Salem Media Group, Inc. Announces First Quarter 2019 Total Revenue of $60.5 Million
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CAMARILLO, Calif.–(BUSINESS WIRE)–Salem Media Group, Inc. (Nasdaq: SALM) released its results for the
three months ended March 31, 2019.
First Quarter 2019 Results
For the quarter ended March 31, 2019 compared to the quarter ended March
31, 2018:
Consolidated
- Total revenue decreased 5.2% to $60.5 million from $63.8 million;
-
Total operating expenses increased 5.7% to $61.5 million from $58.1
million; -
Operating expenses, excluding gains or losses on the disposition of
assets, stock-based compensation expense, depreciation expense and
amortization expense (1) decreased 1.0% to $53.0 million from $53.6
million; -
Operating income decreased to a $1.0 million operating loss from $5.7
million operating income; -
Net income decreased 61.1% to $0.3 million, or $0.01 net income per
diluted share from $0.8 million, or $0.03 net income per diluted share; - EBITDA (1) decreased 64.1% to $3.7 million from $10.2 million;
-
Adjusted EBITDA (1) decreased 25.4% to $7.6 million from $10.2
million; and -
Net cash provided by operating activities decreased 30.3% to $9.0
million from $12.9 million.
Broadcast
-
Net broadcast revenue decreased 4.1% to $46.1 million from $48.1
million; -
Station Operating Income (“SOI”) (1) decreased 21.6% to $9.6 million
from $12.3 million; -
Same Station (1) net broadcast revenue decreased 2.9% to $45.5 million
from $46.8 million; and -
Same Station SOI (1) decreased 22.7% to $9.9 million from $12.8
million.
Digital Media
-
Digital media revenue decreased 1.5% to $10.2 million from $10.4
million; and -
Digital Media Operating Income (1) increased 8.0% to $2.2 million from
$2.0 million.
Publishing
-
Publishing revenue decreased 22.7% to $4.1 million from $5.4 million;
and -
Publishing Operating Loss (1) increased to $0.7 million from $0.2
million.
Included in the results for the quarter ended March 31, 2019 are:
-
A $4.0 million ($2.4 million, net of tax, or $0.09 per share) net loss
on the disposition of assets including a $3.8 million estimated
pre-tax loss for the sale of WSPZ-AM in Washington, D.C., a $0.2
million pre-tax loss on the sale of Mike Turner’s line of investment
products and a $0.2 million pre-tax loss on the sale of
HumanEvents.com offset by a $0.1 million pre-tax gain on the sale of
Newport Natural Health; -
A $0.4 million gain ($0.3 million, net of tax, or $0.01 per diluted
share) on early redemption of long-term debt due to the repurchase of
the company’s 6.75% senior secured notes due 2024; -
A $0.2 million one-time expense associated with the adoption of ASC
842 ($0.1 million, net of tax) and -
A $176,000 non-cash compensation charge ($106,000, net of tax) related
to the expensing of stock options and restricted stock consisting of:-
$107,000 non-cash compensation charge included in corporate
expenses; -
$39,000 non-cash compensation charge included in broadcast
operating expenses; -
$26,000 non-cash compensation charge included in digital media
operating expenses; and -
the remaining $4,000 non-cash compensation charge included in
publishing operating expenses.
-
$107,000 non-cash compensation charge included in corporate
Included in the results for the quarter ended March 31, 2018 are:
-
A $46,000 non-cash compensation charge ($28,000, net of tax) related
to the expensing of stock options and restricted stock consisting of:-
$24,000 non-cash compensation charge included in corporate
expenses; -
$13,000 non-cash compensation charge included in broadcast
operating expenses; -
$5,000 non-cash compensation charge included in digital media
operating expenses; and -
the remaining $4,000 non-cash compensation charge included in
publishing operating expenses.
-
$24,000 non-cash compensation charge included in corporate
Per share numbers are calculated based on 26,193,307 diluted weighted
average shares for the quarter ended March 31, 2019, and 26,304,891
diluted weighted average shares for the quarter ended March 31, 2018.
Balance Sheet
As of March 31, 2019, the company had $231.9 million outstanding on the
6.75% senior secured notes due 2024 and $16.0 million outstanding under
the Asset Based Revolving Credit Facility (“ABL Facility”) as of March
31, 2019.
Acquisitions and Divestitures
The following transactions were completed since January 1, 2019:
-
On March 21, 2019, the company sold Newport Natural Health, an
e-commerce website operated by Eagle Wellness for $0.9 million in
cash. The company recognized a pre-tax gain of $0.1 million associated
with the sale reflecting the sales price as compared to the carrying
value of the assets and the closing costs. -
On March 18, 2019, the company acquired the pjmedia.com website for
$0.1 million in cash. -
On February 28, 2019, the company sold Mike Turner’s line of
investment products, including TurnerTrends.com and other domain names
and related assets. The company received no cash from the buyer who
assumed all deferred subscription liabilities for Mike Turner’s
investment products. The company recognized a pre-tax loss of
approximately $0.2 million associated with the sale reflecting the
sales price as compared to the carrying value of the assets and the
closing costs. -
On February 27, 2019, the company sold HumanEvents.com, a conservative
opinion website, for $0.3 million in cash. The company recognized a
pre-tax loss of approximately $0.2 million associated with the sale
reflecting the sales price as compared to the carrying value of the
assets and the closing costs.
Pending transactions:
-
On April 29, 2019 the company entered into an agreement to exchange FM
Translator W276CR, in Bradenton, Florida with FM Translator W262CP in
Bayonet Point, Florida. No cash will be exchanged for the assets. -
On March 19, 2019, the company entered into an agreement to sell radio
station WSPZ-AM (previously WWRC-AM) in Washington D.C. for $0.8
million. The company recorded an estimated pre-tax loss of assets of
$3.8 million as of March 31, 2019, which reflected the sales price as
compared to the carrying value of the assets and the estimated costs
of the sale. The sale is expected to close in the second quarter of
2019. On April 3, 2019, the company entered into a Time Brokerage
Agreement (“TBA”) effective April 12, 2019, under which radio station
WSPZ-AM, is operated by the buyer pending the sale of the station. -
In December 2018, Word Broadcasting notified the company of their
intent to purchase its Louisville radio stations. They began operating
the stations under a Time Brokerage Agreement beginning on January 3,
2017 that will continue until the purchase agreement is executed and
the transaction closes. -
On April 26, 2018, the company entered an agreement to exchange radio
station KKOL-AM, in Seattle, Washington for KPAM-AM in Portland,
Oregon. The transaction is expected to close in the first half of 2019.
Conference Call Information
Salem will host a teleconference to discuss its results on May 10, 2019
at 12:00 p.m. Pacific Time. To access the teleconference, please dial
(877) 524-8416, and then ask to be joined into the Salem Media Group
First Quarter 2019 call or listen via the investor relations portion of
the company’s website, located at investor.salemmedia.com.
A replay of the teleconference will be available through May 24, 2019
and can be heard by dialing (877) 660-6853, passcode 13688917 or on the
investor relations portion of the company’s website, located at investor.salemmedia.com.
Second Quarter 2019 Outlook
For the second quarter of 2019, the company is projecting total revenue
to be between a decrease of 1% and an increase of 1% from second quarter
2018 total revenue of $66.3 million. Excluding the impact of political
revenue and recent acquisitions and dispositions, the company is
projecting total revenue to increase between 1% and 3%. The company is
also projecting operating expenses before gains or losses on the
disposition of assets, stock-based compensation expense, changes in the
estimated fair value of contingent earn-out consideration, impairments,
depreciation expense and amortization expense to be between flat and an
increase of 3% compared to the second quarter of 2018 non-GAAP operating
expenses of $55.1 million.
A reconciliation of non-GAAP operating expenses, excluding gains or
losses on the disposition of assets, stock-based compensation expense,
changes in the estimated fair value of contingent earn-out
consideration, impairments, depreciation expense and amortization
expense to the most directly comparable GAAP measure is not available
without unreasonable efforts on a forward-looking basis due to the
potential high variability, complexity and low visibility with respect
to the charges excluded from this non-GAAP financial measure, in
particular, the change in the estimated fair value of earn-out
consideration, impairments and gains or losses from the sale or disposal
of fixed assets. The company expects the variability of the above
charges may have a significant, and potentially unpredictable, impact on
its future GAAP financial results.
About Salem Media Group, Inc.
Salem Media Group is America’s leading multimedia company specializing
in Christian and conservative content, with media properties comprising
radio, digital media and book and newsletter publishing. Each day Salem
serves a loyal and dedicated audience of listeners and readers numbering
in the millions nationally. With its unique programming focus, Salem
provides compelling content, fresh commentary and relevant information
from some of the most respected figures across the Christian and
conservative media landscape. Learn more about Salem Media Group, Inc.,
at www.salemmediagroup.com,
Facebook and Twitter (@SalemMediaGrp).
Forward-Looking Statements
Statements used in this press release that relate to future plans,
events, financial results, prospects or performance are forward-looking
statements as defined under the Private Securities Litigation Reform Act
of 1995. Actual results may differ materially from those anticipated as
a result of certain risks and uncertainties, including but not limited
to the ability of Salem to close and integrate announced transactions,
market acceptance of Salem’s radio station formats, competition from new
technologies, adverse economic conditions, and other risks and
uncertainties detailed from time to time in Salem’s reports on Forms
10-K, 10-Q, 8-K and other filings filed with or furnished to the
Securities and Exchange Commission. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date hereof. Salem undertakes no obligation to update or revise
any forward-looking statements to reflect new information, changed
circumstances or unanticipated events.
(1) Regulation G
Management uses certain non-GAAP financial measures defined below in
communications with investors, analysts, rating agencies, banks and
others to assist such parties in understanding the impact of various
items on its financial statements. The company uses these
non-GAAP financial measures to evaluate financial results, develop
budgets, manage expenditures and as a measure of performance under
compensation programs.
The company’s presentation of these non-GAAP financial measures
should not be considered as a substitute for or superior to the most
directly comparable financial measures as reported in accordance with
GAAP.
Regulation G defines and prescribes the conditions under which
certain non-GAAP financial information may be presented in this earnings
release. The company closely monitors EBITDA, Adjusted EBITDA,
Station Operating Income (“SOI”), Same Station net broadcast revenue,
Same Station broadcast operating expenses, Same Station Operating
Income, Digital Media Operating Income, Publishing Operating Income
(Loss), and operating expenses excluding gains or losses on the
disposition of assets, stock-based compensation, changes in the
estimated fair value of contingent earn-out consideration, impairments,
depreciation and amortization, all of which are non-GAAP financial
measures. The company believes that these non-GAAP financial
measures provide useful information about its core operating results,
and thus, are appropriate to enhance the overall understanding of its
financial performance. These non-GAAP financial measures are
intended to provide management and investors a more complete
understanding of its underlying operational results, trends and
performance.
The company defines Station Operating Income (“SOI”) as net broadcast
revenue minus broadcast operating expenses. The company defines Digital
Media Operating Income as net Digital Media Revenue minus Digital Media
Operating Expenses. The company defines Publishing Operating
Income (Loss) as net Publishing Revenue minus Publishing Operating
Expenses. The company defines EBITDA as net income before
interest, taxes, depreciation, and amortization. The company
defines Adjusted EBITDA as EBITDA before gains or losses on the
disposition of assets, before changes in the estimated fair value of
contingent earn-out consideration, before changes in the fair value of
interest rate swap, before impairments, before net miscellaneous income
and expenses, before gain on bargain purchase, before (gain) loss on
early retirement of long-term debt and before non-cash compensation
expense. SOI, Digital Media Operating Income, Publishing
Operating Loss, EBITDA and Adjusted EBITDA are commonly used by the
broadcast and media industry as important measures of performance and
are used by investors and analysts who report on the industry to provide
meaningful comparisons between broadcasters. SOI, Digital Media
Operating Income, Publishing Operating Loss, EBITDA and Adjusted EBITDA
are not measures of liquidity or of performance in accordance with GAAP
and should be viewed as a supplement to and not a substitute for or
superior to its results of operations and financial condition presented
in accordance with GAAP. The company’s definitions of SOI,
Digital Media Operating Income, Publishing Operating Loss, EBITDA and
Adjusted EBITDA are not necessarily comparable to similarly titled
measures reported by other companies.
The company defines Adjusted Free Cash Flow as Adjusted EBITDA less
cash paid for capital expenditures, less cash paid for income taxes, and
less cash paid for interest. The company considers Adjusted Free
Cash Flow to be a liquidity measure that provides useful information to
management and investors about the amount of cash generated by its
operations after cash paid for capital expenditures, cash paid for
income taxes and cash paid for interest. A limitation of Adjusted
Free Cash Flow as a measure of liquidity is that it does not represent
the total increase or decrease in its cash balance for the period. The
company uses Adjusted Free Cash Flow, a non-GAAP liquidity measure, both
in presenting its results to stockholders and the investment community,
and in its internal evaluation and management of the business. The
company’s presentation of Adjusted Free Cash Flow is not intended to be
considered in isolation or as a substitute for the financial information
prepared and presented in accordance with GAAP. The company’s
definition of Adjusted Free Cash Flow is not necessarily comparable to
similarly titled measures reported by other companies.
The company defines Same Station net broadcast revenue as broadcast
revenue from its radio stations and networks that the company owns or
operates in the same format on the first and last day of each quarter,
as well as the corresponding quarter of the prior year. The
company defines Same Station broadcast operating expenses as broadcast
operating expenses from its radio stations and networks that the company
owns or operates in the same format on the first and last day of each
quarter, as well as the corresponding quarter of the prior year. The
company defines Same Station SOI as Same Station net broadcast revenue
less Same Station broadcast operating expenses. Same Station
operating results include those stations that the company owns or
operates in the same format on the first and last day of each quarter,
as well as the corresponding quarter of the prior year. Same
Station operating results for a full calendar year are calculated as the
sum of the Same Station-results for each of the four quarters of that
year. The company uses Same Station operating results, a non-GAAP
financial measure, both in presenting its results to stockholders and
the investment community, and in its internal evaluations and management
of the business. The company believes that Same Station operating
results provide a meaningful comparison of period over period
performance of its core broadcast operations as this measure excludes
the impact of new stations, the impact of stations the company no longer
owns or operates, and the impact of stations operating under a new
programming format. The company’s presentation of Same Station
operating results are not intended to be considered in isolation or as a
substitute for the financial information prepared and presented in
accordance with GAAP. The company’s definition of Same Station
operating results is not necessarily comparable to similarly titled
measures reported by other companies.
For all non-GAAP financial measures, investors should consider the
limitations associated with these metrics, including the potential lack
of comparability of these measures from one company to another.
The Supplemental Information tables that follow the condensed
consolidated financial statements provide reconciliations of the
non-GAAP financial measures that the company uses in this earnings
release to the most directly comparable measures calculated in
accordance with GAAP. The company uses non-GAAP financial
measures to evaluate financial performance, develop budgets, manage
expenditures, and determine employee compensation. The company’s
presentation of this additional information is not to be considered as a
substitute for or superior to the directly comparable measures as
reported in accordance with GAAP.
Salem Media Group, Inc. | |||||||||
Condensed Consolidated Statements of Operations | |||||||||
(in thousands, except share and per share data) | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2018 | 2019 | ||||||||
(Unaudited) | |||||||||
Net broadcast revenue | $ | 48,050 | $ | 46,093 | |||||
Net digital media revenue | 10,394 | 10,240 | |||||||
Net publishing revenue | 5,351 | 4,136 | |||||||
Total revenue | 63,795 | 60,469 | |||||||
Operating expenses: | |||||||||
Broadcast operating expenses | 35,750 | 36,449 | |||||||
Digital media operating expenses | 8,374 | 8,058 | |||||||
Publishing operating expenses | 5,587 | 4,822 | |||||||
Unallocated corporate expenses | 3,921 | 3,871 | |||||||
Depreciation and amortization | 4,487 | 4,229 | |||||||
Net (gain) loss on the disposition of assets | 5 | 4,024 | |||||||
Total operating expenses | 58,124 | 61,453 | |||||||
Operating income (loss) | 5,671 | (984) | |||||||
Other income (expense): | |||||||||
Interest income | 2 | 1 | |||||||
Interest expense | (4,518) | (4,425) | |||||||
Gain on early retirement of long-term debt | — | 426 | |||||||
Net miscellaneous income and expenses | 75 | 1 | |||||||
Net income (loss) before income taxes | 1,230 | (4,981) | |||||||
Provision for (benefit from) income taxes | 402 | (5,303) | |||||||
Net income | $ | 828 | $ | 322 | |||||
Basic earnings per share Class A and Class B common stock | $ | 0.03 | $ | 0.01 | |||||
Diluted earnings per share Class A and Class B common stock | $ | 0.03 | $ | 0.01 | |||||
Basic weighted average Class A and Class B common stock shares outstanding |
26,171,539 | 26,186,112 | |||||||
Diluted weighted average Class A and Class B common stock shares outstanding |
26,304,891 | 26,193,307 | |||||||
Salem Media Group, Inc. | ||||||||
Condensed Consolidated Balance Sheets | ||||||||
(in thousands) | ||||||||
December 31, 2018 | March 31, 2019 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Cash | $ | 117 | $ | 4 | ||||
Trade accounts receivable, net | 33,020 | 30,405 | ||||||
Other current assets | 10,500 | 9,423 | ||||||
Property and equipment, net | 96,344 | 95,546 | ||||||
Operating and financing lease right-of-use assets | 164 | 63,339 | ||||||
Intangible assets, net | 414,646 | 408,386 | ||||||
Deferred financing costs | 381 | 338 | ||||||
Other assets | 3,856 | 4,826 | ||||||
Total assets | $ | 559,028 | $ | 612,267 | ||||
Liabilities and Stockholders’ Equity | ||||||||
Current liabilities | $ | 52,878 | $ | 66,440 | ||||
Long-term debt | 234,030 | 227,683 | ||||||
Operating and financing lease liabilities, less current portion | 105 | 62,003 | ||||||
Deferred income taxes | 35,272 | 29,968 | ||||||
Other liabilities | 14,874 | 5,508 | ||||||
Stockholders’ Equity | 221,869 | 220,665 | ||||||
Total liabilities and stockholders’ equity | $ | 559,028 | $ | 612,267 | ||||
SALEM MEDIA GROUP, INC. |
|||||||||||||||||||||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY |
|||||||||||||||||||||||||||||||||||
(Dollars in thousands, except share and per share data) |
|||||||||||||||||||||||||||||||||||
Class A | Class B | ||||||||||||||||||||||||||||||||||
Common Stock | Common Stock | Additional | |||||||||||||||||||||||||||||||||
Paid-In | Retained | Treasury | |||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Earnings | Stock | Total | ||||||||||||||||||||||||||||
Stockholders’ |
22,950,066 | $ | 227 | 5,553,696 | $ | 56 | $ | 245,220 | $ | 10,372 | $ (34,006 | ) | $ | 221,869 | |||||||||||||||||||||
Stock-based |
— | — | — | — | 176 | — | — | 176 | |||||||||||||||||||||||||||
Cash distributions | — | — | — | — | — | (1,702 | ) | — | (1,702 | ) | |||||||||||||||||||||||||
Net income | — | — | — | — | — | 322 | — | 322 | |||||||||||||||||||||||||||
Stockholders’ |
22,950,066 | $ | 227 | 5,553,696 | $ | 56 | $ | 245,396 | $ | 8,992 | $ (34,006 | ) | $ | 220,665 | |||||||||||||||||||||
Distributions per |
$ | 0.065 | $ | 0.065 | |||||||||||||||||||||||||||||||
Class A | Class B | ||||||||||||||||||||||||||||||||||
Common Stock | Common Stock | Additional | |||||||||||||||||||||||||||||||||
Paid-In | Retained | Treasury | |||||||||||||||||||||||||||||||||
Shares | Amount | Shares | Amount | Capital | Earnings | Stock | Total | ||||||||||||||||||||||||||||
Stockholders’ |
22,932,451 | $ | 227 | 5,553,696 | $ | 56 | $ | 244,634 | $ | 20,370 | $ (34,006 | ) | $ | 231,281 | |||||||||||||||||||||
Stock-based |
— | — | — | — | 46 | — | — | 46 | |||||||||||||||||||||||||||
Options exercised | 8,125 | — | — | — | 19 | — | — | 19 | |||||||||||||||||||||||||||
Cash distributions | — | — | — | — | — | (1,701 | ) | — | (1,701 | ) | |||||||||||||||||||||||||
Net income | — | — | — | — | — | 828 | — | 828 | |||||||||||||||||||||||||||
Stockholders’ |
22,940,576 | $ | 227 | 5,553,696 | $ | 56 | $ | 244,699 | $ | 19,497 | $ (34,006 | ) | $ | 230,473 | |||||||||||||||||||||
Distributions per |
$ | 0.065 | $ | 0.065 |
SALEM MEDIA GROUP, INC. |
||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||||||
(Dollars in thousands) | ||||||||||
(Unaudited) | ||||||||||
Three Months Ended | ||||||||||
March 31, |
||||||||||
2018 | 2019 | |||||||||
OPERATING ACTIVITIES | ||||||||||
Net income | $ | 828 | $ | 322 | ||||||
Adjustments to reconcile net income to net cash provided by operating activities: |
||||||||||
Non-cash stock-based compensation | 46 | 176 | ||||||||
Depreciation and amortization | 4,487 | 4,229 | ||||||||
Amortization of deferred financing costs | 270 | 258 | ||||||||
Non-cash lease expense | — | 2,267 | ||||||||
Accretion of acquisition-related deferred payments and contingent consideration |
16 | 1 | ||||||||
Provision for bad debts | 146 | 320 | ||||||||
Deferred income taxes | 382 | (5,304 | ) | |||||||
Gain on early retirement of long-term debt | — | (426 | ) | |||||||
Net (gain) loss on the disposition of assets | 5 | 4,024 | ||||||||
Changes in operating assets and liabilities: | ||||||||||
Accounts receivable and unbilled revenue | 1,176 | 1,758 | ||||||||
Inventories | (78 | ) | (256 | ) | ||||||
Prepaid expenses and other current assets | (69 | ) | 1,387 | |||||||
Accounts payable and accrued expenses | 6,629 | 3,449 | ||||||||
Deferred rent expense | (119 | ) | — | |||||||
Operating lease liabilities | — | (3,458 | ) | |||||||
Contract liabilities | (938 | ) | 133 | |||||||
Deferred rent income | (23 | ) | (43 | ) | ||||||
Income taxes payable | 115 | 130 | ||||||||
Net cash provided by operating activities | 12,873 | 8,967 | ||||||||
INVESTING ACTIVITIES | ||||||||||
Cash paid for capital expenditures net of tenant improvement allowances |
(2,472 | ) | (2,404 | ) | ||||||
Capital expenditures reimbursable under tenant improvement allowances and trade agreements |
(4 | ) | — | |||||||
Escrow deposits paid related to acquisitions | (240 | ) | — | |||||||
Escrow deposits received related to radio station sale | 500 | — | ||||||||
Purchases of digital media businesses and assets | — | (100 | ) | |||||||
Proceeds from sale of assets | 1 | 1,255 | ||||||||
Other | (170 | ) | (139 | ) | ||||||
Net cash used in investing activities | (2,385 | ) | (1,388 | ) | ||||||
FINANCING ACTIVITIES | ||||||||||
Payments to repurchase 6.75% Senior Secured Notes | — | (6,123 | ) | |||||||
Proceeds from borrowings under ABL Facility | 10,334 | 22,189 | ||||||||
Payments on ABL Facility | (19,334 | ) | (25,849 | ) | ||||||
Refund (payments) of debt issuance costs | 41 | (13 | ) | |||||||
Proceeds from the exercise of stock options | 19 | — | ||||||||
Payments on financing lease liabilities | (31 | ) | (21 | ) | ||||||
Payment of cash distribution on common stock | (1,701 | ) | (1,702 | ) | ||||||
Book overdraft | 187 | 3,827 | ||||||||
Net cash used in financing activities | (10,485 | ) | (7,692 | ) | ||||||
Net increase (decrease) in cash and cash equivalents | 3 | (113 | ) | |||||||
Cash and cash equivalents at beginning of year | 3 | 117 | ||||||||
Cash and cash equivalents at end of period | $ | 6 | $ | 4 | ||||||
Contacts
Evan D. Masyr
Executive Vice President & Chief Financial Officer
(805)
384-4512
[email protected]
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Indivior
Indivior Provides Update on Aelis Farma’s Clinical Phase 2B Study Results with AEF0117 in Participants with Cannabis Use Disorder
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF THE MARKET ABUSE REGULATION (EU) 596/2014 (AS IT FORMS PART OF DOMESTIC LAW IN THE UK BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018).
- Primary and Secondary End Points of the Study were Not Met
- Indivior Does Not Currently Expect to Exercise AEF0117 Option
SLOUGH, United Kingdom and RICHMOND, Va., Sept. 4, 2024 /PRNewswire/ — Indivior PLC (Nasdaq/LSE: INDV) is today providing an update following Aelis Farma’s announcement of the results from its clinical Phase 2B trial with AEF01171, evaluating the efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder (CUD). The purpose of this trial was twofold: (1) to show that AEF0117 (0.1, 0.3, 1 mg once a day for 12 weeks) lowers cannabis use and (2) to determine the endpoints and optimal dosage of AEF0117 for use in future studies. In this phase 2B study, patients were treatment-seeking participants, 84% of whom had severe CUD.
The results of the study demonstrated that the primary endpoint, the proportion of participants who reduced their cannabis use to ≤1 day per week, as well as secondary endpoints measuring the proportion of participants reaching either complete abstinence or who used ≤2 day per week, were not met. Although these results are disappointing, they indicate that significant work remains to be done to understand subpopulations of patients with CUD, specifically those with severe CUD.
This clinical Phase 2B study is part of the strategic collaboration between Aelis Farma and Indivior, which includes an exclusive option for Indivior to license the global rights to AEF0117. Given the lack of separation from placebo on primary and secondary endpoints and before seeing further additional favorable clinical data, Indivior does not currently expect to exercise its option.
Important Cautionary Note Regarding Forward-Looking Statements
This news release contains certain statements that are forward-looking. Forward-looking statements include, among other things, express and implied statements regarding whether: we will be able to ultimately demonstrate the safety and efficacy of AEF0117, which is a prerequisite to filing any New Drug Application; we might ever exercise our option for AEF0117 and, if so, when; and other statements containing the words “believe,” “anticipate,” “plan,” “expect,” “intend,” “estimate,” “forecast,” “strategy,” “target,” “guidance,” “outlook,” “potential,” “project,” “priority,” “may,” “will,” “should,” “would,” “could,” “can,” “outlook,” “guidance,” the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.
Actual results may differ materially from those because they relate to future events. Various factors may cause differences between Indivior’s expectations and actual results, including, among others, the risks described in our most recent annual report on Form 20-F beginning on page 9 as filed with the U.S. SEC and in subsequent releases; legal and market restrictions that may limit how quickly we can repurchaser our shares; the substantial litigation and ongoing investigations to which we are or may become a party; our reliance on third parties to manufacture commercial supplies of most of our products, conduct our clinical trials and at times to collaborate on products in our pipeline; our ability to comply with legal and regulatory settlements, healthcare laws and regulations, requirements imposed by regulatory agencies and payment and reporting obligations under government pricing programs; risks related to the manufacture and distribution of our products, most of which contain controlled substances; market acceptance of our products as well as our ability to commercialize our products and compete with other market participants; competition; the uncertainties related to the development of new products, including through acquisitions, and the related regulatory approval process; our dependence on third-party payors for the reimbursement of our products and the increasing focus on pricing and competition in our industry; unintended side effects caused by the clinical study or commercial use of our products; our ability to successfully execute acquisitions, partnerships, joint ventures, dispositions or other strategic acquisitions; our ability to protect our intellectual property rights and the substantial cost of litigation or other proceedings related to intellectual property rights; the risks related to product liability claims or product recalls; the significant amount of laws and regulations that we are subject to, including due to the international nature of our business; macroeconomic trends and other global developments such as armed conflicts and pandemics; the terms of our debt instruments, changes in our credit ratings and our ability to service our indebtedness and other obligations as they come due; changes in applicable tax rate or tax rules, regulations or interpretations and our ability to realize our deferred tax assets; and volatility in our share price due to factors unrelated to our operating performance or that may result from the potential move of our primary listing to the U.S.
Forward-looking statements speak only as of the date that they are made and should be regarded solely as our current plans, estimates and beliefs. Except as required by law, we do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events.
This release is being made by Kathryn Hudson, Company Secretary Indivior PLC.
About Indivior
Indivior is a global pharmaceutical company working to help change patients’ lives by developing medicines to treat substance use disorders (SUD), overdose and serious mental illnesses. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease.
Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD. Headquartered in the United States in Richmond, VA, Indivior employs over 1,000 individuals globally and its portfolio of products is available in over 30 countries worldwide. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.
References:
- National Library of Medicine (U.S.) (2022, April). Effect of AEF0117 on treatment-seeking patients with cannabis use disorder (CUD) (SICA2). Identifier
NCT05322941 https://www.clinicaltrials.gov/study/NCT05322941
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Innocan
Innocan Pharma Announces Closing of Private Placement and Grant of Stock Options
![innocan-pharma-announces-closing-of-private-placement-and-grant-of-stock-options](https://grassnews.net/wp-content/uploads/2024/08/61828-innocan-pharma-announces-closing-of-private-placement-and-grant-of-stock-options.jpg)
HERZLIYA, Israel and CALGARY, Alberta, Aug. 29, 2024 /PRNewswire/ — Innocan Pharma Corporation (CSE: INNO) (FSE: IP4) (OTCQB: INNPF) (“Innocan” or the “Company”), a pioneer in the pharmaceutical and biotechnology industries, is pleased to announce that it has completed its previously announced non-brokered private placement offering of 5,025,725 units of the Company (the “Units”) at a price of C$0.22 per Unit for gross proceeds of C$1,105,659.50 (the “Offering”).
Each Unit is comprised of: (i) one (1) common share in the capital of the Company (each a “Common Share”); and (ii) one (1) common share purchase warrant (each a “Warrant”). Each Warrant will entitle the holder thereof to purchase one Common Share at a price of C$0.32 for a period of four (4) years from the date of issuance.
Innocan intends to use the proceeds of the Offering for working capital and general corporate purposes.
The securities issued to Canadian subscribers in connection with the Offering are subject to a hold period of four months and one day from the date of issuance, in accordance with applicable Canadian securities laws.
Iris Bincovich, Chief Executive Officer of the Company, stated “we are very pleased with our successful offering. I would like to extend my sincere gratitude to our investors for their unwavering support. We see this as a strong vote of confidence by both existing and new investors which demonstrates investor support of our vision and strategic direction. These new funds will provide us with additional working capital to enable us to capitalize on new opportunities and allow us to advance strongly on our growth plans.”
The Company is also pleased to announce that it has granted an aggregate of 300,000 stock options (each an “Option“) to certain consultants of the Company pursuant to the Company’s stock option plan (the “Plan“). Each Option may be exercised for one (1) common share in the capital of the Company (each, a “Share“) at a price of $0.25 per Share. The Options expire on August 27, 2029.
All Options granted vest in accordance with the following vesting schedule: (i) 1/3rd of the Options vested immediately at grant; (ii) 1/3rd of the Options will vest on February 28, 2025; and (iii) 1/3rd will vest on August 27, 2025; all subject to the terms and conditions of the Plan.
About Innocan Pharma:
Innocan is a pharmaceutical tech company that operates under two main segments: Pharmaceuticals and Consumer Wellness. In the Pharmaceuticals segment, Innocan focuses on developing innovative drug delivery platform technologies comprises with cannabinoids science, to treat various conditions to improve patients’ quality of life. This segment involves two drug delivery technologies: (i) LPT CBD-loaded liposome platform facilitating exact dosing and the prolonged and controlled release of CBD into the blood stream. The LPT delivery platform research is in the preclinical trial phase for two indications: Epilepsy and Pain Management. In the Consumer Wellness segment, Innocan develops and markets a wide portfolio of innovative and high-performance self-care products to promote a healthier lifestyle. Under this segment Innocan has established a Joint Venture by the name of BI Sky Global Ltd. that focuses developing on advanced targeted online sales. https://innocanpharma.com/
Contact Information:
For Innocan Pharma Corporation:
Iris Bincovich, CEO
+1 5162104025
+972-54-3012842
+442037699377
[email protected]
NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
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Cannabis
Europe Medical Cannabis Market Forecast 2024-2032: Tilray, Aurora Cannabis, and GW Pharmaceuticals Dominate the Market Landscape
![](https://grassnews.net/wp-content/uploads/2024/08/europe-medical-cannabis-market-forecast-2024-2032-tilray-aurora-cannabis-and-gw-pharmaceuticals-dominate-the-market-landscape.gif)
Dublin, Aug. 29, 2024 (GLOBE NEWSWIRE) — The “Europe Medical Cannabis Oil Market Size, Industry Dynamics, Opportunity Analysis and Forecast 2024-2032.” report has been added to ResearchAndMarkets.com’s offering.
The Europe Medical Cannabis Oil market is poised for significant growth, projected to escalate from US$ 0.91 billion in 2023 to US$ 2.40 billion by 2032, advancing at a CAGR of 12.08%. In this comprehensive research report, the market is analyzed by:
- Derivatives;
- Source;
- Application;
- Route of Administration;
- End-user;
- Distribution Channel; and
- Country.
Market Highlights Identified in the Report
- Progressive legalization across Europe is creating a favorable regulatory environment, enhancing market expansion for medical cannabis oil products.
- Germany leads the market with a robust infrastructure and supportive regulations, while other countries like the UK, Italy, and Spain show significant growth potential based on evolving regulatory landscapes and market dynamics.
- Key players such as Tilray, Aurora Cannabis Inc., and GW Pharmaceuticals dominate the market, emphasizing research, strategic partnerships, and innovation to maintain competitive edge amidst evolving industry dynamics.
The medical cannabis oil market has experienced substantial growth as legalization and acceptance of cannabis-based treatments expand globally. Cannabis oil, derived from the cannabis plant through extraction methods, contains cannabinoids such as THC and CBD, known for their therapeutic properties. Increasing recognition of cannabis oil’s potential in alleviating symptoms of various medical conditions, including chronic pain, epilepsy, and anxiety disorders, has driven its adoption in medical settings.
Governments in several countries are progressively legalizing medical cannabis, creating a conducive regulatory environment for market expansion. Additionally, growing consumer awareness about alternative and natural therapies has fueled the demand for cannabis oil products. The market is characterized by diverse product offerings, including full-spectrum and CBD-isolate oils, catering to different therapeutic needs and preferences.
Despite regulatory challenges and stigma associated with cannabis, the medical cannabis oil market continues to evolve, driven by ongoing research, favorable legislative changes, and shifting attitudes toward cannabis-based therapies in healthcare.
Regional Insights
Germany is likely to maintain its leadership position in the European medical cannabis oil market due to its established infrastructure, supportive regulations, and strong healthcare system. Germany legalized medical cannabis in 2017, giving the market a head start compared to many other European countries. This established infrastructure and experience position Germany as a leader in the field. As awareness and acceptance of medical cannabis increase, the number of patients seeking treatment in Germany is steadily rising. This fuels market growth and incentivizes further investment in research and development.
Germany’s regulatory framework for medical cannabis is considered relatively patient-friendly compared to some other European countries. This facilitates access for patients with qualifying conditions. The UK legalized medical cannabis in 2018 and is experiencing an increase in patient access programs. This, coupled with ongoing research, could lead to significant market growth. Italy legalized medical cannabis in 2006 but has faced challenges with availability. As regulations become more streamlined and patient access expands, the Italian market holds significant growth potential. Spain has a well-established medical cannabis industry with a focus on domestic production. As regulations evolve and export opportunities increase, the Spanish market could see a boost.
Competitive Landscape
The Medical Cannabis Oil market is characterized by a vigorous competitive landscape, with prominent entities like Tilray, Aurora Cannabis Inc., GW Pharmaceuticals, Almiral, Bedrocan, and others at the forefront, collectively accounting for approximately 41 % of the overall market share. This competitive milieu is fueled by their intensive efforts in research and development as well as strategic partnerships and collaborations, underscoring their commitment to solidifying market presence and diversifying their offerings.
The primary competitive factors include pricing, product caliber, and technological innovation. As the Medical Cannabis Oil industry continues to expand, the competitive fervor among these key players is anticipated to intensify. The impetus for ongoing innovation and alignment with evolving customer preferences and stringent regulations is high. The industry’s fluidity anticipates an uptick in novel innovations and strategic growth tactics from these leading corporations, which in turn propels the sector’s comprehensive growth and transformation.
Key Topics Covered
Chapter 1. Research Framework
Chapter 2. Research Methodology
Chapter 3. Executive Summary: Europe Medical Cannabis Oil Market
Chapter 4. Europe Medical Cannabis Oil Market Overview
Chapter 5. Europe Medical Cannabis Oil Market Analysis, by Derivatives
Chapter 6. Europe Medical Cannabis Oil Market Analysis, by Source
Chapter 7. Europe Medical Cannabis Oil Market Analysis, by Application
Chapter 8. Europe Medical Cannabis Oil Market Analysis, by Route of Administration
Chapter 9. Europe Medical Cannabis Oil Market Analysis, by End-user
Chapter 10. Europe Medical Cannabis Oil Market Analysis, by Distribution Channel
Chapter 11. Europe Medical Cannabis Oil Market Analysis, by Country
Chapter 12. The UK Medical Cannabis Oil Market Analysis
Chapter 13. Germany Medical Cannabis Oil Market Analysis
Chapter 14. The Netherlands Medical Cannabis Oil Market Analysis
Chapter 15. Italy Medical Cannabis Oil Market Analysis
Chapter 16. Spain Medical Cannabis Oil Market Analysis
Chapter 17. Poland Medical Cannabis Oil Market Analysis
Chapter 18. Rest of Europe Medical Cannabis Oil Market Analysis
Chapter 19. Company Profiles (Company Overview, Financial Matrix, Key Product Landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)
A selection of companies mentioned in this report includes, but is not limited to:
- Aurora Cannabis Inc.
- Bedrocan
- Biocann
- BIOTA Biosciences LLC
- Cannamedical
- Mary Jane CBD
- Sanity Group GmbH
- Tilray
- Valcon Medical
For more information about this report visit https://www.researchandmarkets.com/r/dh7q46
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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