Episurf Medical AB B(EPIS B)
(EPIS B)
Q4-rapport
69 dagar sedan‧11min
0,00 SEK/aktie
Senaste utdelning
Orderdjup
Stängd
Antal
Köp
103
Sälj
Antal
18 574
Senaste avslut
| Tid | Pris | Antal | Köpare | Säljare |
|---|---|---|---|---|
| 56 | - | - | ||
| 707 | - | - | ||
| 6 750 | - | - | ||
| 1 555 | - | - | ||
| 1 313 | - | - |
Volymvägt snittpris (VWAP)
0,703VWAP
0,703Omsättning (SEK)
693 651Mäklarstatistik
Ingen data hittades
Företagshändelser
| Nästa händelse | |
|---|---|
| 2024 Q1-rapport | 24 apr. 6 dagar |
| Tidigare händelser | ||
|---|---|---|
| 2023 Årsstämma | 9 apr. | |
| 2023 Q4-rapport | 9 feb. | |
| 2023 Q3-rapport | 27 okt. 2023 | |
| 2023 Q2-rapport | 14 juli 2023 | |
| 2022 Årsstämma | 2 maj 2023 |
Data hämtas från Millistream, Quartr
Nyheter & Analyser
Nyheter och/eller generella investeringsrekommendationer alternativt utdrag därav på denna sida och relaterade länkar är framtagna och tillhandahålls av den leverantör som anges. Nordnet har inte medverkat till framtagandet, granskar inte och har inte gjort några ändringar i materialet. Läs mer om investeringsrekommendationer.
Q4-rapport
69 dagar sedan‧11min
Nyheter & Analyser
Nyheter och/eller generella investeringsrekommendationer alternativt utdrag därav på denna sida och relaterade länkar är framtagna och tillhandahålls av den leverantör som anges. Nordnet har inte medverkat till framtagandet, granskar inte och har inte gjort några ändringar i materialet. Läs mer om investeringsrekommendationer.
Företagshändelser
| Nästa händelse | |
|---|---|
| 2024 Q1-rapport | 24 apr. 6 dagar |
| Tidigare händelser | ||
|---|---|---|
| 2023 Årsstämma | 9 apr. | |
| 2023 Q4-rapport | 9 feb. | |
| 2023 Q3-rapport | 27 okt. 2023 | |
| 2023 Q2-rapport | 14 juli 2023 | |
| 2022 Årsstämma | 2 maj 2023 |
Data hämtas från Millistream, Quartr
Shareville
Delta i diskussionerna på SharevilleFå inspiration från tusentals portföljer och diskutera med andra duktiga investerare.
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Man skal ikke bli forelsket i en aksje men det er vel lov med litt mancrush på vd? https://twitter.com/palryfors/status/1476680079405199364
The Q2 report was essentially in line with our expectations. Episurf plans to file for a 510(k) clearance in the US in Q4 for the Patellofemoral implant system. There have been some delays in the EPIC knee trial and we have pushed the completion and subsequent launch back c1 year (launch in the US in 2025). We have lifted our fair value for the shares to SEK2.7-8.2 (previously SEK2.5-8). Q2 report essentially in line with our expectations. The company reported revenues of SEK2.1m (our estimate: cSEK2m). Product sales were cSEK2m (our estimate: cSEK1.9m). Sales were up by c233% YOY but Q2 last year was hurt by the pandemic outbreak. Overall costs were essentially in line with our estimates and at quarter-end, the company had cSEK121m in cash on the balance sheet. New markets added to the sales organisation. During H1, the company added several new distributor markets to its sales organisation. Among others, the company struck agreements in Australia, New Zealand, Portugal, and Spain. In addition, it recently announced a distribution agreement in the UK to complement its own sales reps. It also hired a sales rep in the Benelux region. EPIC Knee trial delayed. We believe the EPIC knee trial (the US PMA trial for the Episealer Implant System) is delayed. The combination of the pandemic and too-strict inclusion criteria for the trial appear to have made it hard to recruit patients. However, protocol amendments should be in place during the autumn and all paperwork (ethics committees, etc) should be completed so new patients could be operated on according to the amended protocol in Q4 this year. We estimate that this has led to a c1 year delay from our original forecast to get the implant system approved and launched in the US. Might reach the US market in 2022. Despite the delay in EPIC knee, we believe the Patellofemoral implant product could reach the market in the US next year, as this product needs only a 510(k) clearance and the company plans to submit the application in Q4 this year (normally a 90-day process). We believe the company will hire a few staff in a US subsidiary but work mainly with one or more of the independent distributor networks available in the US. New fair value of SEK2.7-8.2/share. We believe the company is moving in the right direction, with growth in its clinical documentation set to continue into 2022. The new patella implant product could add revenues earlier than previously forecast and allow entry into the US market sooner than with the Episealer implant system. We believe its financial position is stable, and its cash should take it into 2023. Click here to view full report (https://www.dnb.no/seg-fundamental/fundamentalweb/GetReports.aspx?file=CMPSP_178712.pdf&Sid=1-7XT0MIJ) Best regards- Episurf Medical (NASDAQ: EPIS B) today announces that the development of the companys Episealer Patellofemoral System is progressing according to plan. The previously communicated plan to submit a 510(k) application before the end of the year to the US FDA for US market clearance is still valid. The design for the system is now set and final device testing is presently being conducted. Episealer Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint. Simultaneously, the company is preparing for a commercial launch in the US of the Episealer Patellofemoral System during 2022. Our excitement about this project is growing as we are approaching filing of the 510(k) as well as the subsequent commercialisation in the US market. We will then enter the largest orthopaedic market in the world, which will be a tremendous milestone for us, comments Pål Ryfors, CEO Episurf Medical. For more information, please contact: Pål Ryfors, CEO, Episurf Medical Tel:+46 (0) 709 62 36 69 Email: pal.ryfors@episurf.com
Kommentarerna ovan kommer från användare på Nordnets sociala nätverk Shareville och har varken redigerats eller på förhand granskats av Nordnet. Det innebär inte att Nordnet tillhandahåller investeringsrådgivning eller investeringsrekommendationer. Nordnet påtar sig inget ansvar för kommentarerna eller eventuella felaktigheter i automatiska översättningar.
Q4-rapport
69 dagar sedan‧11min
0,00 SEK/aktie
Senaste utdelning
Nyheter & Analyser
Nyheter och/eller generella investeringsrekommendationer alternativt utdrag därav på denna sida och relaterade länkar är framtagna och tillhandahålls av den leverantör som anges. Nordnet har inte medverkat till framtagandet, granskar inte och har inte gjort några ändringar i materialet. Läs mer om investeringsrekommendationer.
0,00 SEK/aktie
Senaste utdelning
Shareville
Delta i diskussionerna på SharevilleFå inspiration från tusentals portföljer och diskutera med andra duktiga investerare.
Logga in
- Man skal ikke bli forelsket i en aksje men det er vel lov med litt mancrush på vd? https://twitter.com/palryfors/status/1476680079405199364
- The Q2 report was essentially in line with our expectations. Episurf plans to file for a 510(k) clearance in the US in Q4 for the Patellofemoral implant system. There have been some delays in the EPIC knee trial and we have pushed the completion and subsequent launch back c1 year (launch in the US in 2025). We have lifted our fair value for the shares to SEK2.7-8.2 (previously SEK2.5-8). Q2 report essentially in line with our expectations. The company reported revenues of SEK2.1m (our estimate: cSEK2m). Product sales were cSEK2m (our estimate: cSEK1.9m). Sales were up by c233% YOY but Q2 last year was hurt by the pandemic outbreak. Overall costs were essentially in line with our estimates and at quarter-end, the company had cSEK121m in cash on the balance sheet. New markets added to the sales organisation. During H1, the company added several new distributor markets to its sales organisation. Among others, the company struck agreements in Australia, New Zealand, Portugal, and Spain. In addition, it recently announced a distribution agreement in the UK to complement its own sales reps. It also hired a sales rep in the Benelux region. EPIC Knee trial delayed. We believe the EPIC knee trial (the US PMA trial for the Episealer Implant System) is delayed. The combination of the pandemic and too-strict inclusion criteria for the trial appear to have made it hard to recruit patients. However, protocol amendments should be in place during the autumn and all paperwork (ethics committees, etc) should be completed so new patients could be operated on according to the amended protocol in Q4 this year. We estimate that this has led to a c1 year delay from our original forecast to get the implant system approved and launched in the US. Might reach the US market in 2022. Despite the delay in EPIC knee, we believe the Patellofemoral implant product could reach the market in the US next year, as this product needs only a 510(k) clearance and the company plans to submit the application in Q4 this year (normally a 90-day process). We believe the company will hire a few staff in a US subsidiary but work mainly with one or more of the independent distributor networks available in the US. New fair value of SEK2.7-8.2/share. We believe the company is moving in the right direction, with growth in its clinical documentation set to continue into 2022. The new patella implant product could add revenues earlier than previously forecast and allow entry into the US market sooner than with the Episealer implant system. We believe its financial position is stable, and its cash should take it into 2023. Click here to view full report (https://www.dnb.no/seg-fundamental/fundamentalweb/GetReports.aspx?file=CMPSP_178712.pdf&Sid=1-7XT0MIJ) Best regards
- Episurf Medical (NASDAQ: EPIS B) today announces that the development of the companys Episealer Patellofemoral System is progressing according to plan. The previously communicated plan to submit a 510(k) application before the end of the year to the US FDA for US market clearance is still valid. The design for the system is now set and final device testing is presently being conducted. Episealer Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint. Simultaneously, the company is preparing for a commercial launch in the US of the Episealer Patellofemoral System during 2022. Our excitement about this project is growing as we are approaching filing of the 510(k) as well as the subsequent commercialisation in the US market. We will then enter the largest orthopaedic market in the world, which will be a tremendous milestone for us, comments Pål Ryfors, CEO Episurf Medical. For more information, please contact: Pål Ryfors, CEO, Episurf Medical Tel:+46 (0) 709 62 36 69 Email: pal.ryfors@episurf.com
Kommentarerna ovan kommer från användare på Nordnets sociala nätverk Shareville och har varken redigerats eller på förhand granskats av Nordnet. Det innebär inte att Nordnet tillhandahåller investeringsrådgivning eller investeringsrekommendationer. Nordnet påtar sig inget ansvar för kommentarerna eller eventuella felaktigheter i automatiska översättningar.
Orderdjup
Stängd
Antal
Köp
103
Sälj
Antal
18 574
Senaste avslut
| Tid | Pris | Antal | Köpare | Säljare |
|---|---|---|---|---|
| 56 | - | - | ||
| 707 | - | - | ||
| 6 750 | - | - | ||
| 1 555 | - | - | ||
| 1 313 | - | - |
Volymvägt snittpris (VWAP)
0,703VWAP
0,703Omsättning (SEK)
693 651Mäklarstatistik
Ingen data hittades
Företagshändelser
| Nästa händelse | |
|---|---|
| 2024 Q1-rapport | 24 apr. 6 dagar |
| Tidigare händelser | ||
|---|---|---|
| 2023 Årsstämma | 9 apr. | |
| 2023 Q4-rapport | 9 feb. | |
| 2023 Q3-rapport | 27 okt. 2023 | |
| 2023 Q2-rapport | 14 juli 2023 | |
| 2022 Årsstämma | 2 maj 2023 |
Data hämtas från Millistream, Quartr