Earnings Labs

Ionis Pharmaceuticals, Inc. (IONS)

Q1 2011 Earnings Call· Thu, May 5, 2011

$73.77

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Transcript

Operator

Operator

Welcome to Isis Pharmaceuticals First Quarter Financial Results Conference Call. Leading the call today from Isis is Dr. Stan Crooke, Isis’ Chairman and CEO. Dr. Crooke, please begin. Stan Crooke – Chairman and Chief Executive Officer: Good afternoon and thanks everyone for joining us on today’s conference call to discuss our first quarter financial results. Lynne will discuss our financials and then after that I’ll give you a brief update on how we’re tracking against our key goals for 2011. Joining us on the call today are Lynne Parshall, Chief Operating Officer and CFO; Beth Hougen, Vice President of Finance; and Kristina Lemonidis, Director of Corporate Communications. Kris, can you read our forward-looking language statement please? Kristina Lemonidis – Director, Corporate Communications: Sure, Stan. Good afternoon, everyone. A reminder to everyone, this webcast includes forward-looking statements regarding Isis’ business and financial outlook for Isis and the therapeutic and commercial potential of Isis’ technologies and products in development. Any statement describing Isis’ goals, expectations, financials or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis’ forward-looking statements also involve assumptions that if never materialize or proved correct could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although, Isis’ forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. And as a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis’ programs are described…

Operator

Operator

Thank you. (Operator Instructions) And our first question will come from the line of Eun Yang with Jefferies. Please proceed. Eun Yang – Jefferies: Thanks. I want to ask you the mipomersen NDA, is it going to be submitted to the cardiorenal division or metabolic division at the FDA?

Stan Crooke

Analyst · Jefferies

It will be submitted to the metabolic division of the FDA. Eun Yang – Jefferies: Okay.

Stan Crooke

Analyst · Jefferies

It’s been managed by the metabolic division of the FDA throughout. Eun Yang – Jefferies: Okay. And then can you give us an update on the talking about the safety study that you are going to be running in heterozygous patients?

Stan Crooke

Analyst · Jefferies

We are just finishing the planning of that study with Genzyme and getting it ready to go and we’ll be providing details of that once the study begins, but it’s in line with all of the plans that we’ve described for you, which is that we plan additional studies to go to get heterozygous in Europe and we plan this additional study to gain the severe in the U.S. It’s in the same size range. Those studies are in the same size range as we described and they don’t include an outcome study. Eun Yang – Jefferies: Okay, thanks.

Stan Crooke

Analyst · Jefferies

You bet.

Operator

Operator

(Operator Instructions) And our next question will come from the line of Shiv Kapoor with Morgan Joseph. Please proceed. Shiv Kapoor – Morgan Joseph: Thanks for taking my question. I have a question on your revenues, what percentage of your revenues, R&D revenue are partner-related and could you provide us of any guidance to what you expect over the next two quarters and year?

Lynne Parshall

Analyst · Morgan Joseph

Shiv, all of our revenue is partner-related, because we don’t have commercial sales of products all of our revenue is from partners or licensing income. Shiv Kapoor – Morgan Joseph: And is most of it amortized or is amortized recognized as it comes in?

Lynne Parshall

Analyst · Morgan Joseph

So, we have revenue that does both. The largest component of our revenue this quarter is the amortization of the GSK upfront license fee, but we also very frequently receive milestone payments from partners for achievement of a variety of different things. For example, when we had the development candidate for TTR we got a large milestone from GSK, and so all of our partnership agreements provide for milestone payments of different kinds and with different timing. We expect to achieve a variety of milestones this year as I said the next upcoming one will be associated with start of clinical trials for the TTRRX drug in the GSK collaboration. When we achieved milestones, they are not amortized. So they are recognized in the quarter in which we receive them in totality. So upfront license fees generally are amortized over the period of performance and milestones generally are taken in their entirety in the quarter in which they are earned. Shiv Kapoor – Morgan Joseph: So that would hold true for mipomersen milestones in the future.

Lynne Parshall

Analyst · Morgan Joseph

Absolutely. Shiv Kapoor – Morgan Joseph: Okay. And so, in the next two quarters, this rate of about 20 million per quarter, is that the right assumption going forward?

Lynne Parshall

Analyst · Morgan Joseph

In this quarter we had a small milestone payment, but when you look at the largest single component of revenue which is amortization of GSK licensee that will stay flat over the course of the year. But, in the quarters in which we have milestones, for example the quarter in which we start the TTR clinical trial, or the quarter in which the FDA accepts our NDA filing for mipomersen will have milestones that will obviously increase that revenue in that quarter. Shiv Kapoor – Morgan Joseph: Okay.

Stan Crooke

Analyst · Morgan Joseph

Shiv, I think it’s awfully hard for somebody on the outside to parse what happens with us quarter by quarter. I think the things that we said that are really important is we are right on track to meet our guidance and our guidance does not include any new transactions. Shiv Kapoor – Morgan Joseph: Fair enough, definitely helpful. Thank you.

Stan Crooke

Analyst · Morgan Joseph

You bet.

Operator

Operator

And our next question will come from the line of Nick Bishop with Cowen and Company. Please proceed. Nick Bishop – Cowen and Company: Good afternoon. Thanks for taking my questions. I just had one quick one, I wonder if you can elaborate at all on sanofi’s marketing plans and how they relate to be the new guidelines that will be coming out later this month? Specifically, you mentioned that they would involve driving towards early diagnosis, addition of mipomersen to other therapies and driving referral to the lipidologists. Can you just elaborate a bit on mechanistically how that’s going to accomplished?

Stan Crooke

Analyst · Cowen and Company

Lynn, do you want to take that?

Lynne Parshall

Analyst · Cowen and Company

Sure, I mean the key elements of the Genzyme marketing plan because the Genzyme business unit is the business unit that is going to continue to work with this drug. The key elements of their plan are two. Number one, focusing on lipids specialists and directly marketing to the physicians who treat these very high-risk patients. Number two and a key element to their strategy is increasing awareness of FH and increasing referrals from other physicians to the lipid specialists. So that focus will be on cardiologists, internal medicine specialists etcetera. They are already at the upcoming NLA meeting that’s happening in New York in a couple of weeks. They have a very significant presence and have actually quite a number of medical meetings leading up to this. And so again the focus is on early diagnosis, appropriate referrals, aggressive treatment. And so they have been planning all of this in advance of the FH guidance has come out. And so the guidance is very, very supportive of the plan that Genzyme has had all along to market mipomersen.

Stan Crooke

Analyst · Cowen and Company

And tactically, there is a lot of work going on that takes off from where we begin, with identifying the lipid centers, the lipidologists characterizing the kinds of physicians who see these patients primarily, what the referral characteristics are, and of course the profile of the drug and the NLA guidance just place perfectly into what our hopes for mipomersen are which is that it is a drug that will be used in combination with maximum dose lipid lowering therapy to get patients to us low level of LDL, apo-B, Lp(a) and triglycerides as possible. Nick Bishop – Cowen and Company: Okay, that’s helpful. That’s all. Thanks for hosting the call.

Stan Crooke

Analyst · Cowen and Company

Thanks.

Operator

Operator

At this time, we have no further questions in question. I would like to turn the call back over to Dr. Stan Crooke for any closing remarks. Stan Crooke – Chairman and Chief Executive Officer: If there are no more questions, then I want to thank you for participating in our call. We are right on track for our annual financial guidance and we are right on track with the pursuits of mipomersen. In that I think we are tremendously benefited by the NLA physicians that have just been announced and the participation of sanofi in our relationship. And finally, I think you should expect lots of entertaining news this year from our pipeline drugs other than mipomersen.

Operator

Operator

Thank you for your participation in today’s conference. This concludes your presentation. You may now disconnect and good day everyone.