Market Newsdesk

TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — Sprott Inc. (NYSE/TSX: SII) (“Sprott” or the “Company”) today announced its financial results for the three months ended September 30, 2020.

As previously disclosed, all financial figures are now reported in US dollars unless indicated otherwise.

Financial Overview (3 months results)

• Assets Under Management (“AUM”) were $16.3 billion as at September 30, 2020, up $2.4 billion (17%) from June 30, 2020.
• Total net revenues (net of commission expenses, trailer fees and sub-advisor fees, carried interest and performance fee payouts) were $31.3 million, reflecting an increase of $14.1 million (82%) from the 3 months ended September 30, 2019.
• Total expenses (excluding commission expenses, trailer fees and sub-advisor fees, carried interest and performance fee payouts) were $21 million, reflecting an increase of $9.6 million (85%) from the 3 months ended September 30, 2019. The increase was primarily due to:
  • Higher salaries from new hires related to the acquisition of the Tocqueville gold strategies (“the Acquisition”) and higher AIP on increased revenues and earnings across the Company.
  • Higher contingent consideration related to the Acquisition as a result of higher estimated future operating performance of the acquired assets
  • These increases were partially offset by lower LTIP amortization and SG&A in the quarter.
• Net income was $8.7 million ($0.36 per share), reflecting an increase of $4.4 million from the 3 months ended September 30, 2019.
• Adjusted base EBITDA was $12 million ($0.49 per share), an increase of $4.4 million (58%) from the 3 months ended September 30, 2019.

Subsequent Events

• On November 12, 2020, the Sprott Board of Directors announced an 8.7% increase to the Company’s quarterly dividend, effective immediately

“Our assets under management have increased by 76% in 2020, driven by strong precious metals prices, significant sales in our exchange listed products segment and excellent performance in our managed equities segment,” said Peter Grosskopf, CEO of Sprott.  “As a result of our robust financial performance and strong capital position, we are pleased to announce that the Board of Directors has approved an increase of the quarterly dividend to USD $0.25 per share, effective immediately. We are confident that our business will support this dividend level without impacting our ability to fund future growth initiatives.”

“During the third quarter, Sprott was also added to the S&P/TSX Composite Index and ranked  among the 30 top-performing TSX stocks over a three-year period based on dividend adjusted share price appreciation, through inclusion in the TSX30 program,” added Mr. Grosskopf.

 

Assets Under Management (3 months results)

(In millions $)	AUM Jun. 30, 2020	Net     Inflows (1)		Market Value Changes	Other (2)		AUM Sep. 30, 2020
Exchange Listed Products
– Physical Trusts	9,181	890		1,060	—		11,131
– ETFs	328	27		26	—		381
	9,509	917		1,086	—		11,512
Managed Equities
– Precious Metals Strategies	2,279	(57)		225	—		2,447
– Other	277	19		16	—		312
	2,556	(38)		241	—		2,759
Lending	893	17		18	(22)		906	(3)
Other	935	—		147	—		1,082
Total	13,893	896		1,492	(22)		16,259

⁽¹⁾ See ‘Net Inflows’ in the key performance indicators (non-IFRS financial measures) section of this MD&A.

⁽²⁾ Includes new AUM from fund acquisitions and lost AUM from fund divestitures and capital distributions of our lending LPs.

⁽³⁾ $1.2 billion of committed capital remains uncalled, of which $0.5 billion earns a commitment fee (AUM), and $0.7 billion does not (future AUM).

Dividends

On November 12, 2020, a dividend of US$0.25 per common share was declared for the quarter ended September 30, 2020.

Conference Call and Webcast

A conference call and webcast will be held today, November 13, 2020 at 10:00 am ET to discuss the Company’s financial results. To participate in the call, please dial (855) 458-4215 ten minutes prior to the scheduled start of the call and provide conference ID 6191323  A taped replay of the conference call will be available until Friday, November 20, 2020 by calling (855) 859-2056, reference number 6191323. The conference call will be webcast live at www.sprott.com and https://edge.media-server.com/mmc/p/6kpdmwn6 

 *Non-IFRS Financial Measures

This press release includes financial terms (including AUM, net revenues, expenses, adjusted base EBITDA and net sales) that the Company utilizes to assess the financial performance of its business that are not measures recognized under International Financial Reporting Standards (“IFRS”). These non-IFRS measures should not be considered alternatives to performance measures determined in accordance with IFRS and may not be comparable to similar measures presented by other issuers. For additional information regarding the Company’s use of non-IFRS measures, including the calculation of these measures, please refer to the “Non-IFRS Financial Measures” section of the Company’s Management’s Discussion and Analysis and its annual financial statements available on the Company’s website at www.sprott.com and on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.

A reconciliation from net income to adjusted base EBITDA is shown below:

	3 months ended
(in thousands $)	Sept. 30, 2020		Sept. 30, 2019
Net income for the periods	8,704		4,336
Adjustments:
Interest expense	320		297
Provision (recovery) for income taxes	1,613		1,473
Depreciation and amortization	992		893
EBITDA	11,629		6,999
Other adjustments:
(Gains) losses on investments (1)	(4,408	)	(600	)
Non-cash stock-based compensation	871		1,212
Other expenses (2)	3,932		1
Adjusted EBITDA	12,024		7,612
Other adjustments:
Carried interest and performance fees	—		—
Carried interest and performance fee related expenses	—		—
Adjusted base EBITDA	12,024		7,612

⁽¹⁾  This adjustment removes the income effects of certain gains or losses on short-term investments, co-investments and digital gold strategies to ensure the reporting objectives of our EBITDA metric as described above are met.

⁽²⁾  In addition to the items outlined in Note 6, Other expenses also includes severance and new hire accruals of $0.2 million for the 3 months ended (3 months ended September 30 – $0.2 million) and excludes income attributable to non-controlling interests (see Other expenses in Note 6 of the interim financial statements)

Forward Looking Statements

Certain statements in this press release contain forward-looking information and forward-looking statements (collectively referred to herein as the “Forward-Looking Statements”) within the meaning of applicable Canadian and U.S. securities laws. The use of any of the words “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “project”, “should”, “believe”, “plans”, “intends” and similar expressions are intended to identify Forward-Looking Statements. In particular, but without limiting the forgoing, this press release contains Forward-Looking Statements pertaining to: (i) market outlook and future metal prices, including that long-term trends that will determine precious metals prices remain in place and that we expect that future monetary and fiscal interventions by central banks are likely to increase in scale and frequency; (ii) activity in new product development and the pursuit of new avenues for growth; and (iii) the declaration, payment and designation of dividends and confidence that our business will support the dividend level without impacting our ability to fund future growth initiatives.

Although the Company believes that the Forward-Looking Statements are reasonable, they are not guarantees of future results, performance or achievements. A number of factors or assumptions have been used to develop the Forward-Looking Statements, including, without limitation: (i) the impact of increasing competition in each business in which the Company operates will not be material; (ii) quality management will be available; (iii) the effects of regulation and tax laws of governmental agencies will be consistent with the current environment; and (iv) the impact of COVID-19; and (v) those assumptions disclosed under the heading “Significant Accounting Judgments, Estimates and Changes in Accounting Policies” in the Company’s MD&A for the period ended June 30, 2020. Actual results, performance or achievements could vary materially from those expressed or implied by the Forward-Looking Statements should assumptions underlying the Forward-Looking Statements prove incorrect or should one or more risks or other factors materialize, including: (i) difficult market conditions; (ii) poor investment performance; (iii) failure to continue to retain and attract quality staff; (iv) employee errors or misconduct resulting in regulatory sanctions or reputational harm; (v) performance fee fluctuations; (vi) a business segment or another counterparty failing to pay its financial obligation; (vii) failure of the Company to meet its demand for cash or fund obligations as they come due; (viii) changes in the investment management industry; (ix) failure to implement effective information security policies, procedures and capabilities; (x) lack of investment opportunities; (xi) risks related to regulatory compliance; (xii) failure to manage risks appropriately; (xiii) failure to deal appropriately with conflicts of interest; (xiv) competitive pressures; (xv) corporate growth which may be difficult to sustain and may place significant demands on existing administrative, operational and financial resources; (xvi) failure to comply with privacy laws; (xvii) failure to successfully implement succession planning; (xviii) foreign exchange risk relating to the relative value of the U.S. dollar; (xix) litigation risk; (xx) failure to develop effective business resiliency plans; (xxi) failure to obtain or maintain sufficient insurance coverage on favourable economic terms; (xxii) historical financial information being not necessarily indicative of future performance; (xxiii) the market price of common shares of the Company may fluctuate widely and rapidly; (xxiv) risks relating to the Company’s investment products; (xxv) risks relating to the Company’s proprietary investments; (xxvi) risks relating to the Company’s lending business; (xxvii) risks relating to the Company’s brokerage business; (xxviii) those risks described under the heading “Risk Factors” in the Company’s annual information form dated February 27, 2020; and (xxix) those risks described under the headings “Managing Risk: Financial” and “Managing Risk: Non-Financial” in the Company’s MD&A for the period ended June 30, 2020. In addition, the payment of dividends is not guaranteed and the amount and timing of any dividends payable by the Company will be at the discretion of the Board of Directors of the Company and will be established on the basis of the Company’s earnings, the satisfaction of solvency tests imposed by applicable corporate law for the declaration and payment of dividends, and other relevant factors. The Forward-Looking Statements speak only as of the date hereof, unless otherwise specifically noted, and the Company does not assume any obligation to publicly update any Forward-Looking Statements, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

About Sprott

Sprott is an alternative asset manager and a global leader in precious metal and real asset investments. Through its subsidiaries in Canada, the US and Asia, Sprott is dedicated to providing investors with specialized investment strategies that include Exchange Listed Products, Managed Equities, Lending and Brokerage. Sprott’s common shares are listed on the New York Stock Exchange under the symbol (NYSE: SII) and Toronto Stock Exchange under the symbol (TSX: SII). For more information, please visit www.sprott.com.

Investor contact information:

Glen Williams
Managing Director
Investor and Institutional Client Relations
(416) 943-4394
[email protected] 

• Phase 1 trial completed in Lilly Morphomer™ Tau partnership program with plans to evaluate candidates in Alzheimer’s disease and NeuroOrphan indications
• First-in-class TDP-43 therapeutic and diagnostic programs advance as the target’s role in a newly defined form of age-related dementia, limbic-predominant age-related TDP-43 encephalopathy (LATE), gains prominence, with a highly competitive grant awarded
• All clinical and preclinical programs remain on track to meet all milestones expected in 2020
• CHF 246.6 million in cash ensures operations are fully financed through Q1 2024             

LAUSANNE, Switzerland, Nov. 13, 2020 (GLOBE NEWSWIRE) — AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical-stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, today announced financial results for Q3 2020 and provided a business update. The Company ended the third quarter with CHF 246.6 million in cash, which ensures operations are fully financed through Q1 2024 allowing the Company to advance our clinical and preclinical projects to key value inflection points while investing further in our diverse pipeline.

Prof. Andrea Pfeifer, CEO of AC Immune SA, commented: “AC Immune continued to advance its world-leading pipeline in Q3 2020, underpinned by our proprietary discovery platforms SupraAntigen^TM and Morphomer^TM and solid financial position.  Our proven business model of early development and partnering of validated therapeutic and diagnostic candidates has made us a global leader in precision medicine for neurodegenerative diseases. All clinical and preclinical milestones  expected this year remain on track with key data across our  Alzheimer’s disease (AD) vaccines,  alpha-synuclein and NLRP3–ASC inflammasome programs this year – ­with the latter becoming a focus for neurodegenerative diseases and non-CNS applications. Together these milestones highlight progress in our late stage clinical programs and focus in NeuroOrphan indications with multiple near and mid-term catalysts.”

The strength of the Company’s diversified approach continues to be demonstrated with the announcement today that the Phase 1 study of the small molecule Morphomer™ Tau aggregation inhibitor, ACI-3024 in healthy young, elderly and Japanese volunteers, has been completed.  In the study, which was conducted in partnership with Eli Lilly and Company, single and multiple dosing with the Morphomer^TM Tau ACI-3024 resulted in a dose-dependent exposure and brain penetration by achieving the desired levels of ACI-3024 in the cerebrospinal fluid. The program will be expanded to NeuroOrphan indications and ACI-3024 will be further evaluated for efficacy in models of rare Tauopathies. Continued candidate characterization across the research program has also identified new and highly differentiated candidates with excellent cerebrospinal fluid exposure and selectivity for pathological aggregated Tau. These will be broadly developed in Tau-dependent neurodegenerative diseases.

Prof. Pfeifer commented: “The pharmacokinetic observations from the Phase 1 trial in our Lilly Morphomer™ Tau partnership program show the first evidence of a Morphomer™ Tau entity meeting the target CNS concentration in humans. Compared to other Tau-targeting molecules in development, the key potential differentiating factor is that our Morphomer™ Tau molecules have been shown to act intracellularly to address Tau pathology, potentially saving affected neurons that otherwise might die. Our Morphomer™ Tau program is the most advanced orally available small molecule therapeutic candidate of its kind in development.”

Q3 2020 Research & Development Updates and Highlights:

• The next phase of the strategic partnership between AC Immune and WuXi was  unveiled with plans to accelerate advancement of AC Immune’s TDP-43 antibody into clinical development. A particular focus is developing the clinical antibody candidate to ensure it has high-affinity for TDP-43 and is capable of preventing the intercellular spread of toxic species. With no disease modifying therapies currently available that target TDP-43 there is significant unmet need and market potential 
• 
  A highly competitive European Union grant was awarded
  to support the partnership between AC Immune and the EU Joint Programme – Neurodegenerative Disease Research (JPND) ImageTDP-43 consortium to accelerate development of the Company’s first-in-class TDP-43 positron emission tomography (PET) tracer. Advancement of the tracer may enable the development of precision medicine approaches for the large and growing proportion of patients with TDP-43-related pathologies, such as patients with LATE and AD
• Top line results from a Phase 2 trial of the anti-Tau antibody in early (prodromal to mild) AD showed that semorinemab did not meet the co-primary efficacy endpoint or two secondary endpoints in the Tauriel study; the primary safety endpoint was met. Additional data presented at the CTAD 2020 Alzheimer Congress by our partner, Genentech, a member of the Roche group, confirm that semorinemab did not slow clinical progression or Tau accumulation relative to placebo with any of the three different  doses tested. Dose-dependent increases were seen in serum pharmacokinetics and there was clear and consistent evidence of plasma target engagement. Preliminary analysis continues to suggest that semorinemab has an acceptable and well-tolerated safety profile. A second Phase 2 (Lauriet) study of semorinemab in patients with moderate AD remains ongoing
• Initiation of investigational new drug (IND)-enabling studies for AC Immune’s first-in-class therapeutic antibody targeting TDP-43. The anti-TDP-43 antibody is the first therapeutic candidate shown to mitigate TDP-43 neuropathology in vivo and the Company plans to develop the antibody for the treatment of NeuroOrphan indications.  Effectively slowing or stopping the spread of TDP-43 pathology throughout the brain could provide the first antibody-based TDP-43 targeted therapeutic approach for treating conditions such as LATE, amyotrophic lateral sclerosis (ALS) and frontotemporal lobar degeneration with TDP-43 pathology, representing 50 per cent of all FTLD cases.

Update on Covid-19

AC Immune remains in continuous contact with its partners and other important stakeholders, including the Swiss government, trial investigators and contractors, and at this stage the Company is not modifying guidance with respect to the multiple clinical and preclinical data readouts anticipated this year. AC Immune will continue to keep the market apprised of any new developments or information that may impact clinical timelines.

Analysis of Financial Statements for the Three and Nine Months Ended September 30, 2020

• Revenues: Revenues for the three and nine months ended September 30, 2020 totaled CHF 1.1 million and CHF 14.5 million, respectively. This represents a decrease of CHF 32.1 million and CHF 95.1 million over the comparable periods in 2019. The decrease for the three months ended September 30, 2020 relates to the prior recognition of CHF 30 million for the first installment of the first milestone achieved with Lilly and CHF 2.2 million for the initiation of a Phase 2 trial of Tau PET tracer with Life Molecular Imaging that did not repeat in the current quarter. The decrease for the nine months ended September 30, 2020 predominantly relates to CHF 104.5 million recognized in the prior period associated with our license agreement with Lilly offset by a recognition of a CHF 10 million milestone payment and CHF 4.1 million for research and development activities performed in the current period
• R&D Expenditures: For the three and nine months ended September 30, 2020, R&D expenses increased by CHF 4.0 million (+35.2%) and CHF 7.8 million (+21.7%) to CHF 15.5 million and CHF 43.5 million, respectively. For R&D expenses directly allocated to R&D programs, the Company increased investments in its non-AD programs predominantly led by increases in ACI-24 in Down syndrome related to scaling up activities for a Phase 2 clinical study, investments to advance our alpha-synuclein projects and the development of our anti-TDP-43 antibody with the initiation of IND-enabling studies. For AD, the Company’s expenditures for ACI-24 in AD decreased due to completing the manufacturing process development. The Company also spent less for ACI-35 in the current period related to toxicology and manufacturing costs for clinical trial material in the prior period that did not repeat in the current period
  Additionally, personnel costs in R&D increased by CHF 0.6 million and CHF 2.0 million for the three and nine months ended September 30, 2020, respectively driven by an increase of 11 FTEs during the year. The remaining increases of CHF 0.9 million and CHF 1.8 million relate to an increase in regulatory and quality assurance, intellectual property and other unallocated research and development costs
• G&A Expenses: For the three and nine months ended September 30, 2020, G&A expenses increased CHF 0.9 million (+23.7%) and CHF 2.7 million (+25.1%) to CHF 4.9 million and CHF 13.6 million, respectively. Increases were driven by an addition of 4 FTEs as well as an increase in professional services and depreciation expenses.
• IFRS (Loss)/Income for the period: The Company incurred a net loss after taxes of CHF 19.0 million and CHF 42.4 million for the three and nine months ended September 30, 2020, respectively, compared with net income of CHF 18.2 million and CHF 64.9 million for the comparable periods in 2019, predominantly related to the variance in revenues and operating expenses discussed above
• Cash Position: The Company had a total cash balance of CHF 246.6 million, comprised of CHF 176.6 million in cash and cash equivalents and CHF 70 million in short-term financial assets. This compares to a total cash balance of CHF 288.6 million as of December 31, 2019. This decrease of CHF 42 million is principally due to the factors noted above in the income statement which resulted in a CHF 42.4 million net loss for the period and changes in our working capital. Further details are available in our Statements of Cash Flows on the accompanying Form 6-K

About AC Immune SA

AC Immune SA is a Nasdaq-listed clinical-stage biopharmaceutical company, which aims to become a global leader in precision medicine for neurodegenerative diseases. The Company utilizes two proprietary platforms, SupraAntigen^TM and Morphomer^TM, to design, discover and develop small molecule and biological therapeutics as well as diagnostic products intended to diagnose, prevent and modify neurodegenerative diseases caused by misfolding proteins. The Company’s pipeline features nine therapeutic and three diagnostic product candidates, with six currently in clinical trials. It has collaborations with major pharmaceutical companies including Genentech, a member of the Roche group, Eli Lilly and Company, and Janssen Pharmaceuticals.

For further information, please contact:

Head of Investor Relations Joshua Drumm, Ph.D. AC Immune Phone: +1 917 809 0814 Email: [email protected]	US Media Katie Gallagher LaVoieHealthScience Phone: +1 617 792 3937 Email: [email protected]
Global Head of Communications Judith Moore AC Immune Phone: +41 79 826 63 82 Email: [email protected]	European Investors & Media Chris Maggos LifeSci Advisors Phone: +41 79 367 6254 Email: [email protected]

Forward looking statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or AC Immune’s strategies or expectations. In some cases, you can identify these statements by forward-looking words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “outlook” or “continue,” and other comparable terminology. Forward-looking statements are based on management’s current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include those described under the captions “Item 3. Key Information – Risk Factors” and “Item 5. Operating and Financial Review and Prospects” in AC Immune’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission. These include: the impact of Covid-19 on our business, suppliers, patients and employees and any other impact of Covid-19. Forward-looking statements speak only as of the date they are made, and AC Immune does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Balance Sheets
(in CHF thousands)
	As of September 30, 2020			As of December 31, 2019
ASSETS
Non-current assets
Property, plant and equipment	3,785			3,917
Right-of-use assets	1,932			2,255
Long-term financial assets	304			304
Total non-current assets	6,021			6,476
Current assets
Prepaid expenses	2,764			2,788
Accrued income	944			1,095
Other current receivables	314			304
Short-term financial assets	70,000			95,000
Cash and cash equivalents	176,567			193,587
Total current assets	250,589			292,774
Total assets	256,610			299,250
SHAREHOLDERS’ EQUITY AND LIABILITIES
Shareholders’ equity
Share capital	1,539			1,437
Share premium	346,842			346,526
Treasury shares	(100	)		—
Accumulated losses	(115,038	)		(75,521	)
Total shareholders’ equity	233,243			272,442
Non-current liabilities
Long-term lease liabilities	1,491			1,813
Net employee defined benefit liabilities	8,029			7,485
Total non-current liabilities	9,520			9,298
Current liabilities
Trade and other payables	1,020			142
Accrued expenses	10,996			11,797
Short-term deferred income	1,080			4,477
Short-term financing obligation	310			652
Short-term lease liabilities	441			442
Total current liabilities	13,847			17,510
Total liabilities	23,367			26,808
Total shareholders’ equity and liabilities	256,610			299,250

Statements of Income/(Loss)
(in CHF thousands except per share data)
	For the Three Months Ended September 30,					For the Nine Months Ended September 30,
	2020			2019		2020				2019
Revenue
Contract revenue	1,123			33,208		14,487					109,596
Total revenue	1,123			33,208		14,487					109,596
Operating expenses
Research & development expenses	(15,518	)		(11,478	)	(43,536			)		(35,770	)
General & administrative expenses	(4,892	)		(3,956	)	(13,553			)		(10,835	)
Other operating income/(expenses)	482			203		807					368
Total operating expenses	(19,928	)		(15,231	)	(56,282			)		(46,237	)
Operating income/(loss)	(18,805	)		17,977		(41,795			)		63,359
Finance expense, net	(146	)		249		(552			)		(1,564	)
Change in fair value of conversion feature	—			—		—					4,542
Interest income	—			73		78					237
Interest expense	(43	)		(86	)	(152			)		(1,686	)
Finance result, net	(189	)		236		(626			)		1,529
Income/(loss) before tax	(18,994	)		18,213		(42,421			)		64,888
Income tax expense	—			—		—					—
Income/(loss) for the period	(18,994	)		18,213		(42,421			)		64,888
Earnings/(loss) per share (EPS):
Basic income/(loss) for the period attributable to equity holders	(0.26	)		0.25		(0.59			)		0.92
Diluted income/(loss) for the period attributable to equity holders	(0.26	)		0.25		(0.59			)		0.92

Statements of Comprehensive Income/(Loss)	For the Three Months Ended September 30,				For the Nine Months Ended September 30,
(in CHF thousands)	2020		2019		2020			2019
Income/(loss) for the period	(18,994	)	18,213		(42,421	)		64,888
Other comprehensive income/(loss) not to be reclassified to income or loss in subsequent periods (net of tax):
Re-measurement losses on defined benefit plans	—		—		—			—
Total comprehensive income/(loss), net of tax	(18,994	)	18,213		(42,421	)		64,888

  

Reconciliation of Income/(Loss) to Adjusted Income/(Loss) and
Earnings/(Loss) Per Share to Adjusted Earnings/(Loss) Per Share
	For the Three Months Ended September 30						For the Nine Months Ended September 30,
	2020			2019			2020			2019
	(in CHF thousands except for share and per share data)
Income/(Loss)	(18,994	)		18,213			(42,421	)		64,888
Adjustments:
Non-cash share-based payments (a)	1,233			882			3,079			2,027
Foreign currency losses (b)	187			(272	)		686			286
Effective interest expense (c)	—			—			—			1,355
Change in fair value of conversion feature (d)	—			—			—			(4,542	)
Adjusted Income/(Loss)	(17,574	)		18,823			(38,656	)		64,014
Earnings/(Loss) per share – basic	(0.26	)		0.25			(0.59	)		0.92
Earnings/(Loss) per share – diluted	(0.26	)		0.25			(0.59	)		0.92
Adjustment to earnings/(loss) per share – basic	0.02			0.01			0.05			(0.01	)
Adjustment to earnings/(loss) per share – diluted	0.02			0.01			0.05			(0.01	)
Adjusted earnings/(loss) per share – basic	(0.24	)		0.26			(0.54	)		0.91
Adjusted earnings/(loss) per share – diluted	(0.24	)		0.26			(0.54	)		0.91
Weighted-average number of shares outstanding Adjusted earnings/(loss)–basic	71,925,009			71,822,884			71,888,273			70,184,257
Weighted-average number of shares outstanding Adjusted earnings/(loss)–diluted	71,925,009			72,281,264			71,888,273			70,700,690

(a)	Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.
(b)	Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.
(c)	Effective interest expense for the period relates to the accretion of the Company’s convertible loan in accordance with the effective interest method.
(d)	Change in fair value of conversion feature that is bifurcated from the convertible loan host debt with Lilly.

Adjustments for the three and nine months ended September 30, 2020, were CHF 1.4 million and CHF 3.8 million decreases in net losses compared with an increase to net income and a decrease to net income of CHF 0.6 million and CHF 0.9 million for the comparable periods in 2019, respectively. The Company recorded CHF 1.2 million and CHF 3.1 million for the three and nine months, respectively, for share-based compensation expenses. There were foreign currency remeasurement losses of less than CHF 0.2 million and CHF 0.7 million, respectively, predominantly related to the movement in our forward contract settled in Q2 2020. For the three months ended September 30, 2019, the Company recorded CHF 0.9 million for share-based compensation expenses. For the nine months ended September 30, 2019, the Company recorded CHF 2.0 million for share-based compensation expense. Additionally, the Company recorded CHF 1.4 million for amortization of effective interest and a CHF 4.5 million gain for the change in fair value of the liability related to the conversion feature for the nine months ended September 30, 2019. These were not repeated in the current period.

PRINCETON, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases, today announced new data from its Phase 2 IMPERIAL clinical trial evaluating OC-01 (varenicline) nasal spray in the treatment of the signs and symptoms of dry eye disease in adults at the American Academy of Ophthalmology (AAO) 2020 Virtual Annual Meeting, being held on November 13-15.

A single administration of OC-01 nasal spray significantly reduced goblet cell area and perimeter as measured by in vivo confocal microscopy as compared to placebo in subjects with dry eye disease. Goblet cells in the conjunctiva are responsible for releasing mucus and, based on clinical data, may help re-establish tear film homeostasis. OC-01 nasal spray was found to be safe and well-tolerated in the study, with the most commonly reported treatment-related event being sneeze.

“The positive results from IMPERIAL add to the growing body of evidence around the safety and efficacy of OC-01 in addressing the signs and symptoms of dry eye disease, a condition that impacts the day-to-day lives of millions of adults in the United States despite current treatments,” said Pedram Hamrah, M.D., principal investigator for the IMPERIAL study and an ophthalmologist and cornea specialist at Tufts Medical Center, and professor of ophthalmology at Tufts University School of Medicine. “The data from this clinical study show how parasympathetic activation may stimulate mucin production at the ocular surface.”

The single-center, randomized, double-masked, placebo-controlled trial included 18 patients with dry eye disease. The objective of the study was to assess the effect of OC-01 nasal spray on goblet cell alterations by in vivo confocal microscopy (IVCM). IVCM images of the bulbar conjunctiva, the membrane covering the outer surface of the eye, taken prior to and 10 minutes after administration showed that OC-01 significantly reduced goblet cell area and perimeter in dry eye disease, indicating goblet cell degranulation, which releases lubricating mucus.

Details of the Poster Presentation

Title: OC-01 (Varenicline) Nasal Spray Induces Goblet Cell Alterations in Patients with Dry Eye Disease

Authors: Gabriela Dieckmann, M.D.; Stephanie M. Cox, O.D.; Maria J. Lopez, M.D.; M. Cunyet Ozmen, M.D.; Leyla Yavouz-Saricay, M.D.; Betul N. Bayraktutar, M.D.; William W. Binotti, M.D.; Jeffrey Nau, Ph.D., M.M.S.; Pedram Hamrah, M.D.

Abstract #: PO092

In addition to the poster presentation, Oyster Point Pharma president and CEO, Jeffrey Nau Ph.D., M.M.S., will present at the AAO Industry Showcase on Friday, Nov. 13 from 12:50 to 1:20 p.m. EST.

Presentations will be available to view during the event for those registered through the following link: https://www.aao.org/annual-meeting.

About OC-01 Nasal Spray

OC-01 is a highly selective nicotinic cholinergic agonist, being developed as a preservative free nasal spray to treat the signs and symptoms of dry eye disease. The parasympathetic nervous system, the “rest and digest” system of the body, controls tear film homeostasis partially via the trigeminal nerve, which is accessible within the nose. Administered as a preservative-free, aqueous nasal spray, OC-01’s novel mechanism of action activates the trigeminal parasympathetic pathway in the nasal cavity to stimulate natural tear film production. Human tear film is a complex mixture of more than 1,500 different proteins, including growth factors and antibodies, as well as numerous classes of lipids and mucins. This complex tear film coating is responsible for forming the primary refracting surface of the cornea, as well as protecting and moisturizing the cornea.

About Dry Eye Disease

Dry eye disease is a chronic, progressive condition that impacts more than 30 million people in the United States and is growing in prevalence. An estimated 16 million adults in the U.S. have been diagnosed with dry eye disease, a multifactorial condition of the ocular surface characterized by disruption of the tear film. A healthy tear film protects and lubricates the eyes, washes away foreign particles, contains growth factors and antimicrobial components to reduce the risk of infection, and creates a smooth surface that contributes refractive power for clear vision. Dry eye disease can have a significant impact on a person’s day-to-day quality of life, as it can cause persistent stinging, scratching, burning sensations, sensitivity to light, blurred vision and eye fatigue. Despite the large prevalence of dry eye and the burden of the disease, there remains a significant unmet need for effective therapies.

About Oyster Point Pharma

Oyster Point Pharma is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ocular surface diseases. Oyster Point Pharma’s lead product candidate, OC-01 nasal spray, a highly selective cholinergic agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. OC-01 nasal spray’s novel mechanism of action re-establishes tear film homeostasis by activating the trigeminal parasympathetic pathway to stimulate the glands and cells responsible for natural tear film production, known as the lacrimal functional unit.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions and on information currently available to us. The forward-looking statements in this press release represent our views as of the date of this press release. These statements may include but are not limited to statements regarding future events, including our plans for and the anticipated benefits of and safety of our product candidates, the timing, objectives and results of the clinical studies and anticipated regulatory and development milestones, including potential timing of NDA submission and potential commercialization. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Forward-looking statements may involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Important factors that could cause our actual results to differ materially are detailed from time to time in the reports we file with the Securities and Exchange Commission, copies of which are posted on our website and are available from us without charge. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties.

Investor Contact: 
Tim McCarthy 
LifeSci Advisors, LLC 
(212) 915-2564 
[email protected]

Media
C
ontact:

Sheryl Seapy, W2O Group
(213) 262-9390
[email protected] 

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TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — Onex Corporation (TSX: ONEX) today announced its financial results for the third-quarter and nine-months ended September 30, 2020 and an update on matters following quarter end.

“Building on our portfolio improvements last quarter, we continue to demonstrate increased momentum in our private equity and credit portfolios, resulting in a very good quarter for Onex,” said Gerry Schwartz, Chairman and Chief Executive Officer of Onex. “Earlier this quarter, I was delighted to announce Bobby Le Blanc as President of Onex, in recognition of his leadership ability and the positive role he continues to play in our success.”

Highlights

• Onex reported segment net earnings for the three months ended September 30, 2020 of $515 million ($5.39 per fully diluted share), comprised of net earnings of $492 million from its investing segment and net earnings of $23 million from its asset and wealth management segment.
• Onex reported segment net earnings for the nine-months ended September 30, 2020 of $152 million ($1.55 per fully diluted share), comprised of net earnings of $164 million from its investing segment and a net loss of $12 million from its asset and wealth management segment.
• Onex’ private equity investments generated gross returns of 14% and 9% during the three and nine-months ended September 30, 2020, respectively.
• Onex’ total shareholder capital per fully diluted share increased by approximately 10% in the third-quarter to $74.04 (C$98.76), primarily driven by net increases in Onex’ private equity and credit investments.
• In August, Onex Partners sold approximately 32.0 million shares of SIG Combibloc Group (SWX: SIGN) at a price of CHF 15.50 per share. Onex’ share of the net proceeds was $162 million as a Limited Partner in Onex Partners IV and as a co-investor.
• In August, Onex invested $35 million in Onex Partners V as part of the Fund’s investment in preferred shares of Emerald Holdings, Inc. (NYSE: EEX). This attractively valued investment supports a business with a solid collection of assets with an opportunity remaining to improve operations.
• In September, Onex invested $64 million in Onex Partners V as part of the fund’s investment in Independent Clinical Services Group Ltd.
• In October, Onex Partners agreed to make a majority investment in OneDigital, a leading U.S. provider of employee benefits insurance brokerage and retirement consulting services. The transaction values OneDigital at $2.65 billion. The new equity investment of approximately $725 million will be made by Onex Partners V, Onex’ share will be approximately $200 million.
• Onex deployed $444 million (C$595 million) during the first ten months of 2020 by repurchasing 9,780,411 Subordinate Voting Shares at an average cost per share of C$60.86.

Financial


Results

For the three-months ended September 30, 2020, total segment net earnings were $515 million ($5.39 per fully diluted share). Investing segment earnings of $492 million ($5.17 per fully diluted share) were primarily driven by net gains on Onex’ private equity and credit investments consistent with the recovery in those markets during the quarter. Third-quarter asset and wealth management segment earnings of $23 million ($0.22 per fully diluted share) were driven by management and advisory fees as well as an increase in unrealized carried interest.

For the nine-months ended September 30, 2020, total segment net earnings were $152 million ($1.55 per fully diluted share). Investing segment earnings of $164 million ($1.67 per fully diluted share) were primarily driven by a net gain on Onex’ private equity investments which reflects the overall resiliency and diversification of the operating businesses that Onex has invested in. The asset and wealth management segment loss for the nine-months ended September 30, 2020 was $12 million ($0.12 per fully diluted share) driven primarily by a net reversal of unrealized carried interest.

Enclosed are supplementary schedules and non-IFRS measures related to Onex’ consolidated net earnings for the three- and nine-months ended September 30, 2020, shareholder capital at September 30, 2020 and cash and near-cash changes for the nine-months ended September 30, 2020. The financial statements prepared in accordance with International Financial Reporting Standards (IFRS), including Management’s Discussion and Analysis of the results, are posted on Onex’ website, www.onex.com, and are also available on SEDAR at www.sedar.com. A supplemental information package with additional information is available on Onex’ website, www.onex.com.

Webcast

Onex management will host a webcast to review Onex’ third-quarter 2020 results on Friday, November 13 at 11:00 a.m. ET. The webcast will be available in listen-only mode from the Presentations and Events section of Onex’ website, https://ir.onex.com/events-and-presentations. A 90-day on-line replay will be available shortly following the completion of the event.

About Onex

Founded in 1984, Onex invests and manages capital on behalf of its shareholders, institutional investors and high net worth clients from around the world. Onex’ platforms include: Onex Partners, private equity funds focused on larger opportunities in North America and Europe; ONCAP, private equity funds focused on middle market and smaller opportunities in North America; Onex Credit, which manages primarily non-investment grade debt through collateralized loan obligations, senior loan strategies and other private credit strategies; and Gluskin Sheff’s wealth management services including its actively managed public equity and public credit funds. In total, Onex has approximately $36.6 billion of assets under management, of which approximately $6.7 billion is its own shareholder capital. With offices in Toronto, New York, New Jersey and London, Onex and its experienced management teams are collectively the largest investors across Onex’ platforms.

The Onex Partners and ONCAP businesses have assets of $36 billion, generate annual revenues of $22 billion and employ approximately 149,000 people worldwide. Onex shares trade on the Toronto Stock Exchange under the stock symbol ONEX. For more information on Onex, visit its website at www.onex.com. Onex’ security filings can also be accessed at www.sedar.com.

Forward-Looking Statements

This press release may contain, without limitation, statements concerning possible or assumed future operations, performance or results preceded by, followed by or that include words such as “believes”, “expects”, “potential”, “anticipates”, “estimates”, “intends”, “plans” and words of similar connotation, which would constitute forward-looking statements. Forward-looking statements are not guarantees. The reader should not place undue reliance on forward-looking statements and information because they involve significant and diverse risks and uncertainties that may cause actual operations, performance or results to be materially different from those indicated in these forward-looking statements. Except as may be required by Canadian securities law, Onex is under no obligation to update any forward-looking statements contained herein should material facts change due to new information, future events or other factors. These cautionary statements expressly qualify all forward-looking statements in this press release.

Non-GAAP Financial Measures

This press release may contain non-GAAP financial measures which have been calculated using methodologies that are not in accordance with IFRS. The presentation of financial measures in this manner does not have a standardized meaning prescribed under IFRS and is therefore unlikely to be comparable to similar financial measures presented by other companies. Onex management believes these financial measures provide helpful information to investors. Reconciliations of the non-GAAP financial measures to information contained in the consolidated financial statements have been presented where practical.

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Jill Homenuk
Managing Director, Shareholder Relations and Communications
Tel: +1 416.362.7711

Supplementary
and
Non-IFRS Measures

Summarized Consolidated Net


Earnings


(


Loss


)

(Unaudited) ($ millions except per share amounts) Three months ended September 30 , 2020		Investing (i)			Asset and Wealth Management (i)			Total
Segment income	$	492		$	93		$	585
Segment expenses		–			(70)			(70)
Segment net earnings	$	492		$	23		$	515
Stock-based compensation recovery								3
Amortization of property and equipment and other intangible assets, excluding right-of-use assets								(12)
Integration expense								(5)
Net earnings							$	501
Segment net earnings per share(ii)	$	5.17		$	0.22		$	5.39
Net earnings per share
Basic							$	5.30
Diluted							$	5.29

(i)	Refer to the unaudited interim consolidated financial statements for segment presentation and allocation considerations.
(ii)	Calculated on a fully diluted basis.

(Unaudited) ($ millions except per share amounts) Nine months ended September 30, 2020		Investing (i)			Asset and Wealth Management (i)			Total
Segment income	$	164		$	182		$	346
Segment expenses		–			(194)			(194)
Segment net earnings (loss)	$	164		$	(12)		$	152
Stock-based compensation recovery								108
Amortization of property and equipment and other intangible assets, excluding right-of-use assets								(35)
Integration expense Impairment of goodwill								(7) (85)
Net earnings							$	133
Segment net earnings (loss) per share(ii)	$	1.67		$	(0.12)		$	1.55
Net earnings per share
Basic							$	1.36
Diluted							$	1.36

(i)	Refer to the unaudited interim consolidated financial statements for segment presentation and allocation considerations.
(ii)	Calculated on a fully diluted basis.

Shareholder Capital

(Unaudited) ($ millions except per share amounts) As at September 3 0 , 2020		Investing			Asset and Wealth Management			Total
Total segmented assets	$	6,260		$	780		$	7,040
Accounts payable and accrued liabilities		–			(33)			(33)
Accrued compensation		–			(86)			(86)
Lease and other liabilities		–			(118)			(118)
DSU hedge assets		–			(61)			(61)
Total shareholder capital (i)	$	6,2 60		$	48 2		$	6, 742
Shareholder capital per share (i)(ii)	$	6 8.74		$	5. 30		$	74.04

(i)

Shareholder capital and shareholder capital per share are non-GAAP financial measures which have been calculated using methodologies that are not in accordance with IFRS. A reconciliation of total segmented assets to shareholder capital is presented in this table. The presentation of financial measures in this manner does not have a standardized meaning prescribed under IFRS and is therefore unlikely to be comparable to similar financial measures presented by other companies. Management believes that shareholder capital is useful to investors as the metric is used, in part, to assess Onex’ performance.

(ii)

Calculated on a fully diluted basis using the treasury stock method. Fully diluted shares for shareholder capital per share were 91.1 million at September 30, 2020.

Cash and Near-Cash

The table below provides a reconciliation of the change in cash and near-cash from December 31, 2019 to September 30, 2020.

(Unaudited) ($ millions)
Cash and near-cash on hand at December 31, 2019(i)	$	1,842
Private equity realizations		582
Private equity investments		(325)
Real estate distributions		15
Net Onex Credit strategies investment activity, including warehouse facilities		(53)
Onex share repurchases, options exercised, dividends and director DSU redemption		(472)
Net other, including capital expenditures, management fees, operating costs and treasury income		12
Cash and near-cash on hand at September 30 , 20 20 (i)	$	1, 601

(i)	Includes $934 million (December 31, 2019 – $395 million) of treasury investments, $96 million (December 31, 2019 – $97 million) invested in an Onex Credit unlevered senior secured loan strategy fund and $192 million (December 31, 2019 – $190 million) of management fees.

Patient Dosing Continues in the Phase 1/2 PROPEL Trial of PR001 for Parkinson’s Disease with GBA1 Mutations

Phase 1/2 PROVIDE Trial of PR001 for Type 2 Gaucher Disease and Phase 1/2 PROCLAIM Trial of PR006 for Frontotemporal Dementia with GRN Mutations Expected to Initiate Enrollment in Fourth Quarter of 2020

PR001 Receives U.S. FDA Fast Track Designation for Neuronopathic Gaucher Disease

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Prevail Therapeutics Inc. (Nasdaq: PRVL), a biotechnology company developing potentially disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases, today reviewed recent clinical and business updates and reported financial results for the third quarter ended September 30, 2020.

“We’re pleased to be making significant progress across our pipeline as we seek to develop urgently needed disease-modifying gene therapy treatments for patients with neurodegenerative diseases,” said Asa Abeliovich, M.D., Ph.D., Founder and Chief Executive Officer of Prevail. “We are encouraged by the continuation of patient dosing in our Phase 1/2 PROPEL trial of PR001 for Parkinson’s disease with GBA1 mutations, and we are excited to advance our PROVIDE and PROCLAIM clinical trials for Type 2 Gaucher disease and frontotemporal dementia with GRN mutations, respectively, this year.”

Recent Business
Updates

Patient Dosing Continues in Phase 1/2 PROPEL Trial of PR001 for P
arkinson’s disease with

GBA1

mutations (PD-GBA)
: Enrollment in the Phase 1/2 PROPEL clinical trial for PD-GBA has resumed following implementation of modifications to the clinical protocol. As previously announced, Prevail elected to modify the immunosuppression regimen in the clinical protocol for PROPEL and has adapted the trial design to be open-label. The Company expects to provide the next biomarker and safety analysis on a subset of patients in the PROPEL trial by mid-2021.

Phase 1/2 PROVIDE Trial Expected to Initiate Enrollment in Fourth Quarter of 2020: Initiation of patient enrollment remains on track for the fourth quarter of 2020 for the Phase 1/2 PROVIDE clinical trial of PR001 for Type 2 Gaucher disease. The optimized immunosuppression regimen used in the amended PROPEL trial will also be implemented in the PROVIDE trial. The Company currently anticipates it will provide the next update on PR001 biomarker and safety data for neuronopathic Gaucher disease (nGD) in 2021.

Phase 1/2 PROCLAIM Trial Expected to Initiate Enrollment in Fourth Quarter of 2020: Initiation of patient enrollment remains on track for the fourth quarter of 2020 for the Phase 1/2 PROCLAIM clinical trial of PR006 for frontotemporal dementia with GRN mutations (FTD-GRN). The optimized immunosuppression regimen used in the amended PROPEL trial will also be implemented in the PROCLAIM trial. The Company currently anticipates it will provide a biomarker and safety analysis on a subset of patients in the PROCLAIM trial in 2021.

PR001 Granted U.S. FDA Fast Track Designation for
nGD
: The U.S. Food and Drug Administration (FDA) granted Fast Track designation for PR001 for the treatment of nGD. The FDA previously granted PR001 Rare Pediatric Disease designation for the treatment of nGD, and Orphan Drug designation for the treatment of patients with Gaucher disease. In addition, the FDA has granted Fast Track designation for PR001 for the treatment of PD-GBA.

Strengthened Leadership with Board Appointment: Prevail has appointed William H. Carson, M.D., to its Board of Directors. Dr. Carson was most recently the President and CEO of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), leading the development and regulatory approvals of Otsuka’s global compounds. Before joining Otsuka, he held several roles in the CNS Research and Development department at Bristol Myers Squibb. Dr. Carson currently serves as Chairman of the Board of Directors of OPDC and is also the Chairman of the Board of the Sozosei Foundation, a newly established Otsuka charitable organization with a main focus on decriminalization of mental illness. He is a Board Member of Excision Biotherapeutics and Trustee of the non-profit Internet2. He is a Distinguished Fellow of the American Psychiatric Association, the National Medical Association and the Executive Leadership Council. Prior to joining the pharmaceutical industry, Dr. Carson, a board-certified psychiatrist, was an Associate Professor in the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina.

Favorable Decision Received in Alector Arbitration: Prevail announced a favorable decision in the arbitration proceeding brought in 2019 by Alector Inc. against Prevail’s Founder and Chief Executive Officer, Asa Abeliovich, M.D., Ph.D. The arbitrator rejected Alector’s claims against Dr. Abeliovich that Alector confidential information was used in connection with his work on behalf of Prevail and that Alector had rights to Prevail’s patents and patent applications. The arbitrator found that Dr. Abeliovich did not breach his confidentiality obligations to Alector under his consulting agreement. Prevail was not a party to this arbitration.

Third Quarter 2020 Financial Results

• Cash Position: Cash, cash equivalents and investments were $114.3 million as of September 30, 2020, as compared to $131.2 million and $168.1 million as of June 30, 2020 and December 31, 2019, respectively. The Company continues to anticipate that its cash runway will extend into the first half of 2022.
   
• R&D Expenses: R&D expenses were $12.3 million for the third quarter of 2020 compared to $16.8 million for the third quarter in 2019. The decrease was primarily due to a decrease of $3.9 million in external manufacturing costs due to the timing of production of clinical and preclinical supply, a decrease of $1.5 million in direct clinical trial costs, and a decrease of $0.5 million related to external preclinical studies. These decreases were partially offset by an increase of $1.4 million in employee-related costs, resulting from an increase in research and development employees hired to execute the development of our clinical-stage product candidates and preclinical pipeline.
   
• G&A Expenses: G&A expenses were $6.3 million for the third quarter of 2020, compared to $4.5 million for the third quarter of 2019. The increase was primarily due to a $1.3 million increase in employee related costs, resulting from an increase in general and administrative employees to support our expanded operations and establish capabilities to operate as a public company, a $0.8 million increase in legal fees, offset by a decrease of $0.2 million in other professional services and facilities cost.
   
• Net Loss: Net loss was $18.6 million, or $0.55 loss per share, for the third quarter of 2020, compared to $20.3 million, or $0.62 loss per share, for the third quarter of 2019.

About Prevail Therapeutics

Prevail is a gene therapy company leveraging breakthroughs in human genetics with the goal of developing and commercializing disease-modifying AAV-based gene therapies for patients with neurodegenerative diseases. The Company is developing PR001 for patients with Parkinson’s disease with GBA1 mutations (PD-GBA) and neuronopathic Gaucher disease (nGD); PR006 for patients with frontotemporal dementia with GRN mutations (FTD-GRN); and PR004 for patients with certain synucleinopathies.

Prevail was founded by Dr. Asa Abeliovich in 2017, through a collaborative effort with The Silverstein Foundation for Parkinson’s with GBA and OrbiMed, and is headquartered in New York, NY.

Forward-Looking Statements Related to Prevail

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning the potential for Prevail’s gene therapy candidates to modify the course of neurodegenerative diseases; the anticipated timing of Prevail’s clinical trials of PR001 in PD-GBA and in Type 2 Gaucher disease and Prevail’s clinical trial of PR006 in FTD-GRN; the expected timing of reporting of additional interim data for a subset of patients from the PROPEL trial; and expectations regarding Prevail’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Prevail’s novel approach to gene therapy makes it difficult to predict the time, cost and potential success of product candidate development or regulatory approval; Prevail’s gene therapy programs may not meet safety and efficacy levels needed to support ongoing clinical development or regulatory approval; the regulatory landscape for gene therapy is rigorous, complex, uncertain and subject to change; the fact that gene therapies are novel, complex and difficult to manufacture; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises. These and other risks are described more fully in Prevail’s filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the SEC, and its other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Prevail undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Pr
evail Therapeutics Inc.

Statements of Operations

(Unaudited)
(in thousands, except share and per share data)

		Three Months Ended September 30,												Nine Months Ended September 30,
		2020						2019						2020						2019
Operating Expenses:
Research and development		$	12,321					$	16,836					$	36,681					$	37,202
General and administrative			6,303						4,452						23,373						10,050
Total operating loss			(18,624	)					(21,288	)					(60,054	)					(47,252	)
Other income			—						—						210						—
Interest income, net			37						989						582						1,905
Total other income			37						989						792						1,905
Net loss		$	(18,587	)				$	(20,299	)				$	(59,262	)				$	(45,347	)
Other comprehensive income			5						—						4						—
Comprehensive loss		$	(18,582	)				$	(20,299	)				$	(59,258	)				$	(45,347	)
Net loss per share, basic and diluted		$	(0.55	)				$	(0.62	)				$	(1.77	)				$	(1.68	)
Weighted average shares outstanding, basic and diluted			33,636,651						32,864,156						33,457,768						26,950,854

Prevail Therapeutics Inc.

Balance
Sheets

(Unaudited)
(in thousands, except share and per share data)

		September 30, 2020				December 31, 2019
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	81,732			$	168,051
Investments			9,755				—
Prepaid expenses and other current assets			4,839				6,410
Total current assets			96,326				174,461
Property and equipment, net			2,746				2,549
Investments			22,861				—
Operating lease right-of-use assets			9,023				10,001
Other long-term assets			3,068				—
Restricted cash			91				91
TOTAL ASSETS		$	134,115			$	187,102
LIABILITIES AND STOCKHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable		$	2,597			$	5,162
Accrued expenses and other current liabilities			8,651				5,330
Operating lease liabilities			1,500				1,341
Total current liabilities			12,748				11,833
Long-term operating lease liabilities			8,787				9,927
TOTAL LIABILITIES			21,535				21,760
COMMITMENTS AND CONTINGENCIES (Note 13)
STOCKHOLDERS’ EQUITY
Preferred stock – $0.0001 par value, 10,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively; no shares issued as of September 30, 2020 and December 31, 2019, respectively			—				—
Common stock – $0.0001 par value, 200,000,000 shares authorized as of September 30, 2020 and December 31, 2019, respectively, 34,245,433 and 34,138,750 shares issued and outstanding as of September 30, 2020 and December 31, 2019, respectively			3				3
Additional paid-in capital			255,937				249,441
Accumulated deficit			(143,364	)			(84,102	)
Accumulated other comprehensive income			4				—
Total stockholders’ equity			112,580				165,342
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY		$	134,115			$	187,102

Media Contact
:

Lisa Qu
Ten Bridge Communications
[email protected]
678-662-9166

Investor Contact
:

[email protected]

 

TEL AVIV, Israel and RALEIGH, N.C., Nov. 13, 2020 (GLOBE NEWSWIRE) — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg, RedHill’s Chief Business Officer, will present a corporate overview and host 1-on-1 investor meetings at the German Equity Forum (Deutsches Eigenkapital Forum) 2020, one of Europe’s largest investor events, on Tuesday, November 17, 2020, at 9:30 a.m. CET.

The presentation will be available via replay for 30 days on the Company’s website: https://ir.redhillbio.com.

About RedHill Biopharma           
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Movantik^® for opioid-induced constipation in adults¹, Talicia^® for the treatment of Helicobacter pylori (H. pylori) infection in adults², and Aemcolo^® for the treatment of travelers’ diarrhea in adults³. RedHill’s key clinical late-stage development programs include: (i) RHB-204, with a planned Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) infections; (ii) opaganib (Yeliva^®), a first–in–class SK2 selective inhibitor targeting multiple indications with a Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (iv) RHB-102 (Bekinda^®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (v) RHB-107, a Phase 2-stage first-in-class, serine protease inhibitor, targeting cancer and inflammatory gastrointestinal diseases and is also being evaluated for COVID-19 and (vi) RHB–106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,”
“hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties
include
risks and uncertainties
associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia

^®

; (v) the Company’s ability to successfully commercialize and promote Movantik

^®

, Talicia

^®

and Aemcolo

^®

; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on
M
arch 4, 2020. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected]

Media contact (U.S.): Bryan Gibb Vice President Finn Partners +1 212 529 2236 [email protected]

^{_____________
1} Full prescribing information for Movantik^® (naloxegol) is available at: www.Movantik.com.
² Full prescribing information for Talicia^® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       
³ Full prescribing information for Aemcolo^® (rifamycin) is available at: www.Aemcolo.com.

CAMBRIDGE, Mass., Nov. 13, 2020 (GLOBE NEWSWIRE) — Checkmate Pharmaceuticals,Inc. (NASDAQ: CMPI) (“Checkmate”), a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, today announced third quarter 2020 financial results and provided an update on recent progress.

“We are enthusiastic as we advance CMP-001 toward registration in melanoma and expand toward potential proof of concept in additional indications,” said Barry Labinger, Chief Executive Officer. “We remain on track to initiate key new clinical trials by late 2020/early 2021 as planned.”

Recent
Progress

• During SITC’s 35^th Anniversary Annual Meeting, three new data presentations were given evaluating CMP-001, Checkmate’s advanced generation Toll-like receptor 9 (TLR9) agonist. These data continue to demonstrate the clinical activity of CMP-001 in combination with anti-PD-1 antibodies in patients with melanoma.
• Checkmate is actively engaging with potential clinical sites and remains on track to initiate three Phase 2 trials combining CMP-001 with PD-1 blockade by late 2020/early 2021 for the treatment of:
  • First-line head and neck cancer
  • Anti-PD-1 refractory melanoma
  • First-line metastatic or unresectable melanoma

Third
Quarter 2020 Financial Results

• Cash and cash equivalents: Cash and cash equivalents were $137.3 million as of September 30, 2020.
• Research and development expenses
  (R&D): R&D expenses were $6.7 million for the quarter ended September 30, 2020, compared to $5.1 million for the quarter ended September 30, 2019. The increase was primarily attributable to increased headcount and clinical trial expenses in connection with increased patient enrollment in the ongoing clinical trials of CMP-001 and preparations for the initiation of planned additional clinical trials of CMP-001. These increases were partially offset by a decrease in contract manufacturing costs.
• General and administration expenses
  (G&A)
  : G&A expenses were $3.2 million for the quarter ended September 30, 2020, compared to $1.2 million for the quarter ended September 30, 2019. The increase was primarily attributable to increases in personnel and other operating expenses incurred in connection with Checkmate beginning to operate as a publicly-traded company.
• Net loss
  and comprehensive loss
  : Net loss and comprehensive loss was $9.8 million for the quarter ended September 30, 2020, compared to $6.2 million for the quarter ended September 30, 2019.

About
Checkmate
Pharmaceuticals

Checkmate Pharmaceuticals is a clinical stage biotechnology company focused on developing its proprietary technology to harness the power of the immune system to combat cancer. Checkmate’s product candidate, CMP-001, is an advanced generation TLR9 agonist delivered as a biologic virus-like particle designed to trigger the body’s innate immune system to attack tumors in combination with other therapies. Information regarding Checkmate is available at www.checkmatepharma.com.

Availability of Other Information About Checkmate

Investors and others should note that we communicate with our investors and the public using our website (www.checkmatepharma.com), our investor relations website (ir.checkmatepharma.com), and on social media (Twitter and LinkedIn), including but not limited to: investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Checkmate posts on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward Looking Statements

Various statements in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. These statements include those regarding our product candidate, including its development and therapeutic potential and the advancement of our clinical and preclinical pipeline; expectations regarding the results and analysis of data; and expectations regarding the timing, initiation, implementation and success of its planned clinical trials for CMP-001.  Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. These forward-looking statements are subject to risks and uncertainties, including those related to the development of our product candidate, including any delays in our ongoing or planned preclinical or clinical trials, positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies, the impact of the ongoing COVID-19 pandemic on our business, operations, clinical supply and plans, the risks inherent in the drug development process, the risks regarding the accuracy of our estimates of expenses and timing of development, our capital requirements and the need for additional financing, and obtaining, maintaining and protecting its intellectual property. These and additional risks are discussed in the sections titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 dated September 18, 2020, as filed with the Securities and Exchange Commission pursuant to Rule 424(b) under the Securities Act 1933, as amended, which is available on the Securities and Exchange Commission’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

CHECKMATE PHARMACEUTICALS
,
INC
.

SUMMARY
STATEMENT
S
OF OPERATIONS

(Unaudited)

(
I
n thousands)

	Three Months Ended  September 30,								Nine Months Ended September 30,
		2020				2019				2020				2019
Operating expenses:
Research and development	$	6,673			$	5,076			$	19,462			$	17,126
General and administrative		3,160				1,208				6,465				3,365
Total operating expenses		9,833				6,284				25,927				20,491
Loss from operations		(9,833	)			(6,284	)			(25,927	)			(20,491	)
Other income (expense), net:
Interest income		4				43				32				160
Change in fair value of convertible loan notes		—				—				(83	)			—
Total other income (expense), net		4				43				(51	)			160
Net loss and comprehensive loss	$	(9,829	)		$	(6,241	)		$	(25,978	)		$	(20,331	)

CHECKMATE PHARMACEUTICALS
,
INC
.

SUMMARY
BALANCE SHEETS

(In thousands)

(Unaudited)

		September 30,				December 31,
			2020				2019
Cash and cash equivalents		$	137,340			$	4,185
Other current assets			6,725				941
Total assets		$	144,065			$	5,126
Current liabilities		$	8,860			$	5,634
Total liabilities		$	8,860			$	5,634
Series A redeemable convertible preferred stock			—				32,482
Series B redeemable convertible preferred stock			—				64,446
Total stockholders’ equity (deficit)			135,205				(97,436	)
Total liabilities, redeemable convertible preferred stock and stockholders’ (deficit)		$	144,065			$	5,126

Investor Contact
Kleem Chaudhary
Chief Business Officer
[email protected]

Media Contact
Karen Sharma
MacDougall 
781-235-3060
[email protected]

SASKATOON, Saskatchewan, Nov. 13, 2020 (GLOBE NEWSWIRE) — GFG Resources Inc. (TSX-V: GFG) (OTCQB: GFGSF) (“GFG” or the “Company”) has announced the election of four board members at its annual meeting held on November 12, 2020.

Shareholders elected board members Patrick Downey, Arnold Klassen, Brian Booth and Brian Skanderbeg.

Voting Results for
GFG

Nominee	Votes For	% Votes For	Withheld	% Votes Withheld
Patrick Downey	33,928,214	99.895	35,600	.105
Arnold Klassen	33,925,202	99.886	38,612	.114
Brian Booth	33,928,214	99.895	35,600	.105
Brian Skanderbeg	33,888,839	99.779	74,975	.221

About GFG Resources Inc.


GFG Resources is a North American precious metals exploration company focused on district scale gold projects in tier one mining jurisdictions, Ontario and Wyoming. In Ontario, the Company owns 100% of the Pen and Dore gold projects, two large and highly prospective gold properties west of the prolific gold district of Timmins, Ontario, Canada. The Pen and the Dore gold projects have similar geological settings that host most of the gold deposits found in the Timmins Gold Camp which have produced over 70 million ounces of gold. The Company also owns 100% of the Rattlesnake Hills Gold Project, a district scale gold exploration project located approximately 100 kilometres southwest of Casper, Wyoming, U.S. The geologic setting, alteration and mineralization seen in the Rattlesnake Hills are similar to other gold deposits of the Rocky Mountain alkaline province which, collectively, have produced over 50 million ounces of gold.

For further information, please contact:

Brian Skanderbeg, President & CEO
Phone: (306) 931-0930
or
Marc Lepage, Vice President, Business Development
Phone: (306) 931-0930
Email: [email protected]
Website: www.gfgresources.com

Stay Connected with Us

Twitter: @GFGResources
LinkedIn: https://www.linkedin.com/company/gfgresources/
Facebook: https://www.facebook.com/GFGResourcesInc/

Third Quarter Highlights

• Adjusted basic earnings per Class B share⁽³⁾ of $0.93 up 29.2%; basic earnings per Class B share of $0.86 up 21.1%; currency $0.02 per Class B share positive impact
• Sales increased 1.2% on 2.5% organic decline offset by 2.2% acquisition growth and 1.5% positive currency translation
• CCL Segment sales increased 5.5%, 4.2% organically; operating income
  ⁽¹⁾
  up 26.4%
• Checkpoint and Innovia operating income
  ⁽¹⁾
  up 5.7% and 225.8%, respectively
• Consolidated
  operating margin⁽¹⁾ of 17.9%, up 240 bps

Nine-Month Highlights

• Adjusted basic earnings per Class B share⁽³⁾ of $2.24 up 5.7%; basic earnings per Class B share of $2.15 up 2.9%; currency $0.01 per Class B share positive impact
• Sales down 3.8%, principally on declines at Avery and Checkpoint
• Consolidated operating income
  ⁽¹⁾
  down 0.5%, driven by declines of 29.0% and 32.6% for Avery and Checkpoint, respectively
• Consolidated operating margin⁽¹⁾ 15.7%, up 50 bps

TORONTO, Nov. 13, 2020 (GLOBE NEWSWIRE) — CCL Industries Inc. (TSX:CCL.A) (TSX:CCL.B) (“the Company”), a world leader in specialty label, security and packaging solutions for global corporations, government institutions, small businesses and consumers, today reported 2020 third quarter results.

Sales for the third quarter of 2020 increased 1.2% to $1,373.4 million, compared to $1,357.1 million for the third quarter of 2019, with 2.5% organic decline offset by 2.2% acquisition-related growth and 1.5% positive impact from foreign currency translation.

Operating income⁽¹⁾ for the third quarter of 2020 increased 17.4% to $246.3 million compared to $209.8 million for the comparable quarter of 2019.  Operating income⁽¹⁾ increased 16.0%, excluding currency translation. 

Restructuring and other items were a $16.2 million expense for the 2020 third quarter that included severance costs principally for the Checkpoint and Avery Segments amounting to $6.8 million and the final judgement for an Innovia pre-acquisition lawsuit that exceeded the acquisition accrual by $9.4 million. For the third quarter of 2019, restructuring and other items totaled $1.7 million primarily for severance costs associated with the CCL Segment and other acquisition transaction costs. 

Tax expense for the third quarter of 2020 was $50.6 million compared to $43.9 million in the prior year period.  The effective tax rate for the 2020 and 2019 third quarters was 25.1% and 25.7%, respectively.

Net earnings were $153.3 million for the 2020 third quarter compared to $127.7 million for the 2019 third quarter. Basic and adjusted basic earnings per Class B share⁽³⁾ for the third quarter of 2020 were $0.86 and $0.93, respectively, compared to basic and adjusted basic earnings per Class B share⁽³⁾ of $0.71 and $0.72, respectively, in the prior year third quarter. Foreign currency translation had a positive impact of $0.02 on earnings per share.

For the nine-month period ended September 30, 2020, sales and operating income⁽¹⁾ declined 3.8% and 0.5% to $3.9 billion and $610.2 million, respectively, however net earnings increased 3.0% to $383.8 million, compared to the same nine-month period in 2019. The 2020 nine-month period included results from thirteen acquisitions completed since January 1, 2019, delivering acquisition-related sales growth for the period of 1.8%. Organic sales decline was 5.9% and foreign currency translation was a 0.3% positive impact. For the nine-month period ended September  30, 2020, basic and adjusted basic earnings per Class B share⁽³⁾ were $2.15 and $2.24, respectively, compared to basic and adjusted basic earnings per Class B share⁽³⁾ of $2.09 and $2.12, respectively, in the prior year nine-month period. Foreign currency translation had a positive impact of $0.01 on earnings per share.

Geoffrey T. Martin, President and Chief Executive Officer, commented, “I am very pleased to report record quarterly earnings. This outstanding performance, in the midst of ‘once in a generation’ pandemic challenges, speaks to the resilience of our business model and the unrelenting commitment and dedication of our front line people around the world.  Supported by our global leadership team, they met diverse needs of customers, delivering industry-leading quality, service and operational improvement, while ensuring the health and safety of our entire organization during highly unusual operating conditions.”

Mr. Martin continued, “The CCL Segment posted organic sales growth of 4.2% and a 300 basis point improvement in operating margin.  CCL Secure’s performance improved significantly on favourable mix coupled with unusually strong demand for currency. Both CCL Design electronics and Healthcare & Specialty maintained second quarter momentum, as sales increased on share gains and higher consumer demand from the pandemic driving strong profit improvement. CCL Design automotive sales and profitability rebounded much faster than expected from the industry shutdown. Home & Personal Care label sales increased, especially in the United States, as high demand for skin sanitizers and cleansers significantly improved profitability. Tube sales for beauty, cosmetic and skin care products sold in travel and specialty retail stores and hair salons recovered sequentially driving higher profits but results in aerosols declined on slow demand in the United States. Sleeve sales continued to grow on share gains in North America and recovering conditions in Brazil, more than offsetting slower markets in Europe.  Pressure sensitive Food & Beverage label results declined as ‘on-premise’ demand, especially for mineral water and soft drinks, remains below normal levels. Earnings from our ventures in Russia and the Middle East were strong.  Avery ‘WePrint’ and kids’ labels direct-to-consumer franchises were strong globally but not enough to offset steep declines in event and name badging as attended sports events, concerts, trade conventions and business meetings temporarily disappeared. Back-to-school performance, while initially encouraging, faded amid a somewhat chaotic return to schools and colleges in North America. Workplace-related demand improved sequentially, but remained below prior year, especially in the United States. Cost savings contributed to a creditable 20% operating margin. Checkpoint sales declined compared to a strong prior year in the MAS business but overall profitability improved as apparel labeling demand rebounded, results aided by strong growth in RFID and cost saving initiatives.  Innovia demand softened after the second quarter pantry loading hike, but sales increased on the Polish acquisition; profitability gained  dramatically on significantly improved mix, cost savings and productivity initiatives throughout the Segment.”

Mr. Martin added, “Although October activity levels were consistent with the summer recovery period, November and December are always affected by the holiday season and even in normal circumstances, difficult to predict.  Clearly, the second wave of the virus is now impacting many parts of the world, with subsequent economic effects largely unknown. Regardless, the Company’s leadership priority is to ensure the health and safety of its employees and as necessary, adapt operations and cost structures to match activity levels as we have throughout the pandemic. Foreign currency translation could be a slight tailwind at current exchange rates for the fourth quarter compared to the same quarter in 2019.”

Mr. Martin concluded, “The Company completed the third quarter with a stronger balance sheet driven by persistent free cash flow⁽⁴⁾, reducing the Company’s net leverage ratio⁽⁵⁾ to 1.51 times adjusted EBITDA compared to 1.8 times at the end of 2020 second quarter.  Our liquidity position was robust with cash-on-hand of $760.2 million and US$1.2 billion undrawn capacity on our syndicated revolving credit facility. Given the much-improved quarterly results, projected 2020 capital spending has been revised to approximately $290 million, still less than the $350 million originally planned. The Board of Directors declared its regular quarterly dividend of $0.18 per Class B non-voting share and $0.1775 per Class A voting share, payable to shareholders of record at the close of business on December 15, 2020, to be paid on December 29, 2020.”

2020 Third Quarter Segment Highlights

CCL

• Sales increased 5.5% to $877.0 million; 4.2% organic growth and 0.9% positive impact from currency translation and 0.4% acquisition contribution
• Regional organic sales performance: North America up low-single digit, Europe up mid-single digit, Latin America up double digit and Asia Pacific declined slightly
• Operating income⁽¹⁾ $160.8 million, 18.3% operating margin⁽¹⁾, up 300 bps
• Label joint ventures added $0.01 earnings per Class B share

Avery

• Sales decreased 14.1% to $178.4 million; 19.8% organic decline, 3.9% acquisition contribution and 1.8% positive impact from currency translation
• Operating income⁽¹⁾ $35.7 million, 20.0% operating margin⁽¹⁾, down 330 bps

Checkpoint

• Sales decreased 6.0% to $169.7 million; 8.5% organic decline, 0.7% acquisition contribution and 1.8% positive impact from foreign currency translation
• Operating income⁽¹⁾ $29.6 million, 17.4% operating margin⁽¹⁾, up 190 bps

Innovia  

• Sales increased 7.6% to $148.3 million; 8.3% organic decline, 12.8% acquisition contribution and 3.1% positive impact from foreign currency translation 
• Operating income⁽¹⁾ $20.2 million, 13.6% operating margin⁽¹⁾, up 910 bps

CCL will hold a conference call at 7:30 a.m. EST on Friday November 13, 2020, to discuss these results. The analyst presentation will be posted on the Company’s website.

To access this call, please dial:
1 (844) 347-1036 Toll Free
1 (209) 905-5911 International Dial-In Number
3498305:  Optional Conference Passcode

The press release and conference call presentation will be posted on the Company’s website on Friday, November 13, 2020 – www.cclind.com.

Audio replay service for the conference call will be available Friday, November 13, 2020, at 10:30 a.m. EST until Sunday, November 29, 2020, at 10:30 a.m. EST.

To access Conference Replay, please dial:
1 (855) 859-2056 Toll Free
1 (404) 537-3406 International Dial-In Number
Conference Passcode: 3498305

For more information on CCL, visit our website – www.cclind.com or contact:

Sean Washchuk	Senior Vice President and Chief Financial Officer	416-756-8526

Forward-looking Statements

This press release contains forward-looking information and forward-looking statements (hereinafter collectively referred to as “forward-looking statements”), as defined under applicable securities laws, that involve a number of risks and uncertainties.  Forward-looking statements include all statements that are predictive in nature or depend on future events or conditions.  Forward-looking statements are typically identified by the words “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans” or similar expressions. Statements regarding the operations, business, financial condition, priorities, ongoing objectives, strategies and outlook of the Company, other than statements of historical fact, are forward-looking statements. Specifically, this press release contains forward-looking statements regarding the continuing impact of the COVID-19 pandemic, the impact of foreign currency exchange rates for the next quarter; the levels of demand for the products of the Company’s segments for the balance of 2020; the ability of the Company to continue to adapt operations and cost structures to changing activity levels; the level of capital spending; the strength of the Company’s cash flow, income and profitability of the Company’s segments; and the Company’s expectations regarding general business and economic conditions.

Forward-looking statements are not guarantees of future performance. They involve known and unknown risks and uncertainties relating to future events and conditions including, but not limited to, the extent and duration of the adverse impact of the COVID-19 pandemic on the Company, its employees, customers, suppliers, the global economy and financial markets; the impact of competition; consumer confidence and spending preferences; general economic and geopolitical conditions; currency exchange rates; interest rates and credit availability; technological change; changes in government regulations; risks associated with operating and product hazards; and the Company’s ability to attract and retain qualified employees. Do not unduly rely on forward-looking statements as the Company’s actual results could differ materially from those anticipated in these forward-looking statements.  Forward-looking statements are also based on a number of assumptions, which may prove to be incorrect, including, but not limited to, assumptions about the following: global economic environment and consumer spending; customer demand for the Company’s products; market growth in specific sectors and entering into new sectors; the Company’s ability to provide a wide range of products to multinational customers on a global basis; the benefits of the Company’s focused strategies and operational approach; the achievement of the Company’s plans for improved efficiency and lower costs, including stable aluminum costs; trends for the CCL Segment’s Healthcare & Specialty and CCL Design electronics businesses will remain resilient and augmented; management will successfully curtail cost structures to match reduced demand levels; the ability of the Company to participate in certain government assistance programs; the Company’s expectation of the magnitude of the COVID-19 pandemic on certain of Avery Segment’s direct-to-consumer businesses; consumable sales in grocery and drug store channels will remain solid for the Checkpoint Segment; mandatory closures and other restrictions imposed by governments on businesses as a result of the latest increase in the number of COVID-19 infections will generally be more targeted and more limited in duration than the closures and restrictions previously imposed in 2020 and will have a lesser adverse economic impact; governments will continue to phase-in the re-opening of retail stores and manufacturing facilities and positively impact the results for the Checkpoint Segment; the Checkpoint Segment will successfully align its cost structure to best match the downturn in volume while positioning operations for improved profitability; demand for consumer packaging and product labels will positively impact results for the Innovia Segment; the Innovia Segment will continue to benefit from pricing, productivity initiatives, mix and stable resin costs; the availability of cash and credit;  fluctuations of currency exchange rates; fluctuations in resin prices; the Company’s continued relations with its customers; the Company’s estimated annual cost reductions; and economic conditions. Should one or more risks materialize or should any assumptions prove incorrect, then actual results could vary materially from those expressed or implied in the forward-looking statements.  Further details on key risks can be found in the 2019 Annual Report, Management’s Discussion and Analysis, particularly under Section 4: “Risks and Uncertainties” as well as the 2020 Third Quarter Report, Management’s Discussion and Analysis under Section 12 “Risks and Strategies.”  CCL Industries Inc.’s annual and quarterly reports can be found online at www.cclind.com and www.sedar.com or are available upon request.

Except as otherwise indicated, forward-looking statements do not take into account the effect that transactions or non-recurring or other special items announced or occurring after the statements are made may have on the Company’s business. Such statements do not, unless otherwise specified by the Company, reflect the impact of dispositions, sales of assets, monetizations, mergers, acquisitions, other business combinations or transactions, asset write-downs or other charges announced or occurring after forward-looking statements are made. The financial impact of these transactions and non-recurring and other special items can be complex and depends on the facts particular to each of them and therefore cannot be described in a meaningful way in advance of knowing specific facts. The forward-looking statements are provided as of the date of this press release and the Company does not assume any obligation to update or revise the forward-looking statements to reflect new events or circumstances, except as required by law.

The financial information presented herein has been prepared on the basis of International Financial Reporting Standards (IFRS) for financial statements and is expressed in Canadian dollars unless otherwise stated.

Financial Information

CCL Industries Inc. Consolidated condensed interim statements of financial position Unaudited
In millions of Canadian dollars
	As at September 30, 2020				As at December 31, 2019
Assets
Current assets
Cash and cash equivalents	$	760.2			$	703.6
Trade and other receivables		971.3			849.2
Inventories		552.8			481.6
Prepaid expenses		38.2			36.6
Income taxes recoverable		18.4			34.0
Derivative instruments		0.2			–
Total current assets		2,341.1			2,105.0
Non-current assets
Property, plant and equipment		1,884.2			1,818.2
Right-of-use assets		163.3			146.5
Goodwill		1,907.7			1,794.4
Intangible assets		1,025.1			1,028.7
Deferred tax assets		32.6			30.8
Equity-accounted investments		63.3			62.0
Other assets		29.0			34.5
Derivative instruments		17.9			17.9
Total non-current assets		5,123.1			4,933.0
Total assets	$	7,464.2			$	7,038.0
Liabilities
Current liabilities
Trade and other payables	$	1,094.2			$	1,035.6
Current portion of long-term debt		63.9				38.8
Lease liabilities		35.5				35.3
Income taxes payable		44.0				38.1
Derivative instruments		–				0.2
Total current liabilities		1,237.6				1,148.0
Non-current liabilities
Long-term debt		2,186.9				2,234.8
Lease liabilities		124.8				110.9
Deferred tax liabilities		268.2				245.4
Employee benefits		401.3				364.9
Provisions and other long-term liabilities		11.6				11.4
Derivative instruments		58.7				24.9
Total non-current liabilities		3,051.5				2,992.3
Total liabilities		4,289.1				4,140.3
Equity
Share capital		370.0				365.5
Contributed surplus		91.7				81.5
Retained earnings		2,811.3				2,540.0
Accumulated other comprehensive loss		(97.9	)			(89.3	)
Total equity attributable to shareholders of the Company		3,175.1				2,897.7
Total liabilities and equity	$	7,464.2			$	7,038.0

CCL Industries Inc. Consolidated condensed interim income statements Unaudited
	Three Months Ended September 30								Nine Months Ended September 30
In millions of Canadian dollars, except per share information		2020				2019				2020				2019
Sales	$	1,373.4			$	1,357.1			$	3,891.7			$	4,043.4
Cost of sales		954.4				967.4				2,774.6				2,882.4
Gross profit		419.0				389.7				1,117.1				1,161.0
Selling, general and administrative expenses		185.0				198.0				537.2				594.8
Restructuring and other items		16.2				1.7				21.8				5.2
Earnings in equity-accounted investments		(2.5	)			(1.1	)			(5.5	)			(3.4	)
		220.3				191.1				563.6				564.4
Finance cost		15.4				18.8				46.4				59.9
Finance income		(0.6	)			(0.9	)			(1.9	)			(2.7	)
Interest on lease liabilities		1.6				1.6				4.9				4.9
Net finance cost		16.4				19.5				49.4				62.1
Earnings before income tax		203.9				171.6				514.2				502.3
Income tax expense		50.6				43.9				130.4				129.7
Net earnings for the period	$	153.3			$	127.7			$	383.8			$	372.6
Basic earnings per Class B share	$	0.86			$	0.71			$	2.15			$	2.09
Diluted earnings per Class B share	$	0.86			$	0.71			$	2.14			$	2.08

CCL Industries Inc. Consolidated condensed interim statements of cash flows Unaudited
	Three Months Ended September 30								Nine Months Ended September 30
In millions of Canadian dollars		2020				2019				2020				2019
Cash provided by (used for)
Operating activities
Net earnings	$	153.3			$	127.7			$	383.8		$		372.6
Adjustments for:
Property, plant and equipment depreciation		62.2				58.3				185.2				174.9
Right-of-use assets depreciation		10.6				9.8				31.1				28.9
Intangibles amortization		14.3				14.0				43.1				42.4
Earnings in equity-accounted investments, net of dividends received		(2.5	)			(0.5	)			(2.0	)			(0.1	)
Net finance costs		16.4				19.5				49.4				62.1
Current income tax expense		45.6				42.0				112.6				107.2
Deferred tax expense		5.0				1.9				17.8				22.5
Equity-settled share-based payment transactions		3.5				13.5				11.0				27.0
Gain on sale of property, plant and equipment		–				(1.4	)			(2.5	)			(2.4	)
		308.4				284.8				829.5				835.1
Change in inventories		19.8				9.5				(62.9	)			(2.8	)
Change in trade and other receivables		(33.6	)			11.6				(100.4	)			(17.4	)
Change in prepaid expenses		(3.2	)			(1.3	)			(0.9	)			(5.0	)
Change in trade and other payables		5.6				(10.3	)			14.4				(168.4	)
Change in income taxes receivable and payable		1.7				(1.2	)			6.6				(6.3	)
Change in employee benefits		5.4				9.2				16.2				2.1
Change in other assets and liabilities		7.2				(10.4	)			(27.7	)			(16.4	)
		311.3				291.9				674.8				620.9
Net interest paid		(3.1	)			(11.4	)			(35.1	)			(49.6	)
Income taxes paid		(30.5	)			(22.3	)			(88.3	)			(90.5	)
Cash provided by operating activities		277.7				258.2				551.4				480.8
Financing activities
Proceeds on issuance of long-term debt		14.9				8.3				875.3				121.7
Repayment of long-term debt		(52.4	)			(23.6	)			(955.9	)			(139.6	)
Payment of lease liabilities		(10.3	)			(9.4	)			(34.0	)			(27.3	)
Proceeds from issuance of shares		0.4				1.9				3.7				13.0
Dividends paid		(32.1	)			(30.3	)			(96.4	)			(90.8	)
Cash used for financing activities		(79.5	)			(53.1	)			(207.3	)			(123.0	)
Investing activities
Additions to property, plant and equipment		(47.5	)			(74.8	)			(204.6	)			(285.8	)
Proceeds on disposal of property, plant and equipment		0.2				1.9				14.3				6.4
Business acquisitions and other long-term investments		(10.9	)			(0.1	)			(111.2	)			(33.2	)
Cash used for investing activities		(58.2	)			(73.0	)			(301.5	)			(312.6	)
Net increase in cash and cash equivalents		140.0				132.1				42.6				45.2
Cash and cash equivalents at beginning of period		619.4				481.5				703.6				589.1
Translation adjustment on cash and cash equivalents		0.8				(12.3	)			14.0				(33.0	)
Cash and cash equivalents at end of period	$	760.2			$	601.3			$	760.2		$		601.3

CCL Industries Inc. Segment Information Unaudited
In millions of Canadian dollars
	Three Months Ended September 30												Nine Months Ended September 30
	Sales						Operating Income						Sales						Operating Income
		2020			2019			2020			2019			2020			2019			2020			2019
CCL	$	877.0		$	831.2		$	160.8		$	127.2		$	2,497.4		$	2,513.8		$	416.4		$	386.2
Avery		178.4			207.6			35.7			48.4			483.4			568.5			86.3			121.6
Checkpoint		169.7			180.5			29.6			28.0			446.2			531.3			48.1			71.4
Innovia		148.3			137.8			20.2			6.2			464.7			429.8			59.4			34.1
Total operations	$	1,373.4		$	1,357.1		$	246.3		$	209.8		$	3,891.7		$	4,043.4		$	610.2		$	613.3
Corporate expense								(12.3	)		(18.1	)								(30.3	)		(47.1	)
Restructuring and other items								(16.2	)		(1.7	)								(21.8	)		(5.2	)
Earnings in equity-accounted investments								2.5			1.1									5.5			3.4
Finance cost								(15.4	)		(18.8	)								(46.4	)		(59.9	)
Finance income								0.6			0.9									1.9			2.7
Interest on lease liabilities								(1.6	)		(1.6	)								(4.9	)		(4.9	)
Income tax expense								(50.6	)		(43.9	)								(130.4	)		(129.7	)
Net earnings							$	153.3		$	127.7								$	383.8		$	372.6

	Total Assets						Total Liabilities						Depreciation and Amortization						Capital Expenditures
	September 30			December 31			September 30			December 31			Nine Months Ended September 30						Nine Months Ended September 30
		2020			2019			2020			2019			2020			2019			2020			2019
CCL	$	3,803.7		$	3,634.3		$	1,038.3		$	964.1		$	173.4		$	165.8		$	150.0		$	230.8
Avery		729.0			638.2			237.9			236.7			19.7			17.8			14.9			10.5
Checkpoint		995.1			934.1			497.3			486.8			28.6			28.0			17.5			20.8
Innovia		1,155.6			1,090.8			302.4			261.7			36.5			33.4			22.2			23.4
Equity-accounted investments		63.3			62.0			–			–			–			–			–			–
Corporate		717.5			678.6			2,213.2			2,191.0			1.2			1.2			–			0.3
Total	$	7,464.2		$	7,038.0		$	4,289.1		$	4,140.3		$	259.4		$	246.2		$	204.6		$	285.8

Non-IFRS Measures

The Company measures the success of its business using a number of key performance measures, certain of which are not in accordance with IFRS. These non-IFRS measures do not have standardized meanings and may not be comparable to similar-named measures presented by other issuers. The non-IFRS measures should not be considered as an alternative to or replacement of net earnings or other measures of performance under IFRS.

⁽¹⁾ Operating income and operating income margin are non-IFRS financial measures used to assist in understanding the profitability of the Company’s business units. Operating income is defined as earnings before corporate expenses, net finance cost, goodwill impairment loss, earnings in equity-accounted investments, restructuring and other items, and taxes. Operating income margin, also known as return on sales, is defined as operating income over sales.

⁽²⁾ Adjusted EBITDA is a non-IFRS financial measure used extensively in the packaging industry and other industries to assist in understanding and measuring operating results. Adjusted EBITDA is also considered as a proxy for cash flow and a facilitator for business valuations. This non-IFRS financial measure is defined as earnings before net finance cost, taxes, depreciation and amortization, goodwill impairment loss, non-cash acquisition accounting adjustments to inventory, earnings in equity-accounted investments and restructuring and other items.  The Company believes that this is an important measure as it allows management to assess the ongoing business without the impact of net finance cost, depreciation and amortization and income tax expenses, as well as non-operating factors and one-time items.  As a proxy for cash flow, it is intended to indicate the Company’s ability to incur or service debt and to invest in property, plant and equipment, and it allows management to compare the business to those of the Company’s peers and competitors who may have different capital or organizational structures. Adjusted EBITDA is tracked by financial analysts and investors to evaluate financial performance and is a key metric in business valuations.  Adjusted EBITDA is considered an important measure by lenders to the Company and is included in the financial covenants included in the senior notes and bank lines of credit.

Unaudited (In millions of Canadian dollars)
	Three months ended September 30								Nine months ended September 30
		2020				2019				2020				2019
Net earnings	$	153.3			$	127.7			$	383.8			$	372.6
Corporate expense		12.3				18.1				30.3				47.1
Earnings in equity-accounted investments		(2.5	)			(1.1	)			(5.5	)			(3.4	)
Finance cost, net		16.4				19.5				49.4				62.1
Restructuring and other items		16.2				1.7				21.8				5.2
Income taxes		50.6				43.9				130.4				129.7
Operating income(1)	$	246.3			$	209.8			$	610.2			$	613.3
Less: Corporate expense		(12.3	)			(18.1	)			(30.3	)			(47.1	)
Add: Depreciation and amortization		87.1				82.1				259.4				246.2
Adjusted EBITDA	$	321.1			$	273.8			$	839.3			$	812.4

⁽³⁾ Adjusted basic earnings per Class B share is an important non-IFRS measure to assist in understanding the ongoing earnings performance of the Company excluding items of a one-time or non-recurring nature.  It is not considered a substitute for basic net earnings per Class B share but it does provide additional insight into the ongoing financial results of the Company.  This non-IFRS financial measure is defined as basic net earnings per Class B share excluding gains on business dispositions, goodwill impairment loss, non-cash acquisition accounting adjustments to inventory, restructuring and other items, and tax adjustments.

Reconciliation of Basic Earnings per Class B Share to Adjusted Basic Earnings per Class B Share

Unaudited

	Three months ended September 30								Nine months ended September 30
		2020				2019				2020				2019
Basic earnings per Class B Share	$	0.86			$	0.71			$	2.15			$	2.09
Net loss from restructuring and other items		0.07				0.01				0.09				0.03
Adjusted Basic Earnings per Class B Share	$	0.93			$	0.72			$	2.24			$	2.12

 ⁽⁴⁾ Free Cash Flow from Operations is a measure indicating the relative amount of cash generated by the Company during a period and available to fund dividends, debt repayments and acquisitions. It is calculated as cash flow from operations less capital expenditures, net of proceeds from the sale of property, plant and equipment.

The following table reconciles the measure of free cash flow from operations to IFRS measures reported in the consolidated condensed interim statements of cash flows for the period ended as indicated.

Free Cash Flow from Operations Unaudited (In millions of Canadian dollars)	Nine months ended September 30, 2020
Cash provided by operating activities	$	551.4
Less: Additions to property, plant and equipment		(204.6	)
Add:  Proceeds on disposal of property, plant and equipment		14.3
Free Cash Flow from Operations	$	361.1

⁽⁵⁾ Leverage ratio is a measure that indicates the Company’s ability to service its existing debt.  Leverage ratio is calculated as net debt divided by Adjusted EBITDA.

	September 30, 2020
Unaudited (In millions of Canadian dollars)
Current portion of long-term debt	$	63.9
Current lease liabilities		35.5
Long-term debt		2,186.9
Long-term lease liabilities		124.8
Total debt	$	2,411.1
Cash and cash equivalents		(760.2	)
Net debt	$	1,650.9
Adjusted EBITDA for 12 months ending September 30, 2020    (see below)		1,094.1
Leverage Ratio		1.51
Adjusted EBITDA for 12 months ended December 31, 2019	$	1,067.2
less: Adjusted EBITDA for nine months ended September 30, 2019		(812.4	)
add: Adjusted EBITDA for nine months ended September 30, 2020		839.3
Adjusted EBITDA for 12 months ended September 30, 2020	$	1,094.1

Supplemental Financial Information

Sales Change Analysis

Revenue Growth Rates (%)

	Three Months Ended September 30, 2020								Nine Months Ended September 30, 2020
	Organic		Acquisition		FX				Organic		Acquisition		FX
	Growth		Growth		Translation		Total		Growth		Growth		Translation		Total
CCL	4.2	%	0.4	%	0.9	%	5.5	%	(0.9	%)	0.4	%	(0.2	%)	(0.7	%)
Avery	(19.8	%)	3.9	%	1.8	%	(14.1	%)	(19.6	%)	3.1	%	1.5	%	(15.0	%)
Checkpoint	(8.5	%)	0.7	%	1.8	%	(6.0	%)	(17.3	%)	0.6	%	0.7	%	(16.0	%)
Innovia	(8.3	%)	12.8	%	3.1	%	7.6	%	(3.4	%)	9.9	%	1.6	%	8.1	%
Total	(2.5	%)	2.2	%	1.5	%	1.2	%	(5.9	%)	1.8	%	0.3	%	(3.8	%)

Business Description

CCL Industries Inc. employs approximately 21,700 people operating 188 production facilities in 42 countries with corporate offices in Toronto, Canada, and Framingham, Massachusetts. CCL is the world’s largest converter of pressure sensitive and specialty extruded film materials for a wide range of decorative, instructional, functional and security applications for government institutions and large global customers in the consumer packaging, healthcare & chemicals, consumer electronic device and automotive markets. Extruded & laminated plastic tubes, aluminum aerosols & specialty bottles, folded instructional leaflets, precision decorated & die cut components, electronic displays, polymer banknote substrate and other complementary products and services are sold in parallel to specific end-use markets. Avery is the world’s largest supplier of labels, specialty converted media and software solutions for short-run digital printing applications for businesses and consumers available alongside complementary products sold through distributors, mass market stores and e-commerce retailers. Checkpoint is a leading developer of RF and RFID based technology systems for loss prevention and inventory management applications, including labeling and tagging solutions, for the retail and apparel industries worldwide. Innovia is a leading global producer of specialty, high performance, multi-layer, surface engineered films for label, packaging and security applications. The Company is partly backward integrated into materials science with capabilities in polymer extrusion, adhesive development, coating & lamination, surface engineering and metallurgy; deployed as needed across the four business segments.

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, will participate in a fireside chat during the Jefferies Virtual London Healthcare Conference. The fireside chat is scheduled to take place on Tuesday, November 17, 2020, at 2:20 PM ET/ 7:20 PM GMT.

A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at http://ir.tgtherapeutics.com/events.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is in late stage clinical development with two investigational compounds, ublituximab and umbralisib, the combination of which is referred to as “U2”, targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib (TGR-1202) is an oral, once-daily dual inhibitor of PI3K-delta and CK1-epsilon. Umbralisib is currently under review by the U.S. Food and Drug Administration (FDA) for accelerated approval as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen or follicular lymphoma (FL) who have received at least two prior systemic therapies. The Company also has a fully enrolled Phase 3 clinical trial evaluating U2 in patients with treatment naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), and two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis (RMS). Additionally, the Company has recently brought into Phase 1 clinical development its anti-PD-L1 monoclonal antibody, cosibelimab (TG-1501), its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801. TG Therapeutics is headquartered in New York City.

CONTACT:

Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: [email protected]