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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): August 14, 2023
RVL Pharmaceuticals plc
(Exact name of registrant as specified in its charter)
Ireland |
|
001-38709 |
|
Not Applicable |
(State or other jurisdiction
of incorporation) |
|
(Commission File Number) |
|
(IRS Employer Identification No.) |
400
Crossing Boulevard
Bridgewater, NJ |
|
08807 |
(Address of principal executive offices) |
|
(Zip Code) |
(Registrant’s telephone number, including
area code): (908) 809-1300
Not Applicable
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class |
Trading
Symbol(s) |
Name
of each exchange on which
registered |
Ordinary Shares |
RVLP |
Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act.
Item 2.02 Results
of Operations and Financial Condition.
On August 14, 2023, RVL Pharmaceuticals plc
(the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023. A copy of
the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.
The information contained
in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed”
for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and shall not be
deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly
set forth by specific reference in such filing.
Item 9.01 Financial
Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
RVL PHARMACEUTICALS PLC |
|
|
|
Dated: August 14, 2023 |
By: |
/s/ Brian Markison |
|
|
Brian Markison |
|
|
Chief Executive Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
RVL Pharmaceuticals
plc Reports Second Quarter 2023 Financial Results; Provides Update on Strategic Business Review
-- UPNEEQ® remains a significant
potential value driver given its rapid early acceptance by providers, large total addressable market and untapped consumer opportunity
--
-- Executed financing amendment with Athyrium,
which, subject to certain conditions, would provide meaningful flexibility as part of our ongoing strategy to invest in UPNEEQ and drive
growth --
-- The Company is in discussions with strategic
targets that could accelerate UPNEEQ sales, broaden the Company’s portfolio and leverage the field force investment --
-- Second quarter 2023 UPNEEQ net product sales
of $8.3 million and operating expenses of $14.4 million, down 2% and 32%, respectively, compared to the prior year period, highlighting
lower baseline of operating expense --
-- The Company streamlined operating expense
in order to extend runway, optimize marketing mix, and support strategic business development --
-- Initiated creative development for our 1st
Branded Direct-to-Consumer (“DTC”) campaign --
-- E-Commerce platform, Elevate, rollout on
track –
BRIDGEWATER, N.J., August 14, 2023 –
RVL Pharmaceuticals plc (Nasdaq: RVLP) (“RVL” or the “Company”), a specialty pharmaceutical company focused
on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment of acquired
blepharoptosis, or low-lying eyelid, in adults, today announced financial results for the three months ended June 30, 2023, and provided
an update on its business review.
“During the past several months, we have
focused on expense reduction to extend runway, optimize marketing mix, and support business development efforts. While this streamlining
had a modest unfavorable impact on sales during the quarter, we have gained greater conviction that driving consumer awareness is
the next lever that may unlock meaningful growth for UPNEEQ. Importantly, we have also compiled encouraging data around our large total
addressable market, or TAM, and the exceptionally low level of consumer awareness for UPNEEQ,” stated Brian Markison, Chief Executive
Officer of RVL.
“In addition, we have continued our strategic
business review, and are in advanced discussions with certain companies that we could potentially partner with or acquire to support
growth and integrate into our infrastructure with meaningful synergies,” continued Markison.
“We have been working closely with our
lender, Athyrium, and have recently executed an amendment to our note purchase agreement in order to support our growth and business
development strategy,” continued Markison.
“Looking ahead, we believe that UPNEEQ
is a significant potential value driver. We expect that our future marketing mix will shift to the consumer to complement our personal
selling efforts across the board. Conversions to Elevate, our new e-commerce platform, which is designed to enable us to offer subscription
options to all of our customers and a Business-to-Business-to-Consumer (B-B-C) program for direct purchasing locations, are off to an
encouraging start,” concluded Markison.
Second Quarter 2023 Financial Highlights
| · | UPNEEQ net product sales were $8.3 million,
a decrease of $0.1 million, or 2%, from the second quarter of 2022. |
| o | 5,400
cumulative unique medical aesthetics practices had placed orders for UPNEEQ at quarter end,
an increase of 13% from the end of the first quarter of 2023. |
| o | 21,000
cumulative unique prescribers had written a paid prescription for UPNEEQ at quarter end,
an increase of 6% compared to the end of the first quarter of 2023. |
| · | Total operating expenses were $28.3 million,
inclusive of a $13.9 million impairment charge. Absent the impairment charge, total operating
expenses were $14.4 million, a decrease of $6.9 million, or 32%, from the second quarter
of 2022. |
| · | Net loss was $(23.9) million, compared
to a net loss of $(12.1) million in the prior year period. Adjusted EBITDA1
loss was $(7.4) million, compared to an Adjusted EBITDA loss of $(11.8) million
in the second quarter of 2022. |
| · | At June 30,
2023, the Company had cash and cash equivalents of $19.2 million and senior secured indebtedness
with aggregate principal maturities of $70.7 million. |
Second Quarter 2023 Financial Results
Net product sales, relating entirely to sales
of UPNEEQ, decreased by $0.1 million to $8.3 million in the three months ended June 30, 2023, as compared to $8.4 million in the
three months ended June 30, 2022. The year-over-year decrease was primarily due to a decrease in sales volume partially offset by
nominally higher pricing, partly attributable to a price increase implemented during April 2022.
1
Adjusted EBITDA is a non-GAAP financial measurement, see “Presentation of Non-GAAP Financial Measures.”
Total cost of goods sold, which relate exclusively
to net product sales, decreased by $0.3 million to $1.9 million in the three months ended June 30, 2023, as compared to $2.2 million
in the three months ended June 30, 2022. The year-over-year decrease was primarily driven by lower sales volumes and royalty expense,
inclusive of contingent earn out obligations particular to the 2022 period.
Gross profit percentage from net product sales
was 76% and 74% in the 2023 and 2022 periods, respectively, primarily reflecting lower royalty expense, inclusive of contingent earn
out obligations.
Selling, general and administrative expenses
decreased by $6.3 million to $13.9 million in the three months ended June 30, 2023, as compared to $20.2 million in the three months
ended June 30, 2022. The year-over-year decrease was primarily driven by (i) $4.2 million in lower net compensation and training
costs primarily relating to the absence of an eye care salesforce in the 2023 period, (ii) $0.9 million in lower insurance, rent,
legal and other professional fees, (iii) $0.8 million in lower share-based compensation, and (iv) $0.2 million in lower marketing
expenses for UPNEEQ.
Research and development expenses decreased by
$0.7 million to $0.5 million in the three months ended June 30, 2023, as compared to $1.2 million in the three months ended June 30,
2022. The year-over-year decrease primarily reflects $0.3 million in lower project spending and $0.2 million in lower share-based compensation
expense.
During the three months ended June 30, 2023,
and following our discontinuance of marketing efforts associated with arbaclofen extended release, an In-Process Research and Development
project-based intangible asset, we recognized impairment charges of $13.9 million. No such impairments were recognized in the three months
ended June 30, 2022.
Total operating expenses were $28.3 million,
inclusive of a $13.9 million impairment, in the three months ended June 30, 2023. Excluding the impairment, total operating expenses
were $14.4 million, a decrease of $6.9 million, or 32%, compared to the three months ended June 30, 2022.
Total other non-operating activities represented
$2.0 million of net expense and $3.3 million of net income in the three months ended June 30, 2023, and 2022, respectively. Net
non-operating income or expense in the 2023 and 2022 periods was primarily influenced by fair value re-measurements required under our
debt and warrants.
Net loss was $(23.9) million in the three months
ended June 30, 2023, as compared to a $(12.1) million loss in the three months ended June 30, 2022. Adjusted EBITDA loss decreased
by $4.4 million, or 38%, to a $(7.4) million loss in the three months ended June 30, 2023, as compared to an $(11.8) million loss
in the three months ended June 30, 2022.
Liquidity
At June 30, 2023, the Company had cash and
cash equivalents of $19.2 million and senior secured indebtedness with aggregate principal maturities of $70.7 million, which are reflected
on its balance sheet at fair value of $57.3 million.
Presentation of Non-GAAP Financial Measures
In addition to our results determined in accordance
with accounting principles generally accepted in the United States of America (“GAAP”) throughout this press release, we
also present Adjusted EBITDA loss, which is a non-GAAP financial measurement. Adjusted EBITDA loss represents earnings before interest,
taxes, depreciation and amortization (or “EBITDA”) adjusted for (i) non-operating income or expense and (ii) the
impact of certain non-cash, non-recurring or other items that are included in net loss and EBITDA that we do not consider indicative
of our ongoing operating performance. In particular, our measurement of Adjusted EBITDA loss excludes the following from EBITDA: licensing-related
revenues, net of transaction costs; divestiture-related contingent milestone payments, net of fees; changes in the fair value of our
debt and interest expense and warrant liability recognized through earnings; gains or losses on the sale of product rights; impairments
of intangible assets; asset disposal charges; debt financing costs; share-based compensation expense; severance expenses; foreign currency
translation; legal settlements and expenses and other expenses.
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, the rollout
of Elevate, our next generation e-commerce portal, and our future marketing mix shift to consumers, expectations regarding our total
addressable market and consumer awareness, plans to potentially partner with
or acquire companies to support growth and integrate into our infrastructure and the potential synergies resulting from such partnership
or acquisition, 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; 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
March 20, 2023, and our Quarterly Report on Form 10-Q filed on May 11, 2023, and other filings that the Company makes
with the Securities and Exchange Commission. These forward-looking statements speak only as of the time of this press release and we
do not undertake to publicly update or revise them, whether as a result of new information, future events or otherwise, except as required
by law.
Conference Call
As previously
announced, RVL management will host its second quarter 2023 financial results conference call as follows:
Date |
Monday, August 14, 2023 |
Time |
8:30 a.m. ET |
Register* (audio only) |
Click here |
Webcast (live and replay) |
https://ir.rvlpharma.com/ under the “Investors & News” section |
* Conference
call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address.
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 RVL Pharmaceuticals plc
RVL Pharmaceuticals plc is a specialty pharmaceutical
company focused on the commercialization of UPNEEQ® (oxymetazoline hydrochloride ophthalmic solution), 0.1%, for the treatment
of acquired blepharoptosis, or low-lying eyelid, in adults. UPNEEQ is the first non-surgical treatment option approved by the FDA for
acquired blepharoptosis.
Investor and Media Relations for RVL Pharmaceuticals plc
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
-Financial Tables Follow-
RVL Pharmaceuticals plc
Unaudited Condensed Consolidated Balance Sheets
(in thousands)
| |
June 30, 2023 | | |
December 31, 2022 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 19,159 | | |
$ | 44,543 | |
Accounts receivable and other receivables | |
| 1,932 | | |
| 3,031 | |
Inventories, net | |
| 1,356 | | |
| 784 | |
Prepaid expenses and other current assets | |
| 3,305 | | |
| 8,617 | |
Total current assets | |
| 25,752 | | |
| 56,975 | |
Property, plant and equipment, net | |
| 3,440 | | |
| 1,276 | |
Operating lease assets | |
| 365 | | |
| 512 | |
Indefinite-lived intangible assets | |
| - | | |
| 13,900 | |
Goodwill | |
| 55,847 | | |
| 55,847 | |
Total assets | |
$ | 85,404 | | |
$ | 128,510 | |
| |
| | | |
| | |
Liabilities and Shareholders' Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Trade accounts payable | |
$ | 2,530 | | |
$ | 2,407 | |
Accrued liabilities | |
| 7,857 | | |
| 15,395 | |
Current portion of debt ($57,300 measured at fair value and representing $70,666 of aggregate unpaid principal at June 30, 2023) | |
| 57,748 | | |
| 1,432 | |
Current portion of obligations under finance leases | |
| 10 | | |
| 10 | |
Current portion of lease liability | |
| 197 | | |
| 435 | |
Income taxes payable - current portion | |
| 50 | | |
| 44 | |
Total current liabilities | |
| 68,392 | | |
| 19,723 | |
Long-term debt (measured at fair value and representing $75,000 of aggregate unpaid principal at December 31, 2022) | |
| — | | |
| 55,500 | |
Warrant liability | |
| 469 | | |
| 1,951 | |
Long-term portion of obligation under finance leases | |
| 12 | | |
| 18 | |
Long-term portion of lease liability | |
| 180 | | |
| 94 | |
Income taxes payable - long term portion | |
| — | | |
| 70 | |
Deferred taxes | |
| 25 | | |
| 61 | |
Total liabilities | |
| 69,078 | | |
| 77,417 | |
Shareholders' equity: | |
| | | |
| | |
Ordinary shares | |
| 994 | | |
| 992 | |
Additional paid in capital | |
| 620,055 | | |
| 619,323 | |
Accumulated deficit | |
| (604,723 | ) | |
| (569,222 | ) |
Total shareholders' equity | |
| 16,326 | | |
| 51,093 | |
Total liabilities and shareholders' equity | |
$ | 85,404 | | |
$ | 128,510 | |
RVL Pharmaceuticals plc
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net product sales | |
$ | 8,258 | | |
$ | 8,448 | | |
$ | 17,090 | | |
$ | 14,392 | |
Royalty and licensing revenue | |
| — | | |
| — | | |
| — | | |
| 15,500 | |
Total revenues | |
| 8,258 | | |
| 8,448 | | |
| 17,090 | | |
| 29,892 | |
Cost of goods sold | |
| 1,946 | | |
| 2,227 | | |
| 4,245 | | |
| 4,371 | |
Gross profit | |
| 6,312 | | |
| 6,221 | | |
| 12,845 | | |
| 25,521 | |
Selling, general and administrative expenses | |
| 13,886 | | |
| 20,169 | | |
| 30,084 | | |
| 44,003 | |
Research and development expenses | |
| 547 | | |
| 1,176 | | |
| 1,173 | | |
| 2,038 | |
Impairment of intangible assets | |
| 13,900 | | |
| — | | |
| 13,900 | | |
| — | |
Total operating expenses | |
| 28,333 | | |
| 21,345 | | |
| 45,157 | | |
| 46,041 | |
Operating loss | |
| (22,021 | ) | |
| (15,124 | ) | |
| (32,312 | ) | |
| (20,520 | ) |
Interest expense and amortization of debt discount | |
| 13 | | |
| 978 | | |
| 39 | | |
| 1,963 | |
Change in fair value of debt and interest expense | |
| 3,144 | | |
| (740 | ) | |
| 10,493 | | |
| 304 | |
Change in fair value of warrants | |
| (805 | ) | |
| (3,455 | ) | |
| (1,482 | ) | |
| 1,053 | |
Other non-operating income, net | |
| (371 | ) | |
| (78 | ) | |
| (5,806 | ) | |
| (5,115 | ) |
Total other non-operating expense (income) | |
| 1,981 | | |
| (3,295 | ) | |
| 3,244 | | |
| (1,795 | ) |
Loss before income taxes | |
| (24,002 | ) | |
| (11,829 | ) | |
| (35,556 | ) | |
| (18,725 | ) |
Income tax (benefit) expense | |
| (113 | ) | |
| 277 | | |
| (55 | ) | |
| 202 | |
Net loss | |
$ | (23,889 | ) | |
$ | (12,106 | ) | |
$ | (35,501 | ) | |
$ | (18,927 | ) |
Change in fair value of debt due to change in credit risk, net of tax | |
| — | | |
| - | | |
| - | | |
| (1,700 | ) |
Comprehensive loss | |
$ | (23,889 | ) | |
$ | (12,106 | ) | |
$ | (35,501 | ) | |
$ | (20,627 | ) |
Loss per ordinary share: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
$ | (0.24 | ) | |
$ | (0.14 | ) | |
$ | (0.36 | ) | |
$ | (0.23 | ) |
Weighted average ordinary shares outstanding: | |
| | | |
| | | |
| | | |
| | |
Basic and diluted | |
| 99,370,291 | | |
| 83,580,906 | | |
| 99,345,933 | | |
| 83,535,655 | |
RVL Pharmaceuticals plc
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
| |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | |
Cash Flows from Operating Activities: | |
| | | |
| | |
Net loss | |
$ | (35,501 | ) | |
$ | (18,927 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 187 | | |
| 180 | |
Share compensation | |
| 731 | | |
| 2,418 | |
Change in fair value of debt | |
| 6,134 | | |
| (2,600 | ) |
Change in fair value of warrants | |
| (1,482 | ) | |
| 1,053 | |
Impairment of intangible assets | |
| 13,900 | | |
| — | |
Deferred income tax (benefit) expense | |
| (37 | ) | |
| 23 | |
Gain on sale of fixed and leased assets | |
| (166 | ) | |
| (94 | ) |
Amortization of deferred financing and loan origination fees | |
| — | | |
| 1,935 | |
Change in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable and other receivables | |
| 1,099 | | |
| 300 | |
Inventories, net | |
| (572 | ) | |
| 310 | |
Prepaid expenses and other current and non-current assets | |
| 5,313 | | |
| 3,614 | |
Trade accounts payable | |
| 124 | | |
| 1,659 | |
Accrued and other current liabilities | |
| (7,610 | ) | |
| (1,151 | ) |
Net cash used in operating activities | |
| (17,880 | ) | |
| (11,280 | ) |
Cash Flows from Investing Activities: | |
| | | |
| | |
Proceeds from sale of fixed and leased assets | |
| 166 | | |
| 94 | |
Purchases of property, plant and equipment | |
| (2,350 | ) | |
| (27 | ) |
Net cash (used in) provided by investing activities | |
| (2,184 | ) | |
| 67 | |
Cash Flows from Financing Activities: | |
| | | |
| | |
Payments on finance lease obligations | |
| (5 | ) | |
| (4 | ) |
Payments on insurance financing loan | |
| (984 | ) | |
| (1,802 | ) |
Payments for taxes related to net share settlement of share-based awards | |
| (89 | ) | |
| (131 | ) |
Proceeds from issuance of ordinary shares under the ESP Plan | |
| 92 | | |
| 119 | |
Debt repayments | |
| (4,334 | ) | |
| — | |
Net cash used in financing activities | |
| (5,320 | ) | |
| (1,818 | ) |
Net change in cash and cash equivalents | |
| (25,384 | ) | |
| (13,031 | ) |
Cash and cash equivalents, beginning of period | |
| 44,543 | | |
| 40,444 | |
Cash and cash equivalents, end of period | |
$ | 19,159 | | |
$ | 27,413 | |
RVL Pharmaceuticals plc
GAAP to Non-GAAP Reconciliations
Adjusted EBITDA (Unaudited)
(in thousands)
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2023 | | |
2022 | | |
2023 | | |
2022 | |
Net loss | |
$ | (23,889 | ) | |
$ | (12,106 | ) | |
$ | (35,501 | ) | |
$ | (18,927 | ) |
Interest expense and amortization of debt discount | |
| 13 | | |
| 978 | | |
| 39 | | |
| 1,963 | |
Income tax (benefit) expense | |
| (113 | ) | |
| 277 | | |
| (55 | ) | |
| 202 | |
Depreciation and amortization expense | |
| 94 | | |
| 91 | | |
| 187 | | |
| 180 | |
| |
| | | |
| | | |
| | | |
| | |
EBITDA | |
| (23,895 | ) | |
| (10,760 | ) | |
| (35,330 | ) | |
| (16,582 | ) |
| |
| | | |
| | | |
| | | |
| | |
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) | |
| 3,144 | | |
| (740 | ) | |
| 10,493 | | |
| 304 | |
Change in fair value of warrants(4) | |
| (805 | ) | |
| (3,455 | ) | |
| (1,482 | ) | |
| 1,053 | |
Impairment of intangible assets(5) | |
| 13,900 | | |
| — | | |
| 13,900 | | |
| — | |
Share-based compensation expense | |
| 232 | | |
| 1,209 | | |
| 731 | | |
| 2,418 | |
Severance expense | |
| — | | |
| 1,859 | | |
| - | | |
| 1,859 | |
Foreign currency translation | |
| 33 | | |
| 48 | | |
| 67 | | |
| 62 | |
Other | |
| — | | |
| 85 | | |
| - | | |
| 86 | |
Adjusted EBITDA Loss | |
$ | (7,391 | ) | |
$ | (11,754 | ) | |
$ | (16,046 | ) | |
$ | (30,650 | ) |
(1) - 2022 includes $15,500 in licensing
revenue recognized in connection with an amendment of our License Agreement with Santen, effective March 31, 2022, net of a
$500 transaction fee expense classified in selling, general and administrative expenses. |
(2) - Relates to contingent gains related
to milestone payments earned subsequent to the sale of our legacy business to Alora Pharmaceuticals. |
(3) - 2023 relates to $575 in mandatory
debt repayment fees, classified in selling, general and administrative expenses, incurred as a result of our receipt of a contingent
milestone payment. 2022 relates to $150 in consent fees, classified in selling, general and administrative expenses, incurred with
our lendor upon the issuance of waivers of mandatory repayments of debt following receipt of a contingent milestone payment. |
(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 October 2021. Changes in the fair value of debt and
warrants are accounted for at fair value, inclusive of related accrued interest expense in respect of debt, and are presented as
periodic gains or losses in our consolidated statements of operations and comprehensive loss. |
(5) - Relates to non-cash impairment charges
associated with arbaclofen extended release, an In-Process Research and Development project-based intangible asset. |
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