NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
1. Business Organization and Presentation
Business organization
Vanda Pharmaceuticals Inc. (the Company) is a global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. The Company commenced its operations in 2003 and operates in
one
reporting segment. The Company’s portfolio includes the following products:
|
|
•
|
HETLIOZ
®
(tasimelteon), a product for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24), was approved by the U.S. Food and Drug Administration (FDA) in January 2014 and launched commercially in the U.S. in April 2014. In July 2015, the European Commission (EC) granted centralized marketing authorization with unified labeling for HETLIOZ
®
for the treatment of Non-24 in totally blind adults. HETLIOZ
®
was commercially launched in Germany in August 2016. HETLIOZ
®
has potential utility in a number of other circadian rhythm disorders and is presently in clinical development for the treatment of Pediatric Non-24, jet lag disorder and Smith-Magenis Syndrome (SMS).
|
|
|
•
|
Fanapt
®
(iloperidone), a product for the treatment of schizophrenia, the oral formulation of which was approved by the FDA in May 2009 and launched commercially in the U.S. by Novartis Pharma AG (Novartis) in January of 2010. Novartis transferred all the U.S. and Canadian commercial rights to the Fanapt
®
franchise to the Company on December 31, 2014. Additionally, the Company’s distribution partners launched Fanapt
®
in Israel in 2014. Fanapt
®
has potential utility in a number of other disorders. An assessment of new Fanapt
®
clinical opportunities is ongoing.
|
|
|
•
|
Tradipitant (VLY-686), a small molecule neurokinin-1 receptor (NK-1R) antagonist, which is presently in clinical development for the treatment of chronic pruritus in atopic dermatitis and the treatment of gastroparesis.
|
|
|
•
|
VTR-297, a small molecule histone deacetylase (HDAC) inhibitor presently in clinical development for the treatment of hematologic malignancies.
|
|
|
•
|
Portfolio of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) activators and inhibitors.
|
|
|
•
|
VQW-765, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist.
|
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements for the fiscal year ended
December 31, 2017
included in the Company’s annual report on Form 10-K. The financial information as of
June 30, 2018
and for the
three and six
months ended
June 30, 2018
and
2017
is unaudited, but in the opinion of management, all adjustments considered necessary for a fair statement of the results for these interim periods have been included. The condensed consolidated balance sheet data as of
December 31, 2017
was derived from audited financial statements but does not include all disclosures required by GAAP.
The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. The financial information included herein should be read in conjunction with the consolidated financial statements and notes in the Company’s annual report on Form 10-K for the fiscal year ended
December 31, 2017
.
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates that affect the reported amounts of assets and liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts of revenue and expenses during the reporting period. Management continually re-evaluates its estimates, judgments and assumptions, and management’s evaluation could change. Actual results could differ from those estimates.
Revenue Recognition
In accordance with Accounting Standards Codification (ASC) Subtopic 606
Revenue from Contracts with Customers
(ASC 606), which the Company adopted January 1, 2018, the Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. The Company recognizes revenue when control of the product is transferred to the customer in an amount that reflects the consideration the Company expects to be entitled to in exchange for those product sales, which is typically once the product physically arrives at the customer. Sales taxes, value add taxes, and usage-based taxes are excluded from revenues.
The Company’s revenues consist of net product sales of HETLIOZ
®
and net product sales of Fanapt
®
. Net sales by product for the three and
six
months ended
June 30, 2018
and
2017
were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
(in thousands)
|
June 30,
2018
|
|
June 30,
2017
|
|
June 30,
2018
|
|
June 30,
2017
|
HETLIOZ
®
product sales, net
|
$
|
28,045
|
|
|
$
|
22,507
|
|
|
$
|
53,468
|
|
|
$
|
42,689
|
|
Fanapt
®
product sales, net
|
19,305
|
|
|
19,549
|
|
|
37,474
|
|
|
36,782
|
|
|
$
|
47,350
|
|
|
$
|
42,056
|
|
|
$
|
90,942
|
|
|
$
|
79,471
|
|
Major Customers
HETLIOZ
®
is only available in the U.S. for distribution through a limited number of specialty pharmacies, and is not available in retail pharmacies. Fanapt
®
is available in the U.S. for distribution through a limited number of wholesalers and is available in retail pharmacies. The Company invoices and records revenue when its customers, specialty pharmacies and wholesalers, receive product from the third-party logistics warehouse which is the point at which control is transferred to the customer. There were
five
major customers that each accounted for more than 10% of total revenues and, as a group, represented
88%
of total revenues for the
six
months ended
June 30, 2018
. There were
five
major customers that each accounted for more than 10% of accounts receivable and, as a group, represented
90%
of total accounts receivable at
June 30, 2018
. The Company evaluates outstanding receivables to assess collectability. In performing this evaluation, the Company analyzes economic conditions, the aging of receivables and customer specific risks. Using this information, the Company reserves an amount that it estimates may not be collected.
Reserves for Variable Consideration
The transaction price is determined based upon the consideration to which the Company will be entitled in exchange for transferring product to the customer. The Company’s product sales are recorded net of applicable discounts, rebates, chargebacks, service fees, co-pay assistance and product returns that are applicable for various government and commercial payors. The Company estimates the amount of variable consideration that should be included in the transaction price utilizing the most likely amount method and updates its estimate at each reporting date. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Reserves for variable consideration for rebates, chargebacks and co-pay assistance are based upon the insurance benefits of the end customer, which are estimated using historical activity and, where available, actual and pending prescriptions for which the Company has validated the insurance benefits. Reserves for variable consideration are classified as product revenue allowances on the condensed consolidated balance sheets, with the exception of prompt-pay discounts which are classified as reductions of accounts receivable. The reserve for product returns for which the product may not be returned for a period of greater than one year from the balance sheet date is included as a component of other non-current liabilities in the condensed consolidated balance sheets. Uncertainties related to variable consideration are generally resolved in the quarter subsequent to period end, with the exception of product returns which are resolved during the product expiry period specified in the customer contract. The Company currently records sales allowances for the following:
Prompt-pay:
Specialty pharmacies and wholesalers are offered discounts for prompt payment. The Company expects that the specialty pharmacies and wholesalers will earn prompt payment discounts and, therefore, deducts the full amount of these discounts from total product sales when revenues are recognized.
Rebates:
Allowances for rebates include mandated and supplemental discounts under the Medicaid Drug Rebate Program as well as contracted rebate programs with other payors. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public
sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory or contracted discount rates and expected patient utilization.
Chargebacks:
Chargebacks are discounts that occur when contracted indirect customers purchase directly from specialty pharmacies and wholesalers. Contracted indirect customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy or wholesaler, in turn, charges back the difference between the price initially paid by the specialty pharmacy or wholesaler and the discounted price paid to the specialty pharmacy or wholesaler by the contracted customer.
Medicare Part D Coverage Gap:
Medicare Part D prescription drug benefit mandates manufacturers to fund approximately
50%
of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Vanda accounts for the Medicare Part D coverage gap using a point of sale model. Estimates for expected Medicare Part D coverage gap are based in part on historical activity and, where available, actual and pending prescriptions for which the Company has validated the insurance benefits.
Service Fees:
The Company receives sales order management, data and distribution services from certain customers. These fees are based on contracted terms and are known amounts. The Company accrues service fees at the time of revenue recognition, resulting in a reduction of product sales and the recognition of an accrued liability, unless it is a payment for a distinct good or service from the customer in which case the fair value of those distinct goods or services are recorded as selling, general and administrative expense.
Co-payment Assistance:
Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Co-pay assistance utilization is based on information provided by the Company’s third-party administrator.
Product Returns
: Consistent with industry practice, the Company generally offers direct customers a limited right to return as defined within the Company’s returns policy. The Company considers several factors in the estimation process, including historical return activity, expiration dates of product shipped to specialty pharmacies, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors. The Company does not expect returned goods to be resalable. There was no right of return asset as of
June 30, 2018
or
December 31, 2017
.
Non-Cash Investing and Financing Activities
As of
June 30, 2018
and
2017
, the Company accrued property, plant and equipment purchases in the amount of
zero
and
$0.3 million
, respectively.
Recent Accounting Pronouncements
In November 2016, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-18,
Restricted Cash
. The new standard requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The standard is effective for annual reporting periods beginning after December 15, 2017, and interim periods within annual periods beginning after December 15, 2017. The Company adopted this new standard in the first quarter of 2018 and applied the provisions retrospectively. As a result of the adoption of the new guidance, the Company increased the beginning of year total amount shown on the condensed consolidated statements of cash flows by
$0.7 million
for the
six
months ended
June 30, 2018
, equal to the balance of restricted cash included in the condensed consolidated balance sheets as of
December 31, 2017
. The Company increased the beginning of year and end of year total amounts shown on the consolidated statements of cash flows by
$0.8 million
for the
six
months ended
June 30, 2017
, equal to the balance of restricted cash included in the condensed consolidated balance sheets as of the period ended
June 30, 2017
and
December 31, 2016
. Restricted cash relates primarily to amounts held as collateral for letters of credit for leases for office space at the Company’s Washington, D.C. headquarters. As of
June 30, 2018
, restricted cash of
$0.1 million
and
$0.6 million
is included in prepaid and other current assets and other non-current assets, respectively. As of
December 31, 2017
, restricted cash of
$0.7 million
is included in other non-current assets.
In August 2016, the FASB issued ASU 2016-15,
Statement of Cash Flows – Classification of Certain Cash Receipts and Cash Payments
, to clarify guidance on the classification of certain cash receipts and cash payments in the statement of cash flow. The standard is effective for annual reporting periods beginning after December 15, 2017, and interim periods within annual periods
beginning after December 15, 2017. The Company’s adoption of this standard in the first quarter of 2018 had no impact to the Company’s condensed consolidated financial statements.
In June 2016, the FASB issued ASU 2016-13,
Financial Instruments – Credit Losses,
related to the measurement of credit losses on financial instruments. The standard will require the use of an “expected loss” model for instruments measured at amortized cost. The standard is effective for years beginning after December 15, 2019, and interim periods within annual periods beginning after December 15, 2019. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s consolidated financial statements.
In February 2016, the FASB issued ASU 2016-2,
Leases
, which was further clarified by ASU 2018-10,
Codification Improvements to Topic 842, Leases
, and ASU 2018-11,
Leases - Targeted Improvements
, issued in July 2018. The new standard requires that lessees will need to recognize a right-of-use asset and a lease liability for virtually all of their leases (other than leases that meet the definition of a short-term lease). The liability will be equal to the present value of lease payments. The asset will be based on the liability subject to certain adjustments. For income statement purposes, the FASB retained a dual model, requiring leases to be classified as either operating or finance. Operating leases will result in straight-line expense (similar to current operating leases) while finance leases will result in a front-loaded expense pattern (similar to current capital leases). The new standard is effective for annual periods ending after December 15, 2018, and interim periods within annual periods beginning after December 15, 2018. Early adoption is permitted. The Company is evaluating the impact of this standard on the Company’s consolidated financial statements; however, based on the Company’s current operating leases, it is expected that most operating lease commitments will be recognized as operating lease liabilities and right-of-use assets upon adoption.
In May 2014, the FASB issued ASU 2014-9,
Revenue from Contracts with Customers
. This ASU supersedes the revenue recognition requirements in ASC 605,
Revenue Recognition
, and creates ASC 606,
Revenue from Contracts with Customers
. ASC 606 requires companies to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for those goods or services. Under the new standard, revenue is recognized when a customer obtains control of a good or service. The standard allows for two transition methods—entities can either apply the new standard (i) retrospectively to each prior reporting period presented (full retrospective), or (ii) retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial adoption (modified retrospective). In July 2015, the FASB issued ASU 2015-14,
Revenue from Contracts with Customers
, which defers the effective date by one year to December 15, 2017 for fiscal years, and interim periods within those fiscal years, beginning after that date. Early adoption of the standard is permitted, but not before the original effective date of December 15, 2016. In March 2016, the FASB issued ASU 2016-8
Revenue from Contracts with Customers, Principal versus Agent Considerations (Reporting Revenue versus Net),
in April 2016, the FASB issued ASU 2016-10,
Revenue from Contracts with Customers, identifying Performance Obligations and Licensing
, and in May 2016, the FASB issued ASU 2016-12,
Revenue from Contracts
with Customers, Narrow-Scope Improvements and Practical Expedients, which provide additional clarification on certain topics addressed in ASU 2014-9. ASU 2016-8, ASU 2016-10, and ASU 2016-12 follow the same implementation guidelines as ASU 2014-9 and ASU 2015-14. The Company adopted this new standard in the first quarter of 2018 using the modified retrospective method to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with historic accounting under ASC 605. There was no impact to opening retained earnings as of January 1, 2018 as a result of adoption of the new standard. The impact to the condensed consolidated statements of operations if the Company had applied ASC 605 for the three and
six
months ended
June 30, 2018
is not material. As a result of adoption, the Company reclassified the provision for product revenue returns of
$3.9 million
from accounts receivable, net to product revenue allowances and other non-current liabilities in the condensed consolidated balance sheets as of
June 30, 2018
. The provision for product returns as of
December 31, 2017
of
$4.1 million
is included in accounts receivable in the condensed consolidated balance sheet.
3. Marketable Securities
The following is a summary of the Company’s available-for-sale marketable securities as of
June 30, 2018
, which all have contract maturities of less than one year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2018
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Market
Value
|
(in thousands)
|
|
|
|
U.S. Treasury and government agencies
|
$
|
70,254
|
|
|
$
|
—
|
|
|
$
|
(48
|
)
|
|
$
|
70,206
|
|
Corporate debt
|
80,215
|
|
|
126
|
|
|
(14
|
)
|
|
80,327
|
|
Asset-backed securities
|
19,793
|
|
|
—
|
|
|
(1
|
)
|
|
19,792
|
|
|
$
|
170,262
|
|
|
$
|
126
|
|
|
$
|
(63
|
)
|
|
$
|
170,325
|
|
The following is a summary of the Company’s available-for-sale marketable securities as of
December 31, 2017
, which all have contract maturities of less than one year:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017
|
Amortized
Cost
|
|
Gross
Unrealized
Gains
|
|
Gross
Unrealized
Losses
|
|
Fair
Market
Value
|
(in thousands)
|
|
|
|
U.S. Treasury and government agencies
|
$
|
60,681
|
|
|
$
|
—
|
|
|
$
|
(63
|
)
|
|
$
|
60,618
|
|
Corporate debt
|
49,168
|
|
|
12
|
|
|
(12
|
)
|
|
49,168
|
|
|
$
|
109,849
|
|
|
$
|
12
|
|
|
$
|
(75
|
)
|
|
$
|
109,786
|
|
4. Fair Value Measurements
Authoritative guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:
|
|
•
|
Level 1 — defined as observable inputs such as quoted prices in active markets
|
|
|
•
|
Level 2 — defined as inputs other than quoted prices in active markets that are either directly or indirectly observable
|
|
|
•
|
Level 3 — defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions
|
Marketable securities classified in Level 1 and Level 2 as of
June 30, 2018
and
December 31, 2017
consist of available-for-sale marketable securities. The valuation of Level 1 instruments is determined using a market approach, and is based upon unadjusted quoted prices for identical assets in active markets. The valuation of investments classified in Level 2 also is determined using a market approach based upon quoted prices for similar assets in active markets, or other inputs that are observable for substantially the full term of the financial instrument. Level 2 securities include certificates of deposit, commercial paper, corporate notes and asset-backed securities that use as their basis readily observable market parameters. The Company did not transfer any assets between Level 2 and Level 1 during the
six
months ended
June 30, 2018
and
2017
.
As of
June 30, 2018
, the Company held certain assets that are required to be measured at fair value on a recurring basis, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement as of June 30, 2018 Using
|
|
June 30,
2018
|
|
Quoted Prices in
Active Markets for
Identical Assets
|
|
Significant Other
Observable Inputs
|
|
Significant
Unobservable
Inputs
|
(in thousands)
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
U.S. Treasury and government agencies
|
$
|
98,196
|
|
|
$
|
98,196
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
85,312
|
|
|
—
|
|
|
85,312
|
|
|
—
|
|
Asset-backed securities
|
19,792
|
|
|
—
|
|
|
19,792
|
|
|
—
|
|
|
$
|
203,300
|
|
|
$
|
98,196
|
|
|
$
|
105,104
|
|
|
$
|
—
|
|
As of
December 31, 2017
, the Company held certain assets that are required to be measured at fair value on a recurring basis, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement as of December 31, 2017 Using
|
|
December 31,
2017
|
|
Quoted Prices in
Active Markets for
Identical Assets
|
|
Significant Other
Observable Inputs
|
|
Significant
Unobservable
Inputs
|
(in thousands)
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
U.S. Treasury and government agencies
|
$
|
60,618
|
|
|
$
|
60,618
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Corporate debt
|
53,164
|
|
|
—
|
|
|
53,164
|
|
|
—
|
|
|
$
|
113,782
|
|
|
$
|
60,618
|
|
|
$
|
53,164
|
|
|
$
|
—
|
|
Total assets measured at fair value as of
June 30, 2018
and
December 31, 2017
include
$33.0 million
and
$4.0 million
, respectively, of cash equivalents.
The Company also has financial assets and liabilities, not required to be measured at fair value on a recurring basis, which primarily consist of cash and cash equivalents, accounts receivable, restricted cash, accounts payable and accrued liabilities, and milestone obligations under license agreements, the carrying values of which materially approximate their fair values.
5. Inventory
The Company evaluates expiry risk by evaluating current and future product demand relative to product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. Inventory levels are evaluated for the amount of inventory that would be sold within one year. At certain times, the level of inventory can exceed the forecasted level of cost of goods sold for the next twelve months. The Company classifies the estimate of such inventory as non-current. Inventory consisted of the following as of
June 30, 2018
and
December 31, 2017
:
|
|
|
|
|
|
|
|
|
(in thousands)
|
June 30,
2018
|
|
December 31,
2017
|
Current assets
|
|
|
|
Work-in-process
|
$
|
66
|
|
|
$
|
80
|
|
Finished goods
|
1,127
|
|
|
760
|
|
|
$
|
1,193
|
|
|
$
|
840
|
|
Non-Current assets
|
|
|
|
Raw materials
|
$
|
87
|
|
|
$
|
87
|
|
Work-in-process
|
2,422
|
|
|
2,821
|
|
Finished goods
|
388
|
|
|
408
|
|
|
$
|
2,897
|
|
|
$
|
3,316
|
|
6. Intangible Assets
HETLIOZ
®
.
In January 2014, the Company announced that the FDA had approved the New Drug Application (NDA) for HETLIOZ
®
. As a result of this approval, the Company met a milestone under its license agreement with Bristol-Myers Squibb (BMS) that required the Company to make a license payment of
$8.0 million
to BMS. The
$8.0 million
is being amortized on a straight-line basis over the estimated economic useful life of the related product patents which is the remaining life of the U.S. method of use patent for HETLIOZ
®
that expires in
May 2034
.
In April 2018, the Company met its final milestone under its license agreement when cumulative worldwide sales of HETLIOZ
®
reached
$250.0 million
. As a result of the achievement of this milestone, the Company made a payment to BMS of
$25.0 million
in the second quarter of 2018. The
$25.0 million
obligation was recorded as a current liability as of
December 31, 2017
. The
$25.0 million
was determined to be additional consideration for the acquisition of the HETLIOZ
®
intangible asset and is being amortized on a straight-line basis over the estimated economic useful life of the related product patents which is the remaining life of the U.S. method of use patents for HETLIOZ
®
that expire in
May 2034
.
Fanapt
®
. In 2009, the Company announced that the FDA had approved the NDA for Fanapt
®
. As a result of this approval, the Company met a milestone under its original sublicense agreement with Novartis that required the Company to make a license payment of
$12.0 million
to Novartis. The
$12.0 million
was amortized on a straight-line basis over the remaining life of the U.S. composition of matter patent for Fanapt
®
to
November 2016
.
Pursuant to a settlement agreement entered into in December 2014, Novartis transferred all U.S. and Canadian rights in the Fanapt
®
franchise to the Company. As a result, the Company recognized an intangible asset of
$15.9 million
on December 31, 2014 related to the reacquired rights to Fanapt
®
, which was fully amortized on a straight-line basis as of
November 2016
. The useful life estimation for the Fanapt
®
intangible asset was based on the market participant methodology prescribed by ASC 805, and therefore does not reflect the impact of additional Fanapt
®
patents solely owned by the Company with varying expiration dates, the latest of which is December 2031.
The following is a summary of the Company’s intangible assets as of
June 30, 2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2018
|
(in thousands)
|
Estimated
Useful Life
(Years)
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Carrying
Amount
|
HETLIOZ
®
|
May 2034
|
|
$
|
33,000
|
|
|
$
|
7,681
|
|
|
$
|
25,319
|
|
Fanapt
®
|
November 2016
|
|
27,941
|
|
|
27,941
|
|
|
—
|
|
|
|
|
$
|
60,941
|
|
|
$
|
35,622
|
|
|
$
|
25,319
|
|
The following is a summary of the Company’s intangible assets as of
December 31, 2017
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017
|
(in thousands)
|
Estimated
Useful Life
(Years)
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Carrying
Amount
|
HETLIOZ
®
|
May 2034
|
|
$
|
33,000
|
|
|
$
|
6,931
|
|
|
$
|
26,069
|
|
Fanapt
®
|
November 2016
|
|
27,941
|
|
|
27,941
|
|
|
—
|
|
|
|
|
$
|
60,941
|
|
|
$
|
34,872
|
|
|
$
|
26,069
|
|
Intangible assets are amortized over their estimated useful economic life using the straight-line method. Amortization expense was
$0.4 million
for each of the three months ended
June 30, 2018
and
2017
. Amortization expense was
$0.8 million
and
$0.9 million
for the
six
months ended
June 30, 2018
and
2017
, respectively. The following is a summary of the future intangible asset amortization schedule as of
June 30, 2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
Total
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
Thereafter
|
HETLIOZ
®
|
$
|
25,319
|
|
|
$
|
795
|
|
|
$
|
1,591
|
|
|
$
|
1,591
|
|
|
$
|
1,591
|
|
|
$
|
1,591
|
|
|
$
|
18,160
|
|
7. Accounts Payable and Accrued Liabilities
The following is a summary of the Company’s accounts payable and accrued liabilities as of
June 30, 2018
and
December 31, 2017
:
|
|
|
|
|
|
|
|
|
(in thousands)
|
June 30,
2018
|
|
December 31,
2017
|
Research and development expenses
|
$
|
4,129
|
|
|
$
|
4,663
|
|
Consulting and other professional fees
|
2,793
|
|
|
3,961
|
|
Compensation and employee benefits
|
5,035
|
|
|
5,323
|
|
Royalties payable
|
4,684
|
|
|
4,394
|
|
Other
|
1,921
|
|
|
1,994
|
|
|
$
|
18,562
|
|
|
$
|
20,335
|
|
8. Commitments and Contingencies
The following is a summary of our noncancellable long-term contractual cash obligations as of
June 30, 2018
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Payments Due by Year
|
(in thousands)
|
Total
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
Thereafter
|
Operating leases
|
$
|
23,979
|
|
|
$
|
1,198
|
|
|
$
|
2,495
|
|
|
$
|
2,505
|
|
|
$
|
2,337
|
|
|
$
|
2,355
|
|
|
$
|
13,089
|
|
Milestone obligations
|
2,000
|
|
|
2,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Purchase commitments
|
11,025
|
|
|
2,461
|
|
|
6,371
|
|
|
847
|
|
|
890
|
|
|
456
|
|
|
—
|
|
|
$
|
37,004
|
|
|
$
|
5,659
|
|
|
$
|
8,866
|
|
|
$
|
3,352
|
|
|
$
|
3,227
|
|
|
$
|
2,811
|
|
|
$
|
13,089
|
|
Operating leases
Commitments relating to operating leases represent the minimum annual future payments under operating leases and subleases for its Company’s headquarters at 2200 Pennsylvania Avenue, N.W. in Washington, D.C., and operating leases for office space in London and Berlin.
In June 2011, the Company entered into an operating lease for its headquarters at 2200 Pennsylvania Avenue, N.W. in Washington, D.C. for
21,400
square feet of office space. The Company subsequently amended the lease in March 2014 and March 2018 to increase the office space under lease to
33,534
square feet and, in March 2018, extended the lease term to
July 2028
. Subject to the prior rights of other tenants, the Company has the right to renew the lease for
five
years following its expiration. The Company has the right to sublease or assign all or a portion of the premises, subject to standard conditions. The lease may be terminated early by the Company or the landlord under certain circumstances.
In June 2016, the Company entered into a sublease under which the Company leases
9,928
square feet of office space for its headquarters at 2200 Pennsylvania Avenue, N.W. in Washington, D.C. The sublease term began in January 2017 and ends in
July 2026
, but may be terminated earlier by either party under certain circumstances. The Company has the right to sublease or assign all or a portion of the premises, subject to standard conditions.
The Company has an operating lease for
2,880
square feet of office space for the Company’s European headquarters in London that has a noncancellable lease term ending in
2021
, and
1,249
square feet of office space in Berlin under a short-term operating lease.
Rent expense under operating leases was
$0.9 million
and
$0.8 million
for the three months ended
June 30, 2018
and
2017
, respectively. Rent expense under operating leases was
$1.8 million
and
$1.6 million
for the
six
months ended
June 30, 2018
and
2017
, respectively.
Guarantees and Indemnifications
The Company has entered into a number of standard intellectual property indemnification agreements in the ordinary course of its business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners or customers, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third party with respect to the Company’s products. The term of these indemnification agreements is generally perpetual from the date of execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. Since inception, the Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. The Company also indemnifies its officers and directors for certain events or occurrences, subject to certain conditions.
License Agreements
The Company’s rights to develop and commercialize its products are subject to the terms and conditions of licenses granted to the Company by other pharmaceutical companies.
HETLIOZ
®
.
In February 2004, the Company entered into a license agreement with BMS under which it received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize HETLIOZ
®
. As a result of the FDA’s approval of the HETLIOZ
®
NDA in January 2014, the Company made an
$8.0 million
milestone payment to BMS in the first quarter of 2014 under the license agreement that was capitalized as an intangible asset and is being amortized over the estimated economic useful life of the related product patents which is the
remaining life of the U.S. method of use patent for HETLIOZ
®
in the U.S. In April 2018, the Company met another milestone under its license agreement when cumulative worldwide sales of HETLIOZ
®
reached
$250.0 million
. As a result of the achievement of this milestone, the Company made a payment to BMS of
$25.0 million
in the second quarter of 2018. The
$25.0 million
milestone obligation was capitalized as an intangible asset in the first quarter of 2015 and is being amortized over the estimated economic useful life of the related product patents which is the remaining life of the U.S. method of use patents for HETLIOZ
®
in the U.S. The Company has no remaining milestone obligations to BMS. Additionally, the Company is obligated to make royalty payments on HETLIOZ
®
net sales to BMS in any territory where the Company commercializes HETLIOZ
®
for a period equal to the greater of 10 years following the first commercial sale in the territory or the expiry of the new chemical entity (NCE) patent in that territory. During the period prior to the expiry of the NCE patent in a territory, the Company is obligated to pay a
10%
royalty on net sales in that territory. The royalty rate is decreased by half for countries in which no NCE patent existed or for the remainder of the 10 years after the expiry of the NCE patent. The Company is also obligated under the license agreement to pay BMS a percentage of any sublicense fees, upfront payments and milestone and other payments (excluding royalties) that it receives from a third party in connection with any sublicensing arrangement, at a rate which is in the
mid-twenties
. The Company has agreed with BMS in the license agreement for HETLIOZ
®
to use its commercially reasonable efforts to develop and commercialize HETLIOZ
®
.
Fanapt
®
.
Pursuant to the terms of a settlement agreement entered into with Novartis, Novartis transferred all U.S. and Canadian rights in the Fanapt
®
franchise to the Company on December 31, 2014. The Company has no remaining milestone obligations related to Fanapt
®
. The Company was obligated to make royalty payments to Sanofi S.A. (Sanofi) and Titan Pharmaceuticals Inc. (Titan) at a percentage rate equal to
23%
on annual U.S. net sales of Fanapt
®
up to
$200.0 million
, and at a percentage rate in the
mid-twenties
on sales over
$200.0 million
through November 2016. In February 2016, the Company amended the agreement with Sanofi and Titan to remove Titan as the entity through which royalty payments from the Company are directed to Sanofi following the expiration of the NCE patent for Fanapt
®
in the U.S. on November 15, 2016. Under the amended agreement, the Company pays directly to Sanofi a fixed royalty of
3%
of net sales from November 16, 2016 through December 31, 2019 related to manufacturing know-how. The Company made a
$2.0 million
payment during the year ended December 31, 2016 that applied to this
3%
manufacturing know-how royalty. No further royalties on manufacturing know-how are payable by the Company after December 31, 2019. The Company is also obligated to pay Sanofi a fixed royalty on Fanapt
®
net sales equal up to
6%
on Sanofi know-how not related to manufacturing under certain conditions for a period of up to
10 years
in markets where the NCE patent has expired or was not issued.
Tradipitant.
In April 2012, the Company entered into a license agreement with Eli Lilly and Company (Lilly) pursuant to which the Company acquired an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize an NK-1R antagonist, tradipitant, for all human indications. The patent describing tradipitant as a NCE expires in April 2023, except in the U.S., where it expires in June 2024 absent any applicable patent term adjustments. Lilly is eligible to receive future payments based upon achievement of specified development and commercialization milestones as well as tiered-royalties on net sales at percentage rates up to the
low double digits
. These milestones include
$4.0 million
for pre-NDA approval milestones and up to
$95.0 million
for future regulatory approval and sales milestones. The
$4.0 million
of pre-NDA approval milestones includes
$2.0 million
due upon enrollment of the first subject into a Phase III study for tradipitant and
$2.0 million
due upon the filing of the first marketing authorization for tradipitant in either the U.S. or the European Union. The Company enrolled the first subject into a Phase III study for tradipitant in July 2018 and expects to pay the enrollment milestone obligation in the third quarter of 2018. The likelihood of achieving this milestone was determined to be probable during the third quarter of 2017. As a result, the obligation of
$2.0 million
tied to such milestone was recorded as research and development expense in the consolidated statement of operations for the year ended
December 31, 2017
and a current liability in the condensed consolidated balance sheet as of
June 30, 2018
and
December 31, 2017
. The Company is obligated to use its commercially reasonable efforts to develop and commercialize tradipitant.
VQW-765.
In connection with a settlement agreement entered into with Novartis relating to Fanapt
®
, the Company received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize VQW-765, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. Pursuant to the license agreement, the Company is obligated to use its commercially reasonable efforts to develop and commercialize VQW-765 and is responsible for all development costs. The Company has no milestone obligations; however, Novartis is eligible to receive tiered-royalties on net sales at percentage rates up to the
mid-teens
.
Portfolio of CFTR activators and inhibitors
. In March 2017, the Company entered into a license agreement with the University of California San Francisco (UCSF), under which the Company acquired an exclusive worldwide license to develop and commercialize a portfolio of CFTR activators and inhibitors. Pursuant to the license agreement, the Company will develop and commercialize the CFTR activators and inhibitors and is responsible for all development costs under the license agreement, including current pre-investigational new drug development work. The license agreement provides for an initial license fee of
$1.0 million
that was paid by the Company in the first quarter of 2017, annual maintenance fees and up to
$46.0 million
in potential regulatory and sales milestone obligations. UCSF is eligible to receive
single-digit
tiered royalties on net sales.
Purchase commitments
In the course of its business, the Company regularly enters into agreements with clinical organizations to provide services relating to clinical development and clinical manufacturing activities under fee service arrangements. The Company’s current agreements for clinical and marketing services may be terminated on generally
60
days’ notice without incurring additional charges, other than charges for work completed but not paid for through the effective date of termination and other costs incurred by the Company’s contractors in closing out work in progress as of the effective date of termination. Purchase commitments included in the table above include noncancellable purchase commitments longer than one year and primarily relate to commitments for advertising and data services.
9. Public Offering of Common Stock
In March 2018, the Company completed a public offering of
6,325,000
shares of its common stock, including the exercise of the underwriters’ option to purchase an additional
825,000
shares of common stock, at a price to the public of
$17.00
per share. Net cash proceeds from the public offering were
$100.9 million
, after deducting the underwriting discounts and commissions and offering expenses.
10. Accumulated Other Comprehensive Income (Loss)
The accumulated balances related to each component of other comprehensive income (loss) were as follows as of
June 30, 2018
and
December 31, 2017
:
|
|
|
|
|
|
|
|
|
(in thousands)
|
June 30,
2018
|
|
December 31,
2017
|
Foreign currency translation
|
$
|
16
|
|
|
$
|
29
|
|
Unrealized gain (loss) on marketable securities
|
63
|
|
|
(63
|
)
|
|
$
|
79
|
|
|
$
|
(34
|
)
|
There was
no
tax provision (benefit) included in accumulated other comprehensive income (loss) as of
June 30, 2018
and
December 31, 2017
. There were
no
reclassifications out of accumulated other comprehensive loss for either of the
six
months ended
June 30, 2018
or
2017
.
11. Stock-Based Compensation
As of
June 30, 2018
, there were
5,691,322
shares that were subject to outstanding options and restricted stock units (RSUs) under the 2006 Equity Incentive Plan (2006 Plan) and the Amended and Restated 2016 Equity Incentive Plan (2016 Plan, and together with the 2006 Plan, Plans). The 2006 Plan expired by its terms on April 12, 2016, and the Company adopted the 2016 Plan. Outstanding options and RSUs under the 2006 Plan remain in effect and the terms of the 2006 Plan continue to apply, but no additional awards can be granted under the 2006 Plan. In June 2016, the Company’s stockholders approved the 2016 Plan. The 2016 Plan has been amended and restated twice to increase the number of shares reserved for issuance, among other administrative changes. Both amendments and restatements of the 2016 Plan were approved by the Company's stockholders. There are a total of
7,100,000
shares of common stock reserved for issuance under the 2016 Plan,
4,673,775
shares of which remained available for future grant as of
June 30, 2018
.
Stock Options
The Company has granted option awards under the Plans with service conditions (service option awards) that are subject to terms and conditions established by the compensation committee of the board of directors. Service option awards have
10 years
contractual terms. Service option awards granted to new employees vest and become exercisable on the first anniversary of the grant date with respect to the
25%
of the shares subject to service option awards. The remaining
75%
of the shares subject to the service option awards vest and become exercisable monthly in equal installments thereafter over
three years
. Service option awards granted to existing employees vest and become exercisable monthly in equal installments over
four years
. The initial service option awards granted to directors upon their election vest and become exercisable in equal monthly installments over a period of
four years
, while the subsequent annual service option awards granted to directors vest and become exercisable in
either equal monthly installments over a period of
one year
or on the first anniversary of the grant date. Certain service option awards to executives and directors provide for accelerated vesting if there is a change in control of the Company. Certain service option awards to employees and executives provide for accelerated vesting if the respective employee’s or executive’s service is terminated by the Company for any reason other than cause or permanent disability.
As of
June 30, 2018
,
$8.3 million
of unrecognized compensation costs related to unvested service option awards are expected to be recognized over a weighted average period of
1.4 years
. No option awards are classified as a liability as of
June 30, 2018
.
A summary of option activity under the Plans for the
six
months ended
June 30, 2018
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 and 2016 Plans
(in thousands, except for share and per share amounts)
|
Number of
Shares
|
|
Weighted Average
Exercise Price at
Grant Date
|
|
Weighted Average
Remaining Term
(Years)
|
|
Aggregate
Intrinsic
Value
|
Outstanding at December 31, 2017
|
4,719,784
|
|
|
$
|
10.03
|
|
|
5.63
|
|
$
|
24,421
|
|
Granted
|
477,500
|
|
|
18.80
|
|
|
|
|
|
Forfeited
|
(231,385
|
)
|
|
14.01
|
|
|
|
|
|
Exercised
|
(605,195
|
)
|
|
8.84
|
|
|
|
|
4,937
|
|
Outstanding at June 30, 2018
|
4,360,704
|
|
|
10.94
|
|
|
5.72
|
|
35,364
|
|
Exercisable at June 30, 2018
|
3,292,006
|
|
|
9.80
|
|
|
4.80
|
|
30,445
|
|
Vested and expected to vest at June 30, 2018
|
4,202,009
|
|
|
10.72
|
|
|
5.59
|
|
35,005
|
|
The weighted average grant-date fair value of options granted was
$10.40
and
$7.81
per share for the
six
months ended
June 30, 2018
and
2017
, respectively. Proceeds from the exercise of stock options amounted to
$5.4 million
and
$4.4 million
for the
six
months ended
June 30, 2018
and
2017
, respectively.
Restricted Stock Units
An RSU is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s stock on the date of grant. The Company has granted RSUs under the Plans with service conditions (service RSUs) that generally vest in
four
equal annual installments provided that the employee remains employed with the Company. Annual RSUs granted to directors vest on the first anniversary of the grant date.
As of
June 30, 2018
,
$18.2 million
of unrecognized compensation costs related to unvested service RSUs are expected to be recognized over a weighted average period of
1.9 years
. No RSUs are classified as a liability as of
June 30, 2018
.
A summary of RSU activity under the Plans for the
six
months ended
June 30, 2018
follows:
|
|
|
|
|
|
|
|
|
Number of
Shares
Underlying
|
|
Weighted
Average
Grant Date
|
2006 and 2016 Plans
|
RSUs
|
|
Fair Value
|
Unvested at December 31, 2017
|
1,357,838
|
|
|
$
|
12.72
|
|
Granted
|
658,086
|
|
|
18.72
|
|
Forfeited
|
(177,689
|
)
|
|
14.75
|
|
Vested
|
(507,617
|
)
|
|
12.57
|
|
Unvested at June 30, 2018
|
1,330,618
|
|
|
15.48
|
|
The grant date fair value for the
507,617
shares underlying RSUs that vested during the
six
months ended
June 30, 2018
was
$6.4 million
.
Stock-Based Compensation
Stock-based compensation expense recognized for the three and
six
months ended
June 30, 2018
and
2017
was comprised of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
(in thousands)
|
June 30,
2018
|
|
June 30,
2017
|
|
June 30,
2018
|
|
June 30,
2017
|
Research and development
|
$
|
316
|
|
|
$
|
285
|
|
|
$
|
637
|
|
|
$
|
694
|
|
Selling, general and administrative
|
2,405
|
|
|
2,371
|
|
|
5,235
|
|
|
4,218
|
|
|
$
|
2,721
|
|
|
$
|
2,656
|
|
|
$
|
5,872
|
|
|
$
|
4,912
|
|
The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model that uses the assumptions noted in the following table. Expected volatility rates are based on the historical volatility of the Company’s publicly traded common stock and other factors. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception (other than a dividend of preferred share purchase rights, which was declared in September 2008) and does not plan to pay dividends in the foreseeable future. Assumptions used in the Black-Scholes-Merton option pricing model for stock options granted during the
six
months ended
June 30, 2018
and
2017
were as follows:
|
|
|
|
|
|
|
|
Six Months Ended
|
|
June 30,
2018
|
|
June 30,
2017
|
Expected dividend yield
|
0
|
%
|
|
0
|
%
|
Weighted average expected volatility
|
57
|
%
|
|
57
|
%
|
Weighted average expected term (years)
|
5.90
|
|
|
5.89
|
|
Weighted average risk-free rate
|
2.66
|
%
|
|
1.97
|
%
|
12. Income Taxes
Deferred tax assets are reduced by a tax valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. The fact that the Company has historically generated pretax losses in the U.S. serves as strong evidence that it is more likely than not that deferred tax assets in the U.S. will not be realized in the future. Therefore, the Company had a full tax valuation allowance against all deferred tax assets in the U.S. as of
June 30, 2018
and
December 31, 2017
. As a result of the tax valuation allowance against deferred tax assets in the U.S., there was no benefit for income taxes associated with the income (loss) before income taxes for
three and six
months ended
June 30, 2018
and
2017
. Taxes have been recorded related to certain U.S. state jurisdictions and non-U.S. income for the
three and six
months ended
June 30, 2018
and
2017
.
Certain tax attributes of the Company, including net operating losses (NOLs) and credits, would be subject to a limitation should an ownership change as defined under the Internal Revenue Code of 1986, as amended (IRC), Section 382, occur. The limitations resulting from a change in ownership could affect the Company’s ability to utilize its NOLs and credit carryforward (tax attributes). Ownership changes occurred in the years ended December 31, 2014 and December 31, 2008. The Company believes that the ownership changes in 2014 and 2008 will not impact its ability to utilize NOL and credit carryforwards; however, future ownership changes may cause the Company’s existing tax attributes to have additional limitations. Because the Company maintains a valuation allowance on its U.S. tax attributes, any limitation as a result of application of IRC Section 382 limitation would not have a material impact on the Company’s provision for income taxes for the
three and six
months ended
June 30, 2018
.
The Tax Cuts and Jobs Act (TCJA) was enacted in December 2017. The TCJA reduces the U.S. federal corporate tax rate from
35%
to
21%
, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously deferred and creates new taxes on certain foreign sourced earnings. As of
June 30, 2018
, the Company has not completed our accounting for the tax effects of the TCJA. Certain U.S. federal deferred tax assets and liabilities were remeasured as of
December 31, 2017
based on the rates at which they are expected to reverse in the future, which is generally
21%
. However, the Company is still analyzing certain aspects of the U.S. international and executive compensation provisions of the TCJA and refining our calculations, which could potentially affect the measurement of these balances or potentially give
rise to new deferred tax amounts. Because the Company has recorded a valuation allowance against deferred tax assets in the U.S., future adjustments recorded as we complete our analysis will not have a material impact to our net deferred tax asset or liability.
13. Earnings per Share
Basic earnings per share (EPS) is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding. Diluted EPS is computed by dividing the net loss by the weighted average number of shares of common stock outstanding, plus potential outstanding common stock for the period. Potential outstanding common stock includes stock options and shares underlying RSUs, but only to the extent that their inclusion is dilutive.
The following table presents the calculation of basic and diluted net loss per share of common stock for the three and
six
months ended
June 30, 2018
and
2017
:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Six Months Ended
|
(in thousands, except for share and per share amounts)
|
June 30,
2018
|
|
June 30,
2017
|
|
June 30,
2018
|
|
June 30,
2017
|
Numerator:
|
|
|
|
|
|
|
|
Net income (loss)
|
$
|
4,611
|
|
|
$
|
(1,534
|
)
|
|
$
|
7,677
|
|
|
$
|
(9,179
|
)
|
Denominator:
|
|
|
|
|
|
|
|
Weighted average shares outstanding, basic
|
52,172,982
|
|
|
44,718,597
|
|
|
49,270,829
|
|
|
44,559,368
|
|
Effect of dilutive securities
|
1,772,658
|
|
|
—
|
|
|
1,830,635
|
|
|
—
|
|
Weighted average shares outstanding, diluted
|
53,945,640
|
|
|
44,718,597
|
|
|
51,101,464
|
|
|
44,559,368
|
|
Net income (loss) per share, basic and diluted:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.09
|
|
|
$
|
(0.03
|
)
|
|
$
|
0.16
|
|
|
$
|
(0.21
|
)
|
Diluted
|
$
|
0.09
|
|
|
$
|
(0.03
|
)
|
|
$
|
0.15
|
|
|
$
|
(0.21
|
)
|
Antidilutive securities excluded from calculations of diluted net income (loss) per share
|
1,364,535
|
|
|
3,409,711
|
|
|
1,210,990
|
|
|
3,285,106
|
|
The Company incurred a net loss for the
three and six
months ended
June 30, 2017
causing inclusion of any potentially dilutive securities to have an anti-dilutive effect, resulting in dilutive loss per share and basic loss per share attributable to common stockholders being equivalent.
14. Legal Matters
Fanapt
®
. In June 2014, the Company filed suit against Roxane Laboratories, Inc. (Roxane) in the U.S. District Court for the District of Delaware (Delaware District Court). The suit sought an adjudication that Roxane has infringed one or more claims of the Company’s U.S. Patent No. 8,586,610 (‘610 Patent) by submitting to the FDA an Abbreviated New Drug Application (ANDA) for a generic version of Fanapt
®
prior to the expiration of the ‘610 Patent in November 2027. In addition, pursuant to a settlement agreement with Novartis, the Company assumed Novartis’ patent infringement action against Roxane in the Delaware District Court. That suit alleges that Roxane has infringed one or more claims of U.S. Patent RE39198 (‘198 Patent), which is licensed exclusively to the Company, by filing an ANDA for a generic version of Fanapt
®
prior to the expiration of the ‘198 Patent in November 2016. These two cases against Roxane were consolidated by agreement of the parties and were tried together in a five-day bench trial that concluded in March 2016. In August 2016, the Delaware District Court ruled that the Company is entitled to a permanent injunction against Roxane enjoining Roxane from infringing the ‘610 Patent, including the manufacture, use, sale, offer to sell, sale, distribution or importation of any generic iloperidone product described in the ‘610 Patent ANDA until the expiration of the ‘610 Patent in November 2027. If the Company obtains pediatric exclusivity, the injunction against Roxane would be extended until May 2028 under the Delaware District Court’s order. In September 2016, Roxane filed a notice of appeal with the Federal Circuit Court of Appeals (Federal Circuit). In July 2017, Roxane, now a subsidiary of Hikma Pharmaceuticals PLC (Hikma), petitioned the Federal Circuit to substitute Roxane with new defendants West-Ward Pharmaceuticals International Limited and West-Ward Pharmaceuticals Corp. (each of which is a subsidiary of Hikma and both of which are referred to collectively herein as West-Ward). In April 2018, the Federal Circuit affirmed the Delaware District Court’s decision that West-Ward infringed the ‘610 Patent. In June 2018, West-Ward filed with the Federal Circuit a petition seeking rehearing en banc. The Federal Circuit invited the Company to respond to West-Ward’s petition; the Company's response was filed in July 2018.
In 2015, the Company filed six separate patent infringement lawsuits in the Delaware District Court against Roxane, Inventia Healthcare Pvt. Ltd. (Inventia), Lupin Ltd. and Lupin Pharmaceuticals, Inc. (Lupin), Taro Pharmaceuticals USA, Inc. and Taro Pharmaceutical Industries, Ltd. (Taro), and Apotex Inc. and Apotex Corp. (Apotex, and collectively with Roxane, Inventia, Lupin and Taro, the Defendants). The lawsuits each seek an adjudication that the respective Defendants infringed one or more claims of the ‘610 Patent and/or the Company’s U.S. Patent No. 9,138,432 (‘432 Patent) by submitting to the FDA an ANDA for a generic version of Fanapt
®
prior to the expiration of the ‘610 Patent in November 2027 or the ‘432 Patent in September 2025. The Defendants denied infringement and counterclaimed for declaratory judgment of invalidity and noninfringement of the ‘610 Patent and the ‘432 Patent. Certain Defendants have since entered into agreements resolving these lawsuits, as discussed below. The remaining parties are scheduled to submit to the Delaware District Court a status report and request a schedule for trial no later than 14 days after the Federal Circuit issues its mandate in the West-Ward appeal. The Company entered into a confidential stipulation with each of Inventia and Lupin regarding any potential launch of Inventia’s and Lupin's generic ANDA products.
Lupin filed counter claims for declaratory judgment of invalidity and noninfringement of seven of the Company’s method of treatment patents that are listed in the
Approved Drug Products with Therapeutic Equivalence Evaluations
(Orange Book) related to Fanapt
®
(such seven patents, the Method of Treatment Patents). The Company has not sued Lupin for infringing the Method of Treatment Patents. In October 2016, the Company and Lupin filed a Stipulation of Dismissal in the Delaware District Court pursuant to which Lupin’s counterclaims relating to the Method of Treatment Patents were dismissed without prejudice in recognition of an agreement reached between the parties by which the Company would not assert those patents against Lupin absent certain changes in Lupin’s proposed prescribing information for its iloperidone tablets.
Taro and Apotex each entered into separate License Agreements (together, the License Agreements) resolving these lawsuits in October 2016 and December 2016, respectively. The License Agreements grant Taro and Apotex non-exclusive licenses to manufacture and commercialize a version of Fanapt
®
in the U.S. effective November 2027, unless prior to that date the Company obtains pediatric exclusivity for Fanapt
®
, in which case, the license will be effective May 2028. Taro and Apotex each may enter the market earlier under certain limited circumstances. The License Agreements, which are subject to review by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ), provide for a full settlement and release of all claims that are the subject of the respective litigation with Taro and Apotex.
In February 2016, Roxane filed suit against the Company in the U.S. District Court for the Southern District of Ohio (Ohio District Court). The suit sought a declaratory judgment of invalidity and noninfringement of the Method of Treatment Patents. In December 2016, the Ohio District Court dismissed Roxane’s suit without prejudice for lack of personal jurisdiction.
In February 2016, Roxane filed a Petition for
Inter Partes
Review (IPR) of the ‘432 Patent with the Patent Trials and Appeals Board (PTAB) of the U.S. Patent and Trademark Office. In August 2016, the PTAB denied the request by Roxane to institute an IPR of the ‘432 Patent. In September 2016, Roxane filed a Petition for Rehearing with the PTAB. In November 2016, the PTAB denied Roxane’s Petition for Rehearing.
HETLIOZ
®
. In March 2018, the Company received a Paragraph IV certification notice letter from Teva Pharmaceuticals USA, Inc. (Teva) notifying the Company that Teva had submitted an ANDA for HETLIOZ
®
to the FDA requesting approval to market, sell and use a generic version of the 20mg HETLIOZ
®
capsules for Non-24-Hour-Sleep-Wake Disorder. In its notice letter, Teva alleges that the Company’s Orange Book listed U.S. Patent No. RE46,604, U.S. Patent No. 9,060,995, U.S. Patent 9,539,234, U.S. Patent 9,549,913, U.S. Patent 9,730,910 and U.S. Patent 9,885,241, (collectively, the Vanda Patents), which cover methods of using HETLIOZ
®
, are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of the product described in its ANDA. The Company received similar notice letters in April 2018 from MSN Pharmaceuticals Inc. and MSN Laboratories Private Limited (together, MSN) and Apotex. The composition and use of HETLIOZ
®
are currently protected by seven patents that are listed in the FDA’s Orange Book.
In April 2018, the Company filed a patent infringement lawsuit in the Delaware District Court against Teva and in May 2018, the Company filed patent infringement lawsuits in the Delaware District Court against MSN and Apotex. The lawsuits seek an adjudication that Teva, MSN and Apotex have infringed one or more claims of the Vanda Patents by submitting to the FDA an ANDA for a generic version of HETLIOZ
®
prior to the expiration of the latest to expire of the Vanda Patents in 2034. The relief requested by the Company in the lawsuits includes requests for permanent injunctions preventing Teva, MSN and Apotex from infringing the asserted claims of the Vanda Patents by engaging in the manufacture, use, offer to sell, sale, importation or distribution of generic versions of HETLIOZ
®
before the last expiration date of the Vanda Patents. The lawsuits automatically preclude the FDA from approving the submitted ANDAs until the earlier of 30 months from the date the Company received a notice letter, or entry of a district court decision finding the Vanda Patents invalid, unenforceable or not infringed. In June 2018, Teva and MSN each answered the Company’s complaint, and counterclaimed for declarations that the Vanda Patents are invalid.