Mydayis sales shine as Shire still looks to divest neuro
- The highlight of Shire plc's third quarter was an uptick in the immunology franchise of 32%, pushing up overall product sales by 7% year-on-year to $3.5 billion. Net cash grew by 101% to $1.1 billion, and will be used to pay down debt.
- The promised strategic review of neuroscience remains "on track," according to the company, with an update planned for the end of 2017. The company has also completed two of the planned divestitures of manufacturing facilities, with three remaining.
- Shire reiterated its 2017 full year guidance. While the shares nudged higher on the London Stock Exchange on the release of the results, overall the market didn't react strongly.
In its second quarter earnings call, Shire announced a strategic review of its neuroscience franchise, potentially resulting in its listing as an independent company. This franchise includes a number of approved ADHD products, including the newly-launched Mydayis (mixture of amphetamine salts), and made up 19.6% of the company's overall sales.
Mydayis was one of the stars of the results call, with the drug already taken up by over 3,000 physicians and over 11,000 patients, and more than 19,000 prescriptions issued as of October 2017. The U.S. sales in the third quarter were $10.2 million with a mid-quarter launch. According to CEO Flemming Ornskov, this is more than any other ADHD product launched since 2010.
Shire faced a manufacturing stumble during the third quarter for Cinryze (C1 esterase inhibitor [human]), one of its products for the treatment of the rare disease hereditary angioedema (HAE). This resulted in a product shortage, knocking Cinryze sales down 66% year-on-year to $56.9 million (largely in the U.S.) and the genetic diseases franchise down 7%. Shire shipped $100 million of product in early October.
"There has been a strong demand for Cinryze, both in the U.S. and internationally. We have now resolved the Cinryze manufacturing issue, and we worked with the HAE community throughout the shortage. We got a lot of good feedback about our openness. A long term sustainable supply will be achieved by adding a second manufacturing site. We expect to begin in-house production by first quarter 2018," said Ornskov. "The in-house production will be huge advantage for patients, for physicians, and for us."
CSL Behring launched a competing product to Cinryze during the quarter, its subcutaneous Haegarda. "We have seen some loss of new patients to our competitor because of the subcutaneous dosing, but we haven't seen a major impact and we are confident that we can maintain the market," Ornskov added. "Our patients are loyal. I think we faired pretty well."
Shire's SHP643 is nearing the market for HAE, with a biologics license application planned for late-2017 or early-2018. The follow-on product could be on the market sometime in 2018, explained Ornskov.
- Shire plc Earnings statement
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