v3.19.2
Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2019
Accounting Policies [Abstract]  
Business Description of Entity [Policy Text Block]
AcelRx Pharmaceuticals, Inc., or the Company or AcelRx, was incorporated in Delaware on
July 13, 2005
as SuRx, Inc., and in
January 2006,
the Company changed its name to AcelRx Pharmaceuticals, Inc. The Company’s operations are based in Redwood City, California.
 
AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA
®
(known as DZUVEO in Europe) and Zalviso
®
, are
both focused on the treatment of acute pain, and each utilize sufentanil, delivered via a non-invasive route of sublingual administration, exclusively for use in medically supervised settings. On
November 2, 2018,
the U.S. Food and Drug Administration, or FDA, approved DSUVIA for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. In
June 2018,
the European Commission, or EC, granted marketing approval of DZUVEO for the treatment of patients with moderate-to-severe acute pain in medically monitored settings. AcelRx is further developing a distribution capability and commercial organization to continue to market and sell DSUVIA in the United States. The commercial launch of DSUVIA in the United States occurred in the
first
quarter of
2019.
In geographies where AcelRx decides
not
to commercialize products by itself, including for DZUVEO in Europe, the Company
may
seek to out-license commercialization rights. The Company currently intends to commercialize and promote DSUVIA/DZUVEO outside the United States with
one
or more strategic partners, although it has
not
yet entered into any such arrangement. The Company is currently evaluating the timing of the resubmission of the new drug application, or NDA, for Zalviso. AcelRx intends to seek regulatory approval for Zalviso in the United States and, if successful, potentially promote Zalviso either by itself or with strategic partners. Zalviso is approved in Europe and is currently being commercialized by Grünenthal GmbH, or Grünenthal.
 
DSUVIA
/DZUVEO
 
DSUVIA, known as DZUVEO in Europe, approved by the FDA in
November 2018,
is indicated for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. DSUVIA was designed to provide rapid analgesia via a non-invasive route and to eliminate dosing errors associated with IV administration. DSUVIA is a single-strength solid dosage form administered sublingually via a single-dose applicator, or SDA, by healthcare professionals. Sufentanil is an opioid analgesic currently marketed for intravenous, or IV, and epidural anesthesia and analgesia. The sufentanil pharmacokinetic profile when delivered sublingually avoids the high peak plasma levels and short duration of action observed with IV administration. The EC approved DZUVEO for marketing in Europe in
June 2018.
 
DSUVIA was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which restricts distribution to certified medically supervised healthcare settings in order to prevent respiratory depression resulting from accidental exposure. DSUVIA will only be distributed to facilities certified in the DSUVIA REMS program following attestation by an authorized representative to comply with appropriate dispensing and use restrictions of DSUVIA. To become certified, a healthcare setting will need to train their healthcare professionals on the proper use of DSUVIA and have the ability to manage respiratory depression. DSUVIA will
not
be available in retail pharmacies or for outpatient use. As part of the REMS program, the Company will monitor distribution and audit wholesalers’ data, evaluate proper usage within the healthcare settings and monitor for any diversion and abuse. Additionally, AcelRx will de-certify healthcare settings that are non-compliant with the REMS program.
 
Zalviso
 
Zalviso delivers
15
mcg sufentanil sublingually through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia, or PCA, system. Zalviso is approved in Europe and is in late-stage development in the United States. The Company had initially submitted to the FDA an NDA seeking approval for Zalviso in
September 2013
but received a complete response letter, or CRL, on
July 25, 2014.
Subsequently, the FDA requested an additional clinical study,
IAP312,
designed to evaluate the effectiveness of changes made to the functionality and usability of the Zalviso device and to take into account comments from the FDA on the study protocol. In the
IAP312
study, for which top-line results were announced in
August 2017,
Zalviso met safety, satisfaction and device usability expectations. These results will supplement the
three
Phase
3
trials already completed in the Zalviso NDA resubmission. The Company is currently evaluating the timing of the NDA resubmission for Zalviso.
 
On
December 16, 2013,
AcelRx and Grünenthal entered into a Collaboration and License Agreement, or the License Agreement, which was amended effective
July 17, 2015
and
September 20, 2016,
or the Amended License Agreement, which grants Grünenthal rights to commercialize the Zalviso PCA system, or the Product, in the countries of the European Union, or EU, Switzerland, Liechtenstein, Iceland, Norway and Australia (collectively, the Territory) for human use in pain treatment within, or dispensed by, hospitals, hospices, nursing homes and other medically supervised settings, (collectively, the Field). In
September 2015,
the EC approved the marketing authorization application, or MAA, previously submitted to the EMA, for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. On
December 16, 2013,
AcelRx and Grünenthal, entered into a Manufacture and Supply Agreement, or the MSA, and together with the License Agreement, the Agreements. Under the MSA, the Company will exclusively manufacture and supply the Product to Grünenthal for the Field in the Territory. On
July 22, 2015,
the Company and Grünenthal amended the MSA, or the Amended MSA, effective as of
July 17, 2015.
The Amended MSA and the Amended License Agreement are referred to as the Amended Agreements.
 
The Company has incurred recurring operating losses and negative cash flows from operating activities since inception. Although Zalviso has been approved for sale in Europe, on
September 18, 2015,
the Company sold the majority of the royalty rights and certain commercial sales milestones it is entitled to receive under the Amended License Agreement with Grünenthal to PDL BioPharma, Inc., or PDL, in a transaction referred to as the Royalty Monetization. The FDA approved DSUVIA in
November 2018
and the Company began its commercial launch of DSUVIA in the
first
quarter of
2019.
As a result, the Company expects to continue to incur operating losses and negative cash flows until such time as DSUVIA has gained market acceptance and generated significant revenues. 
 
Except as the context otherwise requires, when we refer to "we," "our," "us," the "Company" or "AcelRx" in this document, we mean AcelRx Pharmaceuticals, Inc., and its consolidated subsidiary. “DZUVEO” is a trademark, and “ACELRX”, “DSUVIA” and “Zalviso” are registered trademarks, all owned by AcelRx Pharmaceuticals, Inc. This report also contains trademarks and trade names that are the property of their respective owners.
Consolidation, Policy [Policy Text Block]
Principles of Consolidation
 
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, ARPI LLC, which was formed in
September 2015
for the sole purpose of facilitating the Royalty Monetization. All intercompany accounts and transactions have been eliminated in consolidation. Refer to Note
8
“Liability Related to Sale of Future Royalties” for additional information.
Reclassification, Policy [Policy Text Block]
Reclassifications
 
Certain prior year amounts in the condensed consolidated financial statements have been reclassified to conform to the current year's presentation.
Basis of Accounting, Policy [Policy Text Block]
Basis of Presentation
 
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and the rules and regulations of the United States. Securities and Exchange Commission, or SEC. Accordingly, they do
not
include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.
 
Operating results for the
three
and
six
months ended
June 30, 2019,
are
not
necessarily indicative of the results that
may
be expected for the year ending
December 
31,
2019.
The condensed consolidated balance sheet as of
December 31, 2018,
was derived from the Company’s audited financial statements as of
December 31, 2018,
included in the Company’s Annual Report on Form
10
-K filed with the SEC. These financial statements should be read in conjunction with the Company’s Annual Report on Form
10
-K for the year ended
December 31, 2018,
which includes a broader discussion of the Company’s business and the risks inherent therein.
Use of Estimates, Policy [Policy Text Block]
Use of Estimates
 
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes 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 could differ from those estimates.
Inventory, Policy [Policy Text Block]
Inventories
 
Inventories are valued at the lower of cost and net realizable value. Cost is determined using the
first
-in,
first
-out method for all inventories. Inventory includes the cost of the active pharmaceutical ingredients, or API, raw materials and
third
-party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are allocated to the appropriate cost pool and then absorbed into inventory based on the units produced or distributed, assuming normal capacity, in the applicable period. Indirect overhead costs in excess of normal capacity are recorded as period costs in the period incurred. DSUVIA was approved by the FDA in
November 2018.
Prior to FDA approval, all manufacturing costs for DSUVIA were expensed to research and development. Upon FDA approval, manufacturing costs for DSUVIA manufactured for commercial sale have been capitalized.
 
The Company's policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The Company periodically evaluates the carrying value of inventory on hand for potential excess amount over demand using the same lower of cost or market approach as that used to value the inventory. Because the predetermined, contractual transfer prices the Company is receiving from Grünenthal are less than the direct costs of manufacturing, all Zalviso inventories are carried at net realizable value.
Lessee, Leases [Policy Text Block]
Leases
 
In
February 2016,
the FASB issued Accounting Standards Update, or ASU,
No.
2016
-
02,
Leases (Topic
842
)
, to enhance the transparency and comparability of financial reporting related to leasing arrangements. The Company adopted the standard effective
January 1, 2019.
 
At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically
not
readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset
may
be required for items such as initial direct costs paid or incentives received.
 
Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, the Company
no
longer recognizes deferred rent on the balance sheet.
Revenue from Contract with Customer [Policy Text Block]
Revenue
from Contracts with Customers
 
Beginning
January 
1,
2018,
the Company has followed the provisions of Accounting Standards Codification, or ASC, Topic
606,
Revenue from Contracts with Customers
. The guidance provides a unified model to determine how revenue is recognized. The Company recognizes revenue upon transfer of control of promised products or services to customers in an amount that reflects the consideration the Company expects to receive in exchange for those products or services.
 
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under its agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.
 
Net product sales
revenue
 
Revenues from product sales are recognized when distributors obtain control of the Company’s product, which occurs at a point in time, upon delivery to such distributors. These distributors subsequently resell the product to certified medically supervised healthcare settings, such as hospitals, surgical centers, and emergency departments. In addition to distribution agreements with these customers, the Company enters into arrangements with group purchasing organizations, or GPOs, and/or privately-negotiated discounts with respect to the purchase of its products. Revenue from product sales is recorded at the transaction price, net of estimates for variable consideration consisting of discounts, returns and GPO discounts and administrative fees. Variable consideration is recorded at the time product sales are recognized resulting in a reduction in product revenue. Variable consideration is estimated using the most-likely amount method, which is the single-most likely outcome under a contract and is typically at the stated contractual rate. Actual amounts of consideration ultimately received
may
differ from the Company’s estimates. If actual results vary materially from the Company’s estimates, the Company will adjust these estimates, which will affect revenue from product sales and earnings in the period such estimates are adjusted. These items include:
 
 
Distributor Fees – The Company offers contractually determined discounts to its Customers. These discounts are paid
no
later than
two
months after the quarter in which product was shipped.
 
GPO Discounts - The Company offers discounts to GPO members. These discounts are taken when the GPO members purchase DSUVIA from the Company’s customers, who then charge the discount amount back to the Company.
 
GPO Administrative Fees - The Company pays administrative fees to GPOs for services and access to data. These fees are based on contracted terms and are paid after the quarter in which the product was purchased by the GPOs’ members.
 
Returns – The Company allows its Customers to return product for credit
12
months after its product expiration date. As such, there
may
be a significant period of time between the time the product is shipped and the time the credit is issued on returned product.
 
The Company believes its estimated allowance for product returns requires a high degree of judgment and is subject to change based on its experience and certain quantitative and qualitative factors. The Company believes its estimated allowances for distributor fees, GPO discounts and administrative fees do
not
require a high degree of judgment because the amounts are settled within a relatively short period of time.
 
Amounts accrued for product revenue allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate and to reflect actual experience. Product revenue-related liabilities are recorded in the Company’s condensed consolidated balance sheets as Accrued liabilities. The Company will continue to assess its estimates of variable consideration as it accumulates additional historical data and will adjust these estimates accordingly. Changes in sales allowance estimates could materially affect the Company’s results of operations and financial position.
 
Collaboration
agreement
r
evenue
 
The Company generates revenue from collaboration agreements. These agreements typically include payments for upfront signing or license fees, cost reimbursements for development and manufacturing services, milestone payments, product sales, and royalties on licensee’s future product sales.
 
Contract
and other
revenue
 
The Company entered into award contracts with U.S. Department of Defense, or the DoD, to support the development of DSUVIA. These contracts provided for the reimbursement of qualified expenses for research and development activities. Revenue under these arrangements was recognized when the related qualified research expenses were incurred. The Company was entitled to reimbursement of overhead costs associated with the study costs under the DoD arrangements. The Company estimated this overhead rate by utilizing forecasted expenditures. Final reimbursable overhead expenses were dependent on direct labor and direct reimbursable expenses throughout the life of each contract. The DoD Contract period of performance ended on
February 28, 2019.
 
Performance Obligations
 
A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic
606.
The Company’s performance obligations include delivering product to its distributors, commercialization license rights, development services, services associated with the regulatory approval process, joint steering committee services, demo devices, manufacturing services, material rights for discounts on manufacturing services, and product supply.
 
The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services.
 
Transaction Price
 
The Company has both fixed and variable consideration. Variable consideration for product revenue is described as Net product sales in the condensed consolidated statements of comprehensive loss. For collaboration agreements, non-refundable upfront fees and product supply selling prices are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation.
 
At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would
not
occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are
not
within the control of the Company, such as approvals from regulators, are
not
considered probable of being achieved until those approvals are received.
 
For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).
 
Allocation of Consideration
 
As part of the accounting for collaboration arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights and material rights for discounts on manufacturing services are calculated using an income approach model and can include the following key assumptions: the development timeline, sales forecasts, costs of product sales, commercialization expenses, discount rate, the time which the manufacturing services are expected to be performed, and probabilities of technical and regulatory success. For all other performance obligations, the Company uses a cost- plus margin approach.
 
Timing of Recognition
 
Revenues from product sales are recognized when distributors obtain control of the Company’s products, which occurs at a point in time, upon delivery to such distributors. Significant management judgment is required to determine the level of effort required under collaboration arrangements and the period over which the Company expects to complete its performance obligations under the arrangement. The Company estimates the performance period or measure of progress at the inception of the arrangement and re-evaluates it each reporting period. This re-evaluation
may
shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch up basis. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for products at a point in time when control of the product is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to in exchange for those product sales, which is typically once the product physically arrives at the customer, and for licenses of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that the Company has incurred to perform the services using the cost-to-cost input method.
Cost of Goods and Service [Policy Text Block]
Cost of Goods Sold
 
Cost of goods sold for product revenue includes
third
party manufacturing costs, shipping costs, and indirect overhead costs associated with production and distribution which are allocated to the appropriate cost pool and recognized when revenue is recognized. Indirect overhead costs in excess of normal capacity are recorded as period costs in the period incurred.
 
Under the Amended Agreements with Grünenthal, the Company sells Zalviso to Grünenthal at predetermined, contractual transfer prices that are less than the direct costs of manufacturing and recognizes indirect costs as period costs where they are in excess of normal capacity and
not
realizable on a lower of cost or market basis. Cost of goods sold for Zalviso shipped to Grünenthal includes the inventory costs of API,
third
-party contract manufacturing costs, packaging and distribution costs, shipping, handling and storage costs, depreciation and costs of the employees involved with production.
Interest Expense, Policy [Policy Text Block]
Non-Cash Interest Income (Expense) on Liability Related to Sale of Future Royalties
 
In
September 2015,
the Company sold certain royalty and milestone payment rights from the sales of Zalviso in the European Union by its commercial partner, Grünenthal, pursuant to the Collaboration and License Agreement, dated as of
December 16, 2013,
as amended, to PDL for gross proceeds of
$65.0
million, referred to as the Royalty Monetization. The Company continues to have significant continuing involvement in the Royalty Monetization primarily due to an obligation to supply Zalviso to Grünenthal. Under the relevant accounting guidance, because of the Company’s significant continuing involvement, the Royalty Monetization is accounted for as a liability that is being amortized using the effective interest method over the life of the arrangement. In order to determine the amortization of the liability, the Company is required to estimate the total amount of future royalty and milestone payments to be received by ARPI LLC and payments made to PDL, up to a capped amount of
$195.0
million, over the life of the arrangement. The aggregate future estimated royalty and milestone payments (subject to the capped amount), less the
$61.2
million of net proceeds the Company received, are amortized as interest expense over the life of the liability. Consequently, the Company imputes interest on the unamortized portion of the liability and records interest expense, or interest income, as estimates are updated related to the Royalty Monetization, accordingly.
 
There are a number of factors that could materially affect the amount and timing of royalty and milestone payments from Zalviso in Europe, most of which are
not
within the Company’s control. Such factors include, but are
not
limited to, the success of Grünenthal’s sales and promotion of Zalviso, changing standards of care, the introduction of competing products, manufacturing or other delays, intellectual property matters, adverse events that result in governmental health authority imposed restrictions on the use of Zalviso, significant changes in foreign exchange rates as the royalties remitted to ARPI LLC are made in U.S. dollars, and other events or circumstances that could result in reduced royalty payments from European sales of Zalviso, all of which
may
result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the Royalty Monetization. Conversely, if sales of Zalviso in Europe are more than expected, the non-cash royalty revenues and the non-cash interest expense recorded by the Company would be greater over the term of the Royalty Monetization. The Company periodically assesses the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments are greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the amortization of the liability and the interest rate. Because estimated sales forecasts and payments
may
vary over the life of the Royalty Monetization, the Company
may
be required to recognize interest income as the imputed interest rate is adjusted prospectively to reflect the revised effective interest rate over the term of the Royalty Monetization.
 
The Company records non-cash royalty revenues and non-cash interest income (expense), within its Consolidated Statements of Comprehensive Loss over the term of the Royalty Monetization.
 
When the expected payments under the Royalty Monetization are lower than the gross proceeds of
$65.0
million received, the Company defers recognition of any probable contingent gain until the Royalty Monetization liability expires.
New Accounting Pronouncements, Policy [Policy Text Block]
Recently Adopted Accounting Standards
 
On
August 29, 2018,
the Financial Accounting Standards Board, or FASB, issued ASU
No.
2018
-
15,
Intangibles – Goodwill and Other – Internal Use Software (Subtopic
350
-
40
)
. The FASB’s new guidance aligns the requirements for capitalizing implementation costs in a Cloud Computing Arrangement, or CCA, service contract with the requirements for capitalizing implementation costs incurred for an internal-use software license.
 
The amendments in ASU
No.
2018
-
15
require the entity to present the expense related to the capitalized implementation costs in the same line item in the statement of income as the fees associated with the hosting element (service) of the arrangement and classify payments for capitalized implementation costs in the statement of cash flows in the same manner as payments made for fees associated with the hosting element. The entity is also required to present the capitalized implementation costs in the statement of financial position in the same line item that a prepayment for the fees of the associated hosting arrangement would be presented.
 
ASU
No.
2018
-
15
is effective for public business entities for fiscal years beginning after
December 15, 2019,
and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period for which financial statements have
not
been issued. Entities can choose to adopt the new guidance (
1
) prospectively to eligible costs incurred on or after the date this guidance is
first
applied or (
2
) retrospectively. The Company early adopted ASU
No.
2018
-
15
effective
January 1, 2019
under the prospective method, which did
not
have a material effect on the Company’s results of operations, financial condition or cash flows.
 
In
August 2018,
the SEC published Release
No.
33
-
10532,
Disclosure Update and Simplification
,
or DUSTR, which adopted amendments to certain disclosure requirements that have become redundant, duplicative, overlapping, outdated or superseded, in light of other SEC disclosure requirements, U.S. Generally Accepted Accounting Principles, or GAAP, or changes in the information environment. While most of the DUSTR amendments eliminate outdated or duplicative disclosure requirements, the final rule amends the interim financial statement requirements to include a reconciliation of changes in stockholders’ equity (deficit) in the notes or as a separate statement for each period for which a statement of comprehensive income (loss) is required to be filed. The new interim reconciliation of changes in stockholders’ equity (deficit) is included herein as a separate statement.
 
In
February 2016,
the FASB issued ASU
No.
2016
-
02,
 
Leases (Topic
842
)
, which establishes a new lease accounting model for lessees. In
January,
July
and
December 2018,
the FASB issued additional amendments to the new lease guidance relating to, transition, and clarification. The
July 2018
amendment, ASU
No.
2018
-
11,
 
Leases (Topic
842
): Targeted Improvements
, provided an optional transition method that allows entities to elect to apply the standard prospectively at its effective date, versus recasting the prior periods presented. The new standard establishes a right-of-use, or ROU, model that requires a lessee to record an ROU asset and a lease liability on the balance sheet for all leases with terms longer than
12
months. Disclosure requirements have been enhanced with the objective of enabling financial statement users to assess the amount, timing, and uncertainty of cash flows arising from leases. ASU
No.
2016
-
02
became effective for the Company on
January 1, 2019.
The Company has implemented the standard using an optional transition method that allows the Company to initially apply the new leases standard as of the adoption date and recognize a cumulative-effect adjustment to the opening balance of accumulated deficit in the period of adoption. In connection with the adoption, the Company has elected to utilize the package of practical expedients, including: (
1
)
not
reassess the lease classification for any expired or existing leases, (
2
)
not
reassess the treatment of initial direct costs as they related to existing leases, and (
3
)
not
reassess whether expired or existing contracts are or contain leases. In addition, the Company elected the hindsight practical expedient to determine the lease term for existing leases. The election of the hindsight practical expedient resulted in the extension of the lease term for the Company’s embedded lease.
 
The adoption of the new leases standard resulted in the following adjustments to the consolidated balance sheet as of
January 1, 2019 (
in thousands):
 
   
Increase/(Decrease)
 
Operating lease right-of-use assets
  $
4,730
 
Accrued liabilities
(a)
  $
(100
)
Operating lease liabilities
  $
484
 
Operating lease liabilities, net of current portion
  $
4,610
 
Deferred rent, net of current portion
  $
(416
)
Accumulated deficit
(b)
  $
(153
)
 
 
(a)
Represents current portion of Deferred rent reclassified to Operating lease liabilities.
     
  (b) Represents cumulative-effect adjustment upon adoption of ASU
No.
2016
-
02.
 
The adoption of ASU
No.
2016
-
02,
the new leases standard, did
not
impact previously reported financial results because the impact to prior periods was reflected as a cumulative-effect adjustment to the accumulated deficit under the optional transition method.
 
Recently Issued Accounting Standards
 
In
June 2016,
the FASB issued ASU
2016
-
13,
Financial
Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments
,
” or ASU
2016
-
13.
ASU
2016
-
13
replaces the incurred loss impairment methodology in current GAAP with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. ASU
2016
-
13
is effective for public companies for interim and annual periods beginning after
December 15, 2019.
In
May 2019,
the FASB issued ASU
2019
-
05,
Financial Instruments – Credit Losses”
, or ASU
2019
-
05,
to allow entities to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost upon adoption of the new credit losses standard. The new effective dates and transition align with those of ASU
2016
-
13.
Management is currently assessing the impact ASU
2016
-
13
and ASU
2019
-
05
will have on the Company, but it does
not
anticipate adoption of these new standards to have a material impact on the Company’s financial position, results of operations and cash flows.