Jul. 31, 2014, 9:11 AM| 4 Comments
Jun. 19, 2014, 9:11 AM
Jun. 11, 2014, 9:13 AM
May. 15, 2014, 12:53 PM
- Through its wholly-owned subsidiary Corsicanto Limited, certain holders of Amarin's (AMRN -8.6%) outstanding 3.50% Exchangeable Senior Notes issued on January 9, 2012 valued at $118.7M exchange their holdings for new Exchangeable Senior Notes with a lower conversion price. The original notes' conversions were 113.4752 ADSs/$1000 in principal amount. Amarin's price/ADS was, of course, much higher at the time. The new debt will have a conversion option of 384.6154 ADSs/$1000 in principal amount.
- The conversion rates in the old and new notes are based on ADS prices of $8.81 and $2.60, respectively.
May. 15, 2014, 9:15 AM
May. 9, 2014, 7:37 AM
- Amarin Corp (AMRN) Vascepa sales: $11M (+378.3%); gross margin: 61.3% (+36.2%); operating loss: ($25.6M) (+57.4%); loss/share: ($0.15) (+65.1%); quick assets (ex-A/R): $164.9M (-14.3%).
- Formulary coverage now >200M lives including >100M Tier 2 coverage. Estimated Vascepa prescriptions by Symphony Health Solutions and IMS Health were 93K and 78K, respectively.
- $100M will be required to finish the REDUCE-IT clinical trial. The company states it may be difficult to complete it without the expected revenues from the previously anticipated ANCHOR indication. Without modification or termination, REDUCE-IT will not be completed until 2017.
- $11M in Vascepa sales was based on sales to distributors not the resale of the product to fill prescriptions, which was the method it used until it gained a reliable estimate of returns. Under its old method, Vascepa sales would have been $10M.
May. 9, 2014, 7:02 AM| 2 Comments
May. 8, 2014, 5:30 PM
May. 6, 2014, 7:08 AM
- The FDA approves AstraZeneca's (AZN) Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (>=500 mg/dl). It is the first approved omega-3 in free fatty acid form. Patients can take as few as two capsules/day.
- In some patients Epanova increases LDL-Cholesterol so this parameter should be monitored periodically during therapy. This will undoubtedly be a selling point for Amarin's (AMRN) Vascepa (icosapent ethyl) since it lowers LDL-C.
Mar. 31, 2014, 5:03 PM
- Amarin (AMRN) is partnering with Japan's Kowa Pharmaceuticals to co-promote Vascepa in the U.S.
- Kowa's 250 U.S. sales reps will join Amarin's 130 sales reps in selling Vascepa. Kowa will be paid a co-promotion fee based on a percentage of Vascepa's gross margins "that increase during the agreement's term, from the high single digits in 2014 to the low twenty percent levels in 2018, subject to certain adjustments."
- The initial deal term runs through 2018.
- More on Vascepa
Mar. 5, 2014, 12:17 PM
- Amarin (AMRN) sues Omthera Pharmaceuticals, now part of AstraZeneca (AZN), claiming its cholesterol-lowering drug, Epanova, infringes on one of Vascepa's patents.
- Epanova's target user population is the same as Vascepa's and GSK's Lovaza.
- AZN expects the FDA to rule on Epanova's NDA by May 5.
- Lovaza sales are ~$1B.
Feb. 27, 2014, 4:02 PM| 3 Comments
Feb. 27, 2014, 12:10 AM
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Feb. 26, 2014, 5:35 PM
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Feb. 24, 2014, 3:16 PM
- The FDA awarded Amarin (AMRN +3.2%) three years of marketing exclusivity that extends through July 25, 2015, but not new chemical entity status, says analyst Jon LeCroy, lowering his fair value estimate to $1.75 from $2.50.
- He expects generic pharmaceutical companies to file Paragraph Four applications in the next several months, and for Amerin to file suit against the filers which will start a 30-month stay. "Vascepa has 40 issued and allowed U.S. patents that could protect Vascepa from generic entry to 2030, but the courts will decide whether any generic entrant would infringe on these patents."
- He expects Amarin to challenge the FDA's decision, but nothing to come of it, and thus lowers his valuation multiple on estimated 2017 sales to 3x from 4x.
Feb. 21, 2014, 4:22 PM
- The FDA has given Amarin (AMRN) three years of marketing exclusivity for its Vascepa triglyceride-reduction drug.
- Though exclusivity officially only extends through July 25, 2015, Amarin expects it to be "supplemented by a 30-month stay under the Hatch-Waxman Amendments that would be triggered after patent infringement litigation initiated by Amarin" in response to the approval of a generic version of Vascepa.
- Amarin says it's "evaluating whether to challenge" the FDA's decision to give only three years of exclusivity, rather than five, and insists its efforts to bolster Vascepa's patent position have lowered the relative value of marketing exclusivity.
- More on Amarin/Vascepa
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