Mylan reports third quarter 2017 results and updates 2017 guidance.

Mylan N.V. announced its financial results for the quarter and nine months ended September 30, 2017.

Third Quarter 2017 Financial Highlights 

• Total revenues of $2.99 billion, down 2 percent compared to the prior year period 
  • North America segment third party net sales of $1.17 billion, down 22 percent; and down approximately 6 percent excluding the decrease in sales of the EpiPen Auto-Injector of $245.1 million
  • Europe segment third party net sales of $1.04 billion, up 24 percent 
  • Rest of World segment third party net sales of $743.3 million, up 9 percent 
• U.S. GAAP diluted earnings per ordinary share (U.S. GAAP EPS) of $0.16, up 170 percent over the prior year period. 
• Adjusted diluted earnings per ordinary share (adjusted EPS) of $1.10 in line with our expectations, down 20 percent over the prior year period. 
• U.S. GAAP net cash provided by operating activities for the nine months ended September 30, 2017 of $1.57 billion, down 8 percent compared to $1.70 billion in the prior year period. 
• Adjusted free cash flow for the nine months ended September 30, 2017 of $1.91 billion, up 13 percent compared to $1.69 billion in the prior year period. 
• Mylan is not providing forward looking guidance for U.S. GAAP reported financial measures or a quantitative reconciliation of forward-looking non-GAAP financial measures.

“Our third quarter results, which included adjusted EPS of $1.10, were especially strong considering the ongoing challenges we experienced in the U.S., including accelerated deceleration of EpiPen sales — both from our launch of an authorized generic as well as the contraction of the overall epinephrine auto-injector market,” Mylan CEO Heather Bresch commented. “Our third quarter results also continue to show the durability of our resilient global platform, where we now believe that approximately 75 percent of our more-than-$2 billion adjusted operating cash flows stems from more predictable, recurring revenues across all markets around the world.

“As impressive, we recently received approval from the U.S. Food and Drug Administration of our Glatiramer Acetate product. Being first to market with the 40-mg strength — as well as offering the 20-mg strength — is a milestone because it underscores our scientific, regulatory and commercialization capabilities for this very complex product; it also paves the path for the many other complex products we have in our pipeline,” Bresch added. “Given that, and the stability of our global platform, we see a strong finish ahead for the year. As a result, we are increasing the low end of our adjusted EPS guidance range, where we now expect to generate between $4.45 and $4.70 per share.

“We also see sustainable momentum globally as we head into the new year, which is why we remain confident in our 2018 target of at least $5.40 in adjusted EPS,” Brech said.
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Financial Summary

 

	Three Months Ended										Nine Months Ended
	September 30,										September 30,
(Unaudited; in millions, except per share amounts)	2017				2016				Percent Change		2017				2016				Percent Change
Total Revenues	$	2,987.1			$	3,057.1			(2)%		$	8,668.8			$	7,809.1			11%
North America (1)	1,172.2				1,505.5				(22)%		3,666.7				4,064.5				(10)%
Europe (1)	1,040.8				841.2				24%		2,887.1				2,026.4				42%
Rest of World (1)	743.3				682.8				9%		2,016.4				1,654.6				22%
Other Revenues	30.8				27.6				12%		98.6				63.6				55%
US GAAP Gross Profit	1,178.1				1,283.3				(8)%		3,488.5				3,362.0				4%
US GAAP Gross Margin	39.4%				42.0%				(6)%		40.2%				43.1%				(7)%
Adjusted Gross Profit (2)	1,572.6				1,735.0				(9)%		4,621.8				4,364.5				6%
Adjusted Gross Margin (2)	52.6%				56.8%				(7)%		53.3%				55.9%				(5)%
US GAAP Net Earnings (Loss)	88.3				(119.8)				174%		451.7				62.5				623%
US GAAP EPS	$	0.16			$	(0.23)			170%		$	0.84			$	0.12			600%
Adjusted Net Earnings (2)	589.7				726.4				(19)%		1,679.5				1,705.1				(2)%
Adjusted EPS (2)	$	1.10			$	1.38			(20)%		$	3.13			$	3.31			(5)%
EBITDA (2)	$	776.9			$	294.7			164%		$	2,339.2			$	1,333.7			75%
Adjusted EBITDA (2)	$	923.8			$	1,060.9			(13)%		$	2,667.2			$	2,466.0			8%

(1)        As previously reported, effective October 1, 2016, we expanded our reportable segments as follows: North America, Europe and Rest of World. As a result, the amounts previously reported under the Specialty segment have been recast to North America and amounts related to Brazil are included in Rest of World for all periods presented. Segment amounts represent third party net sales.

(2)        Non-GAAP financial measures. Please see “Non-GAAP Financial Measures” for additional information.
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“We continue to see the benefits of our geographic, product, channel and pipeline diversification as well as the integration of Mylan,” Mylan President Rajiv Malik said. “We also continue to see the strength of our science, especially as it relates to complex products, and we now believe Mylan is well-positioned to deliver on future opportunities.

“The submission of Insulin Glargine in the U.S., which currently is under active review with FDA; our continued work with FDA on generic Advair; and our progress with several of our biosimilar programs are great opportunities for us to bring additional value to our shareholders as we continue to execute on our promising complex product pipeline,” Malik added.

(Source: Mylan N.V.)