NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES
Organization
Anthera Pharmaceuticals, Inc. (“the Company”) is a biopharmaceutical company focused on advancing the development and commercialization of innovative medicines that benefit patients with unmet medical needs. The Company currently has two compounds in development, Sollpura and blisibimod. The Company licensed Sollpura from Eli Lilly & Co (“Eli Lilly”) in July 2014. Sollpura is a novel non-porcine investigational Pancreatic Enzyme Replacement Therapy (“PERT”) intended for the treatment of patients with Exocrine Pancreatic Insufficiency (“EPI”), often seen in patients with cystic fibrosis and other conditions. The Company licensed blisibimod from Amgen, Inc. (“Amgen”) in December 2007. Blisibimod targets B-cell activating factor or (“BAFF”) which has been shown to be elevated in a variety of B-cell mediated autoimmune diseases, including Immunoglobulin A nephropathy, or IgA nephropathy
.
Liquidity and Need for Additional Capital
The Company’s planned principal operations are acquiring product and technology rights, raising capital and performing research and development activities. The Company is currently conducting research and development activities to treat
EPI and
IgA Nephropathy
. The Company’s activities are subject to significant risks and uncertainties. Successful completion of the Company’s development programs and, ultimately, the attainment of profitable operations are dependent on future events, including, among other things, its ability to access potential markets; secure financing; develop a customer base; attract, retain and motivate qualified personnel; and develop strategic alliances.
Since inception in 2004, the Company has funded its operations through equity offerings, private placements of convertible debt, debt financing, equity investment and cost reimbursement from a former collaborative partner, and a research award from Cystic Fibrosis Foundation Therapeutics Incorporated ("CFFT"). On April 21, 2016, the Company entered into an At Market Issuance Sales Agreement (“ATM Agreement”) with H.C. Wainwright & Co., LLC (“H.C. Wainwright”) to create an at-the-market equity program under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25 million through H.C Wainwright, as agent, which was amended and reduced to $23 million on March 14, 2017.
In March 2017, the Company entered into an underwriting agreement with H.C. Wainwright, pursuant to which the Company sold an aggregate of 3,750,000 shares of its common stock and agreed to issue warrants (the “Tranche 1 Warrants” and the “Tranche 2 Warrants”) to purchase an aggregate of 7,500,000 shares of its common stock. The financing transaction resulted in proceeds of $14.1 million.
To fully execute its business plan, the Company will need to complete certain research and development activities and clinical studies. Further, the Company’s product candidates will require regulatory approval prior to commercialization. These activities may span many years and require substantial capital to complete and may ultimately be unsuccessful. Any delays in completing these activities could adversely impact the Company. The Company will need substantial additional financing to continue development of its product candidates, obtain regulatory approvals, and prepare for commercial readiness if the clinical trials are successful; such financing may not be available on terms favorable to the Company, if at all, which raises substantial doubt about the Company’s ability to continue as a going concern as of the date of this report and that is not alleviated after consideration management’s plans to mitigate such concerns. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. If adequate funds are not available, the Company may be required to delay, reduce the scope of, or eliminate one or more of its clinical trials. The Company plans to meet its capital requirements primarily through issuances of equity securities, future partnerships, debt financing, and in the longer term, revenue from product sales. Failure to generate revenue or raise additional capital would adversely affect the Company’s ability to achieve its intended business objectives.
Basis of Presentation
The accompanying unaudited Condensed Consolidated Financial Statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for Quarterly Reports on Form 10-Q and do not contain all of the information and footnotes required by U.S. generally accepted accounting principles (“U.S. GAAP”) for complete financial statements. The accompanying unaudited Condensed Consolidated financial statements and notes thereto should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the SEC on March 16, 2017. In the opinion of management, the accompanying unaudited Condensed Consolidated financial statements reflect all adjustments, which include only normal recurring adjustments necessary to present fairly the Company’s interim consolidated financial information. The results for the three months ended March 31, 2017 are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or for any other period. The consolidated balance sheet as of December 31, 2016 has been derived from the audited financial statements as of that date but it does not include all of the information and notes required by U.S. GAAP.
On April 28, 2017, the Company announced a 1-for-8 reverse split of its outstanding common stock resulting in a reduction of its total common stock issued and outstanding from 80,609,310 shares to 10,076,164 shares (the “Reverse Stock Split”). The Reverse Stock Split affected all stockholders of the Company’s common stock equally; the Reverse Stock Split was effective on April 28, 2017. The par value of the Company’s common stock and preferred stock remains unchanged at $0.001 per share and the number of authorized shares of common stock and preferred stock remained unchanged at 100,000,000 and 5,000,000, respectively, after giving effect to the Reverse Stock Split. All references to shares of common stock, stock options, warrants to purchase common stock, the conversion rate of preferred stock and outstanding per share data for all periods presented in the accompanying financial statements and notes thereto have been adjusted to reflect the reverse split on a retroactive basis and all share information is rounded down to the nearest whole share after reflecting the reverse split.
The Company has evaluated events and transactions subsequent to the balance sheet date and has disclosed all events or transactions that occurred subsequent to the balance sheet date but prior to filing this Quarterly Report on Form 10-Q that would require recognition or disclosure in the unaudited Condensed Consolidated Financial Statements.
Use of Estimates
The preparation of these condensed consolidated financial statements in conformity with GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to clinical trial accruals, the tax provision, stock-based compensation, and warrant liabilities. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates.
Financial Instruments with Characteristics of Both Equity and Liabilities
The Company has issued certain financial instruments, including warrants to purchase common stock, which have characteristics of both liability and equity. Financial instruments such as warrants that are classified as liabilities are fair valued upon issuance and are re-measured at fair value at subsequent reporting periods with the resulting change in fair value recorded in other income/(expense). The fair value of warrants is estimated using valuation models that require the input of subjective assumptions including stock price volatility, expected life,
and the probability of future equity issuances and their impact to the price protection feature
.
Recent Accounting Pronouncements
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (ASC Topic 606). The standards update outlines a single comprehensive model for entities to utilize to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that will be received in exchange for the goods and services. Additional disclosures will also be required to enable users to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. In 2016, the FASB issued accounting standards updates to address implementation issues and to clarify the guidance for identifying performance obligations, licenses and determining if a company is the principal or agent in a revenue arrangement. In August 2015, the FASB issued ASU 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which deferred the effective date of ASU 2014-09. The mandatory adoption date of ASC 606 for the Company is now January 1, 2018. There are two methods of adoption allowed, either a “full” retrospective adoption or a “modified” retrospective adoption. The Company expects to adopt the standard on a modified retrospective basis applying the new rules to all contract existing at January 1, 2018, with an adjustment for the cumulative effect of all changes recognized in beginning retained earnings. Given that the Company is not currently generating revenue and most likely will not be generating revenue at the date of adoption, the adoption of this guidance is not expected to materially impact
the Company’s
consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02 Leases
(Topic 842). ASU 2016-02 impacts any entity that enters into a lease with some specified scope exceptions. This new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The guidance updates and supersedes Topic 840, Leases. For public entities, ASU 2016-02 is effective for fiscal years, and interim periods with those years, beginning after December 15, 2018, and early adoption is permitted. A modified retrospective transition approach is required for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available. The Company does not expect the adoption of this standard to have a material impact on its financial statements.
Effective January 1, 2017, the Company adopted ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. Among other requirements, the new guidance requires all tax effects related to share-based payments at settlement (or expiration) to be recorded through the income statement. Previously, tax benefits in excess of compensation cost ("windfalls") were recorded in equity, and tax deficiencies ("shortfalls") were recorded in equity to the extent of previous windfalls, and then to the income statement. As required, this change was applied prospectively to all excess tax benefits and tax deficiencies resulting from settlements. Under the new guidance, the windfall tax benefit is to be recorded when it arises, subject to normal valuation allowance considerations. As required, this change was applied on a modified retrospective basis. There was $0.3 million of unrecognized deferred tax assets attributable to excess tax benefits that were not previously recognized as the Company did not reduce income taxes payable. The cumulative adjustment for the adoption of ASU No. 2016-09 did not have an impact on net equity as the incremental deferred tax assets were fully offset by a corresponding increase in the deferred tax asset valuation allowance.
ASU No. 2016-09 addressed the presentation of employee taxes paid on the statement of cash flows. The Company is now required to present the cost of shares withheld from the employee to satisfy the employees’ income tax liability as a financing activity on the statement of cash flows rather than as an operating cash flow. This change is applied on a retrospective basis, as required, but did not impact the statement of cash flows for the three months ended March 31, 2017.
ASU No. 2016-09 also permits entities to make an accounting policy election related to how forfeitures will impact the recognition of compensation cost for stock-based compensation to either estimate the total number of awards for which the requisite service period will not be rendered, as currently required, or to account for forfeitures as they occur. Upon adoption, the Company elected to not make any changes to the current policy of accounting for forfeitures.
2. COLLABORATIVE AGREEMENT
In December 2014, the Company entered into an exclusive license agreement with Zenyaku (“Zenyaku Agreement”) for the development and commercialization of blisibimod in Japan and potentially other countries throughout Asia, while the Company retained full development and commercialization rights of blisibimod for all other global territories including North America and the European Union. The Zenyaku Agreement was mutually terminated in January 2016. Consequently, the Company accelerated the amortization period of its deferred revenue and fully amortized it as of January 7, 2016.
3. RESEARCH AWARD
In March 2015, the Company received a research award of up to $3 million from the CFFT for the Company's development of Sollpura. The Company retains the right to develop and commercialize Sollpura and will owe royalties to CFFT on net sales of any drug candidate approved and commercialized under the collaboration. The funding is disbursed by CFFT to the Company upon the Company’s achievement of milestones specified in the grant agreement. At its discretion, the Company may choose to fund a particular stage of the Sollpura development plan without CFFT funds. Any CFFT funds not expended on the development program of Sollpura must be returned to CFFT and, upon such return, the amounts of such returned funds will not be included as part of the research award for the purpose of calculating royalties or other amounts owed by the Company to CFFT. To the extent CFFT provides or makes available any information, expertise, know-how or other intellectual property related to cystic fibrosis or the treatment, prevention or cure there-of (“CFFT Know-How”) to the Company, CFFT grants to the Company a non-exclusive, transferrable, sublicensable, worldwide rights and license under all of CFFT’s rights in such CFFT Know-How to assist the Company to research, develop, commercialize, make or have made, use, sell, have sold, offer for sale, import, export and otherwise exploit the product.
In consideration for CFFT’s research award and any licenses of intellectual property granted by CFFT, the Company agrees to pay royalties to CFFT as follows: i) a one-time royalty in an amount equal to five times the actual award, payable in three installments between the first and second anniversaries of the first commercial sale of a product; ii) a one-time royalty in an amount equal to the actual award after net product sales reaches $100 million; and iii) in the event of a license, sale or other transfer of the product or a change of control transaction prior to the commercial sale of the product, a milestone payment equal to three times the actual award.
For the three months ended March 31, 2017, the Company recognized $100,000 in research award in connection with achieving certain milestones specified in the CFFT award agreement and included such reward as an offset to operating expense. No research award was recognized for the same period in 2016. As of March 31, 2017, the Company has fully recognized the research award.
4. NET LOSS PER SHARE
Basic net loss attributable to common stockholders per share is computed by dividing income available to common stockholders (the numerator) by the weighted-average number of common shares outstanding (the denominator) during the period. Shares issued during the period and shares reacquired during the period are weighted for the portion of the period that they were outstanding. The computation of diluted Earnings Per Share, or EPS, is similar to the computation of basic EPS except that the denominator is increased to include the number of additional common shares that would have been outstanding if the dilutive potential common shares had been issued. In addition, in computing the dilutive effect of convertible securities, the numerator is adjusted to add back any convertible preferred dividends and the after-tax amount of interest recognized in the period associated with any convertible debt. The numerator also is adjusted for any other changes in income or loss that would result from the assumed conversion of those potential common shares, such as profit-sharing expenses. Diluted EPS is identical to basic EPS since common equivalent shares are excluded from the calculation, as their effect is anti-dilutive.
The following table summarizes the Company’s calculation of net loss per common share (in thousands except share and per share amounts):
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
2017
|
|
|
2016
|
|
Net loss per share
|
|
|
|
|
|
|
Numerator
|
|
|
|
|
|
|
Net loss
|
|
$
|
(11,207
|
)
|
|
$
|
(11,726
|
)
|
Deemed dividend attributable to preferred stock
|
|
|
(2,503
|
)
|
|
|
—
|
|
Net loss applicable to common stockholders
|
|
$
|
(13,710
|
)
|
|
$
|
(11,726
|
)
|
Denominator
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding
|
|
|
6,759,567
|
|
|
|
5,006,237
|
|
Basic and diluted net loss per share
|
|
$
|
(2.03
|
)
|
|
$
|
(2.34
|
)
|
As the Company incurred net losses for all the periods presented, the following outstanding potentially dilutive securities were excluded from the computation of diluted net loss per share, as the effect of including them would have been antidilutive:
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
|
|
2016
|
|
Total options to purchase common stock
|
|
|
750,355
|
|
|
|
608,348
|
|
Total warrants to purchase common stock
|
|
|
274,801
|
|
|
|
5,022
|
|
Series X convertible preferred stock
|
|
|
30,930
|
|
|
|
—
|
|
Total
|
|
|
1,056,086
|
|
|
|
613,370
|
|
5. FAIR VALUE OF FINANCIAL INSTRUMENTS
Pursuant to the accounting guidance for fair value measurement and its subsequent updates, fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (i.e., the “exit price”) in an orderly transaction between market participants at the measurement date. The accounting guidance establishes a hierarchy for inputs used in measuring fair value that minimizes the use of unobservable inputs by requiring the use of observable market data when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on active market data. Unobservable inputs are inputs that reflect the assumptions market participants would use in pricing the asset or liability based on the best information available in the circumstances.
The fair value hierarchy is broken down into the three input levels summarized below:
|
·
|
Level 1
—Valuations are based on quoted prices in active markets for identical assets or liabilities and readily accessible by us at the reporting date. Examples of assets and liabilities utilizing Level 1 inputs are certain money market funds, U.S. Treasuries and trading securities with quoted prices on active markets.
|
|
·
|
Level 2
—Valuations based on inputs other than the quoted prices in active markets that are observable either directly or indirectly in active markets. Examples of assets and liabilities utilizing Level 2 inputs are U.S. government agency bonds, corporate bonds, commercial paper, certificates of deposit and over-the- counter derivatives.
|
|
·
|
Level 3
—Valuations based on unobservable inputs in which there are little or no market data, which require
the Company
to develop
its
own assumptions.
|
The following tables present the Company’s fair value hierarchy for all its financial assets (including those in cash and cash equivalents), in thousands, by major security type measured at fair value on a recurring basis as of March 31, 2017 and December 31, 2016 (in thousands):
|
March 31, 2017
|
|
|
Estimated
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Assets:
|
|
|
|
|
|
|
|
|
Money market funds
|
|
$
|
19,562
|
|
|
$
|
19,562
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
|
|
$
|
14,700
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
14,700
|
|
|
December 31, 2016
|
|
|
Estimated
Fair Value
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Money market funds
|
|
$
|
19,416
|
|
|
$
|
19,416
|
|
|
$
|
—
|
|
|
$
|
—
|
|
The company used quoted market prices to determine the fair value of cash equivalents, which consist of money market funds and therefore these are classified in Level 1 of the fair value hierarchy.
Warrants containing price protection right are accounted for as liabilities, with changes in the fair values included in net loss for the respective periods. Because some of the inputs to the valuation model are either not observable or are not derived principally from or corroborated by observable market data by correlation or other means, the warrant liability is classified as Level 3 in the fair value hierarchy.
The following table summarizes the changes in the Company’s Level 3 warrant liability (in thousands):
|
|
March 31, 2017
|
|
Beginning balance
|
|
$
|
—
|
|
Addition to warrant liability
|
|
|
14,700
|
|
Ending balance
|
|
$
|
14,700
|
|
There were no transfers between Level 1, Level 2 or Level 3 for the three months ended March 31, 2017 and year ended December 31, 2016.
6. WARRANT LIABILITY
Pursuant to the underwriting agreement for the sale of common stock and warrants entered in March 2017, the Company agreed to issue 3,750,000 warrants (“Tranche 1 Warrants”) at an initial exercise price of $4.40 per share and 3,750,000 warrants (“Tranche 2 Warrants”) at an initial exercise price of $4.00 per share to the investors to purchase shares of the Company’s common stock. The Company did not have sufficient authorized but unissued common stock to issue the warrants at the time the underwriting agreement was executed. On April 28, 2017, with shareholders’ approval, the Company effectuated a one-for-eight reverse split of its outstanding common stock. The Reverse Stock Split did not affect the number of authorized shares of common stock, which remained at 100,000,000 and as a result the Company’s authorized but unissued common stock increased upon the Reverse Stock Split, resulting in sufficient authorized shares of common stock to settle the warrant agreement. The Tranche 1 Warrant will expire five years from April 28, 2017 and the Tranche 2 Warrant will expire six months from April 28, 2017. The number of issued and outstanding Tranche 1 Warrants and Tranche 2 Warrants were adjusted on April 28, 2017 on a one-for-eight reverse basis.
The exercise price of the Tranche 1 and Tranche 2 warrants are subject to adjustment in the event of a stock combination, reverse split, or similar transaction involving common stock (each, a “Stock Combination Event”) in which if the average volume weighted average price (“VWAP") of the common stock for the five lowest trading days during the 15 consecutive trading day period ending and including the trading day immediately preceding the 16
th
trading day after such Stock Combination Event, is less than the exercise price of the warrant. In such an event, the exercise price of the warrants is adjusted to the average VWAP.
The Company accounted for the warrants under ASC Topic 815,
Derivatives and Hedging
(“ASC 815”). The Company determined
that, on the date of issuance, the warrants were not considered indexed to its own stock because the underlying instruments were not “fixed-for-fixed” due to the price protection and therefore, the warrants should be accounted for as derivatives. At the end of each reporting period, the changes in fair value during the period are recorded as a component of other income (expense) in the consolidated statement of operations. The initial fair value of the liability associated with these warrants was $14.7 million. The fair value of the warrants remained unchanged at March 31, 2017 based on the Company’s re-measurement. As the initial fair value exceeded proceeds received of $14.1 million, the excess of $600,000 was expensed during the first quarter of 2017.
The Company estimated the fair value of the warrants using the Monte Carlo simulation model,
which combines expected cash outflows with market-based assumptions regarding risk-adjusted yields, stock price volatility, and the probability of future equity events
. Inputs used in the valuation of each tranche on issuance date and March 31, 2017 were as follows:
Issuance Date
|
|
Tranche 1
|
|
|
Tranche 2
|
|
Common stock price
|
|
$
|
3.44
|
|
|
$
|
3.44
|
|
Exercise price
|
|
$
|
4.40
|
|
|
$
|
4.00
|
|
Expected Volatility
|
|
|
112.5
|
%
|
|
|
112.5
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
2.03
|
%
|
|
|
2.03
|
%
|
Expected Term (years)
|
|
|
5
|
|
|
|
0.5
|
|
March 31, 2017
|
|
Tranche 1
|
|
|
Tranche 2
|
|
Common stock price
|
|
$
|
3.44
|
|
|
$
|
3.44
|
|
Exercise price
|
|
$
|
4.40
|
|
|
$
|
4.00
|
|
Expected Volatility
|
|
|
112.3
|
%
|
|
|
112.3
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
1.93
|
%
|
|
|
1.93
|
%
|
Expected Term (years)
|
|
|
4.94
|
|
|
|
0.4
|
4
|
For the fair value determination, the Company computed the historical volatility based on daily pricing observations for a period that corresponds to the expected term of the warrants. The expected term for both valuation dates are based on the remaining contractual term of the warrants. The risk-free interest rates are the U.S. Treasury bond rate as of the valuation dates. With respect to the Tranche 2 warrants, the Company did not assume further reverse split will occur after April 28, 2017 and before the expiration of the 6-month warrants. The fair value of these warrants also incorporates
the Company’s
assumptions about future equity issuances and their impact to the price protection feature.
For the Tranche 1 warrants the valuation factored in 3 potential equity events subsequent to the reverse-split on April 28, 2017 and prior to the expiration of the 5-year term. No subsequent equity events were factored into the valuation of the Tranche 2 warrants prior to the expiration of the 6-month term.
7
.
COMMITMENTS AND CONTINGENCIES
Leases
The Company leases its main operating facility in Hayward, California. The lease is for approximately 14,000 square feet and the lease agreement will expire in September 2017. In April 2016, the Company leased its second operating facility in Pleasanton, California. The lease is for approximately 1,200 square feet and the lease agreement will expire in May 2019.
Other Commitments
In December 2007, the Company and Amgen entered into a worldwide, exclusive license agreement (the “Amgen Agreement”) to develop and commercialize blisibimod in any indication, including for the treatment of systemic lupus erythematosus (“lupus”). Under the terms of the Amgen Agreement, the Company paid a nonrefundable, upfront license fee of $6.0 million. As there was no future alternative use for the technology, the Company expensed the license fee in research and development expenses during 2007. Under the terms of the Amgen Agreement, the Company is obligated to make additional milestone payments to Amgen of up to $33.0 million upon the achievement of certain development and regulatory milestones. The Company is also obligated to pay tiered royalties on future net sales of products, ranging from the high single digits to the low double digits, which are developed and approved as defined by this collaboration. The Company’s royalty obligations as to a particular licensed product will be payable, on a country-by-country and licensed product-by-licensed product basis, for the longer of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by the Company or a sublicense in such country or (b) 10 years after the first commercial sale of the applicable licensed product in the applicable country.
On July 11, 2014, the Company and Eli Lilly and Company (“Eli Lilly”) entered into a worldwide, exclusive license agreement (the “Lilly Agreement”), to develop and commercialize Sollpura, a Phase 3 novel investigational Pancreatic Enzyme Replacement Therapy (“PERT”), for the treatment of patients with Exocrine Pancreatic Insufficiency, or EPI, often seen in patients with cystic fibrosis and other conditions. Under the terms of the Lilly Agreement, the Company was not required to make any up-front payment but is obligated to make milestone payments of up to up to $33.5 million for capsule products and $9.5 million for reformulated products upon the achievement of certain regulatory and commercial sales milestones, none of which have been achieved as of March 31, 2017. In addition, after sales of the licensed products exceed an aggregate of $100.0 million in the United States, the Company is obligated to pay tiered royalties on future net sales of products, ranging from the single digits to the mid-teens, that are developed and approved as defined in the Lilly Agreement. The Company’s royalty obligations as to a particular licensed product will be payable, on a licensed product-by-licensed product basis, for the longer of (a) the date of expiration of the last to expire valid claim within the licensed patents that covers the manufacture, use or sale, offer to sell, or import of such licensed product by the
Company or a sublicense in such country, or (b) 12 years after the first commercial sale of the applicable licensed product in the applicable country.
See Note 3 – “Research Award” for discussion of commitments and contingencies associated with the research award received from the CFFT.
Litigation
On February 13, 2017, a complaint was filed in the United States District Court for the Northern District of California captioned Brian Clevlen v. Anthera Pharmaceuticals, Inc., et al., Case No. 3:17-cv-715, on behalf of a putative class of the Company’s stockholders against the Company and certain of its current and former officers. The complaint asserts claims under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of all stockholders that purchased the Company’s common stock between February 10, 2015 and December 27, 2016. The complaint alleges that the Company made false or misleading statements and/or omissions with respect to the CHABLIS-SC1 trial and SOLUTION study. The complaint seeks unspecified damages, interest, attorneys’ fees, costs, and such other relief at the Court may deem just and proper.
On April 17, 2017, Urešomir Čorak, a putative stockholder of the Company, filed a motion to be appointed as lead plaintiff, and to have the law firm of
Levi & Korsinsky LLP appointed as lead counsel in the action. Also on April 17, 2017, a group of putative stockholders of the Company, comprised of Kent Roberts, Kent Roberts FBO Evan Roberts, Kent Roberts Parent FBO Owen Roberts, and Bobby King, filed a motion to be appointed as lead plaintiff, to have the law firm of Lifschitz & Miller LLP appointed as lead counsel, and to have the law firm of Reich Radcliffe & Hoover LLP appointed as liaison counsel in the action. The Court will have a hearing on these motions on May 25, 2017. The Company intends to vigorously defend itself against the allegations in the action.
The outcome of the legal proceeding is inherently unpredictable, subject to significant uncertainties, and could be material to
the Company’s
operating results and cash flows for a particular period.
8. STOCKHOLDERS’ EQUITY
Preferred Stock
The Company has authorized 5,000,000 shares of $0.001 par value preferred stock. The Company’s Board of Directors is authorized to designate the terms and conditions of any preferred stock issued by the Company without further action by the common stockholders. The Company designated 17,000 shares of its authorized and unissued preferred stock as Series X convertible preferred stock and filed an Amended and Restated Certificate of Designation of Preferences, Rights and Limitations of Series X Convertible Preferred Stock with the Delaware Secretary of State. As of March 31, 2017, there were 487 shares of Series X Convertible Preferred Stock issued and outstanding, all of which were contingently redeemable.
In September 2016, the Company entered into a subscription agreement with certain institutional investors pursuant to which it sold 17,000 (“Initial Tranche”) Series X units for a purchase price of $1,000 per unit in a registered direct offering (the “Subscription Agreement”). Each unit consists of one share of Series X Convertible Preferred Stock and a warrant to purchase 15.87 shares of common stock. The conversion price for the Series X Convertible Preferred Stock became fixed on November 16, 2016 at $15.7536 per share, which represented the VWAP of the Company’s common stock over the five full trading days following the date of the Company’s initial public announcement of topline and/or efficacy data from the CHABLIS-SC1 study on November 10, 2016. The registered direct offering resulted in gross proceeds of $17.0 million. The holders of Series X Convertible Preferred Stock do not have any voting rights nor the right to elect any members to the board of directors. The Series X Convertible Preferred Stock has a contingent redemption clause. The Company is not required to issue any shares of common stock upon conversion of any shares of Series X Convertible Preferred Stock to the extent that (i) the aggregate issuance of common stock will be greater than 1,048,229 shares or 19.99% of the total outstanding shares of the Company (the “Threshold Amount”) and (ii) the conversion has not been approved by the Company’s stockholders in accordance with the stockholder approval requirements of Nasdaq Marketplace Rule 5635(d) (a “Blocked Conversion”). On April 27, 2017, the shareholders approved a proposal to allow holders of Series X Convertible Preferred Stock to convert their shares of Series X Convertible Preferred Stock that converted into common stock in excess of the Threshold Amount which was 30,890 shares of common stock or 487 shares of Series X Convertible Preferred Stock. During January 2017, pursuant to a conversion notice received from the holders of Series X Convertible Preferred Stock, the Company converted 9,012 shares of Series X Convertible Preferred Stock into 572,043 shares of common stock. The conversion was reflected as a reduction in Series X Convertible Preferred Stock. The unamortized discount was recognized as a deemed dividend of $2.5 million in connection with the conversion. As of March 31, 2017, a total of 16,513 shares of Series X Convertible Preferred Stock had been converted into 1,048,189 shares of common stock and no warrants had been exercised.
The Subscription Agreement also provided the investors the right, but not the obligation to make additional investments. These rights expired unexercised on January 26, 2017.
Common Stock
In March 2016, the Company filed a universal shelf registration statement with the SEC on Form S-3 (File No. 333-210166) for the proposed offering from time to time of up to $100.0 million of its securities, including common stock, preferred stock, debt securities and/or warrants. On April 21, 2016, the Company registered $25.0 million under the registration statement for the at-the-market sales agreement with H.C. Wainwright (the “H.C. Wainwright ATM Agreement”). On March 14, 2017, the Company amended the H.C. Wainwright ATM Agreement and reduced the amount registered under the registration statement to $23 million. On April 27, 2016, the Company registered $14.4 million under the registration statement for the equity purchase agreement with Lincoln Park Capital (“LPC Purchase Agreement”). On March 12, 2017, upon the expiration of the LPC Purchase Agreement, $13.4 million of unused amount became available under the registration statement. On September 8, 2016, the Company registered $22.1 million under the registration statement for a subscription agreement with certain institutional investors for the sale of convertible preferred stock and issuance of warrants in a registered direct offering. On March 14, 2017, in connection with a registered direct offering of common stock and warrants, the Company registered $46.5 million under the registration statement. As of March 31, 2017, there was a balance of $7.4 million available for future issuance under the registration statement.
On April 21, 2016, the Company entered into an at-the-market sales agreement with H.C. Wainwright under which the Company from time to time may offer and sell shares of its common stock, par value $0.001 per share, having an aggregate offering price of up to $25.0 million through H.C. Wainwright, as agent. On March 14, 2017, the Company amended the H.C. Wainwright ATM Agreement and reduced the amount of aggregate offering price to $23.0 million. For the year ended December 31, 2016, the Company sold $2.7 million in shares of common stock pursuant to the H.C. Wainwright ATM Agreement, leaving a balance of $20.3 million available for future sale pursuant to the H.C. Wainwright ATM Agreement as of March 31, 2017.
On March 12, 2015, the Company executed an equity purchase agreement with LPC, pursuant to which the Company has the right, but not the obligation, to sell to LPC up to an aggregate of $10.0 million in shares of common stock over a period of two years. In July 2015, the Company amended the equity purchase agreement to reduce the amount available for purchase to $6.0 million. On April 27, 2016, the Company amended the equity purchase agreement and increased the amount of common stock available for purchase to $15.0 million. As of December 31, 2016, the Company sold approximately $1.6 million in shares of common stock pursuant to the equity purchase agreement. In connection with the sale of shares to LPC, for the year ended December 31, 2016, the Company issued 3,103 shares to LPC as commitment fee pursuant to the equity purchase agreement. The equity purchase agreement expired on March 12, 2017.
The S-3 registration statement is subject to Instruction I.B.6. of Form S-3, which imposes a limitation on the maximum amount of securities that
the Company
may sell pursuant to the registration statement during any twelve-month period. When
the Company
sell
s
securities pursuant to the registration statement, the amount of securities to be sold plus the amount of any securities
the Company
has
sold during the prior twelve months in reliance on Instruction I.B.6. may not exceed one-third of the aggregate market value of
its
outstanding common stock held by non-affiliates as of a day during the 60 days immediately preceding such sale, as computed in accordance with Instruction I.B.6. Based on this calculation, the Company expects it will be significantly limited, and likely unable to sell additional securities pursuant to its effective registration statement on Form S-3 for a period of twelve months from March 16, 2017, unless and until the market value of the Company’s outstanding common stock held by non-affiliates increases significantly. If the Company cannot sell securities under its shelf registration, the Company may be required to utilize more costly and time-consuming means of accessing the capital markets, which could materially adversely affect its liquidity and cash position.
In March 2017, the Company entered into an underwriting agreement with H.C. Wainwright, pursuant to which the Company sold an aggregate of 3,750,000 shares of its common stock and agreed to issue warrants (the “Tranche 1 Warrants” and the “Tranche 2 Warrants”) to purchase an aggregate of 7,500,000 shares of its common stock. The financing transaction resulted in proceeds of $14.1 million. The warrants were recorded as liabilities upon issuance due to price protection, as discussed in Note 6. The fair value of these warrants was estimated to be $14.7 million at issuance, which exceeded the proceeds of $14.1 million
.
T
he excess of $0.6 million
between the fair value of the warrants and cash proceeds
was expensed during the first quarter of 2017.
At March 31, 2017, the Company had reserved the following shares for future issuance:
Convertible Series X preferred stock
|
|
|
30,890
|
|
Common stock options outstanding
|
|
|
750,355
|
|
Common stock warrants outstanding
|
|
|
7,774,801
|
|
Common stock options available for future grant under stock option plan
|
|
|
58,232
|
|
Common stock available for future grant under ESPP plan
|
|
|
3,907
|
|
Total
|
|
|
8,618,185
|
|
Warrants
In connection with a venture debt executed in March 2011, the Company issued a seven-year warrant to the lender for the purchase of 5,022 shares of the Company’s common stock at an exercise price of $384.00 per share. The warrant was immediately exercisable and expires in March 2018. As of March 31, 2017, the warrant remained outstanding and exercisable. These warrants are classified in permanent equity on the Company’s consolidated Balance Sheet.
In connection with the issuance of Series X convertible preferred stock in September 2016, the Company issued warrants to certain institutional investors to purchase shares of the Company’s common stock. On November 16, 2016, the exercise price and number of shares of common stock underlying the warrants became fixed at $18.90 and 269,779, respectively. The warrants are exercisable at any time and from time to time after March 13, 2017, and will expire on September 13, 2019. As of March 31, 2017, the warrants remained outstanding. These warrants are classified in permanent equity on the Company’s consolidated Balance Sheet.
In connection with the issuance of common stock in March 2017, the Company agreed to issue 3,750,000 warrants (“Tranche 1 Warrants”) at an initial exercise price of $4.40 per share and 3,750,000 warrants (“Tranche 2 Warrants”) at an initial exercise price of $4.00 per share to the investors to purchase shares of the Company’s common stock.
The Tranche 1 Warrants are exercisable on any day on or after April 28, 2017 and will expire five years thereafter. The Tranche 2 Warrants are exercisable on any day on or after April 28, 2017 and will expire six months thereafter.
These warrants are classified in liability on the Company’s consolidated Balance Sheet until the warrants are exercised or expired.
9. SHARE-BASED COMPENSATION PLANS
2013 Plan
On March 25, 2013, the Company’s board of directors adopted the 2013 Stock Option and Incentive Plan (the “2013 Plan”), which was also approved by the Company’s stockholders at its annual general meeting on May 16, 2013. The Company initially reserved 218,750 shares of its common stock for the issuance of awards under the 2013 Plan, plus all shares remaining available for grant under the Company’s 2010 Stock Option and Incentive Plan (the “2010 Plan”), plus any additional shares returned under the 2010 Plan or 2013 Plan as a result of the cancellation, forfeiture or other termination (other than by exercise) of awards issued pursuant to the 2010 Plan or 2013 Plan, subject in all cases to adjustment including reorganization, recapitalization, reclassification, stock dividend, stock split, reverse stock split or other similar change in the Company’s capital stock. In May 2015, the Company’s shareholders approved an additional 223,852 shares of its common stock for issuance of awards under the 2013 Plan. Of the shares of common stock reserved for issuance under the 2013 Plan, no more than 93,750 shares will be issued to any individual participant as incentive options, non-qualified options or stock appreciation rights during any calendar year. The 2013 Plan permits the granting of incentive and non-statutory stock options, restricted and unrestricted stock awards, restricted stock units, stock appreciation rights, performance share awards, cash-based awards and dividend equivalent rights to eligible employees, directors and consultants. The option exercise price of an option granted under the 2013 Plan may not be less than 100% of the fair market value of a share of the Company’s common stock on the date the stock option is granted. Options granted under the 2013 Plan have a maximum term of 10 years and generally vest over four years. In addition, in the case of certain large stockholders, the minimum exercise price of incentive options must equal 110% of fair market value on the date of grant and the maximum term is limited to five years. Subject to overall Plan limitations, the maximum aggregate number of shares of common stock that may be issued in the form of incentive options shall not exceed 781,250 shares of common stock. The 2013 Plan does not allow the option holders to exercise their options prior to vesting.
The terms of awards granted during the three months ended March 31, 2017 and the method for determining the grant date fair value of the awards were consistent with those described in the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016.
The following table summarizes stock option activity for the three months ended March 31, 2017 (in thousands except share and per share information):
|
|
Number of
Options
|
|
|
Weighted-
Average
Exercise
Price
|
|
|
Weighted-
Average
Remaining
Contractual
Life in Years
|
|
|
Aggregate
Intrinsic
Value
|
|
Balance at December 31, 2016
|
|
|
749,503
|
|
|
$
|
29.82
|
|
|
|
8.19
|
|
|
$
|
—
|
|
Granted
|
|
|
12,500
|
|
|
$
|
5.12
|
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
—
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
Cancelled and expired
|
|
|
(3,231
|
)
|
|
$
|
16.64
|
|
|
|
|
|
|
|
|
|
Forfeited
|
|
|
(8,417
|
)
|
|
$
|
25.53
|
|
|
|
|
|
|
|
|
|
Balance at March 31, 2017
|
|
|
750,355
|
|
|
$
|
29.52
|
|
|
|
7.96
|
|
|
$
|
—
|
|
Exercisable at March 31, 2017
|
|
|
400,137
|
|
|
$
|
32.80
|
|
|
|
7.08
|
|
|
$
|
—
|
|
The intrinsic value of stock options represents the difference between the exercise price of stock options and the market price of our stock on that day for all in-the-money options. As of March 31, 2017, there was $6.54 million of total unrecognized compensation expense related to stock options and is expected to be amortized on a straight-line basis over a weighted-average remaining period of 2.49 years.
The assumptions used in the Black-Scholes option-pricing model to value stock options are as follows:
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
|
|
2016
|
|
Expected Volatility
|
|
|
106
|
%
|
|
|
96
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
2.12
|
%
|
|
|
1.82
|
%
|
Expected Term (years)
|
|
|
6.02
|
|
|
|
6.02
|
|
Weighted-average fair value per option
|
|
$
|
4.20
|
|
|
$
|
22.08
|
|
2010 Employee Stock Purchase Plan (“ESPP”)
Effective July 2010, under the terms of the ESPP, eligible employees of the Company may authorize the Company to deduct amounts from their compensation, which amounts are used to enable the employees to purchase shares of the Company’s common stock. The Company initially reserved 1,562 shares of common stock for issuance thereunder on January 1, 2011, and on each January 1 thereafter, the number of shares of stock reserved and available for issuance under the Plan shall be cumulatively increased by the lesser of (i) one percent (1%) of the number of shares of common stock issued and outstanding on the immediately preceding December 31 or (ii) 3,906 shares of common stock. On January 1, 2017, in accordance with the ESPP’s annual increase provisions, the authorized shares in the ESPP increased by 3,906.
Under the ESPP, eligible employees of the Company may authorize the Company to deduct amounts from their compensation, which amounts are used to enable the employees to purchase shares of the Company’s common stock. The purchase price per share is 85% of the fair market value of the common stock as of the first date or the ending date of the applicable semi-annual purchase period, whichever is less (the “Look-Back Provision”). The 15% discount and the Look-Back Provision make the ESPP compensatory. The Black-Scholes option pricing model was used to value the employee stock purchase rights.
The assumptions used in the Black-Scholes option-pricing model to value the employee stock purchase rights are as follows:
|
|
Three Months Ended
March 31,
|
|
|
|
2017
|
|
|
2016
|
|
Expected Volatility
|
|
|
171
|
%
|
|
|
88
|
%
|
Dividend Yield
|
|
|
0
|
%
|
|
|
0
|
%
|
Risk-Free Interest Rate
|
|
|
0.50
|
%
|
|
|
0.24
|
%
|
Expected Term (years)
|
|
|
0.50
|
|
|
|
0.50
|
|
Stock-Based Compensation Expense
Total stock-based compensation expense, including expense recorded for the ESPP, was as follows (in thousands):
|
Three Months
Ended March 31,
|
|
|
2017
|
|
2016
|
|
Research and development
|
|
$
|
396
|
|
|
$
|
428
|
|
General and administrative
|
|
|
690
|
|
|
|
690
|
|
Total stock-based compensation
|
|
$
|
1,086
|
|
|
$
|
1,118
|
|
10. SUBSEQUENT EVENTS
On April 27, 2017, the Company’s shareholders approved an additional 500,000 and 27,344 shares of its common stock for issuance under the 2013 Plan and 2010 Employee Stock Purchase Plan, respectively. Additionally, the shareholders approved the automatic annual increase of authorized shares pursuant to the evergreen from 3,906 to 31,250 shares for the 2010 Employee Stock Purchase Plan.
On April 28, 2017, the Company effectuated a one-for-eight reverse split of its outstanding common stock (the “Reverse Stock Split”). As a result of the Reverse Stock Split, every eight shares of the Company’s outstanding common stock were converted into one outstanding share of common stock, resulting in a reduction of its total common stock issued and outstanding from 80,609,310 shares to 10,076,164 shares. The reverse split affected all holders of the Company’s common stock equally. The par value of the Company’s common stock and preferred stock remains unchanged at $0.001 per share and the number of authorized shares of common stock and preferred stock remained unchanged at 100,000,000 and 5,000,000 shares, respectively.