Affibody Enters into Agreement with 3P Biopharmaceuticals for Production of ABY-035

On May 27, 2019 Affibody AB ("Affibody"), a clinical stage biopharmaceutical company, reported an agreement with 3P Biopharmaceuticals ("3P") covering process development and GMP manufacturing of Affibody’s ABY-035 drug.
Affibody secures production capacity for ABY-035 (Press release, Affibody, MAY 27, 2019, View Source [SID1234575708]).

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An important next step in the advancement of ABY-035 to late stage clinical development.
"Ensuring large scale high quality production of our ABY-035 drug is a natural next step in our evolution as a company with the ambition to have development, manufacturing, and commercialization expertise", said David Bejker, CEO of Affibody. "The work we have initiated together with 3P is important for us and we look forward to working with 3P."

According to the agreement, 3P is responsible for transferring the process developed by Affibody to its facilities prior to execution of the first GMP manufacturing batches. 3P will also perform the process characterization and the process validation before entering the commercial batch manufacturing stage.

"We are very pleased to be working with Affibody on this project and to create a strong long-term partnership with them. We are sure that this is a mutually beneficial agreement." says Dámaso Molero, General Manager at 3P Biopharmaceuticals.

Nordic Nanovector to Present at Redeye Pre-ASCO Seminar, Jefferies Healthcare Conference and ABGSC Oncology Seminar

On May 27, 2019 Nordic Nanovector ASA (OSE: NANO) reported that members of its senior management team will participate and present at the following upcoming investor conferences during May and June (Press release, Nordic Nanovector, MAY 27, 2019, View Source [SID1234536590]):

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Redeye Pre-ASCO seminar in Stockholm on 28 May
Jefferies Healthcare conference in New York on 4-7 June
ABGSC Oncology seminar in Oslo on 11 June
The company presentation to be given at these events will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentations on the first day of each conference.

For further information, please contact:

IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]

Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]

Medivir to Present at the Redeye Pre-ASCO Seminar on May 28

On May 27, 2019 Medivir AB (Nasdaq Stockholm: MVIR) reported that the company will participate at the Redeye Pre-ASCO Seminar in Stockholm. The presentation will take place at 9.15am on Tuesday, May 28, 2019 (Press release, Medivir, MAY 27, 2019, View Source [SID1234536589]). Dr. Uli Hacksell, CEO of Medivir, will present the latest development and the company´s future.

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The presentation will be available via Medivirs website; www.medivir.com.

For further information, please contact:

Uli Hacksell
CEO, Medivir AB
mobile: +46(0)73-125-0615.

BioMarin to Host Conference Call Tuesday, May 28, 2019 to Provide a Valoctocogene Roxaparvovec Phase 2 and Phase 3 Update

On May 27, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), reported that management will host a conference call and webcast on Tuesday, May 28 at 8:00am ET to discuss program updates (Press release, BioMarin, MAY 27, 2019, https://www.prnewswire.com/news-releases/biomarin-to-host-conference-call-tuesday-may-28-2019-to-provide-a-valoctocogene-roxaparvovec-phase-2-and-phase-3-update-300857066.html [SID1234536588]).

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Conference Call and Webcast Information
Interested parties may access the live video webcast that will include audio and a slide presentation via the investor section of the BioMarin website, www.biomarin.com. A replay of the meeting will be archived on the site for one week.

For those who want access to the audio portion only, please use the dial-in information below:

U.S. / Canada Dial-in Number: (866) 502-9859
International Dial-in Number: (574) 990-1362
Conference ID: 2295086

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 2295086

Medicure Reports Financial Results for Quarter Ended March 31, 2019

On May 27, 2019 Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, reported its results from operations for the quarter ended March 31, 2019 (Press release, Medicure, MAY 27, 2019, View Source [SID1234536587]).

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Quarter Ended March 31, 2019 Highlights:

Recorded net revenue from the sale of AGGRASTAT (tirofiban hydrochloride) of $4.8 million during the quarter ended March 31, 2019 compared to $6.1 million for the quarter ended March 31, 2018;

$55.5 million in cash and short-term investments as at March 31, 2019;

Adjusted earnings before interest, taxes, depreciation and amortization (EBITDA1) for the quarter ended March 31, 2019 was negative $1.7 million compared to adjusted EBITDA of $927,000 for the quarter ended March 31, 2018; and

Net loss for the quarter ended March 31, 2019 was $2.8 million compared to net income of $1.4 million for the quarter ended March 31, 2018.
Financial Results

Net revenues for the three months ended March 31, 2019 were $4.9 million compared to $6.1 million for the three months ended March 31, 2018. Net revenues from AGGRASTAT for the three months ended March 31, 2019 were $4.8 million compared to $6.1 million for the three months ended March 31, 2018. Additionally, ReDSTM point of care system ("ReDSTM"), contributed $103,000 of net revenue for the three months ended March 31, 2019.

The Company continued to experience strong patient market share held and strong hospital demand for AGGRASTAT during the three months ended March 31, 2019, however increases in volume compared to the three months ended March 31, 2018 were offset by increased price competition that resulted in lower discounted prices for AGGRASTAT throughout the quarter.

Diversification of revenues remains an important aspect of the Company’s focus with Medicure concentrating on the sales and marketing of AGGRASTAT, growing the sales of ZYPITAMAGTM (pitavastatin) and marketing the recently licensed ReDSTM device system.

Adjusted EBITDA for the three months ended March 31, 2019 was negative $1.7 million compared to $927,000 for the three months ended March 31, 2018. The decrease in adjusted EBITDA for the three months ended March 31, 2019 is the result of the higher selling, general and administration expenses caused by the incurrence of additional costs relating to the commercial organization due to the Company’s additional products, higher cost of goods sold attributable to an increased volume of AGGRASTAT sold and lower revenues experienced during the quarter ended March 31, 2019.

Net loss for the three months ended March 31, 2019 was $2.8 million or $0.18 per share. This compares to net income of $1.4 million or $0.09 per share for the three months ended March 31, 2018. Similar to the decrease in adjusted EBITDA, the net loss for the three months ended March 31, 2019 is the result of higher selling, general and administration expenses, higher cost of goods sold and lower revenues experienced during the quarter. Foreign exchange loss relating to a decrease in the value of the U.S. dollar experienced during the quarter ended March 31, 2019 also contributed to the net loss.

At March 31, 2019, the Company had unrestricted cash and short-term investments totaling $55.5 million compared to $71.9 million as of December 31, 2018. The decrease in cash is primarily due to the investment made in Sensible Medical Innovations Ltd. and a decrease in the value of the U.S. dollar as at March 31, 2019 compared to December 31, 2018. Cash flows used in operating activities for the three months ended March 31, 2019 totaled $1.9 million.

All amounts referenced herein are in Canadian dollars unless otherwise noted.

Notes

(1) The Company defines EBITDA as "earnings before interest, taxes, depreciation, amortization and other income or expense" and Adjusted EBITDA as "EBITDA adjusted for non-cash and non-recurring items". The terms "EBITDA" and "Adjusted EBITDA", as it relates to the quarters ended March 31, 2019 and 2018 results prepared using International Financial Reporting Standards ("IFRS"), do not have any standardized meaning according to IFRS. It is therefore unlikely to be comparable to similar measures presented by other companies.

Conference Call Info:

Topic: Medicure’s Q1 2019 Results

Call date: Tuesday, May 28, 2019

Time: 7:30 AM Central Time (8:30 AM Eastern Time)

Canada toll-free: 1 (888) 465-5079 Canada toll: 1 (416) 216-4169

United States toll-free: 1 (888) 545-0687

Passcode: 6562291#

Webcast: This conference call will be webcast live over the internet and can be accessed from the Medicure investor relations page at the following link: View Source

You may request international country-specific access information by e-mailing the Company in advance. Management will accept and answer questions related to the financial results and operations during the question-and-answer period at the end of the conference call. A recording of the call will be available following the event at the Company’s website.