On October 31, 2019 Bristol-Myers Squibb Company (NYSE:BMY) reported results for the third quarter of 2019, which were highlighted by strong sales and a robust operating performance, along with the continuing advancement of the company’s pipeline (Press release, Bristol-Myers Squibb, OCT 31, 2019, View Source [SID1234550096]).

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!

"In the third quarter, we delivered strong business performance and made important progress with our pipeline, including the potential to bring our dual Immuno-Oncology combination to patients with lung cancer, a disease where the unmet need remains high," said Giovanni Caforio, M.D., chairman and chief executive officer, Bristol-Myers Squibb. "With strong momentum in our R&D and commercial organizations, I am looking forward to the tremendous opportunity when Bristol-Myers Squibb and Celgene come together as one, to deliver innovative medicines and transform patients’ lives."

Third Quarter

$ amounts in millions, except per share amounts

2019

2018

Change

Total Revenues

$6,007

$5,691

6%

GAAP Diluted EPS

0.83

1.16

(28)%

Non-GAAP Diluted EPS

1.17

1.09

7%

THIRD QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted third quarter revenues of $6.0 billion, an increase of 6% compared to the same period a year ago. Revenues increased 7% when adjusted for foreign exchange impact.
U.S. revenues increased 7% to $3.5 billion in the quarter compared to the same period a year ago. International revenues increased 3%. When adjusted for foreign exchange impact, international revenues increased 7%.
Gross margin as a percentage of revenue decreased from 71.0% to 69.9% in the quarter primarily due to product mix.
Marketing, selling and administrative expenses decreased 4% to $1.1 billion in the quarter.
Research and development expenses increased 8% to $1.4 billion in the quarter.
The effective tax benefit rate was 1.3% in the quarter, compared to an effective tax rate of 11.8% in the same period a year ago. The decrease in the effective tax rate was due to jurisdictional tax rates and other tax impacts attributed to pension settlement charges and the UPSA business divestiture gain in 2019.
The company reported net earnings attributable to Bristol-Myers Squibb of $1.4 billion, or $0.83 per share, in the third quarter, compared to net earnings of $1.9 billion, or $1.16 per share, for the same period a year ago.
The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $1.9 billion, or $1.17 per share, in the third quarter, compared to net earnings of $1.8 billion, or $1.09 per share, for the same period a year ago. An overview of specified items is discussed under the "Use of Non-GAAP Financial Information" section.
Cash, cash equivalents and marketable securities were $33.5 billion as of September 30, 2019. The net cash position was $8.5 billion as of September 30, 2019.
ACQUISITION OF CELGENE CORPORATION

In August, the company announced Celgene Corporation entered into an agreement with Amgen under which Amgen would acquire the global rights to OTEZLA. (link)
In July, the company announced the European Commission (EC) has granted unconditional approval of the company’s pending acquisition of Celgene Corporation. The company expects to close the Celgene transaction by the end of 2019. (link)
OTEZLA is a trademark of Celgene Corporation.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Product Sales/Business Highlights

Growth in global revenues for the third quarter of 2019, compared to the third quarter of 2018, was driven by:

Eliquis , which grew by 22%
Opdivo , which grew by 1%
Orencia , which grew by 14%
Sprycel , which grew by 14%
Yervoy , which decreased by 8%
Opdivo

Regulatory

In October, the company announced the EC approved Opdivo (nivolumab) flat dosing schedule of 240 mg infused over 30 minutes every two weeks or 480 mg infused over 60 minutes every four weeks for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
In August, the company and Nektar Therapeutics announced the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin in combination with Opdivo for the treatment of patients with previously untreated unresectable or metastatic melanoma.
Clinical

In October, the company announced that CheckMate -9LA, a pivotal Phase 3 trial evaluating Opdivo plus low-dose Yervoy (ipilimumab) given concomitantly with two cycles of chemotherapy for the first-line treatment of advanced non-small cell lung cancer, met its primary endpoint of superior overall survival at a pre-specified interim analysis. (link)
In September, at the European Society for Medical Oncology 2019 Congress, the company announced important new data and analysis from four studies evaluating Opdivo as monotherapy and in combination with Yervoy:
ATTRACTION-3: Results from the Phase 3 study evaluating Opdivo versus chemotherapy (docetaxel or paclitaxel) for the treatment of patients with unresectable advanced or recurrent esophageal squamous cell carcinoma. The trial was sponsored by Ono Pharmaceutical Co. Ltd. (link)
Checkmate -227: Results from Part 1 of the Phase 3 study evaluating Opdivo plus low-dose Yervoy as first-line treatment for patients with advanced non-small cell lung cancer. (link)
Checkmate -067: Five-year results from the Phase 3 study evaluating the first-line combination of Opdivo plus Yervoy or Opdivo monotherapy, versus Yervoy alone, in patients with advanced metastatic melanoma. (link)
Checkmate -238: Three-year results from the Phase 3 study evaluating adjuvant use of Opdivo versus Yervoy in patients with Stage III or Stage IV melanoma who were at high risk of recurrence following complete surgical resection. (link)
In September, at the 20th World Conference on Lung Cancer of the International Association for the Study of Lung Cancer, the company announced long-term pooled efficacy and safety results from the Phase 3 CheckMate -017 and CheckMate -057 studies in patients with previously treated advanced non-small cell lung cancer. (link)
In September, the company announced results from the Phase 3 CheckMate -548 trial evaluating the addition of Opdivo to the current standard of care (temozolomide and radiation therapy) versus the standard of care alone in patients with newly diagnosed glioblastoma multiforme that is O6-methylguanine-DNA methyltransferase-methylated. The study did not meet its primary endpoint of progression-free survival. The study remains ongoing for OS. (link)
Eliquis

Clinical

In September, at the European Society of Cardiology Congress 2019, the company and its alliance partner Pfizer announced findings from NAXOS (EvaluatioN of ApiXaban in strOke and Systemic embolism prevention in patients with nonvalvular atrial fibrillation in the real-life setting in France), the largest real-world data analysis on oral anticoagulant effectiveness and safety in Europe among patients with non-valvular atrial fibrillation. (link)
Empliciti

Regulatory

In August, the EC approved Empliciti (elotuzumab) plus pomalidomide and low-dose dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on the last therapy.
2019 FINANCIAL GUIDANCE

Bristol-Myers Squibb is decreasing its 2019 GAAP EPS guidance range from $3.73 – $3.83 to $3.46 – $3.56 and increasing its non-GAAP EPS guidance range from $4.20 – $4.30 to $4.25 – $4.35. Both GAAP and non-GAAP guidance assume current exchange rates. Key revised 2019 GAAP and non-GAAP line-item guidance assumptions are:

An effective tax rate of 13% to 14% for GAAP and approximately 16% for non-GAAP
The financial guidance for 2019 excludes the impact of any potential future strategic acquisitions and divestitures, including any impact of the pending Celgene acquisition other than expenses incurred in 2019, and any specified items that have not yet been identified and quantified. The non-GAAP 2019 guidance also excludes other specified items as discussed under "Use of Non-GAAP Financial Information." Details reconciling adjusted non-GAAP amounts with the amounts reflecting specified items are provided in supplemental materials available on the company’s website.

Guidance inclusive of the Celgene acquisition will be provided after the close of the transaction.

Use of Non-GAAP Financial Information

This earnings release contains non-GAAP financial measures, including non-GAAP earnings and related EPS information that are adjusted to exclude certain costs, expenses, gains and losses and other specified items that are evaluated on an individual basis. These items are adjusted after considering their quantitative and qualitative aspects and typically have one or more of the following characteristics, such as being highly variable, difficult to project, unusual in nature, significant to the results of a particular period or not indicative of future operating results. Similar charges or gains were recognized in prior periods and will likely reoccur in future periods, including acquisition and integration expenses, restructuring costs, accelerated depreciation and impairment of property, plant and equipment and intangible assets, R&D charges or other income resulting from up-front or contingent milestone payments in connection with the acquisition or licensing of third-party intellectual property rights, divestiture gains or losses, pension, legal and other contractual settlement charges, interest expense on the new notes issued in May 2019 in connection with our pending acquisition of Celgene and interest income earned on the net proceeds of those notes and debt redemption gains or losses, among other items. Deferred and current income taxes attributed to these items are also adjusted for considering their individual impact to the overall tax expense, deductibility and jurisdictional tax rates. This earnings release also provides international revenues excluding the impact of foreign exchange. Non-GAAP information is intended to portray the results of the company’s baseline performance, supplement or enhance management, analysts and investors overall understanding of the company’s underlying financial performance and facilitate comparisons among current, past and future periods. For example, non-GAAP earnings and EPS information is an indication of the company’s baseline performance before items that are considered by us to not be reflective of the company’s ongoing results. In addition, this information is among the primary indicators that we use as a basis for evaluating performance, allocating resources, setting incentive compensation targets and planning and forecasting for future periods. This information is not intended to be considered in isolation or as a substitute for net earnings or diluted EPS prepared in accordance with GAAP and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted.

Company and Conference Call Information

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol-Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram. For more information about Bristol-Myers Squibb’s pending acquisition of Celgene, please visit View Source

There will be a conference call on October 31, 2019 at 8:30 a.m. ET during which company executives will review financial information and address inquiries from investors and analysts. Investors and the general public are invited to listen to a live webcast of the call at View Source or by calling the U.S. toll free 800-458-4121 or international 786-789-4772, confirmation code: 532230. Materials related to the call will be available at the same website prior to the conference call. A replay of the call will be available beginning at 11:45 a.m. ET on October 31, 2019 through 11:45 a.m. ET on November 14, 2019. The replay will also be available through View Source or by calling the U.S. toll free 888-203-1112 or international 719-457-0820, confirmation code: 532230.

On October 31, 2019 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported that an abstract for a preclinical investigation from its natural killer cell chimeric antigen receptor (CAR) program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting (Press release, Bellicum Pharmaceuticals, OCT 31, 2019, View Source [SID1234550118]). The meeting is being held November 6-10, 2019 in National Harbor, Md.

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 poster presentation are as follows:

Title: Solid Tumor Cytotoxicity by Natural Killer Cells Expressing a HER2-Directed Chimeric Antigen Receptor Enhanced by MyD88/CD40 (MC)
Poster Board: #P151
Presenter: Henri Bayle, Ph.D.
Time/Location: Friday, November 8, 2019, 7 a.m. to 8 p.m. ET

On October 31, 2019 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported that it will deliver the following poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 34th Annual Meeting to take place November 6-10, 2019 at the Gaylord National Hotel & Convention Center in Baltimore, Maryland (Press release, BioLineRx, OCT 31, 2019, View Source [SID1234550134]):

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!

A poster titled "Combination of BL-8040, anti PD-1 and chemotherapy significantly reduced pancreatic tumor growth and changed the balance between CD4+/FOXP3+ cells and CD8+ cells in the tumor" (Abstract ID: P471) will be presented on Friday, November 8, 2019.
A poster titled "A phase IIB study of Pembrolizumab plus BL-8040 in metastatic pancreatic cancer: Clinical outcomes and biological correlates" (Abstract ID: P328) will be presented on Saturday, November 9, 2019.
About BL-8040

BL-8040 is a short synthetic peptide that functions as a high-affinity best-in-class antagonist for CXCR4, a chemokine receptor over-expressed in many human cancers, where it has been shown to be correlated with poor prognosis, and plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance. CXCR4 is also directly involved in the homing and retention of hematopoietic stem cells (HSCs) and various hematological malignant cells in the bone marrow.

In a number of clinical and pre-clinical studies, BL-8040 has shown a critical role in immune cell trafficking, tumor infiltration by immune effector T cells and reduction in immunosuppressive cells within the tumor niche, turning "cold" tumors, such as pancreatic cancer, into "hot" tumors (i.e., sensitizing them to immune check point inhibitors). BL-8040-mediated inhibition of the CXCR4-CXCL12 (SDF-1) axis has also shown robust mobilization of HSCs for transplantation in hematological malignancies.

BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On October 31, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), the leader and innovator in healthcare workforce solutions and staffing services, reported its third quarter 2019 financial results (Press release, AMN Healthcare Services, OCT 31, 2019, View Source [SID1234550150]). Financial highlights are as follows:

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!

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

Third quarter financial results above high end of Company guidance
Strong demand continues with Nurse and Allied orders at a three-year high, while a tight labor market limits near-term volume growth
Advanced Medical, our recently acquired allied and nursing staffing business, is performing well with double-digit year-over-year revenue growth
Generated $72 million of free cash flow in Q3, driven in part by a reduction in DSO
On October 1, closed on new 8-year, $300 million unsecured debt financing to recharge the Company’s capacity for acquisitions and stock repurchases
"A solid demand environment and sound execution by the AMN team enabled us to beat expectations for revenue and earnings in the third quarter. As healthcare organizations increasingly seek total talent partners, we have been fortunate to expand and add progressive new clients. This gives us the opportunity to help clients optimize their workforce while also providing our candidates with even more attractive career opportunities," said Susan R. Salka, Chief Executive Officer of AMN Healthcare.

"The need for healthcare talent and workforce solutions by our clients has accelerated as labor market conditions remain very constrained. To ensure we have access to the best talent possible for our clients, we are continuing to utilize innovative recruitment strategies, and we have the ability to further leverage our expanded recruitment team from the recent Advanced acquisition," Ms. Salka added.

Third Quarter 2019 Results

Consolidated revenue for the quarter was $568 million, an 8% increase over prior year and 6% higher than prior quarter. On an organic basis, consolidated revenue was up 1% over prior year. Revenue for the Nurse and Allied Solutions segment was $363 million, up 18% year over year (6% organic) and 9% sequentially. Travel Nurse division revenue grew 10% year over year with 4% organic growth. Allied division revenue increased 46% year over year, 11% organic.

The Locum Tenens Solutions segment reported revenue of $84 million, down by 17% year over year but up 3% sequentially. Other Workforce Solutions segment revenue was $121 million for an increase of 1% year over year, driven by growth in our interim leadership and VMS businesses.

Gross margin was 33.5%, higher by 30 basis points year over year and flat sequentially. The year-over-year variance was driven by improved gross margins in the Nurse and Allied and Other Workforce Solutions segments.

SG&A expenses were $133 million, or 23.5% of revenue, compared with $121 million, or 23.0% of revenue, in the same quarter last year. SG&A was $122 million, or 22.7% of revenue, in the previous quarter. The year-over-year increase in SG&A costs came mainly from the recent acquisitions, a higher earn-out provision and higher employee-related expenses, partly offset by lower legal reserves.

Income from operations was $40 million, or 7.0% of revenue, compared with $43 million, or 8.1% of revenue, in the same quarter last year. Adjusted EBITDA was $69 million, a year-over-year increase of 3%. Adjusted EBITDA margin was 12.2%, representing a decrease of 60 basis points year over year.

Net income was $24 million, or $0.49 per diluted share, compared with $28 million, or $0.58 per diluted share, in the same quarter last year. Adjusted diluted EPS was $0.81.

At September 30, 2019, cash and cash equivalents totaled $41 million. Cash flow from operations was $81 million for the quarter, and capital expenditures were $9 million. The Company ended the quarter with total debt outstanding of $620 million, with a leverage ratio as calculated in accordance with the Company’s credit agreement of 2.2 to 1.

October Debt Refinancing

In October, AMN issued $300 million of 4.625% senior notes due in 2027 and used the proceeds to repay the Company’s revolving debt and term loan, which totaled $295 million. After these actions, the Company had total debt of $625 million and unused borrowing capacity of $383 million on its senior credit facility.

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

Revenue in the fourth quarter of 2019 is expected to be approximately 8-9% higher year over year. This guidance does not assume any material labor disruption revenue in the quarter.

Conference Call on October 31, 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 third quarter 2019 financial results and outlook on Thursday, October 31, 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) 288-8960 in the U.S. or (612) 234-9960 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 October 31, 2019, and can be accessed until 11:59 p.m. Eastern Time on November 14, 2019, by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 472944.

On October 31, 2019 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported business highlights and financial results for the third quarter ended September 30, 2019 (Press release, Agios Pharmaceuticals, OCT 31, 2019, View Source [SID1234550097]).

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!

"The third quarter was marked by strong commercial execution, now a full year since the U.S. launch of TIBSOVO, and several meaningful clinical updates spanning our early and late stage oncology programs that advance our strategy," said Jackie Fouse, Ph.D., chief executive officer at Agios. "As we look ahead to the remainder of 2019, we are focused on achieving our remaining key milestones, including completing enrollment in our mitapivat PK deficiency pivotal program, establishing proof of concept for mitapivat in thalassemia, initiating our pivotal trial of vorasidenib in low-grade glioma and submission of the TIBSOVO supplemental new drug application for IDH1 mutant cholangiocarcinoma. These milestones are critical steps toward realizing the value-creation potential for both our oncology and rare genetic disease portfolios in 2020 and beyond."

THIRD QUARTER 2019 HIGHLIGHTS & RECENT PROGRESS

Presented data from the single agent dose-escalation portion of the ongoing Phase 1 study of AG-270 in patients with methylthioadenosine phosphorylase (MTAP)-deleted tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October. The data demonstrated that AG-270 induces reductions in the biomarkers of methionine adenosyltransferase 2A (MAT2A) inhibition, notably plasma concentrations of S-adenosylmethionine (SAM) and tumor levels of symmetrically demethylated arginine (SDMA), at well tolerated doses.
Presented results from the Phase 3 ClarIDHy study of TIBSOVO in previously treated isocitrate dehydrogenase-1 (IDH1) mutant cholangiocarcinoma at the European Society for Medical Oncology Congress in September, demonstrating significant improvement in progression free survival compared to placebo.
Initiated two combination arms for the Phase 1 study of AG-270 in MTAP-deleted tumors, one evaluating AG-270 in combination with docetaxel in MTAP-deleted second-line non-small cell lung cancer and another in combination with nab-paclitaxel and gemcitabine in MTAP-deleted first or second-line pancreatic ductal adenocarcinoma.
Published new data from the core and extension phases of the DRIVE PK Phase 2 study of mitapivat in adults with pyruvate kinase (PK) deficiency in the September 5, 2019 issue of the New England Journal of Medicine, demonstrating sustained increases in hemoglobin for up to 35 months.
KEY UPCOMING MILESTONES

The company plans to achieve the following key milestones in the remainder of 2019:

Oncology:

Submit a supplemental new drug application to the FDA for TIBSOVO for previously treated IDH1 mutant cholangiocarcinoma by year-end.
Initiate the registration-enabling Phase 3 INDIGO study of vorasidenib in Grade 2 non-enhancing glioma with an IDH mutation by year-end. The study will evaluate 366 patients in 1:1 double-blind randomization to either 50 mg of vorasidenib once daily or placebo. The primary endpoint is progression free survival.
Rare Genetic Diseases:

Complete enrollment in two global pivotal trials for mitapivat in adults with PK deficiency by year-end:
ACTIVATE-T: A single-arm trial of up to 40 regularly transfused patients
ACTIVATE: A 1:1 randomized, placebo-controlled trial of up to 80 patients who do not receive regular transfusions
Achieve proof-of-concept for mitapivat in thalassemia in the second half of 2019.
REMAINING 2019 DATA PRESENTATIONS

Updated data from the perioperative study of TIBSOVO and vorasidenib in low-grade glioma have been accepted for presentation at the Society for Neuro-Oncology Annual Meeting taking place in Phoenix from November 22-24, 2019.
Data from the IDH and PKR programs have been accepted for presentation at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place in Orlando, Fla. from December 7-10, 2019, including new data from the extension phase of the Phase 2 DRIVE PK study of mitapivat in adults with PK deficiency and important translational data from the Phase 1 combination study of TIBSOVO and azacitidine in frontline acute myeloid leukemia (AML).
THIRD QUARTER 2019 FINANCIAL RESULTS

Revenue: Total revenue for the third quarter of 2019 was $26.0 million, which includes $17.4 million of net product revenue from U.S. sales of TIBSOVO, $5.5 million in collaboration revenue and $2.7 million in royalty revenue from net global sales of IDHIFA under our collaboration agreement with Celgene. This compares to total revenue of $15.2 million for the third quarter of 2018.

Cost of Sales: Cost of sales were $0.4 million for the third quarter of 2019.

Research and Development (R&D) Expenses: R&D expenses were $101.7 million for the third quarter of 2019 compared to $82.6 million for the third quarter of 2018. The increase in R&D expense was primarily attributable to start-up costs for the Phase 3 INDIGO study of vorasidenib in IDH mutated low-grade glioma, the mitapivat pivotal program in PK deficiency and Phase 2 study in thalassemia, and costs of the ongoing Phase 3 TIBSOVO combination trials in the frontline AML setting.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses were $33.0 million for the third quarter of 2019 compared to $31.1 million for the third quarter of 2018.

Net Loss: Net loss was $106.2 million for the third quarter of 2019 compared to $94.7 million for the third quarter of 2018.

Cash Position and Guidance: Cash, cash equivalents and marketable securities as of September 30, 2019 were $540.5 million compared to $805.4 million as of December 31, 2018. The net decrease of $264.9 million in cash position was primarily driven by net expenditures to fund operations. The company expects that its cash, cash equivalents and marketable securities as of September 30, 2019, together with anticipated product and royalty revenue, anticipated interest income, and anticipated expense reimbursements under our collaboration and license agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its anticipated operating expenses and capital expenditure requirements through at least the end of 2020.

CONFERENCE CALL INFORMATION
Agios will host a conference call and live webcast with slides today at 8:00 a.m. ET to discuss third quarter 2019 financial results and recent business activities. To participate in the conference call, please dial 1-877-377-7098 (domestic) or 1-631-291-4547 (international) and refer to conference ID 5996044. The live webcast can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. The archived webcast will be available on the company’s website beginning approximately two hours after the event.