SEATTLE - Impel Pharmaceuticals Inc. (NASDAQ: IMPL), a commercial-stage biopharmaceutical company with a mission to develop transformative therapies for people suffering from diseases with high unmet medical needs, today reported financial results for the first quarter ended March 31, 2023 and provided a business update.
'Following our strategic reprioritization to focus the company on maximizing the growth potential of Trudhesa, we are pleased with the significant increases in reimbursed prescriptions and new patient starts over the first quarter of 2023,' said Adrian Adams, Chairman of the Board and Chief Executive Officer of Impel Pharmaceuticals. 'Additionally, the ongoing feedback we are receiving from our growing prescriber base on the compelling safety and efficacy profile of Trudhesa reinforces the value-creation opportunity for our shareholders. This is further reflected in the prescription momentum we are seeing in the second quarter of this year.'
Recent Corporate Highlights
Trudhesa (Dihydroergotamine Mesylate) Nasal Spray (0.725 Mg Per Spray)
To-date, Trudhesa continues a strong trajectory with more than 87,000 prescriptions generated since launch. Based on third-party data, it is estimated that at the end of April 2023, Trudhesa accounted for 4.7 percent of branded acute migraine prescriptions (nTRx) among prescribers.
We continue to see the benefits from increasing the sales force in July of 2022. New Trudhesa patients increased by 18 percent from Q4 2022 to Q1 2023, driven by an expanded, more efficient and increasingly productive sales force.
Reimbursement of all shipments was 72 percent in Q1 2023, compared with 60 percent in Q4 2022.
Refill rates have remained solid and consistently high at 62 percent launch-to-date.
Company recently presented Trudhesa data at the 2023 American Academy of Neurology (AAN) Annual Meeting in April suggesting Trudhesa is safe to use when co-administered with commonly prescribed migraine medications, including an analysis from the first-ever pharmacokinetic and pharmacodynamic evaluation of potential drug-drug interactions between Trudhesa and orally administered gepants. Additional analyses from the pivotal STOP 301 trial show concomitant use of Trudhesa with triptans and erenumab (a preventive CGRP medication) were well-tolerated with limited treatment-emergent adverse events reported.
Company Developments
Earlier this week, Impel announced the appointment of Michael W. Kalb, CPA, as Chief Financial Officer, effective May 10, 2023, following his tenure as Executive Vice President & Chief Financial Officer of CinCor Pharma, Inc. (NASDAQ: CINC), where he played an integral role in the company's recent acquisition by AstraZeneca for up to $1.8 billion. Mr. Kalb has more than 30 years of experience in the pharmaceutical and financial service industries.
In April 2023, Impel announced the appointment of Darren Cline to its Board of Directors. Mr. Cline brings more than 30 years of experience in the biopharmaceutical industry, including extensive commercial and operational expertise.
Financial Results for First Quarter 2023
Net Product Revenue: The Company's net revenue from sales of Trudhesa was $4.4 million for Q1 2023. This compared to net revenues of $1.8 million for Q1 2022. The increase is due to growth in Trudhesa sales volume and improvements in net price realization.
Research and Development (R&D) Expenses: R&D expenses were $3.0 million for Q1 2023, compared with $3.7 million for Q1 2022. The decrease is primarily due to lower personnel costs and program costs as the Company redirected its resources from R&D activities and pivoted its focus to supporting commercial operations rather than R&D in Q1 2023.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $22.0 million for Q1 2023, compared with $19.8 million for Q1 2022. The increase in SG&A spending was primarily due to the continued ramp-up in spending to support the commercial, sales and marketing activity in support of Trudhesa.
Net Loss: Net losses for Q1 2023 were $30.1 million, or $1.27 per common share. This compared to net losses of $27.0 million, or $1.17 per common share, for Q1 2022.
Cash on Hand/Cash Runway: As of March 31, 2023, Impel had approximately $35.5 million in cash and cash equivalents. The Company believes, based on its current operating plan, that it has sufficient capital to fund operations into Q3 2023.
Trudhesa Guidance for 2023
The Company continues to project that Trudhesa will deliver prescriptions within the range of 80,000 - 110,000 TRx for full-year 2023.
About Impel Pharmaceuticals
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.
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, the 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 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.
Contact:
Christina Tartaglia
Tel: (1) 212-362-1200
Email: christina.tartaglia@sternir.com
IPI LEGACY LIQUIDATION CO 