On April 29, 2016 Shire plc ("Shire") (LSE: SHP, NASDAQ: SHPG) reported unaudited results for the three months ended March 31, 2016 (Press release, Shire, APR 29, 2016, View Source [SID:1234511736]).

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Financial Highlights Q1 2016 Growth(1) Non GAAP CER(1)(2)
Product sales $1,627 million +14% +16%
Total revenues $1,709 million +15% +17%

Non GAAP operating income $797 million +17% +16%
US GAAP operating income from continuing operations $544 million +15%

Non GAAP EBITDA margin (excluding royalties & other revenues)(3) 46% 0pps(4)
US GAAP net income margin(5) 25% -3pps

Non GAAP net income $632 million +13%
US GAAP net income $419 million +2%

Non GAAP diluted earnings per ADS $3.19 +12% +12%
US GAAP diluted earnings per ADS $2.12 +2%

Non GAAP cash generation $492 million -5%
Non GAAP free cash flow $338 million +38%
US GAAP net cash provided by operating activities $390 million -31%
(1) Percentages compare to equivalent 2015 period.
(2) On a Constant Exchange Rate ("CER") basis, which is a Non GAAP measure.
(3) Non GAAP earnings before interest, tax, depreciation and amortization ("EBITDA") as a percentage of product sales, excluding royalties and other revenues.
(4) Percentage point change ("pps").
(5) US GAAP net income as a percentage of total revenues.

The Non GAAP financial measures included within this release are explained on pages 25 – 26, and are reconciled to the most directly comparable financial measures prepared in accordance with US GAAP on pages 19 – 22.

First Quarter & Recent Highlights:

Product sales growth of 14% (16% on a Non GAAP CER basis) to $1.6 billion, driven by VYVANSE, LIALDA/MEZAVANT, CINRYZE, FIRAZYR, GATTEX/REVESTIVE and NATPARA.
Rare disease products acquired from NPS Pharmaceuticals, Inc. ("NPS") continued to perform well with GATTEX/REVESTIVE sales up 247% (up 97% on a pro-forma basis(1)) to $52 million, and NATPARA sales of $16 million.
Free cash flow remained strong, impacted primarily by net payments and receipts of taxes between Q1 2015 and Q1 2016.
Lifitegrast New Drug Application ("NDA") accepted by the US Food and Drug Administration ("FDA"), with Prescription Drug User Fee Act ("PDUFA") date set for July 22, 2016.
Pipeline progression with positive topline results from SHP465 safety and efficacy study in children and adolescents with Attention Deficit Hyperactivity Disorder ("ADHD").
Completed acquisition of Dyax Corp. ("Dyax") and enrollment on track for SHP643 (formerly DX2930) Phase 3 studies for the treatment of Hereditary Angioedema ("HAE").
Patent upheld for LIALDA (mesalamine) delayed release tablets by U.S. District Court for the Southern District of Florida; the case has been appealed.
Baxalta Incorporated ("Baxalta") acquisition on track with integration progressing well; shareholder votes set for May 27 and closing anticipated in early June.
(1) Sales prior to February 21, 2015 were recorded by NPS.
Flemming Ornskov, M.D. Chief Executive Officer, commented:

"Shire is off to a strong start in 2016, delivering double-digit product sales and Non GAAP earnings per ADS growth, and advancing our innovative pipeline. We were pleased to report positive Phase 3 topline results for SHP465 in children and adolescents with ADHD, a therapeutic area with significant need for additional treatment options. We are also looking forward to hearing from the FDA by late July regarding lifitegrast, a potential new treatment for dry eye disease.

While we maintain our sharp focus on Shire’s business, we closed the acquisition of Dyax during the quarter and we are making excellent progress with the Baxalta integration planning. Our shareholder vote is scheduled for May 27 and the closing is anticipated to follow in early June. We look forward to officially welcoming our Baxalta colleagues to Shire, and creating a global biotechnology leader focused on rare diseases and other highly specialized conditions."

On April 28, 2016 Baxalta Incorporated (NYSE: BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported strong first quarter 2016 financial results (Press release, Baxalta, APR 28, 2016, View Source [SID:1234511527]).

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"Baxalta’s strong financial performance continues to highlight the attractive growth prospects that exist across the portfolio," said Ludwig Hantson, chief executive officer and president, Baxalta. "As we embark on the next phase of our journey, the outstanding contributions of our team will result in enhanced access to differentiated therapies that improve patient care and promising new treatments that address unmet medical needs."

Financial Results for the First Quarter 2016

In the first quarter, Baxalta generated net income on a GAAP basis of $145 million and earnings of $0.21 per diluted share. These results include net after-tax special items totaling $181 million, or $0.26 per diluted share, primarily for intangible asset amortization, expenses associated with the company’s separation from Baxter International (NYSE: BAX) and anticipated merger with Shire plc (LSE: SHP, NASDAQ: SHPG), as well as collaboration and business optimization charges.

On an adjusted basis, excluding special items, Baxalta reported first quarter net income of $326 million, or $0.47 per diluted share, which compares favorably to the company’s previously-issued guidance of $0.44 to $0.46 per diluted share. These financial results reflect robust sales, and higher gross margins, providing enhanced flexibility for accelerated investments in research and development, marketing and launch preparedness, and global infrastructure to position the company for future success.

Sales Momentum Across Differentiated Portfolio

In the first quarter, on a GAAP basis, Baxalta’s worldwide revenues of $1.5 billion advanced 14 percent from the prior-year period. Excluding the impact of foreign currency, sales advanced 18 percent.

On a pro forma basis, worldwide revenues increased 10 percent. Excluding the impact of foreign currency, sales advanced 14 percent, exceeding the company’s previously-issued guidance of growth in the 8 to 9 percent range. Within the United States, sales of $879 million rose 16 percent; international sales of $669 million increased 3 percent. Excluding foreign currency, international sales increased 11 percent.

By business, global hematology revenues of $843 million increased 8 percent (excluding the impact of foreign currency) as the company continues to focus on enhancing access and elevating standards of care worldwide. Growth was driven by the U.S. introduction of ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated], an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, as well as heightened demand for ADVATE [Antihemophilic Factor (Recombinant)] and FEIBA [Anti-Inhibitor Coagulant Complex], an inhibitor treatment. Also contributing to performance was growth of RIXUBIS [Coagulation Factor IX (Recombinant)], a treatment for hemophilia B, and OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence], for the treatment of acquired hemophilia A.

Immunology sales of $653 million advanced 13 percent on a pro forma basis (excluding the impact of foreign currency). The company continues to capitalize on its broad and differentiated portfolio of immunoglobulin therapies, including HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], and is driving strong sales of specialty biotherapeutics.

Baxalta’s new oncology business recorded sales of $52 million in the quarter. This reflects revenues of ONCASPAR (pegaspargase), a marketed biologic treatment for acute lymphoblastic leukemia (ALL).

First Quarter 2016 Highlights and Key Milestone Achievements

Baxalta’s disciplined strategic decisions are accelerating innovation and supporting meaningful pipeline achievements, unlocking value for patients, customers and shareholders.

"Our commitment to serving patients is our inspiration," added Hantson. "We have an incredible legacy of developing differentiated therapies. Baxalta’s patient-centric approach will continue to enhance the lives of people with orphan diseases and underserved conditions, and create sustainable, long-term value for all of our partners and stakeholders."

Complementing the company’s strong financial performance in the first quarter are a number of recent achievements:

Expanding the ADYNOVATE label and geographic reach with approval in Japan for the treatment of pediatric, adolescent and adult patients with hemophilia A and for use during surgery; submission in the U.S. of supplemental Biologics License Applications (sBLAs) to the FDA for the treatment of children under the age of 12 with hemophilia A and for use in surgical settings; and the filing of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for approval under the name, ADYNOVI.
Developing further options for direct factor replacement treatment with the initiation of the Phase 1 first-in-human clinical trial of BAX 826, a second extended half-life treatment based on ADVATE that uses proprietary polysialic acid (PSA) technology and targets weekly dosing for patients with hemophilia A.

Undertaking efforts to expand global access and indications for HYQVIA including recent regulatory approval in Australia. In addition, the company has received orphan drug designation from the FDA for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP), a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms, and a Phase 3 clinical trial is underway.

Leveraging the company’s global development, manufacturing and commercial capabilities to make leading biologics more accessible for patients including BAX 2200 (CHS-0214), a proposed biosimilar of Enbrel (etanercept), which met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of BAX 2200 compared to Enbrel in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone.

Accelerating treatment for patients with significant unmet medical needs with Health Canada’s Priority Review of the New Drug Submission (NDS) for irinotecan liposome injection, also known as "nal-IRI," for the treatment of patients with metastatic adenocarcinoma of the pancreas previously treated with gemcitabine-based therapy. The expedited review is expected to be conducted in the second half of 2016.

Accelerating innovation in growing immuno-oncology portfolio with announcement of global collaboration with Precision BioSciences, a genome editing company, to develop a broad series of allogeneic chimeric antigen receptor (CAR) T cell therapies directed toward areas of major unmet need in multiple cancers. The companies will develop CAR T therapies for up to six unique targets, with the first program expected to enter clinical studies in late 2017.
Additional Information

Given the proposed merger agreement with Shire plc announced on January 11, 2016, Baxalta will not be hosting an investor conference call to discuss financial results. In addition, the company will not be providing financial guidance for the second quarter or full-year 2016, and previously-issued guidance for Baxalta as a standalone entity is no longer applicable.

The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions and approval by both Baxalta’s and Shire’s stockholders. The special meeting of stockholders to adopt the merger agreement with Shire will be held on May 27, 2016, at 7:00 a.m. Central Time, for Baxalta stockholders of record as of the close of business on April 11, 2016. The special meeting will be held at Baxalta’s corporate headquarters, located at 1200 Lakeside Drive, Bannockburn, Illinois 60015. The transaction is expected to close shortly after the special meeting takes place, assuming stockholder approval is received by both companies.

Complementary information related to Baxalta’s first quarter 2016 financial results may be accessed by visiting the Baxalta corporate website at investor.baxalta.com.

On April 28, 2016 Insys Therapeutics, Inc. (NASDAQ:INSY) ("Insys" or "the Company") reported financial results for the three-month period ended March 31, 2016 (Press release, Insys Therapeutics, APR 28, 2016, View Source;p=RssLanding&cat=news&id=2162576 [SID:1234511568]).

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Highlights of and subsequent to the first quarter of 2016 include:

Total net revenue decreased to $62.0 million, compared to $70.8 million for the first quarter of 2015;
Revenue from Subsys (fentanyl sublingual spray) was $62.0, down 12% compared with first quarter 2015 revenue of $70.5 million;
Net income was $2.4 million, or $0.03 per basic and $0.03 per diluted share, compared to net income of $8.0 million, or $0.11 per basic and $0.11 per diluted share, for the first quarter of 2015;
Cash, cash equivalents and investments were $200 million as of March 31, 2016;
Insys enrolled the first patient in its Phase II study for the treatment of infantile spasms using pharmaceutical CBD;
U.S. Food and Drug Administration extended the Prescription Drug User Fee Act (PDUFA) action date for SyndrosTM (dronabinol oral solution) from April 1, 2016 until July 1, 2016; and
Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) declined to institute an inter partes review of U.S. Patent Nos. 8,486,972, 8,835,459 and 8,835,460, which cover the fentanyl formulation of Subsys.
"While our Subsys sales were lower than expected during the first quarter, we look forward to realizing the many exciting opportunities for continued growth and long-term value for Insys shareholders through the commercialization of our pipeline," said Dr. John N. Kapoor, Chairman, President and Chief Executive Officer, of Insys Therapeutics. "We fully expect Syndros to be the next product in our commercial portfolio and are preparing for its launch, assuming FDA approval. We expect to remain profitable and intend to advance our promising pipeline of sublingual spray products and CBD product candidates," he concluded.

First Quarter 2016 Financial Results

Net revenue for the first quarter of 2016 was $62.0 million compared to $70.8 million for the first quarter of 2015, a decrease of 12%. The results reflect a decline in Subsys demand, as Subsys prescription volumes were down, as well as a reduction in Subsys wholesale channel inventory levels.

Gross margin was 92.5% for the first quarter of 2016 compared with 91.0% for the first quarter of 2015.

Sales and marketing expense was $19.8 million during the first quarter of 2016, or 32% of net revenue, compared to $20.9 million, or 30% of net revenue, for the first quarter of 2015.

Research and development expense increased to $20.5 million for the first quarter of 2016, compared to $10.6 million for the first quarter of 2015, largely due to incremental investment in pipeline products.

General and administrative expense increased to $14.7 million for the first quarter of 2016, compared to $13.2 million for the first quarter of 2015.

Income tax expense was $131,000 for the first quarter of 2016, compared to $3.7 million during the first quarter of 2015.

Net income for the first quarter of 2016 was $2.4 million, or $0.03 per basic and $0.03 per diluted share, compared to net income of $8.0 million, or $0.11 per basic and $0.11 per diluted share, for the first quarter of 2015. Non-GAAP adjusted net income for the first quarter of 2016 was $8.2 million, or $0.11 per diluted share, compared to non-GAAP adjusted net income of $23.5 million, or $0.31 per diluted share, in the prior year quarter. The reconciliation of net income to non-GAAP adjusted net income is included at the end of this press release.

Liquidity

The Company had $200 million in cash, restricted cash, cash equivalents, and short-term and long-term investments, no debt, and $250 million in stockholders’ equity as of March 31, 2016.

As previously disclosed, on November 5, 2015, the Insys’ Board of Directors approved the repurchase of up to $50 million of the Company’s common stock. As of March 31, 2016, the Company had expended approximately $30 million to repurchase approximately 1.2 million shares of common stock outstanding. Insys intends to finance the remainder of any share repurchases in this program through available cash on hand.

Conference Call

Insys management will host its first quarter 2016 conference call as follows:

Date: April 28, 2016
Time: 10:00 a.m. EDT
Toll free (U.S): (877) 349-4844
International: (262) 558-6141
Live webcast: www.insysrx.com under the "Investor Relations" section

A telephone replay will be available shortly after the completion of the call for one week by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (International) and entering conference call ID number 92585062.

A live audio webcast and archive of the call will also be available at www.insysrx.com.

On April 28, 2016 Varian Medical Systems reported that it will demonstrate its full range of radiotherapy delivery systems at the 35th ESTRO (European Society for Radiotherapy and Oncology) meeting, taking place here in Turin from April 29th-May 3rd (Press release, InfiMed, APR 28, 2016, View Source [SID:1234511530]). The Varian booth features the company’s technology and products for radiotherapy, radiosurgery, brachytherapy, and proton therapy, and will offer the European clinical community its first glimpse of High Definition Radiotherapy (HDRT).

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Visitors to the Varian booth (No. 5500) can learn about the company’s four pi (4π) non-coplanar treatment technology*, which exploits specific capabilities of the TrueBeam platform and is designed to deliver more compact radiation doses that may fully saturate a targeted tumor and "fall off" sharply outside the target zone, potentially minimizing dose to specific organs requiring more protection.

"We believe this technology could enable High Definition Radiotherapy — the next big advance in radiation oncology, rivaling the development of IMRT in the 1990s, IGRT and volumetric modulated arc therapy (VMAT) in the 2000s, and linac-based radiosurgery in more recent years," says Kolleen Kennedy, president of Varian’s Oncology Systems group. "This has the potential to make a big difference in the treatment of cancer patients."

Also on display on the Varian (NYSE: VAR) booth is the company’s TrueBeam platform for radiotherapy and radiosurgery, along with the RapidArc image-guided intensity-modulated radiotherapy system, the PerfectPitch six-degrees-of-freedom couch, and the Calypso ‘GPS for the Body’ system, all of which are aimed at helping clinicians to deliver treatments with both precision and speed. Varian will also exhibit its powerful family of oncology software products, including RapidPlan software for improving the quality and speed of treatment planning.

Additionally, the Varian booth is spotlighting the company’s ProBeam system, a fully-integrated image-guided IMPT (intensity-modulated proton therapy) solution, which incorporates pencil-beam scanning technology to optimize the dose applied to every point within the area being treated. Varian was recently selected to equip national proton therapy centers in Holland, Denmark and the UK with the ProBeam system.

Varian is hosting an ESTRO symposium entitled ‘Moving Radiotherapy towards the Horizon’ at 1.10pm on Sunday May 1st. This event will be chaired by Dr. Patrick Kupelian, Varian’s vice president of clinical affairs, and will feature presentations from Dr. Clive Peedell from South Tees Hospital in Middlesbrough, UK, and Dr. Max Dahele of VU University Medical Center in Amsterdam. These presentations will focus on technological advances and challenges in accessing new technology.

On April 28, 2016 Acorda Therapeutics, Inc. (Nasdaq:ACOR) today provided a financial and pipeline update for the first quarter ended March 31, 2016 (Filing, Q1, Acorda Therapeutics, 2016, APR 28, 2016, View Source [SID:1234511570]).

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AMPYRA (dalfampridine) 1Q 2016 net revenue was $109.6 Million, a 19% increase over 1Q 2015 net revenue of $92.4 Million. In January 2016, the Company announced an agreement to acquire Biotie, and has received more than 90% of Biotie’s outstanding shares in the tender offer. The Company expects to complete the purchase of 100% of Biotie’s shares in the second half of this year.

"We are well into our transition from a single-product company to a well-diversified biopharmaceutical enterprise, focused on developing therapies to benefit patients with neurological conditions across multiple disease states, including multiple sclerosis, Parkinson’s disease, stroke, migraine and epilepsy," said Ron Cohen, M.D., Acorda’s President and CEO. "Through our business development activities and advancement of our clinical pipeline, we now have four promising Phase 3 assets and, pending successful trial results, have the potential to file for approval of three of these by the end of 2018."

Financial Results

The Company reported a GAAP net loss of $0.5 million for the quarter ended March 31, 2016, or $0.01 per diluted share. The GAAP net loss in the same quarter of 2015 was $3.1 million, or $0.07 per diluted share.

Non-GAAP net income for the quarter ended March 31, 2016 was $3.1 million, or $0.07 per diluted share. Non-GAAP net income in the same quarter of 2015 was $6.5 million, or $0.15 per diluted share. Non-GAAP net income excludes share based compensation charges, non-cash interest charges on our convertible debt, changes in the fair value of acquired contingent consideration, acquisition related expenses, unrealized foreign currency transaction gains, and non-cash tax benefits. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended March 31, 2016, the Company reported AMPYRA net revenue of $109.6 million, up 19% compared to $92.4 million for the same quarter in 2015.

ZANAFLEX CAPSULES (tizanidine hydrochloride), ZANAFLEX (tizanidine hydrochloride) tablets and authorized generic capsules – For the quarter ended March 31, 2016, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $1.2 million compared to $2.6 million for the same quarter in 2015.

FAMPYRA (prolonged-release fampridine tablets) – For the quarter ended March 31, 2016, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.5 million, compared to $2.3 million for the same quarter in 2015.

Research and development (R&D) expenses for the quarter ended March 31, 2016 were $44.6 million, including $2.1 million of share-based compensation, compared to $30.6 million, including $1.8 million of share-based compensation, for the same quarter in 2015.

Selling, general and administrative (SG&A) expenses for the quarter ended March 31, 2016 were $51.8 million, including $6.0 million of share-based compensation, compared to $48.8 million including $5.3 million of share-based compensation for the same quarter in 2015.

Acquisition related expenses for the Biotie transaction incurred in the quarter ended March 31, 2016 were $7.2 million.

Benefit from income taxes for the quarter ended March 31, 2016 was $9.7 million, including $0.2 million of cash taxes, compared to $2.0 million, including $0.7 million of cash taxes for the same quarter in 2015.

At March 31, 2016, prior to the closing of the Biotie acquisition, the Company had cash, cash equivalents and investments of $431.4 million, up from $353.3 million at December 31, 2015. In January 2016, the Company completed a $75.0 million private placement of its common stock.

First Quarter 2016 Highlights

AMPYRA (dalfampridine)

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AMPYRA revenues for the first quarter of 2016 were $109.6 million, up 19% from the first quarter in 2015. This represents the 12th consecutive quarter of double digit, year-over-year growth for AMPYRA, which was launched in 2010.
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In March, a Markman hearing was held in the U.S. District Court for the District of Delaware related to the consolidated lawsuits that the Company filed against companies that submitted Abbreviated New Drug Applications to the FDA seeking marketing approval for AMPYRA. Also in March, the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) instituted the inter partes review (IPR) of four AMPYRA patents. Rulings on the IPR petitions are expected within one year. The Company will continue to defend its intellectual property vigorously.
Dalfampridine in Post-Stroke Walking Difficulty

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In March, the Company completed Phase 1 single-dose pharmacokinetic (PK) studies for three separate once-daily (QD) formulations of dalfampridine. Results for at least one of these formulations met the Company’s criteria. The multi-dose phase of PK testing will begin in the second quarter of 2016.
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Given the progress in its development of a QD formulation of dalfampridine, the Company has made the decision to stop enrollment and conduct an unblinded analysis of the Phase 3 twice-daily (BID) clinical trial data, having reached 50% of its target enrollment in the study, or 270 subjects. As previously stated, unblinding the study ahead of the originally contemplated interim futility analysis was an option. Data are expected by the fourth quarter of 2016 and will be used to inform the design of planned Phase 3 trials in post-stroke.
CVT-301 in Parkinson’s Disease

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In April, data from the CVT-301 Phase 2b clinical trial were one of six platform presentations highlighted during the Movement Disorders Invited Science Session at the 68th Annual Meeting of the American Academy of Neurology.
CVT-427 in Migraine

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In March, the Company announced it had successfully completed a Phase 1 safety/tolerability and pharmacokinetic study for CVT-427. Based on the positive results, the Company is designing protocols for the next phase of development.
Corporate

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In January, the Company announced it had entered into an agreement to acquire Biotie Therapies Corp. The acquisition includes global rights to two clinical-stage compounds in development for treatment of Parkinson’s disease, as well as other assets.
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In April, more than 90% of the outstanding shares of Biotie were tendered to the Company in a tender offer conducted pursuant to the acquisition agreement, meeting the minimum condition to closing the tender offer. The Company expects to complete the acquisition of 100% of Biotie in the second half of 2016.
–
In January, the Company completed a $75 million private placement of its common stock and signed a Commitment Letter with JP Morgan for an asset-based credit facility of up to $60 million, which is expected to close in the second quarter of 2016.
The Company will host a conference call today at 8:30 a.m. ET to review its first quarter 2016 results.

To participate in the conference call, please dial (855) 542-4209 (domestic) or (412) 455-6054 (international) and reference the access code 81540360. The presentation will be available via a live webcast on the Investors section of www.acorda.com. Please log in approximately 5 minutes before the scheduled time of the presentation to ensure a timely connection.

A replay of the call will be available from 11:30 a.m. ET on April 28, 2016 until 11:59 p.m. ET on May 5, 2016. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference the access code 81540360. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.