On April 29, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the quarter ended March 31, 2021 (Press release, Emergent BioSolutions, APR 29, 2021, View Source [SID1234578760]).

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FINANCIAL HIGHLIGHTS (1) (in millions)

Q1 2021
Q1 2020
% Change
Total revenues
$343.0
$192.5
78%
Net income (loss)
$69.7
($12.5)
*
Net income (loss) per diluted share
$1.28
($0.24)
*
Adjusted net income (2)
$83.6
$0.3
*
Adjusted net income (2) per diluted share
$1.53
$0.01
*
Adjusted EBITDA (2)
$123.5
$15.3
*
* % change is greater than 100%
2021 FINANCIAL PERFORMANCE (1)
(I) Quarter Ended March 31, 2021 (Q1)
Revenues
(in millions)
Q1 2021
Q1 2020
% Change
Product sales, net (5):
• NARCAN Nasal Spray
$74.2
$72.2
3%
• Anthrax vaccines
$55.0
$51.9
6%
• Other
$8.7
$24.1
(64)%
Total product sales, net
$137.9
$148.2
(7)%
Contract development and manufacturing (CDMO) services
$183.8
$21.7
*
Contracts and grants
$21.3
$22.6
(6)%
Total revenues
$343.0
$192.5
78%
(5) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.
* % change is greater than 100%

Product Sales, net

For Q1 2021, revenues from NARCAN Nasal Spray and Anthrax vaccines were consistent as compared to Q1 2020.
For Q1 2021, revenues from other product sales decreased $15.4 million as compared to Q1 2020. The decrease is primarily due to lower sales of BAT[Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)], due to timing of deliveries to the U.S. government (USG) and the Strategic National Stockpile, and lower sales of the Company’s travel health vaccines, largely Vivotif (Typhoid Vaccine Live Oral Ty21a), due to the currently low level of global travel.

Contract Development and Manufacturing (CDMO) Services

For Q1 2021, revenue from contract development and manufacturing services was $183.8 million, an increase of
$162.1 million, as compared to Q1 2020. The increase is largely due to the public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) to support the USG’s efforts to address the COVID-19 pandemic and CDMO services in support of commercial innovators.

Contracts and Grants

For Q1 2021, revenues from contracts and grants were consistent as compared to Q1 2020.
Operating Expenses
(in millions)
Q1 2021
Q1 2020
% Change
Cost of product sales and CDMO services
$99.3
$76.9
29%
Research and development
$52.5
$42.7
23%
Selling, general and administrative
$80.9
$69.7
16%
Amortization of intangible assets
$14.9
$14.8
1%
Cost of Product Sales and CDMO Services
For Q1 2021, cost of product sales and contract development and manufacturing services increased $22.4 million as compared to Q1 2020. The increase is primarily due to a higher volume of CDMO services, largely the Company’s arrangements to address the COVID-19 pandemic, partially offset by a decline in costs associated with product sales due to the lower total product sales, net.

Research and Development

For Q1 2021, research and development expenses increased $9.8 million as compared to Q1 2020. The increase is primarily due to higher costs associated with the development of the COVID-HIG therapeutic product candidate, offset by a decline in costs associated with the development of the AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted) product candidate as this program is nearing completion. Net of contracts and grants revenue, which consists primarily of reimbursements against development investments, research and development expenses were $31.2 million for Q1 2021.

Selling, General and Administrative

For Q1 2021, selling, general and administrative expenses increased $11.2 million as compared to Q1 2020. The increase is primarily due to higher staffing and professional service costs to support the Company’s growth.
Additional Financial Information

Gross Margin (2)
(in millions)
Q1 2021
Q1 2020
% Change
Gross margin
$222.4
$93.0
139%
Gross margin % (gross margin divided by adjusted revenues (2))
69%
55%
14%
Adjusted gross margin
$223.5
$93.6
139%
Adjusted gross margin % (adjusted gross margin divided by adjusted revenues (2))
69%
55%
14%
CDMO Metrics
CDMO Backlog Rollforward
(in millions)
Beginning backlog (12/31/2020)
$1,340.0
Revenue recognized during Q1 2021
($183.8)
New business (net new contracted value included in backlog)
$186.6
Ending backlog (3/31/2021)
$1,342.8

(in millions)
March 31, 2021
December 31, 2020
% Change
CDMO services backlog (3)
$1,342.8
$1,340.0
—%
CDMO services opportunity funnel (4)
$807.1
$689.0
17%
Capital Expenditures
(in millions)
Q1 2021
Q1 2020
% Change
Gross capital expenditures
$56.1
$24.2
132%
– Capital expenditures reimbursed
($7.2)
$—
—%
Net capital expenditures
$48.9
$24.2
102%
Gross capital expenditures as a % of total revenues
16%
13%
3%

2021 FINANCIAL FORECAST

For full year 2021, the Company’s revised and previous forecast of the following financial metrics is as follows:
(in millions)
Revised 2021 Forecast
Previous 2021 Forecast
Total revenues
$1,700 – $1,900
$1,950 – $2,050
• NARCAN nasal spray
$305 – $325
$305 – $325
• Anthrax vaccines
$280 – $310
$280 – $310
• ACAM2000
$185 – $205
$185 – $205
• CDMO services
$765 – $875
$925 – $965
Adjusted EBITDA (2)
$620 – $720
$750 – $810
Adjusted net income (2)
$395 – $470
$475 – $525
Gross margin (2)
63% – 65%
65%
The Company’s revised financial forecast for 2021 includes the following additional considerations:

Revised considerations

CDMO services revenues have been reduced primarily due to the hold of certain COVID-19 vaccine bulk drug substance lots and commitment not to initiate new manufacturing at Bayview pending further review by the U.S. Food and Drug Administration (FDA). Even assuming FDA concurrence to re-initiate new manufacturing and/or release of lots, the Company expects a delay in the timing of expected revenue.

Total revenues, specifically other product sales, are expected to be impacted due to the Company’s assumption that a new raxibacumab contract will be awarded later than previously planned.
Unchanged considerations

Anthrax vaccines revenues are expected to continue to primarily reflect procurement of AV7909 under the terms of the Company’s existing contract with BARDA at a more normalized annual level.

ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) vaccine deliveries are expected to continue under the terms of the Company’s existing contract with the U.S. Department of Health and Human Services (HHS) at unit volume levels consistent with 2020 deliveries.

Narcan (naloxone HCl) Nasal Spray revenues assume the naloxone market remains competitive, that at least one new entrant will enter the market by year end, and that no generic entrant will enter the market prior to the anticipated appellate decision related to the pending patent litigation, which is expected in the second half of 2021.
Pipeline progress is expected across the vaccines, therapeutics, and devices portfolios, anticipating at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing.
Capital expenditures, net of reimbursement, are expected to be in a range of 8% to 9% of total revenues, reflecting ongoing investments in capacity and capability expansions in support of the Company’s CDMO services business and product portfolio.

Q2 2021 REVENUE FORECAST

For Q2 2021, the Company expects total revenues of $370 million to $430 million.

FOOTNOTES

(1) All financial information incorporated within this release is unaudited
(2) See "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," "Reconciliation of Gross Margin and Adjusted Gross Margin" and "Reconciliation of Net Research and Development Expenses" for a definition of terms and the reconciliation tables.
(3) CDMO backlog is defined as estimated remaining contract value as of the indicated period pursuant to signed contracts, the majority of which is expected to be recognized over the next 24 months.
(4) CDMO opportunity funnel is defined as proposal values from new work with new customers, new work with existing customers and extensions/expansions of existing contracts with existing customers, that if converted to new business the majority of which is expected to be realized over the next 24 months. This excludes any value associated with an extension of the commercial supply agreements (CSA) with Johnson & Johnson and AstraZeneca.
(5) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.

CONFERENCE CALL, PRESENTATION SUPPLEMENT, AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, April 29, 2021, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following:

Live Teleconference Information:
Dial in: [US] (855) 766-6521; [International] (262) 912-6157
Conference ID: 9153099
Live Webcast Information:
Visit View Source for the webcast.
A replay of the call can be accessed from the Emergent website.

On April 29, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Dr. Helen Torley, president and chief executive officer, will present virtually at the BofA Securities 2021 Virtual Health Care Conference on Tuesday, May 11, 2021 at 12:30 p.m. Eastern Time / 9:30 a.m. Pacific Time (Press release, Halozyme, APR 29, 2021, View Source [SID1234578759]).

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An audio-only direct link of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 6 months following the event. To access the link, please visit Halozyme’s website approximately 10 minutes prior to the presentation to register and download any necessary audio software.

On April 29, 2021 Seagen Inc. (Nasdaq:SGEN) reported financial results for the first quarter and three months ended March 31, 2021 (Press release, Seagen, APR 29, 2021, View Source [SID1234578758]). The Company also highlighted ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib) commercial and development accomplishments, as well as progress with its lead pipeline programs to treat cancer.

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"Year-over-year quarterly net product sales growth of 52 percent was driven by rapid adoption of our newest products, PADCEV and TUKYSA, in addition to strong sales of ADCETRIS. We continue to project 2021 total net product sales in our territories of approximately $1.3 billion," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "Looking ahead, we expect continued global progress across the portfolio. This includes TUKYSA launches in Europe following marketing authorizations received in the first quarter. In collaboration with Astellas we are pursuing several PADCEV marketing applications across the United States, Europe, Japan and Latin America. In addition, we are preparing for potential U.S. launch of a fourth drug following FDA acceptance of our tisotumab vedotin BLA submission with Priority Review. We are continuing to deliver cutting-edge innovation and medicines that make a meaningful difference in the lives of cancer patients."
COMMERCIAL PRODUCTS HIGHLIGHTS

PADCEV

Received European Medicines Agency (EMA) Acceptance of Marketing Authorization Application (MAA): In March 2021, Seagen and Astellas announced that the EMA accepted the PADCEV MAA for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1/L1 inhibitor and who have received a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting. PADCEV will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use can shorten the MAA evaluation timeframe.

Received FDA Filing Acceptance of Two Supplemental Biologics License Applications (sBLAs): In April 2021, the FDA accepted two PADCEV sBLA submissions for review under the Real-Time Oncology Review pilot program. The applications were granted Priority Review with a target action date of August 17, 2021. The review of both applications will be conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. The first sBLA is based on the phase 3 EV-301 trial and seeks to convert PADCEV’s accelerated approval to regular approval. The second sBLA, based on the pivotal trial EV-201’s cohort 2, requests an expansion of the current indication to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

Submitted Several Additional Global Marketing Authorization Applications: In addition to the MAA under review in the European Union (EU), Seagen and Astellas have submitted applications for PADCEV approval in Australia, Canada, Japan, Singapore, Brazil and Switzerland.

Reported Positive EV-201 Cohort 2 and EV-301 Results in Patients with Previously Treated Advanced Urothelial Cancer: In February 2021, results were presented from the phase 3 EV-301 trial comparing PADCEV to chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. The data showed significant improvements in overall and progression-free survival among patients treated with PADCEV compared to those who received chemotherapy. The findings were published in the New England Journal of Medicine and presented during the virtual scientific program of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO-GU). Data were also presented at ASCO (Free ASCO Whitepaper)-GU demonstrating durable tumor responses experienced among patients previously treated with immunotherapy in the second cohort of the pivotal EV-201 trial.
TUKYSA
Received Approval in the EU and Great Britain: In February 2021, TUKYSA was approved by the European Commission for use in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least two prior anti-HER2 treatment regimens. The approval of TUKYSA is valid in all countries of the EU, as well as Norway, Liechtenstein, Iceland and Northern Ireland. In addition, TUKYSA was granted marketing authorization in Great Britain by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the same patient population. MHRA had previously granted TUKYSA a Promising Innovative Medicine designation.

Started Enrolling Multiple Clinical Trials: In the first quarter of 2021, the first patient was enrolled in two new clinical trials. The phase 3 CompassHER2 RD trial is evaluating TUKYSA in combination with Kadcyla (trastuzumab emtansine; T-DM1) compared to Kadcyla alone in the adjuvant HER2-positive breast cancer setting. The trial is being conducted by the Alliance for Clinical Trials in Oncology, a U.S. cooperative group. The second is a phase 2 trial evaluating TUKYSA in combination with trastuzumab in various metastatic solid tumors with HER2 alterations.

ADCETRIS

Expect Publication of 5-year Follow-up Results for ECHELON-1: The five-year update of the phase 3 ECHELON-1 clinical trial have been accepted for publication and should be published in the second quarter 2021. Data showed treatment with ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) resulted in superior long-term outcomes when compared to ABVD, which includes bleomycin, in frontline advanced Hodgkin lymphoma.

PIPELINE HIGHLIGHTS

Received FDA Filing Acceptance of Tisotumab Vedotin BLA for Priority Review: In April 2021, Seagen and Genmab announced the FDA had accepted for Priority Review the tisotumab vedotin BLA for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The FDA has set a target action date of October 10, 2021 submission is based on the results of the innovaTV 204 pivotal phase 2 trial, which were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 and published in The Lancet Oncology in April 2021.

Presented Data Highlighting Pipeline of Novel Targeted Therapies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: In April 2021, Seagen presented preclinical data on three pipeline programs that support the rationale for clinical development. SEA-TGT, an anti-TIGIT antibody using the Company’s sugar-engineered antibody (SEA) technology, and two vedotin-based ADCs, SGN-B6A and SGN-STNV, were highlighted. All of the programs are currently in phase 1 clinical trials.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

FIRST QUARTER 2021 FINANCIAL RESULTS

Revenues: Total revenues for the first quarter ended March 31, 2021 increased to $332.0 million, compared to $234.5 million for the same period in 2020. Growth over 2020 was driven by higher sales of PADCEV and the addition of TUKYSA to the Company’s commercial portfolio. Revenues are composed of the following three components:
Net Product Sales:

Three months ended March 31,
(dollars in millions)
2021

2020

% Change
Total Net Product Sales
$
302.6

$
198.5

52%
ADCETRIS
162.6

164.1

(1)%
PADCEV
69.8

34.5

102%
TUKYSA
70.3

—

N/A
Note: Sum of product sales may not equal total net product sales due to rounding.
Royalty Revenues: Royalty revenues for the first quarter in 2021 were $27.2 million, compared to $20.4 million for the same period in 2020. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, royalties from sales of Polivy (polatuzumab vedotin) by Roche and Blenrep (belantamab mafodotin) by GlaxoSmithKline, which are ADCs that use Seagen technology.

Collaboration and License Agreement Revenues: Amounts earned under the Company’s product, development and technology collaborations were $2.2 million in the first quarter in 2021, compared to $15.6 million for the same period in 2020. Collaboration revenues for the first quarter of 2020 included a regulatory milestone related to Polivy under the collaboration with Roche.

Cost of Sales: Cost of sales for the first quarter in 2021 were $64.1 million, compared to $29.4 million for the same period in 2020. The increase was primarily due to the gross profit share with Astellas based on PADCEV sales, which was $32.5 million in the first quarter of 2021, compared to $16.4 million for the same period in 2020. The increase in cost of sales also reflected amortization of acquired in-process technology costs that began with the approval of TUKYSA in April 2020, and third-party royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales, in addition to cost of products sold.

Research and Development (R&D) Expenses: R&D expenses for the first quarter in 2021 were $230.4 million, compared to $195.2 million for the same period in 2020. The increase in 2021 primarily reflected continued investment in the Company’s pipeline to evaluate new potential indications for the Company’s commercial drugs and to advance novel product candidates and technologies.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the first quarter in 2021 were $159.8 million, compared to $122.2 million for the same period in 2020. The increase was primarily attributed to increased field sales personnel and external spend to support our recently commercialized products, PADCEV and TUKYSA, and higher infrastructure costs to support our continued growth in the U.S. and Europe.
Non-cash, share-based compensation expense for the first three months of 2021 was $38.2 million, compared to $33.6 million for the same period in 2020.

Net Loss: Net loss for the first quarter of 2021 was $121.4 million, or $0.67 per diluted share, compared to net loss of $168.4 million, or $0.98 per diluted share, for the first quarter of 2020. Net loss in the first quarter of 2020 included a non-cash net investment loss of $59.1 million primarily associated with Seagen’s common stock holding in Immunomedics, which was marked-to-market.

Cash and Investments: As of March 31, 2021, Seagen had $2.5 billion in cash and investments.

2021 FINANCIAL OUTLOOK
Seagen anticipates 2021 revenues, operating expenses and other costs to be in the ranges shown in the table below, unchanged from the Company’s previous financial guidance provided on February 11, 2021.
Revenues
ADCETRIS net product sales
$675 million to $700 million
PADCEV net product sales
$310 million to $325 million
TUKYSA net product sales
$300 million to $315 million
Royalty revenues
$125 million to $135 million
Collaboration and license agreement revenues
Less than $20 million
Operating expenses and other costs
Cost of Sales
$270 million to $300 million
R&D expenses
$900 million to $1,000 million
SG&A expenses
$650 million to $725 million
Non-cash expenses1 (primarily attributable to
share-based compensation)
$225 million to $245 million
1. Non-cash expenses include share-based compensation, depreciation and amortization of intangible assets.
Conference Call Details
Seagen management will host a conference call and webcast with supporting slides to discuss its first quarter 2021 and year-to-date financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at www.seagen.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10153242. Supporting slides are available on the Seagen website at www.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website www.seagen.com, under the Investors section.

On April 29, 2021 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it will report first quarter 2021 financial results after the U.S. financial markets close on Thursday, May 6, 2021 (Press release, Oncternal Therapeutics, APR 29, 2021, View Source [SID1234578757]). Oncternal’s management will host a webcast at 2:00 p.m. PT (5:00 p.m. ET) to discuss the Company’s financial results and provide a comprehensive business update.

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The live webcast of the call will be available online via a link from the investor relations page of the Company’s website at www.oncternal.com, and the call will be archived there for at least 30 days.

On April 29, 2021 MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported an update on its recent corporate progress and reported financial results for the quarter ended March 31, 2021 (Press release, MacroGenics, APR 29, 2021, View Source [SID1234578756]).

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"With the recent launch and commercialization of MARGENZA, we are delivering on our vision to provide potentially life-changing therapeutics to patients with cancer. We are well positioned to advance this mission as the growing body of data emerges from our deep pipeline of clinical and pre-clinical product candidates," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics, "and we look forward to sharing additional data with you as the year progresses."

Key Updates on Proprietary Programs

Recent progress and anticipated events in 2021 related to MacroGenics’ approved and investigational product candidates in clinical development are highlighted below.

Margetuximab is an Fc-engineered, monoclonal antibody (mAb) that targets the HER2 oncoprotein, which is expressed by certain breast, gastroesophageal and other solid tumor cells.

MARGENZA (margetuximab-cmkb) commercial launch. In mid-March 2021, MacroGenics and its commercial partner, EVERSANA, launched MARGENZA for the treatment of adult patients with metastatic HER2-positive breast cancer, in combination with chemotherapy, who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Also during the quarter, results from the SOPHIA metastatic breast cancer Phase 3 study of MARGENZA were published in the Journal of the American Medical Association (JAMA) Oncology. Finally, based on the current accrual rate of overall survival (OS) events in the ongoing SOPHIA trial that supported approval by the FDA, the Company now anticipates completing the final analysis of OS data, based on accrual of the 385th OS event, by the end of the third quarter.

Phase 2/3 MAHOGANY study in advanced gastric and gastroesophageal junction cancer. The MAHOGANY clinical program contains two modules designed to evaluate margetuximab as an investigational agent in combination with a checkpoint inhibitor, with or without chemotherapy, as a potential first-line treatment for patients with advanced or metastatic HER2-positive GC/GEJ. All 40 patients have been enrolled in the first part of Module A, which is evaluating margetuximab in combination with retifanlimab (an anti-PD-1 therapy). The Company expects to report safety and efficacy data in the third quarter of 2021. Enrollment in Module B, which is evaluating margetuximab plus MacroGenics’ checkpoint inhibitor molecules in combination with chemotherapy compared to standard of care therapy of trastuzumab with chemotherapy in patients with HER2-positive tumors irrespective of PD-L1 expression, is currently ongoing in coordination with MacroGenics’ regional partner in Greater China, Zai Lab.

Flotetuzumab is a bispecific CD123 × CD3 DART molecule being evaluated in patients with primary induction failure (PIF) and early relapsed (less than six months, or ER6) acute myeloid leukemia (AML). MacroGenics is conducting a single-arm, registration-enabling clinical study to evaluate flotetuzumab in up to 200 patients with PIF/ER6 AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the composite primary endpoint. The Company anticipates providing further updates on the clinical development of flotetuzumab in late 2021 and completing full enrollment of this study in 2022.

MGC018 is an antibody-drug conjugate (ADC) that targets B7-H3. In April 2021, MacroGenics presented pre-clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that at clinically relevant dose levels, MGC018 potentiated antitumor activity in vivo in mouse patient-derived xenograft (PDX) models of squamous cell carcinoma of the head and neck (SCCHN). MacroGenics recently expanded its Phase 1 clinical study to include SCCHN and melanoma; the Company continues to enroll patients with metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC). MacroGenics will provide a clinical data update via poster presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting, June 4-8, 2021.

Enoblituzumab is an Fc‐engineered, anti‐B7‐H3 mAb. During the first quarter, MacroGenics initiated a Phase 2 study of enoblituzumab in a chemotherapy-free regimen in combination with retifanlimab in front-line patients with SCCHN who are PD-L1 positive and with tebotelimab in SCCHN patients who are PD-L1 negative.
Tebotelimab is a bispecific, tetravalent DART molecule targeting PD-1 and LAG-3. Tebotelimab is being evaluated in a Phase 1 dose expansion study as monotherapy in several tumor types. MacroGenics expects to provide updates on the next-stage of development for tebotelimab later this year.

MGD019 is a bispecific, tetravalent DART molecule targeting PD-1 and CTLA-4. The Company is conducting Phase 1 dose expansion cohorts at the recommended Phase 2 dose in patients with microsatellite stable colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC and recently added cohorts of patients with mCRPC and melanoma.

IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types, and is being developed jointly under a 50/50 collaboration with ImmunoGen, Inc. Pre-clinical data recently presented at the AACR (Free AACR Whitepaper) Annual Meeting showed that IMGC936 had activity against multiple solid tumor types in in vivo mouse PDX models. Under the collaboration, ImmunoGen is leading clinical development of IMGC936 in a Phase 1 clinical trial evaluating safety and pharmacokinetics in patients with select cancers and have indicated they anticipate disclosing initial data by early 2022.

MGD024 is a next-generation, bispecific CD123 × CD3 DART molecule in preclinical development. The molecule incorporates a CD3 component designed to minimize cytokine-release syndrome, while maintaining anti-tumor cytolytic activity, along with an Fc domain to permit intermittent dosing through a longer half-life. The Company anticipates submitting an Investigational New Drug (IND) application to the FDA by the end of 2021.

First Quarter 2021 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of March 31, 2021, were $343.2 million, compared to $272.5 million as of December 31, 2020. During the quarter ended March 31, 2021, $98.2 million in net proceeds were received from the sale of 3,622,186 shares of the Company’s common stock pursuant to its at-the-market (ATM) offering.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $16.9 million for the quarter ended March 31, 2021, including $0.9 million net sales of MARGENZA, which was launched in mid-March, compared to $13.7 million for the quarter ended March 31, 2020. This increase was primarily due to the recognition of a $10 million milestone from Incyte, partially offset by a decrease of approximately $5.8 million recognized under a clinical supply agreement with Incyte.

R&D Expenses: Research and development expenses were $53.1 million for the quarter ended March 31, 2021, compared to $48.9 million for the quarter ended March 31, 2020. This increase was primarily due to higher expenses related to flotetuzumab, MGC018, MGD019 and preclinical projects, partially offset by a decrease in development and manufacturing costs for retifanlimab.

SG&A Expenses: Selling, general and administrative expenses were $15.0 million for the quarter ended March 31, 2021, compared to $10.2 million for the quarter ended March 31, 2020. This increase was primarily due to MARGENZA pre-launch and launch costs.

Net Loss: Net loss was $51.3 million for the quarter ended March 31, 2021, compared to net loss of $44.7 million for the quarter ended March 31, 2020.

Shares Outstanding: Shares outstanding as of March 31, 2021 were 60,011,206.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities as of March 31, 2021, as well as anticipated and potential collaboration payments, should enable it to fund its operations through 2023, assuming the Company’s programs and collaborations advance as currently contemplated.

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, 2021 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: 5257004.

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.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)

March 31, 2021

December 31, 2020

(unaudited)

Cash, cash equivalents and marketable securities
$
343,177

$
272,531

Total assets
435,445

378,743

Deferred revenue
10,780

11,382

Total stockholders’ equity
350,531

295,884

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except share and per share data)

Three Months Ended March 31,

2021

2020
Revenues:

Revenue from collaborative and other agreements
$
15,184

$
12,967

Product revenue, net
887

—

Revenue from government agreements
810

715

Total revenues
16,881

13,682

Costs and expenses:

Cost of product sales
17

—

Research and development
53,121

48,894

Selling, general and administrative
15,036

10,233

Total costs and expenses
68,174

59,127

Loss from operations
(51,293
)

(45,445
)
Other income
21

721

Net loss
(51,272
)

(44,724
)
Other comprehensive income:

Unrealized gain on investments
18

56

Comprehensive loss
$
(51,254
)

$
(44,668
)

Basic and diluted net loss per common share
$
(0.90
)

$
(0.91
)
Basic and diluted weighted average common shares outstanding
57,202,846

49,012,663