On May 3, 2018 Teva Pharmaceutical Industries Ltd. (NYSE: TEVA, TASE: TEVA) reported results for the quarter ended March 31, 2018 (Press release, Teva, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346698 [SID1234526094]).
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Mr. Kåre Schultz, Teva’s President and CEO, said "2018 is off to a solid start. Our restructuring program is proceeding well, and we are on track to meet our cost reduction targets of $1.5 billion in 2018 and $3.0 billion by the end of 2019. During this quarter, our strong cash flow allowed us to continue to reduce our outstanding debt, and together with our recent debt issuance and covenant amendment, has placed Teva on a more stable financial footing. We have also benefited this quarter from the durability of COPAXONE and a steady flow of generic launches in the U.S. Our strong first quarter performance, along with our confidence in executing the restructuring program, gives us a solid foundation to raise our guidance for the year."
First Quarter 2018 Consolidated Results
Revenues in the first quarter of 2018 were $5.1 billion, a decrease of 10%, or 15% in local currency terms, compared to the first quarter of 2017, mainly due to adverse market dynamics in the U.S. generics market, generic competition to COPAXONE and loss of revenues following our divestment of certain products and discontinuation of certain activities.
Exchange rate differences between the first quarter of 2018 and the first quarter of 2017 positively impacted our revenues by $240 million, our GAAP operating income by $37 million and our non-GAAP operating income by $46 million.
GAAP gross profit was $2.3 billion in the first quarter of 2018, down 17% compared to the first quarter of 2017. GAAP gross profit margin was 46.4% in the first quarter of 2018, compared to 50.2% in the first quarter of 2017.
Non-GAAP gross profit was $2.7 billion in the first quarter of 2018, a decline of 18% from the first quarter of 2017. Non-GAAP gross profit margin was 52.3% in the first quarter of 2018, compared to 56.9% in the first quarter of 2017. The decrease in gross profit margin, on both a GAAP and a non-GAAP basis, was mainly the result of lower profitability in our North America segment due to lower COPAXONE sales and adverse market dynamics in the U.S. generics market.
Research and Development (R&D) expenses for the first quarter of 2018 were $317 million, down 27% compared to the first quarter of 2017. R&D expenses excluding equity compensation expenses and other R&D expenses were $289 million, or 5.7% of quarterly revenues in the first quarter of 2018, compared to $420 million, or 7.4%, in the first quarter of 2017. The decrease in R&D expenses primarily resulted from pipeline optimization, project terminations, phase 3 studies that ended and related headcount reductions.
Selling and Marketing (S&M) expenses in the first quarter of 2018 were $771 million, a decrease of 20% compared to the first quarter of 2017. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $715 million, or 14.1% of revenues, in the first quarter of 2018, compared to $894 million, or 15.8% of revenues, in the first quarter of 2017. The decrease was mainly due to cost reduction and efficiency measures as part of the restructuring plan.
General and Administrative (G&A) expenses in the first quarter of 2018 were $329 million, a decrease of 10% compared to the first quarter of 2017. G&A expenses excluding equity compensation expenses and other items were $322 million in the first quarter of 2018, or 6.4% of quarterly revenues, compared to $353 million, or 6.2% in the first quarter of 2017. The decrease was mainly due to cost reduction and efficiency measures as part of the restructuring plan.
GAAP other income in the first quarter of 2018 was $203 million, an increase of 182% compared to $72 million in the first quarter of 2017. Non-GAAP other income in the first quarter of 2018 was $110 million, an increase of 53% compared to $72 million in the first quarter of 2017. The increase in other income was primarily the result of higher Section 8 recoveries in Canada and a $93 million net gain related to the divestment of our women’s health business, which was excluded from our non-GAAP results.
GAAP operating income in the first quarter of 2018 was $1.5 billion, compared to $895 million in the first quarter of 2017. Non-GAAP operating income in the first quarter of 2018 was $1.4 billion, a decrease of 11% compared to the first quarter of 2017. GAAP operating margin was 30.0% in the first quarter of 2018 compared to 15.8% in the first quarter of 2017. Non-GAAP operating margin was 28.3% in the first quarter of 2018 compared to 28.7% in the first quarter of 2017.
EBITDA (non-GAAP operating income, which excludes amortization and certain other items, as well as excluding depreciation expenses) was $1.6 billion in the first quarter of 2018, down 10% compared to $1.8 billion in the first quarter of 2017.
GAAP financial expenses for the first quarter of 2018 were $271 million, compared to $207 million in the first quarter of 2017. Non-GAAP financial expenses were $203 million in the first quarter of 2018, compared to $235 million in the first quarter of 2017. The decrease in our non-GAAP financial expenses was mainly due to an increased gain in our hedging and derivatives activities and lower interest expenses resulting from reduced overall debt, partially offset by an increase in interest and foreign exchange rates.
GAAP income taxes for the first quarter of 2018 were $46 million, or 4%, on pre-tax income of $1.3 billion. In the first quarter of 2017, GAAP income taxes were $54 million, or 8%, on pre-tax income of $688 million. Our tax rate for the first quarter of 2018 was mainly affected by one-time legal settlements and divestments that had a low corresponding tax effect. Non-GAAP income taxes for the first quarter of 2018 were $211 million on pre-tax non-GAAP income of $1.2 billion, for a quarterly tax rate of 17%. Non-GAAP income taxes in the first quarter of 2017 were $240 million on pre-tax non-GAAP income of $1.4 billion, for a quarterly tax rate of 17%.
GAAP net income attributable to ordinary shareholders and GAAP diluted EPS in the first quarter of 2018 were $1.1 billion and $1.03, respectively, compared to $580 million and $0.57, respectively, in the first quarter of 2017. Non-GAAP net income attributable to ordinary shareholders and non-GAAP diluted EPS in the first quarter of 2018 were $954 million and $0.94, respectively, compared to $1.1 billion and $1.06 in the first quarter of 2017.
For the first quarter of 2018, the weighted average outstanding shares for the fully diluted EPS calculation on both a GAAP and a non-GAAP basis was 1,020 million, compared to 1,017 million on a GAAP and non-GAAP basis for the first quarter of 2017. Additionally, no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to 64 million (including shares that may be issued due to unpaid dividends to date) for the three months ended March 31, 2018 and 59 million for the three months ended March 31, 2017, as well as for the convertible senior debentures for the respective periods, since both had an anti-dilutive effect on EPS.
Non-GAAP information: Net non-GAAP adjustments in the first quarter of 2018 were positive $101 million. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:
Impairments of $612 million, mainly a goodwill impairment related to Rimsa, impairment of intangible assets of product rights and IPR&D assets related to the Actavis Generics acquisition, as well as impairment for closure of manufacturing sites and other fixed assets. The impairment also includes $56 million related to a plant located in India in connection with the termination of PGT Healthcare joint venture.
Impairments of equity investments of $94 million due to termination of PGT Healthcare joint venture.
Amortization of purchased intangible assets totaling $310 million, of which $264 million is included in cost of goods sold and the remaining $46 million in S&M expenses;
Restructuring expenses of $247 million;
Financial expenses of $68 million mainly related to early redemption fees;
Other non-GAAP items of $104 million;
Divestment benefit of $93 million related to capital gain from the sales of our women health business;
Tax benefit of $165 million; and
Benefits from legal settlements of $1.3 billion mainly related to the Allergan working capital adjustments, the Rimsa settlement and the reversal of the carvedilol judgement against Teva.
Teva believes that excluding such items facilitates investors’ understanding of its business. See the attached tables for a reconciliation of the GAAP results to the adjusted non-GAAP figures. 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 operations during the first quarter of 2018 was $1.5 billion, compared to $0.1 billion in the first quarter of 2017. The increase was mainly due to proceeds from the working capital adjustment with Allergan and the legal settlement with Rimsa, compared to payments made to the SEC and DOJ in connection with the FCPA resolution in the first quarter of 2017.
Free cash flow, excluding net capital expenditures and beneficial interest collected in exchange for securitized trade receivables, was $1.9 billion in the first quarter of 2018, compared to $0.3 billion in the first quarter of 2017. The increase was mainly due to the increase in cash flow from operations as well as lower net capital expenditures investments and higher securitized account receivables.
As of March 31, 2018, our total gross debt was $30.8 billion, compared to $32.5 billion as of December 31, 2017. The decrease was mainly due to $6.5 billion in debt prepayments, partially offset by our March 2018 issuance of an aggregate principal amount of $4.4 billion of senior notes, as well as exchange rate fluctuations. The portion of total debt classified as short-term as of March 31, 2018 was 4%, compared to 11% as of December 31, 2017.
Segment Results for the First Quarter 2018
Due to the organizational changes announced in November 2017, our financial results are now being reported under new segments. Our new reportable segments are:
a) North America segment, which includes the United States and Canada.
b) Europe segment, which includes the European Union and certain other European countries.
c) Growth Markets segment, which includes all countries other than those in our North America and Europe segments.
In addition to these three segments, we have other activities, primarily our API third party manufacturing business and certain contract manufacturing services.
Segment profit is comprised of gross profit for the segment, less R&D, S&M, G&A expenses and other income related to each segment. Segment profit does not include amortization and certain other items.
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 March 31, 2018 and 2017:
Generic products revenues in our North America segment in the first quarter of 2018 decreased by 23% to $1.1 billion, compared to the first quarter of 2017, mainly due to lower volumes and price erosion.
In the first quarter of 2018, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 584 million total prescriptions, representing 15% of total U.S. generic prescriptions according to IQVIA data.
COPAXONE revenues in our North America segment in the first quarter of 2018 decreased by 40% to $476 million compared to the first quarter of 2017, mainly due to generic competition in the United States. COPAXONE revenues in the United States were $462 million in the first quarter of 2018.
BENDEKA and TREANDA combined revenues in our North America segment in the first quarter of 2018 increased by 16% to $181 million, compared to the first quarter of 2017, mainly due to higher volumes resulting from supply stabilization.
ProAir revenues in our North America segment in the first quarter of 2018 increased by 7% to $130 million, compared to the first quarter of 2017, mainly due to higher volumes.
QVAR revenues in our North America segment in the first quarter of 2018 increased by 27% to $107 million, compared to the first quarter of 2017. We launched QVAR RediHaler in the first quarter of 2018. The increase in sales in the first quarter of 2018 was mainly due to slightly higher wholesaler stocking for all QVAR family products in connection with the launch. QVAR maintained its second-place position in the inhaled corticosteroids category in the United States.
AUSTEDO revenues in our North America segment in the first quarter of 2018 were $30 million. AUSTEDO was approved by the FDA for the treatment of chorea associated with Huntington disease and was launched in the United States in April 2017. In August 2017, the FDA approved AUSTEDO for the treatment of tardive dyskinesia.
Distribution revenues in our North America segment which are generated by Anda increased by 12% to $331 million in the first quarter of 2018, compared to the first quarter of 2017, mainly due to the severe cold, cough and influenza season in the first quarter of 2018, which increased demand for certain medicines.
North America Gross Profit
Gross profit from our North America segment in the first quarter of 2018 was $1.4 billion, a decrease of 31% compared to $2.1 billion in the first quarter of 2017. The decrease was mainly due to lower revenues from COPAXONE and generic products.
Gross profit margin for our North America segment in the first quarter of 2018 decreased to 56.6%, compared to 64.2% in the first quarter of 2017. This decrease was mainly due to lower COPAXONE revenues and continued price erosion of generic products.
North America Profit
Profit from our North America segment in the first quarter of 2018 was $915 million, a decrease of 30% compared to $1.3 billion in the first quarter of 2017. The decrease was mainly due to lower revenues due to generic competition for COPAXONE and continued price erosion in the U.S. generics market, partially offset by cost reduction and higher other income.
Europe Segment
Our Europe segment includes the European Union and certain other European countries.
Segment profit does not include amortization and certain other items. The data presented for prior periods have
been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018.
Revenues from our Europe segment in the first quarter of 2018 were $1.4 billion, an increase of $101 million or 8%, compared to the first quarter of 2017. In local currency terms, revenues decreased by 6%, mainly due to the loss of revenues from the closure of our distribution business in Hungary and the sale of our women’s health business, partially offset by new generic product launches.
Revenues by Major Products and Activities
Generic products revenues in our Europe segment in the first quarter of 2018, including OTC products, increased by 17% to $997 million, compared to the first quarter of 2017. In local currency terms, revenues increased by 2%, mainly due to new product launches and volume growth in OTC, partially offset by price reductions.
COPAXONE revenues in our Europe segment in the first quarter of 2018 increased by 1% to $153 million, compared to the first quarter of 2017. In local currency terms, revenues decreased by 13%, mainly due to price reductions resulting from the entry of generic competition.
Respiratory products revenues in our Europe segment in the first quarter of 2018 increased by 35% to $113 million, compared to the first quarter of 2017. In local currency terms, revenues increased by 18%, mainly due to the launch of BRALTUS in 2017.
Europe Gross Profit
Gross profit from our Europe segment in the first quarter of 2018 was $797 million, an increase of 9% compared to $734 million in the first quarter of 2017. The increase was mainly due to the positive impact of currency fluctuations, partially offset by the loss of revenues from the sale of our women’s health business.
Gross profit margin for our Europe segment in the first quarter of 2018 increased to 55.3%, compared to 54.7% in the first quarter of 2017. This increase was mainly due to the closure of our distribution business in Hungary, partially offset by other production costs.
Europe Profit
Profit from our Europe segment in the first quarter of 2018 was $377 million, an increase of 41% compared to $268 million in the first quarter of 2017. The increase was mainly due to higher revenues as well as cost reductions and efficiency measures as part of the restructuring plan.
Growth Markets Segment
Our Growth Markets segment includes all countries other than those in our North America and Europe segments. The key markets in this segment are Japan, Russia and Israel.
Segment profit does not include amortization and certain other items. The data presented for prior periods have
been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018.
Revenues from our Growth Markets segment in the first quarter of 2018 were $750 million, an increase of $32 million, or 4%, compared to the first quarter of 2017. In local currency terms, revenues were flat compared to the first quarter of 2017, mainly due to higher sales in Israel, Japan and Russia, partially offset by the effect of the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business.
Revenues by Major Products and Activities
Generic products revenues in our Growth Markets segment in the first quarter of 2018, which includes OTC products, were flat compared to the first quarter of 2017. In local currency terms, revenues decreased by 3%, mainly due to the effect of the deconsolidation of our subsidiaries in Venezuela.
COPAXONE revenues in our Growth Markets segment in the first quarter of 2018 decreased by 24% to $16 million, compared to the first quarter of 2017. In local currency terms, revenues decreased by 20%.
Distribution revenues in our Growth Markets segment in the first quarter of 2018 increased by 22%, compared to the first quarter of 2017. In local currency terms, revenues increased by 13%.
Growth Markets Gross Profit
Gross profit from our Growth Markets segment in the first quarter of 2018 was $313 million, an increase of 7% compared to $292 million in the first quarter of 2017. The increase was mainly due to higher revenues in Japan, including Azilect approval payment from Takeda, and Israel, partially offset by the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business.
Gross profit margin for our Growth Markets segment in the first quarter of 2018 increased to 41.7%, compared to 40.7% in the first quarter of 2017. This increase was mainly due to higher gross profit in Japan, partially offset by the deconsolidation of our subsidiaries in Venezuela.
Growth Markets Profit
Profit from our Growth Markets segment in the first quarter of 2018 was $122 million, compared to $40 million in the first quarter of 2017. The increase was mainly due to higher revenues, as well as cost reductions and efficiency measures as part of the restructuring plan.
During the fourth quarter of 2017, we deconsolidated our subsidiaries in Venezuela from our financial results. Consequently, results of operations of our subsidiaries in Venezuela are not included in our financial results for the first quarter of 2018.
Other Activities
We have other sources of revenues, primarily our API manufacturing business and certain contract manufacturing services. These other activities are not included in our North America, Europe or Growth Markets segments.
Our revenues from other activities in the first quarter of 2018 decreased by 2.6% to $342 million. In local currency terms, revenues decreased by 8%, mainly due to lower API sales to third parties.
API sales to third parties in the first quarter of 2018 decreased by 9% to $179 million. In local currency terms, revenues decreased by 10%, mainly due to the timing of certain shipments in the first quarter of 2018.
R&D Pipeline Update
fremanezumab – We do not expect to receive FDA approval on our Biologics License Applications (BLA) for fremanezumab on the mid-June PDUFA date. We are engaged in a constructive dialogue with the FDA in close collaboration with our partner Celltrion, Inc. We expect an FDA pre-approval inspection to take place in the coming months and to receive FDA approval and launch before the end of 2018.
These estimates reflect management’s current expectations for Teva’s performance in 2018. Actual results may vary, whether as a result of exchange rate differences, market conditions or other factors. In addition, the non-GAAP measures exclude the amortization of purchased intangible assets, costs related to certain regulatory actions, inventory step-up, legal settlements and reserves, impairments and related tax effects.
See "Non-GAAP Financial Measures" below.
Conference Call
Teva will host a conference call and live webcast along with a slide presentation on Thursday, May 3, 2018 at 8:00 a.m. ET to discuss its first quarter 2018 results and overall business environment. A question & answer session will follow.
In order to participate, please dial the following numbers (at least 15 minutes before the scheduled start time):
United States 1-866-254-0808
International 44 (0) 1452 541003
for a list of other international toll-free numbers, click here.
Passcode: 9496209
A live webcast of the call will also be available on Teva’s website at: www.ir.tevapharm.com. Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software.
Following the conclusion of the call, a replay of the webcast will be available within 24 hours on Teva’s website. The replay can also be accessed until May 31, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222 or International 44(0)1452550000; passcode: 9496209.