On November 2, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the third quarter ended September 30, 2016 (Press release, NanoString Technologies, NOV 2, 2016, View Source [SID1234516304]).

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Third Quarter Financial Highlights

Total revenue of $23.9 million, 53% year-over-year growth
Total product and service revenue of $19.2 million, 38% year-over-year growth
Consumables revenue of $11.5 million, including $1.1 million of Prosigna IVD kits, 27% year-over-year growth
Instrument revenue of $6.9 million, 62% year-over-year growth
Collaboration revenue of $4.8 million
"We continued to execute well during the third quarter, generating strong growth across our business while advancing our product pipeline and partnerships," said president and chief executive officer Brad Gray. "A highlight of the quarter was the robust demand for our nCounter SPRINT Profiler, which helped drive 62% year-on-year growth in instrument revenue and validated that SPRINT’s ability to reach new customers is accelerating instrument placement."

Recent Business Highlights

Grew installed base to approximately 450 nCounter Analysis Systems at September 30, 2016
Launched new nCounter Vantage 3D Solid Tumor Panels for proteins and single nucleotide variations to enable simultaneous analysis of DNA mutations, messenger RNA, fusion genes, and proteins on a single platform
Presented data demonstrating the potential workflow advantages of Hyb & Seq sequencing chemistry, requiring less than 60 minutes of sample processing to enable initiation of a sequencing run
Appointed Kirk Malloy, Ph.D., seasoned life sciences executive, to the company’s board of directors
Third Quarter Financial Results

Revenue for the three months ended September 30, 2016 increased by 53% to $23.9 million, as compared to $15.7 million for the third quarter of 2015. Instrument revenue was $6.9 million, up 62% versus the prior year period, with nCounter SPRINT systems representing approximately half of systems sold. Consumables revenue, excluding Prosigna, was $10.3 million for the third quarter of 2016, 23% higher than in the comparable 2015 quarter. Prosigna IVD kit revenue was $1.1 million for the quarter, an increase of 73% over the third quarter of 2015. Collaboration revenue totaled $4.8 million, compared to $1.8 million for the third quarter of 2015. Gross margin on product and service revenue was 58% for the third quarter of 2016, up from 55% for the prior year period.

Research and development expense increased by 50% to $8.7 million for the third quarter of 2016 versus $5.8 million for the third quarter of 2015, reflecting increased costs associated with biopharma collaborations announced earlier this year and new products and technologies under development for the life science research market. Selling, general and administrative expense increased by 30% to $15.6 million for the third quarter of 2016 compared to $12.0 million for the prior year period.

Net loss for the three months ended September 30, 2016 increased to $10.1 million, or a loss of $0.51 per share, compared with $9.5 million, or a loss of $0.49 per share, for the third quarter of 2015.

Outlook for 2016

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

Total revenue in the range of $89 million to $93 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 $37 million to $40 million
Net loss per share in the range of $2.15 to $2.30
Cash from collaborations in 2016 in the range of $40 million to $45 million

On November 2, 2016 Immunomedics, Inc. (Nasdaq:IMMU) reported financial results for the first quarter ended September 30, 2016. The Company also highlighted recent key developments and planned activities for its clinical pipeline (Filing, Q3, Immunomedics, 2016, NOV 2, 2016, View Source [SID1234516285]).

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First Quarter Fiscal 2017 Results

Total revenues for the first quarter ended September 30, 2016, were $0.7 million, the same amount reported for the quarter ended September 30, 2015.

Total costs and expenses for the quarter ended September 30, 2016 were $15.7 million, compared to $14.8 million for the same quarter in fiscal 2016, an increase of $0.9 million, or approximately 6%. The increase was due primarily to a $4.9 million increase in research and development expenses related to manufacturing and Phase 2 clinical trials of the antibody-drug conjugates, including sacituzumab govitecan (IMMU-132), which was offset partially by a $3.0 million decrease in research and development expense from the early termination of the Phase 3 PANCRIT-1 clinical trial during the third quarter of fiscal 2016, and a $1.1 million decrease from adjustments for deferred unearned executive bonuses.

Interest expense related to the 4.75% Convertible Senior Notes due 2020 was $1.4 million for both quarters ended September 30, 2016 and September 30, 2015, including amortization of $0.2 million debt issuance costs in each quarter.

Net loss attributable to stockholders was $16.2 million, or $0.17 per basic and diluted share, for the first quarter of fiscal year 2017, compared with net loss attributable to stockholders of $15.4 million, or $0.16 per basic and diluted share, for the same quarter in fiscal 2016, an increase of $0.8 million, or approximately 5%. The increase was due primarily to increased research and development expenses, as described above.

Cash, cash equivalents, and marketable securities were $33.0 million as of September 30, 2016. On October 12, 2016, the Company sold 10 million shares of its common stock and warrants to purchase up to 10 million shares of common stock for net proceeds of approximately $28.5 million.

"The recent offering of stock and warrants has strengthened our balance sheet, which we believe should facilitate uninterrupted clinical and manufacturing activities for IMMU-132, while simultaneously continuing our out-licensing efforts," commented Michael R. Garone, Vice President Finance and Chief Financial Officer. "We are committed to pursuing these strategic goals to completion for the benefit of cancer patients; particularly those with metastatic triple-negative breast cancer, for whom there are no targeted therapies currently available." Mr. Garone added.

The Company’s key clinical developments and future planned activities:

Sacituzumab Govitecan (IMMU-132)

Updated Phase 2 clinical trial results of IMMU-132 in patients with metastatic triple-negative breast (TNBC) have been submitted for publication

Manufacturing of clinical materials for the Phase 3 confirmatory trial in TNBC is progressing according to plan. Large-scale batches have been produced by our Contract Manufacturing Organizations, and are moving through quality control and comparability testing requirements

Patient enrollment in the Phase 2 clinical trial in TNBC is nearing completion with the 100 assessable patients for planned accelerated approval application

On November 2, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in the efficacy portion of its Phase 2 clinical study of BP1001, a liposomal Grb2 antisense for the treatment of acute myeloid leukemia (AML) (Filing, 8-K, Bio-Path Holdings, NOV 2, 2016, View Source [SID1234516251]). The objective of the Phase 2 study is to further assess the efficacy and safety of BP1001, Bio-Path’s lead development candidate.

The Phase 2 clinical trial is a multicenter study of BP1001 in combination with low dose cytarabine (LDAC) in patients with previously untreated AML who are not otherwise eligible for standard or high-intensity chemotherapy regimens or who have elected a low-intensity regimen.

The trial is a single arm, open label, two-stage design to assess the safety profile, pharmacokinetics, pharmacodynamics, and efficacy of 60 mg/m2 of BP1001 in combination with LDAC compared to historical response rates documented for LDAC alone. Evaluable patients will receive an initial dose intravenous (IV) infusion of BP1001 over 60 minutes and every three days thereafter, as eight doses per 28-day cycle of 60 mg/m2 BP1001, and will be administered LDAC as a subcutaneous (SQ) injection, twice daily for 20 consecutive doses per 28-day cycle.

The primary endpoint of the study is the number of patients who achieve Complete Remission (CR), including CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRip). Secondary endpoints assessing the safety and efficacy of BP1001 include overall survival, time to response, duration of response, and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory tests.

The full trial design includes approximately 54 evaluable patients with an interim analysis performed after 19 patients. In the event the interim results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the Company may seek to convert the trial into a registration trial for accelerated approval.

Among the sites registered to conduct the study are Weill Medical College of Cornell University, Baylor Scott & White Health, The University of Kansas and The University of Texas MD Anderson Cancer Center.

"This is an exciting milestone for Bio-Path as it will be the first study to confirm the efficacy of BP1001 as a treatment for AML and to validate our DNAbilizeTM platform," said Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings. "We are particularly pleased with the Phase 2 trial design, which has a built-in interim analysis that offers a pathway to an accelerated approval should the efficacy results for the first 19 evaluable patients demonstrate the high response rate seen in the safety segment of our Phase 2 trial. We look forward to the completion of this study and expect its results to replicate these very promising early data," added Mr. Nielsen.

Patients in the safety segment of the trial treated with 60 mg/m2 and 90 mg/m2 of BP1001 twice a week over a four-week period, in combination with a standard regimen of frontline low-dose cytarabine (LDAC), showed BP1001 to be safe and well tolerated, with signs of significant anti-leukemia activity. Of the six evaluable patients included in both cohorts of the safety segment, three achieved complete remissions, while two others achieved partial remission. There were no attributable adverse events reported.

As previously reported, BP1001’s pharmacokinetics at a dose of 60 mg/m2 had a 30-hour half-life, significantly better than the half-life with a dose of 90 mg/m2. The final analysis of these data, along with the demonstrated reductions in bone marrow blasts, suggested that 60 mg/m2 is the appropriate dose for use in the Phase 2 trial. Administratively, this required Bio-Path to reformat documents for the Phase 2 trial with the 60 mg/m2 dose and resubmit for approvals with the U.S. Food and Drug Administration (FDA) and site Institutional Review Boards, requiring additional time prior to starting the Phase 2 trial.

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On November 2, 2016 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported updates on EXPAREL (bupivacaine liposome injectable suspension) for postsurgical pain in the United States and announced consolidated financial results for the third quarter ended September 30, 2016 (Press release, Pacira Pharmaceuticals, NOV 2, 2016, View Source;p=RssLanding&cat=news&id=2218447 [SID1234516231]).

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"EXPAREL revenues continued to grow year-over-year in the third quarter," said Dave Stack, Chief Executive Officer and Chairman of Pacira. "We believe our steady blocking and tackling of key programs—from developing robust clinical data in support of marketplace use to strategic commercial partnerships that advance opioid minimization protocols for postsurgical pain control—will continue to improve patient lives and contribute to sales growth."

Recent Highlights

EXPAREL Launches in Oral Surgery at AAOMS, with Data Demonstrating Safety and Efficacy for Pain Relief in Third Molar Removal: Pacira officially launched EXPAREL in oral surgery at the American Association of Oral and Maxillofacial Surgeons (AAOMS) annual meeting in September, where the company presented the results from a prospective, randomized, double-blind, placebo-controlled study in third molar (wisdom teeth) extraction. Overall, patients receiving EXPAREL demonstrated a lower mean opioid consumption and significantly lower pain scores at 48 hours in comparison to that of placebo.

Pacira Partners with American College of Surgeons (ACS) in Launching Educational Program for Patients and Surgeons: Opioids and Surgery: Use, Abuse and Alternatives is an initiative designed to support the rapid dissemination of patient education materials regarding opioids and opioid alternatives, as well as to support the surgeon with evidence-based content, including procedure-specific enhanced recovery protocols, managing pain expectations, non-opioid options, screening programs, discharge education and transition management.

Key Executive Appointments Enhance Commercial Team: Pacira recently announced the appointment of Thomas Sluby, Vice President, Sales and Matthew Lehmann, Vice President, Marketing – Emerging Therapies. Mr. Sluby is responsible for overseeing all aspects of sales execution and customer relations, and will work closely with the commercial team on the development and implementation of sales and product strategies for EXPAREL. Mr. Lehmann will be responsible for the development, implementation and execution of market strategies and tactics, initially focusing on the EXPAREL nerve block launch subsequent to approval. Both individuals will report to Robert Weiland, Chief Commercial Officer.
Third Quarter 2016 Financial Results

EXPAREL net product sales were $64.9 million in the third quarter of 2016, a 9% increase over the $59.7 million reported for the third quarter of 2015.

Total revenues were $68.4 million in the third quarter of 2016, a 10% increase over the $62.2 million reported for the third quarter of 2015.

Total operating expenses were $89.2 million in the third quarter of 2016, compared to $57.1 million in the third quarter of 2015. Total operating expenses in the third quarter of 2016 include a $21.9 million charge to cost of goods sold to fully reserve $20.7 million for the cost of EXPAREL batches impacted by a routine stability test that did not meet required specifications and $1.2 million for an estimated number of replacement boxes and other related costs.

GAAP net loss was $22.2 million, or $(0.59) per share (basic and diluted), in the third quarter, compared to GAAP net income of $3.1 million, or $0.08 per share (basic and diluted), in the third quarter of 2015.

Non-GAAP net income was $8.0 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the third quarter of 2016, compared to non-GAAP net income of $12.9 million, or $0.35 per share (basic) and $0.32 per share (diluted), in the third quarter of 2015.

Pacira ended the third quarter of 2016 with cash, cash equivalents and short-term investments ("cash") of $161.1 million.

Pacira had 37.3 million basic weighted average shares of common stock outstanding in the third quarter of 2016.

For non-GAAP measures, Pacira had 40.2 million diluted weighted average shares of common stock outstanding in the third quarter of 2016.
2016 Outlook

Pacira updates its full year 2016 financial guidance as follows:

EXPAREL net product sales of $263 million to $268 million, reflecting management’s revised expectation about when its commercial strategies and creation of opioid-sparing collaborations will accelerate sales growth.

Non-GAAP gross margins of 70% to 73%.

Non-GAAP research and development (R&D) expense of $40 million to $50 million. This reduction in guidance reflects significant cost savings in three randomized clinical trials, along with a change in timing of some costs related to the two nerve block trials that the company expects to complete in the first quarter of 2017.

Non-GAAP selling, general and administrative (SG&A) expense of $125 million to $135 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2016 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, November 2, 2016, at 9 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 12896365.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 12896365. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

On November 2, 2016 Genmad reported its interim Report for First Nine Months Ended September 30, 2016 (Press release, Genmab, NOV 2, 2016, View Source [SID1234516222]).
Highlights
Net Sales of DARZALEX (daratumumab) by Janssen for the first nine months of 2016 were USD 372 million, resulting in royalty income of USD 45 million (DKK 298 million)
Announced U.S. and European regulatory submissions for daratumumab in relapsed or refractory multiple myeloma, triggering USD 25 million in milestone payments
Daratumumab received second Breakthrough Therapy Designation from U.S. Food and Drug Administration (FDA)
Announced FDA approval of Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide for relapsed chronic lymphocytic leukemia (CLL)
Entered commercial license agreement with Gilead Sciences for DuoBody Technology
2016 financial guidance improved
"Throughout the third quarter we continued to see excellent progress in our DARZALEX program with Janssen. Regulatory applications to expand the label for daratumumab to include relapsed or refractory multiple myeloma were submitted in the U.S. and Europe, triggering USD 25 million in milestone payments. Daratumumab also received its second Breakthrough Therapy Designation from the FDA. We continued to see progress with Arzerra too, with another CLL indication approved in the U.S., and we made progress with our DuoBody technology, with a new commercial agreement with Gilead Sciences," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Nine Months of 2016
Revenue was DKK 889 million in the first nine months of 2016 compared to DKK 558 million in the first nine months of 2015. The increase of DKK 331 million, or 59%, was mainly driven by higher royalty and milestone revenue under our daratumumab collaboration with Janssen.
Operating expenses were DKK 544 million in the first nine months of 2016 compared to DKK 380 million in the first nine months of 2015. The increase of DKK 164 million, or 43%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our other pre-clinical programs.
Operating income was DKK 345 million in the first nine months of 2016 compared to DKK 355 million in the first nine months of 2015. The decrease of DKK 10 million, or 3%, was driven by the one-time reversal of the ofatumumab funding liability of DKK 176 million in 2015, combined with increased operating expenses in 2016, which were partly offset by higher revenue in 2016.
On September 30, 2016, Genmab had a cash position of DKK 3,942 million compared to DKK 3,493 million at December 31, 2015. This represented a net increase of DKK 449 million, which was driven primarily by income from operations and the proceeds from the exercise of warrants of DKK 184 million, partially offset by the purchase of treasury shares for DKK 118 million.
Business Progress Third Quarter
Daratumumab
August: Regulatory submission in Europe for daratumumab (DARZALEX) in patients with multiple myeloma who have received at least one prior therapy. In addition, a regulatory application was submitted in the U.S. for the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy. The submissions triggered milestone payments of USD 10 million, and USD 15 million, respectively, to Genmab.
July: The FDA granted Breakthrough Therapy Designation for DARZALEX injection in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Ofatumumab
August: The FDA approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL.
DuoBody
August: Entered an agreement to grant Gilead Sciences, Inc. an exclusive license and an option on a second exclusive license, to use the DuoBody technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab received an upfront payment of USD 5 million from Gilead Sciences.
Subsequent Event
October: The FDA granted Priority Review for the use of daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of February 17, 2017 to take a decision on daratumumab in this indication. In addition, the FDA granted a Standard Review period for the use of daratumumab in combination with pomalidomide and dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor (PI) and an immunomodulatory agent. The PDUFA date for the combination of daratumumab with pomalidomide/dexamethasone is June 17, 2017.
Outlook
Genmab is improving its 2016 financial guidance published on August 9, 2016 due to increased royalty and milestone income related to the sales of DARZALEX resulting in increased operating income and cash position.
MDKK Revised Guidance Previous Guidance
Revenue 1,200 — 1,250 975 — 1,025
Operating expenses (800) — (850) (800) — (850)
Operating income 375 — 425 150 — 200
Cash position at end of year* 3,650 — 3,750 3,550 — 3,650
*Cash, cash equivalents, and marketable securities

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