Release Details
Coherus BioSciences Reports Third Quarter 2021 Results
– Key milestones achieved driving near-term commercial product portfolio expansion –
– Three BLAs now under FDA review: PD-1 inhibitor toripalimab, biosimilar Lucentis®, biosimilar Humira® –
– Multiple additional applications to FDA expected in 2022 –
– UDENYCA® delivers 3rd quarter 2021 net sales of
– Conference call today at
ACHIEVEMENT OF KEY MILESTONES DRIVING NEAR-TERM COMMERCIAL PRODUCT PORTFOLIO EXPANSION
- Successful UDENCYA® on-body injector clinical trial is expected to enable 2022 submission of a prior approval supplement to the UDENYCA® BLA.
- FDA accepted the BLA for CHS-201, a biosimilar Lucentis® (ranibizumab), and assigned a target action date of
August 2022 . - FDA review of the BLA for CHS-1420, a biosimilar Humira® (adalimumab), is advancing toward the target action date in
December 2021 . - FDA accepted the toripalimab BLA for advanced nasopharyngeal carcinoma and granted priority review with a target action date of
April 2022 . - Positive esophageal squamous cell carcinoma Phase 3 clinical data is expected to enable submission of a toripalimab BLA supplement in 2022.
- Positive progression free survival data (PFS) from the CHOICE-01 Phase 3 clinical trial evaluating toripalimab in non-small cell lung cancer were presented in September. A final analysis of PFS and an additional interim overall survival analysis are expected by early first quarter 2022, after which Coherus and partner Junshi Biosciences plan to discuss a potential submission of a BLA supplement with FDA.
THIRD QUARTER 2021 FINANCIAL HIGHLIGHTS
- Net product revenue, consisting of net sales of UDENYCA® (pegfilgrastim-cbqv), was
$82.5 million . - GAAP net loss of
$38.5 million was driven by lower net product revenue and increased R&D and regulatory expenses to support the development and regulatory submissions of toripalimab and biosimilar pipeline product candidates. - Non-GAAP net loss was
$26.6 million , adjusting for$11.9 million in stock-based compensation expense. - At
September 30, 2021 , cash, cash equivalents and marketable securities were$468.7 million .
“With three BLAs currently under FDA review, and positive clinical data expected to enable submission of multiple additional applications for marketing authorization in 2022, we are making rapid progress toward our goals to diversify and grow our commercial product portfolio,” said
THIRD QUARTER 2021 FINANCIAL RESULTS
Net product revenue, consisting of net sales of UDENYCA®, was
Cost of goods sold (COGS) was
Research and development (R&D) expense for the three months ended
Selling, general and administrative (SG&A) expense for the three months ended
Net loss for the third quarter of 2021 was
Non-GAAP net loss for the third quarter of 2021 was $26.6 million, or $(0.34) per share on a diluted basis, compared to non-GAAP net income of $39.7 million, or $0.47 per share on a diluted basis for the same period in 2020. See “Non-GAAP Financial Measures” below for a discussion on how Coherus calculates non-GAAP net (loss) income and a reconciliation to the most directly comparable GAAP measures.
Cash, cash equivalents and investments in marketable securities were
2021 FINANCIAL OUTLOOK
Excluding the upfront payment made to Junshi Biosciences in the first quarter, Coherus projects full year 2021 R&D and SG&A expenses in a range of
This financial guidance excludes the effects of any potential future strategic acquisitions, collaborations or investments, the exercise of rights or options related to collaboration programs, and any other transactions or items not yet identified or quantified. This guidance is subject to a number of risks and uncertainties. See Forward-Looking Statements described in the section below and the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended
Coherus is planning to host an analyst day event in
Conference Call Information
When:
Dial-in: (844) 452-6826 (Toll-Free
Conference ID: 1838568
Webcast: https://investors.coherus.com/upcoming-events
Please dial-in 15 minutes early to ensure a timely connection to the call.
About
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.
For additional information, please visit www.coherus.com.
UDENYCA® is a trademark of Coherus BioSciences, Inc.
Avastin® and Lucentis® are registered trademarks of Genentech, Inc.
Humira® is a registered trademark of AbbVie Inc.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential for UDENYCA® net sales to continue to provide strong funding for Coherus’ operations, investments in its pipeline programs and anticipated commercial launches of new products; Coherus' ability to submit a prior approval supplement to the UDENYCA® BLA on schedule during 2022; the potential approval of the CHS-201 biosimilar candidate to Lucentis® (ranibizumab) in
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2021 |
2020 |
2021 |
2020 |
|||||||||||||
| Revenue: | ||||||||||||||||
| Net product revenue | $ | 82,503 | $ | 113,551 | $ | 253,180 | $ | 365,405 | ||||||||
| Operating expenses: | ||||||||||||||||
| Cost of goods sold | 21,280 | 9,000 | 45,487 | 25,994 | ||||||||||||
| Research and development | 54,085 | 38,851 | 312,343 | 98,131 | ||||||||||||
| Selling, general and administrative | 39,925 | 31,984 | 119,661 | 101,386 | ||||||||||||
| Total operating expenses | 115,290 | 79,835 | 477,491 | 225,511 | ||||||||||||
| (Loss) Income from operations | (32,787 | ) | 33,716 | (224,311 | ) | 139,894 | ||||||||||
| Interest expense | (5,771 | ) | (5,656 | ) | (17,166 | ) | (15,495 | ) | ||||||||
| Other income, net | 30 | 56 | 102 | 548 | ||||||||||||
| Net (loss) income before income taxes | (38,528 | ) | 28,116 | (241,375 | ) | 124,947 | ||||||||||
| Income tax provision | — | 183 | — | 2,411 | ||||||||||||
| Net (loss) income | $ | (38,528 | ) | $ | 27,933 | $ | (241,375 | ) | $ | 122,536 | ||||||
| Net (loss) income per share: | ||||||||||||||||
| Basic | $ | (0.49 | ) | $ | 0.39 | $ | (3.22 | ) | $ | 1.72 | ||||||
| Diluted | $ | (0.49 | ) | $ | 0.33 | $ | (3.22 | ) | $ | 1.52 | ||||||
| Weighted-average number of shares used in computing net (loss) income per share: | ||||||||||||||||
| Basic | 79,013,240 | 71,649,350 | 74,984,811 | 71,138,973 | ||||||||||||
| Diluted | 79,013,240 | 87,470,337 | 74,984,811 | 82,043,469 | ||||||||||||
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
| 2021 | 2020 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 360,540 | $ | 541,158 | ||
| Investments in marketable securities | 108,167 | — | ||||
| Trade receivables, net | 136,346 | 157,046 | ||||
| Inventory | 83,940 | 92,189 | ||||
| Other assets | 52,733 | 51,256 | ||||
| Total assets | $ | 741,726 | $ | 841,649 | ||
| Liabilities and Stockholders’ Equity | ||||||
| Accrued rebates, fees and reserves | $ | 84,744 | $ | 81,529 | ||
| Convertible notes due 2022* | 80,978 | 79,885 | ||||
| Convertible notes due 2022 - related parties* | 26,992 | 26,628 | ||||
| Convertible notes due 2026 | 223,971 | 223,029 | ||||
| Term loan - current portion | 17,308 | — | ||||
| Term loan - non-current portion | 57,924 | 74,481 | ||||
| Other liabilities | 119,049 | 75,123 | ||||
| Total stockholders' equity | 130,760 | 280,974 | ||||
| Total liabilities and stockholders’ equity | $ | 741,726 | $ | 841,649 | ||
* The Convertible notes due 2022 and the Convertible notes due 2022 - related parties were classified in current liabilities as of
Condensed Consolidated Cash Flow
(in thousands)
(unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Cash, cash equivalents and restricted cash at beginning of the period | $ | 330,178 | $ | 225,057 | $ | 541,598 | $ | 177,908 | ||||||||
| Net cash provided by operating activities | $ | 13,711 | $ | 47,353 | $ | 14,890 | $ | 121,021 | ||||||||
| Purchases of investments in marketable securities | (31,449 | ) | (41,981 | ) | (171,779 | ) | (273,845 | ) | ||||||||
| Proceeds from maturities of investments in marketable securities | 47,700 | 63,000 | 62,700 | 63,000 | ||||||||||||
| Upfront and milestone based license fee payments* | — | (2,500 | ) | (136,000 | ) | (7,500 | ) | |||||||||
| Cash used in other investing activities | (261 | ) | (2,112 | ) | (821 | ) | (6,112 | ) | ||||||||
| Net cash provided by (used in) investing activities | $ | 15,990 | $ | 16,407 | $ | (245,900 | ) | $ | (224,457 | ) | ||||||
| Proceeds from issuance of Convertible Notes due 2026, net of issuance costs | — | (674 | ) | — | 222,156 | |||||||||||
| Purchase of capped call options related to convertible notes due 2026 | — | — | — | (18,170 | ) | |||||||||||
| Proceeds from issuance of common stock to Junshi Biosciences, net of issuance costs | — | — | 40,903 | — | ||||||||||||
| Proceeds from issuance of common stock upon exercise of stock options | 1,280 | 4,909 | 9,726 | 13,014 | ||||||||||||
| Proceeds from purchase under the employee stock purchase plan | — | — | 1,985 | 2,557 | ||||||||||||
| Cash used in other financing activities | (179 | ) | (147 | ) | (2,222 | ) | (1,124 | ) | ||||||||
| Net cash provided by financing activities | $ | 1,101 | $ | 4,088 | $ | 50,392 | $ | 218,433 | ||||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ | 30,802 | $ | 67,848 | $ | (180,618 | ) | $ | 114,997 | |||||||
| Cash, cash equivalents and restricted cash at end of the period | $ | 360,980 | $ | 292,905 | $ | 360,980 | $ | 292,905 | ||||||||
| Reconciliation of cash, cash equivalents, and restricted cash | ||||||||||||||||
| Cash and cash equivalents | $ | 360,540 | 292,465 | $ | 360,540 | 292,465 | ||||||||||
| Restricted cash balance | 440 | 440 | 440 | 440 | ||||||||||||
| Cash, cash equivalents and restricted cash | $ | 360,980 | $ | 292,905 | $ | 360,980 | $ | 292,905 | ||||||||
* 2021 payments includes license fees of
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with GAAP, Coherus has also included in this press release non-GAAP net income, and the related per share measures, which exclude from net (loss) income, and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements, costs related to termination of a research and development program as part of a strategic realignment of research and development resources toward other development programs and the related income tax effect of those non-GAAP adjustments. These non-GAAP financial measures are not prepared in accordance with GAAP, do not serve as an alternative to GAAP and may be calculated differently than similar non-GAAP financial information disclosed by other companies. Coherus encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations set forth below, to more fully understand Coherus’ business.
Coherus believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Coherus believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Coherus’ results from period to period, and to identify operating trends in Coherus’ business. Coherus also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.
Reconciliation of GAAP Net (Loss) Income to Non-GAAP Net (Loss) Income
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| 2021 |
2020 |
2021 |
2020 |
|||||||||||||
| GAAP net (loss) income | $ | (38,528 | ) | $ | 27,933 | $ | (241,375 | ) | $ | 122,536 | ||||||
| Adjustments: | ||||||||||||||||
| Stock-based compensation expense | 11,939 | 9,308 | 40,418 | 28,287 | ||||||||||||
| Upfront and milestone based license fees* | — | 2,500 | 136,000 | 7,500 | ||||||||||||
| Costs related to termination of CHS-2020 development program | — | — | 11,503 | — | ||||||||||||
| Income tax effect of the above adjustments | — | (77 | ) | — | (691 | ) | ||||||||||
| Non-GAAP net (loss) income | $ | (26,589 | ) | $ | 39,664 | $ | (53,454 | ) | $ | 157,632 | ||||||
| GAAP net (loss) income per share, basic | $ | (0.49 | ) | $ | 0.39 | $ | (3.22 | ) | $ | 1.72 | ||||||
| GAAP net (loss) income per share, diluted | $ | (0.49 | ) | $ | 0.33 | $ | (3.22 | ) | $ | 1.52 | ||||||
| Non-GAAP net (loss) income per share, basic | $ | (0.34 | ) | $ | 0.55 | $ | (0.71 | ) | $ | 2.22 | ||||||
| Non-GAAP net (loss) income per share, diluted | $ | (0.34 | ) | $ | 0.47 | $ | (0.71 | ) | $ | 1.93 | ||||||
| Shares used in computing basic net (loss) income per share | 79,013,240 | 71,649,350 | 74,984,811 | 71,138,973 | ||||||||||||
| Shares used in computing diluted net (loss) income per share | 79,013,240 | 87,470,337 | 74,984,811 | 82,043,469 | ||||||||||||
* 2021 expense includes license fees of
Contact
Chief Financial Officer
IR@coherus.com
+1 (650) 395-0152
Source: Coherus BioSciences, Inc.