ImmunoGen Reports Pipeline Progress and 2017 Operating Results

On February 8, 2018 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported recent highlights and operating results for the quarter and year ended December 31, 2017 (Press release, ImmunoGen, FEB 9, 2018, View Source [SID1234523873]).

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"We made significant progress with the business in 2017, with four consecutive quarters of strong execution across the Company. Operationally, we advanced our monotherapy registration study and published compelling combination data with mirvetuximab, expanded our clinical pipeline, and established a high-value partnership with Jazz Pharmaceuticals supporting our earlier-stage programs. Financially, we added over $235 million in cash and eliminated roughly $100 million in debt on the balance sheet through business development and financing transactions," said Mark Enyedy, ImmunoGen’s president and chief executive officer. "With the momentum we generated in the last twelve months, we enter 2018 from a position of strength with a number of important catalysts expected during the year. We anticipate completing patient enrollment in our FORWARD I Phase 3 registration trial by mid-year, multiple data readouts from our FORWARD II trial assessing combinations with mirvetuximab beginning next month at the Society of Gynecologic Oncology annual meeting, and clinical data from our Phase 1 trials of both IMGN779 and IMGN632 later in the year. With these anticipated events, we look forward to another productive year in 2018 as we advance our pipeline to bring new therapies to patients and create value for our shareholders."

Recent Pipeline Highlights

Activated more than 100 sites in North America and Europe in the Company’s ongoing Phase 3 FORWARD I trial of mirvetuximab soravtansine as single-agent therapy for platinum-resistant ovarian cancer enabling rapid patient enrollment;
Advanced the Company’s Phase 1b/2 FORWARD II trial in North America and Europe evaluating mirvetuximab soravtansine combination regimens in separate expansion cohorts with Keytruda (pembrolizumab) and Avastin (bevacizumab) for platinum-resistant disease, and initiated patient dosing in a new cohort to evaluate the triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive disease;
Reported updated safety data and preliminary anti-leukemia activity from the dose-escalation phase of the Phase 1 clinical trial of IMGN779 in patients with acute myeloid leukemia (AML) at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting;
Began dosing patients in the Company’s Phase 1 clinical trial of IMGN632, a CD123-targeting ADC integrating a potent DNA-alkylating payload intended to treat a range of hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN); and
Received notice that partner Takeda has filed an IND for TAK-164, an ADC directed to GCC-positive tumors using ImmunoGen’s IGN platform.
Facilities Update

Following an in-depth review of the Company’s manufacturing strategy, ImmunoGen will move to an operating model that will rely on external manufacturing and quality testing for drug substance and drug product for its development programs. The implementation of this new operating model will lead to the ramp-down of manufacturing and quality activities at the Company’s Norwood, Massachusetts facility by the end of 2018, with a full exit of the site by early 2019. Decommissioning the Norwood facility will result in anticipated cost savings of over $20 million during the next five years.
The Norwood facility has been a long-standing staple of ImmunoGen’s business, delivering high-quality products to patients and partners without interruption for more than 25 years. The Company is grateful for the contributions that its Norwood-based employees have made and will support these employees through the transition.
Anticipated 2018 Events

Conduct interim analysis from FORWARD I, for futility only, in 1Q 2018;
Report updated dose-escalation findings from the FORWARD II mirvetuximab plus Keytruda combination cohort at the Society of Gynecologic Oncology annual meeting (March 2018);
Present highlights from ImmunoGen’s technology and innovation in ADCs at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (April 2018);
Anticipate partner Takeda to begin clinical development of TAK-164 in the first half of 2018;
Report updated data from the FORWARD II mirvetuximab plus Avastin combination expansion cohort in over 50 patients in the first half of 2018;
Complete patient enrollment in FORWARD I by mid-year;
Report findings from the FORWARD II mirvetuximab plus Keytruda combination expansion cohort in over 30 patients the second half of the year;
Report additional data from IMGN779 Phase 1 study in 4Q 2018;
Report initial data from IMGN632 Phase 1 study in 4Q 2018; and
Advance our ADAM9 program into IND-enabling activities before year-end.
Financial Results

As previously disclosed, effective January 1, 2017, ImmunoGen transitioned to a fiscal year ending December 31. The years ended December 31, 2017 and 2016 reflect the twelve-month results of the respective calendar years.

Revenues for the year ended December 31, 2017 were $115.4 million, compared to $48.6 million for the year ended December 31, 2016. License and milestone fees of $79.5 million for 2017 included a $30 million paid-up license fee related to an amendment to the Company’s collaboration and license agreement with Sanofi, $29.5 million related to the sale and transfer of the Company’s IMGN529 asset to Debiopharm, $7 million in partner milestone payments and $12.7 million in amortization of a non-cash fee related to the Company’s license agreement with CytomX, compared to $15 million in partner milestone payments received in 2016. Revenues for 2017 included $28.1 million in non-cash royalty revenues, compared with $26.2 million in non-cash royalty revenues for 2016. Revenues for 2017 also included $3.5 million of research and development (R&D) support fees and $4.4 million of clinical materials revenue, compared with $5.2 million and $1.9 million, respectively, for 2016.

Operating expenses, including R&D and G&A expenses, for 2017 were $174.4 million, compared to $184.3 million for 2016. R&D expenses for 2017 decreased to $139.7 million, compared to $141.3 million for 2016, primarily due to a workforce reduction resulting from the strategic review in September 2016 and lower third-party service fees, partially offset by increased clinical trial and drug supply costs driven largely by the advancement of the FORWARD I Phase 3 clinical trial. General and administrative expenses decreased in 2017 to $33.9 million, compared to $38.5 million in 2016, primarily due to lower personnel expenses. Operating expenses for 2016 also included a $4.4 million restructuring charge related to the workforce reduction and a loss on leased office space, compared to a $0.8 million charge in 2017 related to additional loss recorded on leased office space.

In September and November 2017, a total of $97.9 million of convertible debt outstanding was converted into 26.2 million shares of the Company’s common stock, resulting in a $22.9 million non-cash debt conversion charge recorded in 2017. With this conversion, the Company’s outstanding debt is reduced to $2.1 million. In October 2017, pursuant to a public offering, the Company sold an aggregate of 16.7 million shares of its common stock, with net proceeds to the Company of $101.7 million, after deducting underwriting discounts and offering expenses.

ImmunoGen reported a net loss of $96.0 million, or $0.98 per basic and diluted share, for 2017, which included a loss of $0.23 per basic and diluted share relating to the non-cash debt conversion charge, compared to a net loss of $156.7 million, or $1.80 per basic and diluted share, for 2016.

ImmunoGen had $267.1 million in cash and cash equivalents as of December 31, 2017, compared with $160.0 million as of December 31, 2016, and had $2.1 million and $100.0 million of convertible debt outstanding as of December 31, 2017 and December 31, 2016, respectively. Cash provided by operations was $7.6 million for 2017, compared with cash used in operations of $(142.6) million for 2016. The current year benefited from $59.5 million of fees received from Sanofi and Debiopharm, which were included in revenue for 2017, and a $75 million upfront payment received from Jazz, which is included in deferred revenue as of December 31, 2017. Capital expenditures were $1.1 million and $6.7 million for 2017 and 2016, respectively.

Financial Guidance

For 2018, ImmunoGen expects:

revenues between $60 million and $65 million;
operating expenses between $185 million and $190 million; and
cash and cash equivalents at December 31, 2018 between $115 million and $120 million.
ImmunoGen expects that its current cash combined with the expected cash revenues from partners and collaborators will enable the Company to fund its operations into the fourth quarter of 2019.

Conference Call Information
ImmunoGen will hold a conference call today at 8:00 am ET to discuss these results. To access the live call by phone, dial 719-325-4917; the conference ID is 5734226. The call may also be accessed through the Investors section of the Company’s website, www.immunogen.com. Following the webcast, a replay of the call will be available at the same location through February 23, 2018.

AskAt Inc. Announces EP4 Antagonist Immuno-Oncology License Agreement with NewBay Medical Technology Co., Ltd.

On February 8, 2018 AskAt Inc. (AskAt), headquartered in Nagoya, Japan, reported a license agreement with NewBay Medical Technology Co., Ltd. (NewBay), headquartered in Hangzhouwan New Zone, Ningbo, Zhejiang Province, People’s Republic of China (China), granting NewBay exclusive rights to develop, manufacture and commercialize AskAt’s EP4 Antagonist [AAT-008] in China in the area of Immuno-Oncology (Press release, AskAt, FEB 8, 2018, View Source [SID1234535052]). Under the terms of the signed agreement, AskAt will receive upfront payments from NewBay and is eligible to receive Development and Commercial Milestone payments and Royalties on sales of products in China.

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About AAT-008

AAT-008 is a novel prostaglandin EP4 antagonist that has exhibited potent anti-tumor activity in animal models of lung, breast, colon, stomach, prostate, and liver cancers, and synergistic activity in combination with anti-PD-1 anti-body.

10-Q – Quarterly report [Sections 13 or 15(d)]

Cardinal Health has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Cardinal Health, 2018, FEB 8, 2018, View Source [SID1234523809]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Regeneron has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Regeneron, 2018, FEB 8, 2018, View Source [SID1234523808]).

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Teva Reports 2017 Full Year and Fourth Quarter Financial Results

On February 8, 2018 Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today reported results for the year and the quarter ended December 31, 2017 (Press release, Teva, FEB 8, 2018, View Source;p=RssLanding&cat=news&id=2331263 [SID1234523870]).

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FY 2017

Q4 2017

Revenues $22.4 billion $5.5 billion
Cash flow from operations $3.5 billion $1.2 billion
GAAP earnings (loss) per share ($16.26) ($11.41)
Non-GAAP EPS $4.01 $0.93

2018 Business outlook:

Revenues are expected to be $18.3 – 18.8 billion
Non-GAAP EPS is expected to be $2.25-2.50
Kåre Schultz, Teva’s President and CEO, said, "2017 was a challenging year for Teva. Starting 2018 we are focused on meeting our financial obligations and ensuring a much more solid and sustainable business model going forward. We are making strong progress on the restructuring plan, and I am optimistic about the progress made and remain confident in our ability to deliver on our targets in the coming year.

Teva remains a recognized world-class leader in global healthcare, delivering unique value through accessible treatments and innovative medicines. By improving our financial profile through stabilization of our operating profit and cash flow, we will be better positioned to continue serving patients worldwide."

Goodwill Impairment In 2017, we noted significant adverse challenges in the U.S. generics market and the economic environment. These challenges included: (i) additional pricing pressure in the U.S. generics market as a result of customer consolidation into larger buying groups capable of extracting greater price reductions; (ii) pricing challenges due to government regulation; (iii) accelerated FDA approval of additional generic versions of off-patent medicines, resulting in increased competition for these products; (iv) delays in new launches of certain of our generic products; (v) originator strategies to maintain market share, reducing the value of newly launched complex or novel generics (vi) changes to traditional distribution model, and (vii) the recently-enacted U.S. tax reform legislation is expected to limit our ability to achieve targeted tax efficiencies compared to prior estimates. Consequently, we recorded goodwill impairments of $17.1 billion, mainly with respect to our U.S. generics reporting unit.

During the fourth quarter of 2017, we noted further deterioration in the U.S. generics market and economic environment, further limitations on our ability to influence generic medicines pricing in the long term and a decrease in value from future launches. These developments included: (i) additional pricing pressure in the U.S. generics market as a result of customer consolidation into larger buying groups capable of extracting greater price reductions; (ii) pricing challenges due to government regulation; (iii) accelerated FDA approval of additional generic versions of off-patent medicines, resulting in increased competition for these products; (iv) originator strategies to maintain market share, reducing the value of newly launched complex or novel generics; (v) changes to traditional distribution model; and (vi) the recently-enacted U.S. tax reform legislation, which is expected to limit our ability to achieve targeted tax efficiencies compared to prior estimates.

Consequently, we recorded goodwill impairments totaling $17.1 billion in 2017, mainly with respect to our U.S. generics reporting unit.

2017 Annual Results

Revenues in 2017 were $22.4 billion, an increase of 2%, or 6% in local currency terms, compared to 2016, primarily due to: (i) an increase in our generic medicines segment from the inclusion of Actavis Generics revenues for the full year of 2017 as compared to five month in 2016, partially offset by the adverse market dynamics in the United States; (ii) the acquisition of Anda in the fourth quarter of 2016; and (iii) a decrease in revenues of our specialty medicines segment due to generic competition to certain key products.

Exchange rate differences, including the impact of Venezuela, between 2017 and 2016 negatively impacted our revenues by $914 million, our GAAP operating income by $290 million and our non-GAAP operating income by $335 million. Adjustments to the exchange rates used for the Venezuelan bolivar and the November 30, 2017 deconsolidation of our subsidiaries in Venezuela resulted in a decrease of $1,062 million in revenues, a decrease of $249 million in GAAP operating income and a decrease of $323 million in non-GAAP operating income, compared to results in 2016. In light of the political and economic conditions in Venezuela, we excluded changes in revenues and operating profit in Venezuela from any discussion of local currency results.

GAAP gross profit was $10.8 billion in 2017, down 9% compared to 2016. GAAP gross profit margin for the year was 48.4%, compared to 54.1% in 2016. Non-GAAP gross profit was $12.2 billion in 2017, down 9% compared to 2016. Non-GAAP gross profit margin was 54.7% in 2017, compared to 61.3% in 2016. The decrease in GAAP gross profit as a percentage of revenues primarily reflects lower profitability of our generic medicines segment, higher amortization of purchased intangible assets, lower profitability of our specialty medicines segment and the inclusion of Anda, and lower profitability of our other activities, partially offset by lower inventory step-up expenses, inventory related expenses in connection with the devaluation in Venezuela and lower costs related to regulatory actions taken in certain facilities. The decrease in non-GAAP gross profit as a percentage of revenues primarily reflects lower profitability of our generic medicines segment, lower profitability of our specialty medicines segment due to loss of exclusivity of key products, the inclusion of Anda as well as lower profitability of our other activities.

Research and Development (R&D) expenses in 2017 were $1.8 billion, a decrease of 12.5% compared to 2016. R&D expenses excluding equity compensation expenses and purchase of in-process R&D in 2017 were $1.6 billion, or 7.1% of revenues, compared to $1.7 billion, or 7.6%, in 2016. R&D expenses related to our generic medicines segment were $702 million, compared to $659 million in 2016. R&D expenses related to our specialty medicines segment were $884 million, compared to $998 million in 2016.

Selling and Marketing (S&M) expenses in 2017 were $3.7 billion, a decrease of 5.3% compared to 2016. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $3.4 billion, or 15.2% of revenues, in 2017, compared to $3.7 billion, or 17.0% of revenues, in 2016. S&M expenses related to our generic medicines segment were $1.6 billion, a decrease of 8% compared to $1.7 billion in 2016. S&M expenses related to our specialty medicines segment were $1.7 billion, a decrease of 13% compared to $1.9 billion in 2016.

General and Administrative (G&A) expenses in 2017 were $1.3 billion, an increase of $45 million compared to 2016. G&A expenses excluding equity compensation expenses and other expenses were $1.2 billion in 2017, or 5.5% of revenues, compared to $1.2 billion and 5.4% in 2016.

Operating loss was $17.5 billion in 2017, compared to operating income of $2.2 billion in 2016. Non-GAAP operating income was $6.1 billion, down 11% compared to $6.8 billion in 2016.

Adjusted EBITDA (non-GAAP operating income, which excludes amortization and certain other items, and excluding depreciation expenses) for 2017 was $6.7 billion, down 9% compared to 2016.

In 2017, financial expenses were $895 million, compared to $1.3 billion in 2016. Non-GAAP financial expenses were $908 million in 2017, compared to $442 million in 2016.

GAAP income tax expenses in 2017 were $1.9 billion or 11% on a pre-tax loss of $18 billion. In 2016, the provision for income taxes was $521 million or 63% on pre-tax income of $824 million. The provision for non-GAAP income taxes for 2017 amounted to $788 million on pre-tax non-GAAP income of $5.2 billion, for an annual tax rate of 15.3%. The provision for non-GAAP income taxes in 2016 was $1.1 billion on pre-tax non-GAAP income of $6.4 billion, for an annual tax rate of 17.4%.

GAAP net loss attributable to Teva and GAAP diluted loss per share were $16.3 billion and $16.26, respectively, in 2017, compared to net income attributable to Teva of $68 million and a gain per share of $0.07 in 2016. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS were $4.3 billion and $4.01, respectively in 2017, compared to $5.2 billion and $5.14 in 2016.

Non-GAAP information: Net non-GAAP adjustments in 2017 were $20.6 billion. Non-GAAP net income and non-GAAP EPS for the year were adjusted to exclude the following items:

an impairment of goodwill of $17.1 billion, mainly related to our U.S. generics reporting unit;
impairment of long-lived assets of $3.8 billion, mainly related to revaluation of generic products acquired from Actavis Generics, discontinued Actavis Generics products and Rimsa products, product and marketing rights related to our business venture in Japan and an impairment of property, plant and equipment of $544 million
amortization of purchased intangible assets totaling $1.4 billion, of which $1.2 billion is included in cost of goods sold and the remaining $209 million in selling and marketing expenses;
restructuring expenses of $535 million;
charge due to deconsolidation of our subsidiaries in Venezuela of $396 million;
legal settlements and loss contingencies of $500 million ;
contingent consideration of $154 million;
equity compensation of $129 million;
acquisition and integration expenses of $105 million;
other R&D expenses of $221 million;
inventory step-up of $67 million;
costs related to regulatory actions taken in certain facilities of $47 million;
financial income of $13 million;
other non-GAAP items of $160 million;
gain on sale of business of $1.1 billion;
minority interest adjustment of negative $270 million; and
tax effect and other income tax items of $2.7 billion (includes $1.0 billion U.S Tax Cuts and Job Act effect)
We believe that excluding such items facilitates investors’ understanding of Teva’s business. See the attached tables for a reconciliation of our U.S. GAAP results to the adjusted non-GAAP figures.

In light of conditions in Venezuela, we concluded that as of November 30, 2017, we do not meet the accounting criteria for control over our wholly-owned subsidiaries in Venezuela and that we no longer have significant influence over such subsidiaries. Therefore, effective November 30, 2017, we deconsolidated the investment in our subsidiaries in Venezuela, recording deconsolidation charges of $396 million.

Cash flow from operations generated during 2017 was $3.5 billion, down 33% compared to $5.2 billion in 2016. Free cash flow, excluding net capital expenditures, was $2.7 billion compared to $4.4 billion in 2016, a decrease of 38%. The decrease was mainly due to business performance as well as higher payments for legal settlements.

Total balance sheet assets were $70.6 billion as of December 31, 2017, compared to $86.1 billion as of September 30, 2017 and $93.1 billion as of December 31, 2016. The decrease from September 30, 2017 was mainly due to impairment of goodwill and long-lived assets.

Cash and investments at December 31, 2017 decreased to $1.1 billion, compared to $0.9 billion at September 30, 2017 and to $1.9 billion at December 31, 2016.

As of December 31, 2017, our debt was $32.5 billion, a decrease of $2.2 billion compared to $34.7 billion as of September 30, 2017, and a decrease of $3.3 billion compared to $35.8 billion as of December 31, 2016. The decrease was mainly due to $4.4 billion of net debt repayments on our various term loans, our revolving credit facility and other short term loans, partially offset by foreign exchange fluctuations of $1.1 billion. The portion of total debt classified as short-term as of December 31, 2017 was 11%.

Total shareholders’ equity was $17.4 billion at December 31, 2017, compared to $30.3 billion at September 30, 2017 and to $35.0 billion at December 31, 2016.

Fourth Quarter 2017 Results

Revenues in the fourth quarter of 2017 were $5.5 billion, down 16% compared to the fourth quarter of 2016, primarily due to the decrease in revenues of our specialty medicines segment due to generic competition for our key products and the challenging market dynamics in the U.S. generics market. Excluding the impact of foreign exchange fluctuations, revenues decreased 12%.

Exchange rate differences including the impact of Venezuela between the fourth quarter of 2017 and the fourth quarter of 2016 reduced revenues by $274 million, GAAP operating income by $118 million and non-GAAP operating income by $181 million.

In the fourth quarter of 2017, the company announced that it would not be paying annual bonuses for 2017 due to the financial results of the company being significantly below the company’s original annual operating plan for the year. As a result, in the fourth quarter of 2017, we reversed amounts accrued for such bonuses during the first three quarters of 2017 and made no further accrual for such bonuses.

GAAP gross profit was $2.5 billion in the fourth quarter of 2017, down 25% compared to the fourth quarter of 2016. GAAP gross profit margin was 46.6% in the quarter, compared to 52.2% in the fourth quarter of 2016. Non-GAAP gross profit was $2.8 billion in the fourth quarter of 2017, down 26% from the fourth quarter of 2016. Non-GAAP gross profit margin was 52.2% in the fourth quarter of 2017, compared to 59.4% in the fourth quarter of 2016.

Research and Development (R&D) expenses in the fourth quarter of 2017 were $360 million, down 47% compared to the fourth quarter of 2016 mainly due to portfolio optimization ,various efficiency measures as well as the reversal of the annual bonus accrual. R&D expenses excluding equity compensation expenses and purchase of in-process R&D in the fourth quarter of 2017 were $310 million or 5.7% of quarterly revenues, compared to $514 million or 7.9% in the fourth quarter of 2016. R&D expenses related to our generic medicines segment were $149 million, compared to $211 million in the fourth quarter of 2016, a decrease of 29%. R&D expenses related to our specialty medicines segment were $162 million, a decrease of 45% compared to $296 million in the fourth quarter of 2016.

Selling and Marketing (S&M) expenses in the fourth quarter of 2017 were $865 million, a decrease of 23% compared to the fourth quarter of 2016. S&M expenses excluding amortization of purchased intangible assets and equity compensation expenses were $791 million, or 14.5% of revenues, in the fourth quarter of 2017, compared to $1.1 billion, or 17% of revenues, in the fourth quarter of 2016 mainly due to various efficiency measures as well as the reversal of the annual bonus accrual. S&M expenses related to our generic medicines segment were $382 million, a decrease of 30% compared to $549 million in the fourth quarter of 2016, mainly due to lower expenses in Venezuela following exchange rate adjustments as well as certain other efficiency measures. S&M expenses related to our specialty medicines segment were $372 million, a decrease of 26% compared to $506 million in the fourth quarter of 2016. The decrease was mainly due to cost reduction and efficiency measures in our commercial operations, aligning with the life cycle of our product portfolio.

General and Administrative (G&A) expenses in the fourth quarter of 2017 were $492 million, compared to $360 million in the fourth quarter of 2016. G&A expenses excluding equity compensation expenses were $477 million in the fourth quarter of 2017, or 8.7% of revenues, compared to $344 million and 53% in the fourth quarter of 2016.

GAAP operating loss was $13.0 billion in the fourth quarter of 2017, compared to an operating loss of $0.1 billion in the fourth quarter of 2016. Non-GAAP operating income was $1.4 billion, down 29%, compared to $1.9 billion in the fourth quarter of 2016.

Adjusted EBITDA (non-GAAP operating income, which excludes amortization and certain other items, and excluding depreciation expenses) was $1.5 billion, down 27% compared to $2.1 billion in the fourth quarter of 2016.

GAAP financial expenses for the fourth quarter of 2017 were $191 million, compared to $777 million in the fourth quarter of 2016. This decrease is mainly due to an impairment of our monetary assets balance sheet items related to Venezuela in the fourth quarter of 2016. Non-GAAP financial expenses were $209 million in the fourth quarter of 2017, compared to $233 million in the fourth quarter of 2016.

We recorded a GAAP income tax benefit for the fourth quarter of 2017 of $1.5 billion, or 11% on pre-tax loss of $13.2 billion., GAAP income taxes in the fourth quarter of 2016 were $57 million, or 6% on pre-tax loss of $914 million. Non-GAAP income taxes for the fourth quarter of 2017 were $183 million on pre-tax non-GAAP income of $1.2 billion, for a quarterly tax rate of 15.6%. Non-GAAP income taxes in the fourth quarter of 2016 were $218 million on pre-tax non-GAAP income of $1.7 billion, for a quarterly tax rate of 12.7%.

GAAP net loss attributable to Teva and GAAP diluted loss per share were $11.6 billion and a loss of $11.41, respectively, in the fourth quarter of 2017, compared to a GAAP net loss of $973 million and a loss of $1.10, respectively, in the fourth quarter of 2016. Non-GAAP net income attributable to ordinary shareholders for calculating diluted EPS and non-GAAP diluted EPS were $1.0 billion and $0.93, respectively, in the fourth quarter of 2017, compared to $1.5 billion and $1.38 in the fourth quarter of 2016.

For the fourth quarter of 2017, the weighted average outstanding shares for the fully diluted earnings per share calculation was 1,017 million on a GAAP basis and 1,018 million on a non-GAAP basis. The number of average weighted diluted shares outstanding used for the fully diluted share calculation for the fourth quarter of 2016 was 1,015 million shares on a GAAP basis and 1,076 million on a non-GAAP basis. The number of shares on a non-GAAP basis in 2016 includes the potential dilution resulting from our mandatory convertible preferred shares, which had a dilutive effect on our non-GAAP earnings per share.

As of December 31, 2017, the fully diluted share count for calculating Teva’s market capitalization was approximately 1,086 million shares.

Non-GAAP information: Net non-GAAP adjustments in the fourth quarter of 2017 were $12.5 billion. Non-GAAP net income and non-GAAP EPS for the quarter were adjusted to exclude the following items:

impairment of goodwill of $11.0 billion, mainly related to our U.S. generics reporting unit;
impairment of long lived assets of $3.2 billion, mainly related to revaluation of generics products acquired from Actavis Generics, as well as discontinued Actavis Generics and Rimsa products and an impairment of property, plant and equipment of $392 million
deconsolidation of our subsidiaries in Venezuela of $396 million;
amortization of purchased intangible assets totaling $356 million, of which $291 million is included in cost of goods sold and the remaining $65 million in selling and marketing expenses;
restructuring expenses of $235 million;
other R&D expenses of $45 million;
acquisition, integration and related expenses of $18 million;
contingent consideration income of $25 million;
equity compensation expenses of $26 million;
legal settlements and loss contingencies of $176 million;
other non GAAP items of $41million;
gain on sale of business of $1.1 billion;
minority interest adjustment of negative $226 million; and
tax benefit and other income tax items of $1.7 billion (includes $1.0 billion U.S Tax Cuts and Job Act Effect)
We believe 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.

Cash flow from operations generated during the fourth quarter of 2017 was $1.2 billion, a decrease of 17% compared to the fourth quarter of 2016. Free cash flow, excluding net capital expenditures, was $0.9 billion, down 16% compared to the fourth quarter of 2016.

Segment Results for the Fourth Quarter 2017

Generic Medicines Segment

Three Months Ended December 31,
2017 2016
(U.S. $ in millions / % of Segment Revenues)

Revenues $ 3,114 100.0% $ 3,716 100.0%
Gross profit 1,271 40.8% 1,835 49.4%
R&D expenses 149 4.8% 211 5.7%
S&M expenses 382 12.2% 549 14.8%
Segment profit* $ 740 23.8% $ 1,075 28.9%
_______________

* Segment profit consists of gross profit for the segment, less R&D and S&M expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items.

Generic Medicines Revenues

Generic medicines revenues in the fourth quarter of 2017 were $3.1 billion, a decrease of 16% compared to the fourth quarter of 2016.

Generic revenues consisted of:

U.S. revenues of $1.2 billion, a decrease of 15% compared to the fourth quarter of 2016, mainly due to challenging market dynamics including pricing declines resulting from customer consolidation into large buying groups and accelerated FDA approvals for additional generic versions of competing off-patent medicines, partially offset by new product launches.
European revenues of $1.1 billion, flat compared to the fourth quarter of 2016, or a decrease of 8% in local currency terms, compared to the fourth quarter of 2016, mainly due to the exclusion of revenues of Actavis U.K., which was divested in January 2017.
ROW revenues of $864 million, a decrease of 31%, or an increase of 2% in local currency terms, compared to the fourth quarter of 2016. The increase in local currency terms was mainly due to increased sales in Russia and Israel.
Our OTC revenues related to PGT were $217 million, a decrease of 46% compared to $399 million in the fourth quarter of 2016. In local currency terms, revenues increased 9%. PGT’s in-market sales excluding Venezuela were $353 million in the fourth quarter of 2017, an increase of $45 million, or 10% in local currency terms, compared to the fourth quarter of 2016.
API sales to third parties of $181 million (which are included in the market revenues above) were flat compared to the fourth quarter of 2016.
Generic medicines revenues comprised 57% of our total revenues in the fourth quarter of 2017, the same as in the fourth quarter of 2016.

Generic Medicines Gross Profit

Gross profit of our generic medicines segment in the fourth quarter of 2017 was $1.3 billion, a decrease of 31% compared to $1.8 billion in the fourth quarter of 2016. The lower gross profit was mainly due to higher production expenses, market dynamics in the United States as well as lower revenues in Venezuela following the continued currency devaluation.

Gross profit margin for our generic medicines segment in the fourth quarter of 2017 decreased to 40.8%, compared to 49.4% in the fourth quarter of 2016.

Generic Medicines Profit

Our generic medicines segment generated profit of $740 million in the fourth quarter of 2017, a decrease of 31% compared to the fourth quarter of 2016. Generic medicines profitability as a percentage of generic medicines revenues was 23.8% in the fourth quarter of 2017, down from 28.9% in the fourth quarter of 2016.

Specialty Medicines Segment

Three Months Ended December 31,
2017 2016
(U.S. $ in millions / % of Segment Revenues)

Revenues $ 1,795 100.0% $ 2,203 100.0%
Gross profit 1,515 84.4% 1,926 87.4%
R&D expenses 162 9.0% 296 13.4%
S&M expenses 372 20.7% 506 23.0%
Segment profit* $ 981 54.7% $ 1,124 51.0%
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* Segment profit is comprised of gross profit for the segment, less R&D and S&M expenses related to the segment. Segment profit does not include G&A expenses, amortization and certain other items.

Specialty Medicines Revenues

Specialty medicines revenues in the fourth quarter of 2017 were $1.8 billion, down 19% compared to the fourth quarter of 2016. The decrease in specialty medicines revenues compared to the fourth quarter of 2016 was primarily due to lower sales of our CNS products and the November 2017 divestiture of certain women health products in the United States. In addition, in the fourth quarter of 2016, we also benefited from a payment of $150 million, which we received in connection with our agreement to sell our royalties and other rights in Ninlaro (ixazomib) to a subsidiary of Takeda.

U.S. specialty medicines revenues were $1.2 billion, down 32% compared to the fourth quarter of 2016. European specialty medicines revenues were $476 million, an increase of 24%, or 14% in local currency terms, compared to the fourth quarter of 2016. ROW specialty revenues were $154 million, up 51%, or 49% in local currency terms, compared to the fourth quarter of 2016. The increase in specialty medicines revenues in ROW compared to the fourth quarter of 2016 was primarily due to reclassification of income from certain intangible assets which were previously recorded in G&A accounts. Specialty medicines revenues comprised 33% of our total revenues in the quarter, compared to 34% in the fourth quarter of 2016.

The following table presents revenues by therapeutic area and key products for our specialty medicines segment for the three months ended December 31, 2017 and 2016:



Three Months Ended December 31
December 31,

Percentage Change
2017 2016 2017 – 2016
(U.S. $ in millions)
CNS $ 984 $ 1,243 (21%)
Copaxone 821 1,015 (19%)
Azilect 40 88 (55%)
Nuvigil 9 25 (64%)
Respiratory 293 325 (10%)
ProAir 102 139 (27%)
QVAR 61 116 (47%)
Oncology 283 268 6%
Bendeka and Treanda 157 150 5%
Women’s Health 68 122 (44%)
Other Specialty* 167 245 (32%)
Total Specialty Medicines $ 1,795 $ 2,203 (19%)

Global revenues of COPAXONE were $821 million in the fourth quarter of 2017, a decrease of 19% compared to the fourth quarter of 2016.

In October 2017, the FDA approved a generic version of Copaxone 40 mg /mL and an additional generic version of COPAXONE 20 mg/mL. A generic version of COPAXONE 40 mg /mL was launched in the U.S. market. In the EU, a non-substitutable version of COPAXONE 40 mg/mL was approved.

COPAXONE revenues in the United States were $622 million, down 25% compared to $829 million in the fourth quarter of 2016, mainly due to generic competition, which resulted in higher rebates and lower volumes, partially offset by a price increase of 7.9% in January 2017, for both the 20 mg/mL and 40 mg/mL versions. At the end of the fourth quarter of 2017, according to December 2017 IQVIA (formerly IMS Health) data, our U.S. market share for the COPAXONE products in terms of new and total prescriptions were 27.8% and 25.7%, respectively. Copaxone revenues outside the United States were $199 million, an increase of 7%, or flat in local currency terms, compared to the fourth quarter of 2016.

Our global AZILECT revenues were $40 million, a decrease of 55% compared to the fourth quarter of 2016 following the introduction of generic competition to AZILECT in the United States in 2017.

Revenues of our respiratory products were $293 million in the fourth quarter of 2017, down 10% compared to $325 million in the fourth quarter of 2016. ProAir revenues in the quarter were $102 million, down 27% compared to the fourth quarter of 2016. QVAR global revenues were $61 million in the fourth quarter of 2017, down 47% compared to the fourth quarter of 2016. Both ProAir and QVAR were affected by negative net pricing effects.

Revenues of our oncology products were $283 million in the fourth quarter of 2017, up 6% compared to the fourth quarter of 2016. Revenues of TREANDA and BENDEKA were $157 million, up 5% compared to the fourth quarter of 2016.

Specialty Medicines Gross Profit

Gross profit of our specialty medicines segment was $1.5 billion in the fourth quarter of 2017, down 21% compared to $1.9 billion in the fourth quarter of 2016. Gross profit margin for our specialty medicines segment in the fourth quarter of 2017 was 84.4%, compared to 87.4% in the fourth quarter of 2016.

Specialty Medicines Profit

Our specialty medicines segment profit was $1.0 billion in the fourth quarter of 2017, down 13% compared to the fourth quarter of 2016.

Specialty medicines profit as a percentage of segment revenues was 54.7% in the fourth quarter of 2017, up from 51.0% in the fourth quarter of 2016.

The following tables present details of our multiple sclerosis franchise and of our other specialty medicines for the three months ended December 31, 2017 and 2016:

Multiple Sclerosis
Three months ended December 31,
2017 2016
(U.S.$ in millions / % of MS Revenues)

Revenues $ 821 100.0% $ 1,015 100.0%
Gross profit 747 91.0% 927 91.3%
R&D expenses 11 1.3% 30 3.0%
S&M expenses 66 8.1% 81 7.9%
MS profit $ 670 81.6% $ 816 80.4%

Other Specialty
Three months ended December 31,
2017 2016
U.S.$ in millions / % of Other Specialty Revenues

Revenues $ 974 100.0% $ 1,188 100.0%
Gross profit 768 78.9% 999 84.1%
R&D expenses 151 15.5% 266 22.4%
S&M expenses 306 31.5% 425 35.8%
Other Specialty profit $ 311 31.9% $ 308 25.9%

In December 2017, our Biologics License Application for fremanezumab was accepted for filing by the FDA and was granted fast track designation for the prevention of cluster headache. On February 2, 2018, the EMA accepted a Marketing Authorization Application for fremanezumab.

Celltrion is our sole source for API production for fremanezumab and also for Celltrion’s products CT-P10 (biosimilar candidate to Rituxan US) and CT-P6 (biosimilar candidate to Herceptin US). In January 2018, Celltrion received an FDA warning letter for its facility in Incheon, South Korea. It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA. We are in active dialogue with the FDA in an effort to maintain our priority date for the approval of fremanezumab.

Other Activities

Other revenues, primarily sales of third-party products for which we act as distributor, mostly in the United States via Anda, as well as in Israel and Hungary, sales of medical devices, contract manufacturing services related to products divested in connection with the Actavis Generics acquisition and other miscellaneous items, were $550 million in the fourth quarter of 2017, compared to $573 million, in the fourth quarter of 2016.

Outlook for 2018 Non-GAAP Results


FY 2018

Revenues $18.3-18.8 billion
Non-GAAP Operating Income $4.0-4.3 billion
EBITDA $4.7-5.0 billion
Non-GAAP EPS $2.25-2.50
Weighted average number of shares 1,030 million
Free Cash flow $2.6-2.8 billion

These estimates reflect management`s current expectations for Teva’s performance in 2018. Actual results may vary, whether as a result of market conditions, exchange rate fluctuations, or other factors. In addition, the non-GAAP figures 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.

Dividends

As part of our restructuring plan, in December 2017, we announced an immediate suspension of dividends on our ordinary shares and ADSs and that dividends on our mandatory convertible preferred shares will be evaluated on a quarterly basis per current practice.

Teva has suspended dividends on its mandatory convertible preferred shares in the fourth quarter of 2017, due to its negative net retained earnings

Conference Call

Teva will host a conference call and live webcast along with a slide presentation on Thursday, February 8, 2018 at 8:00 a.m. ET. to discuss its fourth quarter and annual 2017 results and overall business environment. A question & answer session will follow.

In order to participate, please dial the following numbers (at least 10 minutes before the scheduled start time): United States 1-866-869-2321; Canada 1-866-766-8269 or International +44(0) 203 0095710; passcode: 5279244. For a list of other international toll-free numbers, click here.

A live webcast of the call will also 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 applicable audio software.

Following the conclusion of the call, a replay of the webcast will be available within 24 hours on the Company’s website. The replay can also be accessed until March 8, 2018, 9:00 a.m. ET by calling United States 1-866-247-4222; Canada 1-866-878-9237 or International +44(0) 1452550000; passcode: 5279244.