Cash and investments in marketable securities at March 31, 2022 were approximately $704.4 million as compared to $798.8 million at December 31, 2021, which is expected to support operations into 2025.
"The new strategic plan that we recently announced refocuses our company around specific investment into our most important pipeline programs – NKTR-358, NKTR-255, and core preclinical candidates," said Howard
Revenue in the first quarter of 2022 was
Total operating costs and expenses in the first quarter of 2022 were
R&D expense in the first quarter of 2022 was
G&A expense was
Net loss for the first quarter of 2022 was
On
This press release contains forward-looking statements which can be identified by words such as: "will," "may," "extend," "potential," "create," "provide"" 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 NKTR-358, NKTR-255 and our other drug candidates in research programs, the prospects and plans for our collaborations with other companies, the timing of the initiation of clinical studies and the data readouts for our drug candidates, and our expectations (including our expected charges and cost savings) following our corporate restructuring, reorganization and workforce reduction, and our expected working capital and our cash runway. 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 NKTR-358,NKTR-255 and our other drug candidates are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) NKTR-358,NKTR-255 and our other drug candidates 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) NKTR-358,NKTR-255 and our other drug candidates 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, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) we may not achieve the expected costs savings we expect from the restructuring and reorganization, (vi) 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 (vii) certain other important risks and uncertainties set forth in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 1, 2022. 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.
Contact:
628-895-0661
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CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||||||
|
(In thousands) |
|||||||||||
|
(Unaudited) |
|||||||||||
|
ASSETS |
|
|
(1) |
||||||||
|
Current assets: |
|||||||||||
|
Cash and cash equivalents |
$ 67,993 |
$ 25,218 |
|||||||||
|
Short-term investments |
599,032 |
708,737 |
|||||||||
|
Accounts receivable |
30,220 |
22,492 |
|||||||||
|
Inventory |
15,379 |
15,801 |
|||||||||
|
Other current assets |
20,831 |
23,333 |
|||||||||
|
Total current assets |
733,455 |
795,581 |
|||||||||
|
Long-term investments |
37,363 |
64,828 |
|||||||||
|
Property, plant and equipment, net |
60,980 |
60,510 |
|||||||||
|
Operating lease right-of-use assets |
114,296 |
117,025 |
|||||||||
|
|
76,501 |
76,501 |
|||||||||
|
Other assets |
1,521 |
2,744 |
|||||||||
|
Total assets |
$ 1,024,116 |
$ 1,117,189 |
|||||||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||||
|
Current liabilities: |
|||||||||||
|
Accounts payable |
12,617 |
9,747 |
|||||||||
|
Accrued compensation |
22,653 |
15,735 |
|||||||||
|
Accrued clinical trial expenses |
33,403 |
26,809 |
|||||||||
|
Other accrued expenses |
17,011 |
15,468 |
|||||||||
|
Operating lease liabilities, current portion |
19,597 |
17,441 |
|||||||||
|
Total current liabilities |
105,281 |
85,200 |
|||||||||
|
Operating lease liabilities, less current portion |
122,638 |
125,736 |
|||||||||
|
Development derivative liability |
- |
27,726 |
|||||||||
|
Liabilities related to the sales of future royalties, net |
185,604 |
195,427 |
|||||||||
|
Other long-term liabilities |
2,704 |
3,592 |
|||||||||
|
Total liabilities |
416,227 |
437,681 |
|||||||||
|
Commitments and contingencies |
|||||||||||
|
Stockholders' equity: |
|||||||||||
|
Preferred stock |
- |
- |
|||||||||
|
Common stock |
19 |
19 |
|||||||||
|
Capital in excess of par value |
3,537,790 |
3,516,641 |
|||||||||
|
Accumulated other comprehensive loss |
(6,532) |
(4,157) |
|||||||||
|
Accumulated deficit |
(2,923,388) |
(2,832,995) |
|||||||||
|
Total stockholders' equity |
607,889 |
679,508 |
|||||||||
|
Total liabilities and stockholders' equity |
$ 1,024,116 |
$ 1,117,189 |
|||||||||
|
(1) The consolidated balance sheet at |
|||||||||||
|
of the information and notes required by generally accepted accounting principles in |
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|
|
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|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||
|
(In thousands, except per share information) |
|||||||||||
|
(Unaudited) |
|||||||||||
|
Three months ended |
|||||||||||
|
2022 |
2021 |
||||||||||
|
Revenue: |
|||||||||||
|
Product sales |
$ 5,688 |
$ 4,795 |
|||||||||
|
Non-cash royalty revenue related to the sales of future royalties |
17,561 |
18,798 |
|||||||||
|
License, collaboration and other revenue |
1,573 |
54 |
|||||||||
|
Total revenue |
24,822 |
23,647 |
|||||||||
|
Operating costs and expenses: |
|||||||||||
|
Cost of goods sold |
5,315 |
5,756 |
|||||||||
|
Research and development |
107,253 |
95,604 |
|||||||||
|
General and administrative |
27,339 |
31,679 |
|||||||||
|
Restructuring, impairment and other costs of terminated program |
1,475 |
- |
|||||||||
|
Total operating costs and expenses |
141,382 |
133,039 |
|||||||||
|
Loss from operations |
(116,560) |
(109,392) |
|||||||||
|
Non-operating income (expense): |
|||||||||||
|
Change in fair value of development derivative liability |
33,427 |
(1,599) |
|||||||||
|
Non-cash interest expense on liabilities related to the sales of future royalties |
(7,529) |
(13,296) |
|||||||||
|
Interest income and other income (expense), net |
395 |
1,412 |
|||||||||
|
Total non-operating expense, net |
26,293 |
(13,483) |
|||||||||
|
Loss before provision for income taxes |
(90,267) |
(122,875) |
|||||||||
|
Provision for income taxes |
126 |
92 |
|||||||||
|
Net loss |
$ (90,393) |
$ (122,967) |
|||||||||
|
Basic and diluted net loss per share |
$ (0.49) |
$ (0.68) |
|||||||||
|
Weighted average shares outstanding used in computing basic and diluted net loss per share |
185,848 |
181,370 |
|||||||||
|
|
|||||||||||
|
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS |
|||||||||||
|
(In thousands) |
|||||||||||
|
(Unaudited) |
|||||||||||
|
Three months ended |
|||||||||||
|
2022 |
2021 |
||||||||||
|
Cash flows from operating activities: |
|||||||||||
|
Net loss |
$ (90,393) |
$ (122,967) |
|||||||||
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|||||||||||
|
Non-cash royalty revenue related to the sales of future royalties |
(17,561) |
(18,798) |
|||||||||
|
Non-cash interest expense on liabilities related to the sales of future royalties |
7,529 |
13,296 |
|||||||||
|
Change in fair value of development derivative liability |
(33,427) |
1,599 |
|||||||||
|
Non-cash research and development expense |
4,951 |
2,248 |
|||||||||
|
Stock-based compensation |
20,961 |
23,898 |
|||||||||
|
Depreciation and amortization |
3,730 |
3,543 |
|||||||||
|
Amortization of premiums (discounts), net and other non-cash transactions |
1,276 |
2,345 |
|||||||||
|
Changes in operating assets and liabilities: |
|||||||||||
|
Accounts receivable |
(7,728) |
9,733 |
|||||||||
|
Inventory |
422 |
(1,516) |
|||||||||
|
Operating leases, net |
1,787 |
1,541 |
|||||||||
|
Other assets |
2,864 |
6,183 |
|||||||||
|
Accounts payable |
2,998 |
779 |
|||||||||
|
Accrued compensation |
6,918 |
8,981 |
|||||||||
|
Other accrued expenses |
7,249 |
(7,950) |
|||||||||
|
Net cash used in operating activities |
(88,424) |
(77,085) |
|||||||||
|
Cash flows from investing activities: |
|||||||||||
|
Purchases of investments |
(93,493) |
(295,314) |
|||||||||
|
Maturities of investments |
227,974 |
303,612 |
|||||||||
|
Sales of investments |
- |
5,036 |
|||||||||
|
Purchases of property, plant and equipment |
(4,203) |
(2,876) |
|||||||||
|
Net cash provided by investing activities |
130,278 |
10,458 |
|||||||||
|
Cash flows from financing activities: |
|||||||||||
|
Proceeds from shares issued under equity compensation plans |
188 |
17,106 |
|||||||||
|
Cash receipts from development derivative liability |
750 |
750 |
|||||||||
|
Net cash provided by financing activities |
938 |
17,856 |
|||||||||
|
Effect of foreign exchange rates on cash and cash equivalents |
(17) |
(20) |
|||||||||
|
Net increase (decrease) in cash and cash equivalents |
42,775 |
(48,791) |
|||||||||
|
Cash and cash equivalents at beginning of period |
25,218 |
198,955 |
|||||||||
|
Cash and cash equivalents at end of period |
$ 67,993 |
$ 150,164 |
|||||||||
|
Supplemental disclosure of cash flow information: |
|||||||||||
|
Operating lease right-of-use asset recognized in exchange for lease liabilities |
$ - |
$ 1,057 |
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