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
HighlightsTrudhesa® (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.
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 first quarter 2023 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.
About Impel
PharmaceuticalsImpel 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®
IndicationTrudhesa® 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:
- Have any disease affecting your
heart, arteries, or blood circulation.
- Are taking certain anti-HIV
medications known as protease inhibitors (such as ritonavir or
nelfinavir).
- Are taking a macrolide antibiotic
such as clarithromycin or erythromycin.
- Are taking certain antifungals such
as ketoconazole or itraconazole.
- Have taken certain medications such
as triptans or ergot-type medications for the treatment or
prevention of migraine within the last 24 hours.
- Have taken any medications that
constrict your blood vessels or raise your blood pressure.
- Have severe liver or kidney
disease.
- Are allergic to ergotamine or
dihydroergotamine.
Before taking Trudhesa, tell your doctor
if:
- You have high blood pressure, chest
pain, shortness of breath, heart disease; or risk factors for heart
disease (such as high blood pressure, high cholesterol, obesity,
diabetes, smoking, strong family history of heart disease or you
are postmenopausal, or male over 40); or problems with blood
circulation in your arms, legs, fingers, or toes.
- You have or had any disease of the
liver or kidney.
- You are taking any prescription or
over-the-counter medications, including vitamins or herbal
supplements.
- You are pregnant, planning to
become pregnant or are nursing, or have ever stopped medication due
to an allergy or bad reaction.
- This headache is different from
your usual migraine attacks.
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:
- Numbness or tingling in your
fingers and toes
- Severe tightness, pain, pressure,
heaviness, or discomfort in your chest
- Muscle pain or cramps in your arms
or legs
- Cold feeling or color changes in
one or both legs or feet
- Sudden weakness
- Slurred speech
- Swelling or itching
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
StatementsThis 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.
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.
|
|
|
|
|
|
|
Impel
Pharmaceuticals Inc. |
|
|
Condensed
Consolidated Statement of Operations and Comprehensive
Loss |
|
|
(in
thousands) |
|
|
|
|
|
|
|
|
|
For the Three Months Ended March 31, |
|
|
|
2023 |
|
2022 |
|
|
Product revenue, net |
$ |
4,372 |
|
|
$ |
1,759 |
|
|
|
Cost of
goods sold |
|
2,285 |
|
|
|
1,033 |
|
|
|
Gross profit |
|
2,087 |
|
|
|
726 |
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
3,003 |
|
|
|
3,650 |
|
|
|
Selling, general and administrative |
|
22,037 |
|
|
|
19,799 |
|
|
|
Restructuring |
|
1,483 |
|
|
|
— |
|
|
|
Total
operating expenses |
|
26,523 |
|
|
|
23,449 |
|
|
|
Loss from
operations |
|
(24,436 |
) |
|
|
(22,723 |
) |
|
|
Other income
(expense), net : |
|
|
|
|
|
Interest income (expense), net |
|
(2,933 |
) |
|
|
(4,427 |
) |
|
|
Other income (expense), net |
|
(2,698 |
) |
|
|
180 |
|
|
|
Total other
income (expense), net |
|
(5,631 |
) |
|
|
(4,247 |
) |
|
|
Loss before
income taxes |
|
(30,067 |
) |
|
|
(26,970 |
) |
|
|
Provision
(benefit) for income taxes |
|
— |
|
|
|
— |
|
|
|
Net loss and
comprehensive loss |
$ |
(30,067 |
) |
|
$ |
(26,970 |
) |
|
|
Net loss per
share, basic and diluted |
$ |
(1.27 |
) |
|
$ |
(1.17 |
) |
|
|
Weighted-average shares used in computing net loss per share —
basic and diluted |
|
23,745,871 |
|
|
|
23,143,773 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
IMPEL
PHARMACEUTICALS INC. |
|
|
Condensed
Consolidated Balance Sheet |
|
|
(In
thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
35,465 |
|
|
$ |
60,654 |
|
|
|
Trade receivables, net |
|
6,280 |
|
|
|
7,444 |
|
|
|
Inventory |
|
8,014 |
|
|
|
8,427 |
|
|
|
Prepaid expenses and other current assets |
|
2,125 |
|
|
|
3,284 |
|
|
|
Total
current assets |
|
51,884 |
|
|
|
79,809 |
|
|
|
Property and
equipment, net |
|
4,081 |
|
|
|
3,863 |
|
|
|
Operating
lease right-of-use assets |
|
4,833 |
|
|
|
3,132 |
|
|
|
Other
assets |
|
3,931 |
|
|
|
1,746 |
|
|
|
Total assets |
$ |
64,729 |
|
|
$ |
88,550 |
|
|
|
Liabilities and stockholders’ (deficit)
equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
6,133 |
|
|
$ |
6,092 |
|
|
|
Accrued liabilities and other liabilities |
|
11,723 |
|
|
|
12,503 |
|
|
|
Current portion of deferred royalty obligation |
|
2,690 |
|
|
|
2,027 |
|
|
|
Current portion of operating lease liability |
|
1,736 |
|
|
|
1,541 |
|
|
|
Total
current liabilities |
|
22,282 |
|
|
|
22,163 |
|
|
|
Operating lease liability, net of current portion |
|
3,074 |
|
|
|
1,573 |
|
|
|
Deferred royalty obligation, net of current portion |
|
64,183 |
|
|
|
60,899 |
|
|
|
Long-term debt |
|
48,095 |
|
|
|
48,072 |
|
|
|
Total liabilities |
|
137,634 |
|
|
|
132,707 |
|
|
|
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;
23,746,257 and 23,739,313 shares issued and outstanding at March
31, 2023 and December 31, 2022, respectively |
|
24 |
|
|
|
24 |
|
|
|
Additional paid-in capital |
|
278,248 |
|
|
|
276,929 |
|
|
|
Accumulated deficit |
|
(351,177 |
) |
|
|
(321,110 |
) |
|
|
Total
stockholders’ (deficit) equity |
|
(72,905 |
) |
|
|
(44,157 |
) |
|
|
Total liabilities and stockholders’ (deficit)
equity |
$ |
64,729 |
|
|
$ |
88,550 |
|
|
|
|
|
|
|
|
Contact: |
|
Investor Relations: |
Media Relations: |
Christina Tartaglia |
Melyssa Weible |
Stern Investor Relations |
Elixir Health Public Relations |
Phone: (1) 212-362-1200 |
Phone: (1) 201-723-5805 |
Email: christina.tartaglia@sternir.com |
Email: mweible@elixirhealthpr.com |
Impel Pharmaceuticals (NASDAQ:IMPL)
Historical Stock Chart
From Apr 2024 to May 2024
Impel Pharmaceuticals (NASDAQ:IMPL)
Historical Stock Chart
From May 2023 to May 2024