Antares: Presentation Highlights from Deutsche Bank Conference (ATRS, Buy, $0.97)
Overview
I listened to CEO Bob Apple speak at the Deutsche Bank conference and wanted to pass along a few pieces of information that are incremental to my recent report. Antares: An Outstanding Product Pipeline Promises Dramatic Growth Through 2022
AB EpiPen
In regard to AB EpiPen, he said that they are working with Teva to respond to the CRL. Antares is responsible for answering questions on the device and Mr. Apple is confident that they can answer the FDA’s questions with existing data and no new trials, but one can never be sure with FDA. He gave no timetable on when Teva will respond to the CRL or a possible timeframe for approval and launch. He was asked if Antares/ Teva would market the product as a branded product if it is not approved as substitutable for EpiPen.  He just said the companies are committed to gaining an AB rating. However, I note that this is a $2 billion market with essentially only one product and there is probably reasonable potential in introducing it as a branded product.
AB Forteo
Mr. Apple sees the potential for Forteo to be as profitable as EpiPen. I actually projected in my recent report that pretax profits from AB Forteo in 2020 could reach $23 million versus $15 million for AB EpiPen assuning it is approved. My projections are summarized in my recent report as sited above.
QST
Mr. Apple believes that the Company is on track for a commercial launch in early 2018. The Company intends to market the product directly to urologists and endocrinologist with its own sales force and partner market with a larger firm to reach general practitioners. This was the model followed by Auxiiliun in marketing its testosterone gel Testim. Auxiiliun kept expanding its sales force as sales of Testim grew until the sales force reached 150 reps. Its peak sales were $211 million in 2013. Then the side effect issues arose and sale plummeted to $85 million in 2014. I believe that QST has major advantages over Testim and perhaps the $200 million or more is a  reasonable sales target say five years after launch.
Mr. Apple said that the Antares Auto-Injector using a small diameter 27 guage needle (as in the QST device) registered 2 on a pain scale in which 0 is no pain and 100 is excruciating pain. It is virtually painless. In addition, the PK levels produced by QST over the course of a week are superior to probably all other products. I think it could be the case that this is the safest and most effective product on the market that requires only one virtually pain free injection per week. These are impressive product characteristics that should allow QST to compete against not only injectable formulations (half the market) but also gels.
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Thanks Larry.
A few more tidbits I heard….regarding Gx Epi, Bob Apple did seem very confident that the existing data would sufficiently address all the device related questions. If I heard correctly, the user study portion for the filing alone resulted in an 800 page section of the ANDA filing. Wow (at least that was my response when I heard the number). The total filing was thought to be thousands of pages long. An AB rating appears to be Teva’s steadfast goal. I still wonder about the REMS (Risk Evaluation and Mitigation Strategies) aspect of the filing and wonder to what extent Mylan has cooperated, or not, to get that part completed. It is not uncommon for the branded drug company to make compliance with the REMS aspect painful and time consuming – using this as a delay strategy to force CRLs and extend the time needed to obtain approval.
The Makena program is doing well. You elaborated on that aspect the other day. Bob Apple did reiterate that based on sales, the royalty aspect for Antares will be anywhere from the high single digits to the low double digits. Device sales to Makena will include the cost of the total loaded and packaged device plus a markup, as opposed to Epi which is the only alliance drug where they get paid just for the device (not the loaded, packaged device – though they still make a high single digit royalty on sales).
Development revenues should become stronger as the year progresses due to their alliance deals (Makena, Exenatide, Forteo) all being in the commercial development stage. When Gx Forteo and Exanatide do become available, evidently their royalty and device deals will be similar to that of Makena’s.
Bob seemed bullish on Suma’s financial impact (expected to launch by 2nd half of the year), and alluded to financial stability (break even?) being a attainable yet this year. He wouldn’t specifically state that (no actual bottom line guidance), but he did seem very confident that top line would be 10% higher this year versus last and that cash burn was currently low and being well managed.
Bob did hint (first time I’ve heard this) that QS-T might be launched in late 2017 (contingent on when it gets approved). The QS-T safety trial is about to complete later this month. If that completes as hoped (without incident), and coupled with the efficacy trial results (stellar, best in industry and for a week-long duration per dose), the QS-T NDA should be confidently filed later this year, hopefully by early Q4. If they follow the same path as with Otrexup, they’ll hire consultants to expedite the process and complete the NDA filing as quickly as sensible. The Otrexup NDA was completed in less than 3 months.
Bob Apple also made mention (starting around the 3:43 mark) that all three open Antares-related ANDA filings (all tied to Teva) are under priority review with the FDA. I’ve reached out to the FDA to see what that means in terms of expedited protocol. All three of those ANDAs would be big first generics (Epi, Exenatide, and Teriparatide) which is at least in part why they qualified for priority review. An ANDA can be approved before the RLD patents expire via the “tentative approval” status. In other words, Exenatide could be approved at any time. Teriparatide, probably not for awhile since the paragraph IV aspect wasn’t submitted until July 2015. Still, it’s feasible that it could be approved sometime next year. I believe the Teri EU patent protection expires in late 2017, making launch over there possible much sooner than here in the US. Of course we’re dealing with the FDA so I’m not holding my breath, yet. Still, in theory, Antares could have the following drugs approved before the end of 2017 – Makena AI (probable), QS-T (probable), Exenatide (TBD), and Teriparatide (TBD). If the chips fall right, all could be launched by Q4 2017 except Teriparatide (not until early 2018 in EU, I believe). If the above would happen or even close to those timelines, Antares could be poised to have a massive breakout in 2017.
One more to add to the above, Gx Epi could also be approved in 2017 depending on how soon and effectively Teva responds to the FDA’s Epi CRL.
Teriparatide probably won’t be approved at the soonest until 2018.
Antares had their Q1 earnings call today. Lot’s of things happening, but cash burn concerns have resurfaced. What will the company do to preserve cash, and if/when it does need cash for 2017 what will they do to raise it?
Teva conference call from June 8…Per Siggi Olafsson…”nothing in CRL to prevent Teva from continuing with AB rated Epipen. Will Take 9 months after CRL issues are resolved which they are resolvable with AB launch end of 2017 or early 2018.”
Antares confirmed via their June 8 CC presentation that QST is expected to be filed Q4 2016 – they removed the Q1 2017 possibility. Approval, sans a delay, would occur no later than early Q4 2017. That means drug approvals for Antares/Teva/AMAG for 2017 could include Exenatide,Makena, QST, and Gx Epipen.
I don’t believe the value for any of the drugs just mentioned are reflected in the share price.