Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
1. DESCRIPTION OF BUSINESS, BASIS OF PRESENTATION, AND OPERATING SEGMENT
(a) Description of Business
Spectrum Pharmaceuticals, Inc. (“Spectrum”, the “Company”, “we”, “our”, or “us”) is a biopharma company, with a primary strategy comprised of acquiring, developing, and commercializing a broad and diverse pipeline of clinical and commercial products. We have an in-house clinical development organization with regulatory and data management capabilities, in addition to commercial and marketing capabilities upon product launch.
We have
two
drugs in late-stage and active development:
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•
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Poziotinib, a novel pan-HER inhibitor used in the investigation for non-small cell lung cancer (“NSCLC”) tumors with either EGFR or HER2 exon 20 insertion mutations; and
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•
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ROLONTIS, a novel long-acting granulocyte colony-stimulating (“G-CSF”) analog for chemotherapy-induced neutropenia.
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Our business strategy is to further the development of our late stage assets through commercialization and acquire new assets through partnerships or acquisitions.
(b) Basis of Presentation
Interim Financial Statements
The interim financial data for the
three
months ended
March 31, 2019
and
2018
, respectively, is unaudited, and is not necessarily indicative of our operating results for a full year. In the opinion of our management, the interim data includes normal and recurring adjustments necessary for a fair presentation of our financial results for the
three
months ended
March 31, 2019
and
2018
. Certain information and footnote disclosures normally included in annual financial statements prepared in accordance with United States (“U.S.”) generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to the U.S. Securities and Exchange Commission (“SEC”) rules and regulations relating to interim financial statements. The accompanying Condensed Consolidated Financial Statements should be read in conjunction with our audited Consolidated Financial Statements and Notes thereto included within our Annual Report on Form 10-K for the fiscal year ended
December 31, 2018
(filed with the SEC on
February 28, 2019
).
Discontinued Operations - Sale of our Product Portfolio
On March 1, 2019, we completed the sale of our
seven
then-commercialized drugs, including FUSILEV, KHAPZORY, FOLOTYN, ZEVALIN
,
MARQIBO, BELEODAQ, and EVOMELA (the “Commercial Product Portfolio”) to Acrotech Biopharma LLC (“Acrotech”) (the “Commercial Product Portfolio Transaction”). Upon closing we received
$158.8 million
in an upfront cash payment (of which
$4 million
is held in escrow). We are also entitled to receive up to an aggregate of
$140 million
upon Acrotech's achievement of certain regulatory (totaling
$40 million
) and sales-based milestones (totaling
$100 million
) relating to the Commercial Product Portfolio.
These Condensed Consolidated Financial Statements are recast for all periods presented to reflect the sale of the assets and liabilities associated with our Commercial Product Portfolio, as well as the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations” - see
Note 11
. We have presented our face financial statements in general conformity with our historical format, even where presented values are $-0- within continuing operations due to required discontinued operations classification for all periods presented. We believe this format provides increased clarity and comparability with our previously filed financial statements, as well as our expectation that these financial statement captions and included footnote disclosures will remain relevant to our future business activities.
Principles of Consolidation
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
The accompanying Condensed Consolidated Financial Statements have been prepared in accordance with U.S. GAAP and with the rules and regulations of the SEC. These financial statements include the financial position, results of operations, and cash flows of Spectrum and its subsidiaries, all of which are wholly-owned (except for Spectrum Pharma Canada (“SPC”), as discussed below. All inter-company accounts and transactions among these legal entities have been eliminated in consolidation.
Variable Interest Entity
We own
fifty
-percent of SPC, a legal entity organized in Quebec, Canada in January 2008. Some of our clinical studies are conducted through this “variable interest entity” (as defined under applicable GAAP). We fund all of SPC’s operating costs, and since we assume all risks and rewards for this entity, we meet the criteria as being its “primary beneficiary” (as defined under applicable GAAP). Accordingly, SPC’s balance sheets and statements of operations are included in our Condensed Consolidated Financial Statements as if it were a wholly-owned subsidiary for all periods presented.
(c) Operating Segment
We operate
one
reportable operating segment that is focused exclusively on developing (and eventually marketing) oncology and hematology drug products. For the
three
months ended
March 31, 2019
and
2018
, all of our revenue and related expenses were solely attributable to these activities (and as applicable, currently and retrospectively classified as “discontinued” within the accompanying Condensed Consolidated Balance Sheet and Condensed Consolidated Statement of Operations - see
Note 11
). All of our assets are held in the U.S, except for cash held in certain foreign bank accounts.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF ESTIMATES
The preparation of financial statements in conformity with GAAP requires our management to make informed estimates and assumptions that affect our reported amounts of assets, liabilities, revenues, and expenses. These amounts may materially differ from the amounts ultimately realized and reported due to the inherent uncertainty of any estimate or assumption. On an on-going basis, our management evaluates its most critical estimates and assumptions, including those related to: (i) gross-to-net revenue adjustments; (ii) the timing of revenue recognition; (iii) the collectability of customer accounts; (iv) whether the cost of our inventories can be recovered; (v) the realization of our tax assets and estimates of our tax liabilities; (vi) the fair value of our investments; (vii) the valuation of our stock options and the periodic expense recognition of stock-based compensation; and (viii) the potential outcome of our ongoing or threatened litigation.
Our accounting policies and estimates that most significantly impact the presented amounts within these Condensed Consolidated Financial Statements are further described below:
(i) Revenue Recognition
Impact of the Adoption of the New Revenue Recognition Standard
:
ASU No. 2014-09
,
Revenue from Contracts with Customers
(
“Topic 606”
), became effective for us on January 1, 2018. Our disclosure within the below sections to this footnote reflects our updated accounting policies that are affected by this new standard. We applied the “modified retrospective” transition method for open contracts for the implementation of
Topic 606;
this
resulted in the recognition of an aggregate
$4.7 million
, net of tax, decrease to our January 1, 2018 “accumulated deficit” on our accompanying Condensed Consolidated Balance Sheets for the cumulative impact of applying this new standard. We made no adjustments to our previously-reported total revenues, as those periods continue to be presented in accordance with our historical accounting practices under
Topic 605, Revenue Recognition (“Topic 605”)
.
Required Elements of Our Revenue Recognition
:
Revenue from our (a) product sales, (b) out-license arrangements, and (c) service arrangements is recognized under
Topic 606
in a manner that reasonably reflects the delivery of our goods and/or services to customers in return for expected consideration and includes the following elements:
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(1)
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we ensure that we have an executed contract(s) with our customer that we believe is legally enforceable;
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(2)
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we identify the “performance obligations” in the respective contract;
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(3)
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we determine the “transaction price” for each performance obligation in the respective contract;
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Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
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(4)
|
we allocate the transaction price to each performance obligation; and
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(5)
|
we recognize revenue only when we satisfy each performance obligation.
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These five elements, as applied to each of our revenue categories, are summarized below:
(a)
Product Sales
: We sell our products to pharmaceutical wholesalers/distributors (i.e., our customers), except for our U.S. sales of ZEVALIN, and limited sales of EVOMELA, in which case the end-user (i.e., clinic or hospital) is our customer. Our wholesalers/distributors in turn sell our products directly to clinics, hospitals, and private oncology-based practices. Revenue from our product sales is recognized as physical delivery of product occurs (when our customer obtains control of the product), in return for agreed-upon consideration.
Our gross product sales (i.e., delivered units
multiplied by
the contractual price per unit) are reduced by our corresponding gross-to-net (“GTN”) estimates using the “expected value” method, resulting in our reported “product sales, net” in the accompanying Condensed Consolidated Statements of Operations, reflecting the amount we ultimately expect to realize in net cash proceeds, taking into account our current period gross sales and related cash receipts, and the subsequent cash disbursements on these sales that we estimate for the various GTN categories discussed below. These estimates are based upon information received from external sources (such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period), in combination with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount incurred (of some, or all) of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, and distribution, data, and GPO administrative fees may be materially above or below the amount estimated, then requiring prospective adjustments to our reported net product sales.
These GTN estimate categories are each discussed below:
Product Returns Allowances
: Our FUSILEV, MARQIBO, and BELEODAQ customers are contractually permitted to return purchased products beginning at its expiration date and within
six
months thereafter. Our EVOMELA customers are permitted to return purchased product beginning at
six
months prior to its respective expiration date, and within
12
months thereafter (as well as for overstock inventory, as determined by end-users). ZEVALIN and FOLOTYN returns for expiry are not contractually permitted. Returns outside of this aforementioned criteria are not customarily allowed. We estimate expected product returns for our allowance based on our historical return rates. Returned product is typically destroyed, since substantially all returns are due to expiry and cannot be resold.
Government Chargebacks
: Our products are subject to pricing limits under certain federal government programs (e.g., Medicare and 340B Drug Pricing Program). Qualifying entities (i.e., end-users) purchase products from our customers at their qualifying discounted price. The chargeback amount we incur represents the difference between our contractual sales price to our customer, and the end-user’s applicable discounted purchase price under the government program. There may be significant lag time between our reported net product sales and our receipt of the corresponding government chargeback claims from our customers.
Prompt Pay Discounts
:
Discounts for prompt payment are estimated at the time of sale, based on our eligible customers’ prompt payment history and the contractual discount percentage.
Commercial Rebates
:
Commercial rebates are based on (i) our estimates of end-user purchases through a group purchasing organization (“GPO”), (ii) the corresponding contractual rebate percentage tier we expect each GPO to achieve, and (iii) our estimates of the impact of any prospective rebate program changes made by us.
Medicaid Rebates
:
Our products are subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with our product is covered under Medicaid, resulting in a discounted price for our product under the applicable Medicaid program. Our Medicaid rebate accrual calculations require us to project the magnitude of our sales, by state, that will be subject to these rebates. There is a significant time lag in us receiving rebate notices from each state (generally several months or longer after our sale is recognized). Our estimates are based on our historical claim levels by state, as supplemented by management’s judgment.
Distribution, Data, and GPO Administrative Fees
:
Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of our products (except for U.S. sales of ZEVALIN) for various commercial services including:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of our applicable sales.
(b)
License Fees
:
Our out-license arrangements allow licensees to market our product(s) in certain territories for a specific term (representing the out-license of “functional intellectual property”). These arrangements may include one or more of the following forms of consideration: (i) upfront license fees, (ii) sales royalties, (iii) sales milestone-achievement fees, and (iv) regulatory milestone-achievement fees. We recognize revenue for each based on the contractual terms that establish our right to collect payment once the performance obligation is achieved, as follows:
(1) Upfront License Fees:
We determine whether upfront license fees are earned at the time of contract execution (i.e., when rights transfer to the customer) or over the actual (or implied) contractual period of the out-license. As part of this determination, we evaluate whether we have any other requirements to provide substantive services that are inseparable from the performance obligation of the license transfer. Our customers’ “distinct” rights to licensed “functional intellectual property” at the time of contract execution results in concurrent revenue recognition of all upfront license fees (assuming that there are no other performance obligations at contract execution that are inseparable from this license transfer).
(2)
Royalties
:
Under the “sales-or-usage-based royalty exception” we recognize revenue in the same period that our
licensees complete product sales in their territory for which we are contractually entitled to a percentage-based royalty receipt.
(3)
Sales Milestones
:
Under the “sales-or-usage-based royalty exception” we recognize revenue in full within the period that our licensees achieve annual or aggregate product sales levels in their territories for which we are contractually entitled to a specified lump-sum receipt.
(4)
Regulatory Milestones
:
Under the terms of the respective out-license, regulatory achievements may either be our responsibility, or that of our licensee.
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•
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When our licensee is responsible for the achievement of the regulatory milestone, we recognize revenue in full (for the contractual amount due from our licensee) in the period that the approval occurs (i.e., when the “performance obligation” is satisfied by our customer) under the “most likely amount” method. This revenue recognition remains “constrained” (i.e., not recognized) until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
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•
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When we are responsible for the achievement of a regulatory milestone, the “relative selling price method” is applied for purposes of allocating the transaction price to our performance obligations. In such case, we consider (i) the extent of our effort to achieve the milestone and/or the enhancement of the value of the delivered item(s) as a result of milestone achievement and (ii) if the milestone payment is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement. We have historically assessed the contractual value of these milestones upon their achievement to be identical to the allocation of value of our performance obligations and thus representing the “transaction price” for each milestone at contract inception. We recognize this revenue in the period that the regulatory approval occurs (i.e., when we complete the “performance obligation”) under the “most likely amount” method, and revenue recognition is otherwise “constrained” until regulatory approval occurs, given its inherent uncertainty and the requirement of a significant revenue reversal not being probable if achievement does not occur. At each reporting period, we re-evaluate the probability of milestone achievement and the associated revenue constraint; any resulting adjustments would be recorded on a cumulative catch-up basis, thus reflected in our financial statements in the period of adjustment.
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(c)
Service Revenue
: We receive fees under certain arrangements for (i) sales and marketing services, (ii) supply chain services, (iii) research and development services, and (iv) clinical trial management services.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
Our rights to receive payment for these services may be established by (1) a fixed-fee schedule that covers the term of the arrangement, so long as we meet ongoing performance obligations, (2) our completion of product delivery in our capacity as a procurement agent, (3) the successful completion of a phase of drug development, (4) favorable results from a clinical trial, and/or (5) regulatory approval events.
We consider whether revenue associated with these service arrangements is reportable each period, based on our completed services or deliverables (i.e., satisfied “performance obligations”) during the reporting period, and the terms of the arrangement that contractually result in fixed payments due to us. The promised service(s) within these arrangements are distinct and explicitly stated within each contract, and our customer benefits from the separable service(s) delivery/completion. Further, the nature of the promise to our customer as stated within the respective contract is to deliver each named service individually (not a transfer of combined items to which the promised goods or services are inputs), and thus are separable for revenue recognition.
(ii) Cash and Cash Equivalents
Cash and cash equivalents consist of bank deposits and highly liquid investments with maturities of
three
months or less from the purchase date. Our restricted cash is currently held in an escrow account as part of our completed Commercial Product Portfolio Transaction (see
Note 1(b)
).
(iii) Marketable Securities
Our marketable securities consist of our holdings in equity securities, mutual funds, and bank certificates of deposit (“Bank CDs”). Our realized and unrealized (losses) gains on marketable securities are included in “other (expense) income, net” on the accompanying Condensed Consolidated Statements of Operations.
(iv) Accounts Receivable
Our accounts receivable are derived from our product sales and license fees, and do not bear interest. The allowance for doubtful accounts is management’s best estimate of the amount of probable credit losses in our existing accounts receivable. Account balances are charged off against the allowance after appropriate collection efforts are exhausted.
(v) Inventories
We value our inventory at the
lower of
(i) the actual cost of its purchase or manufacture, or (ii) its net realizable value. Inventory cost is determined on the first-in, first-out method. We regularly review our inventory quantities in process of manufacture and on hand. When appropriate, we record a provision for obsolete and excess inventory to derive its new cost basis, which takes into account our sales forecast by product and corresponding expiry dates of each product lot.
Manufacturing costs of drug products that are pending U.S. Food and Drug Administration (“FDA”) approval are fully expensed through “research and development” on the accompanying Condensed Consolidated Statements of Operations.
(vi) Stock-Based Compensation
Stock-based compensation expense for equity awards granted to our employees and members of our Board of Directors is recognized on a straight-line basis over each award’s vesting period. Recognized compensation expense is net of an estimated forfeiture rate, representing the percentage of awards that are expected to be forfeited prior to vesting, though is ultimately adjusted for actual forfeitures. We use the Black-Scholes option pricing model to determine the fair value of stock options (as of the date of grant) that have service conditions for vesting. We use the Monte Carlo valuation model to value equity awards (as of the date of grant) that have combined market conditions and service conditions for vesting.
The recognition of stock-based compensation expense and the initial calculation of stock option fair value requires uncertain assumptions, including (a) the pre-vesting forfeiture rate of the award, (b) the expected term that the stock option will remain outstanding, (c) our stock price volatility over the expected term (and that of our designated peer group with respect to certain market-based awards), and (d) the prevailing risk-free interest rate for the period matching the expected term.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
With regard to (a)-(d): We estimate forfeiture rates based on our employees’ overall forfeiture history, which we believe will be representative of future results. We estimate the expected term of stock options granted based on our employees’ historical exercise patterns, which we believe will be representative of their future behavior. We estimate the volatility of our common stock on the date of grant based on the historical volatility of our common stock for a look-back period that corresponds with the expected term. We estimate the risk-free interest rate based upon the U.S. Department of the Treasury yields in effect at award grant, for a period equaling the expected term of the stock option.
(vii) Basic and Diluted Net Loss per Share
We calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented. In periods of a net loss, basic and diluted loss per share are the same. For the diluted earnings per share calculation, we adjust the weighted average number of common shares outstanding to include only dilutive stock options, warrants, and other common stock equivalents outstanding during the period.
(viii) Income Taxes
Deferred tax assets and liabilities are recorded based on the estimated future tax effects of temporary differences between the tax basis of assets and liabilities and amounts reported in the financial statements, as well as operating losses and tax credit carry forwards using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Realization of deferred tax assets is dependent upon future earnings, the timing and amount of which are uncertain.
We have recorded a valuation allowance to reduce our deferred tax assets, because we believe that, based upon a weighting of positive and negative factors, it is more likely than not that these deferred tax assets will not be realized. If/when we were to determine that our deferred tax assets are realizable, an adjustment to the corresponding valuation allowance would increase our net income in the period that such determination was made.
In the event that we are assessed interest and/or penalties from taxing authorities that have not been previously accrued, such amounts would be included in “benefit for income taxes from continuing operations” within the Condensed Consolidated Statements of Operations for the period in which we received the notice.
(ix) Research and Development Costs
Our research and development costs are expensed as incurred (see
Note 9(c)
), or as certain milestone payments become contractually due to our licensors, as triggered by the achievement of clinical or regulatory events.
(x) Fair Value Measurements
We determine measurement-date fair value based on the proceeds that would be received through the sale of the asset, or that we would pay to settle or transfer the liability, in an orderly transaction between market participants. We utilize valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible. Fair value measurements are based on a three-tier hierarchy that prioritizes the inputs used to measure fair value. These tiers include the following:
Level 1:
Quoted prices (unadjusted) in active markets for identical assets or liabilities that are publicly accessible at the measurement date.
Level 2:
Observable prices that are based on inputs not quoted on active markets, but that are corroborated by market data. These inputs may include quoted prices for similar assets or liabilities or quoted market prices in markets that are not active to the general public.
Level 3:
Unobservable inputs are used when little or no market data is available.
3. BALANCE SHEET ACCOUNT DETAIL
The composition of selected financial statement captions that comprise the accompanying Condensed Consolidated Balance Sheets are summarized below:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
(a) Cash and Cash Equivalents and Marketable Securities
As of
March 31, 2019
and
December 31, 2018
, our “cash and cash equivalents” were held with major financial institutions. Our “marketable securities” primarily relate to our equity holdings in CASI Pharmaceuticals, Inc. (“CASI”).
We maintain cash balances in excess of federally insured limits with reputable financial institutions. To a limited degree, the Federal Deposit Insurance Corporation and other third parties insure these investments. However, these investments are not insured against the possibility of a complete loss of earnings or principal and are inherently subject to the credit risk related to the continued credit worthiness of the underlying issuer and general credit market risks. We manage such risks in our portfolio by investing in highly liquid, highly-rated instruments, and limit investing in long-term maturity instruments.
Our investment policy requires that purchased investments in marketable securities may only be in highly-rated instruments, which are primarily U.S. treasury bills or treasury-backed securities, and also limits our investments in securities of any single issuer (excluding any debt or equity securities received from our strategic partners in connection with an out-license arrangement, as discussed in
Note 7
).
The carrying amount of our equity securities, money market funds, and Bank CDs approximates their fair value (utilizing “
Level 1”
or “
Level 2”
inputs – see
Note 2(x)
) because of our ability to immediately convert these instruments into cash with minimal expected change in value.
The following is a summary of our presented “cash and cash equivalents” and “marketable securities”:
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Cost
|
|
Foreign Currency Translation
|
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Gross
Unrealized
Gains
|
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Estimated
Fair
Value
|
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Cash and Cash
Equivalents
|
|
Marketable Securities
|
|
March 31, 2019
|
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Equity securities* (see
Note 7
)
|
$
|
8,710
|
|
|
$
|
(3,265
|
)
|
|
$
|
27,697
|
|
|
$
|
33,142
|
|
|
$
|
—
|
|
|
$
|
33,142
|
|
|
Bank deposits
|
15,649
|
|
|
—
|
|
|
—
|
|
|
15,649
|
|
|
15,649
|
|
|
—
|
|
|
Money market funds
|
257,003
|
|
|
—
|
|
|
—
|
|
|
257,003
|
|
|
257,003
|
|
|
—
|
|
|
Bank CDs
|
87
|
|
|
—
|
|
|
—
|
|
|
87
|
|
|
—
|
|
|
87
|
|
|
Total cash and cash equivalents and marketable securities
|
$
|
281,449
|
|
|
$
|
(3,265
|
)
|
|
$
|
27,697
|
|
|
$
|
305,881
|
|
|
$
|
272,652
|
|
|
$
|
33,229
|
|
|
December 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity securities* (see Note 7)
|
$
|
8,710
|
|
|
$
|
(2,168
|
)
|
|
$
|
39,880
|
|
|
$
|
46,422
|
|
|
$
|
—
|
|
|
$
|
46,422
|
|
|
Bank deposits
|
14,735
|
|
|
—
|
|
|
—
|
|
|
14,735
|
|
|
14,735
|
|
|
—
|
|
|
Money market funds
|
142,745
|
|
|
—
|
|
|
—
|
|
|
142,745
|
|
|
142,745
|
|
|
—
|
|
|
Bank CDs
|
86
|
|
|
—
|
|
|
—
|
|
|
86
|
|
|
—
|
|
|
86
|
|
|
Total cash and cash equivalents and marketable securities
|
$
|
166,276
|
|
|
$
|
(2,168
|
)
|
|
$
|
39,880
|
|
|
$
|
203,988
|
|
|
$
|
157,480
|
|
|
$
|
46,508
|
|
* Beginning January 1, 2018, under the requirements of
ASU 2016-01, Recognition and Measurement of Financial Assets and Liabilities
, the unrealized (loss) gain on our CASI equity securities are recognized as an (decrease) increase to “other (expense) income, net” on the Condensed Consolidated Statements of Operations (rather than through “other comprehensive loss” on the Condensed Consolidated Statements of Comprehensive Loss). Our adoption of
ASU 2016-01
on January 1, 2018 resulted in a
$17.2 million
cumulative-effect adjustment, net of income tax, recorded as a decrease to “accumulated other comprehensive loss” and a decrease to “accumulated deficit” on the accompanying Condensed Consolidated Balance Sheets. Our recognized unrealized (loss) gain on these equity securities for the
three
months ended
March 31, 2019
and 2018 was
$(12.2) million
and
$10.2 million
, respectively, as reported in “other (expense) income, net” on the accompanying Condensed Consolidated Statements of Operations.
As of
March 31, 2019
,
no
ne of the securities that we hold were in an unrealized loss position with respect to our cost basis.
(b) Property and Equipment, net of Accumulated Depreciation
“Property and equipment, net of accumulated depreciation” consists of the following:
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
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|
|
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|
|
March 31, 2019
|
|
December 31, 2018
|
|
Computer hardware and software
|
$
|
3,075
|
|
|
$
|
3,079
|
|
|
Laboratory equipment
|
669
|
|
|
635
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|
|
Office furniture
|
227
|
|
|
212
|
|
|
Leasehold improvements
|
2,957
|
|
|
2,957
|
|
|
Property and equipment, at cost
|
6,928
|
|
|
6,883
|
|
|
(Less): Accumulated depreciation
|
(6,462
|
)
|
|
(6,498
|
)
|
|
Property and equipment, net of accumulated depreciation
|
$
|
466
|
|
|
$
|
385
|
|
Depreciation expense (included within “total operating costs and expenses” in the accompanying Condensed Consolidated Statements of Operations) for the
three
months ended
March 31, 2019
and
2018
, was
$0.1 million
, and
$49 thousand
, respectively.
(c) Prepaid Expenses and Other Assets
“Prepaid expenses and other assets” consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Deposits and other
|
$
|
6,760
|
|
|
$
|
6,792
|
|
|
Value of equity forward-sale contract (see
Note 7
)
|
793
|
|
|
—
|
|
|
Prepaid insurance
|
402
|
|
|
782
|
|
|
Prepaid expenses and other assets
|
$
|
7,955
|
|
|
$
|
7,574
|
|
(d) Other Receivables
“Other receivables” consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
FDA refund due
|
$
|
1,941
|
|
|
$
|
—
|
|
|
Other miscellaneous receivables (including Medicaid rebate credits and royalty receivables from licensees)
|
1,575
|
|
|
1,189
|
|
|
Income tax receivable - current portion
|
643
|
|
|
643
|
|
|
Insurance receivable
|
1,576
|
|
|
206
|
|
|
Secured promissory note (see
Note 7
)
|
1,527
|
|
|
1,525
|
|
|
Reimbursements due from development partners for incurred research and development expenses
|
204
|
|
|
135
|
|
|
Other receivables
|
$
|
7,466
|
|
|
$
|
3,698
|
|
(e) Other Assets
“Other assets” consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Key employee life insurance – cash surrender value associated with deferred compensation plan (
Note 9(f)
)
|
$
|
7,270
|
|
|
$
|
6,274
|
|
|
Income tax receivable - non-current portion*
|
668
|
|
|
668
|
|
|
Research & development supplies and other
|
242
|
|
|
246
|
|
|
Other assets
|
$
|
8,180
|
|
|
$
|
7,188
|
|
* This value represents the non-current portion of the refundable alternative minimum tax credit that is expected to be received over the next few years (see
Note 10
).
(f) Facility and Equipment Under Lease
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
“Facility and equipment under lease” consists of the following
:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Office and research facilities
|
$
|
3,287
|
|
|
$
|
—
|
|
|
Office equipment
|
487
|
|
|
—
|
|
|
Facility and equipment under lease (
Note 9(a)
)
|
$
|
3,774
|
|
|
$
|
—
|
|
(g) Accounts Payable and Other Accrued Liabilities
“Accounts payable and other accrued liabilities” consists of the following
:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Trade accounts payable and other
|
$
|
41,788
|
|
|
$
|
44,919
|
|
|
Lease liability - current portion (
Note 9(a)
)
|
808
|
|
|
—
|
|
|
Accrued commercial/Medicaid rebates
|
6,370
|
|
|
8,371
|
|
|
Accrued product royalty due to licensors
|
1,910
|
|
|
4,337
|
|
|
Allowance for product returns
|
5,325
|
|
|
5,171
|
|
|
Accrued data and distribution fees
|
2,398
|
|
|
3,248
|
|
|
Accrued GPO administrative fees
|
150
|
|
|
296
|
|
|
Accrued inventory management fees
|
368
|
|
|
388
|
|
|
Allowance for government chargebacks
|
1,185
|
|
|
2,730
|
|
|
Accounts payable and other accrued liabilities
|
$
|
60,302
|
|
|
$
|
69,460
|
|
Amounts presented within “accounts payable and other accrued liabilities” in the accompanying Condensed Consolidated Balance Sheets for our categories of GTN estimates (see
Note 2(i)
) were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commercial/Medicaid Rebates and Government Chargebacks
|
|
Distribution, Data, Inventory and
GPO Administrative Fees
|
|
Product Return Allowances
|
|
Balance as of December 31, 2017
|
$
|
10,358
|
|
|
$
|
5,727
|
|
|
$
|
4,045
|
|
|
Add: GTN accruals recorded for product sales
|
65,751
|
|
|
13,962
|
|
|
1,700
|
|
|
(Less): Payments made and credits against GTN accruals
|
(65,008
|
)
|
|
(15,757
|
)
|
|
(574
|
)
|
|
Balance as of December 31, 2018
|
$
|
11,101
|
|
|
$
|
3,932
|
|
|
$
|
5,171
|
|
|
Add: GTN accruals recorded for product sales
|
5,452
|
|
|
12
|
|
|
167
|
|
|
(Less): Payments made and credits against GTN accruals
|
(8,998
|
)
|
|
(1,028
|
)
|
|
(13
|
)
|
|
Balance as of March 31, 2019
|
$
|
7,555
|
|
|
$
|
2,916
|
|
|
$
|
5,325
|
|
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
(h) Contract Liabilities
“Contract liabilities” consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Customer deposit for EVOMELA supply in China territory (
see Note 7
)
|
$
|
4,850
|
|
|
$
|
4,850
|
|
|
Contract liabilities
|
$
|
4,850
|
|
|
$
|
4,850
|
|
(i) Other Long-Term Liabilities
“Other long-term liabilities” consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
|
|
December 31, 2018
|
|
Deferred compensation liability (
Note 9(f)
)
|
$
|
6,499
|
|
|
$
|
5,474
|
|
|
Lease liability - non-current portion (
Note 9(a)
)
|
3,114
|
|
|
—
|
|
|
Other tax liabilities
|
176
|
|
|
176
|
|
|
Other long-term liabilities
|
$
|
9,789
|
|
|
$
|
5,650
|
|
4. STOCK-BASED COMPENSATION
We report our stock-based compensation expense (inclusive of our incentive stock plan, employee stock purchase plan, and 401(k) contribution matching program) in the accompanying Condensed Consolidated Statements of Operations, based on the assigned department of the recipient. Stock-based compensation expense, included within “total operating costs and expenses” for the
three
months ended
March 31, 2019
and
2018
, was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2019
|
|
2018
|
|
Selling, general and administrative
|
$
|
3,626
|
|
|
$
|
2,253
|
|
|
Research and development
|
969
|
|
|
632
|
|
|
Total stock-based compensation
|
$
|
4,595
|
|
|
$
|
2,885
|
|
5. NET LOSS PER SHARE
Net loss per share was computed by dividing net loss by the weighted average number of common shares outstanding for the
three
months ended
March 31, 2019
and
2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2019
|
|
2018
|
|
Weighted average shares outstanding - basic and diluted
|
109,552,602
|
|
|
100,809,853
|
|
|
Net loss
|
$
|
(19,155
|
)
|
|
$
|
(15,816
|
)
|
|
Net loss per share – basic and diluted
|
$
|
(0.17
|
)
|
|
$
|
(0.16
|
)
|
The below outstanding securities were excluded from the above calculation of net loss because their impact under the “treasury stock method” and “if-converted method” would have been anti-dilutive due to our net loss per share for the
three
months ended
March 31, 2019
and
2018
, respectively.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
2019
|
|
2018
|
|
Common stock options
|
1,816,531
|
|
|
5,589,852
|
|
|
Restricted stock awards
|
1,374,954
|
|
|
1,875,569
|
|
|
Restricted stock units
|
343,334
|
|
|
210,214
|
|
|
Employee stock purchase plan shares
|
38,848
|
|
|
24,064
|
|
|
2018 Convertible Notes
|
—
|
|
|
3,854,959
|
|
|
Common stock warrants
|
—
|
|
|
261,622
|
|
|
Total
|
3,573,667
|
|
|
11,816,280
|
|
6. FAIR VALUE MEASUREMENTS
The table below summarizes certain asset and liability fair values that are included within our accompanying Condensed Consolidated Balance Sheets, and their designations among the three fair value measurement categories (see
Note 2(x))
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2019
Fair Value Measurements
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
Bank CDs
|
$
|
—
|
|
|
$
|
87
|
|
|
$
|
—
|
|
|
$
|
87
|
|
|
|
Money market funds
|
257,003
|
|
|
—
|
|
|
—
|
|
|
257,003
|
|
|
|
Equity securities (
Note 7
)
|
33,142
|
|
|
—
|
|
|
—
|
|
|
33,142
|
|
|
|
Equity forward-sale contract (
Note 7
)
|
793
|
|
|
—
|
|
|
—
|
|
|
793
|
|
|
|
Mutual funds
|
—
|
|
|
65
|
|
|
—
|
|
|
65
|
|
|
|
Deferred compensation investments (life insurance cash surrender value (
Note 3(e)
)
|
—
|
|
|
7,270
|
|
|
—
|
|
|
7,270
|
|
*
|
|
Restricted cash
|
4,000
|
|
|
—
|
|
|
—
|
|
|
4,000
|
|
|
|
|
$
|
294,938
|
|
|
$
|
7,422
|
|
|
$
|
—
|
|
|
$
|
302,360
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
Deferred compensation liability (
Note 9(f)
)
|
$
|
—
|
|
|
$
|
7,223
|
|
|
$
|
—
|
|
|
$
|
7,223
|
|
*
|
|
|
$
|
—
|
|
|
$
|
7,223
|
|
|
$
|
—
|
|
|
$
|
7,223
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018
Fair Value Measurements
|
|
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
Bank CDs
|
$
|
—
|
|
|
$
|
86
|
|
|
$
|
—
|
|
|
$
|
86
|
|
|
|
Money market funds
|
—
|
|
|
142,745
|
|
|
—
|
|
|
142,745
|
|
|
|
Equity securities (
Note 7
)
|
46,422
|
|
|
—
|
|
|
—
|
|
|
46,422
|
|
|
|
Mutual funds
|
—
|
|
|
78
|
|
|
—
|
|
|
78
|
|
|
|
Deferred compensation investments (life insurance cash surrender value (
Note 3(e)
)
|
—
|
|
|
6,274
|
|
|
—
|
|
|
6,274
|
|
*
|
|
|
$
|
46,422
|
|
|
$
|
149,183
|
|
|
$
|
—
|
|
|
$
|
195,605
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
Deferred compensation liability (
Note 9(f)
)
|
$
|
—
|
|
|
$
|
6,167
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
*
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
|
$
|
—
|
|
|
$
|
6,167
|
|
|
* The reported amount of “deferred compensation investments” is based on the cash surrender value of employee life insurance policies at each period-end, while the reported amount of “deferred executive compensation liability” is based on the period-end market value of investments selected by employee participants of the deferred compensation plan.
We did not have any transfers between
“Level 1”
and
“Level 2”
(see
Note 2(x)
) measurement categories for any periods presented.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
Our carrying amounts of financial instruments such as cash equivalents, prepaid expenses, accounts payable, and accrued liabilities approximate their related fair values due to their short-term nature.
7. CASI HOLDINGS AND EVOMELA SUPPLY CONTRACT
Overview of CASI Transaction
In 2014, we executed
three
perpetual out-license agreements for our former products ZEVALIN, MARQIBO, and EVOMELA (“CASI Out-Licensed Products”) with CASI, a publicly-traded biopharmaceutical company (NASDAQ: CASI) with a primary focus on the China market (collectively, the “CASI Out-License”). Under the CASI Out-License, we received CASI common stock and a secured promissory note and CASI gained the exclusive rights to distribute the CASI Out-Licensed Products in greater China (which includes Taiwan, Hong Kong and Macau). On March 1, 2019, we completed the Commercial Product Portfolio Transaction and substantially all of the contractual rights and obligations associated with the Commercial Product Portfolio, including the CASI Out-License, were transferred to Acrotech at closing. However, we will continue to supply CASI with EVOMELA under an active contract that tentatively was not assumed by Acrotech as part of our Commercial Product Portfolio Transaction (see
Note 3(h)
). After we fulfill this open order, Acrotech will then assume future supply of this product to CASI and we will not have any further involvement with the arrangement.
Our Ownership in CASI at
March 31, 2019
Under certain conditions that expired in December 2017, we exercised our rights during 2016 and 2017 to purchase additional shares of CASI common stock at par value in order to maintain our post-investment ownership percentage. Our aggregate holding of
11.5 million
CASI common shares as of
March 31, 2019
represented an approximate
12.1%
ownership with a fair market value of
$33.1 million
(see
Note 3(a)
)
.
In April 2019, we completed the sale of
1.5 million
of these shares under a forward-sales contract (see
Note 3(c)
).
8. CONVERTIBLE SENIOR NOTES AND INTEREST EXPENSE
Overview of 2013 Convertible Notes
On December 17, 2013, we entered into an agreement for the sale of
$120 million
aggregate principal amount of
2.75%
Convertible Senior Notes (the “2013 Convertible Notes”). During 2016 and 2017 we completed certain open market purchases to retire
$79.5 million
of principal. Maturity of the 2013 Convertible Notes occurred on December 15, 2018 and substantially all remaining notes were converted into our common stock at a rate of
95
shares per
$1,000
principal units.
Components of Interest Expense on 2013 Convertible Notes
The following table sets forth the components of interest expense recognized in the accompanying Condensed Consolidated Statements of Operations for the 2013 Convertible Notes:
|
|
|
|
|
|
|
|
|
Three months ended March 31, 2018
|
|
Stated coupon interest expense
|
$
|
279
|
|
|
Amortization of debt issuance costs
|
61
|
|
|
Accretion of debt discount
|
533
|
|
|
Total
|
$
|
873
|
|
|
Effective interest rate
|
8.4
|
%
|
9. FINANCIAL COMMITMENTS & CONTINGENCIES AND KEY LICENSE AGREEMENTS
(a) Facility and Equipment Leases
Overview
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
In the ordinary course of our business, we enter into leases with unaffiliated parties for the use of (i) office and research facilities and (ii) office equipment. Our current leases have remaining terms ranging from less than
one year
to
five years
and none include any residual guarantees, restrictive covenants, or options to extend or early-terminate.
Our office and research facilities leases have minimum annual rents, payable monthly, and some carry fixed annual rent increases. Under some of these arrangements, real estate taxes, insurance, certain operating expenses, and common area maintenance are reimbursable to the lessor. These amounts are expensed as incurred, as they are typically variable and therefore excluded from the measurement of the right-of-use asset and lease liability.
Adoption of the New Lease Accounting Standard
On January 1, 2019, we adopted
ASU 2016-02, Leases
(“
Topic 842
”). Under this new lease standard, we are required to recognize a "right-of-use asset" and "lease liability" on our accompanying Condensed Consolidated Balance Sheets for all leases (except for any lease with an original term of less than 12 months).
In July 2018, the FASB issued ASU 2018-11, Lease (Topic 842) Targeted Improvements, providing a package of practical expedients and an optional transition method, in which the new standard is not applied to prior periods. We elected the optional transition method upon adoption of this ASU on January 1, 2019 and the package of practical expedients available under the transition provisions. Therefore, we did not reassess the following upon adoption: (i) whether expired or existing contracts contain leases, (ii) lease classification, and (iii) initial direct costs for existing leases.
This asset and liability substantially represents our aggregate benefit of use and present-value obligation to make corresponding minimum lease payments for the duration of each lease term, respectively. Since the implicit rate is not readily determinable in any of our leases, we apply an estimated incremental borrowing rate as of the lease commencement date using the “effective interest method” to derive the present value of our aggregate lease liability. Accordingly, we recorded
$4.2 million
to our January 1, 2019 balance sheet for both our right-of-use asset within “facility and equipment under lease” and our lease liability within “accounts payable and accrued liabilities” and “other long-term liabilities.” The asset and liability associated with each lease is amortized over the respective lease term, based on the incremental borrowing rate for each.
We elected to not separate lease components from non-lease components in our measurement of minimum lease payments for (i) facility, and (ii) office equipment leases. We also elected the short-term lease practical expedient, in which we will not recognize a right-of-use asset and lease liability for leases with a term of 12 months or less. We recognize lease expense on a straight-line basis over the expected lease term, as reported within “selling, general and administrative” expense on the accompanying Condensed Consolidated Statement of Operations, as have only operating leases. For the three months ended March 31, 2019 and 2018, this expense aggregated
$0.6 million
and
$0.4 million
, respectively.
Financial Reporting Captions
The below table summarizes these lease asset and liability accounts presented on our accompanying Condensed Consolidated Balance Sheets:
|
|
|
|
|
|
|
|
|
|
|
Operating Leases*
|
|
Condensed Consolidated Balance Sheet Caption
|
|
Balance at March 31, 2019
|
|
Operating lease right-of-use assets - non-current
|
|
Facility and equipment under lease
|
|
$
|
3,774
|
|
|
|
|
|
|
|
|
Operating lease liabilities - current
|
|
Accounts payable and other accrued liabilities
|
|
$
|
808
|
|
|
Operating lease liabilities - non-current
|
|
Other long-term liabilities
|
|
3,114
|
|
|
Total operating lease liabilities
|
|
|
|
$
|
3,922
|
|
* As of March 31, 2019, we have no “finance leases” as defined in
Topic 842
.
Components of Lease Expense
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
We report our total operating lease expense, (inclusive of our variable lease payments and short-term lease cost) in the accompanying Condensed Consolidated Statements of Operations. Total lease expense, included within “total operating costs and expenses” for the
three
months ended
March 31, 2019
, was as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, 2019
|
|
Operating lease cost
|
|
$
|
459
|
|
|
Variable lease cost
|
|
108
|
|
|
Short-term lease cost
|
|
15
|
|
|
Total lease cost*
|
|
$
|
583
|
|
* As of March 31, 2019, we have no “sublease income” as defined in
Topic 842
.
Weighted Average Remaining Lease Term and Discount Rate
|
|
|
|
|
|
|
|
|
|
|
|
Weighted Average Remaining Lease Term
|
|
Weighted Average Discount Rate
|
|
Operating leases as of March 31, 2019
|
|
3 years
|
|
7.8
|
%
|
Future Lease Payments
The below table summarizes our (i) minimum lease payments over the next five years, (ii) implied interest (from the application of our incremental borrowing rate), and (iii) present value of future lease payments:
|
|
|
|
|
|
|
|
|
Operating Leases - future payments
|
|
March 31, 2019
|
|
2019 (remaining)
|
|
$
|
1,015
|
|
|
2020
|
|
1,252
|
|
|
2021
|
|
1,303
|
|
|
2022
|
|
828
|
|
|
2023
|
|
87
|
|
|
Total future lease payments, undiscounted
|
|
$
|
4,485
|
|
|
Less: Implied interest
|
|
(563
|
)
|
|
Present value of operating lease payments
|
|
$
|
3,922
|
|
The below table summarizes our future minimum lease payments under our operating leases as of December 31, 2018:
|
|
|
|
|
|
|
|
|
Year ended December 31, 2018
|
|
Operating Lease
Minimum
Payments
|
|
2019
|
|
1,486
|
|
|
2020
|
|
1,441
|
|
|
2021
|
|
1,465
|
|
|
2022
|
|
828
|
|
|
2023 and thereafter
|
|
87
|
|
|
|
|
$
|
5,308
|
|
As of March 31, 2019, we have an operating lease which has not yet commenced with total undiscounted lease obligations of
$0.7 million
. This agreement was entered into during the first quarter of 2019 to lease office space for our principle executive office in Henderson, Nevada. The lessor is currently having tenant improvements constructed and we do not have access to the
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
building until construction is complete. The lease is expected to commence in the second quarter of 2019 when construction of the tenant improvements is completed.
(b) In/Out Licensing Agreements and Co-Development Arrangements
Overview
The in-license agreements for our development-stage drug products provide us with territory-specific rights to their manufacture and distribution (including further sub-licensing/out-licensing rights). We are generally responsible for all related clinical development costs, patent filings and maintenance costs, marketing costs, and liability insurance costs. We are also obligated to make specified milestone payments to our licensors upon the achievement of certain regulatory and sales milestones, and to pay royalties based on our net sales of all in-licensed products. We also may enter into out-license agreements for territory-specific rights to these drug products which include one or more of: upfront license fees, royalties from our licensees’ sales, and/or milestone payments from our licensees’ sales or regulatory achievements. For certain drug products, we may enter into cost-sharing arrangements with licensees and licensors.
Impact of Commercial Product Portfolio Transaction on Rights and Obligations associated with the Product Portfolio
On March 1, 2019, we completed the Commercial Product Portfolio Transaction and substantially all of the contractual rights and obligations associated with the Product Portfolio (as previously disclosed in
Note 17(b)
to our 2018 Annual Report on Form 10-K) were transferred to Acrotech at closing. These Condensed Consolidated Financial Statements are recast for all periods presented to reflect the sale of the assets and liabilities associated with our Product Portfolio, as well as the corresponding revenue-deriving activities and allocable expenses of this commercial business within “discontinued operations” - see
Notes 1
and
11
. Our most significant remaining agreements associated with our
continuing operations
are listed below, along with the key financial terms and our corresponding accounting and reporting conventions for each:
(i) ROLONTIS: Co-Development and Commercialization Agreement with Hanmi Pharmaceutical Co. Ltd
In October 2014, we exercised our option under a License Option and Research Collaboration Agreement dated January 2012 (as amended) with Hanmi Pharmaceutical Co. Ltd., or Hanmi, for ROLONTIS (formerly referred to as “LAPS-G-CSF” or “SPI-2012”), a drug based on Hanmi’s proprietary LAPSCOVERY™ technology for the treatment of chemotherapy induced neutropenia. Under the terms of this agreement, as amended, we have primary financial responsibility for the ROLONTIS development plan and hold its worldwide rights (except for Korea, China, and Japan). We are contractually obligated to pay Hanmi tiered royalties that range from the low double-digits to mid-teen on our net sales of ROLONTIS.
In January 2016, the first patient was dosed with ROLONTIS as part of our clinical trial. This triggered our contractual milestone payment to Hanmi, and in April 2016, we issued
318,750
shares of our common stock to Hanmi. We are responsible for further contractual payments upon our achievement of regulatory and sales milestones of
$13 million
and
$225 million
maximum, respectively. We will record “cost of product sales” and “other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs.
(ii) Poziotinib: In-License Agreement with Hanmi and Exclusive Patent and Technology License Agreement with MD Anderson
In February 2015, we executed an in-license agreement with Hanmi for poziotinib, a pan-HER inhibitor in Phase 2 clinical trials, (which has also shown single agent activity in the treatment of various cancer types during Phase 1 studies, including breast, gastric, colorectal, and lung cancers), and made an upfront payment for these rights. We are contractually obligated to pay Hanmi royalties in the low to mid-teen digits on our net sales of poziotinib.
Under the terms of this agreement, we received the exclusive rights to commercialize poziotinib, excluding Korea and China. Hanmi and its development partners are fully responsible for the completion of on-going Phase 2 trials in Korea. We are financially responsible for all other clinical studies. We are contractually obligated to make payments to Hanmi upon our achievement of certain regulatory and sales milestones, aggregating
$33 million
and
$325 million
, respectively. We will record “cost of product sales” and “other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs. We will pay Hanmi royalties in the low to mid-teen digits on our net sales of poziotinib, potentially reduced by royalties due to other third parties.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
In April 2018, we executed an exclusive patent and technology agreement for the use of poziotinib in treating patients with EGFR and HER2 exon 20 mutations in cancer and HER2 exon 19 mutations in cancer with The University of Texas M.D. Anderson Cancer Center (“MD Anderson”) that had discovered its use in treating these patient-types (“Exon 19/20 Patients”).
We are contractually obligated to make fixed payments to MD Anderson upon our achievement of certain regulatory and sales milestones, aggregating
$11 million
and
$23 million
, respectively. We will record “cost of product sales” and “other accrued liabilities” in the earliest period that we determine the respective milestone achievement is probable or occurs.
(c) Service Agreements for our Research and Development Activities
We have entered into various contracts with numerous third party service providers for the execution of our research and development initiatives (to which we assign discreet project codes in order to compile and monitor such expenses). These vendors include raw material suppliers and contract manufacturers for drug products not yet FDA approved, clinical trial sites, clinical research organizations, and data monitoring centers, among others. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on the achievement of certain events specified in the agreements - such as contract execution, progress of service completion, delivery of drug supply, and the dosing of patients in clinical studies.
We recognize these “research and development” expenses and corresponding “accounts payable and other accrued liabilities” in the accompanying financial statements based on estimates of our vendors’ progress of performed services, patient enrollments and dosing, completion of clinical studies, and other events. Should we decide to discontinue and/or slow-down the work on any project, the associated costs for those projects would typically be limited to the extent of the work completed, as we are generally able to terminate these contracts with adequate notice.
(d) Supply and Service Agreements for our Commercial Products
We have entered into various supply and service agreements, and/or have issued purchase orders, which obligate us to complete agreed-upon raw material purchases from certain vendors for the production of our in-development drug products through designated contract manufacturers. These commitments do not exceed our planned commercial requirements, and the contracted prices do not exceed current fair market values.
(e) Employment Agreements
We entered into revised employment agreements with each of our named executive officers (chief executive officer, chief operating officer, chief financial officer, and chief legal officer) in April and June 2018, which supersede any prior Change in Control Severance Agreements with such individuals. These agreements provide for the payment of certain benefits to each executive upon his separation of employment under specified circumstances. These arrangements are designed to encourage each to act in the best interests of our stockholders at all times during the course of a change in control event or other significant transaction.
(f) Deferred Compensation Plan
The Spectrum Pharmaceuticals, Inc. Deferred Compensation Plan (the “DC Plan”) is administered by the Compensation Committee of our Board of Directors and is intended to comply with the requirements of Section 409A of the Internal Revenue Code of 1986, as amended.
The DC Plan is maintained to provide special benefits for a select group of our employees (the “DC Participants”). DC Participants make annual elections to defer a portion of their eligible cash compensation which is then placed into their DC Plan accounts. We match a fixed percentage of these deferrals, and may make additional discretionary contributions. At
March 31, 2019
and
December 31, 2018
, the aggregate value of this DC Plan liability was
$7.2 million
and
$6.2 million
, respectively, and is included within “accounts payable and other accrued liabilities” and “other long-term liabilities” in the accompanying Condensed Consolidated Balance Sheets.
(g) Litigation
We are involved from time-to-time with various legal matters arising in the ordinary course of business. These claims and legal proceedings are of a nature we believe are normal and incidental to a pharmaceutical business, and may include product liability, intellectual property, employment matters, and other general claims. We may also be subject to derivative lawsuits from time to time.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are assessed at least quarterly and adjusted to reflect the impact of any settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. Although the ultimate resolution of these various matters cannot be determined at this time, we do not believe that such matters, individually or in the aggregate, will have a material adverse effect on our consolidated results of operations, cash flows, or financial condition.
Stockholder Litigation
Olutayo Ayeni v. Spectrum Pharmaceuticals, Inc., et al.
(Filed September 21, 2016 in the United States District Court, Central District of California; Case No. 2:16-cv-07074) (the “Ayeni Action”) and Glen Hartsock v. Spectrum Pharmaceuticals, Inc., et al. (Filed September 28, 2016 in the United States District Court, District Court of Nevada Case; No. 2:16-cv-02279-RFB-GWF) (the “Hartsock Action”). On November 15, 2016, the Ayeni Action was transferred to the United States District Court for the District of Nevada. The parties have stipulated to a consolidation of the Ayeni Action with the Hartsock Action. These class action lawsuits allege that we and certain of our executive officers made false or misleading statements and failed to disclose material facts about our business and the prospects of approval for our New Drug Application to the FDA for QAPZOLA in violation of Section 10(b) (and Rule 10b-5 promulgated thereunder) and 20(a) of the Securities Exchange Act of 1934, as amended. The plaintiffs seek damages, interest, costs, attorneys’ fees, and other unspecified equitable relief. We believe that these claims are without merit, and intend to vigorously defend against these claims. Furthermore, as of
March 31, 2019
, the value of a potential settlement cannot be reasonably estimated given its highly uncertain nature.
10. INCOME TAXES
We apply an estimated annual effective tax rate (“ETR”) approach for calculating a tax provision for interim periods, as required under GAAP. We recorded a benefit for income taxes from continuing operations of
$8.2 million
and
$1.1 million
for the
three
months ended
March 31, 2019
and
2018
, respectively. Our ETR differs from the U.S. federal statutory tax rate of
21%
primarily as a result of nondeductible expenses and the impact of the valuation allowance on our deferred tax assets.
Our provision for income taxes is computed using the asset and liability method, under which deferred tax assets and liabilities are recognized for the expected future tax consequences of temporary differences between the financial reporting and tax bases of assets and liabilities, and for the expected future tax benefit to be derived from tax loss and credit carryforwards. Deferred tax assets and liabilities are determined using the enacted tax rates in effect for the years in which those tax assets are expected to be realized. A valuation allowance is established when it is more likely than not the future realization of all or some of the deferred tax assets will not be achieved. The evaluation of the need for a valuation allowance is performed on a jurisdiction by jurisdiction basis, and includes a review of all available positive and negative evidence. We recognize the impact of a tax position in our financial statements only if that position is more likely than not to be sustained upon examination by taxing authorities, based on the technical merits of the position. Any interest and penalties related to uncertain tax positions will be reflected in income tax expense.
The intraperiod tax allocation guidance require that we allocate income taxes between continuing operations and other categories of earnings. When we have a year-to-date pre-tax loss from continuing operations and year-to-date pre-tax income in discontinued operations, applicable GAAP (
ASC 740-20-45-7
) requires that we allocate the income tax provision to other categories of earnings (including discontinued operations), and then record a related tax benefit in continuing operations. For the
three
months ended
March 31, 2019
and 2018, we recognized net income from discontinued operations while sustaining losses from continuing operations. Because of the required allocation, we recorded an income tax benefit of
$8.2
and
$1.1 million
within “benefit for income taxes from continuing operations” and income tax expense of
$6.8 million
and
$1.1 million
within “income from discontinued operations, net of income taxes” on the Condensed Consolidated Statements of Operations for the
three
months ended
March 31, 2019
and 2018, respectively.
Our net tax benefit for the three months ended March 31, 2019, prior to the application of intraperiod tax allocation guidance was
$1.5 million
. This tax benefit arose from the reversal of deferred tax liabilities recorded on our Condensed Consolidated Balance Sheet as of December 31, 2018 that were associated with indefinite-lived intangible assets that were sold as part of our Commercial Product Portfolio Transaction. The tax benefit for the three months ended March 31, 2018, prior to the application of intraperiod tax allocation guidance was zero.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
11. DISCONTINUED OPERATIONS
Overview
On March 1, 2019, we completed the Commercial Product Portfolio Transaction -- see
Note 1(b)
(as we first announced on January 17, 2019 on Form 8-K, upon the signing of a definitive asset purchase agreement).
In accordance with applicable GAAP (
ASC 205-20, Presentation of Financial Statements
), the revenue-deriving activities and allocable expenses of our sold commercial operation, as well as the assets and liabilities connected to the Commercial Product Portfolio, are separately classified as “discontinued” for all periods presented within the accompanying Condensed Consolidated Statement of Operations and Condensed Consolidated Balance Sheet.
Condensed Consolidated Statement of Operations
The following table presents the various elements of “income from discontinued operations, net of income taxes” as reported in the accompanying Condensed Consolidated Statement of Operations for the three months ended
March 31, 2019
and
2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2019
|
|
2018
|
|
Product sales, net
|
|
$
|
14,183
|
|
|
$
|
28,111
|
|
|
License fees and service revenue
|
|
290
|
|
|
2,384
|
|
|
Total revenues
|
|
$
|
14,473
|
|
|
$
|
30,495
|
|
|
Operating costs and expenses:
|
|
|
|
|
|
Cost of sales (excluding amortization of intangible assets)
|
|
3,168
|
|
|
6,813
|
|
|
Selling, general and administrative
|
|
5,951
|
|
|
7,488
|
|
|
Research and development
|
|
2,536
|
|
|
4,530
|
|
|
Amortization of intangible assets
|
|
1,248
|
|
|
6,947
|
|
|
Restructuring - employee severance (
Note 12
)
|
|
6,297
|
|
|
—
|
|
|
Total operating costs and expenses
|
|
$
|
19,200
|
|
|
$
|
25,778
|
|
|
Loss from discontinued operations
|
|
$
|
(4,727
|
)
|
|
$
|
4,717
|
|
|
Other income (expense):
|
|
|
|
|
|
Change in fair value of contingent consideration
|
|
(1,478
|
)
|
|
(291
|
)
|
|
Gain on sale of Commercial Product Portfolio*
|
|
33,644
|
|
|
—
|
|
|
Total other income (expense)
|
|
$
|
32,166
|
|
|
$
|
(291
|
)
|
|
Income from discontinued operations before income taxes
|
|
27,439
|
|
|
4,426
|
|
|
Provision for income taxes from discontinued operations**
|
|
(6,774
|
)
|
|
(1,070
|
)
|
|
Income from discontinued operations, net of income taxes
|
|
$
|
20,665
|
|
|
$
|
3,356
|
|
*This pre-tax gain on sale represents the
$158.8 million
proceeds from the Commercial Product Portfolio Transaction
less
our
$121.2
book value of transferred net assets (inclusive of assumed liabilities) to Acrotech on the March 1, 2019 closing date,
less
legal and banker fees for the
three
months ended
March 31, 2019
aggregating
$3.9 million
.
**This income tax provision represents an allocation of taxes as required under intraperiod allocation guidance (see
Note 10
). Due to our aggregate net operating loss-carryforwards, no
federal or state income tax payments are expected to be made relating to our current year activity, inclusive of our gain on sale of the Commercial Product Portfolio.
Condensed Consolidated Balance Sheets
Accounts receivable derived from our product sales on and prior to February 28, 2019 was not transferred to Acrotech as part of Commercial Product Portfolio Transaction, nor were our GTN liabilities and trade accounts payable assumed by Acrotech that were associated with our commercial activities on and prior to February 28, 2019 (see
Note 3(g)
). Accordingly, these specific assets and liabilities remain presented within “accounts receivable, net of allowance for doubtful accounts” and “accounts payable and other accrued liabilities” on the accompanying Condensed Consolidated Balance Sheets.
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
The following table presents a summary of our “discontinued operations, assets” and “discontinued operations, liabilities” as of December 31, 2018 within the accompanying Condensed Consolidated Balance Sheets (representing those assets and liabilities transferred to Acrotech as part of the Commercial Product Portfolio Transaction):
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018
|
|
Inventories
|
|
$
|
3,550
|
|
|
Prepaid expenses and other assets
|
|
2,005
|
|
|
Discontinued operations, current assets
|
|
$
|
5,555
|
|
|
|
|
|
|
Intangible assets, net of accumulated amortization
|
|
111,594
|
|
|
Goodwill
|
|
18,061
|
|
|
Other assets
|
|
2,970
|
|
|
Discontinued operations, non-current assets
|
|
$
|
132,625
|
|
|
|
|
|
|
FOLOTYN development liability
|
|
2,311
|
|
|
Discontinued operations, current liabilities
|
|
$
|
2,311
|
|
|
|
|
|
|
FOLOTYN development liability, less current portion
|
|
9,686
|
|
|
Acquisition-related contingent obligations
|
|
4,345
|
|
|
Discontinued operations, non-current liabilities
|
|
$
|
14,031
|
|
Condensed Consolidated Statement of Cash Flows
The following table presents significant non-cash items for our discontinued operations that are included as adjustments in the accompanying Condensed Consolidated Statements of Cash Flows for the three months ended
March 31, 2019
and
2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2019
|
|
2018
|
|
Depreciation and amortization
|
|
$
|
1,263
|
|
|
$
|
6,969
|
|
|
Stock-based compensation
|
|
$
|
3,405
|
|
|
$
|
1,593
|
|
|
Change in fair value of contingent consideration
|
|
$
|
1,478
|
|
|
$
|
291
|
|
12. RESTRUCTURING COSTS RELATED TO SALE OF COMMERCIAL PRODUCT PORTFOLIO
Employee Severance
On March 1, 2019, we completed the Commercial Product Portfolio Transaction (see
Note 1(b)
) and
88
of our employees were (1) terminated at closing or (2) given notice of their May 31, 2019 termination date and asked to provide transition services for the benefit of Acrotech (as provided by an agreement with Acrotech entered into contemporaneously with our sale). For the three months ended March 31, 2019, we recognized
$0.2 million
of income for services rendered to Acrotech for this transition services agreement.
The employees in (1) above were entitled to cash severance payments and acceleration of their unvested restricted stock awards and stock options. For the
three
months ended
March 31, 2019
, we fully recognized the aggregate value of
$8.3 million
for this severance benefit, of which
$6.3 million
,
$1.5 million
, and
$0.5 million
is included on the accompanying Condensed Consolidated Statements of Operations within “income from discontinued operations, net of income taxes” (see
Note 11
), “selling, general, and administrative” expenses and “research and development” expenses, respectively.
The employees in (2) above are also entitled to cash severance payments and acceleration of their unvested restricted stock awards and stock options, though on May 31, 2019. The aggregate value of these one-time cash payments and stock-
Notes to Condensed Consolidated Financial Statements
(all tabular amounts presented in thousands, except share, per share, interest rate, and number of years)
(Unaudited)
based award accelerations is
$0.6 million
. Due to the ongoing service requirements of these employees, we are amortizing this value through expense on a ratable basis beginning March 1, 2019 through May 31, 2019. For the
three
months ended
March 31, 2019
, we recognized
$0.2 million
for this severance benefit and is included within “selling, general, and administrative” expenses on the accompanying Condensed Consolidated Statements of Operations, and within “accrued payroll and benefits” and “additional paid-in capital” (for stock-based awards) on the accompanying Condensed Consolidated Balance Sheets. We will recognize the remaining
$0.4 million
within “selling, general, and administrative” expense through May 31, 2019.
The unpaid cash severance for our former employees was
$1.1 million
at
March 31, 2019
, of which
$0.4 million
is reported within “discontinued operations, current liabilities” and
$0.7 million
is recorded within “accrued payroll and benefits” on the accompanying Condensed Consolidated Balance Sheets.
13. SUBSEQUENT EVENT
In-License Agreement with ImmunGene
On April 15, 2019 we executed a license agreement with ImmunGene, Inc. (“ImmunGene”) for
two
innovative early stage drugs, and an exclusive license for the intellectual property related to the FIT antibody-interferon fusion technology drug delivery platform. The first drug is an antibody-interferon fusion molecule directed against CD20 (Anti-CD20-IFNá), and is in Phase 1 development for treating relapsed or refractory non-Hodgkin lymphoma, including diffuse large b-cell lymphoma patients (representing a considerable unmet medical need). The second drug is an antibody-interferon fusion molecule directed against GRP94, a target for which currently there are no existing approved therapies, and has the potential for treating both solid and hematologic malignancies. Under the terms of this agreement, we received the exclusive rights to commercialize these drugs for any indication, and are financially responsible for the clinical and regulatory development programs.
We are contractually obligated to make an upfront payment of approximately
$3.0 million
to ImmunGene, in addition to further contractual payments upon our achievement of certain regulatory and sales milestones, and royalties on our net sales of each drug.
ITEM 2.