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Agenus Inc. (AGEN)

Q2 2018 Earnings Call· Thu, Aug 9, 2018

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Agenus Second Quarter Financial Results Conference Call. As a reminder, today's conference is being recorded. Now, I would like to turn the conference over to Dr. Jennifer Buell, Head of External Affairs and Communications at Agenus. Please go ahead, Dr. Buell.

Jennifer Buell

Operator

Thank you. Welcome to Agenus second quarter financial results conference call. Before we provide an update, I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development plans, timelines, partnership opportunities, timelines for dose and our financial position. These statements are subject to risks and uncertainties and we refer you to our SEC filings for more details on these risks. As a remainder, this call is being recorded for audio broadcast. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Sunil Gupta, Head of Regulatory and Pharmacovigilance; and Christine Klaskin, our Vice President of Finance. During this call, Garo will provide a corporate update, Sunil will summarize our clinical progress and paths to BLA, and Christine will provide a financial review. We will then open the call for questions. With that, let me turn the call over to Garo.

Garo Armen

Analyst · Jefferies. Please go ahead

Thank you, Dr. Buell. And good morning and thank you for joining us for our quarterly update today. In 2014, we started the transformation of Agenus, with an intent to make it an immuno-oncology engine. In the past four years, we have built a company that is delivering innovation with speed. Today, I will describe our progress and achievements in three areas, which are of great interest to you and to us. First, we have made substantial progress in delivering our discoveries into the clinic and advancing our PD-1 and CTLA-4 programs, which are in the clinic and on a pass for a potential BLA filing. The evidence for our progress is easy to track. We filed five INDs in the 18 months prior to the start of 2018. Our programs are on track for additional sixth IND filing this year, three of which have already been filed. Furthermore, we are working to file two more INDs in the first half of 2019. All of these represents discoveries from our research pipeline and our either best-in-class or first-in-class compounds. They also represent products designed to address tumor resistant pathways with the potential to be the next major breakthroughs in immuno-oncology. In addition, as I alluded to, our proprietary CTLA-4 and PD-1 antibodies are progressing towards a planned BLA filing in 2020. Second, I will discuss our cash position and balance sheet. Please know that we are aware of concerns related to these issues and I will address them. As I mentioned, we are progressing our programs and filing INDs at a record pace. At the same time, as you will hear shortly, we are prudently satisfying our near term cash needs. Third, I will provide an update on our recent progress in establishing new strategic partnerships. We expect these to…

Sunil Gupta

Analyst

Thank you, Garo. I am very excited to be part of a very talented team at Agenus and furthermore I'm awed by the prolific pipeline and I aspire to rapidly take these programs into market in the next few years. Let me share some of my observations on the regulatory environment. CTLA-4 and PD-1 is the only validated IO/IO combination. In fact this is the only immune-oncology combination with approvals in three distinct indications two of which was secured this year. Today the regulatory landscape is changing rapidly and this focus on science, adaptive and clinical seamless clinical trial methodology including acceptance of surrogate or early markers of activity. Recently the FDA commissioner has outlined a plan for modernizing drug development to keep pace with the rapid advancing science and to ensure that innovation remains affordable for patients. We intend to leverage these initiatives to take out Phase 1 Phase 2 trials to product registration. The FDA oncology division has been particularly progressive and has taken actions to promptly improve products that provide greater clinical benefit to patients in relatively small trials. In some cases in single arm trials using surrogate endpoints, in a few dozen patients, and in a few years of first in human studies. From a regulatory perspective we have positioned to take advantage of this small progressive landscape and accelerated pathways for approval. We intend to have early and frequent interactions with the FDA in this endeavor. Of note CTLA-4 and PD-1 antibodies have been such programs with accelerated approvals granted for these products in less than four years after first in clinical studies. In cervical cancer, our AGEN1884 and AGEN2034 regimen represents the most clinically advanced combination with registration potential in second line cervical cancer. This is an indication for which there is still a…

Garo Armen

Analyst · Jefferies. Please go ahead

Thank you very much, Sunil. And I will now turn it over to Christine Klaskin, VP of Finance to provide financial highlights.

Christine Klaskin

Analyst

Thank you Garo, and I am happy to review our second quarter 2018 financial results. Let me first update you on our cash position. At the end of 2017, our cash balance was $60 million. We closed the first quarter with $51 million and closed the most recent quarter with $43 million. As you can see from these numbers, we have managed our cash prudently from quarter-to-quarter. As Garo said earlier, based on our current plans we expect our cash balance to be similar to or higher than the end of the current quarter. For the second quarter ended June 30, 2018 we reported a net loss of $25 million or $0.24 per share compared to a net loss for the same period in 2017 of $32 million or $0.32 per share. In this second quarter, we recognized net revenues of $16 million which includes milestone achievements and non-cash royalties earned. For the six months ended June 30, 2018, we reported a net loss of $80 million or $0.76 per share compared to a net loss for the same period in 2017 of $49 million or $0.51 per share. The increased net loss reflects reduced revenue due to an accelerated milestone received during 2017 from Incyte and the loss on the early extinguishment of our debt. I will now turn the call back to Garo.

Garo Armen

Analyst · Jefferies. Please go ahead

Thank you, Christine. In closing, let me outline our key milestones expected over the next 12 months. Number one, complete accrual of our CTLA-4 and PD-1 trials, which are expected to support our path to BLA and our endeavors to develop, register, and launch our CTLA-4 and PD-1 antibodies. Two, advancing six new discoveries to clinical trials for patient benefit, namely, our two first-in-class bispecific antibodies, our next generation CTLA-4, our TIGIT, which is a differentiated molecule, and our CD137 antibodies, as well as our personalized neoantigen vaccine, particularly in combination with immuno-oncology agents that we control. Three, initiate combination of neoantigen vaccines with our [indiscernible] CTLA-4 and PD-1 antibodies. And four, close at least one of our ongoing partnership discussions. And five, with AgenTus, we expect to complete a private placement followed by a potential public offering in the next U.S. territory. We're progressing our lead AgenTus cell therapy program into the clinic and expect to file an IND within approximately the next 12 months. And that concludes my formal remarks. And I believe we're now ready to take questions.

Operator

Operator

[Operator Instructions] Our first question comes from Biren Amin of Jefferies. Please go ahead.

Biren Amin

Analyst · Jefferies. Please go ahead

Garo, you mentioned that you're hoping to get two milestones this quarter. Can you just detail for us what the amount would be for those two milestones and what's the amount for the third milestone that you're expecting by the end of the year?

Garo Armen

Analyst · Jefferies. Please go ahead

For the first two it will be approximately $10 million and for the third one another $5 million, specifically from these transactions of these milestone payment. We also potentially expect which we have not outlined, a number of other proceeds from several other transactions, including potentially additional royalty capturing transactions that we are actively pursuing and the moment.

Biren Amin

Analyst · Jefferies. Please go ahead

And then what about the Shingrix, you mentioned Shingrix sales are currently ahead of forecast and that you could potentially anticipate milestones from that royalty transaction, what would those amount to, if any of this year?

Garo Armen

Analyst · Jefferies. Please go ahead

So, those milestones will not be this year. Even though, as I mentioned earlier, Shingrix sales are tracking 3x, what the initial estimates were in the beginning of the year. We expect the milestones that I was referring to which are revenue performance milestones and they are in the billions or certainly over $1 billion, those not to be achieved during the course of 2018.

Biren Amin

Analyst · Jefferies. Please go ahead

And then as it relates to the second line cervical cancer trial, can you just update us on enrollment and what we can expect the next date update from that study?

Garo Armen

Analyst · Jefferies. Please go ahead

Jen, if you could give us - Sunil will be updating you on these things go forward, but as you know he has been with the Company only for a few weeks now. So I will defer to Jen on this until the next call.

Jennifer Buell

Operator

As we have mentioned, we anticipate sharing data out on our three programs at upcoming conferences, major conferences this year. So, accrual is advancing, we're seeing some very good signals of activity as Garo mentioned during the call and we will be providing detailed updates at major conferences.

Garo Armen

Analyst · Jefferies. Please go ahead

And also for your benefit this trial got initiated very, very recently. So we will have more meaningful approved numbers for you I'd say by October or November of this year.

Operator

Operator

This concludes our question-and-answer session. I'd like to turn the conference back over to Dr. Garo Armen for any closing remarks.

Garo Armen

Analyst · Jefferies. Please go ahead

Thank you very much, Andrea. I think this call will be broadcast on our website and via webcast and please if you have any question subsequently don't hesitate to contact us. We have a very active communications efforts ongoing as you can see recently with the publication of our news letter, which will be a regular publication to be published every other Monday and are also present in social media. One of the reasons, that we've undertaken this bolstered effort of communications is because we get a lot of questions from investors and others about our vaccine programs and the world still perceives us as an only vaccine company or vaccine only company. And as I said earlier, those that have followed us have witnessed the fact that the company has transformed itself in the last four years to be a very diversified in oncology player, and as such we take the responsibility for educating our investors going forward and so we will have a much more aggressive stance to provide you with information that you need to understand our company better.

Operator

Operator

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.