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Æterna Zentaris (NASDAQ:AEZS)

Q4 2012 Earnings Call

March 22, 2013 8:30 am ET

Executives

Paul Burroughs - Director of Communications

Juergen Engel - Chief Executive Officer, President and Director

Dennis Turpin - Chief Financial Officer and Senior Vice President

Paul Blake - Chief Medical Officer and Senior Vice President

Nicholas J. Pelliccione - Senior Vice President of Regulatory Affairs & Quality Assurance

Analysts

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

Jason Kolbert - Maxim Group LLC, Research Division

George B. Zavoico - MLV & Co LLC, Research Division

Operator

Good morning. My name is Simon, and I will be your conference operator today. At this time, I would like to welcome everyone to the Aeterna Zentaris' Q4 and Full Year 2012 Financial and Operating Results Conference Call. [Operator Instructions]

Thank you. I will now turn the call over to Mr. Paul Burroughs, Director of Communications. Please go ahead, sir.

Paul Burroughs

Thank you. Good morning, everyone, and welcome. Today with me are Juergen Engel, President and CEO; Paul Blake, Chief Medical Officer; Dennis Turpin, Chief Financial Officer; and Nick Pelliccione, Senior VP of Regulatory Affairs and Quality Assurance.

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 22, 2013, 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 securities regulatory authority. However, we may choose to update, and if we do so, we will disseminate the updates to the investing public.

It's now my pleasure to introduce the President and CEO of Aeterna Zentaris, Dr. Juergen Engel.

Juergen Engel

Thanks, Paul. Good morning to all of you and thanks for joining the call. 2012 was a challenging year for the company, as we had to face disappointing Phase III results for perifosine in colorectal cancer and subsequent to year-end interim results in multiple myeloma. We therefore decided to discontinue the development program for perifosine. We now look to 2013 with great focus on our lead drug development programs.

Let's start with our lead anticancer compound, AEZS-108, our LHRH agonist peptide carrier linked to doxorubicin. This compound is part of our personalized medicine approach, which focuses on tailoring a treatment according to specific characteristics of a patient's cancer. AEZS-108 specifically targets LHRH receptors, which are present in endometrial, breast, bladder, prostate and ovarian cancer. By specifically targeting these receptors, we hope that AEZS-108 would prove to be a more efficient and less toxic cancer treatment than conventional chemotherapy.

During the fourth quarter of 2012, we were granted a Special Protocol Assessment by the FDA for our Phase III registration trial with AEZS-108 in endometrial cancer. Subject to a positive outcome in the trial, the SPA states that the proposed protocol design, clinical endpoints and planned analyses are acceptable to the FDA to support a regulatory submission. This is an open-label, randomized multicenter Phase III trial comparing AEZS-108 with doxorubicin as second-line therapy for locally-advanced, recurrent or metastatic endometrial cancer. The primary efficacy endpoint will be a 3-month improvement in medium overall survival.

We are going to conduct the study in 15 to 20 countries: U.S., Canada, Europe and other countries such as Israel. It will involve about 500 patients and approximately 384 events will trigger final analysis of the data. There is a preplanned interim analysis when about 128 events will have occurred.

Many trial activities are already ongoing and we expect patient recruitment to start in April. Endometrial cancer is the most common gynecologic malignancy. According to the American Cancer Society, an estimated -- about 50,000 new cases of endometrial cancer in the U.S. and approximately 36,000 in Europe are expected during 2013, with about 20% of recurrent disease. To our knowledge, no drug has been approved in the U.S. and in most of Europe in this indication, which therefore, could represent an interesting global business opportunity.

Let me now turn to Phase II clinical studies with AEZS-108. Last month, we announced the first patient treated for the Phase II trial in chemotherapy refractory triple-negative breast cancer. In bladder cancer, we opened a second site at the hospital of the University of Pennsylvania. Finally, in castration- and taxane-resistant prostate cancer, the Phase I portion of the NIH-funded Phase I/II trial has been completed, and recruitment for the Phase II portion is ongoing. Expansion into these other fields is a further indication of the potential of this innovative compound in a variety of cancer indications for both women and men. The development of a companion diagnostic for LHRH-positive cancers is applicable to all these indications and also to our treatment programs for our proprietary disorazol Z conjugates.

Continuing with AEZS-130, our novel orally active ghrelin agonist, as a diagnostic test for adult growth hormone deficiency, we expect to submit an NDA within the next 6 weeks. We believe that AEZS-130 could become the first approved oral test of this indication, providing patients with a potential safe, accurate and more convenient alternative to the current injectable tests.

During the fourth quarter of 2012, we presented Phase III results for AEZS-130 in adult growth hormone deficiency at the 6th International Congress of the GRS and IGF Society in Munich. The data presented by Dr. George Merriam extended those presented on the same study last June at the ENDO Annual Meeting by Dr. Jose Garcia. Both confirm AEZS-130's potential to be the first approved oral diagnostic test for adult growth hormone deficiency.

Finally, we also announced that the U.S. and European authorities had granted patents for AEZS-130 as a diagnostic in growth hormone deficiency valid until 2027. This is part of our strategy to increase the protection of this proprietary compound for which we hold worldwide rights.

We are also developing AEZS-130 as a treatment for cancer-induced cachexia. Cachexia, characterized by diminished appetite and food intake in cancer patient, is defined as an involuntary weight loss of at least 5% of the pre-illness body weight of the previous 6 months. This condition affects a great number of cancer patients and is associated with more than 20% of all cancer deaths.

In August 2012, we announced that the first patient had been recruited for the Phase IIa trial in cancer-induced cachexia. The trial is being conducted by Dr. Garcia of the Michael Debakey Veterans Affairs Medical Center in Houston, which is funding the study under a trade-up between our company and the VA Center. This is a double-blind randomized placebo-controlled Phase IIa trial to test the effects of different doses of AEZS-130 in 18 to 26 patients with cancer cachexia. Treatment with AEZS-130 in cancer cachexia may lead to better quality of life for patients, especially, since there are currently no approved treatments for this condition.

Our pipeline also encompasses earlier stage novel targeted anticancer compounds. One of them is AEZS-120, an oral tumor vaccine candidate for prostate cancer. During the year, we presented preclinical data on AEZS-120 at the Congress of the Société Internationale d'Urologie in Japan. The presentation underlined the feasibility of an oral therapeutic vaccination approach against prostate cancer. The production, pharmacology, safety and toxicology program was conducted and successfully finalized in agreement with the regulatory authorities. This program was partially sponsored by a grant from the German government.

In all, the nonclinical studies suggest that the safety and toxicological profile of AEZS-120 is similar to the approved oral salmonella typhoid vaccine, which has already been safely administered in more than 350 million doses over the last 20 years. GMP material for clinical use has been produced and released. We have completed the preclinical program and we expect to file a clinical trial application, shortly followed by the initiation of a Phase I clinical study during the next quarter.

At the 24th EMA meeting in Dublin last November, we presented encouraging in vivo proof of concept results with our disorazol Z cytotoxic conjugates, such as AEZS-125 and 138 which, like AEZS-108, target LHRH receptor of human tumor cells. For all conjugates, proof of concept was demonstrated in an LHRH-receptor-positive A2780 ovarian cancer xenograft model. The project is part of our strategy to develop targeted therapies in oncology in collaboration with several institutions in Germany, and is sponsored by the German Federal Ministry of Education and Research with an amount of about USD 3 million. We have much to look forward to in 2013 with the expected submission of the NDA for AEZS-130 as a diagnostic for adult growth hormone deficiency and the opening of the Phase III trial in endometrial cancer with AEZS-108. Our team remains fully committed to the development of novel treatment options for patients with unmet medical needs.

I will now turn the call over to our CFO, Dennis Turpin, for our financial activities.

Dennis Turpin

Thank you, Juergen. Let me start with an update on our recent financing activities and our existing cash position. First, the company consolidated its issued and outstanding common shares on a 6-to-1 basis effective as of October 2, 2012, in order to regain compliance with the NASDAQ's stock market minimum bid price requirement. The company was successful in regaining NASDAQ compliance on October 19, 2012.

Next, on October 17, 2012, the company completed a public offering of 6.6 million units at a purchase price of $2.50 per unit. Each unit was composed of 1 common share and 0.45 of a warrant to purchase common shares at an exercise price of $3.45 per share, generating net proceeds of nearly $15.1 million at closing.

As of December 31, 2012, our cash and cash equivalents total $39.5 million. Based on our current expectation, we believe our capital resources as of December 31, 2012, will be sufficient to fund our currently planned operations into, at least, the first half of 2014.

Now regarding our consolidated results, as at and for the fourth quarter ended December 31, 2012, revenues were $9.5 million for the quarter ended December 31, 2012, compared to $12.6 million for the same period in 2011. The decrease is mainly due to the recording of a $2.6 million milestone payment from Yakult Honsha, our partner for perifosine for the Japanese market, with respect to the initiation of a Phase I trial in Japan during the last quarter of 2011.

R&D costs, net of refundable tax credits and grants, were $5.5 million for the quarter ended December 31, 2012, compared to $7.8 million for the same period in 2011. The decrease is attributable to lower employee compensation and benefit costs, as no annual cash bonuses were recorded during the fourth quarter of 2012, as well as to continued cost saving measures resulting in a lower number of employees. The decrease is also related to comparative lower third-party costs associated with the development of PI3K/Erk inhibitors and other products during the fourth quarter of 2012, as well as the weakening of the euro against the U.S. dollar.

Net loss for the quarter ended December 31, 2012, was $6.9 million or $0.29 per basic and diluted share, compared to $7.5 million or $0.44 per basic and diluted share for the same period in 2011. The decrease in net loss is largely due to lower net R&D costs, SG&A expenses and income tax expense, as well as to higher margin contribution from Cetrotide, partly offset by the significant decrease in license fee revenues and in net finance income.

Now regarding the consolidated results for the year ended December 2012. Revenues were $33.7 million compared to $36.1 million for the same period in 2011. The decrease is mainly due to the recording of the $2.6 million milestone payment from Yakult, as I already described.

R&D costs, net of refundable tax credits and grants, were $20.6 million for the year ended December 31, 2012, compared to $24.5 million for the same period in 2011. The decrease is attributable to lower employee compensation benefit costs, as no annual cash bonuses were recorded during the fourth quarter of 2012, as well as to continued cost saving measures resulting in a lower number of employees. The decrease is also related to comparative lower third-party costs associated with the development of most of the company's products, except for AEZS-108 and perifosine, as well as the weakening of the euro against the U.S. dollar.

Net loss for the year was $20.4 million or $1.03 per basic and diluted share compared to $27.1 million or $1.72 per basic and diluted share for the same period in 2011. The decrease is largely due to lower net R&D costs, SG&A expenses and income tax expense, as well as to higher margin contribution from sales and higher net finance income, partly offset by the significant decrease in license fee revenues.

Our guidance for 2013 is that we expect to invest between $20 million and $22 million in R&D. We expect, also, to have an operational burn rate between $2.5 million and $2.7 million per month. This is well described in our MD&A.

Thank you for your attention.

Juergen Engel

Thank you, Dennis. We will now answer your questions and I'm, therefore, turning the call over to the operator for instructions on the question-and-answer period.

Question-and-Answer Session

Operator

[Operator Instructions] Your first question comes from the line of Joe Pantginis with Roth Capital Partners.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

With the perifosine news behind us now, I was just looking towards your views on how you look to potentially rejigger your budgeting and development plans. Specifically, are you able to now focus on some products and accelerate some products that you might not have, based on your previous budgeting for perifosine?

Juergen Engel

Joe, thanks for the question. We -- as we stated, we will focus on our lead stage development project, this means AEZS-108, AEZS-130, and we will be able, also, to move with the new tumor vaccine project into Phase I, AEZS-120. As we always stated, for the earlier project, we are looking for non-dilutive financing. As you may know, we have in place an agreement with various [ph] Corporation to help us to form, kind of, joint ventures or get financing for our earlier projects in Asia, especially in China, and we are making progress there. We have term sheets on the table, but as you know, partnering discussions will take longer and may be uncertain of the outcome, but we are making progress there.

Joseph Pantginis - Roth Capital Partners, LLC, Research Division

That's great. And then, just maybe a quick follow-up on 120. Obviously, as you mentioned too there's increasing visibility around this product and I think it would be helpful -- it's my understanding that based on the platform that you're using, you do have the ability to, essentially, look at multiple tumor types and look to even switch out the antigens to have broad potential applicability.

Juergen Engel

That's correct, Joe. We can -- in our platform technology, we can change the antigen. To give you an example, we have already [indiscernible] vaccine proven in vivo activity in melanoma on the shelf, but we will need to focus first on the Phase I study to demonstrate that we really see the immune effect and then, we may -- we can go immediately into the next development step for the potentially -- melanoma vaccine. We have good patent protection on this specific proprietary technology, the patents were filed in 2007 up to 2009 and one has been already granted by the European Patent Office.

Operator

Your next question comes from the line of Jason Kolbert with Maxim Group.

Jason Kolbert - Maxim Group LLC, Research Division

I'd echo Joe's comments, it's good to have perifosine behind us. Going forward, just a couple of things, I'd like to touch on some of the financial guidance. Dennis, you mentioned a $2.5 million monthly burn on corporate expenses. I think you meant quarterly not monthly, can you just confirm that?

Dennis Turpin

Oh, I meant $2.5 million per month of operational burn rate, is our guidance.

Jason Kolbert - Maxim Group LLC, Research Division

Oh okay, that clarifies it. And then, my other question, really, is on AEZS-130, on the ghrelin diagnostic. Can you walk us through what the marketing and launch strategy, and what you think the market potential is? And are you considering maybe monetizing that asset with a partner? And then, help me understand the therapeutic direction as you look to develop that, and how would the rising differential be between the diagnostic and the therapeutic and the time line that staggers them?

Juergen Engel

Jason, I would -- I'd like to start to answer the question regarding the potential possibilities we have if we -- the diagnostic will be approved. I think we are following all opportunities, this includes on marketing and also partnering and get -- sale of the asset. But at present, we are following all opportunities. And I think regarding the market potential, I will ask Paul to give a comment there.

Paul Blake

Jason, thanks for the question. As we look at the existing market, we understand it's made up with -- of no approved product at the moment. So everything used is used without a label to support it. We think there are about 40,000 tests performed with 1 or other of the current agents, all of which are injectable and perhaps, the gold standard is the insulin tolerance test. So I think if you look at the market, with about 40,000 tests done in the U.S., with an insulin tolerance test leading that with its complications and medical risks, we look to making a big impact within that market in the U.S. We look to extend it into other countries and we look to extend it into children. And the potential upside for us, I think, is in the increasing recognition of traumatic brain injury as one of the causes of pituitary deficiencies in neurohumoral disorders. There are about 230,000 survivors of traumatic brain injury in the U.S. alone. And according to recent publications, between 1/3 and 1/2 of these people will have some kind of neuroendocrine disorder, for a period, that will complicate and delay recovery. And it's an entirely treatable condition. So if we have an orally available, simple-to-use test available, we think that, that market that we know today will increase. And we also note that the neurohumoral consequences of traumatic brain injury may take some time to develop, so current guidelines suggest people might need 2 or even 3 tests before you exclude pituitary disorders, such as growth hormone deficiency. So the market with a simple oral test available, could expand somewhat significantly from where we think it is. And we can, of course, go to other countries with the data and develop it in children as well. So we're excited about the potential there. You asked about pricing for it, that's a very difficult thing to establish because our test is so different from what's available at the moment. So we can't give you a precise answer for that today.

Jason Kolbert - Maxim Group LLC, Research Division

Okay. Can we just talk a little bit about the transition in -- from a diagnostic to a therapeutic and what that -- just, would you remind us where is that program therapeutically? We what are the next steps and what does the time line look like?

Paul Blake

Yes, there's a pilot study ongoing at the moment. It's being conducted in Houston by Dr. Jose Garcia. It's a pilot study, so we're looking for efficacy. It's a double-blind placebo-controlled trial. It started in the summer. It's in patients with cancer cachexia, the first few are in and in fact, through it and we're pleased we've not seen any adverse reactions of consequence. It's a difficult condition to identify and treat because of the protocol exclusion and inclusion requirements. And you'll appreciate that many patients with cancer cachexia may appear to be suitable for this study but develop some complication between accepting to take part and actually going in. So it's a relatively slow study to recruit to, but the preliminary data that we've seen, still double-blinded, are very encouraging. And we will have to extend that as long we get a good signal in the coming months.

Jason Kolbert - Maxim Group LLC, Research Division

So as a Phase II pilot study, what I hear you saying is that it's slow to recruit, when do you think enrollment might be complete on that study?

Paul Blake

I don't want to give a precise time line, Jason. It's certainly going to be several months. And I don't want to say more than that at the moment.

Juergen Engel

Jason, it is also -- those escalation study and these can -- the study can stop with 18 patients, but can also be prolonged to 26 patients, depending on the tolerability.

Jason Kolbert - Maxim Group LLC, Research Division

And so I just want to clarify 1 other point because you used the word pilot. So on the therapeutic side, will this be going through a PMA pathway? And where I'm going with this is, you -- what would you need in terms of a Phase III trial? Really, it sounds like 1 Phase III, not 2 matching Phase III if you're, in fact, going through the device pathway?

Nicholas J. Pelliccione

Jason, this is Nick Pelliccione. It wouldn't be a device pathway. Actually, even our current indication in growth hormone deficiency is not a device or a diagnostic pathway, it's a New Drug Application because this is orally administered.

Jason Kolbert - Maxim Group LLC, Research Division

Okay. Yes, thank you for clarifying, it was the word pilot that threw me. Okay, got it. Appreciate it.

Juergen Engel

It's a proof of concept study, Jason. And for this indication, we -- our intention is really to find partners and we have some interests from companies there, but it is too early to give any guidance yet. But I think this will a real therapeutic development with maybe 2 pivotal Phase III studies.

Jason Kolbert - Maxim Group LLC, Research Division

Got you. And I think -- and just, just can you expand on that just for 1 more minute? And again, I'm sorry for pushing, but I'm just trying to get an understanding, at what point can you walk out and say, "We've got proof of concept that this test works." And it sounds like it's a 2014 event, maybe 2013 to complete enrollment with the idea that sometime in 2014 we'd walk out with an understanding of whether we've -- there's a value proposition for going to pivotal or not.

Paul Blake

It depends, as Juergen Engel said, that the number of patients depends on the dose responses we see. So if we get there quickly, then, we may have data before the year end. If not, it will take us into the early part of 2014.

Juergen Engel

And the primary efficacy criteria is a gain of body weight, and this will be the major point to consider when we have to start for the clinical development program. There are other secondary endpoints, also, maybe Paul can also elaborate on the other primary efficacy endpoints. And all these will give us the guidance to move into further clinical programs.

Jason Kolbert - Maxim Group LLC, Research Division

I'll follow-up with you offline because I have some additional questions when we move back to the doxorubicin conjugate.

Operator

[Operator Instructions] Your next question comes from the line of George Zavoico with MLV.

George B. Zavoico - MLV & Co LLC, Research Division

With perifosine, first question regarding perifosine. You had a number of partnerships with Yakult, as you mentioned on the call, and Hikma in the Middle East. What is the status of perifosine with those partners? They all -- I believe at least Yakult, you mentioned, had a trial going. At Hikma, I'm not -- I don't recall precisely. What's going on with those partnerships in perifosine?

Juergen Engel

Yes. I will answer this question, George. The -- Hikma was never involved in the clinical program. The license agreement was quite different, so they would submit their approval if we have an NDA approval. So that's a completely different situation in contrast to Yakult. Yakult will also terminate the running multiple myeloma Phase I, Phase II study, but they will continue, according to our knowledge today, with 2 additional clinical studies in 2 different indications. And they have indicated this already before we got the negative data, that they want to continue even in the situation where we get a negative interim analysis. So we are supplying them with the clinical samples and they have to pay according to the license agreement and they will continue the clinic development. As we know, as of today, we will have a meeting with them in the next week -- in the other week, beginning of April, in Tokyo.

George B. Zavoico - MLV & Co LLC, Research Division

Okay. With regard to -- moving on to AEZS-130 now. Paul, I'm intrigued by the potential market growth opportunity with TBI, traumatic brain injury. The diagnostic is being developed for adult growth hormone deficiency, and as you mentioned, this is emerging as a potential indication. What is the prevailing view on this among the trauma physicians? Is this something that you feel needs a concerted education effort on the part of Aeterna Zentaris to educate them that this is something they should be looking at? What do you need to do to grow this market, putting the question very briefly?

Paul Blake

Okay, well, the first thing is you've got to file the NDA and get it approved. And secondly, I think, recognize that already in the Phase III study that's the main clinical part of the NDA, there are already patients in there with traumatic brain injury as the cause of their growth hormone deficiency. So it's something that's being studied in part of this -- the program. And it's something we need to evaluate whilst the file is being continued, to see what else we need to do. It's an asset that we need to learn about before we can be specific about what we would do. But I think there's an exciting potential there that we should learn about and explore.

George B. Zavoico - MLV & Co LLC, Research Division

So potentially, you see this as, depending on pricing, of course, this might be a routine test in the -- in the best case scenario, routine test that anybody who comes in with a concussion would undergo? Is that fair to say or is that a stretch?

Paul Blake

Well I think it's a stretch today. I mean, it might be something you dream about. But I don't think it's anything we could expect. So I think it's something we need to keep exploring and learn more about. There's great potential there to look into. I think you need to bear in mind that there are at least 2 medical populations looking at this. Obviously, there are traumatic brain injury people who work in the emergency rooms and trauma care centers and then, there are the endocrinologists, and they may have different views. And they're beginning to talk to each other, but it's perhaps not as defined an area as we might hope it will become in future.

Juergen Engel

But on the other hand, it is established in the literature and some guidance already that is very well known, that in these kind of patients, in the high percentage, there is growth hormone deficiency. And I think that's the important point.

George B. Zavoico - MLV & Co LLC, Research Division

Juergen, when you say high percentage, 20%, 30%, 60%?

Juergen Engel

40%. 40%.

Paul Blake

It depends on which publication you look at, George. We look at publications, let's say, between 35% and 50% of survivors of traumatic brain injury have some measurable pituitary hormonal dysfunction. And growth hormone deficiency is one of the common ones. And obviously, it depends I think how efficient and easy to use the test is, as to whether you put patient through some kind of screening with an insulin tolerance test or will you do it with something that's much easier and less risky to use.

George B. Zavoico - MLV & Co LLC, Research Division

And is there any correlation between the severity of TBI and the likelihood of growth hormone deficiency?

Paul Blake

I'm not sure of the precise answer for that. One interesting feature that I find is that the pituitary hormone deficiencies that do occur don't necessarily occur right after the injury, so you may need to keep looking for some months afterwards to see if this is the reason why the patient isn't recovering as you had otherwise hoped and expected they would.

George B. Zavoico - MLV & Co LLC, Research Division

That prolongs the, obviously, the window for use of the diagnostic, which is good for you. One last question, Juergen, you mentioned a little bit about how you've reduced headcount, restructuring a little bit. Could you give a little bit more detail, how many full-time employees do you have now and what was the reduction?

Juergen Engel

So at present, we have about 81 FTEs in all of our 3 locations. And 7 from them are financed by a governmental grants. We have additional 3 financed by our partners, with which we are cooperating. And there will be coming even more finance in the near future and we have also a plan in place to even reduce it, continue to reduce it a bit over the year of 2013.

Operator

There are no further questions at this time. I turn the call back over to our presenters.

Juergen Engel

We thank you for your attention and look forward to speaking with you in the near future. Thank you.

Operator

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.

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