Analyst Conference Summary

biotechnology

conference date: April 30, 2020, @ 5:00 AM Pacific Time
for quarter ending: March 31, 2020 (Q1, first quarter 2020)

Forward-looking statements

Overview: Revenue ramping, but on a small base, so a long way from break even.

Basic data (GAAP):

Revenue was $87.1 million, up 146% sequentially from $35.4 million, and up 188% from $30.2 million year-earlier.

Net income was negative $40.3 million, up sequentially from negative $102 million, and up from negative $93.1 million year-earlier.

EPS (diluted GAAP) was negative $0.59, up sequentially from negative $1.60, and up from negative $1.59 year-earlier.

Guidance:

Reiterated 2020 Tibsovo sales guidance of $105 to $115 million. Expects cash runway through June 2022.

Conference Highlights:

Jackie Fouse, CEO of Agios said "Despite the challenges we faced in the first quarter in the wake of the COVID-19 pandemic, we made significant clinical and commercial progress, including completing enrollment in the ACTIVATE pivotal trial of mitapivat in PK deficiency, delivering strong Tibsovo performance and achieving key U.S. and EU regulatory milestones. We have also made important resource allocation decisions with the goal of delivering on our key business objectives while conserving cash and increasing our financial flexibility. Through these efforts, we remain on track to achieve our Agios 2025 strategic vision. As we have all worked to adapt to these unexpected and trying circumstances, the teamwork and resilience demonstrated by my colleagues has truly been remarkable and provides confidence that we will come out of these challenging times even stronger than we were before." There was an acceleration of sales from March into April.

Reducing spending where possible.

2025 Vision is for 4 commercial medicines with at least 8 indication. Hopes for 6 or more molecules in the clinic, and positive cash flow.

Increasing treatment duration with Tibsovo is the main driver of revenue growth at present.

EU Tibosvo for AML application should get a CHMP opinion by year-end 2020. Growth of Tibsovo in the U.S. remains strong as prescriber base broadens and frontline approval ramps. There are about 10,000 newly diagosed IDH1/2 newly diagnosed AML patients in the US and EU combined, annually.

Tibsovo plus Vidaza is in a Phase 3 trial that should complete enrollment by year-end 2020. Investigator-sponsored studies are testing tibsovo with various other agents for AML.

Tibsovo net sales were $22.7 million, up 16% sequentially from $19.6 million. $3.3 million of revenue in the quarter was from royalties for Idhifa from Bristol, up sequentially from $3.0 million. $61.1 million was from collaborations.

Agios plans to submit an sNDA to the FDA for Tibsovo for first line IDH1 mutant cholangiocarcinoma by year-end 2020.

As of April 2020, Agios anticipates some delays in clinical programs due to hospitals shifting resources to deal with the pandemic.

Initiated a registration-enabling Phase 3 study of vorasidenib (AG-881) in low-grade glioma with an IDH1 mutation at year-end 2019. Updated data due at ASCO in May 2020.

AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, for methylthioadenosine phosphorylase (MTAP)-deleted tumors initiated expansion arms, including a single-agent arm in a variety of MTAP-deleted cancers and a combination arm in a solid tumor in Q3 of 2019. Phase 1 daa reported in October 2019 showed biomarker activity. In Q3 2019 Agios initiated two combination arms for the Phase 1 study of AG-270 in MTAP-deleted tumors, one evaluating AG-270 in combination with docetaxel in second-line non-small cell lung cancer and another in combination with nab-paclitaxel and gemcitabine in first or second-line pancreatic ductal adenocarcinoma. Bristol-Myers is collaborating on AG-270.

Completed enrollment in two global pivotal Phase 3 trials for mitapivat (AG-348) in adults with pyruvate kinase (PK) deficiency. Phase 3 topline data expected by year-end 2020. There are no currently approved therapies for this indication. In March 2020 received Orphan Drug status in EU, which gives 10 years of exclusivity. Beta thalassemia Phase 2 trial data to be presented at EHA in June 2020.

AG-636 for advanced lymphoma study, stopped in-house development, but Agios is looking for a partner.

AG-881 (vorasidenib) was chosen (in Q1 2019) as the molecule to continue in the IDH1-mutant glioma study. By end of 2019 will initiate the registration-enabling Phase 3 INDIGO study of vorasidenib in Grade 2 non-enhancing glioma with an IDH mutation.

With Bristol, Agios is enrolling a Phase 3 trial for frontline AML combining ivosidenib or enasidenib with 7+3 chemotherapy.

Agios received IND clearance for AG-946, a next generation PKR activator (post mitipicat), in March 2020. Will initiate a first-in-human study in healthy volunteers in the first half of 2020.

Further combination trials with a variety of agents and target variants are planned for ivosidenib.

Cash (including equivalents & securities) ended at $613 million, down sequentially from $718 No debt.

Cost of Sales $0.5 million. GAAP operating expenses were $130.3 million, consisting of: $91.3 million for R&D and $38.5 million for G&A. Loss from operations was $43.2 million. Interest income was $2.9 million.

Q&A:

Mitapivat for sickle cell data timeline? We will give topline data when it is available. For proof of concept we need to see two efficacy readouts, vaso-oclusive crisis, and hemoglobin levels and related endpoints. 100 mg BID dose is well below the dosing in the PKD trials, but they started NIH trial at lower doses.

We are hoping clinical trial enrollments will pick back up. The reductions for cash runway extension are flexible.

NIH study can be between 15 and 25 patients. They have not given us an exact number, it probably depends on when they can open up again.

Idhifa competition? Strong partnership with BMS. We hear Bristol wishes to retain its leading rights. We believe Idhifa has some advantages over the new oral competitor.

We have seen no evidence of stockpiling of Tibsovo.

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