NOVN held an investor call to review the ASCLEPIOS data on ofatumumab that was presented on Friday at ECTRIMS (multiple sclerosis). The company continued to build the case for investors why a self-administered, monthly, home-based delivery of a highly-efficacious b-cell depleting therapy will resonate well with the market place. Most questions from analysts centered on comparing ofa to ROGs highly-successful Ocrevus, which requires in-office infusion every 6-mo. Its arguments are sound, and while not “high science” per se – i.e. coming to market as a second entrant into the anti-CD20 class with a clinical data package that more or less looks the same – there is a reasonable value proposition with self-administration meaning ofatumumab is likely to find a home. Further, Novartis knows the MS market well by virtue of selling Gilenya and newer oral therapy Mayzent.
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ROG is holding an R&D day today that we are attending. It consists of two parts – the first are various sessions with all attendees, the second is select break-out sessions. This write-up summarizes the first part. On balance, have been no major new disclosures that are meaningful, either positive or negative. ROG talked about strides it is making in R&D productivity, gave assurances that it can manage the upcoming biosimilar erosion through the launch of innovative therapies, showcased recent drug approval successes both in- and outside of oncology (Ocrevus, Hemlibra, Polivy, Rozlytrek, Tecentriq line extension, and others), and generally had one slide per product for a host of pipeline candidates across various disease areas.
This report covers the bull/bear case, current controversies, relative growth prospects and more for our 10 US & EU global pharmaceutical companies.
Investor expectations on LOXO-292 are high at baseline, and today’s results (9/9/19) did not disappoint. The continue to show great activity in the very small percentage of lung cancer patients who have RET alterations. There is investor interest in how LLY’s drug will compare to Blueprint Medicine’s BLU-667 – LLY painted a picture of confidence. We and consensus model sales of ‘292 surpassing $1B by 2026. ‘292 is a nice asset to have, but it is more peripheral to the story relative to other drivers of LLY’s future growth, such as Trulicity.
Pfizer top-lined that a phase 2 proof of concept trial with its “Prevnar 20v” (an upgraded version of its on-market Prevnar-13v that adds coverage for 7 more strains into the mix) was positive. This disclosure occurred on a timeline previously given by the company (i.e. sometime in Q3).
Today (9/1/19) at the ESC Congress in Paris, AZN presented details on DAPA-HF examining Farxiga added to standard of care in patients with reduced ejection heart failure (HFrEF) for the reduction of CV death or worsening of heart failure. The study was in patients both with and without diabetes – the latter segment is what is incrementally new here, and results did not disappoint.
It’s been a while since BMY has had any good news but the price it is getting from AMGN for the FTC-mandated divestiture of CELG’s Otezla certainly qualifies. When it was first announced on June 24 that BMY/CELG would have to divest Otezla to satisfy FTC concerns, the company gently thumbed down our suggestion of perhaps 5x sales as a selling price. The $13.4B it is receiving from Amgen in fact ends up being ~7.1x 2019E sales. This is a taxable amount probably on the order of 20%.
On December 6th 2018, we published a report claiming MRK’s Gardasil was likely substantially under-modeled by analysts. Stemming from our analysis, we gapped up our Gardasil revenue estimates meaningfully, going from $5B to $7B in 2025 (and continuing to grow to $8.2B by 2028). This compared to consensus of ~$4B in 2025. See Global Pharmaceuticals - MRK: Gardasil - A Major, Under-Appreciated Growth Driver: Under-Modeled by Billions of Dollars.
A recap of our quarterly emerging markets report, with a specific focus on China, looking at the potential overhang faced by our coverage heading into 2020 and expansions of the “4+7” program.
We track Emerging Markets growth rates for our covered companies. It has accelerated consistently since mid-2016; in Q2 2019 it was 11.4% y/y. From Q1 2012 to Q2 2019, y/y growth has been: 6.4% →10.3% →9.1% →9.5% →7.4% →6.1% →3.9% →9.5% →6.4% →8.3% →10.9% →8.0% →7.5% →4.7% →3.6% →3.2% →4.4% →1.8% →3.6% →3.3% →5.8% →6.1% →7.4% →7.5% →9.1% →9.5% →11.6% →9.3% →13.3% →11.4% (Exhibit 1).
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