On August 8, 2019 Pacira BioSciences, Inc. (Nasdaq: PCRX), a leading provider of innovative non-opioid pain management options, reported financial results for the second quarter of 2019 (Press release, Pacira Pharmaceuticals, AUG 8, 2019, View Source;991.htm [SID1234538430]).

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"During the second quarter, we made meaningful progress across key areas including commercial, clinical and corporate. We delivered yet another quarter of outstanding results highlighted by continued strong top-line growth, the addition of the novel ioverao system to our commercial offering, and the enhancement of our leadership team with the addition of Max Reinhardt as our newly appointed President," said Dave Stack, chairman and chief executive officer of Pacira BioSciences. "We continue to see robust growth for EXPAREL (bupivacaine liposome injectable suspension) with growing penetration across a wide-range of soft tissue and orthopedic procedures and the shifting of inpatient procedures to the ambulatory setting through the expanding utilization of EXPAREL-based opioid-sparing protocols."

"Looking ahead, EXPAREL continues to be well positioned for long-term market leadership as the only opioid-free, long-acting, local and regional analgesic approved for infiltration, field blocks and interscalene brachial plexus nerve block. We are also pleased with the progress we have made integrating ioverao into our commercial offering, which is expected to deliver accelerating accretion beginning in the second half of 2020." added Mr. Stack.

Second Quarter 2019 Financial Results

Total revenues were $102.6 million in the second quarter of 2019, a 22 percent increase over the $84.1 million reported for the second quarter of 2018.

Total net product sales were $101.8 million in the second quarter of 2019, a 26 percent increase over the $80.7 million reported for the second quarter of 2018.

Net product sales of EXPAREL/bupivacaine liposome injectable suspension were $99.8 million in the second quarter of 2019, a 24 percent increase over the $80.7 million reported for the second quarter of 2018.

EXPAREL net product sales were $98.9 million in the second quarter of 2019, compared to $80.4 million in the second quarter of 2018. Sales of bupivacaine liposome injectable

suspension to a third-party licensee for use in animals were $0.9 million in the second quarter of 2019, compared to $0.3 million in the second quarter of 2018.

iovera° net product sales during the second quarter of 2019 were $2.0 million. Pacira began recognizing sales of iovera° in April 2019 after completing its acquisition of MyoScience, Inc., a privately held medical technology company.

Total operating expenses were $97.3 million in the second quarter of 2019, compared to $77.6 million in the second quarter of 2018.

GAAP net income was $2.7 million, or $0.06 per diluted share, in the second quarter of 2019, compared to $2.6 million, or $0.06 per diluted share, in the second quarter of 2018.

Non-GAAP net income was $17.5 million, or $0.41 per diluted share, in the second quarter of 2019, compared to $9.9 million, or $0.24 per diluted share, in the second quarter of 2018.

Pacira ended the second quarter of 2019 with cash, cash equivalents, short-term and long-term investments ("cash") of $317.6 million. Cash provided by operations was $22.8 million in the second quarter of 2019, compared to $13.7 million in the second quarter of 2018.

See "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP 2019 Financial Guidance" below.

Recent Business Highlights

Validation of EXPAREL Marketing Authorization Application from European Medicines Agency. In June, Pacira announced that the company’s Marketing Authorization Application (MAA) for EXPAREL for postsurgical analgesia was validated by the European Medicines Agency (EMA). With this validation, the Pacira application is complete and the EMA Committee for Medicinal Products for Human Use will now begin the review procedure with an opinion expected in the second half of 2020.

Appointment of former Johnson & Johnson executive, Max Reinhardt, as President. In June, Pacira announced the appointment of Max Reinhardt as the company’s president. Mr. Reinhardt will report to Dave Stack, chairman and chief executive officer of Pacira, and be responsible for overseeing all commercial and medical affairs functions at Pacira. Mr. Stack will maintain leadership of the overall Pacira corporate strategy.

New analysis shows use of EXPAREL associated with improved clinical and economic outcomes following hip replacement surgery. In June, Pacira announced new data on the use of EXPAREL following total hip arthroplasty (THA). The findings show that patients receiving EXPAREL had a significant reduction in opioid use, hospital length of stay and total hospitalization costs compared to THA patients who did not receive the product. The results were published in The Journal of Medical Economics.

Publication of pivotal study of EXPAREL as a single-dose interscalene brachial plexus nerve block in patients undergoing shoulder surgery. In June, Pacira announced the publication of its multinational Phase 3 study supporting the efficacy and safety of EXPAREL as a single-injection interscalene plexus nerve block in patients undergoing total shoulder arthroplasty or rotator cuff repair. The data, which provided the basis for FDA approval for this indication, were published in Pain Medicine.

Phase 4 study demonstrates superiority of EXPAREL plus bupivacaine versus bupivacaine alone in Cesarean Section procedures. In May 2019, Pacira announced full results from its Phase 4 study of EXPAREL administered via TAP field block in patients undergoing C-Section. EXPAREL achieved its primary endpoint with a statistically significant reduction in total postsurgical opioid consumption through 72 hours. EXPAREL also achieved statistical significance for reduction in pain intensity scores through 72 hours.

2019 Financial Guidance

Pacira updated its guidance for selling, general and administrative (SG&A) expense and reiterated its remaining guidance. For the full year 2019, the company currently expects:

EXPAREL net product sales in the range of $400 million to $410 million.

iovera° net product sales in the range of $8 million to $10 million.

Non-GAAP gross margins in the range of 75% to 76%.

Non-GAAP research and development (R&D) expense in the range of $60 million to $70 million.

Non-GAAP SG&A expense in the range of $180 million to $190 million versus the company’s previously guided range of $165 million to $175 million. Non-GAAP SG&A guidance was increased primarily due to the inclusion of commercial infrastructure costs for iovera°.

Stock-based compensation in the range of $30 million to $35 million.

On August 8, 2019 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a biopharmaceutical company focused on commercializing its novel tetracycline XERAVATM (eravacycline for injection) to treat serious and life-threatening infections, reported financial results for the second quarter ended June 30, 2019 (Press release, Tetraphase, AUG 8, 2019, View Source [SID1234538446]).

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"In the second quarter, we continued to work diligently to increase formulary uptake for XERAVA and are excited to report that strong month over month sales growth resulted in a 133% increase in XERAVA revenue compared with the previous quarter, with 154 new ordering customers in the second quarter," said Larry Edwards, President and Chief Executive Officer of Tetraphase. "During the quarter, we also undertook a corporate reorganization aimed at maximizing the commercial opportunity of our lead asset, XERAVA. XERAVA is a critically important new addition to the hospital antibiotic armamentarium, and as a newly streamlined organization, we are concentrating our efforts entirely on ensuring its commercial success. We believe the growth rate in XERAVA revenues will continue to be strong for the foreseeable future."

Second Quarter and Recent Highlights

Continued to Progress Launch of XERAVA in U.S. Hospitals With High Antibiotic Usage
The Company continues to see increased formulary uptake, with a 99.7% success rate for all formulary reviews to date. Tetraphase’s salesforce is now focusing on bringing XERAVA to both Tier 1 as well as Tier 2 institutions, which are the highest users of antibiotics defined by days of therapy. The reorder rate for XERAVA continues to be greater than 50%, with the reorder rates as high as 65% within the tier 1 account segment. XERAVA is available at over 500 accounts and approximately 300 formulary reviews are pending or planned to take place by the end of the fourth quarter of 2019.
Implemented Corporate Reorganization Aimed at Maximizing XERAVA Commercial Opportunity
In June, the Company announced a corporate reorganization, which included the elimination of the Company’s internal research function and an exploration of out-licensing opportunities for the Company’s pipeline of innovative early-stage antibiotic and oncology product candidates. As part of the reorganization, Larry Edwards, who previously served as Chief Operating Officer, was appointed President and Chief Executive Officer, effective August 1st. Mr. Edwards also joined the Board of Directors. Former President and CEO Guy Macdonald remains on the Board and will serve as a consultant to the Company into December 2019. The Company expects that the reorganization and other cost-saving efforts will result in an approximate $8.0 million reduction in net cash required for operating activities on an annualized basis.
Presented New Studies Highlighting Activity of XERAVA at the 2019 Surgical Infection Society (SIS) Congress and at the American Society for Microbiology (ASM) Microbe 2019 Annual Meeting
In June at the SIS Congress in Coronado, California, the Company presented positive data from three studies further evaluating XERAVA in complicated intra-abdominal infections (cIAI), as well as data from a retrospective study of hospital-based outcomes in cIAI, underscoring XERAVA’s role as an empiric treatment option for patients with this type of infection. Also in June, the Company presented new data from several studies at the American Society for Microbiology (ASM) Microbe 2019 Annual Meeting in San Francisco, highlighting the activity of XERAVA against gram-negative and gram-positive clinical isolates, including multidrug resistant pathogens.
First Patient Dosed in Phase 3 Clinical Trial of Eravacycline for cIAI in China
Everest Medicines Limited, which has the exclusive license to develop and commercialize eravacycline in China, dosed the first patient in its Phase 3 clinical trial of eravacycline for cIAI in China. The Phase 3, randomized, multicenter, double-blind, double-dummy, parallel-group, controlled study is designed to evaluate the efficacy, safety and tolerability of eravacycline versus ertapenem for the treatment of cIAI in hospitalized adult patients.
Expansion of Territories under the Everest Medicines License Agreement
In July 2019, the Company and Everest Medicines Limited entered into an amendment to the license agreement to extend Everest Medicines’ exclusive license to develop and commercialize eravacycline for cIAI to the jurisdictions of the Malaysian Federation, the Kingdom of Thailand, the Republic of Indonesia, the Socialist Republic of Vietnam and the Republic of the Philippines.
Second Quarter 2019 Financial Results

As of June 30, 2019, Tetraphase had cash and cash equivalents of $71.0 million and 54.3 million shares outstanding. The Company expects that its cash and cash equivalents, as well as expected revenue, will be sufficient to fund operations into the middle of the third quarter of 2020.

For the second quarter of 2019, Tetraphase reported a net loss of $22.9 million, or $0.42 per share, compared to a net loss of $9.5 million, or $0.18 per share, for the same period in 2018. The increased loss was largely due to a decrease in license and collaboration revenue and government revenue of $11.3 million in the second quarter of 2019 compared with the second quarter of 2018.

Revenues from sales of XERAVA were $0.8 million in the second quarter of 2019 compared with $0.3 million in the first quarter of 2019. Total revenues, including License and Collaboration Revenue and Government Revenue, were $1.1 million for the second quarter of 2019, compared to $11.6 million for the same period in 2018. Total revenues for the second quarter of 2019 consisted of XERAVA product revenue of $0.8 million as well government contract revenue of $0.3 million. The decrease in total revenues for the second quarter of 2019 compared to the same prior-year period was due to a decrease in both revenue from our collaboration with Everest Medicines and government revenue, offset in part by XERAVA revenue.

Research and development (R&D) expenses for the second quarter of 2019 were $8.2 million, compared to $14.4 million for the same period in 2018. The decrease in R&D expenses for the second quarter of 2019 compared to the same prior-year period was primarily due to a decrease in activity across all of our pipeline programs vs. the prior year, and lower license and milestone payments to Harvard University that occurred in the second quarter of 2018.

Selling, general and administrative (SG&A) expenses for the second quarter of 2019 were $15.1 million, compared to $7.2 million for the same period in 2018. This increase in SG&A expenses for the second quarter of 2019 compared to the same prior-year period was primarily due to an increase in commercial-related expenses for XERAVA.

Conference Call and Webcast Information

Tetraphase will host a conference call today at 4:30 p.m. ET to discuss its financial results and provide an update on the Company. The call can be accessed by 844-831-4023 (U.S. and Canada) or 731-256-5215 (international) and entering conference ID number 2336585. To access the live audio webcast, visit the "Investors — Events & Presentations" section of the Tetraphase website at www.tphase.com.

A replay of the conference call will be available from 7:30 p.m. ET on Thursday, August 8, 2019, through 7:30 p.m. ET on Thursday, August 15, 2019 by dialing and dialing 855-859-2056 (U.S. and Canada) and 404-537-3406 for (international) callers. The conference ID number is 2336585. A replay of the webcast will be available by visiting Tetraphase’s website.

About XERAVATM

XERAVA(eravacycline for injection) is a tetracycline class antibacterial indicated for the treatment of complicated intra-abdominal infections (cIAI) in patients 18 years of age and older. XERAVA was investigated for the treatment of cIAI as part of the Company’s IGNITE (Investigating Gram-Negative Infections Treated with Eravacycline) Phase 3 program. In the first pivotal Phase 3 trial in patients with cIAI, twice-daily intravenous (IV) XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to ertapenem and was well-tolerated. In the second Phase 3 clinical trial in patients with cIAI, twice-daily IV XERAVA met the primary endpoint by demonstrating statistical non-inferiority of clinical response compared to meropenem and was well-tolerated. In both trials, XERAVA achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.

XERAVATM Important Safety Information

XERAVA is a tetracycline class antibacterial indicated for the treatment of complicated intra‑abdominal infections in patients 18 years of age and older.

XERAVA is not indicated for the treatment of complicated urinary tract infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XERAVA and other antibacterial drugs, XERAVA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

XERAVA is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs or to any of the excipients. Life-threatening hypersensitivity (anaphylactic) reactions have been reported with XERAVA.

The use of XERAVA during tooth development (last half of pregnancy, infancy and childhood to the age of eight years) may cause permanent discoloration of the teeth (yellow-gray-brown) and enamel hypoplasia.

The use of XERAVA during the second and third trimester of pregnancy, infancy and childhood up to the age of eight years may cause reversible inhibition of bone growth.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis.

The most common adverse reactions observed in clinical trials (incidence ≥ 3%) were infusion site reactions, nausea, and vomiting.

XERAVA is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse reactions. Adverse reactions including photosensitivity, pseudotumor cerebri, and anti‑anabolic action which has led to increased blood urea nitrogen, azotemia, acidosis, hyperphosphatemia, pancreatitis, and abnormal liver function tests, have been reported for other tetracycline-class antibacterial drugs, and may occur with XERAVA. Discontinue XERAVA if any of these adverse reactions are suspected.

To report SUSPECTED ADVERSE REACTIONS, contact Tetraphase Pharmaceuticals Inc., at 1-833-7-XERAVA (1-833-793-7282) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.

On August 8, 2019 Coordination Pharmaceuticals Inc. (CPI), a privately-held oncology drug development company reported that the first patient has been dosed in a Phase 1 study of CPI-200 in patients with advanced tumors (Press release, Coordination Pharmaceuticals, AUG 8, 2019, View Source [SID1234538464]). CPI-200 is a novel nanoscale coordination polymer (NCP) containing two new molecular entities (NMEs) with synergistic antitumor activities. In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 is another NCP containing two synergistic NMEs to activate tumor microenvironments for combination therapy with an immune checkpoint inhibitor while RiMO-301 elicits unprecedented radiotherapy-radiodynamic therapy (RT-RDT) to enhance the efficacy of X-ray radiotherapy.

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"Initiation of this study represents a significant milestone for CPI as CPI-200 is the company’s third candidate to enter clinical studies in the past year," said Wenbin Lin, Ph.D., founder and chairman of RiMO and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We believe our two innovative technology platforms have the potential to change treatment paradigms for multiple cancer types and significantly benefit patients."

Dr. Lin and coworkers have pioneered the development of the NCP and RiMO technology platforms, publishing extensively on these novel nanotherapeutics. "We expect that this study will generate important insights about the safety and pharmacokinetics of CPI-200 and the synergistic actions of the two NMEs on patients’ tumors which no longer respond to standard therapies," said Everett Vokes, M.D., University of Chicago Medicine.

About the Studies

The Phase 1 study is a prospective, open-label, single-arm, non-randomized study of CPI-200 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary anti-tumor activity of CPI-200. For additional clinical trial details, please refer to View Source;rank=1.

For CPI-100 Phase I study: View Source;rank=1

For RiMO-301 Phase I study: View Source;rank=1

. CPI-200 is a novel nanoscale coordination polymer (NCP) containing two new molecular entities (NMEs) with synergistic antitumor activities. In addition, CPI is also conducting Phase 1 studies of CPI-100 and RiMO-301 on patients with advanced tumors. CPI-100 is another NCP containing two synergistic NMEs to activate tumor microenvironments for combination therapy with an immune checkpoint inhibitor while RiMO-301 elicits unprecedented radiotherapy-radiodynamic therapy (RT-RDT) to enhance the efficacy of X-ray radiotherapy.

"Initiation of this study represents a significant milestone for CPI as CPI-200 is the company’s third candidate to enter clinical studies in the past year," said Wenbin Lin, Ph.D., founder and chairman of RiMO and also the James Franck Professor of Chemistry, Radiation & Cellular Oncology, and the Ludwig Center for Metastasis Research at the University of Chicago. "We believe our two innovative technology platforms have the potential to change treatment paradigms for multiple cancer types and significantly benefit patients."

Dr. Lin and coworkers have pioneered the development of the NCP and RiMO technology platforms, publishing extensively on these novel nanotherapeutics. "We expect that this study will generate important insights about the safety and pharmacokinetics of CPI-200 and the synergistic actions of the two NMEs on patients’ tumors which no longer respond to standard therapies," said Everett Vokes, M.D., University of Chicago Medicine.

About the Studies

The Phase 1 study is a prospective, open-label, single-arm, non-randomized study of CPI-200 in patients with advanced tumors. The primary objectives in the study include determining maximum tolerated dose (MTD), pharmacokinetics and preliminary anti-tumor activity of CPI-200. For additional clinical trial details, please refer to View Source;rank=1.

For CPI-100 Phase I study: View Source;rank=1

For RiMO-301 Phase I study: View Source;rank=1

On August 8, 2019 DiaMedica Therapeutics Inc. (Nasdaq: DMAC) reported that its second quarter 2019 financial results will be released after the markets close on Tuesday, August 13th (Press release, DiaMedica, AUG 8, 2019, View Source [SID1234538496]). DiaMedica will host a live conference call on Wednesday, August 14th at 7:00am Central Time to discuss its business update and financial results.

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Conference Call details:

Date: Wednesday, August 14, 2019
Time: 7:00 AM CT / 8:00 AM ET
Web access: View Source
Dial In: (866) 962-3583 (domestic)
(630) 652-5857 (international)
Conference ID: 9274148
Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until August 21, 2019, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), replay passcode 9274148.

On August 8, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported its financial results for the second quarter ended June 30, 2019. As of June 30, 2019, cash equivalents and investments totaled $153.2 million (Press release, Calithera Biosciences, AUG 8, 2019, View Source [SID1234538415]).

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"In the second quarter, we achieved clinical proof of concept for our glutaminase inhibitor telaglenastat, with positive topline results of the randomized phase 2 ENTRATA study," said Susan Molineaux, PhD, president and chief executive officer of Calithera. "After completing a secondary offering in the quarter, we are well positioned to execute on our strategy and advance our pipeline forward. In the second half of the year, we look forward to completing enrollment in our registrational CANTATA trial evaluating telaglenastat for the treatment of patients with renal cell carcinoma, as well as presenting data from our arginase inhibitor program INCB001158."

Second Quarter 2019 and Recent Highlights

Achieved positive topline results in randomized Phase 2 ENTRATA study of telaglenastat (CB-839) with everolimus in renal cell carcinoma. The ENTRATA trial (NCT03163667) was a Phase 2 randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including at least one prior VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA was progression-free survival (PFS). The combination doubled the median PFS in heavily pretreated patients with advanced RCC. Telaglenastat, when added to everolimus, doubled the median PFS to 3.8 months as compared to 1.9 months for everolimus alone and reduced the risk of disease progression or death by 36% (HR=0.64, p=0.079 one-sided). The primary endpoint of the trial was PFS per investigator assessment with a predetermined threshold of p£0.2 one-sided. The secondary endpoint of overall survival is not yet mature.

Initiated Phase 1/2 clinical trial of telaglenastat in combination with palbociclib for solid tumors. The Phase 1/2 clinical trial is evaluating telaglenastat in combination with Pfizer’s CDK4/6 inhibitor palbociclib, also known as Ibrance. The study will evaluate the safety and anti-tumor activity of telaglenastat plus palbociclib in patients with KRAS-mutated colorectal cancer (CRC) and KRAS-mutated non-small cell lung cancer (NSCLC).

Advanced INCB001158 arginase inhibitor immuno-oncology program. INCB001158 is being evaluated in multiple clinical trials for the treatment of patients with cancer both as a monotherapy, and in combination with immunotherapies and chemotherapy. INCB001158 is being developed as part of a collaboration and license agreement with Incyte. Data from INCB001158 are expected to be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September.

Presented new preclinical data for CB-708 at AACR (Free AACR Whitepaper) Annual Meeting. CB-708 is a selective, oral inhibitor of CD73, an enzyme that synthesizes the immunosuppressive agent adenosine and is over expressed in multiple tumor types. By blocking adenosine production in the tumor, CB-708 is designed to enhance T-cell activation leading to anti-tumor activity. Calithera anticipates that CB-708 will enter clinical trials in the second half of 2019.

Completed public offering of common stock. In June 2019, Calithera completed an underwritten public offering of common stock. Gross proceeds from the offering, before underwriting discounts and commissions and offering expenses, were $57.5 million.

Selected Second Quarter 2019 Financial Results

Cash, cash equivalents and investments totaled $153.2 million at June 30, 2019.

Research and development expenses were $20.9 million for the three months ended June 30, 2019, compared with $17.3 million for the same period in the prior year. The increase of $3.6 million was primarily due to a $1.5 million increase in the telaglenastat program, including for the CANTATA trial, an increase of $1.5 million in the INCB001158 program, and an increase of $0.7 million in the CB-280 program, partially offset by a decrease of $0.1 million for investment in our early stage research programs.

General and administrative expenses were $4.0 million for the three months ended June 30, 2019, compared with $3.5 million for the same period in the prior year. The increase of $0.5 million was related to higher professional services costs.

Net loss for the three months ended June 30, 2019 was $24.2 million, or $0.58 per share.

Conference Call Information

Calithera will host an update conference call today, Thursday, August 8 at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time. The call may be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 and referring to conference ID 9239839. To access the live audio webcast or the subsequent archived recording, visit the Investors section of the Calithera website at www.calithera.com. The webcast will be recorded and available for replay on Calithera’s website for 30 days.