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Note 3 - Accounting Policies
3 Months Ended
Mar. 31, 2017
Notes to Financial Statements  
Significant Accounting Policies [Text Block]
3.
     Accounting Policies
 
Principles of Consolidation
 
The accompanying unaudited condensed consolidated financial statements include the accounts of Heron Therapeutics, Inc. and its wholly owned subsidiary, Heron Therapeutics, B.V., which was organized in the Netherlands in
March
2015.
Heron Therapeutics, B.V. has no operations and no material assets or liabilities, and there have been no significant transactions related to Heron Therapeutics, B.V. since its inception.
 
Use of Estimates
 
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and disclosures made in the accompanying notes to the financial statements. Our critical accounting policies that involve significant judgment and estimates include revenue recognition, inventory, accrued clinical liabilities, income taxes and stock-based compensation. Actual results could differ materially from those estimates.
 
Cash, Cash Equivalents and Short-Term Investments
 
Cash and cash equivalents consist of cash and highly liquid investments with original maturities from purchase date of
three
months or less.
 
 
Short-term investments consist of securities with contractual maturities of
one
year or less. We have classified our short-term investments as available-for-sale securities in the accompanying unaudited condensed consolidated financial statements. Available-for-sale securities are stated at fair market value, with unrealized gains and losses reported in other comprehensive loss and realized gains and losses included in interest expense, net. The cost of securities sold is based on the specific-identification method. Interest and dividends on securities classified as available-for-sale are included in interest income.
 
The following is a summary of our short-term, available-for-sale securities (in thousands):
 
 
 
 
March 31, 2017
 
 
 
 
 
 
 
Gross
 
 
Gross
 
 
 
 
 
 
 
Amortized
 
 
Unrealized
 
 
Unrealized
 
 
Estimated
 
 
 
Cost
 
 
Gains
 
 
Losses
 
 
Fair Value
 
United States government and agency
  $
24,971
    $
    $
    $
24,971
 
United States corporate debt
   
35,052
     
     
(29
)
   
35,023
 
Foreign corporate debt
   
8,301
     
     
(1
)
   
8,300
 
United States commercial paper
   
36,897
     
     
     
36,897
 
Foreign commercial paper
   
16,933
     
     
     
16,933
 
Total
  $
122,154
    $
    $
(30
)
  $
122,124
 
 
 
 
December 31, 2016
 
 
 
 
 
 
 
Gross
 
 
Gross
 
 
 
 
 
 
 
Amortized
 
 
Unrealized
 
 
Unrealized
 
 
Estimated
 
 
 
Cost
 
 
Gains
 
 
Losses
 
 
Fair Value
 
United States corporate debt
  $
12,048
    $
    $
(9
)
  $
12,039
 
Foreign corporate debt
   
14,065
     
     
(8
)
   
14,057
 
United States commercial paper
   
8,635
     
     
     
8,635
 
Foreign commercial paper
   
2,993
     
     
     
2,993
 
Total
  $
37,741
    $
    $
(17
)
  $
37,724
 
 
The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. We regularly monitor and evaluate the realizable value of our marketable securities. We did
not
recognize any impairment losses for each of the
three
months ended
March
31,
2017
and
2016.
 
Realized gains and losses associated with our investments, if any, are reported in the statement of comprehensive loss. There were
no
realized gains or losses for each of the
three
months ended
March
31,
2017
and
2016.
 
 
Our bank and investment accounts have been placed under control agreements in accordance with our Senior Secured Convertible Notes (the “Convertible Notes”) and Subordinated Secured Promissory Note (the
“Promissory Note”) (see Note
6).
 
Concentration of Risk
 
Cash, cash equivalents and short-term investments are financial instruments that potentially subject us to concentrations of credit risk. We deposit our cash in financial institutions. At times, such deposits
may
be in excess of insured limits. We
may
also invest our excess cash in money market funds, U.S. government and agencies, corporate debt securities and commercial paper. We have established guidelines relative to our diversification of our cash investments and their maturities in an effort to maintain safety and liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in yields and interest rates.
 
Sales of SUSTOL to ASD Specialty Healthcare, Inc. and Cardinal Health, Inc. each accounted for
10%
or more of our net revenues for the quarter ended
March
31,
2017.
The loss of either of these customers could materially and adversely affect our business, results of operations, financial condition and cash flows.
 
Inventory
 
Inventory is stated at the lower of cost or estimated net realizable value, on a
first
-in,
first
-out, or FIFO, basis. We periodically analyze our inventory levels, and write down inventory that has become obsolete, inventory that has a cost basis in excess of its estimated realizable value and inventory quantities that are in excess of expected sales requirements as cost of product sales. The determination of whether inventory costs will be realizable requires estimates by management. If actual market conditions are less favorable than projected by management, additional write-downs of inventory
may
be required, which would be recorded as a cost of product sales.
 
As of
March
31,
2017,
inventory totaled
$4.6
million and consisted of raw materials of
$1.6
million and finished goods of
$3.0
million. For the
three
months ended
March
31,
2017,
we recognized cost of product sales of
$0.3
million for sales of SUSTOL, which primarily included raw materials, labor and overhead related to the manufacturing of SUSTOL, as well as shipping and distribution costs. In addition, cost of product sales for the
first
quarter of
2017
included a
one
-time charge of
$0.9
million resulting from the write-off of short-dated inventory.
 
Revenue Recognition
 
Product Sales
 
SUSTOL is distributed in the U.S. through a limited number of specialty distributors (“Customers”) that resell SUSTOL to healthcare providers, the end users of SUSTOL. Product sales are recorded net of sales allowances and estimated rebates, chargebacks, distributor fees, and other deductions.
 
Product sales are recognized as revenue when there is persuasive evidence that an arrangement exists, delivery has occurred and title has passed, the price is fixed or determinable and we are reasonably assured of collecting the resulting receivable. Product sales are recorded net of sales allowances and estimated rebates, chargebacks, distributor fees and other deductions. At this point in the SUSTOL commercial launch, we do not yet have sufficient historical data regarding the
third
-party payor mix and resulting rebates related to shipments of SUSTOL to our Customers. In addition, we do not currently have the data necessary to provide sufficient visibility into the ultimate utilization of SUSTOL, which inhibits our ability to determine a reasonable estimate of potential returns. As a result, we are not yet able to make reliable estimates necessary to meet certain of the key recognition criteria to recognize product sales as revenue with respect to shipments of SUSTOL to our Customers. Accordingly, revenue related to shipments to our Customers is deferred, except to the extent that our Customers have resold SUSTOL to healthcare providers (sell-through approach). As of
March
31,
2017,
product sales of
$5.2
million to our Customers have been deferred and are recorded as deferred revenue on our unaudited condensed consolidated balance sheet.
 
 
Product Sales Allowances
 
We recognize product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with Customers, historical product returns, rebates or discounts taken, the shelf life of the product, and specific known market events, such as competitive pricing and new product introductions. If actual future results vary from our estimates, we
may
need to adjust these estimates, which could have an effect on product sales and earnings in the period of adjustment. Our product sales allowances include:
 
●     
Product Returns — We allow our 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.
 
●     
Distributor Fees — We offer contractually determined discounts to our Customers. These discounts are paid on a quarterly basis within
two
months after the quarter in which product was shipped.
 
●    
Group Purchasing Organization (“GPO”) Discounts and Rebates — We offer cash discounts to GPO members. These discounts are taken when the GPO members purchase SUSTOL from our Customers, who then charge back to us the discount amount. Additionally, we offer volume and contract-tier rebates to GPO members. Rebates are estimated based on actual purchase levels during the quarterly or semi-annual rebate purchase period.
 
 
●     
GPO Administrative Fees — We pay administrative fees to GPO’s 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 GPO’s members.
 
●     
Medicaid Rebates — We participate in Medicaid rebate programs, which provide assistance to certain low-income patients based on each individual state's guidelines regarding eligibility and services. Under the Medicaid rebate programs, we pay a rebate to each participating state, generally within
three
months after the quarter in which SUSTOL was sold.
 
We believe our estimated allowance for product returns requires a high degree of judgment and is subject to change based on our experience and certain quantitative and qualitative factors. We believe our estimated allowances for distributor fees, GPO discounts, rebates and administrative fees, and Medicaid rebates do not require a high degree of judgement because the amounts are settled within a relatively short period of time.
 
Our product sales allowances and related accruals are evaluated each reporting period and adjusted when trends or significant events indicate that a change in estimate is appropriate. Changes in sales allowance estimates could materially affect our results of operations and financial position.
 
The following provides a summary of activity with respect to our accrued distributor fees, rebates and chargebacks and product returns for the quarter ended
March
31,
2017
(in thousands):
 
 
 
Product
Returns
 
 
Distributor
Fees
 
 
Rebates and
Chargebacks
 
 
Total
 
                                 
Balance at December 31, 2016
  $
49
    $
72
    $
221
    $
342
 
Provision
   
153
     
215
     
1,114
     
1,482
 
Payments/credits
   
     
(119
)    
(243
)    
(362
)
Balance at March 31, 2017
  $
202
    $
168
    $
1,092
    $
1,462
 
 
Comprehensive Income (Loss)
 
Comprehensive income (loss) is defined as the change in equity during a period from transactions and other events and circumstances from non-owner sources.
Unrealized gains and losses on available-for-sale securities are included in other comprehensive loss and represent the difference between our net loss and comprehensive loss for both periods presented.
 
Earnings per Share
 
Basic earnings per share (“EPS”) is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period, without consideration of common share equivalents. Diluted EPS is computed by dividing the net loss by the weighted-average number of common shares and common share equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, warrants and common stock underlying Convertible Notes are considered to be common stock equivalents and are included in the calculation of diluted EPS only when their effect is dilutive.
 
Because we have incurred a net loss for all periods presented in the unaudited condensed consolidated statements of comprehensive loss, stock options, warrants and shares of common stock underlying Convertible Notes are not included in the computation of net loss per share because their effect would be anti-dilutive.
 
The following table includes the number of stock options, warrants and shares of common stock underlying Convertible Notes not included in the computation as of the dates shown below (in thousands):
 
 
 
As of March 31,
 
 
 
2017
 
 
2016
 
                 
Stock options outstanding
   
11,849
     
8,961
 
Warrants outstanding
   
625
     
3,565
 
Shares of common stock underlying Convertible Notes outstanding
   
7,634
     
7,193
 
 
Recent Accounting Pronouncements
 
Recently Adopted
 
In
March
2016,
the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No.
2016
-
09,
Compensation – Stock Compensation: Improvements to Employee Share-Based Payment Accounting
(“ASU 
2016
-
09”).
 ASU
2016
-
09
addresses several aspects of the accounting for share-based payment award transactions, including: (a) income tax consequences; (b) classification of awards as either equity or liabilities; and (c) classification on the statement of cash flows. We adopted the provisions of ASU
2016
-
09
in the
first
quarter of
2017.
We have elected to continue to estimate forfeitures based on the estimated number of awards expected to vest. In addition, the adoption of ASU
2016
-
09
will result in the recognition of
$3.6
million of previously unrecognized excess tax benefits in deferred tax assets, fully offset by a valuation allowance. All tax-related cash flows resulting from stock-based compensation, including the excess tax benefits related to the settlement of stock-based awards, will be classified as cash flows from operating activities on our consolidated statements of cash flows. The adoption of ASU
2016
-
09
did not have a material impact on our results of operations or financial condition.
 
In
July
2015,
FASB issued ASU No.
2015
-
11,
Inventory (Topic
330)
(“ASU
2015
-
11”).
ASU
2015
-
11
requires entities to measure inventory at the lower of cost or net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predicable costs of completion, disposal and transportation. Subsequent measurements are unchanged for inventory measured using LIFO or the retail inventory method. We adopted the provisions of ASU
2015
-
11
in the
first
quarter of
2017,
which did not have a material impact on our results of operations or financial condition.
 
 
Not Yet Adopted
 
In
February
2016,
FASB issued ASU No.
2016
-
02,
Leases
(“ASU
2016
-
02”).
ASU
2016
-
02
requires a lessee to record on the balance sheet the assets and liabilities for the rights and obligations created by leases with lease terms of more than
12
months. In addition, ASU
2016
-
02
requires both lessees and lessors to disclose certain key information about lease transactions. ASU
2016
-
02
is effective for fiscal years beginning after
December
15,
2018,
including interim periods within those fiscal years. We plan to adopt the provisions of ASU
2016
-
02
in the
first
quarter of
2019,
and we are currently evaluating the impact on our results of operations and financial condition.
 
In
May
2014,
FASB issued ASU No.
2014
-
09,
Revenue from Contracts with Customers (Topic
606)
(“ASU
2014
-
09”).
ASU
2014
-
09
is based on the principle that revenue should be recognized to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU
2014
-
09
is effective for fiscal years beginning after
December
15,
2017,
including interim periods within those fiscal years. The provisions of ASU
2014
-
09
allow for either a full retrospective or a modified retrospective adoption approach. We plan to adopt the provisions of ASU
2014
-
09
in the
first
quarter of
2018.
Although we are currently evaluating our method of adoption and the guidance in ASU
2014
-
09,
including the evaluation of our contracts with our customers and the impact on prior period financial statements, we expect the adoption of ASU
2014
-
09
to have a material impact on our consolidated financial statements and related disclosures. Specifically, as disclosed above in our revenue recognition policy, we recognize revenue using the sell-through approach through
March
31,
2017.
Under ASU
2014
-
09
we will be required to estimate our sales allowances at the time of sale, resulting in earlier recognition of revenue.