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AMAG Pharmaceuticals' Q3 Results Overshadowed by Ominous FDA Panel Recommendation

By Keith Speights – Nov 1, 2019 at 1:06PM

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The drugmaker's Q3 results didn't matter very much in light of the prospect that it might have to yank Makena from the market.

It's been a bad year so far for AMAG Pharmaceuticals (AMAG). The pharmaceutical stock had dropped 19% year to date heading into this week. But then AMAG's shares tanked on Wednesday after the company announced an FDA advisory committee recommended pulling one of its top-selling drugs, Makena, from the market.

AMAG reported its third-quarter results before the market opened on Friday. Unfortunately, there wasn't any good news to reassure investors. Here are the highlights from AMAG's Q3 update.

Dollar sign formed from pills

Image source: Getty Images.

By the numbers

AMAG reported that its revenue fell 31% year over year in the third quarter to $84.1 million. Analysts were expecting that the company's revenue for the third quarter would be close to $88.3 million.

The company announced a net loss in the third quarter of $23 million, or $0.70 per share, based on generally accepted accounting principles (GAAP). The company's bottom line reflected an improvement from the prior-year period GAAP net loss of $30.8 million, or $1.88 per share. However, analysts were expecting a Q3 adjusted net loss of $0.66 per share.

AMAG ended the third quarter with cash, cash equivalents, and marketable securities of $191.5 million. The company had a cash stockpile of $394.2 million at the end of 2018.

Behind the numbers

AMAG Pharmaceuticals' year-over-year revenue decline in Q3 came entirely from the company's decision to stop selling Makena in the intramuscular market. Its other products performed well. Sales for Feraheme jumped 20% to $44.2 million. The subcutaneous auto-injector version of Makena brought in sales of $41.3 million, up 5% from the prior-year period. Sales for Intrarosa increased 14% year over year to $5.6 million.

Those results were notable for a couple of key reasons. Feraheme's sales were an all-time high. And AMAG's Makena subcutaneous auto-injector was able to retain its market share and deliver sales growth in the face of stiff generic competition.

AMAG significantly reduced its operating expenses in the third quarter compared to the prior-year period. This helped the company's net loss be a little better than it would have otherwise been. However, the company boosted research and development spending as it continues ongoing clinical studies and added other sites in Europe for studies evaluating AMAG-423.

Looking ahead

AMAG now anticipates revenue between $320 million and $330 million in full-year 2019, down from its previous guidance of $325 million to $355 million. The company also projected that its 2019 operating loss will be between $278 million and $268 million, compared to its previous outlook of an operating loss between $286 million to $276 million.

The FDA advisory committee recommendation to withdraw Makena from the market, though, makes AMAG Pharmaceuticals arguably one of the riskiest pharmaceutical stocks around right now. CFO Ted Myles acknowledged that this recommendation "heightens uncertainty around the durability of Makena revenue." 

Keith Speights has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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