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The company earned $7.27 per share last quarter, which was better than the $6.86 analysts expected. However, revenue fell about 2 percent to $783 million, slightly missing the $800 million target. This small dip in sales is a reminder that the company is in a transition phase as it waits for its next round of products to reach the market.
The bigger news for long-term owners is that the company has submitted two major applications to the FDA, the agency that approves new medicines. These filings are for ralinepag, a pill for lung-artery disease, and a new version of Tyvaso for lung scarring. If approved next year, these treatments could significantly expand the number of patients the company can treat, which is the primary way it plans to grow its sales through the end of the decade.
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Source: 8-K filing
The Lancet published data showing that ralinepag reduced the risk of clinical worsening by 55 percent compared to a placebo in patients with pulmonary arterial hypertension. This is a condition where high blood pressure in the lung arteries makes the heart work too hard.
These results provide the clinical evidence needed to support the company's recent application for FDA approval. If approved, this drug would become a core part of the company's lung-disease business and help offset potential competition for its older treatments.
Source: Business Wire
Dr. Victor Dzau has joined the board after serving twelve years as the head of the National Academy of Medicine. He also previously led the health system at Duke University. Adding a director with this level of medical and regulatory experience is a logical move for a company focused on complex drug approvals and organ manufacturing. While this does not change the company's daily operations, it strengthens the group overseeing its long-term strategy.
Source: 8-K filing
Management has a habit of clearing the bar, beating analyst profit targets in most of the last eight quarters even when revenue is a bit choppy.
| Expectation | |
|---|---|
| EPS | $6.55 |
| Revenue | $791M |
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