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Wynn Resorts, Limited Reports First Quarter 2019 Results

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LAS VEGAS–(BUSINESS WIRE)–Wynn Resorts, Limited (NASDAQ: WYNN) (“the Company”) today reported
financial results for the quarter ended March 31, 2019.

Operating revenues were $1.65 billion for the first quarter of 2019, a
decrease of 3.7%, or $64.0 million, from $1.72 billion for the first
quarter of 2018. Operating revenues increased $60.8 million at Wynn
Palace and decreased $94.4 million and $30.5 million at Wynn Macau and
our Las Vegas Operations, respectively.

On a U.S. generally accepted accounting principles (“GAAP”) basis, net
income attributable to Wynn Resorts, Limited was $104.9 million, or
$0.98 per diluted share, for the first quarter of 2019, compared to a
net loss attributable to Wynn Resorts, Limited of $204.3 million, or
$1.99 per diluted share, in the first quarter of 2018. The change was
primarily due to a litigation settlement of $463.6 million, partially
offset by an income tax benefit of $111.0 million, recorded in the first
quarter of 2018. Adjusted net income attributable to Wynn Resorts,
Limited (1) was $172.6 million, or $1.61 per diluted share, for the
first quarter of 2019, compared to $237.0 million, or $2.30 per diluted
share, for the first quarter of 2018.

Adjusted Property EBITDA (2) was $494.8 million for the first quarter of
2019, a decrease of 12.3%, or $69.6 million, from $564.3 million for the
first quarter of 2018. Adjusted Property EBITDA increased $10.7 million
at Wynn Palace and decreased $45.9 million and $34.3 million at Wynn
Macau and our Las Vegas Operations, respectively.

Wynn Resorts, Limited also announced today that the Company has approved
a cash dividend of $1.00 per share, payable on May 30, 2019 to
stockholders of record as of May 22, 2019.

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Macau Operations

Wynn Palace

Operating revenues from Wynn Palace were $726.6 million for the first
quarter of 2019, a 9.1% increase from $665.8 million for the first
quarter of 2018. Adjusted Property EBITDA from Wynn Palace was $222.6
million for the first quarter of 2019, a 5.0% increase from $211.9
million for the first quarter of 2018.

Casino revenues from Wynn Palace were $623.2 million for the first
quarter of 2019, a 9.6% increase from $568.5 million for the first
quarter of 2018. Table games turnover in VIP operations was $12.63
billion, a 17.9% decrease from $15.39 billion for the first quarter of
2018. VIP table games win as a percentage of turnover was 3.91%, above
the expected range of 2.7% to 3.0% and above the 2.60% experienced in
the first quarter of 2018. Table drop in mass market operations was
$1.30 billion, a 7.1% increase from $1.22 billion in the first quarter
of 2018. Table games win in mass market operations was $315.5 million, a
1.7% increase from $310.2 million for the first quarter of 2018. Table
games win percentage in mass market operations was 24.2%, below the
25.5% experienced in the first quarter of 2018. Slot machine handle was
$975.0 million, a 7.8% decrease from $1.06 billion for the first quarter
of 2018. Slot machine win decreased 7.9% to $51.4 million for the first
quarter of 2019, compared to $55.8 million for the first quarter of 2018.

Non-casino revenues from Wynn Palace were $103.4 million for the first
quarter of 2019, a 6.2% increase from $97.4 million for the first
quarter of 2018. Room revenues were $43.3 million for the first quarter
of 2019, a 7.1% increase from $40.4 million for the first quarter of
2018. Average daily rate (“ADR”) was $271, a 7.7% increase from $252 for
the first quarter of 2018. Occupancy increased to 97.2% for the first
quarter of 2019, from 96.8% for the first quarter of 2018. Revenue per
available room (“REVPAR”) was $264, an 8.2% increase from $244 for the
first quarter of 2018.

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Wynn Macau

Operating revenues from Wynn Macau were $523.9 million for the first
quarter of 2019, a 15.3% decrease from $618.2 million for the first
quarter of 2018. Adjusted Property EBITDA was $163.9 million for the
first quarter of 2019, a 21.9% decrease from $209.8 million for the
first quarter of 2018.

Casino revenues from Wynn Macau were $450.2 million for the first
quarter of 2019, a 16.5% decrease from $539.0 million for the first
quarter of 2018. Table games turnover in VIP operations was $10.19
billion, a 40.3% decrease from $17.09 billion for the first quarter of
2018. VIP table games win as a percentage of turnover was 2.90%, within
the expected range of 2.7% to 3.0% and above the 2.61% experienced in
the first quarter of 2018. Table drop in mass market operations was
$1.35 billion, a 2.2% increase from $1.32 billion for the first quarter
of 2018. Table games win in mass market operations was $264.5 million, a
3.1% increase from $256.5 million for the first quarter of 2018. Table
games win percentage in mass market operations was 19.6%, above the
19.4% experienced in the first quarter of 2018. Slot machine handle was
$794.4 million, a 20.8% decrease from $1.00 billion for the first
quarter of 2018. Slot machine win decreased 9.3% to $37.9 million for
the first quarter of 2019, compared to $41.8 million for the first
quarter of 2018.

Non-casino revenues from Wynn Macau were $73.6 million for the first
quarter of 2019, a 7.0% decrease from $79.2 million for the first
quarter of 2018. Room revenues were $28.9 million for the first quarter
of 2019, a 1.6% increase from $28.4 million for the first quarter of
2018. ADR was relatively flat at $290 when compared to the same period
of 2018. Occupancy increased to 99.3% for the first quarter of 2019,
from 99.0% for the same period of 2018. REVPAR was flat at $288 when
compared to the same period of 2018.

Las Vegas Operations

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Operating revenues from our Las Vegas Operations were $401.0 million for
the first quarter of 2019, a 7.1% decrease from $431.5 million for the
first quarter of 2018. Adjusted Property EBITDA from our Las Vegas
Operations was $108.3 million, a 24.0% decrease from $142.6 million for
the first quarter of 2018.

Casino revenues from our Las Vegas Operations were $111.7 million for
the first quarter of 2019, a 17.1% decrease from $134.6 million for the
first quarter of 2018. Table games drop was $404.1 million, a 24.7%
decrease from $536.6 million for the first quarter of 2018. Table games
win was $111.4 million, a 27.9% decrease from $154.4 million for the
first quarter of 2018. Table games win percentage was 27.6%, above the
property’s expected range of 22% to 26%, but below the 28.8% experienced
in the first quarter of 2018. Slot machine handle was $789.3 million, a
6.1% increase from $744.1 million for the first quarter of 2018. Slot
machine win increased 10.7% to $54.5 million, compared to $49.3 million
for the first quarter of 2018.

Non-casino revenues from our Las Vegas Operations were $289.3 million
for the first quarter of 2019, a 2.5% decrease from $296.8 million for
the first quarter of 2018. Room revenues were $119.1 million for the
first quarter of 2019, a 1.9% decrease from $121.5 million for the first
quarter of 2018. ADR was $338, a 0.6% decrease from $340 in the first
quarter of 2018. Occupancy decreased to 82.6% for the first quarter of
2019, from 83.9% for the first quarter of 2018. REVPAR was $279, a 2.1%
decrease from $285 for the first quarter of 2018. Food and beverage
revenues decreased 1.8%, to $123.6 million for the first quarter of
2019, compared to $125.8 million for the first quarter of 2018.
Entertainment, retail and other revenues decreased 5.9%, to $46.6
million for the first quarter of 2019, compared to $49.6 million in the
first quarter of 2018.

Development Projects

We are currently constructing Encore Boston Harbor, an integrated casino
resort in Everett, Massachusetts, located adjacent to Boston along the
Mystic River. The resort will contain a hotel, a waterfront boardwalk,
meeting and convention space, casino space, a spa, retail offerings and
food and beverage outlets. The total project budget, including gaming
license fees, construction costs, capitalized interest, pre-opening
expenses and land costs, is estimated to be approximately $2.6 billion.
As of March 31, 2019, we have incurred $2.26 billion in total project
costs. We expect to open Encore Boston Harbor in mid-2019.

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We are currently constructing an approximately 430,000 square foot
meeting and convention facility at Wynn Las Vegas and have begun
construction activities in connection with the reconfiguration of the
Wynn Las Vegas golf course, which we closed in the fourth quarter of
2017. Based on current designs, we estimate the total project budget to
be approximately $425 million. As of March 31, 2019, we have incurred
$181.5 million in total project costs. We expect to reopen the golf
course in the fourth quarter of 2019 and open the additional meeting and
convention space in the first quarter of 2020.

Balance Sheet

Our cash and cash equivalents and restricted cash as of March 31, 2019
totaled $1.83 billion.

Total current and long-term debt outstanding at March 31, 2019 was $9.17
billion, comprised of $3.73 billion of Macau related debt, $3.10 billion
of Wynn Las Vegas debt, $983 million of Wynn America debt, $740 million
of Wynn Resorts debt, and $611 million of debt held by the retail joint
venture which we consolidate.

As previously disclosed, on March 8, 2019, the Company entered into an
Incremental Joinder Agreement that amended the Wynn Resorts Term Loan
Credit Agreement to, among other things, provide the Company with an
additional $250 million term loan on substantially similar terms as the
Wynn Resorts Term Loan.

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Conference Call and Other Information

The Company will hold a conference call to discuss its results,
including the results of Wynn Las Vegas, LLC, on May 9, 2019 at 1:30
p.m. PT (4:30 p.m. ET). Interested parties are invited to join the call
by accessing a live audio webcast at http://www.wynnresorts.com.

On May 9, 2019, the Company will make Wynn Las Vegas, LLC financial
information for the quarter ended March 31, 2019 available to
noteholders, prospective investors, broker-dealers and securities
analysts. Please contact our investor relations office at 702-770-7555
or at [email protected],
to obtain access to such financial information.

Forward-looking Statements

This release contains forward-looking statements regarding operating
trends and future results of operations. Such forward-looking statements
are subject to a number of risks and uncertainties that could cause
actual results to differ materially from those we express in these
forward-looking statements, including, but not limited to, controversy,
regulatory action, litigation and investigations related to Stephen A.
Wynn and his separation from the Company, extensive regulation of our
business, pending or future claims and legal proceedings, ability to
maintain gaming licenses and concessions, dependence on key employees,
general global political and economic conditions, adverse tourism
trends, dependence on a limited number of resorts, competition in the
casino/hotel and resort industries, uncertainties over the development
and success of new gaming and resort properties, construction risks,
cybersecurity risk and our leverage and debt service. Additional
information concerning potential factors that could affect the Company’s
financial results is included in the Company’s Annual Report on Form
10-K for the year ended December 31, 2018 and the Company’s other
periodic reports filed with the Securities and Exchange Commission. The
Company is under no obligation to (and expressly disclaims any such
obligation to) update or revise its forward-looking statements as a
result of new information, future events or otherwise.

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Non-GAAP Financial Measures

(1) “Adjusted net income attributable to Wynn Resorts, Limited” is net
income (loss) attributable to Wynn Resorts, Limited before litigation
settlement expense, nonrecurring regulatory expense, pre-opening
expenses, property charges and other, change in derivatives fair value,
change in Redemption Note fair value, gain on extinguishment of debt,
foreign currency remeasurement loss, net of noncontrolling interests and
income taxes calculated using the specific tax treatment applicable to
the adjustments based on their respective jurisdictions. Adjusted net
income (loss) attributable to Wynn Resorts, Limited and adjusted net
income (loss) attributable to Wynn Resorts, Limited per diluted share
are presented as supplemental disclosures to financial measures in
accordance with GAAP because management believes that these non-GAAP
financial measures are widely used to measure the performance, and as a
principal basis for valuation, of gaming companies. These measures are
used by management and/or evaluated by some investors, in addition to
net income (loss) and earnings per share computed in accordance with
GAAP, as an additional basis for assessing period-to-period results of
our business. Adjusted net income (loss) attributable to Wynn Resorts,
Limited and adjusted net income (loss) attributable to Wynn Resorts,
Limited per diluted share may be different from the calculation methods
used by other companies and, therefore, comparability may be limited.

(2) “Adjusted Property EBITDA” is net income (loss) before interest,
income taxes, depreciation and amortization, litigation settlement
expense, pre-opening expenses, property charges and other, management
and license fees, corporate expenses and other, stock-based
compensation, gain on extinguishment of debt, change in derivatives fair
value, change in Redemption Note fair value and other non-operating
income and expenses. Adjusted Property EBITDA is presented exclusively
as a supplemental disclosure because management believes that it is
widely used to measure the performance, and as a basis for valuation, of
gaming companies. Management uses Adjusted Property EBITDA as a measure
of the operating performance of its segments and to compare the
operating performance of its properties with those of its competitors,
as well as a basis for determining certain incentive compensation. The
Company also presents Adjusted Property EBITDA because it is used by
some investors to measure a company’s ability to incur and service debt,
make capital expenditures and meet working capital requirements. Gaming
companies have historically reported EBITDA as a supplement to GAAP. In
order to view the operations of their casinos on a more stand-alone
basis, gaming companies, including Wynn Resorts, Limited, have
historically excluded from their EBITDA calculations pre-opening
expenses, property charges, corporate expenses and stock-based
compensation, that do not relate to the management of specific casino
properties. However, Adjusted Property EBITDA should not be considered
as an alternative to operating income as an indicator of the Company’s
performance, as an alternative to cash flows from operating activities
as a measure of liquidity, or as an alternative to any other measure
determined in accordance with GAAP. Unlike net income, Adjusted Property
EBITDA does not include depreciation or interest expense and therefore
does not reflect current or future capital expenditures or the cost of
capital. The Company has significant uses of cash flows, including
capital expenditures, interest payments, debt principal repayments,
income taxes and other non-recurring charges, which are not reflected in
Adjusted Property EBITDA. Also, Wynn Resorts’ calculation of Adjusted
Property EBITDA may be different from the calculation methods used by
other companies and, therefore, comparability may be limited.

The Company has included schedules in the tables that accompany this
release that reconcile (i) net income (loss) attributable to Wynn
Resorts, Limited to adjusted net income attributable to Wynn Resorts,
Limited, (ii) operating income (loss) to Adjusted Property EBITDA, and
(iii) net income (loss) attributable to Wynn Resorts, Limited to
Adjusted Property EBITDA.

WYNN RESORTS, LIMITED AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
(unaudited)
 
  Three Months Ended March 31,
  2019       2018  
Operating revenues:
Casino $ 1,185,101 $ 1,242,139
Rooms 191,270 190,310
Food and beverage 173,219 172,222
Entertainment, retail and other   101,956     110,907  
Total operating revenues   1,651,546     1,715,578  
Operating expenses:
Casino 750,071 764,401
Rooms 63,706 63,197
Food and beverage 148,761 137,658
Entertainment, retail and other 44,044 48,030
General and administrative 217,322 169,585
Litigation settlement 463,557
Provision for doubtful accounts 5,422 691
Pre-opening 27,713 10,345
Depreciation and amortization 136,557 136,357
Property charges and other   2,774     3,051  
Total operating expenses   1,396,370     1,796,872  
Operating income (loss)   255,176     (81,294 )
Other income (expense):
Interest income 7,287 7,220
Interest expense, net of amounts capitalized (93,180 ) (98,227 )
Change in derivatives fair value (1,509 )
Change in Redemption Note fair value (69,331 )
Gain on extinguishment of debt 2,329
Other   (6,358 )   (9,220 )
Other income (expense), net   (93,760 )   (167,229 )
Income (loss) before income taxes 161,416 (248,523 )
Benefit (provision) for income taxes   (1,685 )   111,045  
Net income (loss) 159,731 (137,478 )
Less: net income attributable to noncontrolling interests   (54,859 )   (66,829 )
Net income (loss) attributable to Wynn Resorts, Limited $ 104,872   $ (204,307 )
Basic and diluted income (loss) per common share:
Net income (loss) attributable to Wynn Resorts, Limited:
Basic $ 0.98 $ (1.99 )
Diluted $ 0.98 $ (1.99 )
Weighted average common shares outstanding:
Basic 106,792 102,570
Diluted 107,073 102,570
Dividends declared per common share: $ 0.75 $ 0.50
 
WYNN RESORTS, LIMITED AND SUBSIDIARIES
RECONCILIATION OF NET INCOME (LOSS) ATTRIBUTABLE TO WYNN RESORTS,
LIMITED
TO ADJUSTED NET INCOME ATTRIBUTABLE TO WYNN RESORTS, LIMITED
(in thousands, except per share data)
(unaudited)
 
  Three Months Ended March 31,
  2019       2018  
Net income (loss) attributable to Wynn Resorts, Limited $ 104,872 $ (204,307 )
Litigation settlement expense 463,557
Nonrecurring regulatory expense 35,000
Pre-opening expenses 27,713 10,345
Property charges and other 2,774 3,051
Change in derivatives fair value 1,509
Change in Redemption Note fair value 69,331
Gain on extinguishment of debt (2,329 )
Foreign currency remeasurement loss 6,358 9,220
Income tax impact on adjustments (2,692 ) (108,827 )
Noncontrolling interests impact on adjustments   (2,950 )   (3,068 )
Adjusted net income attributable to Wynn Resorts, Limited $ 172,584   $ 236,973  
Adjusted net income attributable to Wynn Resorts, Limited per
diluted share
$ 1.61   $ 2.30  
 
Weighted average common shares outstanding – diluted 107,073 103,155
 
WYNN RESORTS, LIMITED AND SUBSIDIARIES
RECONCILIATION OF OPERATING INCOME (LOSS) TO ADJUSTED PROPERTY
EBITDA
(in thousands)
(unaudited)
 
  Three Months Ended March 31, 2019

Operating

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income

(loss)

 

Pre-opening

expenses

 

Depreciation

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and

amortization

 

Property

charges and

other

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Management

and license

fees

 

Corporate

expenses

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and other

 

Stock-based

compensation

 

Adjusted

Property

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EBITDA

Macau Operations:
Wynn Palace $ 125,791 $ $ 66,066 $ 1,120 $ 27,220 $ 1,284 $ 1,105 $ 222,586
Wynn Macau 118,397 21,912 393 18,986 1,495 2,706 163,889
Other Macau   (3,303 )     1,117   6         1,913   267  
Total Macau Operations 240,885 89,095 1,519 46,206 4,692 4,078 386,475
Las Vegas Operations 38,924 44,590 510 18,721 3,965 1,592 108,302
Corporate and Other   (24,633 )   27,713   2,872   745     (64,927 )   53,892   4,338  
Total $ 255,176   $ 27,713 $ 136,557 $ 2,774   $   $ 62,549 $ 10,008 $ 494,777
 
Three Months Ended March 31, 2018

Operating

income

(loss)

Pre-opening

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expenses

Depreciation

and

amortization

Property

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charges and

other

Management

and license

fees

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Corporate

expenses and

other (1)

Stock-based

compensation

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Adjusted

Property

EBITDA

Macau Operations:
Wynn Palace $ 119,471 $ $ 64,424 $ 1,027 $ 24,225 $ 1,452 $ 1,312 $ 211,911
Wynn Macau 159,461 22,170 768 23,366 1,864 2,193 209,822
Other Macau   (3,970 )     1,106   9         2,690   165  
Total Macau Operations 274,962 87,700 1,804 47,591 6,006 3,670 421,733
Las Vegas Operations 71,874 6 45,783 1,329 20,039 2,948 617 142,596
Corporate and Other (1)   (428,130 )   10,339   2,874   (82 )   (67,630 )   479,612   3,017  
Total $ (81,294 ) $ 10,345 $ 136,357 $ 3,051   $   $ 488,566 $ 7,304 $ 564,329
 

(1) Corporate expense and other includes the litigation settlement
expense of $463.6 million in the first quarter of 2018.

 
WYNN RESORTS, LIMITED AND SUBSIDIARIES
RECONCILIATION OF NET INCOME (LOSS) ATTRIBUTABLE TO WYNN RESORTS,
LIMITED TO
ADJUSTED PROPERTY EBITDA
(in thousands)
(unaudited)
 
  Three Months Ended March 31,
  2019       2018  
Net income (loss) attributable to Wynn Resorts, Limited $ 104,872 $ (204,307 )
Net income attributable to noncontrolling interests 54,859 66,829
Litigation settlement expense 463,557
Pre-opening expenses 27,713 10,345
Depreciation and amortization 136,557 136,357
Property charges and other 2,774 3,051
Corporate expenses and other 62,549 25,009
Stock-based compensation 10,008 7,304
Interest income (7,287 ) (7,220 )
Interest expense, net of amounts capitalized 93,180 98,227
Change in derivatives fair value 1,509
Change in Redemption Note fair value 69,331
Gain on extinguishment of debt (2,329 )
Other 6,358 9,220
(Benefit) provision for income taxes   1,685     (111,045 )
Adjusted Property EBITDA $ 494,777   $ 564,329  
 
WYNN RESORTS, LIMITED AND SUBSIDIARIES
SUPPLEMENTAL DATA SCHEDULE
(dollars in thousands, except for win per unit per day, ADR and
REVPAR)
(unaudited)
 
  Three Months Ended March 31,
  2019       2018  
Macau Operations:
Wynn Palace:
VIP:
Average number of table games 111 115
VIP turnover $ 12,627,262 $ 15,385,833
VIP table games win (1) $ 493,184 $ 399,891
VIP table games win as a % of turnover 3.91 % 2.60 %
Table games win per unit per day $ 49,156 $ 38,533
Mass market:
Average number of table games 211 211
Table drop (2) $ 1,303,924 $ 1,217,201
Table games win (1) $ 315,469 $ 310,159
Table games win % 24.2 % 25.5 %
Table games win per unit per day $ 16,646 $ 16,341
Average number of slot machines 1,091 1,062
Slot machine handle $ 975,048 $ 1,058,096
Slot machine win (3) $ 51,401 $ 55,785
Slot machine win per unit per day $ 524 $ 584
Room statistics:
Occupancy 97.2 % 96.8 %
ADR (4) $ 271 $ 252
REVPAR (5) $ 264 $ 244
 
Wynn Macau:
VIP:
Average number of table games 113 114
VIP turnover $ 10,194,031 $ 17,087,455
VIP table games win (1) $ 295,298 $ 445,189
VIP table games win as a % of turnover 2.90 % 2.61 %
Table games win per unit per day $ 29,099 $ 43,531
Mass market:
Average number of table games 206 203
Table drop (2) $ 1,351,693 $ 1,322,815
Table games win (1) $ 264,542 $ 256,481
Table games win % 19.6 % 19.4 %
Table games win per unit per day $ 14,283 $ 14,042
Average number of slot machines 826 939
Slot machine handle $ 794,367 $ 1,002,819
Slot machine win (3) $ 37,894 $ 41,765
Slot machine win per unit per day $ 510 $ 494
Room statistics:
Occupancy 99.3 % 99.0 %
ADR (4) $ 290 $ 291
REVPAR (5) $ 288 $ 288
 
WYNN RESORTS, LIMITED AND SUBSIDIARIES
SUPPLEMENTAL DATA SCHEDULE
(dollars in thousands, except for win per unit per day, ADR and
REVPAR)
(unaudited) (continued)
 
  Three Months Ended March 31,
  2019       2018  
Las Vegas Operations:
Average number of table games 238 238
Table drop (2) $ 404,073 $ 536,581
Table games win (1) $ 111,370 $ 154,433
Table games win % 27.6 % 28.8 %
Table games win per unit per day $ 5,198 $ 7,212
Average number of slot machines 1,807 1,829
Slot machine handle $ 789,310 $ 744,133
Slot machine win (3) $ 54,544 $ 49,264
Slot machine win per unit per day $ 335 $ 299
Room statistics:
Occupancy 82.6 % 83.9 %
ADR (4) $ 338 $ 340
REVPAR (5) $ 279 $ 285

Contacts

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Vincent Zahn
702-770-7555
[email protected]

Read full story here

Indivior

Indivior Provides Update on Aelis Farma’s Clinical Phase 2B Study Results with AEF0117 in Participants with Cannabis Use Disorder

Published

on

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. 

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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.

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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:

  1. 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

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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.

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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:

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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

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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

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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.

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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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