2023 Q1 Form 10-K Financial Statement

#000137251423000050 Filed on March 23, 2023

View on sec.gov

Income Statement

Concept 2023 Q1 2022 Q4 2022
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $1.269M $2.778M $8.278M
YoY Change -23.75% 101.44% 55.49%
% of Gross Profit
Research & Development $438.3K $841.6K $3.449M
YoY Change -38.09% -15.97% -35.54%
% of Gross Profit
Depreciation & Amortization $10.08K $10.29K $41.61K
YoY Change -6.45% -6.79% -8.14%
% of Gross Profit
Operating Expenses $1.917M $2.635M $12.31M
YoY Change -46.3% 38.34% -27.35%
Operating Profit -$1.917M -$12.31M
YoY Change -46.3% -27.35%
Interest Expense $33.47K $24.48K $8.599K
YoY Change 15113.64% -739.16% 25.51%
% of Operating Profit
Other Income/Expense, Net $48.13K -$940.00 -$1.387M
YoY Change 986.97% -671.38%
Pretax Income -$1.869M -$2.611M -$13.70M
YoY Change -47.59% -56.08% -17.98%
Income Tax -$113.0K -$113.0K
% Of Pretax Income
Net Earnings -$1.869M -$2.498M -$13.58M
YoY Change -47.59% -56.58% -17.15%
Net Earnings / Revenue
Basic Earnings Per Share -$1.00 -$18.55
Diluted Earnings Per Share -$1.00 -$1.76 -$18.55
COMMON SHARES
Basic Shares Outstanding 1.919M shares 1.142M 732.3K shares
Diluted Shares Outstanding 1.863M shares 732.3K shares

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $3.426M $5.965M $5.965M
YoY Change -32.39% -24.06% -24.06%
Cash & Equivalents $3.426M $5.965M $5.965M
Short-Term Investments
Other Short-Term Assets $489.0K $343.1K $343.1K
YoY Change -47.44% -43.44% -43.44%
Inventory
Prepaid Expenses $489.0K $343.1K
Receivables
Other Receivables
Total Short-Term Assets $5.618M $7.681M $7.681M
YoY Change -14.23% -14.57% -14.57%
LONG-TERM ASSETS
Property, Plant & Equipment $51.35K $55.18K $172.2K
YoY Change -23.7% -25.44% -39.25%
Goodwill $0.00
YoY Change
Intangibles $10.74M $10.74M
YoY Change -0.23% -0.23%
Long-Term Investments
YoY Change
Other Assets $32.67K $33.00K $82.26K
YoY Change -39.3% -23.19% -6.48%
Total Long-Term Assets $10.91M $11.00M $11.00M
YoY Change -1.59% -1.27% -1.27%
TOTAL ASSETS
Total Short-Term Assets $5.618M $7.681M $7.681M
Total Long-Term Assets $10.91M $11.00M $11.00M
Total Assets $16.53M $18.68M $18.68M
YoY Change -6.29% -7.21% -7.21%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $587.5K $1.008M $1.008M
YoY Change 94.36% 527.73% 527.73%
Accrued Expenses $1.182M $1.836M $1.758M
YoY Change -35.53% 38.03% 23.8%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $2.156M $3.272M $3.272M
YoY Change -14.5% 103.3% 103.3%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $3.527M $3.309M $3.309M
YoY Change 15.46% 5.4% 5.4%
Total Long-Term Liabilities $4.216M $3.998M $3.309M
YoY Change 9.32% 1.44% 5.4%
TOTAL LIABILITIES
Total Short-Term Liabilities $2.156M $3.272M $3.272M
Total Long-Term Liabilities $4.216M $3.998M $3.309M
Total Liabilities $6.372M $7.271M $7.271M
YoY Change -0.1% 30.97% 30.97%
SHAREHOLDERS EQUITY
Retained Earnings -$136.3M -$134.5M
YoY Change 9.53% 11.24%
Common Stock $19.21K $17.99K
YoY Change -84.83% -85.8%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $10.16M $11.41M $11.41M
YoY Change
Total Liabilities & Shareholders Equity $16.53M $18.68M $18.68M
YoY Change -6.29% -7.21% -7.21%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$1.869M -$2.498M -$13.58M
YoY Change -47.59% -56.58% -17.15%
Depreciation, Depletion And Amortization $10.08K $10.29K $41.61K
YoY Change -6.45% -6.79% -8.14%
Cash From Operating Activities -$3.070M -$2.129M -$10.43M
YoY Change 8.37% -33.42% -4.22%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00
YoY Change -100.0%
Acquisitions $0.00
YoY Change -100.0%
Other Investing Activities $0.00 $0.00 $6.380K
YoY Change -100.0% -100.0% -106.85%
Cash From Investing Activities $0.00 $0.00 $6.375K
YoY Change -100.0% -100.0% -104.06%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $513.2K 3.243M $8.621M
YoY Change 4820.65% -51.55%
NET CHANGE
Cash From Operating Activities -$3.070M -2.129M -$10.43M
Cash From Investing Activities $0.00 0.000 $6.375K
Cash From Financing Activities $513.2K 3.243M $8.621M
Net Change In Cash -$2.584M 1.114M -$1.886M
YoY Change -7.31% -134.55% -128.28%
FREE CASH FLOW
Cash From Operating Activities -$3.070M -$2.129M -$10.43M
Capital Expenditures $0.00 $0.00
Free Cash Flow -$2.129M -$10.43M
YoY Change -33.42% -4.78%

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Business, Presentation and Recent Accounting Pronouncements<div style="margin-bottom:9pt;margin-top:9pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Business Overview</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">Kiora is a clinical-stage specialty pharmaceutical company developing and commercializing therapies for the treatment of ophthalmic diseases. On November 5, 2021, Kiora Pharmaceuticals, Inc. (formerly known as EyeGate Pharmaceuticals, Inc.) (“Kiora” or the “Company”) filed with the Secretary of State of the State of Delaware, a Certificate of Ownership and Merger, merging its wholly-owned Delaware subsidiary, Kiora Pharmaceuticals, Inc., (incorporated in October 2021) into the Company and amending the Company’s certificate of incorporation to change its name to “Kiora Pharmaceuticals, Inc.” effective November 8, 2021 (the “Name Change”).</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">The Company's lead product is KIO-301 with an initial focus on patients with later stages of disease progression due to Retinitis Pigmentosa (any and all sub-forms). KIO-301 is a potential vision-restoring small molecule that acts as a “photoswitch” specifically designed to restore vision in patients with inherited and age-related degenerative retinal diseases. The molecule is specifically designed to restore the eyes’ ability to perceive and interpret light in visually impaired patients. It selectively enters viable downstream retinal ganglion cells (no longer receiving electrical input due to degenerated rods and cones) and is intended to turn them into light sensing cells, capable of signaling the brain as to the presence or absence of light. The Company initiated a Phase 1b clinical trial in the third quarter of 2022. On March 17, 2022, the Company was granted Orphan Drug Designation from the U.S. FDA for the Active Pharmaceutical Ingredient (“API”) in KIO-301. KIO-301 (formerly known as B-203) was acquired through the Bayon Therapeutics, Inc. (“Bayon”) transaction which closed October 21, 2021.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">KIO-101 is a product that focuses on patients with Ocular Presentation of Rheumatoid Arthritis (“OPRA+”). KIO-101 is a next-generation, non-steroidal, immune-modulatory and small-molecule inhibitor of Dihydroorotate Dehydrogenase (“DHODH”) with what the Company believes to be best-in-class picomolar potency and a validated immune modulating mechanism designed to overcome the off-target side effects and safety issues associated with commercially available DHODH inhibitors. In the fourth quarter of 2021, the Company reported top-line safety and tolerability from a phase 1b proof-of-concept (“POC”) study evaluating KIO-101 in patients with ocular surface inflammation. The Company expects to initiate a Phase 2 clinical trial in the first quarter of 2023. KIO-101 (formerly known as PP-001) was acquired through the acquisition of Panoptes Pharma Ges.m.b.H “Panoptes” in the fourth quarter of 2020.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">In addition, the Company is developing KIO-201, for patients with Persistent Corneal Epithelial Defects ("PCED"), which is an orphan disease and as such, the Company is currently seeing orphan drug designation. The Company is also evaluating KIO-201 in patients recovering from surgical wounds, such as those undergoing photorefractive keratectomy ("PRK") surgery for corneal wound repair after refractive surgery. KIO-201 is a modified form of the natural polymer hyaluronic acid, designed to protect the ocular surface to permit re-epithelialization of the cornea and improve and maintain ocular surface integrity. KIO-201 has unique properties that help hydrate and protect the ocular surface. The Company is currently evaluating KIO-201 in a Phase 2 clinical trial in patients with PCEDs and released top-line data in Q1 2023. We expect to release full data in Q2 2023. The Company is in planning stages of a Phase 3b trial for patients recovering from the laser vision correction procedure PRK and plans to initiate the study before the end of 2023.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">Since its inception, Kiora has devoted substantially all of its efforts to business planning, research and development, and raising capital.</span></div><div style="margin-bottom:9pt;margin-top:9pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Going Concern</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">The accompanying Consolidated Financial Statements have been prepared assuming that Kiora will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal </span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">course of business. At December 31, 2022, Kiora had unrestricted Cash and Cash Equivalents of $6.0 million, and an Accumulated Deficit of $134.5 million. Kiora has incurred losses and negative cash flows since inception, and future losses are anticipated. Based on its cash on hand at December 31, 2022, the Company anticipates having sufficient cash to fund planned operations into July 2023, however, the acceleration or reduction of cash outflows by Company management can significantly impact the timing for the need to raise additional capital to complete development of its products. To continue development, Kiora will need to raise additional capital through equity financing, license agreements, and/or additional U.S. government grants. Although historically the Company has been successful at raising capital, most recently raising net proceeds of approximately $2.7 million in a warrant inducement transaction that closed on November 22, 2022, net of placement agent fees of $0.3 million and expense of $0.1 million, additional capital may not be available on terms favorable to Kiora, if at all. The Company does not know if any future offerings will succeed. Accordingly, no assurances can be given that Company management will succeed in these endeavors. The Company’s recurring losses from operations have caused management to determine there is substantial doubt about the Company’s ability to continue as a going concern. The Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:125%">Reverse Stock Split</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">On September 23, 2022, the Company filed a Certificate of Amendment to its Restated Certificate of Incorporation (the “Amendment”) with the Secretary of State of the State of Delaware to effect a one-for-forty (1-for-40) reverse stock split of its outstanding common stock. The Amendment was approved by the Company’s stockholders at the Company’s 2022 Annual Meeting of Stockholders held on September 23, 2022, and by the Company’s board of directors. The Amendment became effective on September 27, 2022.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">The reverse stock split affected all shares of the Company’s common stock outstanding immediately prior to the effective time of the Amendment. As a result of the reverse stock split, proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all stock options, and restricted stock awards issued by the Company and outstanding immediately prior to the effective time of the Amendment, which resulted in a proportionate decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options, and restricted stock awards, and, in the case of stock options, a proportionate increase in the exercise price of all such stock options. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective time of the Amendment was reduced proportionately. The reverse stock split did not affect the number of shares or par value of common stock authorized for issuance under the Company’s Amended and Restated Certificate of Incorporation, which remained at 50,000,000 shares.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">No fractional shares were issued as a result of the reverse stock split. Stockholders of record who would otherwise have been entitled to receive a fractional share received a cash payment in lieu thereof. The reverse stock split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of the Company’s common stock (except to the extent that the reverse stock split results in any stockholder owning only a fractional share). As a result of the reverse stock split, the number of the Company’s outstanding shares of common stock as of September 27, 2022 decreased from 43,163,123 (pre-split) shares to 1,079,045 (post-split) shares.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">All share and per share amounts in the accompanying financial statements and related footnotes have been adjusted retroactively to reflect the reverse stock split as if it had occurred at the beginning of the earliest period presented. While the number of warrants outstanding did not change, the underlying shares did and are presented reflecting the split. The Company’s common stock began trading on The Nasdaq Capital Market on a split-adjusted basis when the market opened on September 27, 2022.</span></div><div style="margin-bottom:9pt;margin-top:9pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Adoption of Accounting Standards</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">In August 2020, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity. This guidance removes the liability and equity separation models for convertible instruments with a cash conversion feature or beneficial conversion feature. As a result, companies will more likely account for a convertible debt instrument wholly as debt, and for convertible preferred stock wholly as preferred stock (i.e., as a single unit of account). In addition, the guidance simplifies the settlement assessment that issuers perform to determine whether a contract in their own equity qualifies for equity classification. Finally, the guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The Company adopted ASU 2020-06 on January 1, 2022. The adoption of ASU 2020-06 did not have a material effect for the Company.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) to clarify an issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options (for example, warrants) that remain equity classified after modification or exchange. Specifically, the ASU provides a principles-based framework to determine whether an issuer should recognize the modification or exchange as an adjustment to equity or an expense. The guidance is effective for annual reporting periods beginning after December 15, 2021, and interim periods within those fiscal years. The Company adopted ASU 2021-04 on January 1, 2022. The adoption of ASU 2021-04 did not have a material effect for the Company.</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">In November 2021, the FASB issued ASU 2021-10, which requires business entities to disclose information about certain government assistance they receive. Such disclosure requirements include the nature of the transactions and the related accounting policy used, the line items on the balance sheet and income statement that are affected and the amounts applicable to each financial statement line item and significant terms and conditions of the transactions. ASU 2021-10 was effective for the Company January 1, 2022. The adoption of ASU 2021-10 did not have a material effect for the Company.</span></div>
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CY2022 us-gaap Use Of Estimates
UseOfEstimates
<div style="margin-bottom:9pt;margin-top:9pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of Estimates</span></div><div style="margin-bottom:12pt;margin-top:6pt;text-align:justify"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:125%">The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The Company makes significant estimates and assumptions in recording the accruals for the Company’s clinical trial and research activities, establishing the useful lives of intangible assets and property and equipment, conducting impairment reviews of goodwill, in-process research and development (IPR&amp;D), stock-based compensation, assumptions used to value warrants including warrant modifications and </span></div>inducements, and contingent considerations payable. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Although the Company monitors and regularly assesses these estimates, actual results could differ significantly from these estimates. The Company records changes in estimates in the period that it becomes aware of the change.
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