PLx Pharma Inc. Reports Second Quarter 2022 Results and Provides Business Update
- Initiates Evaluation of Strategic Alternatives to Enhance Stockholder Value
- Reports Positive Results of VAZALORE® 81 mg
- Streamlines Sales & Marketing Plan
- Total
Net Sales of$0.5 Million , Including$0.4 Million of Unfavorable Adjustments for Additional Trade Allowances and Incremental Sales Returns Reserves in Second Quarter of 2022 - Total Operating Expenses Were Lower by
$4.9 Million in Second Quarter of 2022 vs. Q1 2022 - GAAP Net Loss of (
$0.43 ) Per Diluted Share in Second Quarter of 2022; Adjusted Non-GAAP Net Loss Per Diluted Share of ($0.52 ) - Cash & Cash Equivalent Balance of
$35.7 Million as ofJune 30, 2022
“A key priority for us in the second quarter was implementing our refined marketing plan, putting greater emphasis on more cost efficient nonpersonal promotion, such as virtual and digital communications,” said PLx’s President & CEO
Giordano added, “Despite these challenges, we remain as confident as ever in VAZALORE’s potential to transform the standard of aspirin therapy for secondary prevention of cardiovascular events and to reinvent aspirin for pain relief. Our product has been well received by early adopters and findings from those adopters, along with online reviews and results from our recent
Executive Chairman of the Board,
Highlights of Second Quarter and Other Recent Events
- Recently engaged
Raymond James & Associates, Inc. as financial advisor to explore and evaluate strategic alternatives to enhance stockholder value. - Reported positive results from initial VAZALORE 81 mg
Patient Experience Survey . Click here to read press release.- Highlights of results from 130 respondents through
August 3, 2022 :- 97% felt “they are doing all they can to help support their heart health.”
- 96% felt “no issues with their stomach when taking, either with or without food.”
- 90% indicated their intent to purchase VAZALORE.
- Highlights of results from 130 respondents through
- Streamlined sales and marketing plan to include more nonpersonal programs, such as email campaigns, medical education programs, and social media advertising, in promoting VAZALORE’s benefits in both
Heart Health and Pain to a broader audience of healthcare professionals (HCPs) and consumers. InAugust 2022 , the Company significantly reduced its Cardiovascular Care Specialist team. - Expanded email campaign target audience to more than 500,000 HCPs, to include Advanced Practice Providers, largely Nurse Practitioners and Physician Assistants. Email open rates across all target audiences performed at more than three-times industry benchmarks on average.
- Initiated a broad-reaching email program targeting approximately 10 million consumers, to highlight benefits of VAZALORE and provide high-value savings coupon, which resulted in more than two-times the normal website activity on VAZALORE.com.
- Launched PLx social media channels (Facebook, Twitter, LinkedIn) in
July 2022 , with VAZALORE-sponsored advertising on Facebook, targetingHeart Health and Pain Relief audiences. - Developed feature story published under the titles, “Aspirin 101: What You Need To Know About This Foundational Therapy” and “Benefits of Taking Aspirin and the Main Reasons People Take It” to inform and educate patients and providers on the benefits of aspirin therapy, common side effects and available formulations, including FDA-approved VAZALORE liquid-filled capsules. Click here to read article.
- To date, the article has earned more than 1,000 placements, including in the 10 largest media markets in the
U.S. , and the online audience exceeds 250 million.
- To date, the article has earned more than 1,000 placements, including in the 10 largest media markets in the
- Received acceptance of the manuscript titled, “Pharmacokinetic and Pharmacodynamic profiles of Novel Phospholipid-Aspirin Complex Liquid Formulation and Low Dose Enteric-Coated Aspirin: Results from a Prospective, Randomized, Crossover Study,” for publication by the “Journal of Thrombosis and Thrombolysis.”
- A series of educational webinars in
June 2022 was led by interventional cardiologist and thought leaderC. Michael Gibson , MS, MD, consultant atBoston Clinical Research Institute , titled, “Secondary Prevention with Aspirin – Learn about the Latest FDA Approved Aspirin Formulation.” Click here to access webcast replay.- These virtual programs provided HCPs, and others, a forum to learn about the differences in available aspirin formulations, including VAZALORE liquid-filled aspirin capsules, and the importance of tailoring aspirin therapy to an individual patient profile.
Second Quarter 2022 Financial Highlights
Total revenues for the second quarter of 2022 were
Cost of sales for the second quarter of 2022 were
Total operating expenses were
Research and development expenses declined approximately 43% to
Selling, marketing and administrative expenses totaled
Other income (expense), net totaled
Net loss attributable to common stockholders for the second 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
2022 Second Quarter Conference Call
The Company’s 2022 second 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 and follow us on Facebook.
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; risks that PLx may lack the financial resources and access to capital to fund proposed operations; the impact of difficult macroeconomic conditions, such as inflation and reductions in consumer spending, on the demand for PLx’s products; and risks relating to PLx’s ability to identify, evaluate and complete any strategic alternative that yields value for its stockholders. 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 Annual Report on 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 | $ | 35,730 | $ | 69,392 | |||
| Accounts receivable | 490 | 634 | |||||
| Inventory, net | 3,883 | 2,458 | |||||
| Prepaid expenses and other current assets | 1,376 | 992 | |||||
| TOTAL CURRENT ASSETS | 41,479 | 73,476 | |||||
| NON-CURRENT ASSETS | |||||||
| Property and equipment, net | 798 | 858 | |||||
| 2,061 | 2,061 | ||||||
| Other assets | 202 | 247 | |||||
| TOTAL ASSETS | $ | 44,540 | $ | 76,642 | |||
| LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable and accrued liabilities | $ | 8,212 | $ | 10,600 | |||
| Accrued bonuses | 729 | 1,163 | |||||
| Other current liabilities | 127 | 116 | |||||
| TOTAL CURRENT LIABILITIES | 9,068 | 11,879 | |||||
| NON-CURRENT LIABILITIES | |||||||
| Warrant liability | 2,759 | 12,818 | |||||
| Accrued dividends | 129 | 129 | |||||
| Other liabilities | 79 | 136 | |||||
| TOTAL LIABILITIES | 12,035 | 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 | 187,380 | 183,912 | |||||
| Accumulated deficit | (170,917 | ) | (148,274 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY | 16,491 | 35,666 | |||||
| TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | $ | 44,540 | $ | 76,642 | |||
| UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| REVENUES: | |||||||||||||||
| Net sales | $ | 483 | $ | - | $ | 2,566 | $ | - | |||||||
| TOTAL REVENUES | 483 | - | 2,566 | - | |||||||||||
| Cost of sales | 820 | - | 1,989 | - | |||||||||||
| GROSS PROFIT | (337 | ) | - | 577 | - | ||||||||||
| OPERATING EXPENSES: | |||||||||||||||
| Research and development | 556 | 983 | 1,210 | 1,942 | |||||||||||
| Selling, marketing and administrative | 13,645 | 5,498 | 32,101 | 8,134 | |||||||||||
| TOTAL OPERATING EXPENSES | 14,201 | 6,481 | 33,311 | 10,076 | |||||||||||
| OPERATING LOSS | (14,538 | ) | (6,481 | ) | (32,734 | ) | (10,076 | ) | |||||||
| OTHER INCOME (EXPENSE): | |||||||||||||||
| Interest income (expense), net | 29 | 4 | 32 | (6 | ) | ||||||||||
| Change in fair value of warrant liability | 2,651 | (10,028 | ) | 10,059 | (17,963 | ) | |||||||||
| TOTAL OTHER INCOME (EXPENSE) | 2,680 | (10,024 | ) | 10,091 | (17,969 | ) | |||||||||
| LOSS BEFORE INCOME TAXES | (11,858 | ) | (16,505 | ) | (22,643 | ) | (28,045 | ) | |||||||
| Income taxes | - | - | - | - | |||||||||||
| NET LOSS | (11,858 | ) | (16,505 | ) | (22,643 | ) | (28,045 | ) | |||||||
| Preferred dividends | - | (2,203 | ) | - | (2,525 | ) | |||||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (11,858 | ) | $ | (18,708 | ) | $ | (22,643 | ) | $ | (30,570 | ) | |||
| Net loss per common share - basic and diluted | $ | (0.43 | ) | $ | (0.79 | ) | $ | (0.82 | ) | $ | (1.53 | ) | |||
| Weighted average shares of common shares - basic and diluted | 27,693,527 | 23,638,239 | 27,616,804 | 20,020,012 | |||||||||||
| 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 | Six Months Ended | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Net loss attributable to common stockholders - GAAP | $ | (11,858 | ) | $ | (18,708 | ) | $ | (22,643 | ) | $ | (30,570 | ) | |||
| Adjustments: | |||||||||||||||
| Change in fair value of warrant liability | (2,651 | ) | 10,028 | (10,059 | ) | 17,963 | |||||||||
| Preferred dividends | - | 2,203 | - | 2,525 | |||||||||||
| Adjusted non-GAAP net loss attributable to common stockholders | $ | (14,509 | ) | $ | (6,477 | ) | $ | (32,702 | ) | $ | (10,082 | ) | |||
| Adjusted non-GAAP net loss per common share - basic and diluted | $ | (0.52 | ) | $ | (0.27 | ) | $ | (1.18 | ) | $ | (0.50 | ) | |||
| Weighted average shares of common shares - basic and diluted | 27,693,527 | 23,638,239 | 27,616,804 | 20,020,012 | |||||||||||
Source: PLx Pharma Inc.