BeiGene Reports Third Quarter 2017 Financial Results

CAMBRIDGE, Mass. and BEIJING, China, November 13, 2017 (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 reported business highlights and financial results for the third quarter and first nine months of 2017.

“BeiGene has achieved several important milestones since the beginning of the third quarter.  Our strategic collaboration with Celgene Corporation has transformed us into a commercial-stage company in China and is expected to enhance the potential of our investigational PD-1 inhibitor, BGB-A317. We have also made important clinical progress with the expansion of the global pivotal program for our BTK inhibitor BGB-3111, the initiation of the first Phase 3 study for BGB-A317 in China, and the completion of patient enrollment of our first China pivotal trials for both BGB-3111 and BGB-A317.  In addition, we strengthened our balance sheet with the upfront payment and investment from Celgene as well as our public offering in August,” said John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

“Looking ahead, we plan to present additional data on BGB-3111 at the 59 th American Society of Hematology Annual Meeting in December. We also look forward to initiating additional pivotal trials for our portfolio assets in the coming months,” commented Mr. Oyler.

Third Quarter 2017 and Recent Business Highlights

Clinical Programs:

BGB-3111 ,  an investigational small molecule inhibitor of Bruton’s tyrosine kinase (BTK)

BGB-A317 ,  an investigational humanized monoclonal antibody against the immune checkpoint receptor PD-1

BGB-290 ,  an investigational small molecule PARP inhibitor

Corporate Development:

Expected Upcoming Milestones

BGB-3111 (BTK Inhibitor)

BGB-A317 (PD-1 Antibody)

BGB-290 (PARP Inhibitor)

Third Quarter 2017 Financial Results

Cash, Cash Equivalents, and Short-Term Investments  were $757.44 million as of September 30, 2017, compared to $407.43 million as of June 30, 2017 and $368.17 million as of December 31, 2016.  The increase in the quarter was primarily attributable to the Celgene strategic collaboration. Funding from Celgene includes upfront licensing fees of $263.00 million, $92.05 million of which was received as of September 30, 2017 and the rest of which is payable in the fourth quarter of 2017, and an equity investment of $150.00 million. In addition, net proceeds from our August 2017 follow-on public offering contributed $188.52 million, after deducting underwriting discounts and offering-related expenses.  These were partially offset by cash used in operating activities and for capital expenditures during the three months ended September 30, 2017.

The Company consolidates the BeiGene Biologics joint venture in its consolidated financial statements. As of September 30, 2017, cash, cash equivalents and short-term investments included  $141.64 million of cash held by BeiGene Biologics. 

Cash provided by operations for the three months ended September 30, 2017 was $6.60 million, compared to a use of cash of $24.28 million for the same period in 2016.  The increase in cash flow from operating activities was primarily attributable to upfront licensing fees of the Celgene collaboration, which offset increased research and development (R&D) and selling, general and administrative (SG&A) expenses in the period. Capital expenditures for the quarter ended September 30, 2017 were $18.79 million, including $13.94 million attributable to BeiGene Biologics, compared to $6.68 million for the same period in 2016. The increase was primarily attributable to increased investment in our manufacturing facilities in Guangzhou and Suzhou.  

Revenue  for the three months ended September 30, 2017 was $220.21 million, compared to nil in the same period in 2016, and was comprised of $8.82 million of net product revenue and $211.39 million of collaboration revenue. The product revenues represent net product sales of Abraxane and

Revlimid in China following the effective date of the Celgene transaction, August 31, 2017. The collaboration revenue recognized in the period relates to the upfront fee allocated to the BGB-A317 license element of the arrangement.

R&D Expenses  for the three months ended September 30, 2017 were $87.66 million, compared to $30.11 million in the same period in 2016. The increase was primarily attributable to increased spending on clinical activities and manufacturing for BGB-3111, BGB-A317, and BGB-290 due to expansion of ongoing clinical programs and   increased employee compensation-related expenses as a result of increased headcount to support a broader clinical program. R&D-associated share-based compensation expense was $10.38 million for the three months ended September 30, 2017, compared to $2.14 million for the same period in 2016, primarily due to increased headcount, higher share price, and increased expense attributable to non-employee consultant awards. 

SG&A Expenses  for the three months ended September 30, 2017 were $15.64 million compared to $4.72 million in the same period in 2016. The increase was primarily attributable to increased employee compensation-related expenses as a result of increased headcount, including personnel costs for the employees transferred from Celgene China and higher share price as well as higher professional service fees, including legal, finance and accounting fees related to the Celgene transaction, patent prosecution activities and costs to support our growing operations. In addition, SG&A-associated share-based compensation expense was $2.95 million for the three months ended September 30, 2017, compared to $0.64 million for the same period in 2016.

Net Income  attributable to BeiGene, Ltd. for the three months ended September 30, 2017 was $117.39 million compared to a net loss of $35.49 million in the same period in 2016.

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 700 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. i  

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding BeiGene’s financial condition; results of operations and business outlook; the momentum of its business, as well as the advancement of, and anticipated clinical development and regulatory milestones and plans related to BeiGene’s drug candidates and clinical trials, including commencing new trials and providing data readouts and updates for its drug candidates. Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including risks related to BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials and to manufacture its products and product candidates; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's

subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law.

Investor/Media Contact

Lucy Li, Ph.D.

+1 781-801-1800

ir@beigene.com

media@beigene.com 

___________________________

i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation.

BeiGene Expands Global Pivotal Program for BTK Inhibitor BGB-3111

CAMBRIDGE, Mass., and BEIJING, China, November 13, 2017 (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 the initiation of  two  new global pivotal clinical trials of BGB-3111, an investigational Bruton’s Tyrosine Kinase (BTK) inhibitor, including a Phase 3 trial of BGB-3111 in previously untreated patients with CLL/SLL and a pivotal Phase 2 trial of BGB-3111 in combination with GAZYVA® (obinutuzumab) in patients with relapsed or refractory FL. Along with a global Phase 3 trial comparing BGB-3111 to ibrutinib in Waldenström’s macroglobulinemia (WM), initiated in early 2017, BGB-3111 is now being evaluated in   global pivotal trials in three distinct indications. Additionally, BGB-3111 is being evaluated in a broad pivotal clinical development program in China, including ongoing pivotal Phase 2 trials in MCL, CLL, and WM, which was initiated in August 2017. BeiGene also announced today that enrollment in the pivotal Phase 2 trial of BGB-3111 in China in MCL patients was completed in September 2017.

“The initiation of two additional pivotal trials expands our global registration-directed clinical development of BGB-3111 to additional indications, including patients with

follicular lymphoma, a common B cell malignancy for which BTK inhibitors are not yet approved. We look forward to continuing the development of BGB-3111 as a potentially best-in-class BTK inhibitor for patients worldwide who suffer from hematological malignancies,” commented John V. Oyler, Founder, Chief Executive Officer, and Chairman of BeiGene.

“We believe that these two new pivotal trials are supported by our growing clinical experience with BGB-3111, in which over 600 patients have been dosed to date. With the newly initiated Phase 3 CLL/SLL trial, we aim to investigate whether BGB-3111 could be an effective treatment option for a broad population of CLL/SLL patients requiring initial treatment. The initiation of the pivotal trial in follicular lymphoma is an effort to determine whether the combination of BGB-3111 and obinutuzumab represents an effective treatment option for a high-unmet-need population of relapsed or refractory patients to potentially support the pursuit of accelerated or conditional approval of this regimen,” commented Jane Huang, M.D., Chief Medical Officer, Hematology.

Trial Design 

The Phase 3 trial in CLL/SLL is designed to compare BGB-3111 to BR and will be conducted in North America, Europe, Australia, New Zealand, and Asia. The study will enroll previously untreated CLL/SLL patients ineligible for intensive chemo-immunotherapy (i.e., fludarabine, cyclophosphamide, and rituximab), who will be divided into two cohorts. The first cohort is designed to include 420 patients without a 17p deletion (del17p),  who will be randomized in a 1:1 ratio to receive either BGB-3111 until progression or six cycles of BR. Crossover will be allowed in the BR arm upon progression. The primary endpoint will be progression-free survival (PFS), and secondary endpoints include overall response rate (ORR), duration of response (DOR), overall survival (OS), and patient-reported outcomes. Patients with del17p will be enrolled in a second cohort to receive BGB-3111 until progression and will be assessed for response and safety.

The pivotal Phase 2 trial in FL is designed to evaluate  BGB-3111 in combination with obinutuzumab in patients who have had at least two prior lines of therapy and who progressed within 12 months of their last treatment or were refractory to their last treatment. The primary endpoint will be ORR and obinutuzumab monotherapy will be included as a comparator, in order to evaluate the contribution of BGB-3111. The trial is expected to enroll approximately 210 patients in North America, Europe, Australia, and New Zealand who will be randomized 2:1 to receive either BGB-3111 with obinutuzumab or obinutuzumab alone. Patients in the obinutuzumab arm will have the option to add BGB-3111 after 12 months if a response has not been achieved. Secondary endpoints of the study include DOR, PFS, OS, and time to response.

About BGB-3111

BGB-3111 is a potent and highly selective investigational small molecule inhibitor of BTK. BGB-3111 has demonstrated higher selectivity against BTK than ibrutinib, a BTK inhibitor currently approved by the U.S. Food and Drug Administration and the European Medicines Agency, based on biochemical assays, higher exposure than ibrutinib based on their respective Phase 1 experience in separate trials, and sustained 24-hour BTK occupancy in both the peripheral blood and lymph node compartments.

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 700 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. i

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the encouraging clinical data of BGB-3111 and BeiGene’s advancement of, and anticipated clinical development and regulatory milestones and plans related to BGB-3111.  Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeiGene's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; BeiGene's ability to achieve market acceptance in the medical community necessary for commercial success; BeiGene's ability to obtain and maintain protection of intellectual property for its technology and drugs; BeiGene's reliance on third parties to conduct preclinical studies and clinical trials; BeiGene’s limited operating history and BeiGene's ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates, as well as those risks more fully discussed in the section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeiGene's subsequent filings with the U.S. Securities and Exchange Commission.  All information in this press release is as of the date of this press release, and BeiGene undertakes no duty to update such information unless required by law. 

Investor/Media Contact

Lucy Li, Ph.D.

+1 781-801-1800

ir@beigene.com

media@beigene.com

____________________________

i ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation.