Despite another profitable quarter, the YTD performance and Q4 outlook comments, Alvotech reiterated its full-year sales guidance with the Q3 results, which seems slightly conservative to us. The pipeline is evolving as expected, and we believe several new products should reach the market in the coming years, with the biosimilar to Stelara slated for a US launch in late February. We reiterate our BUY and USD21 target price.
While up 7% YOY (currency-neutral sales growth 5.3%), revenues of NOK132.8m were below our forecast of NOK136m. The EBIT margin of 24% (Q3 2023: 27%) also fell shy of our forecast of 28.6%. We still see signs that the company’s ‘going direct’ efforts should eventually bear fruit, but we now believe their effect on the revenue side and on margins will take longer to materialise than we initially expected. We also note the cardiac segment is seeing slower progress than we expected, causing us conc...
Q2 revenues were cUSD199m, in line with our estimate, and adj. EBITDA was cUSD102m, slightly above our forecast. While revenues were as expected driven by large milestone payments, product sales also saw strong growth (c190%+ YOY for H1 and c660%+ for Q2), in line with our expectation. We reiterate our BUY and USD21 target price.
Revenues of NOK144.9m were a quarterly record-high, up 5.5% YOY (currency-neutral sales +4.1%) and above our NOK135m estimate. The EBIT margin (28.5%) expanded further from its low in Q4 2023 (16.4%) and, while we believe it will continue to ‘normalise’, the company’s ‘going direct’ efforts will likely prevent it from rising significantly short-term. However, we believe these efforts are moving in the right direction, validating the strategy. We have upgraded to BUY (HOLD) but we reiterate our N...
With its fiscal Q1 report, Alvotech increased its full-year guidance for revenues and the lower end of the guided adj. EBITDA range. Q1 product sales were somewhat soft YOY and QOQ; however, Simlandi (Humira biosimilar) was not officially launched in the US until May. We expect a strong Q2 given recently signed deals (for private-label shipments of AVT02 to the US market and out-licensing of AVT03 to Dr. Reddy’s). We reiterate our BUY and USD21 target price.
Revenues grew 3.5% YOY in Q1 (currency-neutral total sales grew 2.2%), below our estimate c6%. The EBIT margin of 24% was almost back to normal and in our view shows the low margin in Q4 2023 (16.4%) should be seen as a one-off. However, we remain concerned about revenue growth, especially in the Americas, after the fifth consecutive quarter of declining currency-neutral sales. Thus, while we reiterate our HOLD, we have lowered our 2024–2026e sales by c3–8% and cut our target price to NOK190 (21...
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).
Revenues were down in all regions in Q4, with currency-neutral total sales down c13.7% YOY. Due to various strategic initiatives, the EBIT margin was unusually low in the quarter, but we expect it to gradually come back to ‘normal’ levels of 25–30%. However, we have lowered our sales estimates, downgraded to HOLD and lowered our target price to NOK210 (260).
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 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...
Medistim’s Q3 sales growth of 6.5% YOY was helped by favourable currency. Currency-neutral sales growth was negative, especially in the Americas, causing us to cut our sales estimates (especially in this region). Following adjustments of our sales forecasts, we have lowered our target price to NOK260 (290), but reiterate our BUY.
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).
Medistim reported Q2 sales and EBIT above our estimates, but the company benefited from favourable currency effects. Despite the temporarily increased expenses related to the establishment of direct-sales operations, the EBIT margin remained above 30%. We reiterate our BUY and NOK290 target price.
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...
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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