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Mettler-Toledo International Inc. Reports Second Quarter 2019 Results

On August 1, 2019 Mettler-Toledo International Inc. (NYSE: MTD) reported second quarter results for 2019. Provided below are the highlights (Press release, Mettler-Toledo, AUG 1, 2019, View Source [SID1234538049]):

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Reported sales increased 1% compared with the prior year. In local currency, sales increased 5% in the quarter as currency reduced sales growth by 4%.
Net earnings per diluted share as reported (EPS) were $5.06, compared with $4.31 in the prior-year period. Adjusted EPS was $5.16, an increase of 11% over the prior-year amount of $4.65. Adjusted EPS is a non-GAAP measure, and we have included a reconciliation to EPS on the last page of the attached schedules.
Second Quarter Results

Olivier Filliol, President and Chief Executive Officer, stated, "Sales growth was solid in the quarter with excellent growth in our Laboratory product lines and good growth in our Core Industrial business. Sales growth in the Americas and China was particularly strong while sales growth in Europe was impacted by strong prior-year comparisons. With the benefit of our margin initiatives, and despite significant challenges from the adverse impact of currency and tariff costs, we achieved strong growth in earnings in the quarter."

GAAP Results
EPS in the quarter was $5.06, compared with the prior-year amount of $4.31.

Compared with the prior year, total reported sales increased 1% to $731.4 million. By region, reported sales increased 7% in the Americas and 2% in Asia/Rest of World. Reported sales in Europe declined by 6%. Earnings before taxes amounted to $155.2 million, compared with $143.6 million in the prior year.

Non-GAAP Results
Adjusted EPS was $5.16, an increase of 11% over the prior-year amount of $4.65.

Compared with the prior year, total sales in local currency increased 5% as currency reduced reported sales growth by 4%. By region, local currency sales increased 7% in the Americas and 7% in Asia/Rest of World. Local currency sales declined 1% in Europe. Adjusted Operating Profit amounted to $177.7 million, a 5% increase from the prior-year amount of $169.3 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Six Month Results

GAAP Results
EPS was $9.48, compared with the prior-year amount of $7.88.

Compared with the prior year, total reported sales increased 2% to $1.411 billion. By region, reported sales increased 5% in the Americas and 3% in Asia/Rest of World. Reported sales in Europe declined 2%. Earnings before taxes amounted to $280.9 million, compared with $261.0 million in the prior year.

Non-GAAP Results
Adjusted EPS was $9.26, an increase of 11% over the prior-year amount of $8.38.

Compared with the prior year, total sales in local currency increased 6% as currency reduced reported sales growth by 4%. By region, local currency sales increased 5% in the Americas, 4% in Europe and 8% in Asia/Rest of World. Adjusted Operating Profit amounted to $325.6 million, a 5% increase from the prior-year amount of $308.8 million.

Adjusted EPS and Adjusted Operating Profit are non-GAAP measures. Reconciliations to the most comparable GAAP measures are provided in the attached schedules.

Outlook

The Company said that based on its assessment of market conditions today, management anticipates local currency sales growth in 2019 will be approximately 5%. This sales growth is expected to result in Adjusted EPS in the range of $22.60 to $22.75, a growth rate of 11% to 12%. This compares with previous Adjusted EPS guidance of $22.55 to $22.75.

Based on today’s assessment of market conditions, management anticipates that local currency sales growth in the third quarter 2019 will be in the range of 4% to 5%, and Adjusted EPS is forecasted to be in the range of $5.65 to $5.75, an increase of 10% to 12%.

While the Company has provided an outlook for local currency sales growth and Adjusted EPS, it has not provided an outlook for reported sales growth or EPS as it would require an estimate of currency exchange fluctuations and non-recurring items, which are not yet known. The Company noted in making its outlook that economic uncertainty remains in certain regions of the world and market conditions are subject to change.

Conclusion

Filliol concluded, "With the exception of our Food Retail business, demand in our markets is favorable and our growth initiatives continue to generate tangible results. We assume market conditions will remain unchanged and our outlook for the third quarter is positive. As we look to the later part of the year, we acknowledge there is more uncertainty due to macroeconomic data. We remain focused on our growth strategy and believe we can continue to gain market share regardless of the economy. Based on market conditions today, we believe we can deliver strong results in 2019."

Other Matters

The Company will host a conference call to discuss its quarterly results today (Thursday, August 1) at 5:00 p.m. Eastern Time. To hear a live webcast or replay of the call, visit the investor relations page on the Company’s website at www.mt.com/investors. The presentation referenced in the conference call will be located on the website prior to the call.

Select Medical Holdings Corporation Announces Results For Its Second Quarter Ended June 30, 2019

On August 1, 2019 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM) reported results for its second quarter ended June 30, 2019 (Press release, Select Medical, AUG 1, 2019, View Source [SID1234538048]).

For the second quarter ended June 30, 2019, net operating revenues increased 5.0% to $1,361.4 million, compared to $1,296.2 million for the same quarter, prior year. Income from operations increased 3.6% to $124.9 million for the second quarter ended June 30, 2019, compared to $120.6 million for the same quarter, prior year. Net income was $60.0 million for the second quarter ended June 30, 2019, compared to $60.6 million for the same quarter, prior year. For the second quarter ended June 30, 2018, net income included a pre-tax non-operating gain of $6.5 million. Adjusted EBITDA increased 4.5% to $186.2 million for the second quarter ended June 30, 2019, compared to $178.2 million for the same quarter, prior year. Earnings per common share was $0.33 on a fully diluted basis for the second quarter ended June 30, 2019, compared to $0.35 for the same quarter, prior year. Excluding the non-operating gain and its related tax effects, adjusted earnings per common share was $0.31 on a fully diluted basis for the second quarter ended June 30, 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

For the six months ended June 30, 2019, net operating revenues increased 5.4% to $2,686.0 million, compared to $2,549.2 million for the same period, prior year. Income from operations increased 3.2% to $236.6 million for the six months ended June 30, 2019, compared to $229.2 million for the same period, prior year. Net income increased 8.4% to $113.3 million for the six months ended June 30, 2019, compared to $104.5 million for the same period, prior year. For the six months ended June 30, 2019, net income included a pre-tax non-operating gain of $6.5 million. For the six months ended June 30, 2018, net income included pre-tax losses on early retirement of debt of $10.3 million, pre-tax non-operating gains of $6.9 million, and pre-tax U.S. HealthWorks acquisition costs of $2.9 million. Adjusted EBITDA increased 4.4% to $356.4 million for the six months ended June 30, 2019, compared to $341.5 million for the same period, prior year. Earnings per common share increased to $0.63 on a fully diluted basis for the six months ended June 30, 2019, compared to $0.60 for the same period, prior year. Adjusted earnings per common share was $0.60 per diluted share for both the six months ended June 30, 2019 and 2018. For the six months ended June 30, 2019, adjusted earnings per common share excludes the non-operating gain and its related tax effects. For the six months ended June 30, 2018, adjusted income per common share excludes the losses on early retirement of debt, non-operating gains, U.S. HealthWorks acquisition costs, and their related tax effects. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of income per common share to adjusted income per common share is presented in table X of this release.

Company Overview

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Our reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of June 30, 2019, Select Medical operated 100 critical illness recovery hospitals in 28 states, 28 rehabilitation hospitals in 12 states, and 1,695 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 526 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At June 30, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

During the three months ended June 30, 2019, Select Medical began reporting the net operating revenues and expenses associated with employee leasing services provided to our non-consolidating subsidiaries as part of our other activities. Previously, these services were reflected in the financial results of our reportable segments. Under these employee leasing arrangements, actual labor costs are passed through to our non-consolidating subsidiaries, resulting in Select Medical’s recognition of net operating revenues equal to the actual labor costs incurred. Prior year results presented herein have been changed to conform to the current presentation.

Critical Illness Recovery Hospital Segment

For the second quarter ended June 30, 2019, net operating revenues for the critical illness recovery hospital segment increased 4.2% to $461.1 million, compared to $442.5 million for the same quarter, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 5.6% to $64.1 million for the second quarter ended June 30, 2019, compared to $60.7 million for the same quarter, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 13.9% for the second quarter ended June 30, 2019, compared to 13.7% for the same quarter, prior year. Certain critical illness recovery hospital key statistics are presented in table VII of this release for both the second quarters ended June 30, 2019 and 2018.

For the six months ended June 30, 2019, net operating revenues for the critical illness recovery hospital segment increased 1.3% to $918.7 million, compared to $907.1 million for the same period, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 2.6% to $137.1 million for the six months ended June 30, 2019, compared to $133.7 million for the same period, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 14.9% for the six months ended June 30, 2019, compared to 14.7% for the same period, prior year. Certain critical illness recovery hospital key statistics for both the six months ended June 30, 2019 and 2018 are presented in table VIII of this release.

Rehabilitation Hospital Segment

For the second quarter ended June 30, 2019, net operating revenues for the rehabilitation hospital segment increased 10.8% to $160.4 million, compared to $144.8 million for the same quarter, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 6.3% to $30.0 million for the second quarter ended June 30, 2019, compared to $28.2 million for the same quarter, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 18.7% for the second quarter ended June 30, 2019, compared to 19.5% for the same quarter, prior year. The Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $6.0 million for the second quarter ended June 30, 2019, compared to approximately $2.1 million of start-up losses for the same quarter, prior year. Certain rehabilitation hospital key statistics are presented in table VII of this release for both the second quarters ended June 30, 2019 and 2018.

For the six months ended June 30, 2019, net operating revenues for the rehabilitation hospital segment increased 9.3% to $314.9 million, compared to $288.1 million for the same period, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 1.4% to $55.8 million for the six months ended June 30, 2019, compared to $55.0 million for the same period, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 17.7% for the six months ended June 30, 2019, compared to 19.1% for the same period, prior year. The Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $8.8 million for the six months ended June 30, 2019, compared to approximately $3.0 million for the same period, prior year. Certain rehabilitation hospital key statistics for both the six months ended June 30, 2019 and 2018 are presented in table VIII of this release.

Outpatient Rehabilitation Segment

For the second quarter ended June 30, 2019, net operating revenues for the outpatient rehabilitation segment increased 3.1% to $261.9 million, compared to $253.9 million for the same quarter, prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 1.5% to $42.6 million for the second quarter ended June 30, 2019, compared to $41.9 million for the same quarter, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 16.3% for the second quarter ended June 30, 2019, compared to 16.5% for the same quarter, prior year. Certain outpatient rehabilitation key statistics are presented in table VII of this release for both the second quarters ended June 30, 2019 and 2018.

For the six months ended June 30, 2019, net operating revenues for the outpatient rehabilitation segment increased 2.1% to $508.8 million, compared to $498.1 million for the same period, prior year. Adjusted EBITDA for the outpatient rehabilitation segment was $71.6 million for the six months ended June 30, 2019, compared to $72.5 million for the same period, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 14.1% for the six months ended June 30, 2019, compared to 14.5% for the same period, prior year. Certain outpatient rehabilitation key statistics for both the six months ended June 30, 2019 and 2018 are presented in table VIII of this release.

Concentra Segment

The financial results for the Concentra segment include U.S. HealthWorks beginning February 1, 2018.

For the second quarter ended June 30, 2019, net operating revenues for the Concentra segment increased to $413.5 million, compared to $412.8 million for the same quarter, prior year. Adjusted EBITDA for the Concentra segment increased 4.8% to $76.1 million for the second quarter ended June 30, 2019, compared to $72.6 million for the same quarter, prior year. The Adjusted EBITDA margin for the Concentra segment was 18.4% for the second quarter ended June 30, 2019, compared to 17.6% for the same quarter, prior year. Certain Concentra key statistics are presented in table VII of this release for both the second quarters ended June 30, 2019 and 2018.

For the six months ended June 30, 2019, net operating revenues for the Concentra segment increased 5.3% to $809.8 million, compared to $768.9 million for the same period, prior year. Adjusted EBITDA for the Concentra segment increased 9.2% to $142.3 million for the six months ended June 30, 2019, compared to $130.4 million for the same period, prior year. The Adjusted EBITDA margin for the Concentra segment was 17.6% for the six months ended June 30, 2019, compared to 17.0% for the same period, prior year. Certain Concentra key statistics for both the six months ended June 30, 2019 and 2018 are presented in table VIII of this release.

Stock Repurchase Program

The board of directors of Select Medical has authorized a common stock repurchase program to repurchase up to $500.0 million worth of shares of its common stock. The program has been extended until December 31, 2019, and will remain in effect until then, unless further extended or earlier terminated by the board of directors. Stock repurchases under this program may be made in the open market or through privately negotiated transactions, and at times and in such amounts as Holdings deems appropriate. Holdings funds this program with cash on hand and borrowings under the Select revolving facility.

During the three and six months ended June 30, 2019, Holdings repurchased 902,313 shares at a cost of approximately $13.1 million, an average cost per share of $14.55, which includes transaction costs. Since the inception of the program through June 30, 2019, Holdings has repurchased 36,826,441 shares at a cost of approximately $327.9 million, or $8.90 per share, which includes transaction costs.

Issuance and Sale of Senior Notes

On August 1, 2019, Select Medical issued and sold $550.0 million aggregate principal amount of senior notes due August 15, 2026. Select Medical intends to use a portion of the net proceeds of the senior notes, together with a portion of the proceeds from the incremental term loan borrowings under its senior secured credit agreement (as described below), to redeem in full the $710 million 6.375% senior notes due 2021, to repay in full the outstanding borrowings under the revolving credit facility, and pay related fees and expenses associated with the financing.

Interest on the senior notes accrues at the rate of 6.250% per annum and is payable semi-annually in arrears on February 15 and August 15 of each year, commencing on February 15, 2020. The senior notes are senior unsecured obligations which are subordinated to all of our existing and future secured indebtedness, including the senior secured credit agreement. The senior notes rank equally in right of payment with all other existing and future senior unsecured indebtedness and senior in right of payment to all existing and future subordinated indebtedness. The senior notes are unconditionally guaranteed on a joint and several basis by each of Select Medical’s direct or indirect existing and future domestic restricted subsidiaries, other than certain non-guarantor subsidiaries.

Select Medical may redeem some or all of the senior notes prior to August 15, 2022 by paying a "make-whole" premium. Select Medical may redeem some or all of the senior notes on or after August 15, 2022 at specified redemption prices. In addition, prior to August 15, 2022, Select Medical may redeem up to 40% of the principal amount of the senior notes with the net proceeds of certain equity offerings at a price of 106.250% plus accrued and unpaid interest, if any. Select Medical is obligated to offer to repurchase the senior notes at a price of 101% of their principal amount plus accrued and unpaid interest, if any, as a result of certain change of control events. These restrictions and prohibitions are subject to certain qualifications and exceptions.

The terms of the senior notes contains covenants that, among other things, limit Select Medical’s ability and the ability of certain of its subsidiaries to (i) grant liens on its assets, (ii) make dividend payments, other distributions or other restricted payments, (iii) incur restrictions on the ability of its restricted subsidiaries to pay dividends or make other payments, (iv) enter into sale and leaseback transactions, (v) merge, consolidate, transfer or dispose of substantially all of their assets, (vi) incur additional indebtedness, (vii) make investments, (viii) sell assets, including capital stock of subsidiaries, (ix) use the proceeds from sales of assets, including capital stock of restricted subsidiaries, and (x) enter into transactions with affiliates. These covenants are subject to a number of exceptions, limitations and qualifications.

Amendment to Senior Secured Credit Agreement

On August 1, 2019, Select Medical entered into Amendment No. 3 to its senior secured credit agreement dated March 6, 2017. Among other things, the amendment (i) provided for an additional $500.0 million in term loans that, along with the existing term loan, have a maturity date of March 6, 2025, (ii) extended the maturity date of the revolving credit facility from March 6, 2022 to March 6, 2024, and (iii) increased the total net leverage ratio permitted under the senior secured credit agreement.

Business Outlook

Select Medical reaffirms its 2019 business outlook, provided most recently in its May 2, 2019 press release, for net operating revenues, Adjusted EBITDA, and fully diluted earnings per common share. Select Medical continues to expect consolidated net operating revenues for the full year 2019 to be in the range of $5.2 billion to $5.4 billion. Select Medical continues to expect Adjusted EBITDA for the full year 2019 to be in the range of $660.0 million to $700.0 million. Select Medical continues to expect fully diluted earnings per common share for the full year 2019 to be in the range of $1.00 to $1.16. Select Medical expects adjusted earnings per common share to be in the range of $0.97 to $1.13. Adjusted earnings per common share excludes the non-operating gain and its related tax effects. The above estimates do not include the effects of the financing transactions which closed on August 1, 2019.

Conference Call

Select Medical will host a conference call regarding its second quarter results, as well as its business outlook, on Friday, August 2, 2019, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 5489707. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, August 9, 2019. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 5489707. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

Certain statements contained herein that are not descriptions of historical facts are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements due to factors including the following:

changes in government reimbursement for our services and/or new payment policies may result in a reduction in net operating revenues, an increase in costs, and a reduction in profitability;

the failure of our Medicare-certified long term care hospitals or inpatient rehabilitation facilities to maintain their Medicare certifications may cause our net operating revenues and profitability to decline;

the failure of our Medicare-certified long term care hospitals and inpatient rehabilitation facilities operated as "hospitals within hospitals" to qualify as hospitals separate from their host hospitals may cause our net operating revenues and profitability to decline;

a government investigation or assertion that we have violated applicable regulations may result in sanctions or reputational harm and increased costs;

acquisitions or joint ventures may prove difficult or unsuccessful, use significant resources or expose us to unforeseen liabilities;

our plans and expectations related to our acquisitions, including the acquisition of U.S. HealthWorks by Concentra, and our ability to realize anticipated synergies;

private third-party payors for our services may adopt payment policies that could limit our future net operating revenues and profitability;

the failure to maintain established relationships with the physicians in the areas we serve could reduce our net operating revenues and profitability;

shortages in qualified nurses, therapists, physicians, or other licensed providers could increase our operating costs significantly or limit our ability to staff our facilities;

competition may limit our ability to grow and result in a decrease in our net operating revenues and profitability;

the loss of key members of our management team could significantly disrupt our operations;

the effect of claims asserted against us could subject us to substantial uninsured liabilities;

a security breach of our or our third-party vendors’ information technology systems may subject us to potential legal and reputational harm and may result in a violation of the Health Insurance Portability and Accountability Act of 1996 or the Health Information Technology for Economic and Clinical Health Act; and

other factors discussed from time to time in our filings with the Securities and Exchange Commission (the "SEC"), including factors discussed under the heading "Risk Factors" of the quarterly reports on Form 10-Q and of the annual report on Form 10-K for the year ended December 31, 2018.
Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements, whether as a result of any new information, future events, or otherwise. You should not place undue reliance on our forward-looking statements. Although we believe that the expectations reflected in forward-looking statements are reasonable, we cannot guarantee future results or performance.

bluebird bio Reports Second Quarter 2019 Financial Results and Highlights Operational Progress

On August 1, 2019 bluebird bio, Inc. (NASDAQ: BLUE) reported financial results and business highlights for the second quarter ended June 30, 2019 (Press release, bluebird bio, AUG 1, 2019, View Source [SID1234538047]).

"With the approval of our first gene therapy, bluebird bio has entered into an exciting, and potentially transformative time for patients and for the company. We are focused on getting our qualified treatment centers up and running in Europe, ensuring we are prepared to deliver ZYNTEGLO to patients, and advancing the implementation of our value and outcomes-based payment model," said Nick Leschly, chief bluebird. "In the weeks since announcing our approval, we have been encouraged by our progress across these fronts and by the receptivity to our payment model from payers in our initial European launch markets. In the second half of the year, we are focused on executing our clinical studies as well as initiating new studies in sickle cell disease, multiple myeloma, and early stage oncology programs. I am incredibly grateful for our amazing and growing flock of bluebirds who are working to ensure that we do our best for patients every day."

Recent Highlights:

TDT

EU CONDITIONAL MARKETING AUTHORIZATION – In June 2019, bluebird bio announced that the European Commission (EC) granted conditional marketing authorization for ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene, known as LentiGlobin for TDT), a gene therapy for patients 12 years and older with transfusion-dependent β-thalassemia (TDT) who do not have a β0/β0 genotype, for whom hematopoietic stem cell (HSC) transplantation is appropriate but a human leukocyte antigen (HLA)-matched related HSC donor is not available. The PRIME and Adaptive Pathway programs allowed for early and enhanced dialogue and accelerated assessment of ZYNTEGLO, which was completed on the shortest timetable for an advanced therapy medicinal product (ATMP) by the EMA to date. ZYNTEGLO is bluebird bio’s first gene therapy to gain regulatory approval. bluebird bio will continue the country-by-country reimbursement process to help ensure access to ZYNTEGLO for appropriate patients.
DATA FROM NORTHSTAR, NORTHSTAR-2 AND NORTHSTAR-3 PRESENTED – At the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress in June 2019, bluebird bio presented new data from its studies of LentiGlobin in patients with TDT: long-term data from the completed Phase 1/2 Northstar study (HGB-204), updated data from the Phase 3 Northstar-2 study (HGB-207) in patients with non-β0/β0 genotypes, and updated data from the Phase 3 Northstar-3 study (HGB-212) in patients with β0/β0 genotypes or an IVS-I-110 mutation.
SCD

DATA FROM HGB-206 PRESENTED – At EHA (Free EHA Whitepaper) in June 2019, bluebird bio presented new data from patients in Group C of its ongoing Phase 1/2 HGB-206 study of the company’s investigational LentiGlobin gene therapy for sickle cell disease (SCD). Group C patients are being treated under an updated study protocol, which includes the implementation of mobilization and apheresis with plerixafor.
TDT & SCD

HGB-205 STUDY COMPLETION – In February 2019, the final patient completed primary follow up in the HGB-205 study of patients with TDT and SCD. All patients will continue to be monitored for long term outcomes.
COMPANY

ANALYST DAY – In May 2019, bluebird bio hosted an analyst day in New York that highlighted significant progress in the company’s emerging immuno-oncology and severe genetic disease pipeline, launch plans for its first gene therapy product, and key aspects of its long-term growth strategy. bluebird bio also announced a new research collaboration with Seattle Children’s Research Institute in Acute Myeloid Leukemia (AML), a planned Phase 1/2 study in Merkel Cell Carcinoma (MCC) in collaboration with the Fred Hutchinson Cancer Research Center and preclinical programs in Diffuse Large B-cell Lymphoma (DLBCL), MAGE-A4 positive solid tumors and Mucopolysaccharidosis (MPSI).
Upcoming Anticipated Milestones:

TDT
Initiation of a rolling Biologics Licensing Application submission to the U.S. FDA for ZYNTEGLO in patients with TDT and non-β0/β0 genotypes by the end of 2019
Presentation of ZYNTEGLO clinical data from the Northstar-2 (HGB-207) clinical study in patients with TDT and non-β0/β0 genotypes by the end of 2019
Presentation of ZYNTEGLO clinical data from the Northstar-3 (HGB-212) clinical study in patients with TDT and a β0/β0 genotype or an IVS-I-110 mutation by the end of 2019
SCD
Initiation of Phase 3 HGB-210 study of LentiGlobin in patients with SCD by the end of 2019
Presentation of LentiGlobin clinical data from the HGB-206 clinical study in patients with SCD by the end of 2019
Multiple Myeloma
ide-cel clinical data update from the registration-enabling KarMMa study in patients with relapsed/refractory multiple myeloma by the end of 2019
Presentation of bb21217 clinical data from the CRB-402 clinical study in patients with relapsed/refractory multiple myeloma by the end of 2019
CALD
Presentation of updated clinical data from the Starbeam (ALD-102) study in patients with cerebral ALD by the end of 2019
Second Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of June 30, 2019 and December 31, 2018 were $1.54 billion and $1.89 billion, respectively. The decrease in cash, cash equivalents and marketable securities is primarily related to cash used in support of normal operating activities and cash used to purchase property, plant and equipment as the company continues the buildout of its manufacturing facility in Durham, North Carolina.
Revenues: Collaboration and license and royalty revenues were $13.3 million for the three months ended June 30, 2019 compared to $7.9 million for the three months ended June 30, 2018. The increase of $5.4 million was primarily attributable to an increase in collaboration revenue under our arrangement with Celgene as well as an increase in license and royalty revenue. Collaboration and license and royalty revenues were $25.8 million for the six months ended June 30, 2019 compared to $23.8 million for the six months ended June 30, 2018. The increase of $2.0 million was primarily attributable to an increase in license and royalty revenue, offset by a decrease in collaboration revenue under our arrangement with Celgene.
R&D Expenses: Research and development expenses were $146.5 million for the three months ended June 30, 2019 compared to $115.0 million for the three months ended June 30, 2018. Research and development expenses were $269.2 million for the six months ended June 30, 2019 compared to $212.1 million for the six months ended June 30, 2018. The increase in both periods was primarily driven by costs incurred to advance and expand the company’s pipeline.
G&A Expenses: General and administrative expenses were $68.6 million for the three months ended June 30, 2019 compared to $41.2 million for the three months ended June 30, 2018. General and administrative expenses were $128.9 million for the six months ended June 30, 2019 compared to $76.1 million for the six months ended June 30, 2018. The increase in both periods was largely attributable to costs incurred to support the company’s overall growth of its pipeline as well as commercial-readiness activities.
Net Loss: Net loss was $195.8 million for the three months ended June 30, 2019 compared to $146.0 million for the three months ended June 30, 2018. Net loss was $360.2 million for the six months ended June 30, 2019 compared to $261.1 million for the six months ended June 30, 2018.

NUBEQA® (darolutamide), FDA Approved for Treatment of High-Risk Non-Metastatic Prostate Cancer, Available at Biologics by McKesson

On August 1, 2019 Biologics by McKesson, an independent specialty pharmacy for oncology and other complex therapeutic areas, reported that it was selected by Bayer HealthCare as a specialty pharmacy provider for NUBEQA (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) (Press release, McKesson, AUG 1, 2019, View Source [SID1234538046]).

NUBEQA, an androgen receptor inhibitor, was approved by the FDA on July 30, 2019, for the treatment of men with prostate cancer that has not spread to other parts of the body and no longer responds to a medical or surgical treatment that lowers testosterone. NUBEQA is different from existing therapies for nmCRPC because it does not cross the blood-brain barrier. Therefore, it has less potential than its predecessors for drug-drug interactions as well as central nervous side effects such as seizures, falls and cognitive impairment. In April 2019, the FDA accepted, with Priority Review, a New Drug Application (NDA) for NUBEQA based on results of the phase 3 ARAMIS trial, in which NUBEQA demonstrated a 59% reduction in the risk of metastases or death compared with placebo in this patient population.

"Prostate cancer is the second most commonly diagnosed cancer in men worldwide with more than 1.2 million men diagnosed in 2018," said Ann Steagall, BSN, RN, OCN, director of Clinical Policy at Biologics. "We are excited to work with Bayer to help make this new therapy available to patients with this advanced form of prostate cancer where effective treatments have been limited. Designed to inhibit the growth of prostate cancer cells, NUBEQA has shown to improve metastasis-free survival. Biologics is proud to offer a robust care plan to ensure that patients get the level of care they need."

Biologics is committed to and recognized for its high level of customer service as well as its innovative, high-touch and multidisciplinary patient-centric approach. Each team includes a pharmacist with in-depth knowledge of therapies, an experienced nurse and a financial counselor who is familiar with various financial assistance programs and organizations that help patients. This highly-skilled care team works together to develop individualized care plans that address each patient’s unique clinical, financial and emotional needs and streamlines communication back to the treating provider, enabling high-quality care and differentiated outcomes. In addition, the Biologics team works closely with payers to ensure patients can access the specialty medications they need.

Physicians may submit prescriptions to Biologics via phone (800.850.4306), fax (800.823.4506) or eScribe. For electronic prescribing systems, physicians may search for Biologics within their EMR system.

Verastem Oncology Reports Second Quarter 2019 Financial Results and Highlights Recent Company Progress

On August 1, 2019 Verastem, Inc. (Nasdaq: VSTM), operating as Verastem Oncology (or "the Company"), focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported financial results for the three months ended June 30, 2019, and provided an overview of recent accomplishments and clinical development progress for duvelisib (COPIKTRA) (Press release, Verastem, AUG 1, 2019, View Source [SID1234538045]).

"With the third full quarter of the COPIKTRA launch now complete, including the first full quarter of the follicular lymphoma (FL) marketing campaign, net sales are up 81% quarter-over-quarter," said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. "We have begun to see early signs that our physician education efforts are having an impact and overcoming the historical misperceptions that surround PI3K inhibitors, namely through strong key opinion leader engagement, increased podium presentations and numerous new requests for investigator-sponsored research. Overall, we are encouraged by the breadth of reach the commercial team is achieving with hematologic oncologists and we look forward to building on this strong momentum for the remainder of 2019."

Key Second Quarter 2019 and Recent Accomplishments:

Corporate and Financial

Brian Stuglik Appointed Chief Executive Officer and Other Leadership Changes – In July, Verastem Oncology announced the appointment of Brian Stuglik as Chief Executive Officer. Mr. Stuglik, who has served as a member of the Company’s Board of Directors since September 2017, succeeds Robert Forrester who stepped down in June 2019. Other leadership changes include Dan Paterson, the Company’s Chief Operating Officer, assuming the role of President and Chief Operating Officer and Rob Gagnon, the Company’s Chief Financial Officer, appointed to Chief Business and Financial Officer.
Signed Exclusive License Agreement with Sanofi for the Development and Commercialization of Duvelisib in Select Eurasian Territories – In July 2019, the Company announced its entry into an exclusive license agreement with Sanofi, under which Verastem Oncology granted exclusive rights to Sanofi to develop and commercialize products containing COPIKTRA in Russia and CIS, Turkey, the Middle East and Africa. Under the terms of the agreement, Verastem Oncology will receive an upfront payment of $5 million (USD) and is eligible to receive aggregate payments of up to $42 million if certain development and sales milestones are successfully achieved, plus double-digit percentage royalties based on future net sales of COPIKTRA in the licensed territories. In exchange, Sanofi received exclusive rights to develop and commercialize COPIKTRA and hold the marketing authorization and product license for COPIKTRA in the licensed territories. Additionally, Sanofi will have the right to collaborate with Verastem Oncology on certain global development and clinical trial activities.
COPIKTRA (duvelisib)

Ongoing Commercialization of COPIKTRA in the United States (U.S.) – Verastem Oncology continued the ongoing launch of COPIKTRA, an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, in the U.S. for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies or relapsed or refractory FL after at least two prior systemic therapies. Accelerated approval in FL was based on overall response rate and continued approval may be contingent upon confirmatory trials, the first of which is expected to start in 2019. During the second quarter of 2019, the number of prescribing physicians increased by over 50% and the Company has now achieved reimbursement coverage for COPIKTRA with virtually all the targeted insurance plans. COPIKTRA contains a BOXED WARNING and Verastem Oncology has implemented a Risk Evaluation and Mitigation Strategy to provide appropriate dosing and safety information to better support physicians in managing their patients on COPIKTRA.
Presented COPIKTRA Data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting – In early June, an abstract was presented at ASCO (Free ASCO Whitepaper) 2019 that highlighted dose modification data from the Phase 3 DUO study evaluating COPIKTRA in patients with relapsed or refractory CLL after at least two prior therapies. This is the same indication for which COPIKTRA received approval from the FDA in September 2018. These new data demonstrated that dose modifications of COPIKTRA may be used to effectively manage treatment-emergent adverse events, while allowing patients to remain on therapy. Specifically, the data suggest that dosing interruptions of a median of 15 days resulted in similar response rates and progression-free survival to the 16.4 months shown in the COPIKTRA label. The data also showed that when adverse events of special interest (AESIs) occur, they tend to appear in the first few months of treatment, followed by a proportionate decrease in the number of patients experiencing AESIs.
Presented COPIKTRA Data at the European Hematology Association (EHA) (Free EHA Whitepaper) 2019 Annual Meeting – In June, two posters were presented at EHA (Free EHA Whitepaper) 2019. The first poster described results from a post-hoc analysis evaluating the effect of COPIKTRA on lymphocytosis in patients with relapsed or refractory CLL/SLL from the Phase 3 DUO study. In this analysis, treatment with COPIKTRA rapidly increased lymphocytes and resulted in shrinkage of lymph nodes, with 86% of patients achieving a lymph node response. The data were similar in high-risk patients. COPIKTRA also resulted in resolution of lymphocytosis at up to 21 weeks. The other poster was an encore presentation of the COPIKTRA dose modification data from ASCO (Free ASCO Whitepaper) 2019.
Presented Supportive Duvelisib Data in Relapsed or Refractory PTCL at the 15th International Congress on Malignant Lymphoma (ICML) – In June, Dr. Steven Horwitz, MD, Memorial Sloan Kettering Cancer Center, and lead investigator of the Company’s ongoing Phase 2 PRIMO study, gave an oral presentation highlighting supportive data from two Phase 1 clinical studies evaluating duvelisib in patients with relapsed or refractory PTCL. Across both studies, patients treated with duvelisib demonstrated preliminary, but compelling clinical activity, including a positive trend in response rates. The preliminary safety profile of duvelisib in patients with relapsed or refractory PTCL was considered reasonable and consistent with prior studies. The goal of the ongoing Phase 2 PRIMO study is to provide guidance on a duvelisib monotherapy dosing regimen in patients with relapsed or refractory PTCL and to further characterize its efficacy and tolerability in this population.

Other abstracts presented at ICML included an analysis of efficacy and safety of duvelisib compared to ofatumumab from the Phase 3 DUO study in patients with relapsed or refractory CLL/SLL after ≥2 prior therapies, characterization of duvelisib in patients with refractory marginal zone lymphoma from the Phase 2 DYNAMO study, and an overview of preclinical data showing the potential of duvelisib in mantle cell lymphoma.
Second Quarter 2019 Financial Results

Net product revenue for the three months ended June 30, 2019 (2019 Quarter) was $3.0 million, which reflects the third full quarter of recorded sales for COPIKTRA. The Company did not have any product revenue for the three months ended June 30, 2018 (2018 Quarter) as the FDA approved COPIKTRA on September 24, 2018. License and collaboration revenue for the 2019 Quarter was $0.1 million, compared to $10.0 million for the 2018 Quarter. The 2018 Quarter included license revenue of $10.0 million, related to the upfront payment received in connection with the license and collaboration agreement with Yakult in June 2018.

Research and development (R&D) expense for the 2019 Quarter was $11.3 million, compared to $12.4 million for the 2018 Quarter. The decrease of $1.1 million, or 8%, was primarily related to a decrease in consulting fees as a result of activities to file a New Drug Application for COPIKTRA in the 2018 Quarter and lower R&D costs associated with the development of COPIKTRA as a result of site closures in the Company’s Phase 3 DUO and Phase 2 DYNAMO studies throughout 2018 and 2019 as patients continued to complete treatment. All of these lower costs were partially offset by an increase in costs related to the Company’s Phase 2 PRIMO study for the treatment of patients with relapsed or refractory PTCL.

Selling, general and administrative expense for the 2019 Quarter was $29.3 million, compared to $15.8 million for the 2018 Quarter. The increase of $13.5 million, or 85%, was primarily due to higher personnel and related costs, as well as promotional and consulting costs in support of the launch of COPIKTRA which includes executive and non-executive separation costs, debt advisory and other costs of $2.7 million.

Net loss for the 2019 Quarter was $42.2 million, or $0.57 per share (basic and diluted), compared to $18.4 million, or $0.30 per share (basic and diluted), for the 2018 Quarter.

For the 2019 Quarter, non-GAAP adjusted net loss was $35.7 million, or $0.48 per share, compared to non-GAAP adjusted net loss of $16.7 million, or $0.27 per share, for the 2018 Quarter. Please refer to the GAAP to Non-GAAP Reconciliation attached to this press release.

As of June 30, 2019, Verastem Oncology had cash, cash equivalents and short-term investments of $187.3 million.

Financial Guidance for Fiscal 2019

Verastem Oncology is raising its full-year guidance for net product revenue of COPIKTRA. The Company now expects net product revenue of COPIKTRA to be in the range of $12-14 million, higher than the previous estimate of $10-12 million. This guidance is based on product revenue to date, current run rates and near-term expectations.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast today, Thursday, August 1, 2019, at 4:30 PM (ET). The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 6256817.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at www.verastem.com. A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are cancers that affect lymphocytes and are essentially the same disease, with the only difference being the location where the cancer primarily occurs. When most of the cancer cells are located in the bloodstream and the bone marrow, the disease is referred to as CLL, although the lymph nodes and spleen are often involved. When the cancer cells are located mostly in the lymph nodes, the disease is called SLL. The symptoms of CLL/SLL include a tender, swollen abdomen and feeling full even after eating only a small amount. Other symptoms can include fatigue, shortness of breath, anemia, bruising easily, night sweats, weight loss, and frequent infections. However, many patients with CLL/SLL will live for years without symptoms. In 2018, there were approximately 200,000 patients in the United States affected by CLL/SLL with nearly 20,000 new diagnoses. While there are therapies currently available, real-world data reveals that a significant number of patients either relapse following treatment, become refractory to current agents, or are unable to tolerate treatment, representing a significant medical need. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with CLL/SLL.

About Follicular Lymphoma

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. In 2018, this lymphoma subtype accounted for 20 to 30 percent of all NHL cases, with more than 140,000 people in the United States with FL and more than 13,000 newly diagnosed patients. Common symptoms of FL include enlargement of the lymph nodes in the neck, underarms, abdomen, or groin, as well as fatigue, shortness of breath, night sweats, and weight loss. Often, patients with FL have no obvious symptoms of the disease at diagnosis. Follicular lymphoma is usually not considered to be curable, but more of a chronic disease, with patients living for many years with this form of lymphoma. The potential of additional oral agents, particularly as a monotherapy that can be used in the general community physician’s armamentarium, may hold significant value in the treatment of patients with FL.

About Peripheral T-Cell Lymphoma

Peripheral T-cell lymphoma (PTCL) is a rare, aggressive type of non-Hodgkin lymphoma (NHL) that develops in mature white blood cells called "T cells" and "natural killer (NK) cells"1 which circulate with the lymphatic system.2 PTCL accounts for between 10-15% of all non-Hodgkin lymphomas (NHLs) and generally affects people aged 60 years and older.1 Although there are many different subtypes of peripheral T-cell lymphoma, they often present in a similar way, with widespread, enlarged, painless lymph nodes in the neck, armpit or groin.2 There is currently no established standard of care for patients with relapsed or refractory disease.1

About COPIKTRA (duvelisib)

COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase (PI3K), and the first approved dual inhibitor of PI3K-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells. PI3K signaling may lead to the proliferation of malignant B-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.3,4,5 COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after at least two prior therapies and relapsed or refractory follicular lymphoma (FL) after at least two prior systemic therapies. COPIKTRA is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), for which it has received Fast Track status, and is being investigated in combination with other agents through investigator-sponsored studies.6 For more information on COPIKTRA, please visit www.COPIKTRA.com. Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.