Oncopeptides (No_rec, TP: SEK) - Rights issue announced

Oncopeptides this morning announced plans for a cSEK300m fully guaranteed rights issue. This should not come as a surprise to the market as the company was very clear in its Q4 report that it had financial resources to last into Q2 2024. Due to DNB Markets’ role in the rights issue, we have withdrawn our target price and recommendation.

Oncopeptides (Hold, TP: SEK5.50) - US not an option, focus on Europe

In line with our base-case scenario, the FDA has withdrawn the accelerated approval for Pepaxto in the US. As a result, the focus is now growth in Europe, where it has full approval. Q4 earnings were weaker than we expected, but we believe the sales trend is moving in the right direction. We reiterate our HOLD, but have lowered our target price to SEK5.5 (7).

Oncopeptides (Hold, TP: SEK7.00) - Europe launch progressing

Q3 sales were slightly below our forecast. However, Q4 seems to be off to a good start (almost as many vials sold in October as in Q3). A new official price is in place in Germany, with which Oncopeptides is satisfied (we had expected a higher price). The company said its liquidity would take it to end-Q2 next year, and thus we believe the financial risks are increasing. We reiterate our HOLD but have cut our target price to SEK7 (8.5).

Northern Lights

Oncopeptides (Hold, TP: SEK8.50) - Downgraded to HOLD

Q2 product sales were in line with our forecast; however, we believe a Pepaxti roll-out in Europe will take longer than previously anticipated and that a potential Type 2 variation is now of less value. Oncopeptides is appealing the FDA’s formal request for the withdrawal of Pepaxto from the US market, and expects a response from the agency in H2. We have cut our target price to SEK8.5 (15) (our target price includes potential dilution from future share issues). Given the limited potential upsid...

Oncopeptides (Buy, TP: SEK15.00) - Growing its market presence

Oncopeptides reported its Q1 results on 4 May. Sales, but also operating expenses, were lower than we expected (mainly due to a repayment of R&D costs). The company said its plan, based on the activities in Europe only, would take it to profitability in 2026, one year later than we initially expected. Our forecasts include additional capital raises in 2023 and 2024 (and the corresponding dilution). Based on our forecast adjustments, we reiterate our BUY but have cut our target price to SEK15 (22...

Northern Lights

Oncopeptides (Buy, TP: SEK22.00) - First Pepaxti sales in Europe

Oncopeptides reported an operating loss in Q4, but also booked the first (limited) sales of Pepaxti in Germany. However, we expect a slow ramp up given sales and marketing activities and launch “pressure testing” are ongoing; as a result we have cut our Pepaxti sales growth forecasts. In addition, we now assume Oncopeptides will go it alone rather than out-license Pepaxti. We reiterate our BUY but have cut our target price to SEK22 (28).

Oncopeptides (Buy, TP: SEK28.00) - Launch in Germany

The Q3 report contained no big surprises. While SG&A costs were above our estimate, this is explained by the start of EU commercialisation. The company indicated a target population in the region implying cUSD150m–200m in annual revenues. We have tweaked our cost estimates and reiterate our BUY and SEK28 target price.

Sector Fast Comment - Hospital data update

Better hospital margins in September Weaker procedure volume momentum into Q4 Small positive for capex exposure

Oncopeptides - Q3 report neutral: December a defining month

No material updates in the Q3 report Onco projects: SEK 1.5-2bn EU sales, ABG at SEK 1.5bn Q3 neutral to case: FDA update & GSK data in mid-Dec

Oncopeptides - DREAMM-3 turns into a nightmare for GSK

GSK’s OCEAN replica shows worse OS (HR: 1.114) Lack of age sub-group data limits read-across for now More data possible at ASH; slight positive for Onco

Oncopeptides - When it can’t get worse, it can only get better

ABGSCe & market already pricing Onco ex-US market… …while lack of update suggests FDA bartering underway Up to HOLD on limited downside & slim upside potential

Oncopeptides (Buy, TP: SEK28.00) - US out of the picture

We believe the Oncologic Drugs Advisory Committee (ODAC) meeting put the final nail in the coffin for Pepaxto in the US last night. While the FDA has not announced a final decision, we believe the odds are very much stacked against Pepaxto, and for Oncopeptides in the US at this stage. As a result, we have removed the US from our forecasts, but also trimmed potential uptake in Europe. Nevertheless, we believe the negative share price reaction in recent days is overdone, and reiterate our BUY, bu...

Oncopeptides - A day late and a dollar short

ODAC votes 14 to 2 against Pepaxto Sales alongside new Ph 3 even less likely; cripples case Upside to TP 12/share relies on external luck; Steer clear

Oncopeptides - Anticipated trouble turns into FDA rubble

Briefing documents even worse than feared Best case is new Ph 3, but likely without parallel 5L sales We exclude US market: SELL (Hold), TP SEK 12/share

Oncopeptides - Is the juice worth the squeeze?

KOLs inform retake on market; USD 500m sales potential But licensing deal & commercial headwinds cap LT value ODAC turbulence ahead – HOLD (Buy), TP of SEK 43

Sector Fast Comment - Entering a new era of US drug price control

Pushes and pulls in Biden’s Inflation Reduction Act 2022 Max impact ’26–early ’30s, possible mitigations thereafter Negative but manageable for AZN, biotech largely spared

Oncopeptides (Buy, TP: SEK55.00) - All the right moves

Q2 was a truly transformative quarter for Oncopeptides. It received a positive opinion from the CHMP (meaning lead candidate melflufen should receive full approval within weeks), it raised cSEK436m at market price, securing its financial runway for the next 12 months (at least) we believe, and, discussions with the FDA are progressing (an ODAC meeting is scheduled for 22 September). We have now included a return to the US market (with a reasonable probability); we reiterate our BUY and have rais...

Oncopeptides - Eyes on the FDA and commerical potential

No material updates in the Q2 report Solid cost control, opex to rise in coming quarters ODAC on Sep 22 the next material milestone