On February 20, 2020 Pacira BioSciences, Inc. (Nasdaq: PCRX) reported financial results for the fourth quarter and full-year of 2019 and provided 2020 financial guidance (Press release, Pacira Pharmaceuticals, FEB 20, 2020, View Source;991.htm [SID1234554551]).

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"By every measure, 2019 was an outstanding year for Pacira. We are delighted to report record revenues for EXPAREL with our sixth consecutive quarter of more than 20 percent growth," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "Demand has continued to mount within the anesthesia community as EXPAREL-based nerve and field blocks take hold as institutional protocol. Additionally, we enhanced our non-opioid pain management product portfolio with the addition of iovera° and we are seeing great interest from the marketplace around this innovative system."

"Looking forward, we intend to capitalize on this momentum with robust topline growth that will drive substantial operating leverage and cash flow, providing significant financial flexibility to invest in future growth opportunities. Our mission for 2020 remains steadfast as we continue to propel our global leadership in non-opioid pain management and deliver multiple milestones, including the publication of new data in C-section, label-expansion initiatives for pediatrics and lower extremity nerve block, and the advancement of regulatory activities in Europe, Canada, and China," added Mr. Stack.

2019 Full-Year and Fourth Quarter Financial Highlights

Full-year revenues of $421.0 million and fourth quarter revenues of $122.4 million.

Full-year EXPAREL (bupivacaine liposome injectable suspension) net product sales of $407.9 million and fourth quarter EXPAREL net product sales of $116.9 million.

Full-year iovera° net product sales were $7.9 million and fourth quarter iovera° net product sales of $3.2 million. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.

Full-year GAAP net loss of $11.0 million or $0.27 per share (basic and diluted).

Full-year non-GAAP net income of $70.7 million or $1.67 per diluted share.

Fourth quarter GAAP net loss of $4.9 million or $0.12 per share (basic and diluted).

Fourth quarter non-GAAP net income of $23.8 million or $0.56 per diluted share.

Recent Highlights

Launch of national regional anesthesia training initiative with Envision Physician Services.
In January 2020, Pacira announced a collaboration with Envision Physician Services to train anesthesiology clinicians on ultrasound-guided regional anesthesia techniques utilizing long-acting local anesthetics like EXPAREL via a series of interactive workshops held across the country. The program supports the ongoing efforts by both organizations to advance the delivery of high-quality, patient-centered care.

EXPAREL achieves primary and key secondary endpoints in Phase 4 CHOICE study in cesarean section patients. In January 2020, Pacira announced that its Phase 4 study of EXPAREL in patients undergoing Cesarean section achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption while maintaining pain scores through 72 hours (P≤0.001). EXPAREL demonstrated statistical significance for the key secondary endpoint of a reduction in the incidence and severity of itching for 72 hours after surgery (P≤0.05). Full study results will be submitted for publication in the peer-reviewed medical literature later this year.

Phase 3 PLAY study of EXPAREL in pediatric patients achieves positive results. In December 2019, Pacira announced positive results from its Phase 3 PLAY study of EXPAREL administered as a single-dose infiltration in pediatric patients undergoing spinal or cardiac surgeries. Overall findings were consistent with the pharmacokinetic and safety profiles for adult patients with no safety concerns identified at a dose of 4 mg/kg. These results will provide the foundation for the company’s supplemental New Drug Application submission in the first half of 2020 to the U.S. Food and Drug Administration (FDA) seeking expansion of the EXPAREL label to include children aged six and over.

Fourth Quarter 2019 Financial Results

Total revenues were $122.4 million in the fourth quarter of 2019, a 29% increase over the $95.1 million reported for the fourth quarter of 2018.

EXPAREL net product sales were $116.9 million in the fourth quarter of 2019, a 24% increase over the $94.4 million reported for the fourth quarter of 2018.

Fourth quarter iovera° net product sales were $3.2 million. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.

Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $1.7 million in the fourth quarter of 2019, compared to $0.3 million in 2018.

Fourth quarter royalty revenue was $0.6 million compared to $0.4 million in 2018.

Total operating expenses were $120.7 million in the fourth quarter of 2019, compared to $82.9 million in the fourth quarter of 2018.

Research and development (R&D) expenses were $19.7 million in the fourth quarter of 2019, compared to $14.2 million in the fourth quarter of 2018. The company’s R&D expenses include $8.7 million and $6.5 million of product development and manufacturing capacity expansion costs in the fourth quarters of 2019 and 2018, respectively.

Selling, general and administrative (SG&A) expenses were $54.2 million in the fourth quarter of 2019, compared to $44.6 million in the fourth quarter of 2018.

GAAP net loss was $4.9 million, or $0.12 per share (basic and diluted) in the fourth quarter of 2019, compared to GAAP net income of $8.3 million, or $0.20 per share (basic and diluted), in the fourth quarter of 2018.

Non-GAAP net income was $23.8 million, or $0.57 per share (basic) and $0.56 per share (diluted), in the fourth quarter of 2019, compared to non-GAAP net income of $19.8 million, or $0.48 per share (basic) and $0.47 per share (diluted), in the fourth quarter of 2018.

Pacira had 41.8 million basic weighted average shares of common stock outstanding in the fourth quarter of 2019.

For non-GAAP measures, Pacira had 42.6 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2019.

Full-Year 2019 Financial Results

Total revenues were $421.0 million in 2019, a 25% increase over the $337.3 million reported in 2018.

EXPAREL net product sales were $407.9 million in 2019, a 23% increase over the $331.1 million reported in 2018.

Full-year iovera° net product sales were $7.9 million. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.

Sales of bupivacaine liposome injectable suspension to a third-party licensee for use in veterinary practice were $3.2 million in 2019, compared to $1.3 million in 2018.

Full-year royalty revenue was $2.1 million compared to $1.9 million in 2018.

Total operating expenses were $410.5 million in 2019, compared to $321.4 million in 2018.

Research and development (R&D) expenses were $72.1 million in 2019, compared to $55.7 million in 2018. The company’s R&D expenses include $29.7 million and $28.5 million of product development and manufacturing capacity expansion costs in 2019 and 2018, respectively.

Selling, general and administrative (SG&A) expenses were $200.8 million in 2019, compared to $177.3 million in 2018.

GAAP net loss was $11.0 million, or $0.27 per share (basic and diluted) in 2019, compared to a GAAP net loss of $0.5 million, or $0.01 per share (basic and diluted) in 2018.

Non-GAAP net income was $70.7 million, or $1.70 per share (basic) and $1.67 per share (diluted), in 2019, compared to non-GAAP net income of $43.5 million, or $1.06 per share (basic) and $1.04 per share (diluted), in 2018.

Pacira ended 2019 with cash, cash equivalents, short-term and long-term investments ("cash") of $356.7 million. Cash provided by operations was $70.5 million in 2019, compared to $48.9 million in 2018.

Pacira had 41.5 million basic weighted average shares of common stock outstanding in 2019.

For non-GAAP measures, Pacira had 42.4 million diluted weighted average shares of common stock outstanding in 2019.

2020 Outlook
Pacira announces its full-year 2020 financial guidance as follows. Pacira expects:

Total revenues to be between $485 million and $500 million

EXPAREL net product sales to be between $465 million and $475 million;

iovera° net product sales to be between $15 million and $20 million;

Non-GAAP gross margins to be between 76% and 78%;

Non-GAAP research and development (R&D) expense to be between $60 million to $70 million;

Non-GAAP selling, general and administrative (SG&A) expense to be between $180 million and $190 million; and

Stock-based compensation to be between $35 million and $40 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2020 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, February 20, 2020, at 8:30 a.m. ET. To participate in the conference call, dial 1-877-845-0779 and provide the passcode 8765839. 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 8765839. 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, non-GAAP net income 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; acquisition-related charges, product discontinuation costs and other expense; stock-based compensation; amortization of debt discount; amortization of acquired intangible assets; an income tax benefit and step-up in basis of inventory in connection with the acquisition of MyoScience, Inc.; and loss on investment and other non-operating income.

These measures supplement Pacira’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 2020 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 its 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 2020 financial guidance for gross margins, R&D expense and SG&A expense.

On February 20, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and leader in predictive target discovery, reported its plan to initiate a Phase 1/2 study evaluating a triple combination of Compugen’s COM701, an investigational anti-PVRIG antibody, in combination with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor Opdivo (nivolumab) and BMS-986207, Bristol-Myers Squibb’s investigational anti-TIGIT antibody (Press release, Compugen, FEB 20, 2020, View Source [SID1234554585]).

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The triple combination study is designed to evaluate the blockade of the three immune checkpoint pathways – PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s science-driven DNAM axis hypothesis in various advanced solid tumors. The study is expected to commence in the second half of 2020, following the clearance of a new Investigational New Drug Application by the U.S. Food and Drug Administration. Compugen will be the study sponsor with Opdivo and BMS-986207 supplied by Bristol-Myers Squibb.

"We are excited to expand our collaboration with Bristol-Myers Squib with this biomarker-informed triple combination study to accelerate the clinical evaluation of COM701," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The triple combination regimen allows us to ultimately test our science-driven hypothesis that the dual inhibition of the DNAM axis with PVRIG and TIGIT blockers, together with the inhibition of the PD-1 pathway, will enable robust activation of T cells leading to anti-tumor immune responses in cancer patients who are non-responsive or refractory to PD-1 blockers."

"The initial encouraging signals of anti-tumor activity observed in heavily pretreated patients in the monotherapy dose escalation arm of our ongoing Phase 1 study, paired with our strong scientific rationale and preclinical data, support to our decision to evaluate whether the combination of these three immune checkpoint inhibitors improve patient outcomes and broaden the patient population that will respond to immunotherapies," added Dr. Cohen-Dayag.

Under the existing collaboration with Bristol-Myers Squibb, COM701 is being investigated as a monotherapy and in combination with Opdivo in an ongoing Phase 1 study. Following the Companies’ joint decision to move forward with a triple combination study, Compugen will complete the dose escalation arm of the dual combination of COM701 with Opdivo under its ongoing Phase 1 study. Future studies evaluating COM701 in combination with a PD-1 inhibitor in specific tumor types will be assessed at a later date. As previously indicated, Compugen plans to present initial data from the combination dose escalation study of COM701 with Opdivo in the second half of 2020. Compugen will continue to advance the biomarker informed monotherapy expansion arm of the ongoing COM701 Phase 1 study, as planned.

The planned open-label Phase 1/2 trial is designed to evaluate the safety, tolerability and antitumor activity of COM701 in combination with Opdivo and BMS-986207. The study will evaluate a safe and tolerable dose of the combination during dose escalation and antitumor activity in selected tumor types in the expansion cohorts (ovarian cancer, endometrial cancer and a biomarker-driven arm of tumor types with high expression of PVRL2). Dose levels for Opdivo and BMS-986207 combinations have already been determined through prior testing by Bristol-Myers Squibb, allowing for dose escalation of COM701 with fixed doses of Opdivo and BMS‑986207.

About COM701

COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, blocking the interaction with its ligand, PVRL2. Blockade of PVRIG by COM701 has demonstrated potent, reproducible enhancement of T cell activation, consistent with the desired mechanism of action of activating T cells in the tumor microenvironment to generate anti-tumor immune responses. PVRIG and TIGIT, also discovered by Compugen’s computational discovery platform in 2009, constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory molecule on T cells and NK cells. As such, preclinical data suggest that the inhibition of PVRIG together with TIGIT and/or PD-1 has the potential to further enhance anti-tumor immune response and improve patient outcomes in a broad variety of tumor types.

COM701 is being evaluated as a monotherapy and in combination with Opdivo (nivolumab), Bristol-Myers Squibb’s PD-1 inhibitor in a Phase 1 open-label clinical trial in patients with advanced solid tumors. Primary end points of the trial are safety and tolerability; secondary endpoints include preliminary anti-tumor activity, pharmacokinetics and pharmacodynamics in patients with selected tumor types. Data from the monotherapy dose escalation study (n=13) presented at SITC (Free SITC Whitepaper) 2019 showed that COM701 is well-tolerated and demonstrated preliminary signs of anti-tumor activity in heavily pretreated patient population Additional information is available at www.clinicaltrials.gov (NCT03667716).

Conference Call and Webcast Information

Compugen management will hold a conference call today, February 20, 2020, at 8:30 AM ET. To access the conference call by telephone, please dial 1-888-407-2553 from the United States, or +972-3-918-0610 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

On February 20, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported that it has received an independent assessment of the absence of cardiotoxicity in patients treated with Annamycin in both its US and European open label and single arm Phase 1 clinical trials (Press release, Moleculin, FEB 20, 2020, View Source [SID1234554627]). Data from the first 5 patients in the US and the first 9 patients in Europe were made available to an expert in chemotherapy who is affiliated with a leading cancer research institute in assessing cardiotoxicity. After review of this data, the independent expert concluded that he "does not see evidence of cardio-toxicity."

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

The data made available included left ventricular ejection fraction (LVEF) as determined by echocardiograms, ECHO strain imaging, and Troponin levels. For a small population of patients, ECHO strains were not provided due to the limitations of delivery of such data by the clinical sites. "ECHO strain imaging" is a method in echocardiography (medical ultrasound) for measuring regional or global deformation of the myocardium (heart muscle). By strain rate imaging, the simultaneous function of different regions can be displayed and measured. Cardiac health biomarkers such as blood Troponin levels are considered an indicator of potential long-term heart damage.

"We are pleased to receive this independent assessment which further validates the absence of cardiotoxicity in patients to date of Annamycin," stated Wally Klemp, Chairman and CEO of Moleculin. "Currently approved anthracyclines are notoriously cardiotoxic, so demonstrating that Annamycin is not cardiotoxic, even in patients who have received more than the lifetime maximum cumulative anthracycline exposure established by the FDA, supports our claim that Annamycin is truly in a class by itself, and indeed a ‘Next Generation’ anthracycline." He continued, "We are excited to continue to demonstrate Annamycin’s excellent safety profile. We believe continuing to demonstrate the lack of cardiotoxicity, along with initial efficacy data shown while increasing the dosage to a therapeutic level, will make Annamycin an extremely promising new drug candidate."

On February 20, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers, reported new clinical data from pre-planned interim analyses of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) and data from a dose escalation study of AGEN1181, a novel multi-functional enhanced CTLA-4 antibody (Press release, Agenus, FEB 20, 2020, View Source [SID1234554552]).

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The interim analysis from 34 evaluable patients treated with the combination of balstilimab (anti-PD-1) and zalifrelimab (anti-CTLA-4) demonstrated a 20.6% overall response rate (ORR), which included a complete response (CR) rate of 8.8% in second-line cervical cancer. The interim analysis from 44 evaluable patients treated with balstilimab monotherapy demonstrated an ORR of 11.4% in second-line cervical cancer. The clinical activity observed in both studies are comparable to other agents in these therapeutic classes. Both balstilimab monotherapy and the combination of balstilimab and zalifrelimab were well-tolerated with no new safety signals.

Additionally, early clinical data from a dose-escalation study of AGEN1181 revealed a confirmed CR in a patient with a difficult-to-treat, PD-L1 negative, microsatellite stable, endometrial cancer. The patient was treated with a low dose of AGEN1181 (1 mg/kg) and had failed prior treatment with a PD-1 inhibitor. Additionally, stable disease was noted in the majority of patients treated. AGEN1181 monotherapy was well-tolerated. Balstilimab, zalifrelimab and AGEN1181 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.

Details for today’s Investor Day:

Date:

Thursday, February 20, 2020

Time:

9:00 – 11:00AM

Location:

New York, NY (by invitation only)

Link to Webcast

Presenters will include global experts in immune-oncology, Dr. Chuck Drake, Co-Director, Cancer Immunotherapy Program, Columbia University Herbert Irving Comprehensive Cancer Center, and Dr. Bradley Monk, M.D., FACS, FACOG, Co‐Director of GOG Partners, Arizona Oncology (US Oncology Network) and Professor, Gynecologic Oncology at University of Arizona, and Creighton University, Medical Director of US Oncology Research Gynecology program in Phoenix, Arizona.

The event will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website at www.agenusbio.com or by using the link below. A replay of the webcast, as well as a copy of the slide presentations that will be presented at the event, will be available on the Agenus website following the event.

On February 20, 2020 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that it will host a conference call and audio webcast on Thursday, February 27, 2020 at 3:00 pm CET (9:00 am ET) to discuss its 2019 financial results and provide a fourth quarter business update (Press release, argenx, FEB 20, 2020, View Source [SID1234554569]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To participate in the conference call, please select your phone number below and use the confirmation code 2484158. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

A replay of the webcast will also be available at the argenx website.