Nutrien’s First Quarter Impacted by Harsh Weather; Maintains Guidance

Published

5 years ago

May 9, 2019

Reading Time: 16 minutes

All amounts are in US dollars

SASKATOON, Saskatchewan–(BUSINESS WIRE)–Nutrien Ltd. (Nutrien) announced today its 2019 first-quarter results,
with net earnings from continuing operations of $41 million($0.07
diluted earnings per share). First-quarter adjusted net earnings was
$0.20 per shareand adjusted EBITDA was $697 million.
Adjusted net earnings (total and per share amounts), adjusted EBITDA and
related annual guidance are non-IFRS financial measures. See pages 2 and
15 for further information.

“Nutrien’s first-quarter adjusted EBITDA was 22 percent higher than 2018
despite being impacted by the second wettest six-month period in the US
in 125 years. While some regions are still receiving excess moisture,
planting is underway and we expect strong crop input demand in the
second quarter. As such, we are maintaining our annual guidance for
2019,” commented Chuck Magro, Nutrien’s President and CEO.

“Our organization is focused on what it can control and how best to
deliver long-term value to stakeholders. In the first quarter, we
allocated almost $1 billion towards growing our Retail business in core
markets and repurchased over $800 million of our stock. We also continue
to pursue operational enhancements across our world-class integrated
network and to lead the way in digital transformation of the ag-retail
industry,” added Mr. Magro.

Highlights:

Retail EBITDA in the first quarter was lower compared to the same
period last year due to an extremely wet spring season and flooding in
parts of the US. Continued progress was made on Nutrien Ag Solutions
digital platform, with customers representing 58 percent of our North
American Retail sales signed up on the platform within nine months of
launch.
Potash EBITDA was 41 percent higher in the first quarter compared to
the same period last year due to higher net selling prices and strong
offshore demand, partially offset by lower North American sales.
Nitrogen EBITDA in the first quarter was slightly higher than the same
period last year due mainly to higher urea and UAN prices being offset
by lower total sales volumes resulting from the excess wet weather
across the US.
We strengthened our US Retail business including the acquisitions of
Actagro, LLC, Van Horn, Inc., and Security Seed and Chemical, Inc.,
and completing the remainder of the Agrichem acquisition in Brazil
with combined annual revenue of approximately $400 million for these
businesses. We also entered into a binding agreement to acquire
Ruralco Holdings Limited, the third largest agriculture retailer in
Australia.
Nutrien achieved $621 million in annual run-rate synergies as at March
31, 2019, surpassing the target of $600 million for the end of 2019.
This represents a 24 percent increase from the original target of $500
million and was achieved well ahead of schedule.
Nutrien announced an additional five percent normal course issuer bid
program in February 2019 and to date, has repurchased approximately 21
million shares representing over 3 percent of Nutrien’s outstanding
shares.
Nutrien full-year 2019 adjusted net earnings per share and adjusted
EBITDA guidance is maintained at $2.80 to $3.20 per share and $4.4
billion to $4.9 billion, respectively. First-half 2019 guidance is
provided at $1.75 to $1.95 adjusted net earnings per share.
We have provided a new financial data tool on our website, allowing
stakeholders to view our historical annual and quarterly information
in an easy to use and downloadable format. It is located at: https://www.nutrien.com/interactive-datatool

Adjusted Net Earnings

	Three Months Ended March 31, 2019
Dollars (millions), except per share amounts	Increases (Decreases)		Post-Tax		Per Diluted Share Advertisement
Net earnings			$	41	$	0.07
Adjustments:
Merger and related costs	$	11		8		0.02
Share-based compensation		57		44		0.07
Impairment		33		25		0.04
Adjusted net earnings			$	118	$	0.20

Management’s Discussion and Analysis

The following management’s discussion and analysis (MD&A) is the
responsibility of management and dated as of May 9, 2019. The Board of
Directors (Board) of Nutrien carries out its responsibility for review
of this disclosure principally through its audit committee, comprised
exclusively of independent directors. The audit committee reviews and,
prior to its publication approves this disclosure pursuant to the
authority delegated to it by the Board. The term “Nutrien” refers to
Nutrien Ltd. and the terms “we,” “us,” “our,” “Nutrien” and “the
Company” refer to Nutrien and, as applicable, Nutrien and its direct and
indirect subsidiaries as a group. Additional information relating to
Nutrien (which, except as otherwise noted, is not incorporated by
reference herein), including our 2018 Annual Report dated February 20,
2019, which includes our consolidated financial statements and
management’s discussion and analysis and our Annual Information Form,
each for the year ended December 31, 2018, can be found on SEDAR at www.sedar.com
and on EDGAR at www.sec.gov.
The Company is a foreign private issuer under the rules and regulations
of the US Securities and Exchange Commission (the SEC).

This MD&A is based on the Company’s unaudited interim condensed
consolidated financial statements as at and for the three months ended
March 31, 2019 (interim financial statements) prepared in accordance
with International Financial Reporting Standards as issued by the
International Accounting Standards Board (IFRS) and prepared in
accordance with International Accounting Standard 34 “Interim Financial
Reporting” unless otherwise stated. It contains certain non-IFRS
financial measures and forward-looking statements which are described in
the “Non-IFRS Financial Measures” section which begins on page 15 and
the “Forward-Looking Statements” section on page 12 respectively. For
the definitions of financial and non-financial terms used in this MD&A,
as well as a list of abbreviated company names and sources, see pages
87, 157 and 158 of our 2018 Annual Report. All references to per share
amounts pertain to diluted net earnings (loss) per share and all
financial data are stated in millions of US dollars unless otherwise
noted.

Market Outlook

Agriculture and Retail

Trade disruptions continue to impact North American growers. US
soybean exports to China are down 55 percent year-over-year, while
China has also placed import restrictions on two of Canada’s largest
canola exporters.
Unfavorable weather in the US since the fourth quarter of 2018 has
narrowed the application window. However, the US Department of
Agriculture (USDA) projects corn plantings will reach nearly 93
million acres, which would be the highest since 2016 and favorable for
nutrient demand, seed expenditures and custom application services.

We expect a two to four percent increase in North American crop
protection expenditures in 2019 due to higher corn acreage and
increased weed pressure this year given the limited ability for
growers to use post-harvest applications last fall.
Seed expenditures are also expected to be supported by increased corn
acreage in the US.

Crop Nutrient Markets

Global potash market fundamentals have remained strong, as suppliers
are comfortably sold forward in 2019 and Canpotex is fully committed
until June. We maintain our forecast that 2019 deliveries will be
between 67 and 69 million tonnes, underpinned by good affordability in
the US and most key offshore markets, particularly in Brazil and
China. While weak palm oil prices are a headwind for demand in
Southeast Asia, we believe the downside risks are relatively limited
as potash is applied on a wide range of crops in the region.
We expect strong nitrogen demand to emerge in the second quarter of
2019 from the US, Europe and Latin America. In the US, we expect
overall nitrogen demand will be at historically strong levels in the
second and third quarter with some weather-related product mix shift
towards urea and UAN as opposed to ammonia. In recent weeks, this has
led to NOLA urea prices increasing by almost $50 per tonne from
February lows.
Slow global demand and lower input costs pressured phosphate prices
over the past quarter, although we expect some support from an
improvement in demand in Latin America, India and the US in the second
quarter.

Financial Outlook and Guidance

Based on the market factors detailed above, we are maintaining 2019
adjusted net earnings guidance of $2.80 to $3.20 per share and adjusted
EBITDA guidance of $4.4 billion to $4.9 billion. First-half 2019
guidance is provided at $1.75 to $1.95 adjusted net earnings per share.

As the 2019 guidance has not changed, all related assumptions and
sensitivities can be found on page 62 of Nutrien’s 2018 Annual Report.

All guidance numbers, including those noted above, are outlined in the
table below:

2019 Guidance Ranges ¹	Low			High
Adjusted net earnings per share ²	$	2.80		$	3.20
Adjusted first-half net earnings per share ²	$	1.75		$	1.95 Advertisement
Adjusted EBITDA (billions) ²	$	4.40		$	4.90
Retail EBITDA (billions)	$	1.30		$	1.40
Potash EBITDA (billions)	$	1.80		$	2.00
Nitrogen EBITDA (billions)	$	1.30		$	1.50
Phosphate EBITDA (billions)	$	0.20		$	0.30
Potash sales tonnes (millions)³		13.0			13.4
Nitrogen sales tonnes (millions) ³		10.6			11.0
Depreciation and amortization (billions)	$	1.80		$	1.90
Merger and related costs (millions)	$	50		$	75
Effective tax rate on continuing operations		24	%		26	%
Sustaining capital expenditures (billions)	$	1.00		$	1.10

^{1 See Forward-Looking Statements section starting on page 12.}
^{2

See Non-IFRS Financial Measures section starting on page 15.}
^{3

Manufactured products only. Nitrogen excludes ESN® and Rainbow products.}

Consolidated Results

	Three months ended March 31
(millions of US dollars)	2019			2018			% Change
Sales ¹	$	3,691		$	3,666			1
Freight, transportation and distribution		(171	)		(208	)		(18	)
Cost of goods sold ¹		(2,545	)		(2,611	)		(3	)
Gross margin		975			847			15
Expenses		(799	)		(771	)		4
Net earnings (loss)		41			(1	)	n/m
EBITDA ²		596			487			22
Adjusted EBITDA ²		697			569			22

^{1 Certain immaterial figures have been reclassified or grouped

together for the three months ended March 31, 2018.}
^{2

See Non-IFRS Financial Measures section starting on page 15.}
^{n/m

= Not meaningful}

Nutrien’s first-quarter net earnings were up from the loss in the
first quarter of 2018, supported by higher global nutrient prices,
strong operational results and the continued benefit of synergy
realization. Partially offsetting this was lower overall sales volumes
of nutrients and lower Retail earnings related to the extremely wet
weather in the US and dry conditions in Australia.

Segment Results

In the first quarter of 2019, our Executive Leadership Team reassessed
our product groupings and decided to evaluate the performance of
ammonium sulfate as part of the Nitrogen segment, rather than the
Phosphate and Sulfate segment as reported in 2018. Effective January 1,
2019, we have four reportable operating segments: Retail, Potash,
Nitrogen and Phosphate. Comparative amounts presented on a segmented
basis have been restated accordingly. We also renamed our “Others”
segment to “Corporate and Others”.

Detailed descriptions of our operating segments can be found in our 2018
Annual Report on pages 32-35 (Retail), 39-41 (Potash), 45-47 (Nitrogen)
and 51-53 (Phosphate).

Our discussion of segment results set out on the following pages is a
comparison of our first quarter 2019 results to our first quarter 2018
results unless otherwise noted.

Retail

	Three months ended March 31
	Dollars (millions)									Gross Margin Dollars (millions)							Gross Margin (%)
	2019			2018			% Change			2019		2018		% Change			2019		2018
Sales
Crop nutrients ¹	$	687		$	684			–		$	131	$	123		7			19		18
Crop protection products		744			774			(4	)		117		128		(9	)		16		17
Seed		356			341			4			50		44		14			14		13
Merchandise ²		108			120			(10	)		19		23		(17	)		18		19
Services and other		144			151			(5	)		92		90		2			64		60
		2,039			2,070			(1	)	$	409	$	408		–			20		20
Cost of goods sold ²		(1,630	)		(1,662	)		(2	)
Gross margin		409			408			–
Expenses ³		(571	)		(541	)		6
Earnings before finance costs and taxes (EBIT) Advertisement		(162	)		(133	)		22
Depreciation and amortization		136			123			11
EBITDA	$	(26	)	$	(10	)		160

^{1 Includes intersegment sales. See Note 2 to the interim financial

statements.}
^{2 Certain immaterial figures have been

reclassified or grouped together for the three months ended March 31,

2018.}
^{3 Includes selling expenses of $532 million (2018

– $523 million).}

Retail EBITDA was lower as planting and applications were
delayed by extreme wet weather across the US and dryness in Australia.
Sales of crop protection, crop nutrients and associated application
services were most notably affected; however, higher crop nutrient
prices and margins helped partly offset the effects of the postponed
applications. Total gross margin percentage remained flat compared to
the same period last year.
Crop nutrients sales were flat as higher sales prices were
offset by lower sales volumes. Gross margin increased primarily
because of higher selling prices.
Crop protection products sales were lower as adverse US and
Australian weather impacted herbicide applications. Gross margin
percentage decreased due to a combination of higher competition
related to elevated inventories, and higher costs of raw materials
sourced from China.
Seed sales and gross margin percentage increased slightly
compared to the same quarter in 2018 as US growers look to plant
higher corn acreage than soybeans in 2019. Proprietary seed gross
margins are up across all geographies resulting in favorable product
mix and improved overall gross margin.
Merchandise sales declined as a result of lower equipment sales
in the Canadian operations to focus more on core Retail products.
Services and other sales were down due to lower livestock
export shipments and wool commissions in Australia and the delayed
start to the spring application season across the US. The sales mix
change resulted in a higher gross margin percentage compared to the
same period in 2018.

Potash

	Three months ended March 31
	Dollars (millions)									Tonnes (thousands)							Average per Tonne
	2019			2018			% Change			2019		2018		% Change Advertisement			2019			2018			% Change
Manufactured product ¹
Net sales
North America	$	245		$	250			(2	)		976		1,254		(22	)	$	250		$	199			26
Offshore		451			324			39			1,944		1,871		4			232			173			34
		696			574			21			2,920		3,125		(7	)		238			184			29
Cost of goods sold		(272	)		(279	)		(3	)									(93	)		(90	)		3
Gross margin		424			295			44										145			94			54
Other ²		1			–			–		Depreciation and amortization								34			29			17
Gross margin		425			295			44		Gross margin excluding
Expenses ³		(64	)		(58	)		10		depreciation and amortization ⁴								179			123			46
EBIT		361			237			52		Cash cost of product
Depreciation and amortization		100			91			10		manufactured ⁴								58			61			(5	)
EBITDA	$	461		$	328			41

^{1 Includes intersegment sales. See Note 2 to the interim financial

statements.}
^{2 Includes other potash and purchased

products and is comprised of net sales of $1 million (2018 – $1 million)

less cost of goods sold of $Nil (2018 – $1 million).}
^{3

Includes provincial mining and other taxes of $63 million (2018 – $48

million).}
^{4 See Non-IFRS Financial Measures section

starting on page 15.}

EBITDA increased significantly due to a combination of higher
global potash prices and strong offshore sales volumes, partially
offset by lower domestic demand related to extremely wet weather in
the US which impacted fertilizer applications both this spring and
last fall.
Sales volumes were down as strong demand in offshore markets
only partially offset weather-related lower sales volumes in the US.
Canpotex Limited (Canpotex) shipped record volumes in the first
quarter of 2019 and recently announced that it is fully committed
until June 2019. North American potash deliveries were slow due to the
late start to the spring season compounded by high retail inventories
as a result of the short fall application season.
Net realized selling price increased due to strong global
demand and tight supply.
Cost of goods sold per tonne was slightly higher due to higher
depreciation and amortization. Cash cost of product manufacturedwas$58 per tonne in the first quarter, down 5 percent from the same
quarter in 2018.

Canpotex Sales by Market

	Three months ended March 31
(percentage of sales volumes)	2019		2018		% Change
Other Asian markets¹		33		29		14
China		30		32		(6	)
Latin America		19		21		(10	)
India		10		6		67
Other markets		8		12		(33	)
		100		100

^{1 All Asian markets except China and India.}

Nitrogen

	Three months ended March 31
	Dollars (millions)									Tonnes (thousands)							Average per Tonne
	2019			2018 ¹			% Change			2019		2018 ¹		% Change			2019			2018 ¹			% Advertisement Change
Manufactured product ²
Net sales
Ammonia	$	162		$	208			(22	)		644		744		(13	)	$	252		$	280			(10	)
Urea		213			212			–			647		724		(11	)		330			294			12
Solutions, nitrates and sulfates		171			155			10			948		907		5			180			170			6
		546			575			(5	)		2,239		2,375		(6	)		244			242			1
Cost of goods sold		(398	)		(438	)		(9	)									(178	)		(184	)		(3	)
Gross margin		148			137			8										66			58			14
Other ³		18			16			13		Depreciation and amortization								50			56			(11	)
Gross margin		166			153			8		Gross margin excluding
Expenses		(5	)		(16	)		(69	)	depreciation and amortization								116			114			2
EBIT		161			137			18		Urea controllable cash cost of
Depreciation and amortization		113			134			(16	)	product manufactured ⁴								74			69			7
EBITDA	$	274		$	271			1

^{1 Restated for the reclassification of sulfate from the Phosphate

segment. See page 4 of this document and Note 2 to the interim financial

statements.}
^{2 Includes intersegment sales. See Note 2

to the interim financial statements.}
^{3 Includes other

nitrogen (including ESN® and Rainbow) and purchased products and is

comprised of net sales of $131 million (2018 – $120 million) less cost

of goods sold of $113 million (2018 – $104 million).}
^{4

See Non-IFRS Financial Measures section starting on page 15.}

EBITDA increased slightly as a result of higher urea, UAN and
sulfate sales prices, primarily offset by lower nitrogen sales volumes
due to delayed applications in the US.
Sales volumes for nitrogen decreased due to lower ammonia and
urea sales volumes, associated with wet weather in key US regions that
delayed nitrogen applications.
Net realized selling price of nitrogen increased as higher
average prices for urea, UAN, and sulfates more than offset lower
prices for ammonia. Ammonia prices declined as a result of weak demand
for this product due to poor application conditions since the fourth
quarter of 2018, which provided support for alternative nitrogen
products such as urea.
Cost of goods sold per tonne of nitrogen decreased overall due
to lower depreciation and amortization more than offsetting increased
costs from lower operating rates. As a result, urea controllable cash
cost of product manufactured increased by $5 per tonne.

Natural Gas Prices

	Three months ended March 31
(Dollars per MMBtu)	2019		2018		% Change
Overall gas cost excluding realized derivative impact	$	2.98	$	2.73		9
Realized derivative impact		0.05		0.29		(83	)
Overall gas cost	$	3.03	$	3.02		–

Average NYMEX	$	3.15	$	3.00		5
Average AECO		1.47		1.48		(1	)

Gas costs were similar to the same quarter in 2018 as lower
realized derivative losses offset higher gas prices in Trinidad and
the US.

Phosphate

	Three months ended March 31
	Dollars (millions)									Tonnes (thousands)							Average per Tonne
	2019			2018 ¹			% Advertisement Change			2019		2018 ¹		% Change			2019			2018 ¹			% Change Advertisement
Manufactured product ²
Net sales
Fertilizer	$	208		$	240			(13	)		491		605		(19	)	$	423		$	396			7
Industrial and feed		111			106			5			204		221		(8	)		545			481			13
		319			346			(8	)		695		826		(16	)		459			419			10
Cost of goods sold		(304	)		(322	)		(6	)									(437	)		(390	)		12
Gross margin		15			24			(38	)									22			29			(24	)
Other ³		(1	)		–			–		Depreciation and amortization								86			56			54
Gross margin		14			24			(42	)	Gross margin excluding
Expenses		(6	)		(6	)		–		depreciation and amortization								108			85			27
EBIT		8			18			(56	)
Depreciation and amortization		60			46			30
EBITDA	$	68		$	64			6

^{1 Restated for the reclassification of sulfate to the Nitrogen

segment. See page 4 of this document and Note 2 to the interim financial

statements.}
^{2 Includes intersegment sales. See Note 2 to

the interim financial statements.}
^{3 Includes other

phosphate and purchased products and is comprised of net sales of $30

million (2018 – $35 million) less cost of goods sold of $31 million

(2018 – $35 million)}

EBITDA increased due to higher realized prices. This was
partially offset by the impact of higher cost of goods sold per tonne.
Sales volumes decreased as wet weather in the US delayed the
application season and lower demand from India impacted export volumes.
Net realized selling price increased for the majority of our
phosphate products, even though phosphate benchmark prices declined.
This is due to first quarter presold phosphate sales at higher
benchmark prices and the settlement of new industrial contracts.
Cost of goods sold per tonne increased due to higher
depreciation and amortization in 2019 and because the first quarter of
2018 benefited from asset retirement obligation adjustments.

Expenses & Income Below Gross Margin

	Three months ended March 31
Dollars (millions), except percentage amounts	2019			2018			% Change
Selling expenses ¹	$	(538	)	$	(532	)		1
General and administrative expenses ²		(95	)		(103	)		(8	)
Provincial mining and other taxes ³		(65	)		(48	)		35
Share-based compensation expenses		(57	)		(16	)		256
Other expenses		(44	)		(72	)		(39	)
Finance costs		(123	)		(119	)		3
Income tax (expense) recovery		(12	)		42		n/m
Other comprehensive income (loss)		32			(70	)	n/m

^{1 Expenses are primarily in the Retail segment. See page 4 for

analysis.}
^{2 Includes expenses of $64 million (2018 – $68

million) in the Corporate and Others segment.}
^{3 Expenses

are primarily in the Potash segment. See page 5 for analysis.}
^{n/m

= not meaningful}

Share-based compensation expenses increased due to improved
performance towards vesting conditions and a higher Nutrien share
price.
Other expenses decreased primarily due to lower costs
associated with the merger of Potash Corporation of Saskatchewan Inc.
and Agrium Inc. (Merger) more than offsetting the $33 million
impairment of our intangible assets as a result of Fertilizantes
Heringer S.A. filing for bankruptcy protection in the first quarter of
2019.
Income tax (expense) recovery changed as we had earnings before
income taxes for the three months ended March 31, 2019 compared to a
loss before income taxes for the same period in 2018. In addition,
discrete tax adjustments increased tax expense by $15 million for the
three months ended March 31, 2019 compared to a discrete tax recovery
of $3 million for the same period in 2018. As a result, an income tax
expense was realized for the three months ended March 31, 2019 as
compared to an income tax recovery for the same period last year.
Other comprehensive income (loss) was impacted primarily by
unrealized gains in our investment in Sinofert Holdings Limited
(Sinofert) compared to unrealized losses in Sinofert and a realized
loss in Israel Chemicals Ltd. (ICL) in the comparative quarter, as
well as a gain on translation of our operations in Canada and
Australia compared to a loss on translation of those operations in the
same period in 2018 due to decreases in the value of the Canadian
dollar and Australian dollar relative to the US dollar.

Financial Condition Review

The following balance sheet categories contained variances that were
considered significant:

	As at
Assets	March 31, 2019 Advertisement		December 31, 2018		$ Variance			% Advertisement Change
Cash and cash equivalents	$	373	$	2,314		(1,941	)		(84	)
Inventories		6,560		4,917		1,643			33
Prepaid expenses and other current assets		688		1,089		(401	)		(37	)
Property, plant and equipment		19,834		18,796		1,038			6
Goodwill		11,817		11,431		386			3

Liabilities and Equity
Short-term debt	$	1,652	$	629		1,023			163
Current portion of long-term debt		1,197		1,003		194			19
Payables and accrued charges		6,602		6,703		(101	)		(2	)
Long-term debt		7,917		7,591		326			4
Share capital		16,316		16,740		(424	)		(3	)
Retained earnings		7,405		7,745		(340	)		(4	)

Contacts

Investor and Media Relations:
Richard Downey
Vice
President, Investor & Corporate Relations
(403) 225-7357
[email protected]

Investor Relations:
Jeff Holzman
Senior Director,
Investor Relations
(306) 933-8545

Todd Coakwell
Director, Investor Relations
(403) 225-7437

Selected financial data for download can be found in our data tool at https://www.nutrien.com/interactive-datatool
Such
data is not incorporated by reference herein.

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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

Published

4 days ago

September 4, 2024

CISION (PR Newswire)

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

Published

1 week ago

August 29, 2024

CISION (PR Newswire)

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) 1/3^rd of the Options vested immediately at grant; (ii) 1/3^rd of the Options will vest on February 28, 2025; and (iii) 1/3^rd 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

Published

1 week ago

August 29, 2024

GlobeNewswire

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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