I can add a little more but was late so caught the latter half of Mark's questions.
1. I cited a large tier 1 hospital close to HQ that still had not added Andexxa to formulary, citing cost, lack of convincing evidence of effectiveness, and current SOC of PCCs and plasma being effective enough for most bleeders. I asked what PTLA is doing to convince these hospitals to capitulate from their position.
Sheldon Koenig took the question and said that they are working on studies that will show the opportunity cost of NOT using Andexxa, which will highlight elevated costs from mortality, longer hospital stays for recovery, etc. Nothing noted on legal consequences, which I think will be more convincing, but I think I see the pharmoeconomic arguments he is getting at. I appreciate the attempt to quantify these costs, but still am skeptical about how this will win over staunch critics. As a follow up question, I asked whether there is any consideration to focus on a drip and ship strategy for hospitals surrounding tier 1 center hospitals. I think if you have just one hospital that stocks Andexxa (and with the J-code, they actually get paid to administer the drug), that could be just as effective as stocking at the T1 location. SG replied that the community hospitals typically look to the tier 1 hospital for guidance on adding a drug like Andexxa, and that the potential for usage is substantially more at T1 hospitals. They have seen more interest in community hospitals but stopped short of saying they are targeting them. He went on to say that the process is methodical; identifying KOLs and having several conversations with them, sometimes as little as once per month, to try to clear any misperceptions. I can see why SG has said it takes 6-9 months to get the drug on formulary.
2. I anticipate the PCC study to be insightful, but does anyone think this will change hearts and minds knowing that this is a study from a biased stakeholder?
3. Mark made it clear that he saw it as a disappointment that the expectation was linear growth and asked SG whether he was happy with linear growth. SG responded by saying that this launch is going better than any in-hospital drug to date.
4. Mark grilled SG for more color on partnerships and whether any talks have ever taken place. SG said he cannot provide any further details on that question as it is material non-public information that is best to be closely held by management.
Separately, I asked Mardi about the cash burn. She said that she is watching it closely, and the main factors for it to increase is the European launch (ex partnership) and development of C. She did not mention anything about label expansion or B marketing. She said that they still have a few levers to pull, which, coupled with SG's earlier comments about looking for B and C partners and the laser focus on A, if I read between the lines correctly, I think she meant that they will consider partnering those assets to bring down the burn rate prior to a dilution (IF A is a dud and they are cash flow negative in 2020). This could be pure speculation on my part, but let's hope it doesn't come to that. Mark had mentioned to me that SG has stated in prior calls that any partner will not be pushing these drugs as hard as internally developed ones.
Unrelated to the ASM, but I came across the following tweet on Stocktwits just tonight from a poster who I, and I think Mark, hold in high regard (probably at the same level as our beloved Ernie). I think he has a good point, but it is next to impossible to get analysts to model Andexxa revs out further. What do others think about this statement?
"Underrated point by Garland that Andexxa needs to be modeled based on Alteplase sales. Analysts are currently modeling it like an outpatient small molecule drug, which has about half the value per peak revenue of an on hospital biologic. There are very few examples of biologics that fit this category. It takes a bit more time to hit peak sales since you have to win formulary battles at individual hospital systems over time. But once you have a foothold, you get much longer exclusivity. It is not only very difficult for a biosimilar to get approved, but it is equally as hard for them to get into hospitals and takes a long time. Analysts have peak sales for Andexxa slated for 2025, but may actually be 2035 or even further out"