PRA Health Sciences, Inc. Reports First Quarter 2019 Results

On May 1, 2019 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) today reported financial results for the three months ended March 31, 2019 (Press release, PRA Health Sciences, MAY 1, 2019, View Source [SID1234535618]).

"The year is off to a solid start and I am delighted to report that our first quarter results were in line with our expectations" said Colin Shannon, PRA’s Chief Executive Officer. "Our key financial metrics continue to improve, as we continue to see strong book-to-bill ratios and expanding margins. The entire team continues to focus on our commitment to client delivery and we look forward to delivering strong results for the remainder of 2019."

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Net new business for our Clinical Research segment for the three months ended March 31, 2019 was $664.6 million, representing a net book-to-bill ratio of 1.27 for the period. This net new business contributed to an ending backlog of $4.4 billion at March 31, 2019.

For the three months ended March 31, 2019, revenue was $722.0 million, which represents growth of 2.9%, or $20.2 million, compared to the three months ended March 31, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $30.8 million, an increase of 4.4% compared to the first quarter of 2018. By segment, the Clinical Research segment generated revenues of $666.6 million, while the Data Solutions segment generated revenues of $55.4 million.

Direct costs, exclusive of depreciation and amortization, were $377.9 million during the three months ended March 31, 2019 compared to $381.4 million for the three months ended March 31, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased $11.2 million compared to the first quarter of 2018. The increase in direct costs was primarily driven by an increase in labor-related costs in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels. Direct costs were 52.3% of revenue during the first quarter of 2019 compared to 54.3% of revenue during the first quarter of 2018.

Selling, general and administrative expenses were $97.1 million during the three months ended March 31, 2019 compared to $91.7 million for the three months ended March 31, 2018. Selling, general and administrative costs were 13.4% of revenue during the first quarter of 2019 compared to 13.1% of revenue during the first quarter of 2018. The increase in selling, general and administrative expenses as a percentage of revenue is primarily related to increased stock-based compensation during the current year.

GAAP net income was $44.1 million for the three months ended March 31, 2019, or $0.66 per share on a diluted basis, compared to GAAP net income of $39.0 million for the three months ended March 31, 2018, or $0.59 per share on a diluted basis.

EBITDA was $112.2 million for the three months ended March 31, 2019, representing an increase of 13.6% compared to the three months ended March 31, 2018. Adjusted EBITDA was $117.1 million for the three months ended March 31, 2019, representing growth of 22.4% compared to the three months ended March 31, 2018.

Adjusted net income was $73.3 million for the three months ended March 31, 2019, representing growth of 30.3% compared to the three months ended March 31, 2018. Adjusted net income per diluted share was $1.10 for the three months ended March 31, 2019, representing growth of 29.4% compared to the three months ended March 31, 2018.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2019 guidance, to the corresponding GAAP measures is included in this press release.

Guidance

The Company is reaffirming its 2019 revenue guidance of between $3.09 billion and $3.20 billion, representing as reported and constant currency growth of 8% to 11%. We are reaffirming our GAAP net income per diluted share of between $3.65 and $3.80 and Adjusted Net Income per diluted share of between $4.93 and $5.08, representing growth of 15% to 19%. We continue to estimate our annual effective income tax rate at approximately 24%. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.15 and a GBP rate of 1.35. All other foreign currency exchange rates are as of January 31, 2019.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on May 2, 2019, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 1876878. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 1876878.

Additional Information

A financial supplement with results for the three months ended March 31, 2019, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q1 2019 Earnings Presentation."

Adaptimmune to Provide Clinical and Business Update on Monday May 6th, 2019

On May 1, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that it will provide a clinical and business update before the U.S. markets open on Monday May 6, 2019 (Press release, Adaptimmune, MAY 1, 2019, View Source;p=RssLanding&cat=news&id=2396538 [SID1234535608]). Following the announcement, the Company will host a live teleconference and webcast with accompanying slides at 8:00 a.m. EDT (1:00 p.m. BST) on the same day (details below).

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Conference Call and Webcast Link for Clinical and Business Update Slide Presentation on May 6th
The Company will host a live teleconference and slide presentation at 8:00 a.m. EDT (1:00 p.m. BST) on Monday May 6, 2019. The live webcast of the conference call and slides will be available at View Source An archive will be available after the call at the same address. To participate in the live webinar, if preferred, please dial (833) 652-5917 (U.S. and Canada) or +1 (430) 775-1624 (International).

UNITED THERAPEUTICS CORPORATION REPORTS FIRST QUARTER 2019 FINANCIAL RESULTS

On May 1, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported its financial results for the quarter ended March 31, 2019 (Press release, United Therapeutics, MAY 1, 2019, View Source [SID1234535560]).

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"I’m very pleased to report that last quarter we helped more pulmonary arterial hypertension (PAH) patients with our Remodulin, Tyvaso and Orenitram medicines than ever before," said Martine Rothblatt, Ph.D., Chairman and Chief Executive Officer of United Therapeutics. "While we did also experience the disappointment of being unable to prove a morbidity/mortality benefit of esuberaprost in our BEAT phase III trial, it is of course the nature of science that hypotheses are disproven as well as proven. No string of successes is without its setbacks, and we are confident of positive results being proven amongst our many other pivotal studies including the DISTINCT study of dinutuximab for small cell lung cancer, the INCREASE study of Tyvaso in pulmonary hypertension (PH) associated with interstitial lung disease, the PERFECT study of Tyvaso in PH associated with COPD, the SOUTHPAW study of Orenitram in PH associated with heart failure, the ADVANCE OUTCOMES study of ralinepag in PAH, the SAPPHIRE study of autologous gene therapy in PAH and our lung transplantation study."

Revenues for the three months ended March 31, 2019 decreased by $26.6 million as compared to the same period in 2018.

Remodulin net product sales for the three months ended March 31, 2019 increased by $28.7 million as compared to the same period in 2018. U.S. Remodulin net product sales increased by $18.8 million, primarily due to an increase in the number of patients being treated with Remodulin and a price increase implemented in April 2018, which was the first price increase for Remodulin since 2010. International Remodulin net product sales increased by $9.9 million, primarily due to an increase in quantities shipped to international distributors.

Tyvaso net product sales for the three months ended March 31, 2019 increased by $9.2 million as compared to the same period in 2018. This increase was primarily due to an increase in the number of patients being treated with Tyvaso and a price increase implemented in January 2019.

Orenitram net product sales for the three months ended March 31, 2019 increased by $6.2 million as compared to the same period in 2018. This increase was primarily due to an increase in the number of patients being treated with Orenitram and a price increase implemented in January 2019.

Unituxin net product sales for the three months ended March 31, 2019 increased by $6.9 million as compared to the same period in 2018. This increase was primarily due to an increase in the number of vials sold.

Adcirca net product sales for the three months ended March 31, 2019 decreased by $77.6 million as compared to the same period in 2018. This decrease was due to a decrease in bottles sold following the onset of generic competition for Adcirca beginning in August 2018.

Refer to Share-based compensation below for discussion.

Cost of product sales, excluding share-based compensation. The decrease in cost of product sales of $31.1 million for the three months ended March 31, 2019, as compared to the same period in 2018, was primarily attributable to a $32.8 million decrease in royalty expense for Adcirca because fewer bottles were sold due to the onset of generic competition for Adcirca beginning in August 2018.

Research and development expense, excluding share-based compensation. The increase in research and development expense of $835.6 million for the three months ended March 31, 2019, as compared to the same period in 2018, was driven by continued investment in our product pipeline. Research and development expense for the treatment of cardiopulmonary diseases increased by $829.2 million for the three months ended March 31, 2019, as compared to the same period in 2018, due to: (1) an $800.0 million upfront payment to Arena Pharmaceuticals under our license agreement related to ralinepag, and $8.9 million of expenditures associated with the phase III ADVANCE studies of ralinepag during the three months ended March 31, 2019; (2) a $12.5 million payment under our license and collaboration agreement with MannKind; (3) increased spending of $5.6 million on the development of drug delivery devices, including the Implantable System for Remodulin; and (4) increased spending on several clinical and non-clinical studies.

Share-based compensation. The increase in share-based compensation expense of $130.3 million for the three months ended March 31, 2019, as compared to the same period in 2018, was primarily due to: (1) a $126.0 million increase in STAP expense (benefit) driven by an 8% increase in our stock price for the three months ended March 31, 2019, as compared to a 24% decrease in our stock price for the same period in 2018; and (2) a $3.0 million increase in stock option expense due to additional awards granted and outstanding in 2019.

Income Tax (Benefit) Expense

The income tax benefit was $156.0 million for the three months ended March 31, 2019, as compared to income tax expense of $64.5 million for the same period in 2018. Our effective income tax rate (ETR) for the three months ended March 31, 2019 and

2018 was 24 percent and 21 percent, respectively. We recognized a loss before income taxes, and a corresponding income tax benefit, for the three months ended March 31, 2019, as a result of the one-time $800.0 million payment to Arena in January 2019. As a result of this loss, our anticipated tax credits, partially offset by non-deductible compensation expense, increase our tax benefit and resulting ETR for the three months ended March 31, 2019, compared to the three months ended March 31, 2018.

Non-GAAP Earnings

Non-GAAP earnings is defined as net income, adjusted for: (1) share-based compensation expense (including expenses relating to stock options, restricted stock units, share tracking awards and our employee stock purchase plan); (2) license-related fees; and (3) tax impact on non-GAAP earnings adjustments.

Conference Call

We will host a half-hour teleconference on Wednesday, May 1, 2019, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code: 5569533.

This teleconference will also be webcast and can be accessed via our website at View Source

Operational Update

On May 1, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported an update for the ongoing development of its product candidates (Press release, Immutep, MAY 1, 2019, View Source [SID1234535559]).

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Efti Clinical Update

AIPAC – Phase IIb Clinical Trial

To date, there have been 211 patients enrolled in the Company’s Phase IIb AIPAC clinical trial, which is evaluating eftilagimod alpha ("efti" or "IMP321") in combination with paclitaxel, a chemotherapy, in metastatic breast cancer. Full recruitment of the trial, 226 patients, is expected to occur in the second quarter of this year. The trial is being conducted at 33 clinical trial sites across Germany, the UK, France, Hungary, Belgium, Poland and the Netherlands.

The first read out of Progression Free Survival (PFS) data is expected within the next 11 months, but not before Q4 2019, depending on the number of predefined progression events. Other endpoints include Overall Response Rate (ORR) and Overall Survival (OS).

TACTI-002 – Phase II Clinical Trial

15 patients have been enrolled in Immutep’s Phase II TACTI-002 clinical trial across seven clinical sites in the U.S., Europe and Australia. This figure includes 11 patients in the first line non-small cell lung cancer (NSCLC) cohort, which requires 17 patients to complete recruitment of this initial cohort.

The TACTI-002 study is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada) and is evaluating the combination of efti with MSD’s KEYTRUDA (or pembrolizumab, an anti-PD-1 therapy) in up to 109 patients with second line head and neck squamous cell carcinoma or NSCLC in first and second line.

Patient recruitment is ongoing and Immutep expects to report first data from the study in mid-2019.

LOGO

TACTI-mel – Phase I Clinical Trial

Immutep reported positive, more mature data from its ongoing and fully recruited TACTI-mel Phase I clinical study in melanoma in March. The trial is evaluating the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma.

Key findings from the ongoing trial were as follows:


Part A (starting cycle 5 of

pembrolizumab therapy) N=18


Part B (starting day 1 cycle 1 of

pembrolizumab therapy) N=6

Overall Response Rate (ORR)

33% (61%*) 50%
Disease Control Rate (DCR)

66% 66%
*Exploratory ORR when tumour size is measured according to irRC from day 1 of cycle 1 of pembrolizumab and following combination therapy (which starts at cycle 5 of prembrolizumab treatment).

In addition, efti continues to have a very favorable safety profile in doses up to 30 mg administered s.c. every 2 weeks. The data was presented at the World Immunotherapy Congress 2019.

INSIGHT & INSIGHT-004 – Phase I Clinical Trials

INSIGHT-004 is a Phase I clinical trial in collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc. and the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH (IKF) which is evaluating the combination of efti with avelumab, a human anti-PD-L1 antibody, in patients with advanced solid malignancies. The trial protocol has now been approved by the competent authority and ethics committee and Immutep expects the first patient to be recruited in Q2 2019.

This study is taking place as an extension to the INSIGHT trial, an investigator sponsored explorative trial which is already underway and being run by our partner, IKF.

13 patients are now enrolled in the INSIGHT clinical trial, which is evaluating the potential of efti in different settings in terms of route of administration and indications.

IMP761 Update

IMP761—Preclinical Results

Immutep reported positive results from its preclinical study of IMP761, a novel LAG-3 agonist antibody being developed for the treatment of autoimmune diseases, in March. The preclinical results showed that IMP761 decreases inflammation at the tissue site, demonstrating its potential as a new therapy that could treat the cause of autoimmune disease, rather than just the symptoms.

Specifically, in vitro results showed that IMP761 caused the down-regulation of human T cell proliferation and activation. In addition, the in vivo studies showed that IMP761 causes down-modulation of T cell infiltration in a non-human-primate animal model. These results were presented at the 14th Congress of European Crohn’s and Colitis Organisation (ECCO) Conference.

The Company is continuing cell line development and GMP manufacturing preparations for IMP761 to progress the antibody towards clinical development.

Update on programs fully funded by Immutep’s licensing partners

GlaxoSmithKline – GSK2831781 / IMP731

GlaxoSmithKline (GSK) has announced that it will be pursuing a proof-of-concept study in ulcerative colitis for GSK2831781, which is derived from Immutep’s IMP731 antibody. This Phase II clinical study is expected to commence shortly.

Novartis—LAG525 / IMP701

Novartis is continuing its clinical development program for LAG525, or IMP701, in oncology. Currently, there are five ongoing Phase I/II clinical trials evaluating this product candidate.

CYTLIMIC—efti

Immutep is working with CYTLIMIC to prepare for CYTLIMIC’s clinical trials to evaluate efti as part of a therapeutic cancer vaccine, called CYT001. The vaccine contains cancer antigens to boost a patient’s own immune cells to recognise and kill cancer cells related to the antigens.

Eddingpharm (EOC Pharma)—efti

Immutep’s partner and Chinese licensee, EOC Pharma, is continuing the recruitment of patients for its Phase I clinical study of efti for the treatment of metastatic breast cancer. Immutep expects further progress from EOC Pharma later in 2019.

MacroGenics Provides Update on Corporate Progress and First Quarter 2019 Financial Results

On May 1, 2019 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, provided an update on its corporate progress and reported financial results for the quarter ended March 31, 2019 (Press release, MacroGenics, MAY 1, 2019, View Source [SID1234535558]).

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"In February, we reported topline results from SOPHIA showing that in the Phase 3 trial, progression-free survival was prolonged following treatment with margetuximab and chemotherapy compared to trastuzumab with chemotherapy. We look forward to presenting detailed results at ASCO (Free ASCO Whitepaper). In addition, we anticipate submitting a BLA for this program to the FDA in the second half of 2019. If approved by regulators, margetuximab could offer the potential of a new treatment option for patients living with HER2-positive metastatic breast cancer in a third line and beyond setting where there are currently no FDA-approved therapies. In seeking to address unmet needs of patients with HER2-postive cancers beyond breast cancer, we plan to initiate in the second half of 2019 a registration-directed trial to evaluate margetuximab for treating gastric cancer patients in the frontline setting," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics.

"Mechanistically, we believe the results achieved in the SOPHIA study have validated our Fc-optimization technology, also used in enoblituzumab, our investigational monoclonal antibody targeting B7-H3," continued Dr. Koenig. "To date, we have made tremendous progress with our immuno-oncology pipeline of nine clinical product candidates with multiple molecules demonstrating clinical proof of concept to support ongoing and/or planned registration studies."

Key Pipeline Updates
Margetuximab. Recent updates related to the Company’s investigational Fc-optimized monoclonal antibody (mAb) that targets human epidermal growth factor receptor 2 (HER2) include:

•Oral Presentation of SOPHIA Data at ASCO (Free ASCO Whitepaper); Plans to Submit BLA in 2H2019: In February 2019, MacroGenics announced that SOPHIA, the Phase 3 clinical trial of margetuximab in patients with HER2-positive metastatic breast cancer, met the trial’s first sequential primary endpoint of prolongation of progression-free survival (PFS) in patients treated with the combination of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy. An abstract containing data from SOPHIA was selected for presentation in an oral session to be held on Tuesday, June 4, 2019 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. MacroGenics anticipates submitting a Biologics License Application (BLA) to the U.S. FDA for margetuximab, based on the PFS results, in the second half of 2019.
•Additional Validating Mechanistic Data in Posters at AACR (Free AACR Whitepaper) and ASCO (Free ASCO Whitepaper): Data presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2019 showed improved Fc-dependent activity of margetuximab compared to trastuzumab in vitro. These preclinical data validate the molecule’s underlying mechanism of action and the Company’s Fc-optimization platform. In addition, an abstract containing data describing HER2-specific immunity observed in patients with HER2-positive cancers treated with margetuximab in the Phase 1 trial was selected for presentation in a poster session at ASCO (Free ASCO Whitepaper) on Sunday, June 2, 2019.

Exhibit 99.1
•Plans to Initiate Front-line Gastric Cancer Trial in 2H2019: At the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2019, data were presented demonstrating encouraging anti-tumor activity and acceptable safety and tolerability of margetuximab in combination with an anti-PD-1 mAb in a Phase 2 clinical trial in patients with HER2-positive gastric or gastroesophageal junction cancer. MacroGenics and its partner in Greater China, Zai Lab, expect to initiate a Phase 2/3 registration-directed clinical trial of margetuximab in combination with checkpoint inhibitor molecules, including MGA012 (anti-PD-1 mAb) and MGD013 (bispecific PD-1 x LAG-3 DART molecule) in the second half of 2019.

B7-H3 Franchise. MacroGenics is developing a portfolio of investigational antibody-based therapeutics that target B7-H3 through complementary mechanisms of action taking advantage of this antigen’s broad expression across multiple solid tumor types. Recent program highlights include:

•Plans to Advance Enoblituzumab in Head and Neck Cancer Study: Enoblituzumab is an Fc-optimized mAb that targets B7-H3. Encouraging data from the Phase 1 clinical study of enoblituzumab in combination with an anti-PD-1 mAb were presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2018. Based on these data, MacroGenics is planning to initiate a Phase 2 study of enoblituzumab in combination with MGA012 in patients with squamous cell carcinoma of the head and neck (SCCHN) in the second half of 2019.
•MGD009 Phase 1 Studies Ongoing: MGD009 is a bispecific DART molecule designed to target B7-H3 expressed on tumor cells and CD3 expressed on normal T cells. MacroGenics is enrolling patients in two Phase 1 clinical trials of MGD009, one as monotherapy and another in combination with MGA012.
•MGC018 Dose Escalation Ongoing: MGC018 is an antibody-drug conjugate (ADC) designed to target solid tumors expressing B7-H3. MacroGenics is evaluating MGC018 in a Phase 1 dose escalation study.

PD-1 Franchise. MacroGenics is advancing multiple investigational PD-1-directed programs to provide differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:

•MGA012 Registration-directed Studies Ongoing: MGA012 (INCMGA0012) is an anti-PD-1 mAb exclusively licensed to Incyte Corporation on a worldwide basis. Incyte is initially pursuing development of MGA012 monotherapy through three potentially registration-directed trials in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer and Incyte and MacroGenics are each conducting multiple studies of MGA012 in combination with other agents. MacroGenics retains the right to develop its pipeline of product candidates in combination with MGA012.
•MGD013 Dose Expansion Ongoing: MGD013 is a first-in-class bispecific DART molecule designed to provide co-blockade of PD-1 and LAG-3, two immune checkpoint molecules expressed on T cells. MacroGenics is evaluating MGD013 in a Phase 1 dose expansion study in up to nine tumor types and expects to present data from this trial in the second half of 2019.
•MGD019 Dose Escalation Ongoing: MGD019 is a bispecific DART molecule designed to provide co-blockade of PD-1 and CTLA-4, two immune checkpoint inhibitors expressed on T cells. MacroGenics is currently evaluating MGD019 in a Phase 1 dose escalation study.

Flotetuzumab. A recent update related to the Company’s investigational, bispecific DART molecule that recognizes both CD123 and CD3, includes:

•Data from Ongoing Study Expected 2H2019: Based on data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018 showing anti-leukemic activity and acceptable tolerability of flotetuzumab in patients with relapsed/refractory AML, MacroGenics is enrolling additional patients in a dose expansion cohort enriched for primary refractory patients and expects to announce updated data from the trial in the second half of 2019. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

First Quarter 2019 Financial Results

Exhibit 99.1
•Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2019, were $320.4 million, compared to $232.9 million as of December 31, 2018.
•Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $9.7 million for the quarter ended March 31, 2019, compared to $4.7 million for the quarter ended March 31, 2018. Revenue from collaborative agreements included revenue received under a clinical supply agreement with Incyte, as well as the recognition of deferred revenue from payments received in previous periods and payments received during the quarter.
•R&D Expenses: Research and development expenses were $47.1 million for the quarter ended March 31, 2019, compared to $45.7 million for the quarter ended March 31, 2018. This increase was due to increased clinical trial costs for MGD013, MGC018 and flotetuzumab, as well as increased development/manufacturing costs related to MGA012 (largely offset by revenue from Incyte). These increases were partially offset by decreased expenses related to the SOPHIA and enoblituzumab clinical studies.
•G&A Expenses: General and administrative expenses were $10.2 million for the quarter ended March 31, 2019, compared to $9.2 million for the quarter ended March 31, 2018.
•Net Loss: Net loss was $45.0 million for the quarter ended March 31, 2019, compared to net loss of $49.5 million for the quarter ended March 31, 2018.
•Shares Outstanding: Shares outstanding as of March 31, 2019 were 48,805,008.

Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended March 31, 2019 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 8788605.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.