false000144549900014454992023-03-242023-03-24

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): March 24, 2023

 

IMPEL PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		001-40353		26-3058238
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

201 Elliott Avenue West, Suite 260 Seattle, WA	98119
(Address of principal executive offices)	(Zip Code)

 

(206) 568-1466

(Registrant’s telephone number, including area code)

 

N/A

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

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

 

Title of each class	Trading symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 Par Value Per Share	IMPL	The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

 

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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. 

 

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Item 2.02 Results of Operations and Financial Condition.

On March 24, 2023, Impel Pharmaceuticals Inc. issued a press release announcing its financial results for the fourth quarter and full year ended December 31, 2022. A copy of the press release is attached as Exhibit 99.1 to this report.

The information in this Item 2.02, including Exhibit 99.1 to this report, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01	Financial Statements and Exhibits.

(d) Exhibits

 

Exhibit No.		Description
99.1		Press release issued by Impel Pharmaceuticals Inc. regarding its financial results for the fourth quarter and full year ended December 31, 2022, dated March 24, 2023.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

				IMPEL PHARMACEUTICALS, INC.
Date: March 24, 2023				By:		/s/ Rajiv Amin
						Rajiv Amin
						Vice President, Controller & Interim Chief Financial Officer

 

 

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Exhibit 99.1

Exhibit 99.1

IMPEL PHARMACEUTICALS ANNOUNCES FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

 

Trudhesa® Achieved nTRx of Over 58.4K in 2022; nTRx Increased by 19.4% in Q4 vs. Q3 2022

 

Net Product Revenue Finished Year at $12.7 Million; Increased 62% in Q4 vs. Q3 2022 to $5 Million

 

Impel to Host Investor Conference Call Today at 8:30 a.m. ET

 

SEATTLE, March 24, 2023 — Impel Pharmaceuticals Inc. (NASDAQ: IMPL), a commercial-stage pharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today reported financial results for the fourth quarter and full year ended December 31, 2022 and provided a business update.

 

“We continued to see strong growth in Trudhesa® prescriptions as we moved into 2023. The Company’s priority objective is to maximize the growth potential of Trudhesa in a market where we already hold 4.3 percent of total branded acute migraine prescriptions among Trudhesa prescribers,” said Adrian Adams, Chairman of the Board and Chief Executive Officer of Impel Pharmaceuticals. “Additionally, we continue to see increased productivity and efficiency from the field force expansion we completed in July 2022. This, together with the increased number of prescriptions reimbursed and resultant positive impact on revenue growth, points to the value creation opportunity with Impel.”

 

Recent Corporate Highlights

Trudhesa® (Dihydroergotamine Mesylate) Nasal Spray (0.725 Mg Per Spray)

 

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Clinical Developments

 

Financial Results for Fourth Quarter and Year End 2022

 

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Trudhesa Guidance for 2023

 

Conference Call Information

Impel Pharmaceuticals’ Executive Management will host a live conference call and webcast at 8:30 a.m. ET today to discuss the fourth quarter and full year 2022 financial results and provide a corporate and business update. To access the live conference call, please register using the conference link: Conference Registration (vevent.com). A live webcast of the event will be available on the Investors section of the Impel Pharmaceuticals website at https://investors.impelpharma.com/. A replay of the webcast and accompanying slides will be available on the Impel Pharmaceuticals website following the event.

 

Non-GAAP Financial Measures

We have provided in this press release certain financial information that has not been prepared in accordance with generally accepted accounting principles in the United States (“GAAP”). Our management uses these non-GAAP financial measures internally in analyzing our financial results and believes that use of these non-GAAP financial measures is useful to investors as an additional tool to evaluate ongoing operating results and trends and in comparing our financial results with other companies in our industry, many of which present similar non-GAAP financial measures. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable financial measures prepared in accordance with GAAP and should be read only in conjunction with our consolidated financial statements prepared in accordance with GAAP. A reconciliation of our historical non-GAAP financial measures to the most directly comparable GAAP measures has been provided in the financial statement tables included in this press release, and investors are encouraged to review these reconciliations.

 

About Impel Pharmaceuticals

 

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Impel Pharmaceuticals is a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs. Impel offers treatments that pair its proprietary POD® technology with well-established therapeutics. In September 2021, Impel received U.S. FDA approval for its first product, Trudhesa® nasal spray, which is approved in the U.S. for the acute treatment of migraine with or without aura in adults. In addition to Trudhesa, the Company continues to address patient needs via licensing and partnerships.

 

About Impel’s Precision Olfactory Delivery (POD®) Technology:

Impel’s proprietary POD® technology is able to deliver a range of therapeutic molecules and formulations into the vascular-rich upper nasal space, believed to be a gateway for unlocking the previously unrealized full potential of these molecules. By delivering predictable doses of drug directly to the upper nasal space, Impel’s precision performance technology has the goal of enabling increased and consistent absorption of drug, overriding the high variability associated with other nasal delivery systems, yet without the need for an injection. While an ideal target for drug administration, to date no technology has been able to consistently deliver drugs to the upper nasal space. By utilizing this route of administration, Impel Pharmaceuticals has been able to demonstrate blood concentration levels for its investigational therapies that are comparable to intramuscular (IM) administration and can even reach intravenous (IV)-like systemic levels quickly, which could transform the treatment landscape for a broad range of disorders. Importantly, the POD® technology offers propellant-enabled delivery of dry powder and liquid formulations that eliminates the need for coordination of breathing, allowing for self- or caregiver-administration in a manner that may improve patient outcome, comfort, and potentially, compliance.

 

About Trudhesa®

Indication

Trudhesa® is used to treat an active migraine headache with or without aura in adults. Do not use Trudhesa to prevent migraine when you have no symptoms. It is not known if Trudhesa is safe and effective in children.

 

Important Safety Information

Serious or potentially life-threatening reductions in blood flow to the brain or extremities due to interactions between dihydroergotamine (the active ingredient in Trudhesa) and strong CYP3A4 inhibitors (such as protease inhibitors and macrolide antibiotics) have been reported rarely. As a result, these medications should not be taken together.

 

Do not use Trudhesa if you:

 

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Before taking Trudhesa, tell your doctor if:

 

The use of Trudhesa should not exceed dosing guidelines and should not be used on a daily basis. Serious cardiac (heart) events, including some that have been fatal, have occurred following the use of dihydroergotamine mesylate, particularly with dihydroergotamine for injection, but are extremely rare.

 

You may experience some nasal congestion or irritation, altered sense of taste, sore throat, nausea, vomiting, dizziness, and fatigue after using Trudhesa.

Contact your doctor immediately if you experience:

 

The risk information provided here is not comprehensive. To learn more, talk about Trudhesa with your healthcare provider or pharmacist. The FDA-approved product labeling can be found at www.Trudhesa.com or 1-800-555-DRUG. You can also call 1-833-TRUDHESA (1-833-878-3437) for additional information.

 

Cautionary Note on Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, our expected full year 2023 reported TRx guidance, the potential clinical benefits of Trudhesa®, the market opportunities of Trudhesa within the migraine market, the speed of uptake and market growth of Trudhesa, the

 

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effectiveness of the Trudhesa sales force, and Impel’s cash runway. Forward-looking statements can be identified by words such as: “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” or the negative or plural of these words or similar expressions. These statements are subject to numerous risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including but not limited to, Impel’s ability to maintain regulatory approval of Trudhesa, its ability to execute its commercialization strategy for Trudhesa, its ability to develop, manufacture and commercialize any other product candidates including plans to address additional indications for which Impel may pursue regulatory approval, and the effects of general market and macroeconomic conditions on business operations and any future clinical programs. Many of these risks are described in greater detail in Impel’s filings with the Securities and Exchange Commission. Any forward-looking statements in this press release speak only as of the date of this press release. Impel assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

 

Impel, POD, Trudhesa and the Impel logo are registered trademarks of Impel Pharmaceuticals Inc. To learn more about Impel Pharmaceuticals, please visit our website at https://impelpharma.com.
 

 

 

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Exhibit 99.1

IMPEL PHARMACEUTICALS INC. Condensed Consolidated Balance Sheet (In thousands, except share and per share data)
		December 31, 2022				December 31, 2021
Assets
Current assets:
Cash and cash equivalents		$	60,654			$	88,212
Trade receivables, net			7,444				1,352
Inventory			8,427				2,824
Prepaid expenses and other current assets			3,284				2,188
Total current assets			79,809				94,576
Property and equipment, net			3,863				3,149
Operating lease right-of-use assets			3,132				—
Other assets			1,746				187
Total assets		$	88,550			$	97,912
Liabilities and stockholders’ (deficit) equity
Current liabilities:
Accounts payable		$	6,092			$	6,367
Accrued liabilities			12,242				8,950
Current portion of deferred royalty obligation			2,027				—
Current portion of operating lease liability			1,541				—
Common stock warrant liability			261				637
Total current liabilities			22,163				15,954
Operating lease liability, net of current portion			1,573				—
Deferred royalty obligation, net of current portion			60,899				—
Long-term debt			48,072				29,450
Total liabilities			132,707				45,404
Commitments and contingencies
Stockholders’ (deficit) equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized: none issued			—				—
Common stock, $0.001 par value; 300,000,000 shares authorized; 23,739,313 and 23,123,062 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively			24				23
Additional paid-in capital			276,929				267,283
Accumulated deficit			(321,110	)			(214,798	)
Total stockholders’ (deficit) equity			(44,157	)			52,508
Total liabilities and stockholders’ (deficit) equity		$	88,550			$	97,912

 

 

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Impel Pharmaceuticals Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands)
		For the Three Months Ended  December 31,								Year Ended  December 31,
		2022				2021				2022				2021
Product revenue, net		$	5,008			$	577			$	12,652			$	668
Cost of goods sold			2,217				441				6,495				691
Gross profit			2,791				136				6,157				(23	)
Operating expenses:
Research and development			700				4,460				11,456				20,563
Selling, general and administrative			20,332				19,929				77,885				50,900
Total operating expenses			21,032				24,389				89,341				71,463
Loss from operations			(18,241	)			(24,253	)			(83,184	)			(71,486	)
Other income (expense), net :
Interest income (expense), net			(2,766	)			(772	)			(13,835	)			(4,243	)
Other income (expense), net			(2,034	)			285				(9,293	)			(805	)
Total other income (expense), net			(4,800	)			(487	)			(23,128	)			(5,048	)
Loss before income taxes			(23,041	)			(24,740	)			(106,312	)			(76,534	)
Provision for income taxes			—				2				—				2
Net loss and comprehensive loss		$	(23,041	)		$	(24,742	)		$	(106,312	)		$	(76,536	)
Accretion on redeemable convertible preferred stock			—				—				—				129
Net loss attributable to common stockholders		$	(23,041	)		$	(24,742	)		$	(106,312	)		$	(76,665	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.97	)		$	(1.07	)		$	(4.53	)		$	(5.25	)
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted			23,739,312				23,067,570				23,445,096				14,600,346

 

 

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Impel Pharmaceuticals Inc. Earnings Per Share (in thousands, except share and per share amounts)
		For the Three Months Ended  December 31,								For the Years Ended, December 31,
		2022				2021				2022				2021
GAAP Basic and Diluted EPS
Numerator:
Net loss and comprehensive loss		$	(23,041	)		$	(24,742	)		$	(106,312	)		$	(76,536	)
Add: Accretion of preferred stock to redemption value			—				—				—				(129	)
Net loss attributable to common shareholders		$	(23,041	)		$	(24,742	)		$	(106,312	)		$	(76,665	)
Denominator:
Weighted-average common shares outstanding, basic and diluted			23,739,312				23,067,570				23,445,096				14,600,346
Net loss per share attributable to common shareholders, basic and diluted		$	(0.97	)		$	(1.07	)		$	(4.53	)		$	(5.25	)
		For the Three Months Ended  December 31,								For the Years Ended, December 31,
		2022				2021				2022				2021
Non-GAAP loss per share information:
Numerator:
Historical net loss attributable to common shareholders		$	(23,041	)		$	(24,742	)		$	(106,312	)		$	(76,665	)
Accretion of preferred stock to redemption value			—				—				—				129
Change in fair value of convertible notes			—				—				—			839
Change in fair value of redeemable convertible preferred stock warrant liabilities			—				—				—				55
Interest expense on convertible notes			—				—				—			55
Non-GAAP pro forma net loss attributable to common stockholders		$	(23,041	)		$	(24,742	)		$	(106,312	)		$	(75,587	)
Denominator:
Common shares outstanding:
Weighted average common shares outstanding			23,739,312				23,067,570				23,445,096				14,600,346
Shares issued in IPO			—				—				—				1,694,977
Common shares issued upon conversion of preferred stock			—				—				—				4,006,227
Automatic exchange of Avenue warrant			—				—				—				34,216
Issuance of shares of common stock pursuant to the cash and net exercise of warrants			—				—				—				19,550
Shares issued upon conversion of convertible notes			—				—				—				177,841
Weighted-average number of common shares outstanding used to compute pro forma net loss per share, as adjusted, basic and diluted			23,739,312				23,067,570				23,445,096				20,533,157
Pro forma net loss per share attributable to common shareholders, basic and diluted		$	(0.97	)		$	(1.07	)		$	(4.53	)		$	(3.68	)

 

 

 

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Exhibit 99.1

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Contact:

Investor Relations:
Christina Tartaglia
Stern Investor Relations
Phone: (1) 212-362-1200
Email: christina.tartaglia@sternir.com

 

Media Relations:

Melyssa Weible
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: mweible@elixirhealthpr.com

 

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