Osiris Therapeutics, Inc Reports Third Quarter 2018 Results
07 Novembro 2018 - 7:15PM
Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine
company focused on developing and marketing products for wound
care, orthopedics, and sports medicine, today reported its results
for the third quarter ending September 30, 2018.
Business Highlights
- GrafixPL PRIMETM launched on October 1, 2018
- Enrollment of patients in a clinical trial evaluating GrafixPL
PRIME in the treatment of chronic venous leg ulcers
- Company re-listed on the Nasdaq Global Market on August 1,
2018
Quarterly Financial Summary
Revenue was $36.5 million for the three-month period ended
September 30, 2018, which increased $6.7 million or 22.4%,
compared to revenue of $29.8 million for the three-month period
ended September 30, 2017. The increase in revenue was
primarily due to higher Grafix®/Stravix® revenue of $5.6 million as
a result of increased demand from market awareness and acceptance
as we increased selling efforts in the operating room and surgical
settings as well as hospital outpatient wound care centers.
In addition, we received a one-time settlement payment of $1.3
million from a former distributor that was accounted for on a cash
basis, as collection was not reasonably assured, to settle amounts
owed to us from previous years, primarily 2015 and 2016.
BIO4® revenue increased $1.1 million, or 18.1%, due to
increased demand from our distribution arrangement with
Stryker.
Gross profit was $26.7 million for the three-month period ended
September 30, 2018, which increased $4.8 million or 22.0%, compared
with gross profit of $21.9 million for the three-month period ended
September 30, 2017. This increase was primarily due to higher
revenues and the collection of the $1.3 million settlement from a
former distributor that was accounted for on a cash basis, which
did not have any cost of revenue as the cost of revenue was
recognized in the periods the product was shipped.
Cash flow from operations was $8.1 million for the three-month
period ended September 30, 2018, which was driven by net income of
$4.2 million, collection of outstanding accounts receivable of $2.9
million, and the add back of the non-cash accrued shareholder
litigation expense of $0.9 million.
See the Management’s Discussion and Analysis of Financial
Condition and Results of Operations section of our Quarterly Report
on Form 10-Q filed today with the Securities and Exchange
Commission for additional information concerning our operating
results for the three- and nine month periods ended September 30,
2018.
About Osiris Therapeutics
Osiris Therapeutics, Inc., based in Columbia, Maryland,
researches, develops, manufactures and commercializes regenerative
medicine products intended to improve the health and lives of
patients and lower overall healthcare costs. We have achieved
commercial success with products in orthopedics, sports medicine
and wound care, including the Grafix product line, Stravix®, BIO4®
and Cartiform®. We continue to advance our research and
development by focusing on innovation in regenerative medicine,
including the development of bioengineered stem cell and
tissue‑based products. Osiris®, Grafix®, GrafixPL®, GrafixPL
PRIME™ Cartiform®, and Prestige Lyotechnologysm are our trademarks.
BIO4® is a trademark of Howmedica Osteonics Corp., a subsidiary of
Stryker Corporation. More information can be found on the Company’s
website, www.Osiris.com. (OSIR-G)
Forward-Looking Statements
Statements herein relating to the future of Osiris Therapeutics,
Inc. and the ongoing research and development of our products are
forward-looking statements. Osiris Therapeutics, Inc.
cautions that these forward looking statements are subject to
numerous risks and uncertainties, which could cause actual results
to differ materially from those expressed or implied by such
statements. These risks and uncertainties include those
identified under the heading “Risk Factors” in the Osiris
Therapeutics Inc. Annual Report on Form 10-K for the years ended
December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q
for the quarters ended March 31, 2018, June 30, 2018 and September
30, 2018 as filed with the Securities and Exchange Commission
(SEC). We caution investors not to place considerable
reliance on the forward-looking statements contained in this press
release. Examples of forward-looking statements may include,
without limitation, statements regarding the anticipated
efficiencies and advantages of products and the likelihood of
customer clinical adoption of any new products. Although well
characterized in scientific literature and studies, preservation of
tissue integrity, including cells, may not be indicative of
clinical outcome. Accordingly, you should not unduly rely on
these forward-looking statements. You are encouraged to read our
filings with the SEC, available at sec.gov, for a discussion of
these and other risks and uncertainties. The forward-looking
statements in this press release speak only as of the date of this
document, and we undertake no obligation to update or revise any of
the statements. Our business is subject to substantial risks
and uncertainties, including those referenced above. Investors,
potential investors, and others should give careful consideration
to these risks and uncertainties.
For additional information, please
contact:Diane SavoieOsiris Therapeutics, Inc.(443)
545-1834OsirisPR@Osiris.com
FINANCIAL TABLES TO FOLLOW
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OSIRIS
THERAPEUTICS, INC.CONDENSED CONSOLIDATED
BALANCE SHEETS(amounts in thousands, except per
share data)(Unaudited) |
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September 30, |
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December 31, |
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2018 |
|
2017 |
Assets |
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|
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Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
31,658 |
|
|
$ |
3,081 |
|
Short-term investments |
|
|
8,701 |
|
|
|
24,807 |
|
Trade receivables, net |
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|
20,592 |
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|
|
26,053 |
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Inventory, net |
|
|
10,576 |
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|
|
11,278 |
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Insurance receivable |
|
|
4,788 |
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|
|
4,788 |
|
Prepaid expenses and other current assets |
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3,421 |
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|
|
2,920 |
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Total current assets |
|
|
79,736 |
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|
|
72,927 |
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Property and equipment, net |
|
|
3,116 |
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|
|
3,587 |
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Other assets |
|
|
1,849 |
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|
|
1,608 |
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Total assets |
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$ |
84,701 |
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$ |
78,122 |
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Liabilities and Equity |
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Current liabilities |
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Accounts payable |
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$ |
4,291 |
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$ |
5,269 |
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Accrued liabilities |
|
|
10,704 |
|
|
|
9,399 |
|
Accrued shareholder litigation |
|
|
19,400 |
|
|
|
18,500 |
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Other current liabilities |
|
|
1,994 |
|
|
|
1,934 |
|
Total current liabilities |
|
|
36,389 |
|
|
|
35,102 |
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Other long-term liabilities |
|
|
2,450 |
|
|
|
1,626 |
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Total liabilities |
|
|
38,839 |
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|
|
36,728 |
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Equity |
|
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|
|
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Common stock, $0.001 par value, 72,000 shares
authorized, 34,526 shares issued and outstanding at September 30,
2018, and 90,000 shares authorized, 34,526 shares issued and
outstanding at December 31, 2017 |
|
|
35 |
|
|
|
35 |
|
Additional paid-in-capital |
|
|
284,124 |
|
|
|
283,905 |
|
Accumulated other comprehensive loss |
|
|
(330 |
) |
|
|
(208 |
) |
Accumulated deficit |
|
|
(237,967 |
) |
|
|
(242,338 |
) |
Total equity |
|
|
45,862 |
|
|
|
41,394 |
|
Total liabilities and equity |
|
$ |
84,701 |
|
|
$ |
78,122 |
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OSIRIS
THERAPEUTICS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF COMPREHENSIVE INCOME(amounts in
thousands, except per share
data)(Unaudited) |
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Three Months
Ended |
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Nine Months
Ended |
|
|
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September 30, |
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September 30, |
|
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
Revenue |
|
$ |
36,491 |
|
|
$ |
29,806 |
|
|
$ |
102,001 |
|
|
$ |
85,938 |
|
|
Cost of revenue |
|
|
9,808 |
|
|
|
7,926 |
|
|
|
28,333 |
|
|
|
23,405 |
|
|
Gross profit |
|
|
26,683 |
|
|
|
21,880 |
|
|
|
73,668 |
|
|
|
62,533 |
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|
Operating expenses: |
|
|
|
|
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|
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|
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Research and development |
|
|
1,590 |
|
|
|
909 |
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|
|
4,886 |
|
|
|
3,052 |
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Sales and marketing |
|
|
15,931 |
|
|
|
14,825 |
|
|
|
49,107 |
|
|
|
44,256 |
|
|
General and administrative |
|
|
4,302 |
|
|
|
6,634 |
|
|
|
15,150 |
|
|
|
16,920 |
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Shareholder litigation expense |
|
|
900 |
|
|
|
— |
|
|
|
900 |
|
|
|
— |
|
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Total operating expenses |
|
|
22,723 |
|
|
|
22,368 |
|
|
|
70,043 |
|
|
|
64,228 |
|
|
Income (loss) from continuing operations |
|
|
3,960 |
|
|
|
(488 |
) |
|
|
3,625 |
|
|
|
(1,695 |
) |
|
Other (expense) income, net |
|
|
(21 |
) |
|
|
(1,763 |
) |
|
|
548 |
|
|
|
(1,371 |
) |
|
Income (loss) before income taxes from continuing operations |
|
|
3,939 |
|
|
|
(2,251 |
) |
|
|
4,173 |
|
|
|
(3,066 |
) |
|
Income tax (expense) benefit |
|
|
(100 |
) |
|
|
198 |
|
|
|
(170 |
) |
|
|
134 |
|
|
Income (loss) from continuing operations |
|
|
3,839 |
|
|
|
(2,053 |
) |
|
|
4,003 |
|
|
|
(2,932 |
) |
|
Discontinued operations, net of tax |
|
|
368 |
|
|
|
9,811 |
|
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|
368 |
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|
|
9,811 |
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Net income |
|
|
4,207 |
|
|
|
7,758 |
|
|
|
4,371 |
|
|
|
6,879 |
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Other comprehensive income (loss): |
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Unrealized (loss) gain on investments |
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(100 |
) |
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(21 |
) |
|
|
(122 |
) |
|
|
33 |
|
|
Comprehensive income |
|
$ |
4,107 |
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|
$ |
7,737 |
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$ |
4,249 |
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|
$ |
6,912 |
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Net income (loss) per share from continuing
operations: |
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|
|
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Basic |
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$ |
0.11 |
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|
$ |
(0.06 |
) |
|
$ |
0.12 |
|
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$ |
(0.08 |
) |
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Diluted |
|
$ |
0.11 |
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|
$ |
(0.06 |
) |
|
$ |
0.12 |
|
|
$ |
(0.08 |
) |
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Net income per share from discontinued
operations: |
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|
|
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|
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Basic |
|
$ |
0.01 |
|
|
$ |
0.28 |
|
|
$ |
0.01 |
|
|
$ |
0.28 |
|
|
Diluted |
|
$ |
0.01 |
|
|
$ |
0.28 |
|
|
$ |
0.01 |
|
|
$ |
0.28 |
|
|
Net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
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Basic |
|
$ |
0.12 |
|
|
$ |
0.22 |
|
|
$ |
0.13 |
|
|
$ |
0.20 |
|
|
Diluted |
|
$ |
0.12 |
|
|
$ |
0.22 |
|
|
$ |
0.13 |
|
|
$ |
0.20 |
|
|
Weighted average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
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Basic |
|
|
34,526 |
|
|
|
34,526 |
|
|
|
34,526 |
|
|
|
34,524 |
|
|
Diluted |
|
|
34,594 |
|
|
|
34,526 |
|
|
|
34,565 |
|
|
|
34,525 |
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OSIRIS
THERAPEUTICS, INC.CONDENSED CONSOLIDATED
STATEMENTS OF CASH FLOWS(amounts in
thousands)(Unaudited) |
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Nine Months Ended
September 30, |
|
|
|
2018 |
|
|
2017 |
|
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CASH FLOWS FROM OPERATING ACTIVITIES |
|
|
|
|
|
|
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Net income |
|
$ |
4,371 |
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$ |
6,879 |
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|
Adjustments to reconcile net income to net cash provided by (used
in) operating activities: |
|
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|
|
|
|
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Receipt of Mesoblast common stock |
|
|
— |
|
|
|
(10,000 |
) |
|
Shareholder litigation expense |
|
|
900 |
|
|
|
— |
|
|
Provision for excess and obsolete inventory |
|
|
1,238 |
|
|
|
180 |
|
|
Loss on disposal of fixed assets |
|
|
— |
|
|
|
123 |
|
|
Realized loss on investments |
|
|
240 |
|
|
|
2,102 |
|
|
Depreciation |
|
|
658 |
|
|
|
518 |
|
|
Stock-based compensation expense |
|
|
219 |
|
|
|
49 |
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Accounts receivables, net |
|
|
5,461 |
|
|
|
1,220 |
|
|
Inventory, net |
|
|
(536 |
) |
|
|
(1,228 |
) |
|
Prepaid expenses and other assets |
|
|
(742 |
) |
|
|
(651 |
) |
|
Accounts payable, accrued liabilities, and other
liabilities |
|
|
1,211 |
|
|
|
(1,791 |
) |
|
Net cash provided by (used in) operating activities |
|
|
13,020 |
|
|
|
(2,599 |
) |
|
CASH FLOWS FROM INVESTING ACTIVITIES |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(187 |
) |
|
|
(718 |
) |
|
Proceeds from sale of investments |
|
|
16,248 |
|
|
|
23,250 |
|
|
Purchases of investments |
|
|
(504 |
) |
|
|
(19,660 |
) |
|
Net cash provided by investing activities |
|
|
15,557 |
|
|
|
2,872 |
|
|
CASH FLOWS FROM FINANCING ACTIVITIES |
|
|
|
|
|
|
|
Proceeds from the exercise of options to purchase common stock |
|
|
— |
|
|
|
128 |
|
|
Net cash provided by financing activities |
|
|
— |
|
|
|
128 |
|
|
NET INCREASE IN CASH AND CASH EQUIVALENTS |
|
|
28,577 |
|
|
|
401 |
|
|
Cash and cash equivalents at beginning of period |
|
|
3,081 |
|
|
|
2,833 |
|
|
Cash and cash equivalents at end of period |
|
$ |
31,658 |
|
|
$ |
3,234 |
|
|
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