PLx Pharma Inc. Reports First Quarter 2022 Results and Provides Business Update
BUILDING A SOLID BASE OF VAZALORE® USERS
- Total
Net Sales of$2.1 Million in the First Quarter of 2022, an Increase of Approximately 31% from Fourth Quarter of 2021 - GAAP Net Loss of (
$0.39 ) Per Diluted Share in the First Quarter 2022; Adjusted Non-GAAP Net Loss Per Diluted Share of ($0.66 ) - Cash & Cash Equivalent Balance of
$52.5 Million as ofMarch 31, 2022 - Disciplined Spending to Support Strategic Growth
“Our solid base of VAZALORE users continues to grow, and feedback from consumers and healthcare professionals is overwhelmingly positive,” said
Giordano continued, “We are intensifying our focus to more strongly differentiate VAZALORE from the limitations of other aspirins. VAZALORE provides fast, predictable absorption and was designed to help protect the gastroduodenal lining. We are executing enhanced messaging and some unique programs to increase trial and conversion among a broader community of consumers and healthcare professionals.”
Select Business Highlights of First Quarter 2022 and Recent Key Accomplishments
Progress in
- Retail consumption data for the most recent 13-week period showed steady growth of VAZALORE in a declining
Heart Health category.1 - Feedback from healthcare professionals (HCPs) and consumers is overwhelmingly positive.
- HCPs recognize VAZALORE as an innovative aspirin therapy, and how important it is for their secondary prevention patients to achieve the antiplatelet benefit of aspirin in a reliable and consistent way every day.
- Consumer sentiment of VAZALORE centers on the following themes: easy to swallow, did not upset my stomach, and effective for pain relief.
- The Company’s cardiovascular care specialists are implementing new VAZALORE sampling and patient-use survey programs to drive physician adoption and consumer trial.
- A manuscript of recently reported pharmacokinetic/pharmacodynamic results on VAZALORE 81 mg has been submitted to a journal for publication and is under review.
- The study was led by Drs.
Franchi and Angiolillo from theUniversity of Florida titled, Pharmacokinetic and Pharmacodynamic Profile of PL-ASA, a Novel Phospholipid-Aspirin Complex Liquid Formulation, Compared to Enteric-coated Aspirin at an 81 mg Dose – Results from a Prospective, Randomized Crossover Study, was a randomized, open-label, crossover pharmacokinetic and pharmacodynamic study in healthy volunteers. - As expected and consistent with earlier studies at 325 mg, compared to enteric-coated aspirin VAZALORE 81 mg provided faster and more complete absorption after a single dose, with earlier and more potent inhibition of platelet aggregation.
- The study was led by Drs.
- Cardiovascular thought leaders held a virtual town hall meeting on
March 28, 2022 , titled “Aspirin in 2022: A New Aspirin for a New Chapter” as a public health service to help clarify aspirin therapy in secondary prevention of cardiac events and dual anti-platelet therapy (DAPT) for the practicing clinician.
First Quarter 2022 Financial Highlights
Total revenues for the first quarter of 2022 were
Gross margin of 44% was in-line sequentially with the fourth quarter of 2021 and reflected a favorable product mix consisting of higher sales of VAZALORE 81 mg.
Total operating expenses were
Research and development expenses declined approximately 32% to
Selling, marketing and administrative expenses totaled
Other income (expense), net totaled
Net loss attributable to common stockholders for the first quarter of 2022 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.
Liquidity
As of
1 Nielsen, Single entity Heart Health Aspirin xAOC; 13-week period ended
2022 First Quarter Conference Call
The Company’s 2022 first 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:
| UNAUDITED CONSOLIDATED BALANCE SHEETS | ||||||||
| (in thousands, except share and per share data) | ||||||||
2022 |
2021 |
|||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash and cash equivalents | $ | 52,499 | $ | 69,392 | ||||
| Accounts receivable | 698 | 634 | ||||||
| Inventory, net | 3,839 | 2,458 | ||||||
| Prepaid expenses and other current assets | 712 | 992 | ||||||
| TOTAL CURRENT ASSETS | 57,748 | 73,476 | ||||||
| NON-CURRENT ASSETS | ||||||||
| Property and equipment, net | 828 | 858 | ||||||
| Right of use assets | 204 | 230 | ||||||
| 2,061 | 2,061 | |||||||
| Security deposit | 17 | 17 | ||||||
| TOTAL ASSETS | $ | 60,858 | $ | 76,642 | ||||
| LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | ||||||||
| CURRENT LIABILITIES | ||||||||
| Accounts payable and accrued liabilities | $ | 12,716 | $ | 10,600 | ||||
| Accrued bonuses | 394 | 1,163 | ||||||
| Other current liabilities | 120 | 116 | ||||||
| TOTAL CURRENT LIABILITIES | 13,230 | 11,879 | ||||||
| NON-CURRENT LIABILITIES | ||||||||
| Warrant liability | 5,410 | 12,818 | ||||||
| Accrued dividends | 129 | 129 | ||||||
| Other liabilities | 106 | 136 | ||||||
| TOTAL LIABILITIES | 18,875 | 24,962 | ||||||
| Series A convertible preferred stock: |
13,708 | 13,708 | ||||||
| Series B convertible preferred stock: |
2,306 | 2,306 | ||||||
| STOCKHOLDERS' EQUITY | ||||||||
| Preferred stock; |
- | - | ||||||
| Common stock; |
28 | 28 | ||||||
| Additional paid-in capital | 185,000 | 183,912 | ||||||
| Accumulated deficit | (159,059 | ) | (148,274 | ) | ||||
| TOTAL STOCKHOLDERS' EQUITY | 25,969 | 35,666 | ||||||
| TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | $ | 60,858 | $ | 76,642 | ||||
| UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| 2022 | 2021 | |||||||
| REVENUES: | ||||||||
| Net sales | $ | 2,083 | $ | - | ||||
| TOTAL REVENUES | 2,083 | - | ||||||
| Cost of sales | 1,169 | - | ||||||
| GROSS PROFIT | 914 | - | ||||||
| OPERATING EXPENSES: | ||||||||
| Research and development | 654 | 959 | ||||||
| Selling, marketing and administrative | 18,456 | 2,636 | ||||||
| TOTAL OPERATING EXPENSES | 19,110 | 3,595 | ||||||
| OPERATING LOSS | (18,196 | ) | (3,595 | ) | ||||
| OTHER INCOME (EXPENSE): | ||||||||
| Interest income (expense), net | 3 | (10 | ) | |||||
| Change in fair value of warrant liability | 7,408 | (7,935 | ) | |||||
| TOTAL OTHER INCOME (EXPENSE) | 7,411 | (7,945 | ) | |||||
| LOSS BEFORE INCOME TAXES | (10,785 | ) | (11,540 | ) | ||||
| Income taxes | - | - | ||||||
| NET LOSS | (10,785 | ) | (11,540 | ) | ||||
| Preferred dividends | - | (322 | ) | |||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (10,785 | ) | $ | (11,862 | ) | ||
| Net loss per common share - basic and diluted | $ | (0.39 | ) | $ | (0.73 | ) | ||
| Weighted average shares of common shares - basic and diluted | 27,539,229 | 16,361,583 | ||||||
| PLx Pharma Inc. | ||||||||
| RECONCILIATION OF GAAP TO ADJUSTED NON-GAAP NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS AND ADJUSTED NON-GAAP EARNINGS PER SHARE | ||||||||
| (in thousands, except share and per share data) | ||||||||
| Three Months Ended | ||||||||
| 2022 | 2021 | |||||||
| Net loss attributable to common stockholders - GAAP | $ | (10,785 | ) | $ | (11,862 | ) | ||
| Adjustments: | ||||||||
| Change in fair value of warrant liability | (7,408 | ) | 7,935 | |||||
| Preferred dividends | - | 322 | ||||||
| Adjusted non-GAAP net loss attributable to common stockholders | $ | (18,193 | ) | $ | (3,605 | ) | ||
| Adjusted non-GAAP net loss per common share - basic and diluted | $ | (0.66 | ) | $ | (0.22 | ) | ||
| Weighted average shares of common shares - basic and diluted | 27,539,229 | 16,361,583 | ||||||
Source: PLx Pharma Inc.