Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical
company focused primarily on treatments for gastrointestinal (GI)
diseases, today announced its financial results for the first
quarter ended March 31, 2022, and recent corporate developments.
“We are encouraged by the incremental improvement in net GIMOTI
sales and prescriptions and continue to receive positive feedback
from patients and physicians. Working closely with our strategic
commercial partner, Eversana, we continue to implement and execute
strategies as we seek continued improvement in the quarters ahead,”
said David A. Gonyer, R.Ph., President and CEO of Evoke Pharma. “We
have achieved four consecutive quarters of increased revenue with
an additional 16% this quarter, to $418,000. In addition, the
number of GIMOTI prescribers increased by approximately 41%, to 538
cumulative new healthcare providers (HCPs) through March 31, 2022.
Finally, prescriptions received into our specialty pharmacies
increased by 22% in the first quarter. More patients than ever – as
well as their healthcare providers – are experiencing the benefits
of GIMOTI’s novel nasal solution for diabetic gastroparesis.”
First Quarter
2022 Developments
and Recent
Progress:
GIMOTI was added to two state Medicaid
Programs
- New York Medicaid; Coverage allows
for more rapid utility of GIMOTI
- Texas Medicaid Preferred Drug List
(PDL); Effective April 12, 2022, approximately 5 million additional
patients are able to quickly access GIMOTI
- Medicaid and Medicare made up
approximately 51% of the filled prescriptions for GIMOTI in the
first quarter of 2022
New drug product exclusivity granted by the FDA for
GIMOTI nasal spray
- Company now has Hatch-Waxman Act exclusive marketing rights for
three years from approval date
Piloted strategic collaboration with vitaCare
(subsidiary of GoodRx.com)
- Quick and convenient electronic
submission of prescriptions by doctors to pharmacies online
- More effective and accelerated
insurance approval of prescriptions by pharmacies, state Medicaid
agencies and private insurance companies
- Commercial patients may receive trial
samples while awaiting insurance reimbursement
Abstract on association between tardive dyskinesia (TD)
and potential risk factors accepted as poster of distinction at
Digestive Disease Week (DDW) on May 21, 2022 in San
Diego
- Data will update TD incidence in
metoclopramide which may have been previously overestimated
- Additional medical subgroups analyzed
to inform physicians of possible additional treatment factors
Extends cash runway into Q2, 2023
- ATM program accessed for additional
sales runway
First Quarter 2022
Financial Review
For the first quarter of 2022, net product sales
were approximately $418,000 compared to approximately $90,000
during the first quarter of 2021, and the net loss was
approximately $2.2 million, or $0.07 cents per share compared with
$2.6 million, or $0.08 per share, for the first quarter of 2021.
The increase in net sales was primarily driven by increased
educational and promotional activities of the Eversana sales
force.
For the first quarter of 2022, selling, general
and administrative expenses were approximately $2.4 million
compared with $2.3 million for the first quarter of 2021. We expect
that selling, general and administrative expenses may increase in
the future as we continue to progress with the commercialization of
GIMOTI and we reimburse Eversana from the net profits attained from
the sales of GIMOTI.
Total operating expenses for the first quarter
of 2022 were approximately $2.5 million compared with $2.7 million
for the same period of 2021.
As of March 31, 2022, cash and cash equivalents
were approximately $7.7 million. We also received net proceeds of
approximately $7.1 million from sales under our ATM program after
March 31, 2022. 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 second 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.
Follow GIMOTI on Facebook:
https://www.facebook.com/GIMOTI-metoclopramide-nasal-spray-104672345100289
Follow Evoke Pharma on Facebook:
https://www.facebook.com/Evoke-Pharma-Inc-131313647029724Follow
Evoke Pharma on LinkedIn:
https://www.linkedin.com/company/evoke-pharma/
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 the 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 and sales 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 Evoke’s future capital requirements. 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 Contact: Daniel Kontoh-BoatengDKB
PartnersTel: 862-213-1398dboateng@dkbpartners.net
Source: Evoke Pharma, Inc.
(Financial Statements to
Follow)
Evoke
Pharma, Inc.Condensed Balance Sheets |
|
|
March 31,
2022 |
|
December 31,
2021 |
|
(Unaudited) |
|
|
Assets |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
7,701,201 |
|
|
$ |
9,144,710 |
|
Accounts receivable, net |
|
418,910 |
|
|
|
295,193 |
|
Prepaid expenses |
|
615,832 |
|
|
|
923,746 |
|
Inventory |
|
278,776 |
|
|
|
185,534 |
|
Other current assets |
|
11,551 |
|
|
|
11,551 |
|
Total
current assets |
|
9,026,270 |
|
|
|
10,560,734 |
|
Operating
lease right-of-use asset |
|
— |
|
|
|
12,428 |
|
Total
assets |
$ |
9,026,270 |
|
|
$ |
10,573,162 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
944,478 |
|
|
$ |
874,028 |
|
Accrued compensation |
|
412,198 |
|
|
|
519,317 |
|
Operating lease liability |
|
— |
|
|
|
12,428 |
|
Total
current liabilities |
|
1,356,676 |
|
|
|
1,405,773 |
|
Long-term
liabilities |
|
|
|
Note payable |
|
5,000,000 |
|
|
|
5,000,000 |
|
Accrued interest payable |
|
735,583 |
|
|
|
612,295 |
|
Total
long-term liabilities |
|
5,735,583 |
|
|
|
5,612,295 |
|
Total
liabilities |
|
7,092,259 |
|
|
|
7,018,068 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Common stock |
|
3,292 |
|
|
|
3,266 |
|
Additional paid-in capital |
|
111,527,397 |
|
|
|
110,974,841 |
|
Accumulated deficit |
|
(109,596,678 |
) |
|
|
(107,423,013 |
) |
Total
stockholders' equity |
|
1,934,011 |
|
|
|
3,555,094 |
|
Total
liabilities and stockholders' (deficit) equity |
$ |
9,026,270 |
|
|
$ |
10,573,162 |
|
|
|
|
|
Evoke Pharma, Inc.Condensed Statements of
Operations |
|
|
Three Months Ended March 31, |
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
Net product sales |
$ |
418,380 |
|
|
$ |
90,421 |
|
Operating expenses: |
|
|
|
Cost of goods sold |
|
22,760 |
|
|
|
64,751 |
|
Research and development |
|
41,717 |
|
|
|
277,825 |
|
Selling, general and administrative |
|
2,405,075 |
|
|
|
2,338,295 |
|
Total operating expenses |
|
2,469,552 |
|
|
|
2,680,871 |
|
Loss from operations |
|
(2,051,172 |
) |
|
|
(2,590,450 |
) |
Other income (expense): |
|
|
|
Forgiveness of paycheck protection loan and accrued interest |
|
— |
|
|
|
105,130 |
|
Interest income |
|
795 |
|
|
|
3,164 |
|
Interest expense |
|
(123,288 |
) |
|
|
(123,339 |
) |
Total other income (expense) |
|
(122,493 |
) |
|
|
(15,045 |
) |
Net loss |
$ |
(2,173,665 |
) |
|
$ |
(2,605,495 |
) |
|
|
|
|
Net loss per share of common stock, basic and diluted |
$ |
(0.07 |
) |
|
$ |
(0.08 |
) |
|
|
|
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
32,777,294 |
|
|
|
31,158,065 |
|
|
|
|
|
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Evoke Pharma (NASDAQ:EVOK)
Historical Stock Chart
From Apr 2023 to Apr 2024