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The company’s performance has been mixed so far, having topped earnings estimates in two and missing in other two of the trailing four quarters. The company reported an average negative earnings surprise of 3.53% over the said time frame.
In the last reported quarter, the company beat earnings estimates by 1.42%. Let’s see how things are shaping up for this announcement.
Mylan’s stock has lost 3.3% in the last six months compared with the industry’s decline of 6.3%.
Factors to Consider This Quarter
Mylan expects revenues of $11.75-$13.25 billion in 2018. The Zacks Consensus Estimate is $12.45 billion. Mylan anticipates adjusted EPS of around $5.20-$5.60 in 2018, while the Zacks Consensus Estimate is pegged at $5.35.
Mylan has one of the largest product portfolios among all generic pharmaceutical companies. After a challenging 2017, things are looking up for Mylan in 2018. The company got a major boost with the FDA’s approval of a generic version of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone 40 mg.
Notably, this is the first generic of Copaxone that has been approved. Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate injection, 40 mg/mL containing a Paragraph IV certification, the company and other first filers may be eligible for 180 days of generic drug exclusivity. The company also received an FDA approval for Ogiviri, a biosimilar version of Herceptin.
Although volatility in the U.S. market is expected to persist in 2018, yet these approvals should position Mylan better in the year ahead and help combat the decline in EpiPen sales. The company has more than 30 submissions planned in 2018. The launch of generic version of Estrace cream is also underway.
Meanwhile, key anticipated approvals include a biosimilar version of Neulasta with a target action date in June 2018. The company expects to launch the biosimilar in the second half assuming approval. The EMA has also accepted applications for both the biosimilars.
Mylan and partner Momenta will initiate a patient clinical trial of M710 — a proposed biosimilar of ophthalmology drug Eylea — in the first half of 2018. The trial will be a randomized, double-blind, active-control, multi-center study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with the reference drug.
The company is also looking forward for a tentative approval of generic Restatis with a target action date in July 2018.
However, sales from EpiPen continue to decline due to increased competition and the impact of the launch of the authorized generic. Sales are expected to decline further as with mounting competition.
During the earnings call, we expect investors to focus on the performance of EpiPen, newly launched drugs and the progress of the company’s biosimilars pipeline.
Earnings Whispers
Our proven model doesn’t show that Mylan is likely to beat estimates this quarter. This is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) to be able to beat on earnings. That is not the case here as you will see below.
Zacks ESP: The Earnings ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is -0.45%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Mylan currently carries a Zacks Rank #3. While the rank is favorable, the company’s negative ESP makes surprise prediction difficult. Note that we caution against Sell-rated stocks (#4 or 5) should never be considered going into an earnings announcement, especially when the company is seeing negative estimate revisions.
Stock to Consider
Here is a pharma company that you may consider, as our model shows that it has the right combination of elements to deliver an earnings beat this quarter.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Image: Bigstock
Mylan (MYL) to Report Q1 Earnings: What's in the Offing?
Mylan N.V. is scheduled to report first-quarter 2018 results on May 9, before the market opens.
Mylan N.V. Price, Consensus and EPS Surprise
Mylan N.V. Price, Consensus and EPS Surprise | Mylan N.V. Quote
The company’s performance has been mixed so far, having topped earnings estimates in two and missing in other two of the trailing four quarters. The company reported an average negative earnings surprise of 3.53% over the said time frame.
In the last reported quarter, the company beat earnings estimates by 1.42%. Let’s see how things are shaping up for this announcement.
Mylan’s stock has lost 3.3% in the last six months compared with the industry’s decline of 6.3%.
Factors to Consider This Quarter
Mylan expects revenues of $11.75-$13.25 billion in 2018. The Zacks Consensus Estimate is $12.45 billion. Mylan anticipates adjusted EPS of around $5.20-$5.60 in 2018, while the Zacks Consensus Estimate is pegged at $5.35.
Mylan has one of the largest product portfolios among all generic pharmaceutical companies. After a challenging 2017, things are looking up for Mylan in 2018. The company got a major boost with the FDA’s approval of a generic version of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone 40 mg.
Notably, this is the first generic of Copaxone that has been approved. Since Mylan was one of the first applicants to submit a substantially complete ANDA for glatiramer acetate injection, 40 mg/mL containing a Paragraph IV certification, the company and other first filers may be eligible for 180 days of generic drug exclusivity. The company also received an FDA approval for Ogiviri, a biosimilar version of Herceptin.
Although volatility in the U.S. market is expected to persist in 2018, yet these approvals should position Mylan better in the year ahead and help combat the decline in EpiPen sales. The company has more than 30 submissions planned in 2018. The launch of generic version of Estrace cream is also underway.
Meanwhile, key anticipated approvals include a biosimilar version of Neulasta with a target action date in June 2018. The company expects to launch the biosimilar in the second half assuming approval. The EMA has also accepted applications for both the biosimilars.
Mylan and partner Momenta will initiate a patient clinical trial of M710 — a proposed biosimilar of ophthalmology drug Eylea — in the first half of 2018. The trial will be a randomized, double-blind, active-control, multi-center study in patients with diabetic macular edema to compare the safety, efficacy and immunogenicity of M710 with the reference drug.
The company is also looking forward for a tentative approval of generic Restatis with a target action date in July 2018.
However, sales from EpiPen continue to decline due to increased competition and the impact of the launch of the authorized generic. Sales are expected to decline further as with mounting competition.
During the earnings call, we expect investors to focus on the performance of EpiPen, newly launched drugs and the progress of the company’s biosimilars pipeline.
Earnings Whispers
Our proven model doesn’t show that Mylan is likely to beat estimates this quarter. This is because a stock needs to have both a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) to be able to beat on earnings. That is not the case here as you will see below.
Zacks ESP: The Earnings ESP, which represents the difference between the Most Accurate estimate and the Zacks Consensus Estimate, is -0.45%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.
Zacks Rank: Mylan currently carries a Zacks Rank #3. While the rank is favorable, the company’s negative ESP makes surprise prediction difficult. Note that we caution against Sell-rated stocks (#4 or 5) should never be considered going into an earnings announcement, especially when the company is seeing negative estimate revisions.
Stock to Consider
Here is a pharma company that you may consider, as our model shows that it has the right combination of elements to deliver an earnings beat this quarter.
GW Pharmaceuticals plc is expected to report quarterly results on May 8. The company has an Earnings ESP of +8.11% and a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2020.
Click here for the 6 trades >>