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Mylan (MYL) Announces Multiple Generic Launches in the U.S.
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The final month of 2016 saw several important initiatives being undertaken by generic drug maker, Mylan N.V. .
The company announced quite a few generic launches in the U.S. in December. However, the one that drew the maximum attention was the roll out of the first generic version of its life-saving allergy treatment, EpiPen auto-injector, at more than 50% discount on the branded product’s price. The company launched the authorized generic version in the second half of the month.
Mylan has been under immense pressure ever since it came under the spotlight for the massive price hike of EpiPen. The huge increase in the cost of the drug drew flak from lawmakers, consumers and the common people alike. The pricing controversy even led to a congressional hearing and was severely criticised by former U.S. presidential candidate, Hillary Clinton.
We note that the introduction of the authorized generic was one of several initiatives announced by the company in its efforts to counter negative publicity related to the price hike issue, which also included changes in EpiPen access programs like raising the savings card program from $100 to $300, and doubling the eligibility of the patient assistance programs.
Despite these challenges, shares of the company have outperformed the Zacks categorized Medical-Generic Drugs industry year to date. In fact, the company has lost 30.9% year to date, while the industry witnessed a decline of 37%.
Mylan launched quite a few generics this week, including the launch of its generic version of Johnson & Johnson (JNJ - Free Report) Janssen Pharmaceuticals, Inc.’s Concerta tablets (methylphenidate hydrochloride extended-release; 18 mg, 27 mg, 36 mg and 54 mg). Concerta is approved for the treatment of attention deficit hyperactivity disorder. As per IMS Health data, Concerta generated annual sales of approximately $1.59 billion in the U.S. as of Oct 31, 2016.
The company also announced the launch of its generic version of Pfizer Inc.’s (PFE - Free Report) Cerebyx injection (fosphenytoin sodium). Cerebyx is approved for the treatment of certain types of severe seizures. As per IMS Health data, Cerebyx generated annual sales of approximately $36.3 million in the U.S. as of Oct 31, 2016.
In addition, Mylan announced the launch of its generic version of Zovia 1/50E-28 tablets (ethynodiol diacetate and ethinyl estradiol; 1 mg/0.05 mg). It is approved for use by women to prevent pregnancy.
We believe these generic launches should boost Mylan’s Generics segment, which recorded sales of $6.7 billion in the first nine months of 2016, reflecting a year-over-year increase of 12%.
Currently, Mylan has more than 240 abbreviated new drug application (ANDAs) pending FDA approval, representing approximately $95.6 billion in annual brand sale. Mylan believes that of these pending ANDAs around 41 are first-to-file opportunities, representing annual branded U.S. sales of $32.5 billion.
Adamas’ loss estimates narrowed from $3.16 to $3.11 for 2016 and from $3.02 to $2.90 for 2017 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 9.02%. Its share price has surged almost 28% year to date.
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Mylan (MYL) Announces Multiple Generic Launches in the U.S.
The final month of 2016 saw several important initiatives being undertaken by generic drug maker, Mylan N.V. .
The company announced quite a few generic launches in the U.S. in December. However, the one that drew the maximum attention was the roll out of the first generic version of its life-saving allergy treatment, EpiPen auto-injector, at more than 50% discount on the branded product’s price. The company launched the authorized generic version in the second half of the month.
Mylan has been under immense pressure ever since it came under the spotlight for the massive price hike of EpiPen. The huge increase in the cost of the drug drew flak from lawmakers, consumers and the common people alike. The pricing controversy even led to a congressional hearing and was severely criticised by former U.S. presidential candidate, Hillary Clinton.
We note that the introduction of the authorized generic was one of several initiatives announced by the company in its efforts to counter negative publicity related to the price hike issue, which also included changes in EpiPen access programs like raising the savings card program from $100 to $300, and doubling the eligibility of the patient assistance programs.
Despite these challenges, shares of the company have outperformed the Zacks categorized Medical-Generic Drugs industry year to date. In fact, the company has lost 30.9% year to date, while the industry witnessed a decline of 37%.
Mylan launched quite a few generics this week, including the launch of its generic version of Johnson & Johnson (JNJ - Free Report) Janssen Pharmaceuticals, Inc.’s Concerta tablets (methylphenidate hydrochloride extended-release; 18 mg, 27 mg, 36 mg and 54 mg). Concerta is approved for the treatment of attention deficit hyperactivity disorder. As per IMS Health data, Concerta generated annual sales of approximately $1.59 billion in the U.S. as of Oct 31, 2016.
The company also announced the launch of its generic version of Pfizer Inc.’s (PFE - Free Report) Cerebyx injection (fosphenytoin sodium). Cerebyx is approved for the treatment of certain types of severe seizures. As per IMS Health data, Cerebyx generated annual sales of approximately $36.3 million in the U.S. as of Oct 31, 2016.
In addition, Mylan announced the launch of its generic version of Zovia 1/50E-28 tablets (ethynodiol diacetate and ethinyl estradiol; 1 mg/0.05 mg). It is approved for use by women to prevent pregnancy.
We believe these generic launches should boost Mylan’s Generics segment, which recorded sales of $6.7 billion in the first nine months of 2016, reflecting a year-over-year increase of 12%.
Currently, Mylan has more than 240 abbreviated new drug application (ANDAs) pending FDA approval, representing approximately $95.6 billion in annual brand sale. Mylan believes that of these pending ANDAs around 41 are first-to-file opportunities, representing annual branded U.S. sales of $32.5 billion.
MYLAN NV Price and Consensus
MYLAN NV Price and Consensus | MYLAN NV Quote
Mylan currently carries a Zacks Rank #3 (Hold).
A Key Pick
Adamas Pharmaceuticals, Inc. is a better-ranked stock in the industry. The company carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.
Adamas’ loss estimates narrowed from $3.16 to $3.11 for 2016 and from $3.02 to $2.90 for 2017 over the last 60 days. The company posted a positive surprise in three of the four trailing quarters with an average beat of 9.02%. Its share price has surged almost 28% year to date.
Now See Our Private Investment Ideas
While the above ideas are being shared with the public, other trades are hidden from everyone but selected members. Would you like to peek behind the curtain and view them? Starting today, for the next month, you can follow all Zacks' private buys and sells in real time from value to momentum . . . from stocks under $10 to ETF and option moves . . . from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors. Click here for Zacks' secret trades >>