Full Press Release Details
Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results
FRANCISCO, Feb. 25, 2021/PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for
the fourth quarter and full year ended December 31, 2020.
and investments in marketable securities at December 31, 2020 were approximately $1.2 billion as compared to $1.6
billion at December 31, 2019.
past year, Nektar made significant progress advancing our clinical pipeline of novel cytokine therapeutics," said Howard
W. Robin, President and CEO of Nektar. "Our broad registrational program evaluating bempegaldesleukin (BEMPEG) plus nivolumab
is progressing well with five registrational studies underway in melanoma, renal cell carcinoma and bladder cancer. We also recently
added a sixth study to the registrational program to evaluate BEMPEG in combination
with pembrolizumab in head and neck cancer and are pleased to be collaborating with Merck on the study. For our PROPEL study, we
look forward to reporting the first data for BEMPEG plus pembrolizumab in patients with metastatic non-small cell lung cancer in
the second half of 2021."
our second cytokine program, NKTR-255, we were very encouraged by the early signs of clinical activity that we recently
reported at the SITC 2020 meeting, and are now advancing two Phase 1 clinical studies in combination with ADCC antibodies,
one in hematological malignancies and one in solid tumors," continued Mr. Robin. "Finally, our partner Eli Lilly
is conducting a broad Phase 2 program for NKTR-358, our T regulatory cell IL-2 agent, with Phase 2 studies in both lupus and
ulcerative colitis and plans to initiate additional Phase 2 studies in immune-mediated diseases over the next
of Financial Results
in the fourth quarter of 2020 was $23.5 million as compared to $33.9 million in the fourth quarter of 2019.
Revenue for the year ended December 31, 2020 was $152.9 million as compared to $114.6 million in 2019 and
was higher primarily due to the recognition of $50.0 million in total milestones from Bristol-Myers Squibb related
to the start of two new registrational trials of bempegaldesleukin plus Opdivo (nivolumab) in adjuvant
melanoma and muscle-invasive bladder cancer.
operating costs and expenses in the fourth quarter of 2020 were $134.2 million as compared to $143.5 million in the fourth
quarter of 2019. Total operating costs and expenses for 2020 were $578.0 million as compared to $554.7 million in 2019.
Total operating costs and expenses for full year 2020 increased as compared to 2019 primarily as a result of $45.2 million in
impairment charges in the first quarter of 2020 resulting from the discontinuation of the NKTR-181 program, partially offset by
a decrease in R&D expense.
R&D expense in the fourth quarter of 2020 was $102.7 million
as compared to $110.4 million for the fourth quarter of 2019. R&D expense for the year ended December 31, 2020 was $408.7
million as compared to $434.6 million in 2019. Excluding pre-commercial manufacturing costs for NKTR-181 incurred during 2019,
research and development expense increased for the full year 2020 primarily due to the clinical development of bempegaldesleukin
in five registrational trials.
G&A expense was $27.1 million in the fourth quarter of 2020
and $27.1 million in the fourth quarter of 2019. G&A expense for 2020 was $104.7 million as compared to $98.7
loss for the fourth quarter of 2020 was $117.2 million or $0.65 basic and diluted loss per share as compared to a net loss
of $112.2 million or $0.64 basic and diluted loss per share in the fourth quarter of 2019. Net loss for the year
ended December 31, 2020 was $444.4 million or $2.49 basic and diluted loss per share as compared to net loss of $440.7
million or $2.52 basic and diluted loss per share in 2019.
and Year-to-Date 2021 Business Highlights:
Call to Discuss Fourth Quarter and Year-End 2020 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific
Time, Thursday, February 25, 2021.
press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page
and Investors section of the Nektar website: https://ir.nektar.com/. The web broadcast of the conference call will be available
for replay through March 25, 2021.
access the conference call, follow these instructions:
Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Conference ID: 3857247 (Nektar Therapeutics is the host)
the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release,
or explained on the conference call, related information will be made available on the Investors page at the Nektar website as
soon as practical after the conclusion of the conference call.
Therapeutics is a biopharmaceutical company with a robust, wholly owned R&D pipeline of investigational medicines in oncology,
immunology, and virology as well as a portfolio of approved partnered medicines. Nektar is headquartered in San Francisco, California,
with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development
programs and capabilities may be found online at http://www.nektar.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "may,"
"design," "potential," "advance," "plan" and similar references to future periods.
Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of, and future
development plans for, bempegaldesleukin, NKTR-358 and NKTR-255, and the timing of the initiation of clinical studies and the
availability of clinical data for our drug candidates. Forward-looking statements are neither historical facts nor assurances
of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future
of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances
that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those
indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important
factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include,
among others: (i) our statements regarding the therapeutic potential of bempegaldesleukin, NKTR-358 and NKTR-255 are based
on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) bempegaldesleukin,
NKTR-358 and NKTR-255 are investigational agents and continued research and development for these drug candidates is subject to
substantial risks, including negative safety and efficacy findings in ongoing clinical studies (notwithstanding positive findings
in earlier preclinical and clinical studies); (iii) bempegaldesleukin, NKTR-358 and NKTR-255 are in various stages of clinical
development and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing
of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges
caused by the COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing
standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes and competitive factors; (v) patents
may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional
intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set
forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2020. Any forward-looking
statement made by us in this press release is based only on information currently available to us and speaks only as of the date
on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be
made from time to time, whether as a result of new information, future developments or otherwise.
Wu of Nektar Therapeutics
CONSOLIDATED BALANCE SHEETS
| December 31, 2020 | December 31, 2019 (1) | |||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 198,955 | $ | 96,363 | ||||
| Short-term investments | 862,941 | 1,228,499 | ||||||
| Accounts receivable | 38,889 | 36,802 | ||||||
| Inventory | 15,292 | 12,665 | ||||||
| Advance payments to contract manufacturers | 3,908 | 31,834 | ||||||
| Other current assets | 18,020 | 15,387 | ||||||
| Total current assets | 1,138,005 | 1,421,550 | ||||||
| Long-term investments | 136,662 | 279,119 | ||||||
| Property, plant and equipment, net | 59,662 | 65,665 | ||||||
| Operating lease right-of-use assets | 126,476 | 134,177 | ||||||
| Goodwill | 76,501 | 76,501 | ||||||
| Other assets | 1,461 | 344 | ||||||
| Total assets | $ | 1,538,767 | $ | 1,977,356 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Senior secured notes, net and interest payable | $ | - | $ | 252,891 | ||||
| Accounts payable | 22,139 | 19,234 | ||||||
| Accrued compensation | 14,532 | 11,467 | ||||||
| Accrued clinical trial expenses | 44,207 | 32,626 | ||||||
| Accrued contract manufacturing expenses | 11,310 | 7,304 | ||||||
| Other accrued expenses | 9,585 | 12,338 | ||||||
| Operating l ease liability, current portion | 13,915 | 12,516 | ||||||
| Deferred revenue, current portion | 91 | 5,517 | ||||||
| Total current liabilities | 115,779 | 353,893 | ||||||
| Operating l ease liability, less current portion | 136,373 | 142,730 | ||||||
| Liabilities related to the sale of future royalties, net | 200,340 | 72,020 | ||||||
| Deferred revenue, less current portion | 2,464 | 2,554 | ||||||
| Other long-term liabilities | 6,516 | 768 | ||||||
| Total liabilities | 461,472 | 571,965 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock | - | - | ||||||
| Common stock | 18 | 17 | ||||||
| Capital in excess of par value | 3,388,730 | 3,271,097 | ||||||
| Accumulated other comprehensive loss | (2,295 | ) | (1,005 | ) | ||||
| Accumulated deficit | (2,309,158 | ) | (1,864,718 | ) | ||||
| Total stockholders' equity | 1,077,295 | 1,405,391 | ||||||
| Total liabilities and stockholders' equity | $ | 1,538,767 | $ | 1,977,356 |
CONSOLIDATED STATEMENTS OF OPERATIONS
thousands, except per share information)
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Revenue: | ||||||||||||||||
| Product sales | $ | 2,884 | $ | 5,815 | $ | 17,504 | $ | 20,117 | ||||||||
| Royalty revenue | (412 | ) | 12,214 | 30,999 | 41,222 | |||||||||||
| Non-cash royalty revenue related to sale of future royalties | 20,562 | 8,718 | 48,563 | 36,303 | ||||||||||||
| License, collaboration and other revenue | 428 | 7,115 | 55,849 | 16,975 | ||||||||||||
| Total revenue | 23,462 | 33,862 | 152,915 | 114,617 | ||||||||||||
| Operating costs and expenses: | ||||||||||||||||
| Cost of goods sold | 4,323 | 5,989 | 19,477 | 21,374 | ||||||||||||
| Research and development | 102,724 | 110,369 | 408,678 | 434,566 | ||||||||||||
| General and administrative | 27,136 | 27,142 | 104,682 | 98,712 | ||||||||||||
| Impairment of assets and other costs for terminated program | - | - | 45,189 | - | ||||||||||||
| Total operating costs and expenses | 134,183 | 143,500 | 578,026 | 554,652 | ||||||||||||
| Loss from operations | (110,721 | ) | (109,638 | ) | (425,111 | ) | (440,035 | ) | ||||||||
| Non-operating income (expense): | ||||||||||||||||
| Interest expense | - | (5,428 | ) | (6,851 | ) | (21,310 | ) | |||||||||
| Non-cash interest expense on liability related to sale of future royalties | (8,183 | ) | (7,191 | ) | (30,267 | ) | (25,044 | ) | ||||||||
| Interest income and other income (expense), net | 1,829 | 10,371 | 18,282 | 46,335 | ||||||||||||
| Total non-operating expense, net | (6,354 | ) | (2,248 | ) | (18,836 | ) | (19 | ) | ||||||||
| Loss before provision for income taxes | (117,075 | ) | (111,886 | ) | (443,947 | ) | (440,054 | ) | ||||||||
| Provision for income taxes | 128 | 278 | 493 | 613 | ||||||||||||
| Net loss | $ | (117,203 | ) | $ | (112,164 | ) | $ | (444,440 | ) | $ | (440,667 | ) | ||||
| Net loss per share: | ||||||||||||||||
| Basic | $ | (0.65 | ) | $ | (0.64 | ) | $ | (2.49 | ) | $ | (2.52 | ) | ||||
| Diluted | $ | (0.65 | ) | $ | (0.64 | ) | $ | (2.49 | ) | $ | (2.52 | ) | ||||
| Weighted average shares outstanding used in computing net loss per share: | ||||||||||||||||
| Basic | 179,684 | 176,130 | 178,581 | 174,993 | ||||||||||||
| Diluted | 179,684 | 176,130 | 178,581 | 174,993 |
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended December 31, | ||||||||
| 2020 | 2019 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | (444,440 | ) | $ | (440,667 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Non-cash royalty revenue related to sale of future royalties | (48,563 | ) | (36,303 | ) | ||||
| Non-cash interest expense on liability related to sale of future royalties | 30,267 | 25,044 | ||||||
| Stock-based compensation | 94,261 | 99,795 | ||||||
| Depreciation and amortization | 14,182 | 13,156 | ||||||
| Impairment of advance payments to contract manufacturers and equipment for terminated program | 20,351 | - | ||||||
| Accretion of premiums (discounts), net and other non-cash transactions | 3,943 | (11,394 | ) | |||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts receivable | 1,913 | 6,411 | ||||||
| Inventory | (2,627 | ) | (1,284 | ) | ||||
| Operating leases, net | 2,743 | 13,090 | ||||||
| Other assets | 4,476 | 1,190 | ||||||
| Accounts payable | 2,382 | 12,967 | ||||||
| Accrued compensation | 4,697 | 1,530 | ||||||
| Other accrued expenses | 8,644 | 4,349 | ||||||
| Deferred revenue | (5,516 | ) | (16,565 | ) | ||||
| Net cash used in operating activities | (313,287 | ) | (328,681 | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchases of investments | (987,533 | ) | (1,380,865 | ) | ||||
| Maturities of investments | 1,449,304 | 1,614,036 | ||||||
| Sales of investments | 41,700 | - | ||||||
| Purchases of property, plant and equipment | (7,258 | ) | (26,285 | ) | ||||
| Net cash provided by investing activities | 496,213 | 206,886 | ||||||
| Cash flows from financing activities: | ||||||||
| Proceeds from sale of future royalties, net of $3.8 million of transaction costs | 146,250 | - | ||||||
| Repayment of senior notes | (250,000 | ) | - | |||||
| Proceeds from shares issued under equity compensation plans | 23,396 | 23,355 | ||||||
| Net cash provided by financing activities | (80,354 | ) | 23,355 | |||||
| Effect of exchange rates on cash and cash equivalents | 20 | (102 | ) | |||||
| Net increase (decrease) in cash and cash equivalents | 102,592 | (98,542 | ) | |||||
| Cash and cash equivalents at beginning of year | 96,363 | 194,905 | ||||||
| Cash and cash equivalents at end of year | $ | 198,955 | $ | 96,363 | ||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid for interest | $ | 9,742 | $ | 19,199 | ||||
| Cash paid for income taxes | $ | 539 | $ | 555 | ||||
| Right-of-use assets recognized in exchange for operating lease liabilities | $ | 2,133 | $ | 57,691 |