Analyst Conference Summary

biotechnology

conference date: April 30, 2019 @ 2:00 PM Pacific Ti
for quarter ending: March 31, 2019 (first quarter, Q1)

Forward-looking statements

Regrets, this file and its backup were accidentally corrupted, my bad. -WPM (but should be okay from the drug table down.)

Overview: Hanging in there, waiting for new product approavals.

Basic data (GAAP):

Revenue was $ billion, up % sequentially from $5.56 billion and % from $ billion in the year-earlier quarter.

Net income was $ billion, up % sequentially from $1.99 billion, and down % from $ billion year-earlier.

Earnings Per Share (diluted EPS) were $, up % sequentially from $3.18, but down % from $ year-earlier.

Guidance:

Conference Highlights:

Robert A. Bradway, CEO said ""

Many of the therapies in the pipeline have potential to be either first-in-class or best-in-class. We are excited by what we are seeing in our oncology pipeline.

Aimovig was approved by the FDA late in Q2 2018.In March, 2019 the FDA approved a supplemental BLA to add 140 mg/mL single-dose autoinjector and pre-filled syringe dosing options.

Neulasta is seeing biosimilar competition, which will increase in 2019. Onpro and reputation for quality may slow the erosion.

Aranesp revenue is expected to decline more rapidly in 2019 due to competition.

Repatha is launching in China.

Income taxes in Q2 increased due to the ex-US repatriation tax.

Non-GAAP numbers: net income was $ billion, up % sequentially from $2.23 billion, and down % from $ billion year-earlier. EPS was $, up % sequentially from $3.56 and up % from $ year-earlier.

Product sales were $ billion, up % sequentially from $5.29 billion, and down % y/y from $ billion, with $ billion in the U.S. and $ billion international. Non-product revenue was $ million, up from $ million year-earlier.

Cash and equivalents balance ended at $26.3 billion, down sequentially from $29.3 billion. Operating cash flow $1.8 billion. Free cash flow was $1.7 billion. At the end of quarter debt was $33 billion. Capital expenditures $0.1 billion. $3.0 billion worth of shares were repurchased in the quarter. Dividend payments were $0.9 billion.

In April the FDA approved Evenity for the treatment of osteoporosis in postmenopausal women at high risk for fracture.

In April, Corlanor (ivabradine) was approved by the FDA for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

In December 2018, a Biologics License Application (BLA) for Kanjinti, a biosimilar Herceptin (trastuzumab), was resubmitted to the FDA. In December and January, the Company submitted a BLA to the FDA, and a Marketing Authorization Application to the EMA, respectively, for ABP 710, a biosimilar candidate to Remicade(infliximab).

Tezepelumab was granted breakthrough therapy designation by the FDA in September 2018 for severe asthma.

Dose escalation data of AMG 510, a small molecule KRAS G12C inhibitor, in patients with solid tumors, will be presented at ASCO in June 2019. Also to be presented are updated dose escalation data of AMG 420, a BiTE (bi-specific T-cell engager) immunotherapy targeting B-cell maturation antigen (BCMA), in patients with relapsed/refractory multiple myeloma and dose escalation data of AMG 212, a BiTE immunotherapy targeting prostate-specific membrane antigen (PSMA), in patients with metastatic castration-resistant prostate cancer.

Amgen has 13 Bite programs in progress, including AMG 562, AMB 427, AMG 420, AMG 673, AMG 701, AMG 757, and AMG 330. AMG 420 presented first data (70% response rate) in Q4, as did AMG 330.

Seven first in class studies were initiated in Q3 2018: AMG 119, 397, 424, 427, 510, 562, 1n3 890. 510 first data should come in by midyear 2019.

AMG 594, a cardiac troponin activator, is advancing to Phase 1 for heart failure. AMG 890 continued a Phase 1 study for cardiovascular patients with elevated Lp(a). It is an siRNA molecule.

See also the Amgen pipeline.

GAAP cost of sales was $1.06 billion. Research and development expense was $0.88 billion; selling general and administrative expense $1.15 billion; and other expense $0.0 million, for total operating expenses of $3.09 billion. Operating income was $2.47 billion. Interest and other expense net was $158 million, income taxes $322 million.

Q&A:

KRAS dose escalation speed? We will present the data at ASCO, we were able to more through that quickly based on tolerability. We had pre-identified potential patients.

PD-1 combinations? It is early, we are moving quickly to investigate both monotherapy and combinations therapies, PD-1 and others.

Part B demonstration project? It is a proposed rule. Many groups have commented to the administration. We have expressed our concerns. We do not want access of patients to new medicines impeded. In the U.S. patients get rapid access to new patients, much better than in France, for instance. The rule would impair investments in innovation. We are supporting other, better measures.

Neulasta price drop, trend going forward? We are pleased how we are performing against biosimilar competitors. But we expect further price and share erosion, particularly when new entrants hit the market.

Believes can compete effectively with Aimovig and the population that can benefit is large. Working through the free drug to paid transition.

Our 2019 guidance is still quite broad because we don't know if there will be new Sensipar competition launches, which depends on court ourcomes.

Humira biosimilar in Europe vs. competitors? We are seeing more rapid penetration. We are seeing higher volume, but lower prices than we expected. We see our biosimilar business as a significant revenue driver.

Aimovig data coming up is long-term data for chronic migraine, where we showed that two-thirds of patients were able to reduce to episodic, which is a very significant impact. Also, some patients are complete responders.

Enbrel IP case? If judgement goes against us we will appeal.

Aimovig case? We feel our partner is enabling a competitor product, we have a clause in the contract, so we are in court.

We are seeing persistence effects for Aimovig that we did not see in the trials, it will take us some time to understand it.

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