Innovation In Ophthalmology Corporate Overview March 2021 NOT FOR PROMOTIONAL USE Disclaimers and Notices This presentation 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 Company's products, EYSUVISTM, for the short term (up to two weeks) relief of the signs and symptoms of dry eye disease, INVELTYS®, the first and only topical twice-daily ocular corticosteroid fo ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or other ju ...

Start Time: 08:00 January 1, 0000 8:48 AM ET Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q4 2020 Earnings Conference Call February 25, 2021, 08:00 AM ET Company Participants Mark Iwicki - Chairman, President and CEO Mary Reumuth - CFO Todd Bazemore - COO Kim Brazzell - Chief Medical Officer Hongming Chen - Chief Scientific Officer Niranjan Kameswaran - SVP, Strategy Conference Call Participants Christopher Neyor - JPMorgan Andreas Argyrides - Wedbush Securities François Brisebois - Oppenheimer Biren Amin - Jef ...

Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q3 2020 Earnings Conference Call November 5, 2020 8:00 AM ET Company Participants Niranjan Kameswaran - SVP, Strategy Mary Reumuth - CFO Mark Iwicki - Chairman, President and CEO Kim Brazzell - Chief Medical Officer Todd Bazemore - COO Hongming Chen - Chief Scientific Office Conference Call Participants Liana Moussatos - Wedbush Securities Christopher Neyor - JPMorgan François Brisebois - Oppenheimer Yi Chen - H.C. Wainwright Operator Good morning, and welcome to the ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or ...

Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q2 2020 Earnings Conference Call August 6, 2020 8:00 AM ET Company Participants Niranjan Kameswaran - SVP, Strategy Mary Reumuth - CFO Mark Iwicki - Chairman, President and CEO Kim Brazzell - Chief Medical Officer Todd Bazemore - COO Hongming Chen - Chief Scientific Officer Conference Call Participants Christopher Neyor - JPMorgan Kit Ma - Jefferies Yi Chen - H.C. Wainwright François Brisebois - Oppenheimer Tazeen Ahmad - Bank of America Andreas Argyrides - Wedbush S ...

Innovation In Ophthalmics Corporate Overview August 2020 NOT FOR PROMOTIONAL USE 2 Disclaimers and Notices This presentation 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 INVELTYS® and its commercial progress, the Company's lead product candidate, EYSUVISTM, for the short-term relief of the signs and symptoms of dry eye disease, including expectations regarding t ...

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements) The company presents unaudited financial statements showing a net loss of $45.3 million and a significant increase in assets Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Cash and cash equivalents | $128,023 | $85,449 | | Total current assets | $197,024 | $105,484 | | Total assets | $245,510 | $154,323 | | Total liabilities | $116,567 | $124,631 | | Total stockholders' equity | $128,943 | $29,692 | Condensed Consolidated Statements of Operations Highlights (in thousands) | Account | Three Months Ended June 30, 2020 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Product revenues, net | $833 | $1,904 | | Total costs and expenses | $22,113 | $43,309 | | Loss from operations | $(21,280) | $(41,405) | | Net loss | $(23,312) | $(45,267) | | Net loss per share | $(0.42) | $(0.94) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Account | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(39,134) | $(51,596) | | Net cash used in investing activities | $(57,450) | $(943) | | Net cash provided by financing activities | $139,160 | $19 | [Nature of Business and Liquidity](index=9&type=section&id=1.%20NATURE%20OF%20BUSINESS%20AND%20BASIS%20OF%20PRESENTATION) The biopharmaceutical company faces significant losses and COVID-19 impacts but believes cash is sufficient for one year - The company's lead product candidate, EYSUVIS™, has a Prescription Drug User Fee Act (PDUFA) goal date of **October 30, 2020**, for its NDA review by the FDA[19](index=19&type=chunk) - As of June 30, 2020, the company had an accumulated deficit of **$340.7 million**, having incurred significant losses since inception[22](index=22&type=chunk) - Management believes that existing cash, cash equivalents, and short-term investments as of June 30, 2020, will be **sufficient to fund planned operating expenses for at least the next twelve months**[23](index=23&type=chunk)[24](index=24&type=chunk) - The **COVID-19 pandemic has adversely affected the market for INVELTYS** due to moratoria on elective ocular surgeries, resulting in a significant reduction in demand[25](index=25&type=chunk) [Revenue & Accounts Receivable, Net](index=16&type=section&id=5.%20REVENUE%20%26%20ACCOUNTS%20RECEIVABLE%2C%20NET) The company recognizes revenue from INVELTYS sales upon delivery, with net sales reflecting various deductions and reserves - Revenue from product sales is recognized at the point the customer obtains control of the product, which occurs upon delivery[45](index=45&type=chunk) Activity in Product Revenue Provisions and Allowances (in thousands) | Category | Balance at Dec 31, 2019 | Provision for H1 2020 Sales | Payments/Credits in H1 2020 | Balance at June 30, 2020 | | :--- | :--- | :--- | :--- | :--- | | Trade Discounts, Allowances and Chargebacks | $1,783 | $1,060 | $(2,450) | $398 | | Product Returns | $180 | $0 | $(1) | $64 | | Rebates and Incentives | $10,044 | $6,770 | $(11,103) | $5,570 | [Debt](index=23&type=section&id=9.%20DEBT) The company holds a $75.0 million term loan at a fixed rate, secured by company assets and requiring a minimum cash balance - On October 1, 2018, the company entered into the Athyrium Credit Facility and borrowed the full **$75.0 million principal amount** of the Term Loan A[65](index=65&type=chunk) - The loan bears a fixed interest rate of **9.875% per annum**, with principal payments starting on the fourth anniversary of the loan (October 2022)[66](index=66&type=chunk) Carrying Value of Debt (in thousands) | Component | June 30, 2020 | December 31, 2019 | | :--- | :--- | :--- | | Principal loan balance | $75,000 | $75,000 | | Unamortized debt discount and issuance cost | $(3,559) | $(3,999) | | Cumulative accretion of exit fee | $256 | $183 | | **Long-term debt, net** | **$71,697** | **$71,184** | [Equity Financings](index=26&type=section&id=11.%20EQUITY%20FINANCINGS) The company raised over $137 million in net proceeds from equity offerings in H1 2020 and established new financing facilities - In Q1 2020, the company raised net proceeds of **$12.5 million** by issuing 2,352,671 shares through its at-the-market (ATM) offering[77](index=77&type=chunk) - In March and April 2020, the company sold 16,979,371 shares in an underwritten offering, resulting in total net proceeds of **$125.4 million**[78](index=78&type=chunk)[80](index=80&type=chunk) - In May 2020, the company filed a new **$350.0 million shelf registration statement** and entered into a new amended and restated sales agreement for up to **$75.0 million** of common stock under an ATM offering[81](index=81&type=chunk)[82](index=82&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=33&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses financial performance, highlighting COVID-19's impact on revenue and improved liquidity from recent capital raises - The company's primary focus is on the commercialization of INVELTYS and the development and potential launch of EYSUVIS, which has a PDUFA goal date of **October 30, 2020**[111](index=111&type=chunk)[115](index=115&type=chunk) - The **COVID-19 pandemic has adversely impacted INVELTYS sales** by reducing elective ocular surgeries and has restricted sales force activities, leading to lower-than-expected revenue[124](index=124&type=chunk)[125](index=125&type=chunk)[129](index=129&type=chunk) - As of June 30, 2020, the company had **$128.0 million in cash and cash equivalents** and **$56.5 million in short-term investments**, sufficient to fund operations into at least Q2 2022[8](index=8&type=chunk)[183](index=183&type=chunk)[222](index=222&type=chunk) [Results of Operations](index=43&type=section&id=Results%20of%20Operations) This section details how decreased product revenue from COVID-19 was offset by lower SG&A and R&D operating expenses - The decrease in product revenue was primarily driven by a reduction in total units sold, attributed to the **decline in elective surgeries resulting from COVID-19 restrictions**[145](index=145&type=chunk)[154](index=154&type=chunk) - The decrease in R&D expenses was mainly due to a **$1.9 million reduction in external spending** on the STRIDE 3 clinical trial for EYSUVIS, which concluded in March 2020[150](index=150&type=chunk) Comparison of Results for the Three Months Ended June 30 (in thousands) | Account | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $833 | $2,057 | $(1,224) | | Selling, general and administrative | $15,301 | $17,007 | $(1,706) | | Research and development | $6,053 | $7,108 | $(1,055) | | Net loss | $(23,312) | $(23,825) | $513 | Comparison of Results for the Six Months Ended June 30 (in thousands) | Account | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Product revenues, net | $1,904 | $3,443 | $(1,539) | | Selling, general and administrative | $30,709 | $35,243 | $(4,534) | | Research and development | $11,487 | $14,067 | $(2,580) | | Net loss | $(45,267) | $(49,213) | $3,946 | [Liquidity and Capital Resources](index=50&type=section&id=Liquidity%20and%20Capital%20Resources) The company raised $137.9 million from stock offerings in H1 2020, ensuring sufficient liquidity into at least Q2 2022 - In H1 2020, the company raised **$125.4 million from an underwritten offering** and **$12.6 million from an ATM offering**, for total net proceeds of $139.2 million from financing activities[167](index=167&type=chunk)[170](index=170&type=chunk)[179](index=179&type=chunk) - Management estimates that existing cash, cash equivalents, and short-term investments of **$184.6 million** as of June 30, 2020, will fund operations into at least the second quarter of 2022[183](index=183&type=chunk)[222](index=222&type=chunk) - **Net cash used in operating activities decreased to $39.1 million** in H1 2020 from $51.6 million in H1 2019, reflecting lower operating expenses[173](index=173&type=chunk)[174](index=174&type=chunk)[175](index=175&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=57&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk is low, with investments in short-term government securities and fixed-rate debt - The company's cash, cash equivalents, and short-term investments of **$184.6 million** are held in short-term U.S. Government securities, with low sensitivity to a 10% change in interest rates[196](index=196&type=chunk) - The **$75.0 million outstanding debt** under the Athyrium Credit Facility has a fixed interest rate of 9.875%, posing no risk from interest rate fluctuations[197](index=197&type=chunk) [Controls and Procedures](index=57&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes during the quarter - Based on an evaluation as of June 30, 2020, the CEO and CFO concluded that the company's **disclosure controls and procedures were effective** at the reasonable assurance level[198](index=198&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, such controls[199](index=199&type=chunk) PART II – OTHER INFORMATION [Legal Proceedings](index=59&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports that it is not currently subject to any material legal proceedings - The company is **not currently subject to any material legal proceedings**[200](index=200&type=chunk) [Risk Factors](index=60&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including a history of losses, product dependency, COVID-19 impacts, and IP reliance - The company has a history of significant losses (**$340.7M accumulated deficit** as of June 30, 2020) and expects to incur further losses, requiring substantial additional funding[203](index=203&type=chunk)[218](index=218&type=chunk) - The business is **highly dependent on the commercial success of INVELTYS** and obtaining marketing approval for its lead product candidate, EYSUVIS[238](index=238&type=chunk) - The **COVID-19 pandemic has adversely impacted operations** and the market for INVELTYS due to reduced elective surgeries and may continue to adversely affect the business[259](index=259&type=chunk)[260](index=260&type=chunk) - The company **relies on third-party manufacturers** like Catalent for commercial supply, which increases risks related to production issues, regulatory compliance, and supply chain disruptions[294](index=294&type=chunk)[301](index=301&type=chunk)[302](index=302&type=chunk) - A substantial portion of the company's patent portfolio, including for INVELTYS and EYSUVIS, is **in-licensed from The Johns Hopkins University (JHU)**, making the company dependent on this agreement[348](index=348&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=150&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued unregistered inducement stock options to new employees in accordance with Nasdaq listing rules - On April 15, 2020, the company granted stock options to purchase **8,000 shares of common stock** to two new employees as an inducement grant[459](index=459&type=chunk) - These options were granted outside of the company's 2017 Equity Incentive Plan, in accordance with **Nasdaq Listing Rule 5635(c)(4)**[459](index=459&type=chunk) [Exhibits](index=152&type=section&id=Item%206.%20Exhibits) This section lists key filed exhibits, including sales and license agreements, and required CEO/CFO certifications - Key exhibits filed include the Amended and Restated Sales Agreement with Jefferies LLC and the Fifth Amendment to the Exclusive License Agreement with The Johns Hopkins University[464](index=464&type=chunk) - The filing also includes **CEO and CFO certifications** pursuant to Sarbanes-Oxley Act Sections 302 and 906[464](index=464&type=chunk)

Kala Pharmaceuticals, Inc. (NASDAQ:KALA) Q1 2020 Earnings Conference Call May 7, 2020 8:00 AM ET Company Participants Niranjan Kameswaran - Senior Vice President, Strategy Mary Reumuth - Chief Financial Officer Mark Iwicki - Chairman, President and Chief Executive Officer Kim Brazzell - Chief Medical Officer Todd Bazemore - Chief Operating Officer Conference Call Participants Chris Neyor - JP Morgan Liana Moussatos - Wedbush Securities Biren Amin - Jefferies LLC Yi Chen - H.C. Wainwright & Co. Tazeen Ahmad ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-38150 KALA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 27-0604595 (State or oth ...