Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results
– Completed Last Patient Last Visit for STRIDE 3 Dry Eye Disease Trial; Topline Results on Track for First Quarter of 2020 –
– Achieved Full Year 2019 INVELTYS® Revenues of
– Conference Call and Webcast Today at
“The last patient has now completed their final study visit in the STRIDE 3 Phase 3 trial,” said
Fourth Quarter and Recent Highlights:
EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: In
INVELTYS® (loteprednol etabonate ophthalmic suspension) 1%: INVELTYS was launched in
- Over 144,000 INVELTYS prescriptions have been reported as of
January 31, 2020 . - INVELTYS has achieved approximately 11.2% branded new prescription market share.
- Over 3,300 eye care professionals have prescribed INVELTYS.
- INVELTYS has achieved approximately 80% unrestricted Commercial market access, and approximately 23% unrestricted
Medicare Part D market access, for an aggregate total of approximately 145 million covered lives.
In the fourth quarter, approximately 47,000 INVELTYS prescriptions were reported by
Financial Results:
The financial results below contain both GAAP and non-GAAP financial measures. The non-GAAP financial measures exclude stock compensation, depreciation and non-cash interest expense. See “Non-GAAP Financial Measures” below; for a full reconciliation of our GAAP to non-GAAP financial measures, please refer to the tables at the end of this press release.
Cash Position:
- As of
December 31, 2019 , Kala had cash of$85.4 million , compared to$170.9 million as ofDecember 31, 2018 . - Kala anticipates that its existing cash resources, together with projected INVELTYS revenue, will enable it to fund its operations into the second quarter of 2021.
Fourth Quarter 2019 Financial Results:
- Net Product Revenues: For the quarter ended
December 31, 2019 , Kala reported net product revenue of$1.2 million relating to sales of INVELTYS, which was launched inJanuary 2019 . Revenue is recognized when products are delivered to distributors. - Cost of Product Revenues: Cost of product revenues for the quarter ended
December 31, 2019 were$0.7 million , compared to $0 for the same period in 2018. Non-GAAP cost of product revenues were$0.6 million for the quarter endedDecember 31, 2019 , compared to $0 for the same period in 2018. - SG&A Expenses: For the quarter ended
December 31, 2019 , selling, general and administrative (SG&A) expenses were$14.5 million , compared to$14.3 million for the same period in 2018. The increase in SG&A expenses for the quarter endedDecember 31, 2019 was primarily due to costs associated with commercial infrastructure being in place for the entire fourth quarter of 2019 as compared to only a portion of the fourth quarter of 2018, an increase in facility-related costs, partially offset by lower pre-launch external costs incurred during the fourth quarter of 2018. Non-GAAP SG&A expenses were$12.7 million for the quarter endedDecember 31, 2019 , consistent with the same period in 2018. - R&D Expenses: For the quarter ended
December 31, 2019 , research and development (R&D) expenses were$6.1 million , compared to$9.2 million for the same period in 2018. The decrease in R&D expenses for the quarter endedDecember 31, 2019 was primarily due to the NDA filing fee for EYSUVIS of$2.6 million incurred in the fourth quarter of 2018. Non-GAAP R&D expenses were$5.5 million for the quarter endedDecember 31, 2019 , compared to$8.6 million for the same period in 2018. - Operating Loss: For the quarter ended
December 31, 2019 , loss from operations was$20.2 million compared to$23.6 million for the same period in 2018. Non-GAAP operating loss was$17.6 million for the quarter endedDecember 31, 2019 , compared to$21.3 million for the same period in 2018. - Net Loss: Net loss was
$22.0 million , or$0.63 per share, for the quarter endedDecember 31, 2019 , compared to a net loss of$25.2 million , or$0.76 per share, for the same period in 2018. For the quarter endedDecember 31, 2019 , non-GAAP net loss was$19.2 million , compared to$22.7 million for the same period in 2018.
The weighted average number of shares outstanding used to calculate net loss per share was 34.9 million for the quarter ended
Full Year 2019 Financial Results:
- Net Product Revenues: For the full year ended
December 31, 2019 , Kala reported net product revenues of$6.1 million relating to sales of INVELTYS, which was launched inJanuary 2019 . The Company did not recognize revenues in 2018. - Cost of Product Revenues: Cost of product revenues for the full year ended
December 31, 2019 was$2.0 million , compared to $0 for the same period in 2018. Non-GAAP cost of product revenues was$1.7 million for the full year endedDecember 31, 2019 , compared to $0 for the same period in 2018. - SG&A Expenses: For the full year ended
December 31, 2019 , SG&A expenses were$65.0 million , compared to$35.4 million for the same period in 2018. The increase in SG&A expenses for the year endedDecember 31, 2019 was primarily due to costs associated with hiring additional personnel, building the commercial organization to support the launch of INVELTYS, and an increase in facility-related costs. Non-GAAP SG&A expenses were$57.6 million for the full year endedDecember 31, 2019 , compared to$29.4 million for the same period in 2018. - R&D Expenses: For the full year ended
December 31, 2019 , R&D expenses were$27.3 million , compared to$29.3 million for the same period in 2018. The decrease in R&D expenses for the year endedDecember 31, 2019 was primarily due to a decrease in INVELTYS-related manufacturing and headcount costs, which in 2018 were expensed as R&D prior toFDA approval and the NDA filing fee for EYSUVIS expensed in 2018. These costs were partially offset by an increase in spending on STRIDE 3, and an increase in facility-related costs in 2019. Non-GAAP R&D expenses were$24.1 million for the full year endedDecember 31, 2019 , compared to$26.3 million for the same period in 2018. - Operating Loss: For the full year ended
December 31, 2019 , loss from operations were$88.2 million compared to$64.7 million for the same period in 2018. Non-GAAP operating loss was$77.4 million for the full year endedDecember 31, 2019 , compared to$55.8 million for the same period in 2018. - Net Loss: Net loss was
$94.3 million , or$2.76 per share, for the full year endedDecember 31, 2019 , compared to a net loss of$66.7 million , or$2.49 per share, for the same period in 2018. For the full year endedDecember 31, 2019 , non-GAAP net loss was$82.6 million , compared to$57.5 million for the same period in 2018.
The weighted average number of shares outstanding used to calculate net loss per share was 34.2 million for the year ended
Conference Call Information:
Kala will host a live conference call and webcast today,
About
Kala is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies for diseases of the eye. Kala has applied its AMPPLIFYTM mucus penetrating particle Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in the
Non-GAAP Financial Measures:
In this press release, the financial results of Kala are provided in accordance with accounting principles generally accepted in
Forward-Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, that involve substantial risks and uncertainties, including statements regarding INVELTYS, including progress of commercial launch, status of insurance coverage and the availability of reimbursements for commercial and
Financial Tables: |
|||||||
Kala Pharmaceuticals, Inc. |
|||||||
Balance Sheet Data |
|||||||
(in thousands) |
|||||||
(unaudited) |
|||||||
December 31, |
December 31, |
||||||
2019 |
2018 |
||||||
Cash |
$ |
|
85,449 |
$ |
|
170,898 |
|
Total assets |
154,323 |
220,966 |
|||||
Working capital (1) |
80,710 |
160,018 |
|||||
Long‑term debt, net of discounts |
71,184 |
70,226 |
|||||
Other long‑term liabilities |
28,673 |
28,752 |
|||||
Total Stockholders’ equity |
29,692 |
104,978 |
|||||
(1) The Company defines working capital as current assets less current liabilities. See the Company's |
Kala Pharmaceuticals, Inc. |
||||||||||||||||||||||||
Consolidated Statement of Operations |
||||||||||||||||||||||||
(in thousands, except share and per share data) |
||||||||||||||||||||||||
(unaudited) |
||||||||||||||||||||||||
Quarter Ended |
Year Ended |
|||||||||||||||||||||||
December 31, |
December 31, |
|||||||||||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||||||||||
|
|
|
|
|||||||||||||||||||||
Product revenues, net |
$ |
|
1,180 |
|
$ |
|
— |
$ |
|
6,074 |
|
$ |
|
— |
||||||||||
Costs and expenses: |
||||||||||||||||||||||||
Cost of product revenues |
747 |
|
— |
2,008 |
|
— |
||||||||||||||||||
Selling, general and administrative |
14,492 |
|
14,329 |
|
65,015 |
|
35,431 |
|
||||||||||||||||
Research and development |
|
6,138 |
|
|
|
9,239 |
|
|
|
27,275 |
|
|
|
29,290 |
|
|
||||||||
Total operating expenses |
|
21,377 |
|
|
|
23,568 |
|
|
|
94,298 |
|
|
|
64,721 |
|
|
||||||||
Loss from operations |
(20,197 |
) |
(23,568 |
) |
(88,224 |
) |
(64,721 |
) |
||||||||||||||||
Other income (expense): |
||||||||||||||||||||||||
Interest income |
384 |
|
840 |
|
2,357 |
|
1,687 |
|
||||||||||||||||
Interest expense |
(2,145 |
) |
(2,100 |
) |
(8,480 |
) |
(3,314 |
) |
||||||||||||||||
Loss on extinguishment of debt |
|
— |
|
|
(390 |
) |
|
|
— |
|
|
(390 |
) |
|
||||||||||
Net loss |
|
(21,958 |
) |
|
|
(25,218 |
) |
|
|
(94,347 |
) |
|
|
(66,738 |
) |
|
||||||||
Net loss per share attributable to |
$ |
|
(0.63 |
) |
|
$ |
|
(0.76 |
) |
|
$ |
|
(2.76 |
) |
|
$ |
|
(2.49 |
) |
|
||||
Weighted average shares |
|
34,899,019 |
|
|
|
33,234,169 |
|
|
|
34,209,756 |
|
|
|
26,753,906 |
|
|
Kala Pharmaceuticals, Inc. |
||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures |
||||||||||||||||||||||
(in thousands) |
||||||||||||||||||||||
(unaudited) |
||||||||||||||||||||||
Quarter Ended |
Year Ended |
|||||||||||||||||||||
December 31, |
December 31, |
|||||||||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||
Net loss (GAAP) |
$ |
|
(21,958 |
) |
$ |
|
(25,218 |
) |
$ |
|
(94,347 |
) |
$ |
|
(66,738 |
) |
||||||
Add-back: stock-based compensation expense |
2,325 |
|
2,198 |
|
9,991 |
|
8,615 |
|
||||||||||||||
Add-back: Non-cash interest |
249 |
|
197 |
|
958 |
|
273 |
|
||||||||||||||
Add-back: depreciation |
229 |
|
109 |
|
843 |
|
352 |
|
||||||||||||||
Non-GAAP Net loss |
$ |
|
(19,155 |
) |
$ |
|
(22,714 |
) |
$ |
|
(82,555 |
) |
$ |
|
(57,498 |
) |
||||||
|
|
|
|
|
|
|
|
|||||||||||||||
Cost of product revenues (GAAP) |
$ |
|
747 |
|
$ |
|
— |
$ |
|
2,008 |
|
$ |
|
— |
||||||||
Less: stock-based compensation expense |
167 |
|
— |
268 |
|
— |
||||||||||||||||
Less: depreciation |
1 |
|
— |
3 |
|
— |
||||||||||||||||
Non-GAAP Cost of product revenues |
$ |
|
579 |
|
$ |
|
— |
$ |
|
1,737 |
|
$ |
|
— |
||||||||
|
|
|
|
|
|
|
|
|||||||||||||||
Selling, general and administrative expenses |
$ |
|
14,492 |
|
$ |
|
14,329 |
|
$ |
|
65,015 |
|
$ |
|
35,431 |
|
||||||
Less: stock-based compensation expense |
1,629 |
|
1,602 |
|
6,879 |
|
5,955 |
|
||||||||||||||
Less: depreciation |
146 |
|
37 |
|
522 |
|
42 |
|
||||||||||||||
Non-GAAP Selling, general and administrative |
$ |
|
12,717 |
|
|
12,690 |
|
$ |
|
57,614 |
|
$ |
|
29,434 |
|
|||||||
|
|
|
|
|
|
|
|
|||||||||||||||
Research and development expenses (GAAP) |
$ |
|
6,138 |
|
$ |
|
9,239 |
|
$ |
|
27,275 |
|
$ |
|
29,290 |
|
||||||
Less: stock-based compensation expense |
529 |
|
596 |
|
2,844 |
|
2,660 |
|
||||||||||||||
Less: depreciation |
82 |
|
72 |
|
318 |
|
310 |
|
||||||||||||||
Non-GAAP research and development |
$ |
|
5,527 |
|
|
8,571 |
|
$ |
|
24,113 |
|
$ |
|
26,320 |
|
|||||||
|
|
|
|
|
|
|
|
|||||||||||||||
Total operating loss (GAAP) |
$ |
|
(20,197 |
) |
$ |
|
(23,568 |
) |
$ |
|
(88,224 |
) |
$ |
|
(64,721 |
) |
||||||
Less: stock-based compensation expense |
2,325 |
|
2,198 |
|
9,991 |
|
8,615 |
|
||||||||||||||
Less: depreciation |
229 |
|
109 |
|
843 |
|
352 |
|
||||||||||||||
Non-GAAP total operating loss |
$ |
|
(17,643 |
) |
$ |
|
(21,261 |
) |
$ |
|
(77,390 |
) |
$ |
|
(55,754 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200212005159/en/
Source:
Investors:
Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200