Biogen Inc
NASDAQ:BIIB
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Biogen Inc
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Good morning. My name is Dan, and I will be your conference operator today. At this time, I would like to welcome everyone to the Biogen Third Quarter 2018 Financial Results and Business Update. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]
Thank you. I would now like to turn the conference over to Mr. Matt Calistri, Vice President, Investor Relations. You may begin your conference.
Thank, Dan. Thank you. And welcome to Biogen's third quarter 2018 earnings conference call.
Before we begin, I encourage everyone to go to the Investors section of biogen.com to find the earnings release and related financial tables, including a reconciliation of the GAAP to non-GAAP financial measures that we will discuss today. Our GAAP financials are provided in Tables 1 and 2. Table 3 includes a reconciliation of our GAAP to non-GAAP financial results. We believe non-GAAP financial results better represent the ongoing economics of our business and reflect how we manage the business internally. We have also posted slides on our website that follow the discussions related to this call.
I would like to point out that we will be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and our actual results may differ materially. I encourage you to consult the Risk Factors discussed in our SEC filings for additional detail.
On today's call, I'm joined by our Chief Executive Officer, Michel Vounatsos; Dr. Michael Ehlers, EVP of Research and Development; and our CFO, Jeff Capello. We will also be joined for the Q&A portion of the call by our Chief Medical Officer, Dr. Al Sandrock.
Before I conclude, I would also like to remind everyone, that we now post releases related to earnings call and Investor Events on the Investors section of Biogen's website, www.biogen.com. And issue statement on Twitter when they become available. We do this instead of publishing earnings releases and any releases related to Investor Events and earnings calls via Newswire services. Our Twitter handle is @biogen.
Now, I’ll turn the call over to Michel.
Good morning, everyone, and thank you for joining us.
First, let me begin with some financial highlights. Compared to the same period a year ago, Biogen's third quarter revenues grew 12% to $3.4 billion, third quarter GAAP earnings per share grew 24% to $7.15 and non-GAAP EPS grew 17% to $7.40. We are pleased with this year-over-year double-digit topline and bottom line growth, as we continue to execute on our strategy to solidify our long-term leadership position in neuroscience.
Now let me review the accomplishments we delivered in the third quarter. First, our MS core business including OCREVUS royalties remained stable versus prior year and delivered revenues of $2.3 billion. The number of patients on our MS products globally also remained relatively stable versus the prior year.
In the U.S. we saw increasing trends for both TECFIDERA and TYSABRI on a year-over-year basis. Outside the U.S., we continued to add patients across multiple geographies.
Second, SPINRAZA global revenues grew to $468 million, driven by quarter-over-quarter and year-over-year revenue growth in the U.S. and even greater revenue growth outside the U.S. The number of commercial patients on SPINRAZA increased by approximately 20% from last quarter and we now have close to 6,000 patients on SPINRAZA, including the expanded access program and clinical trials.
In the U.S., we continued making progress with adults. In the third quarter more then 50% of new starts were adults, increasing the number of adult populated patients on SPINRAZA by more then 20% compared to last quarter.
Outside the U.S., the pace of reimbursement for SPINRAZA across multiple geographies lead to meaningful revenue growth with significant revenue contribution not just from Europe, but also from Asia-Pac and Latin America. We have received regulatory approval in five more countries and we have made two more regulatory filings. We also secured formal reimbursement in four additional countries, including Canada and now have formal reimbursement in 28 markets.
We were very proud to announce new data from the NURTURE study of SPINRAZA of the 25 presymptomatic infants with genetically diagnosed SMA that was treated with SPINRAZA, many were achieving milestones consistent with normal development. All the patients were alive without ventilation and able to sit without support. 22 patients or 88% were able to walk either with assistance or independently and 88% was normal bullbar function.
We believe the long-term data we are generating across a broad patient populations underscore the compelling efficacy profile of SPINRAZA. This is the kind of innovation and progress that inspires us to tackle some of the most difficult and challenging disease areas within neuroscience.
Third, we continue to develop our neuroscience pipeline as we look to prioritize our investments towards areas with highest probability of success, while building depth in core areas of expertise.
Within MS and neuroimmunology we are working to expand our long-term leadership position, and this quarter we completed enrolment of the Phase 2 trial of Opicinumab, a potential remyelination therapy.
Along with Eisai we are presenting data this week for our industry leading Alzheimer's disease portfolio at the CTAD meeting in Barcelona. We are building for the depth in neuromuscular diseases with initiation of a Phase 1 trial of BIIB078, an ASO targeting C9ORF72 the most common genetic cause of ALS and we continue to be optimistic about the potential for BIIB067 targeting SOD-1 for ALS.
We are making notable progress in movement disorders having completed enrolment in the Phase 2 first of BIIB092, an anti-tau antibody, in progressive supranuclear palsy or PSP. BIIB092 has been granted fast-track designation from the FDA. We also continue to advance BIIB054 in Phase 2 for Parkinson's disease.
Within our emerging growth area of acute neurology we dosed the first patient in our Phase 3 trial of BIIB093, a first-in-class IV glibenclamide for large hemispheric infarction. And beyond our neuroscience pipeline we initiated a Phase 2b trial of BG11 in idiopathic pulmonary fibrosis. Mike, will provide more details on the development across our entire pipeline.
Our biosimilar business grew revenues to $135 million, which represents 33% growth year-over-year. We believe that there are now more than 100,000 patients treated with our biosimilars in Europe.
Last week we launched IMRALDI, our adalimumab biosimilar referencing HUMIRA. With an originator market of approximately $4 billion per year in Europe. IMRALDI is now available in several European markets, with IMRALDI we are now able to offer biosimilars of the three main anti-TNFs, providing physicians with more options to meet the needs of patients.
We believe the significant savings from biosimilars in European markets can create headroom for innovative therapies. As a reminder, we exercised our option to own approximately 49.9% of the Samsung Biopis joint venture and we expect this transaction to close by the end of the year.
Importantly, our cash generation remains very strong and continue to provide us with significant optionality and flexibility to allocate capital. Since the beginning of the year, we have completed five business development deals and repurchased 10.5 million shares.
During the third quarter, we generated $1.7 billion in cash flow from operations. We continue to diligently evaluating opportunities for potential business development and M&A and our board has authorized a $3.5 billion share repurchase program.
As we have demonstrated in the past, we are committed to maximizing returns for shareholders, while continuing to bring innovative therapies to patients, something that demands a thoughtful approach towards all our investment over both the short and the long-term.
In summary, Biogen executed on strategy and continued to deliver noticeable progress. Our core MS business demonstrated resilience. SPINRAZA continued to grow in the U.S. and even more so outside of the U.S. and we remain committed to our goal of being the long-term standard of care in SMA.
We initiated a new study in ALS and completed enrolment of studies in MS and PSP, as we aim to develop our neuroscience portfolio and build depths in our most promising core and emerging growth areas.
We grew our biosimilars business and have launched IMRALDI in Europe. We are actively implementing a leaner and simpler operating model and we generated ample cash as we focus on strategically allocating capital to develop and build depths in our neuroscience portfolio, again with a goal of maximizing shareholder returns and bringing innovative therapies to patients.
I will now turn the call over to Mike for a more detailed update on our recent progress in R&D.
Thank you, Michel and good morning, everyone. In the third quarter we made important progress across our differentiated neuroscience pipeline, including our industry leading Alzheimer's disease portfolio.
So I'm delighted today to review advances we made across our core and emerging growth areas, as we prioritize our activities and build depth in our most promising programs in disease areas.
Starting with Alzheimer's disease and dementia. This week we are presenting data at the Clinical Trials and Alzheimer's Disease meeting or CTAD on the safety and efficacy of aducanumab, our monoclonal antibody of the binds soluble and insoluble aggregated forms of beta amyloid, including oligomers, protofibrils and fibrils.
These presentations will include a 36 month analysis of the aducanumab titration dosing regimen and a 48 month analysis of the fixed dose cohort both from the long-term extension of the Phase 1b PRIME study of patients with early Alzheimer's disease.
The results are generally consistent with the previous interim analyses and there were no changes to the risk benefit profile of aducanumab. Live webcasts of our oral presentations, as well as an investor Q&A call will be available on the Investor section of our website.
Also at CTAD, our collaborator Eisai will present a clinical and biomarker updates from the Phase 2 study of BAN2401. These results will be presented in an oral session at CTAD and a live webcast of the presentation will be available on Eisai’s website.
Additionally, Eisai will present safety and efficacy data from the Phase 2 study of elenbecestat, a small molecule base inhibitor being evaluated in two Phase 3 studies in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease.
In parallel to advancing Phase 3 clinical development aducanumab, we are also planning to initiate EVOLVE, a Phase 2 study designed to assess the clinical relevance of asymptomatic amyloid related imaging abnormality or ARIA. Aducanumab has been generally well tolerated in patients with Alzheimer's disease with ARIA being the primary safety and tolerability finding.
The goal of EVOLVE is to test the hypothesis in a prospectively design study that continuation of dosing with aducanumab in the absence of symptoms does not have clinically impactful safety outcomes. We expect this study to begin by the end of the year.
Beyond beta amyloid, we are advancing a number of assets targeting tau, which we believe plays an important and complementary role in Alzheimer's disease pathogenesis. Specifically, we continue to advance BIIB076 and BIIB092 both anti-tau antibodies, as well BIIB080, an antisense oligonucleotide targeting tau production. We expect full data from the Phase 1 study of BIIB076 in early 2020.
Turning to MS and neuroimmunology. This quarter we completed enrolment of FFINITY, a 72 week Phase 2b study of opicinumab as an add-on therapy to disease modifying therapies for relapsing remitting multiple sclerosis.
Opicinumab is a first-in-class human monoclonal antibody directed against LINGO-1 and is being evaluated to determine its potential for improving pre-existing disability in relapsing MS patients through remyelination. Enrolment of FFINITY was completed approximately seven months ahead of schedule and we expect data in mid 2020.
We continue to advance diroximel fumarate or BIIB098 in collaboration with Alkermes, as a new oral option that may provide benefit to many MS patients. We are currently enrolling patients in Part B of the head-to-head tolerability study versus TECFIDERA with data expected in mid 2019.
This study is employing an adaptive trial design in which results from Part A are used to inform Part B and we have used this approach to update the endpoints and increase the sample size by 80 patients to 500. In parallel, Alkermes expects to submit the NDA for BIIB098 to the FDA by the end of this year, potentially positioning us for U.S. approval by early 2020.
We are committed to expanding our leadership position in multiple sclerosis and we believe the next generation fumarate is an important part of our strategy. Earlier this month, Biogen presented data in over 70 oral and poster presentations at the 34th Congress of the European Committee for treatment and research in MS or ECTRIMS in Berlin. Key updates included results from the ENDORSE study, which demonstrate that the clinical benefits of TECFIDERA in newly diagnosed patients were maintained throughout nine years of continuous treatment.
Additionally, an analysis from the TYSABRI observational programs reinforced the long-term safety and consistent effectiveness of TYSABRI over 10 years. We also presented data on serum neurofilament light or NfL, as a biomarker of disease activity in MS.
Data indicated that serum NfL levels above a certain threshold were associated with gadolinium lesion count and new T2 lesion development. The number of patients with serum NfL levels above this threshold was significantly decreased following treatment with disease modifying therapies, particularly TYSABRI.
Turning to our progress in movement disorders. This quarter we completed enrolment of a Phase 2 study of our anti-tau antibody BIIB092 for the treatment of progressive Supranuclear Palsy, a rare and devastating neurodegenerative disease in which tau pathology is believed to be the primary driver of neurodegeneration. BIIB092 has been granted fast track designation by the FDA and results from this 52 week study are expected in the second half of next year.
Combined with our potentially best-in-class anti-alpha-synuclein antibody BIIB054 which is actively enrolling in a Phase 2 study for Parkinson's disease, we are leveraging our core neuroscience expertise to build depth in movement disorders.
We also see strong R&D momentum within neuromuscular disorders. We continue to build on the growing body of clinical evidence for SPINRAZA as the standard-of-care and spinal muscular atrophy.
Earlier this month at the Annual Congress of the World Muscle Society, we presented new interim results from NURTURE, an ongoing open label single arm efficacy and safety study of SPINRAZA in pre symptomatic infants with genetically diagnosed SMA.
As of May, all patients in the study were alive and none required tracheostomy or permanent ventilation. 22 of 25 participants were able to walk either with assistance or independently according to the motor milestones standard of the World Health Organization and all were able to sit without support.
Additionally, assessment of bullbar function revealed that 22 of 25 patients achieved a maximal score on the Hammersmith Infant Neurological Examination Section 1 evaluation of the ability to suck and swallow.
Participants were also evaluated for motor function using the CHOP INTEND scale, out of a maximum of 64 points, mean CHOP INTEND scores were 62.6 per study participants with three copies of the SMN2 gene and 61.0 for those with two copies of the gene.
We believe these data underscore the unprecedented efficacy profile of SPINRAZA as the standard-of-care in SMA with many patients achieving milestones consistent with normal development. We estimate that the majority of the treatable infant population is already being treated with SPINRAZA across multiple geographies.
In our efforts to support the broad use of SPINRAZA, we are working with the SMA community to enable intrathecal dosing for patients with scoliosis or spinal fusions. We have seen meaningful progress in the field, including a recent publication out of Phoenix Children's Hospital outlining a potential treatment paradigm to those patients with complex spines.
This site noted the successful administration of 104 doses amongst 26 children with 100% technical success, utilizing techniques such as imaging directed injection or catheter placement for patients with complex spines.
We are highly encouraged by the strong response to the SMA a clinical community and excellent outcomes that have been achieved to make intrathecal delivery a routine procedure for SMA patients.
Today, we estimate there have been over 30,000 injections of SPINRAZA performed globally and we believe intrathecal injections may become widely used for severe neurological diseases beyond SMA.
As previously communicated, the IND for our SMA gene therapy program is currently on clinical hold in the US. Through additional interactions with the FDA, we have learned that the agency has questions regarding our preclinical data package. We are disappointed with these developments and we are currently assessing options to determine the extent to the viable [ph] path forward.
Beyond SMA, we continue to progress our Phase 1 study of BIIB067 in ALS patients who harbor mutations in superoxide dismutase 1 or SOD1. The genetic cause of familial ALS. BIIB067 is an antisense oligonucleotide designed to directly target and reduce SOD1 expression.
In addition to BIIB067, we have expanded clinical development within genetically defined subpopulations of ALS patients as we build depth in this indication. In collaboration with Ionis, this quarter we dosed the first patient in the Phase 1 trial of BIIB078, an antisense oligonucleotide designed to selectively target hexanucleotide repeat expansion in the chromosome 9 open reading frame 72 gene or C9ORF72, the most common genetic cause of ALS.
BIIB078 selectively target C9ORF72 transcripts that contain hexanucleotide repeat expansions for degradation and may thereby mitigate C9ORF72 mediated pathology. These programs highlight our continued commitment to targeting the genetic origins of severe neurological diseases, including ALS.
Moving to acute neurology. We continue to advance BIIB093, our first-in-class IV glibenclamide therapeutic for the prevention and treatment of cerebral edema associated with large hemisphere infarction.
In the third quarter we dosed the first patient in CHARM, the Phase 3 trial of BIIB093 and we look forward to progressing this novel therapeutic approach in the severe stroke population.
Along with our Phase 2 TMS-007 program, we are encouraged by the potential to advance innovation in this area of significant unmet medical needs. Within neuropathic pain, we recently received the results from the Phase 2b study of vixotrigine or BIIB74 in painful lumbosacral radiculophathy or PLSR.
While the safety data were consistent with the safety profile reported in previous studies, the study did not meet its primary or secondary efficacy endpoints and we will be discontinuing development in this challenging indication. We expect to report more detailed results of this study at a future scientific forum.
We continue to roll a Phase 2 study in small fiber neuropathy. In parallel, we have continued our FDA interactions regarding the design of the potential Phase 3 studies in trigeminal neuralgia. We will delay phase 3 initiation as we await the outcome of these ongoing regulatory interactions, a more detailed review of the PLSR data and insights from the ongoing small fiber neuropathy study.
Outside of our core neuroscience focus, we have continued to advance a small number of legacy programs where the science remains compelling and we believe we can continue to add value.
Earlier today, we announced topline results from a Phase 2b study evaluating the safety and efficacy of dapirolizumab pegol, an anti-CD40 ligand pegylated Fab, in adults with moderately-to-severely active systemic lupus erythematosus despite receiving standard-of-care treatment such as corticosteroids, anti-malarials and non-biological immunosuppressants.
The primary endpoint of the study to demonstrate a dose response at 24 weeks on the British Isles Lupus Assessment Group based Composite Lupus Assessment was not met with a p value of 0.06.
The study did demonstrate consistent and potentially meaningful improvements for the majority of clinical endpoints in patients treated with dapirolizumab pegol compared with placebo.
In addition, biomarker data demonstrated evidence of proof of biology. Dapirolizumab pegol was well tolerated and demonstrated an acceptable safety profile. We continue to further evaluate these data, while assessing potential next steps.
In addition, this quarter we dosed the first patient in the Phase 2b study of BG11 otherwise known as STX-100, a humanized monoclonal antibody directed against the alpha v beta 6 integrin in patients with idiopathic pulmonary fibrosis or IPF.
The primary endpoint of this 52 week study is the yearly rate of change and Forced expiratory Vital Capacity and established measure of pulmonary function in IPF.
BG11 previously demonstrated compelling proof of biology via substantial down regulation of the TGF beta pathway in IPF patients, as measured by inhibition of phosphorylated SMAD and alveolar macrophages isolated by bronchoalveolar lavage.
Overall this quarter, the first patient in a Phase 3 stroke study put [ph] a compelling data supporting SPINRAZA is the standard-of-care in SMA, initiated two new clinical trials completed enrolment in two [ph] Phase 2 studies and continue to make rigorous data driven decisions on clinical development across our portfolio.
Our aim is to continue building a portfolio momentum to realize our vision of being the neuroscience leader and transforming the lives of millions of patients living with neurological diseases.
I will now pass the call to Jeff.
Thanks, Mike. Good morning, everyone. I'll now review our financial performance for the third quarter of 2013 starting with revenues. Total revenues for the third quarter were $3.4 billion, growing 12% year-over-year.
Starting with our MS franchise revenues. Overall our MS business delivered revenues of $2.3 billion in the third quarter of 2018, including OCREVUS royalties for approximate $137 million. MS revenues in the third quarter of 2018 were down 3% versus the per year with OCREVUS royalties and were relatively stable including OCREVUS royalties.
In the U.S., channel inventory levels were relatively stable for TECFIDERA, AVONEX and PLEGRIDY combined. Versus prior year foreign exchange rates and hedging had a minimal impact on ex U.S. MS product revenues for the third quarter.
Global third quarter TECFIDERA revenues were $1.1 billion, a 2% increase versus the prior year. This included revenues of $842 million in the U.S., an increase of 1% versus the third quarter of 2017 and $248 million outside the U.S., an increase of 6% versus the third quarter of 2017.
On a year-over-year basis, TECFIDERA revenues were relatively stable in the U.S. versus the decline we saw in the first and second quarters. In addition, we were very pleased with TECFIDERA’s performance outside the U.S., driven by year-over-year patient growth across each large European market, solid emerging market growth and particularly strong performance in Japan where TECFIDERA has now reached over 25% market share.
Even though trends outside the U.S. were strong, it's important to note that Q3 x U.S. TECFIDERA revenues were negatively impacted by ongoing price decreases in certain European countries.
TYSABRI world wide revenues were $470 million this quarter, relatively stable versus the third quarter 2017. This included $253 million in U.S. and $217 million outside the U.S. In the U.S. revenues declined 5% versus the prior year, primarily due to the launch of OCREVUS.
TYSABRI’s relative performance continues to improve on a year-over-year basis after declining 8% in the second quarter 2018 and 18% in the first quarter of 2018 versus prior year. Outside the U.S., TYSABRI revenues increased 7% versus the prior year.
TYSABRI patients increased in all major European markets versus prior year except for Germany where we have seen a moderate impact from the launch of OCREVUS. TYSABRI also benefited from strong double-digit patient growth in emerging markets.
Interferon revenues including both AVONEX and PLEGRIDY were $590 million from the third quarter, a decrease of 11% versus the third quarter of 2017. This decline was primarily driven by lower volumes, as the market continues to move towards orals and high efficacy therapy's.
Interferon revenues included $421 million in the U.S. and $169 million in sales outside the U.S. Overall, MS revenues, including our royalties on sales of OCREVUS were stable versus prior year.
Moving forward, we expect continued stability through the balance of the year, as we expect the OCREVUS impact to be less significant on a year-over-year basis and we anticipate a moderate inventory channel build in the fourth quarter in the U.S.
Let me now move to SPINRAZA. Global third quarter SPINRAZA revenues were $468 million. This included revenues of $220 formerly in the U.S., representing 9% growth as compared to the second quarter and $244 million outside the U.S., representing 12% growth compared to the second quarter.
The number of patients on therapy in the U.S. increased by over 10%, as compared to the end of the second quarter. Discontinuations remained relatively low and continue to be driven primarily by mortality. We continue to believe there is significant opportunity in adults in the U.S. and are very encouraged by the progress we're making. The number of adults on therapy in the U.S. grew by over 20% versus [ph] the second quarter and in the third quarter are - over half the new patient starts in the U.S. were adults.
In the U.S., we estimate we now have reached approximately 50% of all infants and pediatric patients. And we estimate we've reached approximately 15% of adults, an increase from approximately 10% in the second quarter. We estimate that about a third of our U.S. patients on therapy are now adults.
As a reminder, our data indicate that approximately 5% of the prevalent SMA population are infants, 35% are pediatric patients and 60% are adults, highlighting the large number of untreated adult patients that we believe could benefit from SPINRAZA.
We saw a continued increase in the revenue contribution from maintenance doses this quarter. In U.S. approximately 60% of SPINRAZA units in the third quarter were attributed to maintenance doses, as compared to 55% in the second quarter. In the third quarter the average doses per patient was approximately 1.1, roughly the same as the second quarter.
In the third quarter approximately 15% of U.S. SPINRAZA units were dispensed through our pre-drug program, similar to the second quarter and a decrease from approximately 20% a year ago. We continue to see improved insurance coverage in U.S., as policies broaden their coverage criteria.
We believe the inventory levels for SPINRAZA were relatively flat in the third quarter. We saw an increase in discounts and allowances for approximately 100 basis points versus the second quarter, due primarily to increased treatment through 340B hospitals. If a similar pre-drug percentage is maintained and with continued progress in treating adults, we expect to show stability in U.S. SPINRAZA revenues in the fourth quarter compared to the third quarter, recognizing there may be some seasonal dynamics impacting quarterly revenue trends.
Outside the U.S., the number of commercial SPINRAZA patients increased approximately 29% versus the prior quarter and there are approximately 290 patients active in the expanded access program. We recorded revenues from over 30 international markets with approximately 75% of ex-U.S. SPINRAZA revenue in the third quarter coming from Germany, Italy, Japan, Brazil, Spain, France and Australia.
We continue to believe that the international opportunity for SPINRAZA is even greater than in U.S., as we continued the momentum of the new country launches and we believe there is significant ex-U.S. opportunity not just in Europe, but also in Asia-Pacific and Latin American markets. We expect to see continued revenue growth ex-U.S. for SPINRAZA in Q4, as patient growth continues, although at a more modest rate in more mature markets.
Let me now move onto our biosimilars business, which generated $135 million in revenue this quarter, a 33% increase versus the prior year. We believe that there are now more than 100,000 patients treated with our biosimilars in Europe.
BENEPALI continues to be the market leader in countries such as the U.K., Denmark and Norway and exceeds 40% volume share in Germany, Italy and Sweden. FLIXABI volumes grew by 19% versus the second quarter, mostly in Italy.
Last week we launched IMRALDI, a biosimilar referencing HUMIRA which is now available to several European markets. Overall we expect relatively stable biosimilars revenue in fourth quarter compared to the third quarter.
Turning to our anti-CD20 revenues. We recorded $512 million in third quarter, an increase of 26% versus the prior year, primarily driven by OCREVUS royalties. This includes our estimated OCREVUS royalties of $137 million for the third quarter. It's important to note that typically the fourth quarter with an inventory drawdown for RITUXAN. In addition, we continue to monitor [ph] potential new biosimilar entrants which could begin impacting RITUXAN revenues in 2019.
Total other revenues were $147 million in the third quarter more than three times what we recorded in the third quarter 2017, as we continue to benefit from greater contract manufacturing.
As a reminder, we believe that the fourth quarter of 2017 revenues were abnormally high due the timing of contract manufacturing, creating a difficult comparison for the fourth quarter this year.
Q3 GAAP and non-GAAP gross margin were 87%, a slight decrease from the second quarter due to higher contract manufacturing. Q3 GAAP non-GAAP R&D expense were both 15% of revenue or $580 million [ph] Q3 GAAP SG&A was $498 million and Q3 non-GAAP SG&A was 495 million, both 14% of revenue.
We expect both R&D and SG&A expense to increase in the fourth quarter relative to the third quarter due to the timing of clinical trial expense and market expansion investments, as well seasonality.
GAAP amortization was $282 million, which includes a $189 million impairment related to updates and the development status of [indiscernible] which Mike discussed. The effects of this impairment were partially offset by a $90 billion reduction in our contingent consideration liability.
GAAP other net income was $115 million in the third quarter versus a net expense of $44 million in Q3 of last year. This includes a GAAP only gain of approximately $141 million, related to changes in the fair value of certain equity investments, including shares of Ionis Pharmaceuticals, as of September 30th, 2018.
Non-GAAP other net expense was $26 million in the third quarter versus $44 million in the third quarter of last year. In Q3 our GAAP tax rate was approximately 20% and our non-GAAP tax rate was approximately 21%.
Our weighted average diluted share count in the third quarter was approximately 202 million shares. During the quarter, we did not repurchase any shares of our common stock. However, our board has authorized a new $3.5 billion share repurchase program.
This now brings us to our diluted earnings per share. In the third quarter we booked GAAP earnings per share with $7.15, an increase of 24% versus last year and non-GAAP earnings per share of $7.40, an increase of 17% versus last year.
We generated approximately $1.7 billion of net cash flows from operations in the third quarter. We ended the quarter with approximately $5.7 billion in cash and marketable securities and $5.9 billion in debt.
We believe we have and will continue to have ample capacity to rescue meaningful future business development and M&A activity, as well as return capital to shareholders. We will continue to be disciplined in our approach and focused on value creation.
I’ll now turn the call over to Michel for his closing comments.
Thank you, Jeff. We closed the third quarter with double-digit revenue and earnings growth versus a year ago, an exciting progress across our pipeline. And last week we launched a new biosimilar. Looking forward within the next 12 to 18 months, we expect further progress across our neuroscience pipeline, including Eisai's presentation of the BAN241 data this week at CTAD and assessing next steps.
Data readouts across Alzheimer's, including the final Phase 3 data for aducanumab, as well as MS, PSP, ophthalmology and ALS and filing for regulatory approval in the U.S. for BIIB098 in MS. And using the updated NURTURE data as the most recent example, we continue to see compelling evidence across the neuroscience landscape that leads us to believe we are at the beginning of a period of transformative breakthroughs in the treatment of neurological diseases. We believe we are uniquely positioned to benefit from these potential breakthroughs and Biogen score is to be the long-term leader in neuroscience.
To deliver [ph] on our aspiration we remain focused on executing well on strategic priorities to fortify our in MS and SMA and allocate capital to expand and progress our neuroscience pipeline, while opportunistically returning capital to shareholders.
Finally, I want to reiterate our commitment to maximizing returns to our shareholders and bringing innovative therapies to patients over the long-term. These demands [ph] as we continue to allocate capital efficiently, effectively and appropriately. As we have demonstrated in the past, we will always strive to have an optimal capital structure, as well as aim for super returns from the investment we are making.
Once again, I would like to thank our employees around the world, who are dedicated to making a positive impact on patient’s lives. And all of the physician [indiscernible] and participants in our clinical development programs [ph], our past and future achievements could not be realized without their passion and commitment.
With that, we’ll open the call for questions.
[Operator Instructions] Your first question comes from the line of Umer Raffat with Evercore. Please go ahead.
Hi. Good morning. Thank you for taking my questions. Michel, I think we've all asked Biogen's R&D leaders on this in the past and I'm curious to get your view on this, which is, do you think BAN2401s previously reported results at higher doses were entirely driven by a baseline imbalance on care status?. And based on everything we've seen to date, is Biogen willing to pay for Phase 2 and BAN or is there a way to opt out?
Thanks for the question, Umer. We have seen the data obviously, but we have two days to wait for the 25th in Barcelona. So we have to be patient and Eisai’s presentation we give a slide on the next steps. Please understand. Thank you.
Your next question comes from the line of Geoff Meacham with Barclays. Please go ahead.
Hey, guys. Good morning and thanks for the question. On aducanumab looking at the 3Q slides versus prior periods, this is the first time you guys have noticed that the Phase 3 data for ENGAGE and EMERGE is “final”. Am I reading too much into that? I am just thinking about the willingness to take an interim look? And related on the EVOLVE study, what was the driver for initiating the Phase 2, was it regulatory ongoing analysis or just - a Phase 3 or is it pre-planned? Thank you.
Hi Geoff, its Al Sandrock. Well, I wouldn't read too much into that statement about final analysis. We're not commenting on whether or not we're going to do an interim analysis and help you understand the main reason for that is that we want to maintain clinical trial integrity.
On the drivers for EVOLVE, it really wasn't driven by a regulatory request. It was our desire to see whether or not MRI monitoring was necessary. So in this study you know, what we're looking - what we're doing is, all symptomatic ARIA is being addressed the way it is now in the current clinical trials.
It's really how you deal with the asymptomatic ARIA, which is what the study is looking at and whether or not the MRI monitoring that's being done is actually necessary. And so that's the main purpose.
Your next question comes from the line of Geoffrey Porges with Leerink. Please go ahead.
Thank you very much for taking my quick question, Just a couple of data ones. Could you clarify the contribution of net price to your U.S. market and product performance? And then secondly, could you give us some commentary on SPINRAZA treatment persistence by Type 1, Type 2 and Type 3 patients so far? Thanks.
Hi, Geoff. Its Jeff. So from a pricing perspective in U.S. and MS, we had a slight benefit from a pricing perspective in the U.S. that benefited our products within the quarter based on pricing increases earlier in the year.
And Geof, just commenting on the question on SPINRAZA treatment persistence across SMA types. In our experience, essentially there's been a very durable and persistent treatment effect of SPINRAZA across all types.
Your next question comes from the line of Matthew Harrison with Morgan Stanley. Please go ahead.
Great, good morning. Thanks for taking the question. I guess, I was hoping for a little bit more clarity on what was going on with the SMA gene therapy product and maybe specifically if you could also address that do you think the preclinical observations are centered specifically on this program or do they impact your broader gene therapy pipeline? Thanks.
Hi, Matthew. I'll take that question. I mean, we're not really going to comment on ongoing FDA interactions. I would say of course those interactions are program specific, but we won't really discuss details about those interactions at this point.
Your next question comes from the line of Ying Huang with Bank of America Merrill Lynch. Please go ahead.
Hi, good morning. Thanks for taking my question. To an extent you can comment - can you confirm whether you will interact with FDA about BAN2401 for Phase 3 strategy or even filing for that based on Phase 2b or not. If you cannot answer that, I would like to ask a question about SMA. We have seen data from both Roche and Norvartis on their oral programs, given the setback of you gene therapy program, does that change your strategy about future development in SMA, trying to maintain a leadership here? Thanks.
Hi. This is Al. I’ll take the first part. We're not commenting on regulatory interactions, that we’re basically in the middle of right now, so I can't answer your first question, sorry.
And I'll take the question on the Roche oral and SMA commitment, I mean just to be completely clear we remain highly committed to SMA. We follow other programs and experimental therapeutics and development. We are aware of the data that Roche and PTC have presented around their oral compound.
We know that the field is very interested in the long-term safety and tolerability of that compound as are we. I would say that our - the most recent NURTURE data that I mentioned really highlights the compelling efficacy profile of SPINRAZA and you know, when we look across just the clinical experience to date, I would remind that while we were very interested in - I think it's roughly 21 Type 1, 35 Type 2, Type 3 patients in the Roche PTC study, it had nearly 6000 patients for close to up to six years in some instances of patients on SPINRAZA. So we have the largest body of clinical evidence for any SMA therapy.
If I may, this is Michel. I just wanted to add that we are adding momentum in the U.S. in penetrating the idle h population. And this was unsure at the beginning of the year, uncertain at the beginning of the year and ex-U.S. we have staggering launches in different geographies and if in some, we may see some of the effect we are seeing in the U.S., following the first year of dosing. There are plenty of countries that are being here where we are launching.
We just filed in China, for example, we are unlocking patient population also in Latin America. We are doing extremely well in Japan and continue to well in core Europe. So the momentum is good, but again, the biggest satisfaction is the implementation capability in the U.S. in the 65% of the market that has adult [ph] population.
Your next question comes from the line of Cory Kasimov with JPMorgan. Please go ahead.
Hey. Good morning, guys. Thanks for taking my question. I was wondering if you can comment on the 2019 pricing outlook for your MS franchise based on your formulary negotiations? Thanks.
Unfortunately we will not be able to comment on price. We see the magnitude and the frequency of price being taken in the marketplace in the past, but we cannot comment on the future. Thanks for understanding.
And your next question comes from the line of Michael Yee with Jefferies. Please go ahead.
Great. Thanks for the question. Question on biosimilars. You made a comment that obviously you are launching the HUMIRA biosimilar, but that fourth quarter I guess, biosimilars would be stable. Can you just comment on A, your outlook on a HUMIRA biosimilar versus the type of business you're doing Enbrel business?
And then more importantly, where do you think this $500 million business can go over the next few years, given you've obviously made some bullish comments on that? Thanks.
So Michael, we’re pretty excited about the launch, the team has already hit the ground. I think they're very well-prepared and we'll see some contribution, we believe in the in the fourth quarter. You know, a lot of those contracts, big contracts in Europe are tenders that take a little bit while to kind of ramp up. That's why you won't see as much of an impact in the fourth or quarter.
There's also some pricing pressure across some of the other two lines that we’re - there on. So it kind of negates the benefit we'll get - expect to get from a morality perspective. But we think this business has the opportunity to potentially double over the next couple of years based on morality and we'd like as we said before based on a relationship with Bioepis to add more compounds. So we believe that this is a good growth opportunity for us and we're quite excited about the future.
So this is not the first entity in there that is being launched in Europe, this is the third one. And I would say the purchase pattern and the journey is well set for those countries in terms of two big categories. The one that – from tenders and the one for which decision is left more the physician levels. So we anticipate that to be adalimumab biosimilar we’ll penetrate [ph] at least as strong as the previous one, even stronger.
And I would like to remind you that we are the only company having the three anti-TNFs in the marketplace. So the team is already motivated, supply is ready and while we speak prescriptions are going up.
Your next question comes from the line of Phil Nadeau with Cowen and Company. Please go ahead.
Morning. Thanks for taking my question. I want to ask another one on SPINRAZA competition. It sounds like your expectations for growth for SPINRAZA, especially in the U.S. are largely from the adult population, it does seem like Roche and PTC with an oral compound could have a key differentiating feature for that population. So how do you see competition coming in – in the adult population and how could you differentiate SPINRAZA for those patients? Thanks.
So Phil, maybe I'll start another may have a comment here too. I mean, in essence we – we’re very confident in what we see with the clinical data on SPINRAZA. We're encouraged by the - the ongoing studies in teens and adults that we see in the access, including in complex spine patients, SPINRAZA. But we're very aware of the other competitive programs out there. It's early days and in lot of those.
And like I mentioned we know the field is very interested in the long-term safety and tolerability of the orals. We know that there are questions around the dose selection that will ultimately be used there. And to date it's a relatively small number of patients, but we are certainly staying aware of it.
So we were able somehow together with the physicians to deliver 30,000 dosing of SPINRAZA during the past month is because in real world there is an efficacy perception at the patient level. So its an efficacy play for those patients who are just the right [indiscernible] and the convenience comes after, this is what is being was backed by the customers.
So with 3000 patients being dosed and more than 300 patients in clinical trial, we had a body of evidence that is still difficult to match for the time being.
Your next question comes from the line of Carter Gould with UBS. Please go ahead.
Morning, guys. Thanks for taking the question. I guess for Jeff or Michel, just on the BASR versus committing for BD [ph], obviously, you’ve been pretty active so far this year on the BD front. So maybe just kind of how you see that balance and I guess looking out the next sort of 12 to 18 months, how you see that may be evolving? Thank you.
Yes. So thanks for the question. So you know, I think the nice position we're in is given our cash flows, we generate $1.7 billion of cash flow for the quarter again which is strong cash flow and given our net debt position. We have the luxury of being able to do both, both to invest in the business from a pipeline perspective and return capital to shareholders.
So we've now done eight acquisitions and licensing type deals/acquisitions since Michel is been CEO, so we’re very encouraged by that and we expect to do more. A lot of that been done kind of in the - in the early to mid stage. We'd love to get something later stage done.
But we also have ample cash capacity to return capital to shareholders. We bought back $10 billion of stock over the last couple of years and I would just remind investors that we have a new $3.5 billion share repurchase program that the board has recently authorized.
So we have ample capacity to do both. Certainly we would be a preference to get more done in the pipeline and get more done that’s later stage. So certainly that would be kind of the focus or the preference, but we have the capacity to do both.
So if you look at the momentum that Biogen is able to deliver, year-to-date, if I am not mistaken is 12% on the topline and with leverage P&L. This was not anticipated two years ago because of OCREVUS launch, because of limited potential of SPINRAZA, because of neglected biosimilars and the rest.
And here we are. So we're not on a burning platform and the level of rigor and alignment to the strategy, to the scientific validity, to the IP and to financials criteria remained very rigorous within the organization and even more importantly, we have some very important readouts in the coming months. So in the meantime we deliver, we tightened the belt and we're evaluating opportunities, but in a very best manner.
Your next question comes from the line of Salim Syed with Mizuho. Please go ahead.
Yeah. Hi, guys. Thanks for taking the question. This one's for probably Mike or Al, just on the XLRS gene therapy program. Can you confirm that we're still getting topline data in the fourth quarter of this year? And what are you looking for in terms of deeming the trial a success? Thank you.
Yes. So thanks for the question on this. So you know, right now on the XLRS program, we recall that this is a collaborative program with AGTC. The kind Phase1/2 trial is ongoing. This is an adult subsequent [ph] XLRS and at the moment we are anticipating that we could get a data readout projected in the first part of next year or so.
But of course, these are always dependent on timing and enrolment of the right subjects. We're also very interested in no differences for example in the adult versus pediatric population this disease or some heterogeneity. As you may know in kind of the path of - pathology in XLRS because it has to do with exact location of the retina, specific visual endpoints you need and so forth. But to date the program is on track.
Your next question comes from the line of Robyn Karnauskas with Citi. Please go ahead.
Hi, guys. Thanks for taking my question. So from your from your presentation it's – there is a lot on your pipeline, that it feels like you're focused on – and just trying to understand a little bit, as we see all these reads that are going to come out over the next 12 to 18 months, excluding Alzheimer's programs, which do you think have been the greatest ability to have a read to Phase 3. In other words, like - will give you the most confidence that there is a real proof of concepts or proof of potential success for those indications, as historically we know if something works for Biogen with your leverage the stock's ability to go up a lot. So help us understand which are those you think are the least risky and have the greatest read to the next stage of development?
Okay. So this is Michael. I'll try to take some of that. Thank you by the way for the question. I mean, as we show - I mentioned and so we do have a number of upcoming data readouts at different stages across the pipeline that have, I’d say different ramifications. A few things that we noted there is that we will start getting data on our BIIB67, SOD1 ALS program either towards the end of the year or early next year.
This we think will be important primarily as a second leasing ASO program, in this case an adult indication with a different mechanism of action in the RNase H mediated knockdown of a pathological gene target. So we're very interested to see the biomarker and potential clinical efficacy data from that.
That likewise has the potential to influence our thinking on other genetic targeted ASO programs like BIIB078, like I mentioned C9ORF72 positive ALS, as well as our tau ASO program which is currently in Phase 1 study in Alzheimer's disease.
But I see there are more. We are - we have been very successful in advancing our BIIB092 program in progressive super nuclear policy. This is obviously a rare severe orphan disease. So I think this could give us an accelerator opportunity.
And beyond that we're – we’ve initiated our Phase 3 study in BIIB093, so that will be ongoing. And although it's really first of its kind you know, we're very encouraged by the responsive side. And of course, you know, we announced that earlier this year that we completed enrolment in ENGAGE and EMERGE - aducanumab which is an 18 month dosing period study. That among others I think constitute an array of upcoming data readouts and have the potential to create significant excitement.
Your next question comes from the line of Ronny Gal with Bernstein. Please go ahead.
Good morning, everybody and thank you for hitting me in. Two questions for Mike on the pipeline. Mike, first the BIIB104 AMPA regulator. AMPA is been particularly difficult target to drug. Can you discuss a little bit how you convinced yourself you can avoid the toxicity that has been seen with this target before?
And second about 093 [ph] glyburide program. Essentially, is this one of those programs that has the potential of reading out early? Is there interim analysis here? You kind of think about stroke or something you can accumulate there pretty quickly, how you're thinking about a potential of this program to actually readout head of time?
Okay, thanks, Ronny for the questions and I’ll try to take these briefly. On BIIB104 what we were encouraged by there was - was really a quite differentiated and tight pharmacokinetic profile and safety profile that have been reserved both pre-clinically and clinically. It was really quite different from previous or earlier generation AMPA PAMs. So to date the clinical and preclinical data that have been seen have supported a favorable tolerability profile, as well as showing indications of efficacy in a few different clinical studies and of different designs in the domain of working memory and cognition.
So we think there are differentiating features that have to do with some of the very specific pharmacology of this compound versus others previously in the class. So we think is differentiated.
On BIIB093, we won't talk about an interim analysis on that, but I would say is that we have had a very strong response on site engagement, site activation and investigator interests because obviously there has been really no alternative for patients having a large hemispheric infarc.
Your next question comes from the line of Terence Finn with Goldman Sachs. Please go ahead.
Hi. Thanks for taking the questions. Maybe just first on the financials, I was wondering if you can help us think about your tax rate heading into ’19, you guys - it looks like you’ve continue to bring that lower throughout the course of the year. And then any guidance on the operating margins for the biosimilars franchise that you can offer at this point?
And then just one on the pipeline for 8700, you mentioned some new endpoints in that study. Can you just review what changed there? Thanks.
Thanks. So with regard to the tax rate, we're currently running at low 20% tax rate, as I mentioned in the script. We did mention when tax reform first got implemented that we expected the tax rate to come down again in 2019, as a result of some accounting factors that are more unique to kind of how our tax works around the world. We still expect that to be the case and we'll be able to provide you a more specific expectation on that when we release guidance in January for 2019.
In terms of operating expenses, as I mentioned you know, we expect the fourth quarter to tick up a little bit as we continue to invest in the pipeline and drives some of the growth that we're seeing from a commercial perspective in SMA. We're still in the middle of kind of going through our planning process for next year.
What I can share with you is based on the strength of our lean and simple cost savings initiative, we expect to take money out of kind of the G&A area and invest that back into the pipeline, grow our spend and our and our projects with regard to R&D. So we are very committed to that continuing to increase the innovation in neurology of the company.
So I think it was a question on 8700, I am going to interpret that as BIIB098.
Yes.
If that's not asking, but I’ll just say that on BIIB098 we have used data from the Part A of the study to inform Part B where we've expanded the patient - patient number in the head to head study against TECFIDERA, where again we anticipate that we'll be able to file on this data this year looking an approval potentially in the first half of next year or mid next year.
And your final question comes from the line of Chris Raymond with Piper Jaffray. Please go ahead.
Thanks for squeezing me in. Yes, just another question on BIIB098. Just on the strategy here, I do think this launch could be kind of unique. So you filing under 505 B2 pathway, but you will have a head to head versus TECFIDERA on tolerability, which you talked about. Some of our work indicates that you know that's kind of you know one of the bigger reasons for discontinuation of TECFIDERA tolerability issue.
So if BIIB098 sort of repeat the clinical data we've seen so far that should address you know, essentially a big issue of TECFIDERA. So how do you approach the marketing and positioning of this drug and how should we think about these two drugs coexisting over time?
And then also just on that point, I think in your slide you guys talk about a 2020 approval, but I think I just heard you guys mentioned that or maybe second half 2019 approval, can you sort of talk about that timing? Thanks.
Thanks for the great question. And the first I would like to say that we are pleased with the momentum behind TEC . I think this is important. So TEC will remain always front end center. We are doing well. We grow the volume even if we price, we face some crushing pressure in part of the world like in Europe and we have increasing competition.
So BIIB098 will offer the opportunity eventually to have a an upgrade in terms of safety profile and GI safety and this will be eventually the low hanging fruit that we aim to move further. And the team is working towards the longer term lifecycle management opportunities that these product offers beyond the fumarate. So is what we're working on.
But we are very excited about this opportunity and to expand our leading share of orals, but beyond the fumarate market. So looking forward to this filing and potentially launch towards the end of ‘19 or early 2020.
So at this stage, I would like to close the call by saying a very exciting times that Biogen we are looking forward to the data readouts and I thank you all for attending our call today. Have a good day.
Thank you for joining today's call. Before we conclude, I would like to remind everyone that we plan to host three webcast from CTAD later this week, on Thursday October 25th at 730 a.m. Eastern Time. We will webcast the keynote presentation from Samantha Budd Haeberlein, Vice President, Alzheimer's disease, dementia and movement disorders later stage clinical development, titled what we learned from Aducanumab. Later that day at 4:15 p.m. Eastern Time we will host an Investor Q&A webcast to discuss the Alzheimer's portfolio with Dr. Al Sandrock, our Chief Medical Officer and Samantha Budd Haeberlein and on Friday October 26 at 9:15 a.m. Eastern Time we will webcast the oral presentation titled aducanumab titration dosing regiment, 36 month analysis from PRIME, a Phase 1b study in patients with early Alzheimer's disease. The links to those webcast can be found on the Investor section of Biogen’s website at www.biogen.com. Thank you and we look forward to speaking with you in the future.
Thank you to everyone for attending today. This will conclude today's call and you may now disconnect.