On August 6, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; NASDAQ: MOR) reported its financial results for the second quarter of 2019 (Press release, MorphoSys, AUG 6, 2019, View Source [SID1234538250]).

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"MorphoSys continued to make excellent progress on multiple fronts in the second quarter of 2019," said Dr. Simon Moroney, Chief Executive Officer of MorphoSys AG. "A major step was the appointment of my successor Dr. Jean-Paul Kress as the new CEO of MorphoSys, effective September 1, 2019. Jean-Paul brings a wealth of medical, commercial and leadership expertise and I have every confidence that he will enable MorphoSys to make great strides in the execution of its strategy, especially in the launch and commercialization of our lead program tafasitamab. Topline results from the primary analysis of our L-MIND trial, followed by the presentation of the complete data set at the recent ICML conference, confirmed the potential of this program. We remain on track to completing our BLA filing to FDA by the end of this year and today we also confirmed our intention to submit a Marketing Authorization Application based on L-MIND to the European Medicines Agency. For the B-MIND trial, we have disclosed the biomarker we have implemented as a low baseline peripheral blood natural killer cell count, which may help us to identify patients who could benefit from tafasitamab’s potential efficient recruitment of these cells. Finally, our agreement with Vivoryon Therapeutics, which gives us access to a family of small molecule inhibitors in immuno-oncology, is a potentially invaluable addition to our proprietary portfolio. We are keen to assess the potential of these compounds in combination with our antibodies, first and foremost with tafasitamab", Dr. Moroney continued.

"The L-MIND data we have reported represent a key catalyst for the transformation of MorphoSys and our goal to develop into a fully integrated biopharmaceutical company. Our preparations to further broaden the development of tafasitamab are ongoing and the start of a first line trial in DLBCL is expected later this year. We are also broadening our development of MOR202, which we plan to test in a phase 1/2 clinical trial in a chronic inflammatory autoimmune disease of the kidneys later this year," commented Jens Holstein, Chief Financial Officer of MorphoSys AG. "Our balanced business model is based on the value of our Partnered Discovery segment that allows us to invest in the development and planned commercialization of our proprietary portfolio. The milestone payment of EUR22 million from GSK following the phase 3 start in rheumatoid arthritis with otilimab, formerly MOR103, led us to increase our financial guidance. An increasing royalty stream from Tremfya(R) further strengthens our cash position and we are confident that there will be other compounds that follow Tremfya’s(R) market entry in the future."

Financial Review for the second quarter of 2019 (IFRS; all figures rounded)

In Q2 2019 MorphoSys continued to focus on the research and development of drug candidates both for its own account as well as with its partners. Group revenues increased to EUR34.7 million in Q2 2019 as compared to EUR8.1 million in the second quarter of the previous year. The increase was mainly driven by the milestone payment of EUR22 million from GSK due to the start of the clinical phase 3 program with otilimab (MOR103) in rheumatoid arthritis (RA). This payment was recognized in the second quarter due to the provisions of IFRS 15 on revenues from variable consideration.

Revenues also included an estimate of royalties on net sales of Tremfya(R) amounting to EUR 7.1 million (estimate only since royalties for Q2 2019 had not been reported by Janssen as of the balance date).

In the Proprietary Development segment, MorphoSys focuses on research into, and clinical development of, its own drug candidates in the fields of cancer and inflammation. In Q2 2019, this segment recorded revenues of EUR25.9 million (Q2 2018: EUR0.1 million). In the Partnered Discovery segment, MorphoSys applies its proprietary technology to discover new drug candidates for pharmaceutical companies, benefiting from its partners’ development advancements through R&D funding, licensing fees, success-based milestone payments and royalties. In Q2 2019, revenues in this segment amounted to EUR8.7 million (Q2 2018: EUR8.1 million).

Total operating expenses were EUR40.3 million in the second quarter of 2019 (Q2 2018:
EUR32.7 million). In Q2 2019, research and development expenses amounted to EUR24.7 million, as compared to EUR25.8 million in the second quarter of 2018. Expenses for proprietary R&D, including technology development, amounted to EUR22.5 million (Q2 2018: EUR23.7 million). In the second quarter of 2019, cost of sales amounted to EUR4.9 million (in Q2 2018, this item did not exist), selling expenses amounted to EUR3.2 million (Q2 2018: EUR1.5 million). General and administrative expenses increased from EUR5.5 million in Q2 2018 to EUR7.5 million in Q2 2019.

Earnings before interest and taxes (EBIT) in Q2 2019 was -EUR5.7 million (Q2 2018: -EUR24.1 million). The Proprietary Development segment reported an EBIT of -EUR7.0 million (Q2 2018:
-EUR24.6 million). EBIT in the Partnered Discovery segment was EUR6.3 million (Q2 2018: EUR5.5 million). In Q2 2019, the consolidated net result was -EUR5.9 million (Q2 2018:
-EUR23.5 million). The earnings per share for Q2 2019 was -EUR0.19 (Q2 2018: -EUR0.76).

At the end of Q2 2019, the Company had EUR409.2 million in cash, reported on the balance sheet under the line items "cash and cash equivalents"; "financial assets at fair value through profit or loss"; and current and non-current "other financial assets at amortized cost". On December 31, 2018, the Group’s liquidity position amounted to EUR454.7 million.

The number of shares issued totaled 31,839,572 at the end of Q2 2019 (year-end 2018: 31,839,572).

Results for the first six months 2019

During the first six months of 2019, group revenues increased to EUR48.2 million (Q1-Q2 2018: EUR10.9 million). Revenues in the first half of 2019 comprised the milestone payment by GSK of EUR22.0 million due to the start of phase 3 clinical development of otilimab in RA. Expenditure for proprietary R&D, including technology development, amounted to EUR45.1 million in the first six months of 2019 (Q1-Q2 2018: EUR39.2 million). Consequently the EBIT in the first six months of 2019 amounted to -EUR29.3 million, compared to -EUR43.2 million in the first half of 2018.

Financial Guidance and Operational Outlook for 2019

Following a milestone payment of EUR22 million made by GSK on July 3, 2019 that was triggered by the start of phase 3 clinical development of otilimab (MOR103), MorphoSys increased its financial guidance. For the year 2019, MorphoSys expects revenues in the range EUR65 to 72 million (up from previously EUR43 to 50 million), and EBIT of -EUR105 to -115 million (from previously -EUR127 to -137 million). Expenses for proprietary development and technology development are expected to remain in a corridor of EUR95 to 105 million.

The guidance does not include revenues from potential future partnership or licensing agreements for tafasitamab or any other compound currently in MorphoSys’s Proprietary Development segment. Effects from potential in-licensing or co-development deals for new development candidates are also not included.

In its Proprietary Development segment, MorphoSys expects the following events and activities until the end of 2019:

Tafasitamab (MOR208)

L-MIND trial
Submission of Biologics License Application to U.S. FDA by year-end
Presentation of headline data from virtual, lenalidomide-only control arm planned for year-end
B-MIND trial
Continue phase 3 study evaluating tafasitamab plus bendamustine in r/r DLBCL
Event-driven interim analysis expected to occur in Q4 2019
Front-line DLBCL: Initiate phase 1b trial of tafasitamab in combination with R-CHOP or R2-CHOP in Q4 2019
COSMOS: Continue phase 2 trial of tafasitamab in combination with idelalisib or venetoclax in r/r CLL/SLL, with data to be presented at a medical conference at the end of 2019
MOR202

MorphoSys: Start a clinical phase 1/2 trial of MOR202 in anti-PLA2R antibody positive membranous nephropathy (aMN) in Q4 2019
I-Mab: Continue two clinical trials of MOR202/TJ202 in multiple myeloma in the Chinese region
MOR106

Continue phase 2 intravenous IGUANA study, phase 1 subcutaneous bridging study and the recently started phase 2 GECKO trial as well as prepare for a Japanese ethno-bridging study in atopic dermatitis together with Galapagos and under global licensing agreement with Novartis

In its Partnered Discovery segment, MorphoSys expects the following events until end of 2019:

According to information provided on clinicaltrials.gov, by the end of 2019 primary completion may be reached in up to eight clinical trials in phases 2 and 3 from partners evaluating antibodies made using MorphoSys’s technology. These include:

A potentially pivotal phase 2b study by Mereo BioPharma in osteogenesis imperfecta (brittle bone syndrome) of the HuCAL antibody setrusumab (BSP804) directed against sclerostin (this antibody was generated within the scope of MorphoSys’s partnership with Novartis and subsequently licensed from Novartis to Mereo),
Further phase 3 trials of Tremfya(R) conducted by Janssen in psoriatic arthritis and a potential submission of a BLA planned for later this year as communicated by Janssen.
Moreover, Janssen plans the start of a phase 1 trial of guselkumab in Chinese healthy volunteers, a phase 2 trial of guselkumab in pityriasis rubra pilaris, a phase 2/3 trial in ulcerative colitis and a phase 3 trial in palmoplantar-non-pustular psoriasis, according to clinicaltrials.gov.

Whether, when and to what extent news will be published following the primary completion of trials in the Partnered Discovery segment is at the full discretion of MorphoSys’s partners.

MorphoSys will continue to support its proprietary development activities by evaluating potential in-licensing, co-development, and/or acquisition opportunities or the potential initiation of new proprietary development programs with the goal of maintaining and expanding the Company’s position in its current therapeutic and technological fields of activities.

1) Including MOR107, which concluded a phase 1 study in 2017 and is currently in preclinical investigation with a focus on oncology indications. Tremfya(R) is still considered as a clinical program due to ongoing studies in various indications.

2) Including otilimab (MOR103/GSK3196165), which is fully out-licensed to GSK, and MOR106, for which MorphoSys and Galapagos have signed a global licensing agreement with Novartis.

PP – Percentage points

MorphoSys will hold its conference call and webcast tomorrow, August 7, 2019 to present the second quarter financial results 2019 and a further outlook for 2019.

Dial-in number for the analyst conference call (in English) at 2:00pm CEST; 1:00pm BST; 8:00am EDT:

Germany: +49 69 201 744 220
For UK residents: +44 203 009 2470
For US residents: +1 877 423 0830
Participant PIN: 43166710#

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at View Source

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript will be available at View Source

The Half-Year Report 2019 (IFRS) is available online at
View Source

On August 6, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL), reported financial results for the second quarter ended June 30, 2019, including sales of TAVALISSE (fostamatinib disodium hexahydrate) tablets, for the treatment of adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment (Press release, Rigel, AUG 6, 2019, View Source [SID1234538192]).

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"Execution is the key to Rigel’s success, and has enabled us to increase awareness of the benefits of TAVALISSE for chronic ITP as seen by the 26% growth in net product sales quarter over quarter," stated Raul Rodriguez, president and CEO. "Our commercial team continues to drive uptake of our product and the interest level among the patient and physician communities is very encouraging. In parallel, our pivotal trial of TAVALISSE in warm autoimmune hemolytic anemia is underway and enrolling patients. With the only warm AIHA treatment in a Phase 3 trial and no FDA-approved therapy for the indication, this is a substantial opportunity for Rigel."

Financial Update

For the second quarter of 2019, Rigel reported a net loss of $20.6 million, or $0.12 per share, compared to a net loss of $25.6 million, or $0.16 per share, in the same period of 2018.

For the second quarter of 2019, Rigel reported net product sales from TAVALISSE of $10.2 million, compared to $1.8 million in the same period of 2018. The increase in net product sales reflects the expansion of TAVALISSE use since its commercial launch in May 2018.

Contract revenues from collaborations were $234,000 for the three months ended June 30, 2019, which were related to Rigel’s collaboration agreements with Kissei Pharmaceutical Co., Ltd. and Grifols, S.A. There were no contract revenues from collaborations during the three months ended June 30, 2018.

Rigel reported total costs and expenses of $31.7 million in the second quarter of 2019, compared to $27.9 million for the same period in 2018. The increase in costs and expenses was primarily due to increased personnel costs for Rigel’s customer-facing team and third-party costs related to Rigel’s commercial launch of TAVALISSE in chronic ITP, as well as research and development costs related to its Phase 3 pivotal trial of TAVALISSE in patients with warm AIHA.

For the six months ended June 30, 2019, Rigel reported a net loss of $38.2 million, or $0.23 per share, compared to a net loss of $49.9 million, or $0.32 per share, for the same period of 2018.

Rigel reported total revenues of $23.0 million for the six months ended June 30, 2019, compared to $1.8 million for the same period in 2018. Total revenues for the six months ended June 30, 2019 consisted of $18.2 million in net product sales and $4.8 million in revenue related to Rigel’s collaboration agreements with Grifols and Kissei. Total revenues for the six months ended June 30, 2018 consisted of $1.8 million in net product sales. There were no contract revenues from collaborations for the six months ended June 30, 2018.

Total costs and expenses for the six months ended June 30, 2019 were $62.7 million, compared to $52.6 million, for the same period of 2018. The increase in total costs and expenses was primarily related to the increase in personnel costs for Rigel’s customer-facing team, as well as third party costs related to Rigel’s ongoing commercialization of TAVALISSE in chronic ITP.

As of June 30, 2019, Rigel had cash, cash equivalents and short-term investments of $112.4 million, compared to $128.5 million as of December 31, 2018.

Business Update

·Sales of TAVALISSE have achieved consecutive double-digit quarterly growth since product launch in May of 2018. This reflects an increase in prescribers, a broadening awareness among patients and physicians, growing early line use, and continued strong refill rates.

· Rigel has received the EMA’s 180-day questions related to the European marketing authorization application (MAA) for fostamatinib in chronic ITP. The approval process remains on track for a potential EMA decision by the end of this year.

· The first patients have been enrolled in FORWARD (Fostamatinib Research in Warm Antibody AIHA Disease), Rigel’s pivotal Phase 3 clinical trial in warm AIHA. The addition of clinical trial sites is ramping. Topline results are expected in mid 2021, positioning TAVALISSE to potentially become the first FDA-approved treatment for warm AIHA.

· At the 2019 Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), Rigel presented TAVALISSE data supporting its ability to improve the lives of patients with chronic ITP and highlighting its clinical trial progress in warm AIHA. These data were presented in two posters which highlighted long-term safety and efficacy results of TAVALISSE in a Phase 3 extension study for the treatment of chronic ITP, as well as a Phase 2 open-label extension study in patients with warm AIHA.

· Rigel plans to provide data from its Phase 1 trial of R8351, an IRAK 1/4 inhibitor, in the second half of 2019.

· The company continues to explore additional opportunities to expand its pipeline, which includes pursuing other indications for TAVALISSE to take advantage of the anticipated product exclusivity until 2031.

About ITP
In patients with ITP, the immune system attacks and destroys the body’s own blood platelets, which play an active role in blood clotting and healing. Common symptoms of ITP are excessive bruising and bleeding. People suffering with chronic ITP may live with an increased risk of severe bleeding events that can result in serious medical complications or even death. Current therapies for ITP include steroids, platelet production amplifiers (TPO-RAs – thrombopoietin receptor agonists), and splenectomy. However, not all patients are adequately treated with existing therapies. As a result, there remains a significant medical need for additional treatment options for patients with ITP.

About AIHA
AIHA is a rare, serious blood disorder in which the immune system produces antibodies that result in the destruction of the body’s own red blood cells. AIHA affects approximately 40,000 adult patients in the U.S. and can be a severe, debilitating disease. To date, there are no disease-targeted therapies approved for AIHA, despite the unmet medical need that exists for these patients.

About R8351

The investigational candidate, R835, is an orally available, potent and selective inhibitor of IRAK1 and IRAK4 that has been shown preclinically to block inflammatory cytokine production in response to toll-like receptor (TLR) and the interleukin-1 receptor (IL-1R) family signaling. TLRs and IL-1Rs play a critical role in the innate immune response and dysregulation of these pathways can lead to a variety of inflammatory conditions. R835 is active in multiple rodent models of inflammatory disease including psoriasis, arthritis, lupus, multiple sclerosis and gout. The safety and efficacy of R835 has not been established by the FDA or any healthcare authority.

Conference Call and Webcast with Slides Today at 4:30PM Eastern Time
Rigel will hold a live conference call and webcast today at 4:30pm Eastern Time (1:30pm Pacific Time).

Participants can access the live conference call by dialing (877) 407-8309 (domestic) or (201) 689-8057 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay after the call via the Rigel website.

About TAVALISSE
Indication

TAVALISSE (fostamatinib disodium hexahydrate) tablets is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.

Important Safety Information
Warnings and Precautions

·Hypertension can occur with TAVALISSE treatment. Patients with pre-existing hypertension may be more susceptible to the hypertensive effects. Monitor blood pressure every 2 weeks until stable, then monthly, and adjust or initiate antihypertensive therapy for blood pressure control maintenance during therapy. If increased blood pressure persists, TAVALISSE interruption, reduction, or discontinuation may be required.

· Elevated liver function tests (LFTs), mainly ALT and AST, can occur with TAVALISSE. Monitor LFTs monthly during treatment. If ALT or AST increase to >3 x upper limit of normal, manage hepatotoxicity using TAVALISSE interruption, reduction, or discontinuation.

· Diarrhea occurred in 31% of patients and severe diarrhea occurred in 1% of patients treated with TAVALISSE. Monitor patients for the development of diarrhea and manage using supportive care measures early after the onset of symptoms. If diarrhea becomes severe (≥Grade 3), interrupt, reduce dose or discontinue TAVALISSE.

· Neutropenia occurred in 6% of patients treated with TAVALISSE; febrile neutropenia occurred in 1% of patients. Monitor the ANC monthly and for infection during treatment. Manage toxicity with TAVALISSE interruption, reduction, or discontinuation.

·TAVALISSE can cause fetal harm when administered to pregnant women. Advise pregnant women the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for at least 1 month after the last dose. Verify pregnancy status prior to initiating TAVALISSE. It is unknown if TAVALISSE or its metabolite is present in human milk. Because of the potential for serious adverse reactions in a breastfed child, advise a lactating woman not to breastfeed during TAVALISSE treatment and for at least 1 month after the last dose.

Drug Interactions

· Concomitant use of TAVALISSE with strong CYP3A4 inhibitors increases exposure to the major active metabolite of TAVALISSE (R406), which may increase the risk of adverse reactions. Monitor for toxicities that may require a reduction in TAVALISSE dose.

· It is not recommended to use TAVALISSE with strong CYP3A4 inducers, as concomitant use reduces exposure to R406.

· Concomitant use of TAVALISSE may increase concentrations of some CYP3A4 substrate drugs and may require a dose reduction of the CYP3A4 substrate drug.

· Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (e.g., rosuvastatin) and P-Glycoprotein (P-gp) substrate drugs (e.g., digoxin), which may require a dose reduction of the BCRP and P-gp substrate drug.

Adverse Reactions

·Serious adverse drug reactions in the ITP double-blind studies were febrile neutropenia, diarrhea, pneumonia, and hypertensive crisis, which occurred in 1% of TAVALISSE patients. In addition, severe adverse reactions occurred including dyspnea and hypertension (both 2%), neutropenia, arthralgia, chest pain, diarrhea, dizziness, nephrolithiasis, pain in extremity, toothache, syncope, and hypoxia (all 1%).

·Common adverse reactions (≥5% and more common than placebo) from FIT-1 and FIT-2 included: diarrhea, hypertension, nausea, dizziness, ALT and AST increased, respiratory infection, rash, abdominal pain, fatigue, chest pain, and neutropenia.

Please see www.TAVALISSE.com for full Prescribing Information.

To report side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088 (800-332-1088).

TAVALISSE is a registered trademark of Rigel Pharmaceuticals, Inc.

On August 6, 2019 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 Tim Van Hauwermeiren, Chief Executive Officer, will present at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019 at 10:55 am ET in New York (Press release, argenx, AUG 6, 2019, View Source [SID1234538209]).

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The live webcast may be accessed on the homepage of the argenx website at www.argenx.com. Shortly after the presentation, a replay of the webcast will be available for 90 days on the argenx website.

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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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.

On August 6, 2019 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the second quarter ended June 30, 2019 (Press release, Guardant Health, AUG 6, 2019, View Source [SID1234538251]).
Recent Highlights

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Total revenue for the second quarter of 2019 was $54.0 million, a 178% increase over the second quarter of 2018

Reported 11,875 tests to clinical customers and 5,285 tests to biopharmaceutical customers in the second quarter of 2019, representing increases of 77% and 112%, respectively, over the second quarter 2018

Results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting demonstrated LUNAR RUO assay’s ability to identify early-stage colorectal cancer patients with post-operative molecular residual disease who may benefit from adjuvant therapy. Guardant remains on track to release a CLIA-validated version of the LUNAR assay for prospective clinical trials by the end of 2019

Announced plans to enroll first patient in ECLIPSE, a prospective colorectal screening study, by fourth quarter 2019

Completed an underwritten public offering raising $349.7 million in net proceeds
"During the quarter, the Guardant team made significant progress across multiple areas of our business in support of our mission to expand unprecedented access to cancer’s molecular information throughout all stages of the disease," said Helmy Eltoukhy, PhD, Chief Executive Officer. "We are especially encouraged by the strong adoption of Guardant360 and GuardantOMNI which we are seeing, even in the early phases of shifting the market to a blood-first paradigm for genomic testing."
Second Quarter 2019 Financial Results
Guardant Health adopted a new revenue recognition standard ("ASC 606") effective January 1, 2019, which primarily impacted the company’s recognition of revenue related to patient claims paid by third-party commercial and governmental payors. The company adopted ASC 606 using the modified retrospective method, which means that the total amount of revenue reported for the second quarter 2018 has not been restated in the current financial statements. Instead, the accumulated difference resulting from applying the new revenue standard to all contracts that were not completed as of adoption was recorded to accumulated deficit as of January 1, 2019.
Total revenue was $54.0 million for the three months ended June 30, 2019, a 178% increase from $19.4 million for the corresponding prior year period. Without the adoption of ASC 606, total revenue for the three months ended June 30, 2019 would have been $53.6 million, a 177% increase over the corresponding prior year period. Precision oncology revenue increased 136% driven by higher testing volume and increased revenue per test. There were 11,875 clinical tests and 5,285 biopharmaceutical tests performed during the second quarter of 2019. Development services revenue increased 664% primarily from new projects in 2019 related to companion diagnostic development and regulatory approval services for biopharmaceutical customers.
Gross profit, or total revenue less cost of precision oncology testing and cost of development services, was $37.1 million for the second quarter of 2019, an increase of $27.7 million from $9.4 million in the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 69% as compared to 49% in the corresponding prior year period.
Total operating expenses were $52.4 million for the second quarter of 2019, as compared to $32.1 million in the corresponding prior year period, an increase of 63%.
Net loss attributable to Guardant Health, Inc. common stockholders was $11.6 million in the second quarter of 2019 as compared to $21.6 million in the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.13 in the second quarter of 2019, as compared to $1.75 in the corresponding prior year period.
Cash, cash equivalents and marketable securities were $822.9 million as of June 30, 2019.
2019 Financial Guidance
Guardant Health now expects full year 2019 total revenue to be in the range of $180 million to $190 million, representing 99% to 110% growth over the full year 2018. This compares to the company’s previous full year 2019 total revenue guidance of $145 to $150 million.

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Webcast and Conference Call Information
Guardant Health will host a conference call to discuss the second quarter 2019 financial results after market close on Tuesday, August 6, 2019 at 4:30 PM Eastern Time. The conference call can be accessed live over the phone (866) 417-5537 for U.S. callers or (409) 217-8233 for international callers (Conference ID: 3666557). The webcast can be accessed at View Source