Novartis (NVS -1.14%) is one of the largest and oldest pharmaceutical companies around, with roots going back to the mid-19th century. No business of this size can operate that long without accumulating a lot of skeletons, but the company's adventurous new CEO, Vasant Narasimhan, has had more than his fair share jump out at him since taking the wheel in 2018.
In May, we learned that Novartis paid Michael Cohen, the president's personal lawyer at the time, $1.2 million for access to the White House shortly after his inauguration.
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It's hard to believe, but paying for a chance to influence the president was probably the third worst snafu that Narasimhan has had to deal with since he became CEO. Earlier this year, Novartis was also named in a price-fixing suit filed by 44 states.
Narasimhan has already replaced the top lawyer at Novartis with its chief ethics officer, but there's nobody left to answer for withholding knowledge of false data in an application that led the FDA to approve Zolgensma.
Novartis has defended its decision to sit on knowledge of false pre-clinical data related to Zolgensma's manufacturing process, and the stock price has already returned to levels seen ahead of the FDA's stern letter of complaint. Here are five reasons the company and its shareholders don't seem the least bit bothered.
1. It's not a huge deal
Novartis learned there was something wrong while the FDA was reviewing Zolgensma's application, but didn't mention it to the agency until after the agency gave the new $2.1 million gene therapy for the treatment of spinal muscular atrophy (SMA) a green light. It turns out that AveXis, the company that invented Zolgensma, submitted some false mouse data while adjusting Zolgensma's manufacturing process.
The false submission occurred before Novartis acquired Avexis and the employees responsible for this snafu have already exited the company. Despite the corrective action regarding the false mouse data, the FDA was angry about Novartis' decision not to speak up as soon as the problem came to light. This could lead to minor financial penalties, but it's not a reason to pull Zolgensma from the market during its commercial launch.
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2. There's little risk of de-commercialization
Investors aren't too bothered, because Zolgensma's so important to the patients that need it that removing access for an inconsequential infraction would seem cruel. The disease advances so quickly that infants born with type 1 SMA rarely develop the strength to sit unassisted. Most spend their first birthday on a ventilator because they've already lost the strength to breathe on their own.
A single infusion of Zolgensma allows SMA patients to produce a vital protein that they can't make on their own, permanently. Novartis will have to compete with Biogen (BIIB -1.28%) and its SMA treatment, Spinraza. Biogen's drug requires several doses per year at great expense, and Zolgensma actually looks like a better deal with a $2.1 million list price spread over five years.
3. Entresto sales are soaring
Zolgensma will make a relatively small contribution to Novartis' top line, thanks in part to surging sales of its heart failure drug, Entresto, among patients with reduced ejection fraction (HFrEF). Recent clinical trial results with less severe heart failure patients weren't as convincing as Novartis had hoped, but Entresto sales are climbing fast and have a long way to go with their current indication.
In the first half of 2019, Entresto sales rose 77% to $778 million, and it's on its way to a $4 billion peak annual sales target that Novartis set years ago. There's plenty of growing demand, because HFrEF affects around 5% of people over 75 and it's the leading cause of expensive hospitalizations among older adults in the United States.
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4. This could be the next macular degeneration blockbuster
Age-related macular degeneration (AMD) is the leading cause of blindness among older adults and one of the larger line items on Medicare's list of expenses. In the U.S. alone, sales of the leading treatment used to slow down AMD, Eylea from Regeneron (REGN -5.00%), reached a whopping $2.2 billion in the first half of 2019.
In April, the FDA agreed to give a shortened six-month review to an application for brolucizumab, a potential new treatment for AMD that outperformed Eylea in a head-to-head study. If approved in October, as expected, brolucizumab could divert a large amount of Regeneron's Eylea revenue toward Novartis' income statement.
5. Novartis has a deep bench
Perhaps the biggest reason Novartis investors aren't worried about the Zolgensma affair is the company's huge lineup of growth drivers. In the second quarter, nine drugs added a combined $2.82 billion to the top line, which was $705 million more than the same nine products contributed a year earlier.
Better-than-expected performances from Novartis' innovative medicines segment in the first half of 2019 inspired management to raise expectations for total sales and profits this year. A growing stable of new drugs is expected to push total sales higher by a percentage in the mid- to high-single-digit range. Thanks to wider profit margins from a growing stable of successful drugs, annual operating income's expected to grow by a low-double-digit percentage that could rise to the mid-teens.
Attention, bargain shoppers
Novartis shares have been trading at just 17.6 times earnings expectations, which is near the broad market average. With profits that are soaring now and a solid chance the trend will continue, this might be the best big pharma stock you can buy right now.
