Canada Goose Reports Results for Fiscal Year 2019
Fiscal 2019 Highlights (in millions of Canadian dollars):
- Total revenue increased by 40.5% to $830.5m
- Net income was $143.6m, or $1.28 per diluted share
- Adjusted EBITDA margin expanded by 240 basis points to 27.6%
- Adjusted net income per diluted share increased by 61.9% to $1.36
Adjusted EBITDA margin and adjusted net income per diluted share are
non-IFRS financial measures. See “Note Regarding Non-IFRS Financial
Measures”.
TORONTO–(BUSINESS WIRE)–Canada Goose Holdings Inc. (“Canada Goose” or the “Company”) (NYSE:GOOS,
TSX:GOOS) today announced financial results for the fourth quarter and
fiscal year ended March 31, 2019. The Annual Report, including
Management’s Discussion and Analysis and Audited Consolidated Financial
Statements, will be filed on SEDAR at www.sedar.com,
the EDGAR section of the U.S. Securities and Exchange Commission website
at www.sec.gov.
and posted on the Company’s web site at investor.canadagoose.com.
“I am extremely proud of Canada Goose’s many strategic accomplishments
in fiscal 2019. We entered the year with a very ambitious agenda of
global growth, and we have surpassed it with flying colours,” said Dani
Reiss, President & CEO. “We have come a long way in a short time and we
have done it the right way – by preserving the purity of our brand and
building for the future. Our business and our people have never been
stronger. I believe that we are still just scratching the surface of our
long-term potential as we continue to define performance luxury
globally.”
Fiscal 2019 Business Highlights
-
Growth in every geographic region, with annual revenue increasing by
28.2% in Canada, 36.3% in the United States and 60.5% in Rest of World. -
Successfully launched DTC operations in Greater China, the world’s
largest luxury market. -
Proportion of total revenue generated in Rest of World (34.5%) was
in-line with Canada (35.3%) for the first time. -
Global footprint of 11 directly-operated retail stores and 12 national
e-commerce markets increased DTC sales to over half of total revenue
at 51.9%. -
Established new generations of hero products in nascent rainwear and
knitwear categories, alongside continued innovation in parkas and
lightweight down collections. -
Acquired Baffin, which will provide valuable expertise and
infrastructure to develop a stand-alone Canada Goose footwear offering
in the years to come. -
Eight in-house manufacturing facilities, including two opened during
the year, produced 47% of total down-filled jacket volume.
Fiscal 2019 Results (in Canadian dollars, compared to Fiscal 2018):
-
Total revenue increased by 40.5% to $830.5m from $591.2m, or 39.0% on
a constant currency basis(1). -
Wholesale revenue increased to $399.2m from $336.2m. This was driven
by higher order values from existing partners. Incremental revenue
from Baffin, which was acquired in November 2018, and favourable
foreign exchange fluctuations also contributed positively. -
DTC revenue increased to $431.3m from $255.0m, representing 51.9% of
total revenue compared to 43.1%. The increase was primarily
attributable to incremental revenue from five new retail stores and
one new e-commerce market. This was complemented by strong
performances from established e-commerce markets and retail stores. -
Gross profit increased to $516.8m, a gross margin of 62.2%, compared
to $347.6m, a gross margin of 58.8%. The increase in gross margin was
driven by a greater proportion of DTC revenue, and to a lesser degree,
incremental gross margin expansion at the respective channel levels. -
DTC gross profit was $324.6m, a gross margin of 75.3%, compared to
$189.8m, a gross margin of 74.4%. The increase in gross margin was
primarily driven by pricing, partially offset by manufacturing labour
cost increases. -
Wholesale gross profit was $192.2m, a gross margin of 48.1%, compared
to $157.8m, a gross margin of 46.9%. The increase in gross margin was
primarily attributable to pricing, partially offset by manufacturing
labour cost increases. To a lesser degree, wholesale gross margin also
benefitted from production efficiencies in manufacturing overhead,
partially offset by changes in product mix. -
Operating income was $196.7m, compared to $138.1m. The increase in
operating income was driven by revenue growth and gross margin
expansion, partially offset by SG&A growth investments. -
Unallocated corporate expenses were $169.1m, compared to $107.8m. The
increase was primarily due to investments to support growth in
marketing, corporate headcount and IT, including Greater China
operations. Professional fees and other costs relating to public
company compliance also increased. -
Unallocated depreciation and amortization was $18.0m, compared to
$9.4m, driven by the retail store opening program. -
DTC operating income was $234.6m, an operating margin of 54.4%,
compared to $134.7m, an operating margin of 52.8%. This was driven by
gross margin expansion, strong sales productivity across the channel
and lower pre-opening costs, partially offset by incremental SG&A fees
to operating partners in Greater China. -
Wholesale operating income was $149.2m, an operating margin of 37.3%,
compared to $120.6m, an operating margin of 35.9%. The increase in
operating margin was largely driven by gross margin expansion. -
Net income was $143.6m, or $1.28 per diluted share, compared to
$96.1m, or $0.86 per diluted share. The increase in net income was due
to higher operating income and a lower effective tax rate. -
Adjusted EBITDA(1) was $229.6m, a margin of 27.6%, compared
to $149.2m, a margin of 25.2%. -
Adjusted EBIT(1) was $206.9m, a margin of 24.9%, compared
to $136.4m, a margin of 23.1%. -
Adjusted net income(1) was $151.6m, or $1.36 per diluted
share, compared to adjusted net income(1) of $94.1m, or
$0.84 per diluted share.
(1) See “Note Regarding Non-IFRS Financial Measures”.
Launch of Normal Course Issuer Bid
The board of directors of the Company has authorized a normal course
issuer bid (the “NCIB”) to purchase for cancellation up to 1,600,000
subordinate voting shares of Canada Goose over the twelve-month period
commencing on May 31, 2019 and ending no later than May 30, 2020,
representing approximately 2.70% of the 59,151,443 subordinate voting
shares issued and outstanding as at May 17, 2019. The NCIB will be
conducted through the facilities of the Toronto Stock Exchange (the
“TSX”) and the New York Stock Exchange (the “NYSE”) or alternative
trading systems, if eligible, and will conform to their
regulations. Subordinate voting shares will be acquired under the NCIB
at the market price plus brokerage fees. Purchases under the NCIB will
be made by means of open market transactions or such other means as a
securities regulatory authority may permit. In the event that the
Company acquires subordinate voting shares by other means as a
securities regulatory authority may permit, the purchase price of the
subordinate voting shares may be different than the market price of the
subordinate voting shares at the time of the acquisition. Purchases made
under an issuer bid exemption order will be at a discount to the
prevailing market price as per the terms of the order. Furthermore,
under the NCIB, Canada Goose may make, once per week, a block purchase
(as such term is defined in the TSX Company Manual) at market price, in
accordance with TSX rules. Under TSX rules, block purchases may not be
made, directly or indirectly, from any insider of the Company, including
any funds managed by Bain Capital. Canada Goose will otherwise be
allowed to purchase daily, through the facilities of the TSX, a maximum
of 131,422 subordinate voting shares representing 25% of the average
daily trading volume, as calculated per the TSX rules for the six-month
period starting on November 1, 2018 and ending on April 30, 2019.
Canada Goose currently believes that the purchase of the Company’s
subordinate voting shares under the NCIB is an appropriate and desirable
use of available excess cash.
Canada Goose has not repurchased any of its outstanding subordinate
voting shares under a normal course issuer bid in the past 12 months.
IFRS 16
The Company will adopt IFRS 16, a new standard for lease accounting
which replaces IAS 17, on April 1, 2019. The standard requires
substantially all assets obtained through operating leases to be
capitalized and a related liability to be recorded. The nature and
timing of expenses will also change as IFRS 16 replaces straight-line
operating lease expense with a depreciation charge for right-of-use
assets and interest expense on lease liabilities.
As a result, the Company will replace Adjusted EBITDA and Adjusted
EBITDA margin with Adjusted EBIT and Adjusted EBIT margin in its
supplementary non-IFRS measures and financial outlook. With the
capitalization of operating leases and the movement of lease expenses to
depreciation and interest, management believes that Adjusted EBITDA will
no longer be a meaningful supplemental measure to assess operating
profit and operating profitability. Further details regarding IFRS 16
are provided in Management’s Discussion and Analysis in the Annual
Report.
Fiscal Year 2020 and Long-Term Outlook
For fiscal 2020, the Company currently expects the following:
- Annual revenue growth of at least 20%
- Adjusted EBIT margin expansion of at least 40 basis points
- Annual growth in adjusted net income per diluted share of at least 25%
Key assumptions underlying the fiscal 2020 outlook above are as follows:
-
Wholesale revenue growth in the high-single-digits on a percentage
basis -
Eight new retail stores in operation by the end of the winter selling
season -
One new digital concept store in operation by the end of the winter
selling season, which will be an experiential showroom to drive local
e-commerce sales in the Greater Toronto Area. It is not expected to
generate revenue or operating income at a level consistent with the
Company’s traditional retail store format. -
Materially larger losses in adjusted EBIT and adjusted net income per
diluted share during the fiscal first quarter, due to a larger number
of retail stores operating during off-peak periods and higher
corporate SG&A investments to support growth, including local market
activation ahead of planned retail openings, new product and Greater
China operations. -
Capital expenditures of $75 million including investments in new
retail stores, IT and manufacturing capacity - Weighted average diluted shares outstanding of 112.4 million shares
- An effective annual tax rate approximately in-line with fiscal 2019
Over the next three fiscal years, the Company currently expects the
following:
- Average annual revenue growth of at least 20%
-
Annual adjusted EBIT margin expansion of at least 100 basis points in
fiscal 2022, relative to fiscal 2019 -
Average annual growth in adjusted net income per diluted share of at
least 25%
The long-term outlook assumes, among other things, a continuation of
current economic conditions and execution of the growth strategies
outlined under the heading “Business Overview” in our Annual Report on
Form 20-F for the fiscal year ended March 31, 2019.
The fiscal 2020 and long-term outlooks above constitute forward-looking
statements and forward-looking information within the meaning of
applicable securities laws (see “Cautionary Note Regarding
Forward-Looking Statements”). Actual results could vary materially as a
result of numerous factors, including certain risk factors, many of
which are beyond the Company’s control. The purpose of our fiscal 2020
and long-term outlook is to provide a description of management’s
expectations regarding the Company’s financial performance and may not
be appropriate for other purposes.
Refinancing
On May 10, 2019, the Company refinanced its debt to support the growth
of the business and enhance financial flexibility. The capacity of the
existing Revolving Facility was increased to $300.0m, with a seasonal
increase to up to $350.0m during peak working capital periods, and the
maturity was extended to June of 2024. Concurrently, the maturity of the
existing USD $113.8m Term Loan Facility was extended to December of
2024. Further details regarding the refinancing are provided in
Management’s Discussion and Analysis in the Annual Report.
Conference Call Information
A conference call to discuss fiscal 2019 results is scheduled for today,
May 29, 2019 at 9:00 a.m. Eastern Time. Dani Reiss, President and Chief
Executive Officer and Jonathan Sinclair, EVP and Chief Financial
Officer, will host the conference call. Those interested in
participating in the call are invited to dial (844) 579-6824 or (763)
488-9145 if calling internationally. Please dial in approximately 10
minutes prior to the start of the call and reference Conference ID
2849456 when prompted. A live audio webcast of the conference call will
be available online at http://investor.canadagoose.com.
About Canada Goose
Founded in a small warehouse in Toronto, Canada in 1957, Canada Goose
has grown into one of the world’s leading makers of performance luxury
apparel. Every collection is informed by the rugged demands of the
Arctic and inspired by relentless innovation and uncompromised
craftsmanship. From the coldest places on Earth to global fashion
capitals, people are proud to wear Canada Goose products. Employing more
than 3,900 people worldwide, Canada Goose is a recognized leader for its
Made in Canada commitment, and is a long-time partner of Polar Bears
International. Visit canadagoose.com for more information.
Non-IFRS Financial Measures
This press release includes references to adjusted net income, EBIT,
adjusted EBIT, adjusted EBIT margin, EBITDA, adjusted EBITDA, adjusted
EBITDA margin, and adjusted net income per share and per diluted share.
The Company presents these measures because its management uses these as
supplemental measures in assessing its operating performance, and
believes they are helpful to investors, securities analysts and other
interested parties, in evaluating the Company’s performance. The
measures referenced above are not measurements of financial performance
under IFRS and they should not be considered as alternatives to measures
of performance derived in accordance with IFRS. In addition, these
measures should not be construed as an inference that the Company’s
future results will be unaffected by unusual or non-recurring items.
These measures have limitations as analytical tools, and you should not
consider such measures either in isolation or as substitutes for
analyzing the Company’s results as reported under IFRS.
This press release also includes reference to constant currency revenue.
The Company presents this measure because we use constant currency
information to provide a framework in assessing how our business
segments performed excluding the effects of foreign currency exchange
rate fluctuations and believe this information is useful to investors to
facilitate comparisons of operating results and better identify trends
in our businesses. The constant currency measure is calculated by
translating the prior year reported amounts into comparable amounts
using a single foreign exchange rate for each currency calculated based
on the current period exchange rates as measured by the Bank of Canada.
The Company’s definitions and calculations of these measures are not
necessarily comparable to other similarly titled measures used by other
companies. These non-IFRS financial measures are defined and reconciled
to the most comparable IFRS measures in the tables at the end of this
press release.
A reconciliation of projected adjusted EBIT, and adjusted net income,
which are forward-looking measures that are not prepared in accordance
with IFRS, to the most directly comparable IFRS financial measures, is
not provided because we are unable to provide such reconciliation
without unreasonable effort. The inability to provide a quantitative
reconciliation is due to the uncertainty and inherent difficulty
predicting the occurrence, the financial impact and the periods in which
the components of the applicable IFRS measures and non-IFRS adjustments
may be recognized. The IFRS measures may include the impact of such
items as non-cash share-based compensation, revaluation of the carrying
value of our indebtedness, amortization of intangible assets and the tax
effect of such items, in addition to other items we have historically
excluded from adjusted EBIT (or adjusted EBITDA) and adjusted net
income. We expect to continue to exclude these items in future
disclosures of these non-IFRS measures and may also exclude other
similar items that may arise in the future (collectively, “non-IFRS
adjustments”). The decisions and events that typically lead to the
recognition of non-IFRS adjustments are inherently unpredictable as to
if or when they may occur. As such, for our fiscal 2020 outlook, we have
not included estimates for these items and are unable to address the
probable significance of the unavailable information, which could be
material to future results.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements. These
forward-looking statements generally can be identified by the use of
words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,”
“believe,” “estimate,” “forecast,” “goal,” “project,” and other words of
similar meaning. These forward-looking statements address various
matters including our outlook for fiscal 2020 and our long-term outlook,
related assumptions, and our plans for strategic investments to support
future growth. Each forward-looking statement contained in this press
release is subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by such
statement. Applicable risks and uncertainties include, among others, our
expectations regarding industry trends, our business plan and growth
strategies, our expectations regarding seasonal trends, our inventory
levels ahead of these seasonal trends, our ability to implement our
growth strategies, our ability to keep pace with changing consumer
preferences, our ability to maintain the strength of our brand and
protect our intellectual property, as well as the risks identified under
the heading “Risk Factors” in our Annual Report on Form 20-F for the
fiscal year ended March 31, 2019, and filed with the Securities and
Exchange Commission (“SEC”), and the securities commissions or similar
securities regulatory authorities in each of the provinces and
territories of Canada (“Canadian securities regulatory authorities”), as
well as the other information we file with the SEC and Canadian
securities regulatory authorities. We caution investors not to rely on
the forward-looking statements contained in this press release when
making an investment decision in our securities. The forward-looking
statements in this press release speak only as of the date of this
release, and we undertake no obligation to update or revise any of these
statements. Our business is subject to substantial risks and
uncertainties, including those referenced above. You are encouraged to
read our filings with the SEC, available at www.sec.gov,
and our filings with Canadian securities regulatory authorities
available at www.sedar.com
for a discussion of these and other risks and uncertainties. Investors,
potential investors, and others should give careful consideration to
these risks and uncertainties.
Consolidated Statements of Income and Comprehensive Income |
||||||||||||||||||
(in millions of Canadian dollars, except share and per share |
||||||||||||||||||
Three months ended |
Year ended |
|||||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||||
$ | $ | $ | $ | |||||||||||||||
Revenue | 156.2 | 124.8 | 830.5 | 591.2 | ||||||||||||||
Cost of sales | 53.8 | 46.6 | 313.7 | 243.6 | ||||||||||||||
Gross profit | 102.4 | 78.2 | 516.8 | 347.6 | ||||||||||||||
Gross margin | 65.6 | % | 62.7 | % | 62.2 | % | 58.8 | % | ||||||||||
Selling, general and administrative expenses | 85.0 | 60.9 | 302.1 | 200.1 | ||||||||||||||
SG&A expenses as % of revenue | 54.4 | % | 48.8 | % | 36.4 | % | 33.8 | % | ||||||||||
Depreciation and amortization | 5.7 | 2.5 | 18.0 | 9.4 | ||||||||||||||
Operating income | 11.7 | 14.8 | 196.7 | 138.1 | ||||||||||||||
Operating income as % of revenue | 7.5 | % | 11.9 | % | 23.7 | % | 23.4 | % | ||||||||||
Net interest and other finance costs | 3.1 | 2.8 | 14.2 | 12.9 | ||||||||||||||
Income before income taxes | 8.6 | 12.0 | 182.5 | 125.2 | ||||||||||||||
Income tax (recovery) expense | (0.4 | ) | 3.9 | 38.9 | 29.1 | |||||||||||||
Effective tax rate | (5.1 | )% | 32.7 | % | 21.3 | % | 23.3 | % | ||||||||||
Net income | 9.0 | 8.1 | 143.6 | 96.1 | ||||||||||||||
Other comprehensive (loss) income | (3.0 | ) | (1.4 | ) | 0.7 | (1.8 | ) | |||||||||||
Total comprehensive income | 6.0 | 6.7 | 144.3 | 94.3 | ||||||||||||||
Earnings per share | ||||||||||||||||||
Basic | $ | 0.08 | $ | 0.08 | $ | 1.31 | $ | 0.90 | ||||||||||
Diluted | $ | 0.08 | $ | 0.07 | $ | 1.28 | $ | 0.86 | ||||||||||
Weighted average number of shares |
||||||||||||||||||
Basic | 109,867,553 | 108,074,609 | 109,422,574 | 107,250,039 | ||||||||||||||
Diluted | 111,606,200 | 111,629,427 | 111,767,584 | 111,519,238 | ||||||||||||||
Other data: (1) | ||||||||||||||||||
Adjusted net income | 10.0 | 10.0 | 151.6 | 94.1 | ||||||||||||||
Adjusted net income per share | $ | 0.09 | $ | 0.09 | $ | 1.39 | $ | 0.88 | ||||||||||
Adjusted net income per diluted share | $ | 0.09 | $ | 0.09 | $ | 1.36 | $ | 0.84 | ||||||||||
EBITDA | 19.1 | 19.7 | 219.4 | 152.3 | ||||||||||||||
Adjusted EBITDA | 20.4 | 21.8 | 229.6 | 149.2 | ||||||||||||||
(1) Adjusted net income, adjusted net income per
share and per diluted share, EBITDA, and adjusted EBITDA are non-IFRS
financial measures. See “Reconciliation of Non-IFRS Financial Measures”
for a description of these measures and a reconciliation to the nearest
IFRS measure.
Consolidated Statements of Financial Position | |||||
As at March 31 | |||||
(in millions of Canadian dollars) |
|||||
2019 | 2018 | ||||
Assets | $ | $ | |||
Current assets | |||||
Cash | 88.6 | 95.3 | |||
Trade receivables | 20.4 | 11.9 | |||
Inventories | 267.3 | 165.4 | |||
Income taxes receivable | 4.0 | 5.1 | |||
Other current assets | 32.9 | 23.3 | |||
Total current assets | 413.2 | 301.0 | |||
Deferred income taxes | 12.2 | 3.0 | |||
Property, plant and equipment | 84.3 | 60.2 | |||
Intangible assets | 155.6 | 136.8 | |||
Other long-term assets | 7.0 | 2.1 | |||
Goodwill | 53.1 | 45.3 | |||
Total assets | 725.4 | 548.4 | |||
Liabilities | |||||
Current liabilities | |||||
Accounts payable and accrued liabilities | 110.4 | 109.6 | |||
Provisions | 8.1 | 6.3 | |||
Income taxes payable | 18.1 | 17.7 | |||
Total current liabilities | 136.6 | 133.6 | |||
Provisions | 14.7 | 10.8 | |||
Deferred income taxes | 16.7 | 13.3 | |||
Revolving facility | — | — | |||
Term loan | 145.2 | 137.1 | |||
Other long-term liabilities | 13.1 | 10.0 | |||
Total liabilities | 326.3 | 304.8 | |||
Shareholders’ equity | 399.1 | 243.6 | |||
Total liabilities and shareholders’ equity | 725.4 | 548.4 | |||
Consolidated Statements of Cash Flows | ||||||||||||
(in millions of Canadian dollars) |
||||||||||||
For the three months |
For the year ended |
|||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||
$ | $ | $ | $ | |||||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||||||
Net income | 9.0 | 8.1 | 143.6 | 96.1 | ||||||||
Items not affecting cash: | ||||||||||||
Depreciation and amortization | 7.4 | 4.9 | 22.7 | 14.2 | ||||||||
Income tax (recovery) expense | (0.4 | ) | 3.9 | 38.9 | 29.1 | |||||||
Interest expense | 2.9 | 2.6 | 13.7 | 12.5 | ||||||||
Unrealized foreign exchange (gain) loss | (0.2 | ) | — | 2.7 | (8.6 | ) | ||||||
Share-based compensation | 1.1 | 0.6 | 3.8 | 2.0 | ||||||||
Loss on disposal of assets | 0.2 | 0.2 | 0.2 | 0.2 | ||||||||
20.0 | 20.3 | 225.6 | 145.5 | |||||||||
Changes in non-cash operating items | (13.8 | ) | 22.1 | (100.7 | ) | (2.3 | ) | |||||
Income taxes paid | (5.1 | ) | (2.5 | ) | (41.0 | ) | (7.4 | ) | ||||
Interest paid | (2.1 | ) | (1.9 | ) | (10.5 | ) | (9.6 | ) | ||||
Net cash (used in) from operating activities | (1.0 | ) | 38.0 | 73.4 | 126.2 | |||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||||||
Purchase of property, plant and equipment | (8.9 | ) | (6.2 | ) | (30.3 | ) | (26.1 | ) | ||||
Investment in intangible assets | (5.4 | ) | (1.1 | ) | (19.0 | ) | (7.7 | ) | ||||
Business combination | (0.2 | ) | — | (33.6 | ) | (0.6 | ) | |||||
Net cash used in investing activities | (14.5 | ) | (7.3 | ) | (82.9 | ) | (34.4 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||||||
Net borrowings (repayment) on revolving facility | — | 0.1 | — | (8.8 | ) | |||||||
Deferred financing fees | — | 0.1 | — | (0.3 | ) | |||||||
Exercise of stock options | 0.6 | 0.6 | 3.1 | 1.2 | ||||||||
Net cash from (used in) financing activities | 0.6 | 0.8 | 3.1 | (7.9 | ) | |||||||
Effects of foreign currency exchange rate changes on cash | 1.2 | 1.7 | (0.3 | ) | 1.7 | |||||||
(Decrease) increase in cash | (13.7 | ) | 33.2 | (6.7 | ) | 85.6 | ||||||
Cash, beginning of period | 102.3 | 62.1 | 95.3 | 9.7 | ||||||||
Cash, end of period | 88.6 | 95.3 | 88.6 | 95.3 | ||||||||
Contacts
ICR, Inc.
Investors:
Allison Malkin/Caitlin Churchill
(203)
682-8200
[email protected]/[email protected]
or
Media:
Jessica Liddell/Julia Young
646-277-1280
[email protected]/[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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