Revised and expanded February 28:
My recap of the RBC Healthcare Conference, Wednesday February 27, 2013
Jab9
CEO PW: It’s a great day for us to be presenting to day. Last nite we revd our NDA acceptance letter for our Otrexup, so we hit a big milestone four ourselves yesterday and a natural fact this is just another step in the transition of the company.
Antares is a company that has world leading injectable technology platforms and we r using those platforms to develop pharmaceutical products and Otrexup was our first pipeline product that we r developing ourselves and we have historically worked with companies like Teva, Pfizer, Ferring, Meda, etc.
• We have 5 products with Teva
• Partnership strategy has been very successful and going forward we are pursuing a
• Forward integrating focus
• Focusing on drugs that can be taken out to very specialized segment
• Home setting for drugs
• Re-engineer existing drugs with Antares devices
• October 14, 2013 PDUFA date for Otrexup
• Will be seeking international partners.
Moderator Q: Currently to date your business model is still royalty driven and you talked about partnerships with companies like Teva, so can you talk in more detail of the partnership with Teva and the products you are working on and also how we should think about the revenue breakdown over the next 3 to 5 years as you develop you own products.
PW: Just to be clear, we generate revenues today but we are not an earnings story just yet, so the launch of Otrexup is really the lead into with what we expect to be substantial revenue growth after 2014 but right now the path we are on is to launch Otrexup within the next 12 months. Teva has been an important partner for us. I mentioned the products on the market today, human growth hormone needle free, generic version of epi-pen which is currently with the FDA, Sumatriptan which we also developed with Teva with the autoinjector platform and 2 pen programs in development.
And the partnership with Ferring over in Europe for HgH needle free is important. Part of the importance of those relationships is its help us learn about this complex area for our combination drug device development area which got us kick started and enabled us to really move the Otrexup product thru the pipeline pretty quickly, so fyi, Otrexup took 18 months start to finish on the development program and we are anticipating the Testosterone program is going to be doing the same and we filled them as a 5052B NDA’s so we’ve got this brand new product strategy using a technology platform that has a very strong IP behind it to protect the product.
And Leroux, who just joined us 9 months ago is responsible for taking Otrexup out to the market .
Moderator: So can u talk about the market and why there’s a need for the product and then how you anticipate positioning it especially given the size market as well?
LeRoux J:
• 1 ½ million people with RA most of them are not diagnosed and treated
• Estimates are between 400 and 750k patients actually drug treated in the U.S.
• It’s a huge market, the biologics made a big impact.
• I personally launched Enbrel in the U.S. in 1999 – its interesting for me now to go back and revisit MTX because it is the cornerstone, go to, gold standard DMARD that Rheumatologists go to once they’ve diagnosed RA.
• Patients tend to be treated with DMARD, with DMARD MTX being the DMARD of choice to a point where they have an inadequate response – referred to as a failure to response. You can treat the patient symptomatically with cortisone but that doesn’t stop the disease from progressing. So what they do is to move on to the biologics or they add a biologic.
• Most patients, more than 90% of them, will progress to a MTX treatment period and at that point, either switch to a biologic.
• Here’s where Otrexup comes in, it is an easy to use subcutaneous self administration so yes, there’s a need for a convenient self administration MTX.
• There’s 2 big opportunities:
1. “Braun” study which showed because of the satural limitations of MTX, the ability for the stomach to actually absorb more than 15mg is jeopardized in most patients. If u look at the pharmacokinetic studies, the bioavailability of Subcu MTX gives u almost a dose response linear increase in systemic availability. Once you get to about 15mg, it plateaus off. So if you give 20 or 25mg the body still only gets about 15mg in the blood. However, with Otrexup you give 20mg you get 20mg. You give 25mg you get 25mg – so there’s an extended clinical utility which continues to provide a satisfactory and durable response for treatment so the patients remain symptomatic free. Studies show that when patients are symptom free, their disease is not progressing. So at that point, it could be 6 months, it could b 6 years for some patients, they would switch to a biologic and that’s where the second opportunity comes in and that is ….
2. Financials. Its billions of dollars that payers are putting out for biologics. If you can extend the adequate response by one month, on average a plan may save $1k for 1 patient for 1 month.
PW comment: The other piece of this is that there’s a lot of clinical experience with parenteral MTX coming out of Europe with hundreds of patients and studies and we are using that to support our application. The thing to remember here is that MTX is an already approved drug and the challenge here was being able to convert an approved drug that’s given by intramuscular injection which usually requires a professional to administer it – converting it to an easy to use Subcu route of administration which can be given at home. So we switched the route. We will be the first company to have a Subcu route approval for MTX and that’s really the opportunity and all the work we did in the studies supported that conclusion.
Moderator Q: Can you talk about the manufacturing side of the product because sometimes that comes up as an issue later on.
PW: We’ve got that covered. We actually have, we actually manufacture our prebuilt syringes containing MTX drug solution. The components are manufactured for us by a company up in Massachusetts and they do a lot of this work for other drug companies like Lilly and then the final assembly and packaging is done in a facility down in Pennsylvania. So we already have the supply chain worked out.
Moderator Q: Is this a product you are looking to market on your own or are you looking for a partner?
PW: We will be seeking partners for certainly international opportunities. Right now LeRoux is building up a strategic group within Antares. We are working with Quintiles to provide the beat on the street initially for the product and we’ve got a launch plan for Q1 of next year.
LeRoux what do you think the peak oppty for a product like this would be?
LJ: Our estimates right now based on interviews with Rheumatologists and payers (and we’ve not finalized pricing yet) but its somewhere between 100 – 200 million dollars.
PW: And that’s just for RA – we haven’t factored in any additional sales we might obtain from psoriasis for example which we will also get as an indication from the agency. The development plan we used for RA will enable us to make that claim for psoriasis as well.
LeRoux Jooste:
• MTX is the gold standard as a DMARD
• Stand alone DMARD or with a biologic (see my post titled Formula: MTX + Medi-Jet = delivery of Biologics)
• MTX(Otrexup) revs between $100 - $200 million peak sales potential which DOES NOT include potential sales of another indication like psoriasis.
• I suggest listening to his very detailed segment on the replay!
CEO PW:
• On QS-T: Testosterone replacement therapy is a $2 billion dollar market – highly viscous drug – oily drug
• Potential is a much larger opportunity for Antares than MTX
• Other molecules for VIBEX – 40 drugs we have identified that could be applicable
• We are active on the patent front
• We want to develop drugs that people want to buy
IP question regarding ability to protect both injector and drug (Vibex)
• We’ve protected the platform and you can protect things like the speed of delivery out of the device, the strength of the spring, the lbs / sq in., the design of the devices, all the way thru to what is called the QS system.
• We’ve adopted it for highly viscous material and what we’ve done is we’ve applied that patent base to classes of drugs.
• We have a patent filing called Hazardous Agent filing which we filed 4 yrs ago which will protect Otrexup.
• We are building on that data that’s coming out of clinical trials on the project specific applications of the device
Epi-Pen discussion:
• June 2015 product lauch
• We are manufacturing devices right now
• Market oppty is significant – by the time 2015 comes along this product will be a $ 1 Billion dollar product, even Mylan estimates the projected sales, we could be looking somewhere between 25-40%
• It’s a very important product for us but its less than important product for us in terms of rev than it use to be because of the impact of Otrexup and now Testosterone as well.
• Pipeline snap shot is 2014 – Otrexup
• 2015 Generic Epi-pen
• 2016 QS T
• I believe the real opportunity for epinephrine injection lies in the substitutable product because the epi pen is such a well known brand that the substitutable angle of that cant be ignored
• Pursuing AB rating and not the 505B2
Moderator question regarding regulatory agency approval of epi pen
• You’ll have to ask Teva about that as I’m not privy to their regulatory sheet dialogue, all I’ll say is we’ve got a date in 2015 when we are expecting to launch.
• Teva and ourselves are committing all our efforts on manufacturing expertise of our devices for the launch so you can read between the lines.
Question regading being acquired, staying an independent pharma concern etc.
• First of all, we are not for sale
• The reality is you are dead on with this platform
• We have I think the best devices on the market when you look at other devices on the market they are not as good as ours.
• The applicability of that technology to drugs is quite large and as a company like ours it would be difficult to develop 40 drugs on our own so we will be continuing to seek partnerships
• And of course what happens when you file an NDA with your own product, we’ve been inundated with business development inquires since December when we filed that NDA on Otrexup
• I would anticipate we see more agreements with pharmaceutical companies coming down the road.
Question regarding Valuation:
• This year we are focused on getting approval on Otrexup
• Expect another filing out of Teva pipeline coming along……Moderator: can u tell which one?.......ATRS: NO! (laughter)
