2018 is already half over, but expect fireworks now that President Trump has turned his attention to seeking lower drug prices. The Tweeter-in-Chief publicly shamed companies that have tried to take the typical mid-year price increases.
Without the usual bump in price, some companies are going to face stagnate growth to some of their biggest products. The upcoming second quarter earnings calls promise to offer insights from executives making their stance on the topic known.
Beyond the hot topic of drug pricing, expect updates from several major companies on the impact of gene therapies. Investors will be looking to hear from Biogen about whether the company will bring a one-time treatment into the clinic, while watchers of Pfizer will expect to hear more about its plans to move the hemophilia gene therapy from Spark into late-stage testing.
Here’s a look at the seven companies we have on our radar:
Biogen —July 24
Biogen will report earnings on July 24, followed by a highly anticipated presentation of Alzheimer’s disease data for its mid-stage drug BAN2401 at the Alzheimer’s Association International Convention the following day.
While investors are likely more excited about the BAN2401 results, there should be some interesting tidbits on the earnings call as well.
The spinal muscular atrophy drug Spinraza (nusinersen) has maintained a better-than-expected launch trajectory for several quarters and that is expected to continue within the U.S. Analysts will be watching sales of the drug from launches outside the U.S. more closely though. The questions here will be about the impact of gene therapies eventually entering the market. Look for Biogen to talk about bringing its own into the clinic as well.
Expect management to make comments on the health of the multiple sclerosis franchise. The company dodged a bullet when a court upheld a patent for competing drug Gilenya, delaying generic competition from entering the market. But Roche’s Ocrevus is already starting to cannibalize some of Biogen’s sales (thankfully Biogen gets a piece of those sales too).
Gilead — July 25
Gilead’s hep C drugs Sovaldi (sofosbuvir) and Harvoni (ledipasvir/sofosbuvir) have been on the decline, largely because they’re so effective there are now fewer patients in need of treatment. Investors shouldn’t be surprised to see hepatitis C revenues fall further — the more drastic the decline, however, the more pressure there will be on the big biotech’s HIV portfolio and near-term growth drivers.
On those fronts, the focus will turn to the new-to-market HIV tablet Biktarvy (bictegravir, emtricitabine, and tenofovir alafenamide), prescription volume for which has grown considerably over the past few months, as well as the investigational drugs selonsertib and filgotinib.
Selonsertib targets what many consider the next frontier in liver disease: non-alcoholic steatohepatitis, or NASH. It’s on a short list of late-stage treatments for the disease, yet has garnered more optimism from shareholders and healthcare providers than many rival therapies. Filgotinib, meanwhile, is a Janus kinase inhibitor that faces a less challenging market now that Eli Lilly and Incyte’s Olumiant (baricitinib) poses less of a threat.
Investors will also want updates on Gilead’s CAR-T therapy Yescarta (axicabtagene ciloleucel), particularly after Novartis’ Kymriah (tisagenlecleucel) entered the diffuse large B-cell lymphoma market and themanufacturing snag the Swiss pharma disclosed during its most recent earnings presentation.
Amgen — July 26
Expect some commentary from Amgen on the biosimilar situation.
Mylan gained approval for a Neulasta (pegfilgrastim) biosimilar and is expected to launch at any time. While the big biotech has converted nearly 60% of patients to its Neulasta OnPro system, the remainder of the market is still vulnerable to the copycat competition. A key component of this is whether Amgen is discounting its own product to compete and already cutting into its own sales.
Also watch for discussion of Amgen’s plans for launching its own biosimilar version of AbbVie’s blockbuster Humira (adalimumab) in Europe – the copycat is expected to hit markets overseas in October.
But main focus will go to the launch of the CGRP inhibitor Aimovig (erenumab). The drug launched at a lower price than expected and uptake will be key — pay close attention to the number of patients over the revenues.
Celgene — July 26
Investors just might be starting to regain their faith in Celgene. After a half-year of patience-testing guidance cuts, regulatory setbacks and executive departures, shares in the biotech have perked up of late.
Helping Celgene’s case are two Phase 3 successes for a blood disorder drug that build confidence in the company’s predictions of a future multi-billion dollar product. Luspatercept, as the drug is called, met its goal in both myelodysplastic syndromes and beta-thalassemia.
Celgene has also spent $10 billion on M&A this year to fill its pipeline, taking steps to address concerns of what might eventually replace Revlimid (lenalidomide).
Zoom out, though, and the picture looks a bit less rosy. Celgene stock is down 20% since the beginning of the year and nearly 40% from a year ago. In a world where price hikes look likely to incur presidential wrath, growing Revlimid sales may now be a tougher prospect.
AbbVie — July 27
AbbVie gets the majority of its revenue from a single product, but hasn’t got as much flak as others in the same position. That’s partially because Humira (adalimumab) has for years been the world’s best-selling drug, but also because the company has built a formidable late-stage pipeline.
Execs will undoubtedly discuss that piece of the pipeline during AbbVie’s July 27 earnings call. Among the candidates, Elagolix should get particular attention. Analysts expect the oral gonadotropin-releasing hormone antagonist to become a blockbuster therapy for endometriosis and uterine fibroids in the next several years, yet its approval application recently got delayed at the FDA. Investors will want updates on its approval timeline and whether regulators have any concerns over the drug’s liver data.
On the portfolio side of things, Wall Street predicts another solid performances from Humira and AbbVie’s greener offering Mayvret (glecaprevir/pibrentasvir), a treatment for all major genotypes of hepatitis C that notched impressive 350% year-over-year growth during the first quarter.
Pfizer —July 31
Pfizer CEO Ian Read is definitely in the hot seat. The usually under-the-radar exec has taken center stage recently due to his chats about drug pricing with President Donald Trump. Read will most certainly have to address the moves made regarding price and talk about whether the company is actually going to lower prices instead of just defer price increases for a few months.
The New York-based pharma also took over development of Spark Therapeutics’ hemophilia B gene therapy. It announced it is initiating a Phase 3 study earlier this month – expect updates on its plans.
The other area that Pfizer will likely face questions on is its recent reorganization and the potential to sell off its consumer business. The company has been trying to shed the unit for some time, but with little success.
Spark — To be announced
The biotech that won the first U.S. approval of a gene therapy for an inherited disorder won’t have much in the way of sales to report. Luxturna (voretigene neparvovec), OK’d in December for a rare retinal dystrophy, isn’t likely to bring in hundreds of millions of dollars a quarter anytime soon. (Just look at sales of CAR-T therapies.)
But Spark’s earnings are still worth paying attention to, if only as a gauge of how the company is wrestling with the very real challenges of commercializing an $850,000 gene therapy.
A full pipeline of potential one-time treatments — Spark’s SPK-8011 and -9011 among them — could soon bring new options to hemophilia, beta-thalassemia and other rare diseases. New guidances from the FDA suggest these treatments could meet a welcoming regulator.
But the biotechs that develop them will still need to earn a return on investment in a way that doesn’t bring angry patients to their doorstep. Spark’s experience could hold some lessons.