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Vireo Health Announces First Quarter 2019 Financial Results

— Pro forma Q1 revenue of approximately $7.0 million —
— Total revenue of $5.8 million increased approximately 57 percent year-over-year —
— Minnesota passes law doubling number of licensed dispensaries —

MINNEAPOLIS, May 31, 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 first quarter ended March 31, 2019. All currency figures referenced in this release reflect U.S. dollar amounts, unless otherwise noted.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“We continued to experience strong revenue growth during the first quarter, with increasing patient counts in Minnesota and New York and contributions from wholesale revenue streams in Maryland and Pennsylvania during the quarter,” said Founder & CEO, Kyle Kingsley, M.D. “It was also a very successful quarter from an execution standpoint, as we completed several strategic acquisitions and began construction on many development projects that will help us meet the growing demand for our products across our operating footprint.”

“Following the successful completion of our RTO transaction in March and subsequent acquisition activities, Vireo’s future has never looked brighter. We have a world-class team of professionals leading our expansion strategies, and we believe that our focus on bringing the best of medicine, science, and engineering to the cannabis industry will create compelling long-term value for all of our stakeholders.”

Business Highlights

  • During the first four months of 2019, the Company acquired various cannabis licenses and real estate in the states of Arizona, Massachusetts, Nevada, New Mexico, and Rhode Island. These acquisition activities expanded Vireo’s licensed footprint to 10 states nationwide.
  • The Company generated operating revenue in six states during the first quarter of 2019: Arizona, Maryland, Minnesota, New Mexico, New York and Pennsylvania. Total revenue for Q1 2019 increased 57 percent year-over-year to $5.8 million versus Q1 2018. Pro-forma revenue for the quarter, including total first quarter revenue from recently completed acquisitions in Arizona and New Mexico, was approximately $7.0 million.
  • Net loss for Q1 2019 was approximately $3.4 million, as compared to $2.0 million in the prior year quarter. Adjusted net income, as described in accompanying disclosures and footnotes, was $2.0 million in Q1 2019, as compared to a loss of $0.9 million in the prior year quarter.
  • Q1 2019 EBITDA and Adjusted EBITDA, as described in accompanying disclosures and footnotes, was $172,506 and $3.8 million respectively, as compared to a loss of $856,803 and a gain of $273,521, respectively, during the prior year quarter.
  • 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.

First Quarter 2019 Financial Summary

Total revenue for Q1 2019 was $5.8 million, up 57 percent from $3.7 million in Q1 2018. Revenue growth was driven by a combined increase of $1.3 million in the states of Minnesota and New York, as well as wholesale revenue generation in the states of Maryland and Pennsylvania.

Retail revenue was approximately $5.2 million in Q1 2019, an increase of approximately 40 percent compared to $3.7 million in Q1 2018. Wholesale revenue was $610,881 in Q1 2019 and reflected revenue contributions from wholesale markets in Maryland and Pennsylvania. The Company did not operate any wholesale revenue channels during the prior year quarter.

Gross profit before fair value adjustments was $2.1 million, or 37 percent of revenue, as compared to $1.9 million or 50 percent, in the same period last year. Gross profit after fair value adjustments and net gains on growth of biological assets was $7.2 million or 124 percent of revenue, as compared to 2.3 million and 64 percent in the same period last year. The year-over-over increase in gross margin after fair value adjustments of biological assets was attributable to significant improvements in cultivation yields.

Total operating expenses were $3.7 million, as compared to $3.3 million in the same period last year. Total operating expenses include selling, general and administrative (“SG&A”) expenses, which totaled $1.4 million, as compared to $735,032 last year. The increase in SG&A expenses was primarily attributable to increased salaries and wages, share-based compensation, professional fees, and general and administrative expenses to support the Company’s growing business, as well as start-up expenses related to buildout and pre-revenue operations in the states of Maryland and Ohio.

Total other expense was $4.6 million during Q1 2019. These non-operating expenses primarily reflect listing expenses related to the Company’s recent RTO and subsequent listing on the Canadian Securities Exchange, as well as interest expenses associated with recent sale-and-leaseback transactions of certain cultivation facilities.

Net loss attributable to Vireo in Q1 2019 was $3.4 million, as compared to a net loss of approximately $2.0 million in Q1 2018. Adjusted net income for Q1 2019 was$219,041, as compared to a loss of approximately $0.9 million in the prior year quarter.

Q1 2019 EBITDA was $172,506, as compared to a loss of $856,803 in Q1 2018. Excluding listing expense and share-based compensation expenses, Vireo generated Adjusted EBITDA of $3.8 million in Q1 2019, compared to $273,521 in Q1 2018. 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 May 29, 2019, the Company announced the hiring of Harris Rabin as Chief Marketing Officer. Mr. Rabin will be responsible for overseeing Vireo’s brand marketing, e-commerce, retail, and other sales initiatives. Mr. Rabin is an accomplished marketing leader and joins Vireo with two decades of experience, including senior leadership roles in the consumer healthcare and beverage alcohol industries. He most recently served as Global Vice President of Marketing at Anheuser-Busch InBev (ABInBev), where he oversaw a multi-billion-dollar global portfolio of core beer brands.

On May 30, 2019, the state of Minnesota enacted new legislation amending the state’s medical cannabis program. These measures were passed as part of a health and human services bill, and will allow for the existing licensed operators in the state to double the number of dispensaries, as well as to write off some business expenses and buy hemp from local farmers. These changes will result in Vireo Health increasing its number of dispensaries in the state from four to eight, and increases Vireo’s total number of dispensary licenses to 32 as of the date of this announcement.

Balance Sheet and Liquidity

As of March 31, 2019, total assets were $146.4 million, including cash on hand of $40.4 million. Total long-term liabilities were $37.1 million as of March 31, 2019, with $1.0 million of debt currently due within 12 months.

As of March 31, 2019, there were 21,641,441 equity shares issued and outstanding, and 109,360,128 shares outstanding on an as converted, fully diluted basis.

2019 Outlook

During fiscal year 2019, Vireo continues to expect 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 Arizona, Minnesota, New Mexico and New York
  • Begin build-out of new facilities in Massachusetts, Nevada, Puerto 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
  • The Company currently expects to exit the year with at least 20 operational dispensaries across its nationwide footprint.

Dr. Kingsley commented, “Fiscal year 2019 will be a pivotal year of growth for Vireo Health, as we anticipate the addition of at least six new revenue generating states during the year. The rollout of our Green Goods™ dispensaries in Pennsylvania is on schedule, and we now anticipate that we’ll exit the year with at least 20 operational dispensaries across our nationwide footprint. We are continuing to pursue additional organic and acquisitive growth opportunities, as well as the development of monetizable intellectual property, and we also believe improving regulatory environments in many of our state jurisdictions could present additional opportunities for growth over the near- to medium-term future.”

Conference Call and Webcast Information

Vireo Health management will host a conference call with research analysts on Friday, May 31, 2019 at 8:30 a.m. ET to discuss its financial results for its first quarter ended March 31, 2019. The conference call may be accessed by dialing 866-211-3165 (Toll-Free) or 647-689-6580 (International) and entering conference ID 8184214.

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/events-and-presentations/default.aspx and will be archived for one year.

Additional Information

Additional information relating to the Company’s first quarter and 2019 results 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 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.

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 audited financial statements for the fiscal year ended December 31, 2018, and unaudited condensed interim consolidated financial statements for the fiscal quarter ended March 31, 2019. All financial information contained in this news release is qualified in its entirety with reference to such financial statements. 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
March 31, 2019 and December 31, 2018
(Expressed in United States Dollars)

March 31,

December 31,

2019

2018

ASSETS

Current Assets

Cash

$

40,400,908

$

9,624,110

Receivables

277,254

1,671,257

Inventories

24,841,673

21,379,722

Biological Assets

12,705,374

5,967,150

Prepaid Expenses

1,457,752

962,297

Deferred acquisition costs

838,726

1,885,653

Deferred financing costs

–

448,480

$

80,521,687

$

41,938,669

Non-Current Assets

Property and Equipment

$

28,513,129

$

22,847,283

Deposits

2,238,512

2,259,735

Deferred Loss on Sale Leaseback

26,112

26,596

Goodwill

3,983,559

–

Intangible Asset

31,075,168

2,184,565

Due from Related Party

36,778

–

$

65,873,258

$

27,318,179

Total Assets

$

146,394,945

$

69,256,848

LIABILITIES AND MEMBERS’ EQUITY

Current Liabilities

Accounts Payable and Accrued Liabilities

$

2,919,742

$

2,512,389

Deferred Lease Inducement – Current Portion

449,590

341,555

Income tax payable

670,000

–

Share issuance obligation

2,857,275

–

Current portion lease obligations

846,703

338,638

Current portion of Long-Term Debt

1,010,000

1,010,000

$

8,753,310

$

4,202,582

Long-Term Liabilities

Deferred Rent

$

–

$

271,091

Deferred Income Taxes

7,975,000

6,508,000

Deferred Lease Inducement 

4,945,489

4,781,770

Lease Obligations

15,024,238

11,839,152

Convertible debt

420,663

–

$

37,118,700

$

27,602,595

Shareholders’ Equity

Share Capital

$

110,815,149

$

41,965,556

Reserves

4,985,208

2,766,050

Retained Earnings

(6,524,112)

(3,077,353)

$

109,276,245

$

41,654,253

Total Liabilities and Equity

$

146,394,945

$

69,256,848

 

Vireo Health, Inc.
Consolidated Statements of Loss and Comprehensive Loss
For the Three Months Ended March 31, 2019 and 2018
(Expressed in United States Dollars)

 Three Month 

 Three Month 

 Period Ended 

 Period Ended 

March 31,

March 31,

2019

2018

REVENUE

$

5,777,792

$

3,678,475

Production Costs

(3,665,869)

(1,828,431)

Gross Profit Before Fair Value Adjustments

$

2,111,923

$

1,850,044

Realized Fair Value Amounts Included in Inventory Sold

(3,026,731)

(3,844,189)

Unrealized Fair Value Gain on Growth of Biological Assets

8,065,726

4,335,384

Gross Profit

$

7,150,918

$

2,341,239

EXPENSES

Depreciation

$

373,779

$

56,326

Professional fees

574,260

308,892

Salaries and wages

1,152,940

1,022,240

Selling, general and administrative expenses

1,444,749

735,032

Share Based Compensation

201,187

1,130,324

$

3,746,915

$

3,252,814

OTHER INCOME (EXPENSE)

Loss on Sale of Property and Equipment

$

(484)

$

(597)

Interest Expense 

(1,023,891)

(393,573)

Interest Income

76

–

Accretion expense

(9,671)

–

Listing Expense

(3,464,613)

–

Other Expense

(140,179)

(957)

Total Other Income (Expense)

$

(4,638,762)

$

(395,127)

 INCOME/(LOSS) BEFORE INCOME TAXES 

$

(1,234,759)

$

(1,306,702)

Current income taxes

$

(745,000)

$

(690,000)

Deferred income taxes

(1,467,000)

(33,000)

PROVISION FOR INCOME TAXES

$

(2,212,000)

$

(723,000)

NET LOSS AND COMPREHENSIVE LOSS

$

(3,446,759)

$

(2,029,702)

Weighted Average Shares Outstanding – basic and diluted

59,757,979

52,275,362

Net Loss Per Share – basic and diluted

$

(0.06)

$

(0.04)

 

Vireo Health, Inc.
Statements of Cash Flows
For the Three Months Ended March 31, 2019 and 2018
(Expressed in United States Dollars)

Three Month

Three Month

Period Ended

Period Ended

March 31,

March 31,

2019

2018

Cash Flows from Operating Activities:

Net Loss

$

(3,446,759)

$

(2,029,702)

Items Not Affecting Cash:

Depreciation 

373,779

211,661

Loss on Sale of Property and Equipment

484

–

Share Based Compensation

201,187

1,130,324

Fair Value Adjustment on Sale of Inventory

3,026,731

(3,844,189)

Fair Value Adjustment on Growth of Biological Assets

(8,065,726)

4,335,384

Interest on Lease Obligation

986,016

355,698

Interest on Long-Term Debt

37,875

37,875

Accretion expense

9,671

–

Amortization of Deferred Tenant Improvement

(87,143)

–

Listing expense

2,999,986

–

Deferred financing costs

448,480

–

Deferred Income Taxes

1,467,000

33,000

Deferred gain/loss on sale leaseback

–

598

Changes in non-cash working capital:

Receivables

1,394,003

(168,157)

Due From Related Party

(36,778)

–

Inventory and Biological Assets

(2,082,673)

(994,782)

Prepaid Expenses and Deposits

(495,455)

179,160

Accounts Payable and Accrued Liabilities

407,353

(722,770)

Income Tax  Payable

670,000

690,000

Deferred Rent

–

(498)

Deposits

231,260

(22,200)

Cash Flows Used in Operating Activities

$

(1,960,709)

$

(808,598)

Cash Flows from Investing Activities:

Purchase of Property and Equipment

$

(984,732)

$

(126,321)

Acquisition costs

(12,716,329)

–

Cash acquired on RTO

428

–

Deferred acquisition costs

(48,162)

–

Cash Flows from ( Used in) Investing Activities

$

(13,748,795)

$

(126,321)

Cash Flows from Financing Activities:

Proceeds from private placement, net of issuance costs

$

47,542,878

$

–

Lease payments

(126,251)

–

Proceeds from Debt

–

1,071,013

Interest Paid

(930,325)

(393,573)

Cash Flows from Financing Activities

$

46,486,302

$

677,440

Net Change in Cash

$

30,776,798

$

(257,479)

Cash, Beginning of the Period

9,624,110

2,595,965

Cash, End of the Period

$

40,400,908

$

2,338,486

 

Reconciliation of Non-IFRS Financial Measures

This news release contains references to financial metrics such as Pro Forma Revenue, 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.

Reconciliation of Net Income to Adjusted Net Income and Adjusted EBITDA

Three Months Ended

March 31, 

2019

2018

Net income (loss)

$

(3,446,759)

$

(2,029,702)

Listing expense

3,464,613

–

Share-based compensation

201,187

1,130,324

Adjusted net income (loss) (non-IFRS)

$

219,041

$

(899,378)

Net income (loss)

$

(3,446,759)

$

(2,029,702)

Interest income

(76)

–

Interest expense

1,023,891

393,573

Accretion expense

9,671

–

Income taxes

2,212,000

723,000

Depreciation

373,779

56,326

EBITDA (non-IFRS)

$

172,506

$

(856,803)

Listing expense

3,464,613

–

Share-based compensation

201,187

1,130,324

Adjusted EBITDA (non-IFRS)

$

3,838,306

$

273,521

 

Reconciliation of Reported Revenue to Pro Forma Revenue1

REVENUE BRIDGE

For the quarter ended March 31, 2019

Pro Forma Bridge

US$

1Q’19

Reported Revenue

$          5,777,792

Pro Forma Adjustments

Arizona

975,179

New Mexico

262,286

Pro Forma Revenue

$          7,015,257

1

Reported revenue of $5.8 million in Q1 2019 includes nine days of results from the recently closed acquisition in Arizona and six days results from the recently closed acquisition in New Mexico. Pro forma revenue adjustments include the balance of total first quarter revenue generation in Arizona and New Mexico.

 

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

 

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SOURCE Vireo Health International, Inc.

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AbbVie’s MAVIRETTM now listed in New Brunswick

  • 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), May 30, 2019 – AbbVie (NYSE: ABBV), a global, research and development-based biopharmaceutical company announced today that MAVIRETTM (glecaprevir/pibrentasvir tablets) is now listed on the New Brunswick Drug Plans Formulary. 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.*

 

“Hepatitis C is the leading cause of liver failure and liver cancer in New Brunswick,” states Dr. Meaghan O’Brien, Hepatologist, Upper River Valley Hospital, Assistant professor, Division of General Internal Medicine, Department of Medicine, Dalhousie University. “With the introduction and subsequent approval and reimbursement of the new direct-acting antiviral therapies, such as MAVIRET, we have an opportunity to treat all Canadians living with this devastating and deadly disease. However, we need to ensure that the proper models of care are in place in order to reach our objectives both locally and across Canada.”

 

On the New Brunswick Drug Plans Formulary, MAVIRET is listed for treatment-naïve or treatment- experienced adult patients with chronic hepatitis C virus (HCV) including all genotypes 1-6. The listing became effective on May 16, 2019.3

 

“AbbVie believes that together, through innovative partnerships, we can make hepatitis C elimination the next public health success story. Along with healthcare professionals, governments and patient associations, together we can meet the WHO 2030 objective,” says Stéphane Lassignardie, General Manager, AbbVie Canada. “We are committed to further investigating and identifying opportunities to simplify the path to a cure.”

 

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).

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.4 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.5 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare

 

systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

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 sofosbuvir–ribavirin +/-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 Care

Canadians prescribed MAVIRET will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, personalized education and ongoing disease management support throughout the treatment.

 

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 May 2019. 3 New Brunswick Prescription Drug Program. www2.gnb.ca/content/dam/gnb/Departments/h- s/pdf/en/NBDrugPlan/FormularyUpdates/NBDrugPlansBulletin999.pdf. Accessed May 2019.

4 Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf. Accessed May 2019.

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

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Harris Rabin, former ABInBev & Bayer leader, joins Vireo Health as Chief Marketing Officer

Rabin brings two decades of marketing and innovation experience in consumer healthcare and beverage alcohol industries

NEW YORK, May 29, 2019 /PRNewswire/ — Vireo Health International, Inc. (CSE: VREO), a leading science-focused, multi-state cannabis company, today announced Harris Rabin will be joining the company’s executive team in the newly created role of Chief Marketing Officer. Rabin will be overseeing brand marketing, e-commerce, and sales efforts. Rabin brings two decades of experience, including senior leadership roles in the consumer healthcare and beverage alcohol industries.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

Rabin is an accomplished marketing leader with a proven and consistent track record. He most recently served as Global Vice President of Marketing at Anheuser-Busch InBev (ABInBev), where he led brand building efforts for a multi-billion dollar global portfolio of core beer brands. Rabin led brand development across global markets, including the global expansion of Michelob Ultra, the $1+ billion brand pioneering the “Better-For-You” category.

Prior to ABInBev, Rabin worked for nearly a decade at Bayer HealthCare as a brand builder in the Consumer Health division, where he built brands and ultimately oversaw the Global Aspirin franchise, growing the Aspirin business to the highest on record, consistently exceeding expectations.

“I am thrilled to add a highly-skilled marketer like Harris to the Vireo Health leadership team,” said Chief Executive Officer Kyle Kingsley, M.D. “Harris brings an ideal combination of brand and product marketing experience from relevant industries like consumer healthcare and the alcoholic beverage industry. He will be valuable addition to our team of experienced senior executives.”

“Without a doubt, cannabis will continue to be a positive disruptive force transforming consumer wellness, and my background in consumer health care and beverage alcohol gives me a unique perspective on the potential of the fast-growing cannabis industry,” said Rabin. “I look forward to helping grow Vireo Health’s brands at a time when the company is uniquely positioned to leverage our medical and science expertise to provide best-in-class products and experiences.”

Rabin added, “Cannabis is also a CPG industry. Brands will drive disproportionate market share by understanding and delivering against specific consumer needs, benefits, and occasions. Vireo’s expansive footprint and IP will enable us to develop the most compelling brand portfolio in the industry and engage with our consumers and health care partners to continue to surprise and delight all stakeholders.”

Rabin has a bachelor’s degree with high honors in mathematics & economics from Northwestern University, and an MBA from MIT Sloan School of Management with a focus on marketing and new product development. He lives in NYC with his wife and three children.

Additional members of the sales and marketing team include: Jennie Leuzarder the VP of Sales, who brings years of experience from the highly regulated wines and spirits industry, where she held various leadership positions at global luxury brands Diageo and Pernod Ricard; and Aisha Khan the VP of eCommerce, who joined Vireo after spending over 5 years at Johnson & Johnson, where she led one of the largest Health & Beauty eCommerce businesses in the U.S.

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

The CSE has neither approved nor disapproved the contents of this news release and does not accept responsibility for the adequacy or accuracy of this release.

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, 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 close of all acquisitions, obtaining of all 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.

CisionView original content to download multimedia:http://www.prnewswire.com/news-releases/harris-rabin-former-abinbev–bayer-leader-joins-vireo-health-as-chief-marketing-officer-300857103.html

SOURCE Vireo Health International, Inc.

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AbbVie reaches an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA®, a treatment for chronic lymphocytic leukemia (CLL)

  • Following the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA), Ontario is the first province to reimburse
  • VENCLEXTA is the first and only BCL-2 inhibitor to be approved in
  • A need exists for CLL patients who have failed novel oral i

 

Montreal, QC, May 23, 2019 – AbbVie (NYSE: ABBV), a global, research and development-driven biopharmaceutical company, announced today that Ontario is the first province to reimburse VENCLEXTA® (venetoclax) monotherapy under its Drugs and Devices Division’s (DDD) Exceptional Access Program effective May 13, 2019.ii VENCLEXTA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have no other treatment options. VENCLEXTA is an oral, once-daily medicine.

 

This listing follows the signing of an agreement between AbbVie and the pan-Canadian Pharmaceutical Alliance (pCPA) earlier this year.

 

“People living with chronic lymphocytic leukemia in Ontario finally have access to VENCLEXTA, which is great news considering the nature of this disease. When faced with CLL, which can be recurrent, it is important to offer physicians and their patients highly effective options to tackle this illness,” explains Elizabeth Lye, Director of Research & Programs at Lymphoma Canada. “At Lymphoma Canada, we hope that soon all Canadians will have access to this treatment.”

 

VENCLEXTA monotherapy will be available through the Exceptional Access Program for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in patients who have failed treatment with at least one prior therapy (including B-cell receptor inhibitors) or who have experienced intolerance to ibrutinib.

 

“When I meet a patient for the first time, I always explain that CLL is a type of blood cancer that is chronic and that some may relapse after being in remission. In fact, most of the patients I see in my clinic have often already gone through another line of treatment. Therefore, I want to ensure I have the appropriate treatments available for my patients in a timely manner,” says Dr. Peter Anglin, MD, FRCPC,

MBA, Hematologist and Physician Lead, Stronach Regional Cancer Centre. “I am thrilled that Ontario is

the first province to reimburse venetoclax; it’s a positive step for people living with CLL who need access to this much needed treatment.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and bloodiii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iv

 

“It’s been a long time coming for wonderful news like this. I can remember reading about clinical trials for this treatment several years ago and thinking how promising it sounded for people like me who have already been treated with more than one line of therapy and relapsed,” states Mark Silverstein of

Aurora, Ontario. “Now it’s finally here! Another treatment option in the CLL world has been approved and reimbursed in the province of Ontario, and hopefully soon coming to every Canadian province. And thank you AbbVie for your commitment to bringing VENCLEXTA to those who need it.”

 

VENCLEXTA received a Notice of Compliance with Conditions (NOC/c) from Health Canada on September 30, 2016. The therapy was approved as monotherapy for previously treated CLL patients, who have either a genetic mutation known as 17p deletion, or who do not have the mutation but have no other available treatment options, and who have received at least one other therapy. The 17p deletion is a genetic mutation that is found in 3 to 10 percent of people with previously untreated CLL and up to 50 percent of relapsed or refractory cases.v Under Health Canada’s NOC/c policy, AbbVie will provide Health Canada with data from additional studies to assess the clinical benefit of VENCLEXTA in these patient populations.vi

 

“This agreement with the pCPA and subsequently the listing in Ontario are positive steps towards patients living with CLL accessing a medication that serves an unmet medical need,” stated Stéphane Lassignardie, General Manager of AbbVie Canada. “AbbVie is committed to changing the way blood cancers are treated with innovative new treatment options.”

 

VENCLEXTA continues to be investigated in CLL and other hematological diseases.

 

VENCLEXTA is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the U.S. and by AbbVie outside of the U.S.

Canadians prescribed VENCLEXTA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature care program. The 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 and beyond.

 

About AbbVie

AbbVie is a global, research and development-driven 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.

 

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

iJain P. et al. Long-Term Outcomes for Patients With Chronic Lymphocytic Leukemia Who Discontinue Ibrutinib. Cancer. 2017 Jun 15;123(12):2268-2273.

ii Ontario Ministry of Health and Long-Term Care. http://health.gov.on.ca/en/pro/programs/drugs/eap_mn.aspx. Accessed May 2019.

iii Lymphoma Canada. Chronic lymphocytic leukemia. Available at http://www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed May 2019.

iv Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. http://www.cancer.ca/en/cancer-information/cancer- type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed May 2019.

v Schnaiter A. et al. 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin N Am. 2013;27:289–301.

vi VENCLEXTA product monograph, AbbVie Corporation. Date of Preparation: September 27, 2016. Date of Revision: February 12, 2019. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/VENCLEXTA_PM_EN.pdf. Accessed May 2019.

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Novamind to Assess Opportunities in the Psychedelic Industry

TORONTO, Ontario – May 22, 2019 – Novamind Ventures Inc. (”Novamind”) is pleased to announce that it has incorporated pursuant to the Ontario Business Corporations Act with its registered and head office located at 10 Wanless Ave, Suite 201, Toronto, ON, Canada.

Novamind was formed to pursue a pipeline of early-stage investments in world-leading clinics, retreats and technologies that enable psychedelic treatments and experiences.

Novamind is focused on addressing the world’s mental health crisis through the integration of psychedelic-assisted psychotherapy into modern psychiatry. Early data collected from current U.S Food and Drug Administration clinical trials suggest that psychedelics will revolutionize the treatment of mental health disorders including: anxiety, depression, post-traumatic stress disorder and addiction.

The need for innovative mental healthcare has never been higher. According to the World Health Organization, mental health disorders will affect one in four people worldwide during their lifetime. Mental health disorders are considered among the leading causes of sickness and disability and it is estimated that 450 million people are currently suffering from such disorders.

Throughout 2019, Novamind will announce its first investments that aim to advance psychedelic research and catalyze personal wellness.

About Novamind

Novamind invests in the infrastructure that drives the world’s leading psychedelic clinics and retreats.  We seek to accelerate research and innovation in psychedelic medicine by investing in the people, science and technology required for a regulated psychedelics industry. Novamind is building a new standard of mental healthcare. For more information visit www.novamind.ca.

Contact Information

Yaron Conforti, CEO
T: +1 (647) 953 9512
E: info@novamind.ca

Posted on

Vireo Health to Report First Quarter 2019 Results on May 31, 2019

MINNEAPOLIS, May 21, 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 financial results for its first quarter ended March 31, 2019 on Friday, May 31, 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/events-and-presentations/default.aspx.

The conference call may also be accessed by phone. Dial 866-211-3165 (Toll-Free) or 647-689-6580 (International) and enter conference ID 8184214.

A webcast replay will be available for one year on Vireo’s Investor 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-first-quarter-2019-results-on-may-31-2019-300853910.html

SOURCE Vireo Health International, Inc.

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AbbVie Launches ORILISSATM (elagolix) 200 mg BID Dose for the Treatment of Moderate to Severe Pain Associated with Endometriosis

  • Endometriosis affects up to one in 10 women of reproductive age in 1
  • 7 out of 10 women being managed for endometriosis have unresolved pain throughout the 2

 

Montreal, QC, May 21, 2019 – AbbVie (NYSE: ABBV), a global, research and development-driven biopharmaceutical company, in cooperation with Neurocrine Biosciences, Inc. (NASDAQ: NBIX), announced that ORILISSA™ (elagolix) 200 mg twice daily is now available. ORILISSA is the first and only oral gonadotropin-releasing hormone receptor (GnRHr) antagonist, for the treatment of moderate to severe pain associated with endometriosis.3

 

“Endometriosis is a misunderstood and often mismanaged disease. It has been estimated that on average, it takes 9-10 years for a woman to receive a diagnosis of endometriosis. This is often because patients themselves and physicians normalize the pain these patients are experiencing. This can have a huge impact on their quality of life, relationships and work productivity, Even diagnosed women who suffer from it tend to normalize their pain and downplay the effects it has on all aspects of their lives,” says Dr. Jamie Kroft MD, MSc, FRCSC, Assistant Professor, Minimally Invasive Gynaecologic Surgery, Core Obstetrics & Gynaecology, Sunnybrook Health Sciences Centre. “The women I see in my practice always have a lot of questions, especially around appropriate medical management. I take the time to explain their options so they can make an informed decision. Therefore, the more options that are available, for example ones that are hormone-free and can be customized to my patients’ needs, the better I can treat them. Women should not suffer in silence, especially not when there are new treatment advances.”

 

ORILISSA (elagolix) is a novel, orally administered, highly potent, short-acting, selective, non-peptide small molecule GnRHr antagonist that blocks endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland. Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulation hormone (FSH) levels, leading to decreased blood levels of the ovarian sex hormones, estradiol and progesterone. LH and FSH suppression begins within hours of administration and is readily reversible upon discontinuation of ORILISSA.3

 

“At the Endometriosis Network Canada, we encourage our members to become informed and empowered. Having an accurate diagnosis and getting treatment from an endometriosis expert are important steps in attaining relief from their symptoms. Although endometriosis is currently incurable, there are effective treatments available and in partnership with their healthcare professionals, patients can work on a treatment plan that works for them. Ultimately, we know what people living with this debilitating disease want is to live fulfilling and pain-free lives, where they are able to pursue any

endeavour, both professionally and personally,” explains Philippa Bridge-Cook, Ph.D., Executive Director of The Endometriosis Network Canada.

 

Endometriosis causes chronic pelvic pain and is sometimes associated with infertility. It affects up to one in 10 women of reproductive age in Canada.1 Furthermore, 7 out of 10 women being managed for endometriosis have unresolved pain throughout the month. 2

 

The approval of ORILISSA is supported by data from two replicate studies in the largest endometriosis Phase 3 study program conducted to date, which evaluated nearly 1,700 women with moderate to severe endometriosis pain. Clinical trial data demonstrated ORILISSA significantly reduced the three most common types of endometriosis pain: dysmenorrhea, non-menstrual pelvic pain and dyspareunia. A higher proportion of women treated with ORILISSA 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and non-menstrual pelvic pain compared to placebo in a dose- dependent manner at month three. Women were defined as responders if they experienced a clinically meaningful reduction in daily menstrual pain and non-menstrual pelvic pain with no increase in analgesic use (nonsteroidal anti-inflammatory drug or opioid) for endometriosis-associated pain. 3

 

Both ORILISSA treatment groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain at month six. Women in the Phase 3 studies also provided a daily self-assessment of their endometriosis pain using a numeric rating scale (NRS) and women taking ORILISSA 150 mg once daily and 200 mg twice daily reported a statistically (p <0.001) significant reduction from baseline in NRS scores compared to placebo at month three. Clinical trial data also demonstrated women taking ORILISSA 200 mg twice daily showed statistically significant greater reduction in pain during sexual intercourse from baseline to month three compared to placebo. The most frequent (≥10%) adverse reactions reported in clinical trials with ORILISSA (elagolix) were hot flush, headache and nausea. 3

 

The recommended duration of use for ORILISSA is up to 12months for the 150 mg once daily dose and up to six months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD). BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment.3

 

“We are proud to launch the ORILISSA 200 mg strength. With this dose, we are able to offer physicians the unique ability to individualize the care of their patients. Women with endometriosis now have a hormone-free choice that is customizable based on their unique needs,” says Stéphane Lassignardie, General Manager of AbbVie Canada. “AbbVie is committed to women living with endometriosis as we strive to fill the unmet medical need by providing a safe and efficacious treatment.”

 

About AbbVie Care

Canadian women prescribed ORILISSA will have the opportunity to be enrolled in AbbVie Care, AbbVie’s signature support program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, personalized education and ongoing disease management support throughout their treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie

AbbVie is a global, research and development-driven 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.

 

About Neurocrine Biosciences, Inc.

Neurocrine Biosciences, a San Diego based biopharmaceutical company, is focused on developing treatments for neurological and endocrine related disorders. The company discovered, developed and markets INGREZZA® (valbenazine), the first FDA approved product indicated for the treatment of adults with tardive dyskinesia, a movement disorder. Discovered and developed through Phase II clinical trials by Neurocrine, ORILISSA™ (elagolix), the first FDA-approved oral medication for the management of endometriosis with associated moderate to severe pain in over a decade, is marketed by AbbVie as part of a collaboration to develop and commercialize elagolix for women’s health. Neurocrine’s clinical development programs include opicapone as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in Parkinson’s disease patients, elagolix for uterine fibroids with AbbVie, valbenazine for the treatment of Tourette syndrome, and NBI-74788 for the treatment of congenital adrenal hyperplasia (CAH). For more information and the latest updates from Neurocrine, please visit www.neurocrine.com.

 

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Media Inquiries:

Muriel Haraoui muriel.haraoui@abbvie.com 514.717.3764

 

1YourPeriod.ca. https://www.yourperiod.ca/endometriosis/what-is-endometriosis/. Accessed May 2019.

2De Graaff AA, D’Hooghe TM, Dunselman GAJ, Dirksen CD, Hummelshoj L, WERF EndoCost Consortium, Simoens S. The significant effect of endometriosis on physical, mental and social wellbeing: results from an international cross-sectional survey. Hum Reprod. 2013;28(10):2677-2685.

3Orilissa Product Monograph, AbbVie Corporation, October 4, 2018. http://www.abbvie.ca/content/dam/abbviecorp/ca/en/docs/ORILISSA_PM_EN.PDF. Accessed May 2019.

Posted on

Wuhan Expands Capacity to Produce Medicinal Marijuana and Mushrooms

BARCELONA, Spain, May 17, 2019 (GLOBE NEWSWIRE) — via OTC PR WIRE — Wuhan General Group (China), Inc. (OTC: WUHN) (the “Company” and “Wuhan”), is thrilled to announce the signing of a very remarkable Letter of Intent (LOI) with Biodelta.

The LOI calls for the purchase by Wuhan of 49% of the land, buildings, and infrastructure including the specialized greenhouse and drying ovens. A full agreement between the parties is expected to be reached in 45 days. More details will be made available after the signing of the full agreement. The assets to be acquired include but are not limited to:

  • 1.3 million square feet of cultivation space of which 300,000 square feet is turnkey and ready to go as necessary permits are approved and issued. The additional 1,000,000 sq ft. will be built out and readied for early 2021.
  • Specialized processing factory ISO 22000
  • 8 Industrial GMP compliant dryers
  • Water rights

“When we visited Biodelta in South Africa last month and saw first-hand the opportunity and possibilities we knew this was a deal that had to be made. This puts Wuhan on the global stage immediately in terms of sheer size and cannabis production capacity. Preliminary forecasts would see Wuhan produce 36,000 kg in phase one (300k sq. ft), and 175,000 kg (1.3M sq. ft) at full capacity,” said MJ Medtech CEO Jeff Robinson.

Leon Giese, Biodelta CEO added: “Biodelta has been at the forefront of South Africa’s algal biotech industry since 2004 through its growing and commercialization of Spirulina products into the pharma market in Europe, Asia, and the Americas. Biodelta recognizes the massive opportunity to exploit the growing worldwide demand for South African medicinal herbs. Biodelta has the facilities in place currently to grow under 300,000 square feet of specialized greenhouse and to evaporatively dry, process, formulate, brand and distribute a range of value-added CBD products into its retail pharmacy market throughout Southern Africa as well as its customers worldwide.”

About Biodelta Nutraceuticals

Biodelta Nutraceuticals (ISO 22000 and organic certified) is a Cape Town-based manufacturer and merchandiser of premium health products to all pharmacy & health shop chains across South Africa. For the past 12 years, Biodelta has developed, designed and produced more than 1,000 products for these customers and is now strategically positioned to launch CBD products through these channels. In addition, Biodelta has license applications in process for growing, extracting and product development as well as dossiers for various CBD based products.

For further information contact:

Website: https://biodelta.net/

Public Relations E-mail: info@biodelta.net

About Wuhan General Group (China), Inc.

Wuhan General Group (China), Inc. through its wholly-owned subsidiary MJ MedTech is a nutraceutical biotechnology company that researches, 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: 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.

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Vireo Health Announces Board Of Directors

Company establishes U.S. governance standards with appointment of new directors and sub-committees

MINNEAPOLIS, May 16, 2019 /PRNewswire/ — Vireo Health International, Inc. (“Vireo Health” or the “Company”) (CSE: VREO), a leading science-focused, multi-state cannabis company, today announced the addition of four new Directors to the Company’s Board and the formation of three committees to provide oversight and guidance on Audit, Compensation, and other Corporate Governance matters.

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

“Vireo Health is pleased to have added several highly-regarded industry leaders with deep retail, manufacturing and financial expertise to help guide the Company as we continue to execute upon our ambitious growth plans,” said Chief Executive Officer Kyle Kingsley, M.D. “Together with our extremely talented leadership team and dedicated workforce, I am confident we have the necessary talent to create shareholder value and build the cannabis company of the future.”

“I am honored to join the Vireo Health Board of Directors and offer my consumer branding expertise to a leader in the rapidly growing cannabis industry,” said Chelsea A. Grayson, Vireo Health Director and CEO of True Religion Brand Jeans. “Diversity and equality are extremely important to me and I am delighted to serve alongside two other extraordinarily talented women on the board.”

In addition to Grayson, the four new members of the Board include Chad Martinson, Chief Executive Officer of ACOVA Integrated Health; Amy Langer, co-founder of Salo, LLC and a Director of HealthPartners, a leading non-profit health insurance provider; and Judd Norquist, CPA, a Partner at Abdo, Eick & Meyers, a leading regional accounting firm. The new Board members join Dr. Kingsley, who continues to serve as Chairman, Chief Financial Officer Amber Shimpa, and Chief Operating Officer Ari Hoffnung.

Chelsea A. Grayson, J.D., is the first ever female CEO of True Religion and sits on the True Religion board of directors. Previously, Ms. Grayson was the CEO and a board member of American Apparel, where she significantly improved the Company’s operations before it was sold to Gildan Activewear. Prior to joining American Apparel, Ms. Grayson was an M&A and corporate governance partner with Jones Day. Ms. Grayson is also an advisory board member for Marca Global, a leading online reputation management company and a Board Leadership and Corporate Governance Fellow with the National Association of Corporate Directors (NACD).

Amy L. Langer, CPA, is the Co-founder of Salo LLC. At Salo, Ms. Langer drives growth and brand affinity through analysis of market gaps, architecting and leading innovative strategy, and establishing sustainable and scalable infrastructure. Ms. Langer and Salo have been recognized locally and nationally with a wide range of awards including Ernst & Young, Entrepreneur Magazine, and the Inc500. Her expertise encompasses human resources, finance, and accounting. She began her career as a CPA auditor for KPMG followed by time at one of largest staffing agencies as their National Business Development Director. Ms. Langer also serves on the board of directors for HealthPartners and GreaterMSP.

Chad Martinson MBA, CPA, CMA, is currently the Chief Executive Officer of ACOVA Integrated Health. Previously, he served as Chief Operating Officer and Chief Financial Officer of ACOVA Integrated Health, and as CFO and Executive Vice President of Operations at Upsher-Smith Laboratories, acquired by Sawai Pharmaceutical Co., Ltd. He also previously served as VP of Finance and Business Development at Medtronic in the company’s neuro division, and spent eight years at KPMG in the audit practice.

Judd Nordquist, CPA, is a Partner at Abdo, Eick & Meyers, LLP, serving on their leadership team and leading the firm’s Manufacturing segment. Judd works with business owners solving challenges and creating better bottom line results through tax planning, cash flow management, pricing, budgeting/forecasting, overhead allocation calculations and ultimately assisting owners with their transition planning.

Kyle Kingsley, M.D., is the Founder and CEO of Vireo Health, a board-certified emergency medicine physician, serial entrepreneur, and inventor. His mission is to build the cannabis company of the future by bringing the best of medicine, engineering, and science to the cannabis industry. Under Dr. Kingsley’s leadership, Vireo has experienced exponential growth and is now one of the country’s leading multi-state operators, with licenses in ten states.

Amber Shimpa serves as the Chief Financial Officer for Vireo Health and has held this position since Vireo’s inception in 2015. She is responsible for all aspects of the company’s finance, accounting, treasury, investor relations and administrative functions. She has 14 years of experience as a financial services professional with various commercial and investment banking organizations. Prior to joining Vireo Health, Ms. Shimpa spent nine years as Vice President of a commercial bank focused on nationwide lending.

Ari Hoffnung serves as the Chief Operating Officer of Vireo Health. Mr. Hoffnung previously served as New York City’s Deputy Comptroller for Budget & Public Affairs, where he oversaw the City’s $70 billion budget, managed a staff of more than 100 employees, and served as the chief liaison to all levels of governments and to various labor unions. Prior to his public service, Mr. Hoffnung was a Managing Director at Bear Stearns, where he worked for more than a decade.

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 Health’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

 

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SOURCE Vireo Health, Inc.

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Spherix Reports First Quarter 2019 Results of $11,937,000 in Assets and $982,000 in Liabilities

Agreement to Acquire Assets of CBM BioPharma, Inc. Asset Purchase Agreement Provides for More Favorable Terms to the Company Spherix Also Announces Reverse Stock Split

NEW YORK, May 16, 2019 /PRNewswire/ — Spherix Incorporated (Nasdaq: SPEX) (“Spherix” or the “Company”) today announced that the Company filed its Form-10Q for the period ended March 31, 2019, which showed total assets of $11,937,000.00 and liabilities of $982,000.00, with 2,010,074 shares of common stock outstanding.

Spherix Logo. (PRNewsFoto/Spherix Incorporated)

In addition, the Company announced a restructuring of the terms of its proposed merger with CBM BioPharma, Inc. (CBM), a Delaware corporation.  In lieu of the previously announced merger, the Company announced the terms of an Asset Purchase Agreement with CBM, whereby the Company purchased substantially all of CBM’s assets including, among other things, a license agreement, university contracts, and contracts with a Chief Scientific Officer, as well as a Scientific advisory board.  The revised agreement is significantly less dilutive to Spherix shareholders, as Spherix is paying $8,000,000.00 to CBM in total compensation, as opposed to the previously announced $16,500,000.00, as more fully set forth in the Company’s filings. The acquisition of CBM’s assets is pending shareholder approval.

In addition, the Company announced that it purchased a 20% shareholder’s stake in CBM along with certain interests in DatChat, Inc. Spherix was successful in acquiring these interests in CBM at a substantial discount to CBM’s valuation.  The 20% shareholder stake in CBM will give Spherix the ability to participate in any dividends declared by CBM in the future.

Mr. Anthony Hayes, CEO of Spherix stated, “The revised negotiated terms with CBM BioPharma in the Asset Purchase Agreement will introduce valuable assets into the Spherix family. The new agreement will be less dilutive to Spherix shareholders.  I am also pleased to note that CBM has received some early, favorable correspondence from the Patent Office about its University of Texas patent applications.  We will provide additional information as it comes available, but it is certainly a positive development for CBM.”

“Post-closing, Spherix shareholders will still own a majority interest in the Company.  Further, Spherix’s 20% ownership in CBM is an accretive benefit to Spherix shareholders and by having an ownership interest in CBM, Spherix will participate in any dividend distributions made by CBM in the future.  This may include cash dividends that might result from the future sale of Spherix stock. We look forward to sharing additional information with our shareholders about the proposed asset purchase in the upcoming weeks through both investor outreach and our upcoming SEC filings.”

In addition to the CBM announcement, the Company’s Board of Directors under authority granted by the Company’s stockholders at the Company’s 2019 Annual Meeting, approved a reverse stock split of its common shares at a ratio of 1-for-4.25. The reverse stock split became effective on May 10, 2019, when the shares began trading on the split-adjusted basis on the Nasdaq Capital Market, under the Company’s existing trading symbol “SPEX”.

Further information about the proposed asset purchase agreement and reverse stock split are provided in the Company’s Form 10-Q which was filed on May 15, 2019, with the Securities and Exchange Commission.

About Spherix

Spherix Incorporated is a technology development company committed to the fostering of innovative ideas. Spherix Incorporated was formed in 1967 as a scientific research company.

Our activities generally include the acquisition and development of technology through internal or external research and development. In addition, we seek to acquire existing rights to intellectual property through the acquisition of already issued patents and pending patent applications, both in the United States and abroad. We may alone, or in conjunction with others, develop products and processes associated with technology development and monetizing related intellectual property.

Forward-Looking Statements

Certain statements made herein are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as “may”, “should”, “would”, “plan”, “intend”, “anticipate”, “believe”, “estimate”, “predict”, “potential”, “seem”, “seek”, “continue”, “future”, “will”, “expect”, “outlook” or other similar words, phrases or expressions. These forward-looking statements include statements regarding Spherix’s and CBM’s industry, future events, the proposed transaction between the parties to the Asset Purchase Agreement, the estimated or anticipated future results and benefits of the Company following the transaction, including the likelihood and ability of the parties to successfully consummate the proposed transaction, future opportunities for the combined company, and other statements that are not historical facts. These statements are based on the current expectations of Spherix’s management and are not predictions of actual performance. These statements are subject to a number of risks and uncertainties regarding the businesses of Spherix and the transaction, and actual results may differ materially. These risks and uncertainties include, but are not limited to, changes in the business environment in which Spherix or CBM operates, including inflation and interest rates, and general financial, economic, regulatory and political conditions affecting the industry in which Spherix or CBM operates; changes in taxes, governmental laws, and regulations; competitive product and pricing activity; difficulties of managing growth profitably; the inability of the parties to successfully or timely consummate the proposed transaction, including the risk that any required regulatory approvals are not obtained, are delayed or are subject to unanticipated conditions that could adversely affect the combined company or the expected benefits of the transaction or that the approval of the stockholders of Spherix are not obtained; failure to realize the anticipated benefits of the transaction, including as a result of a delay in consummating the transaction or a delay or difficulty in integrating the assets of CBM; uncertainty as to the long-term value of Spherix’s common stock; those discussed in the Spherix’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other documents of Spherix on file with the SEC or in the registration statement that will be filed with the SEC by Spherix. There may be additional risks that Spherix presently does not know or that Spherix currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements provide Spherix’s expectations, plans or forecasts of future events and views as of the date of this communication. Spherix anticipates that subsequent events and developments will cause Spherix’s assessments to change. However, while Spherix may elect to update these forward-looking statements at some point in the future, Spherix specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Spherix’s assessments as of any date subsequent to the date of this communication.

Contact:          

Investor Relations:    

Hayden IR

Brett Maas, Managing Partner

Phone: (646) 536-7331

Email: brett@haydenir.com

www.haydenir.com

Spherix:                    

Phone: 212-745-1373

Email: investorrelations@spherix.com  

www.spherix.com

 

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SOURCE Spherix Incorporated

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