Evoke Pharma Reports Second Quarter 2023 Financial Results
10 August 2023 - 2:30PM
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, announced its financial
results for the second quarter ended June 30, 2023, and recent
corporate developments.
“The second quarter of 2023 concluded on a highly encouraging
note with $1.1 million in net revenue, a 40% increase from our
sales last quarter. We also recorded increases in other sales
growth-related categories – including prescription fills,
cumulative prescribers, and patient enrollments. At the end of the
second quarter, we captured a total of 1,388 prescribers, a 17%
increase from our reported results in Q1 2023. Our prescription
fill and enrollment rates also improved in the second quarter with
an approximate 16% and 18% surge from last quarter’s metrics,
respectively,” commented David A. Gonyer, R.Ph., Chief Executive
Officer of Evoke Pharma.
“We were honored with recognition at Digestive Disease Week
(DDW) related to recent Real World studies showing patients treated
with GIMOTI used significantly less healthcare resources such as
office visits, inpatient hospitalizations and emergency room visits
compared to patients being treated with oral metoclopramide. While
this data was announced during the second quarter, the process of
educating the professional GI community, healthcare providers,
patients, and investors on the significance of our healthcare
resource utilization data has only just begun. Across the board,
our business is moving in the right direction and we are excited
for the future of GIMOTI within the marketplace,” Mr. Gonyer
added.
Second Quarter 2023 Developments and Recent
Progress
Continued Presentations and Abstract Acceptances at
Renowned Medical Meetings
- Real-world healthcare utilization data demonstrating meaningful
reduction of healthcare resources on GIMOTI usage versus oral
metoclopramide unveiled at DDW 2023 in distinguished plenary
session;
- Abstract accepted for plenary oral presentation at American
College of Gastroenterology (ACG) 2023 Meeting to review tangible
and quantifiable benefits of GIMOTI in relation to reducing
healthcare costs;
- American Neurogastroenterology and Motility Society (ANMS)
accepted healthcare resource utilization abstract for poster
session at annual meeting in August.
Augmented Intellectual Property Estate
- 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" further protecting GIMOTI
from generic drug market.
Second Quarter 2023 Financial Review
For the second quarter of 2023, net product sales
were $1,131,368 compared to $461,795 during the second
quarter of 2022. Similar to last quarter, the increase in net sales
was primarily driven by increased educational and promotional
activities of the EVERSANA sales force and prescription management
through vitaCare.
For the second quarter of 2023, selling, general and
administrative expenses were approximately $2.8
million compared to $2.3 million for the second
quarter of 2022. The increases were due to higher professional fees
and reimbursement and profit-sharing activity with EVERSANA.
Total operating expenses for the second quarter of 2023 were
approximately $2.9 million compared to $2.6
million for the same period in 2022.
As of June 30, 2023, cash and cash equivalents were
approximately $7.0 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 first quarter of
2024.
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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Safe Harbor StatementEvoke 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: GIMOTI’s
potential to reduce healthcare resource utilization by diabetic
gastroparesis patents; and Evoke’s belief that GIMOTI can improve
treatment of diabetic gastroparesis. 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, maintain and successfully enforce intellectual
property protection for GIMOTI; the results of market research
studies may not predict acceptance by patients, healthcare
providers or payors; inadequate efficacy or unexpected adverse side
effects relating to GIMOTI that could result in recalls or product
liability claims; Evoke’s ability to obtain additional financing as
needed to support its operations; Evoke is entirely dependent on
the success of GIMOTI; Evoke’s dependence on third parties for the
manufacture of 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
Evoke Pharma,
Inc |
Condensed Balance
Sheets |
|
|
|
|
|
|
|
|
|
June 30,
2023 |
|
December 31,
2022 |
|
(unaudited) |
|
|
Assets |
|
|
|
Current
Assets: |
|
|
|
Cash and cash equivalents |
$ |
7,006,431 |
|
|
$ |
9,843,699 |
|
Accounts receivable, net |
|
1,023,813 |
|
|
|
624,832 |
|
Prepaid expenses |
|
371,348 |
|
|
|
952,954 |
|
Inventory, net |
|
513,712 |
|
|
|
289,378 |
|
Other current assets |
|
11,551 |
|
|
|
11,551 |
|
Total
current assets |
|
8,926,855 |
|
|
|
11,722,414 |
|
Operating
lease right-of-use asset |
|
52,842 |
|
|
|
129,074 |
|
Total
assets |
$ |
8,979,697 |
|
|
$ |
11,851,488 |
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
Current
Liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
1,415,309 |
|
|
$ |
934,312 |
|
Accrued compensation |
|
612,932 |
|
|
|
591,158 |
|
Operating lease liability |
|
52,842 |
|
|
|
129,074 |
|
Total
current liabilities |
|
2,081,083 |
|
|
|
1,654,544 |
|
Long-term
liabilities |
|
|
|
Note payable |
|
5,000,000 |
|
|
|
5,000,000 |
|
Accrued interest payable |
|
1,360,240 |
|
|
|
1,112,295 |
|
Total
long-term liabilities |
|
6,360,240 |
|
|
|
6,112,295 |
|
Total
liabilities |
|
8,441,323 |
|
|
|
7,766,839 |
|
|
|
|
|
Stockholders' equity: |
|
|
|
Common stock, $0.0001 par value; authorized shares - 50,000,000;
issued and outstanding shares - 3,343,070 at June 30, 2023 and
December 31, 2022, respectively |
|
334 |
|
|
|
334 |
|
Additional paid-in capital |
|
120,296,170 |
|
|
|
119,731,458 |
|
Accumulated deficit |
|
(119,758,130 |
) |
|
|
(115,647,143 |
) |
Total
stockholders' equity |
|
538,374 |
|
|
|
4,084,649 |
|
Total
liabilities and stockholders' equity |
$ |
8,979,697 |
|
|
$ |
11,851,488 |
|
Evoke Pharma,
Inc. |
Condensed Statements
of Operations |
(unaudited) |
|
|
Three Months
Ended |
|
Six Months
Ended |
|
June 30, |
June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
Net product sales |
$ |
1,131,368 |
|
|
$ |
461,795 |
|
|
$ |
1,941,777 |
|
|
$ |
880,175 |
|
Operating
expenses: |
|
|
|
|
|
Cost of goods sold |
|
57,357 |
|
|
|
67,774 |
|
|
|
107,948 |
|
|
|
90,535 |
|
Research and development |
|
92,357 |
|
|
|
191,478 |
|
|
|
159,347 |
|
|
|
233,194 |
|
Selling, general and administrative |
|
2,766,077 |
|
|
|
2,315,175 |
|
|
|
5,614,018 |
|
|
|
4,720,251 |
|
Total
operating expenses |
|
2,915,791 |
|
|
|
2,574,427 |
|
|
|
5,881,313 |
|
|
|
5,043,980 |
|
Loss from
operations |
|
(1,784,423 |
) |
|
|
(2,112,632 |
) |
|
|
(3,939,536 |
) |
|
|
(4,163,805 |
) |
Other income
(expense): |
|
|
|
|
|
Interest income |
|
41,164 |
|
|
|
3,910 |
|
|
|
76,494 |
|
|
|
4,705 |
|
Interest expense |
|
(124,658 |
) |
|
|
(124,658 |
) |
|
|
(247,945 |
) |
|
|
(247,945 |
) |
Total other
(expense) |
|
(83,494 |
) |
|
|
(120,748 |
) |
|
|
(171,451 |
) |
|
|
(243,240 |
) |
Net
loss |
$ |
(1,867,917 |
) |
|
$ |
(2,233,380 |
) |
|
$ |
(4,110,987 |
) |
|
$ |
(4,407,045 |
) |
|
|
|
|
|
|
|
|
Net loss per
share of common stock, basic and diluted |
|
(0.56 |
) |
|
|
(0.71 |
) |
|
|
(1.23 |
) |
|
|
(1.50 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares used to compute basic and diluted net loss
per share |
|
3,343,070 |
|
|
|
3,156,925 |
|
|
|
3,343,070 |
|
|
|
2,944,183 |
|
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