The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
The accompanying notes are an integral part of these consolidated financial statements.
Notes to Consolidated Financial Statements
Paratek Pharmaceuticals, Inc., or the Company or Paratek, is a Delaware corporation with its corporate office in Boston, Massachusetts and an office in King of Prussia, Pennsylvania. The Company is a clinical stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics based upon tetracycline chemistry. The Company has used its expertise in biology and tetracycline chemistry to create chemically diverse and biologically distinct small molecules derived from the minocycline core structure. The Company’s two lead product candidates are the antibacterials omadacycline and sarecycline. The Company has generated innovative small molecule therapeutic candidates based upon medicinal chemistry-based modifications, according to structure-based activity, of all positions of the core tetracycline molecule. These efforts have yielded molecules with broad-spectrum antibiotic properties and narrow-spectrum antibiotic properties, and molecules with potent anti-inflammatory properties to fit specific therapeutic applications. This proprietary chemistry platform has produced many compounds that have shown interesting characteristics in various
in vitro
and
in vivo
efficacy models. Omadacycline and sarecycline are examples of molecules that were synthesized from this chemistry discovery platform.
Omadacycline is the first in a new class of aminomethylcycline antibiotics. Omadacycline is a broad-spectrum, well-tolerated once-daily oral and intravenous, or IV, antibiotic. The Company believes that omadacycline has the potential to become the primary antibiotic choice of physicians for use as a broad-spectrum monotherapy antibiotic for acute bacterial skin and skin structure infections, or ABSSSI, community-acquired bacterial pneumonia, or CABP, urinary tract infection, or UTI, and other serious community-acquired bacterial infections, where resistance is of concern. The Company believes omadacycline, if approved, will be used in the emergency room, hospital and community care settings. The Company has designed omadacycline to provide potential advantages over existing antibiotics, including activity against resistant bacteria, broad spectrum antibacterial activity, oral and IV formulations with once-daily dosing, no known drug interactions, and a favorable safety and tolerability profile.
Omadacycline entered Phase 3 clinical development in June 2015 for the treatment of ABSSSI and in November 2015 for the treatment of CABP. Both of these studies utilized initiation of IV therapy with transitions to oral based therapy on clinical response. During the conduct of these studies, an independent data safety monitoring board, or DSMB, completed multiple planned reviews of the safety data. Following each meeting, the DSMB recommended that the studies continue without modification to the protocols or study conduct. In June 2016, the Company announced positive top-line efficacy and safety data for the ABSSSI study and initiated a Phase 3 clinical study with oral-only administration of omadacycline in ABSSSI compared to oral-only linezolid in August 2016. In January 2017, the Company announced completion of enrollment in the CABP study and anticipates top-line results early in the second quarter of 2017. The Company anticipates top-line results for the oral-only ABSSSI study as early as the late second quarter of 2017.
The Company also recently completed clinical Phase 1 studies with omadacycline that are needed for inclusion in the planned New Drug Application, or NDA, regulatory filing with the FDA. In these Phase 1 studies, omadacycline was generally safe and well-tolerated, consistent with prior Phase 1 studies. In May 2016, the Company initiated its first oral-only and IV-to-oral study of omadacycline dosed for five days in a Phase 1b clinical study in patients with a UTI. This Phase 1b UTI study was recently completed. Data from this study showed that omadacycline achieved proof of principle, by demonstrating high concentration levels of omadacycline in urine, across IV-to-oral and oral-only dosing regimens.
The Company’s second Phase 3 antibacterial product candidate, sarecycline, also known as WC3035, is a new, once-daily, tetracycline-derived compound designed for use in the treatment of acne and rosacea. The Company believes that, based upon the data generated to-date, sarecycline possesses favorable anti-inflammatory activity, plus narrow-spectrum antibacterial activity relative to other tetracycline-derived molecules, oral bioavailability, does not cross the blood-brain barrier, and favorable PK properties that the Company believes make it particularly well-suited for the treatment of inflammatory acne in the community setting. The Company has exclusively licensed U.S. development and commercialization rights to sarecycline for the treatment of acne to Allergan plc, or Allergan, while retaining development and commercialization rights in the rest of the world. Allergan has informed the Company that sarecycline entered Phase 3 clinical trials for the treatment of acne vulgaris in December 2014 and anticipates that top-line data from the Phase 3 trial of sarecycline will be available in the first half of 2017. The Company also granted Allergan an exclusive license to develop and commercialize sarecycline for the treatment of rosacea in the United States, which converted to a non-exclusive license in December 2014 after Allergan did not exercise its development option with respect to rosacea. There are currently no clinical trials with sarecycline in rosacea underway.
Prior to October 30, 2014, the name of the Company was Transcept Pharmaceuticals, Inc., or Transcept. On October 30, 2014, Transcept completed a business combination with privately held Paratek Pharmaceuticals, Inc., or Old Paratek, in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of June 30, 2014, by and among Transcept, Tigris Merger Sub, Inc., or Merger Sub, Tigris Acquisition Sub, LLC, or Merger LLC, and Old Paratek, or the Merger Agreement, pursuant to which
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Merger Sub merged with and into Old Paratek, with Old Paratek surviving as a wholly-owned subsidiary of Transcept, followed by the merger of Old Paratek with and into Merger LLC, with Merger LLC surviving as a wholly-owned subsidiary of Transcept (
the Company refers to these mergers together as the Merger).
Also on October 30, 2014, in connection with, and prior to the completion of the Merger, Transcept effected a 1-for-12 reverse stock split of its common stock, or the Reverse Stock Split, and immediately following the Merger, Transcept changed its name to “Paratek Pharmaceuticals, Inc.”, and Merger LLC changed its name to “Paratek Pharma, LLC.” Following the completion of the Merger, the business conducted by Paratek Pharmaceuticals Inc. became primarily the business conducted by Paratek.
Immediately prior to the Merger, Old Paratek sold 8,068,766 shares of its common stock for an aggregate purchase price of $93.0 million to certain existing Paratek stockholders and certain new investors in Paratek, or the Financing. Immediately prior to the closing of the Financing, the $6.0 million in aggregate principal amount outstanding under, and all accrued interest on, the nonconvertible senior secured promissory notes issued in March 2014, or the 2014 Notes, converted into 1,335,632 shares of Old Paratek’s common stock based on a conversion price of $0.778 per share. Further, and also immediately prior to the closing of the Financing, each share of Old Paratek’s preferred stock outstanding at that time was converted into shares of Old Paratek’s common stock at a ratio determined in accordance with Paratek’s certificate of incorporation then in effect. The parties to the Financing and to the conversion of the 2014 Notes include officers, employees and directors of Paratek, making these transactions related party in nature.
Under the terms of the Merger Agreement, Transcept issued shares of its common stock to Old Paratek’s stockholders, at an exchange rate of 0.0675 shares of common stock, after taking into account the Reverse Stock Split, in exchange for each share of Old Paratek common stock outstanding immediately prior to the Merger. Transcept also assumed all of the stock options outstanding under the Old Paratek 2014 Equity Incentive Plan, as amended, or the Paratek Plan, and stock warrants of Old Paratek outstanding immediately prior to the Merger, with such stock options and warrants henceforth representing the right to purchase a number of shares of Transcept common stock equal to 0.0675 multiplied by the number of shares of Old Paratek common stock previously represented by such options and warrants. Transcept also assumed the Paratek Plan.
After consummation of the Merger, the Old Paratek stockholders, warrant holders and option holders owned approximately 89.6% of the fully-diluted common stock of Paratek, with Transcept’s stockholders and optionholders immediately prior to the Merger, whose shares of Paratek common stock (including shares received upon the cancellation of existing options) remain outstanding after the Merger, owning approximately 10.4% of the fully-diluted common stock of Paratek. Under generally accepted accounting principles in the United States of America, or U.S. GAAP, the Merger was treated as a “reverse merger” under the purchase method of accounting. For accounting purposes, Old Paratek is considered to have acquired Transcept.
The Company has incurred significant losses since inception in 1996. The Company has generated an accumulated deficit of $380.4 million through December 31, 2016 and will require substantial additional funding in connection with the Company’s continuing operations to support commercial activities associated with its lead product candidate, omadacycline.
Based upon the Company’s current operating plan, it anticipates that cash, cash equivalents and available for sale marketable securities of $128.0 million will enable the Company to fund operating expenses and capital expenditure requirements through the first half of 2018.
The Company expects to finance future cash needs primarily through a combination of public or private equity offerings, debt or other structured financings, strategic collaborations and grant funding. The Company is subject to risks common to companies in the biopharmaceutical industry, including, but not limited to, risks of failure of preclinical studies and clinical trials, the need to obtain additional financing to fund the future development of the Company’s product candidates, the need to obtain compliant product from third party manufacturers, the need to obtain marketing approval for the Company’s product candidates, the need to successfully commercialize and gain market acceptance of product candidates, the risks of manufacturing product with an external supply chain, dependence on key personnel, and compliance with government regulations.
2.
|
Summary of Significant Accounting Policies
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Basis of Presentation
The consolidated financial statements have been prepared in accordance with U.S. GAAP as found in the Accounting Standards Codification, or ASC, and Accounting Standards Update, or ASU, of the Financial Accounting Standards Board, or FASB, and pursuant to the rules and regulations of the Securities Exchange Commission, or SEC. Certain reclassifications were made to conform to the current presentation.
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Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the results of operations of Paratek Pharmaceuticals, Inc. and its wholly-owned subsidiaries, Paratek Pharma, LLC, Paratek Securities Corporation, Transcept Pharma, Inc., Paratek UK, Ltd and Paratek Bermuda, Ltd. All significant intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management of the Company to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. These estimates are based on management’s best knowledge of current events and actions the Company may undertake in the future. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. Management must apply significant judgment in this process. In addition, other factors may affect estimates, including: expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes and management must select an amount that falls within that range of reasonable estimates. This process may result in actual results differing materially from those estimated amounts used in the preparation of the financial statements. Estimates are used in accounting for, among other items, intangible assets, goodwill, contingent liabilities, stock-based compensation arrangements, clinical accruals, useful lives for depreciation and amortization of long-lived assets and valuation allowances on deferred tax assets. Actual results could differ from those estimates. The Company evaluates its estimates on an ongoing basis. Changes in estimates are reflected in reported results in the period in which they become known by the Company’s management.
During the year ended December 31, 2016, the Company changed one of its intangible assets’ estimated useful life to better reflect the estimated periods during which the asset will remain in service. Refer to “Valuation of Other Long-Lived Intangible Assets” under Item 7, “Management’s Discussion and Analysis of Financial Condition and Results or Operations,” for further details.
Cash and Cash Equivalents and Marketable Securities
The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and cash equivalents include cash held in banks and amounts held primarily in interest-bearing money market accounts. Cash equivalents are carried at cost, which approximates their fair market value.
The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company classified all of its marketable securities at December 31, 2016 as “available-for-sale” pursuant to ASC 320,
Investments – Debt and Equity Securities.
Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period we intend to hold such securities. Available-for-sale securities are maintained by an investment manager and consist of U.S. treasury and government agency securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders’ equity until realized. Any premium or discount arising at purchase is amortized or accreted to interest expense or income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income or expense. There were no realized gains or losses on marketable securities recognized for the year ended December 31, 2016.
The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations and comprehensive loss if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and duration of the impairment and changes in value subsequent to the end of the period. There were no other-than-temporary impairments of investments recognized for the year ended December 31, 2016.
Fair Value of Financial Instruments
The Company is required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. FASB ASC 820,
Fair Value Measurements and Disclosures
, or ASC 820, establishes a hierarchy of inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of
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unobservable inputs by requiring that the observable inputs be used when available. Observable inputs are those that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy applies only to the valuation inputs used in determining the reported fair value of the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described below:
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.
To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
Items measured at fair value on a recurring basis include marketable securities (Note 7,
Cash and Cash Equivalents and Marketable Securities,
and Note 14,
Fair Value Measurements
) and contingent consideration (Note 14,
Fair Value Measurements
). The carrying amounts of accounts payable and accrued expenses approximate their fair values due to their short-term maturities.
Restricted Cash
Cash accounts with any type of restriction are classified as restricted cash. If restrictions are expected to be lifted in the next twelve months, the restricted cash account is classified as current.
Concentration of Credit Risk
Financial instruments that subject the Company to credit risk consist primarily of cash, restricted cash, and accounts receivable. The Company places its cash in an accredited financial institution and this balance is above federally insured amounts. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. For the year ended December 31, 2016, revenue consisted of royalty income in connection with the collaboration agreement the Company entered into with Purdue Pharma, L.P., or Purdue Collaboration Agreement. No revenue was recorded for the year ended December 31, 2015. For the year ended December 31, 2014, Allergan represented 92% of research and development revenue.
Fixed Assets
Fixed assets, including leasehold improvements, are recoded at cost and depreciated when placed into service using the straight-line method, based on their estimated useful lives as follows:
|
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Estimated
useful Life
In Years
|
|
Laboratory equipment
|
|
|
5
|
|
Office equipment
|
|
|
5
|
|
Computer equipment
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|
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3
|
|
Computer software
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|
|
3
|
|
In addition, leasehold improvements are depreciated over the shorter of their estimated useful lives or the term of the respective lease on a straight-line basis.
Costs for capital assets not yet placed into service have been capitalized as construction-in-progress and will be depreciated in accordance with the above guidelines once placed into service. The Company reviews our long-lived assets for impairment whenever events or changes in business circumstances indicate that the carrying amount of assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Each impairment test is based on a comparison of the undiscounted cash flow to the
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recorded value of the asset. If impairment is indicated, the asset will be written down to its estimated fair value on a discounted cash flow basis. Upon sale or retirement, the asset cost and related accumulated depreciation are removed from the respective accounts, and any related gain or loss is reflected in results of operations. Repair and maintenance costs are expensed as incurred.
Valuation of Other Long-Lived Intangible Assets
The Company’s finite-lived intangible assets are stated at cost less accumulated amortization. The Company calculates amortization expense by the straight-line method using estimated useful lives of the related assets, which range from three to thirteen years. The Company reviews finite-lived assets for impairment whenever events or changes in circumstances occur that indicate that the carrying amount of an asset (or asset group) may not be recoverable. The Company’s impairment review is based on an estimate of the undiscounted cash flows at the lowest level for which identifiable cash flows exist and impairment occurs when the book value of the asset exceeds the estimated future undiscounted cash flows generated by the asset. When an impairment is indicated, a charge is recorded for the difference between the book value of the asset and its fair value. Depending on the asset, estimated fair value may be determined either by use of a discounted cash flow model, or by reference to estimated selling values of assets in a similar condition.
In accordance with the Company’s policy, the Company reviews the estimated useful lives of its long-lived intangible assets on an ongoing basis.
Valuation of Goodwill
The Company tests for goodwill impairment annually, on October 1, unless there are indications during an interim period that these assets are more likely than not to have become impaired. The first step of the goodwill impairment test is to compare the fair value of a reporting unit to its carrying amount to determine if there is potential impairment. If the fair value of the reporting unit is less than its carrying value, the second step of the goodwill impairment test is performed to measure the amount of impairment loss.
The second step of the goodwill impairment test compares the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. If the carrying amount of a reporting unit’s goodwill exceeds the implied fair value of that goodwill, an impairment loss is recognized in an amount equal to that excess. The implied fair value of goodwill is determined in the same manner as the amount of goodwill recognized in a business combination. That is, the fair value of the reporting unit is allocated to all of the assets and liabilities of that unit (including any unrecognized intangible assets) as if the reporting unit had been acquired in a business combination and the fair value was the purchase price paid to acquire the reporting unit.
Determining the fair value of a reporting unit under the first step of the goodwill impairment test and determining the fair value of individual assets and liabilities of a reporting unit (including unrecognized intangible assets) under the second step of the goodwill impairment test is inherently subjective in nature and often involves the use of significant estimates and assumptions based on known facts and circumstances at the time we perform the valuation. The use of different assumptions, inputs and judgments or changes in circumstances could materially affect the results of the valuation and could have a significant impact on whether or not an impairment charge is recognized and the magnitude of any such charge. The Company did not record an impairment charge relating to goodwill for the years ended December 31, 2016, 2015 and 2014.
Accrued Expenses
The Company’s process of determining accrued expense for a financial period-end involves reviewing open contracts and purchase orders, communicating with personnel to identify services that have been performed for the Company and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of the actual cost. The majority of the Company’s service providers invoice periodically in arrears for services performed or when contractual milestones are met. The Company estimates accrued expenses at a financial period-end based on facts and circumstances known at that time and may periodically confirm the accuracy of estimates with its service providers and make adjustments if necessary.
Contingent Consideration
Contingent consideration arising from a business combination is included as part of the purchase price and is recognized at fair value as of the acquisition date. Subsequent to the acquisition date, the Company measures contingent consideration arrangements at fair value for each period until the contingency is resolved. These changes in fair value are recognized in the consolidated statements of operations. Changes in fair values reflect new information about the likelihood of the payment of the contingent consideration and the passage of time.
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Convertible Preferred Stock
Convertible preferred stock is initially recorded at the proceeds received, net of issuance costs and value allocated to warrants, where applicable.
Convertible Preferred Stock Warrants
The Company accounts for free standing warrants as liabilities at their fair value. The Company’s existing warrants prior to the merger were exercisable into convertible preferred stock that was classified as mezzanine equity on the balance sheet and, as such, the fair value of the warrants was recorded as a liability. The Company measured the fair value at the end of each reporting period and recorded the change to other income (expense). The Company continued to record adjustments to the fair value of the warrants until the closing of the merger transaction on October 30, 2014, when they became warrants to purchase shares of common stock, at which point the warrants were no longer subject to ASC Topic 480,
Distinguishing Liabilities From Equity
. As of October 30, 2014, the then-current aggregate fair value of these warrants ($40,000), was reclassified from a liability to additional paid-in capital, a component of stockholders’ equity.
Leases
The company leases our facilities under non-cancelable operating leases that expire at various dates through 2024. The leases contain rent escalation and rent holiday, which are being accounted for as rent expense under the straight-line method. Deferred rent is included in accounts payable and other accrued expenses in the consolidated balance sheet. As of December 31, 2016, the company recorded a lease incentive obligation on the consolidated balance sheets representing a landlord incentive to reimburse the Company up to $0.2 million for construction on additional lease space in accordance with the company’s executed amended lease agreement at its Boston office location. These amounts are treated as reduction to rent expense over the lease term.
Revenue Recognition
The Company enters into product development agreements with collaborators for the research and development of therapeutic products. The terms of these agreements may include nonrefundable signing and licensing fees, funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from collaborations. The Company assesses these multiple elements in accordance with the FASB, Accounting Standards Codification, or ASC 605,
Revenue Recognition
, in order to determine whether particular components of the arrangement represent separate units of accounting.
The Company recognizes upfront license payments as revenue upon delivery of the license only if the license has stand-alone value. If the license does not have stand-alone value, the revenue under the arrangement is recognized as revenue over the estimated period of performance.
Whenever the Company determines that an arrangement should be accounted for as a single unit of accounting, the Company determines the period over which the performance obligations will be performed and revenue will be recognized. If the Company cannot reasonably estimate the timing and the level of effort to complete its performance obligations under the arrangement, then revenue under the arrangement is recognized on a straight-line basis over the period that the Company expects to complete its performance obligations, which is reassessed at each subsequent reporting period.
The Company’s collaboration agreements may include additional payments upon the achievement of performance-based milestones. As milestones are achieved, a portion of the milestone payment, equal to the percentage of the total time that the Company has performed the performance obligations to date over the total estimated time to complete the performance obligations, multiplied by the amount of the milestone payment, is recognized as revenue upon achievement of such milestone. The remaining portion of the milestone will be recognized over the remaining performance period. If the Company has no future obligations under the collaboration agreement, the milestone payments are recognized as revenue in the period the milestone is received. Milestones that are tied to regulatory approval are not considered probable of being achieved until such approval is received. Milestones tied to counterparty performance are not included in the Company’s revenue model until the performance conditions are met.
For the year ended December 31, 2016, Company recognized $29,000 of royalty revenue from its Purdue Collaboration Agreement. No royalty revenue was recognized for the years ended December 31, 2015 and 2014. The Company will continue to recognize royalty revenue upon the sale of the relevant products, provided there are no remaining performance obligations under the arrangement.
On October 28, 2016, in satisfaction of the Company’s payment obligation of the proceeds of sale or disposition of the Intermezzo assets to the former Transcept stockholders under the Merger Agreement, the Company executed the Royalty Sharing
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Agreement. Under the Royalty Sharing Agreement, the Company agreed to pay to the former Transcept stockholders fifty percent of all royalty income received by the Company pursuant to the Purdue Collaboration Agreement, net of all costs, fees and expenses incurred by the Company in connection with the Purdue Collaboration Agreement, related agreements, the Intermezzo product and the administration of the royalty income to the Transcept stockholders. The Company recognizes all royalty income received from Purdue upon the sale of Intermezzo.
The Company also adopted guidance that permits the recognition of revenue contingent upon the achievement of a milestone in its entirety, in the period in which the milestone is achieved, only if the milestone meets certain criteria and is considered to be substantive. As such, the Company plans to recognize revenue in the period in which the milestone is achieved, only if the milestone is considered to be substantive based on the following criteria:
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a.
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The milestone is commensurate with either of the following:
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•
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The vendor’s performance to achieve the milestone.
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•
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The enhancement of the value of the delivered item or items as a result of a specific outcome resulting from the vendor’s performance to achieve the milestone.
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b.
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The milestone relates solely to past performance.
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c.
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The milestone is reasonable relative to all of the deliverables and payment terms (including other potential milestone consideration) within the arrangement.
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The Company did not enter into any significant multiple element arrangements or materially modify any of its existing multiple element arrangements during the years ended December 31, 2016, 2015 and 2014, except for the termination of an existing collaborative research, license and commercialization agreement with a leading global animal health provider and the termination of the SNBL License Agreement. For further information, see Note 5,
License and Collaboration Agreements
.
The Company records deferred revenue when payments are received in advance of the culmination of the earnings process. This revenue is recognized in future periods when the applicable revenue recognition criteria have been met.
Government research grants that provide for payments to the Company for work performed are recognized as revenue when the related expense is incurred. The Company’s government grant payments are nonrefundable and contain no repayment obligations.
Research and Development Expenses
Research and development expenses are charged to expense as incurred. Research and development expenses consist of the costs incurred in performing research and development activities, including personnel-related costs, stock-based compensation, facilities, research-related overhead, clinical trial costs, contracted services, manufacturing, license fees and other external costs. The Company accounts for nonrefundable advance payments for goods and services that will be used in future research and development activities as expenses when the service has been performed or when the goods have been received rather than when the payment is made.
Income Taxes
The company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted rates in effect for the year in which these temporary differences are expected to be recovered or settled. Valuation allowances are provided if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The company provides reserves for potential payments of tax to various tax authorities related to uncertain tax positions and other issues. Reserves are based on a determination of whether and how much of a tax benefit taken by the company in its tax filing is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. Potential interest and penalties associated with such uncertain tax positions recorded as components of income tax expense. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties.
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Stock-Based Compensation
The Company accounts for its stock-based awards in accordance with ASC 718,
Compensation—Stock Compensation
, or ASC 718, which requires all stock-based payments to employees, including grants of stock options, modifications to existing stock options, and restricted stock unit awards, to be recognized as expense
based on their fair values. The Company recognizes the compensation cost of awards subject to performance-based vesting conditions over the requisite service period, to the extent achievement of the performance condition is deemed probable relative to targeted performance using the accelerated attribution method. If achievement of the performance condition is not probable, but the award will vest based on the service condition, the Company recognizes the expense over the requisite service period. A change in the Company's estimate of the probable outcome of a performance condition is accounted for in the period of the change by recording a cumulative catch-up adjustment. The Company accounts for stock-based awards to non-employees using the fair value method on a straight-line basis over the associated service period of the award. The Company expenses restricted stock unit awards to employees based on the fair value of the award on a straight-line basis over the associated service period of the award.
Share-based payments issued to non-employees are recorded at their fair values, are periodically revalued as the equity instruments vest and are recognized as expense over the related service period in accordance with the provisions of ASC 718 and ASC Topic 505 (ASC 505),
Equity
.
The Company estimates the fair value of its stock-based awards to employees and non-employees using the Black-Scholes option pricing model, which requires the input of highly subjective assumptions, including (1) the expected volatility of stock, (2) the expected term of the award, (3) the risk-free interest rate and (4) expected dividends. Due to the lack of a public market for the Company’s common stock prior to completion of reverse merger on October 30, 2014, and resulting lack of company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. For these analyses, the Company has selected companies with characteristics that are comparable, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected life of the stock-based awards. The Company computes the historical volatility data using the daily closing prices for the selected companies' shares during the equivalent period as the calculated expected term of its stock-based awards. During 2015, the Company began to blend its stock price history, for the length of time it has market data for its stock, with the historical volatility of similar public companies for the expected term of each grant. The Company has estimated the expected life of its employee stock options as the average of the midpoints between vesting exercise date for each vesting-trance and the contractual term of the options as the last available exercise date of the option. The risk-free interest rates for periods within the expected life of the option are based on the U.S. Treasury yield curve in effect during the period the options were granted.
The Company also estimates forfeitures at the time of grant and revises those estimates, with any difference recorded as a cumulative adjustment in the period the estimates were revised. Stock-based compensation expense recognized in the consolidated financial statements is based on awards that are ultimately expected to vest. For the years ended December 31, 2016 and 2015, the Company applied an estimated forfeiture rate of approximately 9%.
Comprehensive Income (Loss)
Comprehensive income (Loss) is defined as the change in non-owner sources of equity of a business enterprise durind a period from transactions, other events and circumstances and currently consists of net loss and changes in unrealized gains and losses on available-for-sale securities.
Segment and Geographic Information
Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, and the Company operates in only one geographic segment.
Subsequent Events
The Company considers events or transactions that occur after the balance sheet date, but prior to the issuance of the financial statements to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Refer to the Notes below for further details on subsequent events.
107
Recent Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption.
Between May 2014 and May 2016, the FASB issued three ASUs changing the requirements for recognizing and reporting revenue, or together, herein referred to as the Revenue ASUs: (i) ASU No. 2014-09,
Revenue from Contracts with Customers
, or ASU 2014-09, (ii) ASU No. 2016-08,
Principal versus Agent Considerations (Reporting Revenue Gross versus Net),
or
ASU 2016-08, and (iii) ASU No. 2016-12,
Narrow-Scope Improvements and Practical Expedients
, or ASU 2016-12. ASU 2014-09 provides guidance for revenue recognition to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. ASU 2016-08 is intended to improve the operability and understandability of the implementation guidance on principal versus agent considerations. ASU 2016-12 provides practical expedients and improvements on the previously narrow scope of ASU 2014-09. In August 2015, the FASB issued ASU No. 2015-14,
Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date
, or ASU 2015-14. ASU 2015-14 defers the effective date of ASU 2014-09 by one year to fiscal years, and interim periods within, beginning after December 15, 2017. All subsequent ASUs related to ASU 2014-09, including ASU 2016-08 and ASU 2016-12, assumed the deferred effective date enforced by ASU 2015-14. Early adoption of the Revenue ASUs is permitted for annual periods, and interim periods within, beginning after December 15, 2016. A reporting entity may apply the amendments in the Revenue ASUs using either a modified retrospective approach, by recording a cumulative-effect adjustment to equity as of the beginning of the fiscal year of adoption or full retrospective approach. The Company is evaluating the complete impact of the adoption of the Revenue ASUs on January 1, 2018 to its consolidated financial position and results of operations. Based on the Company’s current assessment of the effect of the new standard on historical revenue under its two current collaboration agreements that is related to upfront and milestone payments, the Company believes these historical amounts will not have a material impact on its consolidated financial statements. The new standard may have a material impact on future revenue to be recognized under the Company’s Allergan Collaboration Agreement. The Company does not believe the new standard will have a material impact on revenue recognized related to its Purdue Collaboration Agreement. The Company
expects to elect the full retrospective application as its transition method.
In June 2014, the FASB issued ASU 2014-12 Compensation—Stock Compensation. In March 2016, the FASB issued ASU 2016-09—Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. This ASU simplifies several areas of accounting for share-based payment transactions, including the income tax consequences, classification of awards as either liabilities or equity and classification of excess tax benefits on the statement of cash flows. This guidance also permits a new entity-wide accounting policy election to either estimate the number of awards that are expected to vest or account for forfeitures when they occur. This guidance will be effective for annual reporting periods beginning after December 15, 2016, including interim periods within those annual reporting periods, and early adoption is permitted. The Company adopted this ASU as of January 1, 2017. The adoption of this standard is expected to impact income tax footnote disclosures. Upon adoption of the standard, the Company expects to make a policy election to realize forfeitures as they occur. As such, the Company expects to record a cumulative-effect adjustment to equity of $0.7 million upon adoption.
In August 2014, the FASB issued ASU 2014-15
Presentation of Financial Statements-Going Concern
. The amendments in this update apply to all reporting entities and require an entity’s management, in connection with preparing financial statements for each annual and interim reporting period, to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the date that the financial statements are available to be issued when applicable). This ASU is effective for annual periods ending after December 15, 2016. The Company adopted this standard for the year ended December 31, 2016. Based on the results of the Company's analysis, no additional disclosures were required.
In February 2016, the FASB issued ASU No. 2016-02,
Leases (Topic 842)
. The amendment requires a lessee to recognize assets and liabilities for leases with a maximum possible term of more than 12 months. A lessee would recognize a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the leased asset (the underlying asset) for the lease term. This ASU is effective for fiscal years beginning after December 15, 2018, including those interim periods within those fiscal years.
The Company is currently evaluating the impact the adoption of the ASU will have on its consolidated financial statements.
In August 2016, the FASB issued ASU No. 2016-15,
Statement of Cash Flows (Topic 230),
which simplifies certain elements of cash flow classification. The new guidance is intended to reduce diversity in practice in how certain transactions are classified in the statement of cash flows. The ASU is effective for annual periods beginning after December 15, 2017.
The Company is currently evaluating the impact the adoption of the ASU will have on its consolidated financial statements.
108
In October 2016, the FASB issued ASU No. 2016-16,
Intra-Entity Transfers of Assets Other Than Inventory
, or ASU 2016-16. The amendments in ASU 2016-16 require an entity to recognize the income tax consequences of intra-entity transfers of assets other than inventory at the time that the transfer occurs. Current guidance does not require recognition of tax consequences until the asset is eventually sold to a third party. ASU 2016-16 is effective for fiscal years, and interim periods within, beginning after December 15, 2017. Early adoption is permitted as of the first interim period presented in a year. A reporting entity must apply the amendments in ASU 2016-16 using a modified retrospective approach by recording a cumulative-effect adjustment to equity as of the beginning of the fiscal year of adoption. The Company is evaluating the impact of the adoption of ASU 2016-16 on January 1, 2018 to its consolidated financial position and results of operations. The Company does not expect the adoption of ASU 2016-16 to have a material impact to its consolidated financial position or results of operations.
In November 2016, the FASB issued ASU No. 2016-18,
Restricted Cash
, or ASU 2016-18. The amendments in ASU 2016-18 require an entity to reconcile and explain the period-over-period change in total cash, cash equivalents and restricted cash within its statements of cash flows. ASU 2016-18 is effective for fiscal years, and interim periods within, beginning after December 15, 2017. Early adoption is permitted. A reporting entity must apply the amendments in ASU 2016-18 using a full retrospective approach.
The Company is currently evaluating the impact the adoption of the ASU will have on its consolidated financial statements.
In January 2017, the FASB issued ASU No. 2017-04,
Simplifying the Test for Goodwill Impairment
, or ASU 2017-04. The amendments in ASU 2017-04 eliminate the current two-step approach used to test goodwill for impairment and require an entity to apply a one-step quantitative test and record the amount of goodwill impairment as the excess of a reporting unit's carrying amount over its fair value, not to exceed the total amount of goodwill allocated to the reporting unit. ASU 2017-04 is effective for fiscal years, including interim periods within, beginning after December 15, 2019 (upon the first goodwill impairment test performed during that fiscal year). Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. A reporting entity must apply the amendments in ASU 2017-04 using a prospective approach. The Company does not expect the adoption of ASU 2017-04 to have a material impact to its consolidated financial position or results of operations.
As described in Note 1,
Organization
, the Company completed the Merger with Transcept on October 30, 2014 for the principal purposes of utilizing the cash resources held by Transcept to continue the development of the late-stage product candidate held by Paratek and for the access to capital markets afforded in Transcept’s public listing.
Purchase Consideration
Purchase consideration amounted to $27.2 million determined based on the fair value of the net assets exchanged detailed as follows (in thousands):
|
|
Purchase
Consideration
|
|
Stock consideration
|
|
$
|
19,786
|
|
Contingent obligations to former Transcept stockholders with
respect to:
|
|
|
|
|
Intermezzo product rights
|
|
|
4,140
|
|
Intermezzo reserve
|
|
|
2,870
|
|
TO-2070 license rights
|
|
|
440
|
|
Total purchase consideration
|
|
$
|
27,236
|
|
Stock consideration in the Merger is determined relative to the publicly traded price of a share of Transcept’s common stock immediately prior to the Merger as adjusted for cash dividends declared by Transcept as part of the Merger. Such dividends also included the right for former Transcept shareholders to receive certain contingent amounts, in the future, consisting of:
|
(i)
|
one hundred percent of any royalty income received by the Company prior to October 30, 2016, pursuant to the United States License and Collaboration Agreement, dated July 31, 2009, as amended November 1, 2011, by and between Transcept and Purdue Pharmaceutical Products L.P.;
|
|
(ii)
|
one hundred percent of any payments received by the Company pursuant to the termination of a License Agreement with SNBL which granted the Company an exclusive worldwide license to commercialize SNBL’s proprietary nasal drug delivery technology for development of TO-2070, a proprietary nasal powder drug delivery system;
|
109
|
(iii)
|
ninety percent of any cash proceeds from a sale or disposition of Intermezzo (less all fees and expenses incurred by the Company in connection with such sale or disposition following the closing date); provided such sale or disposition occurs prior to October 30, 2016, and
|
|
(iv)
|
the amount, if any, of the $3.0 million Intermezzo reserve deposited at closing which is remaining at October 30, 2016.
|
The contingent obligations to former Transcept stockholders as described above were recognized at fair value as of the acquisition date and were subsequently remeasured each reporting period. The change in fair value was recognized in our consolidated statements of operations.
The fair value of the contingent obligations to former Transcept stockholders prior to the second anniversary of the Merger was determined using probability-weighted scenario methodologies, employing cash-flow and sale proceeds income approaches with consideration to the potential timing of possible payments to former Transcept stockholders.
Material assumptions used to value contingent obligations to former Transcept stockholders with respect to Intermezzo product right and the associated Intermezzo reserve included:
|
•
|
probabilities associated with the various outcomes of the ongoing Abbreviated New Drug Application, or ANDA, litigation and the potential sale of Intermezzo product rights;
|
|
•
|
the forecasted Intermezzo product revenues and associated royalties due the Company, as well as the appropriate discount rate given consideration to the market and forecast risk involved; and
|
|
•
|
the potential proceeds associated with, and timing of, the sale of the Company’s Intermezzo product rights.
|
Material assumptions used to value contingent obligations to former Transcept stockholders with respect to Intermezzo product right and the associated Intermezzo reserve included:
|
•
|
probabilities associated with SNBL licensing the TO-2070 license rights under the SNBL Termination Agreement; and
|
|
•
|
potential proceeds associated with, and timing of, the potential payments in accordance with the SNBL Termination Agreement.
|
|
•
|
with SNBL licensing the TO-2070 license rights under the SNBL Termination Agreement; and
|
|
•
|
Potential proceeds associated with, and timing of, the potential payments in accordance with the SNBL Termination Agreement.
|
Allocation of Purchase Consideration
Purchase consideration was allocated to the net tangible and identifiable intangible assets acquired and the liabilities assumed based on their fair values as of October 30, 2014 detailed as follows (in thousands):
|
|
Allocation of
Purchase
Consideration
|
|
Cash
|
|
$
|
13,688
|
|
Bridge loan from Transcept to Paratek
|
|
|
5,100
|
|
Restricted cash—Intermezzo reserve
|
|
|
3,000
|
|
Current liabilities, net
|
|
|
(371
|
)
|
Intangible assets acquired with respect to:
|
|
|
|
|
Intermezzo product rights
|
|
|
4,550
|
|
TO-2070 license rights
|
|
|
440
|
|
Goodwill
|
|
|
829
|
|
Total purchase consideration
|
|
$
|
27,236
|
|
Fair value of cash and other working capital accounts, including accounts receivable, other current assets, accounts payable and accrued expenses, approximates book value on acquisition. Fair values are based on assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.
Given the significant uncertainty concerning the ultimate disposition of both Transcept’s Intermezzo product rights and the TO-2070 license rights, the Company has estimated the fair value of the acquired identifiable intangible assets probability-weighted
110
scenario methodologies, employing cash-flow and sale proceeds income approaches with consideration to the potential timing of possible payments to former Transcept stockholders as described above with respect to the associated contingent liabilities.
Goodwill of $0.8 million resulting from the allocation of total purchase consideration represents effectively the value of Transcept’s public listing. Goodwill is not expected to be deductible for tax purposes.
Pro forma information
The following unaudited pro forma information presents a summary of the Company’s consolidated results of operations as if the Merger had taken place as of January 1, 2014 (in thousands):
|
|
December 31,
2014
|
|
Pro forma combined revenues
|
|
$
|
5,304
|
|
Pro forma combined net loss
|
|
$
|
(12,733
|
)
|
Pro forma basic and diluted net loss per share
|
|
$
|
(1.02
|
)
|
4
.
|
Net Loss Per Share Available to Common Stockholders
|
Basic net loss per share available to common stockholders is calculated by dividing the net loss available to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share available to common stockholders is computed by dividing the net loss available to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury-stock method or the as if converted method, as applicable. For purposes of this calculation, convertible preferred stock, stock options and convertible preferred and common stock warrants are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share available to common stockholders when their effect is dilutive.
The following table presents the computation of basic and diluted net loss per share. For 2014, the table presents the computation of basic and diluted net loss per share reflecting the effect of the reverse stock split in connection with the Merger (in thousands, except share and per share data):
|
|
Year Ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
Numerator
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(111,636
|
)
|
|
$
|
(70,860
|
)
|
|
$
|
(17,835
|
)
|
Less: Unaccreted dividends on convertible preferred
stock
|
|
|
—
|
|
|
|
—
|
|
|
|
(1,927
|
)
|
Net loss attributable to common stockholders
|
|
|
(111,636
|
)
|
|
|
(70,860
|
)
|
|
|
(19,762
|
)
|
Denominator
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding—
basic and diluted
|
|
|
20,253,082
|
|
|
|
16,501,912
|
|
|
|
2,528,595
|
|
Net loss per share—basic and diluted
|
|
$
|
(5.51
|
)
|
|
$
|
(4.29
|
)
|
|
$
|
(7.82
|
)
|
The following outstanding shares subject to options and warrants to purchase common stock were antidilutive due to a net loss in the years presented and, therefore, were excluded from the dilutive securities computation as of the dates indicated below (in thousands):
|
|
Year Ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
Excluded potentially dilutive securities
(1)
:
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares subject to options to purchase common stock
|
|
|
2,780,791
|
|
|
|
2,242,890
|
|
|
|
781,568
|
|
Unvested restricted stock
|
|
|
454,000
|
|
|
|
275,500
|
|
|
|
—
|
|
Shares subject to warrants to purchase common stock
|
|
|
79,454
|
|
|
|
47,426
|
|
|
|
14,734
|
|
Shares issuable under employee stock purchase plan
|
|
|
36,539
|
|
|
|
36,539
|
|
|
|
36,539
|
|
Totals
|
|
|
3,350,784
|
|
|
|
2,602,355
|
|
|
|
832,841
|
|
111
(1)
|
The number of shares is based on the maximum number of shares issuable on exercise or conversion of the related securities as of the year end. Such amounts have not been adjusted for the treasury stock method or weighted average outstanding calculations as required if the securities were dilutive.
|
5
.
|
License and Collaboration Agreements
|
Allergan plc
In July 2007, the Company and Warner Chilcott Company, Inc. (now part of Allergan), entered into a collaborative research and license agreement, or the Allergan Collaboration Agreement, under which the Company granted Allergan an exclusive license to research, develop and commercialize tetracycline products for use in the United States for the treatment of acne and rosacea. Since Allergan did not exercise its development option with respect to the treatment of rosacea prior to initiation of a Phase 3 trial for the product, the license grant to Allergan converted to a non-exclusive license for the treatment of rosacea as of December 2014. Under the terms of the Allergan Collaboration Agreement, the Company and Allergan are responsible for, and are obligated to use, commercially reasonable efforts to conduct specified development activities for the treatment of acne and, if requested by Allergan, the Company may conduct certain additional development activities to the extent the Company determines in good faith that the Company has the necessary resources available for such activities. Allergan has agreed to reimburse the Company for its costs and expenses, including third-party costs, incurred in conducting any such development activities.
Under the terms of the Allergan Collaboration Agreement, Allergan is responsible for and is obligated to use commercially reasonable efforts to develop and commercialize tetracycline compounds that are specified in the agreement for the treatment of acne. Allergan failed to elect to advance the development of sarecycline for the treatment of rosacea in accordance with the terms of the agreement so the license granted to Allergan was converted to a non-exclusive license for the treatment of rosacea The Company has agreed during the term of the Allergan Collaboration Agreement not to directly or indirectly develop or commercialize any tetracycline compounds in the United States for the treatment of acne and rosacea, and Allergan has agreed during the term of the Allergan Collaboration Agreement not to directly or indirectly develop or commercialize any tetracycline compound included as part of the agreement for any use other than as provided in the agreement.
The Company earned an upfront fee in the amount of $4.0 million upon the execution of the Allergan Collaboration Agreement, $1.0 million upon filing of an Investigational New Drug Application in 2010, and $2.5 million upon initiation of Phase 2 trials in 2012. In December 2014, the Company also earned $4.0 million upon initiation of Phase 3 trials associated with the Allergan Collaboration Agreement. In addition, Allergan may be required to pay the Company an aggregate of approximately $17.0 million upon the achievement of specified future regulatory milestones, the next being $5.0 million upon acceptance by the FDA, of a NDA, submission. Allergan is also obligated to pay the Company tiered royalties, ranging from the mid-single digits to the low double digits, based on net sales of tetracycline compounds developed under the Allergan Collaboration Agreement, with a standard royalty reduction post patent expiration for such product for the remainder of the royalty term. Allergan’s obligation to pay the Company royalties for each tetracycline compound it commercializes under the Allergan Collaboration Agreement expires on the later of the expiration of the last to expire patent that covers the tetracycline compound in the United States and the date on which generic drugs that compete with the tetracycline compound reach a certain threshold market share in the United States.
Either the Company or Allergan may terminate the Allergan Collaboration Agreement for certain specified reasons at any time after Allergan has commenced development of any tetracycline compound, including if Allergan determines that it would not be commercially viable to continue to develop or commercialize the tetracycline compound and/or that it is unlikely to obtain regulatory approval of the tetracycline compound, and, in any case, no backup tetracycline compound is in development or ready to be developed and the parties are unable to agree on an extension of the development program or an alternative course of action. Either the Company or Allergan may terminate the Allergan Collaboration Agreement for the other party’s uncured breach of a material term of the agreement on 60 days’ notice (unless the breach relates to a payment term, which requires a 30-day notice) or upon the bankruptcy of the other party that is not discharged within 60 days. Upon the termination of the Allergan Collaboration Agreement by Allergan for the Company’s breach, Allergan’s license will continue following the effective date of termination, subject to the payment by Allergan of the applicable milestone and royalty payments specified in the agreement unless our breach was with respect to certain specified obligations, in which event the obligation of Allergan to pay us any further royalty or milestone payments will terminate. Upon the termination of the Allergan Collaboration Agreement by us for Allergan’s breach or the voluntary termination of the agreement by Allergan, Allergan’s license under the agreement will terminate.
The Company determined whether the performance obligations under the Allergan Collaboration Agreement could be accounted for separately or as a single unit of accounting. The Company determined that the license, participation on steering committees and research and development services performance obligations during the research period of the Allergan Collaboration Agreement represented a single unit of accounting. As the Company could not reasonably estimate its level of effort, the Company recognized
112
revenue from the upfront payment, milestone payment and research and development services payments using the contingency-adjusted performance model over the expected development period. The development period was completed in June 2010. Under this model, when a milestone was earned or research and development services were rendered, revenue was immediately recognized on a pro-rata basis in the period the milestone was achieved or services were delivered based on the time elapsed from the effective date of the agreement. Thereafter, the remaining portion was recognized on a straight-line basis over the remaining development period. The Company has determined that each potential future clinical, regulatory and commercialization milestone is substantive. In making this determination, pursuant to the accounting guidance on revenue recognition for milestone payments, the Company considered and concluded that each individual milestone: (i) relates solely to the past performance of the intellectual property to achieve the milestone; (ii) is reasonable relative to all of the deliverables and payment terms in the arrangement; and (iii) is commensurate with the enhanced value of the intellectual property as a result of the milestone achievement. As the Company’s obligations under this arrangement have been completed, all future milestones, which are all considered substantive, will be recognized as revenue when achieved.
Also, the Company, at its discretion, may provide manufacturing process development services to Allergan in exchange for full-time equivalent based cost reimbursements. The Company determined that the manufacturing process development services are considered a separate unit of accounting as (i) they are set at the Company’s discretion, (ii) they have stand-alone value, as these services could be performed by third parties, and (iii) the full-time equivalent rate paid for such services rendered is considered fair value. Therefore, the Company recognizes cost reimbursements for manufacturing process development services as revenue as the services are performed.
Tufts University
In February 1997, the Company and Tufts University, or Tufts, entered into a license agreement under which the Company acquired an exclusive license to certain patent applications and other intellectual property of Tufts related to the drug resistance field to develop and commercialize products for the treatment or prevention of bacterial or microbial diseases or medical conditions in humans or animals or for agriculture. The Company subsequently entered into nine amendments to that agreement, collectively the Tufts License Agreement, to include patent applications filed after the effective date of the original license agreement, to exclusively license additional technology from Tufts, to expand the field of the agreement to include disinfectant applications, and to change the royalty rate and percentage of sublicense income paid by the Company to Tufts under sublicense agreements with specified sublicensees. The Company is obligated under the Tufts License Agreement to provide Tufts with annual diligence reports and a business plan and to meet certain other diligence milestones. The Company has the right to grant sublicenses of the licensed rights to third parties, which will be subject to the prior approval of Tufts unless the proposed sublicensee meets a certain net worth or market capitalization threshold. The Company is primarily responsible for the preparation, filing, prosecution and maintenance of all patent applications and patents covering the intellectual property licensed under the Tufts License Agreement at its sole expense. The Company has the first right, but not the obligation, to enforce the licensed intellectual property against infringement by third parties.
The Company issued Tufts 1,024 shares of the Company’s common stock on the date of execution of the original license agreement, and the Company may be required to make certain payments of up to $0.3 million to Tufts upon the achievement by products developed under the agreement of specified development and regulatory approval milestones. The Company has already made a payment of $50,000 to Tufts for achieving the first milestone following commencement of the Phase 3 clinical trial for omadacycline. The Company is also obligated to pay Tufts a minimum royalty payment in the amount of $25,000 per year. In addition, the Company is obligated to pay Tufts royalties based on gross sales of products, as defined in the agreement, ranging in the low single digits depending on the applicable field of use for such product sale. If the Company enters into a sublicense under the agreement, based on the applicable field of use for such product, we agreed to pay. Tufts a percentage, ranging from 10% to 14% (ten percent to fourteen percent) of that portion of any sublicense issue fees or maintenance fees received by us that are reasonably attributable to the sublicense of the rights granted to us under the Tufts License Agreement and the lesser of a percentage ranging from the low tens to the high twenties based on the applicable field of use for such product, of the royalty payments made to us by the sublicensee or the amount of toyalty payments that would have been paid by us to Tufts if we had sold the product.
Unless terminated earlier, the Tufts License Agreement will expire at the same time as the last-to-expire patent in the patent rights licensed to the Company under the agreement and after any such expiration the Company will continue to have an exclusive, fully-paid-up license to such intellectual property licensed from Tufts. Tufts has the right to terminate the agreement upon 30 days’ notice should the Company fail to make a material payment under the Tufts License Agreement or commit a material breach of the agreement and not cure such failure or breach within such 30-day period, or if, after the Company has started to commercialize a product under the Tufts License Agreement, the Company ceases to carry on its business for a period of 90 consecutive days. The Company has the right to terminate the Tufts License Agreement at any time upon 180 days’ notice. Tufts has the right to convert the Company’s exclusive license to a non-exclusive license if the Company does not commercialize a product licensed under the agreement within a specified time period.
113
Purdue Pharma L.P.
In July 2009, the Company and Purdue Pharma L.P., or Purdue Pharma, entered into the Purdue Collaboration Agreement, that grants an exclusive license to Purdue Pharma to commercialize Intermezzo in the United States and pursuant to which:
|
•
|
Purdue Pharma paid the Company a $25.0 million non-refundable license fee in August 2009;
|
|
•
|
Purdue Pharma paid the Company a $10.0 million non-refundable intellectual property milestone in December 2011 when the first of two issued formulation patents was listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book;
|
|
•
|
Purdue Pharma paid the Company a $10.0 million non-refundable intellectual property milestone in August 2012 when the first of two issued methods of use patents was listed in the FDA’s Orange Book;
|
|
•
|
The Company transferred the Intermezzo NDA to Purdue Pharma, and Purdue Pharma is obligated to assume the expense associated with maintaining the NDA and further development of Intermezzo in the United States, including any expense associated with post-approval studies;
|
|
•
|
Purdue Pharma is obligated to commercialize Intermezzo in the United States at its expense using commercially reasonable efforts;
|
|
•
|
Purdue Pharma is obligated to pay the Company tiered base royalties on net sales of Intermezzo in the United States ranging from the mid-teens up to the mid-20% level, with each such royalty tiers subject to an increase by a percentage in the low single digits upon a specified anniversary of regulatory approval of Intermezzo. The base royalty is tiered depending upon the achievement of certain fixed net sales thresholds by Purdue Pharma, which net sales levels reset each year for the purpose of calculating the royalty. The royalty tiers are subject to reductions upon generic entry and patent expiration. Purdue Pharma is obligated to pay royalties until the later of 15 years from the date of first commercial sale in the United States or the expiration of patent claims related to Intermezzo; and
|
|
•
|
Purdue Pharma is obligated to pay the Company up to an additional $70.0 million upon the achievement of certain net sales targets for Intermezzo in the United States.
|
The Company had an option to co-promote Intermezzo to psychiatrists in the United States and such option was terminated as a result of the Merger.
The Purdue Collaboration Agreement expires on the expiration of Purdue Pharma’s royalty obligations. Purdue Pharma has the right to terminate the Purdue Collaboration Agreement at any time upon advance notice of 180 days. The Purdue Collaboration Agreement is also subject to termination by Purdue Pharma in the event of FDA or governmental action that materially impairs Purdue Pharma’s ability to commercialize Intermezzo or the occurrence of a serious event with respect to the safety of Intermezzo. The Purdue Collaboration Agreement may also be terminated by the Company upon Purdue Pharma commencing an action that challenges the validity of Intermezzo related patents. The Company also has the right to terminate the Purdue Collaboration Agreement immediately if Purdue Pharma is excluded from participation in federal healthcare programs. The Purdue Collaboration Agreement may also be terminated by either party in the event of a material breach by or insolvency of the other party.
The Company also granted Purdue Pharma and an associated company the right to negotiate for the commercialization of Intermezzo in Mexico in 2013 but retained the rights to commercialize Intermezzo in the rest of the world.
In December 2013, Purdue Pharma notified the Company that it intended to discontinue use of the Purdue Pharma sales force to actively market Intermezzo to healthcare professionals during the first quarter of 2014.
In October 2014, the Company announced that its board of directors had approved a special dividend of, among other things, the right to receive, on a pro rata basis, 100% of any royalty income received by the Company pursuant to the Purdue Collaboration Agreement and 90% of any cash proceeds from a sale or disposition of Intermezzo, less fees and expenses incurred in connection with such activity, to the extent that either occurs prior to the second anniversary of the closing date of the Merger. On October 28, 2016, in satisfaction of the Company’s payment obligation of the proceeds of sale or disposition of the Intermezzo assets to the former Transcept stockholders under the Merger Agreement, the Company executed the Royalty Sharing Agreement with the Special Committee. Under the Royalty Sharing Agreement, the Company agreed to pay to the former Transcept stockholders fifty percent of all royalty income received by the Company pursuant to the Purdue Collaboration Agreement, net of all costs, fees and expenses incurred by the Company in connection with the Purdue Collaboration Agreement, related agreements, the Intermezzo product and the administration of the royalty income to the Transcept stockholders. The remaining balance of the Intermezzo Reserve, with the
114
exception of unpaid legal fees,
as well as any outstanding royalty payments was paid to former Transcept stockholders shortly after the second anniversary of the Merger.
Shin Nippon Biomedical Laboratories Ltd.
In September 2013, the Company and SNBL entered into a License Agreement, or SNBL License Agreement, pursuant to which SNBL granted the Company an exclusive worldwide license to commercialize SNBL’s proprietary nasal drug delivery technology to develop TO-2070. The Company was developing TO-2070 as a treatment for acute migraine using SNBL’s proprietary nasal powder drug delivery system. Under the SNBL License Agreement, the Company was required to fund all development and regulatory approval with respect to TO-2070. Pursuant to the SNBL License Agreement, the Company paid an upfront nonrefundable technology license fee of $1.0 million, and the Company was also obligated to pay up to an aggregate of $41.5 million upon the achievement of certain development, regulatory and sales milestones, and tiered, low double-digit royalties on annual net sales of TO-2070.
In September 2014, the Company and SNBL entered into a Termination Agreement and Release, or the SNBL Termination Agreement, pursuant to which, among other things, the SNBL License Agreement was terminated and the Company assigned all of its rights, interest and title to the TO-2070 license rights to SNBL in exchange for a portion of certain future net revenue received by SNBL as set forth in the SNBL Termination Agreement, up to an aggregate of $2.0 million.
Past Collaborations
Novartis
In September 2009, the Company and Novartis International Pharmaceutical Ltd., or Novartis, entered into a Collaborative Development, Manufacture and Commercialization License Agreement, or the Novartis Agreement, for the co-development and commercialization of omadacycline, which included a $70 million upfront payment from Novartis to the Company, future development and sales milestone payments and future royalty payments, depending on the success of omadacycline. Under the agreement, Novartis was to have led development activities for omadacycline, and the Company was to have co-developed omadacycline and contributed a share of the Company’s development expense.
The Novartis Agreement provided that Novartis would bear the majority of all direct development costs incurred in connection with omadacycline and would assume all responsibility for the manufacturing of omadacycline. The agreement provided Novartis with a global, exclusive patent license for the development, manufacturing and marketing of omadacycline.
Novartis had the right to terminate the agreement without cause upon providing 60 days’ advance written notice. Novartis provided the Company with a notice of intent to terminate the agreement on June 29, 2011, and the termination became effective 60 days later. While Novartis terminated the agreement without cause, Novartis indicated that it elected to terminate the agreement due to the then-existing delays and uncertainties experienced in connection with the regulatory pathway for approval of omadacycline in two core indications, ABSSSI and CABP.
In January 2012, the Company and Novartis entered into a letter agreement, or the Novartis Letter Agreement, in which the Company reconciled shared development costs and expenses and granted Novartis a right of first negotiation with respect to commercialization rights of omadacycline following approval of omadacycline from the FDA, the European Medicines Agency, or EMA, or any regulatory agency, but only to the extent that the Company has not previously granted such commercialization rights for omadacycline to another third party as of any such approval.
Under the Novartis Letter Agreement, the Company agreed to pay Novartis $2.9 million as reconciliation of development costs and expenses. In June 2014, the Company amended the Novartis Letter Agreement, as amended, and Novartis agreed to convert the full amount of development cost share plus any accrued interest into a 0.25% royalty, to be paid from net sales received by the Company in any country following the launch of omadacycline in that country and continuing until the later of expiration of the last active valid patent claim covering such product in the country of sale and 10 years from the date of first commercial sale in such country. The amended Novartis Letter Agreement resulted in a long-term liability in the amount of $3.6 million for the year ended December 31, 2016 and 2015 included within “Other Long Term Liabilities” on the Company’s consolidated balance sheet. There are no other payment obligations to Novartis under the Novartis Agreement or the Novartis Letter Agreement.
115
Global Animal Health Provider
In May 2014, the Company and a leading global animal health provider terminated an existing collaborative research, license and commercialization agreement. The Company has no future obligations under this agreement, and the leading global animal health company retains no rights to our technology. As a result of this termination, in 2014, the Company recognized the remaining $0.3 million of deferred revenue related to the upfront and milestone payments received in 2007 and 2008.
6. Restricted Cash
Short-term restricted cash
Intermezzo Reserve
In accordance with the Merger Agreement, the Intermezzo Reserve has been kept in a separate segregated bank account established at the closing date of the Merger. This account was utilized solely at the direction and in the discretion of the Special Committee, or its authorized delegates in connection with the Special Committee’s management of the Intermezzo assets and the potential Intermezzo asset disposition. The remainder of Intermezzo Reserve, with the exception of unpaid legal fees, was paid out to the former Transcept stockholders shortly after the second anniversary of the Merger. Approximately $0.1 million remains in the reserve as of December 31, 2016. The reserve balance was $2.4 million as of December 31, 2015.
Letter of Credit
During the year ended December 31, 2016, the Company obtained a letter of credit in the amount of $0.8 million, which is collateralized with a bank account at a financial institution, to secure value-added tax registration in certain foreign countries. The letter of credit was cancelled by the Company subsequent to year-end. The Company plans to obtain a new letter of credit for the same value during the first quarter of 2017, depending upon currency rates.
Long-term restricted cash
Letter of Credit
The Company leases its Boston, Massachusetts office space under a non-cancelable operating lease. Refer to Note 18,
Commitments and Contingencies
, for further details.
In accordance with the lease, the Company has a cash-collateralized irrevocable standby letter of credit in the amount of $0.3 million as of December 31, 2016 and 2015, naming the landlord as beneficiary.
7. Cash and Cash Equivalents and Marketable Securities
During 2016, the Company began investing in short-term marketable securities
. The following is a summary of available-for-sale securities as of December 31, 2016 (in thousands):
|
|
Amortized Cost
|
|
|
Unrealized Gains
|
|
|
Unrealized Losses
|
|
|
Fair Value
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities
|
|
$
|
62,574
|
|
|
$
|
—
|
|
|
$
|
(18
|
)
|
|
$
|
62,556
|
|
Government agencies
|
|
|
12,518
|
|
|
|
2
|
|
|
|
—
|
|
|
|
12,520
|
|
Total
|
|
$
|
75,092
|
|
|
$
|
2
|
|
|
$
|
(18
|
)
|
|
$
|
75,076
|
|
No available-for-sale securities held as of December 31, 2016 have remaining maturities greater than one year.
116
Fixed assets consist of the following (in thousands):
|
|
Estimated
|
|
December 31,
|
|
|
|
Useful Life
In Years
|
|
2016
|
|
|
2015
|
|
Office equipment
|
|
5
|
|
|
443
|
|
|
|
424
|
|
Computer equipment
|
|
3
|
|
|
251
|
|
|
|
288
|
|
Computer software
|
|
3
|
|
|
787
|
|
|
|
443
|
|
Leasehold improvements
|
|
|
|
|
137
|
|
|
|
210
|
|
Construction-in-progress
|
|
|
|
|
391
|
|
|
|
—
|
|
Gross fixed assets
|
|
|
|
|
2,009
|
|
|
|
1,365
|
|
Less: Accumulated depreciation and amortization
|
|
|
|
|
(821
|
)
|
|
|
(586
|
)
|
Net fixed assets
|
|
|
|
$
|
1,188
|
|
|
$
|
779
|
|
In addition, leasehold improvements are amortized over the shorter of the lease term or the estimated useful economic lives of the related assets.
Depreciation expense for the years ended December 31, 2016, 2015 and 2014 was approximately $0.3 million, $0.1 million, and $20,000 respectively, which is included in general and administrative and research and development expense on the accompanying consolidated statements of operations.
Construction-in-progress as of December 31, 2016 includes $0.4
million related to construction costs incurred by the Company at its Boston office location.
During 2016, the Company retired a small amount of fixed assets with no gain or loss recognized. During 2015, the Company retired fixed assets of $0.7 million with accumulated depreciation of $0.7 million, which resulted in a net loss of approximately $16,000. During 2014, the Company retired fixed assets of $0.3 million with accumulated depreciation of $0.3 million, which resulted in a net gain on retirement of $15,000 due to proceeds received of $15,000.
9
.
|
Intangible Assets, Net
|
Intermezzo product rights and the TO-2070 license rights were acquired through the Merger. Refer to Note 5,
License and Collaboration Agreements,
for further detail concerning Intermezzo and TO-2070. Intangible assets are reviewed when events or circumstances indicate that the assets might be impaired. An impairment loss would be recognized when the estimated undiscounted cash flows to be generated by those assets are less than the carrying amounts of those assets. If it is determined that the intangible asset is not recoverable, an impairment loss would be calculated based on the excess of the carrying value of the intangible asset over its fair value.
On March 27, 2015, a decision was made by the United States District Court for the District of New Jersey, or the New Jersey District Court, concerning Intermezzo patent infringement claims the Company made in response to the filing of an ANDA with the FDA. The decision made by the New Jersey District Court invalidated several Intermezzo patent claims as obvious. As a result of the New Jersey District Court’s ruling, the Company performed an interim impairment test of the Intermezzo product rights in connection with the preparation of its unaudited condensed consolidated financial statements for the first quarter of 2015. Based on the intangible asset impairment test performed, the Company recorded a non-cash impairment charge of $2.8 million for the first quarter of 2015. The Company appealed the New Jersey District Court’s ruling during the second quarter of 2015. On January 8, 2016 the United States Court of Appeals for the Federal Circuit, or the U.S. Court of Appeals, affirmed the decision of the New Jersey District Court, and no opinion accompanied the judgment. Refer to Note 18,
Commitments and Contingencies,
for further information concerning the litigation.
The January 8, 2016 decision by the U.S. Court of Appeals triggered an evaluation of the carrying value of the Intermezzo product rights and related contingent obligations in light of an expected decline in Intermezzo sales during the second half of 2016. On April 5, 2016, the first generic launch of Intermezzo occurred. The Company performed a recoverability test each reporting period during 2016. It was determined that the summation of the undiscounted future cash flow of the Intermezzo product rights were greater than the carrying value for all reporting periods. As such, the Company did not record an impairment charge during the twelve months ended December 31, 2016.
117
In accordance with the Company’s policy, the estimated useful lives of long-lived intangible assets are reviewed on an ongoing basis. During the year ended December 31, 2016, the execution of the Royalty Sharing Agreement prompted a change in the estimated useful life of the Intermezzo product rights. The Company extended the estimated useful life to better reflect the projected period it will receive royalties from Intermezzo product sales. The estimated useful life of Intermezzo product rights was increased from
five years to fifteen years.
The effect of this change in estimate reduced amortization expense and net loss recognized during the year ended December 31, 2016 by
$60,000
and increased 2016 basic and diluted earnings per share by an immaterial amount. The remaining carrying amount of the Intermezzo product rights will be amortized prospectively over the revised remaining useful life.
During the fourth quarter of 2015, the Company was made aware of the unlikelihood that SNBL will find a potential partner to co-develop the TO-2070 license rights. This significant uncertainty triggered an examination of the carrying value of the TO-2070 product rights and related contingent obligation to former Transcept stockholders. The Company estimated the fair value of the acquired identifiable intangible assets using a probability-weighted cash flow estimation approach for potential milestone payments from SNBL with consideration to the timing of possible payments of associated contingent liabilities to former Transcept stockholders. Based on the intangible asset impairment test performed on the TO-2070 product rights, the Company recorded a non-cash impairment charge of $0.1 million. No such impairment exists as of December 31, 2016.
Intangible assets consist of the following (in thousands):
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
Intermezzo product rights
|
|
$
|
1,410
|
|
|
$
|
1,410
|
|
TO-2070 license rights
|
|
|
170
|
|
|
|
170
|
|
Gross intangible assets
|
|
|
1,580
|
|
|
|
1,580
|
|
Less: Accumulated amortization
|
|
|
(565
|
)
|
|
|
(231
|
)
|
Net intangible assets
|
|
$
|
1,015
|
|
|
$
|
1,349
|
|
Intermezzo product rights were impaired during 2015. After the impairment charge and change in useful life, the Intermezzo product rights is being amortized over a remaining useful life of 13 years as of December 31, 2016. TO-2070 product rights were impaired during the fourth quarter of 2015. TO-2070 product rights are being amortized over a remaining useful life of two years as of December 31, 2016. There was no impairment recorded for the year ended December 31, 2014.
Total amortization expense for the years ended December 31, 2016, 2015, and 2014 was $0.3 million, $0.6 million and $0.2 respectively.
Amortization expense is expected to be as follows for the next five-year period (in thousands):
|
|
Amortization
|
|
Years Ended December 31,
|
|
|
|
|
2017
|
|
$
|
158
|
|
2018
|
|
|
73
|
|
2019
|
|
|
73
|
|
2020
|
|
|
73
|
|
2021
|
|
|
73
|
|
Total
|
|
$
|
450
|
|
118
Accrued expenses consist of the following (in thousands):
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
|
|
Accounts payable
|
|
$
|
4,418
|
|
|
$
|
766
|
|
Accrued legal costs
|
|
|
358
|
|
|
|
615
|
|
Accrued compensation
|
|
|
2,609
|
|
|
|
1,323
|
|
Intermezzo payable
|
|
|
49
|
|
|
|
288
|
|
Accrued professional fees
|
|
|
1,118
|
|
|
|
874
|
|
Accrued contract manufacturing
|
|
|
1,940
|
|
|
|
2,443
|
|
Accrued other
|
|
|
298
|
|
|
|
134
|
|
Total
|
|
$
|
10,790
|
|
|
$
|
6,443
|
|
11.
|
Notes Payable and Derivative Liability—Related Party
|
As a result of the Merger and concurrent recapitalization, there are no notes payables-related party outstanding as of December 31, 2016 and December 31, 2015. Historically, the Company has issued several notes with attendant derivative liabilities detailed as follows:
March 2012 Notes
In February and March 2012, the Company issued nonconvertible notes, or the March 2012 Notes to certain individuals and entities in the original aggregate principal amount of $5.8 million. The holders of the March 2012 Notes included officers, employees and directors of the Company, making the March 2012 Notes related party in nature. Pursuant to the terms of the March 2012 Notes, upon a reorganization, defined as a capital reorganization of the common stock (other than a subdivision, combination, recapitalization, reclassification or exchange of shares), a consolidation or merger of the Company, other than a merger or consolidation of the Company in a transaction in which the Company’s shareholders immediately prior to the transaction possess more than 50% of the voting securities of the surviving entity (or parent, if any) immediately after the transaction, or a sale of all or substantially all of the Company’s assets, the March 2012 Notes would become due and payable and the Company would be required to repurchase each note in an amount equal to the outstanding principal amount of such notes, plus 150% of the outstanding principal amount of each note, together with simple interest at a rate of 10.0% per year.
Upon certain liquidity events, including the license, transfer or assignment of all or a material portion of the Company’s assets or intellectual property, a public offering or any other alternative financing other than a reorganization defined above, the board of directors was required to evaluate whether the Company had sufficient cash on hand to repurchase the March 2012 Notes and to fund the Company’s working capital and funding needs for the Company’s clinical trials and related activities for at least 180 days. If sufficient cash was available, the Company was required to repurchase such notes at an amount equal to the outstanding principal amount of such notes, plus an amount equal to (i) 150% of the outstanding principal amount of each note if such repurchase occurred before August 13, 2013, or (ii) 150% of the outstanding principal amount of each note, together with simple interest at a rate of 10.0% per year, if the repurchase occurred after August 13, 2013. In such instance, if the Company only had sufficient cash to repurchase a portion of the March 2012 Notes, they were required to be repurchased on a pro rata basis. The March 2012 Notes could also have been repurchased by the Company at any time with approval by the board of directors and consent from the holders of more than 50% of the outstanding March 2012 Notes, in an amount equal to the outstanding principal amount of such notes, plus 150% of the outstanding principal amount of each note, together with simple interest at a rate of 10.0% per year. The March 2012 Notes did not have a contractual maturity date.
The purchase agreement pursuant to which the March 2012 Notes were issued included a provision that required the existing convertible preferred stockholders to participate in the offering of the March 2012 Notes based on their pro rata share of the $5.0 million offering amount. On March 21, 2012, pursuant to a vote of certain preferred stockholders, all convertible preferred stock was converted to common stock effective upon the close of business on the day immediately preceding the second closing of the March 2012 Notes financing. The convertible preferred stockholders who contributed at least their pro rata share converted back to their respective series of convertible preferred stock and retained the rights and privileges of their respective preferred stock class. See Note 13,
Preferred Stock
, below for these rights and preferences. In the event that the convertible preferred stockholders did not contribute their pro rata share, these stockholders continued to hold common stock. Upon the completion of the transaction, 1,024,509 shares of convertible preferred stock that were converted into 218,324 shares of common stock remained outstanding as shares of common stock.
119
The March 2012 Notes met the definition of a derivative in their entirety as defined by ASC 815,
Derivatives and Hedging.
The derivative was recorded at a fair value of $11.3 million upon the closing of the transaction within the derivative liability line on the balance sheets. As the fair value of the derivative liability exceeded the proceeds of the March 2012 Notes, the difference of $5.5 million between the fair value of the derivative liability and the proceeds from the March 2012 Notes was recorded as a charge to other expense at the time of the closing of the transaction. The derivative liability was marked to market at each reporting period with the change in fair value recorded in other income and expense.
The fair value of the derivative liability was determined using unobservable inputs and therefore was considered a Level 3 liability in the fair value hierarchy.
October 2012 Notes
In October 2012, the Company entered into a note and stock purchase agreement and issued $5.0 million in aggregate principal amount of convertible notes to certain of the Company’s existing stockholders, or the October 2012 Notes. The holders of the October 2012 Notes included officers, employees and directors of the Company, making the October 2012 Note transaction related party in nature. The terms of the October 2012 Notes were substantially similar to the terms of the March 2012 Notes as described above with the following exceptions:
|
•
|
Each October 2012 Note holder was entitled to receive up to four shares of the Company’s common stock for each $1.00 of notes purchased, with one-third of such shares, the “upfront shares”, issued upon the purchase of the October 2012 Notes, and the remaining two-thirds of such shares, the “deferred shares”, issued upon the completion of an initial public offering, so long as the offering occurred prior to April 2, 2013. The Company issued 224,802 upfront shares associated with the $5.0 million raised in October 2012. The Company would have issued 449,623 shares if the Company had completed an initial public offering by April 2, 2013.
|
|
•
|
If the board of directors approved any other private financing that was completed prior to an initial public offering, each holder would have been entitled to convert such holder’s investment in the notes, including the outstanding principal amount plus accrued and unpaid simple interest at 10.0% from the date of issuance, into the security that was issued as part of such private financing on terms and conditions no less favorable to the other investors participating in such private financing. All holders of the October 2012 Notes who elect to convert their notes, however, were required to forfeit all of their upfront shares, as well as the right to receive any deferred shares.
|
The Company has determined that the upfront and deferred shares were free-standing financial instruments to be separately accounted for as equity.
|
•
|
The 224,802 upfront shares issued simultaneously with the October 2012 Notes were recorded in equity at a fair value of $4.7 million along with a corresponding charge to other expense in the year ended December 31, 2012.
|
|
•
|
The 449,623 deferred shares to be issued upon completion of the initial public offering were recorded in equity at a fair value of $8.9 million along with a corresponding charge to other expense in the year ended December 31, 2012.
|
The October 2012 Notes also met the definition of a derivative in their entirety as set forth in ASC 815,
Derivatives and Hedging
. This derivative was recorded at a fair value of $10.1 million upon the closing of the transaction within the derivative liability line on the balance sheets. The $5.1 million excess of the fair value of the derivative liability over the $5.0 million of proceeds from the October 2012 Notes was recorded as other expense at the time of the closing of the transaction.
Exchange Notes, 2012 Notes
Additionally, in October 2012 the Company and the holders of the March 2012 Notes agreed to exchange all of the March 2012 Notes for notes with substantially similar terms as the October 2012 Notes, or the Exchange Notes, and together with the October 2012 Notes, the 2012 Notes, except that the holders of the Exchange Notes were not entitled to receive any upfront or deferred shares of the Company’s common stock.
2013 Notes
In 2013, the Company issued $4.8 million in aggregate principal amount of additional convertible promissory notes to certain investors, including existing stockholders, or the 2013 Notes. The holders of the 2013 Notes include officers, employees and directors of the Company, making the 2013 Note transaction related party in nature. The terms of the 2013 Notes were identical to the terms of the October 2012 Notes described above. The Company issued 216,087 upfront shares associated with the $4.8 million raised in 2013, which was recorded in equity at a fair value of $2.9 million along with a corresponding charge to other expense in the year ended
120
December 31, 2013. No deferred shares were issued as an initial public offering had not occurred prior to April 2, 2013, and as such there was no value assigned to any deferred shares associated with the 2013 Notes. The $2.0 million excess of the fair value of the derivative liability over the $4.8 million of proceeds from the 2013 Notes was recorded as other expense in the year ended December 31, 2013.
Convertible Notes
Together, the Exchange Notes, the October 2012 Notes and the 2013 Notes are referred to as the Convertible Notes. The Convertible Notes derivative liability was marked to fair value each reporting period with the change in fair value recorded in other income and expense. During the year ended December 31, 2013, the Company recorded $8.0 million in other income related to the re-measurement of the fair value of the derivative liability.
Upon completion of an initial public offering, all of the Convertible Notes would have been exchanged for notes with revised repurchase and conversion terms, or the Post-IPO Notes. Pursuant to the terms of the Post-IPO Notes, the Company would have been obligated to repurchase all Post-IPO Notes in an amount equal to the outstanding principal amount of such notes, plus 150% of the outstanding principal amount of each note, together with simple interest at a rate of 10.0% per year, upon the earlier to occur of (i) a reorganization, which is defined as a capital reorganization of the common stock (other than a subdivision, combination, recapitalization, reclassification or exchange of shares), a consolidation or merger of the Company (other than a merger or consolidation of the Company in a transaction in which the Company’s shareholders immediately prior to the transaction possess more than 50% of the voting securities of the surviving entity (or parent, if any) immediately after the transaction) or a sale of all or substantially all of the Company’s assets, or (ii) approval of any of the Company’s product candidates, including omadacycline, for any indication by the FDA, the EMA or the equivalent regulatory agencies in at least two European countries. Additionally, the Company could have chosen to repurchase the Post-IPO Notes in an amount equal to the outstanding principal amount of such notes, plus 150% of the outstanding principal amount of each note, together with simple interest at a rate of 10.0% per year, prior to the events described in (i) or (ii) above if, after one or more specified liquidity events as described below, such repurchase was permitted under any existing loan documents and the board of directors determined in good faith that (A) none of the proceeds of the planned initial public offering would be used to effect such repurchase and (B) the Company had sufficient cash to fund its general operating needs through the completion of the two planned Phase 3 registration studies for ABSSSI and an additional 12 months thereafter. To effect this early repurchase, one or more liquidity events must have occurred, which include, among other things, a license or a public offering other than the planned initial public offering. In addition, any holder of Post-IPO Notes may convert all or a portion of the then-outstanding principal amount and any unpaid accrued interest of the Post-IPO Notes into shares of common stock in an amount equal to 150% of the principal amount of the Post-IPO Note elected to be converted, plus accrued and unpaid interest, at a conversion price equal to 115% of the initial public offering price. No Post-IPO Notes had been issued as of December 31, 2013 as the Company had not completed an initial public offering.
In 2014, the Company and the holders of the Convertible Notes agreed to convert all outstanding principal and interest into shares of a new series of the Company’s convertible preferred stock. The derivative liability related to the Convertible Notes was eliminated upon their conversion in the March 2014 Notes recapitalization transaction, and the fair value was reclassified to mezzanine equity.
2014 Notes
In March 2014, the Company issued the 2014 Notes to certain individuals and entities in the original aggregate principal amount of $6.0 million in connection with a concurrent recapitalization of the Company’s capital stock (See Note 12,
Common Stock)
. $520 of the $6.0 million raised in the 2014 Note financing had been prefunded by certain investors of the Company in prior periods. The 2014 Notes were collateralized by substantially all of the assets of the Company and accrued interest at a rate of 10% per annum. The holders of the 2014 Notes included officers, employees and directors of the Company, making the 2014 Notes related party in nature. Pursuant to the terms of the 2014 Notes, the aggregate amount of principal outstanding was to have become due and payable upon the first to occur of June 30, 2014 or a number of other defined events that had not transpired and, as a result, an event of default existed that the lenders agreed to forbear subject to a Debt Conversion Agreement, or the Debt Conversion Agreement, entered into in June 2014. Under the Debt Conversion Agreement, the $6.0 million principal amount outstanding under, and all interest accrued ($0.4 million) on, the 2014 Notes were converted into shares of the Company’s common stock immediately prior to the closing of the Financing with a value of $15.4 million and resulted in a $9.0 million loss on exchange of non-convertible note for common stock recorded to other non-operating expenses in the year ended December 31, 2014.
The lead lenders committed to a minimum investment of $3.3 million in the March 2014 secured debt financing. The terms of the March 2014 secured debt financing included a provision that required the other existing holders of the outstanding convertible notes to participate in the offering of the 2014 Notes based on their pro rata share of the remaining $2.8 million offering amount. The convertible note holders who contributed their pro rata share to the March 2014 secured debt financing converted their existing
121
principal amount of convertible notes outstanding into 2.25 shares of newly designated Series A Convertible Preferred Stock, or New Series A Convertible Preferred Stock, for every $1.00 of principal outstanding. The convertible note holders who did not contribute their pro rata share to the March 2014 secured debt financing converted their existing principal amount of convertible notes outstanding into 1.00 share of New Series A Convertible Preferred Stock for every $1.00 of principal outstanding. Moreover, all accrued interest as of February 28, 2014 was converted into New Series A Convertible Preferred Stock on a dollar-for-dollar basis. Upon the closing of the March 2014 transactions, $15.6 million of principal and $2.2 million of accrued interest related to the existing convertible notes converted into 2,256,674 shares of New Series A Convertible Preferred Stock.
Pursuant to the terms of the March 2014 secured debt financing, in April 2014, the Lead Lenders invested the difference between $2.8 million and the amount invested by other holders of the existing convertible notes to bring the total financing proceeds to $6.0 million. The amount of this additional investment by the Lead Lenders was $0.7 million. In connection with this additional investment, the Lead Lenders received warrants exercisable for 9,614 shares of New Series A Convertible Preferred Stock with an exercise price of $0.01 per share, or the New Series A Warrants. The New Series A Warrants have a term of seven years. The New Series A Warrants were recorded at an initial fair value of approximately $40,000.
Following the Merger, the authorized capital stock of the Company consists of 100,000,000 shares of common stock, par value $0.001 per share, and the preferred stock described in Note 13,
Preferred Stock
.
The holders of common stock are entitled to one vote per share on all matters to be voted upon by the stockholders and there are no cumulative rights. Subject to preferences that may be applicable to any outstanding preferred stock, the holders of common stock are entitled to receive ratably any dividends that may be declared from time to time by the board of directors out of funds legally available for that purpose. In the event of liquidation of the Company, dissolution or winding up, the holders of common stock are entitled to share ratably in all assets remaining after payment of liabilities, subject to prior distribution rights of preferred stock then outstanding. The common stock has no preemptive or conversion rights or other subscription rights. There are no redemption or sinking fund provisions applicable to the common stock. The outstanding shares of common stock are fully paid and non-assessable.
On January 12, 2015, the Company filed a registration statement on Form S-3 with the SEC, as amended on April 24, 2015 and declared effective on April 27, 2015, to sell shares of our common stock, par value $0.001 per share, in an aggregate amount of up to $200.0 million to the public in a registered offering or offerings. Under this shelf registration, the Company completed an underwritten offering on May 5, 2015 of 3,089,000 shares of
common
stock at a public offering price of $24.50 per share, which includes 229,000 shares of common stock issued upon the exercise, in part, by the underwriters of an option to purchase additional shares from the Company. The aggregate proceeds received by the Company, after underwriting discounts and commissions and other offering expenses, were $70.4 million.
The Company completed a public offering in June 2016 of 4,887,500 shares of common stock at an offering price of $13.00 per share, which included 637,500 shares of common stock issued upon the exercise by the underwriters of an option to purchase additional shares from the Company. The net proceeds received by us, after underwriting discounts and commissions and other estimated offering expenses, were $59.3 million.
On October 15, 2015, Paratek Pharmaceuticals, Inc. entered into a Controlled Equity Offering
SM
Sales Agreement, or the 2015 Sales Agreement, with Cantor Fitzgerald & Co., or Cantor, under which the Company could, at its discretion, from time to time sell shares of its common stock, with a sales value of up to $50.0 million. The Company provided Cantor with customary indemnification rights, and Cantor was entitled to a commission at a fixed rate of 3% of the gross proceeds per share sold. Sales of the shares under the 2015 Sales Agreement have been and, if there are additional sales under the 2015 Sales Agreement, will be made in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended.
The Company initiated sales of shares under the 2015 Sales Agreement in March 2016, and sold an aggregate of 860,014 shares of common stock through December 31, 2016, resulting in net proceeds of $11.6 million after deducting commissions of $0.4 million. As of February 24, 2017, an additional 870,078 shares were sold under the 2015 Sales Agreement subsequent to December 31, 2016 resulting in net proceeds of $13.1 million after deducting commissions of $0.4 million, which will be recognized during the first quarter of 2017.
122
On February 28, 2017, the Company entered into
a second Controlled Equity Offering
SM
Sales Agreement, or the 2017 Sales Agreement, with Cantor
,
under which the Company could, at its discretion, from time-to-time sell shares of its common stock, with a sales value of up to $50.0 million. The Company provided Cantor with customary indemnification rights, and Cantor was entitled to a commission at a fixed rate of 3% of the gross proceeds per share sold. Any sales of the shares under the 2017 Sales Agreement will be made in transactions deemed to be “at the market offerings” as defined in Rule 415 under the Securities Act of 1933, as amended.
Warrants to Purchase Common Stock
Warrants to purchase preferred stock with intrinsic value issued to HBM Healthcare Investments (Cayman) Ltd., Omega Fund III, L.P., and K/S Danish BioVenture, all beneficial owners of more than 5% of the Company’s common stock, were exchanged for 9,614 warrants to purchase common stock in connection with the Merger. 9,614 warrants to purchase common stock have an exercise price of $0.15 per share and will, if not exercised, expire in 2021. A further 5,120 warrants to purchase common stock with an exercise price of $73.66 per share expired in April 2016.
As described in Note 16,
Long-term Debt
, in connection with the Loan Agreement, the Company issued to each one of Hercules Technology II, L.P. and Hercules Technology III, L.P. a warrant to purchase 16,346 shares of its common stock (32,692 shares of common stock in total) at an exercise price of $24.47 per share, or the Hercules Warrants, on September 30, 2015, which expire five years from issuance or at the consummation of a Public Acquisition, as defined in each of the Hercules Warrant agreements. The Hercules Warrants’ total relative fair value of $0.3 million was determined using a Black-Scholes option-pricing model with the following assumptions:
|
|
September 30,
2015
|
|
Volatility
|
|
|
62.4
|
%
|
Weighted average risk-free interest rate
|
|
|
1.4
|
%
|
Expected dividend yield
|
|
|
0.0
|
%
|
Expected term
|
|
5 years
|
|
As
described in Note 16,
Long-term Debt
, in connection with the Loan Agreement Amendment, the Company issued to each one of Hercules Technology II, L.P. and Hercules Technology III, L.P. a warrant to purchase 18,574 shares of its common stock (37,148 shares of common stock in total) at an exercise price of $13.46 per shares, or the Loan Amendment Warrants.
Additionally, upon the Additional Tranche funding date, the Company will issue an additional warrant to each of Hercules Technology II, L.P. and Hercules Technology III, L.P. which together will be exercisable for an aggregate number of shares equal to $125,000 divided by the arithmetic mean of the Company’s daily closing price per share for the ten trading days preceding the Additional Tranche funding date and each carry an exercise price equal to the arithmetic mean of the Company’s daily closing price per share for the ten trading days preceding the Additional Tranche funding date. Each Warrant may be exercised on a cashless basis. The Warrants are exercisable for a term beginning on the date of issuance and ending on the earlier to occur of five years from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the Warrants. The number of shares for which the Warrants are exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in the Warrants.
The Loan Amendment Warrants’, excluding the Conditional Warrants, total fair value of $0.3 million was determined using a Black-Scholes option-pricing model with the following assumptions:
|
|
December 31,
2016
|
|
Volatility
|
|
|
60.2
|
%
|
Weighted average risk-free interest rate
|
|
|
1.9
|
%
|
Expected dividend yield
|
|
|
0.0
|
%
|
Expected term
|
|
5 years
|
|
Following the Merger, the authorized capital stock of the Company consists of 5,000,000 shares of undesignated preferred stock, par value $0.001 per share, and the common stock described in Note 12,
Common Stock
. There are no shares of preferred stock outstanding.
123
The Company’s Board of Directors has the authority, without further action by the stockholders, to issue up to 5,000,000 shares of preferred stock, in one or more series, and to fix the rights, preferences, privileges and restrictions granted to or imposed upon the preferred stock. Any or all of these rights may be greater than the rights of the common stock.
The board of directors, without stockholder approval, can issue preferred stock with voting, conversion or other rights that could negatively affect the voting power and other rights of the holders of common stock. Preferred stock could thus be issued quickly with terms calculated to delay or prevent a change in control of Paratek or make it more difficult to remove Paratek management. Additionally, the issuance of preferred stock may have the effect of decreasing the market price of Paratek’s common stock.
The board of directors may specify the following characteristics of any preferred stock:
|
•
|
the maximum number of shares;
|
|
•
|
the designation of the shares;
|
|
•
|
the annual dividend rate, if any, whether the dividend rate is fixed or variable, the date or dates on which dividends will accrue, the dividend payment dates, and whether dividends will be cumulative;
|
|
•
|
the price and the terms and conditions for redemption, if any, including redemption at the option of Paratek or at the option of the holders, including the time period for redemption, and any accumulated dividends or premiums;
|
|
•
|
the liquidation preference, if any, and any accumulated dividends upon the liquidation, dissolution or winding up of Paratek affairs;
|
|
•
|
any sinking fund or similar provision, and, if so, the terms and provisions relating to the purpose and operation of the fund;
|
|
•
|
the terms and conditions, if any, for conversion or exchange of shares of any other class or classes of Paratek capital stock or any series of any other class or classes, or of any other series of the same class, or any other securities or assets, including the price or the rate of conversion or exchange and the method, if any, of adjustment;
|
|
•
|
any or all other preferences and relative, participating, optional or other special rights, privileges or qualifications, limitations or restrictions.
|
Any preferred stock issued will be fully paid and nonassessable upon issuance.
As a result of the Merger and concurrent recapitalization, there are no shares of preferred stock issued or outstanding as of December 31, 2016, 2015 and 2014.
Convertible Preferred Stock Warrants
Warrants to purchase preferred stock with intrinsic value issued to HBM Healthcare Investments (Cayman) Ltd., Omega Fund III, L.P., and K/S Danish BioVenture, all beneficial owners of more than 5% of the Company’s common stock, were exchanged for 9,614 warrants to purchase common stock in connection with the Merger. These 9,614 warrants to purchase common stock have an exercise price of $0.15 per share and will, if not exercised, expire in 2021. A further 5,120 warrants to purchase common stock with an exercise price of $73.66 per share expired in April 2016. As of December 31, 2013, the Company had 2,243 warrants to purchase Series H Convertible Preferred Stock outstanding with a weighted-average exercise price of $356.59 each and aggregate fair value of approximately $3,000.
14.
|
Fair Value Measurements
|
Financial instruments, including cash, restricted cash, accounts receivable, accounts payable, accrued expenses and the Intermezzo reserve are carried on the consolidated financial statements at amounts that approximate fair value. The fair value of the Company’s long-term debt is determined using current applicable rates for similar instruments as of the balance sheet date. The carrying value of the long-term debt approximates its fair value as the interest rate is near current market rates. The fair value of the Company’s long-term debt was determined using Level 3 inputs. Fair values are based on assumptions concerning the amount and timing of estimated future cash flows and assumed discount rates, reflecting varying degrees of perceived risk.
The following tables present information about the Company’s financial assets and liabilities that have been measured at fair value as of December 31, 2016 and December 31, 2015, and indicate the fair value hierarchy of the valuation inputs utilized to
124
determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities or other inputs that are observable market data. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability (in thousands):
Description
|
|
Quoted
Prices in
Active
Markets
(Level 1)
|
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
|
December 31,
2016
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. treasury securities
|
|
$
|
62,556
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
62,556
|
|
Government agencies
|
|
|
—
|
|
|
|
12,520
|
|
|
|
—
|
|
|
$
|
12,520
|
|
Total Assets
|
|
$
|
62,556
|
|
|
$
|
12,520
|
|
|
$
|
—
|
|
|
$
|
75,076
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent obligations
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
655
|
|
|
$
|
655
|
|
Total Liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
655
|
|
|
$
|
655
|
|
Description
|
|
Quoted
Prices in
Active
Markets
(Level 1)
|
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
|
December 31,
2015
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent obligations
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,000
|
|
|
$
|
1,000
|
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,000
|
|
|
$
|
1,000
|
|
Prior to the second anniversary of the Merger, contingent obligations represented the right for former Transcept stockholders to receive certain contingent amounts, in the future, which consisted of:
|
(i)
|
one hundred percent of any royalty income received by the Company prior to October 30, 2016, pursuant to the United States License and Collaboration Agreement, dated July 31, 2009, as amended November 1, 2011, by and between Transcept and Purdue Pharmaceutical Products L.P.;
|
|
(ii)
|
one hundred percent of any payments received by the Company pursuant to the termination of a License Agreement with SNBL which granted the Company an exclusive worldwide license to commercialize SNBL’s proprietary nasal drug delivery technology for development of TO-2070, a proprietary nasal powder drug delivery system;
|
|
(iii)
|
ninety percent of any cash proceeds from a sale or disposition of Intermezzo (less all fees and expenses incurred by the Company in connection with such sale or disposition following the closing date); provided such sale or disposition occurs prior to October 30, 2016;
|
|
(iv)
|
the amount, if any, of the $3.0 million Intermezzo reserve deposited at closing which is remaining at October 30, 2016.
|
The contingent obligations to former Transcept stockholders as described above were recognized at fair value as of the acquisition date and subsequently remeasured through the second anniversary of the Merger. The change in fair value was recognized in our consolidated statements of operations. Through the third quarter of 2016, the fair value of the contingent obligations to former Transcept stockholders was determined using probability-weighted scenario methodologies, employing cash-flow and sale proceeds income approaches with consideration to the potential timing of possible payments to former Transcept stockholders.
On October 28, 2016, in satisfaction of the Company’s payment obligation of the proceeds of sale or disposition of the Intermezzo product rights to the former Transcept stockholders under the Merger Agreement, the Company executed the Royalty Sharing Agreement with the Special Committee. Under the Royalty Sharing Agreement, the Company agreed to pay to the former Transcept stockholders fifty percent of all royalty income received by the Company pursuant to the Purdue Collaboration Agreement, net of all costs, fees and expenses incurred by the Company in connection with the Purdue Collaboration Agreement, related agreements, the Intermezzo product and the administration of the royalty income to the Transcept stockholders. The Company determined that the Royalty Sharing Agreement represents a modification to the original contingent obligations established under the Merger Agreement in accordance with ASC 805,
Business Combinations.
125
The significant unobservable inputs used in the fair value measurement of the contingent obligation to former Transcept stockholders with respect to the Intermezzo product rights as of December 31, 2016 were estimated future Intermezzo product revenues and associated royalties due the Company as well as the appropriate discount rate given consideration to the market and forecast risk involved.
The results of this valuation yielded
a
decrease in the contingent obligation to former Transcept stockholders $0.2 million during the twelve months ended December 31, 2016.
Significant increases (decreases) in any of those inputs would result in a substantially lower (higher) fair value measurement.
The contingent obligation associated with the TO-2070 license rights no longer exists as of December 31, 2016 since there were no payments received by the Company pursuant to the termination of the SNBL License Agreement prior to the second anniversary of the Merger. This yielded a decrease in the contingent obligation of $0.1 million during the twelve months ended December 31, 2016.
As of December 31, 2015, the fair value of the contingent obligations to former Transcept stockholders was determined using probability-weighted scenario methodologies, employing cash-flow and sale proceeds income approaches with consideration to the potential timing of possible payments to former Transcept stockholders. The outcome of an Intermezzo patent infringement trial triggered an evaluation of the carrying value of the Intermezzo product rights and related contingent liability in light of an expected decline in Intermezzo sales. As a result of the evaluation, the Company recorded a reduction in contingent obligations to former Transcept stockholders of $3.1 million during 2015. The Company appealed the outcome of the trial during the second quarter of 2015. Based on estimated probability of success of the appeal combined with fair value remeasurements, the Company recorded an additional decrease in contingent obligations to former Transcept stockholders of $0.2 million, for a total net decrease of $3.3 million during the year ended December 31, 2015.
In addition, during the fourth quarter of 2015, the Company was made aware of the unlikeliness of SNBL to find a potential partner to co-develop the TO-2070 license rights. As a result, the Company recorded a reduction in contingent obligations to former Transcept stockholders of $0.3 million during 2015.
The total reduction in contingent obligations to former Transcept shareholders was $3.6 million during the year ended December 31, 2015.
Material assumptions used to value contingent obligations to former Transcept stockholders with respect to Intermezzo product rights as of December 31, 2015 included:
|
•
|
Probabilities associated with the various outcomes of the ongoing ANDA litigation and the potential sale of Intermezzo product rights;
|
|
•
|
The forecasted Intermezzo product revenues and associated royalties due the Company, as well as the appropriate discount rate given consideration to the market and forecast risk involved; and
|
|
•
|
The potential proceeds associated with, and timing of, the sale of the Company’s Intermezzo product rights.
|
Material assumptions used to value contingent obligations to former Transcept stockholders with respect to the TO-2070 product rights include:
|
•
|
Probabilities associated with SNBL licensing the TO-2070 license rights under the SNBL Termination Agreement; and
|
|
•
|
Potential proceeds associated with, and timing of, the potential payments in accordance with the SNBL Termination Agreement.
|
The following table provides a roll forward of the fair value of contingent obligations categorized as Level 3 instruments for the years ended December 31, 2016 and 2015 (in thousands):
|
|
Contingent
liability—
former
Transcept
stockholders
|
|
Balances at December 31, 2014
|
|
$
|
4,560
|
|
Decrease in fair value
|
|
|
(3,560
|
)
|
Balances at December 31, 2015
|
|
|
1,000
|
|
Decrease in fair value
|
|
|
(345
|
)
|
Balances at December 31, 2016
|
|
$
|
655
|
|
126
As of December 31, 2013, the fair value of the convertible preferred stock warrants was determined using the Black-Scholes option valuation model. The quantitative information associated with the fair value measurement of the Company’s Level 3 inputs related to the convertible preferred stock warrants as of December 31, 2013 include the fair value per share of the underlying convertible preferred stock, the remaining contractual term of the warrants (2.21 years), risk-free interest rate (0.34%), expected dividend yield (0%) and expected volatility of the price of the underlying preferred stock (73%) The fair value of the derivative liability related to the nonconvertible and convertible notes was determined using a probability adjusted discounted cash flow model. The quantitative information associated with the fair value measurement of the Company’s Level 3 inputs related to the derivative liability include the probabilities of an event requiring repurchase of the convertible notes, which range from 10.0% to 45.0%, the estimated time to repurchase, which ranges from six months to twelve months, and a discount rate of 20%.
The following table provides a roll-forward of the fair value of the convertible preferred stock warrants, derivative liability and continent liability to former Transcept stockholders categorized as Level 3 instruments for the year ended December 31, 2014 (in thousands):
|
|
Convertible
Preferred
Stock
Warrants
|
|
|
Derivative
Liability
|
|
Balances at December 31, 2013
|
|
$
|
3
|
|
|
$
|
21,022
|
|
Unrealized loss
|
|
|
1
|
|
|
|
118
|
|
Fair value of 2014 warrant issuance
|
|
|
36
|
|
|
|
—
|
|
Conversion to equity
|
|
|
(40
|
)
|
|
|
(21,140
|
)
|
Balances at December 31, 2014
|
|
$
|
—
|
|
|
$
|
—
|
|
15.
|
Stock-Based Compensation
|
Certain employees, officers, directors and consultants have been granted options and other equity instruments to purchase common shares under plans adopted in 1996, 2001, 2002, 2005, 2006, 2014 and 2015, or respectively, the 1996 Plan, the 2001 Plan, the 2002 Plan, the 2005 Plan, the 2006 Plan, the 2014 Plan, the 2015 Plan and the 2015 Inducement Plan. The 2001 Plan, 2002 Plan, and 2006 Plan were former Transcept plans that carried forward to the date of the Merger. The 1996 Plan, 2001 Plan, 2002 Plan, and 2005 Plan were cancelled at the effective time of the Merger. The 2006 Plan and 2014 Plan survived the Merger. Upon effectiveness of the 2015 Plan no further awards will be granted under the 2006 Plan and 2014 Plan.
Incentive stock and non-statutory stock options must be granted with exercise prices of not less than the fair market value of the common stock on the date of grant. Incentive stock options granted to a stockholder owning more than 10% of voting stock of the Company must have an exercise price of not less than 110% of the fair market value of the common stock on the date of grant. The Company determined the fair market value of common stock until the Company became publicly traded. Stock options are generally granted with terms of up to ten years and vest over a period of one to four years.
2006 Plan
The 2006 Plan provided for the grant of incentive stock options, non-statutory stock options, restricted stock, performance share awards, performance stock units, dividend equivalents, restricted stock units, stock payments, deferred stock, performance-based awards and stock appreciation rights. The outstanding employee stock options generally vested over four years, are exercisable over a period not to exceed the contractual term of ten years from the date the stock options are issued and are granted at prices equal to the fair market value of the Company’s common stock on the grant date. The 2006 Plan was most recently amended and restated effective as of the date of the Company’s 2010 Annual Stockholders’ Meeting. Unless earlier terminated, the 2006 Plan will terminate on June 2, 2020.
127
Stock option exercises and restricted stock units are settled with newly issued common stock from the 2006 Plan’s previously authorized and available pool of shares. A total of 200,206 shares of common stock was authorized for issuance pursuant to the 2006 Plan at the time of its most recent amendment and restatement in 2010, plus the number of shares of the Company’s common stock available for issuance under the 2001 Plan that were not subject to outstanding options, as of the effective date of such amendment and restatement of the 2006 Plan (including shares that are subject to stock options outstanding under s 2001 Plan that expired, were cancelled or otherwise terminated unexercised, or shares that otherwise would have reverted to the share reserve of the 2001 Plan following such effective date). The number of shares of common stock reserved for issuance under the 2006 Plan increased automatically on the first day of each fiscal year by a number of shares equal to the least of: (i) 5.0% of shares of the Company’s common stock outstanding on such date; (ii) 125,000 shares; or (iii) a smaller number determined by the Company’s Board of Directors. This provision resulted in an additional 125,000, and 125,000, and
of
the Company’s common stock becoming available for issuance on January 1, 2015 and January 1, 2014.
During the year ended December 31, 2015, prior to the
effectiveness of the 2015 Plan, the Company’s Board of Directors
granted
102,000
restricted stock units to executives and employees of the Company and
397,719
stock options to directors, officers, employees and consultants under the 2006 Plan, with vesting provisions ranging from
one
to
four
years
.
As of December 31, 2016, no additional shares remained available for issuance the 2006 Plan. However, 15,000 restricted stock units and 25,708 stock options granted under the 2006 Equity Incentive Plan were cancelled or forfeited during the year ended December 31, 2016 and the shares underlying such awards became available for grant under the 2015 Plan.
2014 Plan
The 2014 Plan provided for the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards and other stock awards to employees, officers, directors, and consultants of the Company. Under the 2014 Plan, 67,500 shares of common stock were initially approved for grant. 67,500 shares of fully-vested restricted common stock were granted pursuant to the 2014 Plan to current and former employees and directors of the Company in June 2014. Attendant compensation expense of $0.3 million calculated with reference to the then fair market value of the Company’s common stock determined in good faith by the Company’s Board of Directors was recorded in connection with the June 2014 grant.
Also in June 2014, the Board of Directors approved an increase in the shares available for grant under the 2014 Plan to 875,531 shares from the 67,500 shares and granted the resulting 808,031 shares that became available for issuance under the 2014 Plan as options to purchase common stock to certain employees in June 2014. The common stock grants and stock option exercises from the 2014 Plan are settled with newly issued common stock from the 2014 Plan’s previously authorized and available pool of shares.
Certain of the options to purchase common stock issued in June 2014 were subsequently modified in 2014 in connection with the termination of the employment of employees holding such options to provide for, among other changes, accelerated vesting terms.
Further, in February 2015 the Company’s Board of Directors modified the vesting terms of eight grants made to four executives of the Company aggregating 483,114 stock options previously granted under the 2014 Plan from strictly time-based vesting to include certain performance-based vesting terms associated with completion of data lock in the Company’s Phase 3 clinical trials of IV-to-oral omadacycline for the treatment of ABSSSI and CABP. The Company recognizes compensation cost for awards with performance conditions if and when it concludes that it is probable that the performance condition will be achieved over the requisite service period. The Phase 3 ABSSSI IV-to-oral study data lock occurred in June 2016. This resulted in the vesting of 212,516 stock options. Since the Company believes it is more likely than not that data lock will be reached on the Phase 3 CABP IV-to-oral study, the sum of the incremental compensation cost and any remaining unrecognized compensation cost for the original award on the modification date is being recognized, on a prospective basis, through the projected completion of data lock on the study.
During the year ended December 31, 2015, prior to the effectiveness of the 2015 Plan, the Company’s Board of Directors granted 24,000 stock options to directors, officers, employees and consultants to the 2014 Plan with time vesting provisions ranging from one to four years. As of December 31, 2016, no additional shares remained available for issuance the 2014 Plan.
2015 Plans
The Company’s Board of Directors adopted a 2015 Inducement Plan in accordance with NASDAQ Rule 5635(c)(4), reserving 360,000 shares of common stock solely for the grant of inducement stock options to new employees, and granting 353,500 stock options under the plan to executives and employees of the Company under the 2015 Inducement Plan with time vesting provisions ranging from one to four years.
The Company has not made any additional grants under the 2015 Inducement Plan since December 31, 2015. However, 66,667
128
stock options granted under the 2015 Inducement Plan were cancelled during the year ended December 31, 2016.
Although the Company does not currently anticipate the issuance of additional stock options under the 2015 Inducement Plan, 73,167 shares remain available for grant under that plan, as well as any shares underlying outstanding options that may become available for grant pursuant to the plan’s terms. It is therefore possible that the Company may, based on the business and recruiting needs of the Company, issue additional stock options under the 2015 Inducement Plan.
The Company’s Board of Directors also adopted the 2015 Plan, which was approved by Company stockholders at the Annual Meeting held on June 9, 2015, reserving 1,200,000 shares of common stock for the grant of incentive stock options, non-statutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards, performance cash awards and other stock awards to directors, officers, employees and consultants. The 2015 Plan is intended to be the successor to and continuation of the 2006 Plan and the 2014 Plan, or collectively, the Prior Plans. When the 2015 Plan became effective, no additional stock awards were granted under the Prior Plans, although all outstanding stock awards granted under the Prior Plans will continue to be subject to the terms and conditions as set forth in the agreements evidencing such stock awards and the terms of the Prior Plans.
The number of shares available for issuance under the 2015 Plan was initially 1,200,000, plus the number of shares that again become available for grant as a result of forfeited or terminated awards or shares withheld in satisfaction of the exercise price of withholding obligations associated with awards under the Prior Plans, not to exceed 2,000,000 shares. 1,167,931 and 880,430 shares of common stock were automatically added to the shares authorized for issuance under the 2015 Plan on January 1, 2017 and January 1, 2016, respectively, pursuant to a “Share Reserve” provision contained in the 2015 Plan. The Share Reserve will automatically increase on January 1
st
of each year, for the period commencing on (and including) January 1, 2016 and ending on (and including) January 1, 2025, in an amount equal to 5% of the total number of shares of common stock outstanding on December 31st of the preceding calendar year. Notwithstanding the foregoing, the Board of Directors of the Company may act prior to January 1st of a given year to provide that there will be no January 1st increase in the Share Reserve for such year or that the increase in the Share Reserve for such year will be a lesser number of shares of common stock than would otherwise occur.
During the year ended December 31, 2016, the Company’s Board of Directors granted 236,000 restricted stock units to executives and employees of the Company and 723,500 stock options to directors, officers, employees and consultants to the Company under the 2015 Plan with time vesting provisions ranging from one to four years. 42,500 restricted stock units and 90,716 stock options granted under the 2015 Plan were cancelled or forfeited during the year ended December 31, 2016.
Total shares available for future issuance under the 2015 Plan are 337,646 shares as of December 31, 2016.
A summary of stock option activity and related information through December 31, 2016 follows:
|
|
Number
of Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
|
Weighted–
Average
Remaining
Contractual
Term
(in Years)
|
|
|
Aggregate
Intrinsic
Value
|
|
Outstanding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2015
|
|
|
2,242,890
|
|
|
$
|
17.91
|
|
|
|
9.10
|
|
|
$
|
10,692
|
|
Granted
|
|
|
723,500
|
|
|
14.27
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(2,508
|
)
|
|
|
4.30
|
|
|
|
|
|
|
|
|
|
Cancelled or forfeited
|
|
|
(183,091
|
)
|
|
23.18
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2016
|
|
|
2,780,791
|
|
|
$
|
16.63
|
|
|
|
8.27
|
|
|
$
|
8,809
|
|
Exercisable
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016
|
|
|
1,157,002
|
|
|
$
|
16.82
|
|
|
|
7.96
|
|
|
$
|
4,160
|
|
Vested and expected to vest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2016
|
|
|
2,637,577
|
|
|
$
|
16.56
|
|
|
|
8.25
|
|
|
$
|
8,574
|
|
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the common stock for the options that were in the money at December 31, 2016 and 2015.
During the years ended December 31, 2016, 2015 and 2014, the Company granted stock options to purchase an aggregate of 723,500 shares, 1,522,269 shares and 808,027 shares of its common stock, under the equity plans described above, respectively, with weighted-average grant date fair values of options granted of $14.27, $13.45 and $2.71, respectively.
129
The total intrinsic value of stock options exercised was $0, $1.4 million and $0 for the years ended December 31, 2016, 2015 and 2014, respectively.
Restricted Stock Units
The following is a summary of restricted stock unit activity for the year ended December 31, 2016:
|
|
Number of
Shares
|
|
|
Weighted
Average Grant
Date Fair Value
per Share
|
|
Unvested balance at December 31, 2015
|
|
|
275,500
|
|
|
$
|
24.43
|
|
Granted
|
|
|
236,000
|
|
|
$
|
14.07
|
|
Forfeited
|
|
|
(57,500
|
)
|
|
$
|
19.45
|
|
Unvested balance at December 31, 2016
|
|
|
454,000
|
|
|
$
|
19.67
|
|
During the year ended December 31, 2016 the Company granted 236,000 restricted stock units with a weighted-average grant date fair value per share of $14.07. The restricted stock units were granted with a three-year time vesting schedule. During the year ended December 31, 2015 the Company granted 275,500 restricted stock units with a weighted-average grant date fair value per share of $24.43. The Company did not grant any restricted stock units during the years ended December 31, 2014. As of December 31, 2016, no restricted stock units have vested.
Stock-Based Compensation Expense
For stock options issued to employees and members of the Board of Directors, the Company estimates the grant date fair value of each option using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the common stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the common stock.
The relevant data used to determine the value of the stock option grants is as follows:
|
|
Year Ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
Volatility
|
|
|
73.6%
|
|
|
|
60.2%
|
|
|
|
72.0%
|
|
Weighted average risk-free interest rate
|
|
|
1.4%
|
|
|
|
1.7%
|
|
|
|
1.9%
|
|
Expected dividend yield
|
|
|
0.0%
|
|
|
|
0.0%
|
|
|
|
0.0%
|
|
Expected life of options (in years)
|
|
|
5.8
|
|
|
|
6.0
|
|
|
|
5.8
|
|
For all grants, the amount of stock-based compensation expense recognized has been adjusted for estimated forfeitures of awards for which the requisite service is not expected to be provided. Estimated forfeiture rates are developed based on the Company’s analysis of historical forfeiture data.
The Company recognizes the associated compensation expense over the vesting periods of the awards, net of estimated forfeitures. The following table presents stock-based compensation expense included in the Company’s consolidated statements of operations (in thousands):
|
|
Year Ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
Research and development expense
|
|
$
|
3,262
|
|
|
$
|
1,233
|
|
|
$
|
288
|
|
General and administrative expense
|
|
|
7,530
|
|
|
|
3,829
|
|
|
|
418
|
|
Total stock-based compensation expense
|
|
$
|
10,792
|
|
|
$
|
5,062
|
|
|
$
|
706
|
|
Total unrecognized stock-based compensation expense for all stock-based awards was $17.2 million at December 31, 2016. This amount will be recognized over a weighted-average period of 2.13 years.
130
Employee Stock Purchase Plan
The Company’s Employee Stock Purchase Plan adopted in 2009, or the ESPP, is designed to allow eligible employees of the Company to purchase shares of common stock through periodic payroll deductions and during specified offering periods under the plan. The price of common stock purchased under the ESPP is equal to 85% of the lower of the fair market value of the common stock on the commencement date of each offering period or the specified purchase date. As of December 31, 2016 and 2015, 36,539 shares were available for issuance under the ESPP. Since the Merger, the Company has not made the ESPP available to employees.
Reserved Shares
At December 31, 2016, the Company has reserved shares of common stock for future issuance as follows:
|
|
|
Number of
Shares
|
|
Equity plans:
|
|
|
|
|
|
Subject to outstanding options and restricted shares
|
|
|
|
3,234,791
|
|
Available for future grants
|
|
|
|
451,521
|
|
Warrants
|
|
|
|
74,454
|
|
Employee stock purchase plan
|
|
|
|
36,539
|
|
Total
|
|
|
|
3,797,305
|
|
On September 30, 2015, the Company entered into the Loan Agreement with Hercules and certain other lenders, and Hercules Technology Growth Capital, Inc. (as agent). Under the Loan Agreement, Hercules provided the Company with access to term loans with an aggregate principal amount of up to $40.0 million, or collectively, the Term Loan. The Company initially drew a principal amount of $20.0 million, which was funded on September 30, 2015. The remaining $20.0 million under the Loan Agreement was available to be drawn at the Company’s option in minimum increments of $10.0 million through December 31, 2016, or the Draw Period. The Term Loan was repayable in monthly installments commencing on April 1, 2018 through maturity on September 1, 2020. The interest rate was equal to the greater of (i) 8.5%, or (ii) the sum of 8.5%, plus the “prime rate” as reported in The Wall Street Journal minus 5.75% per annum. An end of term charge equal to 4.5% of the issued principal balance of the Term Loan was payable at maturity, including in the event of any prepayment, and was being accrued as interest expense over the term of the loan using the effective interest method. Borrowings under the Loan Agreement were collateralized by substantially all of the assets of the Company.
Upon an Event of Default, an additional 5.0% interest would be applied and Hercules may, at its option, accelerate and demand payment of all or any part of the loan together with the prepayment and end of term charges. An Event of Default is defined in the Loan Agreement as (i) failure to make required payments; (ii) failure to adhere to financial, operating and reporting loan covenants; (iii) an event or development occurs that would be reasonably expected to have a material adverse effect; (iv) false representations in the Loan Agreement; (v) insolvency, as described in the Loan Agreement; (vi) levy or attachments on any of the Company's assets; and (vii) default of any other agreement or subordinated debt greater than $1.0 million. In the event of insolvency, this acceleration and declaration would be automatic. In addition, in connection with the Loan Agreement, the Company agreed to provide Hercules with a contingent security interest in the Company's bank accounts. The Company's control of its bank accounts is not adversely affected unless Hercules elects to obtain unilateral control of the Company's bank accounts by declaring that an Event of Default has occurred. The principal of the Term Loan, which was not due within 12 months of December 31, 2016, has been classified as long-term as the Company determined that a material adverse effect resulting in Hercules exercising its rights under the subjective acceleration clause is remote.
Subject to certain terms, pursuant to the Loan Agreement, Hercules was also granted the right to participate in an amount of up to $2.0 million in subsequent sales and issuances of the Company's equity securities to one or more investors for cash for financing purposes in an offering that is broadly marketed to multiple investors and at the same terms as the other investors. On September 30, 2015, Hercules Technology Growth Capital, Inc. entered into a Stock Purchase Agreement with the Company to purchase 44,782 shares of common stock resulting in proceeds to the Company of approximately $1.0 million. The excess of proceeds received by the Company over the fair value of the common stock issued was allocated as a reduction of the fees paid to Hercules in conjunction with obtaining the initial $20.0 million draw of the Term Loan.
Debt issuance costs of $511,000 were ratably allocated to the initial $20.0 million draw and the remaining unfunded $20.0 million. Debt issuance costs related to the initial $20.0 million draw were presented on the consolidated balance sheet as a direct deduction from the related debt liability rather than capitalized as an asset in accordance with the Company’s early adoption of ASU No. 2015-03,
Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs
, or ASU 2015-
131
03. Issuance costs related to the unfunded amount were capitalized as prepaid asset and were to be amortized ratably through the end of the Draw Period.
In connection with the Loan Agreement, the Company issued to each one of Hercules Technology II, L.P. and Hercules Technology III, L.P., a warrant to purchase 16,346 shares of the Company’s common stock (32,692 shares of common stock in total) at an exercise price of $24.47 per share. The Hercules Warrants’ total relative fair value of $288,000 at September 30, 2015 was determined using a Black-Scholes option-pricing model. The relative fair value of the Hercules Warrants was included as a discount to the Term Loan and also as a component of additional paid-in capital. See Note 12,
Common Stock
, for further description of the Hercules Warrants.
In addition to the Hercules Warrants, the Company paid fees to Hercules in conjunction with obtaining the Term Loan. The Hercules Warrants fair value and fees paid to Hercules, an aggregate of $572,000, were ratably allocated to the initial $20.0 million draw and the remaining unfunded $20.0 million. The $208,000 of costs allocated to the initial $20.0 million draw were recorded as a debt discount and are being amortized as additional interest expense over the term of the loan using the effective interest method. The $364,000 of costs allocated to the unfunded $20.0 million was recorded as prepaid expenses and were being amortized ratably through the end of the Draw Period. In the event the Company exercised its option to borrow additional funds, the remaining unamortized prepaid asset balance related would be reclassified and recorded as debt discount based upon a ratable allocation of the amount drawn compared to the remaining unfunded amount available to the Company and would amortize over the remaining life of the term loan using the effective interest method.
On December 12, 2016, the Company entered into the Loan Agreement Amendment to the Loan Agreement extended the date on which the Company must begin making amortization payments under the Loan Agreement from April 1, 2018 to January 1, 2019, or the Amortization Date. Upon commencement of the Amortization Date, the Company will make amortization payments based upon an amortization schedule equal to thirty consecutive months, with the balance of outstanding loans due on the original maturity date of the Loan Agreement. The Loan Agreement Amendment also increased the amount that the Company may borrow by $10.0 million, from up to $40.0 million to up to $50.0 million in multiple tranches. The additional $10.0 million tranche, or the Additional Tranche, is available at the Company’s option through September 15, 2017 but conditioned upon the Company completing either a second Phase 3 clinical evaluation of omadacycline in patients with ABSSSI or in patients with CABP that is supportive of the Company making a NDA filing with the FDA. If drawn, the Additional Tranche shall bear interest and have the same maturity as all other loans outstanding under the Loan Agreement. The Company borrowed the first tranche of $20.0 million upon the closing of the Loan Agreement on September 30, 2015 and, concurrently with the closing of the Loan Agreement Amendment, the Company borrowed an additional $20.0 million under the Loan Agreement. In connection with the Loan Agreement Amendment, the Company paid Hercules a $0.4 million amendment fee.
The remaining unamortized prepaid asset balance, as of the date of the Loan Agreement Amendment, of $0.1 million was reclassified and recorded as debt discount. The $0.1 million is being amortized over the remaining life of the term loan using the effective interest method.
The end of term charge, discussed above, is equal to 4.5% of the issued principal balance of the Loan Agreement Amendment, and is payable at maturity, including in the event of any prepayment, and is being accrued as interest expense over the term of the loan using the effective interest method. Borrowings under the Loan Agreement Amendment are still collateralized by substantially all of the assets of the Company. If the Company repays all or a portion of the term loans prior to maturity, in addition to the end of term charge, the Company would pay Hercules a prepayment fee as follows: (i) 2.0% of the then outstanding principal amount if the prepayment occurs prior to January 1, 2019 or (ii) no fee if the prepayment occurs on or after January 1, 2019.
In connection with the Loan Agreement Amendment, the Company issued the Loan Amendment Warrants to each of Hercules Technology II, L.P. and Hercules Technology III, L.P. which together are exercisable for an aggregate of 37,148 shares of the Company’s common stock and each carry an exercise price of $13.46 per share, or the “Loan Amendment Warrants. Additionally, upon the Additional Tranche funding date, the Company will issue an additional warrant to each of Hercules Technology II, L.P. and Hercules Technology III, L.P. which together will be exercisable for an aggregate number of shares equal to $125,000 divided by the arithmetic mean of the Company’s daily closing price per share for the ten trading days preceding the Additional Tranche funding date and each carry an exercise price equal to the arithmetic mean of the Company’s daily closing price per share for the ten trading days preceding the Additional Tranche funding date. Each Warrant may be exercised on a cashless basis. The Warrants are exercisable for a term beginning on the date of issuance and ending on the earlier to occur of five years from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the Warrants. The number of shares for which the Warrants are exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in the Warrants.
The modified terms under the Loan Agreement Amendment were not considered substantially different as compared to the terms of the Loan Agreement immediately prior to the Loan Agreement Amendment, pursuant to ASC 470-50,
Modification and
132
Extinguishment
. As such, the Loan Agreement Amendment was accounted for as a debt modification.
The $0.4 million amendment fee paid to Hercules was recorded as debt discount and will be amortized as part of the effective yield. In addition, the unamortized discount on the original loan agreement will be amortized as an adjustment of interest expense over the remaining term of the modified debt using an updated effective interest rate. All costs incurred with third parties were expensed as incurred.
Debt issuance costs are presented on the consolidated balance sheet as a direct deduction from the related debt liability rather than capitalized as an asset in accordance with ASU No. 2015-03,
Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs
, or ASU 2015-03.
As of December 31, 2016 and 2015, the Company has recorded, on its consolidated balance sheet, a long-term debt obligation of $39.0 million, net of debt discount of $1.1 million and $19.6 million, net of debt discount of $0.4 million, and prepaid expenses of $0.5 million, respectively.
Future principal payments, which exclude the 4.5% end of term charge, in connection with the Loan Agreement, as of December 31, 2016 are as follows (in thousands):
2017
|
|
$
|
—
|
|
2018
|
|
|
—
|
|
2019
|
|
|
14,952
|
|
2020
|
|
|
25,048
|
|
2021 and thereafter
|
|
|
—
|
|
Total
|
|
$
|
40,000
|
|
133
(Loss) income before income taxes consists of the following:
|
|
Year Ended December 31,
|
|
(in thousands)
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
United States
|
|
$
|
(98,465
|
)
|
|
$
|
(70,860
|
)
|
|
$
|
(19,762
|
)
|
Foreign
|
|
|
(13,171
|
)
|
|
|
—
|
|
|
|
—
|
|
Total
|
|
$
|
(111,636
|
)
|
|
$
|
(70,860
|
)
|
|
$
|
(19,762
|
)
|
There is no provision related to the Company’s federal, state or foreign tax obligations.
There is no provision for income taxes in the United States because the Company has historically incurred net operating losses and maintains a full valuation allowance against its net deferred tax assets. The reported amount of income tax expense for the years differs from the amount that would result from applying domestic federal statutory tax rates to pretax losses primarily because of changes in valuation allowance.
A reconciliation of the Company’s effective tax rate to the statutory federal income tax rate is as follows:
|
|
Year Ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
Federal statutory rate
|
|
|
35.00
|
%
|
|
|
35.00
|
%
|
|
|
35.00
|
%
|
Change in valuation allowance
|
|
|
(37.31
|
)
|
|
|
(46.61
|
)
|
|
|
(18.84
|
)
|
Permanent differences
|
|
|
0.17
|
|
|
|
1.67
|
|
|
|
(19.89
|
)
|
State taxes, net of federal benefits
|
|
|
4.61
|
|
|
|
6.13
|
|
|
|
2.23
|
|
Other
|
|
|
(2.47
|
)
|
|
|
3.81
|
|
|
|
1.50
|
|
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Significant components of the Company’s net deferred tax assets at December 31, 2016 and 2015 are as follows:
|
|
Year Ended December 31,
|
|
(in thousands)
|
|
2016
|
|
|
2015
|
|
Non-current deferred tax assets
|
|
|
|
|
|
|
|
|
Net operating losses
|
|
$
|
83,480
|
|
|
$
|
57,190
|
|
Accrued expenses
|
|
|
2,774
|
|
|
|
5,413
|
|
Capitalized research and development
|
|
|
29,882
|
|
|
|
18,929
|
|
Tax credit carryforwards
|
|
|
9,478
|
|
|
|
9,174
|
|
Other
|
|
|
100
|
|
|
|
—
|
|
Stock compensation and other
|
|
|
6,425
|
|
|
|
2,190
|
|
Total non-current deferred tax assets
|
|
|
132,139
|
|
|
|
92,896
|
|
Non-current deferred tax liabilities
|
|
|
|
|
|
|
|
|
Intangible assets
|
|
|
(408
|
)
|
|
|
(551
|
)
|
Fixed assets
|
|
|
—
|
|
|
|
(10
|
)
|
Total non-current deferred tax liabilities
|
|
|
(408
|
)
|
|
|
(561
|
)
|
Net non-current deferred tax asset
|
|
|
131,731
|
|
|
|
92,335
|
|
Less: valuation allowance
|
|
|
(131,731
|
)
|
|
|
(92,335
|
)
|
Net deferred tax asset
|
|
$
|
—
|
|
|
$
|
—
|
|
As of December 31, 2016, the Company had federal and state net operating loss carryforwards of $223.4 million and $111.4 million, respectively, which begin to expire in 2018, respectively. Of these amounts, approximately $1.3 million related to stock-based compensation tax deductions in excess of book compensation expense, additional paid-in capital net operating losses, or APIC NOLs, that will be credited to additional paid-in capital when such deductions reduce taxes payable as determined on a “with-and-without” approach. APIC NOLs will reduce federal and state taxes payable if realized in future periods, but the net operating loss carryforwards relating to such benefits are not included in the table above.
As of December 31, 2016, the Company had federal and state research and development tax credits carryforwards of $7.2 million and $3.5 million, respectively, which began to expire in 2018.
134
Management of the Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of net operating loss carryforwards and research and development credits. Under the applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of federal and state deferred tax assets. Accordingly, a full valuation allowance of $131.7 million and $92.3 million, respectively, was established as of December 31, 2016 and 2015. A change in the Company’s valuation allowance was recorded in 2016, in the amount of $39.4 million.
Utilization of the net operating loss and research and development credit carryforwards may be subject to a substantial annual limitation under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively.
During 2016, the Company performed a formal study to determine if any of its remaining NOL and credit attributes might be further limited due to the ownership change rules of Section 382 or Section 383 of the Internal Revenue Code of 1986, as amended. As a result of that study, the Company has identified certain NOLs that might expire unused. The Company has established a full valuation allowance against these attributes.
The Company follows the provisions of ASC 740-10,
Accounting for Uncertainty in Income Taxes—an interpretation of ASC 740
, which requires it to determine whether a tax position of the Company is more likely than not to be sustained upon examination, including resolution of any related appeals of litigation processes, based on the technical merits of the position. For tax positions meeting the more likely than not threshold, the tax amount recognized in the financial statements is reduced by the largest benefit that has a greater than fifty percent likelihood of being realized upon the ultimate settlement with the relevant taxing authority.
The Company is in the process of conducting a study of its research and development credit carryforwards. This study may result in an adjustment to the Company’s research and development credit carryforwards; however until the study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits, and if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Thus, there would be no impact to the consolidated balance sheets or statements of operations if an adjustment were required.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The earliest tax years that remain subject to examination by jurisdiction is 2013 for both federal and Massachusetts. However, to the extent the Company utilizes net operating losses from years prior to 2013, the statute remains open to the extent of the net operating losses or other credits are utilized. The Company’s policy is to record interest and penalties related to income taxes as part of the tax provision. There was no interest or penalties pertaining to uncertain tax positions in 2016 or 2015.
18.
|
Commitments and Contingencies
|
Leases
The Company leases its Boston, Massachusetts and King of Prussia, Pennsylvania office spaces under non-cancelable operating leases expiring in 2021 and 2024, respectively.
The Company entered into the original King of Prussia and Boston leases in January 2015 and April 2015, respectively. The lease terms under the original agreements were for six and four years, respectively. Each agreement had one renewal option for an extended term. The King of Prussia and Boston lease terms under the original agreements began in June 2015 and July 2015, respectively.
The Company executed an amended lease agreement on its Boston office space in July 2016. The amended lease agreement adds 4,153 rentable square feet of office space and extends the original lease term by two years. The total revised lease commitment of $3.4 million is over a remaining five-year lease term. In accordance with the amended lease agreement, the Company paid a security deposit of $0.1 million. The Company is required to make additional payments under the facility operating leases for taxes, insurance, and other operating expenses incurred during the lease period. Because the Company is involved in the construction project, including having responsibility to pay for a portion of the costs of finish work and mechanical, electrical, and plumbing elements of the building, among other items, the Company is deemed for accounting purposes to be the owner of the office space during the construction period. In addition, the lease provided an incentive from the landlord of up to $0.2 million in tenant improvements. The Company capitalized all leasehold improvements as fixed assets and recorded the landlord incentive as a receivable, included within “other receivables” on the Company’s consolidated balance sheet, until payment is received. Accordingly, the Company also recorded a
135
related financing obligation in “other long-term liabilities” on the Company’s consolidated balance sheet. These amounts will be treated as a reduction to rent expense over the lease term. Subsequent to the amended lease agreement, the Company will record monthly rent expense of approximately $54,000 for the Boston office space.
The Company executed an amended lease agreement on its King of Prussia office space in October 2016. The amended lease agreement is for 19,708 rentable square feet of office space, for a total commitment of $3.5 million. The total lease commitment is over a seven-year and seven-month lease term. The lease contains rent escalation and a partial rent abatement period, which will be accounted for as rent expense under the straight-line method. The Company is required to make additional payments under the facility operating leases for taxes, insurance, and other operating expenses incurred during the operating lease period.
Deferred rent is included in accounts payable and other accrued expenses in the consolidated balance sheet as of December 31, 2016 and 2015.
Rent expense, exclusive of related taxes, insurance, and maintenance costs, for continuing operations totaled approximately $0.7 million, $0.3 million and $0.6 million for the years ended December 31, 2016, 2015 and 2014 respectively, and is reflected in operating expenses.
Future minimum operating lease obligations under non-cancelable leases with initial terms of more than one-year are as follows (in thousands):
|
|
Minimum
Lease
Obligation
|
|
Years Ended December 31,
|
|
|
|
|
2017
|
|
$
|
823
|
|
2018
|
|
|
835
|
|
2019
|
|
|
826
|
|
2020
|
|
|
841
|
|
2021
|
|
|
594
|
|
2022 and thereafter
|
|
|
—
|
|
Total
|
|
$
|
3,919
|
|
The $3.5 million obligation under the amended lease agreement on the King of Prussia space is not included within the above table as the Company does not control the space as of December 31, 2016. Included within the above table is the Company’s current obligation at our King of Prussia office space.
Supply Agreements
Cipan
In November 2016, we entered into a manufacturing and services agreement with CIPAN – Companhia Industrial Produtora de Antibióticos, or CIPAN. The agreement provides the terms and conditions under which CIPAN will manufacture and supply to us increased quantities of minocycline starting material and crude omadacycline, or the CIPAN Products, for purification into omadacycline and, subsequently, for use in our products that contain omadacycline as the active pharmaceutical ingredient. Under this agreement, we are obligated to pay a CIPAN Product price in the high three-digit U.S. Dollar range per kilogram for minocycline starting material and in the four-digit or five-digit U.S. Dollar range per kilogram for crude omadacycline, based on the annual volume of crude omadacycline that we order, subject to adjustments as set forth in the agreement. CIPAN will also perform certain services related to development, technology transfer and manufacturing of the CIPAN Products as provided in one or more statements of work, which shall set forth the fees payable by us to CIPAN for such services.
Our agreement with CIPAN will remain in effect for a fixed initial term, after which the agreement will continue, with respect to each CIPAN Product, for successive renewal terms unless either we or CIPAN have given written notice of termination within a certain period prior to the expiration of either the initial or then-current renewal term. The agreement may also be terminated under certain other circumstances, including by either party due to a material uncured breach by the other party or the other party’s insolvency.
Carbogen
136
In December 2016, we entered into an outsourcing agreement with CARBOGEN AMCIS AG, or Carbogen. The agreement provides for the terms and conditions under which Carbogen will manufacture and supply to us the active pharmaceutical ingredient for our omadacycline product in bulk quantities, or the Carbogen Product. Under this agreement, we are responsible for the cost and supply of crude omadacycline that Carbogen requires to manufacture the Carbogen Products and perform related services. We are obligated to initially pay Carbogen an amount in the low seven-digit U.S. Dollar range per batch of Carbogen Product that we order, depending on the size of the campaign, and the price may be adjusted in accordance with the terms of the agreement. We may also request that Carbogen perform certain services related to the Carbogen Product, for which we will pay reasonable compensation to Carbogen.
Our agreement with Carbogen will remain in effect for a fixed initial term and both parties are obligated to use diligent efforts to come to a subsequent long-term agreement to replace this agreement no later than the end of such initial term. If we have not executed a replacement agreement with Carbogen by such time, this agreement will automatically be extended for a fixed period of time. We may terminate this agreement by delivering notice of termination to Carbogen prior to the expiration of the initial or subsequent term. The agreement may also be terminated under certain other circumstances, including by either party due to a material uncured breach by the other party or the other party’s insolvency.
Almac
In December 2016, we entered into a manufacturing and services agreement with Almac Pharma Services Limited, or Almac. The agreement provides for the terms and conditions under which Almac will manufacture, package and supply to us omadacycline oral solid dosage tablets in bulk form, or the Almac Products. Under this agreement, we are required to use commercially reasonable efforts to timely provide Almac with the active pharmaceutical ingredient needed to manufacture the Almac Products and perform related services. We are obligated to pay a supply price in the five-digit range in Great Britain Pounds per batch of the Almac Products, subject to adjustments as provided in the agreement. We will also negotiate with Almac, as part of each individual scope of work, the reasonable costs for the services to be performed for us by Almac.
Our agreement with Almac will remain in effect for a fixed initial term, after which the agreement will continue for successive renewal terms unless either we or Almac have given written notice of termination within a certain period prior to the expiration of the initial or then-current renewal term. The agreement may also be terminated under certain other circumstances, including by either party due to a material uncured breach of the other party or the other party’s insolvency.
Litigation
The following pending litigation was assumed through the Merger.
Intermezzo Patent Litigation
In July 2012, the Company received notifications from three companies, Actavis Elizabeth LLC, or Actavis Elizabeth, Watson Laboratories, Inc.—Florida, or Watson, and Novel Laboratories, Inc., or Novel, in September 2012, from each of Par Pharmaceutical, Inc. and Par Formulations Private Ltd., together, the Par Entities, in February 2013 from Dr. Reddy’s Laboratories, Inc. and Dr. Reddy’s Laboratories, Ltd., together, Dr. Reddy’s, and in July 2013 from TWi Pharmaceuticals, Inc., or Twi, stating that each has filed with the FDA an ANDA, that references Intermezzo. Refer to Item 3, “
Legal Proceedings”
, of the Company’s Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the SEC on March 9, 2016, for a full description of the history of this litigation.
The New Jersey District Court, held a consolidated trial between December 1, 2014 and December 15, 2014 involving Paratek, Purdue Pharma, and their patent infringement claims against Actavis Elizabeth, Novel, and Dr. Reddy’s. The New Jersey District Court then received post-trial briefing and held a February 13, 2015 post-trial hearing. On March 27, 2015, the New Jersey District Court issued an order and accompanying opinion finding that: (a) the asserted claims of U.S. Patent Nos. 7,682,628, 8,242,131, and 8,252,809, are invalid as obvious; (b) Actavis Elizabeth, Novel, and Dr. Reddy’s infringe the ‘131 patent; (c) Novel infringes the ‘628 patent; and (d) Novel and Dr. Reddy’s infringe the ‘809 patent. On April 9, 2015, the New Jersey District Court entered final judgment consistent with the March 27, 2015 opinion and order referenced above. As a result of the New Jersey District Court’s findings, the intangible assets representing Intermezzo product rights were impaired and the related contingent obligation was reduced in light of an expected decline in Intermezzo sales for the three months ended March 31, 2015.
The Company and Purdue Pharma jointly appealed the New Jersey District Court’s final judgment as to the '131 patent to the United States Court of Appeals for the Federal Circuit on May 6, 2015. On January 8, 2016 the U.S. Court of Appeals affirmed the decision of the New Jersey District Court, and no opinion accompanied the judgment. On September 14, 2016, the defendants filed a warrant of satisfaction of judgment in the New Jersey District Court for the costs having been fully paid to defendants.
137
Patent Term Adjustment Suit
In January 2013, the Company filed suit in the Eastern District of Virginia against the United States Patent and Trademark Office, or the USPTO, seeking recalculation of the patent term adjustment of the ’131 Patent. Purdue Pharma has agreed to bear the costs and expenses associated with this litigation. In June 2013, the judge granted a joint motion to stay the proceedings pending a remand to the USPTO, in which the USPTO is expected to reconsider its patent term adjustment award in light of decisions in a number of appeals to the Federal Circuit, including Novartis AG v. Lee 740 F.3d 593 (Fed. Cir. 2014), or the Novartis decision. Since having issued final rules implementing the Novartis decision, the USPTO has been working through the civil action cases and issuing remand decisions. The Company’s case was on remand until the USPTO made its decision on the recalculation of the patent term adjustment. On September 28, 2016, the USPTO issued a decision that the patent term adjustment is 1,038 days, from which the ‘131 Patent expiration would be March 26, 2029.
Other Legal Proceedings
From time to time the Company is involved in legal proceedings arising in the ordinary course of business. The Company believes there is no other litigation pending that could have, individually, or in the aggregate, a material adverse effect on its results of operations or financial condition. The Company does not believe that any of the above matters will result in a liability that is probable or estimable at December 31, 2016.
The Company maintains a defined-contribution savings plan under Section 401(k) of the Internal Revenue Code, or the 401(k) Plan. The 401(k) Plan covers all employees who meet defined minimum age and service requirements, and allows participants to defer a portion of their annual compensation on a pretax basis. The Plan provides for matching contributions on a portion of participant contributions pursuant to the 401(k) Savings Plan’s matching formula. All matching contributions and participant contributions vest immediately. Contributions totaled $0.3 million, $0.2 million and $0.1 million for the years ended December 31, 2016, 2015, and 2014, respectively, and have been recorded in the consolidated statements of operations.
20.
|
Quarterly Results (Unaudited)
|
|
|
Three Months Ended
|
|
|
|
March 31,
2016
|
|
|
June 30,
2016
|
|
|
September 30,
2016
|
|
|
December 31,
2016
|
|
|
|
(in thousands, except per share data)
|
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
29
|
|
Operating expenses
|
|
|
30,732
|
|
|
|
29,752
|
|
|
|
23,113
|
|
|
|
25,918
|
|
Loss from operations
|
|
|
(30,732
|
)
|
|
|
(29,752
|
)
|
|
|
(23,113
|
)
|
|
|
(25,889
|
)
|
Other expense, net
|
|
|
(539
|
)
|
|
|
(531
|
)
|
|
|
(515
|
)
|
|
|
(565
|
)
|
Net loss
|
|
$
|
(31,271
|
)
|
|
$
|
(30,283
|
)
|
|
$
|
(23,628
|
)
|
|
$
|
(26,454
|
)
|
Net loss per share - basic and diluted
|
|
$
|
(1.78
|
)
|
|
$
|
(1.69
|
)
|
|
$
|
(1.04
|
)
|
|
$
|
(1.16
|
)
|
|
|
Three Months Ended
|
|
|
|
March 31,
2015
|
|
|
June 30,
2015
|
|
|
September 30,
2015
|
|
|
December 31,
2015
|
|
|
|
(in thousands, except per share data)
|
|
|
|
(unaudited)
|
|
Operating expenses
|
|
$
|
10,633
|
|
|
$
|
15,679
|
|
|
$
|
23,372
|
|
|
$
|
20,369
|
|
Loss from operations
|
|
|
(10,633
|
)
|
|
|
(15,679
|
)
|
|
|
(23,372
|
)
|
|
|
(20,369
|
)
|
Other expense, net
|
|
|
—
|
|
|
|
(20
|
)
|
|
|
(49
|
)
|
|
|
(737
|
)
|
Net loss
|
|
$
|
(10,633
|
)
|
|
$
|
(15,699
|
)
|
|
$
|
(23,421
|
)
|
|
$
|
(21,106
|
)
|
Net loss per share - basic and diluted
|
|
$
|
(0.74
|
)
|
|
$
|
(0.96
|
)
|
|
$
|
(1.33
|
)
|
|
$
|
(1.20
|
)
|
138