On August 6, 2019 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported financial results for the second quarter of 2019 and updated 2019 financial guidance (Press release, Jazz Pharmaceuticals, AUG 6, 2019, View Source [SID1234538229]).

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"2019 has been notable for significant execution and accomplishments across all aspects of our business, including strong financial results, the U.S. launch of Sunosi and further expansion and diversification of our development pipeline through internal and acquired R&D programs," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "In the second half of the year, we are focused on continuing to deliver innovative therapies to patients and value to shareholders by preparing to file an NDA for JZP-258, our novel oxybate product candidate, advancing our R&D programs and planning for the potential approval of solriamfetol in the EU."

"We look forward to initiating multiple Vyxeos studies and to working with the Children’s Oncology Group to initiate a pivotal Phase 2/3 study this year for JZP-458, our recombinant crisantaspase product candidate for the treatment of acute lymphoblastic leukemia," said Robert Iannone, M.D., M.S.C.E., executive vice president, research and development, of Jazz Pharmaceuticals. "With the addition of the pan-RAF inhibitor program and our exosome therapeutics collaboration, we continue to grow and diversify our R&D pipeline."

Financial Highlights

Three Months Ended
June 30,

Six Months Ended
June 30,

(In thousands, except per share amounts and percentages)

2019

2018

Change

2019

2018

Change

Total revenues

$

534,133

$

500,479

7%

$

1,042,319

$

945,092

10%

GAAP net income

$

261,898

$

92,321

184%

$

347,099

$

138,312

151%

Adjusted net income

$

232,537

$

214,636

8%

$

445,710

$

397,007

12%

GAAP EPS

$

4.56

$

1.50

204%

$

6.01

$

2.26

166%

Adjusted EPS

$

4.05

$

3.49

16%

$

7.72

$

6.48

19%

GAAP net income for the second quarter of 2019 was $261.9 million, or $4.56 per diluted share, compared to $92.3 million, or $1.50 per diluted share, for the second quarter of 2018.

Non-GAAP adjusted net income for the second quarter of 2019 was $232.5 million, or $4.05 per diluted share, compared to $214.6 million, or $3.49 per diluted share, for the second quarter of 2018. Reconciliations of applicable GAAP reported to non-GAAP adjusted information are included at the end of this press release.

In the second quarter of 2019, the company recorded a one-time tax benefit of $112.3 million, or $1.96 per diluted share, on a GAAP basis, resulting from an intra-entity intellectual property asset transfer. This tax benefit has been excluded from adjusted net income and the related per share measures for the three and six months ended June 30, 2019. In the second quarter of 2018, GAAP net income included an impairment charge of $42.9 million resulting from the company’s sale of its rights related to Prialt (ziconotide) intrathecal infusion.

Corporate Updates

In July 2019, the company launched Sunosi (solriamfetol) in the U.S. after receiving a schedule IV designation from the U.S. Drug Enforcement Agency (DEA). Sunosi is the first and only dual-acting dopamine and norepinephrine reuptake inhibitor approved to improve wakefulness in adult patients with excessive daytime sleepiness (EDS) associated with narcolepsy or obstructive sleep apnea (OSA).

The company reported the appointment of Neena M. Patil as General Counsel. Ms. Patil will oversee all legal matters for the company. Ms. Patil has been practicing law for nearly 20 years and was most recently Senior Vice President, General Counsel and Corporate Secretary for Abeona Therapeutics Inc. Prior to Abeona, Ms. Patil was Vice President for Legal Affairs, Associate General Counsel and Assistant Corporate Secretary at Novo Nordisk and held various positions at other global pharmaceutical companies. Ms. Patil received a JD from the University of Michigan Law School, a Masters in Health Services Administration from the University of Michigan School of Public Health and an undergraduate Bachelor of Arts degree from Georgetown University.

Key Regulatory/R&D Updates

In June 2019, the Children’s Oncology Group (COG) presented positive Phase 1/2 Vyxeos data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in children and young adults with relapsed/refractory acute myeloid leukemia (AML). Overall response rate1 was 81.1%, with 70% of patients achieving best response after cycle 1 with Vyxeos and the percent of patients who achieved minimal residual disease (MRD) negative status was 75% post-cycle 1 and 84% overall. Given the robust overall response rate, the company intends to discuss the data and its plans for regulatory submissions with health authorities.

In June 2019, Nippon Shinyaku Co., Ltd. announced that Japan’s Ministry of Health, Labour and Welfare approved the marketing authorization of Defitelio injection 200mg (defibrotide sodium) for the treatment of sinusoidal obstruction syndrome/hepatic veno-occlusive disease.

In July 2019, the company acquired Redx Pharma plc’s (Redx) pan-RAF inhibitor program for the potential treatment of RAF and RAS mutant tumors. Under the terms of the agreement, the company made an upfront payment of $3.5 million. Redx is eligible to receive up to $203 million in development, regulatory and commercial milestone payments from the company, and incremental tiered mid-single digit royalties, based on any future net sales.

In August 2019, the company announced positive results of a Phase 1 study for JZP-458, its recombinant crisantaspase product candidate, and plans to initiate a single-arm, pivotal Phase 2/3 study. JZP-458 is being evaluated as a potential treatment option for patients with acute lymphoblastic leukemia (ALL)/lymphoblastic lymphoma (LBL) who have had hypersensitivity to E. coli- based asparaginase products.

1 Comprised of complete remission + complete remission with incomplete platelet recovery + complete remission with incomplete hematologic recovery (CR+CRp+CRi).

Select 2019 Milestones

Programs

2019 Milestones*

Xyrem (sodium oxybate) oral solution

✔

Launched for the treatment of cataplexy or EDS in pediatric narcolepsy in March

JZP-258

✔

Announced positive top-line results from the Phase 3 narcolepsy study in March

✔

Received Orphan Drug Designation from FDA for the idiopathic hypersomnia indication

•

Top-line results from the Phase 3 narcolepsy study to be presented at the World Sleep Congress meeting in September

•

NDA submission as early as year-end

Sunosi (solriamfetol)

✔

Received FDA approval for EDS in narcolepsy or OSA in March

✔

Received DEA scheduling decision in June

✔

Launched in the U.S. in July

✔

Identified EDS associated with Major Depressive Disorder as a new area of interest

•

Obtain EU approval for EDS in narcolepsy or OSA as early as year-end

Vyxeos (daunorubicin and cytarabine) liposome for injection

✔

Positive data presented by COG in children and young adults with relapsed/refractory AML at ASCO (Free ASCO Whitepaper) in June

✔

Activated sites for Phase 1 attenuated dose finding study of Vyxeos in higher risk myelodysplastic syndrome (MDS) through MD Anderson collaboration

✔

Activated sites for Phase 1b study of low intensity therapy of Vyxeos in combination with venetoclax in first-line, unfit AML

✔

Activated sites for Phase 3 study in adult patients with newly diagnosed standard- and high-risk AML through the AML Study Group, a cooperative group

✔

Activated sites for Phase 2 study in patients with high-risk MDS through the European Myelodysplastic Syndromes Cooperative Group

•

Potential interim combination data results from studies conducted through MD Anderson collaboration

•

Activate sites for Phase 3 study in newly diagnosed pediatric patients with AML (COG)

•

Activate sites for Phase 2 study in newly diagnosed, fit, older adults with high-risk AML

•

Activate sites for Phase 2 study in a broader age range of adults with high-risk AML

Defitelio (defibrotide sodium) / defibrotide

✔

Positive results from DEFIFrance study presented at European Society for Blood and Marrow Transplant meeting in March

✔

Nippon Shinyaku Co., Ltd. received marketing authorization for Defitelio in Japan in June

•

Provide an update regarding the timing of the interim analysis in the prevention of hepatic veno-occlusive disease (VOD) study

•

Complete enrollment in prevention of acute graft-vs-host disease Phase 2 study

•

Activate sites for exploratory Phase 2 study in chimeric antigen receptor t-cell therapy associated neurotoxicity

•

Activate sites for Phase 2 study in transplant-associated thrombotic microangiopathy

JZP-458

•

Activate sites for single-arm, pivotal Phase 2/3 clinical study later this year in ALL/LBL

CombiPlex

•

Continue Investigational New Drug enabling activities for one solid tumor combination and progress exploratory activities for other hematology/oncology candidates

* Milestones denoted as ✔ have been completed; all other milestones are planned or expected in 2019 unless otherwise noted.

Total Revenues

Three Months Ended
June 30,

Six Months Ended
June 30,

(In thousands)

2019

2018

2019

2018

Xyrem (sodium oxybate) oral solution

$

413,212

$

356,008

$

781,529

$

672,785

Erwinaze / Erwinase (asparaginase Erwinia chrysanthemi)

27,622

58,713

88,521

109,340

Defitelio (defibrotide sodium) / defibrotide

46,055

40,498

87,555

75,559

Vyxeos (daunorubicin and cytarabine) liposome for injection

31,362

27,951

60,305

54,179

Other

5,172

12,925

8,844

25,079

Product sales, net

523,423

496,095

1,026,754

936,942

Royalties and contract revenues

10,710

4,384

15,565

8,150

Total revenues

$

534,133

$

500,479

$

1,042,319

$

945,092

Total revenues increased 7% in the second quarter of 2019 compared to the same period in 2018.

Xyrem net product sales increased 16% in the second quarter of 2019 compared to the same period in 2018.

Erwinaze/Erwinase net product sales decreased 53% in the second quarter of 2019 compared to the same period in 2018 due to ongoing quality and supply issues at the sole manufacturer resulting in minimal supply during the quarter. The company anticipates inter-quarter variability in Erwinaze net sales due to expected supply disruptions during the second half of 2019.

Defitelio/defibrotide net product sales increased 14% in the second quarter of 2019 compared to the same period in 2018 primarily due to an increase in volumes. The second quarter included a shipment to Nippon Shinyaku following the recent approval of Defitelio in Japan. The company continues to expect inter-quarter variability in Defitelio net sales.

Vyxeos net product sales increased 12% in the second quarter of 2019 compared to the same period in 2018 primarily due to the ongoing EU launch. The company continues to implement its intensive education and outreach initiatives while advancing a broad development program to support potential expanded uses of Vyxeos.

Operating Expenses

Three Months Ended
June 30,

Six Months Ended
June 30,

(In thousands, except percentages)

2019

2018

2019

2018

GAAP:

Cost of product sales

$

27,676

$

34,714

$

61,182

$

68,633

Gross margin

94.7%

93.0%

94.0%

92.7%

Selling, general and administrative

$

176,014

$

158,579

$

343,961

$

365,792

% of total revenues

33.0%

31.7%

33.0%

38.7%

Research and development

$

62,384

$

56,132

$

122,489

$

118,799

% of total revenues

11.7%

11.2%

11.8%

12.6%

Impairment charges

$

—

$

42,896

$

—

$

42,896

Acquired in-process research and development

$

2,200

$

—

$

58,200

$

—

Income tax provision (benefit)

$

(78,650)

$

36,524

$

(49,534)

$

55,670

Effective tax rate

(42.7)%

28.2%

(16.5)%

28.6%

Three Months Ended
June 30,

Six Months Ended
June 30,

(In thousands, except percentages)

2019

2018

2019

2018

Non-GAAP adjusted:

Cost of product sales

$

25,968

$

32,911

$

57,815

$

65,136

Gross margin

95.0%

93.4%

94.4%

93.0%

Selling, general and administrative

$

155,329

$

137,706

$

302,906

$

269,685

% of total revenues

29.1%

27.5%

29.1%

28.5%

Research and development

$

56,488

$

51,423

$

111,070

$

98,715

% of total revenues

10.6%

10.3%

10.7%

10.4%

Acquired in-process research and development

$

2,200

$

—

$

2,200

$

—

Income tax provision

$

52,027

$

50,336

$

104,741

$

89,029

Effective tax rate

18.2%

19.0%

19.0%

18.3%

Operating expenses changed over the prior year period primarily due to the following:

Selling, general and administrative (SG&A) expenses increased in the second quarter of 2019 compared to the same period in 2018 on a GAAP and on a non-GAAP adjusted basis primarily due to higher expenses related to the U.S. launch of Sunosi and an increase in headcount and other expenses to support expansion of the business.
Research and development (R&D) expenses increased in the second quarter of 2019 on a GAAP and on a non-GAAP adjusted basis primarily due to expenses related to the company’s pre-clinical and clinical development programs and its partner programs.
Cash Flow and Balance Sheet

As of June 30, 2019, cash, cash equivalents and investments were $882.7 million and the outstanding principal balance of the company’s long-term debt was $1.8 billion. During the six months ended June 30, 2019, the company generated $351.1 million of cash from operations, used $171.1 million to repurchase shares, made an upfront payment of $56.0 million to Codiak BioSciences, Inc. under a collaboration agreement and made milestone payments totaling $25.5 million related to Sunosi.

In the six months ended June 30, 2019, the company repurchased approximately 1.3 million ordinary shares under the company’s share repurchase program at an average cost of $131.17 per ordinary share. As of June 30, 2019, the remaining amount authorized for share repurchases was $208.0 million.

2019 Financial Guidance

Jazz Pharmaceuticals is updating its full year 2019 financial guidance as follows (in millions, except per share amounts and percentages):

Includes minimal net sales contribution from Sunosi in the U.S.

Excludes $6-$8 million of share-based compensation expense from estimated GAAP gross margin.

Excludes $82-$90 million of share-based compensation expense from estimated GAAP SG&A expenses.

Excludes $22-$27 million of share-based compensation expense and $0-$11 million of milestone payments from estimated GAAP R&D expenses.

Excludes the income tax effect of adjustments between GAAP reported and non-GAAP adjusted net income and the income tax benefit related to an intra-entity intellectual property asset transfer.

See "Non-GAAP Financial Measures" below. Reconciliations of non-GAAP adjusted guidance measures are included above and in the table titled "Reconciliation of GAAP to Non-GAAP Adjusted 2019 Net Income Guidance" at the end of this press release.

Conference Call Details

Jazz Pharmaceuticals will host an investor conference call and live audio webcast today at 4:30 p.m. EDT (9:30 p.m. IST) to provide a business and financial update and discuss its 2019 second quarter results. The live webcast may be accessed from the Investors section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 5590569.

A replay of the conference call will be available through August 13, 2019 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 5590569. An archived version of the webcast will be available for at least one week in the Investors section of the company’s website at www.jazzpharmaceuticals.com.

On August 6, 2019 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported its financial results and business highlights for the second quarter and six months ended June 30, 2019 (Press release, Cellular Biomedicine Group, AUG 6, 2019, View Source [SID1234538228]).

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"During the second quarter of 2019, we made strides in advancing CBMG’s clinical pipeline in China. This includes expansion to multiple sites, dose escalation and robust patient recruitment for our B cell maturation antigen (BCMA) CAR-T program targeting multiple myeloma (MM). We have finished enrolling patients for the first cohort in a dose escalation study and currently are enrolling patients for the second cohort. We are also expanding the study into multiple sites. We are moving the alpha-fetoprotein T-cell receptor (AFP-TCR-T) program forward and will start to screen and enroll patients in hepatocellular carcinoma (HCC). We are actively preparing for a multisite trial for our AlloJoin therapy for Knee Osteoarthritis (KOA)," commented Tony (Bizuo) Liu, Chief Executive Officer of CBMG.

Mr. Liu continued, "We continue to leverage the investigator initiated trial (IIT) process in China and plan to initiate these cancer clinical trials in the U.S. when we see positive proof of concept signals in the IIT studies in China. This allows us to prioritize and focus on developing clinical assets with the most potential and best chance to win both in China and globally."

Business Highlights for the Second Quarter and First Half 2019:

Advanced myriad of our immune-oncology (I/O) and regenerative medicine assets for the next stage in the translational medicine process, comprised of fine-tuning process development, multiple sites trial, increases in patient recruitment, and dose escalation;
Preparing to bring our I/O assets to the U.S. market.
Upcoming Clinical Milestones:

Present update of clinical data for CBMG’s anti-BCMA CAR-T in the fourth quarter of 2019
Financial Results for the Second Quarter and First Half 2019:

Net loss allocable to common stock holders for the quarter and six months ended June 30, 2019 was $12.1 million and $21.4 million respectively, compared to $9.2 million and $17.7 million for the same periods in 2018.
General and administrative expenses for the quarter and six months ended June 30, 2019 were $3.2 million and $6.6 million, respectively, compared to $3.1 million and $6.3 million for the same periods in 2018.
Research and development expenses for the quarter and six months ended June 30, 2019 were $9.1 million and $15 million respectively, compared $6.2 million and $11.4 million for the same periods in 2018, primarily due to the increased clinical development for our leading cell therapy targets.
Net cash used in operating activities for first half of 2019 was $18.7 million, compared $13.7 million for the same period in 2018.
Cash, cash equivalents and restricted cash was $56.7 million as of June 30, 2019, compared to $62.0 million as of March 31, 2019.
Conference Call and Webcast Information
The Company will host a conference call and webcast with the investment community on Tuesday, August 6th at 4:30 p.m. Eastern Time featuring remarks by Tony Liu, Executive Director, CEO and CFO of CBMG.

Live Call:

Toll-Free: 1-855-327-6838

International: 1-604-235-2082

Webcast:

View Source

Replay:

Toll-Free: 1-844-512-2921

International: 1-412-317-6671

Conference ID: 10007371

(Available approximately two hours after the completion of the live call until 11:59 p.m. ET on August 20, 2019)

On August 6, 2019 CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader using its CytoSorb blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, reported financial and operational results for the quarter ending June 30, 2019 (Press release, Cytosorbents, AUG 6, 2019, View Source [SID1234538227]).

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Second Quarter 2019 Financial Results:

Total Q2 2019 revenues were $6.2 million, including both product sales and grant income, an increase of approximately 8% from $5.8 million in Q2 2018
Product sales for Q2 2019 were approximately $5.9 million, compared to $5.2 million for Q2 2018, an increase of approximately 12%. Q2 2019 product sales would have been approximately $6.2 million, or $357,000(18%) higher than a year ago, had the Euro remained unchanged
Product gross margins for Q2 2019 increased to 76%, compared to 74% in Q2 2018
Executed a loan amendment with Bridge Bank which provided an additional $5 million in debt financing which was received on July 31, 2019, extending the interest-only period of the entire term loan to October 2020, provided certain financial targets are met
Strong cash position with $16.3M at the end of the quarter, and approximately $20 million at the end of July, reflecting the additional proceeds from debt
Second Quarter 2019 Operational Highlights:

67,000+ cumulative CytoSorb treatments have been delivered, up from 46,000 a year ago
CytoSorb product registration has been submitted in Mexico and South Korea with partner Fresenius Medical Care, with concurrent initiation of commercialization planning and pre-launch activities including conferences, marketing, and key opinion leader events. Feedback on the status of registration is expected before the end of this year
Publication of the U.S. REFRESH I study in Seminars in Thoracic and Cardiovascular Surgery, a journal of the American Association for Thoracic Surgery (AATS) and an associated editorial commentary on the clinical trial and the potential clinical importance and value that CytoSorb could have in complex cardiac surgery with future studies
Enrollment in the 400 patient U.S. REFRESH 2-AKI pivotal randomized, controlled trial is currently at 109 patients with 24 active sites
The German government-funded REMOVE endocarditis trial is approximately 90% enrolled, with 222 patients out of a target 250 patients at 15 clinical sites. Completed enrollment is expected by year-end
The HemoDefend-RBC program remains on track for an investigational device exemption (IDE) submission to the FDA this year, enabling the start of the U.S. pivotal trial
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents Corporation, stated, "Q2 2019 product sales rebounded significantly over the past quarter, achieving our guidance as the best quarter of product sales since we began commercialization, and in-line with our historical product sales trajectory of growth. Results were aided by the resumption of ordering from one of our major distributors. We also attained blended product gross margins of 76%, an increase of 200 basis points from the prior quarter, primarily resulting from continued efficiencies in manufacturing, and closing in on our goal of 80% on a quarterly basis this year."

"The new loan amendment with Bridge Bank has expanded our effective working capital position by approximately $9 million, including deferment of principal repayments, and will allow us to continue making the investments in our business that will drive future growth. We expect that product sales in the second half of this year will solidly exceed product sales in the first half, catalyzed by the impact of our expanding sales team, organic growth in existing markets, increased international expansion, publication of new clinical data in a wide variety of clinical applications, and increased partner support."

Dr. Chan concluded, "Lastly, in the independent editorial commentary to the REFRESH I paper that was recently published, we were pleased to note that the authors described the complications of extended cardiopulmonary bypass – including the activation of inflammation, release of free hemoglobin due to hemolysis, and organ injury and failure – as the ‘Achilles heel of complex cardiac surgery’, and that the ‘holy grail of research in this subject would be to find something able to mitigate or eliminate the mediators responsible for these potentially catastrophic downstream effects of prolonged cardiopulmonary bypass.’ In reality, CytoSorb has demonstrated utility in so many different life-or-death applications in critical care and cardiac surgery, that we believe we are one of the leading innovators in bringing game-changing advances to medicine."

"Please join us on our earnings conference call today, details for which are below."

Conference Call Details:
Date: Tuesday, August 6, 2019
Time: 4:45 PM Eastern Time
Participant Dial-In: 877-451-6152
Conference ID: 13692360
Live Presentation Webcast: View Source

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: View Source

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at View Source

Results of Operations

Comparison for the three months ended June 30, 2019 and 2018:

Revenues:

Revenue from product sales was approximately $5,850,000 in the three months ended June 30, 2019, as compared to approximately $5,246,000 in the three months ended June 30, 2018, an increase of approximately $604,000, or 12%. This increase was driven by an increase in direct sales of approximately $520,000 resulting from sales to both new customers and repeat orders from existing customers and an increase in distributor sales of approximately $84,000. In addition, sales were negatively impacted by approximately $357,000 as a result of the decrease in the average exchange rate of the Euro to the U.S. dollar. For the three months ended June 30, 2019, the average exchange rate of the Euro to the U.S. dollar was $1.12 as compared to an average exchange rate of $1.19 for the three months ended June 30, 2018.

Grant income was approximately $382,000 for the three months ended June 30, 2019 as compared to approximately $510,000 for the three months ended June 30, 2018, a decrease of approximately $128,000 or 25%. This decrease was a result of timing of certain grant revenue.

Total revenues were approximately $6,233,000 for the three months ended June 30, 2019, as compared to total revenues of approximately $5,755,000 for the three months ended June 30, 2018, an increase of approximately $478,000, or 8%.

Cost of Revenues:

For the three months ended June 30, 2019 and 2018, cost of revenue was approximately $1,834,000 and $1,786,000, respectively, an increase of approximately $48,000. Product cost of revenues increased approximately $31,000 during the three months ended June 30, 2019 as compared to the three months ended June 30, 2018 due to increased sales. Product gross margins were approximately 76% for the three months ended June 30, 2019 and approximately 74% for the three months ended June 30, 2018.

Research and Development Expenses:

For the three months ended June 30, 2019, research and development expenses were approximately $2,930,000 as compared to research and development expenses of approximately $1,576,000 for the three months ended June 30, 2018. The increase of approximately $1,354,000 was due to an increase in clinical trial costs of approximately $1,215,000, which is primarily related to our REFRESH 2-AKI trial, an increase in non-clinical research and development salary related costs of approximately $11,000 and an increase in other non-clinical research and development costs of approximately $150,000. These increases were offset by an increase in direct labor and other costs being deployed toward grant-funded activities of approximately $18,000, which had the effect of decreasing the amount of our non-reimbursable research and development costs, and a decrease in new product development costs of approximately $4,000.

Legal, Financial and Other Consulting Expense:

Legal, financial and other consulting expenses were approximately $592,000 for the three months ended June 30, 2019, as compared to approximately $458,000 for the three months ended June 30, 2018. The increase of approximately $134,000 was due to an increase in legal fees of approximately $28,000 related to patent matters and certain corporate initiatives, an increase in consulting fees of approximately $55,000, an increase in employment agency fees of approximately $31,000 and an increase in accounting fees of approximately $20,000.

Selling, General and Administrative Expense:

Selling, general and administrative expenses were approximately $4,507,000 for the three months ended June 30, 2019, as compared to approximately $6,124,000 for the three months ending June 30, 2018, a decrease of $1,617,000. The decrease of $1,617,000 was due to a decrease in non-cash stock compensation of approximately $2,228,000, a decrease in travel and entertainment costs of approximately $64,000 and a decrease in other general and administrative expenses of approximately $70,000. These decreases were offset by an increase in salaries, commissions and related costs of approximately $588,000, additional sales and marketing costs, which include advertising and conferences of approximately $92,000, an increase in royalty expenses of approximately $53,000 due to the increase in product sales and an increase in rent expense of approximately $12,000 related to the expansion of manufacturing and office facilities.

Interest Expense, net:

For the three months ended June 30, 2019, interest expense was approximately $215,000, as compared to interest expense of approximately $840,000 for the three months ended June 30, 2018. This decrease in interest expense of approximately $625,000 was primarily a result of the settlement of the Success Fee with Bridge Bank in the amount of $637,000 that became due in May 2018 in accordance with the terms of the 2016 Success Fee Letter with Bridge Bank.

Gain (Loss) on Foreign Currency Transactions:

For the three months ended June 30, 2019, the gain on foreign currency transactions was approximately $297,000 as compared to a loss of approximately $(794,000) for the three months ended June 30, 2018. The 2019 gain was directly related to the increase in the spot exchange rate of the Euro to the U.S. dollar at June 30, 2019 as compared to March 31, 2018. The spot exchange rate of the Euro to the U.S. dollar was $1.14 per Euro at June 30, 2019, as compared to $1.12 per Euro at March 31, 2019. The 2018 loss was directly related to the decrease in the spot exchange rate of the Euro at June 30, 2018 as compared to March 31, 2018. The spot exchange rate of the Euro to the U.S. dollar was $1.17 per Euro at June 30, 2018, as compared to $1.23 per Euro at March 31, 2018.

Comparison for the six months ended June 30, 2019 and 2018:

Revenues:

Revenue from product sales was approximately $10,427,000 in the six months ended June 30, 2019, as compared to approximately $9,679,000 in the six months ended June 30, 2018, an increase of approximately $748,000, or 8%. This increase was driven by an increase in direct sales of approximately $1,160,000 resulting from sales to both new customers and repeat orders from existing customers, offset by a decrease in distributor sales of approximately $412,000. In addition, sales were negatively impacted by approximately $737,000 as a result of the decrease in the average exchange rate of the Euro to the U.S. dollar. For the six months ended June 30, 2019, the average exchange rate of the Euro to the U.S. dollar was $1.13 as compared to an average exchange rate of $1.21 for the six months ended June 30, 2018.

Grant income was approximately $997,000 for the six months ended June 30, 2019 as compared to approximately $1,001,000 for the six months ended June 30, 2018, a decrease of approximately $4,000 or less than 1%.

Total revenues were approximately $11,424,000 for the six months ended June 30, 2019, as compared to total revenues of approximately $10,680,000 for the six months ended June 30, 2018, an increase of approximately $744,000, or 7%.

Cost of Revenues:

For the six months ended June 30, 2019 and 2018, cost of revenue was approximately $3,573,000 and $3,353,000, respectively, an increase of approximately $220,000. Product cost of revenues increased approximately $83,000 during the six months ended June 30, 2019 as compared to the six months ended June 30, 2018 due to increased sales. Product gross margins were approximately 75% for the six months ended June 30, 2019 and approximately 74% for the six months ended June 30, 2018.

Research and Development Expenses:

For the six months ended June 30, 2019, research and development expenses were approximately $5,348,000 as compared to research and development expenses of approximately $3,356,000 for the six months ended June 30, 2018. The increase of approximately $1,992,000 was due to increase in clinical trial costs of approximately $1,993,000, which is primarily related to our REFRESH 2-AKI trial, an increase in non-clinical research and development salary related costs of approximately $20,000 and an increase in other non-clinical research and development costs of approximately $186,000. These increases were offset by an increase in direct labor and other costs being deployed toward grant-funded activities of approximately $136,000, which had the effect of decreasing the amount of our non-reimbursable research and development costs, and a decrease in new product development costs of approximately $71,000.

Legal, Financial and Other Consulting Expense:

Legal, financial and other consulting expenses were approximately $1,154,000 for the six months ended June 30, 2019, as compared to approximately $874,000 for the six months ended June 30, 2018. The increase of approximately $280,000 was due to an increase in legal fees of approximately $194,000 related to patent matters and certain corporate initiatives, an increase in consulting fees of approximately $73,000, and an increase in accounting fees of approximately $17,000. These increases were offset by a decrease in employment agency fees of approximately $4,000.

Selling, General and Administrative Expense:

Selling, general and administrative expenses were approximately $9,265,000 for the six months ended June 30, 2019, as compared to approximately $10,385,000 for the six months ending June 30, 2018. The decrease of $1,120,000 was due to a decrease in non-cash stock compensation of approximately $2,426,000 and other general and administrative expenses of approximately $140,000. These decreases were offset by an increase in salaries, commissions and related costs of approximately $1,142,000, an increase in travel and entertainment and other costs of approximately $33,000, additional sales and marketing costs, which include advertising and conferences of approximately $189,000, an increase in royalty expenses of approximately $60,000 due to the increase in product sales and an increase in rent expense of approximately $22,000 related to the expansion of manufacturing and office facilities.

Interest Expense, net:

For the six months ended June 30, 2019, interest expense was approximately $420,000, as compared to interest expense of approximately $1,079,000 for the six months ended June 30, 2018. This decrease in interest expense of approximately $659,000 was primarily a result of the settlement of the Success Fee with Bridge Bank in the amount of $637,000 that became due in May 2018 in accordance with the terms of the 2016 Success Fee Letter with Bridge Bank and interest earned on our cash balances during the six months ended June 30, 2019.

Gain (Loss) on Foreign Currency Transactions:

For the six months ended June 30, 2019, the loss on foreign currency transactions was approximately $96,000 as compared to a loss of approximately $435,000 for the six months ended June 30, 2018. The 2019 loss was directly related to the decrease in the spot exchange rate of the Euro to the U.S. dollar at June 30, 2019 as compared to December 31, 2018. The spot exchange rate of the Euro to the U.S. dollar was $1.14 per Euro at June 30, 2019, as compared to $1.15 per Euro at December 31, 2018. The 2018 loss was directly related to the decrease in the spot exchange rate of the Euro at June 30, 2018 as compared to the December 31, 2017. The spot exchange rate of the Euro to the U.S. dollar was $1.17 per Euro at June 30, 2018, as compared to $1.20 per Euro at December 31, 2017.

History of Operating Losses:

We have experienced substantial operating losses since inception. As of June 30, 2019, we had an accumulated deficit of approximately $177,955,000, which included losses of approximately $8,431,000 and $8,803,000 for the six-month periods ended June 30, 2019 and 2018, respectively. Historically, losses have resulted principally from costs incurred in the research and development of our polymer technology, clinical studies, and general and administrative expenses.

Liquidity and Capital Resources:

Since inception, our operations have been primarily financed through the issuance of debt and equity securities. At June 30, 2019, we had current assets of approximately $22,214,000 including cash on hand of approximately $16,342,000 and current liabilities of approximately $6,919,000. On July 31, 2019, the Company executed an Amendment to its Loan Agreement with Bridge Bank and simultaneous with this Amendment received $5 million in proceeds from an additional term loan. In addition, the Amendment extends the interest only period of the loan for an additional six months through April 2020, with the ability to further extend the interest-only period for another six months through October 2020 should the Company meet certain conditions.

We believe that we have sufficient cash to fund our operations into 2020.

2019 Third Quarter Revenue Guidance:

CytoSorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, we expect our third quarter 2019 product sales will exceed sales reported in the third quarter of 2018. In addition, we expect that second half 2019 product sales will exceed first half 2019 product sales.

For additional information, please see the Company’s Annual Report on Form 10-K for the year ended December 31, 2018 filed on March 7, 2019 on View Source

On August 6, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in healthcare workforce solutions and staffing services, reported its second quarter 2019 financial results (Press release, AMN Healthcare Services, AUG 6, 2019, View Source [SID1234538226]). Financial highlights are as follows:

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Dollars in millions, except per share amounts.

* See "Non-GAAP Measures" below for a discussion of our use of non-GAAP items and the table entitled "Supplemental Financial and Operating Data" for a reconciliation of non-GAAP items.

Highlights

Second quarter revenue and earnings above Company guidance due primarily to higher performance in the Nurse and Allied segment
Allied division continued strong organic revenue growth of 9% over prior year
Closed and began integration of Advanced Medical, enhancing MSP fulfillment and expanding our clinical staffing in school settings
New and expanded MSP contracts signed year to date, valued at nearly $200 million annualized gross spend at maturity
"The AMN team is performing exceptionally well during this time of increasing need for workforce solutions and severe talent shortages within healthcare," said Susan R. Salka, Chief Executive Officer of AMN Healthcare. "Demand for contingent labor and our solutions continues to rise, with requests for nursing and allied professionals more than 20% above prior-year levels. This reflects the difficulties of an extremely tight labor market and growing demand for healthcare services. AMN is partnering with our clients to deliver innovative solutions and analytics to improve efficiency and the clinician and patient experience."

Second Quarter 2019 Results

Consolidated revenue for the quarter was $535 million, a 4% decrease over prior year but 1% higher than prior quarter. Revenue for the Nurse and Allied Solutions segment was $332 million, flat year over year and down 2% sequentially. Advanced Medical, which was acquired in June, contributed $5 million of revenue in the quarter. Travel Nurse division revenue increased 3% year over year, and Allied division revenue increased 14% year over year, 9% organic. The quarter included revenue from labor disruption activity, but this revenue was lower than prior year due to a large strike last year.

In line with expectations, the Locum Tenens Solutions segment reported revenue of $82 million, down by 24% year over year but up 2% sequentially. Other Workforce Solutions segment revenue was higher than anticipated at $121 million for an increase of 3% year over year, driven by growth in our interim leadership, physician permanent placement and VMS businesses.

Gross margin was 33.5%, higher by 110 basis points year over year and higher by 30 basis points sequentially. The year-over-year variance was driven in part by higher gross margins on labor disruption revenue and a favorable segment revenue mix.

SG&A expenses were $122 million, or 22.7% of revenue, compared with $116 million, or 20.7% of revenue, in the same quarter last year. SG&A was $120 million, or 22.5% of revenue, in the previous quarter. The year-over-year increase was mainly from the recent acquisitions and increased employee-related costs, partially offset by a more favorable professional liability insurance actuarial adjustment.

Income from operations was $45 million, or 8.4% of revenue, compared with $55 million, or 9.8% of revenue, in the same quarter last year. Adjusted EBITDA was $67 million, a year-over-year decrease of 5%. Adjusted EBITDA margin was 12.5%, representing a decrease of 10 basis points year over year and up 10 basis points from prior quarter.

Net income was $29 million, or $0.61 per diluted share, compared with $36 million, or $0.73 per diluted share, in the same quarter last year. Adjusted diluted EPS was $0.77.

At June 30, 2019, cash and cash equivalents totaled $21 million. Cash flow from operations was $29 million for the quarter, and capital expenditures were $8 million. The Company ended the quarter with total debt outstanding of $671 million, with a leverage ratio as calculated in accordance with the Company’s credit agreement of 2.4 to 1.

Third Quarter 2019 Outlook

*Note: Guidance percentage metrics are approximate. For a reconciliation of adjusted EBITDA margin, see the table entitled "Reconciliation of Guidance Adjusted EBITDA Margin to Guidance Operating Margin" below.

Revenue in the third quarter of 2019 is expected to be approximately 7% higher year over year, including a full-quarter contribution from the Advanced acquisition. Organic consolidated revenue would be expected to be flat to up 1%.

Conference Call on August 6, 2019

AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, will host a conference call to discuss its second quarter 2019 financial results on Tuesday, August 6, 2019, at 5:00 p.m. Eastern Time. A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 230-1092 in the U.S. or (612) 288-0329 internationally. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available starting at 7:30 p.m. Eastern Time on August 6, 2019, and can be accessed until 11:59 p.m. Eastern Time on August 20, 2019, by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 469775.

On August 6, 2019 Community Healthcare Trust Incorporated (NYSE: CHCT) (the "Company") reported results for the three months ended June 30, 2019 (Press release, Community Health Systems, AUG 6, 2019, View Source [SID1234538225]). The Company reported net income for the second quarter of approximately $2.1 million, or $0.09 per diluted common share. Funds from operations and adjusted funds from operations ("AFFO") for the three months ended June 30, 2019 totaled $0.40 and $0.42, respectively, per diluted common share.

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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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Highlights include:

During the second quarter of 2019, the Company issued, through its at-the-market offering program ("ATM Program"), 497,453 shares of common stock at an average gross sales price of $37.85 per share and received net proceeds of approximately $18.5 million at an approximate 4.38% current equity yield.
During the second quarter of 2019, the Company acquired three real estate properties totaling approximately 110,000 square feet for an aggregate purchase price of approximately $31.9 million and cash consideration of approximately $30.7 million. Upon acquisition, the properties were approximately 97.1% leased in the aggregate with lease expirations through 2034.
Subsequent to June 30, 2019, the Company acquired three real estate properties, including one that was previously under construction, totaling approximately 130,000 square feet for a purchase price of approximately $52.6 million and cash consideration of approximately $52.2 million. Upon acquisition, the properties were 100.0% leased in the aggregate with lease expiration through 2034.
The Company has five properties under definitive purchase agreements for an aggregate expected purchase price of approximately $15.8 million. The Company’s expected aggregate returns on these investments range from approximately 9.2% to 10.1%. The Company anticipates the properties will close during the third quarter of 2019. However, the Company is currently performing due diligence procedures customary for these types of transactions and cannot provide assurance as to the timing of when, or whether, these transactions will actually close.
The Company has four properties under definitive purchase agreements, to be acquired after completion and occupancy, for an aggregate expected purchase price of approximately $87.0 million. The Company’s expected aggregate returns on these investments range from approximately 9.5% to 11.0%. The Company expects to close these properties through 2020; however, the Company cannot provide assurance as to the timing of when, or whether, these transactions will actually close.
On August 1, 2019, the Company’s Board of Directors declared a quarterly common stock dividend in the amount of $0.4125 per share. The dividend is payable on August 30, 2019 to stockholders of record on August 16, 2019.
Highlands Transition Update:

A new operator is currently managing Highlands Hospital pursuant to a management agreement; continues to perform due diligence; and is in the process of preparing for transfer of licenses and other assets.
The Company’s lease with the new operator will become effective upon the transfer of the licenses to the new operator, which is anticipated to happen in the second half of 2019.
The Company has received and anticipates continuing to receive monthly payments of approximately $0.3 million.
Though the Company has experienced some short-term effects from the timing of receipts or reimbursement of expenses, the Company does not anticipate any material adverse long-term effect to its cash flows or net income related to the transition or subsequent leasing of this facility.
The Company cannot provide assurance as to the timing or whether, this transaction will actually close.