On May 8, 2018 Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today provided a corporate update and reported financial results for the first quarter ended March 31, 2018 (Press release, Acceleron Pharma, AUG 8, 2018, View Source [SID1234526277]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"2018 is an important year for our Company, as we prepare for the upcoming top-line results from our MEDALIST and BELIEVE Phase 3 trials with luspatercept expected mid-year. We and Celgene continue to invest heavily in the overall luspatercept opportunity by targeting myelodysplastic syndromes, beta-thalassemia, and myelofibrosis," said Habib Dable, Chief Executive Officer of Acceleron. "The joint collaboration teams recently kicked off strategic preparations for the anticipated regulatory and commercial activities planned to follow the luspatercept Phase 3 results."

Added Mr. Dable: "Our team continues to make meaningful progress in the advancement of our wholly-owned clinical programs. In neuromuscular disease, we presented preliminary results from our Phase 2 trial of ACE-083 in FSHD for the first time and recently initiated Part 2 of the trial. In pulmonary, we expect to initiate our first Phase 2 trial with sotatercept in pulmonary arterial hypertension in the second quarter."

Development Program Highlights

Hematology

Luspatercept:

Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)

Luspatercept is a first-in-class erythroid maturation agent (EMA) designed to treat the late-stage red blood cell (RBC) maturation defect that results in chronic anemia and the need for regular RBC transfusions in adults with rare blood disorders. Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene.

Top-line results from the MEDALIST and BELIEVE Phase 3 trials in MDS and beta-thalassemia, respectively, are expected in mid-2018.
The initiation of the COMMANDS Phase 3 trial in first-line, lower-risk MDS patients is planned for the first half of 2018.
Enrollment and treatment are ongoing in the BEYOND Phase 2 trial in non-transfusion-dependent beta-thalassemia and the Phase 2 trial in MF.
The Company expects to provide updates from the ongoing long-term Phase 2 extension trials in MDS and beta-thalassemia at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 23rdCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.
Neuromuscular Disease

ACE-083:

Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie-Tooth (CMT) Disease

ACE-083 is a locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause focal muscle weakness. ACE-083 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta ligands.

Preliminary results from dose cohorts 1 and 2 in Part 1 of the ACE-083 Phase 2 trial in patients with FSHD were highlighted in a "Best of Neuromuscular Disease" clinical session at the American Academy of Neurology (AAN) 70th Annual Meeting on April 26, 2018.
The Company plans to present additional preliminary results from all Part 1 dose cohorts during the second half of 2018.
Part 2 of the Phase 2 trial was recently initiated and preliminary results are expected in the second half of 2019.
ACE-083 received FDA Fast Track designation in FSHD.
Enrollment and treatment are ongoing in Part 1 of the Phase 2 trial in patients with CMT disease.
The Company plans to present preliminary Part 1 results in the second half of 2018 and to initiate Part 2 of the Phase 2 trial by the end of 2018.
ACE-2494:

ACE-2494 is designed to have a systemic effect on muscle mass and strength for diseases that cause muscle weakness throughout the body. ACE-2494 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta ligands.

Enrollment and treatment are ongoing in the Phase 1 healthy volunteer trial.
Preliminary results from the Phase 1 trial are expected in the first half of 2019.
Pulmonary Disease

Sotatercept:

Pulmonary Arterial Hypertension (PAH)

Sotatercept is a ligand trap for members in the TGF-beta superfamily involved in remodeling a variety of different tissues, including the vasculature and fibrosis. In multiple preclinical studies in PAH, sotatercept decreased vessel muscularization, improved pulmonary arterial pressures, and decreased indicators of right heart failure.

The Company expects to initiate the PULSAR Phase 2 trial during the second quarter of 2018.
Preliminary results from the PULSAR Phase 2 trial are expected in the first half of 2020.
Financial Results

Cash position – Cash, cash equivalents and investments as of March 31, 2018 were $353.3 million. As of December 31, 2017, the Company had cash, cash equivalents and investments of $372.9 million. The Company believes that existing cash, cash equivalents and investments will be sufficient to fund projected operating requirements into 2021.
Revenue – Collaboration revenue for the first quarter was $3.2 million. The revenue is all from Acceleron’s partnership with Celgene and is primarily related to expenses incurred by the Company in support of luspatercept.
Costs and expenses – Total costs and expenses for the first quarter were $30.8 million. This includes R&D expenses of $23.4 million and G&A expenses of $7.4 million.
Net loss – The Company’s net loss for the first quarter ended March 31, 2018 was $26.2 million.
Conference Call and Webcast

The Company will host a webcast and conference call to discuss its first quarter financial results for 2018 and provide an update on recent corporate activities on May 8, 2018, at 5:00 p.m. EDT.

The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at www.acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron First Quarter 2018 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On May 8, 2018 X4 Pharmaceuticals, a clinical stage biotechnology company developing novel CXCR4 inhibitor drugs to improve immune cell trafficking to treat cancer and rare disease, reported that an abstract highlighting X4P-001-IO, the company’s CXCR4 antagonist, has been selected for poster and oral presentation at the 16th Annual Meeting of the Association for Cancer Immunotherapy (CIMT) (Free CIMT Whitepaper), taking place May 15-17 in Mainz, Germany (Press release, X4 Pharmaceuticals, MAY 8, 2018, View Source [SID1234526276]). The presentations will describe clinical results from a pilot study of X4P-001-IO in combination with Opdivo (nivolumab) in patients with clear cell renal cell carcinoma (ccRCC), expanding the range of combination treatment settings in which X4P-001-IO has been studied.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the presentations on X4P-001 are as follows:

Title: The safety, tolerability, and preliminary clinical activity of the CXCR4 inhibitor X4P-001 and nivolumab in renal cell carcinoma patients that are refractory to nivolumab monotherapy

Author: David F. McDermott, M.D., Beth Israel Deaconess Medical Center, Harvard Medical School

Abstract #: 77

Poster Session: Tumor Biology and Interaction with the Immune System, May 15th, 3:00 – 5:00 PM CET

Oral Presentation Session: Clinical Trials, May 17th, 11:45 AM – 1:00 PM CET

About X4P-001-IO in Cancer

X4P-001-IO is an investigational selective, oral, small molecule antagonist of C-X-C receptor type 4 (CXCR4). CXCR4 is a chemokine receptor present in abundance on certain immune cells and cancer cells and it plays a critical role in immune cell trafficking, infiltration and activation in the tumor microenvironment. CXCR4 signaling is disrupted in a broad range of cancers, facilitating tumor growth by allowing cancer cells to evade immune detection and creating a pro-tumor microenvironment. X4P-001-IO has the ability to help restore immunity within the tumor microenvironment and has the potential to enhance the anti-tumor activity of approved and emerging oncology agents, such as checkpoint inhibitors and targeted therapies. X4P-001-IO is being investigated in several clinical studies in solid tumors.

On May 8, 2018 Rocket Pharmaceuticals, Inc. (NASDAQ:RCKT) ("Rocket"), a leading U.S.-based multi-platform gene therapy company, reported that Gaurav Shah, M.D., Chief Executive Officer and President of Rocket, will present a company overview at the following investor conferences (Press release, Rocket Pharmaceuticals, MAY 8, 2018, View Source;p=irol-newsArticle&ID=2347578 [SID1234526275]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Bank of America Merrill Lynch Health Care Conference 2018 on May 15, 2018, at 9:20 a.m. Pacific Time in Las Vegas, NV.
UBS Global Healthcare Conference on May 23, 2018, at 9:30 a.m. Eastern Time in New York City.
A live audio webcast of the UBS presentation will be available on the Investors section of the company’s website, www.rocketpharma.com. A replay of the presentation will be archived on the Rocket website following the conference.

On May 8, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the pivotal QuANTUM-R phase 3 study of single agent quizartinib met its primary endpoint of significantly prolonging overall survival compared to salvage chemotherapy in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3-ITD mutations after first-line treatment with or without hematopoietic stem cell transplantation (HSCT) (Press release, Daiichi Sankyo, MAY 8, 2018, View Source [SID1234526274]). Safety appears consistent with that observed at similar doses in the quizartinib program.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Single agent quizartinib is the first FLT3 inhibitor to show a significant improvement in overall survival compared to cytotoxic chemotherapy in a randomized phase 3 study of patients with relapsed/refractory AML with FLT3-ITD mutations, a very aggressive form of the disease with limited treatment options," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "We sincerely thank all of the investigators and patients who participated in this study and will share the results of the QuANTUM-R study at an upcoming medical meeting. We look forward to working with regulatory authorities worldwide to potentially bring quizartinib to patients as quickly as possible."

QuANTUM-R is a pivotal, global, phase 3, open-label randomized study that enrolled 367 patients with FLT3-ITD-mutated AML who were refractory to or in relapse (with duration of remission of six months or less) following standard first-line AML therapy with or without HSCT. Patients were randomized in a 2:1 ratio to receive either single agent oral quizartinib or salvage chemotherapy. The primary objective of the study was to determine whether single agent quizartinib prolonged overall survival compared to salvage chemotherapy.

Daiichi Sankyo intends to initiate regulatory submissions worldwide for quizartinib on the basis of the QuANTUM-R results. The topline results of QuANTUM-R will be presented at an upcoming scientific conference.

About Quizartinib

Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in phase 3 development for relapsed/refractory (QuANTUM-R) and newly-diagnosed (QuANTUM-First) AML with FLT3-ITD mutations globally, and phase 2 development for relapsed/refractory AML with FLT3-ITD mutations in Japan.

Quizartinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory AML. Quizartinib also has been granted Orphan Drug designation by the FDA and European Medicines Agency (EMA) for the treatment of AML. Quizartinib is an investigational agent that is not approved for any indication in any country. Safety and efficacy have not been established.

About Acute Myeloid Leukemia with FLT3-ITD Mutations

AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.1 The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.1

FLT3 gene mutations are one of the most common genetic abnormalities in AML.2 The FLT3-ITD mutation is the most common FLT3 mutation, affecting approximately one in four patients with AML.3,4,5,6 Patients with FLT3-ITD-mutated AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse,and a higher likelihood of relapse following HSCT as compared to those without this mutation.7,8

On May 8, 2018 Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) reported its financial results for the first quarter ended March 31, 2018 and provided a corporate update (Press release, Momenta Pharmaceuticals, MAY 8, 2018, View Source [SID1234526273]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made important progress in the first quarter of 2018 across our complex generic, biosimilar and novel drug portfolios. Importantly, Glatopa 40 mg/mL received FDA approval and, with Sandoz’s commercial launch now underway, we look forward to the potential for accelerated adoption by customers as the year progresses. In addition, we are looking forward to the start-up of the pivotal patient trial for M710, our proposed biosimilar to EYLEA being developed in collaboration with Mylan, in the first half of 2018," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "Our novel drug portfolio targeted at rare autoimmune indications also continues to advance. Earlier this year, we announced positive topline data from the Phase 1 study of M281, our potentially best-in-class anti-FcRn candidate; and CSL’s initiation of a Phase 1 study of M230, our potential first-in-class recombinant Fc multimer. M254, our hyper-sialylated IVIg, also remains on track to enter a Phase 1 study this year."

Wheeler continued, "The strategic review of our business announced earlier this year is active and we are evaluating options for our business including the potential for new partnerships across the portfolio or the sale of one or more of our biosimilar assets. We expect to complete this strategic review by the end of the second quarter of 2018."

First Quarter Highlights and Recent Events

Complex Generics:

Glatopa Products: a fully substitutable, AP-rated generic version of three-times-a-week COPAXONE 40 mg/mL and daily COPAXONE 20 mg/mL (glatiramer acetate injection)

for patients with relapsing forms of multiple sclerosis developed in collaboration with Sandoz

On February 13, 2018, Momenta announced that the FDA had approved Sandoz’s Abbreviated New Drug Application for Glatopa 40 mg/mL and that Sandoz initiated the launch of the product in the US. Sandoz has secured customer contracts and orders of Glatopa 40 mg/mL have been shipped. Sandoz had to build inventory of Glatopa 40 mg/mL for the US launch and expects accelerated adoption by customers as the year progresses.

In the first quarter of 2018, Momenta recorded $3.5 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products, reflecting $13.3 million in profit share, net a deduction of $9.8 million in the first quarter of 2018 for 50% of Glatopa 40 mg/mL inventory reserves.

Enoxaparin Sodium Injection: First FDA-approved, substitutable generic LOVENOX (Enoxaparin Sodium Injection) used for the prevention and treatment of deep vein thrombosis developed in collaboration with Sandoz

On March 20, 2018, the US District Court of Massachusetts issued its final judgment affirming its February 2018 decision in the Company’s patent litigation against Amphastar involving US Patent No. 7,575,886, covering methods for the manufacturing control of generic LOVENOX, finding that the Company’s ‘886 patent was infringed by two separate methods used by Amphastar, but invalid for lack of written description and enablement. Momenta and Sandoz have appealed the case to the Court of Appeals for the Federal Circuit. Amphastar has moved to seek damages under the bond posted in connection with the preliminary injunction granted in 2010. Momenta and Sandoz have opposed the motion as premature pending a final ruling on appeal.

On March 20, 2018, the US District Court of Massachusetts also denied Momenta and Sandoz’s motion to dismiss Amphastar’s antitrust lawsuit. A trial is scheduled for September 2019. Momenta has filed a motion to certify the denial of the motion to dismiss as eligible for interlocutory appeal on the grounds that dismissal is warranted under law and an appeal at this time could resolve the case.

Biosimilars:

M923: a fully-owned proposed biosimilar to HUMIRA (adalimumab)

In January 2018, the Company announced that the Biologics License Application (BLA) for M923 is prepared to be filed with the FDA. The timing of Momenta’s filing of the BLA is dependent on the outcome of the Company’s ongoing strategic review.

M834: a proposed biosimilar to ORENCIA (abatacept) being developed in collaboration with Mylan

In late 2017, Momenta announced that M834 did not meet its primary pharmacokinetic endpoints in a Phase 1 study to compare the pharmacokinetics, safety and immunogenicity of M834 to US- and EU-sourced ORENCIA in normal healthy volunteers. Momenta and Mylan continue to investigate these results in order to determine the next steps for the program.

M710: a proposed biosimilar to EYLEA (aflibercept) candidate being developed in collaboration with Mylan

In January 2018, Momenta and Mylan disclosed that M710 is a proposed biosimilar to EYLEA and announced IND acceptance by the FDA. The companies plan to start-up the pivotal clinical trial in patients in the first half of 2018.

Novel Drugs for Rare Autoimmune and Immune-mediated Diseases:

M281 (anti-FcRn): a fully human anti-neonatal Fc receptor (FcRn) aglycosylated immunoglobulin G (IgG1) monoclonal antibody (mAb)

In January 2018, the Company reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study in normal human volunteers. Over the 98-day MAD study, M281 exhibited no serious adverse events, was well tolerated, and decreased circulating IgG levels up to 89% with a mean reduction of 84%.

Momenta is finalizing its development strategy for M281 and is planning two proof of concept clinical trials in the second half of 2018, pending regulatory feedback.

M230 (CSL730): a recombinant Fc multimer being developed in collaboration with CSL

In late January 2018, CSL began dosing subjects in the Phase 1 trial in healthy volunteers to evaluate the safety and tolerability of M230. The Phase 1 study is targeted to be completed in 2019.

M254 (hsIVIg): a hyper-sialylated immunoglobulin designed to be a higher potency alternative to intravenous immunoglobulin (IVIg) with the potential for enhanced safety and convenience

The Company is on track to complete the IND-enabling toxicology study this year and is targeting the initiation of a clinical trial in the second half of 2018.

First Quarter 2018 Financial Results

Revenue: In the first quarter of 2018, the Company recorded $3.5 million in product revenues from Sandoz’s sales of Glatopa 20 mg/mL and 40 mg/mL products reflecting $13.3 million in profit share, net a deduction of $9.8 million for 50% of Glatopa 40 mg/mL

inventory reserved by Sandoz, compared to $23.4 million in profit share from Sandoz sales of Glatopa 20 mg/mL for the same period in 2017. The decrease in product revenues of $19.9 million, or 85%, was primarily due to lower net sales driven by market decline, Mylan N.V.’s entry into the COPAXONE market, and Glatopa 40 mg/mL pre-launch inventory reserves.

Research and development revenue for the first quarter of 2018 was $1.3 million compared to $3.2 million recorded in the same quarter last year. The decrease in research and development revenue of $1.9 million, or 59%, was primarily due to lower revenue recognized from the Mylan upfront payment as compared to the amount recognized in the 2017 period and lower reimbursable expenses for the Company’s complex generic programs.

Total revenues for the first quarter of 2018 were $4.9 million compared to $26.6 million for the same period in 2017.

Operating Expenses: Total GAAP operating expenses were $53.9 million in the first quarter of 2018.

Research and development expenses for the first quarter of 2018 were $33.2 million, compared to $36.1 million for the same period in 2017. The decrease of $2.9 million, or 8%, was primarily due to a decrease in external R&D expenses for M923 offset by increases in spending for M710 and M281.

General and administrative expenses for the first quarter of 2018 were $20.6 million, compared with $23.1 million for the same period in 2017. The decrease of $2.5 million, or 11%, was primarily driven by lower legal expenses related to the Company’s litigation.

First quarter non-GAAP operating expense was $48.4 million, within the range of previously provided guidance of $45 – $55 million. Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. See "Non-GAAP Financial Information and Other Disclosures" and the table below entitled "Reconciliation of GAAP Results to Non-GAAP Financial Measures" for a reconciliation of GAAP operating expense to non-GAAP operating expense.

Net Loss: The Company reported a net loss of $47.6 million, or $0.63 per share for the first quarter of 2018 compared to a net loss of $31.8 million, or $0.46 per share for the same period in 2017.

Cash Position: At March 31, 2018, Momenta had $346.0 million in cash, cash equivalents and marketable securities compared to $379.9 million at December 31, 2017.

2018 Financial Guidance

Momenta provides non-GAAP operating expense guidance, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP financial measures. Refer to the section of this press release below entitled "Non-GAAP Financial Information and Other Disclosures" for further discussion of this subject.

Non-GAAP operating expense is total operating expenses (which excludes collaboration expenses reimbursable by Mylan), less stock-based compensation expense and collaborative reimbursement revenues. Today, Momenta is reiterating non-GAAP operating expense guidance of approximately $180 – $220 million for 2018 and $45 – $55 million for the second quarter of 2018. The Company expects to continue to recognize revenue from Mylan’s $45 million upfront payment on a quarterly basis. The Company also estimates that collaborative reimbursement revenues will be approximately $0 – $2 million per quarter in 2018. The Company’s guidance for 2018 is subject to potential changes in operating plans based on the outcome of the strategic review.

Non-GAAP Financial Information and Other Disclosures

Momenta uses a non-GAAP financial measure, non-GAAP operating expense, to provide operating expense guidance. Momenta believes this non-GAAP financial measure is useful to investors because it provides greater transparency regarding Momenta’s operating performance as it excludes non-cash stock compensation expense and collaborative reimbursement revenues. This non-GAAP financial measure should not be considered a substitute or an alternative to GAAP total operating expense and should not be considered a measure of Momenta’s liquidity. Instead, non-GAAP operating expense should only be used to supplement an understanding of Momenta’s operating results as reported under GAAP. Momenta has not provided GAAP reconciliation for its forward-looking non-GAAP annual or quarterly operating expense because Momenta cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the forward-looking non-GAAP financial measure. The Company has provided the estimated reconciling information that is available without unreasonable effort in the section of this press release above entitled "2018 Financial Guidance."

Conference Call Information

Management will host a conference call and webcast today at 8:00 am ET to discuss these results and provide an update on the Company. A live webcast of the conference call may be accessed on the "Investors" section of the Company’s website, www.momentapharma.com.

An archived version of the webcast will be posted on the Momenta website approximately two hours after the call.

To access the call you may also dial (877) 224-9084 (domestic) or (720) 545-0022 (international) prior to the scheduled conference call time and provide the access code 7665388. A replay of the call will be available approximately two hours after the conclusion of the call and will be accessible through 7665388. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and provide the access code 7665388.