Analyst Conference Summary

biotechnology

conference date: May 28, 2024
for quarter ending: March 31, 2024 (first quarter, Q1)

Forward-looking statements

Overview: Revenue from Aphexda ramping, but slowly.

Basic data (GAAP):

Revenue was $6.9 million, up from $0 year-earlier.

Net income was negative $0.7 million, up from negative $12.2 million year-earlier.

Earnings per share, diluted, (EPS) was $0.00, up from negative $0.01 year-earlier.

Note: American Depository Shares traded on NASDAQ appear to represent 15 ordinary shares in the Israeli company SEC filings. The EPS listed on press releases seems to correspond to ordinary shares, so would be 15X if listed for ADS shares.

Guidance:

none

Conference Highlights:

Philip Serlin, CEO of BioLineRx, said "In this first full quarter post Aphexda approval, we were pleased by the steady growth in adoption and repeat purchases by transplant centers, which is consistent with our expectations during this foundational period. This growth comes as we see continued increases in the number of transplant centers that have completed Pharmacy and Therapeutics committee reviews and granted approval for Aphexda usage. As a reminder, end users of Aphexda are well defined, with 80 of the 212 U.S. transplant centers performing approximately 85% of all transplant procedures. Importantly, among these top 80 transplant centers, we have secured formulary placement to date at institutions representing ~26% of stem cell transplant procedures performed, keeping us on track to reach our stated goal of 35% by the end of Q2." Feedback from transplant centers has been positive. Greater certainty of success with Aphexda is very appealing, leading to lower overall costs and better outcomes.

Evaluating Aphexda for supporting sickle cell gene therapies in a Phase 1 trial, with data in 2024. Continues Phase 2 programs in pancreatic cancer combined with a PD-1 inhibitor.

Revenue consisted of $0.9 million for Aphexda and $5.9 million from Gloria Biosciences for the new license agreement and a milestone payment.

Launch activities for Aphexda for stem cell mobilization in multiple myeloma continue. Currently about 8,000 stem cell transplants for multiple myeloma currently occur annually. Many patients have trouble getting their stem cells collected. Aphexda is a highly diffentiated, second generation mobilization agent. Competition is the first generation agent and its biosimilars. $5,900 price per vial set for Aphexda, which is significantly more than the generics, but still saves costs given its efficacy. Aphexda now included in NCCN guideline. ASTCT also working on updating its guidelines. In Q2 2024, among the top 80 transplant centers, secured formulary placement at institutions representing ~26% of stem cell transplant procedures performed and is on track to reach stated goal of ~35% by end of Q2 and ~60% by year-end 2024.

The FDA approved Aphexda (motixafortid), in combination with filgrastim, for stem cell mobilization in patients with myeloma, in September 2023. More data was presented at ASH on December 10, 2023.

In Q3 agreed with Gloria Biosciences to partner Aphexda in China, beginning with a bridging study. In February an IND was filed for the bridging study needed for the Asian approval, which is expected to begin in 2H 2024. A few Asian nations do not require the study to proceed and revenue could begin in 2H 2024. China has the largest number of multiple myeloma cases of any nation.

Gloria is also partnering for the study of Aphexa for first-line pancreatic cancer, in combination with a PD-1 inhbitor. In Q3 2023 presented Phase 2 data at AACR. Pilot phase was successful, with 7 of 11 patients getting partial responses. 3 more had disease control. Columbia University and Regeneron with BiolinxRx are expanding into a randomized Phase 2b study, which had its first patient dosed in February 2024. Early Phase 2 data will be presented on June 1, 2024 at ASCO. Gloria also partnering in pancreatic cancer.

In Q3 2023, BiolineRX began Phase 1 enrollment at Washington University for Aphexda for stem cell mobilization in sickle cell gene therapies. The current cell collection therapies are less than optimal for sickle cell.

The other item in the pipeline is AGI-134, a solid tumor immunotherapy. The positive results of a Phase 1/2a study had been announced in Q4 2022.

In Q2 2024 accessed $20 million from the BlackRock lending agreement and completed a $6 million equity offering.

Cash and equivalents ended at $28.2 million, down sequentially from $43 million. Had about $10 million in debt. After the quarter ended received $6 million from a stock offering and $20 million from the BlackRock loan.

Operating expenses consisted of: Cost of sales $1.5 million; R&D $2.5 million; sales/marketing $6.3 million; G&A $1.4 million. Operating loss $4.8 million. Other income $4.5 million. Finanical Expense net $0.4 million.

Q&A, selective summary:

Aphexda launch top factors? The lowered chair time is the top positive factor. Clinical benefit, number of stem cells mobilized per session, also is positive. Which we expected from Phase 3 data.

Formulary committee meetings timing? No phasing by quarter by year, most centers hold these meetings monthly. But it is a multi-step process. Our field teams are hard at work on this.

Centers not currently in target group? 86% of transplants occur in targetted centers. The extended effort to get the remaining 14% is not very efficient. These centers are often not using a boosting agent. But at some point there could be value in sales to them.

In gene therapy we are having active talks with potential partners, including for trials.

We expect gross margins to remain in excess of 90%.

Drug manufacturing and supply? We are well set.

We have not seen instances of denial for Aphexda.

OpenIcon Analyst Conference Summaries Main Page

Search

More Analyst Conference Pages: