Kala Pharmaceuticals Reports Second Quarter 2019 Financial Results
–Conference Call and Webcast Today at 8:00 a.m. ET–
“We are very pleased with our results in the second quarter. The INVELTYS launch is progressing well, with positive feedback from physicians and strong growth in prescriptions, market share, and revenues compared to the first quarter,” said
The PDUFA action date for KPI-121 0.25% is
Second Quarter and Recent Highlights:
INVELTYS®: INVELTYS (loteprednol etabonate ophthalmic suspension) 1% was launched in
- Quarter-over-quarter growth was 173%; approximately 31,000 INVELTYS prescriptions were filled in the second quarter of 2019 compared to approximately 11,000 prescriptions filled in the first quarter of 2019. As of
July 26, 2019 , approximately 53,000 prescriptions of INVELTYS have been filled. - INVELTYS continues to achieve strong market share growth and now has approximately 6.8% branded new prescription market share in just over six months since launch.
- INVELTYS has achieved approximately 50% unrestricted Commercial market access, for a total of approximately 92 million covered commercial lives.
- To date INVELTYS has achieved approximately 23%
Medicare Part D unrestricted market access, for a total of approximately 10 million coveredMedicare Part D lives.Medicare Part D contract negotiations are ongoing with most coverage decisions anticipated in early 2020.
KPI-121 0.25% Dry Eye Program:
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.
Second Quarter 2019 Financial Results
- Net Product Revenue: For the quarter ended
June 30, 2019 , Kala reported net product revenue of$2.1 million relating to sales of INVELTYS, which was launched inJanuary 2019 , compared to$1.4 million for the first quarter of 2019. This represents quarter-over-quarter growth of 50%. The Company did not recognize revenue for the first quarter of 2018. Revenue is recognized when products are delivered to distributors. - Cost of Product Revenues: Cost of product revenues for the second quarter of 2019 was
$0.4 million compared to $0 for the same period in 2018. Non-GAAP cost of product revenues was$0.3 million for the quarter endedJune 30, 2019 compared to $0 for the same period in 2018. - SG&A Expenses: For the quarter ended
June 30, 2019 , selling, general and administrative (SG&A) expenses were$17.0 million compared to$7.2 million for the same period in 2018. The increase in SG&A expenses for the quarter endedJune 30, 2019 was primarily due to costs associated with hiring additional personnel, building the commercial organization and an increase in facility costs associated with Kala’s corporate headquarters under a new lease which commenced in late 2018. Non-GAAP SG&A expenses were$15.1 million for the quarter endedJune 30, 2019 compared to$5.6 million for the same period in 2018. - R&D Expenses: For the quarter ended
June 30, 2019 , research and development (R&D) expenses were$7.1 million compared to$7.4 million for the same period in 2018. The decrease in R&D expenses for the quarter endedJune 30, 2019 was primarily due to a decrease in manufacturing costs associated with INVELTYS, which were expensed as R&D prior toFDA approval, partially offset by an increase in clinical costs associated with the STRIDE 3 clinical trial. Non-GAAP R&D expenses were$6.2 million for the quarter endedJune 30, 2019 compared to$6.5 million for the same period in 2018. - Operating Loss: For the quarter ended
June 30, 2019 , loss from operations was$22.4 million compared to$14.5 million for the same period in 2018. Non-GAAP operating loss was$19.6 million for the quarter endedJune 30, 2019 compared to$12.1 million for the same period in 2018. - Net Loss: Net loss was
$23.8 million , or$0.70 per share, for the quarter endedJune 30, 2019 compared to a net loss of$14.6 million , or$0.60 per share, for the same period in 2018.For the quarter endedJune 30, 2019 , non-GAAP net loss was$20.7 million , compared to$12.2 million for the same quarter of 2018.
The weighted average number of shares outstanding used to calculate net loss per share was 33.9 million for the quarter endedJune 30, 2019 and 24.6 million for the quarter endedJune 30, 2018 .
Year-to-Date Financial Results
- Net Product Revenue: For the six months ended
June 30, 2019 , Kala reported net product revenue of$3.4 million relating to sales of INVELTYS, which was launched inJanuary 2019 . The Company did not recognize revenue in the first half of 2018. - Cost of Product Revenues: Cost of product revenues for the six months ended
June 30, 2019 were$0.6 million compared to $0 for the same period in 2018. Non-GAAP Cost of product revenues were$0.6 million for the six months endedJune 30, 2019 compared to $0 for the same period in 2018. - SG&A Expenses: For the six months ended
June 30, 2019 , SG&A expenses were$35.2 million compared to$12.6 million for the same period in 2018. The increase in SG&A expenses for the six months endedJune 30, 2019 was primarily due to costs associated with hiring additional personnel, building the commercial organization and an increase in facility costs associated with Kala’s corporate headquarters under a new lease which commenced in late 2018. Non-GAAP SG&A expenses were$31.4 million for the six months endedJune 30, 2019 compared to$9.9 million for the same period in 2018. - R&D Expenses: For the six months ended
June 30, 2019 , R&D expenses were$14.1 million compared to$13.0 million for the same period in 2018. The increase in R&D expenses for the six months endedJune 30, 2019 was primarily due primarily due to an increase in clinical costs associated with the STRIDE 3 clinical trial partially offset by a decrease in manufacturing costs associated with INVELTYS which were expensed as R&D prior toFDA approval. Non-GAAP R&D expenses were$12.5 million for the six months endedJune 30, 2019 compared to$11.5 million for the same period in 2018. - Operating Loss: For the six months ended
June 30, 2019 , loss from operations was$46.5 million compared to$25.7 million for the same period in 2018. Non-GAAP operating loss was$41.0 million for the six months endedJune 30, 2019 compared to$21.3 million for the same period in 2018. - Net Loss: Net loss was
$49.2 million , or$1.45 per share, for the six months endedJune 30, 2019 compared to a net loss of$25.9 million , or$1.06 per share, for the same period in 2018. For the six months endedJune 30, 2019 , non-GAAP net loss was$43.3 million compared to$21.6 million for the same period in 2018.
The weighted average number of shares outstanding used to calculate net loss per share was 33.9 million for the six months endedJune 30, 2019 and 24.6 million for the six months endedJune 30, 2018 .
Cash Position
- As of
June 30, 2019 , Kala had cash of$118.0 million compared to$170.9 million as ofDecember 31, 2018 . Kala anticipates that its existing cash on hand will enable it to fund operations through at least the third quarter of 2020, with additional cash runway expected when including INVELTYS revenue.
Conference Call Information
Kala will host a live conference call and webcast today,
About
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFYTM mucus-penetrating particle (MPP) Drug Delivery Technology, with an initial focus on the treatment of eye diseases. Kala has applied the AMPPLIFY 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 for the treatment of inflammation and pain following ocular surgery, including progress of commercial launch, status of insurance coverage and the availability of reimbursements under
Financial Tables:
Kala Pharmaceuticals, Inc. |
|||||||
Balance Sheet Data |
|||||||
(in thousands) |
|||||||
(unaudited) |
|||||||
June 30, |
December 31, |
||||||
2019 |
2018 |
||||||
Cash |
$ |
118,006 |
$ |
170,898 |
|||
Total assets |
178,815 |
220,966 |
|||||
Working capital (1) |
115,102 |
160,018 |
|||||
Long‑term debt, net of discounts |
70,692 |
70,226 |
|||||
Other long‑term liabilities |
29,356 |
28,752 |
|||||
Total stockholders’ equity |
61,066 |
104,978 |
|||||
(1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements for further information regarding its current assets and current liabilities. |
Kala Pharmaceuticals, Inc. | ||||||||||||||||
Condensed Consolidated Statement of Operations | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||||
Product revenues, net |
$ |
2,057 |
$ |
— |
$ |
3,443 |
$ |
— | ||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenues |
352 |
— |
593 |
— | ||||||||||||
Selling, general and administrative |
17,007 |
7,151 |
35,243 |
12,633 |
||||||||||||
Research and development |
7,108 |
7,368 |
14,067 |
13,024 |
||||||||||||
Total operating expenses |
24,467 |
14,519 |
49,903 |
25,657 |
||||||||||||
Loss from operations |
(22,410) |
(14,519) |
(46,460) |
(25,657) |
||||||||||||
Other income (expense): | ||||||||||||||||
Interest income |
646 |
313 |
1,402 |
522 |
||||||||||||
Interest expense |
(2,061) |
(414) |
(4,155) |
(781) |
||||||||||||
Net loss |
(23,825) |
(14,620) |
(49,213) |
(25,916) |
||||||||||||
Net loss per share attributable to common stockholders— basic and diluted |
$ |
(0.70) |
$ |
(0.60) |
$ |
(1.45) |
$ |
(1.06) |
||||||||
Weighted average shares outstanding—basic and diluted |
33,882,939 |
24,567,103 |
33,880,494 |
24,554,834 |
Kala Pharmaceuticals, Inc. | |||||||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | |||||||||||||||||||||||
(In thousands) | |||||||||||||||||||||||
(Unaudited) | |||||||||||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||||||||||
June 30, |
|
|
June 30, |
||||||||||||||||||||
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
2019 |
|
|
|
2018 |
|
|||||
Net loss (GAAP) |
$ |
(23,825 |
) |
|
$ |
(14,620 |
) |
|
|
$ |
|
|
(49,213 |
) |
|
$ |
|
|
(25,916 |
) |
|||
Add-back: stock-based compensation expense |
|
2,621 |
|
|
|
2,291 |
|
|
|
|
5,094 |
|
|
|
4,152 |
|
|||||||
Add-back: Non-cash interest |
|
240 |
|
|
|
20 |
|
|
|
|
472 |
|
|
|
— |
||||||||
Add-back: depreciation |
|
218 |
|
|
|
92 |
|
|
|
|
388 |
|
|
|
173 |
|
|||||||
Non-GAAP Net loss |
$ |
(20,746 |
) |
|
$ |
(12,217 |
) |
|
|
$ |
|
|
(43,259 |
) |
|
$ |
|
|
(21,591 |
) |
|||
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Cost of product revenues (GAAP) |
$ |
352 |
|
|
$ |
|
— |
|
|
$ |
|
|
593 |
|
|
$ |
|
|
— |
||||
Less: stock-based compensation expense |
|
39 |
|
|
— |
|
|
|
41 |
|
|
|
— |
||||||||||
Non-GAAP Cost of product revenues |
$ |
313 |
|
|
$ |
|
— |
|
|
$ |
|
|
552 |
|
|
$ |
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Selling, general and administrative expenses (GAAP) |
$ |
17,007 |
|
|
$ |
7,151 |
|
|
|
$ |
|
|
35,243 |
|
|
$ |
|
|
12,633 |
|
|||
Less: stock-based compensation expense |
|
1,787 |
|
|
|
1,550 |
|
|
|
|
3,651 |
|
|
|
2,772 |
|
|||||||
Less: depreciation |
|
142 |
|
|
|
2 |
|
|
|
|
236 |
|
|
|
3 |
|
|||||||
Non-GAAP Selling, general and administrative expenses |
$ |
15,078 |
|
|
$ |
5,599 |
|
|
|
$ |
|
|
31,356 |
|
|
$ |
|
|
9,858 |
|
|||
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Research and development expenses (GAAP) |
$ |
7,108 |
|
|
$ |
7,368 |
|
|
|
$ |
|
|
14,067 |
|
|
$ |
|
|
13,024 |
|
|||
Less: stock-based compensation expense |
|
795 |
|
|
|
741 |
|
|
|
|
1,402 |
|
|
|
1,380 |
|
|||||||
Less: depreciation |
|
76 |
|
|
|
90 |
|
|
|
|
152 |
|
|
|
170 |
|
|||||||
Non-GAAP research and development expenses |
$ |
6,237 |
|
|
$ |
6,537 |
|
|
|
$ |
|
|
12,513 |
|
|
$ |
|
|
11,474 |
|
|||
|
|
|
|
|
|
|
|
|
|
||||||||||||||
Total operating loss (GAAP) |
$ |
(22,410 |
) |
|
$ |
(14,519 |
) |
|
|
$ |
|
|
(46,460 |
) |
|
$ |
|
|
(25,657 |
) |
|||
Less: stock-based compensation expense |
|
2,621 |
|
|
|
2,291 |
|
|
|
|
5,094 |
|
|
|
4,152 |
|
|||||||
Less: depreciation |
|
218 |
|
|
|
92 |
|
|
|
|
388 |
|
|
|
173 |
|
|||||||
Non-GAAP total operating loss |
$ |
(19,571 |
) |
|
$ |
(12,136 |
) |
|
|
$ |
|
|
(40,978 |
) |
|
$ |
|
|
(21,332 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20190806005239/en/
Source:
Investors:
Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200
Media:
Kari Watson
kwatson@macbiocom.com
781-235-3060