Impel NeuroPharma (NASDAQ: IMPL), a commercial-stage pharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on the central nervous system, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.
“With the approval and timely launch of Trudhesa, the third quarter was truly transformational for Impel. We are delighted by the early uptake and prescription trends we are seeing in the marketplace since our commercial launch in early October,” said Adrian Adams, chairman and chief executive officer of Impel NeuroPharma. “Following the recent follow-on equity offering, we are confident that Impel’s strengthened balance sheet will provide us not only with the resources to continue our successful commercialization of Trudhesa, but also the continued development of INP105 for the potential treatment of agitation and aggression in autism.”
Recent Corporate Highlights
Third Quarter 2021 Financial Results
Conference Call Information
Impel NeuroPharma’s Executive Management will host a live conference call and webcast at 8:30 a.m. ET today to discuss the third quarter 2021 financial results and provide a corporate update. The conference call may be accessed by dialing 877-295-2648 (domestic) or 470-495-9487 (international) and referring to conference ID 8366131. A live webcast of the event will be available on the Investors section of the Impel NeuroPharma website at https://investors.impelnp.com/. A replay of the webcast and accompanying slides will be available on the Impel NeuroPharma 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 NeuroPharma
Impel NeuroPharma, Inc. is a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high unmet medical needs, with an initial focus on diseases of the central nervous system. Impel offers and is developing treatments that pair its proprietary Precision Olfactory Delivery (POD®) technology with well-established therapeutics. In addition to Trudhesa™ (dihydroergotamine mesylate) nasal spray, which is approved in the United States for the acute treatment of migraine with or without aura in adults, Impel is also developing INP105 for the acute treatment of agitation and aggression in patients with autism, and INP107 for OFF episodes in Parkinson’s disease.
Trudhesa™ Indication and Important Safety Information 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:
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.
About INP105
INP105 is an upper nasal formulation of olanzapine administered using Impel’s novel Precision Olfactory Delivery, or POD®, technology and being developed for the potential treatment of agitation and aggression associated with autism spectrum disorder (ASD). The POD is a novel, simple-to-use device designed to deliver consistent and predictable doses of drug. INP105 delivers olanzapine to the richly vascularized upper nasal space offering rapid, consistent, and optimized bioavailability that can be administered by the patient or a caregiver. Olanzapine is the most used treatment for acute agitation, but its use is limited to intramuscular injection and in a hospital setting. INP105 is intended to be a preferred choice for the safe and rapid treatment of acute agitation and, because it is designed to be non-invasive, it has the potential to expand the treatment setting beyond the emergency room, such as inpatient treatment or community care facilities and the patient’s home.
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, the potential clinical benefits of Trudhesa™, the market opportunities of Trudhesa within the migraine market, the speed of uptake and market growth of Trudhesa, and the timing of announcements of clinical results and clinical development activities of Impel’s product candidates. 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 its other product candidates including plans for future development of its POD devices and plans to address additional indications for which Impel may pursue regulatory approval, whether results of preclinical studies or clinical trials will be indicative of the results of future trials, and the effects of COVID-19 on its clinical programs and business operations. 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 and the Impel logo are trademarks of Impel NeuroPharma, Inc. To learn more about Impel NeuroPharma, please visit our website at https://impelnp.com/.
| IMPEL NEUROPHARMA, INC. Condensed Consolidated Balance Sheet (In thousands, except share and per share data) | |||||||||||
| September 30, 2021 | December 31, 2020 | ||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 111,289 | $ | 7,095 | |||||||
| Trade receivables, net | 981 | — | |||||||||
| Inventory | 1,548 | — | |||||||||
| Prepaid expenses and other current assets | 4,385 | 1,077 | |||||||||
| Total current assets | 118,203 | 8,172 | |||||||||
| Property and equipment, net | 3,278 | 3,700 | |||||||||
| Other assets | — | 187 | |||||||||
| Total assets | $ | 121,481 | $ | 12,059 | |||||||
| Liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 8,700 | $ | 4,314 | |||||||
| Accrued liabilities | 6,692 | 3,173 | |||||||||
| Current portion of term debt | — | 417 | |||||||||
| Common stock warrant liabilities | 918 | — | |||||||||
| Redeemable convertible preferred stock warrant liabilities | — | 2,622 | |||||||||
| Total current liabilities | 16,310 | 10,526 | |||||||||
| Long-term debt | 29,285 | 7,994 | |||||||||
| Total liabilities | 45,595 | 18,520 | |||||||||
| Commitments and contingencies (Note 5) | |||||||||||
| Redeemable convertible preferred stock, $0.001 par value; — and 204,198,489 shares authorized at September 30, 2021 and December 31, 2020 respectively; — and 202,009,981 shares issued and outstanding at September 30, 2021 and December 31, 2020 respectively; aggregate liquidation preference of $128,922 at December 31, 2020 | — | 127,039 | |||||||||
| Stockholders’ equity (deficit): | |||||||||||
| Preferred stock, $0.001 par value; 10,000,000 and — shares authorized at September 30, 2021 and December 31, 2020, respectively | — | — | |||||||||
| Common stock, $0.001 par value; 300,000,000 and 266,833,885 shares authorized at September 30, 2021 and December 31, 2020, respectively; 23,037,298 and 755,478 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 23 | - | |||||||||
| Additional paid-in capital | 265,919 | 4,762 | |||||||||
| Accumulated deficit | (190,056 | ) | (138,262 | ) | |||||||
| Total stockholders’ equity (deficit) | 75,886 | (133,500 | ) | ||||||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ | 121,481 | $ | 12,059 | |||||||
| Impel NeuroPharma Inc. Condensed Consolidated Statement of Operations and Comprehensive Loss (in thousands) | ||||||||||||||||||||||
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||||||||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
| Product revenue, net | $ | 91 | $ | — | $ | 91 | $ | — | ||||||||||||||
| Cost of goods sold | 250 | — | 250 | — | ||||||||||||||||||
| Gross profit | (159 | ) | — | (159 | ) | — | ||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||
| Research and development | 5,929 | 6,133 | 16,103 | 19,524 | ||||||||||||||||||
| Selling, general and administrative | 16,338 | 2,866 | 30,971 | 12,240 | ||||||||||||||||||
| Total operating expenses | 22,267 | 8,999 | 47,074 | 31,764 | ||||||||||||||||||
| Loss from operations | (22,426 | ) | (8,999 | ) | (47,233 | ) | (31,764 | ) | ||||||||||||||
| Other (expense) income, net | (2,595 | ) | (93 | ) | (4,561 | ) | (9 | ) | ||||||||||||||
| Loss before income taxes | (25,021 | ) | (9,092 | ) | (51,794 | ) | (31,773 | ) | ||||||||||||||
| Provision (benefit) for income taxes | — | 1 | — | 1 | ||||||||||||||||||
| Net loss and comprehensive loss | $ | (25,021 | ) | $ | (9,093 | ) | $ | (51,794 | ) | $ | (31,774 | ) | ||||||||||
| Accretion on redeemable convertible preferred stock | — | 130 | 129 | 386 | ||||||||||||||||||
| Net loss attributable to common stockholders | $ | (25,021 | ) | $ | (9,223 | ) | $ | (51,923 | ) | $ | (32,160 | ) | ||||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.24 | ) | $ | (15.56 | ) | $ | (4.42 | ) | $ | (73.16 | ) | ||||||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 20,150,990 | 592,550 | 11,746,923 | 439,575 | ||||||||||||||||||
| Impel Neuropharma, Inc. Earnings Per Share (in thousands, except share and per share amounts) | |||||||||||||||
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| GAAP Basic and Diluted EPS | |||||||||||||||
| Numerator: | |||||||||||||||
| Net loss and comprehensive loss | $ | (25,021 | ) | $ | (9,093 | ) | $ | (51,794 | ) | $ | (31,774 | ) | |||
| Add: Accretion of preferred stock to redemption value | - | 130 | 129 | 386 | |||||||||||
| Net loss attributable to common shareholders | $ | (25,021 | ) | $ | (9,223 | ) | $ | (51,923 | ) | $ | (32,160 | ) | |||
| Denominator: | |||||||||||||||
| Weighted-average common shares outstanding, basic and diluted | 20,150,990 | 592,550 | 11,746,923 | 439,575 | |||||||||||
| Net loss per share attributable to common shareholders, basic and diluted | $ | (1.24 | ) | $ | (15.56 | ) | $ | (4.42 | ) | $ | (73.16 | ) | |||
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | ||||||||||||||
| 2021 | 2020 | 2021 | 2020 | ||||||||||||
| Non-GAAP loss per share information: | |||||||||||||||
| Numerator: | |||||||||||||||
| Historical net loss attributable to common shareholders | $ | (25,021 | ) | $ | (9,223 | ) | $ | (51,923 | ) | $ | (32,160 | ) | |||
| Accretion of preferred stock to redemption value | - | 130 | 129 | 386 | |||||||||||
| Change in fair value of convertible notes | - | - | 839 | 0 | |||||||||||
| Change in fair value of redeemable convertible preferred stock warrant liabilities | - | (35 | ) | 222 | (80 | ) | |||||||||
| Interest expense on convertible notes | - | - | 55 | - | |||||||||||
| Non-GAAP pro forma net loss attributable to common stockholders | $ | (25,021 | ) | $ | (9,128 | ) | $ | (50,678 | ) | $ | (31,854 | ) | |||
| Denominator: | |||||||||||||||
| Common shares outstanding: | |||||||||||||||
| Weighted average common shares outstanding | 20,150,990 | 592,550 | 11,746,923 | 439,575 | |||||||||||
| Shares issued in IPO | - | 5,333,334 | 2,266,179 | 5,333,334 | |||||||||||
| Common shares issued upon conversion of preferred stock | - | 12,592,799 | 5,356,311 | 12,592,799 | |||||||||||
| Automatic exchange of Avenue warrant | - | - | 45,747 | - | |||||||||||
| Issuance of shares of common stock pursuant to the cash and net exercise of warrants | - | 67,897 | 26,138 | 68,175 | |||||||||||
| Shares issued upon conversion of convertible notes | - | - | 237,772 | - | |||||||||||
| Weighted-average number of common shares outstanding used to compute pro forma net loss per share, as adjusted, basic and diluted | 20,150,990 | 18,586,580 | 19,679,070 | 18,433,883 | |||||||||||
| Pro forma net loss per share attributable to common shareholders, basic and diluted | $ | (1.24 | ) | $ | (0.49 | ) | $ | (2.58 | ) | $ | (1.73 | ) | |||
Contact:
Investor Relations:
Christina Tartaglia
Stern Investor Relations
Phone: (1) 212-362-1200
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Media Relations:
Melyssa Weible
Elixir Health Public Relations
Phone: (1) 201-723-5805
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
| Last Trade: | US$0.24 |
| Daily Volume: | 0 |
| Market Cap: | US$5.760M |
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