On May 05, 2016 Portola Pharmaceuticals Inc. (NASDAQ:PTLA), today provided a corporate update and reported its financial results for the first quarter ended March 31, 2016 (Press release, Portola Pharmaceuticals, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165766 [SID:1234512036]).

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"During the first quarter of 2016, we continued to advance the development of our three product candidates. We reported acceptance of our ANDEXXA (andexanet alfa) BLA and Phase 3 topline data from the APEX trial of betrixaban, completed a successful FDA pre-approval inspection of our Generation 1 commercial manufacturing process for ANDEXXA and completed the Phase 1 cerdulatinib study," said Bill Lis, chief executive officer of Portola. "We remain focused on successfully launching ANDEXXA, an FDA-designated Breakthrough Therapy and filing an NDA for betrixaban, an FDA-designated Fast Track Therapy, this year."

Recent Achievements, Upcoming Events and Milestones

ANDEXXA (andexanet alfa) – an FDA-designated Breakthrough Therapy Factor Xa inhibitor antidote in development for reversal of anticoagulation in patients treated with a Factor Xa inhibitor who are admitted to the hospital with uncontrolled bleeding or who need urgent surgery

The FDA accepted Portola’s BLA submission for ANDEXXA for filing in February 2016
The FDA completed a successful pre-approval inspection of CMC Biologics’ Generation 1 process; the inspection addressed the Generation 1 2,500 liter scale and the 6×2,000 liter scale process and confirmed alignment with the BLA
Completed Generation 2 GMP batches at the 10,000 liter scale at Lonza and achieved target yields
Entered into collaboration agreements with all of the manufacturers of oral Factor Xa inhibitors in Japan to develop and/or commercialize andexanet alfa in that territory
Enrollment remains on track for ANNEXATM-4, a Phase 3b/4 confirmatory study
Plan to present data from the Phase 2 proof-of-concept study with betrixaban in healthy volunteers at a medical conference this year
Preparing for commercial launch shortly after the PDUFA date of August 17, 2016, if approved
Plan to submit an MAA with the EMA in the third quarter of 2016
Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients

Reported topline results from the pivotal Phase 3 APEX Study
Plan to present data from the APEX Study on Friday, May 27, at the International Society on Thrombosis and Haemostasis (ISTH) 62nd Annual SSC (Scientific and Standardization Committee) Meeting in Montpellier, France; will hold an investor webcast directly following the presentation to discuss the APEX Study data
Plan to meet with the FDA in the second quarter and with the European Medicines Agency (EMA) to discuss the APEX Study results and a regulatory path forward
Pending discussions, plan to submit a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the EMA by the end of the year
Cerdulatinib – an oral, dual syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients

Achieved the maximum tolerated dose and completed the Phase 1 study; plan to present results in a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting in June
Initiated a Phase 2 study and expect to enroll the first patient during the second quarter
First Quarter 2016 Financial Results
Collaboration revenue earned under Portola’s collaborations with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Lee’s Pharmaceutical was $8.3 million for the first quarter of 2016 compared with $2.4 million for the first quarter of 2015. The increase in revenue was primarily the result of achieving certain milestones from Portola’s Daiichi Sankyo and Bayer and Janssen clinical agreements with the filing of the ANDEXXA BLA.

Total operating expenses for the first quarter of 2016 were $73.6 million compared with $48.9 million for the same period in 2015. Total operating expenses for the first quarter of 2016 included $7.1 million in stock-based compensation expense compared with $5.2 million for the same period in 2015.

Research and development expenses were $58.8 million for the first quarter of 2016 compared with $39.9 million for the first quarter of 2015 as Portola continued to support its manufacturing scale-up of ANDEXXA in preparation for commercial launch and work on its larger-scale Generation 2 manufacturing process at Lonza, the Phase 3b/4 ANNEXA-4 study of ANDEXXA, and the Phase 1/2a clinical study of cerdulatinib.

Selling, general and administrative expenses for the first quarter of 2016 were $14.8 million compared with $9.0 million for the same period in 2015 as the Company increased headcount to support its growth and increased pre commercial launch activities, including hiring key regional sales directors and national account managers and further developing medical affairs.

For the first quarter of 2016, Portola reported a net loss of $65.0 million, or $1.15 net loss per share, compared with a net loss of $46.9 million, or $0.95 net loss per share, for the same period in 2015.

As of March 31, 2016, cash, cash equivalents and investments totaled $421.0 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015.

2016 Annual Financial Guidance
For the fiscal year 2016, Portola expects total pro-forma operating expenses to be between $295 million and $320 million, excluding stock-based compensation. These expenses will be primarily in support of submissions of Generation 1 and Generation 2 manufacturing scale-up of ANDEXXA in preparation for commercial launch, the ongoing ANNEXA-4 study of ANDEXXA, the U.S. launch of ANDEXXA, the submission of NDA and MAA for betrixaban, pending regulatory discussions, and the Phase 2 clinical study of cerdulatinib.

Non-GAAP Financial Projection
This press release and the reconciliation table included herein include a non-GAAP projection of 2016 operating expenses, excluding stock-based compensation. A reconciliation to projected GAAP 2016 operating expenses is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Projected Operating Expenses." Portola management believes this non-GAAP information is useful for investors because it provides information about the Company’s ability to independently advance its assets.

On May 5, 2016 PharmaCyte Biotech (OTCQB: PMCB) reported that it has now reached a point in its life cycle where it is ready to start working with the U.S. FDA to get the company’s Phase 2b clinical trial in advanced pancreatic cancer underway (Press release, PharmaCyte Biotech, MAY 5, 2016, View Source [SID:1234512035]). Let that sink in for a moment. PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, has taken up the mantle to move the company’s signature technology, Cell-in-a-Box, to the clinic. And now, three short years later, he has the small biotech on the doorstep of what could be an eye-opening clinical trial to treat pancreatic cancer patients.

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According to the American Cancer Society’s cancer statistics for 2016, pancreatic cancer is the third leading cause of cancer-related deaths in the United States, and it’s one of the few cancers for which survival has not improved substantially over nearly 40 years. But help could be on the way. After PharmaCyte announced last week that the live-cell encapsulation facility where its Cell-in-a-Box capsules are produced is now current Good Manufacturing Practices or cGMP-compliant, the company cleared what was a major milestone on the way to a clinical trial and is now closer than ever to taking on the challenge of improving the lives of pancreatic cancer patients.

These are truly exciting times at PharmaCyte, and with the cell encapsulation facility now cGMP-compliant, the company can set its sights on first requesting a pre-IND (Investigational New Drug application) meeting with the FDA to discuss the design of its upcoming clinical trial.

This pre-IND meeting will be crucial to developing a relationship with the FDA and getting the necessary answers and guidance moving forward that will allow PharmaCyte to submit its formal IND to the FDA. The pre-IND meeting and the IND submission to the FDA are the next two major milestones for PharmaCyte and its investors.

With the encapsulation facility now ready for the production of clinical trial material, let’s look at the trial design that PharmaCyte has announced for its Phase 2b clinical trial:

PharmaCyte’s pancreatic cancer therapy consists of placing microcapsules containing genetically engineered live cells near the blood supply to the pancreas. The cancer prodrug ifosfamide is then given at one-third the normal dose. When the blood carries the chemotherapy drug to where the capsules have been placed, activation of the drug takes place right at the source of the cancer instead of in the patient’s liver, which eliminates any side effects in these patients.
The trial will be a multi-site trial held in both the United States and Europe. It will also be an open-label trial in which the patients will be randomized between two study groups. The trial has been designed to meet a clear unmet medical need that exists for a particular group of pancreatic cancer patients.
The randomization ratio of patients between the two study groups will be 1:1 (an equal number of patients will be randomly assigned to the capecitabine + radiation group and the PharmaCyte pancreatic cancer therapy group).
Only patients who have locally advanced, non-metastatic, inoperable cancer and whose tumors no longer respond after 4-6 months of treatment with either the widely used Abraxane + gemcitabine combination therapy or FOLFIRINOX, will be eligible for the trial. These patients are usually treated with the combination of the chemotherapy drug capecitabine + radiation, but this treatment is only marginally effective and is quite toxic for the patients.
Study sites under consideration in the U.S. include the Mayo Clinic in Scottsdale, Arizona, the Beth Israel Deaconess Cancer Center in Boston, the Dana-Farber Cancer Institute also in Boston, the Baylor Cancer Center in Dallas, Texas, Cedars-Sinai Medical Center in Los Angeles, as well as sites in Germany and Spain.
It is believed that 84 patients will be required to complete the study, although fewer may be required based upon the data developed during the trial.
Unlike in earlier clinical trials using PharmaCyte’s pancreatic cancer therapy where patients received only two cycles of therapy with ifosfamide, multiple cycles of ifosfamide will be given to those being treated with PharmaCyte’s pancreatic cancer therapy. This will continue until the patients’ tumors no longer respond to PharmaCyte’s therapy or until treatment-related toxicity accumulates to unacceptable levels.
And the best news of all for investors heading into these exciting times is that PharmaCyte has been awarded the Orphan Drug designation by both the U.S. FDA and the European Medicines Agency (EMA). This designation means that the company’s pancreatic cancer therapy will have complete protection and market exclusivity for years to come. After PharmaCyte’s therapy is approved for marketing by these two regulatory agencies, they will enjoy 7 years of market exclusivity in the United States and 10 years of protection in the European Union.

PharmaCyte’s CEO also recently stated that the company’s pancreatic cancer therapy qualifies for 12 years of data exclusivity because it is considered a "biologic" as outlined by the Biologics Price Competition and Innovation Act (BPCIA).

So, as the company marches headlong into a Phase 2b clinical trial in the U.S. and Europe with a built in "hard stop" about half way through the trial to review the data, there is no better time than the present to get excited about this small biotechnology company and what could very well be a significant contribution to the treatment of pancreatic cancer.

On May 05, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel anti-cancer stem cell (CSC) and immuno-oncology therapeutics, reported first quarter financial results (Press release, OncoMed, MAY 5, 2016, View Source [SID:1234512033]). The company also highlighted data presentations related to six oncology drug candidates, including robust preclinical anti-tumor activity data presented at the AACR (Free AACR Whitepaper) Annual Meeting for its wholly owned GITRL-Fc candidate and upcoming presentations at the ASCO (Free ASCO Whitepaper) Annual Meeting from clinical trials of vantictumab, ipafricept, demcizumab and tarextumab. As of March 31, 2016, cash, cash equivalents and short-term investments totaled $193.5 million.

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"Recent highlights include the presentation of new and compelling data at the AACR (Free AACR Whitepaper) Annual Meeting for our proprietary GITRL-Fc immuno-oncology therapeutic. We observed highly differentiated preclinical data including robust single-agent activity for GITRL-Fc compared to an alternate GITR agonist antibody strategy. We look forward to filing INDs on two distinct IO agents, GITRL-Fc and an undisclosed agent, termed ‘IO#2′, with the first of these IND filings by year-end." said Paul J. Hastings, Chairman and Chief Executive Officer. "Looking ahead, we have a steady stream of data presentations planned, starting with several at the ASCO (Free ASCO Whitepaper) Annual Meeting for ongoing clinical trials, including new data from two of our Phase 1b combination studies for Wnt inhibitors vantictumab and ipafricept, as well as updated Phase 1b survival data for demcizumab in NSCLC."

Corporate Update and Recent Highlights

Initiated a Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) plus anti-PD-1 (pembrolizumab) in solid tumor patients

Presented five posters at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting:
Preclinical data comparing efficacy and immune system activation of OncoMed’s wholly owned GITRL-Fc to GITR agonist antibodies and evaluating GITRL-Fc alone and in combination with anti-PDL1 and anti-PD1
Predictive biomarker assays for anti-RSPO3 (OMP-131R10) in solid tumors and vantictumab (anti-Fzd7, OMP-18R5) in pancreatic cancer
Preclinical data detailing anti-DLL4’s activity in non-small cell lung cancer, including immunomodulatory mechanism

Announced acceptance of several clinical abstracts for presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2016 Annual Meeting being held June 3-7, 2016 in Chicago, IL. Presentations include:
The first clinical data from Phase 1b trials of the company’s Wnt pathway inhibitors, vantictumab and ipafricept (FZD8-Fc, OMP-54F28), in combination therapy in breast cancer and ovarian cancer, respectively
Updated survival data from OncoMed’s Phase 1b clinical trials of demcizumab (OMP-21M18, anti-DLL4) in non-small cell lung cancer (NSCLC) and of tarextumab (anti-Notch2/3, OMP-59R5) in small cell lung cancer

First Quarter 2016 Financial Results
Cash, cash equivalents and short-term investments totaled $193.5 million as of March 31, 2016, compared to $157.3 million as of December 31, 2015. During the quarter, OncoMed received a $70 million payment from Celgene related to the demcizumab safety milestone achieved in the fourth quarter of 2015. This milestone was recorded as deferred revenue and will be amortized over the performance period.

Revenues for the first quarter 2016 totaled $6.4 million, as compared to $9.7 million in the first quarter of 2015. The decrease in revenue over the same period in 2015 was primarily due to achievement in 2015 of a $5.0 million milestone from GlaxoSmithKline related to brontictuzumab, partially offset by increased amortization of revenue from Celgene related to the demcizumab safety milestone.

Research and development (R&D) expenses for the first quarter 2016 were $28.4 million compared with $19.4 million for the same period in 2015. Higher R&D expenditures during the first quarter 2016 compared to the first quarter of 2015 were attributable to increased Phase 2 costs for the demcizumab and tarextumab programs as well as IND-enabling manufacturing and toxicology costs for the GITRL-Fc and IO#2 programs.

General and administrative (G&A) expenses for the quarter ended March 31, 2016 were $5.2 million, compared to $4.8 million for the same period in 2015. Increased costs during the first quarter 2016 were due to higher employee-related costs including stock-based compensation expenses.

Net loss for the first quarter 2016 was $27.2 million ($0.90 per share), compared to $14.5 million ($0.49 per share) for the same period of 2015. The change in net loss from the prior year quarter was due to an increase in operational expenses, primarily research and development costs, and lower collaboration revenues.

2016 Financial Guidance
OncoMed reiterated financial guidance for the full year 2016. Based on its current plans and expectations, OncoMed anticipates:

Cash expenses in the range of approximately $110-$120 million
2016 year-end cash balance of more than $100 million, without taking into account potential future milestones or payments from partners
Existing cash is anticipated to fund company operations through the first quarter of 2018, without taking into account potential future milestones or payments from partners

Potential milestone and opt-in payments from partners GSK, Bayer and Celgene over the course of 2016, 2017, and 2018 total over $270 million.

On May 5, 2016 Neurocrine Biosciences, Inc. (NASDAQ:NBIX) reported its financial results for the quarter ended March 31, 2016 (Press release, Neurocrine Biosciences, MAY 5, 2016, View Source;p=RssLanding&cat=news&id=2165670 [SID:1234512030]). For the first quarter of 2016, the Company reported a net loss of $19.3 million, or $0.22 loss per share, compared to a net loss of $1.2 million, or $0.01 loss per share, for the same period in 2015.

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The Company’s balance sheet at March 31, 2016 reflected cash, cash equivalents, investments and receivables of $448.6 million compared to $464.3 million at December 31, 2015.

"2015 was a very successful year for Neurocrine and we have carried this momentum into the first quarter of 2016 beginning with positive top-line data from the second Phase III study of elagolix in endometriosis, the initiation of two Phase III studies of elagolix in uterine fibroids, the start of our Phase II T-Force GREEN study of valbenazine in children and adolescents with Tourette syndrome, as well as the acceptance of seven valbenazine abstracts at the American Academy of Neurology and American Psychiatric Association Annual Meetings" said Kevin Gorman, Ph.D., President and Chief Executive Officer of Neurocrine Biosciences. "Our focus for the coming months is to continue to execute across all aspects of our business; advancing compounds from research into the clinic, executing on clinical trials, filing the valbenazine NDA, and interacting with providers and payers as we prepare for the commercial launch of valbenazine for tardive dyskinesia upon FDA approval."

The $15.0 million of revenue for the first quarter of 2016 represents a milestone payment from AbbVie related to the commencement of Phase III studies of elagolix in uterine fibroids. The $19.8 million of revenue for the first quarter of 2015 represents recognized revenue in the form of license fees from the NBI-98854 (valbenazine) collaboration and license agreement with Mitsubishi Tanabe.

Research and development expenses increased to $23.9 million during the first quarter of 2016 from $16.6 million during the same period in 2015. This increase was primarily due to higher external clinical development expenses and associated internal costs related to the Company’s VMAT2 inhibitor, valbenazine, which is being evaluated in both tardive dyskinesia and Tourette syndrome. Additionally, expenses related to the Company’s preparation of the New Drug Application for valbenazine in tardive dyskinesia accounted for a portion of the increase in expenses quarter over quarter.

General and administrative expenses increased from $5.5 million in the first quarter of 2015 to $12.0 million for the first quarter of 2016, primarily due to pre-commercialization activities for valbenazine. Personnel related costs increased by $3.9 million quarter over quarter primarily due to the expansion of sales and marketing and medical affairs personnel. This increase in personnel related costs includes a $2.4 million increase in share-based compensation expense. Additionally, a significant increase in other pre-commercialization activities contributed to the overall growth in general and administrative expenses.

Pipeline Highlights

Valbenazine Update

During the fourth quarter of 2015, the Company announced positive efficacy results from the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder who underwent six weeks of placebo controlled assessment. Subsequent to the initial six weeks of treatment, subjects were eligible to continue in the Kinect 3 study for an additional 42 week open-label safety assessment. The open-label safety evaluation is anticipated to complete dosing in mid-2016.

In addition to the ongoing safety assessment of Kinect 3, during the first quarter of 2016 the Company completed enrollment in a separate one-year open-label safety study of valbenazine, Kinect 4, to support the anticipated 2016 filing of a New Drug Application of valbenazine in tardive dyskinesia.

The Company also recently initiated a valbenazine roll-over study for those patients who complete the one year of dosing in either the Kinect 3 or Kinect 4 studies. This roll-over study is designed to permit open-label access to valbenazine for up to an additional 72 weeks of treatment.

As announced previously, Neurocrine has received Breakthrough Therapy Designation from the FDA for valbenazine in the treatment of tardive dyskinesia.

The Company is also exploring valbenazine in Tourette syndrome. The Company recently announced the initiation of two Phase II Tourette syndrome studies evaluating valbenazine in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively.

The T-Forward study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group, study of up to 90 adults. Subjects will receive once-daily dosing of valbenazine during an eight-week treatment period to assess the safety, tolerability and efficacy of valbenazine in adult Tourette patients. The primary endpoint of this study is a change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8.

The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group study of up to 90 children and adolescents. Subjects will receive once-daily dosing of valbenazine during a six-week treatment period to assess the safety, tolerability and efficacy of valbenazine in pediatric Tourette patients. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of Week 6.

Data from both of these Tourette studies is expected around year-end 2016.

The Company has submitted and had accepted seven valbenazine abstracts at two major medical conferences during the second quarter. Valbenazine data from all three Kinect clinical trials were presented at podium and plenary sessions at the American Academy of Neurology Annual Meeting in April. In addition, four valbenazine scientific abstracts were submitted and accepted for the American Psychiatric Association Annual Meeting in May.

Elagolix Update

During the first quarter of 2016, AbbVie announced positive top-line results from the second of two Phase III clinical trials, the Solstice Study, a multinational study designed to evaluate the efficacy and safety of elagolix in 815 premenopausal women with endometriosis. The top-line results from this trial were consistent with those of the initial Phase III clinical trial, the Violet Petal Study, where after six months of treatment, both doses of elagolix (150 mg once-daily and 200 mg twice-daily) met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea) associated with endometriosis at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale. The observed safety profile of elagolix in the Solstice study was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache, and nausea. While most AEs were similar across treatment groups some, such as hot flush and bone mineral density loss, were dose-dependent. AbbVie is targeting a 2017 New Drug Application filing with the FDA for elagolix in endometriosis.

In early 2016, AbbVie announced the initiation of the Phase III uterine fibroids program consisting of two replicate randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with add-back therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies are expected to enroll approximately 400 subjects each for an initial six-month placebo-controlled dosing period. At the end of the six-months of placebo-controlled evaluation, subjects are eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing, and six months post-dosing.

Essential Tremor Program (NBI-640756) Update

NBI-640756 for patients with essential tremor was discovered in the Neurocrine laboratories. The Company has completed dosing in a single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers. The study was conducted in multiple sequential cohorts of eight subjects per cohort. Data from this initial Phase I study is expected in the second quarter of 2016.

On May 05, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today reported financial results for the first quarter ended March 31, 2016 (Press release, NanoString Technologies, MAY 5, 2016, View Source [SID:1234512029]).

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First Quarter Financial Highlights

Total revenue of $14.7 million, 27% year-over-year growth
Total product and service revenue of $12.1 million, 12% year-over-year growth
Consumables revenue of $8.0 million, including $0.8 million of Prosigna IVD kits, 35% year-over-year growth
Instrument revenue of $3.4 million, 22% year-over-year decline
Collaboration revenue of $2.6 million
"We continue to strengthen our leadership in precision oncology on all fronts, while our new biopharma partnerships helped deliver positive operating cash flow during the first quarter," said president and chief executive officer, Brad Gray. "We generated 27% year-on-year revenue growth despite lower than expected instrument sales, as some orders slipped into the second quarter. We have seen a strong recovery in instrument sales during April, expect instrument revenue growth to normalize over the balance of the year, and reiterate our guidance for total revenue of $86 to $90 million for fiscal year 2016."

Recent Business Highlights

Grew installed base to over 370 nCounter Analysis Systems at March 31, 2016
Introduced the nCounter Vantage portfolio of assays that power 3D Biology experiments in cancer research, including immuno-oncology
Presented first proof-of-concept data for digital immunohistochemistry (IHC), a novel technology to simultaneously count multiple protein targets in the spatial context of tumor tissue biopsies
Entered into a collaboration with HalioDx SAS to develop gene expression assays for assessing response to cancer immunotherapies using the nCounter system
Received favorable final Medicare local coverage determination for Prosigna by Noridian Healthcare Solutions and Novitas Solutions, Inc. covering 22 states
Entered into two collaborations with Merck and with Medivation and Astellas to develop and commercialize novel diagnostic tests to predict drug response
First Quarter Financial Results

Revenue for the three months ended March 31, 2016 increased by 27% to $14.7 million, as compared to $11.6 million for the first quarter of 2015. Instrument revenue was $3.4 million, down 22% versus the prior year period, resulting from seasonal trends compounded by slower than expected conversion of sales opportunities into orders, as well as a lower overall average selling price resulting from the mid-2015 launch of the nCounter SPRINT Profiler. Consumables revenue, excluding Prosigna, was $7.2 million for the first quarter of 2016, 31% higher than in the comparable 2015 quarter. Prosigna IVD kit revenue was $0.8 million for the quarter, and collaboration revenue totaled $2.6 million. Gross margin on product and service revenue was 52% for the first quarter of 2016, up from 51% for the first quarter of 2015.

Research and development expense increased by 22% to $7.2 million for the first quarter of 2016 versus $5.9 million for the first quarter of 2015, reflecting increased costs associated with collaboration activities and new products and technologies under development for the life science research market. Selling, general and administrative expense was $14.9 million for the first quarter of 2016 compared to $14.1 million for the prior year period.

Net loss for the three months ended March 31, 2016 declined to $14.6 million, or a loss of $0.74 per diluted share, compared with $14.9 million, or a loss of $0.81 per diluted share, for the first quarter of 2015.

Outlook for 2016

The company’s financial outlook for 2016 is unchanged, and includes:

Total revenue in the range of $86 million to $90 million
Gross margin on product and service revenues in the range of 54% to 55%
Operating expenses in the range of $94 million to $99 million
Operating loss in the range of $40 million to $43 million
Net loss per share in the range of $2.30 to $2.45
Cash from collaborations in 2016 in the range of $40 million to $45 million