Kala Pharmaceuticals Reports Third Quarter 2019 Financial Results
–Conference Call and Webcast Today at 8:00 a.m. ET–
“INVELTYS demonstrated growing demand in the third quarter, with positive feedback from physicians and a continued uptick in prescriptions and market share. Additionally, we made important progress in expanding payor coverage,” said
If approved, Kala believes EYSUVIS will be the ideal prescription therapy for treating dry eye flares that affect the vast majority of dry eye patients.
Third Quarter and Recent Highlights:
INVELTYS®: INVELTYS (loteprednol etabonate ophthalmic suspension) 1% was launched in
- Quarter-over-quarter prescription growth was 30%; approximately 40,000 INVELTYS prescriptions were reported by
Symphony Health in the third quarter of 2019 compared to approximately 31,000 prescriptions reported in the second quarter of 2019. As ofOctober 25, 2019 , approximately 97,000 prescriptions of INVELTYS have been reported. - INVELTYS continues to achieve strong market share growth and now has over 10% branded new prescription market share in just over ten months since launch. Branded new prescription market share grew by 55% in the third quarter compared to the second quarter.
- INVELTYS prescribers grew by 19% quarter-over-quarter. Launch to date, approximately 2,700 eye care professionals have prescribed INVELTYS, which represents nearly 40% of Kala’s targets.
- INVELTYS has achieved approximately 75% unrestricted Commercial market access, for a total of approximately 125 million covered commercial lives.
- 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 2020.
EYSUVISTM (loteprednol etabonate ophthalmic suspension) 0.25% Dry Eye Program: On
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
September 30, 2019 , Kala had cash of$97.6 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 operations through the next 18 months.
Third Quarter 2019 Financial Results
- Net Product Revenue: For the quarter ended
September 30, 2019 , Kala reported net product revenue of$1.5 million relating to sales of INVELTYS, which was launched inJanuary 2019 . Revenue is recognized when products are delivered to distributors. Included in net product revenue for the three months endedSeptember 30, 2019 , is a$0.6 million reduction of reported revenue resulting from a change in the estimate of our payor mix related to the first two quarters of 2019. - Cost of Product Revenues: Cost of product revenues for the quarter ended
September 30, 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 endedSeptember 30, 2019 compared to $0 for the same period in 2018. - SG&A Expenses: For the quarter ended
September 30, 2019 , selling, general and administrative (SG&A) expenses were$15.3 million compared to$8.5 million for the same period in 2018. The increase in SG&A expenses for the quarter endedSeptember 30, 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$13.5 million for the quarter endedSeptember 30, 2019 compared to$6.9 million for the same period in 2018. - R&D Expenses: For the quarter ended
September 30, 2019 , research and development (R&D) expenses were$7.1 million consistent with the same period in 2018. A decrease in INVELTYS-related R&D costs for the third quarter of 2019 was offset by an increase in facility-related costs for the same period in 2018. Non-GAAP R&D expenses were$6.1 million for the quarter endedSeptember 30, 2019 compared to$6.3 million for the same period in 2018. - Operating Loss: For the quarter ended
September 30, 2019 , loss from operations was$21.6 million compared to$15.5 million for the same period in 2018. Non-GAAP operating loss was$18.8 million for the quarter endedSeptember 30, 2019 compared to$13.2 million for the same period in 2018. - Net Loss: Net loss was
$23.2 million , or$0.68 per share, for the quarter endedSeptember 30, 2019 compared to a net loss of$15.6 million , or$0.63 per share, for the same period in 2018. For the quarter endedSeptember 30, 2019 , non-GAAP net loss was$20.1 million , compared to$13.2 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 quarter endedSeptember 30, 2019 and 24.6 million for the quarter endedSeptember 30, 2018 .
Year-to-Date Financial Results
- Net Product Revenue: For the nine months ended
September 30, 2019 , Kala reported net product revenue of$4.9 million relating to sales of INVELTYS, which was launched inJanuary 2019 . The Company did not recognize revenue in the first nine months of 2018. - Cost of Product Revenues: Cost of product revenues for the nine months ended
September 30, 2019 were$1.3 million compared to $0 for the same period in 2018. Non-GAAP Cost of product revenues were$1.2 million for the nine months endedSeptember 30, 2019 compared to $0 for the same period in 2018. - SG&A Expenses: For the nine months ended
September 30, 2019 , SG&A expenses were$50.5 million compared to$21.1 million for the same period in 2018. The increase in SG&A expenses for the nine months endedSeptember 30, 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$44.9 million for the nine months endedSeptember 30, 2019 compared to$16.7 million for the same period in 2018. - R&D Expenses: For the nine months ended
September 30, 2019 , R&D expenses were$21.1 million compared to$20.0 million for the same period in 2018. The increase in R&D expenses for the nine months endedSeptember 30, 2019 was primarily due to an increase in spending on STRIDE 3, an increase in facility-related costs in 2019, 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$18.6 million for the nine months endedSeptember 30, 2019 compared to$17.8 million for the same period in 2018. - Operating Loss: For the nine months ended
September 30, 2019 , loss from operations was$68.0 million compared to$41.2 million for the same period in 2018. Non-GAAP operating loss was$59.7 million for the nine months endedSeptember 30, 2019 compared to$34.5 million for the same period in 2018. - Net Loss: Net loss was
$72.4 million , or$2.13 per share, for the nine months endedSeptember 30, 2019 compared to a net loss of$ 41.5 million , or$1.69 per share, for the same period in 2018. For the nine months endedSeptember 30, 2019 , non-GAAP net loss was$63.4 million compared to$34.8 million for the same period in 2018.
The weighted average number of shares outstanding used to calculate net loss per share was 34.0 million for the nine months endedSeptember 30, 2019 and 24.6 million for the nine months endedSeptember 30, 2018 .
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) | ||||||||
September 30, | December 31, | |||||||
2019 |
2018 |
|||||||
Cash |
$ |
97,556 |
$ |
170,898 |
||||
Total assets |
161,013 |
220,966 |
||||||
Working capital (1) |
94,490 |
160,018 |
||||||
Long‑term debt, net of discounts |
70,935 |
70,226 |
||||||
Other long‑term liabilities |
29,026 |
28,752 |
||||||
Total Stockholders’ equity |
43,056 |
104,978 |
||||||
(1) The Company defines working capital as current assets less current liabilities. See the |
Kala Pharmaceuticals, Inc. | ||||||||||||||||
Condensed Consolidated Statement of Operations | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
(Unaudited) | ||||||||||||||||
Quarter Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||||
Product revenues, net |
$ |
1,451 |
$ |
— |
$ |
4,894 |
$ |
— | ||||||||
Costs and expenses: | ||||||||||||||||
Cost of product revenues |
668 |
— |
1,261 |
— | ||||||||||||
Selling, general and administrative |
15,280 |
8,469 |
50,523 |
21,102 |
||||||||||||
Research and development |
7,070 |
7,027 |
21,137 |
20,051 |
||||||||||||
Total operating expenses |
23,018 |
15,496 |
72,921 |
41,153 |
||||||||||||
Loss from operations |
(21,567) |
(15,496) |
(68,027) |
(41,153) |
||||||||||||
Other income (expense): | ||||||||||||||||
Interest income |
571 |
325 |
1,973 |
848 |
||||||||||||
Interest expense |
(2,180) |
(432) |
(6,335) |
(1,214) |
||||||||||||
Net loss |
(23,176) |
(15,603) |
(72,389) |
(41,519) |
||||||||||||
Net loss per share attributable to common stockholders—basic and diluted |
$ |
(0.68) |
$ |
(0.63) |
$ |
(2.13) |
$ |
(1.69) |
||||||||
Weighted average shares outstanding—basic and diluted |
34,168,282 |
24,600,080 |
33,977,477 |
24,570,081 |
Kala Pharmaceuticals, Inc. | ||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures | ||||||||||||||
(In thousands) | ||||||||||||||
(Unaudited) | ||||||||||||||
Quarter Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2019 |
|
2018 |
|
|
2019 |
|
2018 |
|||||||
Net loss (GAAP) |
$ |
(23,176) |
$ |
(15,603) |
$ |
(72,389) |
$ |
(41,519) |
||||||
Add-back: stock-based compensation expense |
2,572 |
2,265 |
7,666 |
6,417 |
||||||||||
Add-back: Non-cash interest |
237 |
75 |
709 |
75 |
||||||||||
Add-back: depreciation |
226 |
70 |
614 |
243 |
||||||||||
Non-GAAP Net loss |
$ |
(20,141) |
$ |
(13,193) |
$ |
(63,400) |
$ |
(34,784) |
||||||
Cost of product revenues (GAAP) |
$ |
668 |
$ |
— |
$ |
1,261 |
$ |
— | ||||||
Less: stock-based compensation expense |
60 |
— |
101 |
— | ||||||||||
Less: depreciation |
2 |
— |
2 |
— | ||||||||||
Non-GAAP Cost of product revenues |
$ |
606 |
$ |
— |
$ |
1,158 |
$ |
— | ||||||
Selling, general and administrative expenses (GAAP) |
$ |
15,280 |
$ |
8,469 |
$ |
50,523 |
$ |
21,102 |
||||||
Less: stock-based compensation expense |
1,599 |
1,581 |
5,250 |
4,353 |
||||||||||
Less: depreciation |
140 |
13 |
376 |
16 |
||||||||||
Non-GAAP Selling, general and administrative expenses |
$ |
13,541 |
$ |
6,875 |
$ |
44,897 |
$ |
16,733 |
||||||
Research and development expenses (GAAP) |
$ |
7,070 |
$ |
7,027 |
$ |
21,137 |
$ |
20,051 |
||||||
Less: stock-based compensation expense |
913 |
684 |
2,315 |
2,064 |
||||||||||
Less: depreciation |
84 |
57 |
236 |
227 |
||||||||||
Non-GAAP research and development expenses |
$ |
6,073 |
$ |
6,286 |
$ |
18,586 |
$ |
17,760 |
||||||
Total operating loss (GAAP) |
$ |
(21,567) |
$ |
(15,496) |
$ |
(68,027) |
$ |
(41,153) |
||||||
Less: stock-based compensation expense |
2,572 |
2,265 |
7,666 |
6,417 |
||||||||||
Less: depreciation |
226 |
70 |
614 |
243 |
||||||||||
Non-GAAP total operating loss |
$ |
(18,769) |
$ |
(13,161) |
$ |
(59,747) |
$ |
(34,493) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20191107005279/en/
Source:
Investors:
Hannah Deresiewicz
hannah.deresiewicz@sternir.com
212-362-1200
Media:
Kari Watson
kwatson@macbiocom.com
781-235-3060