Antares (NYSE: ATRS) is a drug device company that takes drugs currently in use and develops simple delivery devices, such as the auto injector, for easier delivery for the patients. The pipeline as well as the current products in the market are available to view here.
Products on the market:
- Quickshot M/Quickshot T/Xyosted – NDA has been filed for these
- Epi – ANDA
- Zomacton for the US – SNDA
- Teriparatide – ANDA
- Exenatide – ANDA
- Makena – SNDA
Quickshot T/Xyosted is the much awaited catalyst for Antares in 2017; a response from the FDA is expected by the end of the year.
When patients are diagnosed with low testosterone, they are given a choice of either injecting themselves with a syringe, utilizing a topical gel, or utilizing an implant that is placed under the arm. Many patients opt for the syringe since an implant requires a procedure – small as it may be – and most patients avoid the topical gel due to the possibility of passing the testosterone to those close to them via accidental contact. Antares’ device is a quick injector, much like the Epi-Pen, that prioritizes simplicity and ease of use.
The results of their studies for the device were very promising. One major issue I see would be the possibility of warning restrictions – focused level of testosterone – but studies have shown that this shouldn’t be an issue. Another issue that could potentially harm the share price is if the FDA responds with a CRL (complete response letter) about the manufacturing. Though that’s a more general issue most medical device companies face constantly.
The PDUFA should be around October 20, 2017.
With Mylan’s recalls, there are many other companies that are attempting to snatch market share away from them. Antares received a CRL last year but are still working to clear that error. I am optimistic about the approval, but the number of competitors squashes any optimism I may have about snatching any large amount of market share.
Albeit, as the saying goes…
Every little bit helps.
This drug is for diabetics and is a GLP-1 (glucagon-like-peptide-1) analog. Currently partnered with Teva and if all else goes well, it will go to market by the end of 2017.
Teriparatide treats osteoporosis but there is currently a lawsuit by Eli Lilly disputing the patent. It shouldn’t affect Antares too much since it has already been approved in Europe and has filed for marketing authorization in 17 different countries in Europe.
This is a drug that prevents preterm births. Antares has partnered with AMAG Pharmaceuticals to bring it to market. Currently we inject via IM, but Antares is offering a once-a-week, subcutaneous auto injector.
Target action date is somewhere around February 2018.
Launched in 2015 for the treatment of rheumatoid arthritis, Otrexup brought in some revenue – $15m – in 2016. It has been increasing 14 – 16% per quarter though.
This is a generic drug for acute migraine that works relatively well and has had success. Currently, patients take tablets of various dosages which takes time to bring relief. Studies show that injectable sumatriptan is much faster acting and more potent than the oral formulation – likely due to its bypassing of the first pass effect. As of last earnings report, it achieved 26% market share.
As of last earnings report, the company had $33m in cash – $83m total asset – with a $13m per quarter revenue and $10.5m per quarter burn rate. Adjusting for the cost of revenue, the company burns $3m per quarter, which is great! The 10q can be found here. They also completed a non-dilutive debt financing from Hercules Capital; a 5 year loan that provides $35m with an initial draw of $25m.
With multiple catalysts coming at the end of 2017 and revenue increasing quarter by quarter, I’m highly optimistic to see their stock price rise within the year. The actual amount it’ll rise by isn’t something I can give too much introspection for, but the company has solid prospects.
Disclosure: I currently have a long position in ATRS.
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