Company explanation on last call to a question about lag to shipment: So we're not changing the timing of what we expect, I think based on any of that. I think as we've discussed several times in the past few years, there is a lag between the approval and the product launch for these two products because there are new chemical entities and that takes several months. And so maybe to give you some insight as to what's happening there, so while the manufacturing scale for FDA approval is significant, the scale that is required to support what we believe to be very two large commercial products was even larger. And our approach has not been the scale off all the way to that commercial scale at risk. And so what that means is significant post approval work, and that includes in some cases transferring the API or active pharmaceutical ingredient manufacturing, in other cases moving the formulation of the drug product or packaging and really process improvements.
And so when you make those sorts of changes and moves, those things that required various filings with the FDA to make sure that they understand everything that you're doing. I mean we need to let those play out before we can actually ship products to customers and then of course I think some good news is at this point, we believe that we've basically made all the necessary filing. This is a matter of playing those out.
And then beyond the regulatory requirements, both Aratana and our collaborators have certain quality standards and procedures that they have to be sad aside before a product is released to market and I think that's true for basically all pharmaceuticals. And so that's all what's happening over the next weeks to months, to support the timelines that we've articulated
Bottom line: Company appears to have decided to lag their commerical and manufacturing readiness to after approval. Likely to conserve cash burn. The market reality though is that these FDA approved products are taking many months to generate revenues so hard to get any read on what kind of ramp to expect. Current rev est for Q4 is less than $1 but C17 looks pretty solid.
Aratana scheduled earnings call for May 9. Analysts have $3.07m ($1-5m range) as consensus rev estimate which is really the only key catalyst. Spending/burn rate will be of interest but real focus is on revenue and market data.
Reminder: They received 3 FDA approved pet therapeutic products in C16 but the launch timetable kept slipping.
Galliprant Pain and inflammation relief for dogs. Available w/Elanco collaboration: Q416 cc So how is it going with GALLIPRANT? I will say that while early in the launch, from Aratana's perspective, the GALLIPRANT roll-out is going extremely well. We can safely state that it is exceeding Aratana's expectations. As mentioned, GALLIPRANT is FDA approved to treat the pain and inflammation associated with osteoarthritis in dogs. It's administered as a once-daily oral flavored tablet.
GALLIPRANT enters an established multi-hundred million dollar market in the United States. However, GALLIPRANT has a unique mechanism of action, it is an EP4 receptor antagonist. We believe that GALLIPRANT can participate in the market by, one, competing for market share and perhaps more importantly; two, by expanding the market by offering a new tool with, which to manage OA pain from the earliest stages of disease. GALLIPRANT was made commercially available in late January 2017.
Elanco has communicated to us that distributors have already shipped GALLIPRANT to more than 5,000 clinics in the first month. That is a great outcome. As a reminder, there are approximately 25,000 clinics in the United States. We believe that most of those clinics have prescribed the existing OA therapies for decades. So to get 5,000-plus clinics to order a new therapeutic in the first month is impressive.
Entyce Oral colution to stimulate appetite in dogs (cancer etc.) Available Late 2017 CC: According to our market research, inappetence in dogs is seen in veterinary clinics more than 10 million times per year in the United States. Inappetence can be an acute problem or a chronic problem, and currently ENTYCE is the only FDA-approved therapeutic for inappetence in dogs.
Note that Entyce mfg availability slipped which was a primary driver of the selloff.
Nocita- drug for ligament surgery in dogs. Available cc: And as we said in the past, our initial focus is gaining access to those several hundred surgeons who frequently perform these procedures. We continue to be pleased with the access that we have achieved and we are pleased that we have had approximately 200 accounts place an initial order. The focus is now to drive reorders and eventually we believe we can expand the number of accounts. Aratana is conducting additional clinical work in other surgical procedures to expand the NOCITA label in dogs and we are also conducting a pivotal field effectiveness study in cats. However, the sales cycle is long and the uptake is slower than a general practice therapeutic
DrGeo I'm a veterinarian, doing per diem/relief work in NH. I am a holder of about 7,000 shares. I have to say that you misquoted the cost of a cruciate surgery in dogs. The price varies much more than that, depending on a whole lot of factors, but $5,000-7,000 is at the very high end. More like $2000-7000 maybe, with plenty of surgeries at the lower end - $2500ish. That matters because if a vet uses a $180 bottle on a 100 lb dog, and marks it up say 50%, then that adds $270 to the already high fee for this procedure. As for using one vial on several dogs, I believe that is technically a no-no (although vets do it all the time), as injectable drugs from a multi-use vial are supposed to be discarded after 14 days. And, as one boarded surgeon told me, he didn't feel that the added cost of Nocita did justified the added benefit. Although theoretically less of the other pain modalities could be used if Nocita were used on a dog, which could partly offset the cost of Nocita. I think that Nocita is a great concept, and I would love to see its use take off. It would be very very cool to see it being sold in small vials for single use, and priced accordingly. And it would be nice to see vets using it for routine surgeries, such as spays and neuters, lumpectomies and many other surgeries.
I have found the Galliprant situation to be interesting. I don't understand exactly what is going on with it, but it does seem that after it was sold to 5,000 hospitals, it was on backorder. When they starting selling it earlier this year, Elanco was offering a pretty good deal if you bought a certain amount of it, and vets being vets - a lot of them went for it. I think that there was an underestimate of the number of hospitals that would buy that opening deal. So, the question then becomes: can they make sure to keep product moving, so that when animals on it need to refill, they can get it? And of course, will people refill? It is fairly expensive compared to generic carprofen, but it is as you say, much safer. And, another possible use of this drug would be for post-operative pain. Most vets currently prescribe carprofen, or meloxicam, plus Tramadol (which is a somewhat questionable opioid medication) for peri- and post-operative pain medicine after routine surgeries, dentistries, after cruciate surgery, etc. Using Galliprant instead would make sense because of its safety margin.
All that said, as a relief vet who works at a number of vet hospitals, I have only seen the product in one hospital. They still had most of their opening order remaining. Most vets that I have talked to still either haven't heard of it or just aren't buying it (yet). It will be interesting to see what happens in the future. It might just start to get some momentum as vets go to conferences and hear experts touting it, and as word gets out better, and as vets get more experience with it. Cost is a big factor with arthritis drugs (unless an owner has pet insurance) and many people will stop refilling their pain meds for their pets.
It is too bad what has happened with Entyce. I don't really understand it. But, that said,it is going to be a killer product, because vets are always needing something to stimulate the appetite of their sick patients - those with cancer, kidney disease, nonspecific ailments, etc. Especially cats.
DrGeo MoneyPro - thanks for the comments. I'm not very savvy to all of this stuff, but as a vet I thought this company seemed exciting to invest in. It is exciting still, that is for sure. While I don't quite understand the deal between Aratana and Elanco, I'm pretty sure that what happened is that Elanco offered opening deals to vet hospitals to buy a bundle of the product at a reduced price - the company makes a number of dose strengths of Galliprant according to body weight. So, something like 5,000 hospitals loaded up wit this starter deal. it wasn't a tone of product for each hospital - it was a few bottles of each size. And then, immediately after that, when vets wanted to by more, they couldn't. So, yes, I guess that is good news that 5,000 hospitals bought into the product, as they should have because of how cool this drug is supposed to be (safe, and effective for pain). And yes, it must have been much more than they were expecting. I spoke to an Elanco rep about 3 weeks ago and he told me they were expecting to, or hoping to, have more product out soon, or something to that effect. And that it was about unexpected demand. Well, I remember when Zoetis (animal division of Pfizer) came out with an amazing product for allergic dogs (Apoquel), and it was on back order and very difficult to get FOR YEARS! Not sure what the reason for that was. At the last conference call, the CEO of PETX said that 5,000 hospitals had bought into the product, and how positive that is (and the stock tanked that day (22%). At the next conference call, is he going to report that they are unable to supply vets (and their clients and pets) with more product? That should be interesting.
Analyst likely have very little to go on to estimate revenues at this stage which explains the $1-5m range for Q1. The current ramp shows $6m in 1H2017 and $8.5m in 2H leading to revs of $44m in C18.
Company has around $88m in cash and $40m of debt as of 12/31. They will need to raise cash soon IMO so I'd expect an announcement of a secondary fairly quickly if they have good news and a rally in the stock. That's the primary reason I haven't added to my position which I've held despite the selloff.
Q1 2017 earnings: Beat rev/Met EPS Aratana recorded $3.8 million in net revenues for the quarter ended March 31, 2017: - $2.5M GALLIPRANT product sales under its supply arrangement with Elanco, - $903k GALLIPRANT licensing and collaboration revenue - $327k NOCITA net product sales
First commercial revenues for Galliprant. Nocita was launched late Q4 2016 conf call 5/9 8:30an ET
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6