PLx Pharma Inc. Reports Third Quarter 2022 Results and Provides Business Update
- Significant Reduction in Operating Expenses
- Strategic Alternatives Process Ongoing
- Total
Net Sales of$0.4 Million , Including$0.3 Million of Unfavorable Adjustments for Additional Trade Allowances and Incremental Sales Returns Reserves in Q3 2022 - Total Operating Expenses Significantly Lower by
$2.8 Million , or 22%, in Q3 2022 vs. Q3 2021;$4.4 Million or 31% Lower Sequentially vs. Q2 2022 - GAAP Net Loss of (
$0.30 ) Per Diluted Share in Q3 2022; Adjusted Non-GAAP Net Loss Per Diluted Share of ($0.37 ) - Cash & Cash Equivalent Balance of
$25.8 Million as ofSeptember 30, 2022
“During the first year of VAZALORE launch, we have invested in building a base of awareness among consumers and healthcare professionals,” said PLx’s President & CEO
Highlights of Third Quarter and Other Recent Events
- Partnered with two large healthcare systems to incorporate VAZALORE into their “Meds to Beds” cardiovascular discharge programs. The goal is to replicate these programs in other healthcare systems nationwide.
- Expanded reach efficiently to both heart health and pain relief consumer audiences with introduction of VAZALORE ads on Facebook; ads featuring professional baseball legend John Smoltz’s personal experience with VAZALORE 325 mg for fast, effective pain relief were well received and delivered high engagement levels, beating industry benchmarks by four-times.
- Expanded non-personal promotional efforts to over 3,000 cardiologists and neurologists nationwide who opted-in to receive VAZALORE educational materials; materials included clinical study results for healthcare professionals and samples, education brochures and coupons for patients; program slated to run through 1Q 2023.
- Executed targeted digital campaign to over 500,000 healthcare professionals (HCPs), to include cardiologists, pharmacists, and advanced practice providers; message focused on VAZALORE benefits compared with other formulations as key reason to recommend; open rates across all target audiences performed above industry benchmarks.
- Distributed VAZALORE samples and patient education materials to more than 1,000 HCPs who have adopted and are actively recommending VAZALORE in their practices.
- Completed final stage of broad reach consumer email campaign; communication focused on how VAZALORE is different from other aspirin formulations; engagement level exceeded benchmark.
- Published (
Aug. 29, 2022 ) online by theJournal of Thrombosis and Thrombolysis : “Pharmacokinetic and Pharmacodynamic profiles of Novel Phospholipid-Aspirin Complex Liquid Formulation and Low Dose Enteric-Coated Aspirin: Results from a Prospective, Randomized, Crossover Study.”
Third Quarter 2022 Financial Highlights
Total revenues for the third quarter of 2022 were
Cost of sales for the third quarter of 2022 were
Total operating expenses were
Research and development (R&D) expenses declined approximately 60% to
Selling, marketing and administrative (SM&A) expenses of
Other income (expense), net totaled
Net loss attributable to common stockholders for the third 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 Third Quarter Conference Call
The Company’s 2022 third 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) | |||||||
| ASSETS | |||||||
| CURRENT ASSETS | |||||||
| Cash and cash equivalents | $ | 25,834 | $ | 69,392 | |||
| Accounts receivable | 139 | 634 | |||||
| Inventory, net | 3,178 | 2,458 | |||||
| Prepaid expenses and other current assets | 1,070 | 992 | |||||
| TOTAL CURRENT ASSETS | 30,221 | 73,476 | |||||
| NON-CURRENT ASSETS | |||||||
| Property and equipment, net | 768 | 858 | |||||
| 2,061 | 2,061 | ||||||
| Other assets | 174 | 247 | |||||
| TOTAL ASSETS | $ | 33,224 | $ | 76,642 | |||
| LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | |||||||
| CURRENT LIABILITIES | |||||||
| Accounts payable and accrued liabilities | $ | 5,069 | $ | 10,600 | |||
| Accrued bonuses | 1,112 | 1,163 | |||||
| Other current liabilities | 131 | 116 | |||||
| TOTAL CURRENT LIABILITIES | 6,312 | 11,879 | |||||
| NON-CURRENT LIABILITIES | |||||||
| Warrant liability | 536 | 12,818 | |||||
| Accrued dividends | 129 | 129 | |||||
| Other liabilities | 46 | 136 | |||||
| TOTAL LIABILITIES | 7,023 | 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; |
29 | 28 | |||||
| Additional paid-in capital | 189,572 | 183,912 | |||||
| Accumulated deficit | (179,414 | ) | (148,274 | ) | |||
| TOTAL STOCKHOLDERS' EQUITY | 10,187 | 35,666 | |||||
| TOTAL LIABILITIES, SERIES A AND SERIES B CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY | $ | 33,224 | $ | 76,642 | |||
| UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| REVENUES: | |||||||||||||||
| Net sales | $ | 386 | $ | 6,616 | $ | 2,952 | $ | 6,616 | |||||||
| TOTAL REVENUES | 386 | 6,616 | 2,952 | 6,616 | |||||||||||
| Cost of sales | 1,460 | 3,913 | 3,449 | 3,913 | |||||||||||
| GROSS (LOSS) PROFIT | (1,074 | ) | 2,703 | (497 | ) | 2,703 | |||||||||
| OPERATING EXPENSES: | |||||||||||||||
| Research and development | 623 | 1,552 | 1,833 | 3,494 | |||||||||||
| Selling, marketing and administrative | 9,142 | 11,013 | 41,243 | 19,147 | |||||||||||
| TOTAL OPERATING EXPENSES | 9,765 | 12,565 | 43,076 | 22,641 | |||||||||||
| OPERATING LOSS | (10,839 | ) | (9,862 | ) | (43,573 | ) | (19,938 | ) | |||||||
| OTHER INCOME (EXPENSE): | |||||||||||||||
| Interest income (expense), net | 119 | 4 | 151 | (2 | ) | ||||||||||
| Change in fair value of warrant liability | 2,223 | (11,784 | ) | 12,282 | (29,747 | ) | |||||||||
| TOTAL OTHER INCOME (EXPENSE) | 2,342 | (11,780 | ) | 12,433 | (29,749 | ) | |||||||||
| LOSS BEFORE INCOME TAXES | (8,497 | ) | (21,642 | ) | (31,140 | ) | (49,687 | ) | |||||||
| Income taxes | - | - | - | - | |||||||||||
| NET LOSS | (8,497 | ) | (21,642 | ) | (31,140 | ) | (49,687 | ) | |||||||
| Preferred dividends | - | - | - | (2,525 | ) | ||||||||||
| NET LOSS ATTRIBUTABLE TO COMMON STOCKHOLDERS | $ | (8,497 | ) | $ | (21,642 | ) | $ | (31,140 | ) | $ | (52,212 | ) | |||
| Net loss per common share - basic and diluted | $ | (0.30 | ) | $ | (0.80 | ) | $ | (1.11 | ) | $ | (2.34 | ) | |||
| Weighted average shares of common shares - basic and diluted | 28,603,426 | 26,911,855 | 27,949,292 | 22,342,538 | |||||||||||
| 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 | Nine Months Ended | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Net loss attributable to common stockholders - GAAP | $ | (8,497 | ) | $ | (21,642 | ) | $ | (31,140 | ) | $ | (52,212 | ) | |||
| Adjustments: | |||||||||||||||
| Change in fair value of warrant liability | (2,223 | ) | - | 11,784 | (12,282 | ) | - | 29,747 | |||||||
| Preferred dividends | - | - | - | - | - | 2,525 | |||||||||
| Adjusted non-GAAP net loss attributable to common stockholders | $ | (10,720 | ) | $ | (9,858 | ) | $ | (43,422 | ) | $ | (19,940 | ) | |||
| Adjusted non-GAAP net loss per common share - basic and diluted | $ | (0.37 | ) | $ | (0.37 | ) | $ | (1.55 | ) | $ | (0.89 | ) | |||
| Weighted average shares of common shares - basic and diluted | 28,603,426 | 26,911,855 | 27,949,292 | 22,342,538 | |||||||||||
Source: PLx Pharma Inc.