Biogen Inc (BIIB) 2018 Q3 法說會逐字稿

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.

(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.

Thanks, 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 am 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 calls and investor events on the Investors section of Biogen's website, www.biogen.com, and issue a statement on Twitter when they become available.

We do this instead of publishing earnings releases and any releases related to industrial 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 top line 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 the prior year and delivered revenues of $2.3 billion.

The number of patients on our MS product globally also remained relatively stable versus the prior year.

In the U.S., we saw improving 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 revenue 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 than 50% of new starts were adults, increasing the number of adult patients on SPINRAZA by more than 20% compared to last quarter.

Outside the U.S., the pace of reimbursement for SPINRAZA across multiple geographies led 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 5 more countries, and we have made 2 more regulatory filings.

We also seek a formal reimbursement in 4 additional countries, including Canada, and now have formal reimbursement in 28 markets.

We were very proud to announce new data from the neutral study of SPINRAZA.

Of the 25 presymptomatic infants, we genetically diagnosed SMA that were 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% showed normal bulbar 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 enrollment of the Phase II trial of opicinumab, a potential rumination therapy.

Along with SI, 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 the initiation of a Phase I trial of BIIB078 and ASO targeting C9orf72, the most common genetic cause of ALS.

And we continue to be optimistic about the potential for BIIB067 targeting SOD1 for ALS.

We are making notable progress in movement disorders, having completed enrollment in the Phase II trial of BIIB092 and 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 II for Parkinson's disease.

Within our emerging growth area of acute neurology, we dosed the first patient in our Phase III trial of BIIB093, a first-in-class IV glibenclamide for large hemispheric infarction.

And beyond our neuroscience pipeline, we initiated a Phase IIb trial of BG00011 in idiopathic pulmonary fibrosis.

Mike will provide more details on the development across our entire pipeline.

Our biosimilars 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 3 main entity MS, 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 Bioepis 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 5 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 evaluate new potencies 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 our 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 in 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 enrollment of studies in MS and PSP, as we aim to develop our neuroscience portfolio and build depth 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 depth in our neuroscience portfolio, again with the 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 and disease areas.

Starting with Alzheimer's disease and dementia.

This week we are presenting data at the Clinical Trials on Alzheimer's disease meeting, or CTAD, on the safety and efficacy of aducanumab, our monoclonal antibody that 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 cohorts, both from the long-term extension of the Phase Ib PRIME study of patients with early Alzheimer's disease.

The results are generally consistent with previous interim analysis, and there were no changes to the risk-benefit profile of aducanumab.

Live webcast of our oral presentations as well as an investor Q&A call will be available on the Investors section of our website.

Also at CTAD, our collaborator Eisai will present clinical and biomarker updates from the Phase II 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 II study of elenbecestat, a small molecule base inhibitor being evaluated in 2 Phase III studies in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease.

In parallel to advancing Phase III clinical development of aducanumab, we are also planning to initiate EVOLVE, a Phase II 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 designed 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 as BIIB080, an antisense oligonucleotide targeting tau production.

We expect full data from the Phase I study of BIIB076 in early 2020.

Turning to MS and neuroimmunology.

This quarter, we completed enrollment of AFFINITY, a 72-week Phase IIb 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.

Enrollment of AFFINITY was completed approximately 7 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 were 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 a U.S. approval by early 2020.

We are committed to expanding our leadership position in multiple sclerosis, and we believe this next generation of 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 endorsed study, which demonstrated that the clinical benefits of TECFIDERA in newly diagnosed patients were maintained throughout 9 years of continuous treatment.

Additionally, an analysis from the TYSABRI observational program, 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 enrollment of a Phase II 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 II 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 in 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 presymptomatic 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 milestone standard of the World Health Organization and all were able to sit without support.

Additionally, assessment of bulbar 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 for study participants with 3 copies of the SMN2 gene, and 61.0 for those with 2 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 at a Phoenix Children's Hospital, outlining a potential treatment paradigm to dose 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 of the SMA 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, they 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 U.S. 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 of a viable path forward.

Beyond SMA, we continue to progress our Phase I study of BIIB067 in ALS patients who harbor mutations in superoxide dismutase 1, or SOD1, a 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 I 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 targets 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 cerebellum edema associated with large hemisphere infarction.

In the third quarter, we dosed the first patient in CHARM, the Phase III trial of BIIB093, and we look forward to progressing this novel therapeutic approach in this severe stroke population.

Along with our Phase II TMS-007 program, we are encouraged by the potential to advance innovation in this area of significant unmet medical need.

Within neuropathic pain, we recently received the results from the Phase IIb study of vixotrigine or BIIB074 in painful lumbosacral radiculopathy, 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 continued to enroll a Phase II study in small fiber neuropathy.

In parallel, we have continued our FDA interactions regarding the design of the potential Phase III studies in trigeminal neuralgia.

We will delay Phase III 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 top line results from a Phase IIb 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 nonbiological 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.

This 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 IIb study of BG00011, 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 in forced exploratory vital capacity, an established measure of pulmonary function in IPF.

BG00011 previously demonstrated compelling proof of biology via substantial down regulation of the TGF-beta pathway in IPF patients as measured by an addition of phosphorylated SMAD in alveolar macrophages isolated by bronchoalveolar lavage.

Overall this quarter, dosed the first patient in a Phase III stroke study, reported compelling data supporting SPINRAZA as the standard of care in SMA, initiated 2 new clinical trials, completed enrollment in 2 Phase II studies and continued 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.

We'll now review our financial performance for the third quarter of 2018, 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 of approximately $137 million.

MS revenues in the third quarter of 2018 were down 3% versus the prior year, without 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 declines we saw in the first and the 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 ex-U.

S. TECFIDERA revenues were negatively impacted by ongoing price decreases in certain European countries.

TYSABRI worldwide revenues were $470 million this quarter, relatively stable versus the third quarter of 2017.

This included $253 million in the 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 of 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 therapies.

Interferon revenues included $421 million in U.S. and $169 million from sales outside the U.S.

Overall, MS revenues including our royalties on sales of OCREVUS were stable versus the 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 on to SPINRAZA.

Global third quarter SPINRAZA revenues were $468 million.

This included revenues of $224 million 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 remain relatively low and continue to be driven primarily by mortality.

We continue to believe there is significant opportunity in adults in U.S. and are very encouraged by the progress we're making.

The number of adults on therapy in U.S. grew by over 20% for the second quarter, and in the third quarter, 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 1/3 of our U.S. patients on therapy are now adults.

As a reminder, our data indicate that approximately 5% of the prevalent estimated 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 contributions from maintenance doses this quarter.

In the 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 free 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 of approximately 100 basis points versus the second quarter, due primarily to increased treatment through 340B hospitals.

If a similar free 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 revenues 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 the 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 on to our biosimilars business, which generated $135 million in revenues 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, and if only 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.

TYSABRI volumes grew by 19% versus the second quarter, mostly in Italy.

Last week we launched IMRALDI, our biosimilar referencing HUMIRA, which is now available in 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 includes an inventory draw down for RITUXAN.

In addition, we continue to monitor potential new biosimilar entrants, which could begin impacting RITUXAN revenues in 2019.

Total other revenues were $147 million in the third quarter, more than 3x what we recorded in the third quarter of 2017, as we continue to benefit from greater contract manufacturer.

As a reminder, we believe that the fourth quarter of 2017 revenues were abnormally high due to the timing of contract manufacturing, creating a difficult comparison for the fourth quarter this year.

Q3 GAAP and non-GAAP gross margins were 87%, a slight decrease from the second quarter due to higher contract manufacturing.

Q3 GAAP and non-GAAP R&D expense were both 15% of revenue or $508 million.

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 as seasonality.

GAAP amortization was $282 million, which includes a $189 million impairment related to updates in the development status of vixotrigine, which Mike discussed.

The effects of this impairment were partially offset by a $90 million 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 30, 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 for 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 execute 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 a slide presentation of the BAN2401 data this week at CTAD and assessing next steps.

Data readouts across Alzheimer's, including the final Phase III 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 neutral data as the most recent example, we continued to see compelling evidence across the neuroscience landscape that leads us to believe we are at the beginning of a period of transformistic breakthroughs in the treatment of neurological diseases.

We believe we are uniquely positioned to benefit from this potential breakthroughs and Biogen's goal is to be the long-term leader in neuroscience.

To deliver on our aspiration, we remain focused on executing well on our strategic priorities to fortify our core business 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 for our shareholders and bringing innovative therapies to patients over the long term.

These demands that 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 superior 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 patients' lives.

And all of the physician, caregivers and participants in our clinical development programs, 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.

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 BAN2401's 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 III on BAN or is there a way to opt out?

Thanks for the question, Umer.

It's -- we have seen the data obviously, but we have 2 days to wait for the 2015 (sic) [2018] Barcelona.

So we have to be patient and a slide presentation, we'll give a slide on the next steps.

Please understand.

Thank you.

Your next question comes from the line of Geoff Meacham with Barclays.

On aducanumab, looking at the 3Q slides versus prior period.

This is the first time you guys have noted that the Phase III data for ENGAGE and EMERGE is "final." Am I reading too much into that?

I'm just thinking about the willingness to take an interim look.

And related on the EVOLVE study, what was the driver for initiating the Phase II?

Was it regulatory ongoing analysis or just -- of Phase III, or was it preplanned?

Geoff, it's 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 I hope 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 regulatory request.

It was our desire to see whether or not MRI monitoring was necessary.

So in this study, what we're doing is, all symptomatic ARIA is being addressed the way it is now in the clinical trials.

It's really how you deal with the asymptomatic ARIA, which is what this 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.

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?

Geoff, it's 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 Jeff, this is Mike Ehlers.

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.

I guess I was hoping for a little bit more clarity on what was going on with the SMA gene therapy products.

And maybe specifically, if you could also address, do you think the preclinical observations are centered specifically on this program?

Or do they impact your broader gene therapy pipeline?

Matthew, I'll take that question.

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.

Can we expand the comment -- can you confirm whether you will interact with FDA about BAN2401 for a Phase III strategy?

Or even filing from that based on Phase IIb or not?

If you cannot answer that I would like to ask a question about the SMA.

We're seeing data from both Roche and Novartis on their oral programs.

Given the setback of your gene therapy program, does that change your strategy about future business development in SMA, trying to maintain your leadership here?

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 in 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 when we look across just the clinical experience today, I would remind that while we're very interested in, I think, it's roughly 21 Type 1, 35 Type 2, Type 3 patients in the Roche PTC study, we've had nearly 6,000 patients for close to up to 6 years, in some instances, of patients on SPINRAZA.

So we have the largest body of clinical evidence for any SMA therapy.

And just -- if I may, this is Michel.

I just wanted to add that we are adding momentum in the U.S. in penetrating the ideal 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 have seen in the U.S. following the first year of dosing.

There are plenty of countries that are being 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 do well in core Europe.

So the momentum is good, but again, the bigger satisfaction is the implementation capability in the U.S. in the 65% of the market that has ideal population.

Your next question comes from the line of Cory Kasimov with JPMorgan.

I was wondering if you can comment on the 2019 pricing outlook for your MS franchise based on your formulary negotiations.

Yes.

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 your understanding.

And your next question comes from the line of Michael Yee with Jefferies.

A question on biosimilars.

You made a comment that, obviously, you're 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 with the 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?

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 fourth quarter.

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 quarter.

There's also some pricing pressure across some of the other 2 lines that we're -- they're on, so that kind of negates the benefit we'll get -- expect to get from a numerology perspective.

But we think this business has the opportunity to potentially double over the next couple of years, based on the IMRALDI.

And we'd like, as we said before, based on our relationship with Bioepis to add more compounds.

And 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 here that is being launched in Europe, this is the third one.

And I would say the purchase pattern and the year, the journey is well set for those countries in terms of 2 big categories, the one that -- from tenders and the one for which decision is left more at the physician level.

So we anticipate that the adalimumab biosimilar will be in fact 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 3 anti-TNFs in the marketplace.

So the team is really motivated, supply is ready, and while we speak, the prescriptions are going on.

Your next question comes from the line of Phil Nadeau with Cowen and Company.

I wanted to ask another one on the SPINRAZA competition.

It sounds like your expectations for growth for SPINRAZA, especially in the U.S., are largely from the adult population.

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 the adult population?

And how could you differentiate SPINRAZA for those patients?

So Phil, maybe I'll start and others may have a comment here too.

I mean, in essence, we're very confident in what we see with the clinical data on SPINRAZA.

We're encouraged by the study -- the ongoing studies in teens and adults that we see in the access, including in complex spine patients, SPINRAZA.

We're very aware of the other competitive programs out there.

It's early days in a 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 if we're able somehow together with the physicians to deliver 30,000 dosing of SPINRAZA during the past months is because in real world, there is an efficacy perception at the patient level.

So it's an efficacy play for those patients who are just the right segment in order to improve functionally and the convenience comes after.

This is what is being brought back by the customers.

So with 6,000 patients being dosed and more than 300 patients in clinical trial, we have 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.

I guess for Jeff or Michel, just on -- the BASR versus committing more BD.

Obviously, been pretty active so far this year on the BD front.

But 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 maybe evolving?

Yes.

So thanks for the question.

So I think the nice position we're in is, given our cash flows, we generated $1.7 billion of cash flow for the quarter again, which is strong cash flow in our -- given our net debt position.

We have the luxury of being able to do both, both to invest in the business for a pipeline perspective and return capital to shareholders.

So we've now done 8 acquisitions and licensing-type deals/acquisition since Michel has been CEO.

So we're very encouraged by that.

And we expect to do more, a lot of them have been done kind of 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'd bought back $10 billion worth 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, it would be a preference, I think 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'm not mistaken, is 12% on the top line with the leverage P&L.

This was not anticipated 2 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, remain very rigorous within the organization.

And even more importantly, we have some very important results in the coming months.

So in the meantime, we deliver, we tighten the belts, and we are evaluating opportunities.

But in a very paced manner.

Your next question comes from the line of Salim Syed with Mizuho.

This one's for probably Mike or Al.

Just on the XLRS gene therapy program, can you confirm that we're still getting top line data in the fourth quarter of this year?

And what are you looking for in terms of deeming the trial a success?

Yes.

So thanks for the question on this.

So right now with -- on the XLRS program, recall that this is a collaborative program with AGTC.

The kind of Phase I/II trial is ongoing.

This is an adult XLRS, and at the moment, we're 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 enrollment of the right subjects.

We're also very interested -- differences, for example, in the adult versus pediatric populations disease or some heterogeneity as you may know and kind of the path of -- pathology in XLRS because it has to do with exact locations of the retina, the 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.

So from your presentation, it's -- there's a lot on your pipeline that it feels like your 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 our Alzheimer's programs.

Which do you think have the most -- the growth ability to have a read to Phase III, in other words like, give you -- will give you the most confidence, but there's a real proof of concept or proof of potential success for those indications as, historically, we know if something works at Biogen, your -- with your leverage, the stock visibility to go up a lot.

So help us understand, which of those you think are the least risky and have the greatest read to the next stage of development?

Okay, so this is Mike.

I'll try to take some of that.

Thank you, by the way, for the question.

As Michel 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 BIIB067 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 in 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 implement our thinking on other genetic targeted ASO programs like BIIB078, like I mentioned for C9orf72 positive ALS as well as our tau ASO program, which is currently in a Phase I study in Alzheimer's disease.

But I'd say there are more.

We are -- we have been very successful in advancing our BIIB092 program in progressive supranuclear palsy, this is obviously a rare, severe orphan disease.

So I think this could give us some accelerator opportunity.

And beyond that, we're -- we've initiated our Phase III study in BIIB093, so that will be ongoing.

And although it's a really first of its kind, we're very encouraged by the response of sites.

And of course, we announced that earlier this year, that we completed enrollment in engaging immersive aducanumab, which is an 18-month dosing period study.

That, amongst others, I think constitute an array of upcoming data readouts that have the potential to create significant excitement.

Your next question comes from the line of Ronny Gal with Bernstein.

Two questions from Mike on the pipeline.

Mike, first, the BIIB104 AMPA regulator.

AMPA has been a 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 of the glyburide program.

Essentially, is this one of those programs that has the potential of reading out early?

Is there an 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 read out ahead of time?

Okay.

Thanks, Ronny, for the questions.

I'll try to take these briefly.

On BIIB104, what we are encouraged by there was really a quite differentiated and tight pharmacokinetic profile and safety profile that have been reserved both preclinically and clinical.

That was really quite different from previous earlier generation AMPA PAMs.

So to date, the clinical and preclinical data that we've seen have supported a favorable tolerability profile as well as showing indications of efficacy in a few different clinical studies 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 it's differentiated.

On BIIB093, we won't talk about an interim analysis on that, what I would say is that we have had a very strong response on site engagement, site activation and investigator interest because, obviously, there has been really no alternatives for patients having a large hemispheric infarc.

Your next question comes from the line of Terence Flynn with Goldman Sachs.

Maybe just first on the financials.

I was wondering if you can help us think about your tax rate heading into ‘19.

You guys -- looks like you've continued to bring that lower throughout the course of the year.

And then any guidance on the operating margins for the biosimilar 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.

So with regard to the tax rate, we're currently running at a 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 structure 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, we expect the fourth quarter to tick up a little bit as we continue to invest in the pipeline and drive 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 and continue to grow our spend in our projects with regard to R&D.

So we can -- we're very committed to that and continuing to increase the innovation in neurology here for the company.

So I think there was question on 8700.

But I'm going to interpret that as BIIB098.

Yes.

If that was -- if that's not, then ask him.

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 have expanded the patient number in the head-to-head study against TECFIDERA, where again, we anticipate that we'll be able to file on this date of this year looking in approval, potentially in the first half of next year or mid-next year.

And your final question comes the line of Chris Raymond with Piper Jaffray.

Yes.

So just another question on BIIB098.

Just on the strategy here.

I do think this launch could be kind of unique.

So you're filing under a 505 B2 pathway, but you will have a head-to-head versus TECFIDERA on tolerability, which you've talked about.

Some of our work indicates that, that's kind of one of the bigger reasons for discontinuation of TECFIDERA, the tolerability issue.

So if BIIB098 sort of repeats the clinical data we've seen so far, that should address, essentially, the -- a big issue for TECFIDERA.

So how do you approach the marketing and positioning of this drug?

And how should we think about these 2 drugs coexisting over time?

And then also, just on that point, I think in your slides, you guys talked about the 2020 approval, but I think I just heard you guys mention a maybe second half 2019 approval.

Can you sort of talk about that timing?

Thanks for the great question.

And 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 and center.

We are doing well.

We'll grow the volume.

Even if we price, we face some pricing pressure in part of the world like in Europe, and we have increasing competition.

So BIIB098 will offer the opportunity eventually to have 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 a longer-term lifecycle management opportunities that this product offers beyond the fumarate.

So this 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 these 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, very exciting times at Biogen.

We are looking forward to the data readouts, and thank you all for attending our call today.

Have a good day.

Okay.

Thank you for joining today's call.

Before we conclude, I would like to remind everyone that we plan to host 3 webcasts from CTAD later this week.

On Thursday, October 25, at 7:30 a.m.

Eastern Time, we will webcast a keynote presentation from Samantha Budd Haeberlein, Vice President Alzheimer's disease, Dementia and Movement Disorders later-stage clinical development, titled, what have we learned from aducanumab?

Later that day, at 4:15 p.m.

Eastern Time, we will host an investor Q&A webcast to discuss 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 regimen, 36-month analysis from PRIME of Phase Ib study in patients with early Alzheimer's disease.

The links to those webcasts can be find on -- found on the Investors 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.