What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2021-05-05 compared with 2020-11-05 · 206 added, 305 removed, 317 unchanged (62% of the section changed)

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(In thousands, except share and per share amounts)

September 30,

Current assets:

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Long-term liabilities:

Long-term lease liabilities - less current portion

Long-term lease liabilities

Long-term debt

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Common stock, $ 0.001 par value;

120,000,000 shares authorized as of September 30, 2020 and December 31, 2019;

56,061,365 and 36,086,254 shares issued and outstanding as of September 30, 2020 and December 31, 2019 , respectively

120,000,000 shares authorized as of March 31, 2021 and December 31, 2020;

63,805,108 and 58,915,375 shares issued and outstanding as of March 31, 2021 and December 31, 2020 , respectively

Additional paid-in capital

Accumulated other comprehensive loss

Accumulated other comprehensive income

Accumulated deficit

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Three Months Ended

Nine Months Ended

September 30,

Product revenues, net

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Weighted average shares outstanding—basic and diluted

Other comprehensive income (loss):

Change in unrealized gains/losses on investments

Total other comprehensive income (loss)

Other comprehensive loss:

Change in unrealized gains on investments

Total other comprehensive loss

Total comprehensive loss

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CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

Three Months Ended September 30,

(In thousands, except share and per share amounts)

For the Three Months Ended March 31, 2021

$0.001 Par Value

Other Comprehensive

Comprehensive

Stockholders'

Income (Loss)

Balance as of June 30, 2019

At the market offering, net of sales agent commission of $ 66

Exercise of stock options

Issuance under employee stock purchase plan

Stock-based compensation expense

Balance as of September 30, 2019

Balance as of June 30, 2020

Balance as of December 31, 2020

Exercise of stock options

At the market offering, net of sales agent commission of $ 991

Issuance under employee stock purchase plan

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Change in fair value of investments

Balance as of September 30, 2020

See accompanying notes to these unaudited condensed consolidated financial statements

Nine Months Ended September 30,

Balance as of March 31, 2021

For the Three Months Ended March 31, 2020

$0.001 Par Value

Other Comprehensive

Comprehensive

Stockholders'

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Exercise of stock options

Issuance under employee stock purchase plan

Stock-based compensation expense

Balance as of September 30, 2019

Balance as of December 31, 2019

At the market offering, net of sales agent commission of $ 388

Exercise of stock options

Common stock offering, net of issuance cost and underwriting fees of $ 8,475

Common stock offering, net of offering costs of $ 8,011

Issuance under employee stock purchase plan

Stock-based compensation expense

Warrant exercises

Change in fair value of investments

Balance as of September 30, 2020

Balance as of March 31, 2020

See accompanying notes to these unaudited condensed consolidated financial statements.

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(In thousands)

Nine Months Ended

September 30,

Three Months Ended

Cash flows from operating activities:

Adjustments to reconcile net loss to cash used in operating activities:

Depreciation and amortization

Non-cash operating lease cost

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Stock-based compensation

Amortization of discount on available-for-sale securities

Change in operating assets and liabilities:

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Cash flows from investing activities:

Purchases of property and equipment and intangible assets

Purchases of short-term investments

Net cash used in investing activities

Purchases of property and equipment and other assets

Proceeds from sales or maturities of short-term investments

Net cash provided by (used in) investing activities

Cash flows from financing activities:

Proceeds from common stock offerings, net of underwriters' discounts and offering cost

Proceeds from common stock offerings, net of offering costs

Payment of principal on finance lease

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Net cash provided by financing activities

Net decrease in cash, cash equivalents and restricted cash:

Net increase in cash, cash equivalents and restricted cash:

Cash, cash equivalents and restricted cash at beginning of period

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Non-cash investing and financing activities:

Right-of-use asset obtained in exchange for finance lease obligation

Purchases of property and equipment in accounts payable

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The Company has applied its AMPPLIFY ® mucus-penetrating particle (“MPP”) Drug Delivery Technology to loteprednol etabonate (“LE”), a corticosteroid designed for ocular applications, resulting in the U.S.

Food and Drug Administration’s (the “FDA”) approval of 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, and INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1% as the first and only topical twice-daily ocular corticosteroid for treatment of post-operative inflammation and pain following ocular surgery.

In January 2019, the Company launched its first commercial product, INVELTYS, in the United States.

The Company expects to begin shipping its second commercial product, EYSUVIS, to wholesalers in the U.S.

by the end of 2020 and for the full promotional launch to begin in January of 2021.

The Company is engaged in preparing for the launch of EYSUVIS, the commercialization of INVELTYS, research and development activities, raising capital and recruiting skilled personnel.

Food and Drug Administration’s (the “FDA”) approval of 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, and INVELTYS ® (loteprednol etabonate ophthalmic suspension) 1% as the first and only topical twice-daily ocular corticosteroid for treatment of post-operative inflammation and pain following ocular surgery.

In January 2019, the Company launched its first commercial product, INVELTYS, in the United States and began shipping its second commercial product, EYSUVIS, to wholesalers in the United States in late December 2020 with the full promotional launch commencing in early January 2021.

The Company is engaged in the commercialization of EYSUVIS and INVELTYS, research and development activities, raising capital and recruiting skilled personnel.

The Company is subject to a number of risks similar to those of other companies conducting high-risk, research and development of pharmaceutical product candidates and launching products for the first time.

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The Company’s success is dependent upon its ability to successfully commercialize its products, the success of its research and development efforts, its ability to obtain regulatory approval of its product candidates, its ability to raise additional capital when needed and, ultimately, attain profitable operations.

The Company is also evaluating other opportunities for MPP nanosuspensions of LE, compounds in its receptor Tyrosine Kinase Inhibitor program, that inhibit the vascular endothelial growth factor, pathway, for the potential treatment of a number of retinal diseases, and novel next-generation anti-inflammatories designed to exhibit steroid-like anti-inflammatory action for eye disease with the goal of eliminating the risk of interocular pressure increase and cataract formation.

The Company is also progressing its pipeline of proprietary preclinical development programs targeted to address front and back of the eye diseases.

These preclinical development programs, all of which are new chemical entities, include its receptor Tyrosine Kinase Inhibitor program, that is designed to inhibit the vascular endothelial growth factor pathway, for the treatment of retinal diseases, including wet age-related macular degeneration;

its selective glucocorticoid receptor modulators, which are a novel class of therapies designed to modify the downstream activity of the receptors to exhibit the anti-inflammatory and immunomodulatory properties of the corticosteroid class of therapies without their associated side effects;

and its novel surface targeting steroid designed to target the ocular surface and thus have the potential to have fewer side effects compared to traditional topical steroids.

The Company owns all intellectual property and worldwide rights to these pipeline preclinical development programs.

Liquidity — Since inception, the Company has incurred significant losses from operations and negative cash flows from operations.

As of September 30, 2020, the Company had an accumulated deficit of $ 368,671 .

The Company has generated only limited revenues to date from product sales and has financed operations primarily through proceeds from its initial public offering of common stock (“IPO”), public common stock offerings and sales of its common stock under its at-the-market offering facility, private placements of preferred stock, convertible debt financings, borrowings under credit facilities and warrants.

The Company has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials and engaging in activities to launch and commercialize EYSUVIS and INVELTYS.

The Company expects to continue to incur significant expenses and operating losses.

As of March 31, 2021, the Company had an accumulated deficit of $ 430,195 .

As the Company commenced a full promotional launch of EYSUVIS in early January 2021 and commercially launched its first product, INVELTYS, in January 2019, it has had only limited revenues to date from product sales and has financed operations primarily through proceeds from its initial public offering of common stock (“IPO”), follow-on public common stock offerings and sales of its common stock under its at-the-market offering facility, private placements of preferred stock, borrowings under credit facilities, convertible promissory notes and warrants.

The Company has devoted substantially all of its financial resources and efforts to research and development, including preclinical studies and clinical trials, and engaging in activities to commercialize EYSUVIS and INVELTYS.

Although the Company expects to continue to generate revenue from sales of EYSUVIS and INVELTYS, there can be no assurance as to the amount or timing of any such revenue, and it expects to continue to incur significant expenses and operating losses.

Net losses may fluctuate significantly from quarter-to-quarter and year-to-year.

The Company believes that its existing cash, cash equivalents and short-term investments as of September 30, 2020, will enable it to fund its operating expenses, debt service obligations and capital expenditure requirements for at least twelve months from the date these condensed consolidated financial statements were issued.

The Company expects that its cash, cash equivalents and short-term investments as of March 31, 2021, together with anticipated net revenue from sales of EYSUVIS and INVELTYS, will enable it to fund its operating expenses, debt service obligations and capital expenditure requirements for at least twelve months from the date these condensed consolidated financial statements were issued.

This evaluation is based on relevant conditions and events that are known and reasonably knowable at the date that the condensed consolidated financial statements are issued.

As a result, the Company could deplete its available capital resources sooner than it currently expects.

COVID-19 – The ongoing novel coronavirus pandemic, commonly referred to as COVID-19, which was declared a global pandemic by the World Health Organization on March 11, 2020, has caused federal, state, and local governments to implement measures to slow the spread of the outbreak through quarantines, strict travel restriction and bans, heightened border scrutiny and other measures.

The Company is following, and will continue to follow, recommendations from the U.S.

Centers for Disease Control and Prevention as well as federal, state, and local governments regarding working-from-home practices for non-essential employees.

As a result, the Company previously suspended substantially all in-person interactions with customers, including visits to physician offices, clinics, and

KALA PHARMACEUTICALS, INC.

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(In thousands, except share and per share amounts)

hospitals, and was limited to conducting educational and promotional activities virtually, and the Company may be forced to suspend all or some in-person interactions again in the future.

In addition, all office-based personnel have been instructed to work from home and the Company’s laboratory facilities, that support the Company’s early-stage research activities, are being utilized as necessary.

The moratoria on routine medical appointments and elective surgeries that have occurred at times in many jurisdictions, including ocular surgeries, has adversely affected the market for INVELTYS, which is indicated for the treatment of inflammation and pain following ocular surgery, resulting in a significant reduction in the demand for INVELTYS.

The effects of COVID-19 may also disrupt the launch and commercialization of EYSUVIS.

The extent of the impact of COVID-19 on the Company’s operational and financial performance will depend on certain developments, including the length and severity of this pandemic and the impact on its customers, employees, vendors, and government agencies, all of which are uncertain and cannot be predicted.

COVID-19 – The ongoing novel coronavirus pandemic, commonly referred to as COVID-19, which began in December 2019 and was declared a global pandemic by the World Health Organization on March 11, 2020, has spread worldwide, causing federal, state and local governments to implement measures to slow the spread of the pandemic through quarantines, strict travel restrictions and bans, heightened border scrutiny and other measures.

In order to safeguard the health of its employees, the Company is following, and will continue to follow, recommendations from the U.S.

Centers for Disease Control and Prevention, as well as federal, state and local governments, regarding working-from-home practices for non-essential employees.

As a result, all office-based personnel have been instructed to work from home, and the Company’s laboratory facilities that support its early-stage research activities are being utilized as necessary.

In addition, the Company previously suspended its sales force from substantially all in-person interactions with physicians and was limited to conducting educational and promotional activities virtually.

The Company’s sales force has since resumed substantially all in-person interactions in the field, but if the Company suspends all or some in-person interactions with physicians in the future, or to the extent physicians limit in-person interactions, the Company may be limited to conducting educational and promotional activities virtually, which may continue to hamper its ability to market INVELTYS.

The effects of the COVID-19 pandemic may also disrupt the full promotional launch and commercialization of EYSUVIS.

In addition, government restrictions have at times led to moratoria on elective ocular surgeries in many jurisdictions, which has significantly reduced, and may in the future continue to significantly reduce, the demand for INVELTYS, which is indicated for the treatment of post-operative inflammation and pain following ocular surgery.

The extent of the impact of the COVID-19 pandemic on the Company’s commercialization efforts of EYSUVIS and INVELTYS and its operational and financial performance will depend on certain developments, including the length and severity of this pandemic and the impact on the Company’s customers, employees and vendors and government agencies, all of which are uncertain and cannot be predicted.

The Company cannot reasonably estimate the extent to which the disruption may materially impact its condensed consolidated results of operations or financial position.

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The Company evaluates its estimates and assumptions on an ongoing basis.

Estimates and assumptions relied upon in preparing these condensed consolidated financial statements relate to, but are not limited to, revenue recognition, inventory, the present value of lease liabilities and the corresponding right-of-use assets, the fair value of warrants, stock compensation, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance.

Estimates and assumptions relied upon in preparing these condensed consolidated financial statements relate to, but are not limited to, revenue recognition, inventory, the present value of lease liabilities and the corresponding right-of-use assets, the fair value of warrants, stock-based compensation, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance.

Actual results may differ from these estimates under different assumptions or conditions.

Net Loss per Share —Basic net loss per share is computed using the weighted average number of common shares outstanding during the period.

Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, warrants and the assumed issuance of unvested restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”).

The weighted average number of common shares included in the computation of diluted net loss gives effect to all potentially dilutive common equivalent shares, including outstanding stock options, warrants and the assumed issuance of unvested RSUs and PSUs.

Diluted net loss per share is computed using the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options and warrants and the issuance of unvested restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”).

Common stock equivalent shares are excluded from the computation of diluted net loss per share if their effect is antidilutive.

In periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

The Company reported a net loss attributable to common stockholders for each of the three and nine months ended September 30, 2020 and 2019.

The Company reported a net loss attributable to common stockholders for each of the three months ended March 31, 2021 and 2020.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

As of March 31, 2021 and 2020, potentially dilutive securities excluded from the calculation of diluted net loss per share because including such securities would have an anti-dilutive effect consisted of outstanding options to purchase 10,120,453 and 8,817,943 shares of the Company’s common stock, respectively, an aggregate of 1,365,592 unvested RSUs and PSUs as of March 31, 2021 and an aggregate of 248,505 and 297,988 unexercised warrants as of March 31, 2021 and 2020, respectively.

Unaudited Interim Financial Information —The condensed consolidated financial statements of the Company included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities Exchange Commission (“SEC”).

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All intercompany transactions and balances have been eliminated in consolidation.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” to the consolidated financial statements included in the Annual Report.

There have been no material changes to the significant accounting policies during the nine months ended September 30, 2020, other than the addition of the Investments section and certain updates to the Inventory section below.

Investments — The Company determines the appropriate classification of its investments at the time of purchase.

The Company’s investments are classified as available-for-sale in accordance with Accounting Standards Codification (“ASC”) Topic 320.

The Company classifies investments available to fund current operations as current assets on its condensed consolidated balance sheets.

Investments are classified as long-term assets on the condensed consolidated balance sheets if (i) the Company has the intent and ability to hold the investments for a period of at least one year and (ii) the contractual maturity date of the investments is greater than one year.

Available-for-sale investments are recorded at fair value, with unrealized gains or losses included in comprehensive loss on the condensed consolidated statements of operations and in accumulated other comprehensive loss on the condensed consolidated balance sheets.

Realized gains and losses, interest income earned on the Company’s cash, cash equivalents and investments, and amortization or accretion of discounts and premiums on investments are included within other income (expense).

The Company reviews investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time.

Inventory — Inventory is stated at the lower of cost or net realizable value, on a first-in, first-out (“FIFO”) method.

Costs include amounts related to third party manufacturing, transportation, internal labor and overhead.

The Company capitalizes pre-launch inventory when it believes regulatory approval and subsequent commercialization of the product candidate is probable and expects the future economic benefit from the sale of the drug to be realized.

In doing so, management must consider a number of factors in order to determine the amount of inventory to be capitalized, including the historical experience of achieving regulatory approvals for the Company’s similar products, the amount of inventory that is likely to be used in commercial production, receipt and analysis of positive Phase 3 clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications and the compilation of the regulatory application.

The Company also monitors the status of the product within the regulatory review and approval process, including all relevant communication with regulatory authorities.

For inventories capitalized in preparation for product launch, anticipated future sales, expected shelf life and expected approval date are taken into account when evaluating realizability.

The shelf life of a product is determined as part of the regulatory approval process;

however, in assessing whether to capitalize pre-launch inventory, the Company considers the product stability data of all of the pre-approval inventory procured or produced to date to determine whether there is adequate shelf life.

If management is aware of any specific material risks or contingencies other than the normal regulatory review and approval process, or if the criteria for capitalizing inventory produced prior to regulatory approval are otherwise not met, the Company would not capitalize such inventory costs, choosing instead to recognize such costs as a research and development expense in the period incurred.

For INVELTYS, capitalization of costs as inventory began upon U.S.

regulatory approval.

For EYSUVIS, capitalization of costs as inventory began in the third quarter of 2020 when the Company believed regulatory approval and subsequent commercialization of the product candidate was probable and expected the future economic benefit from the sale of the drug to be realized.

Inventory produced that will be used in a promotional sample program is expensed to selling, general and administrative expense when it is designated as a sample.

Long-term inventory includes raw materials, work-in-progress and/or finished goods inventory with an anticipated consumption or sale beyond one year based on the Company’s forecasted expectations.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

There have been no material changes to the significant accounting policies during the three months ended March 31, 2021.

Recent Accounting Pronouncements

In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2018-13, Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measuremen t (“ASU 2018-13”).

ASU 2018-13 is intended to improve the effectiveness of disclosures in the notes to financial statements related to fair value measurements in Topic 820.

The ASU was effective on January 1, 2020 and the adoption of ASU 2018-13 did not have a material effect on the Company’s condensed consolidated financial statements.

In August 2018, the FASB issued ASU 2018-15 , Intangibles - Goodwill and Other - Internal-Use Software -Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (“ASU 2018-15”).

ASU 2018-15 aligns the accounting for implementation costs incurred in a hosting arrangement that is a service contract with the guidance on capitalizing costs associated with developing or obtaining internal-use software.

The ASU was effective on January 1, 2020 and the adoption of ASU 2018-15 did not have a material effect on the Company’s condensed consolidated financial statements.

In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326):

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments - Credit Losses (Topic 326):

Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”).

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ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans and other financial instruments.

In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”) , which is effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be Smaller Reporting Companies (“SRCs”) as defined by the SEC, for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years and for all other entities, including SRCs, for fiscal years beginning December 15, 2022, including interim periods within those fiscal years.

In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842) (“ASU 2019-10”) , which is effective for Smaller Reporting Companies (“SRCs”) as defined by the SEC for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years.

Upon adoption, beginning January 1, 2023, the Company does not expect ASU 2019-10 to have a material effect on its condensed consolidated financial statements.

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● Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The Company’s financial instruments consist primarily of cash, cash equivalents, and short-term investments in money market funds and short-term securities.

Cash, cash equivalents and short-term investments are reported at their respective fair values on the Company’s condensed consolidated balance sheets.

The Company’s financial instruments consist primarily of cash equivalents and short-term investments in money market funds and short-term securities.

Cash equivalents and short-term investments are reported at their respective fair values on the Company’s condensed consolidated balance sheets.

See Note 4, “Investments” for additional information.

The following tables sets forth the fair value of the Company’s financial assets by level within the fair value hierarchy as of March 31, 2021 and December 31, 2020:

March 31, 2021

Cash equivalents

Short-term investments

December 31, 2020

Cash equivalents

Short-term investments

During the three months ended March 31, 2021 and the year ended December 31, 2020, there were no transfers between Level 1, Level 2, and Level 3.

Investments by security type consisted of the following as of March 31, 2021 and December 31, 2020:

March 31, 2021

treasury securities

government agencies securities

KALA PHARMACEUTICALS, INC.

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(In thousands, except share and per share amounts)

The following table sets forth the fair value of the Company’s financial assets by level within the fair value hierarchy as of September 30, 2020:

Carrying Amount

Cash and cash equivalents

Short-term investments

During the three and nine months ended September 30, 2020, there were no transfers between Level 1, Level 2, and Level 3.

Investments by security type consisted of the following as of September 30, 2020:

September 30, 2020

December 31, 2020

treasury securities

government agencies securities

As of September 30, 2020, all of the Company’s investments had a contractual maturity within one year.

As of March 31, 2021 and December 31, 2020, all of the Company’s investments had a contractual maturity within one year.

The fair value of all of the Company’s investments are classified as short-term on its condensed consolidated balance sheets.

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Product revenues, net

The Company sells INVELTYS to wholesalers and/or specialty distributors in the United States (collectively, “Customers”).

The Company sells EYSUVIS and INVELTYS primarily to wholesalers in the United States (collectively, “Customers”).

These Customers subsequently resell the Company’s products to specialty and other retail pharmacies.

In addition to agreements with Customers, the Company enters into arrangements with payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts for the purchase of the Company’s products.

In addition to agreements with Customers, the Company enters into arrangements with third-party payors that provide for government-mandated and/or privately-negotiated rebates, chargebacks and discounts for the purchase of the Company’s products.

The Company also holds inventory at a third-party pharmacy on a consignment basis and records revenue when control of the product transfers to the customer upon sale to the end user.

The amount of inventory held on a consignment basis as of March 31, 2021 and December 31, 2020 was immaterial.

The goods promised in the Company’s product sales contracts represent a single performance obligation.

as the promise to transfer the individual products to the Customer is not separately identifiable from other promises in the contracts and, therefore, not distinct.

The Company recognizes revenue from product sales at the point the Customer

The Company recognizes revenue from product sales at the point the Customer obtains control of the product, which occurs upon delivery.

The transaction price (“net sales price”) that is recognized as revenue for product sales includes the selling price to the Customer and an estimate of variable consideration.

Components of variable consideration include prompt pay and other discounts, product returns, government rebates, third-party payor rebates, coverage gap rebates, incentives such as patient co-pay assistance, and other fees paid to Customers and other third-party payors where a distinct good or service is not received.

Variable consideration is recorded on the condensed consolidated balance sheet as either a reduction of accounts receivable, if payable to a Customer, or as a current liability, if payable to a third-party other than a Customer.

The Company considers all relevant information when estimating variable consideration such as assessment of its current and anticipated sales and demand forecasts, actual payment history, information from third parties regarding the payor mix for products, information from third parties regarding the units remaining in the distribution channel, specific known market events and trends, industry data and current contractual and statutory requirements that are reasonably available.

The Company includes estimated amounts for variable consideration in the net sales price to the extent it is determined probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved.

KALA PHARMACEUTICALS, INC.

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(In thousands, except share and per share amounts)

obtains control of the product, which occurs upon delivery.

The transaction price (“net sales price”) that is recognized as revenue for product sales includes the selling price to the Customer and an estimate of variable consideration.

The Company considers all relevant information when estimating variable consideration such as assessment of its current and anticipated sales and demand forecasts, information from third parties regarding the payor mix for products, information from third parties regarding the units remaining in the distribution channel, specific known market events and trends, industry data and current contractual and statutory requirements that are reasonably available.

The Company includes estimated amounts in the net sales price to the extent it is determined probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved.

Payment terms with Customers do not exceed one year and, therefore, the Company does not account for a significant financing component in its arrangements.

The Company expenses incremental cost of obtaining a contract with a Customer when incurred as the period of benefit is less than one year.

The Company expenses incremental cost of obtaining a contract with a Customer when incurred as the period of benefit is generally less than one year.

Reserves for Variable Consideration :

Trade Discounts and Allowances

The Company provides its Customers with certain trade discounts and allowances including discounts for prompt payments and fees paid for distribution, data and administrative services.

The Company provides its Customers with certain trade discounts and allowances including discounts for prompt payments and other discounts and fees paid for distribution, data and administrative services.

These discounts and fees are based on contractually-determined percentages and are recorded as a reduction of revenue and accounts receivable in the period in which the related product revenue is recognized.

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Product Returns

Consistent with industry practice, the Company has a product returns policy that provides Customers a right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date.

Consistent with industry practice, the Company has a product returns policy that provides Customers right of return for product purchased within a specified period prior to and subsequent to the product’s expiration date.

The Company estimates the amount of its products that may be returned and presents this amount as a reduction of revenue in the period the related product revenue is recognized, in addition to establishing a liability.

The Company’s estimates for product returns are based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel.

The Company’s estimates for product returns are based upon available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel as well as historical returns, which develop over time.

Commercial Payor and Medicare Part D Rebates

The Company contracts with certain third-party payors, primarily pharmacy benefit managers (“PBMs”) and health plans (“Plans”), for the payment of rebates with respect to utilization of its product.

These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the PBMs or the

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

Plans with which it contracts.

The Company estimates the rebates for commercial and Medicare Part D payors based on the contractual discount percentage, the various payor mix for the product as well as future rebates that will be made for product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period.

These rebates are based on contractual percentages applied to the amount of product prescribed to patients who are covered by the PBMs or the Plans with which it contracts.

The Company estimates the rebates for commercial and Medicare Part D payors based on the contractual discount percentage, the various payor mix for EYSUVIS and INVELTYS as well as future rebates that will be made for product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period.

The Company also estimates the number of patients in the prescription drug coverage gap for whom it will owe an additional liability under the Medicare Part D program.

2 unchanged sentences

The Company is subject to discount obligations under Medicaid and other government programs.

For Medicaid, reserves are based on estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Centers for Medicaid and Medicare Services.

The Company’s liability for these rebates consists of estimates of claims for the current period and estimated future claims that will be made for product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period.

For Medicaid, reserves are based on actual payment history, and estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Centers for Medicaid and Medicare Services.

The Company’s liability for these rebates consists of estimates of claims for the current period and estimated future claims that will be made for

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

product that has been recognized as revenue but remains in the distribution channel at the end of each reporting period.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

3 unchanged sentences

Allowances for estimated co-pay claims are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability.

The following table summarizes activity in each of the Company’s product revenue provision and allowance categories for the nine months ended September 30, 2020:

The following tables summarize activity in each of the Company’s product revenue provision and allowance categories for the three months ended March 31, 2021 and 2020:

Trade Discounts,

8 unchanged sentences

Balance as of March 31, 2021

Provision related to current period sales

Changes in estimate related to prior period sales

Credit/payments made

Balance as of June 30, 2020

Trade Discounts,

Allowances and

Chargebacks (1)

Product Returns (2)

Incentives (3)

Balance as of December 31, 2019

Provision related to current period sales

1 unchanged sentence

Credit/payments made

Balance as of September 30, 2020

Balance as of March 31, 2020

(1) Trade discounts, allowances and chargebacks include fees for distribution service fees, prompt pay and other discounts, and chargebacks.

Trade discounts, allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable in the Company’s condensed consolidated balance sheets.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

(2) Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities in the Company’s condensed consolidated balance sheets.

Estimated trade discounts, allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable on the Company’s condensed consolidated balance sheets.

(2) Estimated provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities on the Company’s condensed consolidated balance sheets.

(3) Rebates and incentives include managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances.

Provisions for rebates and discounts are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities in the Company’s condensed consolidated balance sheets.

Estimated provisions for rebates and discounts are deducted from gross revenues at the time revenues are recognized and are included in accrued expenses and other current liabilities on the Company’s condensed consolidated balance sheets.

Accounts Receivable, net

Accounts receivable are reported on the condensed consolidated balance sheets at outstanding amounts due from Customers for product sales.

The Company deducts sales discounts for prompt payments and contractual fees for service arrangements from accounts receivable.

The Company evaluates the collectability of accounts receivable on a regular basis, by reviewing the financial condition and payment history of Customers, an overall review of collections experience on other accounts, and economic factors or events expected to affect future collections experience.

The Company deducts sales discounts for prompt payments and other discounts, contractual fees for service arrangements and chargebacks from accounts receivable.

The Company evaluates the

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

collectability of accounts receivable on a regular basis, by reviewing the financial condition and payment history of Customers, an overall review of collections experience on other accounts, and economic factors or events expected to affect future collections experience.

An allowance for doubtful accounts is recorded when a receivable is deemed to be uncollectible.

The Company recorded no allowance for doubtful accounts as of September 30, 2020 or September 30, 2019.

The Company recorded an allowance of $ 817 and $ 1,107 for expected sales discounts, related to prompt pay discounts and contractual fee for service arrangements, to wholesalers and distributors as of September 30, 2020 and September 30, 2019, respectively.

The Company recorded no allowance for doubtful accounts as of March 31, 2021 or March 31, 2020.

The Company recorded an allowance of $ 1,538 and $ 1,396 for expected sales discounts, related to prompt pay discounts and other discounts, contractual fee for service arrangements and chargebacks, to wholesalers and distributors as of March 31, 2021 and March 31, 2020, respectively.

Inventory consists of the following:

September 30,

Raw materials

2 unchanged sentences

Total inventory

As of September 30, 2020, the Company had $ 7,538 of current inventory and $ 2,689 of long-term inventory.

As of March 31, 2021, the Company had $ 8,241 of current inventory and $ 6,200 of long-term inventory.

As of December 31, 2020, the Company had $ 5,229 of current inventory and $ 6,219 of long-term inventory.

Work in progress inventory as of September 30, 2020 includes $ 1,127 related to the commercial production of pre-launch inventories of EYSUVIS to support the FDA approval of the product with an indication for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease, which occurred in October 2020.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

ACCRUED EXPENSES

Accrued expenses consist of the following:

September 30,

Compensation and benefits

Accrued revenue reserves (1)

Development costs

Commercial costs

Professional services

Commercial cost

Contract manufacturing

Development costs

Accrued expenses

(1) There were additional revenue reserves included in accounts payable of $ 470 and $ 741 , as of September 30, 2020 and December 31, 2019, respectively.

(1) There were additional revenue reserves included in accounts payable of $ 1,325 and $ 280 , as of March 31, 2021 and December 31, 2020, respectively.

Operating leases

On February 28, 2018, the Company entered into a lease agreement for the lease of a portion of the building located at 490 Arsenal Way, Watertown, Massachusetts (the “Watertown Lease”) to be used as the Company’s corporate headquarters.

The Company recognized the right-of-use asset and corresponding lease liability on November 15, 2018, by calculating the present value of lease payments, discounted at 9.9 %, the Company’s estimated incremental borrowing rate, over the 13-year expected term.

In connection with the Watertown Lease, the Company issued a letter of credit to the landlord for $ 2,057 .

The Company secured the letter of credit for the full amount of the letter with cash on deposit, which is reported as restricted cash on the condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019.

For the nine months ended September 30, 2020 and 2019, the variable lease expense for the Watertown Lease, which includes common area maintenance and real estate taxes, was $ 1,472 and $ 882 respectively.

The remaining lease term was 11.1 years as of September 30, 2020.

Vehicle Fleet lease

During the year ended December 31, 2019, the Company entered into a master fleet lease agreement (the “Vehicle Fleet Lease”), pursuant to which it currently leases approximately 65 vehicles.

In connection with the Vehicle Fleet Lease, the Company issued a letter of credit for $ 453 , which was reported as restricted cash on the condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019.

The lease has an expected term of three years , which commenced upon the delivery of the vehicles in March 2019.

As of September 30, 2020, the remaining lease term was 1.4 years.

In connection with the lease of the Company’s corporate headquarters (the “Watertown Lease”), the Company issued a letter of credit to the landlord for $ 2,042 .

KALA PHARMACEUTICALS, INC.

1 unchanged sentence

(In thousands, except share and per share amounts)

For the three months ended March 31, 2021and 2020, the variable lease expense for the Watertown Lease, which includes common area maintenance and real estate taxes, was $ 363 and $ 348 respectively.

The remaining lease term was 10.6 years as of March 31, 2021.

Vehicle Fleet lease

During the year ended December 31, 2019, the Company entered into a master fleet lease agreement (the “Vehicle Fleet Lease”), pursuant to which it leased 65 vehicles.

In connection with the Vehicle Fleet Lease, the Company issued a letter of credit for $ 450 , which was reported as restricted cash on the condensed consolidated balance sheets as of March 31, 2021 and December 31, 2020.

The lease has an expected term of three years , which commenced upon the delivery of the vehicles in March 2019.

During the three months ended March 31, 2021, the Company modified the Vehicle Fleet Lease to add 54 additional vehicles to the fleet.

The new component of the lease has an expected term of approximately three years , which commenced upon the delivery of the additional vehicles in March 2021.

The components of lease expense and related cash flows were as follows:

Three Months Ended

Nine Months Ended

September 30,

Operating lease cost

2 unchanged sentences

Operating cash outflows from operating leases

The weighted average remaining lease term and weighted average discount rate of operating leases are as follows:

Weighted average remaining lease term

Weighted average discount rate

Athyrium Credit Facility

2 unchanged sentences

On October 1, 2018, the Company borrowed the entire principal amount of the Term Loan A.

The Company did not satisfy the conditions to draw down any of the Term Loan B funds, and as a result, the Term Loan B funds are no longer available.

The maturity date of the Athyrium Credit Facility is October 1, 2024, the six-year anniversary of the close.

The Term Loan A bears interest at a rate of 9.875 % per annum, with quarterly, interest-only payments until the fourth anniversary of the Term Loan A.

The unpaid principal amount of the Term Loan A is due and payable in quarterly installments starting on the fourth anniversary of the loan.

The unpaid principal amount of the Term Loan A is due and payable in quarterly installments starting on October 1, 2022.

The Company may make voluntary prepayments, in whole or in part, and subject to certain exceptions, is required to make mandatory prepayments upon the occurrence of certain events of default as defined in the agreement, including but not limited to, the occurrence of a change of control.

In addition, upon payment or repayment of any outstanding balance under the Athyrium Credit Facility, the Company will have to pay a 1 % exit fee of the total principal payments (whether mandatory, voluntary, or at maturity) made throughout the term.

In addition, upon payment or repayment of any outstanding balance under the Athyrium Credit Facility, the Company will have to pay a

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

1 % exit fee of the total principal payments (whether mandatory, voluntary, or at maturity) made throughout the term.

The exit fee of $ 750 based on the $ 75,000 principal amount outstanding, will be accreted to the carrying amount of the debt using the effective interest method over the term of the loan.

5 unchanged sentences

These embedded derivatives were bundled and valued as one compound derivative in accordance with the applicable accounting guidance for derivatives and hedging transactions.

The Company determined that, due to the unlikely event of default, the embedded derivatives have a de minimis value as of September 30, 2020.

The derivative liability will be remeasured at fair value at each reporting

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

date, with changes in fair value being recorded as other income (expense) in the condensed consolidated statements of operations.

The Company determined that, due to the unlikely event of default, the embedded derivatives have a de minimis value as of March 31, 2021.

The derivative liability will be remeasured at fair value at each reporting date, with changes in fair value being recorded as other income (expense) in the condensed consolidated statements of operations and comprehensive loss.

The Athyrium Credit Facility is secured by a pledge of substantially all of the Company’s assets and contains affirmative and negative covenants customary for financings of this type, including limitations on the Company’s and its subsidiaries’ ability to, among other things, incur and prepay additional debt, grant or permit additional liens, make investments and acquisitions, merge or consolidate with others, dispose of assets, change in the nature of business, enter into sale and leaseback transactions, make distributions, and enter into affiliate transactions, in each case, subject to certain exceptions.

In addition, the Athyrium Credit Facility also contains a financial covenant requiring the Company to maintain at least $ 10,000 of cash and cash equivalents.

As a result of this financial covenant, the Company has recorded $ 10,000 as restricted cash as of September 30, 2020 and December 31, 2019.

As a result of this financial covenant, the Company has recorded $ 10,000 as restricted cash on the condensed consolidated balance sheets as of March 31, 2021 and December 31, 2020.

In connection with the Athyrium Credit Facility, the Company issued a warrant (“Warrant”), to purchase up to 270,835 shares of the Company’s common stock, at an exercise price per share of $ 12.18456 .

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These costs, along with the fair value of the Warrant of $ 1,900 are being amortized using the effective interest method over the term of the Athyrium Credit Facility.

The amortization of debt discount and debt issuance cost is included in interest expense within the condensed consolidated statements of operations.

As of September 30, 2020 and September 30, 2019, the effective interest rate was 11.63 %, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt discount and issuance costs.

During each of the three months ended September 30, 2020 and September 30, 2019, the Company recognized interest expense of $ 2,125 , which consisted of amortization of the debt discount of $ 232 , and the contractual coupon interest expense of $ 1,893 .

During the nine months ended September 30, 2020, and September 30, 2019, the Company recognized interest expense of $ 6,308 and $ 6,211 , respectively.

This consisted of amortization of debt discount of $ 671 and $ 595 for the periods ended September 30, 2020 and September 30, 2019, and the contractual coupon interest expense of $ 5,637 and $ 5,616 as of September 30, 2020 and September 30, 2019, respectively.

The amortization of debt discount and debt issuance cost is included in interest expense within the condensed consolidated statements of operations and comprehensive loss.

As of March 31, 2021 and March 31, 2020, the effective interest rate was 11.63 %, which takes into consideration the non-cash accretion of the exit fee and the amortization of the debt discount and issuance costs.

During the three months ended March 31, 2021, the Company recognized interest expense of $ 2,092 , which consisted of amortization of the debt discount of $ 241 , and the contractual coupon interest expense of $ 1,851 .

During the three months ended March 31, 2020, the Company recognized interest expense of $ 2,089 , which consisted of amortization of the debt discount of $ 217 , and the contractual coupon interest expense of $ 1,872 .

KALA PHARMACEUTICALS, INC.

1 unchanged sentence

(In thousands, except share and per share amounts)

The components of the carrying value of the debt as of September 30, 2020 and December 31, 2019 are detailed below:

September 30,

The components of the carrying value of the debt as of March 31, 2021 and December 31, 2020 are detailed below:

Principal loan balance

2 unchanged sentences

Long-term debt, net

The annual principal payments due under the Athyrium Credit Facility as of September 30, 2020 were as follows:

The annual principal payments due under the Athyrium Credit Facility as of March 31, 2021 were as follows:

Years Ending December 31,

2020 (remaining three months)

The following table summarizes the common stock warrants outstanding as of September 30, 2020 and December 31, 2019, each exercisable into the number of shares of common stock set forth below as of the specified dates:

2021 (remaining nine months)

For a description of Loan and Security Agreement (the “Loan Agreement”) that the Company entered into with Oxford Finance LLC, in its capacity as lender and in its capacity as collateral agent on May 4, 2021 and the concurrent repayment and termination of the Athyrium Credit Facility, see Note 15, “Subsequent Events”.

The following table summarizes the common stock warrants outstanding as of March 31, 2021 and December 31, 2020, each exercisable into the number of shares of common stock set forth below as of the specified dates:

Shares Exercisable at

September 30,

November 2024

2 unchanged sentences

On August 9, 2018, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective on August 27, 2018 (the “2018 Shelf Registration”).

Under the 2018 Shelf Registration, the Company may offer and sell up to $ 250,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities, purchase contracts, purchase units or any combination of such securities during the three-year period that commenced upon the 2018 Shelf Registration becoming effective.

In connection with the filing of the 2018 Shelf Registration, the Company entered into a sales agreement (the “2018 Sales Agreement”) with Jefferies, LLC (“Jefferies”) pursuant to which the Company could issue and sell, from time to time, up to an aggregate of $ 50,000 of its common stock in an at-the-market equity offering (“ATM Offering”) through Jefferies, as sales agent.

As of December 31, 2019, the Company issued 2,592,934 shares of its common stock under the ATM Offering, resulting in net proceeds to the Company of $ 13,059 .

During the first quarter of 2020, the Company issued an aggregate of 2,352,671 shares of its common stock under the ATM Offering, resulting in net

Under the 2018 Shelf Registration, the Company could initially offer and sell up to $ 250,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities, purchase contracts, purchase units or any combination of such securities during the three-year period that commenced upon the 2018 Shelf Registration becoming effective.

In connection with the filing of the 2018 Shelf Registration, the Company entered into a sales agreement (the “2018 Sales Agreement”) with Jefferies, LLC (“Jefferies”) pursuant to which the Company may issue and sell, from time to time, up to an aggregate of $ 50,000 of its common stock in an at-the-market equity offering (“ATM Offering”) through Jefferies, as sales agent.

Through the first quarter of 2020, the Company issued an aggregate of 4,945,605 shares of its common stock under the ATM Offering, resulting in net proceeds to the Company of $ 25,605 .

On March 10, 2020 , the Company notified Jefferies that it was suspending and terminating the prospectus related to the 2018 Sales Agreement.

KALA PHARMACEUTICALS, INC.

1 unchanged sentence

(In thousands, except share and per share amounts)

proceeds to the Company of $ 12,546 .

On March 10, 2020 , the Company notified Jefferies that it was suspending and terminating the prospectus related to the 2018 Sales Agreement.

On March 11, 2020, the Company sold 16,000,000 shares of the Company’s common stock (the “2020 Offering Shares”) in an underwritten offering (the “2020 Offering”), pursuant to the 2018 Shelf Registration, at a public offering price of $ 7.89 per share, before underwriting discounts, commissions, and offering expenses, resulting in net proceeds of $ 118,207 .

On March 11, 2020, the Company sold 16,000,000 shares of its common stock (the “2020 Offering Shares”) in an underwritten offering (the “2020 Offering”), pursuant to the 2018 Shelf Registration, at a public offering price of $ 7.89 per share, resulting in net proceeds of $ 118,207 , after underwriting discounts, commissions, and offering expenses.

In addition, the underwriters of the 2020 Offering were granted the option for a period of 30 days to purchase up to an additional 2,400,000 shares of common stock offered in the public offering at the public offering price, less underwriting discounts, commissions and offering expenses.

On April 3, 2020, the underwriters exercised their option and purchased an additional 979,371 shares of common stock at $ 7.89 per share, before underwriting discounts, commissions, and offering expenses, resulting in net proceeds to the Company of $ 7,216 .

On April 3, 2020, the underwriters exercised their option and purchased an additional 979,371 shares of common stock at $ 7.89 per share, resulting in net proceeds to the Company of $ 7,216 , after underwriting discounts, commissions, and offering expenses.

The total number of shares sold by the Company in the 2020 Offering was 16,979,371 , resulting in total net proceeds to the Company, after underwriting discounts, commissions, and offering expenses, of $ 125,423 .

As of September 30, 2020, there was $ 18,334 of securities available to be issued under the 2018 Shelf Registration.

Under the 2018 Shelf Registration, the Company has issued an aggregate of 30,549,976 shares of common stock, including under the ATM Offering, resulting in aggregate gross proceeds of $ 231,666 .

There was $ 18,334 of securities available to be issued under the 2018 Shelf Registration as of March 31, 2021.

On May 7, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC, which was declared effective on May 19, 2020 (the “2020 Shelf Registration”).

Under the 2020 Shelf Registration, the Company may offer and sell up to $ 350,000 of a variety of securities including common stock, preferred stock, warrants, depositary shares, debt securities or units during the three-year period that commenced upon the 2020 Shelf Registration becoming effective.

In connection with the filing of the 2020 Shelf Registration, the Company entered into an amended and restated sales agreement with Jefferies pursuant to which the Company may issue and sell, from time to time, up to an aggregate of $ 75,000 of its common stock under its ATM Offering through Jefferies, as a sales agent.

In connection with the filing of the 2020 Shelf Registration, the Company entered into an amended and restated sales agreement with Jefferies pursuant to which it may issue and sell, from time to time, up to an aggregate of $ 75,000 of its common stock under its ATM Offering through Jefferies, as a sales agent.

During the fourth quarter of 2020, the Company issued an aggregate of 2,821,059 shares of its common stock under the ATM Offering, resulting in net proceeds of $ 20,612 .

During the three months ended March 31, 2021, the Company issued and sold an additional 4,746,072 shares of its common stock under its ATM Offering, resulting in net proceeds of $ 34,709 .

As of March 31, 2021, there was $ 18,051 of shares of common stock remaining under the ATM Offering and, excluding the shares of common stock that may be offered under the ATM Offering, there was approximately $ 275,000 of securities available to be issued under the 2020 Shelf Registration.

In the period beginning April 1, 2021 through the date of this Quarterly Report on Form 10-Q, we issued and sold an additional 837,257 shares of our common stock under our ATM Offering, resulting in our receipt of $ 6,022 in net proceeds.

STOCK‑BASED COMPENSATION

Stock Incentive Plans —In December 2009, the Board of Directors (the “Board”) adopted the 2009 Employee, Director and Consultant Equity Incentive Plan (the “2009 Plan”) for the issuance of common stock and stock options to employees, officers, directors, consultants, and advisors.

In July 2017, the Company’s 2017 Equity Incentive Plan (the “2017 Plan”) became effective.

The 2017 Plan was established to provide equity-based ownership opportunities for employees, officers, directors, consultants, and advisors.

On June 25, 2020, the 2017 Plan was amended to increase the number of shares of common stock authorized for issuance thereunder by 2,000,000 shares.

As of September 30, 2020, there were 1,275,550 shares of common stock available for grant under the 2017 Plan.

In addition, any shares of common stock subject to awards under the 2009 Plan that expire, are forfeited, or are otherwise surrendered, without having been fully exercised or resulting in any common stock being issued will become available for issuance under the 2017 Plan, up to an additional 2,262,070 shares, which is the number of shares issuable pursuant to outstanding awards granted under the prior plan.

Also approved under the 2017 Plan is an annual increase for each of the years through December 31, 2027, equal to the least of (i) 3,573,766 shares of common stock, (ii) 4 % of the shares of common stock outstanding on December 31 of the prior year and (iii) an amount determined by the Board.

Under the plans, the Board determines the number of shares of common stock to be granted pursuant to the awards, as well as the exercise price and terms of such awards.

The exercise price of incentive stock options cannot be less than the fair value of the common stock on the date of grant.

Stock options awarded under the plans expire 10 years after the grant date, unless the Board sets a shorter term.

Options granted under the plans generally vest over a four-year period.

A portion of the unvested stock options will vest upon the sale of all or substantially all of the stock or assets of the Company.

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

Inducement Stock Option Awards —During the nine months ended September 30, 2020 and 2019, the Company granted non-statutory stock options to purchase an aggregate of 40,800 shares and 175,500 shares of the Company’s common stock, respectively.

These stock options will vest over a four-year period, with 25 % of the shares underlying each option award vesting on the one-year anniversary of the applicable employees’ new hire date and the remaining 75 % of the shares underlying each award vesting monthly thereafter for three-years .

Vesting of each option is subject to such employee’s continued service with the Company through the applicable vesting dates.

These stock options were granted outside of the 2017 Plan as an inducement material to each employee’s acceptance of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

A summary of option activity for employee awards under the 2009 Plan, the 2017 Plan and inducement grants for the nine months ended September 30, 2020 is as follows:

(in thousands)

Outstanding as of January 1, 2020

Outstanding as of September 30, 2020

Vested or expected to vest as of September 30, 2020

Options exercisable as of September 30, 2020

The Company records stock-based compensation related to stock options granted at fair value.

The Company utilizes the Black-Scholes option-pricing model to estimate the fair value of stock option grants and to determine the related compensation expense.

The assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates.

The assumptions used in determining fair value of the stock options granted during the nine months ended September 30, 2020 and 2019, are as follows:

Nine Months Ended September 30,

During the three months ended March 31, 2021, the Company granted options for the purchase of 1,512,964 shares of common stock including 56,700 non-statutory stock options granted to new employees and 431,333 restricted stock units.

In January 2021, employees of the Company purchased an aggregate of 74,847 shares under the ESPP.

The assumptions used in determining fair value of the stock options granted during the three months ended March 31, 2021 are as follows:

Three Months Ended March 31, 2021

Expected volatility

2 unchanged sentences

Expected term (in years)

The Company derived the risk-free interest rate assumption from the U.S.

Treasury rates for U.S.

Treasury zero-coupon bonds with maturities similar to those of the expected term of the awards being valued.

The Company based the expected dividend yield on its expectation of not paying dividends in the foreseeable future.

The Company calculated the weighted-average expected term of options using the simplified method, as the Company lacks relevant historical data due to the Company’s limited operating experience.

The expected volatility is based upon the historical volatility of comparable companies with publicly available share prices.

The impact of forfeitures on compensation expense is recorded as they occur.

During the three months ended September 30, 2020 and 2019, the weighted average grant-date fair value of options granted was $ 7.06 and $ 2.82 , respectively.

During the nine months ended September 30, 2020 and 2019, the weighted average grant-date fair value of options granted was $ 4.00 and $ 3.70 , respectively.

The fair value is being expensed over the vesting period of the options on a straight-line basis as the services are being provided.

As of September 30, 2020 and 2019, there was $ 17,483 and $ 20,469 , respectively, of unrecognized compensation cost related

KALA PHARMACEUTICALS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(In thousands, except share and per share amounts)

to the stock options granted, which is expected to be expensed over a weighted-average period of 2.40 years and 2.46 years, respectively.

Stock-based compensation costs capitalized into inventory totaled $ 234 and $ 19 for the three months ended September 30, 2020 and 2019, respectively, and $ 535 and $ 355 for the nine months ended September 30, 2020 and 2019, respectively.

Capitalized stock-based compensation is recognized as an expense in cost of product revenues when the related product is sold or in selling, general and administrative expense when the related sample is issued.

Restricted Stock Units and Performance-Based Restricted Stock Units —In June 2020, the Company issued RSUs to certain executives and Board members, as well as PSUs to certain executives and other employees.

The Company granted 135,560 RSUs to certain executives which vest 50 % on the first anniversary of the grant date, and 50 % on the second anniversary of the grant date.

Additionally, the Company issued 128,000 RSUs to members of the Board which will vest upon the earlier of the first anniversary of the 2020 Annual Meeting of Stockholders or the date of the 2021 Annual Meeting of Stockholders.

The Company issued 693,537 PSUs to certain executives and other employees tied to certain performance criteria, which will vest, if at all, as to 50 % on the first anniversary of satisfying the performance criteria and the remaining 50 % vesting upon the second anniversary of satisfying the performance criteria.

The Company has assessed the probability of achievement of the performance criteria and has recorded related stock compensation expense to this extent as of September 30, 2020.

As of September 30, 2020, a total of 946,767 RSUs and PSUs were unvested and outstanding, which results in unrecognized stock-based compensation of $ 8,586 to be recognized as stock-based compensation expense over the remaining weighted-average vesting period of 1.41 years.

A summary of the outstanding RSUs and PSUs as of September 30, 2020 is as follows:

Weighted Average

Unvested and outstanding balance as of December 31, 2019

Changes during the period:

PSUs forfeited

Unvested and outstanding balance as of September 30, 2020

Employee Stock Purchase Plan —In 2017, the Company approved the 2017 Employee Stock Purchase Plan, which was amended and restated in December 2018 (as amended, the “ESPP”).

The ESPP reserved an aggregate of 223,341 shares of common stock and provides for an annual increase on the first day of each fiscal year, beginning on January 1, 2019 and ending on December 31, 2029, in an amount equal to the lowest of:

(1) 893,441 shares of the Company’s common stock;

(2) 1 % of the total number of shares of the Company’s common stock outstanding on the first day of the applicable fiscal year;

and (3) an amount determined by the Company’s board of directors.

The ESPP provides for two six-month offering periods each year;

the first offering period begins on the first trading day on or after each January 1;

the second offering period begins on the first trading day on or after each July 1.

Under the ESPP, participating employees can authorize the Company to withhold a portion of their base pay during consecutive six-month payment periods for the purchase of shares of the Company’s common stock.

At the conclusion of the period, participating employees can purchase shares of the Company’s common stock at 85 % of the lesser of the closing price of the common stock on (i) the first business day of the plan period or (ii) the exercise date.

The fair value of the purchase rights granted under the ESPP was estimated on the date of grant, using the Black-Scholes option-pricing model.

In January 2020, employees of the Company purchased an aggregate of 85,553 shares under the ESPP.

In July 2020, employees of the Company purchased an aggregate of 228,844 shares under the ESPP.

During the three months ended March 31, 2021 the weighted average grant-date fair value of options granted was $ 4.42 .

KALA PHARMACEUTICALS, INC.

1 unchanged sentence

(In thousands, except share and per share amounts)

Stock-based compensation expense was classified in the condensed consolidated statements of operations as follows for the three and nine months ended September 30, 2020 and 2019:

In June 2020, the Company issued 693,537 PSUs to certain executives and other employees tied to certain performance criteria, which will vest, if at all, as to 50 % on the first anniversary of satisfying the performance criteria and the remaining 50 % vesting upon the second anniversary of satisfying the performance criteria.

The Company has determined that the performance criteria for these awards has been achieved but the awards have not vested as of March 31, 2021.

As of March 31, 2021, a total of 1,365,592 RSUs and PSUs were unvested and outstanding.

Stock-based compensation expense was classified in the condensed consolidated statements of operations and comprehensive loss as follows for the three months ended March 31, 2021 and 2020:

Three Months Ended

Nine Months Ended

September 30,

Cost of product revenues

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Selling, general and administrative

Reserved Shares —As of September 30, 2020 and December 31, 2019, the Company had reserved the following shares of common stock issuable upon exercise of rights under equity compensation plans, inducement stock option awards, and warrant rights to acquire common stock:

September 30,

Warrant rights to acquire common stock

Outstanding inducement stock option awards

The Company did not record a provision or benefit for income taxes during the three months ended September 30, 2020 and 2019.

The Company did not record a provision or benefit for income taxes during the three months ended March 31, 2021 and 2020.

The Company continues to maintain a full valuation allowance for its U.S.

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Under the provisions of Section 382 of the Internal Revenue Code of 1986, as amended, certain substantial changes in the Company’s ownership, including a sale of the Company, or significant changes in ownership due to sales of equity, may have limited, or may limit in the future, the amount of net operating loss carryforwards, which could be used annually to offset future taxable income.

The Company recently completed an analysis and determined that an ownership change had occurred prior to December 31, 2019 and that such change has materially limited the net operating loss carryforwards and research and development tax credits available to offset future tax liabilities.

The Company previously completed an analysis and determined that an ownership change has materially limited the net operating loss carryforwards and research and development tax credits available to offset future tax liabilities.

The Company may be further limited by any changes that may have occurred or may occur subsequent to December 31, 2020.

The Company files its corporate income tax returns in the United States and various states.

All tax years since the date of incorporation remain open to examination by the major taxing jurisdictions (state and federal) to which the Company is subject, as carryforward attributes generated in years past may still be adjusted upon examination by the

The Company is not currently under examination by the IRS or any other jurisdictions for any tax year.

As of March 31, 2021and 2020, the Company had no uncertain tax positions.

The Company’s policy is to recognize interest and penalties related to income tax matters as a component of income tax expense, of which no interest or penalties were recorded for the three months ended March 31, 2021 and 2020.

KALA PHARMACEUTICALS, INC.

1 unchanged sentence

(In thousands, except share and per share amounts)

Internal Revenue Service (“IRS”) or other authorities if they have or will be used in a future period.

The Company is not currently under examination by the IRS or any other jurisdictions for any tax year.

As of September 30, 2020 and 2019, the Company had no uncertain tax positions.

COMMITMENTS AND CONTINGENCIES

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The Company also has an obligation to pay JHU certain one-time development and commercial milestone payments.

During the three months ended September 30, 2020 and 2019, the Company paid JHU $ 8 and $ 34 , respectively, in royalty payments associated with the sale of INVELTYS.

During the nine months ended September 30, 2020 and 2019, the Company paid JHU $ 44 and $ 334 , respectively, in royalty payments associated with the sale of INVELTYS.

The Company recorded other expenses related to the JHU agreement of $ 44 and $ 116 for the three months ended September 30, 2020 and 2019, respectively.

The Company recorded other expenses related to the JHU agreement of $ 121 and $ 197 for the nine months ended September 30, 2020 and 2019, respectively.

The Company is obligated to pay JHU a $ 150 milestone payment within 60 days of the first commercial sale of EYSUVIS in the United States.

During the three months ended March 31, 2021 and 2020, the Company paid JHU $ 22 and $ 12 , respectively, in royalty payments associated with the sales of EYSUVIS and INVELTYS.

The Company paid JHU a $ 150 milestone payment during the three months ended March 31, 2021, which was triggered by the first commercial sale of EYSUVIS in the United States in December 2020.

The Company recorded a credit for other expenses related to the JHU agreement of $ 51 during the three months ended March 31, 2021 and other expenses of $ 46 for the three months ended March 31, 2020.

Litigation —The Company is not currently subject to any material legal proceedings.

Other Commitments — The Company entered into a commercial supply agreement with Catalent Pharma Solutions, LLC to manufacture commercial supplies of INVELTYS and EYSUVIS.

The commercial supply agreement contains annual minimum purchase requirements, which increased upon FDA approval of EYSUVIS on October 26, 2020.

The Company has the following minimum purchase obligations for INVELTYS and EYSUVIS:

Other Commitments — The Company entered into a commercial supply agreement with Woodstock Sterile Solutions, Inc.

(formerly known as Catalent Pharma Solutions, LLC) to manufacture commercial supplies of EYSUVIS and INVELTYS.

The Company has the following minimum purchase obligations for EYSUVIS and INVELTYS as of March 31, 2021:

Years Ending December 31,

2020 (remaining three months)

2021 (remaining nine months)

Total minimum purchase commitments

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SUBSEQUENT EVENTS

On October 26, 2020, the FDA approved the Company’s New Drug Application 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.

Refer to Note 14, “Commitments and Contingencies” for additional commitments identified as a result of the FDA approval of EYSUVIS.

Entry into Loan and Security Agreement

On May 4, 2021 (the “Closing Date”), the Company entered into a Loan and Security Agreement with Oxford Finance LLC, in its capacity as lender (in such capacity, the “Lender”), and in its capacity as collateral agent (in such capacity, the “Agent”), pursuant to which a term loan of up to an aggregate principal amount of $ 125,000 is available to the Company, consisting of (i) a tranche A term loan that was disbursed on the Closing Date in the aggregate principal amount of $ 80,000 ;

(ii) a contingent tranche B term loan in the aggregate principal amount of $ 20,000 available to the Company through June 30, 2023 and within 90 days of the Company achieving trailing 6-month product revenue equal to or greater than $ 75,000 , subject to certain other terms and conditions;

and (iii) a contingent tranche C term loan in the aggregate principal amount of $ 25,000 available to the Company through December 31, 2023 and within 90 days of the Company achieving trailing 6-month product revenue equal to or greater than $ 100,000 , subject to certain other terms and conditions.

The term loans bear interest at a floating rate equal to the greater of 30-day LIBOR and 0.11 %, plus 7.89 %.

The Loan Agreement provides for interest-only payments until December 1, 2024 if neither the tranche B term loan nor the tranche C term loan are made, and until June 1, 2025 if either the tranche B term loan or the tranche C term loan is made (the “Amortization Date”).

The aggregate outstanding principal balance of the term loans are required to be repaid in monthly installments starting on the Amortization Date based on a repayment schedule equal to (i) 18 months if neither the tranche B term loan nor the tranche C term loan is made and (ii) 12 months if either the tranche B term loan or the tranche C term loan is made.

All unpaid principal and accrued and unpaid interest with respect to each term loan is due and payable in full on May 1, 2026 (the “Maturity Date”).

The Company paid a facility fee of $ 400 on the Closing Date and has agreed to pay a facility fee of $ 100 upon closing of the tranche B term loan and a $ 125 facility fee upon the closing of the tranche C term loan.

The Company will be required to make a final payment fee of 7.00 % of the original principal amount of any funded term loan payable on the earlier of (i) the prepayment of the term loan in full or (ii) the Maturity Date.

At the Company’s option, the Company may elect to prepay all, but not less than all, of the outstanding loans, subject to a prepayment fee equal to the following percentage of the principal amount being prepaid:

3.00 % if an advance is prepaid during the first 12 months following the applicable advance date, 2.00 % if an advance is prepaid after 12 months but prior to 24 months following the applicable advance date, and 1.00 % if an advance is prepaid any time after 24 months following the applicable advance date but prior to the Maturity Date.

In connection with its entry into the Loan Agreement, the Company granted the Agent a security interest in substantially all of the Company’s personal property owned or later acquired, including intellectual property.

The Loan Agreement also contains customary representations and warranties and affirmative and negative covenants, as well as customary events of default.

Certain of the customary negative covenants limit the ability of the Company and certain of its subsidiaries, among other things, to incur future debt, grant liens, make investments, make acquisitions, distribute dividends, make certain restricted payments and sell assets, subject in each case to certain exceptions.

Termination of Athyrium Credit Facility

On May 4, 2021, concurrently with the closing of the Loan Agreement and the initial borrowing of the tranche A loan, the Company utilized substantially all of the proceeds from the tranche A loan to repay in full all outstanding amounts owed under the Athyrium Credit Facility, and terminated all commitments by Athyrium to extend further credit thereunder and all guarantees and security interests granted by the Company to the lenders thereunder.

In connection with the termination of the Athyrium Credit Facility, the Company paid to the lenders a prepayment premium of $ 2,250 and an exit fee of $ 750 .

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements