RVL PHARMACEUTICALS PLC -- Third quarter 2022 UPNEEQ® net product sales of
-- Approximately 3,500 cumulative unique medical aesthetics practices placed orders for UPNEEQ through the end of the third quarter 2022, a 59% increase from the end of the second quarter 2022 --
-- Anticipates fourth quarter 2022 UPNEEQ net product sales to grow approximately 20% - 40% over the third quarter 2022, representing sales of approximately
-- Plans to launch new eCommerce platform in first quarter 2023 --
“UPNEEQ continues to gain traction within the eyecare and medical aesthetics markets, as demonstrated by the 19% sequential-quarter increase in net product sales in the third quarter. We continued to execute our multi-channel marketing plan and expanded our reach during the quarter, with approximately 3,500 cumulative unique medical aesthetics practices having placed orders for UPNEEQ and nearly 1,000 practices having placed re-orders as of quarter end,” stated
“As the first and only FDA-approved ophthalmic solution for blepharoptosis, or droopy eyelids, UPNEEQ is being embraced by providers and patients, alike. It is gratifying to see the creation – and development – of this new category, and we look forward to capturing the full value of what we believe is a significant opportunity.
“UPNEEQ is the centerpiece of our strategy to be a leading player in ocular aesthetic medicine,” concluded Markison.
Third Quarter 2022 Financial Highlights
- UPNEEQ net product sales of
$10.0 million , up$7.8 million year-over-year, or 355%, and up$1.6 million , or 19%, from the second quarter of 2022.- Approximately 17,000 cumulative unique pharmacy-paid prescribers at quarter end, an increase of 13% compared to the end of the second quarter of 2022.
- At quarter end, the Company’s optometry and ophthalmology customer base accounted for 68% and 32%, respectively, of its total unique eyecare prescriber base.
- Approximately 3,500 cumulative unique medical aesthetics practices had placed orders for UPNEEQ at quarter end, an increase of 59% from the end of the second quarter of 2022.
- Loss from continuing operations of
$(14.4) million , compared to a loss of$(26.3) million in the prior year period. Adjusted EBITDA1 loss of$(10.9) million , compared to a loss of$(20.3) million in the prior year period. - On
August 8, 2022 , the Company raised an aggregate of$43.9 million , comprised of$23.9 million in aggregate gross proceeds from the private placement of ordinary shares and$20.0 million from the concurrent issuance of second tranche senior secured notes. - At
September 30, 2022 , cash and cash equivalents were$59.8 million and debt and financing obligations had an aggregate principal amount of$75.0 million .
Third Quarter 2022 Financial Results
Total revenues and net product sales, relating entirely to net product sales of UPNEEQ, increased by
Total cost of goods sold increased
Gross profit percentage increased to 75% in the three months ended
Selling, general and administrative expenses decreased
Research and development expenses decreased by
Total other non-operating activities contributed
Liquidity
At
On
Fourth Quarter 2022 UPNEEQ Net Sales Guidance
The Company reaffirms its guidance targeting net sales of UPNEEQ for the fourth quarter of 2022 of between
Presentation of Non-GAAP Financial Measures
In addition to our results determined in accordance with accounting principles generally accepted in
We use Adjusted EBITDA 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 provides investors with useful information to understand our operating results and analyze financial and business trends on a period-to-period basis. Adjusted EBITDA 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 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 may differ from similar measures reported by other companies and may not be comparable to other similarly titled measures. Adjusted EBITDA is reconciled from income or loss from continuing operations, 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, FDA and other regulatory applications, approvals and actions, our plans to launch a new eCommerce platform, the continuation of historical trends, our ability to manage costs and service our debt and the sufficiency of our cash balances and cash generated from operating and financing activities for future liquidity and capital resource needs. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We may not achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place significant reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. Important factors that could cause actual results and events to differ materially from those indicated in the forward-looking statements include the following: UPNEEQ’s ability to reach market acceptance by clinicians and patients; our ability to successfully commercialize UPNEEQ; our customers’ willingness to pay the price we charge for UPNEEQ; the results of our marketing and sales expenditures; our dependence on third-party suppliers and distributors for UPNEEQ; UPNEEQ’s ability to produce its intended effects; failures of or delays in clinical trials or other delays in obtaining regulatory approval or commencing product sales for new products; the impact of legal proceedings; and other risks and uncertainties more fully described in the “Risk Factors” section of our Annual Report on Form 10-K filed on
Conference Call
As previously announced, RVL management will host its third quarter 2022 financial results conference call as follows:
| Date: Time: Toll Free ( International | 800-267-6316 203-518-9856 |
| Webcast (live and replay): | ir.rvlpharma.com under the “Investors & News” section |
A replay of the conference call will be available for two weeks after the call's completion by dialing 888-269-5294 (
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
-Financial Tables Follow-
1 Adjusted EBITDA is a non-GAAP financial measurement, see “Presentation of Non-GAAP Financial Measures.”
| Unaudited Condensed Consolidated Balance Sheets | |||||||
| (in thousands) | |||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 59,752 | $ | 40,444 | |||
| Accounts receivable and other receivables | 3,280 | 2,133 | |||||
| Inventories, net | 621 | 838 | |||||
| Prepaid expenses and other current assets | 7,261 | 12,901 | |||||
| Financial commitment asset | — | 3,063 | |||||
| Total current assets | 70,914 | 59,379 | |||||
| Property, plant and equipment, net | 676 | 866 | |||||
| Operating lease assets | 708 | 1,368 | |||||
| Indefinite-lived intangible assets | 27,210 | 27,210 | |||||
| 55,847 | 55,847 | ||||||
| Total assets | $ | 155,355 | $ | 144,670 | |||
| Liabilities and Shareholders' Equity | |||||||
| Current liabilities: | |||||||
| Trade accounts payable | $ | 7,003 | $ | 3,777 | |||
| Accrued liabilities | 13,949 | 13,077 | |||||
| Current portion of debt | — | 2,409 | |||||
| Current portion of obligations under finance leases | 10 | 5 | |||||
| Current portion of lease liability | 510 | 839 | |||||
| Income taxes payable - current portion | 12 | 1 | |||||
| Total current liabilities | 21,484 | 20,108 | |||||
| Long-term debt (measured at fair value and representing | 55,900 | 43,800 | |||||
| Warrant liability | 8,926 | 3,220 | |||||
| Long-term portion of obligation under finance leases | 20 | — | |||||
| Long-term portion of lease liability | 220 | 592 | |||||
| Income taxes payable-long term portion | 70 | 66 | |||||
| Deferred taxes | 189 | 151 | |||||
| Total liabilities | 86,809 | 67,937 | |||||
| Commitments and contingencies | |||||||
| Shareholders' equity: | |||||||
| Ordinary shares | 992 | 833 | |||||
| Additional paid in capital | 618,457 | 591,730 | |||||
| Accumulated deficit | (550,903 | ) | (517,530 | ) | |||
| Accumulated other comprehensive income | — | 1,700 | |||||
| Total shareholders' equity | 68,546 | 76,733 | |||||
| Total liabilities and shareholders' equity | $ | 155,355 | $ | 144,670 | |||
| Unaudited Condensed Consolidated Statements of Operations | |||||||||||||||
| (in thousands, except share and per share data) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Net product sales | $ | 10,022 | $ | 2,196 | $ | 24,414 | $ | 4,451 | |||||||
| Royalty revenue | — | — | — | 190 | |||||||||||
| Licensing revenue | — | — | 15,500 | 10,000 | |||||||||||
| Total revenues | 10,022 | 2,196 | 39,914 | 14,641 | |||||||||||
| Cost of goods sold | 2,525 | 1,147 | 6,896 | 2,535 | |||||||||||
| Gross profit | 7,497 | 1,049 | 33,018 | 12,106 | |||||||||||
| Selling, general and administrative expenses | 20,375 | 24,841 | 64,378 | 63,769 | |||||||||||
| Research and development expenses | 1,044 | 1,376 | 3,082 | 5,789 | |||||||||||
| Impairment of intangible assets | — | — | — | 7,880 | |||||||||||
| Total operating expenses | 21,419 | 26,217 | 67,460 | 77,438 | |||||||||||
| Operating loss before gain on sales of product rights, net | (13,922 | ) | (25,168 | ) | (34,442 | ) | (65,332 | ) | |||||||
| Gain on sales of product rights, net | — | — | — | 5,636 | |||||||||||
| Operating loss | (13,922 | ) | (25,168 | ) | (34,442 | ) | (59,696 | ) | |||||||
| Interest expense and amortization of debt discount | 1,132 | 735 | 3,095 | 1,750 | |||||||||||
| Change in fair value of debt and interest expense | (5,061 | ) | — | (4,757 | ) | — | |||||||||
| Change in fair value of warrants | 4,653 | — | 5,706 | — | |||||||||||
| Other non-operating (income) expense, net | (263 | ) | 120 | (5,378 | ) | 1,312 | |||||||||
| Total other non-operating expense (income) | 461 | 855 | (1,334 | ) | 3,062 | ||||||||||
| Loss before income taxes | (14,383 | ) | (26,023 | ) | (33,108 | ) | (62,758 | ) | |||||||
| Income tax expense, continuing operations | 63 | 324 | 265 | 415 | |||||||||||
| Loss from continuing operations | (14,446 | ) | (26,347 | ) | (33,373 | ) | (63,173 | ) | |||||||
| Gain on sales of discontinued operations | — | 4,373 | — | 4,373 | |||||||||||
| Income from discontinued operations before income taxes | — | 3,983 | — | 14,219 | |||||||||||
| Income tax (benefit) expense, discontinued operations | — | (132 | ) | — | 617 | ||||||||||
| Income from discontinued operations, net of tax | — | 8,488 | — | 17,975 | |||||||||||
| Net loss | $ | (14,446 | ) | $ | (17,859 | ) | $ | (33,373 | ) | $ | (45,198 | ) | |||
| Change in fair value of debt due to change in credit risk, net of tax | — | — | (1,700 | ) | — | ||||||||||
| Comprehensive loss | $ | (14,446 | ) | $ | (17,859 | ) | $ | (35,073 | ) | $ | (45,198 | ) | |||
| (Loss) earnings per ordinary share: | |||||||||||||||
| Basic and diluted, continuing operations | $ | (0.16 | ) | $ | (0.42 | ) | $ | (0.39 | ) | $ | (1.01 | ) | |||
| Basic and diluted, discontinued operations | $ | - | $ | 0.13 | $ | - | $ | 0.29 | |||||||
| Basic and diluted | $ | (0.16 | ) | $ | (0.28 | ) | $ | (0.39 | ) | $ | (0.72 | ) | |||
| Weighted average ordinary shares outstanding: | |||||||||||||||
| Basic and diluted | 92,756,483 | 62,945,898 | 86,643,040 | 62,798,123 | |||||||||||
| Unaudited Condensed Consolidated Statements of Cash Flows | |||||||
| (in thousands) | |||||||
| Nine Months Ended | |||||||
| 2022 | 2021 | ||||||
| Cash Flows from Operating Activities: | |||||||
| Net loss from continuing operations | $ | (33,373 | ) | $ | (63,173 | ) | |
| Net income from discontinued operations | — | 17,975 | |||||
| Net loss | (33,373 | ) | (45,198 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Depreciation and amortization | 275 | 8,068 | |||||
| Share compensation | 3,176 | 6,592 | |||||
| Change in fair value of debt | (9,600 | ) | — | ||||
| Change in fair value of warrants | 5,706 | — | |||||
| Impairment of intangible assets | — | 7,880 | |||||
| Deferred income tax expense (benefit) | 38 | (180 | ) | ||||
| (Gain) loss on sale of fixed and leased assets | (350 | ) | 1,229 | ||||
| Gain on sales of product rights, net | — | (5,636 | ) | ||||
| Gain on sales of discontinued operations | — | (4,373 | ) | ||||
| Amortization of deferred financing and loan origination fees | 3,063 | 746 | |||||
| Write off of deferred financing and loan origination fees | — | 1,387 | |||||
| Financing fees recognized in earnings associated with debt | 914 | — | |||||
| Change in operating assets and liabilities: | |||||||
| Accounts receivable and other receivables | (1,147 | ) | 4,643 | ||||
| Inventories, net | 217 | 2,256 | |||||
| Prepaid expenses and other current and non-current assets | 5,640 | (3,919 | ) | ||||
| Trade accounts payable | 3,226 | 515 | |||||
| Accrued and other current liabilities | 838 | (4,347 | ) | ||||
| Net cash used in operating activities | (21,377 | ) | (30,337 | ) | |||
| Cash Flows from Investing Activities: | |||||||
| Proceeds from product rights disposal | — | 7,300 | |||||
| Proceeds from discontinued operations | — | 110,845 | |||||
| Proceeds from sale of fixed and leased assets | 350 | 40 | |||||
| Purchase of property, plant and equipment | (52 | ) | (1,657 | ) | |||
| Net cash provided by investing activities | 298 | 116,528 | |||||
| Cash Flows from Financing Activities: | |||||||
| Payments on finance lease obligations | (6 | ) | (35 | ) | |||
| Payments on insurance financing loan | (2,409 | ) | — | ||||
| Payments for taxes related to net share settlement of share-based awards | (134 | ) | (767 | ) | |||
| Proceeds from public offering, net of issuance costs | — | 36 | |||||
| Proceeds from issuance of debt, net of issuance costs | 19,090 | — | |||||
| Proceeds from issuance of ordinary shares, net of issuance costs | 23,655 | — | |||||
| Proceeds from issuance of ordinary shares under ESPP | 191 | 234 | |||||
| Debt repayments | — | (191,360 | ) | ||||
| Net cash provided by (used in) financing activities | 40,387 | (191,892 | ) | ||||
| Net change in cash and cash equivalents | 19,308 | (105,701 | ) | ||||
| Cash and cash equivalents, beginning of period | 40,444 | 114,053 | |||||
| Cash and cash equivalents, end of period | $ | 59,752 | $ | 8,352 | |||
| GAAP to Non-GAAP Reconciliations | |||||||||||||||
| Adjusted EBITDA (Unaudited) | |||||||||||||||
| (in thousands) | |||||||||||||||
| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Loss from continuing operations | $ | (14,446 | ) | $ | (26,347 | ) | $ | (33,373 | ) | $ | (63,173 | ) | |||
| Interest expense and amortization of debt discount | 1,132 | 735 | 3,095 | 1,750 | |||||||||||
| Income tax expense | 63 | 324 | 265 | 415 | |||||||||||
| Depreciation and amortization expense | 95 | 154 | 275 | 1,485 | |||||||||||
| EBITDA | (13,156 | ) | (25,134 | ) | (29,738 | ) | (59,523 | ) | |||||||
| Licensing-related revenues, net of transaction costs(1) | — | — | (15,000 | ) | — | ||||||||||
| Divestiture-related contingent milestone payments, net of fees(2) | — | — | (4,850 | ) | — | ||||||||||
| Change in fair value of debt and interest expense(3) | (5,061 | ) | — | (4,757 | ) | — | |||||||||
| Change in fair value of warrants(3) | 4,653 | — | 5,706 | — | |||||||||||
| Gain on sales of product rights(4) | — | — | — | (5,636 | ) | ||||||||||
| Impairment of intangible assets(5) | — | — | — | 7,880 | |||||||||||
| Asset disposal charge(6) | — | — | — | 1,245 | |||||||||||
| Debt financing costs(7) | 914 | — | 914 | — | |||||||||||
| Share-based compensation expense | 758 | 3,755 | 3,176 | 5,961 | |||||||||||
| Severance expense | 971 | 769 | 2,830 | 4,656 | |||||||||||
| Foreign currency translation | 6 | (28 | ) | 68 | (819 | ) | |||||||||
| Legal settlements and expenses | — | 221 | — | 612 | |||||||||||
| Other | 1 | 94 | 86 | 114 | |||||||||||
| Adjusted EBITDA | $ | (10,914 | ) | $ | (20,323 | ) | $ | (41,565 | ) | $ | (45,510 | ) | |||
| (1) - Includes | |||||||||||||||
| (2) - Includes | |||||||||||||||
| (3) - 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 | |||||||||||||||
| (4) - Relates to our sale of global rights to Osmolex ER to Adamas Pharmaceuticals, Inc., which closed in | |||||||||||||||
| (5) - Relates to impairment charges recognized upon delays in anticipated commercialization of arbaclofen extended release tablets. | |||||||||||||||
| (6) - Relates to restructuring charges associated with a curtailment of Argentinian operations, specifically asset disposal costs related to leasehold improvements at our former | |||||||||||||||
| (7) - Relates to debt issuance costs associated with an amendment of our note purchase agreement in | |||||||||||||||
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