Tag archive for ‘AMAG’
AMAG Pharmaceuticals: AdCom Votes 9 to 7 to Remove Makena from the Market, but I Don’t Think It Will Happen: AMAG (AMAG, $9.80), Antares Pharma (ATRS, $3.40, Buy)
The FDA AdCom meeting voted 9 to 7 to withdraw Makena from the market. However, 6 of 7 practicing OB/GYNs on the panel voted to keep Makenna on the market and to do additional studies to properly define its role in the management of women with singleton pregnancies who previously have had a preterm birth. […]
Antares (ATRS, Buy, $3.51); AMAG Pharmaceuticals (AMAG, $11.73) First Thoughts about How the PROLONG Study Could Affect Makena Usage
Introduction On Friday, the PROLONG clinical study was released that showed no difference in outcomes between Makena and placebo. This was a major surprise and disappointment and caused a sharp decline in the stock price of AMAG and to a lesser extent Antares. This note goes over my preliminary thinking on the possible outcome of […]
AMAG Pharmaceuticals: Trying to Project 2019 Sales for the Makena Franchise (AMAG, $24.45, Buy)
Investment Thesis The investment outlook for AMAG in 2019 is primarily about Makena and this report focuses almost entirely on how much of the franchise can be maintained by the new auto-injector dosage form in the face of generic competition to the older intramuscular formulations. The Wall Street consensus 2019 sales estimate of around $200 […]
AMAG Pharmaceuticals: Strong Launch of Subcu Makena and Pending Sale of Cord Blood Registry is Encouraging (AMAG, $23.55, Buy)
Investment Thesis My April 13, 2018 report AMAG: Upgrading to Buy Based on an In-Depth Analysis of the Outlook for Makena Over the 2018 to 2020 Period (AMAG, Buy, $21.10) was based primarily on the belief that Makena sales could dramatically beat Wall Street analysts’ consensus expectations. Please refer to that report for my detailed […]
AMAG: It Is Early Days, but the Launch of the Subcutaneous Dosage Form of Makena Seems to be Going Very Well (AMAG, Buy, $21.17)
Investment Thesis The investment thesis for AMAG in 2018 and 2019is overwhelmingly dependent on how successful the Company will be in switching patients from the intra-muscular (IM) dosage of Makena to the new subcutaneous (subcu) formulation. The subcu was launched on March 26 and the first patient was injected on March 28. The subcu has […]
AMAG: Upgrading to Buy Based on an In-Depth Analysis of the Outlook for Makena Over the 2018 to 2020 Period (AMAG, Buy, $21.10))
Investment Thesis in Brief I want to emphasize at the very outset of this report that the key takeaway is that I believe that there is reasonable probability that analyst consensus estimates for Makena sales and projeciions for AMAG’s non-GAAP EPS for the period 2018 to 2020 could be substantially low. Management has issued no […]
AMAG Pharmaceuticals: Will FDA Approve Makena SC (AMAG, Neutral, $21.75)
Importance of Makena SC to AMAG? AMAG is engaged in a high stakes clinical development program in which it is endeavoring to gain approval of a subcutaneous dosage form of its key drug Makena. Management has guided that sales of Makena reached $333 to $336 million in 2016 (about 63% of total sales) and issued […]
AMAG and Antares: Update on the Development of Makena SC (AMAG, Neutral, $24.40) (ATRS, Buy, $2.04)
Key Points: Recent announcement that AMAG will not pursue Orphan Drug Exclusivity for Makena SC has hammered the stock of AMAG, but has had only a modest effect on ATRS. I believe that this does not change the commercial opportunity for Makena SC over the next two to three years. This potentially could move the […]
AMAG Pharmaceuticals: Initiation of Research on a Complex but Potentially Very Interesting Investment Situation (AMAG, Neutral, $24)
Organization of Report The first five pages of this report (section 1) provide a quick summary of my view of AMAG’s business outlook and how this leads to my investment thesis. It does not go into great depth as it is intended to give an impression so that you can decide whether you want to […]