PLx Pharma Inc. (NASDAQ: PLXP) (“PLx” or the “Company”), is a
commercial-stage drug delivery platform technology company focused
on its clinically-validated and patent-protected PLxGuard™ that has
the potential to improve the absorption of many drugs currently on
the market and to reduce the risk of stomach injury associated with
certain drugs. The Company, with its lead products VAZALORE 81 mg
and VAZALORE 325 mg liquid-filled aspirin capsules (referred to
together as “VAZALORE®”), announced today certain financial and
operational results for the three and 12 months ended December 31,
2021.
“The VAZALORE launch strategy is on track as
planned. We are excited that VAZALORE is now the number three brand
in the Aspirin Heart Health segment, within six months after
introduction,” said Natasha Giordano, PLx’s President & CEO.
“We are pleased with our progress and our agility in managing the
various market dynamics at play when establishing a new brand.
Across several key performance measures, VAZALORE is building
momentum and the results are positive and trending higher, with
growth rates as we expected for this initial period. We are well
positioned for sales growth and market share expansion in
2022.”
Select Business Highlights of Full Year
2021 and Recent Key Accomplishments
- The Company is executing a fully
integrated, multi-channel commercial strategy for VAZALORE,
including a three-pronged approach focused on healthcare
professionals, retailers, and consumers. The combined efforts of
its cardiovascular care specialists, medical communications,
product display support, and national media campaign are yielding
favorable results across several measures including:
- Retail consumption: VAZALORE
continues to gain momentum, with strong unit and dollar growth over
the last several consecutive four-week periods1.
- Number three brand: VAZALORE has
gone from having zero brand awareness among consumers less than six
months ago, to becoming the number three brand in the Aspirin Heart
Health Segment, on a dollar-share basis2.
- Advertising effectiveness: Through
mid-January 2022, the Company’s national media campaign for
VAZALORE had delivered more than 500 million impressions, reaching
more than 90% of its target audience, or nearly 15 million
consumers, with high frequency.3
- Field force effectiveness: The Company’s cardiovascular care
specialists, coupled with medical communications support, are
effectively targeting healthcare professionals (“HCPs”), affiliated
with the top 100 heart/stroke hospitals in the U.S., and reaching
98% of their top group practices.4 The field force is also
expanding its coverage within existing territories to include
surrounding practices.
- The Company has been engaging and
building advocacy with more than 100 regional and national
cardiovascular thought leaders across the U.S. through various
medical communications programs. Important scientific data
supporting VAZALORE’s pharmacokinetic and pharmacodynamic profile
has also been presented.
- The Company has been supporting
Heart Health Awareness and the benefits of aspirin therapy in
secondary prevention of heart attack or clot-related stroke.
- The Company has implemented the
National Advertising Division’s (“NAD”) recommendations associated
with the VAZALORE television commercial and online advertising to
health care professionals and consumers.
- The NAD closed its compliance
proceeding for PLx on January 27, 2022, and the Federal Trade
Commission subsequently determined not to take additional
action.
Fourth Quarter 2021 Financial
Highlights
Total revenues for the fourth quarter of 2021
were $1.6 million, compared to no revenue in the fourth quarter of
2020, reflecting the timing of trade re-orders following the strong
initial sales distribution of VAZALORE into U.S. retail channels in
the third quarter of 2021. Net sales of the 81 mg dose (consisting
of a 12 count and 30 count SKU), represented approximately 86% of
total net sales in the fourth quarter of 2021.
Gross margin of 44% reflected a slight
sequential improvement from the third quarter of 2021, due to
favorable product mix consisting of higher sales of VAZALORE 81mg.
Cost of goods in the fourth quarter of 2021 primarily reflected
outsourced manufacturing and packaging costs, combined with costs
related to shipping, quality assurance and royalty payments.
Total operating expenses were $21.6 million
during the fourth quarter of 2021, compared to operating expenses
of $3.7 million for the prior year period, reflecting increased
promotional activities and expenses associated with the commercial
launch of VAZALORE during the third quarter of 2021.
Research and development expenses declined
approximately 43% to $0.7 million in the fourth quarter of 2021,
and included costs associated with the VAZALORE 81 mg clinical
study and scale-up of manufacturing activities. In the prior year
period, research and development expenses were $1.2 million, and
included costs associated with manufacturing and validation work to
support the sNDA filings for VAZALORE.
Selling, marketing and administrative expenses
totaled $20.9 million in the fourth quarter of 2021, compared to
$2.5 million in the prior year period, primarily due to higher
sales and marketing expenses associated with the commercial launch
of VAZALORE and increased non-cash stock-based compensation. The
higher year-over-year expense also included a new cardiovascular
specialty field force and national media television campaign, which
were launched during the third quarter of 2021.
Other income (expense), net totaled $24.4
million of other income during the fourth quarter of 2021, compared
to other expense of $4.2 million in the fourth quarter of 2020. The
variance is largely attributable to the non-cash change in fair
value of warrant liability, primarily due to the fluctuation of the
price of the Company’s common stock.
Net income attributable to common stockholders
for the fourth quarter of 2021 was $3.6 million, or a loss of
($0.73) per diluted share, compared to a net loss of $8.5 million,
or ($0.87) per diluted share in the prior year period.
Adjusted non-GAAP net loss per diluted share was
($0.73) in the fourth quarter of 2021, compared to an adjusted net
loss of ($0.38) per diluted share in the fourth quarter of
2020.
See table for reconciliation of GAAP to adjusted
non-GAAP net loss per diluted share.
Full Year 2021 Financial
Highlights
For the full year ended December 31, 2021, total
revenue was $8.2 million, compared with total revenue of $30,000 in
2020, reflecting initial sales of VAZALORE following the strong
initial sales distribution of VAZALORE into U.S. retail channels in
the third quarter of 2021. Net sales of the 81 mg dose represented
approximately 68% of total net sales for the full year 2021.
Revenue in the prior year period was attributable to work performed
under an award of a federal grant from the National Institutes of
Health, which came to an end in the second quarter of 2020.
Gross margin of 41% for the full year 2021 includes outsourced
manufacturing and packaging costs combined with costs related to
shipping, quality assurance and royalty payments. Gross profit from
the VAZALORE 325 mg dose is lower due to proportionally higher raw
materials and smaller batch sizes although with a list price equal
to the 81 mg 30 count bottle.
Total operating expenses were $44.2 million for
full year 2021, compared to operating expenses of $13.5 million for
the prior year period, reflecting increased promotional activities
and expenses associated with the commercial launch of VAZALORE
during the third quarter of 2021.
Net loss attributable to common stockholders for
the year ended December 31, 2021 was $48.6 million or ($2.06) per
diluted share compared to a net loss of $16.9 million, or ($1.74)
per diluted share for 2020.
Adjusted non-GAAP net loss per diluted share was
($1.72) for full year 2021, compared to an adjusted net loss of
($1.42) per diluted share in the prior year period.
See table for reconciliation of GAAP to adjusted
non-GAAP net loss per diluted share.
Liquidity
As of December 31, 2021, the Company had cash
and cash equivalents of $69.4 million, and $0.6 million in accounts
receivable. The Company has zero debt on its balance sheet.
1 |
Nielsen, Single entity Heart Health Aspirin xAOC; 4-week periods
ended 11/6/21, 12/4/21, 1/1/22, 1/29/22 and 2/26/22. |
2 |
Nielsen, Heart Health Aspirin Total xAOC; 26-week period ended
2/26/22. |
3 |
Nielsen, week of 8/23/21 through week of 1/17/22. |
4 |
Internal data. |
2021 Fourth Quarter Conference
CallThe Company’s 2021 fourth quarter conference call with
analysts and investors will be held today at 8:30am ET and may be
accessed by dialing 1-866-394-2901, or if international,
1-616-548-5567, using Conference ID number 2664996. A live audio
webcast of the conference call, along with the earnings press
release and supplemental financial disclosures, will also be
available on the Investor Relations section of the Company's
website at https://ir.plxpharma.com/investor-relations. The webcast
will be available for replay after the call for a period of at
least 30 days.
About VAZALOREVAZALORE is an
FDA-approved liquid-filled aspirin capsule, available in 81 mg and
325 mg doses. VAZALORE delivers aspirin differently from plain and
enteric coated aspirin products. The special complex inside the
capsule is designed for targeted release of aspirin, limiting its
direct contact with the stomach. VAZALORE delivers fast, reliable
absorption for pain relief plus the lifesaving benefits of aspirin.
To learn more about VAZALORE, please visit www.vazalore.com.
About PLx Pharma Inc.PLx Pharma
Inc. is a commercial-stage drug delivery platform technology
company focused on improving how and where active pharmaceutical
ingredients (APIs) are absorbed in the gastrointestinal (GI) tract
via its clinically validated and patent protected PLxGuard™
technology. PLx believes this platform has the potential to improve
the absorption of many drugs currently on the market or in
development, and to reduce the risk of stomach injury associated
with certain drugs. To learn more about PLx Pharma Inc. and its
pipeline, please visit www.plxpharma.com.
Forward-Looking Statements Any
statements made in this press release relating to future financial
or business performance, conditions, plans, prospects, trends, or
strategies and other financial and business matters, including
without limitation, the prospects for commercializing or selling
any products or drug candidates, are forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995. In addition, when or if used in this press release, the
words “may,” “could,” “should,” “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “plan,” “predict” and similar
expressions and their variants, as they relate to PLx may identify
forward-looking statements. PLx cautions that these forward-looking
statements are subject to numerous assumptions, risks, and
uncertainties, which change over time. Important factors that may
cause actual results to differ materially from the results
discussed in the forward-looking statements or historical
experience include risks and uncertainties, including risks
relating to PLx’s ability to successfully further commercialize its
VAZALORE products; the failure by PLx to secure and maintain
relationships with collaborators; risks relating to clinical
trials; risks relating to the commercialization, if any, of PLx’s
proposed product candidates (such as marketing, regulatory, product
liability, supply, competition, and other risks); dependence on the
efforts of third parties; dependence on intellectual property;
developments and projections relating to our competitors or our
industry; and risks that PLx may lack the financial resources and
access to capital to fund proposed operations. Further information
on the factors and risks that could affect PLx’s business,
financial condition and results of operations are contained in
PLx’s filings with the U.S. Securities and Exchange
Commission (“SEC”), which are available at www.sec.gov. Other
risks and uncertainties are more fully described in PLx’s Form 10-K
for the year ended December 31, 2020, filed with the SEC on March
12, 2021, as amended on April 30, 2021, and in other filings that
PLx has made or will make going forward. These forward-looking
statements represent PLx’s estimate as of the date hereof only, and
PLx specifically disclaims any duty or obligation to update
forward-looking statements.
Non-GAAP Measures
PLx’s management considers adjusted non-GAAP net
loss and adjusted non-GAAP net loss per basic and diluted earnings
per share to be important financial indicators of operating
performance, providing investors and analysts with useful measures
of operating results unaffected by the impact on the financial
statements of the volatility of the change in the fair value of the
warrant liability and non-cash and non-recurring dividends and
beneficial conversion features on our preferred stock. Management
uses adjusted non-GAAP net loss and adjusted non-GAAP net loss per
share when analyzing performance. Adjusted non-GAAP net loss and
adjusted non-GAAP net loss per share should be considered in
addition to, but not in lieu of net loss or net loss per share
reported under GAAP.
CONTACTS:Janet M. BarthVice President, Investor
Relations & Corporate Communications, PLx Pharma Inc.(973)
409-6542IR@PLxPharma.com
Lisa M. WilsonFounder & President, In-Site Communications,
Inc.(212) 452-2793lwilson@insitecony.com
Source: PLx Pharma Inc.
PLx Pharma Inc. |
|
CONSOLIDATED BALANCE SHEETS |
|
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
December 31, 2021 |
|
December 31, 2020 |
|
ASSETS |
|
|
|
|
CURRENT ASSETS |
|
|
|
|
Cash and cash equivalents |
$ |
69,392 |
|
|
$ |
22,449 |
|
|
Accounts receivable |
|
634 |
|
|
|
- |
|
|
Inventory |
|
2,458 |
|
|
|
143 |
|
|
Prepaid expenses and other current assets |
|
992 |
|
|
|
394 |
|
|
TOTAL CURRENT ASSETS |
|
73,476 |
|
|
|
22,986 |
|
|
NON-CURRENT ASSETS |
|
|
|
|
Property and equipment, net |
|
858 |
|
|
|
1,226 |
|
|
Right of use assets |
|
230 |
|
|
|
327 |
|
|
Goodwill |
|
2,061 |
|
|
|
2,061 |
|
|
Security deposit |
|
17 |
|
|
|
17 |
|
|
TOTAL ASSETS |
$ |
76,642 |
|
|
$ |
26,617 |
|
|
|
|
|
|
|
LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
CURRENT LIABILITIES |
|
|
|
|
Accounts payable and accrued liabilities |
$ |
10,600 |
|
|
$ |
863 |
|
|
Accrued bonuses |
|
1,163 |
|
|
|
1,185 |
|
|
Accrued interest |
|
- |
|
|
|
597 |
|
|
Term loan, net of discount and fees |
|
- |
|
|
|
622 |
|
|
Other current liabilities |
|
116 |
|
|
|
275 |
|
|
TOTAL CURRENT LIABILITIES |
|
11,879 |
|
|
|
3,542 |
|
|
NON-CURRENT LIABILITIES |
|
|
|
|
Warrant liability |
|
12,818 |
|
|
|
9,692 |
|
|
Accrued dividends |
|
129 |
|
|
|
2,796 |
|
|
Other liabilities |
|
136 |
|
|
|
134 |
|
|
TOTAL LIABILITIES |
|
24,962 |
|
|
|
16,164 |
|
|
|
|
|
|
|
Series A convertible preferred stock: $0.001 par value; liquidation
value of $12,642,000; 45,000 shares authorized, 12,642 and 15,000
issued and outstanding, respectively |
|
13,708 |
|
|
|
13,662 |
|
|
Series B convertible preferred stock: $0.001 par value; liquidation
value of $2,492,722; 25,000 shares authorized, 2,364 and 8,000
issued and outstanding, respectively |
|
2,306 |
|
|
|
7,723 |
|
|
|
|
|
|
|
STOCKHOLDERS' EQUITY (DEFICIT) |
|
|
|
|
Preferred stock; $0.001 par value; 930,000 shares authorized; none
issued and outstanding |
|
- |
|
|
|
- |
|
|
Common stock; $0.001 par value; 100,000,000 shares authorized;
27,539,022 and 13,911,633 shares issued and outstanding,
respectively |
|
28 |
|
|
|
14 |
|
|
Additional paid-in capital |
|
183,912 |
|
|
|
91,203 |
|
|
Accumulated deficit |
|
(148,274 |
) |
|
|
(102,149 |
) |
|
TOTAL STOCKHOLDERS' EQUITY (DEFICIT) |
|
35,666 |
|
|
|
(10,932 |
) |
|
TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED
STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) |
$ |
76,642 |
|
|
$ |
26,617 |
|
|
PLx Pharma Inc. |
CONSOLIDATED STATEMENTS OF OPERATIONS |
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
|
Three Months Ended |
|
Twelve Months Ended |
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
REVENUES: |
|
|
|
|
|
|
Net sales |
$ |
1,592 |
|
|
$ |
- |
|
|
$ |
8,208 |
|
|
$ |
- |
|
Federal grant revenue |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
30 |
|
TOTAL REVENUES |
|
1,592 |
|
|
|
- |
|
|
|
8,208 |
|
|
|
30 |
|
|
|
|
|
|
|
|
Cost of sales |
|
892 |
|
|
|
- |
|
|
|
4,805 |
|
|
|
- |
|
GROSS PROFIT |
|
700 |
|
|
|
- |
|
|
|
3,403 |
|
|
|
30 |
|
|
|
|
|
|
|
|
OPERATING EXPENSES: |
|
|
|
|
|
|
Research and development |
|
688 |
|
|
|
1,223 |
|
|
|
4,182 |
|
|
|
4,339 |
|
Selling, marketing and administrative |
|
20,863 |
|
|
|
2,469 |
|
|
|
40,011 |
|
|
|
9,150 |
|
TOTAL OPERATING EXPENSES |
|
21,551 |
|
|
|
3,692 |
|
|
|
44,193 |
|
|
|
13,489 |
|
OPERATING LOSS |
|
(20,852 |
) |
|
|
(3,692 |
) |
|
|
(40,790 |
) |
|
|
(13,459 |
) |
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE): |
|
|
|
|
|
|
Interest income (expense), net |
|
3 |
|
|
|
(41 |
) |
|
|
1 |
|
|
|
(308 |
) |
Change in fair value of warrant liability |
|
24,411 |
|
|
|
(4,249 |
) |
|
|
(5,336 |
) |
|
|
(1,444 |
) |
TOTAL OTHER INCOME (EXPENSE) |
|
24,414 |
|
|
|
(4,289 |
) |
|
|
(5,335 |
) |
|
|
(1,752 |
) |
INCOME (LOSS) BEFORE INCOME TAXES |
|
3,562 |
|
|
|
(7,981 |
) |
|
|
(46,125 |
) |
|
|
(15,211 |
) |
Income taxes |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
NET INCOME (LOSS) |
|
3,562 |
|
|
|
(7,981 |
) |
|
|
(46,125 |
) |
|
|
(15,211 |
) |
|
|
|
|
|
|
|
Preferred dividends and beneficial conversion feature |
|
- |
|
|
|
(510 |
) |
|
|
(2,525 |
) |
|
|
(1,737 |
) |
NET INCOME (LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS |
$ |
3,562 |
|
|
$ |
(8,491 |
) |
|
$ |
(48,650 |
) |
|
$ |
(16,948 |
) |
|
|
|
|
|
|
|
Net income (loss) per common share - basic |
$ |
0.10 |
|
|
$ |
(0.87 |
) |
|
$ |
(2.06 |
) |
|
$ |
(1.74 |
) |
Net loss per common share - diluted |
$ |
(0.73 |
) |
|
$ |
(0.87 |
) |
|
$ |
(2.06 |
) |
|
$ |
(1.74 |
) |
|
|
|
|
|
|
|
Weighted average shares of common shares - basic |
|
27,531,566 |
|
|
|
9,714,951 |
|
|
|
23,650,457 |
|
|
|
9,714,951 |
|
Weighted average shares of common shares - diluted |
|
28,416,696 |
|
|
|
9,714,951 |
|
|
|
23,650,457 |
|
|
|
9,714,951 |
|
PLx Pharma
Inc. |
RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET INCOME
(LOSS) ATTRIBUTABLE TO COMMON STOCKHOLDERS AND ADJUSTED NON-GAAP
EARNINGS PER SHARE |
(in thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Twelve
Months Ended |
|
December
31, |
|
December
31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Net income
(loss) attributable to common stockholders - GAAP |
$ |
3,562 |
|
|
$ |
(8,491 |
) |
|
$ |
(48,650 |
) |
|
$ |
(16,948 |
) |
Adjustments: |
|
|
|
|
|
|
Change in
fair value of warrant liability |
|
(24,411 |
) |
|
|
4,249 |
|
|
|
5,336 |
|
|
|
1,444 |
|
Preferred
dividends and beneficial conversion feature |
|
- |
|
|
|
510 |
|
|
|
2,525 |
|
|
|
1,737 |
|
Adjusted
non-GAAP net loss attributable to common stockholders |
$ |
(20,848 |
) |
|
$ |
(3,733 |
) |
|
$ |
(40,789 |
) |
|
$ |
(13,767 |
) |
|
|
|
|
|
|
|
Adjusted
non-GAAP net loss per common share -diluted |
$ |
(0.73 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.72 |
) |
|
$ |
(1.42 |
) |
|
|
|
|
|
|
|
Weighted
average shares of common shares - diluted |
|
28,416,696 |
|
|
|
9,714,951 |
|
|
|
23,650,457 |
|
|
|
9,714,951 |
|
|
|
|
|
|
|
|
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