first quarter 2015 results · – 2014 sales of ~$ 300mm – annual price per patient of $80-$85k...
TRANSCRIPT
1
First Quarter 2015 Results April 30, 2015
2 2 Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:
The following discussion and analysis contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements 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 develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (including competition from orally-administered alternatives, as well as from generic equivalents such as the Sandoz product recently approved by the FDA) and our ability to migrate users to our 40 mg/mL version and maintain patients on that version; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2014 and in our other filings with the U.S. Securities and Exchange Commission (the "SEC"). 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 in this report, whether as a result of new information, future events or otherwise. You are advised, however, to consult any additional disclosures we make in our reports to the SEC on Form 6-K. Also note that we provide a cautionary discussion of risks and uncertainties under “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2014. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those listed could also adversely affect us. This discussion is provided as permitted by the Private Securities Litigation Reform Act of 1995.
3 3
Erez Vigodman President & CEO
4 4
Q1 2015* Q1 2014* (1) Change Revenues $m 4,982 5,001 (0.4%)
Operating Income $m 1,533 1,381 11%
Net Income $m 1,165 1,051 11%
EPS $ 1.36 1.23 11%
Cash Flow from Operations $m 1,354 898 51%
Free Cash Flow $m 1,213 673 80%
*Net income, operating income and EPS are non GAAP results. (1) Adjusted for exclusion of equity compensation
Q1 2015 – Financial Highlights Strong Results on All Fronts
5 5 Making Progress on Our Key Priorities for 2015
Continue solidifying the generics business, improve its profitability by additional 400bps and drive organic growth
Deliver on the promise in our specialty pipeline
Further maintain the Copaxone® franchise and continue to enhance our current product offerings
Generate $500m in net cost reductions
Continue enhancing the competitiveness of our operational network
Continue the transformation of the company to create its new future
Strong focus on business development
©
6 6 Generics Highlights Continued Growth and Improvement in Generics
Significantly improved profit despite FX impact - 59% increase to $799 million
Revenues $2.6 billion, up 9%
Major improvement in profitability to 30.5%
US - Successful launch of generic Nexium® US - Solid performance of the base business
International Growth Markets - Double digit growth in local currency terms
EU - Strong performance in Germany, UK and Italy. Record profitability levels
OTC revenues up 20% in local currency terms; Profitability improved significantly
7 7
45.2% 43.5% 41.3% 43.3% 46%
20.2% 19.9% 16.7%
21.9% 27%
10%
20%
30%
40%
50%
FY11 FY12 FY13 FY14 FY15 mid-point
Gross Profit Margin Segment Profit Margin
Profitability consists of gross profit, less S&M and R&D expenses related to the segment * Segment profitability does not include G&A expenses, amortization and certain other items
Continued Growth and Improvement in Generics
Continue to improve operating profitability
More focus on key markets and portfolio management
Execution of growth market strategy
Clear strategy for OTC
Sales force effectiveness in key markets
8 8
Registration
CEP-33237 ER Hydrocodone (abuse det.) US - Pain Copaxone® 40mg 3w ROW Multiple sclerosis Copaxone® 20mg per Day Japan Multiple sclerosis Reslizumab IV Asthma Bendamustine Rapid Infusion* CLL, NHL
CNS & Pain Respiratory Other * Filed by Eagle Pharmaceutical, commercialized by Teva Note: Pipeline correct as of April 15, 2015. Phase 1 includes also projects designated for IND filing
Phase 1
TV-46763 (abuse deterrent) Pain TV-46139 (abuse deterrent) Pain Fluticasone Salmeterol Spiromax EU Asthma, COPD Reslizumab SC Asthma Fluticasone Salmeterol (MDI) EU Asthma, COPD TEV-46017 (tidal inhaler) COPD TEV-48108 (tidal inhaler) COPD TEV-90110 HIV TEV-90112 HIV
Phase 2
Laquinimod Multiple sclerosis (progressive forms) Laquinimod Huntington’s disease Pridopidine Huntington’s disease TV-45070 Topical Osteoarthritis pain TV-45070 Topical Neuropathic pain TEV-48125 (anti CGRP) Chronic and episodic migraine CEP-41750 (mesenchymal precursor cell) Acute myocardial infarction Albutropin Growth hormone deficiency
Phase 3
Laquinimod Multiple sclerosis (relapsing remitting) Fluticasone Propionate MDPI Asthma Fluticasone Salmeterol MDPI Asthma QVAR® (BAI) US Asthma CEP-41750 (mesenchymal precursor cell) Chronic heart failure
SD-809 Tourette syndrome SD-560 Idiopathic pulmonary fibrosis/other fibrotic conditions
SD-809 Tardive dyskinesia SD-809
HD (Mid-2015 NDA filing)
Auspex – pending deal completion
Teva Specialty pipeline - pending Auspex deal
9 9 Delivering On The Promise In Our Pipeline
ProAir® RespiClick NDA approved - first and only breath-actuated dry-powder rescue inhaler for the treatment of acute asthma symptoms. Launch expected in Q2 15.
Reslizumab IV BLA submitted for the treatment of moderate to severe asthma.
TEV-48125 (CGRP MAb) positive phase 2b results in chronic and episodic migraine.
Q1 15 Update
10 10
• TEV-48125 is the first anti-CGRP compound to report positive data in the disease
• The two tested doses were positive on primary and secondary endpoints (decrease in the number of hours and of headache days at three months relative to baseline)
• Both doses also separated from placebo at 1 month
• TEV-48125 significantly decreased consumption of triptans, different than Botox
• Data to be presented at the International Headache Society
Two active doses tested
Endpoints – Decrease in migraine (primary) and headache (secondary) days at three months relative to baseline
Both doses separated from placebo on primary and secondary endpoints (highly statistically significant after adjustments for multiplicity in two-sided tests)
Both doses also significantly separated at 1 month for both endpoints
No safety concerns in the episodic (or chronic) migraine trials
Data submitted to the American Headache Society conference
TEV-48125 Episodic Migraine Chronic Migraine
11 11
• First anti-CGRP antagonist to show positive efficacy results in chronic and episodic migraine
• Four dosing paradigms tested across the two conditions. All positive for primary and secondary endpoints, and at 1 month of therapy
• Only monoclonal antibody anti CGRP that has separated from placebo across the entire duration of the study for primary and secondary
• No important safety concerns were identified
TEV-48125
12 12
SD-809 Provides Substantial Addressable Market Opportunities with Significant Commercial Potential
Huntington’s Disease
Tardive Dyskinesia
Tourette Syndrome
Estimated Patient Population (U.S.)
% of Physicians who suggested they would prescribe SD-8091 Other Considerations
85%
94%
64%
Severe
Moderate
Mild
84%
84%
81%
Severe
Moderate
Mild
89%
90%
73%
Severe
Moderate
Mild
1 Source: Healogix physician survey.
~30,000 Patients
~350,000 Patients
~150,000 Patients
Only one approved drug in the US: Tetrabenazine – Only 5% of patients treated – 2014 sales of ~$300mm – Annual price per patient of $80-$85k – Established reimbursement landscape
Received FDA orphan designation Expected launch in 2016
No approved treatment in the US – Tetrabenazine is approved in the EU
Limited off-label usage of Tetrabenazine in the US despite significant clinical response – Improved profile should result in increased usage
Only one approved drug in the US: Aripiprazole – Associated with drowsiness, agitation, weight
gain, and sleep disturbances Limited off-label usage of Tetrabenazine despite
significant clinical response Received FDA orphan designation
Majority of movement disorder patients treated by neurologists – Highly synergistic with Teva’s premier neuroscience sales force
SD-809: Significant Near-Term Commercial Opportunity
13 13
Frequency of Adverse Events: SD-809 Placebo (%)
Depression 4 % 7 %
Somnolence 11 % 4 %
Akathisia / Restlessness 2 % 2 %
Anxiety 2 % 2 %
Irritability 7 % 13 %
Fatigue 7 % 4 %
Insomnia 7 % 4 %
Parkinsonism / Bradykinesia 0 % 0 %
QT Prolongation: < 5 milliseconds
Dosing Frequency: BID (2 x day)
SD-809: Favorable Side Effect Profile; BID Dosing
14 14
Eyal Desheh EVP, Chief Financial Officer
15
Q1 2015 Results
16 16
Q1 2015* Q1 2014* (1) Change
Revenues $m 4,982 5,001 (0.4%)
Operating Income $m 1,533 1,381 11%
Net Income $m 1,165 1,051 11%
EPS $ 1.36 1.23 11%
Cash flow from Operations $m 1,354 898 51%
*Net income, operating income and EPS are non GAAP results. (1) Adjusted for exclusion of equity compensation
Q1 2015
17 17 Foreign Exchange Impact
Q1 2015 Q1 2014 Change ($m) Fx Effect* ( $m) Real Change
Revenues $m 4,982 5,001 (19) (368) 349
Operating income $m 1,533 1,381 152 (42) 194
*Includes profits from certain hedging transactions
18 18 Cash Flow Trends
673 882
1,218 1,483
1,213 225
171
206
269
141
Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015
$ million
Free Cash Flow*
Asset Purchase, Net
Cash From Operations 898 1,053
1,424
* Commencing Q4 2014, the data presented has been conformed to reflect the revised definition of free cash flow before dividend, for all periods.
1,752
1,354 +51%
+80%
19 19 Quarterly Revenue Breakdown by Segment
2,398 - 48% 2,621 – 52%
1,070 - 21% 924 – 19%
1,044 - 21% 1,032 – 21%
489 - 10% 405 - 8%
Q1 14 Q1 15
OTC & Other
Specialty ex-MS
MS
Generics
$ million
5,001 4,982
20 20
30% 44%
46% 36%
21% 17% 3% 3%
Q1 14 Q1 15
OTC & Others
Specialty ex-MS
MS
Generics
Quarterly Profit* Breakdown by Segment
* Segment profit consists of gross profit, less S&M and R&D expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items.
1,826 1,674
$ million
21 21 Generics Segment Gross Profit and Profitability* Evolution
* Segment profit consists of gross profit, less S&M and R&D expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items. Segment profitability is segment profit as a percentage of segment revenues.
21.0% 21.3% 23.0% 23.0%
30.5%
43.5% 41.7%
44.3% 43.9%
49.0%
Q1 14 Q2 14 Q3 14 Q4 14 Q1 15
Profit Margin* Gross Profit Margin
22 22
2,629 - 53% 2,921 - 59%
1,507 - 30% 1,267 - 25%
865 - 17% 794 - 16%
Q1 14 Q1 15
ROWEuropeUS
5,001 4,982
$ million Quarterly Revenue Breakdown by Market
23 23 Quarterly Revenues
5,001 4,982
431
43 32
368
48 109
Q1 2014 Generics Specialtyex-MS
OTC & Other FX US OTC* MS Q1 2015
All data, except Fx, are net of the impact of foreign exchange fluctuations. *In July 2014, we sold our U.S. OTC plants, previously purchased from P&G, back to P&G.
$ million
24 24 Copaxone® Revenues Evolution
$ million
816 835 732
254 286
192
25%
27%
29%
31%
33%
35%
0
200
400
600
800
1,000
1,200
Q1 14 Q4 14 Q1 15
US sales Ex-US sales US TRx MS*
* Market share data, including historic data, is based on IMS March 2015 data.
Revenues fluctuate but demand in the US is stable
25 25 Quarterly Operating Income bridging
1,381 1,381 1,603 1,575 1,533 1,533
312
90
28 42
Q1 2014 Generics* MS Specialtyex-MS
Fx Q1 2015
* Segment profit consists of gross profit, less S&M and R&D expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items. -Generics includes profit of other activities
$ million
26 26 Liquidity Trends
Leverage
Debt/EBITDA
33% 31% 31% 32% 34% 35% 1.73 1.67 1.76 1.90 2.04 2.16
22.6 23.0 23.6 23.7 23.4 22.7
12.2 11.8 11.2 10.6 10.3 11.0
Q4 2013 Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015
Debt
Equity
Gross debt increased by $0.7B from Dec 31, 2014
$ billion
27 27 Teva’s Dividend Payments
Total dividends represent payment of the dividend declared for the quarter. Current quarter data is an estimate.
164 167 172 203 203 204 190 174
230 237 214
281 268 264 276 291 299 294 272
290 288
$0.00
$0.05
$0.10
$0.15
$0.20
$0.25
$0.30
$0.35
$0.40
0
50
100
150
200
250
300
350
Total Dividend ($m) $ per Share
Q1 2015 dividend per share of $0.34
28 28 2015 Business Outlook: Increased Despite Currency Volatility and Approval of Copaxone® Generic
2015E Net Revenues ($b) 19.0-19.4
Gross Profit (%) 59.5%-61.5%
R&D ($b) 1.3-1.4
S&M ($b) 3.3-3.5
G&A ($b) 1.1-1.2
Operating Income* ($b) 5.7-5.9
Finance Expenses ($m) 250-290
Tax (%) 19%-21%
Number of Shares (M) 850-860
EPS ($) 5.05-5.35
Cash Flow from Operations ($b) 4.3-4.7
Thank You