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%
_______________

* 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.

On February 8, 2018 Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) reported financial results for the fourth quarter and full year of 2017. Total revenues for the full year of 2017 were $3.551 billion, a 15 percent increase compared to 2016 (Press release, Alexion, FEB 8, 2018, View Source [SID1234523813]). The negative impact of foreign currency on total revenues year-over-year was 1 percent or $28.6 million, net of hedging activities. On a GAAP basis, diluted earnings per share (EPS) for the full year of 2017 was $1.97, a 12 percent increase versus the prior year, inclusive of $286.5 million of expenses related to the previously announced restructuring activities. Non-GAAP diluted EPS for the full year of 2017 was $5.86 per share, a 27 percent increase versus the prior year.

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Total revenues in the fourth quarter were $909.7 million, a 9.5 percent increase compared to the same period in 2016. The benefit of foreign currency on total revenues year-over-year was less than 1 percent or $0.1 million, net of hedging activities. On a GAAP basis, diluted EPS in the quarter was $0.13 per share, a 68 percent decrease versus the prior year, inclusive of $95.1 million of expenses related to the previously announced restructuring activities and $45.8 million related to U.S. tax reform. Non-GAAP diluted EPS for the fourth quarter of 2017 was $1.48 per share, a 17 percent increase versus the prior year.

"2017 was a year of rapid transformation for Alexion as we continued to advance our global leadership in rare diseases and position Alexion for the future. I am proud of our accomplishments and performance in 2017, which include strengthening the leadership team and Board of Directors, achieving regulatory approvals for Soliris for the treatment of patients with gMG in the US, Europe and Japan, completing enrollment in the ALXN1210 PNH Phase 3 trials and the Soliris NMOSD Phase 3 trial, strengthening our global patent portfolio for Soliris and continuing to achieve double-digit revenue and volume growth," said Ludwig Hantson, Chief Executive Officer of Alexion. "We enter 2018 with a well-defined strategy to build long-term sustainable value for shareholders. I look forward to providing updates on our progress throughout the year."

Full Year 2017 Financial Highlights

Soliris (eculizumab) net product sales were $3,144.1 million, compared to $2,843.2 million in 2016, representing an 11 percent increase. Soliris volume increased 11 percent year-over-year.
Strensiq (asfotase alfa) net product sales were $339.8 million, compared to $209.4 million in 2016, representing a 62 percent increase. Strensiq volume increased 74 percent year-over-year.
Kanuma (sebelipase alfa) net product sales were $65.6 million, compared to $29.1 million in 2016, representing a 125 percent increase. Kanuma volume increased 136 percent year-over-year.
GAAP cost of sales was $454.2 million, inclusive of restructuring related expenses of $152.1 million, compared to $258.3 million in 2016. Non-GAAP cost of sales was $285.8 million, compared to $236.4 million in 2016.
GAAP R&D expense was $878.4 million, inclusive of restructuring related expenses of $16.3 million, compared to $757.2 million in 2016. Non-GAAP R&D expense was $736.3 million, compared to $690.0 million in 2016.
GAAP SG&A expense was $1,094.4 million, inclusive of restructuring related expenses of $10.9 million, compared to $953.0 million in 2016. Non-GAAP SG&A expense was $927.8 million, compared to $829.3 million in 2016.
GAAP income tax expense was $104.5 million, compared to $176.8 million in 2016. GAAP income tax expense includes a $45.8 million charge related to U.S. tax reform. The charge from U.S. tax reform includes a transition tax expense of $177.9 million and deferred tax expense related to the new GILTI minimum tax of $165.4 million, partially offset by the $297.5 million benefit of revaluing balance sheet taxes. Non-GAAP income tax expense was $186.7 million, compared to $182.8 million in 2016. Both GAAP and non-GAAP income tax expense for 2017 include a benefit from the conclusion of a routine IRS audit for the years 2013 and 2014.
GAAP diluted EPS was $1.97 per share, inclusive of restructuring and related expenses of $286.5 million, compared to $1.76 per share in 2016. Non-GAAP diluted EPS was $5.86 per share, compared to $4.62 per share in 2016.
Fourth Quarter 2017 Financial Highlights

Soliris net product sales were $791.9 million, compared to $748.7 million in the fourth quarter of 2016, representing a 6 percent increase. Soliris volume increased 6 percent year-over-year.
Strensiq net product sales were $95.6 million, compared to $70.5 million in the fourth quarter of 2016, representing a 36 percent increase. Strensiq volume increased 43 percent year-over-year.
Kanuma net product sales were $21.9 million, compared to $11.0 million in the fourth quarter of 2016, representing a 99 percent increase. Kanuma volume increased 82 percent year-over-year.
GAAP cost of sales was $144.6 million, inclusive of restructuring related expenses of $69.1 million, compared to $67.6 million in the same quarter last year. Non-GAAP cost of sales was $72.5 million, compared to $62.3 million in the same quarter last year.
GAAP R&D expense was $265.0 million, inclusive of restructuring related expenses of $15.3 million, compared to $205.9 million in the same quarter last year. Non-GAAP R&D expense was $188.6 million, compared to $186.1 million in the same quarter last year.
GAAP SG&A expense was $296.4 million, inclusive of restructuring related expenses of $4.5 million, compared to $258.5 million in the same quarter last year. Non-GAAP SG&A expense was $245.2 million, compared to $234.0 million in the same quarter last year.
GAAP income tax expense was $59.3 million, compared to $11.7 million in the same quarter last year, driven primarily by the $45.8 million charge related to U.S. tax reform. Non-GAAP income tax expense was $46.8 million, compared to $37.7 million in the same quarter last year.
GAAP diluted EPS was $0.13 per share, inclusive of restructuring and related expenses of $95.1 million, compared to $0.41 per share in the same quarter last year. Non-GAAP diluted EPS was $1.48 per share, compared to $1.26 per share in the fourth quarter of 2016.
Board of Directors Update

In the last six months, Alexion has appointed four new independent directors with deep biopharmaceutical experience to its Board of Directors: Deborah Dunsire, M.D., Paul A. Friedman, M.D., Francois Nader, M.D. and Judith Reinsdorf, J.D. Alexion also previously announced that Directors M. Michele Burns, Alvin S. Parven and Ann M. Veneman, J.D. have advised the Board that they do not plan to stand for re-election at the Company’s next annual meeting of shareholders.

Research and Development

Complement Portfolio Updates

Soliris (eculizumab)- Generalized Myasthenia Gravis (gMG): In December 2017, the Ministry of Health, Labour and Welfare (MHLW) in Japan approved Soliris as a treatment for patients with gMG who are anti-acetylcholine receptor (AchR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).

Soliris (eculizumab)- Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD): Enrollment is complete in the PREVENT study, a single, multinational, placebo-controlled Phase 3 trial of Soliris in patients with NMOSD. Alexion expects to report data in mid-2018.

ALXN1210- Paroxysmal Nocturnal Hemoglobinuria (PNH): Enrollment is complete in a Phase 3 trial comparing ALXN1210 administered intravenously every eight weeks to Soliris in complement inhibitor treatment-naive patients with PNH and in a Phase 3 PNH Switch study of ALXN1210 administered intravenously every eight weeks compared to patients currently treated with Soliris. Alexion expects to report data from these studies in the second quarter of 2018.

ALXN1210- Atypical Hemolytic Uremic Syndrome (aHUS): Enrollment and dosing are ongoing in a Phase 3 trial with ALXN1210 administered intravenously every eight weeks in complement inhibitor treatment-naive adolescent and adult patients with aHUS. Enrollment is expected to be complete in the second quarter of 2018 and Alexion expects to report data from this study in the fourth quarter of 2018. Enrollment and dosing are also ongoing in a Phase 3 trial of ALXN1210 in pediatric patients with aHUS.

ALXN1210- Subcutaneous: Alexion plans to initiate in late 2018 a single, PK-based Phase 3 study of ALXN1210 delivered subcutaneously once per week to support registration in PNH and aHUS. In December 2017, Alexion entered into a collaboration and license agreement with Halozyme Therapeutics, Inc. that enables the Company to use Halozyme’s ENHANZE drug-delivery technology in the development of subcutaneous formulations for its portfolio of products, including a next-generation subcutaneous formulation of ALXN1210 to potentially further extend the dosing interval to once every two weeks or once per month.

2018 financial guidance assumes the following:

A foreign currency benefit, net of hedging activities, of $45 million to $55 million
Unfavorable Soliris revenue impact of $90 million to $110 million from ALXN1210 and other clinical trial recruitment versus prior year
GAAP effective tax rate of 15 to 17 percent; non-GAAP effective tax rate of 16 to 18 percent (both inclusive of Alexion’s provisional assessment of the impact of U.S. tax reform)
Alexion’s financial guidance is based on current foreign exchange rates net of hedging activities and does not include the effect of business combinations, license and collaboration agreements, asset acquisitions, intangible asset impairments, changes in fair value of contingent consideration or restructuring and related activity outside of the previously announced activities that may occur after the day prior to the date of this press release.

Alexion expects to incur additional restructuring and related expenses of approximately $30 million to $70 million related to the 2017 restructuring activities. As the Company continues to execute its strategic business plan and global footprint, it may incur restructuring expenses in 2018 that are materially different from the current estimate.

Conference Call/Webcast Information:

Alexion will host a conference call/audio webcast to discuss the fourth quarter and full year 2017 results, at 10:00 a.m. Eastern Time. To participate in the call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 7453141 shortly before 10:00 a.m. Eastern Time. A replay of the call will be available for a limited period following the call. The replay number is 888-203-1112 (USA) or 719-457-0820 (International), passcode 7453141. The audio webcast can be accessed on the Investor page of Alexion’s website at: View Source

On February 8, 2018 Immunomedics, Inc. (NASDAQ:IMMU) ("Immunomedics" or the "Company") reported financial results for the second quarter ended December 31, 2017 (Press release, Immunomedics, FEB 8, 2018, View Source [SID1234523837]). The Company also highlighted recent key progress and planned activities for its sacituzumab govitecan program. Please refer to the Company’s Quarterly Report on Form 10-Q filed today with the SEC for more details on the Company’s financial results.

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Michael Pehl, President and Chief Executive Officer, stated, "We made significant progress this quarter, taking the necessary steps to bring sacituzumab govitecan to market and achieving our vision of becoming a fully-integrated biopharmaceutical company. In December at the San Antonio Breast Cancer Symposium, we presented exciting Phase 2 results with sacituzumab govitecan, which were met with enthusiasm by clinicians around the world. The strength of the clinical profile of the sacituzumab govitecan program was recognized by Royalty Pharma, leading to an investment of $250 million and providing the necessary financial resources to carry out our strategic plan."

"We continue to work diligently on our BLA to be submitted to the FDA for accelerated approval," added Pehl. "I am pleased with the overall progress across clinical and manufacturing work streams, including successful validation runs. Our focus continues to be on compiling a BLA package that efficiently brings sacituzumab govitecan to market, and one that anticipates and addresses potential FDA requests going forward. As such, we now expect to file the BLA by the end of May 2018."

During the quarter, Immunomedics continued to expand its leadership team with the appointment of Dr. Morris Rosenberg as Chief Technology Officer. Dr. Rosenberg was previously responsible for overseeing manufacturing at Seattle Genetics for over 11 years and was instrumental in the development of Seattle Genetics’ ADC supply chain and the launch of Adcetris in 2011. Dr. Rosenberg has been a key consultant to Immunomedics for the past nine months, focusing on building an outstanding team and preparing for commercial launch, including a robust CMC package for BLA submission.

"Immunomedics’ compelling science, technological resources, and the strength of the leadership team is the right recipe for groundbreaking innovation at the Company," said Dr. Morris Rosenberg, Chief Technology Officer. "I am pleased to be joining a team that is building outstanding clinical, manufacturing and commercial infrastructure and taking so many meaningful steps toward effectively treating patients with significant unmet medical needs."

Recent Highlights

In December 2017, Immunomedics presented updated results of sacituzumab govitecan in mTNBC in an oral presentation during the 2017 San Antonio Breast Cancer Symposium. In 110 patients with relapsed or refractory mTNBC, an objective response rate of 31% and a median duration of response of 9.1 months was determined by an adjudication team of radiologists after a blinded, independent review.

In January 2018, as part of the Company’s strategy to broaden the development of sacituzumab govitecan in difficult to treat solid tumors beyond mTNBC and advanced urothelial cancer, Immunomedics announced a collaboration with the Carbone Cancer Center at the University of Wisconsin, to evaluate sacituzumab govitecan in patients with advanced prostate cancer in an investigator-sponsored Phase 2 trial.

In January 2018, Immunomedics announced a $250 million royalty funding and stock purchase agreement with Royalty Pharma. Immunomedics has agreed to sell tiered, sales-based royalty rights on global net sales of sacituzumab govitecan to Royalty Pharma for $175 million and Royalty Pharma has purchased $75 million in common stock of the Company. This transaction provides for sufficient cash to fund operations into 2020.
Key 2018 Objectives

Continue execution of the confirmatory Phase 3 ASCENT study in third line+ mTNBC; activation of first European centers is expected in the first half of 2018.

Continue development in mTNBC setting with PARP and/or PD-1/PD-L1 inhibitors.

Establish sacituzumab govitecan as a foundational therapy in advanced urothelial cancer, both as monotherapy and in combination.

Define registration and commercialization strategy in Europe; ensure the appropriate balance between bringing sacituzumab govitecan to patients as fast as possible while securing favorable reimbursement.

Establish commercial presence and ensure launch readiness for sacituzumab govitecan upon approval in mTNBC.

Second Quarter Fiscal 2018 Results

Total revenues for the quarter ended December 31, 2017, were $0.6 million, compared to $0.4 million for the same quarter last fiscal year, an increase of 55% due primarily to a $0.2 million increase in LeukoScan product sales in Europe. The Company intends to discontinue the sale of LeukoScan during the third quarter of fiscal 2018 to focus exclusively on its oncology portfolio of antibody-drug conjugates, unlabeled antibodies and immuno-oncology investigational products.

Total costs and expenses for the quarter ended December 31, 2017 were $30.0 million, compared to $15.7 million for the same quarter last fiscal year, an increase of $14.3 million, or 91% due primarily to a $12.8 million increase in research and development expenses including a $6.9 million increase in human resources and consulting costs to prepare for the regulatory submission and commercial launch of sacituzumab govitecan for patients with mTNBC and a $5.9 million increase related to the initiation of the Phase 3 ASCENT clinical trial for mTNBC.

The Company recognized $26.8 million in non-cash income during the quarter ended December 31, 2017, compared to $7.2 million in non-cash expense for the same quarter last fiscal year, a $34.0 million decrease in non-cash cost due to the decrease in the fair value of warrant liabilities.

Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $0.3 million for the quarter ended December 31, 2017, compared to $1.4 million for the same quarter last fiscal year, a decrease of $1.1 million, or 79% due primarily to the accelerated exchange of $80 million Convertible Senior Notes for equity on September 21, 2017. Interest expense includes the amortization of debt issuance costs of $0.1 million and $0.2 million for the quarters ended December 31, 2017 and December 31, 2016, respectively.

Net loss attributable to stockholders was $2.5 million, or $0.02 per share, for the quarter ended December 31, 2017, compared to $24.4 million, or $0.23 per share, for the same quarter last fiscal year, a decrease of $21.9 million due primarily to the $34.0 million decrease in non-cash cost from the decrease in the fair value of warrant liabilities, offset partially by the $14.3 million increase in costs and expenses.

First Half Fiscal 2018 Results

Total revenues for the six months ended December 31, 2017, were $1.3 million, compared to $1.1 million for the same period last fiscal year, an increase of 18% due primarily to a $0.2 million increase in LeukoScan product sales in Europe.

Total costs and expenses for the six-month period ended December 31, 2017 were $52.3 million, compared to $31.4 million for the same period last fiscal year, an increase of 67% due primarily to a $15.5 million increase in research and development expenses resulting from an $8.2 million increase in consulting and contract services costs, a $5.7 million increase in costs related to initiating the Phase 3 ASCENT clinical trial, and a $1.7 million increase in labor related costs in connection with the preparation of the regulatory submission and commercial launch of sacituzumab govitecan. General and administrative expenses increased $4.0 million compared to the same period in the previous year, due primarily to a $2.1 million increase in legal and advisory fees associated with the proxy contest, and a $1.4 million increase in labor related costs.

The Company recognized $59.6 million in non-cash expense during the six-month period ended December 31, 2017, compared to $7.2 million in the same period in fiscal 2017, an increase of $52.4 million due to the increase in the fair value of warrant liabilities. The Company also recognized a $13.0 million non-cash loss on induced exchanges of $80 million of Convertible Senior Notes for equity.

Interest expense related to the Convertible Senior Notes was $2.9 million for the six-month period ended December 31, 2017, compared to $2.7 million for the same period last year, an increase of $0.2 million due primarily to a $1.4 million increase in the amortization of debt issuance costs offset partially by a $1.2 million reduction in interest expense related to the reduction in principal from the accelerated exchange of Convertible Senior Notes.

During the six-month period ended December 31, 2017, the Company received a $4.4 million insurance reimbursement related to legal costs incurred during the Company’s proxy contest in fiscal year 2017.

Net loss attributable to stockholders was $121.3 million, or $0.88 per share, for the six-month period ended December 31, 2017, compared to $40.6 million, or $0.41 per share for the same period last fiscal year, an increase of $80.7 million due primarily to the $52.4 million increase in non-cash expense, the $20.9 million increase in costs and expenses, and the $13.0 million non-cash loss on induced exchanges of debt, offset partially by the receipt of $4.4 million insurance reimbursement.

Cash, cash equivalents, and marketable securities totaled $139.7 million as of December 31, 2017.

"The $250 million funding from Royalty Pharma combined with our cash balance as of December 31, 2017 provides us with the resources required to support our next phase of growth as we focus on developing sacituzumab govitecan in mTNBC, advanced urothelial cancer and other indications of high unmet medical need, further building our clinical, medical affairs, commercial and manufacturing infrastructure and continuing operations into 2020," according to Michael R. Garone, Vice President Finance and Chief Financial Officer.

Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss financial results for the second quarter of fiscal year 2018, and review key clinical developments and planned activities. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1988406. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

On February 8, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported its consolidated financial results for the fourth quarter and full year 2017 and highlighted recent progress in advancing its pipeline (Press release, Alnylam, FEB 8, 2018, View Source [SID1234523814]).

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"2017 was a defining inflection point in Alnylam’s history, with positive results from the APOLLO Phase 3 study culminating in regulatory filings for patisiran, a first-ever milestone for RNAi, with the potential to bring a whole new class of innovative therapeutics to the forefront of medicine. With newly acquired rest-of-world rights, we anticipate making patisiran available to hATTR amyloidosis patients around the world starting with the U.S. in mid-2018, followed by European countries in late 2018, and then Japan and other countries shortly thereafter. To this end, we have initiated a staged build of global medical and commercial capabilities to expand our reach and ensure that patients and physicians are educated about this rare disease and the safety and efficacy profile of patisiran, upon market approval," said John Maraganore, Ph.D., Chief Executive Officer of Alnylam. "Beyond patisiran, we advanced our late-stage pipeline with three additional RNAi therapeutics in Phase 3 development, including givosiran for acute hepatic porphyrias in our ENVISION Phase 3 study, with topline interim analysis results expected in mid-2018. Also, together with our partners Sanofi and The Medicines Company, we restarted fitusiran in the ATLAS Phase 3 study and advanced inclisiran in the ORION-9, -10, and -11 Phase 3 studies, respectively, with results expected for both programs in 2019. In sum, we believe our efforts position the Company to achieve its Alnylam 2020 goals of building a multi-product, commercial-stage company with a deep clinical-stage pipeline and robust product engine by the end of 2020, a profile rarely achieved in biotech history."

Fourth Quarter 2017 and Recent Significant Corporate Highlights

Advanced patisiran, an investigational RNAi therapeutic for the treatment of patients with hereditary ATTR amyloidosis.
Presented positive, final results from the APOLLO Phase 3 pivotal study.
Completed the rolling submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) and submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), with the agencies recently accepting both applications.
Received Breakthrough Therapy Designation and Priority Review status from the FDA, and expansion of patisiran’s Orphan Drug Designation to the "treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis)." In addition, patisiran received Accelerated Assessment status from the EMA, and has been designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K.
In response to the urgent need for treatment of patients living with hATTR amyloidosis, the Company is fulfilling requests from treating physicians for early access or compassionate use of patisiran; the Company announces today that, to date, more than 100 eligible patients have begun treatment with patisiran under these programs in the U.S. and EU.
Advanced ALN-TTRsc02, a once-quarterly, subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis.
Reaffirmed guidance to initiate a comprehensive Phase 3 program for ALN-TTRsc02 in late 2018.
Advanced givosiran, an investigational RNAi therapeutic in development for the treatment of acute hepatic porphyrias (AHPs), with initiation of the ENVISION Phase 3 study.
The Company reached alignment with global regulatory authorities on the design of the ENVISION study, including with the FDA on an interim analysis based on reduction of urinary aminolevulinic acid (ALA), a biomarker that the FDA considers reasonably likely to predict clinical benefit.
The Company announces today that the interim analysis is also designed to conduct a blinded assessment of the porphyria attack rate for the purpose of a study sample size adjustment from approximately 75 patients to up to approximately 94 patients.
The Company has guided that it expects interim analysis results in mid-2018 and, pending FDA review of the program at the time of interim analysis and assuming positive results, it expects to submit an NDA at or around year-end 2018.
Advanced fitusiran, an investigational RNAi therapeutic in development for the treatment of hemophilia A and B with or without inhibitors, and reached alignment with the FDA on safety measures and a risk mitigation strategy resulting in a lift of the temporary hold on clinical studies.
Alnylam’s partner, The Medicines Company, initiated the ORION-9, -10, and -11 Phase 3 clinical studies for inclisiran in patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents, and completed enrollment in the approximately 1,500 patient ORION-11 study ahead of schedule.
Advanced lumasiran (formerly known as ALN-GO1), an investigational RNAi therapeutic in development for the treatment of primary hyperoxaluria type 1 (PH1), with new positive data from the Phase 1/2 study presented at the American Society of Nephrology Kidney Week 2017 Annual Meeting.
Announced a strategic restructuring of the Company’s rare disease alliance with Sanofi, originally formed in 2014, with Alnylam obtaining global rights to its ATTR amyloidosis programs – patisiran and ALN-TTRsc02 – and Sanofi obtaining global rights to fitusiran.
Joined a research consortium with the UK Biobank, Regeneron, and four major pharmaceutical companies aimed at generating 500,000 human exome sequences linked to medical records by the end of 2019.
Announced a licensing agreement with Vir Biotechnology for the development and commercialization of RNAi therapeutics for infectious diseases, including HBV.
Upcoming Events in Early 2018

Alnylam announces today that it will present additional data from the APOLLO Phase 3 study of patisiran at the International Symposium on Amyloidosis (ISA), being held March 26-29, 2018 in Kumamoto, Japan.
The Company also announces that it will present additional data from the Phase 1 and Phase 2 OLE studies of givosiran at the European Association for the Study of the Liver (EASL) 53rd Annual International Liver Congress, being held April 11-15, 2018 in Paris, France, in an oral presentation on Saturday, April 14 at 10:00 am Central European Time (4:00 am ET).
The Medicines Company has guided its intention to complete enrollment in the ORION-9 and -10 pivotal studies of inclisiran in early 2018.
Alnylam and Sanofi expect to enroll patients in the ATLAS Phase 3 program of fitusiran in patients with hemophilia A or B with and without inhibitors throughout the year, with resumption of dosing expected in early 2018.
Financial results for the quarter and year ended December 31, 2017

"Alnylam’s robust balance sheet and overall financial position allow for the staged build of commercial capabilities and the execution of anticipated product launches in the U.S. and Europe during 2018, assuming regulatory approvals," said Manmeet Soni, Chief Financial Officer of Alnylam. "We also continue to invest in our broad pipeline of investigational RNAi therapeutics, advancing our Phase 3 development programs in addition to several other programs in early- to mid-stage clinical development."

Cash and Investments
At December 31, 2017, Alnylam had cash, cash equivalents and fixed income marketable securities, and restricted investments of $1.73 billion, as compared to $1.09 billion at December 31, 2016.

In November 2017, Alnylam sold an aggregate of 6,440,000 shares of its common stock through an underwritten public offering at a price to the public of $125.00 per share. As a result of the offering, which included the full exercise of the underwriters’ option to purchase additional shares, Alnylam received aggregate net proceeds of $784.5 million.

Credit Agreements
In December 2017, Alnylam repaid $120.0 million under its term loan agreements outstanding. The obligations under its remaining term loan agreement are secured by cash collateral equal to the principal amount of the terms loan outstanding. As a result, in connection with this repayment, Alnylam’s restricted investments decreased by $120.0 million in December 2017.

GAAP and Non-GAAP Net Loss
The net loss according to accounting principles generally accepted in the U.S. (GAAP) for the fourth quarter of 2017 was $142.2 million, or $1.48 per share on both a basic and diluted basis, as compared to a net loss of $112.9 million, or $1.32 per share on both a basic and diluted basis, for the same period in the previous year. For the year ended December 31, 2017, the net loss was $490.9 million, or $5.42 per share on both a basic and diluted basis, as compared to a net loss of $410.1 million, or $4.79 per share on both a basic and diluted basis, for prior year.

The non-GAAP net loss for the fourth quarter of 2017 was $115.1 million, or $1.20 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $92.3 million, or $1.08 per share on both a basic and diluted basis for the same period in the previous year. The non-GAAP net loss for the year ended December 31, 2017 was $398.1 million, or $4.40 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $334.6 million, or $3.91 per share on both a basic and diluted basis, for prior year.

The non-GAAP net loss excludes stock-based compensation expense. See "Use of Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP net loss appearing later in this press release.

Revenues
Revenues were $37.9 million in the fourth quarter of 2017, as compared to $17.5 million in the fourth quarter of 2016. Revenues for the fourth quarter of 2017 included $20.1 million from the Company’s alliance with The Medicines Company, $13.4 million from the Company’s alliance with Sanofi Genzyme, and $4.4 million from other sources. Revenues were $89.9 million in the year ended December 31, 2017, as compared to $47.2 million in the year ended December 31, 2016. Revenues for the year ended December 31, 2017 included $54.6 million from the Company’s alliance with Sanofi Genzyme, $30.2 million from the Company’s alliance with The Medicines Company, and $5.1 million from other sources.

GAAP and Non-GAAP Research and Development Expenses
GAAP research and development (R&D) expenses were $117.8 million in the fourth quarter of 2017 as compared to $105.0 million in the fourth quarter of 2016. GAAP R&D expenses were $390.6 million in the year ended December 31, 2017 as compared to $382.4 million for the prior year.

Non-GAAP R&D expenses were $102.9 million in the fourth quarter of 2017 as compared to $95.0 million in the fourth quarter of 2016. Non-GAAP R&D expenses were $338.8 million in the year ended December 31, 2017 as compared to $339.4 million for the prior year. Non-GAAP R&D expenses exclude stock-based compensation expense. A reconciliation between GAAP and non-GAAP R&D expenses appears later in this press release.

GAAP and Non-GAAP General and Administrative Expenses
GAAP general and administrative (G&A) expenses were $67.5 million in the fourth quarter of 2017 as compared to $27.9 million in the fourth quarter of 2016. GAAP G&A expenses were $199.4 million in the year ended December 31, 2017 as compared to $89.4 million for the prior year.

Non-GAAP G&A expenses were $55.2 million in the fourth quarter of 2017 as compared to $17.2 million in the fourth quarter of 2016. Non-GAAP G&A expenses were $158.4 million in the year ended December 31, 2017 as compared to $56.8 million for the prior year. Non-GAAP G&A expenses exclude stock-based compensation expense. A reconciliation between GAAP and non-GAAP G&A expenses appears later in this press release.

2018 Financial Guidance

Alnylam expects that its cash, cash equivalents and fixed income marketable securities, restricted cash and restricted investments balance will be approximately $1.0 billion at December 31, 2018.

The Company expects its 2018 annual Non-GAAP R&D expenses to be in the range of $400 to $440 million and Non-GAAP selling, general and administrative (SG&A) expenses to be in the range of $280 to $320 million. Both Non-GAAP R&D and SG&A expenses exclude stock-based compensation expenses.

Use of Non-GAAP Financial Measures
This press release contains non-GAAP financial measures, including expenses adjusted to exclude certain non-cash expenses. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The item included in GAAP presentations but excluded for purposes of determining non-GAAP financial measures for the periods presented in the press release is stock-based compensation expense. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants for stock options and restricted stock units and changes in the Company’s stock price, which impacts the fair value of these awards.

The Company believes the presentation of non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources and planning and forecasting future periods. Non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between GAAP and non-GAAP measures is provided later in this press release.

Conference Call Information
Management will provide an update on the Company and discuss fourth quarter and year end 2017 results as well as expectations for the future via conference call on Thursday, February 8, 2018 at 8:30 a.m. ET. To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 9496435. A replay of the call will be available beginning at 11:30 a.m. ET on the day of the call. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international), and refer to conference ID 9496435.

About RNAi

RNAi (RNA interference) is a natural cellular process of gene silencing that represents one of the most promising and rapidly advancing frontiers in biology and drug development today. Its discovery has been heralded as "a major scientific breakthrough that happens once every decade or so," and was recognized with the award of the 2006 Nobel Prize for Physiology or Medicine. By harnessing the natural biological process of RNAi occurring in our cells, a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, function upstream of today’s medicines by potently silencing messenger RNA (mRNA) – the genetic precursors – that encode for disease-causing proteins, thus preventing them from being made. This is a revolutionary approach with the potential to transform the care of patients with genetic and other diseases.

Alnylam – Sanofi Genzyme Alliance

In January 2014, Alnylam and Sanofi Genzyme, the specialty care global business unit of Sanofi, formed an alliance to accelerate the advancement of RNAi therapeutics as a potential new class of innovative medicines for patients around the world with rare genetic diseases. The alliance enables Sanofi Genzyme to expand its rare disease pipeline with Alnylam’s novel RNAi technology and provides access to Alnylam’s R&D engine, while Alnylam benefits from Sanofi Genzyme’s proven global capabilities to advance late-stage development and, upon commercialization, accelerate market access for these promising genetic medicine products. In January 2018, Alnylam and Sanofi Genzyme restructured their alliance, providing Alnylam with global rights to develop and commercialize products for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02, and Sanofi Genzyme with global rights to develop and commercialize fitusiran for the treatment of hemophilia and other rare bleeding disorders. Sanofi Genzyme continues to have the right to opt into other Alnylam rare genetic disease programs for development and commercialization in territories outside of the United States, Canada and Western Europe, as well as one right to a global license.

On February 8, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the 2018 CAGNY Conference on Thursday, Feb. 22, at The Boca Raton Resort, Boca Raton, FL. Jorge Mesquita, Executive Vice President, Worldwide Chairman, Consumer and Alison Lewis, Chief Marketing Officer, Consumer will represent the Company in a session scheduled at 2:00 p.m. (Eastern Time) (Press release, Johnson & Johnson, FEB 8, 2018, View Source [SID1234523842]).

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