-- First quarter 2023 UPNEEQ® net product sales grew 49%, or
-- Enhanced operating leverage with a 32%, or
-- Majority of aesthetic orders in the first quarter, or 54%, represented reorder activity --
-- Approximately 4,800 cumulative unique medical aesthetics practices had placed orders for UPNEEQ through the end of the first quarter, a 12% increase from prior quarter end --
-- UPNEEQ Won “Best
“RVL is off to a great start on the year. Our one-of-a-kind product continues to exhibit year-over-year growth as we leverage our cost base for improved efficiency. Our multi-channel strategy is delivering favorable results. In fact, monthly pharmacy prescriptions reached an all-time high during the first quarter of 2023, despite the absence of personal promotional support. Additionally, momentum in aesthetics continued, with growth in the percentage of reorders and in new account openings during the quarter. We believe we have barely scratched the surface of the potential for this amazing product,” stated
“We believe the July rollout of Elevate, our next-generation e-commerce portal, will be a powerful step that will broaden our reach, improve the customer experience and facilitate enhanced access to UPNEEQ – all while providing us with data and analytics to further inform our marketing initiatives,” continued Markison.
“The social proof behind UPNEEQ continues to build, as evidenced by being selected the winner as ‘Best
First Quarter 2023 Financial Highlights
- UPNEEQ net product sales were
$8.8 million , an increase of$2.9 million , or 49%, over the first quarter of 2022.- Approximately 4,800 cumulative unique medical aesthetics practices had placed orders for UPNEEQ at quarter end, an increase of 12% from the end of 2022.
- Approximately 19,900 cumulative unique pharmacy-paid prescribers at quarter end, an increase of 8% compared to the end of 2022.
- At quarter end, the optometry and ophthalmology customer base accounted for 68% and 32%, respectively, of its total unique eye care prescriber base.
- Net loss was
$(11.6) million , compared to a net loss of$(6.8) million in the prior year period. Adjusted EBITDA1 loss was$(8.7) million , compared to an Adjusted EBITDA loss of$(18.9) million in the first quarter of 2022. - At
March 31, 2023 , the Company had cash and cash equivalents of$32.6 million and senior secured indebtedness with aggregate principal maturities of$70.7 million .
First Quarter 2023 Financial Results
Net product sales, relating entirely to sales of UPNEEQ, increased by
Royalty and licensing revenues were
Total revenues decreased by
Total cost of goods sold increased by
Gross profit percentage decreased to 74% in the three months ended
Selling, general and administrative expenses decreased by
Research and development expenses decreased by
Total other non-operating activities were a source of income of
Net loss increased by
Liquidity
At
Presentation of Non-GAAP Financial Measures
In addition to our results determined in accordance with accounting principles generally accepted in
We use Adjusted EBITDA loss for business planning purposes, in assessing our performance and in measuring our performance relative to that of our competitors. We also believe that Adjusted EBITDA loss provides investors with useful information to understand our operating results and analyze financial and business trends on a period-to-period basis. Adjusted EBITDA loss has important limitations as an analytical tool, however, and you should not consider it in isolation or as a substitute for analysis of our results as reported under GAAP. Adjusted EBITDA loss is not intended to replace, and should not be considered superior to, the presentation of our financial results in accordance with GAAP. Our definition of Adjusted EBITDA loss may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. Adjusted EBITDA loss is reconciled from net loss, the most comparable GAAP financial measure, in the attached table “RVL Pharmaceuticals plc - GAAP to Non-GAAP Reconciliations” at the end of this press release.
Forward-Looking Statements
This press release includes statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results and therefore are, or may be deemed to be, “forward-looking statements.” The Company’s actual results may vary significantly from the results anticipated in these forward-looking statements, which can generally be identified by the use of forward-looking terminology, including the terms “believes,” “expects,” “may,” “will,” “should,” “seeks,” “projects,” “approximately,” “intends,” “plans,” “targets,” “estimates” or “anticipates,” or, in each case, their negatives or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. They include statements regarding the Company’s intentions, beliefs or current expectations concerning, among other things, its results of operations, financial condition, liquidity, prospects, financial guidance, growth plan, strategies, trends and other events, particularly relating to sales of UPNEEQ,
Conference Call
As previously announced, RVL management will host its first quarter 2023 financial results conference call as follows:
Date: | ||
Time: | ||
Toll free ( | 800-579-2543 | |
International: | 785-424-1789 | |
Webcast (live and replay): | ir.rvlpharma.com under the “Investors & News” section |
A replay of the conference call will be available for one week after the call's completion by dialing 800-938-0996 (
IMPORTANT SAFETY INFORMATION
INDICATION
UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1% is indicated for the treatment of acquired blepharoptosis in adults.
WARNINGS AND PRECAUTIONS
- Ptosis may be associated with neurologic or orbital diseases such as stroke and/or cerebral aneurysm, Horner syndrome, myasthenia gravis, external ophthalmoplegia, orbital infection and orbital masses. Consideration should be given to these conditions in the presence of ptosis with decreased levator muscle function and/or other neurologic signs.
- Alpha-adrenergic agonists as a class may impact blood pressure. Advise UPNEEQ patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
- Use UPNEEQ with caution in patients with cerebral or coronary insufficiency or Sjögren’s syndrome. Advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
- UPNEEQ may increase the risk of angle closure glaucoma in patients with untreated narrow-angle glaucoma. Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.
- Patients should not touch the tip of the single patient-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.
ADVERSE REACTIONS
Adverse reactions that occurred in 1-5% of subjects treated with UPNEEQ were punctate keratitis, conjunctival hyperemia, dry eye, blurred vision, instillation site pain, eye irritation and headache.
DRUG INTERACTIONS
- Alpha-adrenergic agonists, as a class, may impact blood pressure. Caution in using drugs such as betablockers, anti-hypertensives, and/or cardiac glycosides is advised. Caution should also be exercised in patients receiving alpha adrenergic receptor antagonists such as in the treatment of cardiovascular disease, or benign prostatic hypertrophy.
- Caution is advised in patients taking monoamine oxidase inhibitors which can affect the metabolism and uptake of circulating amines.
About
Investor and Media Relations for
T: 212-452-2793
E: lwilson@insitecony.com
________________________________
1 Adjusted EBITDA is a non-GAAP financial measurement, see “Presentation of Non-GAAP Financial Measures.”
-Financial Tables Follow-
Unaudited Condensed Consolidated Balance Sheets | |||||||
(in thousands) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 32,640 | $ | 44,543 | |||
Accounts receivable and other receivables | 1,879 | 3,031 | |||||
Inventories, net | 213 | 784 | |||||
Prepaid expenses and other current assets | 3,620 | 8,617 | |||||
Total current assets | 38,352 | 56,975 | |||||
Property, plant and equipment, net | 2,487 | 1,276 | |||||
Operating lease assets | 522 | 512 | |||||
Indefinite-lived intangible assets | 13,900 | 13,900 | |||||
55,847 | 55,847 | ||||||
Total assets | $ | 111,108 | $ | 128,510 | |||
Liabilities and Shareholders' Equity | |||||||
Current liabilities: | |||||||
Trade accounts payable | $ | 2,630 | $ | 2,407 | |||
Accrued liabilities | 9,268 | 15,395 | |||||
Current portion of debt ( | 4,150 | 1,432 | |||||
Current portion of obligations under finance leases | 11 | 10 | |||||
Current portion of lease liability | 306 | 435 | |||||
Income taxes payable - current portion | 43 | 44 | |||||
Total current liabilities | 16,408 | 19,723 | |||||
Long-term debt (measured at fair value and representing | 53,039 | 55,500 | |||||
Warrant liability | 1,274 | 1,951 | |||||
Long-term portion of obligation under finance leases | 15 | 18 | |||||
Long-term portion of lease liability | 229 | 94 | |||||
Income taxes payable - long term portion | 71 | 70 | |||||
Deferred taxes | 72 | 61 | |||||
Total liabilities | 71,108 | 77,417 | |||||
Shareholders' equity: | |||||||
Ordinary shares | 993 | 992 | |||||
Additional paid in capital | 619,841 | 619,323 | |||||
Accumulated deficit | (580,834 | ) | (569,222 | ) | |||
Total shareholders' equity | 40,000 | 51,093 | |||||
Total liabilities and shareholders' equity | $ | 111,108 | $ | 128,510 | |||
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
(in thousands, except share and per share data) | |||||||
Three Months Ended | |||||||
2023 | 2022 | ||||||
Net product sales | $ | 8,832 | $ | 5,944 | |||
Royalty and licensing revenue | — | 15,500 | |||||
Total revenues | 8,832 | 21,444 | |||||
Cost of goods sold | 2,299 | 2,144 | |||||
Gross profit | 6,533 | 19,300 | |||||
Selling, general and administrative expenses | 16,198 | 23,834 | |||||
Research and development expenses | 626 | 862 | |||||
Total operating expenses | 16,824 | 24,696 | |||||
Operating loss | (10,291 | ) | (5,396 | ) | |||
Interest expense and amortization of debt discount | 26 | 985 | |||||
Change in fair value of debt and interest expense | 7,349 | 1,044 | |||||
Change in fair value of warrants | (677 | ) | 4,508 | ||||
Other non-operating income, net | (5,435 | ) | (5,037 | ) | |||
Total other non-operating income | 1,263 | 1,500 | |||||
Loss before income taxes | (11,554 | ) | (6,896 | ) | |||
Income tax expense (benefit) | 58 | (75 | ) | ||||
Net loss | $ | (11,612 | ) | $ | (6,821 | ) | |
Change in fair value of debt due to change in credit risk, net of tax | — | (1,700 | ) | ||||
Comprehensive loss | $ | (11,612 | ) | $ | (8,521 | ) | |
Loss per ordinary share: | |||||||
Basic and diluted | $ | (0.12 | ) | $ | (0.08 | ) | |
Weighted average ordinary shares outstanding: | |||||||
Basic and diluted | 99,321,304 | 83,489,900 | |||||
Unaudited Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands) | |||||||
Three Months Ended | |||||||
2023 | 2022 | ||||||
Cash Flows from Operating Activities: | |||||||
Net loss | $ | (11,612 | ) | $ | (6,821 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 93 | 89 | |||||
Share compensation | 499 | 1,209 | |||||
Change in fair value of debt | 5,134 | (400 | ) | ||||
Change in fair value of warrants | (677 | ) | 4,508 | ||||
Deferred income tax benefit | 11 | 9 | |||||
Gain on sale of fixed and leased assets | (79 | ) | (37 | ) | |||
Amortization of deferred financing and loan origination fees | — | 967 | |||||
Change in operating assets and liabilities: | |||||||
Accounts receivable and other receivables | 1,152 | (15,439 | ) | ||||
Inventories, net | 571 | — | |||||
Prepaid expenses and other current and non-current assets | 4,998 | 420 | |||||
Trade accounts payable | 224 | 955 | |||||
Accrued and other current liabilities | (6,132 | ) | 1,264 | ||||
Net cash used in operating activities | (5,818 | ) | (13,276 | ) | |||
Cash Flows from Investing Activities: | |||||||
Proceeds from sale of fixed and leased assets | 79 | 37 | |||||
Purchases of property, plant and equipment | (1,304 | ) | (27 | ) | |||
Net cash (used in) provided by investing activities | (1,225 | ) | 10 | ||||
Cash Flows from Financing Activities: | |||||||
Payments on finance lease obligations | (2 | ) | (2 | ) | |||
Payments on insurance financing loan | (544 | ) | (897 | ) | |||
Payments for taxes related to net share settlement of share-based awards | (72 | ) | (57 | ) | |||
Proceeds from issuance of ordinary shares under the ESP Plan | 92 | 119 | |||||
Debt repayments | (4,334 | ) | — | ||||
Net cash used in financing activities | (4,860 | ) | (837 | ) | |||
Net change in cash and cash equivalents | (11,903 | ) | (14,103 | ) | |||
Cash and cash equivalents, beginning of period | 44,543 | 40,444 | |||||
Cash and cash equivalents, end of period | $ | 32,640 | $ | 26,341 | |||
GAAP to Non-GAAP Reconciliations | |||||||
Adjusted EBITDA (Unaudited) | |||||||
(in thousands) | |||||||
Three Months Ended | |||||||
2023 | 2022 | ||||||
Net loss | $ | (11,612 | ) | $ | (6,821 | ) | |
Interest expense and amortization of debt discount | 26 | 985 | |||||
Income tax expense (benefit) | 58 | (75 | ) | ||||
Depreciation and amortization expense | 93 | 89 | |||||
EBITDA | (11,435 | ) | (5,822 | ) | |||
Licensing-related revenues, net of transaction costs(1) | — | (15,000 | ) | ||||
Divestiture-related contingent milestone payments, excluding fees(2) | (5,000 | ) | (5,000 | ) | |||
Debt financing costs(3) | 575 | 150 | |||||
Change in fair value of debt and interest expense(4) | 7,349 | 1,044 | |||||
Change in fair value of warrants(4) | (677 | ) | 4,508 | ||||
Share-based compensation expense | 499 | 1,209 | |||||
Foreign currency translation | 34 | 14 | |||||
Adjusted EBITDA Loss | $ | (8,655 | ) | $ | (18,897 | ) | |
(1) - 2022 includes | |||||||
(2) - Relates to contingent gains related to milestone payments earned subsequent to the sale of our legacy business to | |||||||
(3) - 2023 relates to | |||||||
(4) - Our senior secured notes issued under our Note Purchase Agreement, a material component of long-term debt, and our warrant liabilities, a material component of total liabilities have each been measured and carried at fair value since their issuance in | |||||||
Source:
2023 GlobeNewswire, Inc., source