Release Details
Coherus BioSciences Reports First Quarter 2020 Financial Results
– First Quarter UDENYCA®
–Net Income of
– Non-GAAP Net Income of
First Quarter 2020 and Recent Corporate Highlights
- Strong financial position and performance to support pipeline development and long-term growth:
- Coherus had cash and cash equivalents of
$193.3 million as ofMarch 31, 2020 . - Completed a convertible notes financing for an aggregate principal amount of
$230 million at a 1.500% coupon inApril 2020 . The net proceeds from this financing will be used for opportunistic pipeline acquisitions or licenses, working capital, and for other general corporate purposes, which may include debt repayment in the future. - Cash flow from operating activities was
$13.5 million for the first quarter of 2020. - Net product revenue for the first quarter of 2020 was
$116.2 million , and net income was$35.6 million , or$0.48 per share on a diluted basis. - Non-GAAP income during the first quarter of 2020 was
$49.8 million , or$0.67 on a diluted basis. - Coherus has remained cash flow positive since the second quarter of 2019.
- Coherus had cash and cash equivalents of
- Coherus completed a key licensing transaction in oncology to enhance its midterm product pipeline in
the United States :- Entered into a license agreement with Innovent Biologics, (
Suzhou ) Co., Ltd., (“Innovent”), a leading biopharmaceutical company headquartered inChina , to commercialize Innovent’s biosimilar candidate to Avastin® (bevacizumab) inthe United States andCanada .
- Entered into a license agreement with Innovent Biologics, (
First Quarter 2020 Financial Results
Net product revenue for first quarter of 2020 was
Research and development (R&D) expenses for the first quarter 2020 were
Selling, general and administrative (SG&A) expenses for the first quarter of 2020 were
Cash, cash equivalents were
Net income (loss) for the first quarter of 2020 was
Non-GAAP net income (loss) for the first quarter of 2020 was
Guidance for the Next Nine Months from
Coherus will continue delivering on the promise of biosimilars and laying the foundation for long-term growth across its three therapeutic areas:
Oncology
- UDENYCA® (pegfilgrastim-cbqv)
- Maintain market position as the leading pegfilgrastim biosimilar of choice leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.
- Increase penetration against all Neulasta® dosage forms, while maintaining average selling price (“ASP”) discipline.
- Maintain market position as the leading pegfilgrastim biosimilar of choice leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments.
- Advance the Company’s Avastin® (bevacizumab) oncology biosimilar candidate in-licensed from Innovent by initiating a planned three-way pharmacokinetic (“PK”) study using innovator Avastin® drug articles from
the United States andChina compared to Innovent’s biosimilar to bevacizumab, and additional analytical similarity exercises. The Company expects to submit a 351(k) BLA with the FDA in 2021, depending on the outcome of these exercises and the timing of required interactions with the FDA. - Diligence the option to commercialize Innovent’s Rituxan® (rituximab) oncology biosimilar in
the United States .
Ophthalmology
- Facilitate Bioeq’s resubmission of a 351(k) BLA with the
U.S. FDA for the biosimilar candidate to Lucentis® (ranibizumab) in the second half of 2020, with expected product launch inthe United States to address a$6 billion anti-VEGF ophthalmology market, if approved, enabling the Company to potentially play a key role in market formation. - Advance the Company’s internally developed CHS-2020 Eylea® (aflibercept) ophthalmology biosimilar currently in preclinical development to an expected Phase 3 clinical trial initiation in 2021, with launch projected in 2025, if approved.
Immunology
- Advance certain manufacturing, regulatory and development activities for the Company’s internally developed CHS-1420 immunology biosimilar to Humira® (adalimumab) with an anticipated filing of a 351(k) BLA in the second half of 2020. The Company expects this timing will enable a projected competitive market entry in
the United States on or afterJuly 1, 2023 , if approved.
CHS-131
- Advance previously announced strategic alternatives for the Company’s program in CHS-131, a small molecule for nonalcoholic steatohepatitis (“NASH”) and multiple sclerosis.
Financial Guidance
- Anticipate that R&D and SG&A expenses combined together will range between
$285 million and$310 million for the full fiscal year 2020, excluding upfront and milestone payments from entering into potential new collaborations.
Conference Call Information
When:
Dial-in: (844) 452-6826 (Toll Free) or (765) 507-2587 (International)
Conference ID: 6167564
Webcast: https://investors.coherus.com/
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.
First quarter 2020 financial results, are posted on the Coherus website at https://investors.coherus.com/.
About
Coherus is a leading biosimilar company that develops and commercializes its own high-quality therapeutics as well as those of others seeking capable access to
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, Coherus’ ability to continue delivering on the promise of biosimilars and laying the foundation for long-term growth across its three therapeutic areas; Coherus’ ability to continue to maintain market position as the leading pegfilgrastim biosimilar of choice leveraging the validated branded-biosimilar strategy of offering a robust value proposition across all key customer segments; Coherus’ ability to continue to increase penetration in market share from both Neulasta® Onpro® and Neulasta® prefilled syringe; Coherus’ ability to maintain ASP discipline for UDENYCA®; Coherus’ ability to advance its Avastin® (bevacizumab) oncology biosimilar candidate in-licensed from Innovent by completing a three-way PK study, as well as completing additional analytical similarity exercises; Coherus’ ability to submit a 351(k) BLA with the FDA in 2021, for the Innovent biosimilar candidate to Avastin®; Coherus’ ability to launch Innovent’s biosimilar candidate to Avastin® in
UDENYCA® is a trademark of
Neulasta® and Onpro® are registered trademarks of Amgen Inc.
Avastin®, Rituxan® and Lucentis® are registered trademarks of
Humira® is a registered trademark of AbbVie Inc.
Eylea® is a registered trademark of Regeneron Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations | ||||||||
(in thousands, except share and per share data) | ||||||||
Three Months Ended | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Revenue: | ||||||||
Net product revenue | $ | 116,180 | $ | 37,098 | ||||
Operating expenses: | ||||||||
Cost of goods sold | 6,855 | 2,225 | ||||||
Research and development | 33,107 | 18,789 | ||||||
Selling, general and administrative | 35,350 | 32,683 | ||||||
Total operating expenses | 75,312 | 53,697 | ||||||
Income (loss) from operations | 40,868 | (16,599 | ) | |||||
Interest expense | (4,431 | ) | (4,216 | ) | ||||
Other income, net | 68 | 811 | ||||||
Net income (loss) before income taxes | 36,505 | (20,004 | ) | |||||
Income tax provision | 933 | ‒ | ||||||
Net income (loss) | $ | 35,572 | $ | (20,004 | ) | |||
Net income (loss) per share: | ||||||||
Basic | $ | 0.50 | $ | (0.29 | ) | |||
Diluted | $ | 0.48 | $ | (0.29 | ) | |||
Weighted-average number of shares used in computing net income (loss) per share: | ||||||||
Basic | 70,662,185 | 69,140,697 | ||||||
Diluted | 74,416,554 | 69,140,697 |
Condensed Consolidated Balance Sheets | ||||||
(in thousands) | ||||||
2020 | 2019 | |||||
(unaudited) | ||||||
Assets | ||||||
Cash and cash equivalents | $ | 193,252 | $ | 177,668 | ||
Trade receivables, net | 167,450 | 141,992 | ||||
Inventory | 65,068 | 55,071 | ||||
Other assets | 40,769 | 34,196 | ||||
Total assets | $ | 466,539 | $ | 408,927 | ||
Liabilities and Stockholders’ Equity | ||||||
Accrued rebate, fees and reserve | $ | 66,157 | $ | 51,120 | ||
Convertible notes | 78,866 | 78,542 | ||||
Convertible notes - related parties | 26,289 | 26,181 | ||||
Term loan | 73,858 | 73,663 | ||||
Other liabilities | 64,094 | 74,207 | ||||
Total stockholders' equity | 157,275 | 105,214 | ||||
Total liabilities and stockholders’ equity | $ | 466,539 | $ | 408,927 |
Condensed Consolidated Cash Flow | ||||||||
(in thousands) | ||||||||
Three Months Ended | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
Cash, cash equivalents and restricted cash at beginning of the period | $ | 177,908 | $ | 73,191 | ||||
Net cash provided by (used in) operating activities | $ | 13,477 | $ | (56,983 | ) | |||
Purchases of investments in marketable securities | ‒ | (14,864 | ) | |||||
Purchases of property and equipment and cash used in other investing activities | (1,616 | ) | (335 | ) | ||||
Net cash used in investing activities | $ | (1,616 | ) | $ | (15,199 | ) | ||
Proceeds from term loan, net of issuance costs | ‒ | 72,876 | ||||||
Proceeds from common stock offering, net of underwriters discounts, commissions and offering costs |
‒ | 8,153 | ||||||
Proceeds from issuance of common stock upon exercise of stock options | 4,803 | 448 | ||||||
Cash used in other financing activities | (880 | ) | ‒ | |||||
Net cash provided by financing activities | $ | 3,923 | $ | 81,477 | ||||
Effect of exchange rate changes on cash | ‒ | (136 | ) | |||||
Net increase in cash, cash equivalents and restricted cash | $ | 15,784 | $ | 9,159 | ||||
Cash, cash equivalents and restricted cash at end of the period | $ | 193,692 | $ | 82,350 | ||||
Reconciliation of cash, cash equivalents, and restricted cash | ||||||||
Cash and cash equivalents | 193,252 | 81,515 | ||||||
Restricted cash balance | 440 | 835 | ||||||
Cash, cash equivalents and restricted cash | $ | 193,692 | $ | 82,350 |
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 (loss), and the related per share measures, which exclude from net income (loss), and the related per share measures, stock-based compensation expense, upfront and milestone payments under the license agreements 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 Income (Loss) to Non-GAAP Net Income (Loss) | ||||||||
(in thousands, except share and per share data) | ||||||||
Three Months Ended | ||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
GAAP net income (loss) | $ | 35,572 | $ | (20,004 | ) | |||
Adjustments: | ||||||||
Stock based compensation expense | 9,555 | 9,494 | ||||||
Upfront payment under the license agreement with Innovent | 5,000 | ‒ | ||||||
Income tax effect of the above adjustments | (362 | ) | ‒ | |||||
Non-GAAP net income (loss) | $ | 49,765 | $ | (10,510 | ) | |||
GAAP net income (loss) per share, basic | $ | 0.50 | $ | (0.29 | ) | |||
GAAP net income (loss) per share, diluted | $ | 0.48 | $ | (0.29 | ) | |||
Non-GAAP net income (loss) per share, basic | $ | 0.70 | $ | (0.15 | ) | |||
Non-GAAP net income (loss) per share, diluted | $ | 0.67 | $ | (0.15 | ) | |||
Shares used in computing basic net income (loss) per share | 70,662,185 | 69,140,697 | ||||||
Shares used in computing diluted net income (loss) per share | 74,416,554 | 69,140,697 |
Contact
Investor Relations & Corporate Affairs
darrington@coherus.com
+1 (650) 395-0196
Source: Coherus BioSciences, Inc.