opnt-20210930

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, 2021


☐			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 280,

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 9, 2021, the registrant had 4,720,285 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	5
	Condensed Consolidated Balance Sheet s (unaudited)	5
	Condensed Consolidated Statements of Operations and Comprehensive Income (L oss ) (unaudited)	6
	Condensed Consolidated Statements of Stockholders ' Equity (unaudited)	7
	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	29
Item 4.	Controls and Procedures	29

PART II— OTHER INFORMATION		30

Item 1.	Legal Proceedings	30
Item 1A.	Risk Factors	30
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	31
Item 3.	Defaults Upon Senior Securities	31
Item 4.	Mine Safety Disclosures	31
Item 5.	Other Information	31
Item 6.	Exhibits	31

SIGNATURES		33

PART 1 - FINANCIAL INFORMATION

Item 1. Financial Statements

Opiant Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets


	September 30, 2021		December 31, 2020
Assets	(unaudited)
Current assets
Cash and cash equivalents	$	35,284,595	$	48,251,336
Marketable securities	15,044,750		—
Accounts receivable	15,425,938		8,910,975
Prepaid and other current assets	2,121,145		1,936,842
Total current assets	67,876,428		59,099,153

Other assets

Property and equipment - net	93,519		171,190
Right of use assets - operating leases	997,777		278,455
Patents and patent applications - net	11,971		13,000
Other non-current assets	—		1,051,234
Total assets	$	68,979,695	$	60,613,032

Liabilities and Stockholders' Equity
Liabilities
Current liabilities
Accounts payable and accrued expenses	$	2,580,904	$	2,966,479
Accrued salaries and wages	1,347,552		908,516
Royalty payable	3,136,677		1,908,072
Deferred revenue	—		354,756
Operating leases	287,139		282,421
Total current liabilities	7,352,272		6,420,244

Long-term liabilities
Operating leases - long term	716,343		—
Convertible debt, net of unamortized discount	18,905,723		18,700,546
Total long-term liabilities	19,622,066		18,700,546

Total liabilities	26,974,338		25,120,790

Stockholders' equity
Common stock; par value $0.001; 200,000,000 shares authorized; 4,618,221 and 4,258,105 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively	4,618		4,259
Additional paid-in capital	104,460,194		100,203,979
Accumulated other comprehensive loss	(26,850)		(26,931)
Accumulated deficit	(62,432,605)		(64,689,065)
Total stockholders' equity	42,005,357		35,492,242

Total liabilities and stockholders' equity	$	68,979,695	$	60,613,032

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

Opiant Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

(unaudited)


	Three months ended September 30,				Nine months ended September 30,
	2021		2020		2021		2020
Revenues
Royalty revenue	$	14,041,006	$	8,600,811	$	27,688,713	$	19,056,999

Grant and contract revenue	2,298,055		505,265		6,296,542		644,195
Total revenue	16,339,061		9,106,076		33,985,255		19,701,194

Operating expenses
General and administrative	3,378,707		2,729,098		8,758,601		8,138,571
Research and development	4,881,398		2,783,452		12,119,088		4,762,749
Sales and marketing	1,059,649		914,349		3,080,211		3,737,793
Royalty expense	3,058,865		1,951,947		6,145,057		4,288,701
Total operating expenses	12,378,619		8,378,846		30,102,957		20,927,814

Income (loss) from operations	3,960,442		727,230		3,882,298		(1,226,620)

Other income (expense)
Interest income	3,498		3,922		10,334		92,015
Interest expense	(547,296)		—		(1,626,273)		—
Gain (loss) on foreign exchange	455		(6,178)		(9,899)		(2,269)
Total other income (expense)	(543,343)		(2,256)		(1,625,838)		89,746

Income (loss) before income taxes	3,417,099		724,974		2,256,460		(1,136,874)

Income tax (expense)	—		—		—		(39,000)

Net income (loss)	$	3,417,099	$	724,974	$	2,256,460	$	(1,175,874)

Other comprehensive income (loss):
Foreign currency translation adjustment	(7,974)		196,076		81		(114,644)

Comprehensive income (loss)	$	3,409,125	$	921,050	$	2,256,541	$	(1,290,518)

Net income (loss) per share of common stock:
Basic	$	0.77	$	0.17	$	0.52	$	(0.28)
Diluted	$	0.56	$	0.15	$	0.41	$	(0.28)
Weighted average shares outstanding used to compute net income (loss) per share:
Basic	4,462,236		4,258,105		4,359,759		4,247,045
Diluted	6,065,044		4,847,211		5,565,065		4,247,045

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, 2020	4,258,105	$	4,259	$	100,203,979	$	(64,689,065)	$	(26,931)	$	35,492,242
Exercise of stock options	65,962	66		579,553		—		—		579,619

Restricted stock issued	6,527	6		(6)		—		—		—
Stock based compensation	—	—		745,620		—		—		745,620
Net loss	—	—		—		(2,844,230)		—		(2,844,230)

Foreign currency translation adjustment	—	—		—		—		12,501		12,501
Balance at March 31, 2021	4,330,594	$	4,331	$	101,529,146	$	(67,533,295)	$	(14,430)	$	33,985,752
Exercise of stock options	5,630	6		36,599		—		—		36,605

Restricted stock issued	13,375	13		(13)		—		—		—
Stock based compensation	—	—		654,562		—		—		654,562
Net income	—	—		—		1,683,591		—		1,683,591
Foreign currency translation adjustment	—	—		—		—		(4,446)		(4,446)
Balance at June 30, 2021	4,349,599	4,350		102,220,294		(65,849,704)		(18,876)		36,356,064
Exercise of stock options	268,622	268		1,545,566		—		—		1,545,834
Stock based compensation	—	—		694,334		—		—		694,334
Net income	—	—		—		3,417,099		—		3,417,099
Foreign currency translation adjustment	—	—		—		—		(7,974)		(7,974)
Balance at September 30, 2021	4,618,221	$	4,618	$	104,460,194	$	(62,432,605)	$	(26,850)	$	42,005,357

Balance at December 31, 2019	4,186,438	$	4,187	$	97,239,455	$	(62,827,616)	$	—	$	34,416,026

Exercise of stock options	12,157	12		89,988		—		—		90,000
Exercise of warrants	59,510	60		595,041		—		—		595,101


Stock based compensation	—	—		686,599		—		—		686,599
Net loss	—	—		—		(1,684,643)		—		(1,684,643)
Foreign currency translation adjustment	—	—