Cash and investments in marketable securities at
"With new and corrected strong clinical data for REZPEG, we look forward to initiating a Phase 2b study of rezpegaldesleukin in patients with atopic dermatitis and achieving our objective to have initial data from this study in the first half of 2025," said
Summary of Financial Results
Revenue in the second quarter of 2023 was
Total operating costs and expenses in the second quarter of 2023 were
R&D expense in the second quarter of 2023 was
G&A expense was
Restructuring, impairment and costs of terminated program were
For the first half of 2023, restructuring, impairment and costs of terminated program were
Net loss for the second quarter of 2023 was
Second Quarter 2023 and Recent Business Updates
- Nektar announced promising new and corrected rezpegaldesleukin efficacy data which were previously reported in 2022 and inaccurately calculated by former collaborator Eli Lilly & Co.
- Nektar continues to execute on several cost reduction initiatives as announced in its strategic reprioritization and cost restructuring plan in
April 2023 . - Nektar continues to evaluate strategic partnership options for NKTR-255, the Company's lead oncology asset, while the Phase 2 study of NKTR-255 in combination with cell therapies and the Phase 2 JAVELIN Bladder Medley Study with partner Merck KGaA progress.
Conference Call to Discuss Second Quarter 2023 Financial Results
Nektar management will host a conference call to review the results beginning at
This press release and 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: http://ir.nektar.com/. The web broadcast of the conference call will be available for replay through
To access the conference call, please pre-register at Nektar Earnings Call Registration. All registrants will receive dial-in information and a PIN allowing them to access the live call.
About
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: "will," "may," "advance," "support," "develop," "provide," "expect," "aim," "potential" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for rezpegaldesleukin, 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 expected working capital and 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 rezpegaldesleukin, 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) rezpegaldesleukin, 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) rezpegaldesleukin, 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 cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (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-Q filed with the
Contact:
For Investors:
Vivian Wu of
628-895-0661
For Media:
(212) 600-1902
david.rosen@argotpartners.com
|
|||||||
CONDENSED CONSOLIDATED BALANCE SHEETS |
|||||||
(In thousands) |
|||||||
(Unaudited) |
|||||||
ASSETS |
|
|
(1) |
||||
Current assets: |
|||||||
Cash and cash equivalents |
$ 50,728 |
$ 88,227 |
|||||
Short-term investments |
358,704 |
416,750 |
|||||
Accounts receivable |
1,335 |
5,981 |
|||||
Inventory, net |
20,689 |
19,202 |
|||||
Other current assets |
9,602 |
15,808 |
|||||
Total current assets |
441,058 |
545,968 |
|||||
Property, plant and equipment, net |
22,554 |
32,451 |
|||||
Operating lease right-of-use assets |
29,015 |
53,435 |
|||||
|
- |
76,501 |
|||||
Other assets |
1,652 |
2,245 |
|||||
Total assets |
$ 494,279 |
$ 710,600 |
|||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||
Current liabilities: |
|||||||
Accounts payable |
$ 2,619 |
$ 12,980 |
|||||
Accrued expenses |
29,142 |
36,557 |
|||||
Operating lease liabilities, current portion |
18,933 |
18,667 |
|||||
Total current liabilities |
50,694 |
68,204 |
|||||
Operating lease liabilities, less current portion |
105,817 |
112,829 |
|||||
Liabilities related to the sales of future royalties, net |
135,659 |
155,378 |
|||||
Other long-term liabilities |
5,151 |
7,551 |
|||||
Total liabilities |
297,321 |
343,962 |
|||||
Commitments and contingencies |
|||||||
Stockholders' equity: |
|||||||
Preferred stock |
- |
- |
|||||
Common stock |
19 |
19 |
|||||
Capital in excess of par value |
3,592,722 |
3,574,719 |
|||||
Accumulated other comprehensive loss |
(6,450) |
(6,907) |
|||||
Accumulated deficit |
(3,389,333) |
(3,201,193) |
|||||
Total stockholders' equity |
196,958 |
366,638 |
|||||
Total liabilities and stockholders' equity |
$ 494,279 |
$ 710,600 |
|||||
(1) The consolidated balance sheet at |
|
|||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||
(In thousands, except per share information) |
|||||||||
(Unaudited) |
|||||||||
Three months ended |
Six months ended |
||||||||
2023 |
2022 |
2023 |
2022 |
||||||
Revenue: |
|||||||||
Product sales |
$ 4,658 |
$ 5,312 |
$ 9,376 |
$ 11,000 |
|||||
Non-cash royalty revenue related to the sales of future royalties |
15,832 |
16,264 |
32,693 |
33,825 |
|||||
License, collaboration and other revenue |
9 |
9 |
24 |
1,582 |
|||||
Total revenue |
20,499 |
21,585 |
42,093 |
46,407 |
|||||
Operating costs and expenses: |
|||||||||
Cost of goods sold |
6,994 |
5,115 |
14,054 |
10,430 |
|||||
Research and development |
29,681 |
42,740 |
60,150 |
149,993 |
|||||
General and administrative |
17,869 |
20,521 |
38,950 |
47,860 |
|||||
Restructuring, impairment, and costs of terminated program |
16,554 |
106,045 |
37,747 |
107,520 |
|||||
Impairment of goodwill |
- |
- |
76,501 |
- |
|||||
Total operating costs and expenses |
71,098 |
174,421 |
227,402 |
315,803 |
|||||
Loss from operations |
(50,599) |
(152,836) |
(185,309) |
(269,396) |
|||||
Non-operating income (expense): |
|||||||||
Change in fair value of development derivative liability |
- |
- |
- |
33,427 |
|||||
Non-cash interest expense on liabilities related to the sales of future royalties |
(6,152) |
(7,228) |
(12,557) |
(14,757) |
|||||
Interest income and other income (expense), net |
5,582 |
1,096 |
9,616 |
1,491 |
|||||
Total non-operating income (expense), net |
(570) |
(6,132) |
(2,941) |
20,161 |
|||||
Loss before provision for income taxes |
(51,169) |
(158,968) |
(188,250) |
(249,235) |
|||||
Provision (benefit) for income taxes |
(47) |
100 |
(110) |
226 |
|||||
Net loss |
$ (51,122) |
$ (159,068) |
$ (188,140) |
$ (249,461) |
|||||
Basic and diluted net loss per share |
$ (0.27) |
$ (0.85) |
$ (0.99) |
$ (1.34) |
|||||
Weighted average shares outstanding used in computing basic and diluted net loss |
189,656 |
186,800 |
189,268 |
186,323 |
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SOURCE