On August 5, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter of 2021 (Press release, Y-mAbs Therapeutics, AUG 5, 2021, View Source [SID1234585881]).

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"We are very pleased with our second quarter 2021 results. The commercialization of DANYELZA (naxitamab-gqgk) is progressing throughout the U.S. as we continue to see new sites gaining experience with DANYELZA. In addition, the DANYELZA BLA submission has recently been accepted by the National Medical Products Administration of China ("NMPA"), and we continue to advance our deep pipeline. We ended the quarter with a cash balance of $233.6 million, so we believe we are well positioned to elevate our business to new levels," stated Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer, continued, "We submitted the European Marketing Authorization Application to the European Medicines Agency (the "EMA") for omburtamab in April. In parallel, after our Type B meeting with the FDA in June, we believe we now have a clearer path towards the resubmission of the omburtamab BLA to the FDA. Pending a positive Type B meeting with the FDA in the third quarter, we hope to initiate rolling resubmission of the omburtamab BLA by the end of the year."

Recent Corporate Developments

After the close of the first quarter, on July 6, 2021, Y-mAbs announced that SciClone Pharmaceuticals had submitted the Biologics License Application to the National Medical Products Administration ("NMPA") of China for DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma.

On June 25, 2021, Y-mAbs announced that 177Lu-omburtamab-DTPA for the treatment of medulloblastoma had received a positive opinion on Orphan Medicinal Product Designation by EMA.

On June 23, 2021, Y-mAbs announced updated timelines for resubmission of the BLA for omburtamab for neuroblastoma, with an anticipated initiation of a rolling BLA submission by the end of 2021.

On May 19, 2021, Y-mAbs announced an exclusive distribution agreement with Adium Pharma S.A. for DANYELZA and omburtamab in Latin America.

On April 27, 2021, Y-mAbs announced the submission to the EMA of a European Marketing Authorization Application for omburtamab for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

On April 12, 2021, Y-mAbs announced data from GPA33-SADA, which in a xenograft model of colorectal cancer showed radioactivity uptake with a tumor to blood ratio of 122 measured 24 hours after injection. We expect to file an IND for GPA33-SADA next year.
Financial Results

Y-mAbs reported net loss of $22.9 million, or ($0.53) per basic and diluted share, for the quarter ended June 30, 2021, compared to a net loss of $40.4 million, or ($1.01) per basic and diluted share, reported for the quarter ended June 30, 2020. The decreased net loss was caused by the DANYELZA revenues in 2021 and the reduced R&D expenses for the quarter ended June 30, 2021 compared to June 30, 2020.

For the six months ended June 30, 2021, Y-mAbs reported a net income of $10.5 million, or $0.25 per basic share and $0.23 per diluted share, compared to the net loss of $66.6 million, or ($1.67) per basic and diluted share, reported for the six months ended June 30, 2020. The net income was primarily caused by the sale of a priority review voucher and the DANYELZA revenues in the first six months of 2021.

Revenues

Y-mAbs reported net revenues of $11.0 million for the quarter ended June 30, 2021, consisting of $9.0 million of DANYELZA revenues and $2.0 million of licensing revenue.

Revenues were $16.3 million for the six months ended June 30, 2021 and consisted of $14.3 million from the sales of DANYELZA and $2.0 million of licensing revenue.

No revenues were reported for the quarter ended and six months ended June 30, 2020.

Operating Expenses

Research and Development
Research and development expenses were $19.8 million for the three months ended June 30, 2021, compared to $30.1 million for the three months ended June 30, 2020, a decrease of $10.3 million. The decrease in research and development expenses was primarily due to the following:

$13.3 million decrease in milestone payments and license acquisition costs driven by the $13.3 million SADA agreement entered into in 2020 which included an upfront payment of $2.0 million, $3.3 million in equity issuances to Memorial Sloan Kettering ("MSK") and Massachusetts Institute of Technology ("MIT"), $7.4 million for the issuance of shares to two non-employees, and $0.6 million for milestone payments which were deemed probable for the period ending June 30, 2020.This decrease was partially offset by a $3.0 million increase in personnel costs.
Research and development expenses were $41.4 million for the six months ended June 30, 2021, compared to $48.7 million for the six months ended June 30, 2020, a decrease of $7.3 million. The decrease in research and development expenses was primarily due to:

$13.3 million decrease in milestone payments and license acquisition costs driven by the $13.3 million SADA agreement which included an upfront payment of $2.0 million, $3.3 million in equity issuances to MSK and MIT, $7.4 million for the issuance of shares to two non-employees, and $0.6 million for milestone payments which were probable for the period ending June 30, 2020; and
$3.5 million decrease in outsourced manufacturing expenses.
These decreases were partially offset by increases of:

$5.5 million in personnel costs;
$1.3 million in outsourced manufacturing;
$0.5 million in clinical trials; and
$1.0 million in premises expenses.
Selling, General, and Administration

Selling, general, and administrative expenses were $13.5 million for the three months ended June 30, 2021, compared to $10.4 million for the three months ended June 30, 2020, an increase of $3.1 million. The increase in selling general and administrative expenses primarily reflects a $3.1 million increase in personnel costs due to the continued hiring of our commercialization team.

Selling, general, and administrative expenses were $25.4 million for the six months ended June 30, 2021, compared to $18.5 million for the six months ended June 30, 2020, an increase of $6.9 million. The increase in selling general and administrative expenses primarily reflects a $6.4 million increase in personnel costs due to the continued hiring of our commercialization team.
Cash and Cash Equivalents

The Company had $233.6 million in cash and cash equivalents as of June 30, 2021, compared to $114.6 million as of December 31, 2020. The increase of $119.0 million was primarily attributable to the following:

The completion of the sale of our DANYELZA priority review voucher in January 2021. Y-mAbs netted $62.0 million after paying 40% of the net proceeds from the sale to MSK pursuant to the terms of the license agreement with MSK, and
$107.7 million in net proceeds raised in our public offering in February 2021.
These increases were partially offset by the net cash used in operational activities of $50.6 million for the six months ended June 2021.

Webcast and Conference Call

The Company will host a conference call on Friday, August 6, 2021 at 9 a.m. Eastern Time. To participate in the call, please dial 855-327-6838 (domestic) or 604-235-2082 (international) and reference the conference ID 10015973. A webcast will be available at: View Source