Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. Use of Estimates The preparation of the accompanying consolidated financial statements in accordance with U.S. GAAP requires us 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 variable consideration and costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. Principles of Consolidation The accompanying consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany transactions and balances have been eliminated upon consolidation. Segment Reporting We have determined that we operate in a single segment based upon the way the business is organized for making operating decisions and assessing performance. We have only one operating segment related to the development of pharmaceutical products. All property and equipment is maintained in the United States. Cash and Cash Equivalents We consider all highly liquid investments with original maturities of three months or less at the time of purchase to be cash equivalents. Cash equivalents, which consist primarily of amounts invested in money market accounts, are stated at fair value. Investments in Marketable Securities We invest in marketable securities, primarily money market funds, corporate debt securities, government securities, government agency securities, and certificates of deposits. We classify our marketable securities as available-for-sale available-for-sale available-for-sale We regularly review all of our investments for other-than-temporary declines in estimated fair value. Our review includes the consideration of the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and duration of the unrealized losses, whether we have the intent to sell the securities and whether it is more likely than not that we will be required to sell the securities before the recovery of their amortized cost basis. When we determine that the decline in estimated fair value of an investment is below the amortized cost basis and the decline is other than temporary, we reduce the carrying value of the security and record a loss for the amount of such decline. Fair Value Measurement The carrying amounts of certain financial instruments, including cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities. Concentration of Risk Credit Risk We invest in a variety of financial instruments and, by our Board approved investment policy, limit the amount of credit exposure with any one issuer, industry or geographic area for investments other than instruments backed by the U.S. federal government. Major Customers We have entered into distribution agreements with certain limited specialty pharmacies and a specialty distributor. For the year ended December 31, 2020, our two largest customers represented approximately 92% of our product revenue and approximately 88% of our accounts receivable balance at December 31, 2020. Major Suppliers We do not currently have any of our own manufacturing facilities, and therefore depend on an outsourced manufacturing strategy for the production of Oxbryta for commercial use and for the production of our product candidates for clinical trials. We have contracts in place with one third-party manufacturer that is approved for the commercial production of Oxbryta and two third-party suppliers that are approved for Oxbryta’s active pharmaceutical ingredient. Although there are potential sources of supply other than our existing manufacturers and suppliers, any new supplier would be required to qualify under applicable regulatory requirements. Accounts Receivables, net Accounts receivables are recorded net of estimates of variable consideration for which reserves are established and which result from discounts and chargebacks that are offered within contracts between us and a limited number of specialty pharmacies and a specialty distributor in the United States. These reserves are classified as reductions of accounts receivable. We estimate the allowance for doubtful accounts using current expected credit loss model, or CECL model. Under the CECL model, the allowance for doubtful accounts reflects the net amount expected to be collected from the account receivables. We evaluate the collectability of these cash flow based on the asset’s amortized cost, the risk of loss even when that risk is remote, losses over an asset’s contractual life, and other relevant information available to us. Accounts receivable balances are written off against the allowance when it is probable that the receivable will not be collected. Given the nature and history of our accounts receivable, we determined that an allowance for doubtful accounts was not required at December 31, 2020. Inventories Inventories are stated at the lower of cost or estimated net realizable value, on a first-in, work-in-process, We began capitalizing costs as inventory when the product candidate received regulatory approval. Prior to regulatory approval, we recorded inventory costs related to product candidates as research and development expenses. We periodically assess the recoverability of our inventory and reduce the carrying value of the inventory when items are determined to be obsolete, defective or in excess of forecasted sales requirements. Inventory write-downs for excess, defective and obsolete inventory are recorded as a cost of sales. There have been no write-downs of our inventories for the periods presented. Property and Equipment, Net Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is provided using the straight-line method over the estimated useful lives of the assets, which is three years for computer equipment and five years for laboratory equipment. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the improvements. Depreciation and amortization begins at the time the asset is placed in service. Maintenance and repairs are charged as expense in the statements of operations and comprehensive loss as incurred. Upon sale or retirement of assets, the cost and related accumulated depreciation and amortization are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations. Impairment of Long-Lived Assets We evaluate our long-lived assets, including property and equipment, for impairment whenever events or changes in circumstances indicate that the carrying value of these assets may not be recoverable. Recoverability of these assets is measured by comparison of the carrying amount of each asset to the future undiscounted cash flows the asset is expected to generate over its remaining life. If the asset is considered to be impaired, the amount of any impairment is measured as the difference between the carrying value and the fair value of the impaired asset. There have been no impairments of our long-lived assets for the periods presented. Restricted Cash Restricted cash consists of cash deposits held by our financial institution as collateral for our letter of credit under our facility lease. Accruals of Research and Development and Manufacturing Costs We record accruals for estimated costs of research, nonclinical and clinical studies and manufacturing development. These costs are a significant component of our research and development expenses. A substantial portion of our ongoing research and development activities are conducted by third-party service providers, including contract research organizations and contract manufacturing organizations. We also accrue for estimated costs of manufacturing activities for inventories. These costs are a significant component of the cost of our inventory. We accrue the costs incurred under our agreements with these third parties based on actual work completed in accordance with agreements established with these third parties. We determine the accruals for research and development costs through discussions with internal personnel and external service providers as to the progress or stage of completion of the clinical studies and the agreed-upon fee to be paid for such services. The accrual for contract manufacturing activities is based on an estimate of manufacturing activities completed to date, contractual rates, and amounts invoiced and paid to date at the end of each reporting period. We determine the percentage of manufacturing activities completed to date based on discussions with the contract manufacturing organizations , oversight of the manufacturing activities and anticipated timeline. As actual costs become known, we adjust our accruals. We have not experienced any material deviations between accrued costs and actual costs. However, actual clinical and manufacturing services performed, number of subjects enrolled, and the rate of subject enrollment may vary from our estimates, resulting in adjustments to research and development costs or inventories in future periods. Changes in these estimates that result in material changes to our accruals of research and development and manufacturing costs could materially affect our results of operations or amounts of inventories capitalized. Revenue Recognition Pursuant to Accounting Standards Codification, Topic 606, Revenue from Contracts with Customers , To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform 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; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect substantially all of the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Product sales, net Our product sales consist of U.S. sales of Oxbryta, which we began shipping to customers in December 2019. Prior to December 2019, we had no product sales. We sell Oxbryta to a limited number of specialty pharmacies and a specialty distributor, or collectively, Customers. These agreements with our Customers provide for transfer of title to the product at the time the product has been delivered to the Customers. The Customers subsequently dispense our products directly to a patient or resell our products to hospitals and certain pharmacies. We recognize revenue on product sales when the Customers obtain control of our product, which occurs at a point in time, typically upon delivery to our Customers. It is at that point that we have a right to payment and that our Customers obtain title and the risks and rewards of ownership. Shipping and handling activities are considered to be fulfillment activities rather than a separate performance obligation. Payment terms are typically 30-60 We consider the effects of items that can decrease the transaction price, such as variable consideration and consideration payable to Customers or payer. Amounts related to such items are estimated at contract inception and updated at the end of each reporting period as additional information becomes available. The amount of variable consideration may be constrained and is included in the transaction price only to the extent it is probable that a significant reversal of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is resolved. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts along with the constraint at the time of revenue recognition: Rebates: Prompt payment discounts Co-payment co-payment co-payment co-payment co-payment Medicare Part D Coverage Gap: Product returns: Chargebacks chargebacks in the same period that the related revenue is recognized, resulting in a reduction of product revenue and receivables. Distributor fees: Other revenue recognition considerations Oxbryta is our only product. The only performance obligation included in our contracts is the delivery of Oxbryta to our Customers. Therefore, no allocation of transaction price amongst performance obligations is necessary. Consequently, the transaction price determined after considering the impacts of variable consideration is recognized at the time control is transferred to our Customers, which is upon delivery of Oxbryta to our Customers. Because all sales of Oxbryta are in the United States and because our Customers are each a large distributor with similar variable consideration impacts, we provide revenue numbers on a total basis without further disaggregation. Additionally, we do not have any contract assets or liabilities, other than accounts receivable, related to our sales of Oxbryta. Cost of Sales Cost of sales consists primarily of direct and indirect costs related to the manufacturing of Oxbryta products sold, including third-party manufacturing costs, packaging services, freight, storage costs, allocation of overhead costs of employees involved with production, and Oxbryta net sales-based royalties payable to the Regents of the University of California. Costs incurred prior to FDA approval of Oxbryta in November 2019 have been recorded as research and development expense in our consolidated statement of operations and comprehensive loss. Leases Pursuant to Accounting Standards Codification, Topic 842, Leases adopted on January 1, 2019 , Right-of-use, As most of our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. We consider our credit risk, term of the lease, and total lease payments and adjust for the impact of collateral, as necessary, when calculating our incremental borrowing rates. The lease terms may include options to extend or terminate the lease when it is reasonably certain that we will exercise any such options. Lease cost for our operating leases is recognized on a straight-line basis over the lease term. We have elected to not separate lease and non-lease non-lease ROU assets and operating lease liabilities are remeasured upon certain modifications to leases using the present value of remaining lease payments and estimated incremental borrowing rate upon lease modification. Leases (Topic 840) Prior to the Adoption of Topic 842 We enter into lease agreements for our office and laboratory facilities. These leases are classified as operating leases. Rent expense is recognized on a straight-line basis over the noncancelable term of the lease and, accordingly, we record the difference between cash rent payments and the recognition of rent expense as a deferred rent liability, which is included within other liabilities on the consolidated balance sheet. Incentives granted under our facilities leases, including rent holiday and allowances to fund leasehold improvements, are deferred and are recognized as adjustments to rental expense on a straight-line basis over the noncancelable term of the lease. Comprehensive Income (Loss) Comprehensive income (loss) is defined as a change in equity of a business enterprise during a period, resulting from transactions from non-owner Research and Development Research and development costs are expensed as incurred and consist of salaries and benefits, stock-based compensation expense, lab supplies and facility costs, as well as fees paid to other nonemployees and entities that conduct certain research and development activities on our behalf. Amounts incurred in connection with license agreements are also included in research and development expense. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are capitalized and then expensed as the related goods are delivered or the services are performed. Long-term Debt Long-term debt consists of our loan agreement, or Term Loan, with funds managed by Pharmakon Advisors LP, which are BioPharma Credit PLC, as collateral agent and a lender, and Biopharma Credit Investments V (Master) LP, as a lender, and collectively, the Lenders. We accounted for the Term Loan as a debt financing arrangement. Interest expense is accrued using the effective interest rate method over the estimated period the debt will be repaid. Debt issuance costs have been recorded as a debt discount in our consolidated balance sheets and are being amortized and recorded as interest expense throughout the life of the Term Loan using the effective interest rate method. We consider whether there are any embedded features in our debt instruments that require bifurcation and separate accounting as derivative financial instruments pursuant to Accounting Standards Codification, or ASC, Topic 815, Derivatives and Hedging There are no embedded features identified from our Term Loan that require bifurcation and separating accounting. Stock-Based Compensation We measure and recognize stock-based compensation expense, including employee and non-employee Income Taxes We use the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. We must then assess the likelihood that the resulting deferred tax assets will be realized. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Due to our lack of earnings history, the net deferred tax assets have been fully offset by a valuation allowance. We recognize benefits of uncertain tax positions if it is more likely than not that such positions will be sustained upon examination based solely on their technical merits, as the largest amount of benefit that is more likely than not to be realized upon the ultimate settlement. It is our policy to include penalties and interest expense related to income taxes as a component of other expense and interest expense, respectively, as necessary. To date, there have been no interest or penalties incurred in relation to the unrecognized tax benefits. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding during the period, without consideration of common stock equivalents. Diluted net loss per share is the same as basic net loss per share, since the effects of potentially dilutive securities are antidilutive given our net loss. Recent Accounting Pronouncements In December 2019, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes 2019-12 Accounting Pronouncements Adopted In August 2018, FASB, issued ASU No. 2018-15, Intangibles—Goodwill and Other—Internal-Use 350-40), Arrangement That Is a Service Contract 2018-15. No. 2018-15 internal-use 350-40 No. 2018-15 In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820) No. 2018-13 No. 2018-13 In June 2016, the FASB issued ASU No. 2016-13, Measurement of Credit Losses on Financial Instruments (Topic 326) U.S. GAAP an impairment model that is based on expected losses rather than incurred losses, which is known as the current expected credit loss, or CECL model. The CECL model applies to most debt instruments (other than those measured at fair value), trade and other receivables, financial guarantee contracts, and loan commitments. Available-for-sale available-for-sale No. 2016-13 |