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
HighlightsTrudhesa® (Dihydroergotamine Mesylate)
Nasal Spray (0.725 Mg Per Spray)
- To-date, Trudhesa continues a
strong trajectory with more than 58,400 prescriptions generated in
2022. Based on third-party data, it is estimated that at the end of
December Trudhesa accounted for 4.3 percent of branded acute
migraine prescriptions (nTRx) among prescribers.
- We continue to see the benefits of
the increased sales force from last July. New Trudhesa
prescriptions increased by 24 percent from Q3 to Q4 2022 driven by
an expanded, more efficient salesforce. Additionally, the existing
(n=60) and new (n=30) sales representatives increased monthly new
patients starts by 29.7 percent and 45.8 percent, respectively,
from October through December 2022, for a total increase in monthly
new patient starts of more than 35 percent during this time
period.
- Reimbursement of all shipments is
60 percent for the fourth quarter 2022. Refill rates have remained
consistently high with 63 percent at the end of 2022.
- Impel will have a presence at the
American Academy of Neurology (AAN) Annual Meeting taking
place in Boston, April 22-27, 2023 and at the American Headache
Society (AHS) Annual Scientific Meeting taking place in Austin,
Texas, June 15-18, 2023.
Clinical Developments
- In November 2022, Impel published a
manuscript in The Journal of Headache and Pain which detailed
results from a review developed to illustrate the variability of
recurrence rates depending on the definition of “recurrence” for
widely used acute treatments for migraine.
- Also in November 2022, Impel
published a manuscript in the Journal of Aerosol Medicine and
Pulmonary Drug Delivery which showed that clinical studies of
Trudhesa demonstrated a favorable pharmacokinetic profile,
consistent and predictable dosing, rapid systemic levels known to
be effective (similar to other DHE mesylate clinical programs),
safety and tolerability on the upper nasal mucosa, and high patient
acceptance. Additionally, the Precision Olfactory Delivery (POD®)
technology may have the potential to overcome the limitations of
traditional nasal delivery systems, while utilizing the nasal
delivery benefits of gastrointestinal tract avoidance, rapid onset,
patient convenience, and ease of use.
- In October 2022, Impel published a
manuscript in the Annals of Otolaryngology and Rhinology Outreach
detailing results from first-of-their-kind safety assessments
designed for and used in the pivotal STOP 301 study of
Trudhesa.
Financial Results for Fourth Quarter and
Year End 2022
- Net Product
Revenue: The Company’s net revenue from sales of
Trudhesa was $5.0 million and $12.7 million for the fourth quarter
and full year 2022, respectively. This compared to net revenues of
$0.6 million and $0.7 million for the fourth quarter and full year
2021, respectively. Shipments of Trudhesa were initiated to
specialty pharmacies in late September 2021 ahead of the October
2021 commercial launch.
- Research and Development
(R&D) Expenses: R&D expenses were $0.7 million and
$11.5 million for the fourth quarter and full year 2022,
respectively, compared with $4.5 million and $20.6 million for the
same periods of 2021, respectively. The decrease in R&D expense
was due to the return of the $2.9 million new drug application fee
from the U.S. Food and Drug Administration (FDA) received in the
fourth quarter of 2022 and a reduction in Trudhesa clinical
expenses as the Phase 3 STOP 301 study was closed. This was
partially offset by an increase in spending for the clinical
development of INP105.
- Selling, General and
Administrative (SG&A) Expenses: SG&A expenses were
$20.3 million and $77.9 million for the fourth quarter and full
year 2022, respectively, compared with $19.9 million and $50.9
million for the same periods of 2021, respectively. 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 the Trudhesa launch.
- GAAP Net Loss: Net
losses for the fourth quarter and full year 2022 were $23.0 million
and $106.3 million, respectively, or $0.97 and $4.53 per common
share, respectively. This compared to net losses of $24.7 million
and $76.7 million, respectively, or $1.07 and $5.25 per common
share, respectively, for the same periods in 2021.
- Non-GAAP Net Loss Per
Share: Non-GAAP Net Loss Per Share for the fourth quarter
and full year 2022 were $0.97 and $4.53, respectively, compared to
a Non-GAAP Net Loss Per Share of $1.07 and $3.68, respectively, for
the same periods in 2021. Non-GAAP Pro Forma Net Loss Per Share
gives effect to the Company’s reverse stock split, the shares of
common stock issued in its April 2021 IPO, shares exchanged for
previously issued and outstanding stock warrants of Impel, and the
conversion of the Company’s convertible preferred stock and its
convertible notes into shares of common stock as if such
conversions occurred at the beginning of each period presented.
Non-GAAP Net Loss Per Share excludes the change in fair value of
the convertible notes and interest expense on Impel’s convertible
notes, the effect of accretion on its redeemable convertible
preferred stock and the change in fair value of its redeemable
convertible preferred stock warrants, all of which converted to
shares of common stock in the Company’s April 2021 IPO. Please
refer to the section in this press release titled "Reconciliation
of GAAP and Non-GAAP Results" for details.
- Cash on Hand/Cash
Runway: As of December 31, 2022, Impel had approximately
$60.7 million in cash and cash equivalents. The Company believes,
based on its current operating plan, that it has sufficient capital
to fund operations into the third quarter of 2023.
Trudhesa Guidance for 2023
- The Company projects Trudhesa will
deliver prescriptions within the range of 80,000 – 110,000 TRx for
full year 2023.
Conference Call
InformationImpel 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:
https://edge.media-server.com/mmc/p/3nhzorse. 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 MeasuresWe
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
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, 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 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.
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 |
|
|
22,870 |
|
|
|
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 |
|
|
|
|
|
|
Impel Pharmaceuticals Inc.Condensed
Consolidated Statement of Operations and Comprehensive
Loss(in thousands) |
|
|
|
For the Three Months EndedDecember
31, |
|
|
Year EndedDecember 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 |
|
Impel Pharmaceuticals Inc.Earnings Per
Share(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
For the Three Months EndedDecember
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 EndedDecember
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 |
) |
Contact: |
|
Investor Relations: |
Media Relations: |
Janhavi Mohite |
Melyssa Weible |
Stern Investor Relations |
Elixir Health Public Relations |
Phone: 212-362-1200 |
Phone: (1) 201-723-5805 |
Email: janhavi.mohite@sternir.com |
Email: mweible@elixirhealthpr.com |
Impel Pharmaceuticals (NASDAQ:IMPL)
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Impel Pharmaceuticals (NASDAQ:IMPL)
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De May 2023 a May 2024