We track Emerging Markets growth rates for our covered companies. It has accelerated consistently since mid-2016; in Q3 2018 it was 11.6% y/y. From Q1 2012 to Q3 2018, y/y growth has been: 6.4% (10.3% (9.1% (9.5% (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% (Exhibit 1).
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On Monday (01/07/19) AZN announced that its R&D organization will be restructured. Included was also news that Dr. Jose Baselga, a well-known oncologist from the academic world, will be joining the company in a leadership role.
This report covers the bull/bear case, current controversies, relative growth prospects and more for our 10 US & EU global pharmaceutical companies.
The Medicare coverage gap, aka “donut hole”, has been a component of the Medicare Part D program since it was established in 2003. The presumed intent of the donut hole was to increase patients’ financial responsibility during some part of their care, with the hope that they would help contribute to making rational drug choice decisions. However, the enactment of the Patient Protection and Affordable Care Act (the “ACA”) in 2010 has sought to undo this – it encompassed legislation to lower beneficiaries’ financial exposure, with the goal of eliminating it completely by 2020.
We recently wrote a brief investor update on the investment case for BMY (BMY: Summarizing the Investment Case). In it, we said that it is time to move on from the idea that Opdivo+Yervoy in lung cancer is going to work. This is because the totality of the evidence thus far (from both BMY and AZN) has been that anti-CTLA4 therapies just don’t seem to do much in this particular tumor type. A bearish view on CTLA4 is not a thesis change for us, but for many of the former “bulls” on the stock it has been, and it is one of the reasons BMY shares have struggled.
On November 19th, we published a report (Global Pharmaceuticals - Removal of "Protected Drug Class" Status Coming?) claiming that the Administration may seek to change language related to the six “protected drug classes” in the near-term. Proposed changes have just been released (along with other proposals aimed at helping to manage healthcare spending; not addressed in this report). These proposals are not finalized, meaning it is not clear what ultimately survives the comment period that comes next; implementation would likely begin in 2020.
Presently, six classes of drugs are protected from aggressive formulary management in Medicare Part D plans. This “protected drug class” policy came into effect in 2003 when Medicare Part D was first established.
AstraZeneca (AZN) reported 3Q18 financial results on Thursday (11/08/18), before the open. The company was in-line on revenues and on EPS, relative to consensus, but was lower versus our estimates. FY2018 guidance was maintained.
AstraZeneca reported 3Q18 financial results this morning (11/08/18). This report summarizes key takeaways from the conference call that go above and beyond information provided in the press release.
AZN reported in-line 3Q18 revenues of $5.34B vs. consensus of $5.28B and our estimate of $5.37B. 3Q18 EPS of $0.71 was also in-line with consensus of $0.70 but lower than our estimate of $0.86. Externalization revenues of $74M were lower than consensus of $151M but higher than our $0. Tagrisso sales of $506M beat consensus of $478M and our $494M – this is a critical growth driver and will likely ultimately become AZN’s biggest product.
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