lower schreef op 7 februari 2017 14:18:
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What To Expect At Shire's FY 2016 Results
Feb. 7, 2017
seekingalpha.com/article/4043237-expe...
In Q3/2016, Shire highlighted that Cinryze suffered from manufacturing supply issues in USA.
"CINRYZE's third quarter performance was impacted by a U.S. supply constraint, resulting in channel destocking during the quarter, holding back sales by approximately $45 million, which more than offset an increased number of patients on therapy."
Source: Shire's Q3/2016 Conference Call Transcript
Shire expects that the issue will be fully resolved by early 2017, thus there could be a negative impact of up to 1% of Shire's Sales in Q4/2016 and there is also a risk of further impact in 2017.
Key catalysts in 2017
There are two key catalysts, which investors will be watching in 2017 to see if Shire can keep its revenue growth going:
SHP643 Phase III data in HAE. Shire will face competition in 2017 in the HAE market because CSL will launch a subcutaneous formulation of Berinert. As I said in a previous article:
"CSL's Haegarda showed a 95% reduction in HAE attacks (P<0.001) at the highest dose (60IU/kg twice per week) while Shire's Cinryze (1000 IU) showed a c50% response rate."
Thus, it's clear that Shire has to report positive results for their SHP643, if they want to maintain their leading competitive position in the HAE space.
As a reminder:
"SHP643 (i.e. DX-2930) offers potentially better efficacy and more convenient dosing for patients suffering from HAE and it has a clear strategic fit within Shire's hereditary angioedema portfolio offering next generation therapy to expand Shire's industry-leading portfolio.
The next key catalyst for Shire to strengthen their position in HAE is DX-2930's Phase III study that will readout in 2Q17. If it will replicate the strong results showed in the Phase I trial, DX-2930 could generate global sales of up to $2.0 billion annually in HAE, driven by market expansion, increasing prophylactic treatment and cannibalizing partially existing Cinryze and Firazyr franchise. In this way, Shire would be able to protect their leading position in HAE from potential competition coming in 2017/2018 from new agents and for potential generic competition on Firazyr from 2019, given that SHP643 has regulatory exclusivity beyond 2030."
In the Phase I trial, SHP643 reported a 100% reduction for the 300 mg dose group and an 88% reduction for the 400 mg dose group (p=0.005) for HAE Attack rate vs. placebo. Thus, if Shire will report similar results for SHP643 in the Phase III trial in 2017, the doubts about the competitive pressure in the HAE space will dissipate.
investors.shire.com/events-calendar.aspx
Feb 16, 2017 Full Year 2016 Results