COLUMBIA, Md., Nov. 07, 2018 (GLOBE NEWSWIRE) — 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 Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com
FINANCIAL TABLES TO FOLLOW
| OSIRIS THERAPEUTICS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands, except per share data) (Unaudited) |
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| September 30, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | 31,658 | $ | 3,081 | ||||
| Short-term investments | 8,701 | 24,807 | ||||||
| Trade receivables, net | 20,592 | 26,053 | ||||||
| Inventory, net | 10,576 | 11,278 | ||||||
| Insurance receivable | 4,788 | 4,788 | ||||||
| Prepaid expenses and other current assets | 3,421 | 2,920 | ||||||
| Total current assets | 79,736 | 72,927 | ||||||
| Property and equipment, net | 3,116 | 3,587 | ||||||
| Other assets | 1,849 | 1,608 | ||||||
| Total assets | $ | 84,701 | $ | 78,122 | ||||
| Liabilities and Equity | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | 4,291 | $ | 5,269 | ||||
| Accrued liabilities | 10,704 | 9,399 | ||||||
| Accrued shareholder litigation | 19,400 | 18,500 | ||||||
| Other current liabilities | 1,994 | 1,934 | ||||||
| Total current liabilities | 36,389 | 35,102 | ||||||
| Other long-term liabilities | 2,450 | 1,626 | ||||||
| Total liabilities | 38,839 | 36,728 | ||||||
| Equity | ||||||||
| 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 | ||||
| OSIRIS THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (amounts in thousands, except per share data) (Unaudited) |
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| Three Months Ended | Nine Months Ended | ||||||||||||||||
| September 30, | 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 | |||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development | 1,590 | 909 | 4,886 | 3,052 | |||||||||||||
| Sales and marketing | 15,931 | 14,825 | 49,107 | 44,256 | |||||||||||||
| General and administrative | 4,302 | 6,634 | 15,150 | 16,920 | |||||||||||||
| Shareholder litigation expense | 900 | — | 900 | — | |||||||||||||
| 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 | 368 | 9,811 | |||||||||||||
| Net income | 4,207 | 7,758 | 4,371 | 6,879 | |||||||||||||
| Other comprehensive income (loss): | |||||||||||||||||
| Unrealized (loss) gain on investments | (100 | ) | (21 | ) | (122 | ) | 33 | ||||||||||
| Comprehensive income | $ | 4,107 | $ | 7,737 | $ | 4,249 | $ | 6,912 | |||||||||
| Net income (loss) per share from continuing operations: | |||||||||||||||||
| Basic | $ | 0.11 | $ | (0.06 | ) | $ | 0.12 | $ | (0.08 | ) | |||||||
| Diluted | $ | 0.11 | $ | (0.06 | ) | $ | 0.12 | $ | (0.08 | ) | |||||||
| Net income per share from discontinued operations: | |||||||||||||||||
| Basic | $ | 0.01 | $ | 0.28 | $ | 0.01 | $ | 0.28 | |||||||||
| Diluted | $ | 0.01 | $ | 0.28 | $ | 0.01 | $ | 0.28 | |||||||||
| Net income per share: | |||||||||||||||||
| Basic | $ | 0.12 | $ | 0.22 | $ | 0.13 | $ | 0.20 | |||||||||
| Diluted | $ | 0.12 | $ | 0.22 | $ | 0.13 | $ | 0.20 | |||||||||
| Weighted average common shares outstanding: | |||||||||||||||||
| Basic | 34,526 | 34,526 | 34,526 | 34,524 | |||||||||||||
| Diluted | 34,594 | 34,526 | 34,565 | 34,525 | |||||||||||||
| OSIRIS THERAPEUTICS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (amounts in thousands) (Unaudited) |
|||||||||
| Nine Months Ended September 30, | |||||||||
| 2018 | 2017 | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | |||||||||
| Net income | $ | 4,371 | $ | 6,879 | |||||
| Adjustments to reconcile net income to net cash provided by (used in) operating activities: | |||||||||
| 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 | |||||
