REMEGEN(9995.HK):AWAITING THE FRUITION OF OVERSEAS BD COLLABORATIONS
REMEGEN(9995.HK):AWAITING THE FRUITION OF OVERSEAS BD COLLABORATIONS
RemeGen recorded RMB1.08bn of revenue in FY23, including RMB1.05bn from product sales (+42% YoY), contributed equally by RC18 and RC48. In FY23, GP margin (vs product sales) increased to 76.9% (vs 63.4% in FY22). Selling expense ratio (vs product sales) increased from 60% in FY22 to 74% in FY23, mainly due to an increase in sales headcount. In FY23, R&D expenses rose by 33% YoY to RMB1,306mn, due to the spending in late-stage trials. RemeGen recorded a wider attributable net loss of RMB1,511mn in FY23 (vs RMB999mn in FY22). As of end-2023, RemeGen had a cash balance of RMB727mn, and mgmt. claimed about RMB4.4bn in bank credit. Mgmt. believes that the current funding levels will sustain business operations for a minimum of two years. Additionally, RemeGen recently announced plans to raise up to RMB2.55bn by issuing additional A-shares.
榮昌生物在23財年錄得10.8億元人民幣的收入，其中包括來自產品銷售的10.5億元人民幣（同比增長42％），由RC18和RC48等額貢獻。在23財年，GP利潤率（與產品銷售額相比）增至76.9％（22財年爲63.4％）。銷售費用比率（相對於產品銷售額）從22財年的60％上升到23財年的74％，這主要是由於銷售人員的增加。在23財年，研發費用同比增長33％，至人民幣13.06億元，這要歸因於後期試驗的支出。榮興通訊在23財年錄得更大的應占淨虧損爲15.11億元人民幣（而22財年爲9.99億元人民幣）。截至2023年底，榮昌生物的現金餘額爲人民幣7.27億元，管理層申請了約44億元人民幣的銀行信貸。Mgmt. 認爲，目前的資金水平將維持業務運營至少兩年。此外，RemeGen最近宣佈計劃通過發行額外的A股籌集高達25.5億元人民幣的資金。
Expect sales to ramp-up quickly in 2024. RemeGen set a FY24 product sales target of at least a 50% YoY increase. We remain positive toward the guidance because: 1) sales of both RC18 and RC48 have performed strongly YTD as per mgmt; 2) the newly added salesforce in 2023 may start to contribute significantly to sales in 2024; and 3) the inclusion of RC18 in over 300 new top-grade hospitals and RC48 in over 200 new top-grade hospitals in 2023 should boost product sales. We expect RC18 and RC48 to experience an uptake in FY24, with RC18 taking a slight lead.
預計銷售將在2024年迅速增長。榮昌生物設定了24財年的產品銷售目標，即同比增長至少50％。我們對該指導方針仍然持樂觀態度，因爲：1) 根據管理數據，RC18和RC48的銷售額年初至今均表現強勁；2) 2023年新增的銷售隊伍可能開始爲2024年的銷售做出重大貢獻；3) 2023年將RC18納入300多家新的頂級醫院，將RC48納入200多家新的頂級醫院，這將促進產品銷售。我們預計，RC18和RC48將在24財年獲得回升，而RC18將略有領先。
Looking forward to next step of RC18's global development. The first stage of RC18's Ph3 global SLE trial has completed enrolment of 90 patients. RemeGen is internally discussing whether to unblind the first-stage study or keep it blinded as part of the second stage. The company expects to start enrolling for the second stage of the Ph3 study by mid-2024, which will be followed by another Ph3 study as required by the FDA. If the data from the first-stage study are released, we believe it could serve as a strong catalyst for RC18's global development strategy and potential out-licensing deals. If kept blinded, it could expedite RC18's global development. Additionally, a Ph3 trial of RC18 in MG is ongoing in the US with a Ph3 pSS trial in planning.
期待RC18全球發展的下一步。RC18的Ph3全球系統性紅斑狼瘡試驗的第一階段已經完成了90名患者的入組。RemeGen內部正在討論是對第一階段研究進行解盲還是將其作爲第二階段的一部分保持盲狀態。該公司預計將在2024年中期開始報名參加第二階段的Ph3研究，隨後將按照FDA的要求進行另一項Ph3研究。如果第一階段研究的數據公佈，我們認爲它可以成爲RC18全球發展戰略和潛在的外包許可協議的強大催化劑。如果保持盲目狀態，它可能會加快RC18的全球發展。此外，美國正在MG進行RC18的Ph3試驗，並計劃進行Ph3 PS試驗。
Awaiting overseas BD collaborations. We believe that RC18 remains the foremost candidate for international BD partnerships. We think RC18 could still be the top priority of overseas BD collaboration. RC88 (MSLN ADC) received a fast track designation from the FDA, with PoC data to be released at ASCO in Jun. RemeGen plans to start a Ph2 MRCT study in the US, EU, China, etc. The prospects for RC88 to secure an out-licensing agreement are promising. We think that revenue streams from such BD collaborations will play a crucial role in underpinning RemeGen's robust growth trajectory.
正在等待海外的BD合作。我們認爲，RC18仍然是國際BD合作伙伴關係的首要候選者。我們認爲RC18仍可能成爲海外BD合作的重中之重。RC88（MSLN ADC）獲得了美國食品藥品管理局的快速通道認證，PoC數據將於6月在ASCO公佈。瑞美進計劃在美國、歐盟、中國等地啓動Ph2 MRCT研究。RC88獲得對外許可協議的前景看好。我們認爲，這種業務合作的收入來源將在支撐RemeGen的強勁增長軌跡方面發揮至關重要的作用。
Maintain BUY. We expect RC18 and RC48 to regain strong sales momentum in 2024 and beyond. We revise our DCF-based TP from HK$57.65 to HK$41.72 (WACC: 11.33%, terminal growth rate: 2.0%).
維持買入。我們預計，RC18和RC48將在2024年及以後恢復強勁的銷售勢頭。我們將基於差價合約的目標股價從57.65港元上調至41.72港元（WACC：11.33％，終端增長率：2.0％）。
譯文內容由第三人軟體翻譯。