Teva Pharmaceutical Industries Ltd. First Quarter 2020...
Transcript of Teva Pharmaceutical Industries Ltd. First Quarter 2020...
Teva Pharmaceutical Industries Ltd. First Quarter 2020 Results May 7, 2020
Cautionary Note Regarding Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the
increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; manufacturing or quality control protocols; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic; costs resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time due to modified government operations due to the COVID-19 pandemic, including effects on product and patent approvals due to the COVID-19 pandemic; disruptions of information technology systems; and our ability to successfully compete in the marketplace;
• our business and operations in general, including: effectiveness of our restructuring plan announced in December 2017; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
• compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2020 and Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors" and “Forward-looking statements.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. Non-GAAP Financial Measures This presentation includes certain non-GAAP financial measures as defined by SEC rules. Please see our press release reporting our 2020 first quarter financial results, as well as our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, for a reconciliation of the GAAP results to the adjusted non-GAAP figures. The non-GAAP data presented by Teva are the results used by Teva's management and board of directors to evaluate the operational performance of the company, to compare against the company's work plans and budgets, and ultimately to evaluate the performance of management. Teva provides such non-GAAP data to investors as supplemental data and not in substitution or replacement for GAAP measure, because management believes such data provides useful information to investors. A reconciliation of forward-looking non-GAAP estimates to the corresponding GAAP measures is not being provided due to the unreasonable efforts required to prepare it.
Kåre Schultz Chief Executive Officer
Teva’s Response to COVID-19
4
~200 million patients continue to have access to our essential medicines
Minimal impact to our R&D programs and product launches
Positive evolution of digital capabilities for field sales force
No job losses related to COVID-19
Business Continuity
All facilities remain open to meet demand for our essential medicines
Adequate inventory of raw materials and finished products across our global network
Safe supply and transport of our medicines and APIs remains largely uninterrupted
The health and well-being of our employees is our priority
Number of people in our facilities were limited to only those who are essential and may not work remotely
Strict guidelines in place to protect and ensure safety of employees including personal protective equipment, hygiene and social distancing
Supporting local governments and health efforts to curb the pandemic
Millions of tablets of investigational treatment are being provided to governments and hospitals
Production of both API and finished doses for potential treatments are being secured and scaled
| 4 |
Sourcing and Production
Our Communities
Our Employees
COVID-19 Dynamics
Positive Risk
- Industry and governments working together to ensure availability of essential medicines
- Sources of raw material and finished dosage concentrated in a few countries
- Worldwide demand for new and existing medicines has not changed
- Overstocking of certain medicines can change the supply dynamics and disrupt forecasting
- New digital capabilities for sales; healthcare moving to virtual system
- Reduced interaction can impact utilization of recently launched products and products with label changes
- No material impact to clinical trials currently ongoing
- Patient recruitment for new trials could face delays
| 5 |
Q1 2020 Highlights
| 6 |
Financial Business
− Revenues of $4.4 billion
− Non-GAAP EBITDA of $1.4 billion
− GAAP EPS of $0.06; Non-GAAP EPS of $0.76
− Free cash flow of >$550 million; >$2.2 billion accumulated last 4 quarters
− Net debt reduction of $600 million to
$24.3 billion
− 2020 outlook reaffirmed
− AJOVY® Autoinjector approved in the U.S.; launch initiated in April 2020
− AJOVY® launches continue in EU;
reimbursement now in 12 countries, NICE approval
− Launch of biosimilar HERZUMA® in U.S.
− ArmonAir® Digihaler™ approved in U.S.
− BENDEKA®/TREANDA® ODE exclusivity extended to December ’22
− Positive ruling protecting BENDEKA® patents until 2031
Revenue Development
521 (13%) 565 (14%)
2,071 (50%)
317 (8%)
1,264 (30%)
1,183 (28%)
2,047 (49%)
Q1-19
1,163 (28%)
342 (8%)
582 (14%)
Q2-19
314 (8%)
2,051 (50%)
Q3-19
332 (7%)
578 (13%)
1,184 (27%)
Q1-20
2,373 (53%)
Q4-19
307 (7%)
565 (13%)
1,402 (32%)
2,082 )48%(
4,149 4,177 4,093 4,468 4,357
North America
Other Activities
Europe International Markets
| 7 | • *Revenues reflect the revision related to the Israeli distribution business, with a change from gross to net basis.
$ millions
Growth Drivers
| 8 |
AUSTEDO® Revenues By Quarter ($ million)
AUSTEDO® TRx and Net Sales Trend
| 9 |
AUSTEDO® TRx Count Per Quarter Highlights
$122M in U.S. net sales for Q1 2020
~32K prescriptions dispensed in Q1 2020
Favorable national formulary
coverage
Commercial: 89%
Medicare Part D: 85%
Source: IQVIA U.S. NPA Audit
1 6
17
30
44
62 69
74
96 105
136
122
0
20
40
60
80
100
120
140
16032,333
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
AJOVY®
| 10 |
AJOVYTM Weekly Normalized TRx Count – U.S.
9,044
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
9/21
/18
10/1
9/18
11/1
6/18
12/1
4/18
1/11
/19
2/08
/19
3/08
/19
4/05
/19
5/03
/19
5/31
/19
6/28
/19
7/26
/19
8/23
/19
9/20
/19
10/1
8/19
11/1
5/19
12/1
3/19
1/10
/20
2/07
/20
3/06
/20
4/03
/20
AJOVYTM NBRx Share* - U.S. Highlights
• $29M in U.S. net sales for Q1 2020
• Normalized TRx Share* of ~15%
• Share is trending upward with changes in promotional strategy; expected to continue with intro of autoinjector in April 2020
• >80% of patients prefer to use an autoinjector
• Increased commercial patient savings offers
• AJOVY® launches continue in EU; reimbursement now in 12 countries, NICE approval
• Approved in Canada April 2020
Source: IQVIA NPA TRx (weekly), normalized - wk ending 04/03/20
3%
14%
27% 29%
30% 28% 28%
26%
21%
18%
15% 13% 14% 13% 13% 13%
11% 11% 12%
Source: IQVIA NPA MD (weekly) *for week ending 04/10/2020
*monthly NBRx share estimated from weekly NBRx data
Gross Margin Improvement Program Focused on 5 Key Levers
Procurement cost
excellence
E2E supply chain
integration Agile
operating model and
organization
Operational & quality
excellence Network optimization & restructuring
| 11 |
(1) Free cash flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.
(2) Operating income margin = Non-GAAP operating income divided by net revenues. (3) All measures including operating income, EBITDA and earnings are presented on a non-GAAP basis. (4) Cash to earnings = free cash flow divided by non-GAAP net income attributable to ordinary shareholders. (5) Net debt/EBITDA = Net debt/non-GAAP EBITDA.
Long-Term Financial Targets
To be achieved by year-end 2023
Operating Income Margin (1)(2)(3) Cash-to-earnings (1)(3)(4) Net debt/EBITDA (1)(3)(5)
28% <3X >80%
Committed to utilizing cash flow to pay down debt; we do not plan to raise equity
| 12 |
EVP & Chief Financial Officer
Eli Kalif
Q1 2020 Summary
$ millions, except EPS Q1 2020 Q1 2019 Q1 2020 Q1 2019
GAAP Non-GAAP
Revenues* 4,357 4,149 4,357 4,149
Operating income 191 134 1,244 1,019
Net income (loss) 69 (105) 835 654
Earnings (loss) per share ($) 0.06
1,096 million shares
(0.10) 1,090 million
shares
0.76 1,096 million
shares
0.60 1,093 million
shares
| 14 | • * Revenues in 2019 reflect the revision related to the Israeli distribution business, with the change from gross to net basis.
Non-GAAP Adjustments
| 15 |
$ millions Q1 2020 Comments
Impairment items* 724
Mainly comprised of impairments of long-lived intangible assets including results in AUSTEDO for the treatment of Tourette syndrome, ongoing regulatory pricing reductions and generic competition in Japan and updated marketing assumptions regarding price and volumes of certain generic products in the U.S.
Amortization 258 Quarterly run-rate
Restructuring 39
Equity compensation plans 30
Other items 37 Finance revaluation of investments, and divestment expenses for sites slated for closure
Legal settlements (25)
Minority (63)
Tax items effect (234)
Total adjustments 766
Q1 2020 Non-GAAP Summary
| 16 |
$ billions, except EPS Q1 2020 Q1 2019 Change
Revenues* 4.4 4.1 5%
Gross profit 2.3 53.1%
2.1 51.8% 8%
Operating income 1.2 28.5%
1.0 24.6% 22%
EBITDA 1.4 1.2 19%
Net income 0.8 0.7 28%
EPS ($) 0.76
1,096 million shares
0.60 1,093 million
shares 27%
Free cash flow** 0.6 0.4 53%
* Revenues in 2019 reflect the revision related to the Israeli distribution business, with the change from gross to net basis. ** Free cash flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.
Revenues by Activity and Geographical Area
| 17 |
$ millions Q1-19 Q2-19 Q3-19 Q4-19 Q1-20 North America Segment 2,047 2,071 2,051 2,373 2,082
Generic Medicines 966 946 914 1,137 952 COPAXONE® 208 274 271 264 198 AJOVY 20 23 25 25 29 BENDEKA and TREANDA 122 125 124 125 105 ProAir®* 59 65 71 80 59 QVAR® 64 60 60 67 45 AUSTEDO 74 96 105 136 122 Distribution 379 351 351 412 426 Other 155 131 131 128 146
Europe Segment 1,264 1,183 1,163 1,184 1,402 Generic Medicines 919 844 836 871 1,032 COPAXONE 114 107 106 106 109 Respiratory products 91 89 87 86 106 Other 140 143 134 122 155
International Markets Segment 521 582 565 578 565 Generic Medicines 441 489 474 489 449 COPAXONE 13 13 20 17 12 Other 67 80 71 73 104
Other 317 342 314 332 307 Total Teva 4,149 4,177 4,093 4,468 4,357
*Excluding ProAir authorized generic.
Spend Base
1,131 (36%)
1,999 (64%)
Q1 2019
1,068 (34%)
2,206 (65%)
1,200 (35%)
Q4 2019
2,046 (66%)
Q1 2020
3,130 3,406
3,114
-17 (-1%) +11 Net of FX
-293 (-9%) -288 Net of FX
OPEX COGS
| 18 |
$ millions
4,149 51.8% 24.6%
4,468 50.6% 23.8%
4,357 53.1% 28.5%
Revenues GP% OP%
Free Cash Flow
| 19 |
$ millions
• * Free cash flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables. • ** Capex, net = gross capital expenditure, net of assets sales.
Free cash flow*
360
168
551
974
551
Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020
LTM = >$2.2 billion
26.7 26.6 25.7 24.9 24.3
4.9 4.6 4.6 4.7 4.9
Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020
Liquidity
| 20 |
$ billions
4.95 5.32 5.62 5.72 5.45
64% 64% 64% 65% 64%
* Net Debt (Gross Debt – Cash Balance) divided by EBITDA MAT (non-GAAP); Teva's Net Debt/EBITDA covenant ratio limits are 6.0x for H1, and 5.75x for H2 2020.
Net Debt
EBITDA MAT
Net Debt / EBITDA MAT
Leverage
2020 Outlook - Main Assumptions
| 21 |
Product / Business FY 2019 Commentary for 2020
Global COPAXONE $1.5 billion Continued generic erosion; revenues of ~$1.2 billion
AUSTEDO $412 million Continued increase of revenues in the U.S. to ~$650 million
Global AJOVY $96 million Continued increase of revenues to ~$250 million
Foreign Exchange Volatile swings in FX can negatively impact revenue and income
Non-GAAP Tax Rate 18% 17% - 18%
CAPEX $0.5 billion $0.6 billion
Reaffirming 2020 Non-GAAP Outlook
$ billions, except EPS 2020 Outlook FY 2019
Revenues 16.6 - 17.0 16.9
Operating Income 4.0 - 4.4 4.1
EBITDA 4.5 - 4.9 4.7
EPS ($)
2.30 - 2.55 1,098 million shares
2.40 1,094 million shares
Free Cash Flow* 1.8 - 2.2 2.1
| 22 | • * Free Cash Flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables.
Q&A
Additional Information
Quarterly GAAP Income Statement
| 25 |
$ millions, except EPS Q1 2020 Q1 2020 Margins Q1 2019 Q1 2019
Margins Change
Revenues* 4,357 4,149 5% COGS* 2,294 52.7% 2,293 55.3% 0% Gross profit 2,063 47.3% 1,856 44.7% 11% R&D 221 5.1% 261 6.3% (15%) S&M 613 14.1% 648 15.6% (5%) G&A 304 7.0% 292 7.0% 4% Legal settlements and loss contingencies (25) (0.6%) 57 1.4% n/a Impairments, restructuring and others 770 17.7% 470 11.3% 64% Other income (13) (0.3%) (6) (0.1%) 115% Operating income 191 4.4% 134 3.2% 43% Finance exp. 224 5.2% 218 5.3% 3% Tax (59) 181.3% 9 (10.8%) n/a Minority and share in profit (loss) (43) (1.0%) 12 0.3% n/a Net income attributable to Teva 69 1.6% (105) (2.5%) n/a Dividends on preferred shares - - Net income attributable to ordinary shareholders 69 (105)
# of shares (diluted, millions) 1,096 1,090
Earnings (loss) per share ($) 0.06 (0.10) n/a
Some amounts may not sum due to rounding.
• *Revenues and COGS reflect the revision related to the Israeli distribution business, with a change from gross to net basis.
Q1 2020 Foreign Exchange Impact
| 26 |
$ millions Q1 2020 Q1 2019 Diff FX Effect* Diff net FX
Revenues 4,357 4,149 208 (3) 211
Operating income GAAP 191 134 57 27 31
Operating income Non-GAAP 1,244 1,019 225 25 200
Some amounts may not sum due to rounding.
* Net of hedging activities.
Net Revenue and Profitability (1/2)(1)
Net Revenues* and Profitability (Non-GAAP)
5,258 4,916
4,551 4,386 4,418 4,149 4,177 4,093
4,468 4,357
52.3% 53.3% 51.4% 51.6% 52.7% 51.8% 52.4% 51.4% 50.6% 53.1%
26.3% 29.2% 27.2% 25.2% 21.4% 24.6% 24.2% 25.7% 23.8% 28.5%
Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020Net Revenues Gross Margin Operating Margin
($ millions)
(1) Source: Company filings.
| 27 | • * Revenues prior to 2020 reflect the revision related to the Israeli distribution business, with a change from gross to net basis.
Net Revenue and Profitability (2/2)(1)
| 28 |
Profits and EPS (Non-GAAP)
1,014 1,019 859 759
597 654 653 637 683 835
1,385 1,435
1,238 1,104
946 1,019 1,011 1,051 1,061
1,244
0.94 0.94 0.78 0.68 0.53 0.60 0.60 0.58 0.62 0.76
Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018 Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020
Net Income Operating Profit EPS
($ millions, EPS in $)
(1) Source: Company filings.
Spend Base Trend (Non-GAAP)
| 29 |
$ millions Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020 COGS 1,999 1,989 1,990 2,206 2,046 S&M 602 621 551 665 570 R&D 255 271 242 237 221 G&A 280 286 270 309 290 Other income (6) (0) (11) (9) (13) Total 3,130 3,167 3,042 3,406 3,114
Quarterly Non-GAAP Operating Income $ millions
| 30 |
99
Q1-19
1,019
North America
1,244
15
Europe
59
International Markets Other Activities Q1-20
52
Quarterly Non-GAAP Operating Income
| 31 |
97 (10%)
403 )40%(
686 )65%(
21(2%)
498 )49%(
1,011
Q2-19 Q1-19
16 (1%) 55 (5%)
136 (13%)
316 )31%(
504 )50%(
130 (12%)
341 )32%(
565 )54%(
Q3-19
17 (2%) 101 (10%)
258 )24%(
Q4-19
1,019 1,051 1,061
Q1-20
1,244
550 )44%(
502 )40%(
156 (13%) 36 (3%)
Other Activities International Markets Europe North America
$ millions
Quarterly EBITDA
| 32 |
$ millions
1,154 1,144 1,183 1,204 1,375
Q1 2019 Q2 2019 Q3 2019 Q4 2019 Q1 2020
* EBITDA is based on non-GAAP operating income (which excludes amortization and certain other items, as well as depreciation expenses).
Q1 2020 EBITDA to Free Cash Flow
* Free cash flow includes cash flow generated from operating activities net of capital expenditures and deferred purchase price cash component collected for securitized trade receivables. | 33 |
1,375
305
551
368
Restructuring Working Capital & Other
(356)
(155)
Operating cash flow
Securitization reclass
Free cash flow
6 (128)
Asset sales; Capex gross
(195)
Non-GAAP EBITDA
(72)
Interest payments, net
Tax payments Legal Settlements,
net
(32)
(259)
(122)
Securitization
(824)
$ millions
Consolidated Balance Sheet
| 34 |
$ billions Mar 31, 2020 Dec 31, 2019 Diff
Cash and Cash Equivalents 1.8 2.0 (0.2) AR Trade 5.2 5.7 (0.5) Pre-paid Expenses and Other Current Assets 2.1 1.9 0.2 Inventory 4.3 4.4 (0.1) Fixed Assets 6.2 6.4 (0.2) Intangible Assets 10.3 11.2 (1.0) Goodwill 24.5 24.8 (0.4) Other Long Term Assets 1.0 1.0 0.0 Total Assets 55.3 57.5 (2.1)
AP Trade 1.7 1.7 (0.0) SR&A 5.7 6.2 (0.5) AP Other 3.3 3.5 (0.1) Total Debt (ST+LT) 26.1 26.9 (0.8) Other Long Term Liabilities 3.9 4.2 (0.2) Minority 1.1 1.1 (0.0) Teva Shareholders’ Equity 13.5 14.0 (0.4) Total Liabilities & Equity 55.3 57.5 (2.1)
Some amounts may not sum due to rounding.
* Net Debt = Gross Debt – Cash Balance.
Q1 2020 Net Debt Movements
| 35 |
Net Debt
$ billions
0.2
December 31, 2019
24.9
-0.1
-0.7
Debt Repayment Decrease in Cash Balance
FX & Other
24.3
March 31, 2020
-0.6 (-3%)
26.1 26.9 Gross Debt
1.8 2.0 Cash Balance