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 fourth
quarter and full year ended December 31, 2023, and recent corporate
developments.
"In 2023, we focused on operational excellence
to expand GIMOTI’s market share and ensure its availability for
patients requiring an improved gastroparesis treatment. Our
commercial team’s dedicated efforts yielded a 107% increase in
year-over-year revenue,” stated Dave Gonyer, R.Ph., CEO of Evoke
Pharma. “The new Healthcare Resource Utilization (HCRU) data has
only been available to our commercial team since near the end of
the year. We believe it is just starting to drive growth beginning
with the addition of new prescribers, a rise in prescription fills,
and an uptick in patient enrollments, solidifying 2023 as an
important year for our product’s market presence. As of December
31, 2023, we’ve seen a 66% rise in cumulative prescribers from the
previous year, totaling 1,689. Prescription fills and patient
enrollments also climbed significantly by 100% and 88%
respectively, year-over-year,” Mr. Gonyer added.
Fourth Quarter
and Full Year 2023
Developments and
Recent Highlights:
- Continued Advocacy for
GIMOTI as the Standard of Care for Diabetic Gastroparesis
Treatment
- Healthcare resource utilization data presented at DDW 2023
revealed that there is statistically signficantly less burden on
healthcare resources and facilities such as hospitical admissions,
emergency department and physician office visits with patients who
are being prescirbed GIMOTI versus those on oral
metoclopramide.
- Based on the reduced utilization data, additional compelling
cost data presented in a distinguished plenary session at ACG 2023
demonstrated financial savings benefits of GIMOTI for patients and
payors compared to oral metoclopramide.
- Abstract focused on the HCRU of diabetic gastroparesis care in
women using nasal metoclopramide to be presented at DDW 2024.
- Transitioned Pharmacy
Service Partnership to ASPN Pharmacies
- Aiming to enhance patient prescription process and enhance
revenues through ASPN’s extensive network of partners with broader
PBM agreements.
- Fortified Patent Estate for
GIMOTI
- Two patents issued in 2023 covering the methods of use for
GIMOTI including two Orange Book listings.
- Teva Pharmaceuticals determination not to pursue a paragraph 4
certification against Gimoti without financial or other
consideration further enhanced Evoke’s intellectual property
position and eliminated 180-day exclusivity opportunity for later
possible generic seeking entities for the future.
- Improved Cash Position
- In February 2024, the Company
closed a $7.5M public offering with fundamental,
healthcare-oriented institutional investors providing the company
runway into the fourth quarter of 2024 with up to an additional
$22.5M available if common stock warrants are exercised in
full.
Mr. Gonyer concluded, “2023 was a milestone year
for GIMOTI with new real-world evidence demonstrating its
superiority over traditional treatments and data showing a marked
decrease in hospitalization and ER visits for GIMOTI over oral
metoclopramide which translated into savings of over $15,000 per
patient in only six months. Our results at major gastroenterology
conferences including Digestive Disease Week 2023 have strengthened
market trust in GIMOTI, bolstering our goal to make it the standard
treatment for diabetic gastroparesis. Current and new IP
protections, coupled with new inquiries about the prevalence GLP-1
associated diabetic gastroparesis, and the recent capital boost
from our public offering further position us to scale our
operations and achieve sustained business growth.”
Fourth Quarter
and Full Year
2023 Financial Review and
Outlook
For the fourth quarter of 2023, net product
sales were approximately $1.7 million compared with $0.8 million
during the fourth quarter of 2022, and the net loss was
approximately $2.0 million, or $0.59 per share compared with $1.8
million, or $0.54 per share, for the fourth quarter of 2022. For
the year ended December 31, 2023, net product sales were
approximately $5.2 million compared with approximately $2.5 million
for the year ended December 31, 2022, and the net loss was
approximately $7.8 million, or $2.33 per share, compared with a net
loss of $8.2 million, or $2.62 per share, for the year ended
December 31, 2022. The year-over-year increase in revenue was due
to higher net product sales in 2023, resulting from:
- Prescription sales through pharmacy
service partnership with ASPN Pharmacy;
- Recapture of prescriptions sent to
retail pharmacies without ability to order product; and
- Marketing of head-to-head
real-world data comparing Gimoti to oral metoclopramide showing
improvements in fewer hospitalizations and ER visits with
GIMOTI.
Research and development expenses totaled
approximately $23,000 for the fourth quarter of 2023 compared with
$27,000 for the fourth quarter of 2022. For the full year of 2023,
research and development expenses were approximately $0.2 million
compared with approximately $0.3 million for the prior year.
For the fourth quarter of 2023 selling, general
and administrative (SG&A) expenses were approximately $3.5
million compared with $2.3 million for the fourth quarter of 2022.
For the year ended December 31, 2023, selling, general and
administrative expenses were approximately $12.2 million versus
approximately $9.6 million for the year ended December 31, 2022.
The increase in SG&A costs year-over-year resulted primarily
from higher marketing and Eversana profit sharing costs. We expect
that selling, general and administrative expenses will increase in
the future as we continue to progress with the commercialization of
GIMOTI.
Total operating expenses for the fourth quarter
of 2023 were approximately $3.6 million compared with $2.3 million
for the same period of 2022. For the year ended December 31, 2023,
total operating expenses were approximately $12.6 million compared
with approximately $10.3 million for the full year of 2022.
As of December 31, 2023, cash and cash
equivalents were approximately $4.7 million. We believe, based on
our current operating plan, that our existing cash and cash
equivalents, including the proceeds of approximately $6.1 million
from the public offering closed in February 2024, as well as future
cash flows from net product sales of Gimoti, will be sufficient to
fund our operations into the fourth quarter of 2024.
Evoke projects net revenue in 2024 of
approximately $14 million. Evoke’s 2024 guidance is dependent on
its current business and expectations, including recent growth
rates in net sales, assumptions regarding reimbursements and
prescription fills, as well as factors that are outside of our
control, such as the global macroeconomic and geopolitical
environment, continued supply chain constraints and inflationary
pressures.
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.
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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 InformationWARNING: 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: guidance
regarding 2024 net product sales; potential future prescribing
trends for GIMOTI based on Evoke’s or EVERSANA’s marketing efforts;
Evoke’s commercialization plans, including the potential that
GIMOTI could become the standard of care for gastroparesis; the
potential for additional funds from the exercise of outstanding
warrants and Evoke’s expected cash runway. 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 may not be able to
achieve it’s guidance for 2024 including as a result of decreased
demand for GIMOTI; 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; Evoke may
use its capital resources sooner than expected; warrant holders may
choose not to exercise any of the outstanding warrants; 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.Balance Sheet
Evoke Pharma, Inc.Statement of Operations
The Financial Statements accompanying this
announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/1505239a-5694-4a7e-99c2-8d96e50a84a3
https://www.globenewswire.com/NewsRoom/AttachmentNg/b26e2618-665c-4966-acc6-c45d683cb7e0
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