Daily Archives: May 4, 2017

Maricann Secures $42,500,000 Non-Dilutive Financing for Further German Expansion

TORONTO, May 04, 2017 (GLOBE NEWSWIRE) — Maricann Group Inc. (CSE:MARI) (Maricann or the “Company”) is pleased to announce that Maricann has secured $42,500,000 in non-dilutive financing to further expand production in Germany.

The $42,500,000 non-dilutive financing comes from The Green Streaming Finance Company of Canada Inc. a Vancouver-based company that provides non-equity financing solutions for cannabis producers. The streaming payment will be made in return for the right to purchase 20% of production at an all in cost + 10% from expansion funded by Green Streaming in Germany. “We are pleased to be funding Maricann and their expansion efforts in Germany. This is a win-win relationship for Maricann and Green Streaming Finance, with no dilution to Maricann shareholders and a stable, reliable, renewable stream of revenue to Green Stream Finance from a proven producer of medicinal cannabis,” said Donald McInnes, founder of Green Streaming Finance. Under the terms of the agreement, Maricann will receive investment in two tranches, $15,000,000 and a $27,500,000.

This financing will fully fund the planned 150,000 sq. ft (13,935 square meters) expansion of cultivation operations in its Ebersbach Facility and an additional 250,000 sq. ft. (23,255 sq. m.) of expansion in a two tiered cultivation plan, as well as an outdoor hemp farm from which Maricann will derive high CBD content active pharmaceutical ingredients. The Ebersbach facility (West of Dresden) is a former Cargill plant constructed 20 years ago at a cost of 80 million EUR at that time. The facility is comprised of multiple individual clean rooms that are ideal for cultivation of cannabis. “The Ebersbach facility offers Maricann a significant advantage in cost of overall construction and speed to market. The infrastructure for cultivation of cannabis in an indoor secured environment is already in place. We simply need to add the fertigation system, lights and benches for growing, and then can be operational. Our competitors are spending north of $70,000,000 CAD for facilities with less than 1/3 the footprint of our Ebersbach location. To construct a similar facility today, the estimated cost would be over 120 million EUR. Maricann entered into a reservation agreement to purchase the facility for a total price of 3,410,000 EUR at closing,” said Benjamin Ward, CEO.

About Maricann Group Inc. 

Maricann is a vertically integrated producer and distributor of marijuana for medical purposes. The company was founded in 2013 and is based in Langton, Ontario, where it operates a medicinal cannabis cultivation, extraction and distribution business under federal licence from the Government of Canada. Maricann, which has federal licences to cultivate, process and distribute cannabis, services a patient base with more than 8,000 total registered patients since inception. Maricann is currently undertaking an expansion of its cultivation and support facilities in Canada in a fully funded 217,000 sq. ft. (20,159 sq. m), to support existing and future patient growth. Maricann GmbH is a 95% owned subsidiary of Maricann Netherlands BV, a 100% wholly owned subsidiary of Maricann Group Inc.

Maricann Milestones

  • April 2013, Maricann Inc. is founded in Langton, Ontario, a well-established agricultural region in southwestern Ontario
  • March 2014, Maricann Inc. obtains its Health Canada licence to cultivate plants
  • December 2014, Maricann Inc. obtains its Health Canada licence to sell dried cannabis
  • January 2015, first dried cannabis sale
  • September 2016, Maricann Inc. earns its Health Canada licence to sell cannabis extracts
  • October 2016, first sale of extracted cannabis
  • December 2016, Maricann Inc. raises $22.5 million in private capital
  • January 2017, commences sale of clones
  • February 2017, Maricann Inc. raises $10 million in private capital
  • April 24, 2017, first day of trading on the CSE
  • April 28, 2017, announces Advisory Board of German subsidiary.

For more information about Maricann please visit our website at www.maricann.ca

Forward Looking Information
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release. This news release contains certain forward-looking statements that reflect the current views and/or expectations of management with respect to performance, business and future events, including but not limited to express or implied statements and assumptions regarding the Company’s business and operations. Forward-looking statements are based on the then-current expectations, beliefs, assumptions, estimates and forecasts about the business and the industry and markets in which the Company operates. Forward-looking statements are not guarantees of future performance and involve risks, uncertainties and assumptions which are difficult to predict. Accordingly, readers should not place undue reliance on forward-looking statements and information, which are qualified in their entirety by this cautionary statement. The Company does not undertake any obligations to release publicly any revisions for updating any voluntary forward-looking statements, except as required by applicable securities law.

Contact Information

Shawn Alexander
VP Investor Relations
[email protected]

Corporate Headquarters:
Maricann Group Inc. (C.MARI)
845 Harrington Court, Unit 3
Burlington Ontario L7N 3P3
Canada

Dial Toll Free in North America:
1.844.Maricann (627.4226)
International Only:
001.416.916.7145

PRA Health Sciences Announces The Center for Pediatric Clinical Development

RALEIGH, N.C, May 04, 2017 (GLOBE NEWSWIRE) — It is a little known fact that 70% of medicines given to children have been studied only in adults. As a result, most drugs used to treat diseases in children are used off-label. While there are pediatric clinical trial regulations in place, testing drugs in children continues to present considerable scientific, clinical, ethical and logistical challenges. In an effort to confront these challenges, PRA Health Sciences (NASDAQ:PRAH) is pleased to announce its new Center for Pediatric Clinical Development.

“PRA has a strong background in conducting pediatric clinical trials,” said Mark Sorrentino, Vice President, The Center for Pediatric Clinical Development. “We see this new center as an opportunity to establish PRA as the industry leader in pediatric drug development and bring innovation to pediatric clinical trial design and implementation.”

PRA has conducted the pivotal and/or supportive trials to gain 12 FDA and/or international regulatory approvals for drugs used in treating pediatric patients across multiple therapeutic areas. The Center for Pediatric Clinical Development is supported by a cross-functional group of experts who will provide strategic pediatric product development consulting services as well as experienced technical and operational services.

“This pediatric collaboration team provides the foundation for The Center for Pediatric Clinical Development,” added Sorrentino. “The team will provide pediatric expertise across functional areas into a single global resource to support all aspects of our clients’ pediatric product development needs.”

The team will help navigate the complexities of pediatric trials and brings a wealth of knowledge in understanding the diverse country-specific regulatory and legal challenges in the pediatric environment. One of the many benefits of the center will be a site network to accelerate patient recruitment, and improve patient engagement and retention.

ABOUT PRA HEALTH SCIENCES

PRA is one of the world’s leading global contract research organizations, by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and over 13,000 employees worldwide. Since 2000, PRA has participated in approximately 3,500 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs. To learn more about PRA, please visit www.prahs.com.

INQUIRIES: Christine Rogers, Manager – Public Relations, Corporate Communications
EMAIL: [email protected] PHONE: +1 919.786.8463

PRA Health Sciences Announces The Center for Pediatric Clinical Development

RALEIGH, N.C, May 04, 2017 (GLOBE NEWSWIRE) — It is a little known fact that 70% of medicines given to children have been studied only in adults. As a result, most drugs used to treat diseases in children are used off-label. While there are pediatric clinical trial regulations in place, testing drugs in children continues to present considerable scientific, clinical, ethical and logistical challenges. In an effort to confront these challenges, PRA Health Sciences (NASDAQ:PRAH) is pleased to announce its new Center for Pediatric Clinical Development.

“PRA has a strong background in conducting pediatric clinical trials,” said Mark Sorrentino, Vice President, The Center for Pediatric Clinical Development. “We see this new center as an opportunity to establish PRA as the industry leader in pediatric drug development and bring innovation to pediatric clinical trial design and implementation.”

PRA has conducted the pivotal and/or supportive trials to gain 12 FDA and/or international regulatory approvals for drugs used in treating pediatric patients across multiple therapeutic areas. The Center for Pediatric Clinical Development is supported by a cross-functional group of experts who will provide strategic pediatric product development consulting services as well as experienced technical and operational services.

“This pediatric collaboration team provides the foundation for The Center for Pediatric Clinical Development,” added Sorrentino. “The team will provide pediatric expertise across functional areas into a single global resource to support all aspects of our clients’ pediatric product development needs.”

The team will help navigate the complexities of pediatric trials and brings a wealth of knowledge in understanding the diverse country-specific regulatory and legal challenges in the pediatric environment. One of the many benefits of the center will be a site network to accelerate patient recruitment, and improve patient engagement and retention.

ABOUT PRA HEALTH SCIENCES

PRA is one of the world’s leading global contract research organizations, by revenue, providing outsourced clinical development services to the biotechnology and pharmaceutical industries. PRA’s global clinical development platform includes more than 70 offices across North America, Europe, Asia, Latin America, South Africa, Australia and the Middle East, and over 13,000 employees worldwide. Since 2000, PRA has participated in approximately 3,500 clinical trials worldwide. In addition, PRA has participated in the pivotal or supportive trials that led to U.S. Food and Drug Administration or international regulatory approval of more than 70 drugs. To learn more about PRA, please visit www.prahs.com.

INQUIRIES: Christine Rogers, Manager – Public Relations, Corporate Communications
EMAIL: [email protected] PHONE: +1 919.786.8463

Abiomed Announces Q4 FY 2017 Revenue of $124.7 Million, Up 33% Over Prior Year and Total Year Revenue of $445.3 Million, Up 35% Over Prior Year

DANVERS, Mass., May 04, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today reported fourth quarter fiscal 2017 revenue of $124.7 million, an increase of 33% compared to revenue of $94.0 million for the same period of fiscal 2016.  For fiscal year 2017, total revenue was $445.3 million, up 35% compared to revenue of $329.5 million in fiscal year 2016.

Fourth quarter fiscal 2017 GAAP net income was $14.9 million or $0.33 per diluted share, impacted by $3.1 million or $0.07 per diluted share of one-time items, described below. For the full fiscal year, GAAP net income was $52.1 million or $1.17 per diluted share.

Financial and operating highlights during the fourth quarter of fiscal 2017 include:

  • Fiscal fourth quarter worldwide Impella® heart pump revenue totaled $118.9 million, an increase of 34% compared to revenue of $88.6 million during
  • U.S. Impella heart pump revenue for the quarter grew 32% to $108.2 million from $81.8 million in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 30%.  Full year U.S. Impella revenue totaled $387.5 million, up 35% compared to $287.2 million in the prior fiscal year.
  • The installed base for Impella 2.5® heart pumps in the U.S. grew by an additional 19 hospitals, which made initial purchases of Impella heart pumps, bringing the installed customer base to 1,138 sites. The installed customer base for Impella CP® heart pumps grew by 44 new U.S. hospitals, bringing the total number of Impella CP sites to 1,016. The installed customer base for Impella 5.0® heart pumps grew by 11 new U.S. hospitals, bringing the total number of Impella 5.0 sites to 453.
  • An additional 7 sites made initial purchases of Impella RP® heart pumps during the quarter, bringing the total number of sites to 127.
  • Gross margin for fiscal fourth quarter 2017 was 84.6% compared to 84.4% in the fourth quarter of fiscal 2016.  For the full fiscal year, gross margin was 84.1% compared to 84.7% in the prior year.
  • Operating income for the fourth quarter of fiscal 2017 was $29.0 million, or 23.3% operating margin, compared to $19.8 million, or 21.1% operating margin in the prior year period. For the full fiscal year, operating income was $90.1 million, or 20.2% of revenue, compared to $65.1 million, or 19.8% of revenue in the prior year.
  • The Company generated $18.2 million in cash, cash equivalents and marketable securities in the fourth quarter of fiscal 2017, bringing the total to $277.1 million as of March 31, 2017. The Company currently has no debt.
  • Fourth quarter fiscal 2017 GAAP net income was $14.9 million or $0.33 per diluted share and full fiscal year GAAP net income was $52.1 million or $1.17 per diluted share. This compares to GAAP net income for the fourth quarter of fiscal 2016 of $11.0 million or $0.24 per diluted share and full fiscal year GAAP net income of $38.1 million or $0.85 per diluted share.  During the fourth quarter of fiscal 2017, the Company recorded a non-recurring income tax charge of $3.1 million, or $0.07 per diluted share, related to uncertainty about the utilization of research and development tax credits.
  • Beginning in the first quarter of fiscal 2018, the Company will adopt a new accounting standard entitled “Improvements to Employee Share-Based Payment Accounting”. Under this new standard, excess tax benefits and deficiencies associated with employee share-based payments will no longer be recognized as additional paid-in capital on the balance sheet, but instead will be recognized directly to income tax expense or benefit in the income statement for the reporting period in which they occur. The adoption of the new accounting standard is likely to introduce positive fluctuations to net income, our tax provision and earnings per share this year, but will not impact Abiomed’s operating income or cash tax paid.
  • On February 23, 2017, Abiomed announced that it has supported more than 50,000 patients in the U.S. with its Impella® heart pumps.
  • On March 19, 2017 at the American College of Cardiology (ACC) 66th Annual Scientific Session in Washington, D.C, Abiomed announced and presented data from the Impella® Quality (IQ) Assurance Program, which includes the IQ Database and cVAD RegistryTM. The Abiomed IQ Assurance Program is a real-world collection of clinical information derived from the treatment of patients with Impella devices since 2008. Trends in the observational IQ Database, combined with information from Abiomed’s Institutional Review Board (IRB)-approved cVAD Registry have helped identify best practices and protocols that are associated with improved survival and native heart recovery in hospitals using Impella devices. The data presented also included new data from the Detroit Cardiogenic Shock Initiative (DCSI), which is an unprecedented collaboration between five heart hospitals in Detroit focused on systematic best practices to increase cardiogenic shock survival rates.
  • On March 30, 2017, Abiomed announced the Grand Opening of Newly-Expanded manufacturing and training space at Danvers, Massachusetts headquarters.
  • Today, Abiomed announced in a separate press release, the first patient enrolled in the STEMI Door to Unloading (DTU) feasibility study.

“Abiomed remains one of the fastest growing GAAP profitable companies and fiscal 2017 was another successful year as we achieved our corporate goals with two FDA approvals, approval in Japan, and dedicated DRGs from the Centers for Medicare and Medicaid Services (CMS),” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed. “We want to thank our shareholders for their support and all of our employees and customers for their hard work and dedication to patients and our mission of heart recovery.”

FISCAL YEAR 2018 OUTLOOK
The Company is giving its fiscal year 2018 guidance for total revenues to be in the range of $555 million to $575 million, an increase of 25% – 29% over the prior year. The Company is also giving its fiscal year 2018 guidance for GAAP operating margin to be in the range of 22% to 24%.

EARNINGS CONFERENCE CALL DETAILS
The Company will host a conference call to discuss the results at 8 a.m. ET on Thursday, May 4, 2017. The conference call releasing full quarterly results will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Michael Tomsicek, Vice President and Chief Financial Officer.

To listen to the call live, please tune into the webcast via http://investor.abiomed.com or dial (855) 212-2361; the international number is (678) 809-1538.  A replay of this conference call will be available beginning at 11 a.m. EDT May 4, 2017 through 11:00 a.m. EDT on May 7, 2017. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 3991529.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella CP, Impella 5.0, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. cVAD Registry is a trademark of ABIOMED, Inc.

ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com

FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including statements regarding development of Abiomed’s existing and new products, the Company’s progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company’s filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

Abiomed, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share data)
  March 31, 2017   March 31, 2016
       
ASSETS
Current assets:
Cash and cash equivalents $   39,040 $   48,231
Short-term marketable securities   190,908   163,822
Accounts receivable, net   54,055   42,821
Inventories   34,931   26,740
Prepaid expenses and other current assets   8,024   6,778
Total current assets   326,958   288,392
Long-term marketable securities   47,143   1,000
Property and equipment, net   87,777   23,184
Goodwill   31,045   33,003
In-process research and development   14,482   15,396
Long-term deferred tax assets, net   34,723   58,534
Other assets   8,286   4,422
Total assets $   550,414 $   423,931
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $   20,620 $   9,381
Accrued expenses   37,703   28,382
Deferred revenue   10,495   8,778
Current portion of capital lease obligation   799   —
Total current liabilities   69,617   46,541
Other long-term liabilities   3,251   220
Contingent consideration   9,153   7,563
Long-term deferred tax liabilities   783   832
Capital lease obligation, net of current portion   15,539   —
Total liabilities   98,343   55,156
Commitments and contingencies
Stockholders’ equity:
Class B Preferred Stock, $.01 par value   —   —
Authorized – 1,000,000 shares; Issued and outstanding – none
Common stock, $.01 par value   437   426
Authorized – 100,000,000 shares; Issued – 45,249,281 shares at March 31, 2017 and 43,973,119 shares at March 31, 2016;
Outstanding – 43,673,286 shares at March 31, 2017 and 42,596,228 shares at March 31, 2016
Additional paid in capital   565,962   508,624
Accumulated deficit   (46,959 )   (99,075 )
Treasury stock at cost – 1,575,995 shares at March 31, 2017 and 1,376,891 shares at March 31, 2016   (46,763 )   (26,660 )
Accumulated other comprehensive loss   (20,606 )   (14,540 )
Total stockholders’ equity   452,071   368,775
Total liabilities and stockholders’ equity $   550,414 $   423,931
Abiomed, Inc. and Subsidiaries  
Consolidated Statements of Operations  
(Unaudited)  
(in thousands, except per share data)  
Three Months Ended
March 31,
Fiscal Years Ended
March 31,
2017   2016 2017   2016
Revenue:
Product revenue $ 124,654 $ 93,951 $ 445,195 $ 329,520
Funded research and development 26 6 109 23
124,680 93,957 445,304 329,543
Costs and expenses:
Cost of product revenue 19,261 14,663 70,627 50,419
Research and development 16,325 14,225 66,386 49,759
Selling, general and administrative 60,100 45,256 218,153 164,261
95,686 74,144 355,166 264,439
Income from operations 28,994 19,813 90,138 65,104
Other income:
Investment income, net 486 186 1,554 395
Other (expense) income, net (124 ) 228 (349 ) 339
362 414 1,205 734
Income before income taxes 29,356 20,227 91,343 65,838
Income tax provision 14,457 9,229 39,227 27,691
Net income $ 14,899 $ 10,998 $ 52,116 $ 38,147
Basic net income per share $ 0.34 $ 0.26 $ 1.21 $ 0.90
Basic weighted average shares outstanding 43,579 42,463 43,238 42,204
Diluted net income per share $ 0.33 $ 0.24 $ 1.17 $ 0.85
Diluted weighted average shares outstanding 44,924 45,112 44,658 44,895

For further information please contact: 

Ingrid Goldberg,
Director, Investor Relations
978-646-1590
[email protected]

Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
[email protected]

Abiomed Announces First Patient Enrolled in STEMI DTU Feasibility Study

DANVERS, Mass., May 04, 2017 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, announced today the enrollment of the first patient in the Food and Drug Administration (FDA) approved prospective feasibility study, STEMI Door to Unloading (DTU) with Impella CP® system in acute myocardial infarction. This trial will focus on feasibility and safety of unloading the left ventricle using the Impella CP heart pump prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST segment elevation myocardial infarction (STEMI) without cardiogenic shock with the hypothesis that this will potentially reduce infarct size.

The study, which received FDA approval in October 2016, is a prospective, multi-center feasibility study led by principal investigators Dr. Navin K. Kapur of Tufts Medical Center and Dr. William W. O’Neill of Henry Ford Medical Center. Up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months.

The first patient in the study was enrolled in late April at Northwell Health System in Long Island, NY under the leadership of Dr. Perwaiz Meraj.

The primary endpoints of the feasibility study will focus on safety, including Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days. All patients will undergo cardiac magnetic resonance (CMR) imaging to assess infarct size as percent of left ventricular mass at 30 days post-PCI. Patients will be randomized to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI. The hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and also initiates a cardio-protective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularization. This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites, patients and will be designed for statistical significance. Abiomed does not plan to announce additional enrollment status.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella CP, Impella 5.0, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries. cVAD Registry is a trademark of ABIOMED, Inc.

ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com

FORWARD-LOOKING STATEMENTS
This release contains forward-looking statements, including statements regarding development of Abiomed’s existing and new products, the Company’s progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company’s actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company’s filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

For further information please contact: 

Ingrid Goldberg
Director, Investor Relations
978-646-1590
[email protected]

Adrienne Smith
Senior Director, Public Relations and Corporate Communications
978-646-1553
[email protected]