Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused primarily on treatments for gastrointestinal (GI)
diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray,
today announced its financial results for the first quarter ended
March 31, 2023, and recent corporate developments.
“We are pleased to witness a solid uptick in most categories of
our sales growth indicators – net revenue, fills, cumulative
prescribers and patient enrollments over the course of the first
quarter of 2023. Looking back at our sales metrics in Q4 2022, we
returned to normal levels of upward revenue growth and recorded
$810,000 in net product sales in Q1 2023, approximately a 2%
increase from Q4 2022, and up 94% year-over-year. Our cumulative
prescribers increased 17% from Q4 2022 and have now reached 1,189.
Prescription fills also continue to rise with an 11% increase over
the previous quarter,” said David A. Gonyer, R.Ph., Evoke Pharma’s
CEO.
“Insights from a recent survey, market data analysis, and
patient and healthcare provider anecdotes, demonstrate the need for
GIMOTI in the marketplace and we believe that the incremental
growth in our sales metrics confirms this sentiment. Our current
sales performance coupled with the Company’s recent corporate
achievements particularly on the intellectual property front, we
believe in the commercial success of GIMOTI while improving the
quality of life for patients living with gastroparesis,” concluded
Mr. Gonyer.
First Quarter 2023 Developments and
Recent Progress
- Further strengthened
intellectual property estate
- Successfully settled Teva
Pharmaceuticals lawsuit with dismissal from both parties, ending
Teva’s attempt of a Paragraph IV ANDA certification
- Granted new U.S. patent (No.
11,628,150) covering the nasal solution of metoclopramide and its
characteristics when formulated
- Newly listed U.S. patent (No.
11,628,150) in the U.S. Food and Drug Administration (FDA) “Orange
Book”
- Presented healthcare resource utilization real-world
data analyses at leading medical meetings
- Data abstract suggesting that GIMOTI
(nasal metoclopramide) patients experience a lower use of
healthcare resources compared to patients receiving oral
metoclopramide accepted and presented in DDW’s distinguished
plenary session
- Compelling real-world data presented
at Academy of Managed Care Pharmacy (AMCP) 2023 also demonstrating
the mitigated use of healthcare resources amongst patients treated
with GIMOTI
First Quarter 2023 Financial
Review
For the first quarter of 2023, net product sales
were approximately $810,000 compared to approximately $418,000
during the first quarter of 2022. The increase in net sales was
primarily driven by increased promotional activities of the
Eversana sales force and prescription management through
vitaCare.
For the first quarter of 2023, selling, general
and administrative expenses were approximately $2.8 million
compared to $2.4 million for the first quarter of 2022. The
increases were due to higher professional fees and reimbursement
and profit-sharing activity with EVERSANA.
Total operating expenses for the first quarter
of 2023 were approximately $3.0 million compared to $2.5 million
for the same period in 2022.
As of March 31, 2023, cash and cash equivalents
were approximately $8.2 million. We believe, based on our current
operating plan, that our existing cash and cash equivalents, as
well as future cash flows from net product sales of GIMOTI, will be
sufficient to fund our operations into the fourth quarter of
2023.
About Evoke
Pharma, Inc.
Evoke is a specialty pharmaceutical company focused primarily on
the development of drugs to treat GI disorders and diseases. The
company developed, commercialized and markets GIMOTI, a nasal spray
formulation of metoclopramide, for the relief of symptoms
associated with acute and recurrent diabetic gastroparesis in
adults.
Diabetic gastroparesis is a GI disorder affecting millions of
patients worldwide, in which the stomach takes too long to empty
its contents resulting in serious GI symptoms as well as other
systemic complications. The gastric delay caused by gastroparesis
can compromise absorption of orally administered medications. Prior
to FDA approval to commercially market GIMOTI, metoclopramide was
only available in oral and injectable formulations and remains the
only drug currently approved in the United States to treat
gastroparesis. Visit www.EvokePharma.com for more information.
Visit www.EvokePharma.com for more information.Follow
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About
Gimoti®
(metoclopramide) nasal
spray
GIMOTI is indicated for the relief of symptoms in adults with
acute and recurrent diabetic gastroparesis. Important Safety
Information
WARNING: TARDIVE DYSKINESIA
- Metoclopramide can cause tardive dyskinesia (TD), a serious
movement disorder that is often irreversible. The risk of
developing TD increases with duration of treatment and total
cumulative dosage.
- Discontinue GIMOTI in patients who develop signs or symptoms of
TD. In some patients, symptoms may lessen or resolve after
metoclopramide is stopped.
- Avoid treatment with metoclopramide (all dosage forms and
routes of administration) for longer than 12 weeks because of the
increased risk of developing TD with longer-term use.
GIMOTI is not recommended for use in:
- Pediatric patients due to the risk of developing tardive
dyskinesia (TD) and other extrapyramidal symptoms as well as the
risk of methemoglobinemia in neonates.
- Moderate or severe hepatic impairment (Child-Pugh B or C),
moderate or severe renal impairment (creatinine clearance less than
60 mL/minute), and patients concurrently using strong CYP2D6
inhibitors due to the risk of increased drug exposure and adverse
reactions.
GIMOTI is contraindicated:
- In patients with a history of tardive dyskinesia (TD) or a
dystonic reaction to metoclopramide.
- When stimulation of gastrointestinal motility might be
dangerous (e.g., in the presence of gastrointestinal hemorrhage
mechanical obstruction, or perforation).
- In patients with pheochromocytoma or other
catecholamine-releasing paragangliomas. Metoclopramide may cause a
hypertensive/pheochromocytoma crisis, probably due to release of
catecholamines from the tumor.
- In patients with epilepsy. Metoclopramide may increase the
frequency and severity of seizures.
- In patients with hypersensitivity to metoclopramide. Reactions
have included laryngeal and glossal angioedema and
bronchospasm.
Potential adverse reactions associated with metoclopramide
include: Tardive dyskinesia (TD), other extrapyramidal effects
(EPS), parkinsonism symptoms, motor restlessness, neuroleptic
malignant syndrome (NMS), depression, suicidal ideation and
suicide, hypertension, fluid retention, hyperprolactinemia, effects
on the ability to drive and operate machinery. Most common adverse
reactions (≥5%) for GIMOTI are: dysgeusia, headache, and fatigue.
These are not all of the possible side effects of GIMOTI. Call your
doctor for medical advice about whether you should take GIMOTI and
the possible risk factors and side effects. You are encouraged to
report negative side effects of prescription drugs to FDA.
Visit www.fda.gov/medwatch or call
1-800-FDA-1088.
Safe Harbor
Statement
Evoke cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negatives of these
terms or other similar expressions. These statements are based on
the company’s current beliefs and expectations. These
forward-looking statements include statements regarding: potential
future prescribing trends for GIMOTI based on Evoke’s or EVERSANA’s
marketing efforts; Evoke’s commercialization plans, including its
plans to increase awareness of and access to GIMOTI and change the
standard of care for diabetic gastroparesis; and Evoke’s future
capital requirements, including whether Evoke’s cash and cash
equivalents and future cash flows from net product sales will be
sufficient to fund its operations into the fourth quarter of 2023 .
The inclusion of forward-looking statements should not be regarded
as a representation by Evoke that any of its plans will be
achieved. Actual results may differ from those set forth in this
press release due to the risks and uncertainties inherent in
Evoke’s business, including, without limitation: Evoke’s and
EVERSANA’s ability to successfully drive market demand for GIMOTI;
Evoke’s ability to obtain additional financing as needed to support
its operations; the COVID-19 pandemic may continue to disrupt
Evoke’s and EVERSANA’s business operations impairing the ability to
commercialize GIMOTI and Evoke’s ability to generate product
revenue; Evoke’s dependence on third parties for the manufacture of
GIMOTI; Evoke is entirely dependent on the success of GIMOTI;
inadequate efficacy or unexpected adverse side effects relating to
GIMOTI that could result in recalls or product liability claims;
Evoke’s ability to maintain intellectual property protection for
GIMOTI; and other risks and uncertainties detailed in Evoke’s prior
press releases and in the periodic reports it files with the
Securities and Exchange Commission. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date hereof, and Evoke undertakes no obligation to
revise or update this press release to reflect events or
circumstances after the date hereof. All forward-looking statements
are qualified in their entirety by this cautionary statement. This
caution is made under the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995.
Investor & Media Contact:Daniel
Kontoh-Boateng DKB PartnersTel:
862-213-1398dboateng@dkbpartners.net
Financial Statements to Follow
Evoke
Pharma, Inc |
Condensed
Balance Sheets |
|
|
|
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
(unaudited) |
|
|
Assets |
|
|
|
|
Current
Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
8,212,804 |
|
|
$ |
9,843,699 |
|
Accounts receivable, net |
|
|
687,302 |
|
|
|
624,832 |
|
Prepaid expenses |
|
|
671,386 |
|
|
|
952,954 |
|
Inventory, net |
|
|
364,867 |
|
|
|
289,378 |
|
Other current assets |
|
|
11,551 |
|
|
|
11,551 |
|
Total
current assets |
|
|
9,947,910 |
|
|
|
11,722,414 |
|
Operating
lease right-of-use asset |
|
|
91,397 |
|
|
|
129,074 |
|
Total
assets |
|
$ |
10,039,307 |
|
|
$ |
11,851,488 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
1,185,925 |
|
|
$ |
934,312 |
|
Accrued compensation |
|
|
400,251 |
|
|
|
591,158 |
|
Operating lease liability |
|
|
91,397 |
|
|
|
129,074 |
|
Total
current liabilities |
|
|
1,677,573 |
|
|
|
1,654,544 |
|
Long-term
liabilities |
|
|
|
|
Note payable |
|
|
5,000,000 |
|
|
|
5,000,000 |
|
Accrued interest payable |
|
|
1,235,583 |
|
|
|
1,112,295 |
|
Total
long-term liabilities |
|
|
6,235,583 |
|
|
|
6,112,295 |
|
Total
liabilities |
|
|
7,913,156 |
|
|
|
7,766,839 |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
Common stock, $0.0001 par value; authorized shares - 50,000,000;
issued and outstanding shares - 3,343,070 and 2,721,373 at March
31, 2023 and December 31, 2022, respectively |
|
|
334 |
|
|
|
334 |
|
Additional paid-in capital |
|
|
120,016,030 |
|
|
|
119,731,458 |
|
Accumulated deficit |
|
|
(117,890,213 |
) |
|
|
(115,647,143 |
) |
Total
stockholders’ equity |
|
|
2,126,151 |
|
|
|
4,084,649 |
|
Total
liabilities and stockholders’ equity |
|
$ |
10,039,307 |
|
|
$ |
11,851,488 |
|
|
|
|
|
|
Evoke
Pharma, Inc. |
Condensed
Statement of Operations |
(unaudited) |
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Net product
sales |
|
$ |
810,408 |
|
|
$ |
418,380 |
|
Operating
expenses: |
|
|
|
|
Cost of goods sold |
|
|
50,591 |
|
|
|
22,760 |
|
Research and development |
|
|
66,990 |
|
|
|
41,717 |
|
Selling, general and administrative |
|
|
2,847,940 |
|
|
|
2,405,075 |
|
Total
operating expenses |
|
|
2,965,521 |
|
|
|
2,469,552 |
|
Loss from
operations |
|
|
(2,155,113 |
) |
|
|
(2,051,172 |
) |
Other income
(expense): |
|
|
|
|
Interest income |
|
|
35,331 |
|
|
|
795 |
|
Interest expense |
|
|
(123,288 |
) |
|
|
(123,288 |
) |
Total other
income (expense) |
|
|
(87,957 |
) |
|
|
(122,493 |
) |
Net
loss |
|
$ |
(2,243,070 |
) |
|
$ |
(2,173,665 |
) |
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
$ |
(0.67 |
) |
|
$ |
(0.80 |
) |
|
|
|
|
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
|
3,343,070 |
|
|
|
2,731,440 |
|
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