Vireo Health to Present at Canaccord Genuity’s 3rd Annual Cannabis Conference

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Psilocybin Mushrooms Decriminalized in Denver

BARCELONA, Spain, May 09, 2019 (GLOBE NEWSWIRE) — via OTC PR WIRE — Wuhan General Group (China), Inc. (OTC PINK: WUHN) (the “Company” and “Wuhan”), and M2BIO is delighted to share the voting results of Initiative 301 held in Denver last night. Denver will become the first US city to effectively decriminalize mushrooms containing the psychedelic psilocybin, also known as “magic mushrooms.”

“This is a big step forward for medicine and research into medicinal mushrooms. No different than how marijuana laws loosened up over time, the same will happen with mushrooms creating huge opportunities,” said Dr. Anna, Medical Doctor, CMO of Wuhan.

This type of pioneering vote isn’t new for Denver or Colorado as a whole. In 2012, Colorado’s and Washington’s state became the first two states to legalize marijuana for recreational use. Oregon and California, are considering measures to change their laws regarding psilocybin as well.

“The Denver vote and results are truly groundbreaking news for Wuhan and M2BIO. We are really looking forward to sharing very soon in details our medicinal mushroom roadmap in South Africa with our partner BioDelta,” said Jeff Robinson, MJ MedTech CEO.

Leon Giese, Biodelta CEO added: “BioDelta has deep experience in producing medicinal plants under ISO 9001 certification and we are eager to be working with Wuhan to grow and commercialize medicinal mushrooms into our existing supply chain.”

About M2BIO

M2BIO aims to develop new therapies that will help patients who suffer from mental illness and ease the burden on healthcare systems globally. This division will be exploring additional indications for psilocybin, with the goal of bringing new therapies to market.

Psilocybin mushrooms (AKA magic mushrooms, or shrooms) is the name given to fungi that contain psilocybin, a naturally occurring psychedelic compound. Psilocybin mushrooms have been used in therapeutic settings to treat a wide variety of ailments and disorders including cluster headaches, obsessive-compulsive disorders, anxiety, depression, and addiction.

About Wuhan General Group (China), Inc.

Wuhan General Group (China), Inc. through its wholly-owned subsidiary MJ MedTech is a nutraceutical biotechnology company that research, develops and commercializes a range of CBD-based products under the Dr. AnnaRx brand. In addition, its new division, M2BIO aims to explore and develop additional indications for psilocybin new therapies that will help patients who suffer from mental illness. Our mission is to advance botanical-based medicine to the forefront by deploying best practice science and medicine, clinical research and emerging technologies.

For further information contact:

Publicly traded company (OTC Pink: WUHN)

Website: www.wuhn.org

Public Relations E-mail: info@wuhn.org

Forward-Looking Statements:

Safe Harbour Statement – In addition to historical information, this press release may contain statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief, or expectations of the Company and members of its management team with respect to the Company’s future business operations and the assumptions upon which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance, and involve risks and uncertainties and that actual results may differ materially from those contemplated by such forward-looking statements. Factors that could cause these differences include, but are not limited to, failure to complete anticipated sales under negotiations, lack of revenue growth, client discontinuances, failure to realize improvements in performance, efficiency and profitability, and adverse developments with respect to litigation or increased litigation costs, the operation or performance of the Company’s business units or the market price of its common stock. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found on the Company’s website. The Company disclaims any responsibility to update any forward-looking statements.

Source: Wuhan General Group (China), Inc.

Vireo Health Announces Full Year 2018 Revenues of $18.5 Million with 70% Year-Over-Year Growth

MINNEAPOLISApril 30, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), a leading science-focused, multi-state cannabis company, today reported financial results for its fourth quarter and full year ended December 31, 2018. All currency figures referenced in this release reflect U.S. dollar amounts.

“2018 was a momentous year for Vireo Health, with strong operating performance and substantial progress toward becoming a truly differentiated multi-state operator,” said Founder & CEO, Kyle Kingsley, M.D. “We achieved significant revenue growth in our existing markets and also laid the groundwork to double our footprint to ten or more states while simultaneously investing in industry-leading research and innovation. Overall, we believe that the Company is better positioned for future growth, profitability, and value creation for shareholders, and we’re looking forward to another successful year in fiscal 2019.”

Business Highlights

  • Vireo generated revenue in three states in 2018: MinnesotaNew York, and Pennsylvania. Total revenue for Q4 2018 increased 72 percent year-over-year to $5.6 million versus Q4 2017. Total revenue for FY 2018 increased approximately 70 percent year-over-year to $18.5 million versus FY 2017.
  • During FY 2018, Company subsidiaries and affiliates were awarded a processing license in the state of Ohio, a grower and processor license in the state of Maryland, and a license in Pennsylvania to open three dispensaries. The Company also signed an agreement to acquire a Puerto Rico company which has received pre-qualifications to obtain required licenses to operate a medical cannabis cultivation facility, a processing facility, and six dispensaries.
  • During the first four months of 2019, the Company acquired various cannabis licenses and real estate in the states of ArizonaMassachusettsNevadaNew Mexico, and Rhode Island. These acquisition activities expanded Vireo’s licensed footprint to 10 states nationwide.
  • Net loss for Q4 and FY 2018 were $1.2 million and $3.1 million, respectively. Adjusted net income for Q4 and FY 2018 were $1.3 million and $1.5 million, respectively.
  • Q4 2018 EBITDA and Adjusted EBITDA, as described in accompanying disclosures and footnotes, were $1.8 million and $4.3 million, respectively. For FY 2018, EBITDA and Adjusted EBITDA were $4.8 million and $9.4 million, respectively.
  • During the year, the Company onboarded 75 new team members, including several key executive hires, bringing total headcount to 224 nationwide as of December 31, 2018. As of the date of this news release, the Company has over 330 team members nationwide.

Fourth Quarter and Fiscal Year 2018 Financial Summary

Total revenue for Q4 2018 was $5.6 million, up 72 percent from $3.3 million in Q4 2017. For FY 2018, total revenue was $18.5 million, up 70 percent from $10.9 million in FY 2017. Fourth-quarter and full-year revenue growth were driven by increased patient counts and demand in the states of Minnesota and New York, as well as the beginning of revenue generation in the state of Pennsylvania.

Gross profit before fair value adjustments for Q4 and FY 2018 was $1.8 million or 31.2 percent of revenue, and $8.9 million or 48.4 percent, respectively, as compared to $922,156 or 28.2 percent, and $5.8 million or 53.0 percent for the same periods last year. Gross profit after fair value adjustments and net gains on growth of biological asset for Q4 and FY 2018 was $5.4 million or 95 percent, and $16.8 million or 90.9 percent, respectively, as compared to 36.1 percent and 58.6 percent for the same periods last year.

Total operating expenses for Q4 and FY 2018 were $3.6 million and $12.2 million, respectively, as compared to $700,224 and $6.4 million for the same periods last year. Total operating expenses include selling, general and administrative (“SG&A”) expenses, which totaled $1.6 million and $3.8 million for Q4 2018 and FY 2018, respectively. The increase in SG&A expenses was primarily driven by investments in talent to support the Company’s growing businesses.

Other expense was $1.2 million in Q4 2018 and $2.5 million for FY 2018. These non-operating expenses primarily reflect interest expenses associated with recent sale-and-leaseback transactions of certain cultivation facilities.

Net loss attributable to Vireo in Q4 2018 was $1.2 million, as compared to net income of approximately $273,098 in Q4 2017. For the FY 2018, net loss was $3.1 million, compared to a net loss of approximately $430,689 in FY 2017.

EBITDA was $1.8 million in Q4 2018, as compared to $603,020 in Q4 2017. Excluding transaction costs, share-based compensation expenses, and new market start-up costs, Vireo generated Adjusted EBITDA of $4.3 million in Q4 2018. For FY 2018, EBITDA was $4.8 million, as compared to $163,352 in 2017. Excluding transaction costs, share-based compensation expenses, and new market start-up costs, Adjusted EBITDA was $9.4 million for the year, as compared to $693,890 in 2017. Please refer to the Supplemental Information and Reconciliation of Non-IFRS Financial Measures at the end of this press release for additional information.

Subsequent Events

On March 20, 2019, Vireo commenced trading on the Canadian Securities Exchange under ticker symbol “VREO” following the successful completion of the Company’s reverse takeover (“RTO”) of Darien Business Development Corp. In conjunction with the RTO, Vireo raised approximately $51.4 million in proceeds through a brokered and non-brokered private placement. The Company intends to utilize the net proceeds from the transaction to help finance M&A activity, as well as for general corporate purposes including business development, capacity expansion projects, working capital requirements and other strategic initiatives.

Balance Sheet and Liquidity

As of December 31, 2018, total assets were $69.3 million, including cash on hand of $9.6 million. Total long-term liabilities were $23.4 million as of December 31, 2018, with $1.0 million of debt currently due within 12 months.

Total equity shares outstanding as of December 31, 2018, were 2,206,269. As of the date of this release, total fully-diluted equity shares outstanding, on an as converted basis, were 111,882,624. The increased share count as compared to December 31, 2018 is primarily attributable to share-split activity as well as the sale of subscription receipts in conjunction with the Company’s RTO during the first quarter of 2019.

2019 Outlook

During fiscal year 2019, Vireo expects to conduct the following development activities:

  • Launch Green Goods™ dispensaries in Pennsylvania and expand existing retail footprint in New Mexico
  • Increase cultivation and processing capacity in ArizonaMinnesotaNew Mexico and New York
  • Begin build-out of new facilities in MassachusettsNevadaPuerto Rico, and Rhode Island
  • Roll out new cannabis brands and innovative products in multiple state-based markets
  • Wholesale Vireo-branded products to third-party dispensaries in Ohio
  • Plant industrial hemp crops for IP development in Minnesota and New York

Dr. Kingsley commented, “Our management team is focused on executing several key strategic initiatives in fiscal year 2019, including the rollout of new dispensary locations, the pursuit of additional organic and acquisitive growth opportunities, and the development of intellectual property that we can monetize for the long-term benefit of patients, consumers, and shareholders. In the coming months, our subsidiaries in Minnesota and New York will also begin planting hemp crops that will support our IP development initiatives. We’re looking forward to sharing updates on those projects, in addition to our ongoing scientific research studies and other growth initiatives, as material updates become available.”

Conference Call and Webcast Information

Vireo Health management will host a conference call with research analysts on Tuesday, April 30, 2019 at 8:30 a.m. ET to discuss its financial results for Q4 and FY ended December 31, 2018. The conference call may be accessed by dialing 866-211-3165 (Toll-Free) or 647-689-6580 (International) and entering conference ID 4176936. A live audio webcast of this event will also be available in the Events & Presentations section of the Company’s Investor Relations website at https://investors.vireohealth.com/ and will be archived for one year.

Additional Information

Additional information relating to the Company’s fourth quarter and fiscal year 2018 results, including performance of Vireo’s predecessor company, Darien Business Development Corp., is available on SEDAR at www.sedar.com.

Vireo Health refers to certain non-IFRS financial measures such as adjusted net income, Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) and adjusted EBITDA (defined as earnings before interest, taxes, depreciation, amortization, less certain non-cash equity compensation expense, one-time transaction fees, and other non-cash items. These measures do not have any standardized meaning prescribed by IFRS and may not be comparable to similar measures presented by other issuers. Please see the Supplemental Information and Reconciliation of Non-IFRS Financial Measures at the end of this news release for more detailed information regarding non-IFRS financial measures.

About Vireo Health International, Inc.

Vireo’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. The Company’s physician-led team of more than 300 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally-friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company is currently licensed in ten states including ArizonaMarylandMassachusettsMinnesotaNevadaNew MexicoNew YorkOhioPennsylvania, and Rhode Island.  For more information about the company, please visit www.vireohealth.com.

Forward-Looking Statement Disclosure

This news release contains forward-looking information within the meaning of applicable securities laws, based on current expectations. Generally, any statements that are not historical facts may contain forward-looking information, and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “look forward to”, “budget” “scheduled”, “estimates”, “forecasts”, “will continue”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or indicates that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, “occur” or “be achieved.” Forward looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, future developments, the future operations, potential market opportunities, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. These statements are based upon certain material factors, assumptions and analyses that were applied in drawing a conclusion or making a forecast or projection, including Vireo’s experience and perceptions of historical trends, current conditions and expected future developments, as well as other factors that are believed to be reasonable in the circumstances.

Examples of the assumptions underlying the forward-looking statements contained herein include, but are not limited to those related to: the achievement of goals, the closing of acquisitions, obtaining of necessary permits and governmental approvals, future market positioning, as well as expectations regarding availability of equipment, skilled labor and services needed for cannabis operations, intellectual property rights,  development, operating or regulatory risks, trends and developments in the cannabis industry, business strategy and outlook, expansion and growth of business and operations, the timing and amount of capital expenditures; future exchange rates; the impact of increasing competition; conditions in general economic and financial markets; access to capital; future operating costs; government regulations, including future legislative and regulatory developments involving medical and recreational marijuana and the timing thereto; receipt of appropriate and necessary licenses in a timely manner; the effects of regulation by governmental agencies; the anticipated changes to laws regarding the recreational use of cannabis; the demand for cannabis products and corresponding forecasted increase in revenues; and the size of the medical marijuana market and the recreational marijuana market.

Although such statements are based on management’s reasonable assumptions at the date such statements are made, there can be no assurance that it will be completed on the terms described above and that such forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking information. Accordingly, readers should not place undue reliance on the forward-looking information. Vireo assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by applicable law.

By its nature, forward-looking information is subject to risks and uncertainties, and there are a variety of material factors, many of which are beyond the control of the Company and that may cause actual outcomes to differ materially from those discussed in the forward-looking statements. These factors include, but are not limited to: denial or delayed receipt of all necessary consents and approvals; need for additional capital expenditures; increased costs and timing of operations; unexpected costs associated with environmental liabilities; requirements for additional capital; reduced future prices of cannabis; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the cannabis industry; delays in obtaining governmental approvals, permits or financing or in the completion of development or construction activities; title disputes; claims limitations on insurance coverage; risks related to the integration of acquisitions; fluctuations in the spot and forward price of certain commodities (such as diesel fuel and electricity); changes in national and local government legislation, taxation, controls, regulations and political or economic developments in the countries where the Company may carry on business in the future;  liabilities inherent in cannabis operations;  risks relating to medical and recreational cannabis; cultivation, extraction and distribution problems; competition for, among other things, capital, licences and skilled personnel;  risks relating to the timing of legalization of recreational cannabis; changes in laws relating to the cannabis industry; and management’s success in anticipating and managing the foregoing factors.

Supplemental Information

The financial information reported in this news release is based on management prepared financial statements for the fiscal year ended December 31, 2018. Accordingly, such financial information may be subject to change. Fully-audited financial statements for the period will be released and filed under the Company’s profile on SEDAR by April 30, 2019. All financial information contained in this news release is qualified in its entirety with reference to such audited financial statements. While the Company does not expect there to be any material changes, to the extent that the financial information contained in this news release is inconsistent with the information contained in the Company’s audited financial statements, the financial information contained in this news release shall be deemed to be modified or superseded by the Company’s audited financial statements. The making of a modifying or superseding statement shall not be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation for purposes of applicable securities laws.

Vireo Health, Inc.

Consolidated Statements of Financial Position

December 31, 2018 and 2017

(Expressed in United States Dollars)

December 31,

December 31,

2018

2017

ASSETS

Current Assets

Cash

$              9,624,110

$           2,595,965

Receivables

1,671,257

Inventories

21,379,722

14,575,040

Biological Assets

5,967,150

2,815,030

Prepaid Expenses

962,297

624,010

Deferred acquisition costs

1,885,653

Deferred financing costs

448,480

41,938,669

20,610,045

Non-Current Assets

Property and equipment

22,847,283

14,805,788

Deposits

2,259,735

966,012

Deferred Loss on Sale Leaseback Transaction

26,596

35,441

Intangible Asset

2,184,565

Due from Related Party

146,893

27,318,179

15,954,134

Total Assets

$            69,256,848

$         36,564,179

LIABILITIES AND SHAREHOLDERS’ EQUITY

Current Liabilities

Accounts Payable and Accrued Liabilities

$              2,512,389

$          1,516,300

Deferred lease inducements

341,555

Current portion of lease obligations

338,638

Current Portion of Long-Term Debt

1,010,000

4,202,582

1,516,300

Long-Term Liabilities

Deferred Rent

271,091

113,242

Deferred income taxes

6,508,000

Deferred lease inducements

4,781,770

Lease Obligations

11,839,152

6,431,129

Long-Term Debt

1,010,000

27,602,595

9,070,671

Shareholders’ Equity

Share Capital

41,965,556

Members’ Capital

22,910,942

Members’ Units Receivable

(1,780)

Reserves

2,766,050

Retained earnings (deficit)

(3,077,353)

4,584,346

41,654,253

27,493,508

Total Liabilities and Shareholders’ Equity

$            69,256,848

$         36,564,179

Vireo Health, Inc.

Consolidated Statements of Loss and Comprehensive Loss

For the Years Ended December 31, 2018 and 2017

(Expressed in United States Dollars)

Year Ended

December 31,

2018

Year Ended

December 31,

2017

REVENUE

$            18,459,069

$            10,867,064

Production Costs

(9,519,433)

(5,104,379)

Gross Profit Before Fair Value Adjustments

8,939,636

5,762,685

 Realized Fair Value Amounts Included in Inventory Sold

(16,457,419)

(5,840,818)

 Unrealized Fair Value Gain on Growth of Biological Assets

24,302,031

6,443,637

Gross Profit

16,784,248

6,365,504

EXPENSES

Depreciation

274,319

213,356

Professional fees

1,862,317

1,013,006

Salaries and wages

4,144,540

3,019,105

Selling, general and administrative expenses

3,831,634

2,159,192

Share-based compensation

2,072,706

(12,185,516)

(6,404,659)

OTHER INCOME (EXPENSE)

Loss on Sale of Property and Equipment

(25,065)

(398)

Interest Expense – Debt

(2,390,422)

(381,960)

Interest Income

1,275

Other Expense

(59,598)

(10,451)

Total Other Income (Expense)

(2,475,085)

(391,534)

INCOME (LOSS) BEFORE TAXES

2,123,647

(430,689)

Current income tax

(2,918,000)

Deferred income tax

(2,283,000)

Total income taxes

(5,201,000)

NET LOSS AND COMPREHENSIVE LOSS

$           (3,077,353)

$              (430,689)

Weighted average shares outstanding – Basic and diluted

2,206,269

N/A

Net loss per share

$                    (1.39)

N/A

Reconciliation of Non-IFRS Financial Measures

This news release contains references to financial metrics such as EBITDA, Adjusted EBITDA, and Adjusted Net Income, which are non-IFRS measures and do not have standardized definitions under IFRS. The Company has provided these non-IFRS financial measures in this news release as supplemental information and in addition to the financial measures that are calculated and presented in accordance with IFRS. These supplemental non-IFRS financial measures are presented because management has evaluated the Company’s financial results both including and excluding the adjusted items and believe that the supplemental non-IFRS financial measures presented provide additional perspective and insights when analyzing the core operating performance of the Company’s business. The Company has provided reconciliations of these supplemental non-IFRS financial measures to the most directly comparable financial measures calculated and presented in accordance with International Financial Reporting Standards. Supplemental non-IFRS financial measures should not be considered superior to, as a substitute for or as an alternative to, and should be considered in conjunction with, the IFRS financial measures presented in this news release.

Three Months Ended

Twelve Months Ended

December 31, 

December 31, 

2018

2017

2018

2017

Net income (loss) (IFRS) 

$  (1,182,621)

$        273,098

$  (3,077,353)

$      (430,689)

Transaction costs

386,882

448,480

Share-based compensation

572,869

2,072,706

New market startup costs(1)

1,561,645

35,010

2,051,350

530,538

Adjusted net income (loss) (non-IFRS)

$    1,338,775

$        308,108

$    1,495,182

$          99,849

Net income (loss) (IFRS) 

$  (1,182,621)

$        273,098

$  (3,077,353)

$      (430,689)

Interest income

319

(8)

(1,275)

Interest expense

1,122,673

267,383

2,390,422

381,960

Income taxes

1,731,000

5,201,000

Depreciation

105,757

62,547

274,319

213,356

EBITDA (non-IFRS)

$    1,777,128

$        603,020

$    4,788,388

$        163,352

Transaction costs

386,882

448,480

Share-based compensation

572,869

2,072,706

New market startup costs(1)

1,561,645

35,010

2,051,350

530,538

Adjusted EBITDA (non-IFRS)

$    4,298,524

$        638,030

$    9,360,923

$        693,890

(1)  New market startup costs include expenses such license application fees, legal and other professional fees, and other administrative start-up expenses

Media Inquiries

Investor Inquiries

Albe Zakes

Sam Gibbons

Vice President, Corporate Communications

Vice President, Investor Relations

albezakes@vireohealth.com 

samgibbons@vireohealth.com 

(267) 221-4800

(612) 314-8995

SOURCE Vireo Health, Inc.

Related Links

https://www.vireohealth.com

Vireo Health to Report Fourth Quarter and Full Year 2018 Results on April 30, 2019

MINNEAPOLIS, April 26, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), a leading science-focused, multi-state cannabis company, today announced that it will report its financial results for the fourth quarter and full year ended December 31, 2018 on Tuesday, April 30, 2019 before the market opens.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

The Company will hold a conference call and webcast to discuss its business and financial results that same day at 8:30 a.m. Eastern Time (7:30 a.m. Central Time). A live audio webcast of the call will be available in the Events & Presentations section of Vireo’s website at https://investors.vireohealth.com. The conference call may also be accessed by dialing 866-211-3165 (Toll-Free) or 647-689-6580 (International) and entering conference ID 4176936. A webcast replay will be available for one year on Vireo’s website.

About Vireo Health International, Inc.
Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. Vireo’s physician-led team of more than 300 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally-friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company is currently licensed in ten states including Arizona, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island. For more information about the company, please visit www.vireohealth.com.

Contact Information 

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

CisionView original content to download multimedia:http://www.prnewswire.com/news-releases/vireo-health-to-report-fourth-quarter-and-full-year-2018-results-on-april-30-2019-300838995.html

SOURCE Vireo Health, Inc.

Vireo Health’s Patent Application For Less Harmful Tobacco Products Infused With Cannabis Is Approved By USPTO

Potential benefits associated with cannabinoid additives in tobacco products include the reduction of irritation, inflammation and carcinogenicity

 

MINNEAPOLIS, April 25, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), a leading science-focused, multi-state cannabis company, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a Notice of Allowance for its patent application titled, “Tobacco Products with Cannabinoid Additives and Methods for Reducing the Harm Associated with Tobacco Use.”

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“This patent is a component of our strategy to disrupt the tobacco industry and help save lives,” said Chief Executive Officer, Kyle Kingsley, M.D. “As a physician, I am passionate about finding ways to use cannabis to reduce the harmful effects of tobacco. We look forward to collaborating with research institutions and tobacco companies committed to developing less harmful tobacco products.”

Vireo’s allowed patent application covers cannabis-based additives that can be formulated into tobacco products to reduce the harm associated with tobacco use. This novel application of cannabis covers the use of one or more carefully formulated cannabinoids as harm reducing agents in tobacco products such as cigarettes, cigars, pipe tobacco and smokeless tobacco products. A Notice of Allowance is issued after the USPTO determines that a patent can be granted from the application, which was filed in March 2017.

Potential benefits associated with cannabinoid additives in tobacco products include the reduction of irritation, inflammation, and carcinogenicity. According to a 2016 study, scientific evidence supports that cannabinoids may have substantial anti-cancer effects.

The Centers for Disease Control & Prevention report that the use of tobacco is not only the leading cause of preventable disease in the U.S., but also imposes significant economic costs. Specifically, smoking-related illness in the United States costs more than $300 billion a year, including nearly $170 billion in direct medical care for adults. In 2017, an estimated 14.0% (34.3 million) of U.S. adults were cigarette smokers.

About Vireo Health International, Inc.
Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. Vireo’s physician-led team of more than 300 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally-friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company currently has operations in ten states including Arizona, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island.  For more information about the company, please visit www.vireohealth.com.

Contact Information

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Forward-Looking Statement Disclosure

This news release contains forward-looking information within the meaning of applicable securities laws, based on current expectations. Generally, any statements that are not historical facts may contain forward-looking information, and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “look forward to”, “budget”, “scheduled”, “estimates”, “forecasts”, “will continue”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or indicates that certain actions, events or results “may”, “could”, “would”, “potentially”, “might” or “will be” taken, “occur” or “be achieved.” Forward looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, future developments, the future operations, potential market opportunities, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. These statements are based upon certain material factors, assumptions and analyses that were applied in drawing a conclusion or making a forecast or projection, including Vireo’s experience and perceptions of historical trends, current conditions and expected future developments, as well as other factors that are believed to be reasonable in the circumstances.

Examples of the assumptions underlying the forward-looking statements contained herein include, but are not limited to those related to: the achievement of goals, the closing of acquisitions, obtaining of necessary permits and governmental approvals, future market positioning, as well as expectations regarding availability of equipment, skilled labor and services needed for cannabis operations, intellectual property rights,  development, operating or regulatory risks, trends and developments in the cannabis industry, business strategy and outlook, expansion and growth of business and operations, the timing and amount of capital expenditures; future exchange rates; the impact of increasing competition; conditions in general economic and financial markets; access to capital; future operating costs; government regulations, including future legislative and regulatory developments involving medical and recreational marijuana and the timing thereto; receipt of appropriate and necessary licenses in a timely manner; the effects of regulation by governmental agencies; the anticipated changes to laws regarding the recreational use of cannabis; the demand for cannabis products and corresponding forecasted increase in revenues; and the size of the medical marijuana market and the recreational marijuana market.

Although such statements are based on management’s reasonable assumptions at the date such statements are made, there can be no assurance that it will be completed on the terms described above and that such forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking information. Accordingly, readers should not place undue reliance on the forward-looking information. Vireo assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by applicable law.

By its nature, forward-looking information is subject to risks and uncertainties, and there are a variety of material factors, many of which are beyond the control of the Company and that may cause actual outcomes to differ materially from those discussed in the forward-looking statements. These factors include, but are not limited to: denial or delayed receipt of all necessary consents and approvals; need for additional capital expenditures; increased costs and timing of operations; unexpected costs associated with environmental liabilities; requirements for additional capital; reduced future prices of cannabis; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the cannabis industry; delays in obtaining governmental approvals, permits or financing or in the completion of development or construction activities; title disputes; claims limitations on insurance coverage; risks related to the integration of acquisitions; fluctuations in the spot and forward price of certain commodities (such as diesel fuel and electricity); changes in national and local government legislation, taxation, controls, regulations and political or economic developments in the countries where the Company may carry on business in the future;  liabilities inherent in cannabis operations;  risks relating to medical and recreational cannabis; cultivation, extraction and distribution problems; competition for, among other things, capital, licences and skilled personnel;  risks relating to the timing of legalization of recreational cannabis; changes in laws relating to the cannabis industry; and management’s success in anticipating and managing the foregoing factors.

 

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SOURCE Vireo Health, Inc.

Health Canada Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis

  • SKYRIZI™(risankizumab) is a novel, humanized immunoglobulin monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit to treat moderate to severe plaque psoriasis1 . IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune
  • Approval of SKYRIZI™ (risankizumab) is based on results from clinical studies showing significant improvement in levels of skin clearance after just 16 weeks and at 52 weeks with every 3 month dosing in more than 2000 adult patients 2-5

 

Montreal, Quebec, April 18, 2019 – AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, announced today that Health Canada has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

 

Canadians living with moderate to severe plaque psoriasis were well represented in all four of the pivotal clinical trials leading to Health Canada’s approval, showing the Canadian leadership in this clinical development program.

 

In clinical studies, SKYRIZI™ significantly improved levels of skin clearance after just 16 weeks and maintained clearance at one year (52 weeks).2-5

 

“When treating patients with a chronic disease like psoriasis, it is important to have several options available. With SKYRIZI™, we can simplify their treatment by offering a greater chance of clear skin with a safe and easy three-month dosing regimen. As a dermatologist, this allows me to spend the time I have with my patients on other issues pertaining to their overall health and well-being,” said Dr. Melinda Gooderham, Dermatologist from the SKiN Centre for Dermatology in Peterborough, Ontario.

 

Kathryn Clay, President, Canadian Association of Psoriasis Patients added “Psoriasis is a chronic condition affecting more than one million Canadians and many patients still do not reach their treatment goals or lose response to medication over time so we need options for them.

Despite tremendous progress, there is still much to be done as highlighted in our report Treat Psoriasis Seriously.”

 

 

 

 

 

 

 

 

Stéphane Lassignardie, General Manager, AbbVie Canada added: “We are committed to continuing to find new and better medications that will improve the lives of those living with psoriasis. There are still areas of unmet medical need and we are thrilled that people will be able to access SKYRIZI™.”

 

SKYRIZI™ received Health Canada approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.2-5 SKYRIZI™ is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

 

 

Highlights from the pivotal Phase 3 program

  • In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI™ I met the co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 (p<0.001).1,4 After 16 weeks of treatment, 88 percent (ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI™ patients achieved sPGA 0/1 and 75 percent of patients receiving SKYRIZI™ in both studies achieved PASI 2,4,5

 

  • Among patients with sPGA of 0/1 at Week 28 in the IMMhance study, 87.4% (97/111) maintained response with continued treatment with SKYRIZI™ compared to 61.3% (138/225) with withdrawal (placebo) at Week 525.

 

  • SKYRIZI™ demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at Week 16 (p<0.001).2,4 Following re-randomization at Week 16, 66 percent of patients who started on adalimumab and switched to SKYRIZI™ achieved PASI 90, compared to 21 percent who continued on adalimumab at Week 44 (p<0.001).2,4 The co-primary endpoints of sPGA 0/1 and PASI 90 at Week 16 were met (p<0.001).2,4, 5

 

 

  • SKYRIZI™ was also reported to improve health-related quality of life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with SKYRIZI™ self- reported a Dermatology Life Quality Index (DLQI) score of 0/1 (no impact on health- related quality of life) at Week 16 (66 percent in ultIMMa-1 and 67 percent in ultIMMa-2) compared with ustekinumab (43 percent in ultIMMa-1 and 47 percent in ultIMMa-2)2,5

 

 

 

 

 

 

 

 

  • The most frequently reported adverse drug reactions through the 16-week placebo- controlled period in the SKYRIZI™ group were upper respiratory tract infections (13%) compared with 10% in the placebo group. Common adverse reactions occurring in ≥ 1% of patients treated with SKYRIZI™ included tinea infections, headache, pruritus, fatigue and injection site 4, 5

 

About AbbVie Care

The AbbVie Care program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment journey. For more information, consult www.abbviecare.ca.

 

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

 

Media:

Eileen Murphy AbbVie Canada (514) 832-7788

eileen.murphy@abbvie.com

 

 

###

 

References:

  1. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J 2017 Apr 20; 376:1551-1560.
  2. Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
  3. Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate- to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology 2018.

 

 

 

 

 

 

 

 

  1. Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219):
  2. SKYRIZI™ (risankizumab) [Canadian Product Monograph]. AbbVie Corporation,

Vireo Health CEO & Founder Kyle Kingsley, M.D. to Present at Two Upcoming Cannabis Investor Conferences

VIEW ALL NEWS

Vireo Health Now Licensed to Operate in Ten States with Acquisition of Nevada Cannabis Company

Company’s double-digit state footprint now includes Arizona, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island

MINNEAPOLIS, April 11, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), America’s leading science-focused, multi-state cannabis company, today announced the acquisition of two medical cannabis licenses in the State of Nevada. The licenses, which are conditionally approved for adult-use cannabis, will enable Vireo to cultivate, manufacture, and wholesale cannabis-based products to Nevada’s licensed dispensaries. This acquisition marks the tenth state in which Vireo is licensed – a milestone achieved by only a select group of multi-state operators (MSO).

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“A multi-state operator’s geographic footprint is a key determinant of its success, and we believe that the ten states in which Vireo is licensed to operate position the Company to deliver significant value to shareholders,” said Chief Executive Officer, Kyle Kingsley, M.D. “Our expansion into Nevada also highlights our commitment to operate in adult-use markets where our physician-led team can help consumers better understand the potential health benefits of replacing opioids, alcohol, and tobacco with cannabis.”

On November 8, 2016, voters in Nevada passed the Regulation and Taxation of Marijuana Act (Ballot Question 2) to allow for the sale, possession, and consumption of recreational marijuana in the state for adults 21 and older. Over $250 million dollars in cannabis-based products were sold in 2018 in Nevada, according to the State’s Department of Taxation.

This transaction, which was previously disclosed in the Company’s CSE listing statement, was financed through a combination of cash and stock and represents Vireo Health’s fourth acquisition since it began trading on the Canadian Securities Exchange under the ticker symbol “VREO.” Vireo Health now has more than 300 employees in ten states including Arizona, Maryland, Massachusetts, Minnesota, Nevada, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island.

About Vireo Health International, Inc.

Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry. Vireo’s physician-led team of more than 300 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally-friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company currently is licensed in ten states including Arizona, Maryland, Massachusetts, Minnesota, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island. For more information about the company, please visit www.vireohealth.com.

Contact Information 

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

This news release does not constitute an offer to sell or a solicitation of an offer to sell any of the securities in the United States. The securities have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to U.S. Persons unless registered under the U.S. Securities Act and applicable state securities laws or an exemption from such registration is available.

Forward-Looking Statement Disclosure

This news release contains forward-looking information within the meaning of applicable securities laws, based on current expectations. Generally, any statements that are not historical facts may contain forward-looking information, and forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “look forward to”, “budget” “scheduled”, “estimates”, “forecasts”, “will continue”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or indicates that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, “occur” or “be achieved.” Forward looking information may include, without limitation, statements regarding the operations, business, financial condition, expected financial results, performance, prospects, opportunities, priorities, targets, goals, ongoing objectives, milestones, strategies and outlook of Vireo, and includes statements about, among other things, future developments, the future operations, potential market opportunities, strengths and strategy of the Company. Forward-looking information is provided for the purpose of presenting information about management’s current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. These statements should not be read as guarantees of future performance or results. These statements are based upon certain material factors, assumptions and analyses that were applied in drawing a conclusion or making a forecast or projection, including Vireo’s experience and perceptions of historical trends, current conditions and expected future developments, as well as other factors that are believed to be reasonable in the circumstances.

Examples of the assumptions underlying the forward-looking statements contained herein include, but are not limited to those related to: the achievement of goals, the closing of acquisitions, obtaining of necessary permits and governmental approvals, future market positioning, as well as expectations regarding availability of equipment, skilled labor and services needed for cannabis operations, intellectual property rights, development, operating or regulatory risks, trends and developments in the cannabis industry, business strategy and outlook, expansion and growth of business and operations, the timing and amount of capital expenditures; future exchange rates; the impact of increasing competition; conditions in general economic and financial markets; access to capital; future operating costs; government regulations, including future legislative and regulatory developments involving medical and recreational marijuana and the timing thereto; receipt of appropriate and necessary licenses in a timely manner; the effects of regulation by governmental agencies; the anticipated changes to laws regarding the recreational use of cannabis; the demand for cannabis products and corresponding forecasted increase in revenues; and the size of the medical marijuana market and the recreational marijuana market.

Although such statements are based on management’s reasonable assumptions at the date such statements are made, there can be no assurance that it will be completed on the terms described above and that such forward-looking information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such forward-looking information. Accordingly, readers should not place undue reliance on the forward-looking information. Vireo assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances unless required by applicable law.

By its nature, forward-looking information is subject to risks and uncertainties, and there are a variety of material factors, many of which are beyond the control of the Company and that may cause actual outcomes to differ materially from those discussed in the forward-looking statements. These factors include, but are not limited to: denial or delayed receipt of all necessary consents and approvals; need for additional capital expenditures; increased costs and timing of operations; unexpected costs associated with environmental liabilities; requirements for additional capital; reduced future prices of cannabis; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes and other risks of the cannabis industry; delays in obtaining governmental approvals, permits or financing or in the completion of development or construction activities; title disputes; claims limitations on insurance coverage; risks related to the integration of acquisitions; fluctuations in the spot and forward price of certain commodities (such as diesel fuel and electricity); changes in national and local government legislation, taxation, controls, regulations and political or economic developments in the countries where the Company may carry on business in the future; liabilities inherent in cannabis operations; risks relating to medical and recreational cannabis; cultivation, extraction and distribution problems; competition for, among other things, capital, licences and skilled personnel; risks relating to the timing of legalization of recreational cannabis; changes in laws relating to the cannabis industry; and management’s success in anticipating and managing the foregoing factors.

 

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SOURCE Vireo Health International, Inc.

AbbVie’s MAVIRETTM now reimbursed in Quebec

  • MAVIRET is now listed under the “Régie de l’assurance maladie du Québec” List of
  • MAVIRET is the first and only 8-week, pan-genotypic treatment for patients with chronic hepatitis C virus (HCV) infection without cirrhosis and who are new to *1
  • MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of chronic kidney disease (CKD).

 

MONTREAL (Quebec), April 11, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRETTM (glecaprevir/pibrentasvir tablets) is now listed as a medication covered under Quebec’s public drug insurance plan. MAVIRET is a once-daily ribavirin-free treatment for adults with chronic hepatitis C virus (HCV) infection across all major HCV genotypes (GT1-6).2 It is the only 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

“Every day at my clinic I see the devastating effects of hepatitis C. The complications from this disease

can be fatal,” stresses Dr. Marc Poliquin, a gastroenterologist with the Clinique de médecine urbaine du Quartier latin and at Hôpital Verdun – CIUSSS du Centre-Sud-de-l’Île-de-Montréal. “Canada is looking to eliminate HCV and MAVIRET, a combination of glecaprevir and pibrentasvir, will help in achieving this objective. When I talk about MAVIRET to my patients, I can give them hope—even the most vulnerable patients. The treatment is short and effective, and has very few related side effects. We may possibly be able to eradicate this disease in Canada and, above all, avoid or reduce complications such as cirrhosis,

liver cancer and the need for liver transplantation.”

 

The reimbursement criteria for MAVIRET are as follows:3

  • As monotherapy for treatment of persons suffering from chronic hepatitis C who have never received an anti-HCV treatment.
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 1, 2, 4, 5 or 6 who have experienced therapeutic failure with a treatment based on pegylated interferon (peg IFN) alfa- or based on sofosbuvir, but who have never been treated with either an NS3/4A protease inhibitor nor with an NS5A protein
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 3 without decompensated cirrhosis and who have experienced treatment failure with an association of ribavirin/pegylated interferon alfa or with an association of sofosbuvir/ribavirin, but have never been treated with either an NS3/4A protease inhibitor or NS5A protein
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 1 without decompensated cirrhosis and who have experienced therapeutic failure with an NS3/4A protease inhibitor, but who have never been treated with an NS5A protein
  • As monotherapy for treatment of persons suffering from chronic hepatitis C genotype 1 without decompensated cirrhosis and who have experienced therapeutic failure with an NS5A protein inhibitor, but who have never been treated with an NS3/4A protease

 

“For 15 years, the Centre Associatif Polyvalent d’Aide Hépatite C (CAPAHC), a hepatitis C support group, has been providing assistance to people living with HCV, while making Quebeckers aware of this insidious disease,” explains Laurence Mersilian, the centre’s general manager. “Today, thanks to treatments like MAVIRET, we can confidently tell our members and their loved ones that we are on the path towards eliminating this virus. However, we need to continue to work together on information, education and screening programs to meet World Health Organization targets.”

 

Approximately 300,000 Canadians are infected with chronic HCV.4 In Quebec, the number of reported cases is 39,136; however, the total number of people living with the disease is estimated to be 70,000. The prevalence is 0.74%. HCV is also the leading cause of liver transplantation in Canada, with an HCV– related death curve exceeding that of the human immunodeficiency virus (HIV) worldwide.5

 

MAVIRET’s efficacy and safety were evaluated in nine phase II-III clinical trials, in over 2300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis).

 

About MAVIRET

MAVIRET is approved in Canada for the treatment of chronic hepatitis C virus (HCV) in adults across all major genotypes (GT1-6).6 MAVIRET is a pan-genotypic, once-daily, ribavirin-free treatment that combines glecaprevir (100 mg), an NS3/4A protease inhibitor, and pibrentasvir (40 mg), an NS5A protein inhibitor. MAVIRET is taken once daily as three oral tablets.6

 

MAVIRET is an 8-week, pan-genotypic treatment that makes a virologic cure** possible in patients without cirrhosis who are new to treatment.*,1 These patients represent the majority of people infected with HCV. MAVIRET is also approved in patients with specific treatment challenges, including those with compensated cirrhosis, who are carriers of one of the major genotypes, and those who previously had limited treatment options, such as patients with severe CKD, post-liver and post-renal transplant recipients*** and those patients with genotype 3 HCV infection.6 MAVIRET is the only pan-genotypic treatment approved for use in patients across all stages of CKD.6

 

Glecaprevir was discovered during the ongoing collaboration between AbbVie and

Enanta Pharmaceuticals (NASDAQ: ENTA) to develop HCV protease inhibitors and therapeutic regimens that include protease inhibitors.

 

* Patients without cirrhosis and new to treatment with direct-acting antivirals (DDAs), (i.e., either treatment-naive or did not respond to previous interferon-based treatments (pegylated interferon [peg IFN] +/- ribavirin or sofosbuvirribavirin +/-peg IFN).

** Patients who achieve a sustained virologic response at 12 weeks post treatment (SVR12) are considered cured of hepatitis C.

***MAVIRET is recommended for 12 weeks in liver or kidney transplant recipients who are HCV GT1-6 treatment-naive or HCV GT-1, -2, -4, -5 or -6 PRS (IFN or peg IFN, ribavirin and/or sofosbuvir)-treatment experienced. A 16-week treatment duration should be considered in transplant patients who are HCV GT-1 NS5A inhibitor experienced (but NS3/4A inhibitor-naive) or HCV GT-3 PRS- treatment experienced.

 

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to

developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at

 

www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

###

 

Media:

Muriel Haraoui AbbVie Canada 514-717-3764

muriel.haraoui@abbvie.com

 

 

1 Decisions Resources Group. Hepatitis C virus: disease landscape & forecast 2016. January 2017.

2 CADTH Canadian Drug Expert Committee Recommendation – Final: www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed April 2019. 3 Régie de l’assurance maladie du Québec. List of medications. Last updated April 11, 2019.

www.ramq.gouv.qc.ca/SiteCollectionDocuments/liste_med/2019/liste_med_2019_04_11_en.pdf. Accessed April 2019.

4 The Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/. Accessed March 2019.

5 Centre Associatif Polyvalent d’Aide Hépatite C. Hepatitis C: Frequently Asked Questions. www.capahc.com/hepatitis-c-faq/. Accessed April 2019.

6 AbbVie Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: November 28, 2018. www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/MAVIRET_PM_EN.p . Accessed April 2019.

Vireo Health CEO & Founder Kyle Kingsley, M.D. to Host Reddit AMA on April 12

MINNEAPOLIS, April 10, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CSE: VREO), a leading science-focused, multi-state cannabis company, today announced that Founder & CEO, Kyle Kingsley, M.D., will host a Reddit Ask Me Anything (AMA) Session on Friday, April 12, 2019 at 8:00 a.m. EDT.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

The Reddit AMA with Dr. Kingsley comes on the heels of several recent Company milestones:

  • listing on the Canadian Securities Exchange under the ticker symbol, VREO;
  • expansion into the Arizona medical cannabis market with the acquisition of four entities which together manage the vertically-integrated medical cannabis business of license-holder Arizona Natural Remedies;
  • acquisition of the management of Red Barn Growers, a holder of one New Mexico’s medical cannabis licenses, which is a vertically-integrated medical cannabis company, operating two medical cannabis dispensaries, located in Santa Fe, NM and Gallup, NM; and
  • entry into Vireo’s first adult-use cannabis market, through the acquisition of Mayflower Botanicals Inc., a Registered Marijuana Dispensary certificate holder in Massachusetts.

The Reddit AMA session will provide participants with an opportunity to ask Dr. Kingsley questions about Vireo Health and discuss his vision for replacing alcohol, tobacco and opioids with cannabis. In order to ask questions, participants must have a Reddit account and visit the forum at http://bit.ly/KingsleyAMA.

About Vireo Health International, Inc.
Vireo Health International, Inc.’s mission is to build the cannabis company of the future by bringing the best of medicine, engineering and science to the cannabis industry.  Vireo’s physician-led team of more than 300 employees provides best-in-class cannabis products and customer experience. Vireo cultivates cannabis in environmentally-friendly greenhouses, manufactures pharmaceutical-grade cannabis extracts, and sells its products at both company-owned and third-party dispensaries. The Company is currently licensed in nine states including Arizona, Maryland, Massachusetts, Minnesota, New Mexico, New York, Ohio, Pennsylvania, and Rhode Island.  For more information about the company, please visit www.vireohealth.com.

Contact Information

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

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SOURCE Vireo Health International, Inc.