OPIANT PHARMACEUTICALS, INC. The interim consolidated financial statements included in this Quarterly Report on Form 10-Q (this "Report") and this Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto in this Report, and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, contained in the Company's Form 10-K for the year endedDecember 31, 2021 (the "Form 10-K"). In addition to historical information, this discussion and analysis contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). These forward-looking statements are subject to risks and uncertainties, including those set forth in Part II - Other Information, Item 1A and in the Form 10-K. Risk Factors below and elsewhere in this Report could cause actual results to differ materially from historical results or anticipated results. Overview We are a specialty pharmaceutical company developing medicines for addiction and drug overdose. We developed NARCAN® (naloxone hydrochloride) Nasal Spray ("NARCAN®"), a treatment to reverse opioid overdose. This product was conceived and developed by us, licensed to Adapt now a wholly owned Subsidiary of EBS, inDecember 2014 and approved by the FDA inNovember 2015 . We have not consistently attained profitable operations and have historically depended upon obtaining sufficient financing to fund our operations. We anticipate if revenues are not sufficient, then additional funding will be required in the form of debt financing and/or equity financing from the sale of our Common Stock, and/or financings from the sale of interests in our prospective products and/or royalty transactions. However, we may not be able to generate sufficient revenues or raise sufficient funding to fund our operations. We have not had a bankruptcy, receivership or similar proceeding. We are 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.
Merger
OnNovember 14, 2022 , we announced that we have entered into a definitive merger agreement under whichIndivior Inc. , a subsidiary of Indivior PLC, ("Indivior") will acquire us for an upfront consideration of$20.00 per share, in cash (approximately$145 million in the aggregate), plus up to$8.00 per share in non-tradable contingent value rights ("CVRs") that may become payable in the event that certain net revenue milestones are achieved by OPNT003 after its approval and US commercial launch. Pursuant to the CVRs, Indivior would pay$2.00 per CVR if OPNT003 achieves the following net revenue thresholds during any period of four consecutive quarters prior to the seventh anniversary of the US commercial launch: (i)$225 million , (ii)$300 million , and (iii)$325 million . The remaining$2.00 per CVR would be paid if OPNT003 achieves net revenue of$250 million during any period of four consecutive quarters prior to the third anniversary of the US commercial launch. The maximum amount payable by Indivior should OPNT003 achieve all four CVRs would be approximately$67 million . The transaction is subject to customary closing conditions, includingU.S. antitrust clearance, clearance by theCommittee on Foreign Investment inthe United States , resolution of any investigation by theUK antitrust authority, and receipt of approval of our stockholders. Pending approvals, we anticipate completing the transaction in the first quarter of 2023.
The merger agreement has been unanimously approved by our board of directors
Plan of Operation
During the fiscal year endingDecember 31, 2022 , we plan to continue to focus on developing medicines in our product pipeline for Opioid Overdose Reversal ("OOR"), Alcohol Use Disorder ("AUD"), and Acute Cannabinoid Overdose ("ACO"). Our lead development product is OPNT003 - Nasal Nalmefene for OOR, which is further described below.
OPNT003 - Nasal Nalmefene for OOR
In 2017, NIH leadership called for the development of stronger,
longer-acting formulations of antagonists to counteract the very high potency
synthetic opioids that are now claiming thousands of lives each year. We are
pursuing a 505(b)(2) development path for OPNT003, with the potential to submit
an NDA for the drug and intranasal delivery device combination in the second
half of 2022. Nalmefene for injection was previously approved by the FDA for
treating suspected or confirmed opioid overdose. The 505(b)(2) pathway allows
companies to rely in part on the FDA's findings of safety and efficacy for a
previously approved product and to supplement these findings with a more limited
set of their own studies to
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--------------------------------------------------------------------------------satisfy FDA requirements, as opposed to conducting the full array of preclinical and clinical studies that would typically be required.
InFebruary 2021 , the first subjects were dosed in a confirmatory pharmacokinetic ("PK") study for OPNT003, nasal nalmefene, for the treatment of opioid overdose. InJuly 2021 , we announced positive top-line results from the study. The study was conducted in 68 healthy subjects and compared OPNT003, nasal nalmefene, with an intramuscular nalmefene hydrochloride injection, 1 mg, which was the comparator previously agreed upon with the FDA.
In
In
InFebruary 2022 , we announced positive topline results from a multi-dose PK study for OPNT003, nasal nalmefene, for the treatment of opioid overdose. The crossover design study was conducted in 23 healthy subjects comparing the PK profile, safety, and tolerability of OPNT003 when given as a single 3mg dose in one nostril, as a single dose in each nostril, and as two doses in one nostril. In April of 2022, we announced positive top-line results from our head-to-head PD study comparing OPNT003, nasal nalmefene, to nasal naloxone. A preliminary analysis of the 50 subjects who received both study drugs found that treatment with OPNT003, nasal nalmefene, produced a greater reversal of respiratory depression that was nearly twice that produced by nasal naloxone at the primary endpoint, five minutes post dosing. The increases in minute ventilation were 5.745 L/min and 3.011 L/min, with nalmefene and naloxone, respectively. OPNT003 met the primary endpoint of non-inferiority, which was designed to assess whether nasal nalmefene performed as well as nasal naloxone. Completion of the PD study concludes the planned clinical development program for OPNT003. In May of 2022, we received minutes for the pre-NDA meeting held with the FDA onMarch 30, 2022 . As a feature of the Fast Track designation we received in November of 2021, the FDA noted that our NDA will qualify for a rolling review. However, the FDA cautioned that if it accepts a portion of the application, this does not necessarily mean that review will commence or proceed before the complete application is submitted. Actual commencement and scheduling of review depends on many factors, including staffing, workload, competing priorities, timeline for completing the application, and the perceived efficiency of commencing review before receipt of the complete submission.
In June of 2022, we announced the submission of the first module of the NDA. We intend to complete the submission of the NDA in the fourth quarter of 2022.
Intellectual Property for OPNT003
OnAugust 2, 2022 , we announced that theU.S. Patent and Trademark Office has issued a Notice of Allowance forU.S. Patent Application No. 16/461,354, with formulation and method of use claims around OPNT003, our investigational treatment for opioid overdose. The allowed patent application, entitled,"Compositions and Methods for the Treatment of Opioid Overdose," includes claims covering combinations of nalmefene and Intravail® in a nasal formulation.
On
Market and Commercial potential for OPNT003
There is a large and growing addressable market for opioid overdose
reversal agents driven by sales into community based and first responder
institutions, as well as directly to patients via pharmacies. The current
addressable market is substantial, to ensure an opioid overdose reversal agent
is available for all first responders, including fire departments, emergency
medical services, federal law enforcement, local law enforcement, and other
community groups. The co-prescribing of opioid overdose reversal agents
alongside prescription opioids has also driven growth. It is estimated that only
five percent of patients at higher risk of an opioid overdose have a naloxone
prescription. Currently there are only twelve states that have some form of
mandatory co-prescription legislation in place, however several states are
considering co-prescribing legislation in the near future.
We have full commercial rights to OPNT003. We were awarded a grant of
approximately $7.4 million from the National Institutes of Health ("NIH"). The
grant provides us with additional resources for the ongoing development of
OPNT003. As of March 31, 2022 , we have completed all the work associated with
the $7.4 million grant. We have also received a contract for approximately $10.8
million from the Biological Advance Research and Development Agency
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("BARDA") to fund development of this project through NDA submission. BARDA has
awarded approximately $8.7 million of the contract through June 30, 2022 , and
the remaining amount of $2.1 million was awarded August 2, 2022 .
As we continue to advance OPNT003 towards market approval and should we
self-commercialize the product, we anticipate that our sales and marketing
expenses will increase in several areas to support the development of a
commercial platform that would allow us to commercialize OPNT003, as well as
future pipeline products. The development of this commercial infrastructure
includes increasing commercial personnel, pre-launch sales and marketing
planning activities, establishing the supply chain and distribution. As we build
this infrastructure, we are continuing to evaluate the ideal go-to-market
strategy that will allow us to maximize the full commercial potential of OPNT003
and shareholder value.
NARCAN® Royalties
We developed NARCAN®, a treatment to reverse opioid overdose. This product was
conceived and developed by us, licensed to Adapt, an Ireland based
pharmaceutical company in December 2014 and approved by the FDA in November
2015 . Emergent BioSolutions, Inc. ("EBS") acquired Adapt in October of 2018 and
Adapt became its wholly owned subsidiary. In exchange for licensing our
treatment to Adapt ("Adapt Agreement"), we receive up to double-digit percentage
royalties on net sales.
On
As provided under the Adapt agreement, in each subsequent quarter after the
launch of a generic version of Narcan®, if aggregate net NARCAN® sales,
including net sales of an authorized generic, on a country-by-country basis are
less than seventy percent of the aggregate net NARCAN® sales in the last full
calendar quarter immediately preceding the date on which a generic product was
first launched in such country, then the royalty rate for that quarter is
reduced to two percent ("the Generic Reduction Clause"). This calculation is
completed separately each quarter.
On November 13, 2022 , we entered into an agreement with EBS, whereby we will
receive a one-time cash payment from EBS of $25.0 million , which includes the
10% owned by SWK Holdings, LLC , and in exchange we will grant EBS a worldwide,
sublicensable, irrevocable, perpetual, fully paid, exclusive license for NARCAN®
Nasal Spray, and to the licensed patents and licensed know-how. Our rights under
the License Agreement , dated as of December 15, 2014 , and as amended from time
to time, to receive any unpaid or future payments under the License Agreement,
including royalties related to Net Sales of Products, including Narcan® Nasal
Spray, has terminated upon the effective date of this agreement. The November
13, 2022 agreement with EBS, including the payment, also resolves the Default
Notice delivered by us to EBS on August 10, 2022 .
Debt Financing
OnDecember 10, 2020 (the "Closing Date"), we entered into a Note Purchase and Security Agreement (the "Loan Agreement") with a syndicate of Pontifax Medison Finance, a healthcare-dedicated venture and debt fund, and Kreos Capital VI (Expert Fund ) LP (collectively, the "Lender"). The Loan Agreement provides for term loans in an aggregate principal amount of up to$50.0 million in three tranches as follows: (a) on the Closing Date, a loan in the aggregate principal amount of$20.0 million , (b) upon the submission of a New Drug Application with theU.S. Food and Drug Administration , a loan in the aggregate principal amount of$10.0 million , and (c) upon FDA approval of an opioid overdose product, a loan in the aggregate principal amount of$20.0 million (each a "Loan, and collectively, the "Loans"). The outstanding principal of each term Loan bears an average interest rate of 8.75% per annum based on the date of issuance and a year consisting of 365 days. There is an interest-only period of 30 months, with interest on outstanding Loans payable on a quarterly basis based on the principal amount outstanding during the preceding quarter. After the interest-only period, principal of the outstanding Loans is payable in ten equal quarterly installments. All Loans have a maturity date ofOctober 1, 2025 .
Each Lender may, at its option, elect to convert up to half of the
then-outstanding Loans and all accrued and unpaid interest thereon into shares
our Common Stock. The "Conversion Price" shall be
On
Financing
OnAugust 13, 2021 , we entered into a Controlled Equity OfferingSM (the "Sales Agreement") withCantor Fitzgerald & Co. ("Cantor"), as agent, pursuant to which we may offer and sell, from time to time through Cantor, shares of our Common 23 -------------------------------------------------------------------------------- Stock. During the nine months endedSeptember 30, 2022 we sold shares of Common Stock under the Sales Agreement, and raised net proceeds of approximately$538 thousand . Historically, we have funded our operations with royalty and milestone revenue received from net sales of NARCAN® by EBS, payments from grants and contract revenue withNIH and BARDA, the sale of our common stock, and from our debt facility. We will need to raise additional capital to commercialize our lead product OPNT003, and to provide additional working capital to fund our business. We have$30.0 million available to be borrowed on our debt facility,$10.0 million of which may be drawn upon the submission of a New Drug Application with theU.S. Food and Drug Administration , and$20.0 million of which may be drawn upon FDA approval of an opioid overdose product. If necessary, we are able to sell additional Common Stock under the Sales Agreement or other equity offerings using our effective S-3 shelf registration statement. After considering our current cash position of$35.4 million atSeptember 30, 2022 , and the above sources of available capital, including the payment from EBS of$22.5 million inNovember 2022 , we believe we have sufficient resources to sustain operations through at least the next 12 months from the date of the filing of this Quarterly Report on Form 10-Q. 24 --------------------------------------------------------------------------------
Results of Operations
The following table sets forth the results of operations for the periods shown
(in thousands):
For the Three Months Ended September 30, For the Nine Months Ended September 30,
2022 2021 Increase 2022 2021 Increase
(Decrease) (Decrease)
Royalty revenue $ - $ 14,041 $ (14,041) $ 4,520 $ 27,689 $ $ (23,169)
Grant and contract revenue 174 2,298 (2,124) 4,018 6,296 (2,278)
Total revenue 174 16,339 (16,165) 8,538 33,985 (25,447)
Operating expenses
General and administrative 3,073 3,379 (306) 11,416 8,759 2,657
Research and development 4,134 4,881 (747) 20,873 12,119 8,754
Sales and marketing 2,597 1,060 1537 8,089 3,080 5,009
Royalty expense - 3,059 (3059) 943 6,145 (5,202)
Total operating expenses 9,804 12,379 (2575) 41,321 30,103 11,218
Income (loss) from operations (9,630) 3,960 (13590) (32,783) 3,882 (36,665)
Other income (expense)
Interest income 160 3 157 228 10 218
Interest expense (391) (546) 155 (1,213) (1,626) 413
Loss on sale of assets (49) - (49) (49) (49)
Gain (loss) on foreign exchange 2 - 2 17 (10) 27
Total other income (expense) (278) (543) 265 (1,017) (1,626) 609
Income (loss) before income taxes (9,908) 3,417 (13325) (33,800) 2,256 (36,056)
Income tax (expense) (9) - (9) (41) - (41)
Net income (loss) $ (9,917) $ 3,417 $ $ (13,334) $ (33,841) $ 2,256 $ $ (36,097) Comparison of Three Months ended
Revenues We recognized$0.2 million of revenue during the three months endedSeptember 30, 2022 , compared to$16.3 million for the three months endedSeptember 30, 2021 . For the three months endedSeptember 30, 2022 , we recognized$0.2 million from grant and contract revenue, and we recorded no royalty revenue as our license agreement with EBS has been terminated (see Note 13). For the three months endedSeptember 30, 2021 , we recognized$14.0 million of revenue from our license agreement with EBS and$2.3 million from grant and contract revenue.
General and Administrative Expenses
Our general and administrative expenses for the three months endedSeptember 30, 2022 decreased by$0.3 million to$3.1 million from$3.4 million for the three months endedSeptember 30, 2021 . Our fees associated with net sales of NARCAN® by EBS decreased by approximately$0.5 million , partially offset by increased personnel and related expense including stock based compensation of$0.1 million and increased legal fees of$0.1 million for the three months endedSeptember 30, 2022 compared to the three months endedSeptember 30, 2021 .
Research and Development Expenses
Our research and development expenses for the three months endedSeptember 30, 2022 decreased by$0.8 million to$4.1 million , from$4.9 million for the three months endedSeptember 30, 2021 . External development expense decreased by$1.1 million primarily due to decreased activity on our lead product candidate, OPNT003 - Nasal Nalmefene for OOR, which was partially offset by an increase in personnel and related expense including stock based compensation of$0.3 million . 25 --------------------------------------------------------------------------------
Sales and Marketing Expenses
Our sales and marketing expenses for the three months endedSeptember 30, 2022 increased by$1.5 million to$2.6 million from$1.1 million for the three months endedSeptember 30, 2021 . Personnel and related expense including stock based compensation increased by$0.4 million and external third party expenses related to pre-commercial activities increased by$1.1 million .
Royalty Expenses
We did not recognize royalty expenses for the three months endedSeptember 30, 2022 . We recognized$3.1 million for the three months endedSeptember 30, 2021 . The decrease of$3.1 million is attributable to there being no royalty revenue recorded from net sales of NARCAN® by EBS during the quarter endedSeptember 30, 2022 (see Note 13). Other Income (expense)
During the three months ended
Comparison of Nine Months ended
Revenues
We recognized$8.5 million of revenue during the nine months endedSeptember 30, 2022 , compared to$34.0 million for the nine months endedSeptember 30, 2021 . For the nine months endedSeptember 30, 2022 we recognized approximately$4.5 million of revenue from our license agreement with EBS and$4.0 million from grant and contract revenue. For the nine months endedSeptember 30, 2021 , we recognized$27.7 million of revenue from our license agreement with EBS and$6.3 million from grant and contract revenue.
General and Administrative Expenses
Our general and administrative expenses increased by$2.6 million to approximately$11.4 million during the nine months endedSeptember 30, 2022 compared to$8.8 million for the nine months endedSeptember 30, 2021 . Personnel and related expense including stock based compensation increased by$2.5 million , and legal and other fees increased by$0.1 million for the nine months endedSeptember 30, 2022 compared to the nine months endedSeptember 30, 2021 .
Research and Development Expenses
Our research and development expenses during the nine months endedSeptember 30, 2022 increased by$8.8 million to$20.9 million , compared to$12.1 million for the nine months endedSeptember 30, 2021 . Our external development expense increased by$6.7 million primarily due to increased activity on our lead product candidate, OPNT003 - Nasal Nalmefene for OOR, and personnel and related expense including stock based compensation increased by$2.1 million .
Sales and Marketing Expenses
Our sales and marketing expenses for the nine months endedSeptember 30, 2022 increased by$5.0 million to$8.1 million from$3.1 million for the nine months endedSeptember 30, 2021 . Personnel and related expense including stock based compensation increased by$2.4 million , and external third party expenses related to pre-commercial activities increased by$2.6 million .
Royalty Expenses
Our royalty expenses were$0.9 million and$6.1 million during the nine months endedSeptember 30, 2022 and 2021, respectively. The decrease of$5.2 million is attributable to the decrease in net royalty revenue recorded from sales of NARCAN® by EBS.
Other Income (expense)
During the nine months endedSeptember 30, 2022 , interest income was$227.8 thousand compared to interest income of$10.3 thousand for the nine months endedSeptember 30, 2021 , which primarily resulted from an increased rate of return on our invested cash balances.
During the nine months ended
Liquidity and Capital Resources
Cash Flows
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--------------------------------------------------------------------------------The following table sets forth the primary sources and uses of cash for each of the periods presented below:
Nine Months Ended September 30,
(in thousands) 2022 2021
Net cash used in operating activities $ (17,469) $ (77)
Net cash provided by (used in) investing activities $ 14,596 $ (15,045)
Net cash provided by financing activities $ 636 $ 2,162 Net cash used in operating activities
During the nine months endedSeptember 30, 2022 , net cash used in operating activities was$17.5 million , which was primarily due to the net loss of$33.8 million , offset by changes in operating assets and liabilities of$11.2 million , and by stock based compensation expense of$4.6 million , and other non-cash expenses totaling$0.5 million .
During the nine months ended
Net cash used in investing activities
During the nine months ended
During the nine months ended
Net cash provided by financing activities
During the nine months ended
During the nine months ended
Critical Accounting Policies and Estimates
We believe that the following critical policies affect our significant judgments and estimates used in preparation of our financial statements.
We prepare our financial statements in conformity with accounting principles generally accepted inthe United States of America ("GAAP"). These principals require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management believes that these estimates are reasonable and have been discussed with the Board; however, actual results could differ from those estimates. We issue options and warrants to consultants, directors, and officers as compensation for services. These options and warrants are valued using the Black-Scholes option pricing model, which focuses on the current stock price and the volatility of moves to predict the likelihood of future stock moves. This method of valuation is typically used to accurately price stock options and warrants based on the price of the underlying stock. We capitalize our office space operating leases under ASC 842. We use best available information to determine the discount rate, which can have significant variability and requires management assessment and judgment.
Revenue Recognition
InMay 2014 , the FASB issued an accounting standard update ("ASU"), 2014-09, Revenue from Contracts with Customers (Topic 606). This ASU amends the existing accounting standards for revenue recognition and is based on the principle that revenue should be recognized to depict the transfer of goods or services to a customer at an amount that reflects the consideration a company expects to receive in exchange for those goods or services. OnJanuary 1, 2018 , we adopted the new Accounting Standards Codification ("ASC") 606, Revenue from Contracts with Customers using the modified retrospective method, and we determined the new guidance does not change our policy of revenue recognition. Our primary source of revenue is through the recognition of royalty and milestone payments from EBS. Milestone revenue is recognized upon successful accomplishment of certain sales targets set forth in the license agreement between us and EBS. Royalty revenue is determined based on the agreed upon royalty rate applied to NARCAN® sales reported by EBS. There are no 27 --------------------------------------------------------------------------------
performance obligations by us and we recognize revenue according to the royalty report provided to us by EBS on a quarterly basis.
InJune 2018 , the FASB issued guidance clarifying the revenue recognition and measurement issues for grants, contracts, and similar arrangements, ASU Topic 958. Government grants and contracts are agreements that generally provide cost reimbursement for certain types of expenditures in return for research and development activities over a contractually defined period. We evaluated our grant withNIH and contract with BARDA and determined they are non-exchange transactions and fall within the scope of ASU 958, and revenue should be recognized in accordance with Topic 958 guidance. Accordingly, we recognize revenue from our grant and contract in the period during which the related costs are incurred, provided that the conditions under which the grant and contract were provided have been met and only perfunctory performance obligations are outstanding. Licensing Agreement Pursuant to the license agreement between us and EBS, we provided a global license to develop and commercialize our intranasal naloxone opioid overdose reversal treatment, now known as NARCAN®. We receive payments upon reaching various sales and regulatory milestones, as well as royalty payments for commercial sales of NARCAN® generated by EBS.
Effect of Inflation
Inflation did not have a significant impact on our revenues, or income from continuing operations for the three months and nine months endedSeptember 30, 2022 andSeptember 30, 2021 .
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements.
Recent Accounting Pronouncements
We reviewed accounting pronouncements and interpretations thereof that have effectiveness dates during the periods reported and in future periods. We have carefully considered the new pronouncements that alter previous generally accepted accounting principles and do not believe that any new or modified principles will have a material impact on our reported financial position or operations in the near term. The applicability of any standard is subject to the formal review of our financial management and certain standards are under consideration. Those standards have been addressed in the notes to the condensed consolidated financial statements contained herein, and in the notes to the audited consolidated financial statements in the Annual Form 10-K and in the Form 10-K itself. Net Profit Interests NARCAN® We have entered into agreements with certain investors whereby, in exchange for funding for the research, development, marketing and commercialization of a product relating to our treatment to reverse opioid overdoses (the Opioid Overdose Reversal Treatment Product or OORTP), we provided such investors with an interest in any pre-tax profits received by us that were derived from the sale of the OORTP less any and all expenses incurred by and payments made by us in connection with the OORTP, including but not limited to an allocation of our overhead devoted by us to product-related activities, which allocation shall be determined in good faith by us (the "OORTP Net Profit").
A summary of the investor agreements is below, and categorized by investor:
In 2013, 2014 and 2015, we entered into a number of agreements with Potomac for funding from Potomac for the research, development, marketing and commercialization of the Opioid Overdose Reversal Treatment Product in the total amount of$2.25 million , in exchange for a 10.21% interest in the OORTP Net Profit in perpetuity (the "Potomac Agreement").
On
OnJuly 22, 2014 , we received a$3.0 million commitment from a foundation (the "Foundation") which later assigned its interest to Valour, from which we had the right to make capital calls from the Foundation for the research, development, marketing, commercialization and any other activities connected to the Opioid Overdose Reversal Treatment Product, certain 28 --------------------------------------------------------------------------------
operating expenses and any other purpose consistent with the goals of the Foundation. In exchange for funds invested by the Foundation, Valour currently owns a 6.0% interest in the OORTP Net Profit in perpetuity.
Royalty Payable
We entered into various agreements and subsequently received funding from
certain investors for use by us for any purpose. In exchange for this funding,
we agreed to provide certain investors with interest in the OORTP Net Profit
generated from net NARCAN® sales by EBS.
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