Kala Pharmaceuticals Reports First Quarter 2019 Financial Results
–Conference Call and Webcast Today at 8:00 a.m. ET–
“We are pleased with our results during the first quarter of 2019,
particularly as it relates to the launch of INVELTYS,” said
First Quarter and Recent Highlights:
INVELTYS® Launch: INVELTYS was launched in
Nearly 20,000 INVELTYS prescriptions have been filled as of
April 26, 2019.
- INVELTYS has achieved approximately 5% branded new prescription market share and is now the third-most prescribed branded ocular steroid
- INVELTYS has achieved unrestricted market access in approximately 41% of all lives covered by commercial payers, for a total of approximately 70 million commercial lives.
Medicare Part Dcontract negotiations are ongoing with most coverage decisions anticipated in early 2020.
KPI-121 0.25% Dry Eye Program:
First Quarter 2019 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 release.
- Cash Position: As of
March 31, 2019, Kala had cash of $138.9 millioncompared to $170.9 millionas of December 31, 2018. Kala anticipates that its existing cash on hand will enable it to fund operations through at least mid-2020, with additional cash runway expected when including INVELTYS revenue.
- Net Product Revenue: For the first quarter of 2019, Kala
reported net product revenue of
$1.4 millionrelating to sales of INVELTYS, which was launched in January 2019. Kala recognizes revenue when products are delivered to distributors. Kala did not generate any revenue from product sales prior to the first quarter of 2019.
- Cost of Product Revenues: Cost of product revenues for the
first quarter of 2019 were
$0.2 millioncompared to $0 for the same period in 2018. Cost of product revenues for the first quarter of 2019 were favorably impacted by certain INVELTYS manufacturing costs which were expensed as R&D prior to FDAapproval in August 2018.
- SG&A Expenses: For the quarter ended
March 31, 2019, selling, general and administrative (SG&A) expenses were $18.2 millioncompared to $5.5 millionfor the same period in 2018. The increases in SG&A expenses for the quarter ended March 31, 2019were primarily due to costs associated with hiring additional personnel, building our commercial organization, external costs associated with the launch of INVELTYS in January 2019, and an increase in our facility costs due to the lease of our new corporate headquarters which commenced in late 2018.
Non-GAAP SG&A expenses were
$16.3 millionfor the quarter ended March 31, 2019compared to $4.2 millionfor the same period in 2018. For a reconciliation of GAAP to non-GAAP SG&A expenses, please see the tables provided below.
- R&D Expenses: For the quarter ended
March 31, 2019, research and development (R&D) expenses were $7.0 millioncompared to $5.7 millionfor the same period in 2018. The increase in R&D expenses for the quarter ended March 31, 2019was primarily due to increased clinical expenses associated with STRIDE 3, which were partially offset by a decrease in manufacturing costs related to INVELTYS which were expensed as R&D prior to FDAapproval.
Non-GAAP R&D expenses were
$6.3 millionfor the quarter ended March 31, 2019compared to $5.0 millionfor the same period in 2018. For a reconciliation of GAAP to non-GAAP R&D expenses, please see the tables provided below.
- Operating Loss: For the quarter ended
March 31, 2019, loss from operations was $24.1 millioncompared to $11.1 millionfor the same period in 2018. Non-GAAP operating loss was $21.4 millionfor the quarter ended March 31, 2019compared to $9.2 millionfor the same period in 2018. For a reconciliation of GAAP to non-GAAP operating loss, please see the tables provided below.
- Net Loss: Net loss was
$25.4 million, or $0.75per share, for the quarter ended March 31, 2019compared to a net loss of $11.3 million, or $0.46per share, for the same period in 2018.
Non-GAAP Net Loss:For the quarter ended
March 31, 2019, non-GAAP net loss was $22.5 million, compared to $9.4 millionfor the same quarter of 2018. For a reconciliation of GAAP to non-GAAP net loss, please see the tables provided below.
The weighted average number of shares outstanding used to calculate net loss per share was 33,878,021 for the quarter ended
March 31, 2019and 24,542,428 for the quarter ended March 31, 2018.
Conference Call Information
Kala will host a live conference call and webcast today,
To access a subsequent archived recording of the call, please visit the “Investors & Media” section on the Kala website at http://kalarx.com.
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 recently
approved INVELTYS® for the treatment of inflammation and pain following
ocular surgery and its lead product candidate, KPI-121 0.25%, for the
temporary relief of the signs and symptoms of dry eye disease, for which
a target action date under the Prescription Drug User Fee Act (PDUFA)
has been set by the
Non-GAAP Financial Measures
In this press release, the financial results of Kala are provided in
accordance with accounting principles generally accepted in
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
|Kala Pharmaceuticals, Inc.|
|Balance Sheet Data|
|March 31,||December 31,|
|Working capital (1)||135,847||160,018|
|Long-term debt, net of discounts||70,457||70,226|
|Other long-term liabilities||29,590||28,752|
|Total Stockholders’ equity||82,367||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.
|Condensed Consolidated Statement of Operations|
|(In thousands, except share and per share data)|
|Product revenues, net||$||1,386||$||—|
|Costs and expenses:|
|Cost of product revenues||241||—|
|Selling, general and administrative||18,236||5,482|
|Research and development||6,959||5,657|
|Total operating expenses||25,436||11,139|
|Loss from operations||(24,050)||(11,139)|
|Other income (expense):|
Net loss per share attributable to common
Weighted average shares outstanding—basic
|Kala Pharmaceuticals, Inc.|
|Reconciliation of GAAP to Non-GAAP Financial Measures|
|Net loss (GAAP)||$||(25,388)||$||(11,297)|
|Add-back: stock-based compensation expense||2,473||1,861|
|Add-back: Non-cash interest||231||—|
|Non-GAAP Net loss||$||(22,514)||$||(9,355)|
|Cost of product revenues (GAAP)||$||241||$||—|
|Less: stock-based compensation expense||2||—|
|Non-GAAP Cost of product revenues||$||239||—|
|Selling, general and administrative expenses (GAAP)||$||18,236||$||5,482|
|Less: stock-based compensation expense||1,864||1,222|
|Non-GAAP Selling, general and administrative expenses||$||16,278||4,180|
|Research and development expenses (GAAP)||$||6,959||$||5,657|
|Less: stock-based compensation expense||607||639|
|Non-GAAP research and development expenses||$||6,276||5,017|
|Total operating loss (GAAP)||$||(24,050)||$||(11,139)|
|Less: stock-based compensation expense||2,473||1,861|
|Non-GAAP total operating loss||$||(21,407)||$||(9,197)|