2021 Q4 Form 10-K Financial Statement

#000159929822000032 Filed on March 17, 2022

View on sec.gov

Income Statement

Concept 2021 Q4 2021 2020 Q4
Revenue $251.0K $1.809M $185.0K
YoY Change 35.68% 110.35% 54.17%
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $7.780M $23.61M $5.802M
YoY Change 34.09% 22.77% 32.77%
% of Gross Profit
Research & Development $23.11M $85.35M $12.30M
YoY Change 87.86% 60.21% 70.36%
% of Gross Profit
Depreciation & Amortization $328.0K $330.0K $458.0K
YoY Change -28.38% 9.27% 27.22%
% of Gross Profit
Operating Expenses $26.30M $109.0M $13.73M
YoY Change 91.48% 48.52% 75.63%
Operating Profit -$86.19M
YoY Change 62.03%
Interest Expense -$2.216M $281.0K $54.00K
YoY Change -4203.7% 10.2% -190.0%
% of Operating Profit
Other Income/Expense, Net $1.164M -$2.416M -$67.00K
YoY Change -1837.31% -953.71%
Pretax Income -$27.10M -$88.60M -$13.56M
YoY Change 99.82% 67.46% 74.77%
Income Tax $0.00 $0.00 -$120.0K
% Of Pretax Income
Net Earnings -$27.10M -$88.60M -$13.44M
YoY Change 101.6% 68.13% 91.21%
Net Earnings / Revenue -10796.41% -4897.84% -7265.95%
Basic Earnings Per Share -$0.96
Diluted Earnings Per Share -$276.9K -$0.96 -$175.9K
COMMON SHARES
Basic Shares Outstanding 97.71M shares 92.24M shares 82.26M shares
Diluted Shares Outstanding 92.24M shares

Balance Sheet

Concept 2021 Q4 2021 2020 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $71.79M $71.79M $66.42M
YoY Change 8.09% 8.09% 388.36%
Cash & Equivalents $71.79M $71.79M $66.42M
Short-Term Investments
Other Short-Term Assets $1.201M $8.362M $1.523M
YoY Change -21.14% -24.46% 8.86%
Inventory
Prepaid Expenses $7.161M $9.547M
Receivables $1.464M $1.464M $331.0K
Other Receivables $15.69M $15.69M $9.856M
Total Short-Term Assets $97.31M $97.31M $87.67M
YoY Change 10.99% 10.99% 10.1%
LONG-TERM ASSETS
Property, Plant & Equipment $694.0K $3.484M $725.0K
YoY Change -4.28% 172.4% 39.96%
Goodwill $2.009M $2.030M
YoY Change -1.03% 3.52%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $170.0K $170.0K $0.00
YoY Change
Total Long-Term Assets $16.06M $16.06M $14.82M
YoY Change 8.35% 8.35% -10.81%
TOTAL ASSETS
Total Short-Term Assets $97.31M $97.31M $87.67M
Total Long-Term Assets $16.06M $16.06M $14.82M
Total Assets $113.4M $113.4M $102.5M
YoY Change 10.61% 10.61% 6.49%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.374M $4.374M $6.140M
YoY Change -28.76% -28.76% 37.33%
Accrued Expenses $7.197M $12.41M $3.278M
YoY Change 119.55% 166.89% -42.88%
Deferred Revenue $7.939M $8.370M
YoY Change -5.15% 220.08%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $25.62M $25.62M $19.89M
YoY Change 28.82% 28.82% 44.48%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change -100.0%
Other Long-Term Liabilities $2.776M $4.467M $2.511M
YoY Change 10.55% 41.58% -7.1%
Total Long-Term Liabilities $2.776M $4.467M $2.511M
YoY Change 10.55% 41.58% -7.1%
TOTAL LIABILITIES
Total Short-Term Liabilities $25.62M $25.62M $19.89M
Total Long-Term Liabilities $2.776M $4.467M $2.511M
Total Liabilities $30.09M $30.09M $23.05M
YoY Change 30.57% 30.57% 32.56%
SHAREHOLDERS EQUITY
Retained Earnings -$299.5M -$210.9M
YoY Change 42.0% 33.3%
Common Stock $980.0K $826.0K
YoY Change 18.64% 22.92%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $83.28M $83.28M $79.45M
YoY Change
Total Liabilities & Shareholders Equity $113.4M $113.4M $102.5M
YoY Change 10.61% 10.61% 6.49%

Cashflow Statement

Concept 2021 Q4 2021 2020 Q4
OPERATING ACTIVITIES
Net Income -$27.10M -$88.60M -$13.44M
YoY Change 101.6% 68.13% 91.21%
Depreciation, Depletion And Amortization $328.0K $330.0K $458.0K
YoY Change -28.38% 9.27% 27.22%
Cash From Operating Activities -$9.179M -$72.59M -$7.971M
YoY Change 15.15% 50.87% 26.93%
INVESTING ACTIVITIES
Capital Expenditures -$120.0K $306.0K -$50.00K
YoY Change 140.0% -27.32% 400.0%
Acquisitions
YoY Change
Other Investing Activities $0.00
YoY Change
Cash From Investing Activities -$120.0K -$306.0K -$50.00K
YoY Change 140.0% -27.32% 400.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $75.00M
YoY Change 50.0%
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 1.261M $77.92M 50.55M
YoY Change -97.51% 54.13% -56264.44%
NET CHANGE
Cash From Operating Activities -9.179M -$72.59M -7.971M
Cash From Investing Activities -120.0K -$306.0K -50.00K
Cash From Financing Activities 1.261M $77.92M 50.55M
Net Change In Cash -8.038M $5.374M 42.53M
YoY Change -118.9% 108.7% -766.57%
FREE CASH FLOW
Cash From Operating Activities -$9.179M -$72.59M -$7.971M
Capital Expenditures -$120.0K $306.0K -$50.00K
Free Cash Flow -$9.059M -$72.89M -$7.921M
YoY Change 14.37% 50.2% 26.33%

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CY2021 us-gaap Nature Of Operations
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Nature of Business and Operations and Recent Events<div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;text-decoration:underline">Nature of Business and Operations</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company is a biopharmaceutical company focused on the discovery, development, and commercialization of patient-, physician-, caregiver- and societal-friendly medicinal therapies intended to improve quality of life, increase life expectancy, and resolve serious unmet needs. The Company's novel mechanism pipeline of product candidates is designed with the goal to become the patient-friendly, new-era standard-of-care medicines, and to work in harmony with the human microbiome. Currently, the Company's lead product candidate, ridinilazole, is a novel first-in-class drug that is engaged in a global Phase III clinical trial program. On December 20, 2021, the Company announced topline results for the Phase III Ri-CoDIFy study evaluating ridinilazole for treating patients suffering from </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:112%">Clostridioides difficile </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">infection, also known as </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:112%">C. difficile </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">infection, or CDI. The Company's second product candidate, SMT-738, was announced in May 2021 for combating multidrug resistant infections, specifically Carbapenem-resistant Enterobacteriaceae (“CRE”) infections. SMT-738 is the first of a novel class of precision antibiotics that has entered into preclinical development. The Company intends to expand its portfolio by developing further new mechanism, new era product offerings that are designed to work in harmony with the human gut microbiome in the therapeutic areas of oncology and infectious diseases. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On September 18, 2020, Summit Therapeutics Inc. ("Summit"), a Delaware corporation, became the successor issuer to Summit Therapeutics plc, a public limited company incorporated under the laws of England and Wales with the Registrar of Companies of England and Wales, United Kingdom ("U.K."), for certain purposes under both the Securities Act of 1933, as amended, and the Securities Exchange Act of 1934, as amended, or the Exchange Act. Such succession occurred pursuant to a statutory scheme of arrangement under U.K. law pursuant to which all Summit Therapeutics plc outstanding ordinary shares were exchanged on a five-for-one basis for newly issued shares of Summit common stock and Summit became the holding company of Summit Therapeutics plc (the predecessor registrant and former holding company) and its subsidiaries (which is referred to as the "Redomiciliation Transaction"). Concurrently, Summit Therapeutics plc was converted into a private limited company under the laws of England and Wales and renamed Summit Therapeutics Limited. In addition, the warrants and stock options to purchase shares of Summit Therapeutics plc were canceled and replacement warrants and stock options to purchase common stock in Summit Therapeutics Inc. were issued. The scheme of arrangement was accounted for as an exchange of equity interests among entities under common control. All assets and liabilities of Summit Therapeutics plc were assumed by Summit, resulting in the retention of the historical basis of accounting as if they had always been combined for accounting purposes and the historical consolidated financial statements of Summit Therapeutics plc became the historical consolidated financial statements of Summit Therapeutics Inc. All share and per share data for periods prior to the Redomiciliation Transaction in the financial statements were retroactively reflected to be presented as shares of the Company's common stock, par value $0.01 per share.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;text-decoration:underline">Recent Events</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On May 12, 2021, the Company closed its rights offering, which was fully subscribed. The Company received aggregate gross proceeds from the rights offering of $75,000 from the sale of 14,312,976 shares of its common stock at a price per share of $5.24. Issuance costs associated with the rights offering were immaterial. In connection with the closing of the rights offering, a promissory note, dated April 20, 2021, was issued by the Company in favor of the Company's Chairman, Chief Executive Officer, and the beneficial owner of approximately 70% of its outstanding common stock prior to this rights offering, Robert W. Duggan, in the principal amount of $55,000, matured and became due and the Company repaid all principal and accrued interest thereunder using a portion of the proceeds from the rights offering. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On August 11, 2021, based on a thorough review of the design and enrollment status of its two ongoing blinded Phase III Ri-CoDIFy trials, the Company announced that it combined its two blinded pivotal Phase III clinical trials evaluating ridinilazole versus vancomycin into a single study and presented this decision to the United States ("U.S.") Food and Drug Administration (the "FDA") as such. During September 2021, the Company received feedback from the FDA that the FDA did not agree with the change to the primary endpoint that the Company proposed and subsequently implemented in its ongoing Phase III Ri-CoDIFy studies when combining the trials. </span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On December 20, 2021, the Company announced topline results for the Phase III Ri-CoDIFy study evaluating ridinilazole, for the treatment of and Sustained Clinical Response (“SCR”), as defined below, for patients suffering from </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">C. difficile</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> infection ("</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">C. diff.</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> infection" or "CDI"). The study showed that ridinilazole resulted in a numerically higher SCR rate than vancomycin, but did not meet the study’s primary endpoint for superiority. The pivotal Phase III clinical trial consisted of two Phase III clinical trials combined into a single study, designed to assess, as the primary endpoint, the superiority of ridinilazole compared to vancomycin in SCR, which is defined as clinical response of the treated episode of CDI and no recurrence of CDI through 30 days after the end of treatment. Additional endpoints included safety, tolerability, analyses of the gut microbiome and metabolome, in addition to quality of life and health economic outcome measures. We are in the process of evaluating the future path forward with respect to ridinilazole, including potential partnership opportunities.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">On March 10, 2022, the Company’s Chief Executive Officer, Robert W. Duggan, entered into a Note Purchase Agreement (the “2022 Note”), pursuant to which he has loaned the Company $25,000 in exchange for the issuance by the Company of an unsecured promissory note in the amount of $25,000. The 2022 Note is to accrue interest at a rate per annum equal to the prime rate as reported in the </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Wall Street Journal</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, which is 3.25% as of the effective date. The 2022 Note becomes due upon the earlier of (i) the consummation of a registered public offering with net proceeds of no less than $25,000 or (ii) 18 months from the date of issuance of the 2022 Note.</span></div>
CY2021Q4 us-gaap Common Stock Par Or Stated Value Per Share
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CY2021 us-gaap Basis Of Accounting
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Basis of Presentation and Use of Estimates <div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The consolidated financial statements include the accounts of Summit Therapeutics Inc. and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("U.S. GAAP") and pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to revenue recognition, accrued research and development expenses, stock-based compensation, intangible assets, goodwill, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The progression of the COVID-19 pandemic continues to evolve and its enduring impact on the Company's business remains uncertain. Management believes the estimates and assumptions underlying its financial statements are reasonable and supportable based on the information available as of December 31, 2021, however, the extent to which the COVID-19 pandemic impacts the Company's financial results beyond December 31, 2021 will depend on future developments that are highly uncertain and cannot be predicted at this time.</span></div>
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The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an on-going basis, management evaluates its estimates and judgments, including those related to revenue recognition, accrued research and development expenses, stock-based compensation, intangible assets, goodwill, other long-lived assets and income taxes. Management bases its estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.<div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Use of Estimates</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of the consolidated financial statements in conformity with U.S. GAAP requires the use of estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.</span></div>
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<div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Concentration of Credit Risk and of Significant Supplier</span></div><div><span><br/></span></div><div><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of short-term cash deposits and accounts and other receivables. The Company's cash is comprised of short-term cash deposits at a variety of financial institutions with strong credit ratings in amounts that may exceed federally insured limits and has not experienced any losses on such accounts. Cash balances maintained during the year have been principally held with reputable U.K.-based and U.S.-based banks. The Company does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.</span></div><div><span><br/></span></div><div><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company maintains deposits in accredited financial institutions in excess of federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality and has not experienced any losses on such accounts and does not believe it is exposed to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The credit risk with respect to customers and funding bodies is limited as the Company has only a small number of these arrangements, including with Eurofarma, BARDA and CARB-X. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company relies, and expects to continue to rely, on a number of vendors to conduct its clinical trials and preclinical studies, manufacture drug product and supply clinical trial and preclinical study materials for its development programs. These programs could be adversely affected by a significant interruption in these services or the availability of materials.</span></div>
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CY2021Q4 us-gaap Class Of Warrant Or Right Outstanding
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CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Number
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CY2021Q4 us-gaap Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Intrinsic Value
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712000 USD
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P2Y2M12D
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1 shares
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17046000 USD
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P1Y

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