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

On August 6, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer therapies, reported financial results for the second quarter ended June 30, 2019 and provided corporate updates (Press release, Arcus Biosciences, AUG 6, 2019, View Source [SID1234538193]).

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"For our lead program, AB928, the first dual adenosine receptor antagonist designed for use in oncology, we have demonstrated excellent safety, maximal receptor coverage, and PK/PD correlation in three different combination regimens. This has enabled broad Phase 1b expansion across multiple tumor types, now including prostate cancer, and we look forward to reporting initial results in mid-2020," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "Arcus’s emphasis on selecting science-driven clinical combinations, adaptive clinical design, and an early commitment to clinical and commercial integration provide a framework that enables us to be well positioned to maximize clinical and commercial value from our pioneering drug discovery efforts in the adenosine space and potentially best-in-class molecules."

Recent Corporate Highlights

In addition to the identification of the recommended dose for expansion (RDE) for AB928 in combination with AB122, identified 150 mg once a day as the RDE for two additional combination regimens:

AB928 with pegylated liposomal doxorubicin (PLD, Doxil)

AB928 with mFOLFOX

Initiated broad Phase 1b expansions for AB928 in combinations with AB122 and/or chemotherapy across multiple tumor types.

This expansion includes metastatic castration resistant prostate cancer (mCRPC) across multiple lines of therapy. The company also plans to explore additional combinations across multiple lines of therapy in mCRPC.

Received IND clearance to initiate a biomarker-selected trial of single-agent AB122 in advanced solid tumors, in collaboration with Strata Oncology, using Strata’s proprietary biomarkers which, using observational study data, have demonstrated potential predictive power for anti-PD-1 efficacy across multiple tumor types.

Reported initial PK data from the healthy volunteer Phase 1 study of AB680, the first small-molecule CD73 inhibitor to enter the clinic, which support an every-two-weeks (Q2W) dosing schedule. Received IND clearance to initiate a Phase 1/1b trial of AB680, in combination with AB122 and chemotherapy, in first-line metastatic pancreatic cancer.

Announced the appointment of Eric Hoefer to Chief Commercial Officer. During the span of Mr. Hoefer’s 20-year career in biopharma, he has been instrumental to the development and commercialization of 15 new medicines, including Avastin, Tarceva, Tecentriq, and Imfinzi. Mr. Hoefer was most recently at AstraZeneca, where he led Immuno-oncology (IO) Global Marketing.

Anticipated Upcoming (2H 2019) Milestones

AB928 (dual adenosine receptor antagonist):

Initiate Phase 1 safety dose-escalation in combination with PLD and IPI-549, a phosphoinositide-3-kinase-gamma (PI3Kg) inhibitor, in triple-negative breast cancer (TNBC) in collaboration with Infinity Pharmaceuticals.

Initiate Phase 1b expansion in combination with AB122, carboplatin and pemetrexed in EGFR-mutated non-small cell lung cancer (NSCLC) patients who have failed tyrosine kinase inhibitor (TKI) therapy.

Present additional safety, PK/PD and translational data from the Phase 1 safety dose-escalation portion of the AB928 combination trials at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Meeting at the end of September in Barcelona, Spain.

AB680 (small-molecule CD73 inhibitor):

Initiate Phase 1 safety dose-escalation in combination with AB122, gemcitabine (Gemzar) and nab-paclitaxel (Abraxane) in patients with first-line metastatic pancreatic cancer.

AB122 (anti-PD-1 antibody):

Initiate a tumor-type agnostic biomarker-selected trial of single-agent AB122 in advanced solid tumors in collaboration with Strata Oncology.

AB154 (anti-TIGIT antibody):

Report preliminary safety and PK/PD data from the Phase 1 safety dose-escalation and initiate an expansion study in combination with AB122 in NSCLC.

Discovery Programs:

Identify a potentially best-in-class clinical development candidate targeting HIF-2α.

Please refer to Arcus’s pipeline at www.arcusbio.com for the company’s most current pipeline and development plans.

Financial Results for the Second Quarter 2019

Cash, cash equivalents and investments in marketable securities were $224.4 million as of the second quarter ended June 30, 2019, compared to $243.1 million at March 31, 2019. The decrease was primarily due to the utilization of cash to fund our operations. Based on our current operating plans, we anticipate that our cash, cash equivalents and investments in marketable securities will be sufficient to fund operations into 2021.

Revenues: Collaboration and license revenue for the second quarter ended June 30, 2019 was $1.8 million, compared to $1.3 million for the same period in 2018. The increase in revenue was primarily attributable to the impact of our adoption of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). Under ASC 606, additional revenue was recognized from our option and license agreement with Taiho Pharmaceutical due to remeasurement of the initial transaction price upon adoption of the new standard. Collaboration and license revenue for the six months ended June 30, 2019 was $3.5 million, compared to $2.5 million for the same period in 2018.

R&D Expenses: Research and development expenses for the second quarter ended June 30, 2019 were $25.0 million, compared to $13.7 million for the same period in 2018. The increase in research and development expenses was primarily due to an increase in clinical activities for our ongoing clinical programs, an increase in R&D headcount, and includes a $7.5 million expense pertaining to the achievement of a clinical development milestone pursuant to our license agreement with WuXi Biologics. Research and development expenses for the six months ended June 30, 2019 were $40.6 million, compared to $25.4 million for the same period in 2018.

G&A Expenses: General and administrative expenses for the second quarter ended June 30, 2019 were $5.9 million, compared to $3.5 million for the same period in 2018. Higher general and administrative expenses were primarily due to an increase in G&A headcount and related costs, as well as costs related to operations as a public company. General and administrative expenses for the six months ended June 30, 2019 were $10.9 million, compared to $6.4 million for the same period in 2018.

Net Loss: Net loss for the second quarter ended June 30, 2019 was $28.1 million, compared to $13.5 million for the same period in 2018. The increase in net loss was primarily attributable to an increase in operating expenses noted above partially offset by an increase in revenues. Net loss for the six months ended June 30, 2019 was $45.8 million, compared to $26.5 million for the same period in 2018.

On August 6, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the fourth quarter ended June 30, 2019 (Press release, Bio-Techne, AUG 6, 2019, View Source [SID1234538210]).

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Fourth Quarter FY2019 Snapshot

Fourth quarter organic growth of 7% (6% reported) to $191.7 million. Full year organic growth of 10% (11% reported) to $714.0 million.
GAAP EPS was $0.42 vs. $1.08 one year ago. Delivered adjusted earnings per share (EPS) of $1.25 vs. $1.34 one year ago. Full year GAAP EPS was $2.47 vs $3.31 one year ago. Full year adjusted EPS was $4.51 vs $4.54 in the prior year despite foreign currency exchange headwinds negatively impacting fiscal year results by $0.14 or 3%.
Protein Sciences Segment delivered 9% organic growth in FY19 Q4. The segment achieved full year organic growth of 13%.
The U.S. Food and Drug Administration granted breakthrough device designation to ExoDx Prostate IntelliScore (EPI) making it the first exosome-based liquid biopsy test to receive a breathrough device designation.
Acquired B-MoGen Biotechnologies Inc. with technology specializing in solving the most complex gene editing problems with proprietary, cutting edge non-viral gene editing and delivery tools.
The company’s consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted dilutive EPS, adjusted net earnings, adjusted gross margin, adjusted operating income, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"We are pleased to deliver strong results in the fourth quarter and finish a phenomenal fiscal year 2019 with 10% organic growth," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Our teams executed well all year on both the top and bottom-line, exceeding market growth in our portfolio of research reagents and instruments."

Kummeth added, "While our Diagnostics tools division was adversely impacted this quarter by the timing of OEM order flow, our Genomics division continues to be in full recovery from earlier in the year and again, topped 20% organic growth in Q4. We also received exciting news that our EPI liquid-biopsy test for prostate cancer was granted breakthrough device designation by the U.S. FDA. To date, over 25,000 EPI tests have already been conducted. Now with FDA support and the draft Local Coverage Decision for EPI issued in May by the National Government Services (NGS), ExosomeDx is in strong position for a full commercialization ramp in FY20."

Kummeth concluded, "All in all, a solid quarter and a truly outstanding year for the company. I am delighted with the performance of our entire Bio-Techne team."

Fourth Quarter Fiscal 2019

Revenue

Net sales for the fourth quarter increased 6% to $191.7 million. Organic growth was 7%, with currency translation having an unfavorable impact of 2% and acquisitions contributing 1% to revenue growth.

GAAP Earnings Results

GAAP EPS was $0.42 per diluted share, versus $1.08 in the same quarter last year. The decrease was driven by changes in the fair value of our CCXI investment, which impacted year over year GAAP EPS by $0.91 per share, partially offset by a gain on our historical investment in B-MoGen of $0.09, which was recognized upon acquisition. GAAP operating income for the fourth quarter of fiscal 2019 increased 1% to $43.3 million, compared with $42.9 million in the fourth quarter of fiscal 2018. GAAP operating margin was 22.6%, compared to 23.8% in the fourth quarter of fiscal 2018. GAAP operating margin compared to prior year was impacted by negative margin acquisitions, namely ExosomeDx.

Non-GAAP Earnings Results

Adjusted EPS was $1.25 per diluted share, versus $1.34 in the same quarter last year. Adjusted operating margin for the fourth quarter of fiscal 2019 decreased to 35.1%, compared with 39.5% in the fourth quarter of fiscal 2018. Adjusted operating margin compared to prior year was impacted by negative margin acquisitions, namely ExosomeDx.

Full Year Fiscal 2019

Revenue

Net sales for the full year fiscal 2019 increased 11% to $714.0 million. Organic growth was 10%, with currency translation having an unfavorable impact of 1% and acquisitions contributing 2% to revenue growth.

GAAP Earnings Results

GAAP EPS decreased to $2.47 per diluted share, versus $3.31 last fiscal year. GAAP operating income for full year fiscal 2019 increased 8% to $146.7 million, compared with $136.2 million in the full year fiscal 2018. GAAP operating margin was 20.5%, compared to 21.2% in the full year fiscal 2018. GAAP operating margin compared to prior year was impacted by unfavorable foreign currency exchange rates and negative margin acquisitions, namely ExosomeDx.

Non-GAAP Earnings Results

Adjusted EPS was $4.51 per diluted share, versus $4.54 in full fiscal year 2018. Adjusted operating margin for full fiscal year 2019 decreased to 34.1%, compared with 37.1% in full year fiscal 2018. Adjusted operating margin compared to prior year was impacted impacted by unfavorable foreign currency exchange rates and negative margin acquisitions, namely ExosomeDx.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology community. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s fourth quarter fiscal 2019 net sales were $143.4 million, an increase of 7% from $133.9 million for the fourth quarter of fiscal 2018. Organic growth for the segment was 9%, with currency translation having an unfavorable impact of 2% on revenue growth. Protein Sciences segment’s operating margin was 45.4% in the fourth quarter of fiscal 2019 compared to 44.5% in the fourth quarter of fiscal 2018. Segment operating margin compared to the prior year was positively impacted by volume leverage and operational productivity.

Protein Sciences segment’s full year fiscal 2019 net sales were $543.2 million, an increase of 13% from $482 million for fiscal 2018. Organic growth for the segment was 13% for the fiscal year, with currency translation having an unfavorable impact of 2% on revenue growth and acquisitions contributing 2%. Protein Sciences segment’s operating margin was 44.4% in fiscal 2019 compared to 43.5% in fiscal 2018. The higher operating margin was driven by strong volume leverage and operational productivity.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, diagnostics immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s fourth quarter fiscal 2019 net sales were $48.5 million, an increase of 4% from $46.6 million for the fourth quarter of fiscal 2018. Organic growth for the segment was 2%, with currency translation having an unfavorable impact of 1% on revenue growth and acquisitions contributing 3% to revenue growth. The Diagnostics and Genomics segment operating margin was 10.3% in the fourth quarter of fiscal 2019 compared to 27.2% in the fourth quarter of fiscal 2018. Segment operating margin compared to the prior year was impacted by negative operating margins for acquisitions made in the segment, namely ExosomeDx.

The Diagnostics segment’s full year fiscal 2019 net sales were $171.7 million, an increase of 7% from $161.2 million for fiscal 2018. Organic growth for the segment was 4%, with acquisitions contributing 3% to revenue growth. The Diagnostics segment’s operating margin was 5.9% in fiscal 2019 compared to 22.0% in fiscal 2018. Operating margin was impacted by negative operating margins for acquisitions made in the segment, namely ExosomeDx.

Conference Call

Bio-Techne will host an earnings conference call today, Tuesday, August 6, 2019, at 8:00 a.m. CST. To listen, please dial 1-888-394-8218 or 1-323-701-0225 for international callers, and reference conference ID 9336552. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call. To access the replay, U.S. callers should dial 1-844-512-2921 or international callers should dial 1-412-317-6671, and enter the replay access code 9336552. The replay can also be accessed by going to: View Source

The replay will be available from 11:00 a.m. CDT on Tuesday, August 6, 2019, until 11:00 p.m. CDT on Friday, September 6, 2019.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic Growth
Adjusted diluted earnings per share
Adjusted net earnings
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months as well as the impact of foreign currency. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, and acquisition related expenses. The Company excludes amortization of purchased intangible assets and purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses, from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

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 Myovant Sciences (NYSE: MYOV), a clinical-stage healthcare company focused on developing and commercializing innovative therapies for women’s health and prostate cancer, reported recent corporate updates and reported financial results for the first fiscal quarter ended June 30, 2019 (Press release, Myovant Sciences, AUG 6, 2019, View Source [SID1234538252]).

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"Myovant Sciences recently announced positive top-line data for the LIBERTY 1 and LIBERTY 2 studies evaluating relugolix combination therapy in women with uterine fibroids, as well as the positive results from a separate bioequivalence study supporting a potential one pill, once-a-day dosing regimen of relugolix combination therapy," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "These results confirm the potential of relugolix to offer a constellation of attributes in a single pill, taken once-a-day and we are now focused on preparing for the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which we plan to file by the end of this calendar year. We also look forward to reporting data from our Phase 3 prostate cancer study later this calendar year and results from our two Phase 3 endometriosis studies in the first and second quarters of calendar year 2020."
First Fiscal Quarter 2019 and Recent Business Highlights
Relugolix Phase 3 Clinical Programs

On May 14, 2019, Myovant Sciences announced positive top-line results from the LIBERTY 1 Phase 3 study evaluating relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) once-a-day in women with uterine fibroids and heavy menstrual bleeding. The study met its primary endpoint with a p-value of <0.0001 and achieved six key secondary endpoints with a well-tolerated safety profile.

On July 23, 2019, Myovant Sciences announced positive top-line results from the LIBERTY 2 Phase 3 study evaluating relugolix combination therapy in women with uterine fibroids and heavy menstrual bleeding. This study also met its primary endpoint with a p-value of <0.0001 and achieved six key secondary endpoints with a well-tolerated safety profile.

On July 23, 2019, Myovant Sciences also announced that the single-tablet relugolix combination therapy met all required FDA criteria in a separate bioequivalence study supporting a potential one-pill, once-a-day dosing regimen of relugolix.

Based on the positive top-line results for LIBERTY 1 and LIBERTY 2, Myovant Sciences currently plans to submit an NDA for one-pill, once-a-day relugolix combination therapy for the treatment of heavy menstrual bleeding and uterine fibroids to the FDA in the fourth quarter of calendar year 2019 and the Marketing Authorisation Application to the European Medicines Agency in the first quarter of calendar year 2020.

Enrollment of approximately 130 additional men with metastatic prostate cancer in the Phase 3 HERO study was completed in July 2019. The objective of enrolling these men was to assess the secondary objective of demonstrating that relugolix can delay the time to progression of the lethal state of the disease, castration-resistant prostate cancer, as compared to leuprolide.
MVT-602 Clinical Program

Myovant Sciences completed a successful dose-finding pharmacokinetic/pharmacodynamic Phase 2a study of MVT-602, a kisspeptin-1 receptor agonist, in healthy women undergoing a minimal controlled ovarian stimulation protocol. Top-line results were presented at the European Society of Human Reproduction in Vienna, Austria in June 2019. The study demonstrated that MVT-602 was generally well-tolerated and produced the desired luteinizing hormone surge associated with high and dose-dependent rates of ovulation in healthy women following a minimal controlled ovarian stimulation protocol.
Corporate

On June 4, 2019, Myovant Sciences completed an underwritten public equity offering, receiving net proceeds of approximately $134.5 million.

In the first quarter of fiscal year 2019, Myovant Sciences received aggregate net proceeds of $2.5 million pursuant to the issuance of common shares under its "at-the-market" equity offering program.
First Fiscal Quarter 2019 Financial Summary
Research and development (R&D) expenses for the quarter ended June 30, 2019, were $51.1 million compared to $51.3 million for the comparable prior year period. The composition of R&D expenses in both periods is similar, and primarily includes expenses related to Myovant Sciences’ Phase 3 clinical studies as well as personnel-related expenses for employees engaged in R&D activities. R&D expenses for the quarter ended June 30, 2018 reflected a ramp up in relugolix Phase 3 study costs primarily related to study enrollment, whereas R&D expenses for the quarter ended June 30, 2019 reflect lower relugolix Phase 3 study costs as certain studies are in the process of winding down. The decrease in relugolix Phase 3 study costs were partially offset by increases in other R&D spending related to Myovant Sciences’ preparations to seek regulatory approval for its product candidates.
General and administrative (G&A) expenses for the quarter ended June 30, 2019, were $14.2 million compared to $8.7 million for the comparable prior year period. The increase primarily reflects increases in personnel-related expenses, professional service fees, share-based compensation, and other general overhead and administrative expenses to support Myovant Sciences’ headcount growth and expanding operations.
Interest expense for the quarter ended June 30, 2019, was $3.8 million compared to $1.6 million in the comparable prior year period. The increase for the quarter was primarily the result of higher outstanding debt balances under the financing agreements as compared to the prior year period.
Interest income for the quarter ended June 30, 2019, was $0.8 million. There was no interest income for the quarter ended June 30, 2018. During the quarter ended June 30, 2019, a portion of Myovant Sciences’ cash was invested in a combination of money market funds and commercial paper. There were no such investments during the prior year period.

Net loss for the quarter ended June 30, 2019, was $67.9 million, compared to $62.1 million for the comparable prior year period. On a per common share basis, net loss was $0.89 and $0.98 for the quarters ended June 30, 2019, and 2018, respectively. The increase in the net loss for the quarter was driven primarily by the increase in costs outlined above.
Capital resources: Cash and cash equivalents totaled $226.7 million as of June 30, 2019. During the quarter ended June 30, 2019, Myovant Sciences raised net proceeds of approximately $134.5 million from an underwritten public equity offering and approximately $2.5 million from its "at-the-market" equity offering program. Myovant Sciences currently has approximately $10.4 million of capacity available under the "at-the-market" equity offering program that it initiated in April 2018.

About Relugolix
Relugolix is a once-a-day, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol and progesterone production, hormones known to stimulate uterine fibroids and endometriosis. Myovant Sciences has successfully completed two Phase 3 clinical studies (LIBERTY 1 and LIBERTY 2) evaluating relugolix combination therapy (relugolix 40 mg plus 1.0 mg estradiol with 0.5 mg norethindrone acetate) in women with heavy menstrual bleeding and uterine fibroids and is studying relugolix combination therapy in two Phase 3 clinical studies (SPIRIT 1 and SPIRIT 2) in women with endometriosis-associated pain. Data from SPIRIT 2 and SPIRIT 1 are expected in the first and second quarters, respectively, of calendar year 2020. Relugolix also lowers testosterone in men, an androgen known to drive the growth of prostate cancer. Myovant Sciences is evaluating relugolix, 120 mg once-a-day, in the Phase 3 HERO study in men with advanced prostate cancer. Top-line results from the HERO study are expected in the fourth quarter of calendar year 2019.

About MVT-602

MVT-602 is an oligopeptide kisspeptin-1 receptor agonist. Kisspeptin, the ligand, is a naturally-occurring peptide that stimulates GnRH release and is required for puberty and maintenance of normal reproductive function, including production of sperm, follicular maturation and ovulation, and production of estrogen and progesterone in women and testosterone in men. A Phase 2a clinical study in healthy female volunteers to characterize the dose-response curve in a minimal controlled ovarian stimulation setting has been completed.