Notes to Unaudited Condensed Consolidated Financial Statements
Note 1. Description of Business
Change in Fiscal Year
On December 8, 2017, the Board of Directors of Opiant Pharmaceuticals, Inc. (“Opiant" or the “Company”), acting pursuant to Section 5.1 of the Company’s Bylaws, approved a resolution changing the Company’s fiscal year-end from July 31 to December 31. As such, the end of the quarters in the new fiscal year do not coincide with the end of the quarters in the Company's previous fiscal years. The Company made this change to align its fiscal year end with other companies within its industry.
Company
Opiant is a specialty pharmaceutical company developing pharmacological treatments for addiction and drug overdose. The Company was incorporated in the State of Nevada in June 2005 as Madrona Ventures, Inc. and, in September 2009, changed its name to Lightlake Therapeutics Inc. In January 2016, the Company again changed its name to Opiant Pharmaceuticals, Inc. On November 4, 2016 the Company formed a wholly-owned subsidiary, Opiant Pharmaceuticals, UK Limited.
On October 2, 2017, the Company changed its state of incorporation from the State of Nevada to the State of Delaware pursuant to an Agreement and Plan of Merger, dated October 2, 2017 whereby the Company merged with and into its recently formed, wholly-owned Delaware subsidiary, Opiant Pharmaceuticals, Inc. Pursuant to the Agreement and Plan of Merger, (i) the Company merged with and into its Delaware subsidiary, (ii) the Company's separate corporate existence in Nevada ceased to exist, (iii) the Company's Delaware subsidiary became the surviving corporation, (iv) each share of the Company's common stock,
$0.001
par value per share (the “Common Stock”), outstanding immediately prior to the effective time was converted into
one
fully-paid and non-assessable share of common stock of Opiant Pharmaceuticals, Inc., a Delaware corporation,
$0.001
par value per share, and (v) the certificate of incorporation and bylaws of the Company's Delaware subsidiary were adopted as its certificate of incorporation and bylaws at the effective time of the merger. The merger and the Agreement and Plan of Merger were approved by the Company's Board of Directors and stockholders representing a majority of the outstanding shares of Common Stock.
The Company conceived, developed and licensed NARCAN® (naloxone hydrochloride) Nasal Spray, a treatment to reverse opioid overdose. This product was approved by the U.S. Food and Drug Administration (“FDA”) in November 2015. It is marketed by Adapt Pharma Operations Limited (“Adapt”), an Ireland-based pharmaceutical company. In October 2018, Emergent BioSolutions, Inc. completed its acquisition of Adapt. The Company plans to replicate this relatively low cost business strategy primarily through developing nasal opioid antagonists in the fields of addiction and drug overdose. The Company primarily aims to identify and progress those drug development opportunities that have the potential to file additional New Drug Applications (“NDA”) with the FDA within three to five years, with larger market opportunities and with the potential to self-commercialize in the fields of addiction and drug overdose.
The Company's current pipeline of product candidates includes pharmacological treatments for Bulimia Nervosa ("BN"), Alcohol Use Disorder ("AUD"), Opioid Use Disorder ("OUD") and a long acting Opioid Overdose Reversal ("OOR") product. We are also pursuing other treatment opportunities within the addiction space.
The Company has not had a bankruptcy, receivership or similar proceeding. The Company is required to comply with all regulations, rules and directives of governmental authorities and agencies applicable to the clinical testing and manufacturing and sale of pharmaceutical products.
`Note 2. Basis of Presentation and Summary of Significant Accounting Policies
Basis of Presentation
The accompanying condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("GAAP") and the applicable rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The condensed consolidated balance sheet at December 31, 2017 has been derived from the audited consolidated financial statements at that date, but does not include all disclosures, including notes, required by GAAP for complete financial statements.
The unaudited interim condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the Company's financial position as of September 30, 2018 and December 31, 2017, results of its operations for the three and nine months ended September 30, 2018 and 2017 and cash flows for the nine months ended September 30, 2018 and 2017. The interim results are not necessarily indicative of the results for any future interim period or for the entire year. Certain prior period amounts have been reclassified to conform to current period presentation. These classifications have no effect on the previously reported net loss or loss per share.
The condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiary, Opiant Pharmaceuticals UK Limited, a company incorporated on November 4, 2016 under the England and Wales Companies Act of 2006. Intercompany balances and transactions are eliminated upon consolidation.
The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the five-month period ended December 31, 2017 included in the Company's Transition Report on Form 10-KT filed with the SEC on March 7, 2018.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities, and reported amounts of expenses in the financial statements and accompanying notes. Actual results could differ from those estimates. Key estimates included in the financial statements include the valuation of: deferred income tax assets, equity instruments, stock-based compensation, acquired intangibles, and allowances for accounts receivable.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents were approximately
$24.8 million
and
$8.1 million
at September 30, 2018 and December 31, 2017, respectively. The Company maintains cash balances at financial institutions insured up to
$250 thousand
by the Federal Deposit Insurance Corporation. Balances in the UK are insured up to
£85 thousand
by the Financial Services Compensation Scheme (UK Equivalent). Although the Company’s cash balances exceeded these insured amounts at various times during the nine months ended September 30, 2018, the Company has not experienced any losses on its deposits of cash and cash equivalents for the periods presented.
Earnings (Loss) Per Share
Basic and diluted loss per share is computed by dividing loss attributable to common stockholders by the weighted average number of shares of Common Stock outstanding during the period. Diluted weighted average shares outstanding for the three and nine months ended September 30, 2018 and 2017 excludes
3.7 million
and
4.1 million
shares, underlying stock options and warrants, respectively, because the effects would be anti-dilutive. Accordingly, basic and diluted loss per share is the same.
Recently Issued Accounting Pronouncements
In May 2014, the FASB issued ASU 2014-09,
“Revenue from Contracts with Customers (Topic 606)”
(“ASU 2014-09”). ASU 2014-09 supersedes the revenue recognition requirements in ASC Topic 605, “Revenue Recognition” and some cost guidance included in ASC Subtopic 605-35, "Revenue Recognition - Construction-Type and Production-Type Contracts.” The core principle of ASU 2014-09 is that revenue is recognized when the transfer of goods or services to customers occurs in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. ASU 2014-09 requires the disclosure of sufficient information to enable readers of the Company’s financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. ASU 2014-09 also requires disclosure of information regarding significant judgments and changes in judgments, and assets recognized from costs incurred to obtain or fulfill a contract. ASU 2014-09 provides two methods of retrospective application. The first method would require the Company to apply ASU 2014-09 to each prior reporting period presented. The second method would require the Company to retrospectively apply ASU 2014-09 with the cumulative effect recognized at the date of initial application.
There have been four new ASUs issued amending certain aspects of ASU 2014-09, ASU 2016-08,
"Principal versus Agent Considerations (Reporting Revenue Gross Versus Net),"
was issued in March 2016 to clarify certain aspects of the principal versus agent guidance in ASU 2014-09. In addition, ASU 2016-10,
"Identifying Performance Obligations and Licensing,"
issued in April 2016, amends other sections of ASU 2014-09 including clarifying guidance related to identifying performance obligations
and licensing implementation. ASU 2016-12,
"Revenue from Contracts with Customers - Narrow Scope Improvements and Practical Expedients"
provides amendments and practical expedients to the guidance in ASU 2014-09 in the areas of assessing collectability, presentation of sales taxes received from customers, noncash consideration, contract modification and clarification of using the full retrospective approach to adopt ASU 2014-09. Finally, ASU 2016-20,
“Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers,”
was issued in December 2016, and provides elections regarding the disclosures required for remaining performance obligations in certain cases and also makes other technical corrections and improvements to the standard. With its evaluation of ASU 2014-09, the Company does not expect a material impact on its consolidated financial statements.
The Company adopted Topic 606 using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. The Company did not have a cumulative impact as of January 1, 2018 due to the adoption of Topic 606 and there was not an impact to its consolidated statements of operations for the three and nine months ended September 30, 2018 as a result of applying Topic 606.
The Company has implemented all new accounting pronouncements that are in effect and that may impact its financial statements and does not believe that there are any other new pronouncements that have been issued that might have a material impact on its financial position or results of operations.
Note 3. Prepaid Expenses and Other Current Assets
As of
September 30, 2018
, the Company had approximately
$346 thousand
recorded as prepaid expenses and other current assets. Of this amount, approximately
$22 thousand
is the amount of remaining prepaid expense related to Renaissance Lakewood, LLC ("Renaissance") (see Note 9 - Commitments). Per the terms of its agreement with Renaissance, the Company was obligated to make a
$245 thousand
deposit during 2017 to fund the initial costs of the product development work to be performed by Renaissance on behalf of the Company.
As of September 30, 2018, the Company has prepaid insurance in the amount of
$104 thousand
.
During the year ended December 31, 2017, the Company purchased approximately
$100 thousand
of research and development supplies related to the above referenced product development work being performed by Renaissance. As provided under the agreement with Renaissance, the Company is obligated to pay for all supplies and materials that are needed to complete this product development work. As of
September 30, 2018
and December 31, 2017, the amount of remaining prepaid expense was
$76 thousand
and
$100 thousand
, respectively because it is estimated that these supplies will be used within 12 months of the reporting date.
The remaining balance consists primarily of prepaid expenses such as rent, other insurance, and software licenses.
Note 4. Related Party Transactions
The Company uses office space provided by Dr. Phil Skolnick, the Company’s Chief Scientific Officer, free of charge.
Note 5. Accounts Receivable
On December 13, 2016, the Company entered into a Purchase and Sale Agreement (the “SWK Purchase Agreement”) with SWK Funding LLC (“SWK”), pursuant to which the Company sold, and SWK purchased, the Company’s right to receive, commencing on October 1, 2016, all Royalties (as defined in the SWK Purchase Agreement) arising from the sale by Adapt of NARCAN or any other Product, in an amount up to (i)
$20,625,000
and then the Residual Royalty thereafter or (ii)
$26,250,000
(the "Capped Royalty Amount"), if Adapt has received in excess of
$25,000,000
of cumulative Net Sales for any two consecutive fiscal quarters during the period from October 1, 2016 through September 30, 2017 from the sale of NARCAN (the “Earn Out Milestone”), and then the Residual Royalty thereafter. The Residual Royalty is defined in the SWK Purchase Agreement as follows: (i) if the Earn Out Milestone is paid, then SWK shall receive
10%
of all Royalties; provided, however, that if no generic version of NARCAN is commercialized prior to the
six
th anniversary of the SWK Closing Date, then SWK shall receive
5%
of all Royalties after such date, and (ii) if the Earn Out Milestone is not paid, then SWK shall receive
7.86%
of all Royalties; provided, however, that if no generic version of NARCAN is commercialized prior to the
six
th anniversary of the SWK Closing Date, then SWK shall receive
3.93%
of all Royalties after such date. Under the SWK Purchase Agreement, the Company received an upfront purchase price of
$13,750,000
less
$40,000
of legal fees on the SWK Closing Date, and
received an additional
$3,750,000
from SWK on August 10, 2017 after the Earn Out Milestone was achieved during the first two calendar quarters in 2017.
As of December 31, 2017, the Company determined that the Capped Royalty Amount provided in the SWK Agreement had been met. As a result,
90%
of any succeeding milestone payments and royalties due from Adapt will revert to the Company while the remaining
10%
will be paid to SWK. As of December 31, 2017, the Company recognized accounts receivable of
$11.7 million
, which is equivalent to
90%
of the milestone payments and royalties earned during the five months ended December 31, 2017.
On February 28, 2018, the Company was notified that Adapt had entered into a license agreement with a Third Party (as defined in the License Agreement) with regard to one or more patents pursuant to which Adapt had invoked its right under Section 5.5 of that certain License Agreement, dated as of December 15, 2014 (the “Initial License Agreement”), by and between the Company and Adapt, as amended (the “License Agreement”), to offset
50%
, or
$6,250,000
, of the payment paid to such Third Party from the amounts payable by Adapt to the Company (under the License Agreement) and to SWK (under the SWK Purchase Agreement). To the extent that the license agreement which Adapt has entered into with the Third Party requires additional payments that fall under the scope of Section 5.5 of the License Agreement, Adapt may seek from the Company future payment offsets of up to
50%
of such amounts that Adapt pays to such Third Party. In accordance with the License Agreement, Adapt may enter into such a licensing arrangement and exercise its right to deduct any payments with respect thereto at any time without the consent of the Company. Under the License Agreement, royalty or milestone payments for a calendar quarter are payable from Adapt to the Company, and Adapt may not deduct more than
50%
of the amount payable for that calendar quarter. The Company has not been given access to the license agreement between Adapt and the Third Party and Adapt may not give the Company notice of any future offset payments until they are incurred. The Company is not aware of any potential offset payments related to the three months ended September 30, 2018.
On March 1, 2018, the Company received net milestone payments of
$6.1 million
. The remaining accounts receivable balance of
$5.6 million
, which is associated with the royalty and milestones earned during the twelve months ended December 31, 2017, was applied as an offset to the license fee owed to Adapt, as provided under Section 5.5 of the License Agreement. The
$5.6 million
of fees paid to Adapt is reported as license fees in the condensed consolidated statements of operations.
At
September 30, 2018
, the Company recorded
$4.1 million
as a receivable relating to royalty revenue recognized during the three months ended
September 30, 2018
.
Note 6. Deferred Revenue
On December 17, 2013, the Company entered into an agreement with an investor, Potomac, and subsequently received additional funding totaling
$250 thousand
for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a
0.5%
interest in the Company’s BED treatment product (the “BED Treatment Product”) and pay the investor
0.5%
of the BED Net Profit in perpetuity (the “2013
0.5%
Investor Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. In the event that the BED Treatment Product was not approved by the FDA by December 17, 2016, the investor would have a
60
-day option to exchange its entire
0.5%
Investor Interest for
31,250
shares of Common Stock of the Company. On February 17, 2017, the investor’s option to receive the shares of Common Stock terminated by its terms, which resulted in the Company beginning to recognize revenue in relation to this agreement in February 2017. The Company estimates that sufficient research and development will be completed by December 31, 2020 to allow the Company to advance the program into final registration studies. Therefore, the Company recognized revenue on a straight-line basis over the expected completion date. The Company recognized approximately
$14.4 thousand
and
$21.7 thousand
of revenue relating to the agreement for the three month period ended September 30, 2018 and 2017, respectively. During the nine months ended September 30, 2018 and 2017 the Company recognized approximately
$43.4 thousand
and
$54.3 thousand
of revenue related to the agreement, respectively.
On September 17, 2014, the Company entered into an agreement with an investor, Potomac, and subsequently received funding totaling
$500 thousand
for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a
1.0%
interest in the Company’s BED Treatment Product and pay the investor
1.0%
of the BED Net Profit generated from the BED Treatment Product in perpetuity (the “
1.0%
Investor Interest”). “BED Net Profit” is defined as the pre-tax profit generated from the BED Treatment Product after the deduction of all expenses incurred by and payments made by the Company in connection with the BED Treatment Product, including but not limited to an allocation of Company overhead. In the event that the BED Treatment Product was not approved by the FDA by September 17, 2017, the investor would have a
60
-day option to exchange its entire
1.0%
Investor Interest for
62,500
shares of Common Stock of the Company. On November 15, 2017, the investor’s option to receive the shares of Common Stock terminated by its terms, which resulted in the Company beginning to recognize revenue in relation to this agreement in November 2017. The Company estimates that sufficient research and development will be completed by December 31, 2020 to allow the Company to advance the program into final registration studies. Therefore, the Company recognized revenue on a straight-line basis over the expected completion date. During the three and nine months ended September 30, 2018, the Company recognized revenue of approximately
$39.2 thousand
and
$117.6 thousand
, respectively related to this agreement. The Company recognized
no
revenue for the three and nine months ended September 30, 2017.
On July 20, 2015, the Company entered into an agreement with an investor, Potomac, and subsequently received funding from an individual investor in the amount of
$250 thousand
for use by the Company for any purpose. In exchange for this funding, the Company agreed to provide the investor with a
0.5%
interest in the BED Net Profit (the “2015
0.5%
Investor Interest”) generated from the BED Treatment Product in perpetuity. The investor also has rights with respect to the 2015
0.5%
Investor Interest if the BED Treatment Product is sold or the Company is sold. If the product is not introduced to the market and not approved by the FDA or an equivalent body in Europe and not marketed by July 20, 2018, the investor will have a
60
-day option to exchange the 2015
0.5%
Investor Interest for
25,000
shares of Common Stock of the Company. As of September 30, 2018, the Company recognized
$8.9 thousand
of revenue related to this agreement.
On September 22, 2015, the Company received a
$1.6 million
commitment from the Foundation which later assigned its interest to Valour in October 2016, from which the Company had the right to make capital calls from the Foundation for the research, development, and any other activities connected to the Company’s opioid antagonist treatments for addictions and related disorders that materially rely on certain studies funded by the Foundation’s investment, excluding the Opioid Overdose Reversal Treatment Product (the “Certain Studies Products”), certain operating expenses, and any other purpose consistent with the goals of the Foundation. In exchange for funds invested by the Foundation, Valour currently owns
2.1333%
interest in the Certain Studies Products Net Profit (the “
2.1333%
Interest”). The “Certain Studies Net Profit” is defined as any pre-tax revenue received by the Company that was derived from the sale of the Certain Studies Products less any and all expenses incurred by and payments made by the Company in connection with the Certain Studies Products, including but not limited to an allocation of Company overhead based on the proportionate time, expenses and resources devoted by the Company to Certain Studies Product-related activities, which allocation shall be determined in good faith by the Company. Valour also has rights with respect to its up to a
2.1333%
Interest if the Certain Studies Product is sold or the Company is sold. Additionally, the Company may buy back, in whole or in part, the
2.1333%
Interest from Valour within
2.5 years
or after
2.5 years
of the initial investment at a price of
two
times or
3.5
times, respectively, the relevant investment amount represented by the interests to be bought back. If an aforementioned treatment is not introduced to the market by September 22, 2018, Valour will have a
60
-day option to exchange its
2.1333%
Interest for shares of the Common Stock of the Company at an exchange rate of one-tenth of a share for every dollar of its investment. On October 2, 2015, December 23, 2015, and May 28, 2016, the Company made capital calls of approximately
$618 thousand
,
$715.5 thousand
, and
$266.5 thousand
, respectively, from the Foundation in exchange for
0.824%
,
0.954%
and
0.355333%
interests in the aforementioned treatments, respectively. The Company will defer recording revenue until such time as Valour’s option expires or Valour’s right to exercise the option is eliminated by the achievement of certain milestones. Upon expiration of the exercise option, the deliverables of the arrangement will be reviewed and evaluated under Accounting Standards Codification (ASC) 605. In the event Valour chooses to exchange its
2.1333%
Interest, in whole or in part, for shares of Common Stock of the Company, that transaction will be accounted for in a manner similar to a sale of shares of Common Stock for cash. As of September 30, 2018,
no
revenue had been recognized in relation to this agreement. During September 2018 Valour elected to exchange its interest for shares of Common Stock and accordingly the Company issued
160,000
shares of its Common Stock to Valour.
On April 17, 2018, the Company was awarded a grant of approximately
$7.4 million
from the National Institutes of Health’s National Institute on Drug Abuse, (NIDA). The grant provides the Company with additional resources for the ongoing development of OPNT003 (intranasal nalmefene), a long-lasting opioid antagonist for the treatment of opioid overdose. The grant includes approximately
$2.6 million
to be funded for the period ending March 31, 2019, with the balance to be funded over the subsequent two years, subject to available funds and satisfactory progress on the development of OPNT003. Government grants are agreements that generally provide cost reimbursement for certain types of expenditures in return for research and development activities over a contractually defined period. The Company recognized revenues from grants in the
period during which the related costs were incurred, provided that the conditions under which the grants were provided had been met and only perfunctory obligations were outstanding. During the nine months ended September 30, 2018 the Company received the first tranche cash draw of
$500
thousand and recognized revenue of
$163
thousand related to this grant.
On September 19, 2018, the Company entered into a contract with the Biomedical Advanced Research and Development Authority (“BARDA”), which is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response, to accelerate the Company’s development of OPTN003, its lead product candidate. OPTN003, nasal nalmefene, is a potent, long-acting opioid antagonist currently in development for the treatment of opioid overdose. The contract will provide potential funding up to a maximum of approximately
$4.6 million
and cover activities related to a potential New Drug Application submission for OPTN003 with the Food and Drug Administration. The Contract will provide approximately
$611,000
for the project through September 30, 2019, with the balance to be funded over the following
two
years, subject to satisfactory project progress, availability of funds and certain other conditions.
No
revenue was recorded for the period ended September 30, 2018.
The following is a summary of the Company’s deferred revenue activity as of September 30, 2018:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
BED
|
Other
Opioid
Treatments
|
|
Grants
|
|
Total
|
Balance as of December 31, 2017
|
|
$
|
895
|
|
|
$
|
1,600
|
|
|
$
|
—
|
|
|
$
|
2,495
|
|
Converted to Equity
|
|
—
|
|
|
(1,600
|
)
|
|
—
|
|
|
(1,600
|
)
|
Increase to deferred revenue
|
|
—
|
|
|
—
|
|
|
500
|
|
|
500
|
|
Recognized as revenue
|
|
(170
|
)
|
|
—
|
|
|
(163
|
)
|
|
(333
|
)
|
Balance as of September 30, 2018
|
|
$
|
725
|
|
|
$
|
—
|
|
|
$
|
337
|
|
|
$
|
1,062
|
|
As of September 30, 2018, the Company had recorded approximately
$660 thousand
of its deferred revenue as a current liability because the Company expects to recognize that amount as revenue during the next 12 months. The remaining
$402 thousand
was recorded as a long-term liability as of September 30, 2018, as detailed in the following table:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands)
|
BED
|
Other
Opioid
Treatments
|
|
Grants
|
|
Total
|
Current portion
|
|
$
|
323
|
|
|
$
|
—
|
|
|
$
|
337
|
|
|
$
|
660
|
|
Long-term portion
|
|
402
|
|
|
—
|
|
|
—
|
|
|
402
|
|
Total
|
|
$
|
725
|
|
|
$
|
—
|
|
|
$
|
337
|
|
|
$
|
1,062
|
|
Note 7. Royalty Payable
The Company entered into various agreements and subsequently received funding from investors for use by the Company for the research and development of its OORT Product. In exchange for this funding, the Company agreed to provide investors with interest in the OORT Net Profit generated from its OORT Product in perpetuity. As of December 31, 2017, the Company determined an OORT Net Profit as a result of NARCAN sales by Adapt and recorded a royalty payable of
$1.4 million
. As of
September 30, 2018
, the Company has a royalty payable of
$800 thousand
to all of the Net Profit Partners.
Note 8. Stockholders' Equity
Common Stock
During the
nine months ended September 30, 2018
, the Company issued
1,259,663
shares of Common Stock.
In October 2017, the Company entered into a Controlled Equity Offering
SM
sales agreement (the "Sales Agreement") with Cantor Fitzgerald & Co., as agent ("Cantor Fitzgerald"), pursuant to which the Company may offer and sell, from time to time through Cantor Fitzgerald, shares of Common Stock having an aggregate offering price as set forth in the Sales Agreement and a related prospectus supplement filed with the SEC on March 19, 2018. The Company agreed to pay Cantor Fitzgerald a cash commission of
3.0%
of the aggregate gross proceeds from each sale of shares under the Sales Agreement. The Company sold
239,270
shares of Common Stock for gross proceeds of
$4.31 million
and received net proceeds of
$4.18 million
, after sales commissions, under the Sales Agreement during the nine months ended September 30, 2018. As of September 30, 2018, the Company does not have the ability to use the Controlled Equity Offering.
On September 27, 2018, the Company completed a registered public offering with Cantor Fitzgerald as underwriter and sold
811,764
shares its Common stock (including
105,882
shares purchased by Cantor Fitzgerald upon the exercise in full of its right to purchase up to an additional
105,882
shares to cover over-allotments) at a price of
$17.00
per share. The Company received approximately
$13.0 million
of net proceeds from the offering after deducting sales commissions.
During the nine months ended
September 30, 2018
, the Company offset net financing proceeds received with
$0.4 million
of current and deferred financing costs. All deferred financing costs were offset against additional paid-in capital as of September 30, 2018. There were
no
additional deferred financing costs at September 30, 2018.
During the nine months ended
September 30, 2018
, the Company issued
3,400
shares of its Common Stock as a result of the exercise of stock purchase warrants with an exercise price of
$10.00
per share for total proceeds of
$34,000
. During the nine months ended September 30, 2018 the Company issued
38,166
shares of its Common stock with an aggregate value of
$782 thousand
for services and
7,063
shares of its Common Stock for a cashless exercise of stock options. On September 5, 2018, the Company also issued
160,000
shares of Common Stock to Valour Fund, LLC, as a result of Valour's exercise of its option to exchange its interest in certain product revenues for Common Stock of the Company
Stock Options
On September 8, 2017, the Company held its Annual Meeting of Stockholders (the “Annual Meeting”), at which time the 2017 Long-Term Incentive Plan ("2017 Plan") was approved by stockholder vote. The 2017 Plan allows the Company to grant both incentive stock options (“ISOs”) and non-qualified stock options (“NSOs”) to purchase a maximum of
400,000
shares of the Company's Common Stock. Under the terms of the 2017 Plan, ISOs may only be granted to Company employees and directors, while NSOs may be granted to employees, directors, advisors, and consultants. The Board has the authority to determine to whom options will be granted, the number of options, the term, and the exercise price. Options are to be granted at an exercise price not less than fair value for an ISO or an NSO. The vesting period is normally over a period of
four years
from the vesting date. The contractual term of an option is no longer than
ten years
.
As provided in the 2017 Plan, on January 1, 2018 the number of options available for issuance was increased by
4%
of the outstanding stock as of December 31, 2017, which represents an increase of
101,431
options.
Prior to adopting the 2017 Plan, the Company did not have a formal long-term incentive stock plan. Prior to the implementation of the 2017 Plan, the Company had discretion to provide designated employees of the Company and its affiliates, certain consultants, and advisors who perform services for the Company and its affiliates, and non-employee members of the Board and its affiliates with the opportunity to receive grants of non-qualified stock options (the "Pre-2017 Non-Qualified Stock Options"). All of the Pre-2017 Non-Qualified Stock Option Grants were intended to qualify as non-qualified stock options. There were no Pre-2017 Non-Qualified Stock Option Grants that were intended to qualify as incentive stock options.
Pre-2017 Non-Qualified Stock Options
As of December 31, 2017, the Company had granted Pre-2017 Non-Qualified Stock Options to purchase, in the aggregate,
2,980,500
shares of the Company's Common Stock. During the
nine months ended September 30, 2018
, the Company did
no
t grant any Pre-2017 Non-Qualified Stock Options.
Stock option activity for the Pre-2017 Non-Qualified Stock Options for the
nine months ended September 30, 2018
is presented in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares
|
|
Weighted- average Exercise Price
|
|
Weighted- average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value (in Thousands)
|
Outstanding at December 31, 2017
|
2,980,500
|
|
|
$
|
7.33
|
|
|
7.06
|
|
$
|
46,606
|
|
Exercised
|
(15,000
|
)
|
|
10.00
|
|
|
|
|
|
|
Forfeited
|
—
|
|
|
—
|
|
|
|
|
|
Outstanding at September 30, 2018
|
2,965,500
|
|
|
$
|
7.32
|
|
|
6.33
|
|
$
|
31,258
|
|
Exercisable at September 30, 2018
|
2,803,399
|
|
|
$
|
7.20
|
|
|
6.19
|
|
$
|
29,889
|
|
A summary of the status of the Company’s non-vested Pre-2017 Non-Qualified Stock Options as of
September 30, 2018
and changes during the
nine months ended September 30, 2018
is presented below:
|
|
|
|
|
|
|
|
|
Number of Options
|
|
Weighted Average Grant Date Fair Value
|
Non-vested at December 31, 2017
|
288,902
|
|
|
$
|
7.87
|
|
Vested
|
(126,801
|
)
|
|
$
|
7.93
|
|
Non-vested at September 30, 2018
|
162,101
|
|
|
$
|
7.82
|
|
During the
nine months ended September 30, 2018
and 2017, the Company recognized approximately
$751 thousand
and
$826 thousand
, respectively, of non-cash expense related to Pre-2017 Non-Qualified Stock Options granted in prior periods. As of September 30, 2018, there was approximately
$342.3 thousand
of unrecognized compensation costs related to non-vested Pre-2017 Non-Qualified Stock Options.
The 2017 Plan
On January 4, 2018, the Company granted options to a number of employees to purchase
57,050
shares of the Company’s Common Stock at an exercise price of
$24.84
per share, which represents the closing price of the Company’s Common Stock on the date of grant. These options were issued under the Company’s 2017 Plan and have
ten
-year terms. The options vest as follows:
25%
on the one year anniversary of the grant date and then 1/48
th
of the options shares vest on such date every month thereafter through the fourth anniversary of the grant date. The Company valued these options using the Black-Scholes option pricing model and estimated the fair value on the date of grant to be
$1.4 million
.
On February 13, 2018, the Company granted an option to an employee to purchase
100,000
shares of the Company’s Common Stock at an exercise price of
$24.79
per share, which represents the closing price of the Company’s Common Stock on the date of grant. This option was issued under the Company’s 2017 Plan and has a
ten
-year term. The option vests as follows:
25%
on the one year anniversary of the grant date and then 1/48
th
of the option shares vest on such date every month thereafter through the fourth anniversary of the grant date. The Company valued this option using the Black-Scholes option pricing model and estimated the fair value on the date of grant to be
$2.5 million
.
During the nine month period ended September 30, 2018, the Company granted
31,500
options to employees and certain Directors of the Board at exercise prices from
$14.31
to
$19.83
, which represents the closing price of the Company's common stock on the date of the grant. These options were issued under the Company's 2017 Plan and have
ten
-year terms. The options vest over a period of
one
to
four
years. The Company valued these options using the Black-Scholes option pricing model and estimated the fair value of these options granted during the nine months ended September 30, 2018 to be
$476,025
.
The assumptions used in the valuation of options granted under the 2017 Plan during the
nine months ended September 30, 2018
are as follows:
|
|
|
|
|
For the Nine Months Ended September 30, 2018
|
Market value of stock on measurement date
|
$14.31 to $24.84
|
|
Risk-free interest rate
|
2.47% to 2.89%
|
|
Dividend yield
|
—
|
|
Volatility factor
|
121% to 324%
|
|
Term
|
5.5 - 10 Years
|
|
Stock option activity for options granted under the 2017 Plan during the
nine months ended September 30, 2018
is presented in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares Available
|
|
Number of Options Outstanding
|
|
Weighted-average Exercise Price
|
|
Weighted-average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value (in Thousands)
|
Outstanding at July 31, 2017
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
Total shares authorized
|
400,000
|
|
|
—
|
|
|
—
|
|
|
|
|
|
Granted
|
(214,000
|
)
|
|
214,000
|
|
|
$
|
37.62
|
|
|
9.71
|
|
|
Exercised
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
Forfeited
|
40,000
|
|
|
(40,000
|
)
|
|
$
|
49.93
|
|
|
|
|
|
Balance at December 31, 2017
|
226,000
|
|
|
174,000
|
|
|
$
|
34.78
|
|
|
9.71
|
|
|
Annual additional options authorized
|
101,431
|
|
|
—
|
|
|
—
|
|
|
|
|
|
Granted
|
(188,550
|
)
|
|
188,550
|
|
|
$
|
23.49
|
|
|
|
|
|
Exercised
|
—
|
|
|
—
|
|
|
—
|
|
|
|
|
|
Forfeited
|
27,000
|
|
|
(27,000
|
)
|
|
$
|
24.84
|
|
|
|
|
|
Balance at September 30, 2018
|
165,881
|
|
|
335,550
|
|
|
$
|
29.24
|
|
|
9.18
|
|
$
|
50
|
|
A summary of the status of the Company’s non-vested options granted under the 2017 Plan as of September 30, 2018 and changes during the
nine months ended September 30, 2018
are presented in the following table:
|
|
|
|
|
|
|
|
|
Number of Shares
|
|
Weighted Average Grant Date Fair Value Per Share
|
Non-vested at December 31, 2017
|
174,000
|
|
|
$
|
34.78
|
|
Granted
|
188,550
|
|
|
$
|
23.19
|
|
Forfeited
|
(27,000
|
)
|
|
$
|
24.84
|
|
Balance at September 30, 2018
|
335,550
|
|
|
$
|
29.07
|
|
Vested
|
(42,500
|
)
|
|
35.01
|
|
Non-vested at September 30, 2018
|
293,050
|
|
|
$
|
28.21
|
|
During the
nine months ended September 30, 2018
and 2017, the Company recognized approximately
$3.9 million
and
$362,986
of non-cash expense related to options granted under the 2017 Plan. As of September 30, 2018, there was approximately
$4.5 million
of unrecognized compensation costs related to non-vested stock options that were granted under the 2017 Plan.
Warrants
During the
nine months ended September 30, 2018
, the Company did
no
t issue any warrants.
Warrant activity for the
nine months ended September 30, 2018
is presented in the table below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares
|
|
Weighted- average Exercise Price
|
|
Weighted- average Remaining Contractual Term (years)
|
|
Aggregate Intrinsic Value (in Thousands)
|
Outstanding at December 31, 2017
|
357,010
|
|
|
$
|
9.78
|
|
|
5.57
|
|
$
|
4,708
|
|
Exercised
|
(3,400
|
)
|
|
$
|
10.00
|
|
|
|
|
|
|
Outstanding at September 30, 2018
|
353,610
|
|
|
$
|
9.78
|
|
|
4.85
|
|
$
|
2,857
|
|
Exercisable at September 30, 2018
|
353,610
|
|
|
$
|
9.78
|
|
|
4.85
|
|
$
|
2,857
|
|
Note 9. Commitments
The Company has entered into various agreements related to its business activities. The following is a summary of the Company’s commitments:
Torreya Agreement
On December 18, 2014, the Company entered into a consulting agreement with Torreya (the "2014 Agreement"), a financial advisory firm, under which Torreya agreed to provide financial advisory services with regard to the License Agreement. The 2014 Agreement also requires the Company to pay an additional fee equivalent to
3.75%
of all amounts received by the Company in excess of
$3.0 million
, in perpetuity.
On April 25, 2016, the Company entered into a consulting agreement with Torreya, under which Torreya agreed to provide financial advisory services for financing activities. In exchange for these services, the Company is required to pay a fee on all funding received by the Company as a result of assistance provided by Torreya. Torreya’s fee would be equal to
5%
of gross funding received by the Company up to
$20 million
plus
3.5%
of any proceeds received in excess of
$20 million
.
On September 8, 2017, the Company and Torreya entered into the Supplemental Engagement Letter to provide financial advisory services with respect to the licensing of the intellectual property rights to develop and commercialize certain products with Adapt. The revised engagement amends total consideration as follows: (i) an aggregate of
$300 thousand
in cash payments to be paid by the Company to Torreya in
three
equal installments over a
16
-month period; (ii) shares of Common Stock, equal to an aggregate value of
$300 thousand
, to be issued by the Company to Torreya in
three
equal installments over a
16
-month period; (iii) if the Earn Out Milestone Payment is paid under the SWK Agreement, approximately
$140.6 thousand
, or
3.75%
of the Earn Out Milestone Payment (as defined in the SWK Agreement), shall be paid by the Company to Torreya within
15 days
of the date that the Earn Out Milestone (as defined in the SWK Agreement) has been paid to the Company; (iv) once SWK has received the Capped Royalty Amount, if the Earn Out Milestone Payment (as defined in the SWK Agreement) is paid, Torreya shall receive
3.375%
of the Total Consideration (as defined in the 2014 Agreement) received thereafter or
3.5625%
of the Total Consideration received thereafter if no generic version of NARCAN is commercialized prior to the
six
th anniversary of the Closing Date (as defined in the SWK Agreement) as per the terms of the SWK Agreement; and (v) once SWK has received the Capped Royalty Amount, if the Earn Out Milestone Payment has not been paid, Torreya shall receive
3.45525%
of the Total Consideration received thereafter or
3.602625%
of the Total Consideration received thereafter if no generic version of NARCAN is commercialized prior to the
six
th anniversary of the Closing Date as per the terms of the SWK Agreement. Payments made by the Company in the form of shares of Common Stock will be a defined number of shares calculated based upon the average closing price of the Common Stock for the
ten
trading days prior to the relevant date for the payment. On September 23, 2017, the Company issued
3,283
shares of its Common Stock to Torreya as payment for
$100 thousand
of fees owed by the Company to Torreya. The Company valued these shares at
$40.58
per share, or approximately
$133 thousand
in the aggregate, which represents the closing price of the Company's Common Stock on September 22, 2017.
The Company had
$639 thousand
recorded as a liability as of December 31, 2017. For the nine months ended September 30, 2018 the Company made payments to Torreya totaling
$344 thousand
representing
3.375%
of the milestone payments the Company received from Adapt during for the same period. As of September 30, 2018, the Company had a liability of
$338 thousand
owed to Torreya as a current liability, because it was due and payable to Torreya within 12 months of September 30, 2018.
During the three months ended September 30, 2018, the Company recorded
$66 thousand
of expense related to Torreya. The Company recorded
$0 thousand
and
$412 thousand
of fees for the three and nine months ended September 30, 2017.
Exclusive License and Collaboration Agreement
On November 19, 2015, the Company issued
14,327
shares of unregistered Common Stock upon the execution of a binding letter of intent to agree to negotiate and enter into an exclusive license agreement and collaboration agreement (“LOI”) with a pharmaceutical company with certain desirable proprietary information. The shares issued in this transaction were valued using the stock price at issuance date and amounted to approximately
$120.3 thousand
. Pursuant to the LOI, the Company is obligated to issue up to an additional
92,634
shares of unregistered Common Stock upon the occurrence of various milestones. A total of
3,582
shares had been issued as of July 31, 2016 due to achievement of certain milestones. On November 10, 2016, the Company issued an additional
14,327
shares of unregistered Common Stock pursuant to the LOI. The shares issued in this transaction were valued using the stock price at issuance date and amounted to approximately
$85.1 thousand
. On March 16, 2017, the Company issued an additional
10,745
shares of unregistered Common Stock pursuant to the LOI. The Company was obligated to issue these shares upon the
one year
anniversary of receipt by the Company of a milestone payment from Adapt for the first commercial sale of the Company’s product, NARCAN, in the U.S. The shares issued on March 16, 2017 were valued on the date of issuance using the March 16, 2017 closing price of the Company’s Common Stock of
$7.75
per share, which resulted in an aggregate value of approximately
$83.3 thousand
. The Company expensed the entire
$83.3 thousand
as non-cash expense during the three months ended March 31, 2017.
As of March 31, 2018, the Company was required to issue an additional
37,866
shares of its unregistered Common Stock pursuant to the LOI. The Company was obligated to issue these shares on the receipt of cumulative royalty payments of
$2 million
from Adapt and milestone payments from Adapt with respect to first achieving the milestones of the first
$30 million
,
$40 million
,
$55 million
and
$75 million
of Net NARCAN Sales. The shares that were issuable as of March 31, 2018, were valued using the March 29, 2018 closing stock price of the Company's Common Stock of
$19.18
per share, which resulted in an aggregate value of approximately
$726 thousand
. On April 19, 2018 the Company issued
37,866
shares of Common Stock. For the nine months ended September 30, 2018 the Company recorded total non-cash expense of
$776 thousand
, of which
$726 thousand
was recorded to research and development expense and
$50 thousand
was recorded to other expense.
Heroin In-License Vaccine
In October 2016, the Company in-licensed a heroin vaccine from the Walter Reed Army Institute of Research ("Walter Reed"). In consideration for the license the Company agreed to pay a royalty of
3%
of net sales if the Company commercializes the vaccine, or
4%
if the vaccine is sublicensed. In addition, the Company agreed to pay a minimum annual royalty of
$10 thousand
, as well as fixed payments of up to approximately
$715.7 thousand
if all of the specified milestones are met. The Company paid
$60 thousand
in cash to Walter Reed, of which
$50 thousand
was a non-recurring execution fee and the remaining
$10 thousand
was the minimum annual royalty for the period of September 2017 through August 2018. The
$10 thousand
minimum annual royalty was recorded as a prepaid expense and is being expensed at the rate of
$833
per month, beginning in September 2017 and ending in August 2018. The Company recorded
$5 thousand
in expense during the nine months ended September 30, 2018. There was
no
expense recorded during the nine months ended September 30, 2017.
Supply Agreement
On June 22, 2017, the Company entered into a license agreement (the "License Agreement") and a related supply agreement (the “Supply Agreement”) with Aegis Therapeutics LLC ("Aegis") pursuant to which the Company was granted an exclusive license (the “License”) to Aegis’ proprietary chemically synthesizable delivery enhancement and stabilization agents, including, but not limited to, Aegis’ Intravail® absorption enhancement agents, ProTek® and HydroGel® (collectively, the “Technology”) to exploit (a) the Compounds (as such are defined in the License Agreement) and (b) a product containing a Compound and formulated using the Technology (“Product”), in each case of (a) and (b) for any and all purposes. The License Agreement restricts the Company's ability to manufacture any Aegis excipients included in the Technology (“Excipients”), except for certain instances of supply failure, supply shortage or termination of the Supply Agreement, and the Company shall obtain all supply of such Excipients from Aegis under the Supply Agreement. The License Agreement also restricts Aegis’s ability to compete with the Company worldwide with respect to the Exploitation (as defined in the License Agreement) of any therapeutic containing a Compound or derivative or active metabolite of a Compound without the Company's prior written consent. The effective date of the License Agreement and the Supply Agreement is January 1, 2017.
As consideration for the grant of the License, the Company paid Aegis
two
immaterial upfront payments, of which the Company paid
50%
by issuing the Company's Common Stock to Aegis, with the number of shares issued equal to
75%
of the average closing price of the Company's Common Stock over the
20
trading days preceding the date of payment. The License Agreement also provides for (A) additional developmental milestone payments for each Product containing a different Compound equal to up to an aggregate of
$1.8 million
, (B) additional commercialization milestone payments for each Product containing a different Compound equal to up to an aggregate of
$5.0 million
, and (C) single low digit royalties on the Annual Net Sales (as defined in the License Agreement) of all Products during the Royalty Term (as defined in the License Agreement) according to a tiered royalty rate based on Annual Net Sales of the Products by the Company, the Company's sublicensees and affiliates. The Company shall also pay to Aegis a sublicense fee based on a sublicense rate negotiated in good faith by the parties. The License
Agreement contains customary representations and warranties, ownership, patent rights, confidentiality, indemnification and insurance provisions. The License Agreement shall expire upon the expiration of the Company's obligation to pay royalties under such License Agreement; provided, however, that the Company shall have the right to terminate the License granted on a Product-by-Product or country-by-country basis upon
30
days’ prior written notice to Aegis. For the nine months ended September 30, 2018, the Company recorded
$125 thousand
of expense associated with the License Agreement.
Under the terms of the Supply Agreement, Aegis shall deliver to the Company any preclinical, clinical and commercial supply of the Excipients, which Aegis sources from various contract manufacturers. The Supply Agreement has a term of
20 years
but shall terminate automatically in the event of expiration or termination of the License Agreement or at any time upon the written agreement of both parties. The Supply Agreement contains customary provisions relating to pricing for such materials, forecasts, delivery, inspection, indemnification, insurance and representations, warranties and covenants. The Supply Agreement includes technology transfer provisions for the transfer of all materials and know-how specific to the manufacturing of the Excipients that is necessary or useful for the Company to manufacture such Excipients. The Company does not have the right to manufacture such Excipients except in the event that Aegis is unable to supply and sell any portion of the material to the Company (subject to a
60
-day cure period).
Research and Development Agreement
On July 14, 2017, Renaissance Lakewood, LLC (“Renaissance”) and the Company entered into a Research and Development Agreement (the “Renaissance Agreement”). Under the Renaissance Agreement, Renaissance will perform product development work on a naltrexone multi-dose nasal product for the treatment of alcohol use disorder pursuant to the terms set forth in a proposal agreed upon by the parties. The Company will bear the costs of all development services, including all raw materials and packaging components, in connection with the performance of the development work under the Renaissance Agreement and in accordance with financials agreed upon through the proposal. Renaissance will conduct quality control and testing, including non-stability, stability, in-use, raw material, and packaging component testing as part of the services provided to the Company under the Renaissance Agreement. The Company will own all formulations provided to Renaissance and any formulations developed in connection with the Renaissance Agreement. Renaissance will own all know-how developed in connection with the performance of the services that is not solely related to a product. The Company has the right to seek patent protection on any invention or know-how that relates solely to a product developed under the Renaissance Agreement or any our formulation, excluding general manufacturing or product development know-how of Renaissance. The Renaissance Agreement is effective until terminated by either party in accordance with its terms. The Company or Renaissance may terminate the project under a proposal to the Renaissance Agreement due to unforeseen circumstances in the development. The Renaissance Agreement may be terminated by the Company, with or without cause, upon
45 days
' written notice. There are also mutual customary termination provisions relating to uncured breaches of material provisions. The Company had previously purchased approximately
$100 thousand
of research and development supplies in relation to the Renaissance Agreement (see Note 3 - Prepaid Expenses and Other Current Assets). During the nine months ended September 30, 2018, the Company recorded expense in the amount of
$396 thousand
related to the product development work.
Separation Agreement
On September 5, 2017, the Company accepted, effective September 11, 2017 (the “Separation Date”), the resignation of Kevin Pollack as (i) the Company’s Chief Financial Officer, Treasurer and Secretary, and (ii) a director of Opiant Pharmaceuticals UK Limited, a wholly owned subsidiary of the Company. On September 5, 2017, the Company and Mr. Pollack entered into a Separation Agreement and General Release (the “Separation Agreement”), with such agreement becoming effective on September 12, 2017 (the "Separation Agreement Effective Date"), which represents the date on which Mr. Pollack's
seven
-day revocation period expired.
Pursuant to the terms of the Separation Agreement, Mr. Pollack received (i) a payment equal to approximately
$1.13 million
relating to certain accrued obligations, payable in a cash lump sum within
three
business days following the Separation Agreement Effective Date; and (ii) a separation payment equal to approximately
$1.44 million
, payable in
one
or
two
installments in accordance with the terms set forth therein. Mr. Pollack also retained previously granted options to purchase, in the aggregate,
948,000
shares of Common Stock of the Company, which options are fully vested and exercisable. Except as set forth in the Separation Agreement, all other options held by Mr. Pollack were forfeited. Additionally, for a period of no more than
12 months
following the Separation Date, Mr. Pollack will cooperate as an adviser with the Company in connection with matters arising out of Mr. Pollack’s service with the Company, in accordance with the terms set forth in the Separation Agreement.
During September 2018, the Company paid
$962 thousand
to Mr. Pollack which represents the final amount due pursuant to the terms of the Separation Agreement.
Facility Leases
The Company’s headquarters through August 31, 2017 were located on the 12
th
Floor of 401 Wilshire Blvd., Santa Monica, CA 90401 and were leased for
$5,056
per month. The lease with Premier Business Centers, LLC (“Premier”), was terminated by the Company effective September 30, 2017. On May 29, 2017, the Company entered into a Sublease (the “Sublease”) with Standish Management, LLC to sublease office space located at 201 Santa Monica Boulevard, Suite 500, Santa Monica, CA 90401. Per the terms of the Sublease, the term commenced on August 1, 2017 and will end on August 31, 2018. The monthly rent for August 2017 was
$5,000
and the monthly rent for the duration of the term is
$9,000
, plus any related operating expenses and taxes. Commencing September 1, 2017, the Company’s headquarters are located at this location.
On April 20, 2017, the Company entered into an Office Service Agreement (the “Office Service Agreement”) with Regus to lease office space at 83 Baker Street, London, England, W1U 6AG. Per the terms of the Office Service Agreement, the first month’s rent is
£2,473
with monthly rental payments of
£7,521
thereafter. The Company was required to pay a security deposit of
£15,042
, which is the equivalent of
two months
of rent. The Office Service Agreement commenced on May 22, 2017 and effective May 31, 2018 continues on a month-to-month basis with either party being able to terminate the agreement by providing
three months
' advance written notice of termination.
During the nine months ended September 30, 2018, the Company incurred approximately
$226 thousand
of rent expense as compared to approximately
$131 thousand
during the nine months ended September 30, 2017.
Note 10. Subsequent Events
From October 1, 2018 through November 5, 2018 the Company issued
39,113
shares of its Common Stock related to stock option exercises.
On October 25, 2018, Emergent BioSolutions’ Adapt subsidiaries and Opiant (collectively, the “Plaintiffs”) filed a complaint for patent infringement against Perrigo UK FINCO Limited Partnership (“Perrigo”) in the United States District Court for the District of New Jersey arising from Perrigo’s Abbreviated New Drug Application ("ANDA") filing with the FDA. As a result of timely filing the lawsuit in accordance with the Hatch-Waxman Act, a
30
-month stay of approval will be imposed by the FDA on Perrigo’s ANDA, which is expected to remain in effect until March 2021 absent an earlier judgment, unfavorable to the Plaintiffs, by the Court. The Plaintiffs seek, among other relief, an order that the effective date of FDA approval of the ANDA be a date no earlier than the expiration of each of the Patents-In-Suit, as well as equitable relief enjoining Perrigo from infringing these patents, and monetary relief as a result of any such infringement. Emergent BioSolution Inc. continues to vigorously enforce the intellectual property portfolio related to NARCAN
®
Nasal Spray.
On October 29, 2018 Craig Collard joined the Board of Directors of the Company. Mr. Collard will serve as a Class I director, with a term expiring at the annual meeting of stockholders to be held in 2021. Mr. Collard will serve on the Audit Committee and Nominating and Corporate Governance Committee of the Board. In addition, the Board determined that Mr. Collard qualifies as independent under the rules of the Nasdaq Stock Market.