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Arbutus Announces Year-End 2016 Financial Results
GlobeNewswire•March 21, 2017
3 HBV Product Candidates in the Clinic in 1Q17
Cash Runway into Late 2018
Company to Host a Corporate Update Conference Call Today at 2:00 PM ET
VANCOUVER, British Columbia and DOYLESTOWN, Pa., March 21, 2017 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (ABUS), an industry-leading Hepatitis B Virus (HBV) therapeutic solutions company, today announced its 2016 financial results and provided a corporate update.
“Arbutus made significant progress in 2016, including demonstrating significant HBsAg reduction in the Phase II trial of ARB-1467,” said Dr. Mark J. Murray, Arbutus’ President and CEO. “We are excited to build on this progress in 2017 with three HBV product candidates in clinical development by the end of 1Q17, continued productivity from our research effort, and additional studies to explore the full potential of ARB-1467 and combining RNAi agents with standard of care in HBV patients.”
Recent Highlights and Developments
ARB-1467 Phase II Cohort 3 in HBeAg+ patients completed dosing in 4Q16, with all patients receiving all three monthly doses of ARB-1467. Data will be presented at EASL.
ARB-1467 Phase II Cohort 4, evaluating bi-weekly dosing, began dosing in 1Q17. Data will be available in 2H17.
ARB-1740 Phase II MAD study began dosing HBV patients in 1Q17. Data will be available in 2H17.
Licensing transaction completed with Alexion Pharmaceuticals, Inc. to access Arbutus' lipid nanoparticle (LNP) delivery technology for use in a single mRNA product candidate. Arbutus will receive upfront and potential milestone payments of over $80 million plus royalties.
Pre-trial injunction granted against Acuitas, preventing Acuitas from sublicensing Arbutus’ LNP technology.
Upcoming Milestones
1Q17: Initiate AB-423 (HBV capsid assembly inhibitor) healthy volunteer clinical study
1H17: Presentation of full data from ARB-1467 Phase II cohorts 1-3
Mid-2017: Phase III results expected for Alnylam’s Patisiran (Arbutus to receive royalties on sales)
2H17: ARB-1467 Phase II Cohort 4 clinical study results
2H17: ARB-1740 multi-dosing patient study results
Financial Results
Cash, Cash Equivalents and Investments
As at December 31, 2016, Arbutus had cash, cash equivalents and restricted investments of $143.2 million, as compared to cash, cash equivalents and short and long-term investments of $191.4 million at December 31, 2015.
On December 27, 2016, the Company secured a $12.0 million loan in support of the build out of newly leased laboratory and office space in Warminster, Pennsylvania. This amount is included in the Company’s cash position.
Net loss
For the year ended December 31, 2016, net loss was $384.1 million ($7.24 per common share) as compared to a net loss of $61.1 million ($1.34 per common share) for 2015. The increase in net loss was primarily due to a $286.3 million impairment of intangible assets and goodwill, net of deferred taxes.
Non-GAAP Net Loss
The non-GAAP net loss for 2016 was $65.8 million ($1.24 loss per common share) as compared to a non-GAAP net loss of $21.6 million ($0.48 loss per common share) for 2015. The non-GAAP net loss has been adjusted to exclude:
a non-cash compensation expense of $32.0 million included in expenses in connection to certain share repurchase provisions related to the merger with Arbutus Inc., described below;
a non-cash net impairment charge related to intangible assets of $148.2 million ($253.2 million less deferred taxes of $105.0 million), described below; and,
a non-cash impairment charge related to goodwill of $138.1 million, described below.
Revenue
Revenue was $1.5 million for 2016 as compared to $24.9 million in 2015.
The revenue generating collaborations with Monsanto and the U.S. Department of Defense were effectively terminated towards the end of 2015. The Dicerna license and collaboration was terminated in November 2016.
At the current time Arbutus does not have any significant revenue generating collaborations but does have ongoing license agreements with Alnylam and Spectrum.
Research, Development, Collaborations and Contracts Expenses
Research, development, collaborations and contracts expenses were $61.3 million in 2016 as compared to $51.5 million in 2015.
R&D expenses increased during 2016 as compared to 2015 as Arbutus increased its spending on the Company’s HBV programs to continue to advance them through the clinic in 2016 when the Company initiated Phase 2 clinical trials for ARB-1467 and prepared to advance AB-423 and ARB-1740 into the clinic. Arbutus also continues to incur incremental costs related to an increase in activities for research and preclinical HBV programs, focusing on advancing the development of candidates to support future clinical combination studies.
R&D compensation expense increased in 2016 as compared to 2015 due to an increase in the number of employees in support of the Company’s expanded portfolio of product candidates. In addition, in the year ended December 31, 2016, the Company incurred a total of $32.0 million of non-cash compensation expense related to the expiry of repurchase rights on shares issued as part of the consideration paid for the merger with Arbutus Inc. of which $6.0 million has been included as part of research, development, collaborations and contracts expense, and $26.0 million included as part of general and administrative expense.
General and Administrative
General and administrative expenses were $39.4 million in 2016 as compared to $26.4 million in 2015.
General and administrative expenses increased in 2016 compared to 2015 due largely to a non-cash compensation expense of $26.0 million incurred in 2016 related to the expiry of repurchase rights on shares issued as part of consideration paid for the merger with Arbutus Inc. compared to $11.9 million in 2015. In Q2 2016, the Company incurred an acceleration of incremental non-cash compensation expense due to the expiration of repurchase rights triggered by the departure of two of the four Arbutus Inc. founders.
Impairment of Intangible Assets and Goodwill
For the year ended December 31, 2016, Arbutus recorded a total intangible asset impairment charge of $148.2 million (net of deferred taxes of $105.0 million) and a goodwill impairment charge of $138.1 million. The impairment charge on goodwill and intangible assets did not impact the Company’s liquidity, operating cash flows, or cash runway.
In 2Q16, Arbutus recorded an impairment charge of $91.5 million (net of deferred taxes of $64.8 million) on intangible assets for the discontinuance of the ARB-1598 program in the Immune Modulator drug class as well as a delay of the cccDNA Sterilizer program. In 4Q16, Arbutus completed its annual impairment analysis and recorded a further impairment charge of $56.7 million (net of deferred taxes of $40.2 million) due to a change in management’s estimate of the cost of capital used in the Company’s valuation models to assess the carrying value of goodwill and intangible assets. The change in cost of capital reflects the sustained discrepancy between the Company’s market capitalization and the estimated fair value of its intangible assets. No other changes in assumptions were introduced in the valuation models and the fundamentals of the underlying development programs remain unchanged.
For the year ended December 31, 2015, Arbutus recorded an impairment charge of $22.8 million (net of deferred taxes of $16.2 million) based on the Company’s decision to discontinue the cyclophilin inhibitors program, OCB-030.
The goodwill impairment charge also results from the change in cost of capital estimate in the Company’s valuation models. The remaining goodwill balance is due to the application of deferred taxes in the goodwill impairment calculation, following the complex requirements of the accou |
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发表于 2017-3-21 22:48
