发布时间:2024-09-29 12:24:43 来源:bus from blacksburg to richmond 作者:Focus
AstraZeneca plc
AZN announced that its lung cancer drug,candy cane mahjongg Tagrisso has received full approval from the FDA.
We remind investors that Tagrisso had earlier received accelerated approval in 2015. The approval of the drug will help it to become a standard for the treatment of EGFR T790M mutation-positive, locally-advanced or metastatic non-small cell lung cancer (NSCLC) in adults, whose disease had progressed following first-line EGFR tyrosine kinase inhibitor (TKI) therapy.
Tagrisso, a third generation, irreversible EGFR inhibitor, is now available in more than 45 countries across the globe including the U.S., EU, Japan and China. Tagrisso is now the only approved drug available in the U.S. for NSCLC patients with EGFR T790 mutation.
Shares of AstraZeneca have risen 14% since the beginning of this year, outperforming the Zacks classified Large Cap Pharmaceuticals industry, which increased 6% in the same period.
Full approval of the drug is based on positive data from the phase III study AURA3 trial
Data from the study demonstrated statistically-significant improvement in progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The data showed that treatment with Tagrisso reduced risk of disease progression by 70% and improved median progression-free survival (PFS) by 10.1 months compared to of 4.4 months in patients treated with platinum-based doublet chemotherapy.
The trial results were presented at the 17th World Conference on Lung Cancer.
The drug is designed to stop the mutation in virus and prevent it from becoming treatment resistant. Patients are treated with Tagrisso only if they are diagnosed with EGFR T790M mutation in the tumor. Meanwhile, Tagrisso is also being investigated for the treatment of adjuvant and metatstatic first line settings patients, with and without brain metastases. It is also being tested for the treatment of leptomeningeal disease and as combination therapies.
According to the data presented in the press release, lung cancer is a major cause of deaths due to cancer in both men and women. As per the numbers, 15-20% of the patients in the U.S. and Europe with NSCLC are diagnosed with EGFR mutation and approximately two-thirds of these patients develop T790 mutation after initial EGFR TKI therapy.
We are encouraged by the full approval of Tagrisso in the U.S. Uptake of the drug among patients worldwide is increasing steadily. Tagrisso earned revenues of $423 million worldwide in 2016. In the fourth quarter of 2016, the drug recorded sales of $147 million, increasing 10.5% sequentially.
Story continues
We remind investors that Roche Holding AG RHHBY had developed a diagnostic test to identify NSCLC patients with a T790M mutation and are eligible for treatment with Tagrisso. The test was approved by the FDA in Nov 2015.
Zacks Rank & Picks
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Vertex Pharmaceuticals Incorporated VRTX and Corvus Pharmaceuticals, Inc. CRVS. Corvus sports a Zacks Rank #1 (Strong Buy) while Vertex carries a Zacks Rank #2 (Buy). You can see
the complete list of today’s Zacks #1 Rank stocks here.
Shares of Vertex have risen 48.4% this year so far while earnings estimates for 2017 have gone up by almost 4% in the past 30 days.
Corvus’ loss estimates narrowed from $3.64 to $3.35 for 2017 over the last 60 days. Shares of the company have risen 45.4% since the beginning of this year.
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As shown below, the results in the quarter materially changed the trend in two-year stacked comps for each of the banners, along with a significant acceleration for consolidated comps.
The increase in consolidated comps was the primary driver of an 8% increase in revenues to $6.3 billion. The company ended the quarter with 15,370 locations, up less than 1% year-over-year. This reflects a 7% increase in Dollar Tree units, offset by a 4% decline in Family Dollar units.
The top-line results at each banner flowed through to their respective income statements, with Dollar Tree gross margins and operating margins declining year-over-year while Family Dollar gross margins and operating margins expanded year-over-year. On a consolidated basis, gross margins contracted by 120 basis points in the quarter to 28.5%, reflective of a shift to lower-margin consumables, tariff costs and the impact of markdowns from the Easter headwinds at the Dollar Tree banner. The company saw slight operating leverage on SG&A from higher comps, with the net result being an 80 basis point contraction in operating margins to 5.8%, with operating income declining 5% to $366 million. This is not adjusted for $73 million of pandemic-related costs, such as PPE supplies.
In the first quarter, the company opened 85 stores (net of closures) and completed 220 Family Dollar renovations to the H2 format. Importantly, comps at renovated Family Dollar stores continue to outpace the chain average by more than 10%. On the call, management indicated that they plan on reducing both the number of new store openings (from 550 to 500) and the number of H2 renovations (from 1,250 to 750) in 2020.
Personally, given the fact that Family Dollar is seeing material benefits to its business from the pandemic with new or lapsed customers coming into its stores, I think the company should try to get more aggressive with its renovation plans, not less. On the other hand, you could argue that renovations cause short-term disruptions and limit their ability to fully capitalize on the business momentum they are currently experiencing.
As a result of fewer new stores and remodels, management now expects 2020 capital expenditures to total $1.0 billion compared to previous guidance of $1.2 billion. In addition, the company has temporarily suspended share repurchases. At quarter's end, the company had $1.8 billion in cash on its balance sheet compared to $4.3 billion in total debt.
Conclusion
In recent years, Dollar Tree has been a tale of two cities. While its namesake banner has generally delivered impressive financial results, Family Dollar has been a persistent underperformer. This quarter, those results flipped, and given what we've seen in the weeks since quarter's end, there's a decent possibility that we will see something similar in the coming months. As the CEO noted, the second quarter is off to a very good start at Family Dollar.
Here's the important question: how useful is that information is in terms of making future predictions about the business? Will recent success at Family Dollar translate into long-term success for the banner? The optimistic take is that new or lapsed customers, especially those visiting the renovated stores, could become recurring business for the banner. The pessimistic take is that they have experienced short-term success out of necessity as people went to any store that was open to try and find essentials like toilet paper and hand sanitizer that were largely out of stock throughout the retail landscape. From that view, many of these customers could abandon the retailer when life returns to normal. As Philbin noted on the conference call, early on [during the pandemic], folks needed us. Will people still shop as much at Family Dollar when it's no longer a necessity?
Personally, I do not place too much weight on the recent results. I will need to see incremental data points that indicate that Family Dollar has truly won sustained business from these new customers. While I still believe that the Dollar Tree banner is a well-positioned retailer with attractive unit returns, I'm not yet willing to say the same thing for Family Dollar. For that reason, along with the recent run-up in the stock price, I plan on staying on the sidelines for now.
Disclosure: None
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