The JP Morgan Healthcare Conference, being held from January 7 through 10 at the Westin St. Francis Hotel in San Francisco, is one of the premier, possible the premier, conferences for the biopharmaceutical industry.
The JP Morgan Healthcare Conference, being held from January 7 through 10 at the Westin St. Francis Hotel in San Francisco, is one of the premier, possible the premier, conferences for the biopharmaceutical industry. Every year biotech, pharmaceutical and medical device company representatives and executives from around the world gather together with members of the investment community to network, cut deals, and provide updates on their pipelines.
In fact, it’s almost surprising that Bristol-Myers Squibb and Celgene didn’t wait a couple days to announce their pending $74 billion merger. Here are 6 stories to watch for.
#1. Moderna. After nabbing the record for largest initial public opening in December 2018, raking in $604.3 million dollars, the company’s chief executive officer, Stephane Bancel, is presenting an update on the company and its pipelines at the JP Morgan conference on Tuesday, January 8. Moderna’s always been good at raising money, even though it has no products on the market. But it currently has 21 programs in development, with 10 in the clinic and another three with open Investigational New Drug (INDs) submissions. Investors are undoubtedly going to be interested in what Moderna is doing with all that money and whether it can live up to the hype.
#2. Sarepta Therapeutics. On December 20, 2018, Sarepta completed the submission of its rolling New Drug Application (NDA) for accelerated approval for golodirsen (SRP-4053), a phosphorodiamidate morpholino oligomer engineered to treat Duchenne muscular dystrophy (DMD) in patients with genetic mutations subject to skipping exon 53 of the Duchenne gene. Sarepta, of course, is the company that brought the world the first treatment for DMD, Exondys 51, in 2016, after a controversial and dramatic year-long approval battle with (and within) the U.S. Food and Drug Administration (FDA). Management is presenting at JP Morgan on Monday, January 7 at 7:30 AM PST. Investors can expect an update on the golodirsen submission and likely questions about how Exondys 51 is doing in the marketplace as well as any follow-up clinical testing that is ongoing.
#3. Biogen. On January 4, Biogen announced it had signed a strategic collaboration deal with C4 Therapeutics to investigate C4T’s protein degradation platform to discover and develop therapies for neurological conditions like Alzheimer’s and Parkinson’s. Biogen is paying C4T up to $415 million in upfront and milestone payments, plus potential royalties. But it would be foolish to assume there won’t be updates and intense questioning about Biogen’s two ongoing Phase III clinical trials of aducanumab for Alzheimer’s disease, that it is developing with Eisai. Data from at least one of the trials is expected late this year. Biogen is presenting on Monday, January 7 at 3:30 PM PST.
#4. Gilead Sciences. Just a couple headlines about Gilead from 2018 tell the story: “Gilead—Down but Not Out?” and “Is Gilead Poised for a Comeback?” Gilead’s success is also its Achilles’ heel. The dominant player in the hepatitis C market, its drugs for HCV are so effective they are basically curing the disease. This results in a smaller and smaller patient pool to draw on. And pricing pressures and competitors are chipping away at the company’s dominance in the HCV market, but the biggest erosion is caused by its own success. Its HIV and Hepatitis B (HBV) products are strong, but whenever Gilead execs make presentations, there’s usually one big question that investors have: Will the company finally buy something meaningful? Gilead execs will participate in a fireside chat on Monday, January 7 at 9:30 A.M. PST.
#5. bluebird bio. Many investors are hoping bluebird bio will dazzle. It’s set up a number of interesting collaborations, including a deal with Gritstone Oncology in August 2018. Analysts expect the company to announce sales of $9.82 million for its current fiscal quarter. Its last quarterly earnings were posted on November 1, 2018. The company focuses on gene therapies for severe genetic diseases and cancer. Its product candidates are Lenti-D, which is in Phase II/III clinical trials for cerebral adrenoleukodystrophy, and LentiGlobin, for the treatment of transfusion-dependent beta-thalassemia and severe sickle cell disease. Company execs are presenting on Tuesday, January 8 at 2:30 P.M. PST. The company, with Celgene, is testing a therapy for multiple myeloma, and both companies have indicated they expect to file an application for the CAR-T treatment in 2020. As a result, late-stage trial data will be released sometime this year.
#6. The Player to be Named Later. There are almost always big surprises that come out of the annual JP Morgan conference—either big deals or surprisingly positive (or negative) pipeline news. One topic likely to be swirling around the conference is related to government proposals regarding drug pricing. Senator Elizabeth Warren (D-MA) recently announced the launch of presidential run shortly after proposing The Affordable Drug Manufacturing Act, which would allow Health and Human Services (HHS) to manufacture or contract out generic drug manufacturing, drug pricing will once again likely be a sizzling political talking point.
And a number of big pharma companies raised their drug prices this week. Allergan increased more than two dozen drugs by almost 10 percent. Many of the drug prices were “relatively modest,” according to FOX Business, but some were “particularly high, including on some generics.”
Senator Ron Wyden (D-Ore.), ranking member of the Senate Finance Committee, proposed a bill, the Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act, which has stalled in the Finance Committee. It would require pharma companies to justify price increases. Wyden has had a long and testy relationship with the drug industry, in particular with Pfizer.
Despite the Democrats taking control of the House, and Senator Chuck Grassley (R-Iowa) taking over leadership of the Senate Finance Committee, the bill may go nowhere. A spokesperson for Sen. Grassley told STAT, “As written, it sounds like it opens the door to price controls. Sen. Grassley opposes federal price controls on prescription drugs, which ultimately limit access for consumers and don’t work in the long-run to keep prices down.”
