AEterna Zentaris Inc. (AEZS)

[chmcnfunds]

Æterna Zentaris CEO Discusses Q4 2013 Results - Earnings Call Transcript

Mar. 21, 2014 11:48 AM ET | About: AEZS

AEterna Zentaris, Inc. (AEZS) Q4 2013 Earnings Conference Call March 21, 2014 8:30 AM ET

Operator

Good morning. My name is Jonathan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Aeterna Zentaris Fourth Quarter and Full Year 2013 Financial and Operating Results Conference Call. [Operator Instructions].

Thank you. Mr. Paul Burroughs, Director of Communications, you may begin your conference.

Paul Burroughs - Director of Communications
Thank you. Good morning everyone. With me today are David Dodd, President and CEO; Dennis Turpin, Chief Financial Officer; Richard Sachse, Chief Scientific Officer and Chief Medical Officer and Jude Dinges, Chief Commercial Officer.

Please take note that during this call, we may be making forward-looking statements regarding future events and the performance of Aeterna Zentaris that involve risks and uncertainties that could cause actual events and results to differ materially. These risks are described in further detail in the company's press releases and reports filed with the U.S. and Canadian securities regulatory authorities. These forward-looking statements represent the company's judgment as of today, Friday, March 21, 2014, and the company disclaims any intent or obligation to update these forward-looking statements unless we are required to do so by applicable law or by a securities regulatory authority. However, we may choose to update, and if we do so, we will disseminate the updates to the investing public.

Its now my pleasure to introduce the President and CEO of Aeterna Zentaris, David Dodd.

David Dodd - President and CEO
Thank you, Paul. Good morning and thank you for your interest in Aeterna Zentaris. The past few months have been a period of transition and progress in our company operations, with a focus on three items; maximizing the efficiency and effectiveness of our organizational design and talent alignment. Second, achieving a more productive product portfolio of development process, including internal development programs, as well as business development activities targeted to obtain either late stage development programs, or on the market products. And finally, ensuring a competitive ability to successfully commercialize products, as the company transforms into a commercial stage business.

In line with these goals, we have further strengthened our leadership team, with the addition of Dr. Richard Sachse, as we noted, is Chief Scientific Officer and Chief Medical Officer.

We have also completed a comprehensive review of our existing portfolio, resulting in an increased focus in our resources from our lead programs, related to MACRILEN for the evaluation of Adult Growth Hormone Deficiency and our pivotal Phase 3 ZoptEC trial in endometrial cancer, utilizing our compound zoptarelin doxorubicin.

Our intent to transform the company into a highly competitive organization, commercializing important products, which improve lives of patients and increase opportunity for successful growth and development of shareholder value.

Recently, continued progress was achieved, with a successful filing of our new drug application for Macimorelin Acetate, now under the trade name MACRILEN, in which adult growth hormone deficiency will be diagnosed, and the expanded patient recruitment for our ZoptEC Phase 3 trial.

Now recall, that MACRILEN is an oral ghrelin agonist for use in evaluating AGHD. The NDA is currently under substance [ph] of a review by the FDA. Our PDUFA date is November 5, 2014, and upon approval MACRILEN would become the first available oral product for use in evaluating adult growth hormone deficiency.

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