On July 28, 2021 Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) reported results for the quarter ended June 30, 2021 (Press release, Teva, JUL 28, 2021, View Source [SID1234585309]).
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Mr. Kåre Schultz, Teva’s President and CEO, said, "We have performed well in the second quarter, improving our profitability and free cash flow generation. This allowed us to reduce our net debt by an additional $500 million to $22.7 billion, once again demonstrating our commitment to and confidence in our long-term goals. Among our growth drivers, AUSTEDO sales increased compared to the second quarter of last year, AJOVY net sales have grown to $70 million worldwide, and our biosimilar Truxima continues to increase its U.S. market share, reaching 25%."
Mr. Schultz continued, "Throughout the pandemic we remain committed to serving patients, maintaining our operations and delivering quality affordable medicines. Due to the effects of the pandemic, we have lowered our 2021 revenue outlook, while reaffirming our earnings and cash flow guidance."
Second Quarter 2021 Consolidated Results
Revenues in the second quarter of 2021 were $3,910 million, an increase of 1% or a decrease of 2% in local currency terms, compared to the second quarter of 2020. This decrease was mainly due to lower revenues in our North America segment, mainly related to COPAXONE and Anda, partially offset by positive foreign currency impacts as well as higher revenues from generic products, OTC, AJOVY and COPAXONE in our Europe segment. Revenues were also affected by changes in demand for certain products resulting from the impact of the COVID-19 pandemic.
Exchange rate movements during the second quarter of 2021, including hedging effects, positively impacted our revenues by $135 million and our GAAP and non-GAAP operating income by $26 million and $30 million, respectively.
GAAP gross profit was $1,873 million in the second quarter of 2021, an increase of 6% compared to the second quarter of 2020. GAAP gross profit margin was 47.9% in the second quarter of 2021, compared to 45.5% in the second quarter of 2020. The increase in gross profit margin was mainly driven by higher profitability in North America resulting from the change in mix of products and network optimization activities, partially offset by lower sales of COPAXONE. Non-GAAP gross profit was $2,084 million in the second quarter of 2021, an increase of 4% compared to the second quarter of 2020. Non-GAAP gross profit margin was 53.3% in the second quarter of 2021, compared to 52.0% in the second quarter of 2020.
GAAP Research and Development (R&D) expenses in the second quarter of 2021 were $248 million, an increase of 10% compared to the second quarter of 2020. Non-GAAP R&D expenses were $243 million, or 6.2% of quarterly revenues, in the second quarter of 2021, compared to $233 million, or 6%, in the second quarter of 2020. In the second quarter of 2021, our R&D expenses related primarily to specialty product candidates in the respiratory, migraine and headache therapeutic areas, with additional activities in selected other areas and generic products including biosimilars. Our higher R&D expenses in the second quarter of 2021, compared to the second quarter of 2020, were mainly due to an increase in respiratory and biosimilar projects as well as various generics projects.
GAAP Selling and Marketing (S&M) expenses in the second quarter of 2021 were $615 million, an increase of 3% compared to the second quarter of 2020. Non-GAAP S&M expenses were $582 million, or 14.9% of quarterly revenues, in the second quarter of 2021, compared to $559 million, or 14.4%, in the second quarter of 2020.
GAAP General and Administrative (G&A) expenses in the second quarter of 2021 were $242 million, a decrease of 8% compared to the second quarter of 2020. Non-GAAP G&A expenses were $231 million, or 5.9% of quarterly revenues, in the second quarter of 2021, compared to $245 million, or 6.3%, in the second quarter of 2020.
GAAP operating income in the second quarter of 2021 was $582 million, compared to $173 million in the second quarter of 2020. This increase was mainly due to lower other asset impairments, restructuring and other items charges and higher profit in our Europe segment, partially offset by higher intangible asset impairment charges. Non-GAAP operating income in the second quarter of 2021 was $1,034 million, an increase of 6%, compared to $979 million in the second quarter of 2020. The increase was mainly due to higher profit in our Europe segment.
EBITDA (defined as operating income, excluding amortization and depreciation expenses) was $887 million in the second quarter of 2021, an increase of 60% compared to $555 million in the second quarter of 2020. Adjusted EBITDA (defined as non-GAAP operating income excluding depreciation expenses) was $1,162 million in the second quarter of 2021, an increase of 5% compared to $1,108 million in the second quarter of 2020.
GAAP financial expenses were $274 million in the second quarter of 2021, compared to $223 million in the second quarter of 2020. Non-GAAP financial expenses were $240 million in the second quarter of 2021, compared to $229 million in the second quarter of 2020. Financial expenses in the second quarter of 2021, were mainly comprised of interest expenses of $240 million and loss on revaluation of marketable securities of $34 million. Financial expenses in the second quarter of 2020 were mainly comprised of interest expenses of $241 million.
In the second quarter of 2021, we recognized a GAAP tax expense of $98 million, on pre-tax income of $308 million. In the second quarter of 2020, we recognized a tax benefit of $104 million, on pre-tax loss of $51 million. Our tax rate for the second quarter of 2021 was mainly affected by impairments, amortization and interest expense disallowance. Non-GAAP income taxes for the second quarter of 2021 were $133 million, or 17%, on pre-tax non-GAAP income of $794 million. Non-GAAP income taxes in the second quarter of 2020 were $128 million, or 17%, on pre-tax non-GAAP income of $751 million. Our non-GAAP tax rate for the second quarter of 2021 was mainly affected by the mix of products we sold and interest expense disallowance.
We expect our annual non-GAAP tax rate for 2021 to be 17%-18%, unchanged from our outlook provided in February 2021.
GAAP net income attributable to Teva and GAAP EPS were $207 million and $0.19, respectively, in the second quarter of 2021, compared to $140 million and $0.13 in the second quarter of 2020. This increase was mainly due to the increase in operating income, as discussed above. Non-GAAP net income attributable to Teva and non-GAAP diluted EPS in the second quarter of 2021 were $651 million and $0.59, respectively, compared to $605 million and $0.55 in the second quarter of 2020.
The weighted average diluted shares outstanding used for the fully diluted share calculation on a GAAP and non-GAAP basis for the three months ended June 30, 2021 and 2020 was 1,109 million and 1,100 million shares, respectively.
As of June 30, 2021 and 2020, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,129 million and 1,119 million, respectively.
Non-GAAP information: Net non-GAAP adjustments in the second quarter of 2021 were $444 million. Non-GAAP net income and non-GAAP EPS for the second quarter of 2021 were adjusted to exclude the following items:
Amortization of purchased intangible assets of $173 million, of which $148 million is included in cost of sales and the remaining $25 million in S&M expenses;
Impairment of long-lived assets of $226 million, comprised mainly of impairment of intangible assets of IPR&D and product rights assets in connection with the Actavis Generics acquisition;
Divested gain in amount of $37 million, mainly from sale of certain OTC assets;
Contingent consideration income of $19 million, mainly related to a decrease in future royalties;
Finance expense of $34 million, mainly related to the American Well equity holding;
Equity compensation expenses of $29 million;
Other items of $74 million; and
Income tax of $36 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 second quarter of 2021 was $218 million, compared to $273 million generated in the second quarter of 2020. The decrease in the second quarter of 2021 was mainly due to favorable collection of payments from customers in the second quarter of 2020, which resulted from increased sales in the first quarter of 2020.
Free cash flow (cash flow from operating activities, cash used for capital investments, beneficial interest collected in exchange for securitized accounts receivables and proceeds from divestitures of businesses and other assets) was $625 million in the second quarter of 2021, compared to $582 million in the second quarter of 2020. The increase in the second quarter of 2021 resulted mainly from higher proceeds from divestitures of businesses and other assets, partially offset by lower cash flow from operating activities.
As of June 30, 2021, our debt was $25,132 million, compared to $24,986 million as of March 31, 2021. This increase was mainly due to exchange rate fluctuations. In July 2021, we repaid $1,475 million of our 2.2% senior notes at maturity. The portion of total debt classified as short-term as of June 30, 2021 was 14%, compared to 11% as of March 31, 2021. Our average debt maturity was approximately 5.3 years as of June 30, 2021, compared to 5.6 years as of March 31, 2021. Our financial leverage was 69% as of June 30, 2021 and as of March 31, 2021.
Segment Results for the Second Quarter of 2021
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 June 30, 2021 and 2020:
Revenues from our North America segment in the second quarter of 2021 were $1,943 million, a decrease of $104 million, or 5%, compared to the second quarter of 2020, mainly due to a decrease in revenues from COPAXONE and Anda, partially offset by higher revenues from generic products, AUSTEDO 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 certain specialty products 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 $1,818 million in the second quarter of 2021, a decrease of $109 million, or 6%, compared to the second quarter of 2020.
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 June 30, 2021 and 2020:
Generic products revenues in our North America segment (including biosimilars) in the second quarter of 2021 were $951 million, an increase of 3% compared to the second quarter of 2020. This increase was mainly due to higher revenues from epipephrine injectable solution (the generic equivalent of EpiPen and EpiPen Jr.), Truxima (the biosimilar to Rituxan) and ProAir authorized generic, partially offset by lower volume and pricing of other generic products.
In the second quarter of 2021, our total prescriptions were approximately 314 million (based on trailing twelve months), representing 8.8% of total U.S. generic prescriptions according to IQVIA data.
AJOVY revenues in our North America segment in the second quarter of 2021 were $46 million, an increase of $11 million, or 32% compared to the second quarter of 2020, mainly due to growth in volume.
AUSTEDO revenues in our North America segment in the second quarter of 2021 increased by 8% to $174 million, compared to $161 million in the second quarter of 2020. This increase was mainly due to growth in volume.
BENDEKA and TREANDA combined revenues in our North America segment in the second quarter of 2021 increased by 3% to $106 million, compared to the second quarter of 2020, mainly due to higher sales of oncology products during the recovery from the COVID-19 pandemic, partially offset by availability of alternative 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 second quarter of 2021 decreased by 36% to $152 million, compared to the second quarter of 2020, mainly due to generic competition in the United States.
ProAir (HFA and RespiClick) revenues in our North America segment in the second quarter of 2021 decreased by 16% to $55 million, compared to the second quarter of 2020. Revenues from our ProAir authorized generic are included in "generic products" above.
Anda revenues in our North America segment in the second quarter of 2021 decreased by 16% to $316 million, compared to $374 million in the second quarter of 2020, mainly due to lower demand by Anda’s customers for generic products.
North America Gross Profit
Gross profit from our North America segment in the second quarter of 2021 was $1,040 million, a decrease of 5%, compared to $1,090 million in the second quarter of 2020. This decrease was mainly due to lower gross profit from Anda and COPAXONE.
Gross profit margin for our North America segment in the second quarter of 2021 increased to 53.5%, compared to 53.3% in the second quarter of 2020. This increase was mainly due to a change in the 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 second quarter of 2021 was $521 million, a decrease of 9% compared to $573 million in the second quarter of 2020, mainly due to lower gross profit, as discussed above, as well as higher R&D expenses.
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 June 30, 2021 and 2020:
Revenues from our Europe segment in the second quarter of 2021 were $1,184 million, an increase of 18%, or $183 million, compared to the second quarter of 2020. In local currency terms, revenues increased by 8%, mainly due to changed buying patterns in the second quarter of 2020 as a result of significant customer stocking due to the COVID-19 pandemic in March 2020, and a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the second quarter of 2020.
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 June 30, 2021 and 2020:
Generic products revenues in our Europe segment in the second quarter of 2021, including OTC products, increased by 19% to $878 million, compared to the second quarter of 2020. In local currency terms, revenues increased by 9% compared to the second quarter of 2020, mainly due to lower revenues in the second quarter of 2020 as a result of significant changes in buying patterns and customer stocking due to the COVID-19 pandemic. In addition, revenues in the second quarter of 2020 were impacted by lower demand of generic products resulting from a decline in doctor and hospital visits by patients resulting in fewer prescriptions as well as lower sales of OTC products resulting from lower demand for cough and cold products, both due to the COVID-19 pandemic.
AJOVY revenues in our Europe segment in the second quarter of 2021 were $19 million, compared to $5 million in the second quarter of 2020, mainly due to launches and reimbursements in additional European countries.
COPAXONE revenues in our Europe segment in the second quarter of 2021 increased by 19% to $100 million, compared to the second quarter of 2020. In local currency terms, revenues increased by 9%, mainly due to customer stocking due to the COVID-19 pandemic in March 2020, resulting in significant changes in buying patterns in the second quarter of 2020.
Respiratory products revenues in our Europe segment in the second quarter of 2021 increased by 7% to $85 million, compared to the second quarter of 2020. In local currency terms, revenues decreased by 4%, mainly due to lower sales in the United Kingdom, partially offset by changes in buying patterns in the second quarter of 2020 as a result of significant customer stocking due to the COVID-19 pandemic in March 2020.
Europe Gross Profit
Gross profit from our Europe segment in the second quarter of 2021 was $661 million, an increase of 21% compared to $548 million in the second quarter of 2020.
Gross profit margin for our Europe segment in the second quarter of 2021 increased to 55.8%, compared to 54.7% in the second quarter of 2020. This increase was mainly due to a change in product mix.
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.
Profit from our Europe segment in the second quarter of 2021 was $343 million, an increase of 41%, compared to $244 million in the second quarter of 2020. This increase was mainly due to higher 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 February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.
The following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2021 and 2020:
Revenues from our International Markets segment in the second quarter of 2021 were $485 million, a decrease of $3 million, or 1%, compared to the second quarter of 2020. In local currency terms, revenues decreased by 3% compared to the second quarter of 2020, mainly due to lower revenues in Japan resulting from the divestment mentioned above, as well as regulatory price reductions and generic competition to off-patented products in Japan and negative impact from hedging activity, partially offset by higher revenues in most other markets as well as lower revenues in certain markets in the second quarter of 2020, resulting from reduced demand due to the impact the COVID-19 pandemic had on purchasing patterns.
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 June 30, 2021 and 2020:
Generic products revenues in our International Markets segment in the second quarter of 2021, which include OTC products, decreased by 5% to $407 million, in both U.S. dollar and local currency terms, compared to the second quarter of 2020. This decrease was mainly due to lower sales in Japan resulting from the divestment mentioned above, as well as regulatory price reductions and generic competition to off-patented products in Japan, partially offset by higher revenues in most other markets as well as lower revenues in certain markets in the second quarter of 2020, resulting from reduced demand due to the impact the COVID-19 pandemic had on purchasing patterns.
COPAXONE revenues in our International Markets segment in the second quarter of 2021 were $7 million, a decrease of 35% compared to $12 million in the second quarter of 2020. In local currency terms, revenues decreased by 33%.
AJOVY was launched in certain markets in our International Markets segment and we are moving forward with plans to launch in other markets. On June 23, 2021, AJOVY was approved for the preventative treatment of migraine in adults in Japan.
AUSTEDO was launched in China for treatment of chorea associated with Huntington disease and for the treatment of tardive dyskinesia in early 2021. We continue with additional submissions in various other countries.
International Markets Gross Profit
Gross profit from our International Markets segment in the second quarter of 2021 was $270 million, an increase of 9% compared to $247 million in the second quarter of 2020.
Gross profit margin for our International Markets segment in the second quarter of 2021 increased to 55.7%, compared to 50.8% in the second quarter of 2020. This increase was mainly due to the divestment in Japan mentioned above and a change in product 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 second quarter of 2021 was $123 million, an increase of 27%, compared to $97 million in the second quarter of 2020. This increase was mainly due to higher gross profit as discussed above.
Other Activities
We have other sources of revenues, primarily the sale of active pharmaceutical ingredients ("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 second quarter of 2021 were $298 million, a decrease of 11% compared to the second quarter of 2020. In local currency terms, revenues decreased by 13%, mainly due to a decrease in volumes from API and Medis resulting from the COVID-19 pandemic.
API sales to third parties in the second quarter of 2021 were $199 million, a decrease of 6% in both U.S. dollar and local currency terms, compared to the second quarter of 2020.
Conference Call
Teva will host a conference call and live webcast including a slide presentation on Wednesday, July 28, 2021 at 8:00 a.m. ET to discuss its second quarter of 2021 results and overall business environment. A question & answer session will follow.
In order to participate, please dial the following numbers:
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: 9693275.