Part 2 will cover other highlights, particularly regarding Fusilev and Zevalin. Of course all of these comments should be taken with a grain of salt given the bombshell press release SPPI released a couple weeks later. In some cases the change in commentary in such a short period of time is very difficult to reconcile.
- year-end 2012 cash balance $143m
- Research and Development expenses 2012: $42m
- SG&A expenses 2012: $92m - now have >60 person commercial org (35-40 new in last 90 days) - all sell all 3 products
- 2012 full-year sales: Fusilev $204m, Zevalin $30m
- "In Q4, we established our global footprint as the single worldwide owner of ZEVALIN. Our commercial team is now in place in the EU, and our partnership with Fuji in Japan is fully operational.
- ZEVALIN revenue was consistent Q3 to Q4, and we expect the impact of our larger U.S. sales team and the renewed promotion in Japan and the EU to lift sales going forward"
- No price increase in the past quarter
- will be moving renazorb into phase 2
- will shortly enroll first patient in SPI-2012 phase 2 (long-acting gCSF)
Question and Answer session:
"So when we look at FUSILEV business right now, what we see is end-user demand, customer-generated demand is very, very stable right now
75% of FUSILEV business is in the clinic setting. That setting is very, very sticky for FUSILEV. Once accounts are using this product, it's very rarely do they go back to generic racemic leucovorin
So when we look at the number of FUSILEV vials that we shipped out was up in Q4 versus Q3, and it's mid-single-digit increase in units, right about that. [but reported sales down 14%]
today and at least for the past 3 or 4 months, the ability for any doctor to get generic racemic leucovorin has been fairly easy. Our research shows that definitively. Right now, there's not a difficulty in getting the product. Therefore, if there are new generics that enter the market, we don't think that's going to impact us much. If it's easy, it's easy. It doesn't make a difference. So I don't think that's going to be an issue at all. What we see when clinics use FUSILEV, they love the idea that it has a separate J-code. They find reimbursement very, very easy. They love the idea that's a pure isomer. So once they've got it, they're very reluctant to switch back, and we see that consistently almost universally in the clinic business. So we don't think that if there are 2 or 3 more generics that hit the market in the next 6 months, we don't see it affecting us much.
Maybe talk a little bit about your perspective on the investment that you're making in [Zevalin]. I think it's a great product. It just doesn't seem like anything really helps to move the needle, and now that we've got some of the oral drugs like lenalidomide and potentially some of the BTK or PI3-kinase inhibitors moving into lymphoma, I'm just wondering how you think about the investment commitment that you made to ZEVALIN and the ultimate payoff for that investment?
[Answer: blah blah blah we expect growth in 2013 over 2012]
this is a drug, which now we are studying for newer indications. The indications that we would like this drug to be approved and marketed for diffuse large B-cell lymphoma for which there's unsatisfactory treatment. And there are number of Phase II studies that have already been completed, not on our nickel, on the investigator's nickel that show that the drug has absolutely outstanding efficacy. And currently, we have a plan to restore ZEVALIN for some of these newer indications.
The bioscan requirement, that removal has been there for a few quarters, but we haven't really seen the revenue pick up. Is there -- could you help me to understand that aspect?
So right now, when we look at the bioscan being removed absolutely, this makes it easy to use ZEVALIN. There's no doubt about it. Because the size of our sales force wasn't large enough to get the message out to the magnitude that we wanted to, many people still today haven't -- don't really understand that. That is changing. That will change imminently. As I mentioned earlier, we just brought the sales team together. We just trained them 3 weeks ago. You'll see that change very, very quickly, and then we'll realize the benefits of the greater ease-of-use that we have today versus 2 years ago.