NDA, or at all, and whether the NDA for EYSUVIS will be approved on the timeline expected, or at all; the Company's ability execute on the commercial launch of EYSUVIS, if and when approved, 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 INVELTYS and the Company's product candidates, including EYSUVIS; 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 release 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.

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  3. -- Announced Positive Results from STRIDE 3 Clinical Trial of EYSUVIS in March 2020, Demonstrating Statistically Significant Results for Primary and Key Secondary Endpoints --

    -- EYSUVISTM NDA Resubmitted on April 30th; Potential Approval and Launch Before Year-End --

    -- Raised $146.9 Million in Gross Proceeds from Sales of Common Stock in Early 2020 --

    -- 1Q 2020 INVELTYS® Revenue of $1.1 Million --

    -- Conference Call and Webcast at 8:00 a.m. ET –

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported financial results for the first quarter ended March 31, 2020.

    "The first quarter of 2020 was…

    -- Announced Positive Results from STRIDE 3 Clinical Trial of EYSUVIS in March 2020, Demonstrating Statistically Significant Results for Primary and Key Secondary Endpoints --

    -- EYSUVISTM NDA Resubmitted on April 30th; Potential Approval and Launch Before Year-End --

    -- Raised $146.9 Million in Gross Proceeds from Sales of Common Stock in Early 2020 --

    -- 1Q 2020 INVELTYS® Revenue of $1.1 Million --

    -- Conference Call and Webcast at 8:00 a.m. ET –

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today reported financial results for the first quarter ended March 31, 2020.

    "The first quarter of 2020 was marked by substantial progress across our business, even as we contended with the uncertainties and unprecedented disruptions imposed by the COVID-19 pandemic," said Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals. "In March, we announced positive results from our STRIDE 3 clinical trial of EYSUVIS, demonstrating statistically significant improvements in both the signs and symptoms of dry eye disease. These results replicated the positive results from prior trials, which highlight the potential of EYSUVIS to be the first prescription medicine for the short-term treatment of dry eye disease, including dry eye flares. As we announced earlier this week, we have resubmitted the NDA for EYSUVIS to the FDA incorporating the positive results from STRIDE 3 and are preparing for a potential approval and launch by year-end."

    COVID-19-related restrictions on elective procedures, which include most ocular surgeries, have affected INVELTYS® prescriptions and revenue, and the impacts are expected to persist through the pandemic. Kala is continuing to support INVELTYS and is preparing for a potential EYSUVIS launch in the second half of 2020. Kala's sales force is utilizing virtual technologies to remain in contact with prescribers and, based on its interactions with eye care professionals across the United States, Kala expects that many deferred ocular surgeries will be rescheduled once conditions permit. Kala remains well-capitalized following its public offering of common stock in March 2020 and anticipates that its existing cash resources will enable it to fund its operations into at least the second quarter of 2022.

    First Quarter and Recent Highlights:

    EYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: In March 2020, Kala announced positive topline results from STRIDE 3, a Phase 3 clinical trial evaluating EYSUVIS for the treatment of dry eye disease. STRIDE 3 met both of its primary efficacy endpoints, demonstrating a statistically significant improvement in the symptom endpoint of ocular discomfort severity at day 15 in the overall intent-to-treat (ITT) population and in the predefined subgroup of ITT patients with more severe ocular discomfort at baseline. Statistical significance was also achieved in conjunctival hyperemia at day 15 in the ITT population (p<0.0001) and ocular discomfort severity at day 8 in the ITT population (p=0.0282). Significant results were also observed for total corneal staining at day 15 in the ITT population (p=0.0042).

    EYSUVIS was well tolerated, with adverse events and intraocular pressure comparable to vehicle. Read the company's press release reporting on the full topline data here.

    On April 30, 2020, Kala resubmitted its New Drug Application (NDA) for EYSUVIS to the U.S. Food and Drug Administration (FDA). Kala believes this application meets the criteria of a Class 2 resubmission, with a target six-month review period under the Prescription Drug User Fee Act (PDUFA).

    INVELTYS® (loteprednol etabonate ophthalmic suspension) 1%: INVELTYS was launched in January 2019 as the first and only twice-daily post-surgical ocular corticosteroid. In the first quarter of 2020, over 42,000 INVELTYS prescriptions were reported by Symphony Health, which represents a decrease of approximately 9.5% over the fourth quarter of 2019.

    Beginning in March 2020 and continuing into the second quarter of 2020, INVELTYS prescriptions and revenue have been adversely affected by the ongoing COVID-19 pandemic as federal, state and local governments implemented restrictions on elective procedures, including most ocular surgeries. Kala believes that physicians will move to reschedule many deferred procedures once conditions permit and expects INVELTYS prescriptions and revenue to return to growth, however the company is unable to project the specific timing or potential impact on future revenues given the continued uncertainty around the impact and duration of the restrictions related to COVID-19.

    Additionally, while Kala has suspended substantially all in-person interactions with customers, including visits to physician offices, clinics and hospitals, Kala's sales force continues to provide support virtually through telephone and web-based technologies. Kala is following recommendations from the U.S. Centers for Disease Control and Prevention (CDC) as well as federal, state and local governments and will continue to assess when it is appropriate for employees to return to normal work practices.

    Corporate:

    In March 2020, Kala closed an underwritten public offering of 16,000,000 shares of common stock and, in early April 2020, sold an additional 979,371 shares of common stock resulting from the partial exercise of the underwriters' option to purchase additional shares, at a public offering price of $7.89 per share. Kala received aggregate gross proceeds of $146.9 million from these transactions and the sale of common stock in early 2020 under its at-the-market offering (ATM) program, before deducting underwriting discounts, commissions and offering expenses.

    Financial Results:

    The financial results below contain both GAAP and non-GAAP financial measures. The non-GAAP financial measures exclude stock compensation, depreciation and non-cash interest expense. See "Non-GAAP Financial Measures" below; for a full reconciliation of our GAAP to non-GAAP financial measures, please refer to the tables at the end of this press release.

    • Cash Position: As of March 31, 2020, Kala had cash of $196.5 million, compared to $85.4 million as of December 31, 2019. In April 2020, Kala received an additional $7.2 million in net proceeds as a result of the partial exercise of the underwriters' option to purchase additional shares in the March 2020 public offering. Kala anticipates that its existing cash resources will enable it to fund its operations into at least the second quarter of 2022.
    • Net Product Revenue: For the quarter ended March 31, 2020, Kala reported net product revenue of $1.1 million relating to sales of INVELTYS, compared to $1.4 million in the first quarter of 2019, a decrease of $0.3 million. Net revenues in the first quarter of 2020 were impacted by higher reserves as compared to the same period in 2019. Kala recognizes revenue when product is shipped to distributors.
    • Cost of Product Revenues: For the quarter ended March 31, 2020, cost of product revenues was $0.4 million, compared to $0.2 million for the same period in 2019. As Kala began capitalizing inventory costs for INVELTYS after receipt of FDA approval on August 22, 2018, cost of product revenues for the quarter ended March 31, 2019 were more favorably impacted by costs which were expensed as research and development prior to FDA approval. Non-GAAP cost of product revenues was $0.3 million for the quarter ended March 31, 2020, compared to $0.2 million for the same period in 2019.
    • SG&A Expenses: For the quarter ended March 31, 2020, selling, general and administrative (SG&A) expenses were $15.4 million, compared to $18.2 million for the same period in 2019. The decrease was primarily due to launch-related marketing and selling expenses incurred during the quarter ended March 31, 2019 associated with the commercial launch of INVELTYS, which were not incurred during the quarter ended March 31, 2020, as well as a decrease in stock compensation costs. Non-GAAP SG&A expenses were $13.5 million for the quarter ended March 31, 2020, compared to $16.3 million for the same period in 2019.
    • R&D Expenses: For the quarter ended March 31, 2020, research and development (R&D) expenses were $5.4 million, compared to $7.0 million for the same period in 2019. The decrease was primarily due to a $1.7 million decrease in external costs related to the STRIDE 3 dry eye clinical trial, for which Kala announced topline data in March 2020, partially offset by an increase in employee-related costs driven by manufacturing employees allocating more time to EYSUVIS research and development. Non-GAAP R&D expenses were $4.6 million for the quarter ended March 31, 2020, compared to $6.3 million for the same period in 2019.
    • Operating Loss: For the quarter ended March 31, 2020, loss from operations was $20.1 million, compared to $24.1 million for the same period in 2019. Non-GAAP operating loss was $17.4 million for the quarter ended March 31, 2020, compared to $21.4 million for the same period in 2019.
    • Net Loss: For the quarter ended March 31, 2020, net loss was $22.0 million, or $0.54 per share, compared to a net loss of $25.4 million, or $0.75 per share, for the same period in 2019. Non-GAAP net loss was $19.0 million for the quarter ended March 31, 2020, compared to $22.5 million for the same period in 2019. The weighted average number of shares used to calculate net loss per share was 40,761,984 for the quarter ended March 31, 2020, and 33,878,021 for the quarter ended March 31, 2019.

    Conference Call Information

    Kala will host a live conference call and webcast today, May 7, 2019 at 8:00 a.m. ET to review its first quarter 2020 financial results. To access the conference call, please dial 866-300-4091 (domestic callers) or 703-736-7433 (international callers) five minutes prior to the start of the call and provide the conference ID: 9468562.

    To access a subsequent archived recording of the call, please visit the "Investors & Media" section on the Kala website at http://kalarx.com.

    Non-GAAP Financial Measures:

    In this press release, the financial results of Kala are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. The items included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in the press release are stock-based compensation expense, non-cash interest and depreciation. Management believes this non-GAAP information is useful for investors, taken in conjunction with Kala's GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Kala's operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of these non-GAAP financial measures to the most comparable GAAP measures, please refer to the table at the end of this press release.

    About Kala Pharmaceuticals:

    Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the January 2019 launch of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25%, which is being studied for the short-term treatment of the signs and symptoms of dry eye disease.

    Forward Looking Statements:

    This press release 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 likelihood of many deferred ocular surgeries being rescheduled once the COVID-19 pandemic subsides and INVELTYS prescriptions and revenue returning to growth, the Company's lead product candidate, EYSUVIS, including the resubmitted NDA meeting the criteria of a Class 2 resubmission, with a target six-month FDA review period, EYSUVIS' potential to be the first prescription medicine for the short-term treatment of dry eye disease, including dry eye flares, and expectations regarding potential launch timing, 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 INVELTYS and any delay in timing of regulatory review of the NDA for EYSUVIS; whether the Company will be able to successfully implement its commercialization plans for INVELTYS and EYSUVIS, if approved; whether the market opportunity for INVELTYS and EYSUVIS is consistent with the Company's expectations and market research; whether any additional clinical trials will be initiated or required for EYSUVIS prior to approval of the NDA, or at all, and whether the NDA for EYSUVIS will be accepted for filing and/or approved on the timeline expected or at all; the Company's ability execute on the commercial launch of EYSUVIS, if and when approved, 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 INVELTYS and the Company's product candidates, including EYSUVIS; 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 release 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.

    Kala Pharmaceuticals, Inc.

    Balance Sheet Data

    (in thousands)

    (unaudited)

     

    March 31,

    December 31,

    2020

    2019

    Cash

    $

           196,456

    $

             85,449

    Total assets

           258,526

           154,323

    Working capital (1)

           192,974

             80,710

    Long‑term debt, net of discounts

             71,438

             71,184

    Other long‑term liabilities

             28,305

             28,673

    Total Stockholders' equity

           141,510

             29,692

    (1) The Company defines working capital as current assets less current liabilities. See the Company's  condensed consolidated financial statements for further information regarding its current assets and current liabilities.

    Kala Pharmaceuticals, Inc.

    Condensed Consolidated Statement of Operations

    (In thousands, except share and per share data)

    (Unaudited)

     

    Three Months Ended

    March 31,

    2020

    2019

     

     

    Product revenues, net

    $

    1,071

    $

    1,386

     

    Costs and expenses:

    Cost of product revenues

    354

    241

    Selling, general and administrative

    15,408

    18,236

    Research and development

     

    5,434

     

     

    6,959

     

    Total operating expenses

     

    21,196

     

     

    25,436

     

    Loss from operations

    (20,125)

    (24,050)

    Other income (expense):

    Interest income

    298

    756

    Interest expense

     

    (2,128)

     

     

    (2,094)

     

    Net loss

     

    (21,955)

     

     

    (25,388)

     

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

    $

    (0.54)

     

    $

    (0.75)

     

    Weighted average shares outstanding—basic and diluted

     

    40,761,984

     

     

    33,878,021

     

    Kala Pharmaceuticals, Inc.

    Reconciliation of GAAP to Non-GAAP Financial Measures

    (In thousands)

    (Unaudited)

     

    Three Months Ended

    March 31,

    2020

    2019

     

     

    Net loss (GAAP)

    $

    (21,955)

    $

    (25,388)

    Add-back: stock-based compensation expense

    2,497

    2,473

    Add-back: Non-cash interest

    253

    231

    Add-back: depreciation

    230

    170

    Non-GAAP Net loss

    $

    (18,975)

    $

    (22,514)

     

    Cost of product revenues (GAAP)

    $

    354

    $

    241

    Less: stock-based compensation expense

    20

    2

    Less: depreciation

    13

    -

    Non-GAAP Cost of product revenues

    $

    321

     

    239

     

     

     

     

    Selling, general and administrative expenses (GAAP)

    $

    15,408

    $

    18,236

    Less: stock-based compensation expense

    1,754

    1,864

    Less: depreciation

    150

    94

    Non-GAAP Selling, general and administrative expenses

    $

    13,504

     

    16,278

     

     

     

     

    Research and development expenses (GAAP)

    $

    5,434

    $

    6,959

    Less: stock-based compensation expense

    723

    607

    Less: depreciation

    67

    76

    Non-GAAP research and development expenses

    $

    4,644

     

    6,276

     

    Total operating loss (GAAP)

    $

    (20,125)

    $

    (24,050)

    Less: stock-based compensation expense

    2,497

    2,473

    Less: depreciation

    230

    170

    Non-GAAP total operating loss

    $

    (17,398)

    $

    (21,407)

     

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  4. Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it will present at the virtual BofA Securities 2020 Health Care Conference. Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals, is scheduled to present a corporate overview on Wednesday, May 13th, 2020 at 4:20 p.m. ET.

    To access a live webcast and subsequent archived recording of the presentation, please visit the "Investors & Media" section on the Kala website at http://kalarx.com

    About Kala Pharmaceuticals, Inc.

    Kala is a biopharmaceutical company focused on the discovery, development and commercialization…

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it will present at the virtual BofA Securities 2020 Health Care Conference. Mark Iwicki, Chairman, President and Chief Executive Officer of Kala Pharmaceuticals, is scheduled to present a corporate overview on Wednesday, May 13th, 2020 at 4:20 p.m. ET.

    To access a live webcast and subsequent archived recording of the presentation, please visit the "Investors & Media" section on the Kala website at http://kalarx.com

    About Kala Pharmaceuticals, Inc.

    Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the January 2019 launch of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25%, which is being studied for the short-term treatment of the signs and symptoms of dry eye disease.

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  5. Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. Kala believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act (PDUFA). Kala is preparing for a potential U.S. approval and launch by the end of 2020.

    Kala resubmitted the NDA in response to the…

    Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25%, its product candidate for the short-term treatment of the signs and symptoms of dry eye disease. Kala believes this application will be considered a Class 2 resubmission, with a targeted six-month review timeline under the Prescription Drug User Fee Act (PDUFA). Kala is preparing for a potential U.S. approval and launch by the end of 2020.

    Kala resubmitted the NDA in response to the complete response letter (CRL) it received from the FDA on August 8, 2019, which indicated that positive data from an additional clinical trial was needed to demonstrate efficacy and support a resubmission of the NDA. The positive results from STRIDE 3 for both signs and symptoms of dry eye disease, along with the positive data from the previous clinical trials of EYSUVIS, served as the basis for Kala's NDA resubmission package. As announced in March 2020, STRIDE 3, a Phase 3 clinical trial of EYSUVIS, met both of its primary symptom endpoints, demonstrating a statistically significant improvement in ocular discomfort severity in both the overall intent-to-treat (ITT) population and in a predefined subgroup of ITT patients with more severe ocular discomfort at baseline. Additionally, statistical significance was achieved in the key secondary endpoints of conjunctival hyperemia at day 15 in the ITT population (p<0.0001) and ocular discomfort severity at day 8 in the ITT population (p=0.0282). Significant results were also observed for total corneal staining at day 15 in the ITT population (p=0.0042). Consistent with prior clinical experience, EYSUVIS was well-tolerated in STRIDE 3, with adverse events and intraocular pressure increases comparable to vehicle.

    "We are pleased to resubmit our NDA, marking an important step toward our goal of delivering EYSUVIS as the first prescription therapy specifically for the short-term treatment needs of patients with dry eye disease," said Kim Brazzell, Ph.D., Chief Medical Officer of Kala Pharmaceuticals. "Our NDA submission now includes data from four clinical trials, which together, we believe, demonstrate that EYSUVIS was well-tolerated and provided rapid relief for both the signs and symptoms of dry eye disease. If approved, we look forward to delivering this important new treatment option to the approximately 17 million diagnosed dry eye patients in the U.S."

    About EYSUVIS™

    Kala is developing EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term treatment of the signs and symptoms of dry eye disease utilizing a two-week course of therapy. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. EYSUVIS utilizes Kala's AMPPLIFY™ mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the eye. Kala has completed one Phase 2 and three Phase 3 clinical trials, STRIDE 1, STRIDE 2 and STRIDE 3 (STRIDE - Short Term Relief In Dry Eye) for EYSUVIS. Kala believes that EYSUVIS' broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and the potential to be complementary to existing therapies, could result in a preferred profile for the short-term treatment of dry eye disease, including the management of dry eye flares and other dry eye associated conditions.

    About Kala Pharmaceuticals:

    Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the January 2019 launch of INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% and its investigational product candidate, EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25%, for which Kala recently resubmitted its New Drug Application to the FDA.

    Forward Looking Statements:

    This press release 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 lead product candidate, EYSUVIS, for the short-term relief of the signs and symptoms of dry eye disease, including the NDA being considered a Class 2 resubmission with a targeted six-month review timeline under PDUFA, expectations regarding approval and launch by year-end 2020, and the market potential for EYSUVIS. 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 INVELTYS and any delay in timing of regulatory review of the NDA for EYSUVIS; whether the Company will be able to successfully implement its commercialization plans for INVELTYS and EYSUVIS, if approved; whether the market opportunity for INVELTYS and EYSUVIS is consistent with the Company's expectations and market research; whether any additional clinical trials will be initiated or required for EYSUVIS prior to approval of the NDA, or at all, and whether the NDA for EYSUVIS will be accepted for filing and/or approved on the timeline expected, or at all; the Company's ability execute on the commercial launch of EYSUVIS, if and when approved, 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 INVELTYS and the Company's product candidates, including EYSUVIS; 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 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 release 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.

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