$EWTX
Edgewise Therapeutics Inc

2023 Q1 Form 10-K Financial Statement

#000155837023001895 Filed on February 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 $5.828M $5.467M $17.63M
YoY Change 57.43% 46.41% 59.86%
% of Gross Profit
Research & Development $19.88M $16.61M $54.03M
YoY Change 78.68% 82.79% 67.86%
% of Gross Profit
Depreciation & Amortization $200.0K $88.00K $400.0K
YoY Change 140.96% 12.82% 33.33%
% of Gross Profit
Operating Expenses $25.70M $22.08M $71.66M
YoY Change 73.37% 72.2% 65.82%
Operating Profit -$25.70M -$71.66M
YoY Change 73.37% 65.82%
Interest Expense $2.866M $2.664M $4.018M
YoY Change 1626.51% 2014.29% 899.5%
% of Operating Profit
Other Income/Expense, Net
YoY Change
Pretax Income -$22.84M -$19.42M -$67.64M
YoY Change 55.78% 52.92% 57.99%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$22.84M -$19.42M -$67.64M
YoY Change 55.78% 52.92% 57.99%
Net Earnings / Revenue
Basic Earnings Per Share -$0.36 -$1.26
Diluted Earnings Per Share -$0.36 -$0.31 -$1.26
COMMON SHARES
Basic Shares Outstanding 63.26M 63.21M 53.59M
Diluted Shares Outstanding 63.27M 53.59M

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $328.0M $351.9M $351.9M
YoY Change 23.37% 25.34% 25.34%
Cash & Equivalents $48.23M $21.99M $21.99M
Short-Term Investments $279.7M $330.0M $330.0M
Other Short-Term Assets $5.411M $5.052M $5.052M
YoY Change 94.36% 69.3% 69.3%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $333.4M $357.0M $357.0M
YoY Change 24.1% 25.8% 25.8%
LONG-TERM ASSETS
Property, Plant & Equipment $10.40M $8.533M $9.851M
YoY Change 622.45% 835.64% 980.15%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $251.0K $251.0K $251.0K
YoY Change -55.1% -54.2% -54.2%
Total Long-Term Assets $13.04M $10.10M $10.10M
YoY Change 215.82% 591.92% 591.92%
TOTAL ASSETS
Total Short-Term Assets $333.4M $357.0M $357.0M
Total Long-Term Assets $13.04M $10.10M $10.10M
Total Assets $346.4M $367.1M $367.1M
YoY Change 27.01% 28.7% 28.7%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $3.875M $6.105M $6.105M
YoY Change -27.43% 58.86% 58.86%
Accrued Expenses $5.969M $5.840M $10.48M
YoY Change 79.9% 50.48% 56.93%
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 $12.72M $16.59M $16.59M
YoY Change 27.1% 57.64% 57.64%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $4.845M $3.800M $3.800M
YoY Change 2490.91% 1055.02% 1055.02%
Total Long-Term Liabilities $4.845M $3.800M $3.800M
YoY Change 2490.91% 1055.02% 1055.02%
TOTAL LIABILITIES
Total Short-Term Liabilities $12.72M $16.59M $16.59M
Total Long-Term Liabilities $4.845M $3.800M $3.800M
Total Liabilities $17.56M $20.39M $20.39M
YoY Change 41.74% 87.88% 87.88%
SHAREHOLDERS EQUITY
Retained Earnings -$167.4M -$144.6M
YoY Change 82.75% 87.89%
Common Stock $6.000K $6.000K
YoY Change 20.0% 20.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $328.8M $346.7M $346.7M
YoY Change
Total Liabilities & Shareholders Equity $346.4M $367.1M $367.1M
YoY Change 27.01% 28.7% 28.7%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$22.84M -$19.42M -$67.64M
YoY Change 55.78% 52.92% 57.99%
Depreciation, Depletion And Amortization $200.0K $88.00K $400.0K
YoY Change 140.96% 12.82% 33.33%
Cash From Operating Activities -$22.83M -$11.82M -$52.64M
YoY Change 81.56% 25.49% 57.09%
INVESTING ACTIVITIES
Capital Expenditures $4.368M $3.293M $5.546M
YoY Change 1083.74% -4268.35% 730.24%
Acquisitions
YoY Change
Other Investing Activities $53.41M -$72.30M -$65.03M
YoY Change 68.19% -609.18% -73.08%
Cash From Investing Activities $49.04M -$75.60M -$70.58M
YoY Change 56.25% -635.34% -70.86%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $129.2M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 21.00K -338.0K 129.6M
YoY Change -71.23% -215.36% -30.45%
NET CHANGE
Cash From Operating Activities -22.83M -11.82M -52.64M
Cash From Investing Activities 49.04M -75.60M -70.58M
Cash From Financing Activities 21.00K -338.0K 129.6M
Net Change In Cash 26.24M -87.75M 6.427M
YoY Change 38.92% -1856.84% -107.19%
FREE CASH FLOW
Cash From Operating Activities -$22.83M -$11.82M -$52.64M
Capital Expenditures $4.368M $3.293M $5.546M
Free Cash Flow -$27.19M -$15.11M -$58.18M
YoY Change 110.14% 61.81% 70.24%

Facts In Submission

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;">NOTE 1  DESCRIPTION OF BUSINESS</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt;"><b style="font-weight:bold;text-decoration-line:underline;text-decoration-style:solid;">Organization and Description of Business</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Edgewise Therapeutics, Inc. (the Company) was incorporated as a Delaware corporation in May 2017, and it is headquartered in Boulder, Colorado. The Company is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. The Company’s lead product candidate, EDG-5506, is an orally administered small molecule designed to address the root cause of dystrophinopathies including Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy (BMD). The Company is currently studying EDG-5506 in Phase 2 trials, which are being held in the U.S. and certain countries in Europe. In addition, the Company has identified EDG-7500, for the potential treatment of hypertrophic cardiomyopathy (HCM) and is conducting nonclinical studies to support advancing the compound into a Phase 1 clinical trial in late 2023. The Company is using its proprietary drug discovery platform to develop a pipeline of precision medicine product candidates that target key muscle proteins and modulators to address a broad array of genetically defined muscle disorders.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt;"><b style="font-weight:bold;text-decoration-line:underline;text-decoration-style:solid;">Initial Public Offering</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">On March 30, 2021, the Company completed its initial public offering (IPO) in which it issued and sold 12,650,000 shares of common stock at a price of $16.00 per share, including 1,650,000 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO was $186.1 million after deducting underwriting discounts and commissions of $14.2 million and offering expenses of approximately $2.1 million. In addition, in connection with the IPO, all shares of convertible preferred stock outstanding at the time of the IPO converted into 35,557,569 shares of common stock. </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt;"><b style="font-weight:bold;text-decoration-color:#000000;text-decoration-line:underline;text-decoration-style:solid;">Risks and Uncertainties </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Board of Directors of the Company discusses with management macroeconomic and geopolitical developments, including COVID-19, the Russia-Ukraine conflict and inflation and the impact on the Company’s personnel, cybersecurity and sanctions so that the Company can be prepared to react to new developments as they arise.<span style="font-size:12pt;"> </span>The Board of Directors and the management of the Company are carefully monitoring these developments and the resulting economic impact on its financial condition and results of operations.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Disruptions caused by the COVID-19 pandemic impacted our productivity, resulted in increased operational expenses, certain adjustments to the operations of our clinical trial, delays in the enrollment of new patients at our clinical trial site, and delays in certain supply chain activities and collecting and analyzing data from patients in our clinical trial. Recently, President Biden announced that the administration intends to end the COVID-19 national and public health emergencies on May 11, 2023. The full impact of the termination of the public health emergencies on FDA and other regulatory policies and operations are unclear<span style="letter-spacing:0.2pt;">.</span><span style="font-size:12pt;"> </span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt;"><b style="font-weight:bold;text-decoration-line:underline;text-decoration-style:solid;">Liquidity and Capital Resources</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company has an accumulated deficit of $144.6 million and, cash, cash equivalents and marketable securities of $351.9 million as of December 31, 2022. The Company’s ability to fund ongoing operations is highly dependent upon raising additional capital through the issuance of equity securities and issuing debt or other financing vehicles. The Company filed: (i) on April 1, 2022, a shelf registration statement on Form S-3 with the U.S. Securities and Exchange Commission (SEC) that became effective on May 5, 2022 and allows us to undertake various equity and debt offerings up to $400,000,000; and (ii) on May 5, 2022 a prospectus supplement to the shelf registration statement that covers the offering, issuance and sale of up to $125 million of our common stock from time to time through an “at-the-market” program under the Securities Act of 1933, as amended (Securities Act). As of December 31, 2022, the Company has not sold any shares under the “at the market” program.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">On September 16, 2022, the Company closed an underwritten public offering of 13,372,093 shares of common stock at a public offering price of $10.32 per share (collectively with the underwriters’ option, the “September 2022 </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">Offering”). The underwriters exercised in full their option to purchase 1,744,186 additional shares of common stock. The aggregate gross proceeds from the September 2022 Offering were $138.0 million, and the net proceeds were $129.2 million after deducting underwriting discounts and commissions of $8.3 million and offering expenses of $0.5 million.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company’s ability to secure capital is dependent upon success in developing its technology and product candidates. The Company cannot provide assurance that additional capital will be available on acceptable terms, if at all. The issuance of additional equity or debt securities will likely result in substantial dilution to the Company’s stockholders. Should additional capital not be available to the Company in the near term, or not be available on acceptable terms, the Company may be unable to realize value from the Company’s assets or discharge liabilities in the normal course of business, which may, among other alternatives, cause the Company to delay, substantially reduce, or discontinue operational activities to conserve cash balances, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The accompanying financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the settlement of liabilities and commitments in the normal course of business. The financial statements do not reflect any adjustments relating to the recoverability and reclassification of assets and liabilities that might be necessary if the Company is unable to continue as a going concern. The Company believes that the $351.9 million of cash, cash equivalents and marketable securities on hand as of December 31, 2022 will be sufficient to fund its operations in the normal course of business and meet its liquidity needs through at least the next 12 months from the issuance of these financial statements.</p>
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