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.
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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.

On April 28, 2016 Kite Pharma, Inc., (Nasdaq:KITE) ("Kite") a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported four presentations to be delivered at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting (Press release, Kite Pharma, APR 28, 2016, View Source [SID:1234511531]). The presentations will address KTE-C19, Kite’s lead chimeric antigen receptor (CAR) product candidate, and, separately, a fully-human anti-CD19 CAR product candidate for the treatment of B-cell lymphomas and leukemias. The fully-human anti-CD19 CAR product candidate is currently being studied in an ongoing Phase 1 clinical trial as part of a Cooperative Research and Development Agreement (CRADA) between Kite and the National Cancer Institute (NCI). Under this CRADA, Kite collaborates with James (Jim) N. Kochenderfer, M.D., an investigator in the Experimental Transplantation and Immunology Branch of the NCI.

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Oral Presentations:

The Impact of Different Hinge and Transmembrane Components on the Function of a Novel Fully-Human Anti-CD19 Chimeric Antigen Receptor

Date: Wednesday, May 4, 2016 4:45-5:00PM Eastern Time
Session: Cancer-Targeted Gene and Cell Therapy (3:30-5:30PM Eastern Time)
Abstract Number: 74
Location: Washington 1-2, Marriott Wardman Park
Presenter: Leah Alabanza, Ph.D., Experimental Transplantation and Immunology Branch, National Cancer Institute, Bethesda, MD

Production of KTE-C19 (Anti-CD19 CAR T Cells) for ZUMA-1: A Phase 1/2 Multi-Center Study Evaluating Safety and Efficacy in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

Date: Thursday, May 5, 2016 4:15-4:30PM Eastern Time
Session: Vector and Cell Engineering/Manufacturing (4:00-5:45PM Eastern Time)
Abstract Number: 287
Location: Washington 1-2, Marriott Wardman Park
Presenter: Marc Better, Ph.D., Kite Pharma, Santa Monica, CA

Updated Phase 1 Results from ZUMA-1: A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-C19 (Anti-CD19 CAR T Cells) in Subjects with Refractory Aggressive Non-Hodgkin Lymphoma (NHL)

Date: Saturday, May 7, 2016 10:15-10:30AM Eastern Time
Session: Cancer-Immunotherapy, Cancer Vaccines III (10:15AM-12:15PM Eastern Time)
Abstract Number: 745
Location: Thurgood Marshall North, Marriott Wardman Park
Presenter: Frederick Locke, M.D., Moffitt Cancer Center, Tampa, FL

Poster Presentation:

Development of a Manufacturing Process Using Monte Carlo Simulations to Support KTE-C19 (Anti-CD19 CAR T Cells) Studies in Leukemia

Date: Friday, May 6, 2016 6:00-8:00PM Eastern Time
Session: Cancer-Immunotherapy, Cancer Vaccines III
Abstract Number: 650
Location: Exhibit Hall C & B South, Marriott Wardman Park
Presenter: Kenny Choi, Kite Pharma, Santa Monica, CA

On April 28, 2016 Onxeo S.A. (Paris:ONXEO) (NASDAQ OMX:ONXEO), an innovative company specializing in the development of orphan oncology drugs, reported an update on financial results and major milestones achieved during the first quarter of 2016, ending March 31, 2016 (Press release, Onxeo, APR 28, 2016, View Source [SID:1234511575]).

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Continued advancement of R&D programs:
Livatag (doxorubicin nanoformulation in Phase III trial for treatment of hepatocellular carcinoma):
Eighth positive DSMB recommendation for the ReLive Phase III clinical trial confirms safety profile
New data on Livatag’s unique mechanism of action presented at the AACR (Free AACR Whitepaper) Annual Meeting in New Orleans, LA, USA
Beleodaq:
Preclinical studies assessing the efficacy of Beleodaq Livatag in combination with other oncology agents; initial data expected mid-2016.
Validive:
Strategic decision to pursue further development only through partnership, following confirmation by the U.S. Food and Drug Administration of the clinical development plan
Expansion of Onxeo’s orphan oncology pipeline through acquisition of DNA Therapeutics and lead compound based on signal-interfering technology:
AsiDNA, first-in-class signal-interfering DNA (siDNA) molecule which accelerates cancer cell death by breaking the cycle of tumor DNA repair:
Technology at the forefront of scientific research for cancers with significant unmet medical needs
Potential to generate substantial shareholder value through new orphan oncology opportunities
€1.7 million cash-free acquisition closed March 25, 2016, concurrent with €1 million investment in Onxeo by former DNA Therapeutics shareholders via private placement. Additional milestone payments are expected once the product reaches the market.
Establishment of New York City-based U.S. subsidiary:
Direct U.S. presence will enable expansion of the Company’s development programs and establishment of closer ties with the scientific and financial communities in this key market
Philippe Maitre, pharmaceutical and biotech industry veteran, appointed Executive VP & Chief of U.S. Operations
Enhancement of the Company’s Board of Directors with the election as Chairman of Joseph Zakrezwski, a top personality in the biotech and pharmaceutical industry, and the appointments of international oncology R&D experts Prof. Jean-Pierre Kinet, M.D. and Jean-Pierre Bizzari, M.D.

Judith Greciet, CEO of Onxeo, commented, "In the first quarter of 2016, we built upon our momentum and reinforced our position as an emerging leader in the development of orphan oncology therapeutics. We advanced the development of our lead asset, Livatag. We are approaching near-term completion of Phase III recruitment, leading to reporting preliminary results mid-2017. The quarter was also highlighted by our acquisition of DNA Therapeutics and its siDNA technology platform, which we believe has the potential to change the paradigm of cancer care while greatly enhancing our ability to develop innovative therapies for patients in need. The DNA Therapeutics acquisition comes less than two years after the merger between BioAlliance Pharma and Topotarget that created Onxeo, and demonstrates our commitment to maximizing the opportunities to grow in the orphan oncology space. We are building a robust portfolio of commercialized products and highly promising product candidates. Collectively, these assets form a strong foundation upon which to grow the Company".

Q1 financial information

Revenues for the first quarter of 2016 totaled €782K, compared with €918K in the first quarter of 2015, impacted by a decrease in non-recurring revenues, from €157K in the first quarter of 2015 to €27K in the first quarter of 2016. This is primarily due to the accounting impact of IFRS relating to recognition of upfront payments on certain licensing agreements.

First quarter 2016 recurring revenues, which relate to product sales to commercial partners and royalties on product sales by Onxeo’s partners, were roughly flat compared to Q1 2015 (€755K compared with €761K in the first quarter of 2015). After the period of integration of Innocutis’ products and teams by Cipher mid-2015, revenues originating from Sitavig are back with a positive trend, resulting notably from an increase in price. Spectrum Pharmaceuticals maintained active marketing efforts to drive the growth of Beleodaq in the highly competitive second-line PTCL market.

As of March 31, 2016, consolidated cash position amounted to €24.4 million, in line with expectations. This figure does not include the €1 million capital increase linked with the acquisition of DNA Therapeutics, which was received subsequent to the end of the first quarter.

"Taking into account the planned reimbursement of the 2015 R&D tax credit of €3.8 million, our current cash position is sufficient to fund development into the second half of 2017, as per our plans, allowing us to deliver on important milestones over that time", concluded Nicolas Fellmann, CFO of Onxeo.