Tricida Announces Second Quarter 2019 Financial Results
Narrows Timing of Planned NDA Submission to the Third Quarter of 2019
Webcast Today at
Recent Highlights
- The Lancet published positive long-term Phase 3 clinical trial results of veverimer (TRC101) in
June 2019 . This publication followed the earlier publication in The Lancet of 12-week, Phase 3 clinical trial results inMarch 2019 . -
Positive pre-NDA meeting with the
FDA . - Received NDA-enabling 12-month registration stability data for veverimer.
Upcoming Events and Projected Milestones
- Planned submission of the NDA for veverimer through the FDA’s Accelerated Approval Program in the third quarter of 2019.
Tricida will host its first Investor Day, planned forOctober 15, 2019 , to highlight its pre-launch activities and commercial strategy for veverimer.Tricida will have a major presence at theAmerican Society of Nephrology (ASN) Kidney Week Meeting inWashington, DC ,November 5-10, 2019 .
“Our planned NDA submission for veverimer this quarter will be a major achievement and I am proud of the
Financial Results for the Quarter Ended
Research and development expense was
General and administrative expense was
Net loss was
As of
Today’s Conference Call and Webcast
Tricida Second Quarter 2019 Conference Call |
|||
4:30 pm Eastern Time Today |
|||
Webcast: |
IR.Tricida.com |
||
Dial-in: |
(877) 377-5478 |
||
International: |
(629) 228-0740 |
||
Conference ID: |
5066987 |
A replay of the webcast will be available on the Investor Relations page of Tricida’s website approximately two hours following the completion of the call and will be available for up to 90 days following the presentation.
About
For more information about
Cautionary Note on Forward-Looking Statements
This press release includes forward-looking statements, including for example, all of the statements under the heading "Upcoming Events and Projected Milestones” and other statements about our ability and timing to submit an NDA or the potential approval and launch of veverimer under the
Tricida, Inc. |
||||||||
Condensed Balance Sheets |
||||||||
(Unaudited) |
||||||||
(In thousands) |
||||||||
|
June 30,
|
|
December 31,
|
|||||
Assets |
||||||||
Current assets: |
|
|
|
|||||
Cash and cash equivalents |
$ |
24,797 |
|
|
$ |
37,172 |
|
|
Short-term investments |
369,037 |
|
|
203,906 |
|
|||
Prepaid expenses and other current assets |
4,666 |
|
|
3,269 |
|
|||
Total current assets |
398,500 |
|
|
244,347 |
|
|||
Long-term investments |
11,497 |
|
|
2,287 |
|
|||
Property and equipment, net |
1,892 |
|
|
1,215 |
|
|||
Operating lease right-of-use assets |
1,843 |
|
|
— |
|
|||
Total assets |
$ |
413,732 |
|
|
$ |
247,849 |
|
|
|
|
|
|
|||||
Liabilities and stockholders’ equity |
|
|
|
|||||
Current liabilities: |
|
|
|
|||||
Accounts payable |
$ |
4,673 |
|
|
$ |
8,460 |
|
|
Current operating lease liabilities |
1,046 |
|
|
— |
|
|||
Accrued expenses and other current liabilities |
22,296 |
|
|
6,344 |
|
|||
Total current liabilities |
28,015 |
|
|
14,804 |
|
|||
|
|
|
|
|||||
Term Loan |
37,463 |
|
|
38,071 |
|
|||
Non-current operating lease liabilities |
994 |
|
|
— |
|
|||
Other long-term liabilities |
416 |
|
|
449 |
|
|||
Total liabilities |
66,888 |
|
|
53,324 |
|
|||
|
|
|
|
|||||
Stockholders’ equity: |
|
|
|
|||||
Preferred stock |
— |
|
|
— |
|
|||
Common stock |
49 |
|
|
42 |
|
|||
Additional paid-in capital |
612,883 |
|
|
386,830 |
|
|||
Accumulated other comprehensive income (loss) |
629 |
|
|
(153 |
) |
|||
Accumulated deficit |
(266,717 |
) |
|
(192,194 |
) |
|||
Total stockholders’ equity |
346,844 |
|
|
194,525 |
|
|||
Total liabilities and stockholders’ equity |
$ |
413,732 |
|
|
$ |
247,849 |
|
Tricida, Inc. |
||||||||||||||||
Condensed Statements of Operations and Comprehensive Loss |
||||||||||||||||
(Unaudited) |
||||||||||||||||
(In thousands, except share and per share amounts) |
||||||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|||||||||
Operating expenses: |
|
|
|
|
|
|
|
|||||||||
Research and development |
$ |
28,976 |
|
|
$ |
21,034 |
|
|
$ |
60,399 |
|
|
$ |
37,667 |
|
|
General and administrative |
8,861 |
|
|
4,245 |
|
|
15,213 |
|
|
7,710 |
|
|||||
Total operating expenses |
37,837 |
|
|
25,279 |
|
|
75,612 |
|
|
45,377 |
|
|||||
Loss from operations |
(37,837 |
) |
|
(25,279 |
) |
|
(75,612 |
) |
|
(45,377 |
) |
|||||
Other income (expense), net |
2,602 |
|
|
827 |
|
|
3,869 |
|
|
740 |
|
|||||
Interest expense |
(1,391 |
) |
|
(910 |
) |
|
(2,780 |
) |
|
(1,229 |
) |
|||||
Net loss |
(36,626 |
) |
|
(25,362 |
) |
|
(74,523 |
) |
|
(45,866 |
) |
|||||
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|||||||||
Net unrealized gain (loss) on available-for-sale investments |
480 |
|
|
41 |
|
|
782 |
|
|
(13 |
) |
|||||
Total comprehensive loss |
$ |
(36,146 |
) |
|
$ |
(25,321 |
) |
|
$ |
(73,741 |
) |
|
$ |
(45,879 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.75 |
) |
|
$ |
(10.89 |
) |
|
$ |
(1.64 |
) |
|
$ |
(19.91 |
) |
|
Weighted-average number of shares outstanding, basic and diluted |
48,674,238 |
|
|
2,329,085 |
|
|
45,489,861 |
|
|
2,304,087 |
|
Tricida, Inc. |
||||||||||||||||
GAAP to non-GAAP reconciliations |
||||||||||||||||
(Unaudited) |
||||||||||||||||
(In thousands) |
||||||||||||||||
A reconciliation between net loss on a GAAP basis and on a non-GAAP basis is as follows: |
||||||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|||||||||
GAAP net loss, as reported |
$ |
(36,626 |
) |
|
$ |
(25,362 |
) |
|
$ |
(74,523 |
) |
|
$ |
(45,866 |
) |
|
Adjustments: |
|
|
|
|
|
|
|
|||||||||
Non-cash stock-based compensation expense |
4,413 |
|
|
970 |
|
|
7,071 |
|
|
1,323 |
|
|||||
Non-cash Term Loan discount and issuance costs |
523 |
|
|
376 |
|
|
1,011 |
|
|
504 |
|
|||||
Changes in fair value of compound derivative liabilities and warrants |
(9 |
) |
|
(372 |
) |
|
165 |
|
|
(236 |
) |
|||||
Total adjustments |
4,927 |
|
|
974 |
|
|
8,247 |
|
|
1,591 |
|
|||||
Non-GAAP net loss |
$ |
(31,699 |
) |
|
$ |
(24,388 |
) |
|
$ |
(66,276 |
) |
|
$ |
(44,275 |
) |
Use of Non-GAAP Financial Measures
We supplement our financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable
“Non-GAAP net loss” is not based on any standardized methodology prescribed by GAAP and represent GAAP net loss adjusted to exclude (1) stock-based compensation expense, (2) non-cash interest expense related to Tricida’s Term Loan discount and issuance costs and (3) changes in fair value of compound derivative liabilities and warrants within our reconciliation of our GAAP to Non-GAAP net loss. Non-GAAP financial measures used by
View source version on businesswire.com: https://www.businesswire.com/news/home/20190808005698/en/
Source:
Jackie Cossmon, IRC
Tricida, Inc.
Vice President of Investor Relations and Communications
IR@Tricida.com