throbber
Third Quarter 2015
`Earnings Conference Call
`
`November 9, 2015
`
`Page 1 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Forward-Looking Statements
`
`This press release contains forward-looking statements, including statements regarding expectations as to future results, including anticipated net product sales,
`operating expenses, and cash flow; expectations with respect to the impact of PCSK9 inhibitors on the JUXTAPID business; the growth of our business; expectations with
`respect to named patient sales outside the U.S and our plans for clinical development, regulatory filings, potential label expansion and pipeline expansion opportunities;
`expectations with respect to business development opportunities; expectations with respect to the outcome of ongoing investigations; and expectations with respect to the
`status of our existing long-term debt arrangement. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a
`variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-
`looking statements. In particular, the risks and uncertainties include, among others: the risk that market acceptance of JUXTAPID and MYALEPT in the U.S. may not
`continue at the levels we expect, and may be lower outside the U.S. than we expect; the risk that the conversion of prescriptions for JUXTAPID or MYALEPT into patients
`on therapy may be lower than we expect or the drop-out rate may be higher than we expect; the risk that the prevalence of the diseases our products treat may be lower
`than our estimates, and that it may be more difficult to identify patients than we expect; the risk that the side effect profile or other results for our products in commercial
`use and in further clinical studies are inconsistent, in scope and severity, with the side effect profile and other results observed in the pivotal study of each drug; the risk
`that the negative impact of launch of PCSK9 inhibitors on JUXTAPID sales will be greater than we expect, particularly in the U.S. where the negative impact has been
`greater than we expected to date, or that other competitive products will negatively impact our results; the risk that private or government payers may refuse to reimburse
`our product, or may impose onerous restrictions that hinder reimbursement or significantly limit or cap the price we charge or the number of reimbursed patients who
`receive our products; the risk that our business may be negatively impacted if there are more Medicaid patients prescribed MYALEPT than we expect; the risk that named
`patient sales in Brazil and other key countries outside the U.S. may not be at the levels we expect; the risk that regulatory authorities in countries where either of our
`products is not yet approved may not be satisfied with the efficacy or safety profile of the product; the risk that we do not receive approval for each product in additional
`countries on a timely basis, or at all, or that regulatory authorities impose significant restrictions on approval or require additional development; the risk that exchange
`rates will negatively impact the amount of net product sales recognized; the risk that technical hurdles may delay initiation of future clinical trials; the risk that we will not
`be successful in our label expansion or business development efforts; the risk that our patent portfolio and marketing and data exclusivity may not be as strong as we
`anticipate; the risk of unexpected manufacturing issues affecting future supply; the risk of an enforcement action or settlement with the government, which we expect is a
`probable result of the ongoing DOJ and SEC investigations, and the terms thereof, with respect to ongoing or future investigations and the risks associated with the
`unpredictable nature and timing of government investigations, and the impact of investigations on our business; the risk that we incur more costs than we expect in
`responding to investigations and defending ourselves in litigation and in connection with any settlement entered into in connection with these investigations; the risk that
`Silicon Valley Bank will accelerate our long-term debt as a result of our breach of certain covenants of our agreement with Silicon Valley Bank; the risk that any of the
`foregoing may cause product sales revenue to be lower than we expect, or that we may incur unanticipated expenses in connection with our activities; and the other risks
`inherent in the commercialization, drug development and regulatory approval process.
`
`For additional disclosure regarding these and other risks we face, see the disclosure contained in the "Risk Factors" section of Aegerion's Quarterly Report on Form 10-Q
`filed on November 9, 2015, and our other public filings with the Securities and Exchange Commission, available on the SEC's website at http://www.sec.gov. We
`undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or
`otherwise.
`
`Unless otherwise noted, persons shown throughout this presentation are models used for illustrative purposes and are not patients.
`
`Proprietary & Confidential. © 2015 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`2
`
`Page 2 of 8
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`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Executing on Key Business Objectives
`
`● US COMMERCIAL OPERATIONS: Growing MYALEPT patient base; managing through
`evolving JUXTAPID market dynamics
`
`● EU MARKET ACCESS: Pricing and reimbursement approval for LOJUXTA® in Netherlands
`
`● LIFE CYCLE MANAGEMENT/BUSINESS DEVELOPMENT: Prioritized initiatives through
`strategic plan
`
`Building a Global Orphan Drug Company
`
`Commercial Product Portfolio
`
`Pipeline Portfolio
`
`MYALEPT® indication expansion
`
`JUXTAPID® 2ND generation
`
`Proprietary & Confidential. © 2014 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`3
`
`*subject to closing
`
`Page 3 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`JUXTAPID: U.S. Metrics
`
`Cumulative
`Dropout
`from launch through 10/30/15
`
`Two factors contributing to +9% increase:
`• Switches to PCSK9 inhibitor
`•
`JUXTAPID discontinuation
`
`Compliance
`launch – 10/30/15
`
`• Steady
`
`Conversion
`Rate
`launch – 10/30/15
`
`• Recently trending lower due to longer
`patient onboarding timelines; payer
`tightening; and PCSK9 sampling
`
`Date
`
`% Increase
`
`Rate
`
`10/30/15
`
`7/31/15
`
`4/24/15
`
`12/31/14
`
`9/30/14
`
`+9%
`
`+3%
`
`+5%
`
`+5%
`
`+5%
`
`58%
`
`49%
`
`46%
`
`41%
`
`36%
`
`Cumulative Dropout: Total # of patients who have
`discontinued therapy from date of launch in January
`2013, as a % of all patients who have received at least
`one shipment.
`
`Proprietary & Confidential. © 2014 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`80-90%
`
`52%
`
`4
`
`Page 4 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`MYALEPT: U.S. Metrics
`
`Active Commercial
`GL Patients on
`Therapy
`as of 10/30/15
`
`Cumulative
`Dropout
`mid-2014 – 10/30/15
`
`Compliance
`Launch through 10/30/15
`
`Payor
`Mix
`Year to Date
`
`78
`
`8%
`
`80-90%
`80-90%
`
`% of
`Medicaid
`Unit
`Shipments
`
`Total
`MYALEPT
`Gross-to-
`Net
`
`~33% 30%
`
`+10 patients since 7/31/15
`
`Cumulative Dropout: Total # of
`patients who have
`discontinued therapy from
`date of launch in mid-2014, as
`a % of all patients who have
`received at least one
`shipment.
`
`Proprietary & Confidential. © 2014 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`5
`
`Page 5 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Clinical & Regulatory Progress
`
`● JUXTAPID®
`
`- J-NDA filing for adult HoFH anticipated in early 2016
`
`- Finalizing pediatric HoFH study protocol; anticipate first pediatric HoFH patient in the
`second quarter of 2016
`
`- Plan to initiate two PCSK9 combination studies in Q2 2016
`
`- Planning for second generation JUXTAPID; expect data to choose path forward at
`end of Q1 2016
`
`● MYALEPT®
`
`- MAA filing for MYALEPT as a treatment for GL in the EU expected in late 2016
`
`- An additional priority is determining the regulatory filing strategy for severe partial
`lipodystrophy in the US and EU.
`
`Proprietary & Confidential. © 2014 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`6
`
`Page 6 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Third Quarter 2015 Financial Results Summary
`
`Total Net Product Sales
`
`$67.3
`
`$9.3
`
`$58.0
`
`ex-US
`
`US
`
`$43.7
`
`$4.1
`
`$39.6
`
`Q3 2014
`
`Q3 2015
`
`GAAP Operating Expenses
`(in millions)
`
`$41.9
`
`$10.4
`
`$31.4
`
`$55.2
`
`$11.3
`
`$43.9
`
`R&D
`
`SG&A
`
`80
`
`70
`
`60
`
`50
`
`40
`
`30
`
`20
`
`10
`
`0
`
`$60
`
`$50
`
`$40
`
`$30
`
`$20
`
`$10
`
`$0
`
`Q3 2015 Net Income (Loss):
`● GAAP:
`$(9.8)M, ($0.34) per share
`● Non-GAAP*:
`$5.7M, $0.20 per basic share
`
`Cash and cash equivalents:
`● $71.7M at September 30, 2015
`● $82.6M at June 30, 2015
`● $375.9 at December 31, 2014 (prior to MYALEPT acquisition)
`
`Financial Guidance:
`● Full-year 2015 global net product sales of JUXTAPID: between
`$205 million and $215 million
`● Full-year 2015 global net product sales of MYALEPT:
`between $25 million and $30 million
`● Full-year total non-GAAP operating expenses:
`between $195 million and $205 million*
`● Positive cash flow from operations for the full-year of 2015
`
`Q3 2014
`
`Q3 2015
`
`Proprietary & Confidential. © 2014 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`*See Q3 2015 earnings press release issued 11/9/15 for GAAP to non-GAAP explanation
`
`8
`7
`
`Page 7 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836
`
`

`
`Thank You
`
`Proprietary & Confidential. © 2015 Aegerion Pharmaceuticals, Inc. All Rights Reserved.
`
`8
`
`Page 8 of 8
`
`PENN EX. 2014
`CFAD V. UPENN
`IPR2015-01836

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