On January 26, 2017 Biogen Inc. (NASDAQ: BIIB) reported full year and fourth quarter 2016 financial results (Filing, Q4/Annual, Biogen, 2016, JAN 26, 2017, View Source [SID1234517572]).
Including:
•
Full year total revenues of $11.4 billion, a 6% increase versus the prior year. On a constant currency basis1, total revenues grew 9%.
◦
Growth was driven by a 9% increase in worldwide TECFIDERA revenues as well as increased revenues from TYSABRI, ELOCTATE, ALPROLIX, and BENEPALI. Revenues were partially offset by a decrease in worldwide interferon sales.
◦
Foreign exchange negatively impacted total revenues by approximately $211 million compared with 2015, primarily driven by changes in hedge results.
•
Full year GAAP net income attributable to Biogen Inc. of $3.7 billion, a 4% increase versus the prior year.
◦
GAAP net income was negatively impacted by $339 million, net of tax, related to the settlement and license agreement with Forward Pharma A/S.
•
Full year GAAP diluted earnings per share (EPS) of $16.93, a 10% increase versus the prior year.
◦
GAAP EPS were negatively impacted by $1.55, net of tax, related to the settlement and license agreement with Forward Pharma.
•
Full year non-GAAP net income attributable to Biogen Inc. of $4.4 billion, a 12% increase versus the prior year.
•
Full year non-GAAP diluted EPS of $20.22, a 19% increase versus the prior year.

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(In millions, except per share amounts)
Q4 ’16

Q3 ’16

Q4 ’15

Q4 ’16 v. Q3 ’16

Q4 ’16 v. Q4 ’15

FY ’16

FY ’15

FY ’16 v. FY ’15
Total revenues
$
2,872

$
2,956

$
2,839

(3%)

1%

$
11,449

$
10,764

6%

GAAP net income*
$
649

$
1,033

$
832

(37%)

(22%)

$
3,703

$
3,547

4%
GAAP diluted EPS
$
2.99

$
4.71

$
3.77

(37%)

(21%)

$
16.93

$
15.34

10%

Non-GAAP net income*
$
1,093

$
1,138

$
995

(4%)

10%

$
4,423

$
3,932

12%
Non-GAAP diluted EPS
$
5.04

$
5.19

$
4.5

(3%)

12%

$
20.22

$
17.01

19%
*Net income attributable to Biogen Inc.

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

"Biogen seeks to advance transformational pipeline programs for some of the greatest challenges in medicine, including Alzheimer’s disease, Parkinson’s, and ALS," said Chief Executive Officer Michel Vounatsos. "SPINRAZA for spinal muscular atrophy is a prime example of the type of groundbreaking innovation that we must continue to pursue. As the first treatment for infants and children with this devastating disease, SPINRAZA has the potential to improve and extend the lives of thousands of patients worldwide."

"In 2016 we saw continued growth from our multiple sclerosis portfolio, which includes the market leading therapies amongst the orals, the interferons, and the high efficacy agents," Vounatsos continued. "Together with AbbVie we are launching ZINBRYTA as a new option for MS patients around the world. Our hemophilia products continued to perform well as we prepare to spin off this business in the coming days, and we are pleased with the strong growth of BENEPALI, an etanercept biosimilar we are commercializing in Europe. I am excited to take the helm of a company with such a strong foundation, and my plan is to maintain a disciplined focus on near-term execution while laying the groundwork for Biogen’s long-term sustainability through continued investment in R&D and innovation and business development."

Revenue Highlights
(In millions)
Q4 ’16

Q3 ’16

Q4 ’15

Q4 ’16 v. Q3 ’16

Q4 ’16 v. Q4 ’15

FY ’16

FY ’15

FY ’16 v. FY ’15
Multiple Sclerosis:

TECFIDERA
$
1,002

$
1,034

$
993

(3%)

1%

$
3,968

$
3,638

9%
Total Interferon
$
688

$
708

$
740

(3%)

(7%)

$
2,795

$
2,969

(6%)
AVONEX
$
564

$
580

$
637

(3%)

(12%)

$
2,314

$
2,630

(12%)
PLEGRIDY
$
125

$
128

$
103

(3%)

21%

$
482

$
338

42%
TYSABRI
$
474

$
515

$
481

(8%)

(1%)

$
1,964

$
1,886

4%
FAMPYRATM
$
22

$
21

$
28

4%

(20%)

$
85

$
90

(5%)
ZINBRYTA
$
6

$
2

$
—

201%

NMF

$
8

$
—

NMF

Hemophilia:

ELOCTATE
$
149

$
132

$
101

13%

47%

$
513

$
320

61%
ALPROLIX
$
93

$
85

$
71

9%

31%

$
334

$
234

42%

Other Product Revenues:

FUMADERMTM
$
11

$
11

$
13

1%

(10%)

$
46

$
51

(11%)
Biosimilars
$
53

$
31

$
—

72%

NMF

$
101

$
—

NMF
ZINBRYTA
$
5

$
—

$
—

NMF

NMF

$
5

$
—

NMF

Total Product Revenues:
$
2,503

$
2,540

$
2,426

(1%)

3%

$
9,818

$
9,188

7%

Anti-CD20 Revenues
$
318

$
318

$
334

0%

(5%)

$
1,315

$
1,339

(2%)
Other Revenues
$
51

$
99

$
79

(48%)

(36%)

$
316

$
237

34%

Total Revenues
$
2,872

$
2,956

$
2,839

(3%)

1%

$
11,449

$
10,764

6%
Note: Numbers may not foot due to rounding.

Expense Highlights

(In millions)
Q4 ’16

Q3 ’16

Q4 ’15

Q4 ’16 v. Q3 ’16

Q4 ’16 v. Q4 ’15

FY ’16

FY ’15

FY ’16 v. FY ’15
GAAP cost of sales
$
378

$
417

$
332

9%

(14%)

$
1,479

$
1,240

(19%)
Non-GAAP cost of sales
$
363

$
396

$
332

8%

(9%)

$
1,426

$
1,240

(15%)

GAAP R&D
$
534

$
529

$
542

(1%)

1%

$
1,973

$
2,013

2%
Non-GAAP R&D
$
531

$
529

$
542

(0%)

2%

$
1,970

$
2,013

2%

GAAP SG&A
$
496

$
463

$
583

(7%)

15%

$
1,948

$
2,113

8%
Non-GAAP SG&A
$
484

$
461

$
583

(5%)

17%

$
1,930

$
2,113

9%
Note: Percent changes represented as favorable & (unfavorable)

•
R&D expense for the fourth quarter of 2016 includes a $50 million milestone to Eisai following the initiation of Phase 3 trials for elenbecestat (E2609), a BACE inhibitor in development for Alzheimer’s disease.
•
Biogen booked a GAAP-only pre-tax charge in Q4 2016 of $455 million related to the recent settlement and license agreement with Forward Pharma. The charge in Q4 2016 represents the portion of the payment attributable to the sales of TECFIDERA during the period April 2014 through December 31, 2016. Upon effectiveness of this agreement, Biogen has agreed to pay Forward Pharma a total of $1.25 billion plus potential royalties.

Other Financial Highlights
•
For 2016, the Company’s full year weighted average diluted shares were 219 million. For the fourth quarter of 2016, the Company’s weighted average diluted shares were 217 million. The Company ended the year with approximately 216 million basic shares outstanding.

•
As of December 31, 2016, Biogen had cash, cash equivalents and marketable securities totaling approximately $7.7 billion, and $6.5 billion in notes payable and other financing arrangements.

•
During the fourth quarter of 2016, Biogen repurchased 2.2 million shares of the Company’s common stock for a total value of $651 million.

2017 Financial Guidance
Biogen also announced its full year 2017 financial guidance. This guidance consists of the following components:

•
Revenue is expected to be approximately $11.1 to $11.4 billion.
•
GAAP and non-GAAP R&D expense is expected to be approximately 16% to 17% of total revenue.
•
GAAP and non-GAAP SG&A expense is expected to be approximately 15% to 16% of total revenue.
•
GAAP diluted EPS is expected to be between $18.00 and $18.80.
•
Non-GAAP diluted EPS is expected to be between $20.45 and $21.25.

Guidance assumptions:
◦
Includes one month of sales for our hemophilia products, ELOCTATE and ALPROLIX, as the spin-off of Bioverativ is expected to complete on February 1, 2017.
◦
GAAP guidance includes the minimum expense we expect to record in 2017 upon the effectiveness of our settlement and license agreement with Forward Pharma. The actual charges recorded will depend on the outcomes of the patent proceedings in the U.S. and E.U.
◦
R&D expense does not include any impact from potential acquisitions or large late-stage business development transactions, as both are hard to predict.
◦
Based on recent rates for foreign exchange.
◦
Does not include any impact from potential U.S. corporate tax reform or changes to the Affordable Care Act.

Biogen may incur charges, realize gains or experience other events in 2017 that could cause actual results to vary from this guidance.

In 2017, the Company plans to provide one update to its annual financial guidance, which is expected to be provided in connection with its second quarter earnings release. This approach is intended to synchronize guidance with internal business planning processes and to ensure a continued focus on long-term value creation.

Recent Events
• In January 2017, Biogen announced that it agreed to enter into a settlement and license agreement with Forward Pharma, subject to the approval of Forward Pharma’s shareholders and other customary conditions. The license agreement will provide Biogen an irrevocable license to all intellectual property owned by Forward Pharma. Upon the effectiveness of the settlement and license agreement, Biogen will provide Forward Pharma a cash payment of $1.25 billion. Under certain circumstances outlined in the agreement, Biogen will pay Forward Pharma royalties on net sales of Biogen products for the treatment of multiple sclerosis that are covered by a Forward Pharma patent and have dimethyl fumarate ("DMF") as an active pharmaceutical ingredient.

• In January 2017, Michel Vounatsos assumed the role of chief executive officer and was appointed as a member of the Board of Directors. Vounatsos previously held the position of executive vice president and chief commercial officer at Biogen.

• In January 2017, Biogen presented new data from the Phase 3 ENDEAR study of SPINRAZA, which demonstrated a statistically significant reduction in the risk of death or permanent ventilation in SPINRAZA-treated infants with spinal muscular atrophy (SMA) compared to untreated infants. The data were presented at the British Paediatric Neurology Association annual conference in Cambridge, UK.

• In December 2016, the U.S. FDA approved Biogen’s SPINRAZA under priority review for the treatment of SMA in pediatric and adult patients. SPINRAZA is the first and only treatment approved in the U.S. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness. The FDA also issued to Biogen a rare pediatric disease priority review voucher with the approval of SPINRAZA, which confers priority review to a subsequent drug application that would not otherwise qualify for priority review.

• In December 2016, Biogen announced that its board of directors approved the planned spin-off of its hemophilia business, which will be known as Bioverativ Inc., and declared a special dividend distribution of all of the outstanding shares of Bioverativ common stock. Shortly thereafter, the U.S. Securities and Exchange Commission (SEC) declared effective the Registration Statement on Form 10 filed by Bioverativ Inc. Biogen expects to complete the separation of Bioverativ into an independent, global biotechnology company focused on hemophilia and other rare blood disorders on February 1, 2017.

• In December 2016, Biogen presented new data from the Phase 1b study of its investigational Alzheimer’s disease (AD) treatment aducanumab at the 9th Clinical Trials on Alzheimer’s Disease Meeting in San Diego. Data presentations included interim results from the titration cohort of the placebo-controlled period of the Phase 1b study as well as data from the first year of the long-term extension study. The results support the ongoing Phase 3 studies of aducanumab for early AD.

• In December 2016, Biogen and Swedish Orphan Biovitrum AB (publ) (Sobi) presented new data, including updated longitudinal safety and efficacy findings from phase 3 and extension studies, on the companies’ extended half-life therapies, ELOCTATE for hemophilia A and ALPROLIX for hemophilia B, at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition in San Diego. The presentations included efficacy data, which show low target joint annual bleeding rates and effective target joint resolution in patients on long-term prophylaxis with ELOCTATE. Biogen also presented preclinical data on recombinant FIXFc-XTEN, a fusion protein being investigated for once-weekly, subcutaneous treatment of hemophilia B. ELOCTATE, ALPROLIX, and the FIXFc-XTEN program are among the hemophilia-related assets included in the spin-off of Bioverativ anticipated to be completed on February 1, 2017.

• In November 2016, Biogen and Ionis Pharmaceuticals announced that SPINRAZA met the primary endpoint at the interim analysis of CHERISH, the Phase 3 study evaluating SPINRAZA in later-onset (consistent with Type 2) SMA. The analysis found that children receiving SPINRAZA experienced a highly statistically significant improvement in motor function compared to those who did not receive treatment. SPINRAZA also demonstrated a favorable benefit-risk profile in the study.

• In November 2016, Biogen announced that its Marketing Authorization Application was validated by the European Medicines Agency (EMA) for SPINRAZA. SPINRAZA had previously been granted Accelerated Assessment status by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The Accelerated Assessment designation can reduce the standard review time.

1 Constant currency measures are non-GAAP measures calculated by translating the current period’s foreign currency values for sales into USD using the average exchange rates from the prior period and comparing them to the prior year values in USD, excluding any gains or losses from hedging.

On January 25, 2017 Integra LifeSciences Holdings Corporation ("Integra") (NASDAQ:IART), a global leader in medical technology, reported that its wholly-owned subsidiary, Integra Derma, Inc. ("Offeror"), is commencing a cash tender offer to purchase all outstanding common and preferred shares of Derma Sciences, Inc. ("Derma Sciences") (NASDAQ:DSCI) at an offer price of $7.00 per share for Derma Sciences’ common stock, $32.00 per share for Derma Sciences’ Series A Convertible Preferred Stock and $48.00 per share for Derma Sciences’ Series B Convertible Preferred Stock (Press release, Integra LifeSciences, JAN 25, 2017, View Source [SID1234517586]). The tender offer is being made pursuant to an Offer to Purchase, dated January 25, 2017 (the "Offer to Purchase"), and in connection with the Agreement and Plan of Merger, dated January 10, 2017, among Integra, Offeror and Derma Sciences (the "Merger Agreement"), which Integra and Derma Sciences previously announced on January 10, 2017.

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The tender offer will expire at 12:00 midnight, New York City time, on Wednesday, February 22, 2017, unless the offer period is extended or earlier terminated in accordance with the terms of the Merger Agreement (such date and time, as it may be extended, the "Expiration Date"). Offeror is required to extend the offer period for any period required by applicable law or rules and regulations of the SEC and for one or more periods of up to ten business days each until, and including, July 15, 2017, if at the Expiration Date any of the conditions to the tender offer have not been satisfied.

There is no financing condition to the tender offer. The obligation of Offeror to pay for shares tendered pursuant to the tender offer is conditioned on the tender and acceptance of that number of shares that, together with the number of shares (if any) then owned by Integra, represents at least a majority of (i) the voting power of all outstanding common and preferred shares, voting together as a single class, (ii) the outstanding shares of Series A Convertible Preferred Stock and (iii) the outstanding shares of Series B Convertible Preferred Stock, as well as other customary conditions. Following the completion of the tender offer, Integra expects to consummate a second-step merger at the same per-share price paid in the tender offer for shares not purchased in the tender offer.

D.F. King & Co., Inc. is acting as information agent and Broadridge Corporate Issuer Solutions, Inc. is acting as depositary and paying agent in the tender offer. Requests for documents and questions regarding the tender offer may be directed to information agent by telephone at (800) 290-6424.

(Filing, Annual, Novartis, 2016, JAN 25, 2017, View Source [SID1234517556])

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On April 12, 2016 Biota Pharmaceuticals, Inc. (NASDAQ:BOTA) reported that the Company has changed its name to Aviragen Therapeutics, Inc., ("Aviragen Therapeutics"), a pharmaceutical company focused on the development of the next generation of direct-acting antivirals that address infections that have limited therapeutic options (Press release, Aviragen Therapeutics, JAN 25, 2017, View Source [SID1234517553]).

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"A meaningful transformation has taken place over the last two years as we transitioned from a drug discovery and early-stage licensing organization to one focused on drug development and progressing key late-stage product candidates in important viral diseases. Our name change reflects this transition and better defines our strategic initiatives moving forward," said Joseph Patti, PhD, President and Chief Executive Officer of Aviragen Therapeutics. "Specifically, our recent initiation of a Phase 2a efficacy study of BTA585 for the treatment of RSV infections highlights our focus on bringing new medicines to treat and prevent viral infections with limited therapeutics options. As Aviragen Therapeutics, we will continue to advance and expand our promising pipeline of anti-viral drugs."

The name change become effective on April 11, 2016 and the Company’s common stock will begin trading on the NASDAQ Stock Exchange under the new ticker symbol "AVIR" on April 13, 2016.

On January 25, 2017 Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, reported research published in the journal Cancer which underscores the need for more access to screenings, improved clinical care and new therapeutic options for all women with cervical cancer (Press release, Advaxis, JAN 25, 2017, View Source [SID1234517558]).

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These important research findings were covered by leading news outlets including The New York Times and CNN, as these data indicate that mortality rates of this deadly form of cancer are significantly higher in the United States than previously reported due to the inclusion of women who have had hysterectomies, highlighting racial and socioeconomic disparities. According to the research, the data revealed a U.S. cervical cancer mortality rate among women without hysterectomies of 10.1 per 100,000 black women and 4.7 per 100,000 white women, up from mortality rates of 5.7 and 3.2, respectively, which were previously reported in research among all women, including those who have had hysterectomies.

The publication of these data coincides with Cervical Health Awareness Month, a national effort designed to promote the need for cervical health education and screenings, which can lead to early detection of cervical cancer when therapies may be most effective.

Advaxis is the only biopharmaceutical company sponsoring global, phase 3 clinical research for advance stage cervical cancer. Last year, the company initiated its Phase 3 AIM2CERV (Advaxis IMmunotherapy 2 prevent CERVical recurrence) trial in high-risk, locally advanced cervical cancer (HRLACC). The company also announced positive, top-line data from the GOG-0265 Phase 2 trial that supports pursuing a global phase 3 study in metastatic recurrent cervical cancer.

"This research highlights disparities in outcomes in the cervical cancer community and underscores the need to work together with policy-makers, providers, academic institutions and the biopharmaceutical industry to raise awareness among minority groups about current treatment options and bring new treatment options forward," said Tamika Felder, Founder of Cervivor. "In doing so, hopefully we can close this gap."

Invasive cervical cancer occurs in women who have been infected by the human papillomavirus (HPV) and is the most common HPV-associated cancer in women. According to the American Cancer Society, approximately 12,000 women in the United States will be diagnosed with cervical cancer in 2017. While vaccines to prevent HPV infection may help prevent cervical cancer if given before exposure, only one-third of the U.S. population has been vaccinated against the virus and the vaccination rate is lower worldwide, which is the main cause of the nearly 500,000 new cases diagnosed each year. Cervical cancer largely affects women who have not received preventative vaccines or regular screenings.