2021 Q4 Form 10-K Financial Statement

#000168954822000014 Filed on February 28, 2022

View on sec.gov

Income Statement

Concept 2021 Q4 2021 Q3 2021
Revenue $0.00 $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $15.15M $11.63M $47.08M
YoY Change 60.44% 239.18% 177.07%
% of Gross Profit
Research & Development $43.51M $33.14M $120.3M
YoY Change 167.43% 159.18% 167.38%
% of Gross Profit
Depreciation & Amortization $93.00K $39.00K $182.0K
YoY Change 365.0% 290.0% 264.0%
% of Gross Profit
Operating Expenses $58.66M $44.77M $167.3M
YoY Change 128.15% 176.09% 170.03%
Operating Profit -$44.77M -$167.3M
YoY Change 176.09% 170.03%
Interest Expense $70.00K $73.00K $271.0K
YoY Change 600.0% 93.57%
% of Operating Profit
Other Income/Expense, Net $73.00K $271.0K
YoY Change 7200.0% 93.57%
Pretax Income -$58.59M -$44.70M -$167.1M
YoY Change 127.88% 175.65% 170.2%
Income Tax -$5.000K $5.000K $0.00
% Of Pretax Income
Net Earnings -$58.58M -$44.71M -$167.1M
YoY Change 127.89% 175.68% 170.24%
Net Earnings / Revenue
Basic Earnings Per Share -$1.00 -$3.94
Diluted Earnings Per Share -$1.302M -$1.00 -$3.94
COMMON SHARES
Basic Shares Outstanding 44.86M shares 44.71M shares 42.45M shares
Diluted Shares Outstanding 44.71M shares 42.45M shares

Balance Sheet

Concept 2021 Q4 2021 Q3 2021
SHORT-TERM ASSETS
Cash & Short-Term Investments $244.4M $277.9M $275.9M
YoY Change -17.61% 142.05% -6.98%
Cash & Equivalents $138.7M $165.7M $138.7M
Short-Term Investments $105.7M $112.2M $137.2M
Other Short-Term Assets $11.50M $4.969M $11.50M
YoY Change 101.72% 351.73% 101.72%
Inventory
Prepaid Expenses
Receivables
Other Receivables
Total Short-Term Assets $287.4M $319.3M $287.4M
YoY Change -4.93% 175.65% -4.93%
LONG-TERM ASSETS
Property, Plant & Equipment $1.213M $625.0K $4.866M
YoY Change 1379.27% 537.76% 508.25%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $472.0K $416.0K $472.0K
YoY Change 3046.67% -79.86%
Total Long-Term Assets $5.338M $5.069M $5.338M
YoY Change 527.26% 37.11% 493.11%
TOTAL ASSETS
Total Short-Term Assets $287.4M $319.3M $287.4M
Total Long-Term Assets $5.338M $5.069M $5.338M
Total Assets $292.7M $324.4M $292.7M
YoY Change -3.44% 171.36% -3.45%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $10.78M $7.544M $10.78M
YoY Change 163.7% 118.54% 162.93%
Accrued Expenses $26.84M $16.53M $27.65M
YoY Change 146.98% 167.2% 138.4%
Deferred Revenue $0.00
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $38.43M $24.75M $38.43M
YoY Change 144.49% 138.39% 144.8%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $3.501M $3.732M $3.501M
YoY Change 1766.0%
Total Long-Term Liabilities $3.501M $3.732M $3.501M
YoY Change 1766.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $38.43M $24.75M $38.43M
Total Long-Term Liabilities $3.501M $3.732M $3.501M
Total Liabilities $41.94M $28.49M $41.94M
YoY Change 166.76% 169.19% 167.1%
SHAREHOLDERS EQUITY
Retained Earnings -$316.6M -$258.0M
YoY Change 111.71% 109.31%
Common Stock $5.000K $5.000K
YoY Change 25.0% 400.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares 0.000 shares 0.000 shares
Shareholders Equity $250.8M $295.9M $250.8M
YoY Change
Total Liabilities & Shareholders Equity $292.7M $324.4M $292.7M
YoY Change -3.44% 171.36% -3.45%

Cashflow Statement

Concept 2021 Q4 2021 Q3 2021
OPERATING ACTIVITIES
Net Income -$58.58M -$44.71M -$167.1M
YoY Change 127.89% 175.68% 170.24%
Depreciation, Depletion And Amortization $93.00K $39.00K $182.0K
YoY Change 365.0% 290.0% 264.0%
Cash From Operating Activities -$44.86M -$23.96M -$124.6M
YoY Change 121.84% 72.51% 136.69%
INVESTING ACTIVITIES
Capital Expenditures -$531.0K -$450.0K $1.050M
YoY Change
Acquisitions
YoY Change
Other Investing Activities $10.70M $14.00M -$139.5M
YoY Change
Cash From Investing Activities $10.17M $13.55M -$140.5M
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $98.41M
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 7.713M 212.0K $107.6M
YoY Change -96.18% -99.81% -64.66%
NET CHANGE
Cash From Operating Activities -44.86M -23.96M -$124.6M
Cash From Investing Activities 10.17M 13.55M -$140.5M
Cash From Financing Activities 7.713M 212.0K $107.6M
Net Change In Cash -26.98M -10.20M -$157.5M
YoY Change -114.83% -110.74% -162.55%
FREE CASH FLOW
Cash From Operating Activities -$44.86M -$23.96M -$124.6M
Capital Expenditures -$531.0K -$450.0K $1.050M
Free Cash Flow -$44.33M -$23.51M -$125.6M
YoY Change 119.22% 69.27% 138.69%

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Nature of the Business<div style="text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Praxis Precision Medicines, Inc. (“Praxis” or the “Company”) is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system, or CNS, disorders characterized by neuronal excitation-inhibition imbalance. Normal brain function requires a delicate balance of excitation and inhibition in neuronal circuits, which, when dysregulated, can lead to abnormal function and disease. The Company is applying insights from genetic epilepsies to both rare and more prevalent neurological and psychiatric disorders, using its understanding of shared biological targets and circuits in the brain. The Company applies a deliberate and pragmatic precision approach, leveraging a suite of translational tools including novel transgenic and predictive translational animal models and electrophysiology markers, to enable an efficient path to proof-of-concept in patients. Through this approach, the Company has established a broad CNS portfolio with multiple programs, including product candidates across psychiatric disorders, movement disorders, epilepsy and other exploratory CNS indications, with three clinical-stage product candidates. Each of the Company's clinical-stage product candidates is advancing in more than one indication and the Company anticipates expansion into additional indications. The Company expects multiple topline readouts from its clinical-stage programs and anticipates the launch of a fourth clinical development program in 2022. In addition, the Company has established a robust pipeline of preclinical stage programs through internal research and in-licensing.</span></div><div style="text-indent:24.75pt"><span><br/></span></div><div style="text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company's broad portfolio of CNS programs is currently structured by therapeutic focus in three primary franchises – Psychiatry, Movement Disorders and Epilepsy. In addition, the Company is pursuing development in other exploratory CNS indications such as rare adult cephalgias. Within the Psychiatry franchise, the Company's most advanced clinical candidate, PRAX-114, is being developed for the treatment of a broad range of patients suffering from major depressive disorder and post-traumatic stress disorder, or PTSD. In addition, the Company has initiated a Phase 2, placebo-controlled study evaluating PRAX-114 for the treatment of PTSD. Within the Movement Disorders franchise, the Company's second clinical candidate, PRAX-944, is being developed for the treatment of Essential Tremor, or ET, and Parkinson's Disease, or PD. The Company has initiated a Phase 2b placebo-controlled dose-range finding trial, the Essential1 Study, to evaluate the tolerability, safety and efficacy of PRAX-944 in adults with ET. The Company also expects to initiate a Phase 2, placebo-controlled, crossover study to evaluate the safety, pharmacokinetics, or PK, and efficacy of daytime dosing of PRAX-114 for the treatment of ET in the first quarter of 2022. The Company expects to initiate a Phase 2, placebo-controlled trial to evaluate the safety, PK and efficacy of PRAX-944 as a non-dopaminergic treatment for the motor symptoms of PD in the second quarter of 2022. Within the Epilepsy franchise, the Company expects to initiate a Phase 2 study with its third clinical-stage candidate, PRAX-562, in the second quarter of 2022 in patients with rare pediatric Developmental and Epileptic Encephalopathies. The Company's most advanced preclinical stage product candidate within its Epilepsy franchise, PRAX-222, is an antisense oligonucleotide, or ASO, designed to decrease the expression levels of the protein encoded by the gene SCN2A in patients with gain-of-function SCN2A mutations.</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company expects to initiate a seamless study of PRAX-222 in the second quarter of 2022, which would be its fourth program to reach clinical stage. The Company also expects to initiate a Phase 2 proof-of-concept clinical trial evaluating PRAX-562 in patients with rare adult cephalgias in the first quarter of 2022. In addition, the Company's preclinical pipeline consists of a discovery program in development for KCNT1 related epilepsy, PRAX-628, a product candidate nominated in the fourth quarter of 2021 for focal epilepsy, three ASOs targeting SCN2A in patients with loss-of-function mutations, PCDH19 and SYNGAP1, respectively, and three additional discovery programs for undisclosed targets in psychiatry, movement disorders and epilepsy. </span></div><div style="margin-top:12pt;text-indent:22.5pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Praxis was incorporated in 2015 and commenced operations in 2016. The Company has funded its operations primarily with proceeds from the issuance of redeemable convertible preferred stock, and from the sale of common stock through an initial public offering ("IPO"), a follow-on public offering and at-the-market offerings under its shelf registration statement. From inception through December 31, 2021, the Company raised $516.4 million in aggregate cash proceeds from these transactions, net of issuance costs.</span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including but not limited to, risks associated with completing preclinical studies and clinical trials, receiving regulatory approvals for product candidates, development by competitors of new biopharmaceutical products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and </span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">the ability to secure additional capital to fund operations. Programs currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance-reporting capabilities. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize revenue from product sales.</span></div><div style="margin-top:12pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Liquidity</span></div><div style="margin-top:4pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">In accordance with the Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2014-15, </span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40)</span><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements are issued.</span></div><div style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company has incurred recurring losses since its inception, including a net loss of $167.1 million for the year ended December 31, 2021. In addition, as of December 31, 2021, the Company had an accumulated deficit of $316.6 million. The Company expects to continue to generate operating losses for the foreseeable future. </span></div>The Company expects that its cash, cash equivalents and marketable securities as of December 31, 2021 of $275.9 million will be sufficient to fund the operating expenditures and capital expenditure requirements necessary to advance its research efforts and clinical trials for at least one year from the date of issuance of these consolidated financial statements. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations. The Company's inability to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. There can be no assurance that the current operating plan will be achieved or that additional funding will be available on terms acceptable to the Company, or at all.
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<div style="margin-top:12pt"><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-top:4pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, accrued and prepaid research and development expenses, stock-based compensation expense and the recoverability of the Company’s net deferred tax assets and related valuation allowance. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ materially from those estimates.</span></div>
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<div style="margin-top:12pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Concentrations of Credit Risk and Significant Suppliers and License Agreements</span></div><div style="margin-top:4pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',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 cash, cash equivalents, restricted cash and marketable securities. The Company's investment portfolio comprises money market funds, marketable debt securities, including debt securities issued by U.S. government agencies and </span></div><div style="margin-top:4pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">corporations, and commercial paper. The Company investments are limited to investment-grade securities with strong credit ratings with the objective of maintaining safety and liquidity. The Company also maintains deposits in accredited financial institutions in excess of federally insured limits. Bank accounts in the United States are insured by the Federal Deposit Insurance Corporation (the “FDIC”) up to $250,000. As of December 31, 2021 and 2020, the Company’s primary operating accounts significantly exceeded the FDIC 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 style="margin-top:12pt;text-indent:24.75pt"><span style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company is dependent on third-party manufacturers to supply materials for research and development activities of its programs, including preclinical and clinical testing. In particular, the Company relies, and expects to continue to rely, on a small number of third-party manufacturers to produce and process its current and potential product candidates and to manufacture supply of its current and potential product candidates for preclinical and clinical activities. These programs could be adversely affected by a significant interruption in the supply of the necessary materials. The Company is also dependent on third parties who provide license rights used in the development of certain programs. The Company could experience delays in the development of its programs if any of these license agreements are terminated, if the Company fails to meet the obligations required under its arrangements, or if the Company is unable to successfully secure new strategic alliances or licensing agreements.</span></div>
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