Correvio Pharma Corp. (NASDAQ:CORV) Q3 2018 Earnings Conference Call Transcript
Nov 06, 2018 • 04:30 pm ET
Good afternoon, ladies and gentlemen, and welcome to Correvio's Third Quarter 2018 Financial Results Conference Call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request.
I would now like to turn the call over to Mr. Justin Renz, CFO of Correvio. Please go ahead, sir.
Good afternoon, and welcome to our third quarter 2018 earnings call. On the call with me today are Dr. Bill Hunter, Correvio's President and CEO; and Ms. Sheila Grant, Correvio's COO.
On today's call, Bill will provide an overview of important recent developments, and then I will discuss highlights from our third quarter 2018 financial results. Bill will then provide some summary remarks. We will then open the call up for your questions for which Sheila will also be available to answer.
Earlier this afternoon, we issued a press release detailing Correvio's financial results for the third quarter of 2018. The release is also available on our website at www.correvio.com.
(Forward-Looking Cautionary Statements)
With that, I will now turn the call over to Bill.
And I'd like to thank everyone for joining us on today's call. The past few months Correvio had been marked by significant achievements across a number of our ongoing programs and initiatives.
Turning to the first slide, I'd like to bring your attention to five really highly significant developments. Perhaps most noteworthy, two weeks ago we announced that based on productive pre-NDA discussions with the U.S. Food and Drug Administration, Correvio plans to resubmit the Brinavess new drug application during the second quarter of 2019.
We also reported positive preliminary data from the SPECTRUM study, a post-marketing authorization safety study conducted in the EU evaluating Brinavess over 2,000 treatment episodes of atrial fibrillation, which I will go into in more detail later.
Three, the licensor of our next European product, Trevyent, was successfully acquired by United Therapeutics, a deal we believe will be beneficial to the overall Trevyent program. Next, we continued 2018 strong performance in our proprietary product portfolio with 58% year-over-year growth achieved by our direct sales team in Europe. And finally, in May, we completed an important strategic corporate transaction, the sale of our Canadian commercial business and product portfolio to Cipher Pharmaceuticals, which has brought in a total of CAD25.5 million in non-dilutive capital.
Before moving on to talk in more depth about the recent U.S. Brinavess developments, I'd like to mention that today we will use the branded name, Brinavess, and the chemical name, vernakalant, interchangeably. Should vernakalant be approved for sale in the United States in the future, it could potentially be under a different brand name than Brinavess.
Moving on to slide four, as previously mentioned, following our discussions with the FDA in October, we intend to resubmit the Brinavess NDA during the second quarter of 2019. As you know, Brinavess, or vernakalant, is an intravenous antiarrhythmic indicated for the rapid conversion of recent onset atrial fibrillation in patients without significant heart failure.