Over the past few weeks, the coronavirus pandemic has hit biotech and pharmaceutical companies hard.
Drugmakers, their hand forced by overwhelmed hospitals, are halting or delaying clinical trials. Development timelines are now at risk of changing, as companies tighten their budgets or redirect resources to priority projects. All of which may slow the progress of experimental medicines for diseases other than COVID-19.
COVID-19's impact will affect more than clinical research, too. This coming month, when drugmakers begin to report quarterly earnings, will begin to shed some light on the potential business impact as well.
Many drugs, especially those that come in pill or tablet form, are dispensed through pharmacies and taken at home. But others, like cancer treatments or injectable medicines, are typically given at a clinic or doctor's office — a routine made suddenly fraught by the risk of coronavirus infection.
This leaves doctors and patients facing difficult decisions about which treatments are essential, and which can wait. For drugmakers, that uncertainty could translate into reduced, or delayed, business. Treatments for cancer, auto-immune conditions, vision loss and aesthetics could be particularly affected.
A cancer care "shakeout"
Ted Okon's voice rises as he describes the stress cancer patients and their community oncology practices — private, physician-owned businesses that treat more than half of the Americans with cancer — are dealing with amid the COVID-19 outbreak.
"It's a very stressful crazy time for, obviously, everybody in the country," says Okon, the executive director of the non-profit Community Oncology Alliance, which advocates for these practices. "But certainly on the cancer front."
Cancer patients have to regularly visit clinics, either for treatment, testing or monitoring.
People with cancer are often older, weaker, and therefore at high risk for serious COVID-19 complications. They may be afraid to come in, delay doing so, or, given social distancing rules, have trouble finding someone to drive them to a clinic, Okon says. That might mean delays in diagnosis, important screenings — like a tumor profiling test — or treatment.
Major cancer centers are being stretched as well. Dana-Farber Cancer Institute, for instance, said in a statement to BioPharma Dive it's still caring for current patients, accepting new ones and providing second opinions.
But it's taking several precautions to protect staff and patients. It's trying to continue clinical research "to the extent possible," but being careful about enrolling new patients into studies and has stopped taking healthy volunteers.
Okon believes there is likely a "shakeout" coming for cancer practices, particularly smaller ones. Such a disruption could mean a slowdown in treatment, although the life-threatening nature of the disease may insulate cancer care from a sharp drop-off in patient visits.
On Wall Street, forecasts are mixed. SVB Leerink put cancer drugs on the list of medicines "protected against demand erosion."
Yet after surveying 135 community-based physicians, many of whom were oncologists, Mizuho Securities analyst Vamil Divan found doctors "from all specialties are expecting a significant reduction in their patient interactions," and that new patient visits are being delayed.
A tough choice to make
Starting patients on new immuno-suppressive drugs or changing their medication in the midst of a global pandemic might make them more vulnerable to SARS-CoV-2 infections. But will patients with arthritis, multiple sclerosis, or other autoimmune conditions, be worse off without those drugs?
It's a tough choice for rheumatologists and their patients to make. A March survey by Piper Sandler found about three quarters of rheumatologists were unlikely to initiate patients on two classes of drugs called anti-TNFs and JAK inhibitors.
These drugs are widely used for many autoimmune diseases, like rheumatoid arthritis, and bring in billions of dollars for top drugmakers. A slowdown could affect first-quarter sales of drugs like AbbVie's Humira and Rinvoq, Amgen's Enbrel, and Eli Lilly and Incyte's Olumiant.
Such a drop could be a foregone conclusion. The American College of Rheumatology and the Multiple Sclerosis International Federation have both put out guidance cautioning against the use of specific medications that suppress the body's immune response.
ACR's guidance is specific to infusion therapies, and suggests that physicians should consider interrupting or temporarily changing treatments. This could affect first-quarter sales of Johnson & Johnson's Remicade, Bristol Myers Squibb's Orencia and Roche's Rituxan.
For self-administered drugs like Humira, the ACR calls for an individualized approach. "In many instances, the risk of disease flares from stopping all immunosuppressive medications may be higher risk than continuing on the prescribed medication regimens," cautioned Kelly Weselman, the chair of the group's coronavirus task force.
The MS Federation's guidance, meanwhile, suggests patients who need to start a new therapy should consider drugs that do not lower levels of disease-fighting white-blood cells, such as interferons, Teva's Copaxone and Biogen's Tysabri.
The group also recommends that patients consider postponing their next dose of Sanofi's Lemtrada, Merck KGaA's Mavenclad, or Roche's Rituxan and Ocrevus.
Vision loss versus infection risk
Drugs that treat a common, creeping form of vision loss known as the "wet" form of age related macular degeneration are big business. The condition affects more than 2 million Americans, according to the National Eye Institute.
Wet AMD patients get periodic, chronic injections of drugs to restore vision and prevent further damage to their eyes. These drugs — Regeneron's Eylea, Roche's Lucentis and Avastin (given off-label), Novartis' Beovu, approved late last year — generate more than $7 billion yearly worldwide. Medicare spent about $3.7 billion on Eylea and Lucentis alone in 2018. Retinal specialists administer them in clinics and hospitals.
The coronavirus outbreak poses a unique threat. As its name suggests, wet AMD is particularly common in the elderly, who are more susceptible to serious complications from COVID-19.
While wet AMD injections are medically necessary, getting them poses an infection risk. Many eye care practices across the country are shutting down routine care, closing doors, or referring patients elsewhere. Yet missing a wet AMD injection could lead to vision loss.
James Handa, an ophthalmology professor at Johns Hopkins Medicine's Wilmer Eye Institute, says some patients are "petrified of coming in," while others are relieved they can still get treated.
He and his team have been taking extreme precautions to protect patients and staff.
They're screening patients for COVID-19 symptoms and cutting down the number of tests they conduct. They're postponing non-urgent appointments, and rescheduling injections for patients who might be able to get by without them. As a result, Wilmer Eye is seeing 30 to 40 patients a day now, down from about 150, though Handa says a "vast majority" of appointments are for wet AMD injections.
Many of our patients are one-eyed and they depend on [injections] to function, to drive, to do the tasks to get through the day," he says. So thus far, "there really hasn't been much of a fall-off of injections."
Bernstein analysts, after polling experts, believe there will be a 10% to 20% decline in injections over the next few months, though it's an "open question" as to what will happen if social distancing measures extend for months.
Patient monitoring requirements, such as those required for Novartis' Beovu, can also present a hurdle. Bernstein analysts noted recently that "adoption of Beovu has essentially stopped."
A reckoning for aesthetics
As states tell people to stay home, and specialists close up their practices, demand could dry up for medical aesthetics, used to change one's appearance.
Social distancing efforts have triggered a sharp economic downturn, which for an area of medicine reliant on out-of-pocket payments means fewer patients with the discretionary income to cover procedures.
A survey of dermatologists and plastic surgeons, conducted by investment bank Stifel in mid-March, found the share of physicians maintaining usual office practices dropped from 73% to 21%.
One-third had closed offices after the U.S. declared a national emergency on Mar. 13. Doctors responding to the survey after the declaration said 44% of their bookings over the next two months had been postponed or canceled.
The effect will be felt most by Allergan, Revance and Evolus, Stifel analyst Annabel Samimy wrote. Already, Revance has delayed the launch of its dermal filler product because of the pandemic.
A business shortfall in aesthetics may pose immediate problems for AbbVie, which is in the process of closing its $63 billion acquisition of Allergan. Stanicky writes that Allergan's Botox-led aesthetics business would represent about 9% of the combined company's revenue, which may be under pressure in the short term.