It seems to have gone unnoticed by many investors that at the start of the year, Chinese regulatory authorities approved a 13-valent pneumococcal conjugate vaccine made by a domestic Chinese pharmaceutical company, Walvax Biotech. In essence, this is a look-alike to Pfizer’s Prevnar-13v (but with an expanded indication in age coverage (6 wks to 5y vs. Prevnar’s 6 wks to 15mo). It was not something previously on our radar; we first mentioned this in our recent “Monthly Controversies” report.
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The Q4 2019 earnings season for our ten covered US/EU pharmaceutical companies is about to begin. It starts Tuesday, January 28th with Pfizer and ends Friday, February 14th with Abbvie. This report contains our updated forecasts (newly extended from 2028 to 2030) and perspectives.
Slides reviewing our Jan ’20 “Monthly Controversies” report with a broad perspective of the sector and investment case for the 10 individual US/EU large cap drug stocks under coverage.
Wolfe Research's Senior Pharma analyst, Tim Anderson, hosted a webcast to discuss the Jan-2020 issue of his "Monthly Controversies" report.
This report covers the bull/bear case, current controversies, relative growth prospects and more for our 10 US & EU global pharmaceutical companies.
On Tuesday before the market open, Eli Lilly reported first-time 2020 guidance (and provided other updates such as upcoming pipeline catalysts). As far back as a year ago, LLY had given 2020 operating margin guidance of ~31% – that guidance element remains unchanged. What was new was other P&L line item specifics. Overall, guidance for 2020 came in about as expected and many of the talking points from Q3 EPS were reiterated. For about the last 8mo until more recently, LLY’s share price had been sideways as the stock paused following a nice run in 2018 and into early 2019. Investors have mainly been concerned about competitive dynamics that could impact Trulicity (and the diabetes portfolio more broadly) and Taltz (immunology/inflammation), two of the company’s biggest future growth drivers. Not much new was revealed on these fronts during the guidance call, relative to what was said at Q3.
GSK held a conference call on Tuesday (12/1719) o answer investor questions about belantamab mafodotin (BCMA ADC) and its pivotal DREAMM-2 trial, published yesterday in Lancet Oncology. In our analysis of the drug released ahead of data presentation, we concluded that belantamab was very likely approvable in its initial 4L setting, but unless its signature corneal toxicity was improved meaningfully, it risked being a mid-sized, niche drug. The DREAMM-2 results confirm our reservations as (1) efficacy (PFS) fell relative to prior results to a level that is at best modest compared to other options (not a surprise really, given the patient population studied) and (2) corneal toxicity remains at a high level despite a lower-dose and mitigation measures.
SAN held its much-anticipated investor day on Tuesday (12/10/19) where new CEO, Paul Hudson, along with other newer members of management, outlined future goals for the company. It had been expected that the company (a) would likely announce a broad cost cutting program, (b) might decide to spin out its Consumer Health division, and (c) might provide new guidance on how it is thinking about M&A from here, given the fact that it has given specific target spending ranges in the past. An update on R&D was also obviously expected.
Roche held a conference call on Tuesday (12/10/19) to highlight key hematology presentations from the American Society of Hematology meeting and update investors on its hematology franchise. For those investors who did not attend ASH, it was incrementally helpful as a distillation of the key messages. We are particularly excited by the emerging NHL portfolio (Gazyva, Polivy, mosunetuzumab, CD20-TCB, Tecentriq), and think ROG could re-write treatment standards with these drugs given in the right sequence and combination(s). We continue to wonder whether an early filing on mosunetuzumab is possible, given the stellar data in its first setting of late-line therapy.
AZN held a conference call this morning (12/10/19) to discuss Calquence phase 3 data that was presented on Saturday at the American Society of Hematology (ASH) conference and to update investors on its aspirations in hematology. Company management and one KOL led the discussion, followed by analyst Q&A. Disclosure was incremental, as might be expected given that Calquence is already approved. The corporate purpose appeared to be to highlight its emerging hematology pipeline, but with heavy emphasis on “emerging”. AZN hematology is basically Calquence in CLL. The pipeline programs highlighted are phase 1 compounds, years from the market at best; and Calquence opportunities outside of CLL seem limited to a vaguely articulated opportunity in DLBCL. Not that it matters, really – Calquence, even if solely in CLL, will likely become a “blockbuster,” and be highly accretive to margin expansion. The product should sell $160M in 2019, rising to ~$2B by 2028 per our forecasts.
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