Business Highlights
Business highlights for the first quarter of 2022 and subsequent weeks include the following:
Acquired ModeX Therapeutics, Inc. (ModeX), gains proprietary immunotherapy technology, new executives and Directors. ModeX is a privately held biotechnology company focused on developing innovative multi-specific immune therapies for cancer and infectious diseases. In connection with the acquisition, Dr.Elias Zerhouni joins OPKO as President and Vice Chairman of the Board of Directors, Dr.Gary Nabel joins as Chief Innovation Officer and a member of OPKO’s Board of Directors, andAlexis Borisy joins OPKO’s Board. OPKO acquired ModeX for$300 million in OPKO common stock.- Completed sale of
GeneDx LLC (formerlyGeneDx, Inc. ) to Sema4 Holdings Corp. (Sema4). Sema4 acquiredGeneDx for an upfront payment of$150 million in cash, subject to adjustments, plus 80 million shares of Sema4 Class A common stock, with up to an additional$150 million in revenue-based milestones over the next two years (payable in cash or Sema4 shares at Sema4’s discretion). Based on the closing price of Sema4’s Class A common stock onApril 29, 2022 , the date the transaction closed, the total upfront consideration is approximately$322 million and the total aggregate consideration including potential milestones is approximately$472 million . - Pfizer launched NGENLA® (Somatrogon) injection in
Germany ,Japan and additional markets. NGENLA was granted marketing authorization by theMinistry of Health, Labour and Welfare inJapan and by theEuropean Commission in January and February of this year, respectively. With the achievement of these milestones, OPKO earned an aggregate of $85 million in milestone payments. NGENLA is a once-weekly injection to treat pediatric patients with growth disturbance due to insufficient secretion of growth hormone. NGENLA provides pediatric patients, their caregivers and healthcare providers with a new treatment option for growth hormone deficiency that reduces the frequency of required injections from once-daily to once-weekly. Pfizer is OPKO’s global commercial partner for Somatrogon. Vifor Fresenius Medical Care Renal Pharma (VFMCRP) launched RAYALDEE® inGermany , and subsequently inSwitzerland . VFMCRP initiated the commercial launch of RAYALDEE (extended-release calcifediol) inGermany , the first launch of RAYALDEE outside theU.S. VFMCRP is OPKO’s commercial partner for RAYALDEE inEurope and selected markets outside theU.S. VFMCRP has received marketing authorizations for RAYALDEE in 11 European countries and expects to launch the product in additional markets.
First Quarter Financial Results
- Diagnostics: Revenue from services in the first quarter of 2022 was
$286.6 million compared with$507.0 million in the prior-year period, with the decrease primarily due to lower COVID-19 testing volume and related reimbursement, partially offset by an improvement in genomic test reimbursement and an increase in clinical and genomic test volumes. BioReference processed approximately 2.0 million COVID-19 PCR tests in the first quarter of 2022 versus 4.1 million in the first quarter of 2021. Total costs and expenses were$330.1 million in the first quarter of 2022 compared with$439.9 million in the first quarter of 2021, resulting in an operating loss of$43.5 million compared with operating income of$67.0 million in the 2021 period. Operating income decreased primarily due to a decline in the volume of COVID-19 tests. - Pharmaceuticals: Revenue from products in the first quarter of 2022 increased to
$36.6 million from$33.9 million in the first quarter of 2021, with the increase primarily attributable to accelerating growth of OPKO’s international pharmaceutical businesses. Revenue from sales of RAYALDEE in the first quarter of 2022 was$5.1 million compared with$5.8 million in the prior-year period. Revenue from the transfer of intellectual property was$6.0 million in the first quarter of 2022 compared with$4.3 million in the 2021 period. During the first quarter of 2022, OPKO recognized a$3.0 million sales milestone from VFMCRP triggered by the first commercial sales inEurope . Total costs and expenses were$60.7 million in the first quarter of 2022 compared with$57.4 million in the prior-year period. The increase was driven by the amortization of NGENLA, which received approval inEurope andJapan during the first quarter of 2022, offset by a reduction in inventory reserve, legal expenses and selling expenses related to RAYALDEE. In addition, research and development expenses decreased reflecting reduced spending on the NGENLA development program. The operating loss was$18.1 million in the first quarter of 2022 compared with an operating loss of$19.2 million in the first quarter of 2021. - Consolidated: Consolidated total revenues for the first quarter of 2022 were
$329.2 million compared with$545.2 million for the comparable period of 2021. Operating loss for the first quarter of 2022 was$72.4 million compared with operating income of$38.5 million for the 2021 quarter. Net loss for the first quarter of 2022 was$55.4 million , or$0.08 per share, compared with net income of$31.1 million , or$0.05 per diluted share, for the 2021 quarter. - Cash and equivalents: Cash and cash equivalents were
$102.3 million as ofMarch 31, 2022 . In addition, OPKO has$64.8 million available under its line of credit with JP Morgan. Subsequent to the close of the quarter, OPKO received$150 million gross proceeds from the sale ofGeneDx to Sema4. Also, OPKO expects to receive$85 million in milestone payments from Pfizer during the second quarter of 2022.
CONFERENCE CALL & WEBCAST INFORMATION
OPKO’s senior management will provide a business update, discuss first quarter financial results and the ModeX acquisition, and answer questions during a conference call and live audio webcast today beginning at
A telephone replay will be available until
About
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance and expectations regarding the market for and sales of our products, whether the acquisition of ModeX, including the expansion of the executive management team, will positively impact the Company, whether expectations after completion of the merger will be met, whether we will receive milestone payments under the Sema4 transaction, the benefits of NGENLA, the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry, whether our products will launch in all the territories in which they have been approved for sale, the timing of such launches, the ability to get beneficial pricing approvals, whether RAYALDEE prescriptions will increase, our product development efforts and the expected benefits of our products, whether our products in development will be commercialized, whether the relationship with our business partners will be successful, whether our business partners will be able to commercialize our products and successfully utilize our technologies, our ability to market and sell any of our products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the
Contacts:
LHA Investor Relations
ybriggs@lhai.com
or
bvoss@lhai.com
—Tables to Follow—
Condensed Consolidated Balance Sheets
(in millions)
Unaudited
As of | |||||||
2022 | 2021 | ||||||
Assets: | |||||||
Cash and cash equivalents | $ | 102.3 | $ | 134.7 | |||
Assets held for sale | 316.4 | 315.0 | |||||
Other current assets | 335.4 | 373.3 | |||||
Total current assets | 754.1 | 823.0 | |||||
In-process research and development and goodwill | 519.1 | 1,110.8 | |||||
Other assets | 1,033.7 | 465.9 | |||||
Total Assets | $ | 2,306.9 | $ | 2,399.7 | |||
Liabilities and Equity: | |||||||
Current liabilities | $ | 280.7 | $ | 301.8 | |||
Liabilities associated with assets held for sale | 28.5 | 28.2 | |||||
Convertible notes | 210.5 | 187.9 | |||||
Deferred tax liabilities, net | 125.0 | 148.5 | |||||
Other long-term liabilities, principally contract liabilities, | |||||||
leases, contingent consideration and lines of credit | 47.3 | 48.2 | |||||
Total Liabilities | 692.0 | 714.6 | |||||
Equity | 1,614.9 | 1,685.1 | |||||
Total Liabilities and Equity | $ | 2,306.9 | $ | 2,399.7 |
Condensed Consolidated Statements of Operations
(in millions, except share and per share data)
Unaudited
For the three months ended | |||||||
2022 | 2021 | ||||||
Revenues | |||||||
Revenue from services | $ | 286.6 | $ | 507.0 | |||
Revenue from products | 36.6 | 33.9 | |||||
Revenue from transfer of intellectual property | 6.0 | 4.3 | |||||
Total revenues | 329.2 | 545.2 | |||||
Costs and expenses | |||||||
Cost of revenues | 243.9 | 363.5 | |||||
Selling, general and administrative | 117.5 | 112.3 | |||||
Research and development | 18.3 | 19.3 | |||||
Contingent consideration | (0.1 | ) | (1.0 | ) | |||
Amortization of intangible assets | 22.0 | 12.6 | |||||
Total Costs and expenses | 401.6 | 506.7 | |||||
Operating income (loss) | (72.4 | ) | 38.5 | ||||
Other income and (expense), net | (4.2 | ) | (6.8 | ) | |||
Income (loss) before income taxes and investment losses | (76.6 | ) | 31.7 | ||||
Income tax benefit (provision) | 21.3 | (0.6 | ) | ||||
Net income (loss) before investment losses | (55.3 | ) | 31.1 | ||||
Loss from investments in investees | (0.1 | ) | (0.0 | ) | |||
Net income (loss) | $ | (55.4 | ) | $ | 31.1 | ||
Income (loss) per share, basic and diluted | $ | (0.08 | ) | $ | 0.05 | ||
Weighted average common shares outstanding, basic and diluted | 660,302,426 | 640,853,200 |
Source:
2022 GlobeNewswire, Inc., source