2022 Q4 Form 10-Q Financial Statement

#000155837022017592 Filed on November 14, 2022

View on sec.gov

Income Statement

Concept 2022 Q4 2022 Q3 2021 Q3
Revenue $238.0K $137.0K
YoY Change
Cost Of Revenue $9.000K $11.00K
YoY Change
Gross Profit $229.0K $126.0K
YoY Change
Gross Profit Margin 96.22% 91.97%
Selling, General & Admin $20.66M $17.05M $14.88M
YoY Change 51.87% 14.62% 76.08%
% of Gross Profit 9023.58% 13534.92%
Research & Development $32.46M $22.06M $11.93M
YoY Change 159.15% 84.88% -26.87%
% of Gross Profit 14174.24% 17509.52%
Depreciation & Amortization $81.00K $85.00K $76.00K
YoY Change 6.58% 11.84% 61.7%
% of Gross Profit 35.37% 67.46%
Operating Expenses $53.12M $39.12M $26.81M
YoY Change 103.29% 45.89% 8.25%
Operating Profit -$52.89M -$38.99M -$26.81M
YoY Change 45.42% 8.25%
Interest Expense -$1.434M $3.700M $11.00K
YoY Change -24000.0% 33536.36% 120.0%
% of Operating Profit
Other Income/Expense, Net -$480.0K $62.00K
YoY Change
Pretax Income -$54.81M -$41.81M -$26.81M
YoY Change 109.79% 55.92% 8.33%
Income Tax
% Of Pretax Income
Net Earnings -$54.81M -$41.81M -$26.81M
YoY Change 109.79% 55.92% 8.31%
Net Earnings / Revenue -23028.57% -30514.6%
Basic Earnings Per Share -$1.49 -$0.96
Diluted Earnings Per Share -$1.95 -$1.49 -$958.5K
COMMON SHARES
Basic Shares Outstanding 28.02M 28.02M 27.97M
Diluted Shares Outstanding 28.02M 27.97M

Balance Sheet

Concept 2022 Q4 2022 Q3 2021 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $193.7M $232.3M $252.9M
YoY Change -16.84% -8.14% 8.36%
Cash & Equivalents $193.7M $232.3M $252.9M
Short-Term Investments
Other Short-Term Assets $3.843M $2.430M $4.017M
YoY Change 301.99% -39.51% 48.78%
Inventory $1.985M $1.408M
Prepaid Expenses
Receivables $248.0K
Other Receivables $0.00
Total Short-Term Assets $202.9M $241.7M $256.9M
YoY Change -14.33% -5.94% 8.82%
LONG-TERM ASSETS
Property, Plant & Equipment $1.084M $1.187M $1.336M
YoY Change -16.23% -11.15% -46.56%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $925.0K $925.0K $1.755M
YoY Change 975.58% -47.29% 1655.0%
Total Long-Term Assets $2.985M $3.157M $4.403M
YoY Change 13.63% -28.3% 69.35%
TOTAL ASSETS
Total Short-Term Assets $202.9M $241.7M $256.9M
Total Long-Term Assets $2.985M $3.157M $4.403M
Total Assets $205.9M $244.8M $261.3M
YoY Change -14.03% -6.32% 9.48%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $10.23M $5.872M $3.439M
YoY Change 118.64% 70.75% -60.01%
Accrued Expenses $18.67M $13.95M $10.72M
YoY Change 62.45% 30.17% 50.93%
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 $32.90M $23.38M $14.60M
YoY Change 97.38% 60.17% -10.45%
LONG-TERM LIABILITIES
Long-Term Debt $93.05M $91.70M $0.00
YoY Change
Other Long-Term Liabilities $3.129M $2.759M $1.180M
YoY Change 183.17% 133.81% -21.33%
Total Long-Term Liabilities $93.05M $91.70M $1.180M
YoY Change 8320.9% 7670.76% -21.33%
TOTAL LIABILITIES
Total Short-Term Liabilities $32.90M $23.38M $14.60M
Total Long-Term Liabilities $93.05M $91.70M $1.180M
Total Liabilities $129.1M $117.8M $15.78M
YoY Change 626.3% 646.91% -11.37%
SHAREHOLDERS EQUITY
Retained Earnings -$411.5M -$356.7M -$219.7M
YoY Change 67.44% 62.4%
Common Stock $28.00K $28.00K $28.00K
YoY Change 0.0% 0.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $76.78M $127.0M $245.6M
YoY Change
Total Liabilities & Shareholders Equity $205.9M $244.8M $261.3M
YoY Change -14.03% -6.32% 9.48%

Cashflow Statement

Concept 2022 Q4 2022 Q3 2021 Q3
OPERATING ACTIVITIES
Net Income -$54.81M -$41.81M -$26.81M
YoY Change 109.79% 55.92% 8.31%
Depreciation, Depletion And Amortization $81.00K $85.00K $76.00K
YoY Change 6.58% 11.84% 61.7%
Cash From Operating Activities -$38.64M -$31.19M -$20.20M
YoY Change 93.85% 54.39% 5.75%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 -$17.00K
YoY Change -100.0% -100.0%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 $0.00 -$17.00K
YoY Change -100.0% -100.0%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 50.00K 30.05M 71.00K
YoY Change 42221.13% -99.96%
NET CHANGE
Cash From Operating Activities -38.64M -31.19M -20.20M
Cash From Investing Activities 0.000 0.000 -17.00K
Cash From Financing Activities 50.00K 30.05M 71.00K
Net Change In Cash -38.59M -1.138M -20.14M
YoY Change 93.49% -94.35% -112.0%
FREE CASH FLOW
Cash From Operating Activities -$38.64M -$31.19M -$20.20M
Capital Expenditures $0.00 $0.00 -$17.00K
Free Cash Flow -$38.64M -$31.19M -$20.18M
YoY Change 93.97% 54.52% 5.66%

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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. Nature of the Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">BioXcel Therapeutics, Inc. (“BTI”) is a biopharmaceutical company focused on drug development that utilizes artificial intelligence (“AI”) to identify improved therapies in neuroscience and immuno-oncology. BTI's drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI's two most advanced clinical development programs are BXCL501, a proprietary, orally dissolving, thin film formulation of the adrenergic receptor agonist dexmedetomidine (“Dex”), for the treatment of agitation, and BXCL701, an orally administered, systemic innate immune activator for the treatment of a rare form of prostate cancer and advanced solid tumors that are refractory or treatment naïve to checkpoint inhibitors.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">As used in these condensed consolidated financial statements, unless otherwise specified or the context otherwise requires, the terms the “Company” or “BTI” refer to BioXcel Therapeutics, Inc., and “BioXcel LLC” refers to the Company’s former parent and current significant stockholder, BioXcel LLC and, its predecessor, BioXcel Corporation. OnkosXcel refers to BTI’s wholly-owned subsidiary for its advanced immuno-oncology assets, OnkosXcel Therapeutics, LLC.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company was incorporated under the laws of the State of Delaware on March 29, 2017. The Company’s principal office is in New Haven, Connecticut.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><span style="font-style:italic;font-weight:bold;">Impact of COVID-19 Pandemic</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">During the first quarter ended March 31, 2020, the novel coronavirus disease (“COVID-19”) was declared a pandemic and spread to multiple regions across the globe, including the U.S. and Europe. The outbreak and government response measures have significantly impacted, both directly and indirectly, businesses and commerce, as worker shortages have occurred; supply chains have been disrupted; facilities and production have been suspended; and demand for certain goods and services spiked, while demand for other goods and services have decreased.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company continues to work closely with its clinical sites to monitor the potential impact of the evolving COVID-19 pandemic and the spread of its variants. BTI remains committed to its clinical programs and development plans. To date, BTI has not experienced any significant delays in any of its ongoing or planned clinical trials, except for occasional COVID-19-related disruptions to its TRANQUILITY II trial. However, this could rapidly change.</p>
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;"><span style="font-style:italic;">Use of Estimates</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-style:italic;font-weight:bold;text-indent:18pt;margin:0pt 0pt 12pt 0pt;"><span style="font-style:normal;font-weight:normal;">The preparation of financial statements in accordance with GAAP requires management to make estimates and assumptions that affect amounts reported in the condensed consolidated financial statements and notes thereto. Although these estimates are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates.</span></p>
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us-gaap Concentration Risk Credit Risk
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 12pt 0pt;"><span style="font-style:italic;">Concentrations of Credit Risk</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-indent:18pt;margin:0pt 0pt 12pt 0pt;"><span style="font-weight:normal;">The Company sells IGALMI</span><sup style="font-size:7.5pt;font-weight:normal;line-height:100%;top:0pt;vertical-align:top;">TM</sup><span style="font-weight:normal;"> through a drop-ship program under which orders from hospitals and similar healthcare institutions are processed through wholesalers, but shipments of the product are sent directly to the individual hospitals and similar healthcare institutions. BTI also contracts directly with intermediaries such as group purchasing organizations (“GPOs”).</span></p>
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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><span style="font-style:italic;font-weight:bold;">Revenue Recognition</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company’s revenues consist of product sales of IGALMI<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM</sup>.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">Under ASC 606, <i style="font-style:italic;">Revenue from Contracts with Customers</i> (“ASC 606”), an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including variable consideration, if any; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the customer and if so, they are considered performance obligations. The exercise of a material right may be accounted for as a contract modification or as a continuation of the contract for accounting purposes.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">For contracts determined to be within the scope of ASC 606, the Company assesses whether the goods or services promised within each contract are distinct to identify those that are performance obligations. This assessment involves subjective determinations and requires management to make judgments about the individual promised goods or services and whether such goods and services are separable from the other aspects of the contractual relationship. Promised goods and services are considered distinct provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and (ii) the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company allocates the transaction price (the amount of consideration it expects to be entitled to from a customer in exchange for the promised goods or services) to each performance obligation and recognizes the associated revenue when (or as) each performance obligation is satisfied. The Company’s estimate of the transaction price for each contract includes all variable consideration to which the Company expects to be entitled.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">BTI distributes IGALMI<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM</sup> in the U.S. through arrangements with a distributor, wholesalers and GPOs. The distributor and wholesalers help process and fulfill orders from hospitals on the Company’s behalf. Based on the guidance in ASC 606, the Company believes the hospitals are its customers.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company recognizes product revenues, net of consideration payable to customers, as well as variable consideration related to certain allowances and accruals that are determined using either the expected value or most likely amount method, depending on the type of the variable consideration, in its condensed consolidated financial statements at the point in time when control transfers to the customer, which is typically when the product has been delivered to the customer’s location. The amount included in the transaction price is constrained to the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. The Company’s only performance obligation identified for IGALMI<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM</sup> is to deliver the quantity of product ordered to the location specified by the customer’s order. The Company records shipping and handling costs associated with delivery of product to its customers within selling, general and administrative expenses on its Condensed Consolidated Statements of Operations. Under the Company’s current product sales arrangements, BTI does not have contract assets (unbilled receivables), as it generally invoices its customer at the time of revenue recognition, and contract liabilities, as the Company generally does not receive prepayments from its customers prior to product delivery.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt;">BTI sells IGALMI<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM</sup> at wholesale acquisition cost and calculate product revenue net of variable consideration and consideration payable to third parties associated with distribution of product. The Company records reserves, based on contractual terms, for the following components of consideration related to product sold during the reporting period. Calculating these amounts involves estimates and judgments, and the Company reviews these estimates quarterly and </p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;margin:0pt 0pt 12pt 0pt;">records any material adjustments in the period they are identified, which affects net product revenue and earnings in the period such variances occur.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><i style="font-style:italic;">Trade Discounts and Allowances</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company provides the distributor and wholesalers with discounts for prompt payment and pays fees to the distributor, wholesalers and GPOs related to distribution of the product. BTI expects the relevant third parties to earn these discounts and fees, and therefore it deducts such amounts from gross product revenue and accounts receivable at the time it recognizes the related revenue.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><i style="font-style:italic;">Government Rebates</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">IGALMI<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">TM</sup> is eligible for purchase by, or qualifies for reimbursement from, Medicaid and other U.S. government programs that are eligible for rebates on the price they pay for the product. To determine the appropriate amount to reserve for these rebates, BTI applies the applicable government discount to these sales, and estimates the portion of total rebates that it anticipates will be claimed. The Company deducts certain government rebates from gross product revenue and accounts receivable at the time it recognizes the related revenue; other government rebates are recognized as an accrued liability at the time BTI recognizes the related revenue.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><i style="font-style:italic;">Chargebacks</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">BTI provides product discounts to hospitals associated with certain GPOs. The Company estimates the chargebacks that it expects to be obligated to provide based upon the terms of the applicable arrangements. BTI deducts such amounts from gross product revenue and accounts receivable at the time it recognizes the related revenue.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 12pt 0pt;"><i style="font-style:italic;">Product Returns</i></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">The Company provides contractual return rights to its customers including the right to return product within six months of product expiration and up to 12 months after product expiration, as well as for incorrect shipments, and damaged or defective product, which the Company expects to be rare. Management expects product returns to be minimal, thus BTI recognizes a nominal allowance for product returns at the time of each sale. In the future, if any of these factors and/or the history of product returns changes, the Company will adjust the allowance for product returns.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 12pt 0pt;">BTI classifies all fees paid to the distributor, other than those discussed above and those related to warehouse operations, as selling, general and administrative expenses on its Condensed Consolidated Statements of Operations. Fees paid to the distributor for warehouse operations are classified as costs of goods sold on BTI’s Condensed Consolidated Statements of Operations.</p>
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