On July 28, 2016 Integra LifeSciences Holdings Corporation (NASDAQ:IART) reported its financial results for the second quarter ending June 30, 2016 (Press release, Integra LifeSciences, JUL 28, 2016, View Source [SID:1234514090]).

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Highlights:

Second quarter revenue increased 17.2% over the prior-year quarter to $249.3 million and organic revenue increased 10.7%;
GAAP gross margin was 64.1% and adjusted gross margin was 69.2%;
GAAP net income increased 6.1% to $12.8 million and adjusted net income increased 21.3% to $30.3 million;
Commercial release of Integra(R) Omnigraft(TM) Dermal Regeneration Matrix began;
Integra Fin-Lock(TM) Glenoid for the Titan(TM) Modular Shoulder System launched; and
Raising 2016 full-year sales guidance range to $992 million to $1.002 billion; Raising organic sales guidance to 9%.
Total revenues for the second quarter were $249.3 million, reflecting an increase of $36.6 million, or 17.2%, over the second quarter of 2015. This reflects strong performance in both business segments; Orthopedics and Tissue Technologies revenue increased 38.2% and Specialty Surgical Solutions revenue increased 7.8%.

Excluding the contribution of revenues from acquisitions, discontinued products and the effect of currency exchange rates, revenues increased 10.7% over the second quarter of 2015.

"Solid performance from our two segments, as well as strength in both U.S. and international sales, contributed to the results for the second quarter," said Peter Arduini, Integra’s President and Chief Executive Officer. "We are accelerating growth as we continue to execute on our clinical and commercial strategy with the launch of several new products, including Omnigraft for the treatment of diabetic foot ulcers."

The Company reported GAAP net income of $12.8 million, or $0.32 per diluted share, for the second quarter of 2016 compared to GAAP net income of $12.0 million, or $0.35 per diluted share, for the second quarter of 2015. Results for the second quarter of 2016 include the addition of 3.8 million shares issued in an equity offering in August 2015 and approximately 1.6 million diluted shares associated with the December 2016 convertible notes and warrants.

Adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.

Adjusted net income for the second quarter of 2016 was $30.3 million, or $0.79 per share, compared to adjusted net income of $24.9 million, or $0.75 per share, in the second quarter of 2015.

Adjusted EBITDA for the second quarter of 2016 was $54.6 million, or 21.9% of revenue, compared to $47.7 million, or 22.4% of revenue, in the prior year’s second quarter.

Operating cash flow for the second quarter was $38.1 million. Adjusted free cash flow conversion for the trailing twelve months ended June 30, 2016 was 59.8% versus 80.6% in the prior-year trailing twelve-month period.

The Company elected to adopt accounting standard FASB Update No. 2016-09 in the second quarter of 2016. Excluding the benefit of this adoption, the Company’s second quarter GAAP earnings per share would have been $0.30, and adjusted earnings per share would have been $0.78. The adoption of this standard allows the Company to recognize increased tax benefits, which were previously recorded in shareholders’ equity, through the income statement when employees exercise options or when shares vest. The adoption of this standard is reflected in our results as if it had occurred at the beginning of the year. The early adoption of this accounting standard decreased our tax expense in the second quarter of 2016 and had a GAAP net impact of $0.07 per share on a year-to-date basis. This impact was a $0.03 benefit to adjusted earnings per share on a six-month basis, since we treat the discrete benefit as a rate item in our adjusted tax rate. We expect that the full-year benefit to both our GAAP and adjusted results will be about $0.07 per share, although the GAAP benefit has been recognized during the first six months of the year, and the adjusted benefit will be recognized as a $0.03 benefit in the first half and approximately $0.04 in the second half of 2016. The Company is providing a supplemental schedule on the website to show first quarter results as if the new standard had been adopted. Access to that supplemental information is available at investor.integralife.com.

Outlook for 2016

Based on the second quarter’s results, the Company is raising its full-year 2016 revenue guidance to a new range of $992 million to $1.002 billion, up from prior guidance of $985 million to $1.0 billion. The Company is raising its full-year 2016 organic revenue growth to 9% from its previous guidance of approximately 8%. The Company is also raising its full-year GAAP and adjusted earnings per share guidance by $0.04 per diluted share and narrowing our guidance range to a new range of $1.78 – $1.88 and $3.43 – $3.53, respectively. This change reflects the impact from the adoption of the new accounting change, the expected additional share dilution on the 2016 convertible notes and warrants, and a slight outperformance in the second quarter results.

"In the second quarter, we continued to see positive momentum across our product portfolio, which allowed us to continue to make investments in our clinical pipeline and commercial infrastructure," said Glenn Coleman, Integra’s Chief Financial Officer. "We continue to expect margin expansion as we move through the back half of the year and are well-positioned to meet our full-year financial and strategic objectives."

In the future, the Company may record, or expects to record, certain additional revenues, gains, expenses or charges as described in the Discussion of Adjusted Financial Measures below that it will exclude in the calculation of adjusted EBITDA and adjusted earnings per share for historical periods and in providing adjusted earnings per share guidance.

On July 28, 2016 Cambrex Corporation (NYSE: CBM, "Cambrex") reported results for the second quarter ended June 30, 2016 (Press release, Cambrex, JUL 28, 2016, View Source [SID:1234514088]).

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Highlights
Sales increased 12% (11% excluding the impact of foreign currency) to $119.1 million compared to $106.4 million in the same quarter last year.
GAAP Diluted EPS from continuing operations was $0.63 compared to $0.60 in the same quarter last year and Adjusted Diluted EPS was $0.68 compared to $0.63 in the same quarter last year.
Adjusted EBITDA increased 6% to $36.7 million compared to $34.6 million in the same quarter last year (see table at the end of this release).
Net cash was $52.5 million at the end of the second quarter, a decrease of $33.1 million during the quarter.
The Company closed on a new five-year $500 million Senior Revolving Credit Facility that provides significant flexibility to execute its growth strategy.
The Company increased its financial guidance for full year sales and Adjusted EBITDA. The Company expects full year 2016 sales, excluding the impact of foreign currency, to increase between 10% and 13% compared to 2015. The Company expects Adjusted EBITDA to be between $144 and $149 million, a 12% to 16% increase compared to 2015 (see Financial Expectations section below).
"We are very pleased with our second quarter and year to date results. Sales growth and profit margins year to date are in line with our outlook coming into the year and we expect continued strong growth in the second half of 2016," commented Steven M. Klosk, President and Chief Executive Officer of Cambrex. "We saw growth across all product categories and we were also awarded two new late stage projects, demonstrating that we continue to be favorably positioned to take advantage of positive market dynamics. Our first half results, coupled with our visibility into the rest of the year, provide the basis for our increased financial guidance.

"Earlier this month we announced the completion and validation of our $50 million state-of-the-art production and warehousing expansion at our Charles City, Iowa facility. As overall industry trends remain favorable, we will continue to invest aggressively to increase our small and large scale capabilities."

Basis of Reporting
The Company has provided a reconciliation of GAAP amounts to adjusted (i.e. Non-GAAP) amounts at the end of this press release. Cambrex management believes that the adjusted amounts provide useful information to investors due to the magnitude and nature of certain expenses recorded in the GAAP amounts.

Second Quarter 2016 Operating Results – Continuing Operations
Sales were $119.1 million, compared to $106.4 million in the same period last year, representing a 12% increase. Foreign exchange favorably impacted reported sales growth by 1%. The sales increase primarily reflects higher volumes in all of our product categories, partially offset by lower pricing.

Gross margins decreased to 41% from 43% compared to the same quarter last year. The decrease was primarily due to lower pricing and higher inventory reserves, including higher reprocessing costs, partially offset by favorable product mix. Foreign currency had a negligible impact on gross margins in the second quarter of 2016.

Selling, general and administrative expenses were $13.6 million, compared to $14.1 million in the same quarter last year. The decrease was mainly due to lower bonus, recruiting and relocation expenses, partially offset by increased personnel costs and sales and marketing expenses.

Research and development expenses were $4.1 million, compared to $2.7 million in the same quarter last year. The increase is primarily related to increased personnel costs and costs to develop new generic drug products.

Operating profit increased to $30.8 million from $29.2 million in the same quarter last year. The increase in operating profit was primarily the result of higher gross profit, partially offset by higher research and development and sales and marketing expenses. Adjusted EBITDA was $36.7 million compared to $34.6 million in the same quarter last year.

Income tax expense was $9.8 million resulting in an effective tax rate of 32% compared to expense of $9.5 million and an effective tax rate of 33% in the same quarter last year.

Income from continuing operations was $20.8 million or $0.63 per share compared to $19.5 million or $0.60 per share in the same quarter last year. Adjusted income from continuing operations was $22.3 million or $0.68 per share, compared to $20.5 million or $0.63 per share in the same quarter last year (see table at the end of this release).

Capital expenditures and depreciation were $9.9 million and $5.5 million, respectively, compared to $14.5 million and $5.2 million, respectively, in the same quarter last year.

The decrease in net cash of $33.1 million during the quarter was primarily due to the timing of accounts receivable collections, increased inventory production and capital spending.

Financial Expectations – Continuing Operations
The following table shows the Company’s current expectations for its full year 2016 financial performance versus its expectations from the previous quarter:

Current Expectations Previous Expectations

Gross sales increase 10% – 13% 8% – 12%

Adjusted EBITDA $144 – $149 million $142 – $148 million

Adjusted income from
continuing operations
per share $2.49 – $2.61 $2.46 – $2.58

Free cash flow $60 – $70 million $60 – $70 million

Capital expenditures $70 – $75 million $70 – $75 million

Depreciation $25 – $27 million $26 – $28 million

Effective tax rate 32% – 34% 32% – 34%

Consistent with prior guidance for the full year 2016, these financial expectations are for continuing operations and exclude the impact of any potential acquisitions, divestitures, restructuring activities, outcomes of tax disputes and any charges related to any future sale of the Company’s Zenara business located in Hyderabad, India. Sales expectations exclude the impact of foreign exchange. EBITDA, Adjusted EBITDA and Adjusted income from continuing operations per share for 2016 will be computed on a basis consistent with the reconciliation of the second quarter 2016 financial results in the tables at the end of this release. Free cash flow is defined as the change in debt, net of cash during the year. The tax rate will be sensitive to the Company’s geographic mix of income.

The financial information contained in this press release is unaudited, subject to revision and should not be considered final until the Company’s second quarter 2016 Form 10-Q is filed with the SEC.

On July 28, 2016 Alexion Pharmaceuticals, Inc. (NASDAQ: ALXN) reported financial results for the second quarter of 2016 (Press release, Alexion, JUL 28, 2016, View Source [SID:1234514086]). Total revenues grew to $753 million, an 18 percent increase, compared to $636 million for the same period in 2015. In the second quarter, the negative impact of currency on total revenue was 3 percent or $18 million, net of hedging activities, compared to the same quarter last year. On a GAAP basis, diluted earnings per share (EPS) for the second quarter of 2016 was $0.51 per share, compared to $0.83 per share in the second quarter of 2015. Non-GAAP diluted EPS for the second quarter 2016 was $1.13 per share, reflecting a reduction of $0.12 per share attributable to the modification of reported non-GAAP income tax expense; prior to this modification non-GAAP diluted EPS would have been reported at $1.25 per share (Table 2). Non-GAAP diluted EPS was $1.30 per share in the second quarter 2015, reflecting a reduction of $0.14 per share attributable to the tax modification.

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Alexion has modified the definition of its non-GAAP income tax expense to align with the Compliance & Disclosure Interpretations (C&DIs) issued by the U.S. Securities and Exchange Commission (SEC) on May 17, 2016, and has reflected this modification in 2015 and 2016 non-GAAP interim period results. Alexion’s modified definition no longer includes the cash tax benefits the Company realizes during the year from net operating losses and income tax credits, and now includes other deferred taxes. The modification does not change the amount of cash taxes the Company will pay in 2016, or in the future, or have any impact on cash flow. A reconciliation of GAAP to non-GAAP financial results (Table 2) and supplemental effective tax rate information for financial guidance (Table 6) are provided later in the press release.

"In Q2 2016, we delivered strong financial performance as we served an increasing number of patients with PNH, aHUS, HPP and LAL-D. We are pleased with the sustained growth in our core Soliris business, the strong launch of Strensiq, and the continued progress with our Kanuma launch," said David Hallal, Chief Executive Officer of Alexion. "In the second half of 2016, we will continue to leverage our rare disease expertise to reach more patients with Soliris, Strensiq and Kanuma while advancing multiple milestones in our robust pipeline."

Second Quarter 2016 Financial Highlights

Soliris (eculizumab) net product sales were $701 million, compared to $636 million in Q2 2015, representing a 10 percent increase. Soliris volume increased 15 percent year-on-year.
Strensiq (asfotase alfa) net product sales were $45 million.
Kanuma (sebelipase alfa) net product sales were $6 million.
GAAP R&D expense was $179 million, compared to $132 million in the same quarter last year. Non-GAAP R&D expense was $165 million, compared to $117 million in the same quarter last year.
GAAP SG&A expense was $232 million, compared to $221 million in the same quarter last year. Non-GAAP SG&A expense was $200 million, compared to $169 million in the same quarter last year.
GAAP diluted EPS was $0.51 per share, compared to $0.83 per share in the same quarter last year. Non-GAAP diluted EPS was $1.13 per share, reflecting a reduction of $0.12 per share attributable to the modification of reported non-GAAP income tax expense, compared to $1.30 per share, reflecting a reduction of $0.14 per share attributable to the modification of non-GAAP income tax expense in the same quarter last year. GAAP and non-GAAP EPS in the second quarter of 2016 includes the impact of a full quarter of Synageva operations, shares issued for the acquisition and interest expense on related borrowings.
Product and Pipeline Updates

Complement Portfolio

Eculizumab- Refractory Generalized Myasthenia Gravis (gMG): Data from the REGAIN study, a single, multinational, placebo-controlled Phase 3 trial of eculizumab in patients with refractory gMG, were presented at the International Congress on Neuromuscular Diseases (ICNMD) meeting. Alexion expects to provide an update on discussions with regulators by the end of the year.

Eculizumab- Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD): Alexion expects to complete enrollment this year in the PREVENT study, a single, multinational, placebo-controlled Phase 3 trial of eculizumab in patients with relapsing NMOSD.
Eculizumab- Delayed Graft Function (DGF): Enrollment is complete in the PROTECT study, a single, multinational, placebo-controlled Phase 3 trial of eculizumab in the prevention of DGF, and data are expected in the second half of 2016.

ALXN1210: New data from the Phase 1/2 study of ALXN1210, a highly innovative longer-acting C5 antibody, in patients with paroxysmal nocturnal hemoglobinuria (PNH) were presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress. Alexion expects to present additional PNH data later this year. Alexion also expects to initiate a clinical program with ALXN1210 in patients with atypical hemolytic uremic syndrome (aHUS) later this year. The European Commission granted Orphan Drug Designation (ODD) to ALXN1210 for the treatment of patients with PNH.

ALXN1007: New data from the Phase 2 study of ALXN1007, a complement inhibitor that targets C5a, in patients with graft-versus-host disease involving the lower gastrointestinal tract (GI-GVHD) were presented at EHA (Free EHA Whitepaper) and Alexion is now evaluating higher doses of ALXN1007 in patients with GI-GVHD.
Metabolic Portfolio

SBC-103: New Phase 1/2 data of SBC-103, a recombinant form of the NAGLU enzyme, in patients with mucopolysaccharidosis IIIB, or MPS IIIB, were presented at the International Symposium on MPS and Related Diseases meeting. Alexion has now completed the planned dose escalation, with all patients now randomized to either a 5 mg/kg or 10 mg/kg dose. A natural history study to characterize the course of disease progression in patients with MPS IIIB is ongoing.
cPMP Replacement Therapy (ALXN1101): Alexion is enrolling patients in a pivotal study to evaluate ALXN1101 in neonates with Molybdenum Cofactor Deficiency (MoCD) Type A. A study to characterize the natural history of MoCD type A was completed in Q2.
Preclinical Portfolio

Alexion has more than 30 diverse preclinical programs across a range of therapeutic modalities, with four of these programs expected to enter the clinic in 2016.
2016 Financial Guidance

Alexion is reiterating its total revenue and Soliris guidance ranges provided on the first quarter of 2016 earnings call on April 28, 2016, and based on the strength of the Strensiq launch is increasing its Metabolic revenue guidance to $200 to $220 million. Alexion is reiterating its non-GAAP operating expense guidance and is updating its non-GAAP tax rate and non-GAAP EPS guidance. Alexion is also issuing 2016 GAAP financial guidance.

2016 financial guidance is as follows:

GAAP Guidance
Updated Non-GAAP Guidance
Prior Non-GAAP Guidance
Total revenues $3,050 to $3,100 million $3,050 to $3,100 million Low end of $3,050 to $3,100 million
Soliris revenues $2,835 to $2,875 million $2,835 to $2,875 million $2,835 to $2,875 million
Metabolic revenues $200 to $220 million $200 to $220 million $180 to $200 million
Cost of sales 8% to 9% 8% to 9% 8% to 9%
Research and development expense $708 to $779 million High end of $650 to $680 million
High end of $650 to $680 million
Selling, general and administrative expense
$883 to $935 million
High end of $760 to $790 million High end of $760 to $790 million
Interest expense $100 million $100 million $100 million
Effective tax rate 32% to 34% 15.5% to 16.5% (1) 7% to 8%
Earnings per share
$1.91 to $2.26
$4.50 to $4.65
Low end of $5.00 to $5.20
Diluted shares outstanding 228 million 230 million 230 million

Alexion’s 2016 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 activity that may occur after the day prior to the date of this press release.

(1) Alexion has modified the definition of its non-GAAP income tax expense. The modified definition no longer includes the cash tax benefits the Company realizes during the year from net operating losses and income tax credits, and now includes other deferred taxes. The modification does not change the amount of cash taxes the Company will pay in 2016, or in the future, or have any impact on cash flow. Refer to the reconciliation of GAAP to non-GAAP financial guidance (Table 3) and the supplemental effective tax rate information for financial guidance (Table 6) provided later in the press release.

On July 28, 2016 Acorda Therapeutics, Inc. (Nasdaq:ACOR) reported a financial and pipeline update for the second quarter ended June 30, 2016 (Press release, Acorda Therapeutics, JUL 28, 2016, View Source [SID:1234514082]).

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"AMPYRA’s continued growth is fueling investment in our late stage pipeline. We expect several important milestones in the second half of 2016 and early 2017, including data from our Phase 3 dalfampridine post-stroke and CVT-301 trials. These near-term opportunities target large, unmet needs and have the potential to improve the lives of people with these serious neurological diseases," said Ron Cohen, M.D., Acorda’s President and CEO. "We are working towards concluding our acquisition of Biotie later this year and excited about the addition of the tozadenant Phase 3 program to our pipeline of late stage assets."

Financial Results

The Company reported a GAAP net loss attributable to Acorda of $18.3 million for the quarter ended June 30, 2016, or $0.40 per diluted share. GAAP net income in the same quarter of 2015 was $1.0 million, or $0.02 per diluted share.

Non-GAAP net income for the quarter ended June 30, 2016, was $3.4 million, or $0.07 per diluted share. Non-GAAP net income in the same quarter of 2015 was $13.5 million, or $0.31 per diluted share. Non-GAAP net income excludes share based compensation charges, non-cash interest expense, acquisition-related expenses, expenses associated with changes in the fair value of acquired contingent consideration, foreign currency losses/(gains) and tax adjustments. A reconciliation of the GAAP financial results to non-GAAP financial results is included in the attached financial statements.

AMPYRA (dalfampridine) Extended Release Tablets, 10 mg – For the quarter ended June 30, 2016, the Company reported AMPYRA net revenue of $122.1 million compared to $105.5 million for the same quarter in 2015.

ZANAFLEX CAPSULES (tizanidine hydrochloride), ZANAFLEX (tizanidine hydrochloride) tablets and authorized generic capsules – For the quarter ended June 30, 2016, the Company reported combined net revenue and royalties from ZANAFLEX and tizanidine of $(0.7) million compared to $3.2 million for the same quarter in 2015. Combined net revenue and royalties for the period ended June 30, 2016, includes a charge of $3.0 million due to an increase in current and estimated future returns for ZANAFLEX.

FAMPYRA (prolonged-release fampridine tablets) – For the quarter ended June 30, 2016, the Company reported FAMPYRA royalties from sales outside of the U.S. of $2.7 million compared to $2.5 million for the same quarter in 2015.

Research and development (R&D) expenses for the quarter ended June 30, 2016, were $50.3 million, including $2.6 million of share-based compensation, compared to $31.2 million, including $2.2 million of share-based compensation for the same quarter in 2015. R&D expenses increased due to investment in our late stage programs, as well as the addition of Biotie R&D expenses from the date of acquisition.

Sales, general and administrative (SG&A) expenses for the quarter ended June 30, 2016, were $53.1 million, including $6.7 million of share-based compensation, compared to $52.8 million, including $6.5 million of share-based compensation for the same quarter in 2015. SG&A expenses exclude transaction expenses related to the Biotie acquisition and include Biotie expenses for the quarter ended June 30, 2016, from the date of acquisition.

Benefit from income taxes for the quarter ended June 30, 2016, was $1.0 million, including $2.4 million of cash taxes, compared to a provision for income taxes of $1.1 million, including $0.6 million of cash taxes, for the same quarter in 2015.

At June 30, 2016, the Company had cash, cash equivalents and investments of $137.4 million. The decrease in cash from December 31, 2015, is primarily attributable to the Company’s acquisition of Biotie. In June 2016, the Company entered into a three-year senior secured revolving credit agreement with JP Morgan Chase Bank, N.A. for up to $60 million.

2016 Financial Guidance

The Company reiterates AMPYRA 2016 net sales guidance of $475-$485 million.
R&D guidance is revised from $165-$175 million to $195-$205 million. This guidance is a non-GAAP projection which excludes share-based compensation, as more fully described below under "Non-GAAP Financial Measures." The increase in R&D expense is primarily driven by the addition of tozadenant, a Phase 3 asset for the treatment of OFF periods for people with Parkinson’s disease.
SG&A guidance remains unchanged at $195-$205 million. This guidance is a non-GAAP projection which excludes share-based compensation for the Company and transaction expenses related to the Biotie acquisition, as more fully described below under "Non-GAAP Financial Measures." SG&A guidance reflects the addition of the Biotie operations, offset by reductions in current and projected SG&A expenses.
The Company expects to be approximately cash flow neutral for the second half of 2016.
Second Quarter 2016 Highlights

Commercial

AMPYRA (dalfampridine)
AMPYRA revenues for the second quarter of 2016 were $122.1 million, up 16% from the second quarter in 2015. This represents the 13th consecutive quarter of double-digit, year-over-year growth for AMPYRA, which was launched in 2010.
In June, the United States Court of Appeals for the Federal Circuit denied a request by Mylan Pharmaceuticals for a rehearing of the Court’s previous decision to uphold a lower court ruling that Acorda’s Abbreviated New Drug Application (ANDA) litigation against Mylan can continue in the District Court of Delaware. Mylan has indicated that it intends to file a petition for certiorari to the United States Supreme Court.
In July, the Company submitted its responses to four Inter Partes Review (IPR) petitions to the United States Patent and Trademark Office (USPTO). A decision on the IPR is expected in March 2017.
A District Court trial for Company’s litigation against six generic companies seeking ANDA approvals is scheduled for September 2016. The Company has five Orange Book-listed patents on AMPYRA and will vigorously defend its intellectual property rights.
Late Stage Clinical Pipeline

Dalfampridine in Post-Stroke Walking Difficulties (PSWD)
Data from an unblinded analysis of the current twice-daily (BID) clinical trial are expected in the fourth quarter of 2016. Data from the Phase 1 multi-dose pharmacokinetic (PK) testing for once-daily (QD) dalfampridine are also expected in the fourth quarter of 2016.
If the multi-dose PK and BID analyses are positive, the Company plans to move forward with two concurrent, pivotal Phase 3 trials of dalfampridine in PSWD in mid-2017 using a QD formulation.
CVT-301 in Parkinson’s Disease
In June, data from the CVT-301 Phase 2b clinical trial were presented in three posters during the 20th International Congress of Parkinson’s Disease and Movement Disorders in Berlin, Germany.
Last patient out (LPO) of the ongoing Phase 3 efficacy study is expected by the end of 2016.
Early Stage Pipeline

CVT-427 in Migraine
Data from a Phase 1 pharmacokinetic (PK) study of CVT-427, an inhaled formulation of zolmitriptan, showed increased bioavailability and faster absorption compared to oral and nasal administration of the same active ingredient. The trial enrolled 21 healthy adults.
The data showed that median TMAX was about 12 minutes for all CVT-427 doses compared to 1.5 hours for the oral tablet and 3.0 hours for the nasal spray.
There were no serious adverse events, dose limiting toxicities, or study discontinuations due to adverse events reported after administration. The most commonly reported treatment-emergent AEs were cough, chest discomfort, headache and feeling hot. Apart from cough, single dose CVT-427 tolerability was generally consistent with the known safety profile of zolmitriptan.
The data were presented at the 58th Annual Scientific Meeting of the American Headache Society in San Diego, CA.
The Company plans to initiate a special population study in the second half of 2016, and expects to advance this program into Phase 2 in 2017.
Other Pipeline
In May, development of PLUMIAZTM, an investigational therapy for the treatment of seizure clusters in people with epilepsy, was discontinued after data from the Phase 3 clinical trials did not demonstrate its bioequivalence to Diastat (diazepam) rectal gel.
Corporate Updates

The Company has received more than 97% of Biotie’s outstanding shares in the tender offer and expects to complete the purchase of 100% of Biotie’s shares in the second half of this year.
In June, Biotie delisted its American Depositary Shares from the NASDAQ following the filing of an application on Form 25 with the U.S. Securities and Exchange Commission.
In July, Dr. Burkhard Blank assumed the role of Chief Medical Officer (CMO). Dr. Blank was named interim CMO in January 2016, and previously served as CMO for several biopharmaceutical companies, including Boehringer Ingelheim, Inc.