Later today, the U.S. Centers for Disease Control and Prevention will brief the media on the coronavirus outbreak in China that has stricken 291 people and killed six, mostly in the city of Wuhan in Hubei province.
Tuesday, January 21, 2020
Stocks drop after report of U.S. coronavirus case
Stocks take a leg down after CNN reports that the U.S. Centers for Disease Control and Prevention is expected to announce the first case of Wuhan coronavirus in the U.S., in Washington state.
The Nasdaq, S&P 500 and Dow each slip 0.2%. At midday, the three major U.S. stock averages had nearly erased their declines in the morning.
The 10-year Treasury increases its gain, pushing yield down 5 basis points to 1.772%.
CNN attributes the news to a federal sources outside to the CDC who was made aware of a CDC media briefing slated for later today.
The virus, which was first identified in Wuan, China, last month, has so far infected more than 300 people and killed six in an outbreak reported in five countries.
5 biopharmas to watch as the decade’s last earnings kick off
January is always a busy time for biopharma. With the latest J.P. Morgan Healthcare Conference now in the books, companies are shifting gears to report full-year results. Johnson & Johnson will, in typical fashion, lead the pack with its earnings presentation set for Wednesday.
Beyond the sales beats and misses, there’s much uncertainty hanging over the sector. Election years typically make pharmaceutical companies even more sensitive to topics such as new regulations or pricing reform. And while J.P. Morgan usually sets the tone for the months ahead, this most recent iteration didn’t have as clear a narrative as in year’s past.
Still, it’s likely that one of investor’s favorite topics, dealmaking, will be a focal point on several calls. Analysts see an impetus for big biotechs such as Biogen and Gilead to use their cash reserves on M&A. Eli Lilly, meanwhile, recently signaled a desire to do at least three more deals this year.
Smaller companies such as Bluebird Bio and Global Blood Therapeutics shouldn’t have deal expectations, but instead will face questions about the launch strategies for their own products.
Below, BioPharma Dive looks at five upcoming earnings calls that could offer notable updates.
Novartis’ next wave of new drugs
The Swiss pharma won approvals for five new drugs in 2020, adding to its business therapies for spinal muscular atrophy, multiple sclerosis, breast cancer, macular degeneration and sickle cell disease.
Regulatory successes like those support company CEO Vas Narasimhan’s ongoing efforts to shift Novartis from a sprawling conglomerate spanning consumer health and eye care to a more narrowly focused drugs business.
So far, that transition has been made easier by the blockbuster performance of Cosentyx and Entresto, two drugs that combined earned Novartis nearly $4 billion through the first nine months of 2019.
An earnings call on Jan. 29 will put a spotlight on the drugs Novartis hopes can follow. Sales of Zolgensma, in particular, will be closely watched by investors and analysts as the spinal muscular atrophy treatment is important for both Novartis and the broader gene therapy field.
Despite a price tag of $2.1 million, insurers have reimbursed for Zolgensma for all but one of the 100 or so infants who were eligible and received treatment through the end of last year. Investors will be looking for that to continue, particularly as crosstown rival Roche could soon debut a competing drug in the U.S.
Biogen’s shot at an Alzheimer’s first
In October, Biogen announced it would file an experimental Alzheimer’s disease drug for approval sometime in early 2020. If approved, the drug, called aducanumab, would become the first commercially available treatment for what many researchers believe is the underlying cause of Alzheimer’s, a title that would almost surely lead to billions of dollars in sales.
Biogen appears confident such a scenario will play out, detailing last week at the J.P. Morgan Healthcare Conference that it’s already preparing a launch team for the drug and increasing manufacturing power to be ready for the demand. Investors, however, are likely to further press the Boston-area biotech about its discussions with regulators and whether those are compelling enough to counter what some see as very low chances of the drug’s approval.
More bearish investors and researchers have pointed to the contrasting results seen across two large, identically designed studies of aducanumab. One study found Alzheimer’s patients who were on a high dose of the drug over enough months showed slower cognitive decline compared to patients given placebo. Yet the other found the opposite, with high-dose aducanumab actually performing worse than placebo.
Peter Bach, a researcher and oncologist at Memorial Sloan Kettering, argued in a recent opinion piece for STAT that regulators should reject aducanumab based on these mixed results, particularly because so many other drugs that work like Biogen’s have failed in the clinic. Using one kind of statistical analysis, Bach wrote that the odds of the successful aducanumab trial being a false positive were around 40%.
While the industry watches for a filing and regulator response, Biogen’s also trying to work through challenges to the rest of its business. A patent dispute is current threatening the biotech’s top-selling drug at the same time its blockbuster Spinraza franchise faces new competition from Novartis and, perhaps soon, Roche.
Eli Lilly eyes some buys
Eli Lilly’s chief financial officer told Reuters last week the company anticipates doing a deal worth $1 billion to $5 billion each quarter in 2020. There’s already an example of what these deals may look like too, as Lilly kicked off the year with a $1 billion acquisition of California-based Dermira and its late-stage eczema drug.
Investors, of course, will want more tidbits about the target companies Lilly would be interested in.
Lilly CEO David Ricks seemed to offer a few hints at the J.P. Morgan conference. He noted, for example, how oncology and immunology have especially large numbers of promising assets.
“While we love diabetes and neuroscience, there are just fewer venture-backed ideas in that space,” Ricks said.
Lilly’s certainly able to do more dealmaking, as evidenced by a recent EY report that listed it among the top pharmaceutical companies with the firepower necessary to do big transactions. The Indianapolis pharma ended the third quarter with $1.56 billion in cash and cash equivalents.
Global Blood’s first launch
Up until late last year, doctors in the U.S. had few treatment options for people suffering from sickle cell disease, an inherited blood disorder that affects about 100,000 Americans.
Approvals for Global Blood’s Oxbryta and Novartis’ Adakveo changed that, doubling the number of drugs cleared to treat sickle cell within the span of two weeks.
Earnings calls with executives from Novartis on Jan. 29 and Global Blood sometime thereafter will offer an early gauge of how sickle cell physicians are responding.
The two drugs might not directly compete with each other, as they work differently and target distinct symptoms of the disease. Oxbryta combats the anemia and blood cell destruction that can lead to organ damage, while Adakveo is designed to reduce the debilitating pain crises that are a hallmark of sickle cell.
For Global Blood, however, launching a new therapy at the same time as global pharmaceutical giant Novartis will put its sales strategy under the microscope.
The California biotech is fielding a team of 75 specialists that will target 5,500 healthcare professionals who work most commonly with sickle cell patients.
While Wall Street analysts forecast eventual billion-dollar sales for Oxbryta, expectations are for a modest launch initially. One uncertainty centers on how widely physicians will use the drug, which is approved for adult and pediatric patients older than 12 years of age. That corresponds to some 86,000 patients, but doctors could choose to focus first on the 22,000 with particularly low hemoglobin levels.
Global Blood priced Oxbryta at roughly $10,000 a month. While the company expects rebates and discounts will result in a net price that’s 25% to 30% lower, insurer reactions to the high cost will be another test.
Bluebird’s gene therapy gets off the ground
For the first time, Bluebird should have sales to discuss on its next corporate earnings call, having announced earlier this month the launch in Germany of its gene therapy Zynteglo for beta-thalassemia.
While Bluebird won approval for the drug — its first ever — last June, the biotech delayed a launch to iron out its manufacturing for the one-time treatment.
Sales aren’t likely to be high, particularly as Zynteglo’s use is limited to qualified treatment centers, the first of which is in southwestern city of Heidelberg. But it’s the first commercial test for Bluebird and an early gauge of how its $1.8 million price will be received in the market.
Bluebird plans to submit Zynteglo for approval in the U.S. this year, and could also file its Lenti-D product for cerebral adrenoleukodystrophy. Partner Bristol-Myers Squibb, meanwhile, expects to soon ask the Food and Drug Administration for approval of the Bluebird-developed CAR-T ide-cel.
ImmuCell Announces Prelim, Unaudited Product Sales Results for 2019 Year
ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell” or the “Company”), a growing animal health company that develops, manufactures and markets scientifically-proven and practical products that improve the health and productivity of dairy and beef cattle, today announced preliminary, unaudited product sales results for the year ended December 31, 2019.
Product Sales Results:Total product sales increased by approximately $2,700,000, or 25%, to approximately $13,700,000 during the year ended December 31, 2019 versus the year ended December 31, 2018. Total product sales increased by approximately $695,000, or 24%, to approximately $3,600,000 during the fourth quarter ended December 31, 2019 versus the comparable period during 2018. These reported figures are preliminary, unaudited estimates and are subject to change.
Management Discussion:“We believe that dairy and beef producers are increasingly coming to understand the value proposition we offer of less needles in cows and less antibiotics in calves,” commented Michael F. Brigham, President and CEO. “We are the only veterinary biologic line offering measured levels of antibody-driven immunity against bacterial and viral scours providing Immediate Immunity™ to newborn dairy and beef calves against the three most prevalent pathogens – E. coli, coronavirus and rotavirus.”
“We are growing and investing in the infrastructure to fuel future growth,” Mr. Brigham added. “To meet growing demand, construction of our expanded manufacturing facility for the First Defense® product line is well under way, and we expect to substantially complete this work around the end of the upcoming second quarter.”
“During the third quarter of 2019, the FDA conducted a pre-approval inspection of our Drug Substance facility for Re-Tain™, a novel treatment for subclinical mastitis without a milk discard requirement that provides an alternative to traditional antibiotics. We responded to most of the FDA’s findings before the end of 2019,” Mr. Brigham continued. “We expect to complete the remaining work, which largely involves some outside laboratory testing, during the first quarter of 2020 without significant cost or any delay to the timeline to product approval.”
The Company expects to file a more detailed press release covering its 2019 financial results after the stock market closes on Tuesday, February 18, 2020 and expects to file its Annual Report on Form 10-K before the end of March. Interested parties can access a conference call scheduled by the Company to review the 2019 financial results at 9:00 AM ET on Wednesday, February 19, 2020. Investors are encouraged to review the Company’s updated Corporate Presentation slide deck that provides an overview of the Company’s business and is available under the “Investors” tab of the Company’s website at www.immucell.com or by request to the Company.
H.C. Wainwright Starts CEL-SCI (CVM) at Buy
Analyst Vernon Bernardino initiates coverage on CEL-SCI (NYSE: CVM) with a Buy rating and a price target of $18.00.
The analyst commented, “CEL-SCI is a clinical-stage biotechnology company focused on developing therapies that activate the immune system to fight cancer and infectious diseases. We are bullish on CEL-SCI shares based on: (1) the potential for lead product Multikine, a patented defined mixture of 14 human cytokines, to be the first neoadjuvant cancer drug to improve survival in head and neck (HN) cancer patients by its administration prior to surgery and initiation of conventional treatment; and (2) Independent Data Monitoring Committee (IDMC) recommendation for advancement of the ongoing Phase 3 clinical trial that we believe suggests a favorable outcome in Multikine-treated patients. While IDMC updates generally provide limited insight into the status of an ongoing clinical trial, the Multikine Phase 3 trial was initiated in 2011 and has been ongoing for approximately eight years, with the last patient enrolled in 2016. We believe reviews the IDMC conducted in 2019 point to an overall survival (OS) benefit with Multikine, and thus, we do not look for the next IDMC review, expected in 2Q20, as required for further confirmation. At this point, we believe ethical issues may need to be considering in continuing the Phase 3 trial, and look for CEL-SCI to pursue a discussion with the FDA and EMA for a regulatory decision that results in the Phase 3 trial being unblinded in 2H20. We believe the potential for Multikine to achieve better survival outcomes remains underappreciated. Therefore, we initiate coverage with a Buy rating and $18 price target.”
Supreme Court declined to hear case challenging legality of Obamacare
The Supreme Court will wait for a federal appeals court to decide on the constitutionality of the Affordable Care Act, meaning that a final decision on the law won’t come before the 2020 election.
The court declined on Tuesday to hear a lawsuit from 17 red states that seeks to dismantle the controversial healthcare law. A group of 20 blue states and the District of Columbia who are fighting the lawsuit had asked the Supreme Court to intervene in the case and circumvent a likely lengthy review by an appellate court.
The blue states had wanted the Supreme Court to intervene to end uncertainty in the healthcare industry because of the lawsuit.
America’s Health Insurance Plans, the leading insurance industry lobbying group, wrote an amicus brief supporting the blue states’ efforts.
The group said that the Supreme Court should hear the lawsuit to remove the “overhanging legal uncertainty” surrounding ACA coverage.
The Supreme Court did not give a reason for not taking up the case.
But red states and the Department of Justice, which is supporting the lawsuit, said that it was too early for the court to weigh in.
A three-judge panel of the Fifth Circuit Court of Appeals decided in December that the ACA’s individual mandate was unconstitutional. However, the court declined to decide on whether the rest of the law should go down with the mandate, which the red states’ lawsuit is requesting.
It punted back to Federal Judge Reed O’Connor, who originally ruled the ACA was unconstitutional. The appellate panel wants the judge to decide if the mandate could be severed.
O’Connor has yet to make a ruling on the mandate.
Chi-Med stops pivotal pancreatic cancer trial upon early success
Hutchison China MediTech has stopped a phase 3 trial of surufatinib in pancreatic neuroendocrine tumors early for positive efficacy. An independent data monitoring committee found the trial had hit its primary endpoint by the time of an interim analysis, enabling Chi-Med to stop the study and start work on a filing for approval.
Surufatinib is an oral angio-immuno kinase inhibitor designed to both inhibit the formation of new blood vessels and promote antitumor immune responses, giving it a dual mechanism of action that Chi-Med thinks will make it suitable for use in immunotherapy combinations.
For now though, the focus is on the use of surufatinib as a monotherapy. Surufatinib has cleared the monotherapy tests put in front of it to date, first coming through a phase 3 trial in advanced extrapancreatic neuroendocrine tumors and now showing efficacy in pancreatic neuroendocrine tumors.
The latest trial to read out enrolled close to 200 patients with advanced pancreatic neuroendocrine tumors in China and randomized them to receive surufatinib or placebo once a day for a month. Chi-Med is yet to share data from the trial, but the progression-free survival results were strong enough for the data committee to recommend stopping the study at a pre-planned interim analysis.
Equipped with the phase 3 data, Chi-Med plans to meet with Chinese regulators to discuss filing for approval of surufatinib in patients with pancreatic neuroendocrine tumors. A filing for approval of the drug in non-pancreatic neuroendocrine tumors is already being assessed by China’s National Medical Products Administration, which put it on its priority review pathway late last year.
Chi-Med CEO Christian Hogg thinks the back-to-back clinical successes position surufatinib to carve out a niche in the treatment of neuroendocrine tumors.
“These positive results for pancreatic neuroendocrine tumors reinforce that surufatinib has the unique opportunity to address all advanced neuroendocrine tumors. We believe that no targeted therapies are approved in China or globally for such a broad spectrum of neuroendocrine tumor disease,” Hogg said.
Chi-Med is now building up a sales and marketing team in China ahead of trying to turn surufatinib into a significant commercial product. Plans are less advanced in the U.S., where Chi-Med is testing the drug in proof-of-concept trials.
Subscribe to:
Posts (Atom)