Full Press Release Details
Relevant portion of the transcript of the oral presentation by Jazz Pharmaceuticals plc at the J.P. Morgan Healthcare Conference in San Francisco,
California on January 9, 2017:
Bruce Cozadd, Chairman & CEO, Jazz Pharmaceuticals plc
2016 was a very busy and productive year for Jazz Pharmaceuticals. On the commercial side, we had strong, double-digit top line growth, driven by volume growth
in Xyrem and Defitelio.
I will make forward-looking statements today. Of course, actual results could differ and are subject to risks and uncertainties that we detail in our SEC
Guidance that I refer to today was provided on November 8, 2016, and unless I expressly say otherwise, it s as of that date.
With reference to slide 7: We gave guidance for total revenues at approximately $1.5 billion, specifically a range of $1.485 to $1.53 billion. And I can
tell you, based on our preliminary analysis, we expect to meet guidance for total revenues. I ll also say at this time we do expect to meet guidance for each of our key products Xyrem, Erwinaze and Defitelio. This revenue growth
represents double-digit growth and, as I said earlier, reflects good volume growth on Xyrem and Defitelio, in particular.
With reference to slide 11: Starting with
Xyrem 2016 represented our first year with over a billion dollars in sales. As I said earlier, we do expect to meet our prior guidance here. Shown in the blue bar, volume growth for the full year was 6%. And for those of you that followed us
over the year, we had first half over first half growth in volume of 4%, so we were very pleased to see the second half come in at a strong 7% volume growth.
With reference to slide 12: Erwinaze growth has
been limited by supply challenges during 2016.
With reference to slide 13: Defitelio had a big year with our U.S. launch in April of 2016. You can see here growth north of 50% in revenues for the
J.P. Morgan Healthcare Conference
Bruce Cozadd | Chairman and CEO January 9, 2017
Forward-Looking Statements
Harbor Statement Under the Private Securities Litigation Reform Act of 1995
This slide deck and the
accompanying oral presentation contain forward-looking statements, including, but not limited to, statements related to Jazz Pharmaceuticals growth strategies and initiatives; corporate development efforts; expected financial and operating
results, including 2016 financial guidance; future product sales and volume; ongoing and future clinical trials and other product development activities, including expected regulatory submissions and other events; expected U.S. commercial launch of
Vyxeos ; 2017 goals (financial and otherwise); the timing of such events and activities; and other statements that are not historical facts. These forward-looking statements are based on the company s current plans, objectives, estimates,
expectations and intentions and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks and uncertainties associated with maintaining or increasing sales of and revenue from Xyrem (sodium oxybate) oral solution, such as the potential introduction of generic competition or
other competitive products, regulatory restrictions and requirements applicable to Xyrem and ongoing patent litigation and related proceedings; effectively commercializing the company s other products and product candidates; the inherent
uncertainty associated with the regulatory approval process; protecting and enhancing the company s intellectual property rights; delays or problems in the supply or manufacture of the company s products and product candidates; complying
with applicable U.S. and non-U.S. regulatory requirements; obtaining and maintaining appropriate pricing and reimbursement for the company s products; the difficulty and uncertainty of pharmaceutical
product development and the uncertainty of clinical success; identifying and acquiring, in-licensing or developing additional products or product candidates, financing these transactions and successfully
integrating acquired businesses; potential restrictions on the company s ability and flexibility to pursue future strategic opportunities as a result of its substantial outstanding debt obligations; the ability to achieve expected future
financial performance and results; and other risks and uncertainties, including those described from time to time under the caption Risk Factors and elsewhere in Jazz Pharmaceuticals plc s Securities and Exchange Commission filings
and reports (Commission File No. 001-33500), including the company s most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2016
and future filings and reports by the company. Other risks and uncertainties of which the company is not currently aware may also affect the company s forward-looking statements and may cause actual results and timing of events to differ
materially from those anticipated. The forward-looking statements made in this slide deck and the accompanying oral presentation are made only as of January 9, 2017 or as of the dates indicated in the forward-looking statements, even if they
are subsequently made available by the company on its website or otherwise. The company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its
expectations or other circumstances that exist after the date as of which the forward-looking statements were made.
Strong Revenue Growth
TOTAL REVENUES1Expect to
1 2014 2015 audited. Total revenues include net product sales, royalties and contract revenues. 2
G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 8, 2016. The company currently expects that, for the year ended December 31, 2016, reported total revenues will meet the guidance range
provided on November 8, 2016. Jazz Pharmaceuticals plc has not finalized its financial results for the year ended December 31, 2016 and actual results may differ.
Continued Strong Sales
NET PRODUCT SALES1Expect to
In millionsmeet guidance
$1,250 $1,100 $1 ,1252
$1,000 $955FDA-approved
$779 for the treatment
$750 of cataplexy and
$500 EDS in patients
1 2014 and 2015 audited. 2 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 8, 2016.
The company currently expects that, for the year ended December 31, 2016, reported Xyrem net product sales will meet the guidance range provided on November 8, 2016. Jazz Pharmaceuticals plc has not finalized its financial results for the
year ended December 31, 2016 and actual results may differ.
FDA = U.S. Food and Drug Administration, EDS
= Excessive Daytime Sleepiness
Focus on Building Inventory
NET PRODUCT SALES1 Indicated as a
$300 In millions Expect tocomponent of a
meet guidancemulti-agent
$200 regimen for the
treatment of patients
$150 with ALL who have
1 2014 and 2015 audited. 2 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 8, 2016. The company currently expects that, for the year ended
December 31, 2016, reported Erwinaze/Erwinase net product sales will meet the guidance range provided on November 8, 2016. Jazz Pharmaceuticals plc has not finalized its financial results for the year ended December 31, 2016 and
actual results may differ.
ALL = Acute Lymphoblastic Leukemia
2016 U.S. Launch Contributing to Growth
EU: Indicated for the
NET PRODUCT SALES1 Expect to VOD in patients
$150 In millions meet guidanceover one month of
$125 $105 $120 2HSCT therapy
$71 $71 U.S.: Indicated for
the treatment of adult
$50 and pediatric patients
with VOD with renal or
$25 pulmonary dysfunction
2015 audited. 2 G=Guidance. Guidance provided by Jazz Pharmaceuticals plc on and as of November 8, 2016. The company currently expects that, for the year ended December 31, 2016, reported Defitelio/defibrotide net product sales will meet
the guidance range provided on November 8, 2016. Jazz Pharmaceuticals plc has not finalized its financial results for the year ended December 31, 2016 and actual results may differ.
EU = European Union, VOD = Hepatic Veno-occlusive Disease, HSCT = Hematopoietic Stem Cell