opnt-20220930

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)


☒			QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022


☐			TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______to______.

Commission File Number: 001-38193

OPIANT PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware

46-4744124

(State or other jurisdiction of incorporation or
organization)

(I.R.S. Employer Identification No.)

233 Wilshire Blvd.

Suite 400

Santa Monica,

90401

(Address of principal executive offices)

(Zip Code)

(310)-598-5410

(Registrant’s telephone number, including area code)

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer”, “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.


Large Accelerated Filer	☐	Accelerated Filer	☐
Non-Accelerated Filer	☒	Smaller Reporting Company	☒
		Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 10, 2022, the registrant had 5,167,814 shares of common stock outstanding.

Securities registered pursuant to Section 12(b) of the Act:


Title of each class	Trading symbol	Name of each exchange on which registered
Common stock, par value $0.001 per share	OPNT	Nasdaq Stock Market LLC

CAUTIONARY STATEMENT ON FORWARD-LOOKING INFORMATION

This Quarterly Report on Form 10-Q (this “Report”) 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”). Forward-looking statements discuss matters that are not historical facts. Because they discuss future events or conditions, forward-looking statements may include words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue”, negatives thereof or similar expressions. Forward-looking statements speak only as of the date they are made, are based on various underlying assumptions and current expectations about the future and are not guarantees. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity, performance or achievement to be materially different from the results of operations or plans expressed or implied by such forward-looking statements.

We cannot predict all of the risks and uncertainties. Accordingly, such information should not be regarded as representations that the results or conditions described in such statements or that our objectives and plans will be achieved and we do not assume any responsibility for the accuracy or completeness of any of these forward-looking statements. These forward-looking statements are found at various places throughout this Report and include information concerning possible or assumed future results of our operations, including statements about potential acquisition or merger targets; business strategies; future cash flows; financing plans; plans and objectives of management, any other statements regarding future acquisitions, future cash needs, future operations, business plans and future financial results, and any other statements that are not historical facts.

From time to time, forward-looking statements also are included in our other periodic reports on Forms 10-K and 8-K, in our press releases, in our presentations, on our website and in other materials released to the public. Any or all of the forward-looking statements included in this Report and in any other reports or public statements made by us are not guarantees of future performance and may turn out to be inaccurate. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors. Many of those factors are outside of our control and could cause actual results to differ materially from the results expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.

Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise.

CERTAIN TERMS USED IN THIS REPORT

When this Report uses the words “we,” “us,” “our,” “Opiant,” and the “Company,” they refer to Opiant Pharmaceuticals, Inc. “SEC” refers to the Securities and Exchange Commission.

OPIANT PHARMACEUTICALS, INC.

TABLE OF CONTENTS


PART I— FINANCIAL INFORMATION

Item 1.	Financial Statements	4
	Condensed Consolidated Balance Sheet s (unaudited)	4
	Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)	5
	Condensed Consolidated Statements of Stockholders' Equity (unaudited)	6
	Condensed Consolidated Statements of Cash Flows (unaudited)	8
	Notes to Condensed Consolidated Financial Statements (unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	30
Item 4.	Controls and Procedures	30

PART II— OTHER INFORMATION		31

Item 1.	Legal Proceedings	31
Item 1A.	Risk Factors	32
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	34
Item 3.	Defaults Upon Senior Securities	34
Item 4.	Mine Safety Disclosures	34
Item 5.	Other Information	34
Item 6.	Exhibits	34

SIGNATURES		36

PART 1 - FINANCIAL INFORMATION

Item 1. Financial Statements

Opiant Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets


	September 30, 2022		December 31, 2021
Assets	(unaudited)
Current assets
Cash and cash equivalents	$	35,375,865	$	37,853,947
Marketable securities	—		15,014,750
Accounts receivable	41,113		13,327,364

Prepaid and other current assets	3,131,299		2,962,903
Total current assets	38,548,277		69,158,964

Other assets
Property and equipment, net	417,646		78,107
Right of use assets - operating leases	2,739,239		999,567
Patents and patent applications, net	10,598		11,628
Other non-current assets	234,389		179,532
Total assets	$	41,950,149	$	70,427,798

Liabilities and Stockholders' Equity
Liabilities
Current liabilities
Accounts payable and accrued liabilities	$	3,113,068	$	3,369,848
Accrued salaries and wages	1,821,438		201,254
Royalty payable	—		2,920,148
Deferred revenue	—		16,618
Operating leases - current	669,209		337,690
Convertible debt - current	1,436,660		—
Total current liabilities	7,040,375		6,845,558

Long-term liabilities
Operating leases - long term	2,083,548		673,347
Convertible debt, net of unamortized discount	12,324,237		16,069,085
Total liabilities	21,448,160		23,587,990

Stockholders' equity
Common stock; par value $0.001; 200,000,000 shares authorized; 5,164,951 and 4,909,846 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively	5,165		4,910
Additional paid-in capital	116,266,243		108,569,988
Accumulated other comprehensive loss	(248,129)		(54,815)
Accumulated deficit	(95,521,290)		(61,680,275)
Total stockholders' equity	20,501,989		46,839,808

Total liabilities and stockholders' equity	$	41,950,149	$	70,427,798

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Opiant Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(unaudited)


	Three months ended September 30,				Nine months ended September 30,
	2022		2021		2022		2021
Revenues
Royalty revenue	$	—	$	14,041,006	$	4,519,505	$	27,688,713
Grant and contract revenue	173,874		2,298,055		4,018,653		6,296,542
Total revenue	173,874		16,339,061		8,538,158		33,985,255

Operating expenses
General and administrative	3,073,114		3,378,707		11,415,746		8,758,601
Research and development	4,133,982		4,881,398		20,873,449		12,119,088
Sales and marketing	2,596,562		1,059,649		8,088,860		3,080,211
Royalty expense	—		3,058,865		943,269		6,145,057
Total operating expenses	9,803,658		12,378,619		41,321,324		30,102,957

Income (loss) from operations	(9,629,784)		3,960,442		(32,783,166)		3,882,298

Other income (expense)
Interest income	160,114		3,498		227,830		10,334
Interest expense	(390,850)		(547,296)		(1,213,021)		(1,626,273)
Loss on sale of assets	(49,437)		—		(49,437)		—
Gain (loss) on foreign exchange	1,868		455		17,818		(9,899)
Total other income (expense)	(278,305)		(543,343)		(1,016,810)		(1,625,838)

Income (loss) before income taxes	(9,908,089)		3,417,099		(33,799,976)		2,256,460

Income tax (expense)	(8,550)		—		(41,039)		—

Net income (loss)	$	(9,916,639)	$	3,417,099	$	(33,841,015)	$	2,256,460

Other comprehensive loss:
Foreign currency translation adjustment	(4,979)		(7,974)		(193,314)		81

Comprehensive income (loss)	$	(9,921,618)	$	3,409,125	$	(34,034,329)	$	2,256,541

Net income (loss) per share of common stock:
Basic	$	(1.93)	$	0.77	$	(6.66)	$	0.52
Diluted	$	(1.93)	$	0.56	$	(6.66)	$	0.41
Weighted average shares outstanding used to compute net income (loss) per share:
Basic	5,138,274		4,462,236		5,083,222		4,359,759
Diluted	5,138,274		6,065,044		5,083,222		5,565,065

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

Opiant Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders' Equity

(unaudited)


	Common Stock			Additional Paid In Capital		Accumulated Deficit		Accumulated Other Comprehensive Loss		Total
	Shares	Amount
Balance at December 31, 2021	4,909,846	$	4,910	$	108,569,988	$	(61,680,275)	$	(54,815)	$	46,839,808
Return of profit	—	—		5,824		—		—		5,824
Exercise of stock options	7,097	7		91,627		—		—		91,634
Restricted stock issued	31,746	32		(32)		—		—		—
Stock issued from converted debt	130,916	131		2,571,069		—		—		2,571,200
Debt issuance cost associated with debt conversion	—	—		(109,399)		—		—		(109,399)
Stock based compensation	—	—		2,079,159		—		—		2,079,159
Net loss	—	—		—		(12,187,830)		—		(12,187,830)

Other comprehensive loss - foreign currency translation adjustment	—	—		—		—		(27,150)		(

SEC Form 10-Q filed by Opiant Pharmaceuticals Inc.