Alvotech (Buy, TP: USD21.00) - Strong fiscal 2024–2025 guidance

Alvotech reported fiscal Q4 2023 earnings and hosted a CMD late last week. These were broadly in line with our expectations, but also rather a non-event given the late reporting and developments that have taken place in Q1 (approval of AVT02 in the US), and approval of AVT04 in the US, expected in April. Guidance for 2024 (and 2025) was stronger than we had expected. Overall, we reiterate our BUY and have raised our target price to USD21 (19).

Alvotech (Buy, TP: USD19.00) - Simlandi approved in the US

Over the weekend, Alvotech announced that the FDA has finally approved Simlandi (AVT02) for sale in the US after its latest inspection of the facility in Reykjavik. We consider this a key event, as Simlandi will be the first biosimilar to Humira in the US, which for the high-concentration formulation (c88% of Humira use is high-concentration in the US) is citric-free and has approved interchangeability. We reiterate our BUY and have raised our target price to USD19 (11).

Alvotech (Buy, TP: USD11.00) - Key FDA inspection in January 2024

Alvotech reported slightly lower Q3 revenues than we expected, and the operating costs were also higher than we forecast. However, we believe the most important event in the coming months will be the FDA inspection of the manufacturing facility in Iceland, which if successful, would probably be the last item needed to receive approval for AVT02 (Humira biosimilar) and AVT04 (Stelara biosimilar) in the US. We reiterate our BUY but have reduced our target price to USD11 (11.5) on our forecast adju...

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Alvotech (Buy, TP: USD11.50) - Product sales on the weak side

Alvotech reported lower than expected Q2 product sales of AVT02, but indicated we should see a rebound in the coming quarters. As for the ongoing registration process for AVT02 in the US, the company recently resubmitted its BLA and a new BsUFA date should be in early 2024. Moreover, the company is ready for a re-inspection of its manufacturing facility in Reykjavik. We reiterate our BUY but have cut our target price to USD11.5 (13).

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Alvotech (Buy, TP: USD13.00) - Another CRL for AVT02 in the US

Alvotech reported late last week that it has received another CRL for the second BLA regarding AVT02 (Humira high-concentration biosimilar with interchangeability). In our view, this is bad news, as a re-inspection of the Reykjavik facility seems necessary and a re-filing of the BLA (triggering a 6-month review period) should lead to an approval in early 2024 (the original plan was to launch in early July this year). The delayed launch will trigger a need for additional cash, and the company hig...

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Alvotech (Buy, TP: USD13.00) - Uncertainty for AVT02 remains

Alvotech reported somewhat lower Q1 earnings than we expected. However, 2023 is set to be back-end loaded, especially on the milestone revenues. There were no timelines presented on the CRL for AVT02 in the US; thus, the uncertainty remains on when the product could be approved and launched. However, Alvotech revealed two new projects in the pipeline, biosimilars for pembrolizumab and vedolizumab. We reiterate our BUY but have cut our target price to USD13 (15).

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Alvotech (Buy, TP: USD15.00) - CRL for AVT02 in the US

Alvotech said on Friday it had received a CRL for the approval application for AVT02 (adalimumab biosimilar) after the FDA’s facility inspection in Reykjavik. This is clearly negative news and introduces high uncertainty in the stock until the manufacturing issues have been resolved. The CRL included no issues relating to the clinical data for AVT02, which was good. Given the CRL and risk of a delayed launch of AVT02 in the US, we have cut our target price to USD15 (19) but reiterate our BUY.

Alvotech (Buy, TP: USD19.00) - FDA inspection likely next catalyst

Alvotech reported 2022 sales and adj. EBITDA at the lower end of its guidance but provided no 2023 guidance (likely with the Q2 report when the outcome of the US approval process for AVT02 is known). Given the high clinical activity (three projects in clinical development), we have increased our operating cost forecasts for the coming years. Moreover, we have reduced our top-line forecasts on the lower-than-expected 2022 revenues. We reiterate our BUY and USD19 target price.

Alvotech (Buy, TP: USD19.00) - In launch mode

Alvotech is still in the early phase of the launch of its first biosimilar (AVT02 – a biosimilar for Humira), which has launched in 16 markets with the majority becoming active in late-Q3. It expects a new facility inspection in early Q1 and hopes to settle the CRL for the US market in late-Q, leading to a full US launch on 1 July, although the risk of a delay is increasing. We reiterate our BUY but have cut our target price to USD19 (21).

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Alvotech (Buy, TP: USD21.00) - First quarter as a listed company

H1 earnings were in line with our expectations, adjusted for one-off items. The focus in H2 will be on the sales trend for AVT02 (Humira biosimilar) in Europe and the progress of its filing in the US, as well as other pipeline developments. Thus far, we believe the company has delivered on its pipeline. Hence, we reiterate our BUY and USD21 target price.

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Alvotech - Initiation of coverage - Pure biosimilar exposure

Alvotech focuses solely on developing biosimilars, a market that Evaluate Pharma estimates is worth USD85bn. Based on its corporate structure and with a pipeline of six disclosed projects and two to be confirmed, while it only recently listed, we believe Alvotech is on course for very healthy margins. We initiate coverage with a BUY and USD21 target price.