$BTAI
BioXcel Therapeutics, Inc.

2023 Q1 Form 10-K Financial Statement

#000155837023003940 Filed on March 16, 2023

View on sec.gov

Income Statement

Concept 2023 Q1 2022 Q4 2022
Revenue $206.0K $238.0K $375.0K
YoY Change
Cost Of Revenue $9.000K $9.000K $20.00K
YoY Change
Gross Profit $197.0K $229.0K $355.0K
YoY Change
Gross Profit Margin 95.63% 96.22% 94.67%
Selling, General & Admin $23.60M $20.66M $68.76M
YoY Change 82.61% 51.87% 26.8%
% of Gross Profit 11977.16% 9023.58% 19369.3%
Research & Development $27.80M $32.46M $91.24M
YoY Change 49.79% 159.15% 73.1%
% of Gross Profit 14111.68% 14174.24% 25701.13%
Depreciation & Amortization $80.00K $81.00K $327.0K
YoY Change 3.9% 6.58% 10.1%
% of Gross Profit 40.61% 35.37% 92.11%
Operating Expenses $51.40M $53.12M $160.0M
YoY Change 63.26% 103.29% 49.62%
Operating Profit -$51.20M -$52.89M -$159.6M
YoY Change 62.64% 49.29%
Interest Expense $3.367M -$1.434M $8.213M
YoY Change 48000.0% -24000.0% 20432.5%
% of Operating Profit
Other Income/Expense, Net -$246.0K -$480.0K -$427.0K
YoY Change
Pretax Income -$52.80M -$54.81M -$165.8M
YoY Change 67.76% 109.79% 55.01%
Income Tax
% Of Pretax Income
Net Earnings -$52.80M -$54.81M -$165.8M
YoY Change 67.76% 109.79% 55.01%
Net Earnings / Revenue -25629.13% -23028.57% -44201.87%
Basic Earnings Per Share -$1.84 -$5.92
Diluted Earnings Per Share -$1.84 -$1.95 -$5.92
COMMON SHARES
Basic Shares Outstanding 29.01M 28.02M 28.02M
Diluted Shares Outstanding 28.62K 28.02M

Balance Sheet

Concept 2023 Q1 2022 Q4 2022
SHORT-TERM ASSETS
Cash & Short-Term Investments $165.5M $193.7M $193.7M
YoY Change -17.42% -16.84% -16.84%
Cash & Equivalents $165.5M $193.7M $193.7M
Short-Term Investments
Other Short-Term Assets $5.006M $3.843M $6.910M
YoY Change 238.7% 301.99% 79.76%
Inventory $1.952M $1.985M $1.985M
Prepaid Expenses
Receivables $283.0K $248.0K $248.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $177.3M $202.9M $202.9M
YoY Change -14.6% -14.33% -14.33%
LONG-TERM ASSETS
Property, Plant & Equipment $1.004M $1.084M $2.060M
YoY Change -24.91% -16.23% -18.93%
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $925.0K $925.0K $925.0K
YoY Change -4.15% 975.58% 975.58%
Total Long-Term Assets $2.835M $2.985M $2.985M
YoY Change -18.6% 13.63% 13.63%
TOTAL ASSETS
Total Short-Term Assets $177.3M $202.9M $202.9M
Total Long-Term Assets $2.835M $2.985M $2.985M
Total Assets $180.1M $205.9M $205.9M
YoY Change -14.66% -14.03% -14.03%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $7.742M $10.23M $10.23M
YoY Change 52.85% 118.64% 118.64%
Accrued Expenses $17.07M $18.67M $22.08M
YoY Change 61.34% 62.45% 92.29%
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 $28.76M $32.90M $32.90M
YoY Change 79.78% 97.38% 97.38%
LONG-TERM LIABILITIES
Long-Term Debt $95.06M $93.05M $93.05M
YoY Change
Other Long-Term Liabilities $3.277M $3.129M $3.129M
YoY Change 218.77% 183.17% 183.17%
Total Long-Term Liabilities $95.06M $93.05M $96.18M
YoY Change 9147.28% 8320.9% 8604.07%
TOTAL LIABILITIES
Total Short-Term Liabilities $28.76M $32.90M $32.90M
Total Long-Term Liabilities $95.06M $93.05M $96.18M
Total Liabilities $127.1M $129.1M $129.1M
YoY Change 646.54% 626.3% 626.3%
SHAREHOLDERS EQUITY
Retained Earnings -$464.3M -$411.5M
YoY Change 67.47% 67.44%
Common Stock $29.00K $28.00K
YoY Change 3.57% 0.0%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $53.01M $76.78M $76.78M
YoY Change
Total Liabilities & Shareholders Equity $180.1M $205.9M $205.9M
YoY Change -14.66% -14.03% -14.03%

Cashflow Statement

Concept 2023 Q1 2022 Q4 2022
OPERATING ACTIVITIES
Net Income -$52.80M -$54.81M -$165.8M
YoY Change 67.76% 109.79% 55.01%
Depreciation, Depletion And Amortization $80.00K $81.00K $327.0K
YoY Change 3.9% 6.58% 10.1%
Cash From Operating Activities -$52.35M -$38.64M -$135.3M
YoY Change 61.52% 93.85% 64.74%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $139.0K
YoY Change -100.0% -100.0% -68.76%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 $0.00 -$139.0K
YoY Change -100.0% -100.0% -68.76%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 24.15M 50.00K 96.24M
YoY Change -6.06%
NET CHANGE
Cash From Operating Activities -52.35M -38.64M -135.3M
Cash From Investing Activities 0.000 0.000 -139.0K
Cash From Financing Activities 24.15M 50.00K 96.24M
Net Change In Cash -28.20M -38.59M -39.24M
YoY Change -13.31% 93.49% -297.71%
FREE CASH FLOW
Cash From Operating Activities -$52.35M -$38.64M -$135.3M
Capital Expenditures $0.00 $0.00 $139.0K
Free Cash Flow -$52.35M -$38.64M -$135.5M
YoY Change 60.92% 93.97% 64.02%

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 10pt 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 10pt 0pt;">BioXcel Therapeutics, Inc. (“BTI” or the “Company”) is a biopharmaceutical company utilizing artificial intelligence (“AI”) approaches to develop transformative medicines in neuroscience and immuno-oncology. The Company is focused on utilizing cutting-edge technology and innovative research to develop high-value therapeutics aimed at transforming patients’ lives. BTI employs a unique AI platform to reduce therapeutic development costs and potentially accelerate timelines. The Company’s approach leverages existing approved drugs and/or clinically evaluated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices. BTI management believes this differentiated approach has the potential to reduce the expense and time associated with drug development in diseases with substantial unmet medical needs.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">As used in these consolidated financial statements, unless otherwise specified or the context otherwise requires, the terms “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 10pt 0pt;">On April 6, 2022, BTI announced that the United States (“U.S.”) Food and Drug Administration (“FDA”) approved IGALMI (dexmedetomidine or “Dex”) sublingual film for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. IGALMI is approved to be self-administrated by patients under the supervision of a health care provider. The Company deployed the first phase of its sales team for high priority targets in May 2022. Furthermore, on July 6, 2022, BTI announced that IGALMI, was commercially available in doses of 120 and 180 microgram through the Company’s third-party logistics provider and was available for order through wholesalers.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">The Company’s most advanced clinical development program is BXCL501, an investigational proprietary, orally dissolving, film formulation of Dex for the treatment of agitation associated with psychiatric and neurological disorders.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">BTI continues to conduct clinical trials evaluating BXCL501 for the acute treatment of agitation in Alzheimer’s disease patients, and for adjunctive treatment of patients with Major Depressive Disorder (“MDD”). The Company is also planning clinical trials for the at-home use of BXCL501 for agitation associated with bipolar disorders and schizophrenia.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">The Company’s advanced immuno-oncology asset, BXCL701, is an investigational, 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 10pt 0pt;">BTI 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 10pt 18pt;"><b style="font-weight:bold;">Impact of COVID-19 Pandemic </b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">The COVID-19 pandemic and responsive measures have significantly impacted, both directly and indirectly, businesses and commerce.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">The Company continues to work closely with clinical sites to monitor the potential impact of the evolving COVID-19 pandemic and the spread of its variants. 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, such as to its TRANQUILITY II trial. However, this could change rapidly.</p>
CY2022 us-gaap Use Of Estimates
UseOfEstimates
<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;margin:0pt 0pt 10pt 18pt;">Use of Estimates</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect amounts reported in the 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.</p>
CY2022 us-gaap Concentration Risk Credit Risk
ConcentrationRiskCreditRisk
<p style="font-family:'Liberation Serif';font-size:10pt;margin:0pt 0pt 10pt 18pt;"><b style="font-family:'Times New Roman','Times','serif';font-weight:bold;">Concentrations of Credit Risk</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-indent:18pt;margin:0pt 0pt 10pt 0pt;"><span style="font-weight:normal;">The Company sells IGALMI through a drop-ship program under which orders from hospitals and similar health care institutions are processed through wholesalers, but shipments of the product are sent directly to the individual hospitals and similar health care institutions. BTI also contracts directly with intermediaries such as group purchasing organizations (“GPOs”). All trade accounts receivables are due from the distributor that fulfills orders on behalf of the Company.</span></p>
CY2022 us-gaap Revenue Recognition Accounting Policy Gross And Net Revenue Disclosure
RevenueRecognitionAccountingPolicyGrossAndNetRevenueDisclosure
<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:0pt;margin:0pt 0pt 10pt 18pt;"><b style="font-weight:bold;">Revenue Recognition</b></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">The Company’s revenues consist of product sales of IGALMI.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">BTI recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration that the Company expects to receive in exchange for those goods or services. To determine revenue recognition, BTI management 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 Company 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 10pt 0pt;">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 Company’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 10pt 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 10pt 0pt;">BTI distributes IGALMI 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. 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 10pt 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 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 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 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 0pt 10pt 0pt;">BTI sells IGALMI at wholesale acquisition cost and calculates 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 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:18pt;margin:0pt 0pt 10pt 0pt;"><span style="font-style:italic;font-weight:bold;">Trade Discounts and Allowances</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 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:18pt;margin:0pt 0pt 10pt 0pt;"><span style="font-style:italic;font-weight:bold;">Government Rebates</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 0pt;">IGALMI 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:18pt;margin:0pt 0pt 10pt 0pt;"><span style="font-style:italic;font-weight:bold;">Chargebacks</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 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:18pt;margin:0pt 0pt 10pt 0pt;"><span style="font-style:italic;font-weight:bold;">Product Returns</span></p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-indent:18pt;margin:0pt 0pt 10pt 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 10pt 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 Consolidated Statements of Operations. Fees paid to the distributor for warehouse operations are classified as costs of goods sold on BTI’s Consolidated Statements of Operations.</p>
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WeightedAverageNumberOfDilutedSharesOutstanding
28015000
CY2021 us-gaap Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
26373000
CY2022 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-5.92
CY2021 us-gaap Earnings Per Share Diluted
EarningsPerShareDiluted
-4.05
CY2022 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
5001000
CY2021 us-gaap Incremental Common Shares Attributable To Share Based Payment Arrangements
IncrementalCommonSharesAttributableToShareBasedPaymentArrangements
4000000
CY2022Q2 us-gaap Significant Supply Commitment Remaining Minimum Amount Committed
SignificantSupplyCommitmentRemainingMinimumAmountCommitted
10000000
CY2022Q2 btai Agreement Commitment Period
AgreementCommitmentPeriod
P3Y

Files In Submission

Name View Source Status
btai-20221231_lab.xml Edgar Link unprocessable
btai-20221231_cal.xml Edgar Link unprocessable
0001558370-23-003940-index-headers.html Edgar Link pending
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btai-20221231.xsd Edgar Link pending
btai-20221231x10k.htm Edgar Link pending
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btai-20221231_def.xml Edgar Link unprocessable
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btai-20221231x10k_htm.xml Edgar Link completed
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