AI Terminal
Teva Pharmaceutical Industries Ltd.
Earnings Release • Nov 5, 2020
7082_rns_2020-11-05_0765c9d8-145f-4691-8625-75262f4511f7.pdf
Earnings Release
Open in ViewerOpens in native device viewer
TEVA REPORTS THIRD QUARTER 2020 FINANCIAL RESULTS
- Revenues of \$4.0 billion
- GAAP diluted loss per share of \$3.97
- Non-GAAP diluted EPS of \$0.58
- Free cash flow of \$506 million
- Full year 2020 business outlook revised:
- o Net revenues of \$16.5-16.8 billion
- o EBITDA of \$4.7 \$4.9 billion
- o EPS of \$2.40 \$2.55
- o Free cash flow of \$1.8 \$2.2 billion
Tel Aviv, November 5, 2020 - Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) today reported results for the quarter ended September 30, 2020.
Mr. Kåre Schultz, Teva's President and CEO, said, "Teva's business and operations have shown resilience as the COVID-19 pandemic continues to impact the world. The quarter saw continued strong performance from our key growth drivers, led by AUSTEDO® and the biosimilar TRUXIMA®, while the market share of AJOVY® continued to grow in the U.S. and Europe. During this quarter we also launched our digital inhalers AirDuo® Digihaler® and ArmonAir® Digihaler® in the U.S. The DigiHaler® portfolio is now the first and only family of digital inhalers with built-in sensors available to patients."
Mr. Schultz continued, "Over the past three years we have reduced our net debt by more than \$10 billion to \$23.8 billion. This debt reduction, and the continued improvement of our profitability, keeps us on track to achieve our long-term financial targets by the end of 2023."
Third Quarter 2020 Consolidated Results
Revenues in the third quarter of 2020 were \$3,978 million, a decrease of 3% in both U.S. dollar and local currency terms, compared to the third quarter of 2019. This decrease was mainly due to lower revenues from generics, OTC and COPAXONE® in all regions and lower revenues from QVAR® and BENDEKA®/TREANDA® in our North America segment, as well as reduced demand for certain products resulting from the impact of the COVID-19 pandemic, partially offset by higher revenues from AUSTEDO and AJOVY.
Exchange rate differences between the third quarter of 2020 and the third quarter of 2019, including hedging effects, positively impacted our revenues by \$14 million and negatively impacted our GAAP and non-GAAP operating income by \$18 million and \$13 million, respectively.
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 | ||
|---|---|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |||
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 | ||
| Israel | Yonatan Beker | 972 (54) 888 5898 |
GAAP gross profit was \$1,852 million in the third quarter of 2020, an increase of 1% compared to the third quarter of 2019. GAAP gross profit margin was 46.6% in the third quarter of 2020, compared to 44.7% in the third quarter of 2019. The increase in gross profit margin was mainly due to higher profitability in North America resulting from the change in mix of products as well as operational cost efficiencies and network optimization, partially offset by lower sales of COPAXONE and other specialty products in all segments. Non-GAAP gross profit was \$2,084 million in the third quarter of 2020, a decrease of 1% compared to the third quarter of 2019. Non-GAAP gross profit margin was 52.4% in the third quarter of 2020, compared to 51.4% in the third quarter of 2019.
GAAP Research and Development (R&D) expenses in the third quarter of 2020 were \$258 million, an increase of 7% compared to the third quarter of 2019. Non-GAAP R&D expenses were \$233 million, or 5.8% of quarterly revenues, in the third quarter of 2020, compared to \$242 million, or 5.9%, in the third quarter of 2019. In the third quarter of 2020, our R&D expenses related primarily to specialty product candidates in the pain, respiratory and neuropsychiatry therapeutic areas, with additional activities in selected other areas and generic products including biosimilars. Our higher R&D expenses in the third quarter of 2020, compared to the third quarter of 2019, were mainly due to an upfront payment made in the third quarter of 2020.
GAAP Selling and Marketing (S&M) expenses in the third quarter of 2020 were \$605 million, an increase of 2% compared to the third quarter of 2019. Non-GAAP S&M expenses were \$566 million, or 14.2% of quarterly revenues, in the third quarter of 2020, compared to \$551 million, or 13.5%, in the third quarter of 2019.
GAAP General and Administrative (G&A) expenses in the third quarter of 2020 were \$279 million, a decrease of 2% compared to the third quarter of 2019. Non-GAAP G&A expenses were \$269 million, or 6.8% of quarterly revenues, in the third quarter of 2020, compared to \$270 million, or 6.6%, in the third quarter of 2019.
We recorded a goodwill impairment charge of \$4,628 million related to our North America reporting unit in the third quarter of 2020, in connection with current market capitalization influenced by uncertainty regarding the timeframe for resolution of certain litigations.
Other income in the third quarter of 2020 was \$8 million, compared to \$14 million in the third quarter of 2019.
GAAP operating loss in the third quarter of 2020 was \$4,342 million, compared to GAAP operating loss of \$81 million in the third quarter of 2019. This decrease was mainly due to the goodwill impairment charge and higher intangible asset impairment in the third quarter of 2020, partially offset by lower legal settlements and loss contingencies charges in the third quarter of 2020.
Non-GAAP operating income in the third quarter of 2020 was \$1,025 million, a decrease of 3%, compared to \$1,051 million in the third quarter of 2019.
EBITDA (non-GAAP operating income, which excludes amortization and certain other items, as well as depreciation expenses) was \$1,153 million in the third quarter of 2020, a decrease of 3% compared to \$1,183 million in the third quarter of 2019.
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 |
|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 |
| Israel | Yonatan Beker | 972 (54) 888 5898 |
GAAP financial expenses were \$117 million in the third quarter of 2020, compared to \$211 million in the third quarter of 2019. Non-GAAP financial expenses were \$241 million in the third quarter of 2020, compared to \$208 million in the third quarter of 2019.
In the third quarter of 2020, we recognized a GAAP tax expense of \$16 million, on pre-tax loss of \$4,459 million. In the third quarter of 2019, we recognized a tax expense of \$11 million, on pretax loss of \$292 million. Our tax rate for the third quarter of 2020 was mainly affected by the goodwill impairment charge that does not have a corresponding tax effect and other changes to tax positions and deductions. Non-GAAP income taxes for the third quarter of 2020 were \$133 million, or 17%, on pre-tax non-GAAP income of \$784 million. Non-GAAP income taxes in the third quarter of 2019 were \$183 million, or 22%, on pre-tax non-GAAP income of \$843 million.
We expect our annual non-GAAP tax rate for 2020 to be 17-18%, unchanged from our outlook provided in February 2020.
GAAP net loss attributable to Teva and GAAP diluted loss per share were \$4,349 million and \$3.97 respectively, in the third quarter of 2020, compared to GAAP net loss and GAAP diluted loss per share of \$314 million and \$0.29 in the third quarter of 2019. This decrease was mainly due to the goodwill impairment charge and higher intangible asset impairment charges in the third quarter of 2020, partially offset by lower legal settlements and loss contingencies in the third quarter of 2020. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS in the third quarter of 2020 were \$637 million and \$0.58, respectively, compared to \$637 million and \$0.58 in the third quarter of 2019.
The weighted average diluted shares outstanding used for the fully diluted share calculation for the three months ended September 30, 2020 and 2019 was 1,096 million and 1,092 million shares, respectively. The weighted average diluted shares outstanding used for the fully diluted share calculation on a non-GAAP basis for the three months ended September 30, 2020 and 2019 was 1,100 million and 1,093 million shares, respectively.
As of September 30, 2020 and 2019, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,118 million and 1,107 million, respectively.
Non-GAAP information: Net non-GAAP adjustments in the third quarter of 2020 were \$4,986 million. Non-GAAP net income and non-GAAP EPS for the third quarter of 2020 were adjusted to exclude the following items:
- A goodwill impairment charge of \$4,628 million related to our North America reporting unit in the third quarter of 2020;
- \$565 million impairment of long-lived assets comprised mainly of impairments of identifiable intangible assets totaling \$509 million (\$360 million of IPR&D assets and \$149 million of identifiable product rights);
- Amortization of purchased intangible assets of \$251 million, of which \$221 million is included in cost of sales and the remaining \$31 million in S&M expenses;
- Contingent consideration income of \$179 million, mainly related to a decrease in future royalties;
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 |
|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 |
| Israel | Yonatan Beker | 972 (54) 888 5898 |
- Gain from equity investment of \$134 million, reflecting the difference between the book value of our investment in American Well Corporation and its fair value as of the date it completed its initial public offering in September 2020;
- Finance income of \$124 million, mainly related to the American Well equity holding;
- Purchase of in-process R&D of \$21 million;
- Legal settlements and loss contingencies of \$21 million;
- Equity compensation expenses of \$30 million;
- Other items of \$24 million; and
- Income tax of \$117 million.
Teva believes that excluding such items facilitates investors' understanding of its business. For further information, see the tables below for a reconciliation of the U.S. GAAP results to the adjusted non-GAAP figures and the information under "Non-GAAP Financial Measures." Investors should consider non-GAAP financial measures in addition to, and not as replacement for, or superior to, measures of financial performance prepared in accordance with GAAP.
Cash flow generated from operating activities during the third quarter of 2020 was \$307 million, compared to \$325 million in the third quarter of 2019. The decrease in the third quarter of 2020 was mainly due to an increase in inventory during the third quarter of 2020 compared to a decrease in inventory in the third quarter of 2019.
Free cash flow (cash flow generated from operating activities, net of cash received for capital investments and beneficial interest collected in exchange for securitized trade receivables) was \$506 million in the third quarter of 2020, compared to \$551 million in the third quarter of 2019. The decrease in the third quarter of 2020 resulted mainly from lower cash flow generated from operating activities.
As of September 30, 2020, our debt was \$25,621 million, compared to \$26,266 million as of June 30, 2020. This decrease was mainly due the repayment at maturity of our €1,010 million 0.375% senior notes in July 2020, partially offset by exchange rate fluctuations. The portion of total debt classified as short-term as of September 30, 2020 was 8%, compared to 6% June 30, 2020. Our average debt maturity was approximately 6 years as of September 30, 2020, compared to 6.1 years as of June 30, 2020. Our financial leverage was 71% as of September 30, 2020, compared to 64% as of June 30, 2020.
IR Contacts United States Kevin C. Mannix (215) 591-8912 Israel Yael Ashman 972 (3) 914-8262 PR Contacts United States Kelley Dougherty
Israel
Yonatan Beker
Segment Results for the Third Quarter of 2020
North America Segment
Our North America segment includes the United States and Canada.
The following table presents revenues, expenses and profit for our North America segment for the three months ended September 30, 2020 and 2019:
| Three months ended September 30, | |||||||
|---|---|---|---|---|---|---|---|
| 2020 | 2019 | ||||||
| (U.S. \$ inmillions / % ofSegmentRevenues) | |||||||
| Revenues | \$ | 2,017 | 100% | \$ | 2,051 | 100% | |
| Gross profit | 1,056 | 52.4% | 1,048 | 51.1% | |||
| R&D expenses | 155 | 7.7% | 156 | 7.6% | |||
| S&M expenses | 250 | 12.4% | 219 | 10.7% | |||
| G&A expenses | 97 | 4.8% | 112 | 5.5% | |||
| Other (income) expense | (5) | § | (5) | § | |||
| Segment profit* | \$ | 560 | 27.7% | \$ | 565 | 27.5% |
* Segment profit does notincludeamortizationand certain otheritems.
§ Represents an amount lessthan0.5%.
Revenues from our North America segment in the third quarter of 2020 were \$2,017 million, a decrease of \$34 million, or 2%, compared to the third quarter of 2019, mainly due to a decrease in revenues of COPAXONE and BENDEKA/TREANDA, partially offset by higher revenues from AUSTEDO, generic products and AJOVY. Our North America segment has experienced some reductions in volume due to less physician and hospital activity during the COVID-19 pandemic, but has also experienced increase in demand for certain products related to the treatment of COVID-19 and its symptoms. In addition, the ability to promote our new specialty products, primarily AJOVY and AUSTEDO, has been impacted by less physician visits by patients and less physician interactions by our sales personnel.
Revenues in the United States, our largest market, were \$1,887 million in the third quarter of 2020, a decrease of \$20 million, or 1%, compared to the third quarter of 2019.
Revenues by Major Products and Activities
The following table presents revenues for our North America segment by major products and activities for the three months ended September 30, 2020 and 2019:
IR Contacts United States Kevin C. Mannix (215) 591-8912 Israel Yael Ashman 972 (3) 914-8262 PR Contacts United States Israel Kelley Dougherty Yonatan Beker (973) 832-2810 972 (54) 888 5898
| Three months ended September 30, |
Percentage Change |
||||
|---|---|---|---|---|---|
| 2020 | 2019 | 2019-2020 | |||
| (U.S. \$ inmillions) | |||||
| Generic products | \$ 928 |
\$ | 914 | 2% | |
| AJOVY | 35 | 25 | 42% | ||
| AUSTEDO | 168 | 105 | 60% | ||
| BENDEKA/TREANDA | 105 | 124 | (15%) | ||
| COPAXONE | 236 | 271 | (13%) | ||
| ProAir* | 50 | 71 | (30%) | ||
| QVAR | 42 | 60 | (29%) | ||
| Anda | 341 | 351 | (3%) | ||
| Other | 113 | 131 | (14%) | ||
| Total | \$ 2,017 |
\$ | 2,051 | (2%) | |
| ___ |
* Does not includerevenuesfromthe ProAir authorized generic,which are included under generic products.
Generic products revenues in our North America segment (including biosimilars) in the third quarter of 2020 were \$928 million, an increase of 2% compared to the third quarter of 2019. This increase was mainly due to higher revenues from TRUXIMA and from our ProAir® authorized generic, partially offset by lower volume of other generic products.
On September 30, 2020, we launched emtricitabine and tenofovir disoproxil fumarate tablets, 200mg/300mg (the generic equivalent of Truvada®), and efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets (the generic equivalent for Atripla®) for the prevention and treatment of HIV, respectively. We did not recognize revenues for these products in the third quarter of 2020.
In the third quarter of 2020, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 365 million total prescriptions (based on trailing twelve months), representing 10.0% of total U.S. generic prescriptions according to IQVIA data.
AJOVY revenues in our North America segment in the third quarter of 2020 were \$35 million, an increase of \$10 million, or 42% compared to the third quarter of 2019, mainly due to growth in volume in the third quarter of 2020.
AUSTEDO revenues in our North America segment in the third quarter of 2020 increased by 60% to \$168 million, compared to \$105 million in the third quarter of 2019. This increase was mainly due to growth in volume in the third quarter of 2020.
IR Contacts United States Kevin C. Mannix (215) 591-8912 PR Contacts United States
Israel Yael Ashman 972 (3) 914-8262
Israel
Kelley Dougherty Yonatan Beker
BENDEKA andTREANDA combined revenues in our North America segment in the third quarter of 2020 decreased by 15% to \$105 million, compared to the third quarter of 2019, mainly due to the emergence of alternative novel therapies and continued competition from Belrapzo® (a ready-to-dilute bendamustine hydrochloride product from Eagle Pharmaceuticals, Inc.).
COPAXONE revenues in our North America segment in the third quarter of 2020 decreased by 13% to \$236 million, compared to the third quarter of 2019, mainly due to generic competition in the United States.
ProAir revenues in our North America segment in the third quarter of 2020 decreased by 30% to \$50 million, compared to the third quarter of 2019. In January 2019, we launched our own ProAir authorized generic in the United States following the launch of a generic version of Ventolin® HFA, another albuterol inhaler. Revenues from our ProAir HFA authorized generic are included in "generic products" above. In July 2020, we announced the launch of ProAir® Digihaler® (albuterol sulfate 117 mcg) inhalation powder, which is the first and only digital rescue inhaler with built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. In September 2020, we announced the launch of AirDuo Digihaler (fluticasone propionate and salmeterol) inhalation powder and the launch of ArmonAir Digihaler (fluticasone propionate) inhalation powder, two digital maintenance inhalers for adolescent and adult patients with asthma.
QVAR revenues in our North America segment in the third quarter of 2020 decreased by 29% to \$42 million, compared to the third quarter of 2019, mainly due to increased price competition and lower volumes.
Anda revenues in our North America segment in the third quarter of 2020 decreased by 3% to \$341 million, compared to \$351 million in the third quarter of 2019, mainly due to slightly lower demand.
North America Gross Profit
Gross profit from our North America segment in the third quarter of 2020 was \$1,056 million, an increase of 1%, compared to \$1,048 million in the third quarter of 2019.
Gross profit margin for our North America segment in the third quarter of 2020 increased to 52.4%, compared to 51.1% in the third quarter of 2019. This increase was mainly due to the change in mix of products.
North America Profit
Profit from our North America segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our North America segment in the third quarter of 2020 was \$560 million, flat compared to \$565 million in the third quarter of 2019, mainly due to lower revenues, offset by a change in mix of products.
IR Contacts United States Kevin C. Mannix (215) 591-8912 Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States
Israel
Kelley Dougherty Yonatan Beker
Europe Segment
Our Europe segment includes the European Union and certain other European countries.
The following table presents revenues, expenses and profit for our Europe segment for the three months ended September 30, 2020 and 2019:
| Three months ended September 30, | |||||||
|---|---|---|---|---|---|---|---|
| 2020 | 2019 | ||||||
| (U.S. \$ inmillions / % ofSegmentRevenues) | |||||||
| Revenues | \$ | 1,116 | 100% | \$ | 1,163 | 100% | |
| Gross profit | 637 | 57.1% | 662 | 56.9% | |||
| R&D expenses | 60 | 5.4% | 63 | 5.4% | |||
| S&M expenses | 200 | 17.9% | 206 | 17.7% | |||
| G&A expenses | 66 | 5.9% | 56 | 4.9% | |||
| Other (income) expense | (1) | § | (4) | § | |||
| Segment profit* | \$ | 312 | 28.0% | \$ | 341 | 29.3% |
* Segment profit does notincludeamortizationand certain otheritems.
§ Represents an amount lessthan0.5%.
___________
Revenues from our Europe segment in the third quarter of 2020 were \$1,116 million, a decrease of 4%, or \$47 million, compared to the third quarter of 2019. In local currency terms, revenues decreased by 7%, mainly due to reduced demand for certain products resulting from the COVID-19 pandemic. The COVID-19 pandemic has led to a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the third quarter of 2020. This decrease is also attributed to price declines for oncology products as a result of generic competition and a decline in COPAXONE revenues due to competing glatiramer acetate products.
Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the three months ended September 30, 2020 and 2019:
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 |
|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 |
| Israel | Yonatan Beker | 972 (54) 888 5898 |
| Three months ended September 30, |
Percentage Change |
||||
|---|---|---|---|---|---|
| 2020 | 2019 | 2019-2020 | |||
| (U.S. \$ inmillions) | |||||
| Generic products | \$ | 824 | \$ | 836 | (1%) |
| COPAXONE | 101 | 106 | (5%) | ||
| Respiratory products | 77 | 87 | (12%) | ||
| AJOVY | 8 | 1 | NA | ||
| Other | 106 | 134 | (21%) | ||
| Total | \$ | 1,116 | \$ | 1,163 | (4%) |
Generic products revenues in our Europe segment in the third quarter of 2020, including OTC products, decreased by 1% to \$824 million, compared to the third quarter of 2019. In local currency terms, revenues decreased by 6% compared to the third quarter of 2019, mainly due to a reduced demand for certain products resulting from the COVID-19 pandemic. The COVID-19 pandemic has led to a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the third quarter of 2020.
COPAXONE revenues in our Europe segment in the third quarter of 2020 decreased by 5% to \$101 million, compared to the third quarter of 2019. In local currency terms, revenues decreased by 9%, due to price reductions and a decline in volume resulting from competing glatiramer acetate products.
Respiratory products revenues in our Europe segment in the third quarter of 2020 decreased by 12% to \$77 million, compared to the third quarter of 2019. In local currency terms, revenues decreased by 15%, mainly due to reduced demand resulting from the impact the COVID-19 pandemic had on purchasing patterns. The COVID-19 pandemic led to increased demand in the first quarter and a correlating decrease in the following quarters.
AJOVY revenues in our Europe segment in the third quarter of 2020 were \$8 million, compared to \$1 million in the third quarter of 2019.
Europe Gross Profit
Gross profit from our Europe segment in the third quarter of 2020 was \$637 million, a decrease of 4% compared to \$662 million in the third quarter of 2019. This decrease was mainly due to lower revenues, as discussed above.
Gross profit margin for our Europe segment in the third quarter of 2020 increased to 57.1%, compared to 56.9% in the third quarter of 2019.
Europe Profit
Profit from our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 |
|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 |
| Israel | Yonatan Beker | 972 (54) 888 5898 |
Profit from our Europe segment in the third quarter of 2020 was \$312 million, a decrease of 8%, compared to \$341 million in the third quarter of 2019. This decrease was mainly due to lower revenues, as discussed above.
International Markets Segment
Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The key markets in this segment are Japan, Russia and Israel.
On July 30, 2020, we entered into an agreement to sell the majority of the generic and operational assets of our business venture in Japan. We expect this transaction to close by early 2021. The closing of the transaction is subject to customary closing conditions.
The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2020 and 2019:
| Three months ended September 30, | ||||||
|---|---|---|---|---|---|---|
| 2020 | 2019** | |||||
| (U.S. \$ inmillions / % ofSegmentRevenues) | ||||||
| Revenues | \$ | 529 | 100% | \$ | 565 | 100% |
| Gross profit | 275 | 52.0% | 295 | 52.2% | ||
| R&D expenses | 17 | 3.2% | 21 | 3.7% | ||
| S&M expenses | 101 | 19.1% | 114 | 20.1% | ||
| G&A expenses | 33 | 6.3% | 32 | 5.6% | ||
| Other (income) expense | (1) | § | (1) | § | ||
| Segment profit* | \$ | 125 | 23.6% | \$ | 130 | 23.0% |
§ Represents an amount lessthan0.5%.
__________
* Segment profit does notincludeamortizationand certain otheritems.
**The data presentedfor prior periods have been revised to reflect a revision in the presentationof net revenues and costofsalesin the consolidated financialstatements.See note 1c to our consolidated financialstatementsfor additionalinformation.
Revenues from our International Markets segment in the third quarter of 2020 were \$529 million, a decrease of \$35 million, or 6%, compared to the third quarter of 2019. In local currency terms, revenues decreased by 1% compared to the third quarter of 2019, mainly due to lower sales in Japan resulting from regulatory price reductions and generic competition to off-patented products, as well as loss of revenues from the sale of certain assets in the Israeli market, partially offset by higher revenues in other markets. Revenues in the third quarter of 2020 were also impacted by reduced demand for certain products resulting from the impact of the COVID-19 pandemic. The
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 |
|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 |
| Israel | Yonatan Beker | 972 (54) 888 5898 |
COVID-19 pandemic has led to a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the third quarter of 2020.
Revenues by Major Products and Activities
The following table presents revenues for our International Markets segment by major products and activities for the three months ended September 30, 2020 and 2019:
| Three months ended September 30, |
Percentage Change 2019-2020 |
||||
|---|---|---|---|---|---|
| 2020 2019* |
|||||
| (U.S. \$ inmillions) | |||||
| Generic products | \$ | 429 | \$ | 474 | (10%) |
| COPAXONE | 14 | 20 | (27%) | ||
| Other | 86 | 71 | 21% | ||
| Total | \$ | 529 | \$ | 565 | (6%) |
*The data presented for prior periods have beenrevisedto reflect a revisionin the presentationof net revenues and costofsalesin the consolidated financialstatements.See note 1c to our consolidated financialstatementsfor additionalinformation.
Generic products revenues in our International Markets segment in the third quarter of 2020, which include OTC products, decreased by 10% to \$429 million, compared to the third quarter of 2019. In local currency terms, revenues decreased by 4%, mainly due to lower sales in Japan resulting from regulatory price reductions and generic competition to off-patented products. Revenues in the third quarter of 2020 were also impacted by reduced demand for certain products resulting from the impact of the COVID-19 pandemic. The COVID-19 pandemic has led to a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the third quarter of 2020.
COPAXONE revenues in our International Markets segment in the third quarter of 2020 decreased by 27% to \$14 million, compared to \$20 million in the third quarter of 2019. In local currency terms, revenues decreased by 14%.
AJOVY On May 12, 2017, we entered into a license and collaboration agreement with Otsuka Pharmaceutical Co., Ltd. ("Otsuka") providing Otsuka with an exclusive license to conduct phase 2 and 3 clinical trials for AJOVY in Japan and, once approved, to commercialize the product in Japan. On July 29, 2020, Otsuka submitted an application to obtain manufacturing and marketing approval for AJOVY in Japan. As a result, Otsuka paid Teva a milestone payment of \$15 million in the third quarter of 2020, which was recorded as revenue under "Other" in the table above.
IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States
Israel
Kelley Dougherty Yonatan Beker
International Markets Gross Profit
Gross profit from our International Markets segment in the third quarter of 2020 was \$275 million, a decrease of 7% compared to \$295 million in the third quarter of 2019.
Gross profit margin for our International Markets segment in the third quarter of 2020 decreased to 52.0%, compared to 52.2% in the third quarter of 2019. This decrease was mainly due to a different portfolio mix.
International Markets Profit
Profit from our International Markets segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our International Markets segment in the third quarter of 2020 was \$125 million, a decrease of 4%, compared to \$130 million in the third quarter of 2019. This decrease was mainly due to lower sales in Japan, partially offset by lower S&M expenses.
Other Activities
We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments described above.
Our revenues from other activities in the third quarter of 2020 were \$316 million, an increase of 1% compared to the third quarter of 2019. In local currency terms, revenues decreased by 1%.
API sales to third parties in the third quarter of 2020 were \$175 million, flat in both U.S. dollar and local currency terms, compared to the third quarter of 2019.
IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States
Israel
Kelley Dougherty Yonatan Beker
Conference Call
Teva will host a conference call and live webcast including a slide presentation on November 5, 2020 at 8:00 a.m. ET to discuss its third quarter of 2020 results and overall business environment. A question & answer session will follow.
United States 1 (866) 966-1396
International +44 (0) 2071 928000
Israel 1 (809) 203-624
Passcode: 7275239.
A live webcast of the call will be available on Teva's website at: ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the required software.
Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company's website or by calling United States 1-866-331-1332; International +44 (0) 3333 009785; passcode: 7275239.
IR Contacts United States Kevin C. Mannix (215) 591-8912
Israel Yael Ashman 972 (3) 914-8262
PR Contacts United States
Israel
Kelley Dougherty Yonatan Beker
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people's lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.
Some amounts in this press release may not add up due to rounding. All percentages have been calculated using unrounded amounts.
Non-GAAP Financial Measures
This press release contains certain financialinformation thatdiffers fromwhat is reported under accountingprinciples generally accepted in the UnitedStates("GAAP").Thesenon-GAAPfinancialmeasures,including, but not limited to, non-GAAPEPS, non-GAAPoperatingincome, non-GAAPgross profit, non-GAAPgross profit margin,EBITDA, non-GAAPfinancialexpenses, non-GAAPincome taxes, non-GAAPnet income andnon-GAAPdilutedEPSare presented in order to facilitates investors' understanding of our business. We utilize certain non-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the non-GAAP measures: our management and board of directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; our annualbudgets are prepared on a non-GAAPbasis; and seniormanagement's annualcompensation is derived,in part, using thesenon-GAAPmeasures.See theattachedtablesfor a reconciliationofthe GAAPresultsto the adjusted non-GAAP figures. Investors should consider non-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP. We are not providing forwardlooking guidance forGAAPreported financialmeasures or a quantitativereconciliationofforwardlooking non-GAAPfinancialmeasurestothe most directly comparable GAAPmeasure because we areunable topredict with reasonable certainty the ultimate outcome of certain significant items withoutunreasonable effort.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaningofthe Private Securities LitigationReform Act of 1995, which are basedon management's current beliefs andexpectations andare subject tosubstantialrisks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly fromthat expressed orimplied by such forward-lookingstatements.Important factorsthat could cause or contribute to such differencesincluderisks relatingto:
• our ability to successfully competein the marketplace,including:that we are substantially dependent on our generic products;consolidation of our customer baseand commercialalliances among our customers;the increase in the number of competitorstargeting generic opportunities and seekingU.S. market exclusivity for generic versions ofsignificant products;competitionfor ourspecialtyproducts, especially COPAXONE®, ourleading medicine,which faces competition fromexisting and potential additionalgeneric versions, competing glatiramer acetate products andorally-administeredalternatives; the uncertainty of commercialsuccess ofAJOVY® orAUSTEDO®; competition fromcompanies with greaterresources andcapabilities; delaysin launches of newproducts andour ability to achieveexpected results frominvestmentsin our product pipeline; ability to developand commercialize biopharmaceuticalproducts; efforts of pharmaceuticalcompaniesto limit the use of generics,including
| IR Contacts | United States | Kevin C. Mannix | (215) 591-8912 |
|---|---|---|---|
| Israel | Yael Ashman | 972 (3) 914-8262 | |
| PR Contacts | United States | Kelley Dougherty | (973) 832-2810 |
| Israel | Yonatan Beker | 972 (54) 888 5898 |
throughlegislationandregulations andthe effectiveness of our patents andothermeasuresto protectour intellectualpropertyrights;
- oursubstantialindebtedness,which may limit our ability to incur additionalindebtedness, engagein additionaltransactions ormake newinvestments,may result in a further downgradeof our credit ratings; and ourinability to raise debt or borrowfundsin amounts or on terms that are favorable to us;
- our business andoperationsin general,including:uncertainty regarding the magnitude, duration, and geographic reach ofthe COVID-19 pandemic and its impact on our business,financialcondition, operations, cash flows, and liquidityand onthe economy in general; our ability to successfully execute and maintain the activities and efforts related to the measures we have takenormay take in response to the COVID-19 pandemic and associatedcoststherewith; effectiveness of ourrestructuring plan announcedin December 2017; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additionalpharmaceuticalproducts; compliancewith anti-corruption sanctions and trade controllaws; manufacturingor qualitycontrolproblems; interruptionsin oursupply chain,including due to potentialeffects ofthe COVID-19 pandemic on our operations and businessin geographic locationsimpacted bythe pandemic and onthe business operations of oursuppliers; disruptions ofinformationtechnologysystems;breaches of our datasecurity;variationsin intellectual propertylaws; challenges associatedwith conductingbusiness globally,includingadverse effects ofthe COVID-19 pandemic, politicalor economic instability,major hostilities orterrorism;significantsalesto a limited number of customers;our ability to successfully bid forsuitable acquisitiontargets orlicensing opportunities, orto consummate andintegrate acquisitions;our prospects and opportunitiesfor growth if we sellassets; and potentialdifficulties relatedto theoperation of our newglobalenterprise resource planning (ERP)system;
- compliance,regulatoryand litigation matters,including:our ability to successfully defend againstthe U.S. Department ofJustice criminalcharges ofSherman Act violations;increased legalandregulatory action in connectionwith public concern overthe abuseof opioid medicationsin the U.S. and our ability to reach a final resolution ofthe remaining opioid-related litigation; costs and delaysresulting fromthe extensive governmentalregulationto which we are subjector delaysin governmentalprocessingtime due to modified governmentoperations dueto the COVID-19 pandemic,includingeffects onproduct and patent approvals due to the COVID-19 pandemic; the effects ofreforms in healthcare regulationand reductionsin pharmaceuticalpricing,reimbursementandcoverage;governmentalinvestigations into S&M practices; potentialliability for patentinfringement;product liability claims; increasedgovernment scrutinyof our patentsettlement agreements;failure to comply with complexMedicare and Medicaid reporting andpaymentobligations;and environmentalrisks;
- otherfinancialand economic risks,including:our exposure to currencyfluctuations andrestrictions as well as credit risks; potentialimpairments of ourintangible assets; potentialsignificantincreasesin tax liabilities; and the effect on our overalleffective taxrate ofthe termination or expiration of governmentalprograms ortaxbenefits, or of a changein our business;
and otherfactors discussedin this pressrelease,in ourQuarterly Report onForm10-Q forthe third quarter of 2020 and in ourAnnualReport on Form10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors" and"Forward LookingStatements." Forward-lookingstatementsspeakonly as ofthe date onwhich theyare made, and we assume no obligation to updateorrevise anyforward-lookingstatements or otherinformation contained herein,whether as a result of newinformation,future events or otherwise.You are cautionednot to putundue reliance on theseforward-lookingstatements.
#
IR Contacts United States Kevin C. Mannix (215) 591-8912 Israel Yael Ashman 972 (3) 914-8262 PR Contacts United States Israel Kelley Dougherty Yonatan Beker (973) 832-2810 972 (54) 888 5898
Consolidated Statements of Income
(U.S. dollars in millions, except share and per share data)
| Three months ended September 30, |
Nine months ended September 30, |
||||
|---|---|---|---|---|---|
| 2020 | 2019 | 2020 | 2019 | ||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | ||
| Net revenues | 3,978 | 4,093 | 12,206 | 12,420 | |
| Cost of sales | 2,126 | 2,264 | 6,528 | 6,841 | |
| Gross profit | 1,852 | 1,830 | 5,678 | 5,579 | |
| Research and development expenses | 258 | 240 | 704 | 778 | |
| Selling and marketing expenses | 605 | 595 | 1,815 | 1,908 | |
| General and administrative expenses | 279 | 285 | 846 | 873 | |
| Intangible assets impairments | 509 | 177 | 1,278 | 1,206 | |
| Goodwill impairment | 4,628 | - | 4,628 | - | |
| Other asset impairments, restructuring and other items | (98) | 160 | 404 | 263 | |
| Legal settlements and loss contingencies | 21 | 468 | 10 | 1,171 | |
| Other income | (8) | (14) | (30) | (29) | |
| Operating (loss) income | (4,342) | (81) | (3,978) | (591) | |
| Financial expenses, net | 117 | 211 | 565 | 635 | |
| Income (loss) before income taxes | (4,459) | (292) | (4,543) | (1,226) | |
| Income taxes (benefit) | 16 | 11 | (147) | (159) | |
| Share in (profits) losses of associated companies- net | (136) | 4 | (135) | 8 | |
| Net income (loss) | (4,340) | (307) | (4,261) | (1,076) | |
| Net income (loss) attributable to non-controlling interests | 10 | 7 | (121) | 33 | |
| Net income (loss) attributable to Teva | (4,349) | (314) | (4,140) | (1,108) | |
| Earnings (loss) per share attributable to Teva: | Basic (\$) | (3.97) | (0.29) | (3.78) | (1.02) |
|---|---|---|---|---|---|
| Diluted (\$) | (3.97) | (0.29) | (3.78) | (1.02) | |
| Weighted average number of shares (in millions): | Basic | 1,096 | 1,092 | 1,095 | 1,091 |
| Diluted | 1,096 | 1,092 | 1,095 | 1,091 |
| Non-GAAP net income attributable to Teva:* | 637 | 637 | 2,077 | 1,943 | |
|---|---|---|---|---|---|
| Non-GAAP net income attributable to Teva for diluted earnings per share: | 637 | 637 | 2,077 | 1,943 | |
| Non-GAAP earnings per share attributable to Teva:* | Basic (\$) | 0.58 | 0.58 | 1.90 | 1.78 |
| Diluted (\$) | 0.58 | 0.58 | 1.89 | 1.78 | |
| Non-GAAP average number of shares (in millions): | Basic | 1,096 | 1,092 | 1,095 | 1,091 |
| Diluted | 1,100 | 1,093 | 1,099 | 1,093 |
* See reconciliation attached.
Condensed Consolidated Balance Sheets
(U.S. dollars in millions)
| September 30, | December 31, | |
|---|---|---|
| 2020 | 2019 | |
| ASSETS | (Unaudited) | (Audited) |
| Current assets: | ||
| Cash and cash equivalents | 1,827 | 1,975 |
| Accounts receivables, net of allowance for credit losses of \$117 million and \$135 million as of September 30, 2020 and December 31, 2019 |
||
| 4,385 | 5,676 | |
| Inventories | 4,516 | 4,422 |
| Prepaid expenses | 895 | 870 |
| Other current assets | 423 | 434 |
| Assets held for sale | 113 | 87 |
| Total current assets | 12,160 | 13,464 |
| Deferred income taxes | 509 | 386 |
| Other non-current assets | 822 | 591 |
| Property, plant and equipment, net | 6,152 | 6,436 |
| Operating lease right-of-use assets | 557 | 514 |
| Identifiable intangible assets, net | 9,308 | 11,232 |
| Goodwill | 20,228 | 24,846 |
| Total assets | 49,737 | 57,470 |
| LIABILITIES & EQUITY Current liabilities: |
||
| Short-term debt | 2,106 | 2,345 |
| Sales reserves and allowances | 4,998 | 6,159 |
| Accounts payables | 1,716 | 1,718 |
| 601 | ||
| Employee-related obligations | 1,735 | 693 |
| Accrued expenses | 946 | 1,869 |
| Other current liabilities | 889 | |
| Total current liabilities | 12,103 | 13,674 |
| Long-term liabilities: | ||
| Deferred income taxes | 874 | 1,096 |
| Other taxes and long-term liabilities | 2,181 | 2,640 |
| Senior notes and loans | 23,515 | 24,562 |
| Operating lease liabilities | 472 | 435 |
| Total long-term liabilities | 27,042 | 28,733 |
| Equity: | ||
| Teva shareholders' equity | 9,593 | 13,972 |
| Non-controlling interests | 999 | 1,091 |
| Total equity | 10,592 | 15,063 |
| Total liabilities and equity | 49,737 | 57,470 |
TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CASH FLOWS (U.S. dollars in millions) (Unaudited)
| Nine months ended | Three months ended September 30, |
|||||
|---|---|---|---|---|---|---|
| September 30, | ||||||
| Operating activities: | 2020 | 2019 | 2020 | 2019 | ||
| (4,261) | ||||||
| Net income (loss) | \$ | (1,076) | (4,339) | \$ | (308) | |
| Adjustments to reconcile net income (loss) to net cash provided by operations: | ||||||
| Depreciation and amortization | 1,162 | 1,306 | 381 | 413 | ||
| Impairment of long-lived assets and assets held for sale | 6,314 | 1,302 | 5,194 | 205 | ||
| Net change in operating assets and liabilities | (1,627) | (784) | (625) | 272 | ||
| Deferred income taxes – net and uncertain tax positions | (656) | (652) | (154) | (290) | ||
| Stock-based compensation | 91 | 99 | 29 | 35 | ||
| Net loss (gain) from investments and from sale of long lived assets | (232) | 10 | (256) | 4 | ||
| Research and development in process | 40 | - | 40 | - | ||
| Other items | 54 | 5 | 37 | (6) | ||
| Net cash provided by operating activities | 885 | 210 | 307 | 325 | ||
| Investing activities: | ||||||
| Beneficial interest collected in exchange for securitized accounts receivables | 1,102 | 1,108 | 333 | 362 | ||
| Purchases of property, plant and equipment | (402) | (406) | (143) | (169) | ||
| Proceeds from sale of long-lived assets | 54 | 167 | 9 | 33 | ||
| Other investing activities | (32) | 56 | (42) | (2) | ||
| Net cash provided by investing activities | 722 | 925 | 157 | 224 | ||
| Financing activities: | ||||||
| Repayment of senior notes and loans and other long-term liabilities | (1,871) | (1,715) | (1,171) | (1,558) | ||
| Net change in short-term debt | 115 | 96 | 115 | 96 | ||
| Tax withholding payments made on shares and dividends | - | (52) | - | - | ||
| Other financing activities | (4) | (14) | (1) | 1 | ||
| Net cash used in financing activities | (1,760) | (1,685) | (1,057) | (1,461) | ||
| Translation adjustment on cash and cash equivalents Net change in cash and cash equivalents |
5 (148) |
9 (541) |
18 (575) |
(12) (924) |
||
| Balance of cash and cash equivalents at beginning of period | 1,975 | 1,782 | 2,402 | 2,165 | ||
| Balance of cash and cash equivalents at end of period | \$ 1,827 |
\$ | 1,241 | \$ 1,827 |
\$ | 1,241 |
| Non-cash financing and investing activities: | ||||||
| Beneficial interest obtained in exchange for securitized accounts receivables | \$ 1,055 |
\$ | 1,123 | \$ 327 |
\$ | 353 |
| GAAP | Excluded for non-GAAP measurement | Non-GAAP | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amortization of purchased intangible assets |
Legal settlements and loss contingencies |
Goodwill impairment |
Impairment of long lived assets |
Other R&D expenses |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Other non GAAP items |
Other items |
Corresponding tax effect |
|||
| Cost of sales | 2,126 | 221 | 6 | 7 | (2) | 1,894 | ||||||||
| R&D expenses | 258 | 21 | 5 | - | 233 | |||||||||
| S&M expenses | 605 | 31 | 8 | - | 566 | |||||||||
| G&A expenses Other (income) |
279 | 10 | - | 269 | ||||||||||
| expense Legal settlements and loss contingencies Other assets impairments, |
(8) 21 |
21 | - | (8) - |
||||||||||
| restructuring and other items Intangible assets |
(98) | 56 | 9 | (179) 15 |
- | |||||||||
| impairments | 509 | 509 | - | |||||||||||
| Goodwill impairment | 4,628 | 4,628 | - | |||||||||||
| Financial expenses, net Income taxes Share in losses of associated companies |
117 16 |
(124) | (117) | 241 133 |
||||||||||
| – net Net income (loss) attributable to non |
(136) | (134) | (1) | |||||||||||
| controlling interests | 10 | (6) | 15 | |||||||||||
| Total reconciled items | 251 | 21 | 4,628 | 565 | 21 | 9 6 |
30 | (179) 14 |
(264) | (117) | ||||
| EPS - Basic | (3.97) | 4.55 | 0.58 | |||||||||||
| EPS - Diluted | (3.97) | 4.55 | 0.58 |
Three Months Ended September 30, 2020 U.S. \$ and shares in millions (except per share amounts)
The non-GAAP diluted weighted average number of shares was 1,100 million for the three months ended September 30, 2020.
| GAAP | Excluded for non-GAAP measurement | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amortization of purchased intangible assets |
Legal settlements and loss contingencies |
Goodwill impairment |
Impairment of long-lived assets |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Other non GAAP items |
Other items |
Corresponding tax effect |
||||
| Cost of sales | 6,528 | 663 | 17 | 19 | 30 | 5,799 | ||||||||
| R&D expenses | 704 | 14 | 3 | 687 | ||||||||||
| S&M expenses | 1,815 | 95 | 25 | - | 1,695 | |||||||||
| G&A expenses | 846 | 31 | 12 | 803 | ||||||||||
| Other (income) expense | (30) | (3) | (27) | |||||||||||
| Legal settlements and loss contingencies Other assets impairments, |
10 | 10 | - | |||||||||||
| restructuring and other items | 404 | 408 | 82 | (96) 10 |
- | - | ||||||||
| Intangible assets impairment |
1,278 | 1,278 | - | |||||||||||
| Goodwill impairment | 4,628 | 4,628 | - | |||||||||||
| Financial expenses, net | 565 | (118) | 683 | |||||||||||
| Income taxes | (147) | (583) | 436 | |||||||||||
| Share in losses of associated companies – net |
||||||||||||||
| (135) | (134) | (1) | ||||||||||||
| Net income (loss) attributable to non-controlling interests |
||||||||||||||
| (121) | (174) | 53 | ||||||||||||
| Total reconciled items | 758 | 10 4,628 |
1,686 | 82 | 17 | 90 | (96) 52 |
(427) (583) |
||||||
| EPS - Basic | (3.78) | 5.68 | 1.90 | |||||||||||
| EPS - Diluted | (3.78) | 5.67 | 1.89 |
Nine Months Ended September 30, 2020 U.S. \$ and shares in millions (except per share amounts)
The non-GAAP diluted weighted average number of shares was 1,099 million for the nine months ended September 30, 2020.
| GAAP Excluded for non-GAAP measurement |
Non-GAAP | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amortization of purchased intangible assets |
Legal settlements and loss contingencies |
Impairment of long lived assets |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Gain on sale of business |
Other non GAAP items |
Other items |
Corresponding tax effect |
||||
| Cost of sales** | 2,264 | 220 | 11 | 7 | 35 | 1,990 | ||||||||
| R&D expenses | 240 | 5 | (7) | 242 | ||||||||||
| S&M expenses | 595 | 35 | 9 | 551 | ||||||||||
| G&A expenses | 285 | 14 | 1 | 270 | ||||||||||
| Other (income) expense (14) Legal settlements and |
(3) | (11) | ||||||||||||
| loss contingencies Other assets impairments, restructuring and other |
468 | 468 | - | |||||||||||
| items | 160 | 28 | 61 | 51 | 21 | - | ||||||||
| Intangible assets impairments |
177 | 177 | - | |||||||||||
| Financial expenses, net | 211 | 3 | 208 | |||||||||||
| Income taxes Share in losses of associated |
11 | (172) | 183 | |||||||||||
| companies – net Net income (loss) |
4 | 4 | ||||||||||||
| attributable to non controlling interests |
7 | (12) | 19 | |||||||||||
| Total reconciled items | 255 | 468 | 204 | 61 | 11 | 35 | 51 | (3) | 51 | (9) | (172) | |||
| EPS - Basic EPS - Diluted |
(0.29) (0.29) |
0.87 0.87 |
0.58 0.58 |
Three Months Ended September 30, 2019 U.S. \$ and shares in millions (except per share amounts)
**The data presented for prior periods has been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c to our consolidated financial statements for additional information.
The non-GAAP diluted weighted average number of shares was 1,093 million for the three months ended September 30, 2019.
Nine months ended September 30, 2019
| U.S. \$ and shares in millions (except per share amounts) | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| GAAP | Excluded for non-GAAP measurement | Non GAAP | |||||||||||||
| Amortization of purchased intangible assets |
Legal settlements and loss contingencies |
Impairment of long-lived assets |
Acquisition, integration and related expenses |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Gain on sale of business |
Other non GAAP items |
Other items |
Corresponding tax effect |
Unusual tax item* |
|||
| Cost of sales** R&D expenses S&M expenses G&A expenses Other (income) |
6,841 778 1,908 873 |
717 105 |
28 21 17 29 37 |
96 (7) - |
5,978 768 1,774 836 |
||||||||||
| expense | (29) | (12) | (17) | ||||||||||||
| Legal settlements and loss contingencies Other assets impairments, restructuring and |
1,171 | 1,171 | - | ||||||||||||
| other items | 263 | 96 | 2 140 |
4 | 22 | - | |||||||||
| Intangible assets impairment |
1,206 | 1,206 | - | ||||||||||||
| Financial expenses, net Income taxes |
635 (159) |
9 | (662) 61 |
626 442 |
|||||||||||
| Share in losses of associated companies – net |
8 | - | 8 | ||||||||||||
| Net income (loss) attributable to non-controlling interests Total reconciled items |
33 | (28) | 61 | ||||||||||||
| EPS - Basic EPS - Diluted |
(1.02) (1.02) |
823 | 1,171 | 1,302 | 2 140 |
28 104 |
4 | (12) 111 |
(19) | (662) 61 2.80 2.80 |
1.78 1.78 |
*Interest disallowance as a result of the U.S Tax Cuts and Jobs Act.
**The data presented for prior periods has been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c to our consolidated financial
statements for additional information.
The non-GAAP diluted weighted average number of shares was 1,093 million for the nine months ended September 30, 2019.
Segment Information
| North America | Europe | International Markets * | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Three months ended September | Three months ended | Three months ended September 30, |
|||||||||||
| 30, | September 30, | ||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | ||||||||
| (U.S. \$ in millions) | (U.S. \$ in millions) | (U.S. \$ in millions) | |||||||||||
| Revenues \$ | 2,017 | \$ | 2,051 | \$ | 1,116 | \$ | 1,163 | \$ | 529 | \$ | 565 | ||
| Gross profit | 1,056 | 1,048 | 637 | 662 | 275 | 295 | |||||||
| R&D expenses | 155 | 156 | 60 | 63 | 17 | 21 | |||||||
| S&M expenses | 250 | 219 | 200 | 206 | 101 | 114 | |||||||
| G&A expenses | 97 | 112 | 66 | 56 | 33 | 32 | |||||||
| Other (income) loss | (5) | (5) | (1) | (4) | (1) | (1) | |||||||
| Segment profit \$ | 560 | \$ | 565 | \$ | 312 | \$ | 341 | \$ | 125 | \$ | 130 |
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements.
| North America | Europe | International Markets * | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Nine months ended September 30, |
Nine months ended | Nine months ended September 30, |
||||||||||||
| September 30, | ||||||||||||||
| 2020 | 2019 | 2020 | 2019 | 2020 | 2019 | |||||||||
| (U.S. \$ in millions) | (U.S. \$ in millions) | (U.S. \$ in millions) | ||||||||||||
| Revenues \$ | 6,146 | \$ | 6,169 | \$ | 3,520 | \$ | 3,611 | \$ | 1,582 | \$ | 1,668 | |||
| Gross profit | 3,208 | 3,155 | 2,009 | 2,066 | 828 | 877 | ||||||||
| R&D expenses | 455 | 497 | 180 | 199 | 51 | 66 | ||||||||
| S&M expenses | 755 | 756 | 590 | 637 | 312 | 348 | ||||||||
| G&A expenses | 325 | 342 | 184 | 175 | 96 | 102 | ||||||||
| Other income | (9) | (6) | (3) | (5) | (10) | (2) | ||||||||
| Segment profit \$ | 1,682 | \$ | 1,566 | \$ | 1,058 | \$ | 1,060 | \$ | 378 | \$ | 363 |
Segment Information
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements.
Reconciliation of our segment profit to consolidated income before income taxes
| Three months ended | ||||
|---|---|---|---|---|
| September 30, | ||||
| 2020 | 2019 | |||
| (U.S.\$ in millions) | ||||
| North America profit | \$ | 560 | \$ | 565 |
| Europe profit | 312 | 341 | ||
| International Markets profit | 125 | 130 | ||
| Total segment profit | 997 | 1,036 | ||
| Profit of other activities | 28 | 16 | ||
| 1,025 | 1,051 | |||
| Amounts not allocated to segments: | ||||
| Amortization | 251 | 255 | ||
| Other asset impairments, restructuring and other items | (98) | 160 | ||
| Intangible asset impairments | 509 | 177 | ||
| Goodwill impairment | 4,628 | - | ||
| Legal settlements and loss contingencies | 21 | 468 | ||
| Other unallocated amounts | 55 | 73 | ||
| Consolidated operating income (loss) | (4,342) | (81) | ||
| Financial expenses - net | 117 | 211 | ||
| Consolidated loss before income taxes | \$ (4,459) | \$ | (292) |
Reconciliation of our segment profit to consolidated income before income taxes
| Nine months ended | ||||
|---|---|---|---|---|
| September 30, | ||||
| 2020 | 2019 | |||
| (U.S.\$ in millions) | ||||
| North America profit | \$ 1,682 |
\$ | 1,566 | |
| Europe profit | 1,058 | 1,060 | ||
| International Markets profit | 378 | 363 | ||
| Total segment profit | 3,118 | 2,989 | ||
| Profit of other activities | 130 | 92 | ||
| 3,248 | 3,081 | |||
| Amounts not allocated to segments: | ||||
| Amortization | 758 | 823 | ||
| Other asset impairments, restructuring and other items | 404 | 263 | ||
| Intangible asset impairments | 1,278 | 1,206 | ||
| Goodwill impairment | 4,628 | - | ||
| Legal settlements and loss contingencies | 10 | 1,171 | ||
| Other unallocated amounts | 148 | 209 | ||
| Consolidated operating income (loss) | (3,978) | (591) | ||
| Financial expenses - net | 565 | 635 | ||
| Consolidated income (loss) before income taxes | \$ (4,543) | \$ (1,226) |
Segment revenues by major products and activities (Unaudited)
| Three months ended | |||||
|---|---|---|---|---|---|
| September 30, 2019 2020 (U.S.\$ in millions) |
Percentage Change 2019-2020 |
||||
| North America segment | |||||
| Generic products | \$ | 928 | \$ | 914 | 2% |
| AJOVY | 35 | 25 | 42% | ||
| AUSTEDO | 168 | 105 | 60% | ||
| BENDEKA/TREANDA | 105 | 124 | (15%) | ||
| COPAXONE | 236 | 271 | (13%) | ||
| ProAir* | 50 | 71 | (30%) | ||
| QVAR | 42 | 60 | (29%) | ||
| Anda | 341 | 351 | (3%) | ||
| Other | 113 | 131 | (14%) | ||
| Total | 2,017 | 2,051 | (2%) |
| Three months ended September 30, |
Percentage Change |
|||||
|---|---|---|---|---|---|---|
| 2019 2020 |
2019-2020 | |||||
| (U.S.\$ in millions) | ||||||
| Europe segment | ||||||
| Generic products | \$ | 824 | \$ | 836 | (1%) | |
| COPAXONE | 101 | 106 | (5%) | |||
| Respiratory products | 77 | 87 | (12%) | |||
| AJOVY | 8 | 1 | NA | |||
| Other | 106 | 134 | (21%) | |||
| Total | 1,116 | 1,163 | (4%) |
| Three months ended | |||||||
|---|---|---|---|---|---|---|---|
| September 30, | Percentage Change |
||||||
| 2020 | 2019 * | 2019-2020 | |||||
| (U.S.\$ in millions) | |||||||
| International Markets segment | |||||||
| Generic products | \$ | 429 | \$ | 474 | (10%) | ||
| COPAXONE | 14 | 20 | (27%) | ||||
| Other | 86 | 71 | 21% | ||||
| Total | 529 | 565 | (6%) |
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements.
Revenues by Activity and Geographical Area
(Unaudited)
| Nine months ended | |||||
|---|---|---|---|---|---|
| September 30, | Percentage Change |
||||
| 2019 2020 |
2019-2020 | ||||
| (U.S.\$ in millions) | |||||
| North America segment | |||||
| Generic products | \$ | 2,804 | \$ | 2,826 | (1%) |
| AJOVY | 98 | 68 | 45% | ||
| AUSTEDO | 451 | 276 | 64% | ||
| BENDEKA / TREANDA | 313 | 371 | (16%) | ||
| COPAXONE | 671 | 753 | (11%) | ||
| ProAir | 175 | 194 | (10%) | ||
| QVAR | 139 | 183 | (24%) | ||
| Anda | 1,141 | 1,080 | 6% | ||
| Other | 354 | 417 | (15%) | ||
| Total | 6,146 | 6,169 | 0% |
| Nine months ended | |||||
|---|---|---|---|---|---|
| September 30, | Percentage Change |
||||
| 2020 | 2019 | 2019-2020 | |||
| (U.S.\$ in millions) | |||||
| Europe segment | |||||
| Generic products | \$ | 2,593 | \$ | 2,599 | - |
| COPAXONE | 294 | 327 | (10%) | ||
| Respiratory products | 263 | 267 | (2%) | ||
| AJOVY | 17 | 1 | NA | ||
| Other | 352 | 416 | (15%) | ||
| Total | 3,520 | 3,611 | (3%) |
| Nine months ended | ||||||
|---|---|---|---|---|---|---|
| September 30, | Percentage Change |
|||||
| 2020 | 2019 * | 2019-2020 | ||||
| (U.S.\$ in millions) | ||||||
| International Markets segment | ||||||
| Generic products | \$ 1,304 |
\$ | 1,404 | (7%) | ||
| COPAXONE | 38 | 46 | (18%) | |||
| Other | 241 | 218 | 10% | |||
| Total | 1,582 | 1,668 | (5%) |
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements.
Free cash flow reconciliation
(Unaudited)
| Three months ended September 30, |
||||
|---|---|---|---|---|
| 2020 | 2019 | |||
| (U.S. \$ in millions) | ||||
| Net cash provided by operating activities Beneficial interest collected in exchange for securitized accounts |
307 | 325 | ||
| receivables, included in investing activities | 333 | 362 | ||
| Capital investment | (143) | (169) | ||
| Proceeds from sale of long lived assets | 9 | 33 | ||
| Free cash flow \$ | 506 | \$ | 551 |
Free cash flow reconciliation
(Unaudited)
| Nine months ended September 30, |
|||||
|---|---|---|---|---|---|
| 2020 | 2019 | ||||
| (U.S. \$ in millions) | |||||
| Net cash provided by operating activities Beneficial interest collected in exchange for securitized accounts |
885 | 210 | |||
| receivables, included in investing activities | 1,102 | 1,108 | |||
| Capital investment | (402) | (406) | |||
| Proceeds from sale of long lived assets | 54 | 167 | |||
| Free cash flow \$ | 1,639 | \$ | 1,079 |