Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update
-- Launched EYSUVIS™, First and Only Prescription Therapy Approved Specifically for Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease --
-- Progressing Pipeline Programs to
-- Cash Position and INVELTYS Revenue Expected to Provide Runway Into at Least 4Q 2022; EYSUVIS Revenue Expected to Provide Additional Runway --
-- Conference Call and Webcast at
“2020 was a pivotal year for Kala, highlighted by
Fourth Quarter and Recent Highlights:
EYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25%: EYSUVIS became commercially available in
As of
INVELTYS® (loteprednol etabonate ophthalmic suspension) 1%: Approximately 41,000 INVELTYS prescriptions were reported by
Kala continues to believe that INVELTYS prescriptions and revenues will grow over time. However, the Company is unable to project the specific timing or quantify the specific potential impact on future revenues given the continued uncertainty around the impact and duration of the COVID-19 pandemic on elective procedures, which includes ocular surgeries. Kala expects that net revenues could continue to be negatively impacted in 2021.
Preclinical Development Program Pipeline: Kala is progressing a pipeline of preclinical development programs targeted to address front and back of the eye diseases. These programs, all of which are new chemical entities (NCEs), include: (1) selective glucocorticoid receptor modulators (SEGRMs), which are a novel class of therapies designed to modify the downstream activity of the glucocorticoid receptor to exhibit the anti-inflammatory and immunomodulatory properties of corticosteroids while potentially avoiding the typical safety concerns of steroids; (2) a receptor Tyrosine Kinase Inhibitor program (rTKI) for the treatment of retinal diseases, including wet age-related macular degeneration (wet AMD); and (3) novel steroids designed to target the ocular surface and thus have the potential to have fewer side effects compared to traditional topical steroids. Kala owns all intellectual property and worldwide rights to these pipeline candidates.
Financial Results:
The financial results below contain both GAAP and non-GAAP financial measures. The non-GAAP financial measures exclude stock-based compensation expense and non-cash interest expense and depreciation and amortization. See “Non-GAAP Financial Measures” below; for a full reconciliation of Kala’s GAAP to non-GAAP financial measures, please refer to the tables at the end of this press release.
- Cash Position: As of
Fourth Quarter 2020 Financial Results
- Net Product Revenues: For the quarter ended
- Cost of Product Revenues: For the quarter ended
- SG&A Expenses: For the quarter ended
- R&D Expenses: For the quarter ended
- Operating Loss: For the quarter ended
- Net Loss: For the quarter ended
Full Year Ended
- Net Product Revenues: For the full year ended
- Cost of Product Revenues: For the full year ended
- SG&A Expenses: For the full year ended
- R&D Expenses: For the full year ended
- Operating Loss: For the full year ended
- Net Loss: For the full year ended
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” section on the Kala website at http://kalarx.com.
Non-GAAP Financial Measures:
In this press release, the financial results of Kala are provided in accordance with accounting principles generally accepted in
About EYSUVIS:
EYSUVIS (loteprednol etabonate ophthalmic suspension) 0.25% is approved for the short-term (up to two weeks) treatment of the signs and symptoms of dry eye disease. EYSUVIS utilizes Kala's AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the ocular surface. In preclinical studies, the AMPPLIFY Drug Delivery Technology increased delivery of LE into target ocular tissues more than three-fold compared to an active LE comparator by facilitating penetration through the tear film mucins. EYSUVIS was approved by the FDA on
EYSUVIS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. The initial prescription and each renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and, where appropriate, fluorescein staining. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, as well as defects in visual acuity and fields of vision. Corticosteroids should be used with caution in the presence of glaucoma. Renewal of the medication order should be made by a physician only after examination of the patient and evaluation of the IOP. Use of corticosteroids may result in posterior subcapsular cataract formation. Use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, corticosteroids may mask infection or enhance existing infection. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid application. Fungus invasion must be considered in any persistent corneal ulceration where a corticosteroid has been used or is in use. The most common adverse drug reaction following the use of EYSUVIS for two weeks was instillation site pain, which was reported in 5% of patients.
Please see full Prescribing Information at www.eysuvis.com
About INVELTYS:
INVELTYS (loteprednol etabonate ophthalmic suspension) 1% is a twice-a-day corticosteroid for the treatment of post-operative inflammation and pain following ocular surgery. INVELTYS utilizes Kala’s proprietary AMPPLIFY mucus-penetrating particle (MPP) Drug Delivery Technology to enhance penetration of loteprednol etabonate (LE) into target tissues of the eye. In preclinical studies, the AMPPLIFY Drug Delivery Technology increased delivery of LE into target ocular tissues more than three-fold compared to an active LE comparator by facilitating penetration through the tear film mucins. INVELTYS was approved by the FDA on
INVELTYS, as with other ophthalmic corticosteroids, is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. A prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. If this product is used for 10 days or longer, IOP should be monitored. Use of corticosteroids may result in posterior subcapsular cataract formation. Use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. Use of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. In clinical trials, the most common adverse drug reactions were eye pain (1%) and posterior capsular opacification (1%). These reactions may have been the consequence of the surgical procedure.
Please see full Prescribing Information at www.inveltys.com
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 AMPPLIFY® mucus-penetrating particle (MPP) Drug Delivery Technology to two ocular therapies, EYSUVIS™ (loteprednol etabonate ophthalmic suspension) 0.25% for the short-term (up to two weeks) treatment of signs and symptoms of dry eye disease and INVELTYS® (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery. The Company also has a pipeline of preclinical development programs targeted to address unmet medical needs, including both front and back of the eye diseases. For more information on Kala, please visit www.kalarx.com
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 the Company engaging in contract discussions with commercial and Medicare Part D health plans and its expectation to further expand formulary coverage in the coming weeks and months; the Company’s belief that INVELTYS prescriptions and revenues will grow over time; the Company’s plans to advance its preclinical pipeline of programs and the potential benefits of such programs; and the Company’s expectations regarding its use of cash, cash runway and anticipated revenues. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenue, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “continue” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on such forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements as a result of various risks and uncertainties including, but not limited to: the impact of extraordinary external events, such as the current pandemic health event resulting from the novel coronavirus (COVID-19), and their collateral consequences, including disruption of the activities of the Company’s sales force and the market for EYSUVIS and INVELTYS; whether the Company will be able to successfully implement its commercialization plans for EYSUVIS and INVELTYS; whether the market opportunity for EYSUVIS and INVELTYS is consistent with the Company’s expectations and market research; the Company’s ability execute on the commercial launch of EYSUVIS on the timeline expected, or at all, including obtaining Commercial and Medicare Part D payor coverage; whether the Company will be able to generate its projected net product revenue on the timeline expected, or at all; whether the Company's cash resources will be sufficient to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company's expected timeline; other matters that could affect the availability or commercial potential of EYSUVIS and INVELTYS; and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K, most recently filed Quarterly Report on Form 10-Q and other filings the Company makes with the
Financial Tables
|
||||||||
|
|
|||||||
2020 |
2019 |
|||||||
Cash, cash equivalents and short-term investments |
$ |
153,540 |
$ |
85,449 |
||||
Total assets |
|
221,606 |
|
154,323 |
||||
Working capital (1) |
|
149,154 |
|
80,710 |
||||
Long‑term debt, net of discounts |
|
72,243 |
|
71,184 |
||||
Other long‑term liabilities |
|
27,143 |
|
28,673 |
||||
Total stockholders’ equity |
|
99,995 |
|
29,692 |
(1) The Company defines working capital as current assets less current liabilities. See the Company's consolidated financial statements for further information regarding its current assets and current liabilities.
|
||||||||||||||||||
Three Months Ended
|
Year Ended
|
|||||||||||||||||
2020 |
2019 |
2020 |
2019 |
|||||||||||||||
|
|
|||||||||||||||||
Product revenues, net |
$ |
2,238 |
|
$ |
1,180 |
|
$ |
6,362 |
|
$ |
6,074 |
|
||||||
Costs and expenses: |
||||||||||||||||||
Cost of product revenues |
|
1,359 |
|
|
747 |
|
|
3,173 |
|
|
2,008 |
|
||||||
Selling, general and administrative |
|
26,466 |
|
|
14,492 |
|
|
81,068 |
|
|
65,015 |
|
||||||
Research and development |
|
3,397 |
|
|
6,138 |
|
|
18,352 |
|
|
27,275 |
|
||||||
Total operating expenses |
|
31,222 |
|
|
21,377 |
|
|
102,593 |
|
|
94,298 |
|
||||||
Loss from operations |
|
(28,984 |
) |
|
(20,197 |
) |
|
(96,231 |
) |
|
(88,224 |
) |
||||||
Other income (expense): |
||||||||||||||||||
Interest income |
|
42 |
|
|
384 |
|
|
493 |
|
|
2,357 |
|
||||||
Interest expense |
|
(2,170 |
) |
|
(2,145 |
) |
|
(8,589 |
) |
|
(8,480 |
) |
||||||
Net loss |
|
(31,112 |
) |
|
(21,958 |
) |
|
(104,327 |
) |
|
(94,347 |
) |
||||||
Net loss per share attributable to common stockholders—basic and diluted |
$ |
(0.55 |
) |
$ |
(0.63 |
) |
$ |
(1.99 |
) |
$ |
(2.76 |
) |
||||||
Weighted average shares outstanding—basic and diluted |
|
56,923,421 |
|
|
34,899,019 |
|
|
52,377,526 |
|
|
34,209,756 |
|
|
||||||||||||||||||
Reconciliation of GAAP to Non-GAAP Financial Measures |
||||||||||||||||||
(In thousands) |
||||||||||||||||||
(Unaudited) |
||||||||||||||||||
Three Months Ended
|
Year Ended
|
|||||||||||||||||
|
|
2020 |
|
2019 |
|
|
2020 |
|
2019 |
|||||||||
Net loss (GAAP) |
$ |
(31,112 |
) |
$ |
(21,958 |
) |
$ |
(104,327 |
) |
$ |
(94,347 |
) |
||||||
Add-back: stock-based compensation expense |
|
|
|
4,063 |
|
|
|
2,325 |
|
|
|
|
13,312 |
|
|
|
9,991 |
|
Add-back: non-cash interest |
|
|
|
277 |
|
|
|
249 |
|
|
|
|
1,059 |
|
|
|
958 |
|
Add-back: depreciation and amortization |
|
|
|
238 |
|
|
|
229 |
|
|
|
|
912 |
|
|
|
843 |
|
Non-GAAP net loss |
$ |
(26,534 |
) |
|
$ |
(19,155 |
) |
$ |
(89,044 |
) |
$ |
(82,555 |
) |
|||||
Cost of product revenues (GAAP) |
$ |
1,359 |
|
$ |
747 |
|
$ |
3,173 |
|
$ |
2,008 |
|
||||||
Less: stock-based compensation expense |
|
|
|
32 |
|
|
|
167 |
|
|
|
|
92 |
|
|
|
268 |
|
Less: depreciation and amortization |
|
|
|
13 |
|
|
|
1 |
|
|
|
|
52 |
|
|
|
3 |
|
Non-GAAP cost of product revenues |
$ |
1,314 |
|
$ |
579 |
|
$ |
3,029 |
|
$ |
1,737 |
|
||||||
|
|
|
|
|||||||||||||||
Selling, general and administrative expenses (GAAP) |
$ |
26,466 |
|
$ |
14,492 |
|
$ |
81,068 |
|
$ |
65,015 |
|
||||||
Less: stock-based compensation expense |
|
|
|
3,207 |
|
|
|
1,629 |
|
|
|
|
10,137 |
|
|
|
6,879 |
|
Less: depreciation and amortization |
|
|
|
171 |
|
|
|
146 |
|
|
|
|
621 |
|
|
|
522 |
|
Non-GAAP selling, general and administrative expenses |
$ |
23,088 |
|
$ |
12,717 |
|
$ |
70,310 |
|
$ |
57,614 |
|
||||||
|
|
|
|
|||||||||||||||
Research and development expenses (GAAP) |
$ |
3,397 |
|
$ |
6,138 |
|
$ |
18,352 |
|
$ |
27,275 |
|
||||||
Less: stock-based compensation expense |
|
|
|
824 |
|
|
|
529 |
|
|
|
|
3,083 |
|
|
|
2,844 |
|
Less: depreciation and amortization |
|
|
|
54 |
|
|
|
82 |
|
|
|
|
239 |
|
|
|
318 |
|
Non-GAAP research and development expenses |
$ |
2,519 |
|
$ |
5,527 |
|
$ |
15,030 |
|
$ |
24,113 |
|
||||||
Total operating loss (GAAP) |
$ |
(28,984 |
) |
$ |
(20,197 |
) |
$ |
(96,231 |
) |
$ |
(88,224 |
) |
||||||
Add-back: stock-based compensation expense |
|
|
|
4,063 |
|
|
|
2,325 |
|
|
|
|
13,312 |
|
|
|
9,991 |
|
Add-back: depreciation and amortization |
|
|
|
238 |
|
|
|
229 |
|
|
|
|
912 |
|
|
|
843 |
|
Non-GAAP total operating loss |
$ |
(24,683 |
) |
$ |
(17,643 |
) |
$ |
(82,007 |
) |
$ |
(77,390 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005229/en/
Investors:
Loraine.Spreen@kalarx.com
857-277-4842
hannah.deresiewicz@sternir.com
212-362-1200
Source: