On April 25, 2017 Novartis reported sales growth across all divisions (Press release, Novartis, APR 25, 2017, View Source [SID1234518696]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Net sales grew 2% (cc, -1% USD), as growth drivers more than offset Gleevec/Glivec impact
Cosentyx (USD 410 million, +136% cc) showing strong growth in all three indications
Entresto (USD 84 million) steadily growing with better access in US and EU
Gilenya (USD 722 million, +5% cc) grew mainly driven by volume
Excluding Gleevec/Glivec, Oncology grew +7% (cc) driven mainly by Promacta/Revolade, Jakavi, Tafinlar + Mekinist and Tasigna

Core[1] operating income down 5% (cc) due to generic erosion and increased investments, mainly in Entresto and Alcon

Core EPS of USD 1.13, down 1% (cc)

Net income declined 15% (cc) mainly due to a net charge related to the discontinuation of RLX030 (USD -0.2 billion), as well as the decline in core operating income
Free cash flow[1] grew USD 0.3 billion versus prior year, to USD 1.7 billion
Innovation momentum maintained:
Kisqali (formerly LEE011) approved and launched in the US for treatment of advanced breast cancer
Sandoz received positive CHMP opinions for biosimilars etanercept and rituximab in April
CTL019 cell therapy granted FDA Priority Review for pediatric ALL and Breakthrough Therapy designation for DLBCL
BAF312 submission for the treatment of multiple sclerosis expected in 2018 in the US
SEG101 submission for treatment of sickle cell pain crises expected in 2018 in the US, 2019 in EU
AMG 334 positive readout for treatment of episodic migraine in April
Alcon growth plan on track, sales grew +1% (cc) driven by Vision Care. Alcon continued to accelerate innovation, strengthen customer relationships and improve operations
2017 Group outlook confirmed:
Net sales expected to be broadly in line with prior year (cc), core operating income expected to be broadly in line or decline low single digit (cc)
Key Q1 figures[1] Q1 2017 Q1 2016 % change
USD m USD m USD cc
Net Sales 11 539 11 600 -1 2
Operating income 1 922 2 451 -22 -19
Net income 1 665 2 011 -17 -15
EPS (USD) 0.70 0.85 -18 -15
Free cash flow 1 665 1 362 22
Core
Operating income 3 010 3 261 -8 -5
Net income 2 690 2 788 -4 -1
EPS (USD) 1.13 1.17 -3 -1
[1] Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 36 of the Condensed Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.

Basel, April 25, 2017 – Commenting on the results, Joseph Jimenez, CEO of Novartis, said:
“Novartis delivered another solid performance in the first quarter. Growth drivers, including Cosentyx and Entresto, more than offset generic erosion, mainly due to Glivec. The innovation momentum continued in the quarter, led by the launch of Kisqali, and the FDA Priority Review for CTL019 in the US. This reinforces our confidence in our next growth phase, which we expect to start in 2018.”

GROUP REVIEW

First quarter Group financials

Net sales were USD 11.5 billion (-1%, +2% cc) in the first quarter, as volume growth of 7 percentage points was partially offset by the negative impact of generic competition (-3 percentage points) and pricing (-2 percentage points). All divisions reported growth in constant currencies.

Operating income was USD 1.9 billion (-22%, -19% cc). Core adjustments amounted to USD 1.1 billion (2016: USD 0.8 billion), including a net charge of USD 0.2 billion related to the discontinuation of RLX030 development.

Core operating income was USD 3.0 billion (-8%, -5% cc). Core operating income margin in constant currencies decreased 1.8 percentage points, mainly due to generic erosion of Gleevec/Glivec and investments behind new launches and the Alcon growth plan. Currency had a negative impact of 0.2 percentage points, resulting in a net decrease of 2.0 percentage points in US dollar terms to 26.1% of net sales.

Net income was USD 1.7 billion (-17%, -15% cc), declining less than operating income due to higher income from associated companies.

EPS was USD 0.70 (-18%, -15% cc), broadly in line with net income.

Core net income was USD 2.7 billion (-4%, -1% cc), declining less than core operating income due to higher income from associated companies.

Core EPS was USD 1.13 (-3%, -1% cc), broadly in line with core net income.

Free cash flow was USD 1.7 billion (USD +0.3 billion), mainly driven by higher cash flows from operating activities.

Innovative Medicines net sales were USD 7.7 billion (0%, +2% cc) in the first quarter, with volume growth of 7 percentage points driven by Cosentyx, Entresto, Promacta/Revolade, Jakavi, Tafinlar + Mekinist and Gilenya. Generic competition had a negative impact of 4 percentage points and pricing had a negative impact of 1 percentage point, both largely due to Gleevec/Glivec genericization in the US and Europe.

Operating income was USD 1.7 billion (-21%, -17% cc) due to generic erosion of Gleevec/Glivec, launch investments and the net charge of USD 0.2 billion related to the discontinuation of RLX030 development. Core operating income was USD 2.4 billion (-7%, -3% cc). Core operating income margin in constant currencies decreased by 1.7 percentage points due mainly to generic erosion and launch investments for Entresto, Cosentyx and Kisqali. Currency had a negative impact of 0.5 percentage points, resulting in a net decrease of 2.2 percentage points to 31.5% of net sales.

Sandoz net sales were USD 2.4 billion (-1%, +1% cc) in the first quarter, as volume growth of 9 percentage points was offset by 8 percentage points of price erosion. Global sales of Biopharmaceuticals (including biosimilars, biopharmaceutical contract manufacturing and Glatopa) grew +30% (cc) to USD 274 million, driven by strong performance of Zarxio (filgrastim) and Glatopa 20mg in the US.

Operating income was USD 343 million (-1%, -2% cc). Core operating income was USD 460 million (-5%, -6% cc). Core operating income margin in constant currencies decreased by 1.3 percentage points, mainly due to higher M&S investment, including biosimilars, and higher Other Expense. Currency had a positive impact of 0.4 percentage points, resulting in a net decrease of 0.9 percentage points to 18.9% of net sales.

Alcon net sales were USD 1.4 billion (-1%, +1% cc) in the first quarter. Vision Care sales (+4% cc) continued to grow, driven by strong performance of the daily contact lens portfolio, including continued double-digit growth of Dailies Total1. Surgical sales (-1% cc) were down, mainly due to continued competitive pressures in IOLs.

Operating loss was USD 43 million, compared to an income of USD 31 million in the prior year quarter. Core operating income was USD 187 million (-23%, -18% cc). Core operating income margin decreased by 3.1 percentage points in constant currencies, mainly impacted by higher M&S investment. Currency had a negative impact of 0.7 percentage points, resulting in a net margin decrease of 3.8 percentage points to 13.2% of net sales.

Key growth drivers

Underpinning our financial results in the first quarter is a continued focus on key growth drivers, including Cosentyx, Entresto, Promacta/Revolade, Jakavi, Tafinlar + Mekinist, Tasigna and Gilenya, as well as Biopharmaceuticals and Emerging Growth Markets.

Growth Drivers

Cosentyx (USD 410 million, +136% cc), continued to show strong launch trajectory in the first quarter of 2017 across its three approved indications. Cosentyx has been used to treat more than 80,000 patients since launch.
Entresto (USD 84 million, USD +67 million), had a solid first quarter, benefitting from the continued access improvements, effects of increased investment in the US, as well as additional launches in Europe.
Promacta/Revolade (USD 175 million, +35% cc) grew strongly, driven by continued worldwide uptake as well as growth of the thrombopoietin class for chronic immune thrombocytopenic purpura.
Jakavi (USD 162 million, +34% cc) growth was driven by increased patients treated for myelofibrosis and the launch of the polycythemia vera indication in key markets.
Tafinlar + Mekinist (USD 187 million, +27% cc) continued to show strong growth, particularly in Europe.
Tasigna (USD 411 million, +9% cc) showed solid growth in the first quarter, particularly in the US, despite multiple generic versions of Gleevec/Glivec.
Gilenya (USD 722 million, +5% cc), exhibited continued volume growth.
Biopharmaceuticals (USD 274 million, +30% cc) grew mainly driven by Zarxio and Glatopa 20mg in the US.

Emerging Growth Markets

Net sales in Emerging Growth Markets – which comprise all markets except the US, Canada, Western Europe, Japan, Australia and New Zealand – grew 1% USD, 6% cc.
Strengthen R&D

Innovation Review

Benefitting from our continued focus on innovation, Novartis has one of the industry’s most competitive pipelines with more than 200 projects in clinical development.

Key developments from the first quarter of 2017 include:

New approvals and regulatory opinions

Kisqali (ribociclib, formerly LEE011) was approved by the FDA in combination with an aromatase inhibitor for treatment of postmenopausal women with HR+/HER2- advanced or metastatic breast cancer.
Tafinlar + Mekinist received EU approval in April for combination therapy to treat patients with advanced or metastatic NSCLC whose tumors express the BRAF V600 mutation.
Votubia (everolimus) dispersible tablets were approved by the EC as an adjunctive treatment for patients whose refractory partial-onset seizures are associated with TSC.
Sandoz biosimilars etanercept (Amgen’s Enbrel) and rituximab (Roche’s MabThera/Rituxan) received positive opinions from the CHMP in April.
AcrySof IQ ReSTOR 2.5D Toric IOL with ACTIVEFOCUS was approved by the FDA to address presbyopia and preexisting astigmatism at the time of cataract surgery.

Regulatory submissions and filings

CTL019 was granted Priority Review by the FDA, in pediatric and young adult patients with acute lymphoblastic leukemia. CTL019 is an investigational CAR-T cell therapy. The FDA has also granted Breakthrough Therapy designation to CTL019 for the treatment of adult patients with r/r diffuse large B-cell lymphoma.
Zykadia (ceritinib) was granted Priority Review from the FDA for use as a first-line treatment for patients with metastatic NSCLC with an ALK mutation, and Breakthrough Therapy designation in this indication for patients with brain metastases.
SEG101 (crizanlizumab) was discussed with health authorities and based on their feedback Novartis expects to submit for regulatory approval for sickle cell pain crises in the US in 2018. This assumes successful PK/PD comparability study to final manufacturing process.
BAF312 (siponimod) was discussed with the FDA and Novartis expects to submit an application for the treatment of relapsing multiple sclerosis (RMS) in 2018.

Results from ongoing trials and other highlights

AMG 334 (erenumab) data from Phase III trials STRIVE and ARISE was presented at American Academy of Neurology, in April. The data confirms the potential of AMG 334 to substantially reduce days with migraine for people experiencing up to 14 migraine days a month. The safety profile of AMG 334 was comparable to placebo.
Entresto analysis presented at the American College of Cardiology of data from a subgroup of patients with reduced ejection fraction heart failure (HFrEF) and diabetes suggests that Entresto may improve glycemic control compared to the ACE-inhibitor enalapril.
Cosentyx analysis was presented at the American Academy of Dermatology that showed patients rapidly regained clear or almost clear skin (Psoriasis Area Severity Index, PASI 90 to 100) following relapse during a treatment pause.
Cosentyx data was presented at the Maui Derm for Dermatologists meeting that showed it may modify the course of moderate-to-severe psoriasis leading to long-term, treatment-free skin clearance in approximately 20% of patients following one year of treatment.
Sandoz biosimilar adalimumab (GP2017) showed equivalent efficacy to the reference medicine, AbbVie’s Humira, in data presented at the American Academy of Dermatology.
Promacta (eltrombopag) achieved complete response (CR) in 58% of patients treated with treatment-naïve severe aplastic anemia (SAA) at six months at the initiation of and concurrently with standard immunosuppressive treatment, according to a study published by NEJM in April.
ECF843 ophthalmic rights were acquired (ex-EU), adding a novel disease-modifying approach for the treatment of dry eye to our leading R&D portfolio in Ophthalmology.
AMG 334 (erenumab). In April, Novartis expanded the global partnership with Amgen to include co-commercialization in the US; Novartis to gain exclusive rights in Canada and retain existing rights in rest of world, excluding Japan.
Allergan and Novartis entered into a clinical trial agreement in April to conduct a phase IIb study, involving the combination of a Novartis FXR agonist and Allergan’s cenicriviroc (CVC) for the treatment of non-alcoholic steatohepatitis (NASH).
RLX030 (serelaxin) phase III trial RELAX-AHF-2 did not meet its primary endpoints.
Transform Alcon into an agile company

The Alcon Division grew sales 1% (cc) in the first quarter and continued to execute against the growth plan, taking actions to accelerate innovation and sales, strengthen customer relationships and to improve the efficiency and effectiveness of operations.

In Vision Care (+4% cc), continued investments in direct to consumer advertising behind key brands in Europe and the US helped drive growth in contact lenses (+7% cc) for the fourth consecutive quarter.

Surgical (-1% cc) continued to strengthen its basic operations and improve supply levels, which led to improved customer service. The pipeline continued to advance with the approval of the AcrySof IQ ReSTOR +2.5D Multifocal Toric IOL with ACTIVEFOCUS in the US. The division also invested in expanding its new product launches, including CyPass and NGENUITY 3D.

In January 2017, Novartis announced a strategic review of Alcon. Options to maximize shareholder value of the Alcon Division are under consideration. A status update will be provided towards the end of 2017.

Create a stronger company for the future

We continued to advance all of our productivity and quality programs in the first quarter:

Novartis Business Services (NBS), our cross-divisional services organization, continues to deliver sustainable savings, with a disciplined approach to investment and ensuring quality services. We are building strategic partnerships with key vendors to create value, and are driving productivity through process simplification and automation. Furthermore, we continue to optimize our geographical footprint to further strengthen our capabilities centered on our five Novartis Global Service Centers.
Novartis Technical Operations (NTO) is fully operating in the new organizational set up and continues to advance our productivity programs. A synergy and savings roadmap is being implemented with a five-year time horizon.
Global Drug Development (GDD) was implemented in 2016, overseeing drug development across the innovative medicines and the biosimilars portfolio. The enterprise-wide approach to portfolio management enables better resource allocation and increased R&D productivity.
Novartis continues to focus on compliance, reliable product quality and sustainable efficiency as part of our quality programs. A total of 46 global health authority inspections were completed in Q1 2017, 12 of which were conducted by the FDA. All were deemed good or acceptable.
Capital structure and net debt

Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.

In January 2017, Novartis announced an up to USD 5 billion share buyback to be executed on the second trading line. In Q1 of 2017, Novartis repurchased 16.2 million shares under this buyback and 2.7 million shares to mitigate dilution related to equity-based participation plans of associates. In addition, 1.7 million shares were repurchased from associates, and 12.1 million treasury shares were delivered as a result of options exercised and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 8.5 million versus December 31, 2016. Novartis aims to fully offset the dilutive impact from equity-based participation plans of associates. These treasury share transactions resulted in a net cash outflow of USD 1.1 billion.

In the first quarter of 2017, Novartis issued bonds denominated in US dollars and euro for total notional amounts of USD 3.0 billion and USD 2.0 billion, respectively.

As of March 31, 2017 net debt increased by USD 7.0 billion to USD 23.0 billion. The increase was mainly driven by the USD 6.5 billion annual dividend payment, share repurchases, and M&A related payments.

The long-term credit rating for the company continues to be double-A (Moody’s Investors Service Aa3; S&P Global Ratings AA-; Fitch Ratings AA).

2017 Outlook

Barring unforeseen events

We confirm our outlook as presented at the beginning of 2017. Group net sales in 2017 are expected to be broadly in line with the prior year (cc), after absorbing the impact of generic competition, including the continued genericization of Gleevec/Glivec in the US and Europe.

From a divisional perspective, we expect net sales performance (cc) in 2017 to be as follows:

Innovative Medicines: revised upward to broadly in line with prior year, to a slight increase
Sandoz: revised down to broadly in line with prior year, due to the delay of US Glatopa 40mg
Alcon: broadly in line with prior year to low single digit growth
Group core operating income in 2017 is expected to be broadly in line with prior year to a low single digit decline (cc).

If mid-April exchange rates prevail for the remainder of 2017, the currency impact for the year would be negative 2 percentage points on sales and negative 3 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Summary Financial Performance

Innovative Medicines Q1 2017 Q1 2016 % change
USD m USD m USD cc
Net Sales 7 692 7 729 0 2
Operating income 1 721 2 180 -21 -17
As a % of sales 22.4 28.2
Core Operating income 2 426 2 602 -7 -3
As a % of sales 31.5 33.7
Sandoz Q1 2017 Q1 2016 % change
USD m USD m USD cc
Net Sales 2 430 2 445 -1 1
Operating income 343 346 -1 -2
As a % of sales 14.1 14.2
Core Operating income 460 485 -5 -6
As a % of sales 18.9 19.8
Alcon Q1 2017 Q1 2016 % change
USD m USD m USD cc
Net Sales 1 417 1 426 -1 1
Operating loss/income -43 31 nm nm
As a % of sales -3.0 2.2
Core Operating income 187 243 -23 -18
As a % of sales 13.2 17.0
Corporate Q1 2017 Q1 2016 % change
USD m USD m USD cc
Operating loss -99 -106 7 -6
Core Operating loss -63 -69 9 -8

Total Group Q1 2017 Q1 2016 % change
USD m USD m USD cc
Net Sales 11 539 11 600 -1 2
Operating income 1 922 2 451 -22 -19
As a % of sales 16.7 21.1
Core Operating income 3 010 3 261 -8 -5
As a % of sales 26.1 28.1
Net income 1 665 2 011 -17 -15
EPS (USD) 0.70 0.85 -18 -15
Cash flow from operating activities 2 045 1 542 33
Free cash flow 1 665 1 362 22
A condensed interim financial report with the information listed in the index below can be found on our website at View Source (link is external).

Novartis Q1 2017 Condensed Interim Financial Report – Supplementary Data

INDEX Page
GROUP AND DIVISIONAL OPERATING PERFORMANCE Q1 2017
Group 2
Innovative Medicines 4
Sandoz 11
Alcon 12
CASH FLOW AND GROUP BALANCE SHEET 14
INNOVATION REVIEW 16
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Consolidated income statements 24
Condensed consolidated statements of comprehensive income 25
Condensed consolidated balance sheets 26
Condensed consolidated changes in equity 27
Condensed consolidated cash flow statements 28
Notes to condensed interim consolidated financial statements, including update on legal proceedings 29
SUPPLEMENTARY INFORMATION 36
CORE RESULTS
Reconciliation from IFRS to core results 38
Group 39
Innovative Medicines 40
Sandoz 41
Alcon 42
Corporate 43
ADDITIONAL INFORMATION
Condensed consolidated changes in net debt / Share information 44
Free cash flow 45
Net sales of the top 20 Innovative Medicines products 46
Innovative Medicines sales by business franchise 47
Net sales by region 48
Currency translation rates 49
Income from associated companies 50
DISCLAIMER 51

On April 25, 2017 Illumina, Inc. (NASDAQ:ILMN) reported its financial results for the first quarter of fiscal year 2017 (Press release, Illumina, APR 25, 2017, View Source [SID1234518689]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

First quarter 2017 results:
•
Revenue of $598 million, a 5% increase compared to $572 million in the first quarter of 2016
•
GAAP net income attributable to Illumina stockholders for the quarter of $373 million, or $2.52 per diluted share, including the impact of a pre-tax gain of $453 million as a result of the GRAIL repurchase of shares from Illumina, compared to $90 million, or $0.60 per diluted share, for the first quarter of 2016
•
Non-GAAP net income attributable to Illumina stockholders for the quarter of $94 million, or $0.64 per diluted share, compared to $106 million, or $0.71 per diluted share, for the first quarter of 2016 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
•
Cash flow from operations of $168 million and free cash flow of $85 million for the quarter, compared to $99 million and $46 million, respectively, in the first quarter of 2016

Gross margin in the first quarter of 2017 was 61.5% compared to 69.4% in the prior year period. Excluding impairment and amortization of acquired intangible assets, but including stock-based compensation expense, non-GAAP gross margin was 66.4% for the first quarter of 2017 compared to 71.3% in the prior year period. Non-GAAP gross margin compared to the prior year period was impacted by the NovaSeq introduction, higher array services revenue and product mix within sequencing consumables.

Research and development (R&D) expenses for the first quarter of 2017 were $145 million compared to $124 million in the prior year period. Excluding an impairment of in-process R&D, but including stock-based compensation expense, R&D expenses as a percentage of revenue were 23.3%, including 2.1% attributable to GRAIL and Helix. This compares to 21.7% in the prior year period, including 0.9% attributable to GRAIL and Helix.

Selling, general and administrative (SG&A) expenses for the first quarter of 2017 were $163 million compared to $150 million in the prior year period. Excluding the effect of performance-based compensation related to the GRAIL Series B financing, acquisition related gain, amortization of acquired intangible assets, and contingent compensation, but including stock-based compensation expense, SG&A expenses as a percentage of revenue were 25.6%, including 1.5% attributable to GRAIL and Helix. This compares to 25.7% in the prior year period, including 0.6% attributable to GRAIL and Helix.



Depreciation and amortization expenses were $38 million and capital expenditures for free cash flow purposes were $83 million during the first quarter of 2017. At the close of the quarter, the company held $1.8 billion in cash, cash equivalents and short-term investments, compared to $1.6 billion as of January 1, 2017.

"We are pleased with our first quarter results," said Francis deSouza, President and CEO. "We are witnessing an exciting uptake of the NovaSeq platform with more than 135 orders placed in Q1, and look forward to the advancements in genomics this instrument will enable for years to come."

Updates since our last earnings release:

•
Launched the VeriSeq NIPT Solution in Europe, a CE-IVD marked next-generation sequencing based approach to noninvasive prenatal testing
•
Contributed more than 8,000 associations of somatic genetic alterations to the Clinical Interpretation of Variants in Cancer (CIViC) database
•
Announced the iHope Network, a consortium of institutions who have committed to providing clinical whole genome sequencing to underserved families
•
Announced that GRAIL raised $900 million in the first close of its Series B financing and that Illumina’s stake is now less than 20 percent of GRAIL
•
Announced that John W. Thompson will join the company’s Board of Directors
•
Repurchased $101 million of common stock under the previously announced share repurchase program thereby completing the authorization

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2017, the company is projecting 10% to 12% revenue growth, GAAP earnings per diluted share attributable to Illumina stockholders of $5.26 to $5.36 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $3.60 to $3.70. Our annual guidance assumes second quarter revenue growth of approximately 7% versus the prior year, GAAP earnings per diluted share attributable to Illumina stockholders of $0.56 to $0.61 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $0.65 to $0.70.

oN aPRIL 25, 2017 Biogen Inc. (NASDAQ: BIIB) reported first quarter 2017 financial results (Filing, Q1, Biogen, 2017, APR 25, 2017, View Source [SID1234518688]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Total revenues of $2.8 billion, a 3% increase versus the prior year and an 8% increase excluding hemophilia revenues*.
TYSABRI revenue grew 14% versus the prior year. Outside the U.S., TYSABRI revenues benefited by approximately $45 million due to reaching an agreement with the Price and Reimbursement Committee of the Italian National Medicines Agency (AIFA) related to TYSABRI sales in prior periods.
Versus Q4 2016, Biogen estimates TECFIDERA U.S. revenues were negatively impacted by approximately $50 million to $60 million due to lower inventory levels in the channel.
Worldwide SPINRAZA revenues were $47 million.
GAAP net income and diluted earnings per share (EPS) attributable to Biogen Inc. of $748 million and $3.46, respectively.
GAAP net income and diluted EPS were negatively impacted by $263 million and $1.22, net of tax, respectively, related to the settlement and license agreement with Forward Pharma including consideration of the U.S. Patent and Trademark Office (USPTO) ruling in favor of Biogen in the interference proceeding.
Non-GAAP net income and diluted EPS attributable to Biogen Inc. of $1.1 billion and $5.20, respectively.
* Total Q1 2017 revenues include hemophilia revenues only for the month of January. The 8% increase in total revenues excludes all hemophilia revenues from Q1 2016 and January 2017. Hemophilia revenues include ELOCTATE and ALPROLIX product revenues as well as royalty and contract manufacturing revenue related to Sobi.


(In millions, except per share amounts) Q1 ’17 Q4 ’16 Q1 ’16
Q1 ’17 v.
Q4 ’16
Q1 ’17 v.
Q1 ’16
Total revenues** $ 2,811 $ 2,872 $ 2,727 (2%)** 3%**

GAAP net income*** $ 748 $ 649 $ 971 15 % (23 %)
GAAP diluted EPS $ 3.46 $ 2.99 $ 4.43 16 % (22 %)

Non-GAAP net income*** $ 1,123 $ 1,093 $ 1,049 3 % 7 %
Non-GAAP diluted EPS $ 5.20 $ 5.04 $ 4.79 3 % 9 %

** Total revenues grew 4% versus Q4 2016 and 8% versus Q1 2016 excluding hemophilia.
***Net income attributable to Biogen Inc.

A reconciliation of GAAP to Non-GAAP quarterly financial results can be found in Table 3 at the end of this press release.

"I am very pleased with the results of the first quarter. We saw continued stability in our MS business, executed a strong launch of SPINRAZA, grew market share for our biosimilars business across Europe, and reinforced the intellectual property for TECFIDERA," said Chief Executive Officer Michel Vounatsos. "Furthermore, we continued to build our neurology pipeline with the anticipated addition of our new Phase 2-ready anti-tau antibody."

"We are encouraged by the progress we made launching SPINRAZA in the U.S., and, following the positive CHMP opinion, we are ramping up pre-launch activities in Europe. The value this therapy provides to patients is compelling, and we are working to accelerate patient access globally," Vounatsos continued. "Overall, I believe we’re building positive momentum at the company, and I look forward to leading Biogen into a new and exciting era."


Revenue Highlights

(In millions) Q1 ’17 Q4 ’16 Q1 ’16
Q1 ’17 v.
Q4 ’16
Q1 ’17 v.
Q1 ’16
Multiple Sclerosis:
TECFIDERA $ 958 $ 1,002 $ 946 (4 %) 1 %
Total Interferon $ 648 $ 688 $ 670 (6 %) (3 %)
AVONEX $ 537 $ 564 $ 564 (5 %) (5 %)
PLEGRIDY $ 112 $ 125 $ 106 (10 %) 5 %
TYSABRI $ 545 $ 474 $ 477 15 % 14 %
FAMPYRATM $ 20 $ 22 $ 20 (7 %) 1 %
ZINBRYTA $ 11 $ 6 $ — 81 % NMF

Hemophilia:
ELOCTATE**** $ 48 $ 149 $ 108 (68 %) (55 %)
ALPROLIX**** $ 26 $ 93 $ 75 (72 %) (65 %)

Spinal Muscular Atrophy
SPINRAZA $ 47 $ 5 $ — NMF NMF

Other Product Revenues:
Biosimilars $ 66 $ 53 $ 2 25 % NMF
FUMADERMTM $ 10 $ 11 $ 11 (15 %) (15 %)

Total Product Revenues: $ 2,380 $ 2,503 $ 2,309 (5 %) 3 %

Anti-CD20 Revenues $ 341 $ 318 $ 329 7 % 3 %
Other Revenues**** $ 90 $ 51 $ 88 77 % 2 %

Total Revenues** $ 2,811 $ 2,872 $ 2,727 (2%)** 3%**

Note: Numbers may not foot due to rounding; percent changes represented as favorable & (unfavorable)
**** Q1 2017 ELOCTATE and ALPROLIX revenues reflect only the month of January, prior to the spin-off of our hemophilia business. Other revenues include royalty and contract manufacturing revenue related to Sobi only for the month of January.


Expense Highlights

(In millions) Q1 ’17 Q4 ’16 Q1 ’16
Q1 ’17 v.
Q4 ’16
Q1 ’17 v.
Q1 ’16
GAAP cost of sales $ 385 $ 378 $ 313 (2 %) (23 %)
Non-GAAP cost of sales $ 385 $ 363 $ 313 (6 %) (23 %)

GAAP R&D $ 423 $ 534 $ 437 21 % 3 %
Non-GAAP R&D $ 421 $ 531 $ 437 21 % 4 %

GAAP SG&A $ 499 $ 496 $ 497 (1 %) (0 %)
Non-GAAP SG&A $ 483 $ 484 $ 497 0 % 3 %
Note: Percent changes represented as favorable & (unfavorable)

Biogen also recorded GAAP-only pre-tax charges in Q1 2017 of $354 million related to the settlement and license agreement with Forward Pharma including consideration of the USPTO ruling in favor of Biogen in the interference proceeding. These charges are included in amortization of acquired intangible assets and exceed the amounts anticipated in Biogen’s previously announced 2017 full year GAAP financial guidance related to this agreement.
Other Financial Highlights

As of March 31, 2017, Biogen had cash, cash equivalents and marketable securities totaling approximately $5.7 billion, and approximately $6.5 billion in notes payable and other financing arrangements.
For the first quarter of 2017, the Company’s weighted average diluted shares were approximately 216 million. The Company ended the quarter with approximately 214 million basic shares outstanding.
During the first quarter of 2017, Biogen repurchased approximately 2 million shares of the Company’s common stock for a total value of $584 million. Since the end of the quarter, the Company has repurchased an additional approximately 2 million shares for a total value of $543 million.
Business Development Highlights

In April 2017, Biogen announced an agreement with Bristol-Myers Squibb to exclusively license BMS-986168, an experimental medicine with potential in Alzheimer’s disease and progressive supranuclear palsy (PSP), a rare condition that affects movement, speech, vision, and cognitive function. Biogen plans to initiate Phase 2 studies for BMS-986168 in both of these indications. Biogen anticipates making an upfront payment of $300 million to Bristol-Myers Squibb in the second quarter of 2017 as well as a near-term $60 million milestone payment to the former stockholders of iPierian, Inc. upon initiation of a Phase 2 trial for BMS-986168. These amounts exceed the estimated $100 million in business development expense assumed in Biogen’s previously announced 2017 full year financial guidance. This agreement is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the second quarter of 2017.
Other Recent Events

At the 69th annual meeting of the American Academy of Neurology (AAN) being held in Boston from April 22 to April 28, 2017, Biogen is presenting data from its portfolio of treatments and investigational therapies for people with serious neurological and neurodegenerative diseases. Platform and poster presentations include new real-world evidence supporting TECFIDERA and TYSABRI, underscoring the importance of early and appropriate treatment for multiple sclerosis (MS); new data demonstrating the clinically meaningful efficacy and favorable benefit-risk profile of SPINRAZA for spinal muscular atrophy; and previously presented results from the Phase 1b studies of aducanumab, an investigational treatment for early Alzheimer’s disease.
In April 2017, Biogen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending the granting of a marketing authorization in the European Union (EU) for SPINRAZA (nusinersen) to treat patients with spinal muscular atrophy. The CHMP reviewed SPINRAZA under an accelerated assessment procedure, which is a regulatory mechanism to facilitate earlier access to patients for medicines that fulfill unmet medical needs. SPINRAZA is the first treatment for spinal muscular atrophy to be recommended by the CHMP for approval in the EU.
In March 2017, the USPTO ruled against the Coalition for Affordable Drugs V LLC, an entity associated with a hedge fund, in the inter partes review of Biogen’s U.S. Patent No. 8,399,514 (the ‘514 patent). The ‘514 patent includes claims covering the treatment of MS with 480 mg of dimethyl fumarate as provided for in Biogen’s TECFIDERA label.
In March 2017, the USPTO ruled against Forward Pharma in the interference proceeding between Forward Pharma’s pending U.S. Patent Application No. 11/576,871 and the ‘514 patent.
In March 2017, Biogen presented data from its Alzheimer’s and Parkinson’s disease programs at the 13th International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD) in Vienna, Austria. The Biogen presentations included data from research of Alzheimer’s and Parkinson’s disease biomarkers; the investigational treatment for Alzheimer’s disease, aducanumab; and the investigational treatment for Parkinson’s disease, BIIB054.
In March 2017, Roche announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted unanimously (11 to 0) that the benefit-risk of rituximab/hyaluronidase for subcutaneous (under the skin) injection was favorable for the treatment of certain blood cancers. This new co-formulation includes the same monoclonal antibody as intravenous RITUXAN (rituximab) and hyaluronidase, a molecule that helps to deliver medicine under the skin. The FDA is expected to make a decision on approval by June 26, 2017. Roche and Biogen collaborate on RITUXAN in the U.S.
In March 2017, Biogen appointed Anirvan Ghosh, Ph.D. as Senior Vice President, Research and Early Development (RED). Dr. Ghosh will lead Biogen’s RED organization in the discovery and development of drug candidates from idea through proof of concept.
In February 2017, Biogen announced the completion of the separation of its global hemophilia business. The new company, known as Bioverativ, is an independent, publicly traded global biotechnology company focused on hemophilia and other rare blood disorders. Bioverativ trades under the symbol "BIVV" on the NASDAQ Global Select Market.
In January 2017, Siemens Healthineers and Biogen announced plans to jointly develop magnetic resonance imaging (MRI) applications with the intent of quantifying key markers of MS disease activity and progression.
In January 2017, Biogen initiated a Phase 1 trial of an anti-tau monoclonal antibody, BIIB076, in healthy volunteers and participants with Alzheimer’s disease. BIIB076 was derived from Neurimmune’s reverse translational medicine platform.