Revised fiscal 2019 guidance
Yesterday, Amarin (AMRN) revised its 2019 revenue guidance upwards from $350 million to $380 million–$420 million due to higher-than-anticipated demand for Vascepa in the first half of 2019. Based on unaudited results, the company estimates its second-quarter revenues to be $97 million–$101 million, which will be a YoY rise of 84% to 92%, while revenues in the first half of 2019 are estimated to be $170 million–$174 million, which is a YoY rise of 76%–80%.
Based on unaudited results, Amarin has estimated its cash and cash equivalents to be $221 million, net accounts receivables to be $94 million, and inventory to be $47 million at the end of June 2019. The company has also highlighted its zero debt at the end of June 2019, except its royalty-bearing instrument.
This news impressed investors, pushing up Amarin’s stock price by 16.27% to close at $22.37 yesterday. The stock closed 851.91% above its 52-week low price of $2.35 and 4.14% lower than its 52-week high price of $23.33.
In March 2019, Amarin submitted an sNDA (supplemental new drug application) seeking label expansion for Vascepa based on the Landmark REDUCE-IT cardiovascular outcomes study. The Prescription Drug User Fee Act date for this application is September 28, 2019. To know more about REDUCE-IT results, please read Vascepa May Prove a Solid Growth Driver for Amarin.
Assuming FDA approval for the expanded indication of Vascepa, the company had previously planned to increase its commercial field force from 400 to 600–800 sales representatives. Yesterday, the company communicated its decision to expand its field force to 800 representatives by October 2019. This expansion bodes well for Amarin’s investors, as increased investment in field force highlights the commitment and confidence of the company about the growth opportunity for Vascepa. While there has been no communication from the FDA to date, Amarin is preparing for an AdCom for Vascepa’s application.
Despite pending FDA approval, the REDUCE-IT results have had a significant positive impact on Vascepa’s prescriptions, driven by off-label usage and improving payer access. In the 2019 BMO Prescription for Success Healthcare Conference, Amarin has estimated the current approval rate for Vascepa’s prescriptions to be close to 80%. The company plans to secure permission from OPDP (Office of Prescription Drug Promotion) for consumer promotion and begin significant DTC (direct-to-consumer) promotion for Vascepa in the second quarter.