On November 1, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported that the Company will present clinical data and preclinical research at the 60th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), taking place December 1st through 4th in San Diego, Calif (Press release, Magenta Therapeutics, NOV 1, 2018, View Source [SID1234530654]). Preliminary data in these abstracts became available on the ASH (Free ASH Whitepaper) conference website at 9:00 a.m. ET today. The Company also provided an update today on its ongoing Phase 2 study of MGTA-456 in inherited metabolic disorders, including recent data from the study.

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ASH Abstracts
"Magenta is developing potentially transformative drugs to broaden the reach of one-time, curative cell therapies – including bone marrow transplant, haploidentical transplant, cell and gene therapy and genome editing – to more patients with devastating diseases, including blood cancers, genetic diseases and autoimmune diseases," said Jason Gardner, D.Phil., president, chief executive officer and co-founder, Magenta Therapeutics. "This year’s nine data presentations at ASH (Free ASH Whitepaper) highlight our patient conditioning, mobilization and stem cell expansion programs, giving further insight into our progress in addressing the major unmet needs of the transplant process, including toxic conditioning regimens, inadequate stem cell mobilization and low cell doses. We anticipate building on this progress over the coming year as we move our mobilization program into the clinic and advance our clinical development plan for stem cell expansion in multiple diseases."

Conditioning Programs

CD117-Amanitin Antibody Drug Conjugates Effectively Deplete Human and Non-Human Primate HSCs: Proof of Concept as a Targeted Strategy for Conditioning Patients for Bone Marrow Transplant, Abstract #3314

Presenter: Brad Pearse, Ph.D., Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Session Date: Sunday, December 2, 2018
Session Time: 6:00 PM – 8:00 PM
Room: San Diego Convention Center, Hall GH

Targeting CD45 with an Amanitin Antibody-Drug Conjugate Effectively Depletes Human HSCs and Immune Cells for Transplant Conditioning, Abstract #4526

Presenter: Rahul Palchaudhuri, Ph.D., Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster III
Session Date: Monday, December 3, 2018
Session Time: 6:00 PM – 8:00 PM
Room: San Diego Convention Center, Hall GH

Single Doses of Antibody Drug Conjugates (ADCs) Targeted to CD117 or CD45 Have Potent In Vivo Anti-Leukemia Activity and Survival Benefit in Patient Derived AML Models, Abstract #3316

Presenter: Jennifer Proctor, Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Session Date: Sunday, December 2, 2018
Session Time: 6:00 PM – 8:00 PM
Room: San Diego Convention Center, Hall GH

Antibody Drug Conjugates Targeted to CD45 or CD117 Enable Allogeneic Hematopoietic Stem Cell Transplantation in Animal Models, Abstract #3324

Presenter: Rahul Palchaudhuri, Ph.D., Magenta Therapeutics
Session Name: 701. Experimental Transplantation: Basic Biology, Pre-Clinical Models: Poster II
Date: Sunday, December 2, 2018
Presentation Time: 6:00 PM – 8:00 PM
Location: San Diego Convention Center, Hall GH

Non-genotoxic conditioning facilitates robust HSPC engraftment and multi-lineage development in a dose dependent manner in Fanconi anemia

Presenter: Meera Srikanthan, Ph.D., Fred Hutchinson Cancer Research Center
Session Name: TBA
Date: TBA
Presentation Time: TBA
Location: TBA

Preclinical Data, Stem Cell Mobilization Program

MGTA-145 in Combination with Plerixafor Rapidly Mobilizes High Numbers of Hematopoietic Stem Cells and Graft-Versus-Host Disease Inhibiting Myeloid-Derived Suppressor Cells in Non-Human Primates, Abstract #116

Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics
Session Name: 711. Cell Collection and Processing I
Session Date: Saturday, December 1, 2018
Session Time: 9:30 AM – 11:00 AM
Presentation Time: 9:45 AM
Room: Manchester Grand Hyatt San Diego, Grand Hall A

Clinical Data, MGTA-456 Stem Cell Expansion Program

Preliminary Phase 2 Results Demonstrate Engraftment with Minimal Neutropenia with MGTA-456, a CD34+ Expanded Cord Blood Product in Patients Transplanted for Inherited Metabolic Disorders, Abstract #3467

Presenter: John Wagner, M.D., Director, Blood and Marrow Transplantation Division, University of Minnesota
Session Name: 732. Clinical Allogeneic Transplantation: Results: Poster II
Session Date: Sunday, December 2, 2018
Session Time: 6:00-8:00 p.m. PT
Room: San Diego Convention Center, Hall GH

MGTA-456 Contains Large Numbers of Expanded Cord Blood (CB) CD34+CD90+ Hematopoietic Stem Cells (HSC) Which Confer All Engraftment Activity and Correlate with Accelerated Neutrophil Recovery after Myeloablative Conditioning in Patients with Hematologic Malignancy, Abstract #2083

Presenter: Tony Boitano, Ph.D., Magenta Therapeutics
Session Name: 721 Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities
Session Date: Saturday, December 1, 2018
Session Time: 6:15-8:15 p.m. PTRoom: San Diego Convention Center, Hall GH

Preclinical Data, MGTA-456 Stem Cell Expansion Program

MGTA-456, A First-in-Class Cell Therapy Produced from a Single Cord Blood Unit, Enables A Reduced Intensity Conditioning Regimen and Enhances Speed and Level of Human Microglia Engraftment in the Brains of NSG Mice, Abstract #115

Presenter: Kevin Goncalves, Ph.D., Magenta Therapeutics
Session Name: 711. Cell Collection and Processing
Session Date: Saturday, December 1, 2018
Presentation Time: 9:30 a.m. PT
Room: San Diego Convention Center, Grand Hall A

MGTA-456 Clinical Development Update

MGTA-456 is a cell therapy providing a high dose of hematopoietic stem cells that are well-matched to the patient, administered through a transplant procedure. The ongoing Phase 2 study in inherited metabolic disorders aims to enroll 12 patients with Hurler’s syndrome, cerebral adrenoleukodystrophy (cALD), metachromatic leukodystrophy or globoid cell leukodystrophy. The primary endpoint is engraftment after transplantation and the secondary endpoint is transplant-related safety and tolerability.

The data as of October 22, 2018 show:

Five patients treated and evaluable: three with Hurler’s syndrome, two with cALD
Five of five patients treated with MGTA-456 met the primary endpoint of successful engraftment by day 42 following the transplant procedure.
In recent historical cohorts of patients undergoing regular cord blood transplantation with identical pre-transplant conditioning, up to 32% did not engraft at comparable time points.
The patients treated with MGTA-456 had minimal neutropenia, lasting for a median of 1 day.
In the historical cohort, neutropenia lasted for a median of 8 days.
Two patients less than 2 years of age with Hurler’s syndrome treated with MGTA-456 in the Magenta study developed autoimmune cytopenia, a known and frequent complication of transplant in these younger patients and patients with Hurler’s syndrome.
The first patient subsequently died from this complication. This was determined to be not related to the MGTA-456 product.
The second patient is currently undergoing treatment for the autoimmune cytopenia.
"Blood stem cell transplantation remains the standard of care for inherited metabolic disorders, which if untreated are generally progressive and lethal. Unfortunately, transplantation remains a difficult and complex procedure," said Paul Orchard, M.D., Medical Director of the Inherited Metabolic & Storage Disease Bone Marrow Transplantation Program, University of Minnesota and principal investigator in the MGTA-456 study. "Many patients experience significant and life-threatening complications, such as dysregulation of the immune system following transplantation, including the emergence of antibodies to components of the blood system. Patients with inherited metabolic disorders, particularly patients with Hurler’s syndrome, are at higher risk for these antibody-associated cytopenias. In a prior transplant protocol using the identical combination of chemotherapy agents for pre-transplant conditioning, evidence of cytopenias was present in 9 of 15 patients under 2 years of age (53%). This has proven less common in older patients."

In light of the elevated incidence of autoimmune cytopenias in very young patients and patients with Hurler’s syndrome, the Company announced today that it has voluntarily focused future enrollment towards pediatric patients older than 2 years of age diagnosed with leukodystrophies. The Company plans to continue enrolling patients with leukodystrophies in the study.

"MGTA-456 is a first-in-class cell therapy with high doses of stem cells, and larger doses of stem cells are correlated with more successful transplant outcomes and faster time to engraftment and immune recovery. It has demonstrated engraftment and robust immune recovery in all 41 evaluable patients that have been treated to date in our Phase 2 study in inherited metabolic disorders and our Phase 1/2 study in blood cancers," said John Davis, M.D., M.P.H., chief medical officer, Magenta Therapeutics. "We are developing MGTA-456 for patients with a broad range of diseases, including leukodystrophies, sickle cell disease and blood cancers, where we believe it has the potential to deliver transformative benefit."

The Company is on track to initiate a Phase 2 study of MGTA-456 in patients with sickle cell disease in the first half of 2019, and an investigator-initiated Phase 2 study in blood cancers is on track to start in 2018.

On November 1, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that an abstract with data pertaining to the use of the Company’s investigational immuno-oncology molecule, indoximod, in combination therapy for patients with newly diagnosed acute myeloid leukemia (AML) has been accepted for an oral presentation at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition to be held at the San Diego Convention Center, San Diego, CA, December 1-4th, 2018 (Press release, NewLink Genetics, NOV 1, 2018, View Source [SID1234530681]).

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"We are pleased to have an abstract accepted for oral presentation at this year’s ASH (Free ASH Whitepaper) Annual Meeting," said Charles J. Link, Jr, MD, Chairman and Chief Executive Officer. "Our updated Phase 1 data for indoximod plus standard-of-care chemotherapy support the potential for improved outcomes for newly diagnosed AML patients."

Abstract #332 entitled, Indoximod combined with standard induction chemotherapy is well tolerated and induces a high rate of complete remission with MRD-negativity in patients with newly diagnosed AML: results from a Phase 1 trial, Emadi, A., et al, to be presented during oral session 616 entitled, "Acute Myeloid Leukemia: Novel Therapy, excluding Transplantation: Combination Therapy," on Sunday, December 2, 2018, from 9:30-11:00 AM PT, at the ASH (Free ASH Whitepaper) Annual Meeting
As of July when the abstract was submitted, 31 newly diagnosed AML patients were consented, with 25 included in the intent-to-treat (ITT) analysis, and 19 meeting qualifications for the per-protocol (PP) analysis. Per-protocol patients were defined as those who took at least 80% of the scheduled indoximod doses. Of 25 ITT patients, 21 (84%) achieved complete response (CR), and 15 of 19 PP patients (79%) achieved CR. Twelve of the 15 PP CR patients had a minimal residual disease (MRD) sample submitted at the end of induction at the time of abstract submission. MRD negativity was defined by a flow cytometry assay at a level of < 0.02% (Hematologics, Inc., Seattle, WA). Ten of these 12 patients (83%) were MRD negative. As to the other three patients, 2 died of complications of AML treatment prior to a MRD marrow sample being submitted while one patient’s results were pending. Of the 12 patients who had MRD samples submitted at the end of induction, one patient went directly to bone marrow transplant without undergoing consolidation therapy and was therefore taken off protocol. Of the remaining 11 patients, all 11 (100%) were MRD negative at the end of consolidation, the pre-specified endpoint of the protocol.

Data from the abstract suggest that a high percentage of newly diagnosed AML patients treated with indoximod plus standard-of-care (SOC) chemotherapy achieved CR and showed no evidence of minimal residual disease, or were MRD negative. In addition, data show that indoximod was well tolerated.

The abstract may be found on the ASH (Free ASH Whitepaper) Annual Meeting website.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target, suppressing immune response and allowing for immune escape by degrading tryptophan with the resultant production of kynurenine. Indoximod reverses the immunosuppressive effects of low tryptophan and high kynurenine through mechanisms that include modulation of the AhR-driven transcription of genes that control immune function. This results in increased proliferation of effector T cells, increased differentiation into helper T cells rather than regulatory T cells, and downregulation of IDO expression in dendritic cells. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications including recurrent pediatric brain tumors, DIPG, and AML.

On November 1, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that abstracts highlighting two of the Company’s experimental ADC therapies, IMGN779 and IMGN632, have been accepted for presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 1-4 in San Diego, California (Press release, ImmunoGen, NOV 1, 2018, View Source [SID1234530514]).

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Both IMGN779 and IMGN632 use ImmunoGen’s novel indolino-benzodiazepine payloads called IGNs, which alkylate DNA without crosslinking. IGNs have been designed to have high potency against acute myeloid leukemia (AML) blasts, while demonstrating less toxicity to normal marrow progenitors than other DNA-targeting payloads.1 IMGN779 is a next-generation anti-CD33 ADC for the treatment of AML, currently in Phase 1 testing. IMGN632 is a CD123-targeting ADC for hematological malignancies, including AML and blastic plasmacytoid dendritic cell neoplasm (BPDCN), and is also in Phase 1 testing.

In an oral presentation, safety and anti-leukemia activity findings from the ongoing dose escalation study of IMGN779 in patients with relapsed or refractory AML will be reported. In a separate oral presentation, initial safety and anti-leukemia activity findings from the dose escalation stage of the first-in-human trial of IMGN632 will be reported. Preclinical data related to IMGN632 will also be presented in poster sessions.

ORAL PRESENTATIONS

Title (Abstract #26): "Maturing Clinical Profile of IMGN779, a Next-Generation CD33-Targeting Antibody-Drug Conjugate, in Patients with Relapsed or Refractory Acute Myeloid Leukemia"
Oral session 613: Saturday, December 1, 2018, 7:45am PST
Title (Abstract #27): "A Phase I, First-in-Human Study Evaluating the Safety and Preliminary Antileukemia Activity of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate, in Patients with Relapsed/Refractory Acute Myeloid Leukemia and Other CD123-Positive Hematologic Malignancies"
Oral session 613: Saturday, December 1, 2018, 8:00am PST.
POSTER SESSIONS

Title (Abstract #2647): "Synergistic anti-leukemia activity of PARP inhibition combined with IMGN632, an anti-CD123 antibody-drug conjugate in acute myeloid leukemia models"
Poster session 604: Sunday, December 2, 2018, 6:00-8:00pm PST
Title (Abstract #3956): "Pre-clinical efficacy of CD123-targeting antibody-drug conjugate IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) models"
Poster session 605: Monday, December 3, 2018, 6:00-8:00pm PST
Additional information can be found at www.hematology.org, including abstracts.

ABOUT IGNs

Indolino-benzodiazepine cancer-killing agents, or IGNs, are a new class of cancer-killing agent developed by ImmunoGen for use in ADCs. These ultra-potent, DNA-acting IGNs alkylate DNA without crosslinking, which preclinically has resulted in potent anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells.

ABOUT IMGN779

IMGN779 is a novel ADC that combines a high-affinity, humanized anti-CD33 antibody, a cleavable disulfide linker, and one of ImmunoGen’s novel indolino-benzodiazepine payloads, called IGNs, which alkylate DNA without crosslinking, resulting in potent preclinical anti-leukemia activity with relative sparing of normal hematopoietic progenitor cells. IMGN779 is in Phase 1 clinical testing for the treatment of AML.

ABOUT IMGN632

IMGN632 is a novel, anti-CD123 antibody-drug conjugate that is a potential treatment for AML, BPDCN, and other CD123-positive malignancies. IMGN632 uses a novel humanized anti-CD123 antibody coupled via a peptide linker to a unique DNA-alkylating IGN payload. In preclinical models, IMGN632 has exhibited potent antitumor activity with a wide therapeutic index in AML, BPDCN, and acute lymphoblastic leukemia (ALL). IMGN632 is in Phase 1 clinical testing for the treatment of AML and BPDCN.

On November 1, 2018 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported it will host a teleconference and webcast with management to discuss the third quarter 2018 financial results, provide an update on the company’s business, and discuss expectations for the future on Thursday, November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific (Press release, Spectrum Pharmaceuticals, NOV 1, 2018, View Source [SID1234530530]).

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Conference Call

Thursday, November 8, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific

Domestic: (877) 837-3910, Conference ID# 3075918
International: (973) 796-5077, Conference ID# 3075918
For interested individuals unable to join the call, a replay will be available from November 8, 2018 @ 7:30 p.m. ET/4:30 p.m. PT through November 15, 2018 until 11:59 p.m. ET/8:59 p.m. PT.

Domestic Replay: (855) 859-2056, Conference ID# 3075918
International Replay: (404) 537-3406, Conference ID# 3075918
This conference call will also be webcast. Listeners may access the webcast, which will be available on the investor relations page of Spectrum Pharmaceuticals’ website: View Source on November 8, 2018 at 4:30 p.m. Eastern/1:30 p.m. Pacific.

On November 1, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) reported consolidated financial results for the third quarter ended September 30, 2018 (Press release, Pacira Pharmaceuticals, NOV 1, 2018, View Source;p=irol-newsArticle&ID=2374725 [SID1234530546]).

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"As evident from these financial results, EXPAREL continues to deliver impressive sales growth with physicians having great success delivering targeted, long-acting, opioid-free local or regional analgesia for postsurgical pain in a variety of procedures," said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. "Specifically we are seeing great enthusiasm around the use of EXPAREL as a brachial plexus nerve block and an increasing number of anesthesiologists incorporating EXPAREL into their suite of postsurgical pain solutions by expanding its use in newer regional anesthesia techniques, such as transverse abdominis, pectoralis and fascial iliaca plane blocks. In addition, our highly successful partnership with Johnson & Johnson remains a key growth driver as we integrate EXPAREL into multiple joint marketing programs, including a new initiative that will feature EXPAREL and TYLENOL as a platform for opioid-free postsurgical pain relief. Overall we are very pleased to be increasing our financial guidance for the second time this year."

"Looking forward we expect various initiatives to expand access to EXPAREL, particularly the assignment of new ambulatory care and dental reimbursement codes at the beginning of 2019, as well as increasing public and private payer recognition of the need for non-opioid pain relief following surgery."

Third Quarter 2018 Financial Results

EXPAREL net product sales were $82.2 million in the third quarter of 2018, a 23% increase over the $66.8 million reported for the third quarter of 2017.

Total operating expenses were $79.4 million in the third quarter of 2018, compared to $70.9 million in the third quarter of 2017.

GAAP net loss was $0.6 million, or $(0.02) per share (basic and diluted), in the third quarter of 2018, compared to a GAAP net loss of $7.6 million, or $(0.19) per share (basic and diluted), in the third quarter of 2017.

Non-GAAP net income was $12.8 million, or $0.31 per share (basic and diluted) in the third quarter of 2018, compared to non-GAAP net income of $4.4 million, or $0.11 per share (basic and diluted) in the third quarter of 2017.

Pacira ended the third quarter of 2018 with cash, cash equivalents and short-term investments ("cash") of $386.4 million.

Pacira had 41.0 million basic weighted average shares of common stock outstanding in the third quarter of 2018.

Pacira had 42.0 million diluted weighted average shares of common stock outstanding in the third quarter of 2018.
2018 Financial Guidance

Today, the company is increasing its full-year 2018 guidance for EXPAREL net product sales and improving its guidance for non-GAAP gross margins. The remainder of the company’s guidance remains unchanged from the ranges previously provided in August 2018. A summary of Pacira’s full-year 2018 financial guidance is outlined below.

EXPAREL net product sales of $325 million to $330 million.

Non-GAAP gross margins of 74% to 75%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 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, Thursday, November 1, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 1988603. International callers may dial 1-720-545-0035 and use the same passcode. In addition, a live audio of the conference call will be available as a webcast. Interested parties can access the event through the "Events" page on the Pacira website at investor.pacira.com.

For those unable to participate in the live call, a replay will be available at 1-855-859-2056 (domestic) or 1-404-537-3406 (international) using the passcode 1988603. The replay of the call will be available for one week from the date of the live call. The webcast will be available on the Pacira website for approximately two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income (loss), non-GAAP net income (loss) per share, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude milestone revenue, stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, exit costs related to the discontinuation of DepoCyt(e) production and loss on an unexercised investment purchase option.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2018 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2018 financial guidance for gross margins, R&D expense and SG&A expense.