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EX-99.1 - EX-99.1 - Baxalta Inc | d39752dex991.htm |
8-K - 8-K - Baxalta Inc | d39752d8k.htm |
Baxalta Incorporated Third Quarter 2015 Financial Results & Business Performance Update October 29 th , 2015 Exhibit 99.2 |
Baxalta Performance Update | Q3 2015 | Page 2 Third Quarter
2015 Earnings Conference Call Agenda
Introduction
Mary Kay
Ladone
Opening Remarks
Ludwig Hantson, Ph.D.
Innovation Update
John Orloff, M.D.
Financial Performance
& Outlook
Robert Hombach
Questions
& Answers
Management Team
Robert Hombach
Executive Vice President,
CFO and COO
Ludwig Hantson, Ph.D.
Chief Executive Officer and
President
John Orloff, M.D.
Executive Vice President,
Head of R&D
Mary Kay Ladone
Senior Vice President,
Investor Relations |
Baxalta Performance Update | Q3 2015 | Page 3
Forward-Looking Statements and
GAAP Reconciliation
Safe Harbor Statement under the Private Securities
Litigation Reform Act of 1995: This presentation includes forward-
looking statements concerning expectations, prospects, estimates
and other matters that are dependent upon future events or developments. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve
factors or circumstances that are beyond Baxalta's
control and which could cause actual results to differ materially from those in the forward-looking statements, including, but not limited to, the following: demand for and market acceptance
of risks for new and existing products; product
development risks; product quality or patient safety concerns; future actions of regulatory bodies and other governmental authorities, including the FDA and foreign counterparts; failures with respect to
compliance programs; future actions of
third-parties, including payers; U.S. healthcare reform and other global austerity measures; pricing, reimbursement, taxation and rebate policies of government agencies and private payers; the impact of
competitive products and pricing, including generic
competition, drug reimportation and disruptive technologies; global, trade and tax policies; accurate identification of and execution on business development and R&D opportunities and
realization of anticipated benefits; fluctuations
in supply and demand and the pricing of plasma-based therapies; the availability of acceptable raw materials and component supply; the inability to create timely production capacity or other
manufacturing or supply difficulties; the ability
to successfully achieve the intended results of the spin-off from Baxter International Inc.; the ability to enforce owned or in-licensed patents, or the patents of third parties preventing or
restricting manufacture, sale or use of affected
products or technology; the impact of global economic conditions; fluctuations in foreign exchange and interest rates; any changes in law concerning the taxation of income, including income earned outside the
United States; actions by tax authorities in
connection with ongoing tax audits; breaches or failures of Baxaltas information technology systems; loss of key employees or inability to identify and recruit new employees; the outcome of pending or
future litigation; the adequacy of Baxaltas
cash flows from operations to meet its ongoing cash obligations and fund its investment program; future actions that may be taken by Shire plc in furtherance of its unsolicited proposal; and other
risks identified in Baxaltas registration
statement on Form 10 and other Securities and Exchange Commission filings, all of which are available on Baxaltas website. This presentation reflects managements views as of October 29, 2015. Except
to the extent required by applicable law, we
undertake no obligation to update or revise any forward-looking statement.
Non-GAAP Financial Measures:
The financial information included in this presentation includes financial measures that are not calculated in accordance with generally accepted accounting principles (GAAP). Reconciliations of the GAAP to
non-GAAP financial measures can be found on
slides 31-36. |
Ludwig Hantson, Ph.D. Delivering Shareholder Value By Executing Our Strategy |
Baxalta Performance Update | Q3 2015 | Page 5 Achieving ~20
new product launches by 2020
Advancing the pipeline with key milestone
achievements
Driving enhanced value from new products with 2015 sales of
~$280 million
Delivering risk-adjusted revenues of $2.8B by 2020 and $7.0B
by 2025 Generating positive momentum across the
portfolio
Pro forma sales growth of 13% (constant currency)
Adjusted EPS of $0.56 per diluted share Augmenting portfolio with disciplined M&A initiatives Creating value with ONCASPAR leukemia portfolio acquisition
Leveraging capabilities as an attractive BD and licensing partner
Creating value with compelling financial profile
Raising sales and EPS guidance for 2H 2015 Providing enhanced outlook for 2016; heightened conviction in
aspiration of double-digits earnings growth beyond
2016 Strong Execution Validates
Baxaltas Commitment To Driving Shareholder
Value |
Baxalta Performance Update | Q3 2015 | Page 6 Driving Strong Q3
2015 Financial Results Adjusted Sales
Growth* % Sales Growth At Constant
Currency 8%-10%
13%
0.0%
5.0%
10.0%
15.0%
Q3 2015
Expectation
Q3 2015
Actual
Adjusted EPS**
$ Per Diluted Share
$0.56
$0.45
$0.50
$0.55
$0.60
Q3 2015
Expectation
Q3 2015
Actual
Positive Momentum Continues Across Broad And Differentiated
Portfolio $0.48-$0.50
*Growth rates are at constant currency and compare to 2014 pro
forma sales **Financial results and guidance exclude
special items and are presented on an adjusted basis;
refer to slides 31-36 for information regarding non-GAAP
measures used throughout the presentation |
Baxalta Performance Update | Q3 2015 | Page 7 Building Three
Sustainable Businesses Q3 Growth* =
10% Q3 Growth* = 13%
Q3 Sales = $34M
Treating unmet medical needs and orphan diseases
Innovating in a focused, targeted manner
Leveraging patient centricity and high touch models
Ensuring sustainable, high quality supply
Enhancing access
and standards
of care
Capitalizing
on differentiated
brands
Accelerating
innovation &
launch excellence
Augmenting
portfolio with BD
Hematology
Immunology
Oncology
Exceeding Sales Expectations Across All Key Product
Categories *Growth rates are at constant currency
and compare to 2014 pro forma sales |
Baxalta Performance Update | Q3 2015 | Page 8 Advancing
Portfolio With Significant Regulatory
Success 7
Regulatory
Approvals
4
Products
Under Review
ADYNOVATE
(U.S.)
VONVENDI
(U.S.)
20% IGSC
(U.S./EU)
nal-IRI
(EU) |
Baxalta Performance Update | Q3 2015 | Page 9 New Product
Sales (Risk-Adjusted)
Meaningful Revenue
Contribution Beyond 2020
$0
$2
$4
$6
$8
2015
Expectation
2016
Expectation
2020
Outlook
2025
Outlook
Risk Adjusted
0%
20%
40%
60%
80%
100%
2015
Expectation
2016
Expectation
2020
Outlook
2025
Outlook
New Product Sales
Total BXLT Sales
~30%
~$2.8B
~$7.0B
~$280M
50%+
New Product Sales
(Risk-Adjusted % of Total)
~$750M
10%+ |
Baxalta Performance Update | Q3 2015 | Page 10 Substantial
Revenues From Late-Stage Assets
Hematology
Hematology
Immunology
Immunology
Oncology
Oncology
2020 New Product Sales
2020 New Product Sales
~90% of Revenues
from products that
are approved,
under regulatory
review, or have
positive phase III
data
Non Risk-Adjusted
Risk-Adjusted
~$2.8 Billion
(including ONCASPAR)
$4.0+ Billion
(including ONCASPAR) |
Baxalta Performance Update | Q3 2015 | Page 11 Multiple R&D
Programs With Revenue Potential Of $500+
Million Oncology
Immunology
Hematology
Early-Stage Assets
Recent Product Launches/
Late-Stage Assets
HYQVIA
20% IGSC
ADYNOVATE
VONVENDI
Pacritinib
nal-IRI
ONCASPAR
BAX 826
Gene Therapy
SuppreMol
Biosimilars
IMALUMAB |
Baxalta Performance Update | Q3 2015 | Page 12
Acquisitions
Partnerships
Advancing External Innovation |
Baxalta Performance Update | Q3 2015 | Page 13 Enhancing Growth
With M&A Initiatives M&A Strategic
Principles
Focusing on value-creation
Evaluating opportunities with strong strategic fit across core therapeutic orphan disease areas: Hematology Immunology Oncology Enhancing integration success by leveraging existing capabilities Applying disciplined financial criteria Cash Flow Reinvestment Dividends M&A / Buyback 0% 100% Disciplined Capital Allocation Framework Executing Transactions With Disciplined Approach Focused On
Generating Strong Returns On Invested Capital
|
Baxalta Performance Update | Q3 2015 | Page 14 Baxalta: A
Compelling & Unique Investment
Opportunity Leadership
Established $6 billion global biopharmaceutical leader focused on orphan diseases
Well positioned in attractive and growing markets with differentiated therapies Strong global channels and patient relationships and potential to broaden access in
emerging markets
Capabilities
Leader in creating dynamic business models to improve patient access
Attractive business development and licensing partner Best-in-class global biologic manufacturing network with proprietary technology
platforms, such as gene therapy
Value
Robust and balanced late-stage pipeline spanning core therapeutic disease areas
Driving acceleration in sales and profitability with ~20 new products by 2020
Attractive financial profile with compelling cash flow generation and disciplined
capital allocation approach
|
John Orloff, M.D. Innovation Update |
Baxalta Performance Update | Q3 2015 | Page 16 Achieving Key
Milestones ADYNOVATE
U.S. regulatory approval pending; favorable FDA late-cycle
review VONVENDI
U.S. regulatory approval pending; favorable FDA late-cycle
review OBIZUR
Received
Canadian
approval
and
positive
opinion
from
EMA
Gene
Therapy
FIX
Progressed Phase I/II open-label study (7 patients
dosed) 20% IGSC
Submitted for U.S. and European regulatory approval for PI
BAX 923
Initiated Phase III trial in patients with chronic plaque
psoriasis Sanquin
Submitted European application for approval of contract
manufacturing site ONCASPAR
Completed acquisition; extracting meaningful value
nal-IRI
Submitted
European
MAA;
FDA
approval
granted
to
Merrimack
Pacritinib
Disclosed accelerated U.S. filing (Q4 2015); requesting priority
FDA review Oncology
Immunology
Hematology |
Baxalta Performance Update | Q3 2015 | Page 17 ~20 New Product
Launches By 2020 RIXUBIS
[EU]
2015
2016
2017
nal-IRI
1
st
line metastatic
Pancreatic Cancer
[EU]
ADYNOVATE
(BAX 855)
[U.S.]
nal-IRI
Pancreatic Cancer
Post-gemcitabine
[EU]
Etanercept
(BAX 2200)
[EU]
Adalimumab
(BAX 923)
[U.S. & EU]
Imalumab
(BAX 069)
Malignant Ascites
[U.S.]
VONVENDI
(BAX 111)
[U.S.]
FEIBA
Recon Reduction
[U.S.]
OBIZUR CHAWI
Surgery
[U.S.]
nal-IRI
1
st
line Gastric
Cancer
[EU]
IG 10% HYQVIA
CIDP
[U.S.]
rFVIIa
(BAX 817)
[U.S.]
rADAMTS13
hTTP
(BAX 930)
[U.S.]
GT FIX
(BAX 335)
[U.S.]
SM101
IgA N
[U.S.]
3
rd
line metastatic
Colorectal
[U.S.]
ONCASPAR
Lyophilized
ALL
[EU]
ALL
[U.S.]
20% IGSC
[U.S. & EU]
OBIZUR
[EU]
Pacritinib
MF
[EU]
Pacritinib
New Indication
[U.S. & EU]
ADYNOVATE
(BAX 855)
[Japan]
ADYNOVATE
(BAX 855)
[EU]
ONCASPAR
ALL
[Japan]
Pacritinib
MF
[Japan]
nal-IRI
Pancreatic Cancer
Post-gemcitabine
[Japan]
2018
-
2020
ONCASPAR
ALL
[EU]
Pacritinib
MF
[U.S.]
(BAX 826)
[U.S.]
Oncology
Immunology
Hematology
ADYNOVATE and Oncology geographic expansion included; excludes
additional externally-sourced assets; pending portfolio funding decisions; New assets, line extension, geographic expansion ONCASPAR Lyophilized ALL [U.S.] EHL rFVIII PSA
Calaspargase
pegol
Imalumab
(BAX 069) |
Bob Hombach Financial Performance |
Baxalta Performance Update | Q3 2015 | Page 19 Q3 2015
Revenues Worldwide Revenues*
$ In Billions
5%
6%
8%
13%
8%
7%
13%
0%
5%
10%
15%
Q1 14
Q2 14
Q3 14
Q4 14
Q1 15
Q2 15
Q3 15
Quarterly Revenue Growth*
% Sales Growth At Constant Currency
*2015 growth rates compare to 2014 pro forma sales; 2014 constant
currency growth rates do not include pro forma
adjustments $1.6B
+13% cc
U.S.
International |
Baxalta Performance Update | Q3 2015 | Page 20
Hematology
Hemophilia
Enhancing access and elevating standards of care globally Global ADVATE growth in double-digits: - Continued rFVIII conversion in Brazil - U.S. sales growth in mid single digits - Cumulative U.S. patient share loss of 2-3 points; pace of losses slowing Inhibitor Therapies FEIBA growth driven by: - Robust demand and conversion to prophylaxis - Modest price improvements - Timing of tender sales in developing markets Contribution of OBIZUR for acquired hemophilia A Q3 2015 Sales % Growth | At Actual % Growth | At Constant $ In Millions U.S. Int. Total U.S. Int. Total U.S. Int. Total Hemophilia $337 $390 $727 +6% -11% -4% +6% +7% +7% Inhibitor Therapies $78 $130 $208 +42% -2% +11% +42% +14% +22% Hematology $415 $520 $935 +11% -9% -1% +11% +9% +10% |
Baxalta Performance Update | Q3 2015 | Page 21 9%
7%
9%
8%
2%
4%
7%
0%
5%
10%
15%
20%
Q1 14
Q2 14
Q3 14
Q4 14
Q1 15
Q2 15
Q3 15
Hematology Sales Growth
Hemophilia
% Sales Growth At Constant Currency
9%
2%
17%
33%
18%
12%
22%
0%
10%
20%
30%
40%
Q1 14
Q2 14
Q3 14
Q4 14
Q1 15
Q2 15
Q3 15
Inhibitor Therapies
% Sales Growth At Constant Currency
|
Baxalta Performance Update | Q3 2015 | Page 22
Immunology*
Immunoglobulin Therapies
Enhancing penetration in under- treated diseases Capitalizing on broad and differentiated portfolio - Higher demand in Primary Immunodeficiency segment - Improved supply - Favorable reception and uptake of HYQVIA BioTherapeutics Strong sales of specialty biotherapeutics - Albumin sales in U.S. and China - Alpha-1 therapies - Contract-manufacturing revenues Q3 2015 Sales % Growth | At Actual % Growth | At Constant $ In Millions U.S. Int. Total U.S. Int. Total U.S. Int. Total Immunoglobulin Therapies $334 $101 $435 +10% -1% +7% +10% +19% +12% BioTherapeutics $64 $127 $191 +7% +5% +6% +7% +18% +14% Immunology $398 $228 $626 +9% +2% +6% +9% +18% +13% *Growth rates compare to 2014 pro forma sales |
Baxalta Performance Update | Q3 2015 | Page 23 2%
3%
-2%
13%
9%
13%
12%
-5%
0%
5%
10%
15%
Q1 14
Q2 14
Q3 14
Q4 14
Q1 15
Q2 15
Q3 15
Immunology Sales Growth
Immunoglobulin Therapies
% Sales Growth At Constant Currency
-11%
15%
21%
19%
24%
4%
14%
-15%
-5%
5%
15%
25%
35%
Q1 14
Q2 14
Q3 14
Q4 14
Q1 15
Q2 15
Q3 15
Pro Forma BioTherapeutics*
% Sales Growth At Constant Currency
*2014 constant currency growth rates do not include pro forma
adjustments |
Baxalta Performance Update | Q3 2015 | Page 24
Oncology
Leveraging expertise in orphan diseases, high touch, service
intensive therapies Focusing on targeted
populations with limited treatment options
Capitalizing on attractive and growing market
Partnering with leading R&D companies on transformational
science Developing a portfolio of effective,
personalized, differentiated treatments Oncaspar
Portfolio Acquisition
Q3 2015 sales of $34
million; annual sales trending at $200 million Accelerates Baxaltas rapid entry into Oncology Leverages global presence Strengthens Baxaltas robust pipeline Complements current partnerships $0 $1 $2 2015 Expectation 2020 Outlook 2025 Outlook $0.7B+ ~$1.5B ~$80M Oncology Sales* *Includes Oncology pipeline sales |
Baxalta Performance Update | Q3 2015 | Page 25 Q3 2015
Financial Results* Q3 2015
Sales ($ in
Millions) $1,595
Gross Margin
61.9%
Operating Margin
31.2%
EBITDA Margin
34.4%
Tax Rate
22.1%
Diluted EPS
$0.56
*Financial results exclude special items and are presented on an
adjusted basis; refer to slides 31-36 for
information regarding non-GAAP measures used throughout the presentation |
Bob Hombach Financial Outlook |
Baxalta Performance Update | Q3 2015 | Page 27 2015 Full Year
Sales Growth Expectations % Growth At Constant
Currency FY 2015
Original*
(Q1 Conference Call)
FY
2015
Guidance**
(Q2 Conference Call)
FY 2015
Guidance**
(Revised)
Hemophilia
0%
-
2%
~2%
~3%
Inhibitor
Therapies
8%+
13% -
14%
10% -
11%
Hematology
2% -
3%
~4%
~5%
Immunoglobulin
Therapies
6% -
8%
~8%
~9%
BioTherapeutics
2%
-
4%
~8%
~10%
Immunology
5% -
7%
~8%
~9%
Oncology
N/A
$50M+
~$80M
Baxalta
~4%
6% -
7%
~8%
*FY 2015 original guidance does not include pro forma
adjustments **Growth compares to 2014 pro forma
sales; H1 2015 results include pro forma adjustments |
Baxalta Performance Update | Q3 2015 | Page 28 2H 2015
Financial Outlook* Q3 2015
Actual Results
Q4 2015
Guidance
2H 2015
Guidance
(Revised)
Sales Growth**
13%
3% -
5%
8% -
9%
Diluted EPS
$0.56
$0.55 -
$0.57
$1.11 -
$1.13
*Financial results and guidance presented on an adjusted
basis; refer to slides 31-36 for additional information **Growth rates are at constant currency and compare to 2014 pro forma sales |
Baxalta Performance Update | Q3 2015 | Page 29 Raising 2H 2015
Financial Guidance* 2H 2015
Guidance
(Investor Conference)
2H 2015
Guidance
(Q2 Conference Call)
2H 2015
Guidance
(Revised)
Sales Growth**
2% -
3%
5% -
6%
8% -
9%
Gross Margin
58%
-
59%
59%
-
60%
~62%
Operating Margin
~29%
30%
-
31%
~31%
EBITDA Margin
~33%
~34%
~35%
Tax Rate
23% -
24%
23% -
24%
~23%
Diluted EPS
N/A
$1.02 -
$1.04
$1.11 -
$1.13
*Financial guidance presented on an adjusted basis; refer
to slides 31-36 for additional information
**Growth rates are at constant currency and compare to 2014 pro
forma sales |
Baxalta Performance Update | Q3 2015 | Page 30 Preliminary Full
Year 2016 Financial Guidance*
FY 2016
Guidance
(Investor Conference)
FY 2016
Guidance
(Revised)
Sales Growth**
Mid-Single Digits
8% -
9%
Gross Margin
~59%
~62%
Operating Margin
~29%
~31%
EBITDA Margin
33% -
34%
~35%
Tax Rate
23% -
24%
~23%
Diluted EPS
N/A
$2.15 -
$2.25
*Financial guidance presented on an adjusted basis; refer
to slides 31-36 for additional information
**Growth rates are at constant currency and compare to 2015 pro
forma sales |
GAAP to Pro Forma Non-GAAP Reconciliations |
Baxalta Performance Update | Q3 2015 | Page 32 Notice To
Investors Non-GAAP Financial Measures: The financial information included in these schedules includes financial measures that are not calculated in accordance with generally accepted accounting principles (GAAP). Reconciliations of the GAAP to
non-GAAP financial measures can be found on
pages 33-36. The non-GAAP financial measures include adjusted gross margin, adjusted operating income, adjusted EBITDA, and adjusted diluted earnings per
share. Non-GAAP financial measures may
provide a more complete understanding of the Companys operations and may facilitate a fuller analysis of the Companys results of operations, particularly in evaluating performance from one period to another. The
Company has presented adjusted operating
income, which excludes interest and other expense and intangible asset amortization; and adjusted EBITDA which, in addition to the previous adjustments, also excludes depreciation
expense. Additionally, the non-GAAP
financial measures presented exclude the impact of certain special items, which are excluded because they are highly variable, difficult to predict, and of a size that may substantially impact the
Companys operations and can facilitate a
fuller analysis of the Companys results of operations, particularly in evaluating performance from one period to another. Upfront and milestone payments related to collaborative arrangements that
have been expensed as research and development
(R&D) are uncertain and often result in a different payment and expense recognition pattern than internal R&D activities and therefore are typically excluded as special items.
Intangible asset amortization is excluded to
facilitate an evaluation of current and past operating performance, particularly in terms of cash returns, and is similar to how management internally assesses performance.
The Companys management uses non-GAAP financial
measures to evaluate the Companys performance and provides them to investors as a supplement to the Companys reported results, as they believe this information provides
additional insight into the Companys
operating performance by disregarding certain nonrecurring items. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to,
similarly titled measures used by other companies.
In addition, these non-GAAP financial measures should not be considered in isolation, as a substitute for, or as superior to, financial measures calculated in accordance with GAAP,
and the Companys financial results calculated
in accordance with GAAP and reconciliations to those financial statements should be carefully evaluated. |
Baxalta Performance Update | Q3 2015 | Page 33 Pro Forma Sales
Reconciliation % Growth @ Actual Rates
% Growth @ Constant Rates
U.S. International Total U.S. International Total U.S. International Total U.S. International Total Hemophilia $337 $390 $727 $318 $437 $755 6% (11%) (4%) 6% 7% 7% Inhibitor Therapies 78 130 208 55 132 187 42% (2%) 11% 42% 14% 22% Hematology $415 $520 $935 $373 $569 $942 11% (9%) (1%) 11% 9% 10% Immunoglobulin Therapies 334 101 435 305 102 407 10% (1%) 7% 10% 19% 12% Pro Forma BioTherapeutics 64 127 191 60 121 181 7% 5% 6% 7% 18% 14% Pro Forma Immunology $398 $228 $626 $365 $223 $588 9% 2% 6% 9% 18% 13% Oncology $28 $6 $34 $ - $ - $ - N/M N/M N/M N/M N/M N/M Pro Forma Total Baxalta $841 $754 $1,595 $738 $792 $1,530 14% (5%) 4% 14% 12% 13% % Growth @ Actual Rates % Growth @ Constant Rates U.S. International Total U.S. International Total U.S. International Total U.S. International Total Hemophilia $964 $1,076 $2,040 $938 $1,212 $2,150 3% (11%) (5%) 3% 5% 4% Inhibitor Therapies 210 347 557 151 372 523 39% (7%) 7% 39% 9% 17% Hematology $1,174 $1,423 $2,597 $1,089 $1,584 $2,673 8% (10%) (3%) 8% 6% 7% Immunoglobulin Therapies 980 297 1,277 906 292 1,198 8% 2% 7% 8% 21% 11% Pro Forma BioTherapeutics 189 370 559 182 339 521 4% 9% 7% 4% 18% 13% Pro Forma Immunology $1,169 $667 $1,836 $1,088 $631 $1,719 7% 6% 7% 7% 19% 12% Oncology $28 $6 $34 $ - $ - $ - N/M N/M N/M N/M N/M N/M Pro Forma Total Baxalta $2,371 $2,096 $4,467 $2,177 $2,215 $4,392 9% (5%) 2% 9% 10% 10% Pro Forma Net Sales Reconciliations % Growth @ Actual Rates % Growth @ Constant Rates U.S. International Total U.S. International Total U.S. International Total U.S. International Total BioTherapeutics $64 $127 $191 $60 $79 $139 7% 61% 37% 7% 81% 49% Pro forma MSA revenue - - - - 42 42 Pro Forma BioTherapeutics $64 $127 $191 $60 $121 $181 7% 5% 6% 7% 18% 14% % Growth @ Actual Rates % Growth @ Constant Rates U.S. International Total U.S. International Total U.S. International Total U.S. International Total BioTherapeutics $189 $288 $477 $182 $216 $398 4% 33% 20% 4% 48% 28% Pro forma MSA revenue - 82 82 - 123 123 Pro Forma BioTherapeutics $189 $370 $559 $182 $339 $521 4% 9% 7% 4% 18% 13% Q3 2015 Q3 2014 YTD 2015 YTD 2014 Q3 2015 Q3 2014 YTD 2015 YTD 2014 |
Baxalta Performance Update | Q3 2015 | Page 34
GAAP-to-Non-GAAP Reconciliation: Gross
Margin
$ in millions
Q3 2015
Gross Margin
962
Gross Margin Percentage
60.3%
Adjustments for special items
25 Adjusted Gross Margin 987
Adjusted Gross Margin Percentage
61.9%
Baxalta has also presented guidance for H2 2015 and 2016 using
the non-GAAP measure of Adjusted Gross
Margin. Baxalta projects that GAAP Gross Margin would be lower than Adjusted Gross Margin by approximately 1% for each period presented, with
reconciling items of intangible asset amortization expense and
other Q3 2015 special items for H2
2015. |
Baxalta Performance Update | Q3 2015 | Page 35
GAAP-to-Non-GAAP Reconciliation:
Operating Income and EBITDA
$ in millions
Q3 2015
Pre-tax Income
354
Pre-tax Income Margin
22.2%
Adjustments for special items
140 Adjusted Pre-tax Income 494
Adjusted Pre-tax Income Margin
31.0%
Remove: Net interest expense
23 Remove: Other income, net
(19) Adjusted Operating Income
498
Adjusted Operating Income Margin
31.2%
Remove: Depreciation
50 Adjusted EBITDA 548
Adjsuted EBITDA Margin
34.4%
Baxalta has also presented guidance for H2 2015 and 2016 using
non-GAAP measures of Adjusted Operating Income
Margin and Adjusted EBITDA Margin. Baxalta projects that GAAP Pre-tax Income Margin would be lower than Adjusted Operating Income
Margin by approximately 6% for H2 2015 and approximately 3% for
2016, with reconciling items of interest expense,
other income and intangible asset amortization
expense, as well as Q3 2015 special items for H2 2015
guidance. GAAP Pre-tax Income Margin
would be lower than Adjusted EBITDA Margin by an approximate additional 4% in both H2 2015 and 2016 related to depreciation expense. |
Baxalta Performance Update | Q3 2015 | Page 36
GAAP-to-Non-GAAP Reconciliation:
Diluted EPS
Q3 2015
Diluted EPS
$0.45
Adjustments for special items
0.11 Adjusted Diluted EPS $0.56 Baxalta has also presented guidance for Q4 2015, H2 2015 and 2016 using the non-
GAAP measure of Adjusted Diluted EPS. Baxalta projects that
GAAP Diluted EPS would be lower than Adjusted
Diluted EPS by approximately $0.02 per diluted share for Q4 2015, approximately $0.13 per diluted share for H2 2015 and approximately $0.08 per
diluted share in 2016, with reconciling items of intangible asset
amortization expense and other Q3 2015 special
items for H2 2015 guidance. |