Health and Healthcare

Will 2017 Be a Make or Break Year for FibroGen?

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FibroGen Inc. (NASDAQ: FGEN) could be a very important stock in the biotech and pharma industries within health care in 2017. While the 35% post-election rally in FibroGen shares is more coincidental around its post-earnings news rather than the election, this move into year-end helped save some of the bullish thesis ahead. Still, FibroGen is not meant for risk-averse investors and for those investors who shy away from volatility. In fact, revenues have been in decline, and the company loses money despite having a $1.4 billion market value.

The company’s roxadustat (FG-4592) candidate is an oral small molecule inhibitor of HIF prolyl hydroxylases in Phase 3 clinical development for the treatment of anemia in chronic kidney disease. FibroGen’s FG-3019 drug candidate is a monoclonal antibody being studied for the treatment of idiopathic pulmonary fibrosis, pancreatic cancer and liver fibrosis. What matters here for FibroGen is that its has data from multiple studies coming out in early 2017.

FibroGen is one of seven catalyst stocks to watch in early 2017. First on deck for 2017, the company is expecting to announce top-line Phase 3 data in early 2017 for its Roxadustat (FG-4592) in the treatment of anemia in chronic kidney disease (CKD). Also Phase 2 interim results for Pamrevlumab (FG-3019) in the treatment of pancreatic cancer are expected in January 2017. Either or both could be major catalysts for the shares, but that also of course implies that there are big risks as well.

The driving force for FibroGen shares since the election was actually on the heels of its earnings report. The company noted at that time that it had also completed the enrollment of Roxadustat in Phase 3 studies in China for anemia in CKD. Also as a positive, the company noted that an independent data safety monitoring board reviewing Phase 3 studies to support U.S. and European regulatory submissions recommended these studies continue without modification to current protocols. On the heels of that announcement, the company said at the time:

In collaboration with our world-class partners, AstraZeneca and Astellas, we have substantially expanded the reach of our global development programs, while efficiently managing use of our resources.

One thing investors might want to consider is an old Leerink report from earlier in 2016, because this report named FibroGen as one of four speculative biotech stocks that could double, though that has not (perhaps yet) taken place.

Leerink’s rating remains at Buy, and its price target is still $52 for FibroGen shares. What attracted the firm to FibroGen is its $1 billion clinical and developmental milestone payment potential from the company’s partner, AstraZeneca and Astellas. It also noted a potential $500 million enterprise value for the large Phase 2 and Phase 3 assets.

Citi’s Buy rating was issued in late 2015, but that was with a more conservative $40 price target at that time.

One thing helping FibroGen is that its balance sheet has lots of cash coming from partner payments. The company ended the September quarter with $241 million in cash and short-term investments, as well as another $98 million in long-term investments. It also has $307 million in total liabilities.

Shares of FibroGen were trading at $21.80 on Friday, with a consensus analyst target of $36.20 and a 52-week trading range of $14.38 to $31.90.

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