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):
January 16, 2018
BEIGENE, LTD.
(Exact name of registrant as specified in its charter)
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Cayman Islands
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001-37686
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98-1209416
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(State or other jurisdiction
of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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c/o Mourant Ozannes Corporate Services (Cayman) Limited
94 Solaris Avenue, Camana Bay
Grand Cayman KY1-1108
Cayman Islands
(Address of principal executive offices) (Zip Code)
+1 (345) 949 4123
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
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Item 2.02
Results of Operations and Financial Condition.
On January 16, 2018, BeiGene, Ltd. (the “Company”) filed with the Securities and Exchange Commission (“SEC”) a preliminary prospectus supplement (the “Preliminary Prospectus Supplement”) pursuant to Rule 424(b)(5) under the Securities Act of 1933, as amended (the “Securities Act”), relating to a proposed underwritten public offering (the “Offering”) of American Depositary Shares (“ADSs”) of the Company, each representing 13 ordinary shares, par value $0.0001 per share, pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-218301). The Company disclosed in the Preliminary Prospectus Supplement for the Offering that it expects that, as of December 31, 2017, the Company’s cash and cash equivalents and short-term investments were between $835 million and $840 million. The Company’s independent registered public accountants have not audited, reviewed or performed any procedures with respect to this financial data and accordingly do not express an opinion or any other form of assurance with respect thereto. This amount could change as a result of further review.
The information in Item 2.02 of this Current Report on Form 8-K is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01
Other Events.
Commencement of Underwritten Public Offering
On January 16, 2018, the Company issued a press release announcing the commencement of the Offering. The Company intends to offer and sell $650 million of its ADSs, before underwriting discounts and commissions and estimated offering expenses. In addition, the Company also announced its intention to grant the underwriters a 30-day option to purchase up to an additional $50 million of the ADSs at the public offering price, less underwriting discounts and commissions. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
This Current Report on Form 8-K, including the exhibits hereto, shall not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company, which is being made only by means of a written prospectus meeting the requirements of Section 10 of the Securities Act, nor shall there be any sale of the Company’s securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
Business Updates
The Preliminary Prospectus Supplement for the Offering contains an updated description of certain aspects of the Company’s business as well as updated Company risk factor disclosure. Accordingly, the Company is filing this information for the purpose of supplementing and updating the business and risk factor disclosures contained in its prior public filings. The updated disclosures are filed herewith as Exhibit 99.2 to this Current Report on Form 8-K and are incorporated herein by reference.
The Company is providing a presentation to prospective investors in the Offering. A copy of the presentation is attached as Exhibit 99.3 to this Current Report on Form 8-K and incorporated herein by reference.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits.
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Exhibit No.
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Description
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99.1
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Press release entitled “BeiGene Announces Proposed Public Offering” issued by BeiGene, Ltd. on January 16, 2018
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99.2
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Updated Company Disclosure
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99.3
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BeiGene, Ltd. presentation dated January 16, 2018
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2
Forward Looking Statements
This Current Report on Form 8-K and certain of the materials filed or furnished herewith contain forward-looking information about the Company within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein and therein which do not describe historical facts, including, among others, statements relating to the Company’s expectations regarding its cash and cash equivalents and short-term investments as of December 31, 2017; the Company’s expectations regarding the completion, timing and size of the Offering; the Company’s expectations with respect to granting the underwriters a 30-day option to purchase additional ADSs or the underwriters’ exercise of the same; and statements in the materials filed herewith identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, (1) the possibility that the closing conditions will not be met and/or that the parties will be unable to consummate the proposed transaction on the anticipated terms or at all; (2) market conditions; (3) that the cost of the transaction to the Company will be more than planned; and (4) other risks identified in the Company’s SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2016, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 and subsequent filings with the SEC, including this Current Report on Form 8-K. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: January 16, 2018
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BEIGENE, LTD.
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By:
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/s/ Scott A. Samuels
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Name:
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Scott A. Samuels
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Title:
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Senior Vice President, General Counsel
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5
Exhibit 99.1
BeiGene Announces Proposed Public Offering
CAMBRIDGE, Mass. and BEIJING, China, January 16, 2018 (GLOBE NEWSWIRE) — BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced a public offering of its American Depositary Shares (ADSs), each representing 13 of its ordinary shares, par value $0.0001 per share.
BeiGene intends to offer and sell $650 million of its ADSs, before underwriting discounts and commissions and estimated offering expenses. In addition, BeiGene expects to grant the underwriters a 30-day option to purchase up to an additional $50 million of ADSs, less underwriting discounts and commissions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Goldman Sachs & Co. LLC, Morgan Stanley, Cowen, and Leerink Partners are acting as joint book-running managers.
The securities described above are being offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (SEC). A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained for free from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, or email: prospectus-ny@ny.email.gs.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, United States, Attn.: Prospectus Department or by calling 1-631-274-2806; or Leerink Partners LLC, Attention: Syndicate Department, One
Federal Street, 37th Floor, Boston, MA 02110, by telephone at 800-808-7525, ext. 6132 or by email at syndicate@leerink.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.
About BeiGene
BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 850 employees in China, the United States, and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle albumin—bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation.
(1)
Forward-Looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to BeiGene’s expectations regarding the completion, timing and size of the public offering, and its expectations with respect to granting the underwriters a 30-day option to purchase additional ADSs. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include risks and uncertainties related to completion of the public offering on the anticipated terms or at all, market conditions and the satisfaction of customary closing conditions related to the public offering. More information about the risks and uncertainties faced by BeiGene is contained or
(1) ABRAXANE
®
, REVLIMID
®
, and VIDAZA
®
are registered trademarks of Celgene Corporation.
incorporated by reference in the preliminary prospectus supplement related to the public offering filed with the SEC. BeiGene disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
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Investor Contact
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Media Contact
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Lucy Li, Ph.D.
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Liza Heapes
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+1 781-801-1800
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+ 1 857-302-5663
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ir@beigene.com
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media@beigene.com
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Exhibit 99.2
Company Overview
We are a commercial-stage biopharmaceutical company rooted in China that is dedicated to becoming a global leader in the discovery, development and commercialization of innovative, molecularly targeted and immuno-oncology drugs for the treatment of cancer.
We have three internally-developed late-stage clinical drug candidates:
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Zanubrutinib (BGB-3111) — an investigational small molecule inhibitor of Bruton’s tyrosine kinase, or BTK, that is currently being evaluated in a broad registrational clinical program globally and in China as a monotherapy and in combination with other therapies to treat various lymphomas;
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Tislelizumab (BGB-A317) — an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1 that is currently being evaluated in a broad registrational clinical program globally and in China as a monotherapy and in combination with other therapies to treat various solid and hematological cancers; and
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Pamiparib (BGB-290) — an investigational small molecule inhibitor of PARP1 and PARP2 that is being evaluated as a potential monotherapy and in combination for various solid tumors. It is currently in a pivotal clinical trial in China and is expected to enter late-stage development globally in 2018.
In 2017, we entered into a strategic collaboration with Celgene Corporation, or Celgene, in which we granted Celgene exclusive rights to develop and commercialize tislelizumab for solid tumors in the United States, Europe, Japan, and the rest of the world outside of Asia. We retained rights to tislelizumab for solid tumors in Asia (ex-Japan) and for hematological malignancies and internal combinations globally.
In addition, Celgene granted us an exclusive license to market its approved cancer therapies ABRAXANE®, REVLIMID®, and VIDAZA® in China excluding Hong Kong, Macau and Taiwan and also transferred its commercial operations and personnel in China to us in connection with our acquisition of 100% of the equity interests of Celgene Pharmaceutical (Shanghai) Co., Ltd., which has allowed us to generate product revenue in China since September 2017 and which we expect to expand in preparation for the potential launch of our internally developed drug candidates and our other in-licensed drug candidates in China.
As of January 1, 2018, we have a global team of over 850 employees, including more than 400 scientists and clinicians, in China, the United States and Australia. Our offices are located in Beijing; Shanghai; Cambridge, MA; Fort Lee, NJ; and the San Francisco Bay Area, CA; including a research and development center in Beijing, manufacturing sites in Suzhou and Guangzhou, and commercial operations in Shanghai.
The following table summarizes the status of our product portfolio and pipeline as of the date of this prospectus supplement:
Abbreviations: WM = Waldenstrom’s macroglobulinemia; CLL = chronic lymphocytic leukemia; MCL = mantle cell lymphoma; FL = follicular lymphoma; NSCLC = non-small cell lung cancer; HCC = hepatocellular carcinoma; MM = multiple myeloma; HL = Hodgkin’s lymphoma; NHL = non-Hodgkin’s lymphoma; DLBCL = diffuse large B-cell lymphoma; MDS = Myelodysplastic syndrome; AML = acute myeloid leukemia; UC = urothelial carcinoma; CMMoL = chronic myelomonocytic leukemia; 1L/2L/3L = first, second or third line; R/R = relapsed/refractory; ND = newly diagnosed.
* Some indications will not require a non-pivotal Phase 2 clinical trial prior to beginning pivotal Phase 2 or 3 clinical trials.
** Confirmatory clinical trials post-approval are required for accelerated approvals.
(1) Celgene has the right to develop and commercialize tislelizumab in solid tumors in the United States, European Union, Japan and the rest-of-world outside of Asia.
(2) Limited collaboration with Merck KGaA.
(3) Partnership with Mirati Therapeutics, Inc.
Recent Developments
On January 9, 2018, we announced that we had entered into a commercial supply agreement with Boehringer Ingelheim Biopharmaceuticals (China) Ltd., or BI, for tislelizumab, which will be manufactured at BI’s facility in Shanghai.
On January 8, 2018, we announced that we had entered into an exclusive license agreement with Mirati Therapeutics, Inc., or Mirati, for the development, manufacturing and commercialization of Mirati’s investigational tyrosine kinase inhibitor sitravatinib in Asia (excluding Japan), Australia, and New Zealand.
We may be a passive foreign investment company in future taxable years, which may have adverse U.S. federal income tax consequences for U.S. shareholders.
U.S. investors should be aware that we determined that we were a passive foreign investment company, within the meaning of Section 1297 of the Internal Revenue Code of 1986, as amended, or PFIC, for 2016. Based on the composition of our assets and income in 2017, we believe we were not a PFIC for 2017 and based on the expected composition of our assets and income, we do not expect to be a PFIC for 2018. However, as our PFIC status must be determined annually with respect to each taxable year and will depend on the composition and character of our assets and income and the value of our assets (which may be determined, in part, by reference to the market value of our ADSs, which may be volatile) over the course of such taxable year and as we currently hold and expect to continue to hold a substantial amount of cash and cash equivalents, we may be a PFIC in any taxable year. If we are a PFIC for any taxable year during a U.S. shareholder’s holding period of the ADSs or ordinary shares, then, regardless of whether we cease to meet the threshold requirements for PFIC status, such U.S. shareholder generally will be required to treat any gain realized upon a disposition of the ADSs or ordinary shares, or any “excess distribution” received on the ADSs or ordinary shares, as ordinary income earned over the U.S. shareholder’s holding period for the ADSs or ordinary shares, and to pay the applicable taxes on such ordinary income along with an interest charge at the rate applicable to underpayments of tax on a portion of the resulting tax liability. In addition, the U.S. shareholder would be subject to the same adverse U.S. federal income tax consequences on (i) certain distributions by any of our subsidiaries treated as PFICs (“lower-tier PFICs”), and (ii) a disposition of shares of a lower-tier PFIC, in each case as if the U.S. shareholder owned the shares of the relevant lower-tier PFIC directly, even though the U.S. shareholder has not received the proceeds of those distributions or dispositions.
For further information, U.S. shareholders should read the discussion under “Taxation—Material United States Federal Income Tax Considerations—Passive Foreign Investment Company” in the accompanying prospectus. Each U.S. shareholder should consult its own tax advisors regarding the PFIC rules and the U.S. federal income tax consequences of the acquisition, ownership and disposition of the ADSs or ordinary shares.
Risks Related to Obtaining Regulatory Approval for Our Drug Candidates
Our drug candidates may cause undesirable adverse events or have other properties that could interrupt, delay or halt clinical trials, delay or prevent regulatory approval, limit the commercial profile of an approved label, or result in significant negative consequences following any regulatory approval.
Undesirable adverse events, or AEs, caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, CFDA, EMA or other comparable regulatory authority. Results of our trials could reveal a high and unacceptable severity or prevalence of AEs. In such an event, our trials could be suspended or terminated and the FDA, CFDA, EMA or other comparable regulatory authorities could order us to cease further development of, or deny approval of, our drug candidates for any or all targeted indications.
Treatment-related serious adverse events, or SAEs, that have been reported in our monotherapy clinical trials include but not are limited to the following: (i) for BGB-3111, petechiae (spots that appear on the skin as a result of bleeding), purpura (subcutaneous bleeding), bruising, other serious hemorrhage (grade 3 hemorrhage or central nervous system, or CNS, hemorrhage of any grade), atrial fibrillation, diarrhea, haemothorax, colitis, febrile neutropenia, neutropenia, anemia, thrombocytopenia, pneumonia, renal hematoma, urinary tract infection, pneumonitis, leukocytosis, lymphocytosis, toxic epidermal necrolsysis, septic shock, cardiac arrest and headache; (ii) for BGB-A317, colitis, hypotension, diarrhea, diabetes mellitus, diabetic ketoacidosis, dyspnea, hypoxia, pneumonitis, fatigue, alanine aminotransferase, or ALT, increase, aspartate aminotransferase, or AST, increase, gamma-glutamyl transferase, or GGT, increase, autoimmune pancreatitis, back pain, dermatitis, hyperglycaemia, hyperthyroidism, nausea, proteinuria, stomatitis, bilirubin increase, leukopenia, neutropenia, pyrexia, mucosal inflammation and hepatitis; (iii) for BGB-290, anemia, neutropenia, nausea, vomiting, thrombocytopenia, diarrhea, fatigue, neutropenia and acute myeloid leukemia / myelodysplastic syndrome; and (iv) for BGB-283, thrombocytopenia, fatigue, nausea, anemia, neutropenia, vomiting, hepatitis, ALT increase, AST increase, GGT increase, pyrexia, decreased appetite, hypophosphataemia, hand-foot syndrome, hypertension, weight decrease, lymphopenia, leukopenia, and constipation. Some of these events have led to patient death.
In addition, treatment-related SAEs that have been reported in our combination clinical trials include the following: (i) for the BGB-3111 and obinutuzumab combination, neutropenia, thrombocytopenia, pneumonia, infusion-related reaction, and serious hemorrhage, including one report of a grade 3 intracranial hemorrhage SAE, which is possibly drug related, in one Diffuse Large B-Cell Lymphoma patient that caused the patient’s treatment with BGB-3111 to be interrupted; (ii) for the BGB-3111 and BGB-A317 combination, haemolytic anaemia, pneumonia, pneumonitis, anemia, autoimmune encephalitis, dyspnea, ALT increase, GGT increase, infusion-related reaction, peripheral edema, pyrexia, thrombocytopenia, limb abscess, ulcerative keratitis, catheter site hemorrhage, hemolytic transfusion reaction, nausea, lymph gland infection and eczema; and (iii) for the BGB-290 and BGB-A317 combination, nausea, vomiting, hepatitis, ALT increase, AST increase, GGT increase, fatigue, anemia, liver injury, hypophysitis, and neutropenia. Some of these events have led to patient death.
Drug-related AEs or SAEs could affect patient recruitment or the ability of enrolled subjects to complete the trial, and could result in potential product liability claims. Any of these occurrences may harm our reputation, business, financial condition and prospects significantly.
Additionally, if we or others identify undesirable side effects caused by our drugs or any future approved drug candidates, a number of potentially significant negative consequences could result, including:
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we may suspend marketing of the drug;
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regulatory authorities may withdraw approvals or revoke licenses of the drug;
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regulatory authorities may require additional warnings on the label;
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we may be required to develop a REMS for the drug, as is the case with REVLIMID®, or, if a REMS is already in place, to incorporate additional requirements under the REMS, or to develop a similar strategy as required by a comparable regulatory authority;
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we may be required to conduct post-market studies;
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we could be sued and held liable for harm caused to subjects or patients; and
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our reputation may suffer.
Any of these events could prevent us from achieving or maintaining market acceptance of the particular drug or drug candidate, and could significantly harm our business, results of operations and prospects.
Further, combination therapy, such as using our wholly-owned drug candidates as well as third-party products, involves unique AEs that could be exacerbated compared to AEs from monotherapies. These types of AEs could be caused by our drug candidates and could also cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, CFDA, EMA or other comparable regulatory authority. Results of our trials could reveal a high and unacceptable severity or prevalence of AEs.
