UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2015
COHERUS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-36721 | 27-3615821 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification Number) |
201 Redwood Shores Parkway, Suite 200
Redwood City, CA 94065
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (650) 649-3530
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 2.02 | Results of Operations and Financial Conditions |
On November 9, 2015, Coherus BioSciences, Inc. (“Coherus”) issued a press release reporting its financial results for its third quarter ended September 30, 2015. The full text of the press release is furnished as Exhibit 99.1 to this Form 8-K.
This information in this Item 2.02 of this Form 8-K and the Exhibit 99.1 attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events |
On November 9, 2015, Coherus and Baxalta Incorporated announced that CHS-0214, Coherus’ etanercept (Enbrel®) biosimilar product candidate, met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study. This 52-week study was designed to evaluate the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe plaque psoriasis. The full text of the press release is furnished as Exhibit 99.2 to this Form 8-K.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| Exhibit No. |
Description | |
| 99.1 | Press release titled “Coherus BioSciences Reports Third Quarter 2015 Financial and Operating Results and Corporate Events”, dated November 9, 2015 | |
| 99.2 | Press release titled “Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoints in Phase 3 Psoriasis Clinical Study (RaPsODY)”, dated November 9, 2015 | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: November 9, 2015 | COHERUS BIOSCIENCES, INC. | |||||
| By: | /s/ Jean-Frédéric Viret | |||||
| Name: | Jean-Frédéric Viret | |||||
| Title: | Chief Financial Officer | |||||
EXHIBIT INDEX
| Exhibit No. |
Description | |
| 99.1 | Press release titled “Coherus BioSciences Reports Third Quarter 2015 Financial and Operating Results and Corporate Events”, dated November 9, 2015 | |
| 99.2 | Press release titled “Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar) Met Primary Efficacy Endpoints in Phase 3 Psoriasis Clinical Study (RaPsODY)”, dated November 9, 2015 | |
Exhibit 99.1
Coherus BioSciences Reports Third Quarter 2015
Financial and Operating Results and Corporate Events
Pegfilgrastim PK/PD Study Completed and Adalimumab Phase 3 Study Initiated
REDWOOD CITY, Calif., November 9, 2015 — Coherus BioSciences, Inc. (Nasdaq: CHRS), a leading pure-play, global biosimilars company with late-stage clinical products, today reviewed corporate events and reported financial results for the third quarter ended September 30, 2015.
Highlights include:
| • | CHS-0214 (etanercept (Enbrel®) biosimilar): Coherus and Baxalta announced today that CHS-0214 met its primary efficacy endpoints in its phase 3 psoriasis clinical study. |
| • | CHS-1701 (pegfilgrastim (Neulasta®) biosimilar): On October 1, 2015, Coherus announced topline results of its pivotal pharmacokinetic (PK) and pharmacodynamic (PD) study, which supports our plan to file a 351(k) biologics license application (BLA) in the first quarter of 2016. In addition, Coherus completed the enrollment of additional healthy volunteers in the immunogenicity study pursuant to this BLA. |
| • | CHS-1420 (adalimumab (Humira®) biosimilar): In August 2015, Coherus initiated dosing of the Phase 3 study in psoriasis. Coherus anticipates initiating the PK bioequivalence bridging study by the end of the first half of 2016 with Phase 3 drug material and filing a BLA in the U.S. in the second half of 2016. |
| • | In September 2015, Coherus entered into and consummated a stock purchase agreement with Baxalta Incorporated, Baxalta US Inc. and Baxalta GmbH (together, “Baxalta”). Pursuant to this agreement, Coherus sold to Baxalta an aggregate of 390,167 shares of common stock for aggregate gross proceeds of approximately $10.0 million. |
| • | On October 15, 2015, Coherus received a $30.0 million milestone payment from Baxalta US Inc., pursuant to its August 30, 2013 license agreement, as amended. The milestone payment related to the successful demonstration of drug product stability for CHS-0214, its etanercept biosimilar candidate. |
| • | Coherus today, pursuant to 35 U.S.C. §§ 311–319 AND 37 C.F.R. § 42, filed in the United States Patent and Trademark Office a petition for Inter Partes Review (“IPR”) of AbbVie’s United States Patent No. 8,889,135 entitled “Methods of Administering Anti-TNFa antibodies” directed to treating rheumatoid arthritis in a human subject via administration, every 13-15 days, of 40 mg of a human anti-TNFa antibody that includes or encompasses adalimumab. |
“Coherus continued to make significant progress on all its late-stage product candidates,” said Denny Lanfear, president and chief executive officer of Coherus. “We expect to file the BLA for CHS-1701 in the first quarter of 2016 and we look forward to reporting the results of the CHS-0214 rheumatoid arthritis Phase 3 clinical study in the first quarter of 2016.”
Third Quarter 2015 Financial Results
Total revenue for the third quarter 2015 was $7.2 million, as compared to $16.1 million in the third quarter of 2014. Total revenue for the nine months ended September 30, 2015 was $19.8 million, as compared to $24.6 million for the same period in 2014. The lower revenue in the third quarter and nine months ended September 30, 2015 over the same periods in 2014 was due to the recognition of a $10.0 million substantive milestone from Baxalta earned in third quarter of 2014, in addition to the collaboration and license revenue recognized over the estimated period of the collaboration.
Research and development (R&D) expenses for the third quarter 2015 were $68.2 million, compared with $18.5 million for the same period in 2014. R&D expenses for the nine months ended September 30, 2015 were $161.6 million, as compared to $51.4 million for the same period in 2014. Increases in R&D expenses over the same periods were mainly attributable to an increase in clinical and manufacturing costs associated with the completion of clinical trial enrollment for the CHS-0214 Phase 3 studies, the enrollment of CHS-1701 BLA-enabling studies and the initiation of CHS-1420 Phase 3 study in psoriasis.
General and administrative (G&A) expenses for the third quarter 2015 were $10.2 million, compared to $4.0 million for the same period in 2014. G&A expenses for the nine months ended September 30, 2015 were $25.1 million, as compared to $11.4 million for the same period in 2014. Increases in G&A expenses over the same periods were mainly attributable to increased employee-related expenses, increased legal and accounting services in support of being a public company and increased patent legal expenses related to the prosecution of patent filings.
Net loss attributable to Coherus for the third quarter 2015 was $71.3 million, or $1.86 per share, compared to $7.9 million, or $1.79 per share, for the same period in 2014.
Cash and cash equivalents totaled $153.7 million at September 30, 2015 compared to $206.1 million as of June 30, 2015, and $150.4 million at December 31, 2014.
Anticipated Near Term Milestones
| • | CHS-1701 (pegfilgrastim biosimilar): File 351(k) BLA in the U.S. in the first quarter of 2016; expect to finalize commercialization strategy in the first half of 2016. |
| • | CHS-1420 (adalimumab biosimilar): Initiate PK bioequivalence bridging study by the end of the first half of 2016 with Phase 3 drug material; file BLA in the U.S. in the second half of 2016. |
| • | CHS-0214 (etanercept biosimilar): Expect to initiate additional studies in mid-2016 to provide comparative PK data on the CHS-0214 drug material used in the Phase 3 studies, the CHS-0214 drug material intended for commercial use, and Enbrel manufactured in Europe; expect to file a Marketing Authorization Application (MAA) in the E.U. in late 2016. |
Conference Call Information
When: November 9, 2015, 1:30 p.m. PT
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID: 69284641
Webcast: http://investors.coherus.com
Please join the conference call at least 10 minutes early to register.
The webcast of the conference call will be available for replay through November 24, 2015.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products. For additional information, please visit www.coherus.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities, expectations, projections, goals, objectives, milestones, strategies, product pipeline, clinical studies, product development, release of data and the potential benefits of its products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ expectations regarding its ability to advance its CHS-1701, CHS-0214 and CHS-1420 biosimilar drug candidates, and initiate and complete the PK bioequivalence bridging study for CHS-1420, complete its BLA-enabling studies for CHS-1701, file BLAs for CHS-1701 and CHS-1420 in the U.S., file an MAA for CHS-0214 in the E.U., obtain any favorable outcome in connection with its petition for IPR, and receive milestone payments under its collaboration agreement with Baxalta. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed with the Securities and Exchange Commission on August 10, 2015, and its future periodic reports to be filed with the Securities and Exchange Commission.
Enbrel® and Neulasta® are registered trademarks of Amgen Inc.
HUMIRA® is a registered trademark of AbbVie Inc.
Coherus BioSciences, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2015 | 2014 | 2015 | 2014 | |||||||||||||
| (unaudited) | (unaudited) | |||||||||||||||
| Revenue: |
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| Collaboration and license revenue |
$ | 7,167 | $ | 15,620 | $ | 19,843 | $ | 23,168 | ||||||||
| Collaboration and license revenue - related party (1) |
— | 432 | — | 1,445 | ||||||||||||
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| Total revenue |
7,167 | 16,052 | 19,843 | 24,613 | ||||||||||||
| Operating expenses: |
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| Research and development |
68,218 | 18,496 | 161,629 | 51,357 | ||||||||||||
| General and administrative |
10,166 | 3,979 | 25,074 | 11,378 | ||||||||||||
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| Total operating expenses |
78,384 | 22,475 | 186,703 | 62,735 | ||||||||||||
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| Loss from operations |
(71,217 | ) | (6,423 | ) | (166,860 | ) | (38,122 | ) | ||||||||
| Interest expense |
(33 | ) | (1 | ) | (33 | ) | (3,900 | ) | ||||||||
| Other expense, net |
(235 | ) | (1,490 | ) | (4,465 | ) | (16,132 | ) | ||||||||
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| Net loss |
(71,485 | ) | (7,914 | ) | (171,358 | ) | (58,154 | ) | ||||||||
| Net loss attributable to non-controlling interest |
151 | 42 | 489 | 155 | ||||||||||||
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| Net loss attributable to Coherus |
$ | (71,334 | ) | $ | (7,872 | ) | $ | (170,869 | ) | $ | (57,999 | ) | ||||
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| Net loss per share attributable to Coherus, basic and diluted |
$ | (1.86 | ) | $ | (1.79 | ) | $ | (4.68 | ) | $ | (13.62 | ) | ||||
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| Weighted-average number of shares used in computing net loss per share attributable to Coherus, basic and diluted |
38,426,734 | 4,409,703 | 36,510,756 | 4,258,770 | ||||||||||||
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| (1) | Represent revenue from Daiichi Sankyo Company, a holder of more than 10% of our common stock until the closing of our initial public offering on November 12, 2014. |
Coherus BioSciences, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
| September 30, | December 31, | |||||||
| 2015 | 2014 | |||||||
| (unaudited | ) | |||||||
| Assets |
||||||||
| Cash and cash equivalents |
$ | 153,691 | $ | 150,392 | ||||
| Other assets |
48,621 | 36,829 | ||||||
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| Total assets |
$ | 202,312 | $ | 187,221 | ||||
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| Liabilities and Stockholders’ Equity |
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| Deferred revenue |
62,295 | 62,699 | ||||||
| Other liabilities |
99,977 | 57,765 | ||||||
| Total stockholders’ equity |
40,040 | 66,757 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 202,312 | $ | 187,221 | ||||
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CONTACT:
Keith Vendola, M.D.
Investor Relations
Coherus BioSciences, Inc.
kvendola@coherus.com
+1 (650) 437-6239
Exhibit 99.2
Coherus and Baxalta Announce CHS-0214 (Investigational Etanercept Biosimilar)
Met Primary Efficacy Endpoints in Phase 3 Psoriasis Clinical Study (RaPsODY)
REDWOOD CITY, Calif. & BANNOCKBURN, Ill., November 9, 2015 — Coherus BioSciences, Inc. (NASDAQ: CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoints in a confirmatory, double-blind, randomized, controlled, two-part Phase 3 study. This on-going 52-week study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel® in patients with moderate-to-severe chronic plaque psoriasis.
“We are pleased with this positive clinical outcome,” said Barbara Finck, M.D., Chief Medical Officer of Coherus. “CHS-0214 is an important option for patients requiring treatment with etanercept. If approved by regulatory agencies, CHS-0214 has the potential to offer patients a high-quality treatment option for conditions for which etanercept is indicated.”
“Achievement of this late-stage clinical milestone further validates the capabilities of our development platform in advancing biosimilar compounds toward approvals within regulated markets,” said Denny Lanfear, President and Chief Executive Officer of Coherus.
The efficacy endpoints were based on a Week 12 assessment of Psoriasis Activity Severity Index (PASI) scores. At Week 12, the primary endpoints, the mean percent change in PASI from baseline and the proportion of subjects achieving 75% improvement in PASI from baseline, were within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel®. There were no clinically meaningful differences in the safety profiles of the products.
“We are encouraged by the data from this confirmatory study,” said Dagmar Rosa-Björkeson, Executive Vice President and President, Biosimilars, Baxalta. “Plaque psoriasis has a significant impact on a patient’s quality of life and self-perception, so early access to treatment is imperative. If approved, CHS-0214 would expand access of treatment options for patients with moderate-to-severe chronic plaque psoriasis.”
The study continues as planned until Week 52. The psoriasis study is one of two, large, Phase 3 confirmatory trials intended for inclusion in global marketing applications for CHS-0214. Results for the second Phase 3 study in patients with rheumatoid arthritis are expected in the first quarter of 2016.
Coherus and Baxalta initiated a collaboration to develop and commercialize CHS-0214 in September of 2013.
About CHS-0214, a proposed biosimilar of Enbrel® (etanercept)
CHS-0214 was evaluated in two comprehensive single-dose, cross-over pharmacokinetic / bioequivalence (PK / BE) studies in healthy volunteers. In both trials, CHS-0214 met PK similarity to Enbrel® based on pre-specified pharmacokinetic criteria. The safety profiles of CHS-0214 and Enbrel® were similar in these studies.
About Coherus BioSciences, Inc.
Coherus is a leading pure-play global biosimilar platform company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products. For additional information, please visit www.coherus.com.
Forward Looking Statement For Coherus
To the extent that statements contained in this press release are not descriptions of historical facts regarding Coherus, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the ability of Coherus to obtain regulatory approval from the FDA for CHS-0214, its ability to submit a 351(k) (biosimilar) license application for CHS-0214 on its desired timeline and the potential benefits of CHS-0214. Such forward-looking statements involve substantial risks and uncertainties that relate to future events and the actual results could differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the biosimilar development process, including the regulatory approval process, the timing of the actions of regulatory bodies and other governmental authorities, clinical results, changes in laws and regulations, product quality or supply for CHS-0214 and Enbrel®, patient safety and patent litigation. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see the company’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2015.
About Baxalta
Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide.
Forward Looking Statement For Baxalta
This release includes forward-looking statements concerning Baxalta’s collaboration with Coherus on CHS-0214, including expectations with regard to future regulatory actions and potential impact on patients. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta’s control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: clinical trial results; satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta’s Registration Statement on Form 10 and other Securities and Exchange Commission filings, all of which are available on Baxalta’s website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.
Enbrel® is a registered trademark of Amgen Inc.
COHERUS INVESTOR AND MEDIA CONTACT:
Keith Vendola, M.D.
kvendola@coherus.com
+1 (650) 437-6239
BAXALTA INVESTOR CONTACT:
Mary Kay Ladone
mary.kay.ladone@baxalta.com
+1 (224) 948-3371
Lorna Williams
lorna.williams@baxalta.com
+1 (224)-948-3511
BAXALTA MEDIA CONTACT:
Albert Liao
media@baxalta.com
+1 (617) 834-9285