- Total
Net Sales of$8.2 Million in Last Five Months of 2021 Net Sales of$1.6 Million in the Fourth Quarter 2021, Reflecting Timing of Trade Re-Orders Following Strong Initial Sales Distribution of VAZALORE in the Third Quarter 2021- Key Performance Measures Are Positive and Trending Higher; Company on Track and Well-Positioned to Grow Sales Substantially in 2022
- GAAP Net Loss of (
$0.73 ) Per Diluted Share in Fourth Quarter 2021; Adjusted Non-GAAP Net Loss Per Diluted Share of ($0.73 ) - Cash & Cash Equivalent Balance of
$69.4 Million at Year-End 2021
“The VAZALORE launch strategy is on track as planned. We are excited that VAZALORE is now the number three brand in the
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 theFederal Trade Commission subsequently determined not to take additional action.
- The NAD closed its compliance proceeding for PLx on
Fourth Quarter 2021 Financial Highlights
Total revenues for the fourth quarter of 2021 were
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
Research and development expenses declined approximately 43% to
Selling, marketing and administrative expenses totaled
Other income (expense), net totaled
Net income attributable to common stockholders for the fourth quarter of 2021 was
Adjusted non-GAAP net loss per diluted share was (
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
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
Net loss attributable to common stockholders for the year ended
Adjusted non-GAAP net loss per diluted share was (
See table for reconciliation of GAAP to adjusted non-GAAP net loss per diluted share.
Liquidity
As of
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 |
4 | Internal data. |
2021 Fourth Quarter Conference Call
The Company’s 2021 fourth quarter conference call with analysts and investors will be held today at
About VAZALORE
VAZALORE 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
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
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:
Vice President, Investor Relations & Corporate Communications,
(973) 409-6542
IR@PLxPharma.com
Founder & President,
(212) 452-2793
lwilson@insitecony.com
Source:
CONSOLIDATED BALANCE SHEETS | ||||||||
(in thousands, except share and per share data) | ||||||||
2021 | 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 | ||||||
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: | 13,708 | 13,662 | ||||||
Series B convertible preferred stock: | 2,306 | 7,723 | ||||||
STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
Preferred stock; | - | - | ||||||
Common stock; | 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 |
CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||
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 |
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 | ||||||||||||||
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 | |||||||||||
Source:
2022 GlobeNewswire, Inc., source