Has the Australian Biotech Industry valuation changed over the past few years?

Investors are relatively neutral on the Australian Biotechs industry at the moment, indicating that they anticipate long term growth rates to remain steady. The industry is trading close to its 3-year average PE ratio of 42.1x. The 3-year average PS ratio of 5.6x is higher than the industry's current PS ratio of 2.7x.

Which industries have driven the changes within the Australian Healthcare industry?

There are no additional sub-industries under this industry.

Australian (ASX) Biotech Industry Analysis

Date	Market Cap	Revenue	Earnings	PE	Absolute PE	PS
Sat, 20 Jun 2026	AU$63.5b	AU$23.5b	AU$1.4b	20.7x	44.1x	2.7x
Mon, 18 May 2026	AU$59.6b	AU$23.1b	AU$1.4b	19.5x	42.6x	2.6x
Wed, 15 Apr 2026	AU$78.1b	AU$23.2b	AU$1.4b	23.9x	55.5x	3.4x
Fri, 13 Mar 2026	AU$79.1b	AU$23.1b	AU$1.4b	25.2x	56.4x	3.4x
Sun, 08 Feb 2026	AU$97.6b	AU$23.4b	AU$3.8b	20.3x	25.6x	4.2x
Tue, 06 Jan 2026	AU$95.5b	AU$24.6b	AU$4.0b	18.5x	23.8x	3.9x
Thu, 04 Dec 2025	AU$100.6b	AU$24.9b	AU$4.1b	19.3x	24.7x	4x
Sat, 01 Nov 2025	AU$99.4b	AU$25.1b	AU$4.1b	18.8x	24.2x	4x
Mon, 29 Sep 2025	AU$106.1b	AU$25.1b	AU$4.1b	20.5x	25.8x	4.2x
Wed, 27 Aug 2025	AU$117.3b	AU$25.3b	AU$4.2b	34.4x	27.7x	4.6x
Fri, 25 Jul 2025	AU$144.6b	AU$24.1b	AU$3.8b	47.9x	38.1x	6x
Sun, 22 Jun 2025	AU$130.0b	AU$24.5b	AU$3.9b	20x	33.6x	5.3x
Tue, 20 May 2025	AU$131.3b	AU$24.7b	AU$3.9b	20.6x	33.7x	5.3x
Thu, 17 Apr 2025	AU$130.9b	AU$24.9b	AU$3.9b	20.5x	33.2x	5.2x
Sat, 15 Mar 2025	AU$135.8b	AU$25.2b	AU$4.0b	21.3x	34x	5.4x
Mon, 10 Feb 2025	AU$148.1b	AU$24.5b	AU$3.7b	24.2x	40.4x	6x
Wed, 08 Jan 2025	AU$153.8b	AU$24.5b	AU$3.7b	24.7x	42x	6.3x
Fri, 06 Dec 2024	AU$150.4b	AU$23.9b	AU$3.6b	25.8x	42.2x	6.3x
Sun, 03 Nov 2024	AU$148.7b	AU$23.5b	AU$3.5b	26.5x	42.6x	6.3x
Tue, 01 Oct 2024	AU$150.6b	AU$22.3b	AU$3.3b	28x	45.8x	6.8x
Thu, 29 Aug 2024	AU$159.8b	AU$22.7b	AU$3.4b	30.7x	46.4x	7x
Sat, 27 Jul 2024	AU$160.3b	AU$22.5b	AU$3.3b	32.2x	48.5x	7.1x
Mon, 24 Jun 2024	AU$153.1b	AU$22.2b	AU$3.3b	31.8x	47x	6.9x
Wed, 22 May 2024	AU$144.1b	AU$22.0b	AU$3.2b	30.9x	44.8x	6.5x
Fri, 19 Apr 2024	AU$140.0b	AU$22.9b	AU$3.4b	29.7x	41.7x	6.1x
Sun, 17 Mar 2024	AU$143.3b	AU$22.4b	AU$3.3b	30.5x	43.7x	6.4x
Tue, 13 Feb 2024	AU$147.7b	AU$21.0b	AU$2.9b	33.7x	51.6x	7x
Thu, 11 Jan 2024	AU$148.3b	AU$20.5b	AU$2.7b	34.9x	54.8x	7.2x
Sat, 09 Dec 2023	AU$135.8b	AU$20.8b	AU$2.8b	33.8x	49.3x	6.5x
Mon, 06 Nov 2023	AU$124.1b	AU$21.1b	AU$2.8b	30x	44.2x	5.9x
Wed, 04 Oct 2023	AU$126.5b	AU$21.6b	AU$2.8b	29x	44.6x	5.9x
Fri, 01 Sep 2023	AU$140.0b	AU$21.3b	AU$2.6b	34.9x	54.3x	6.6x
Sun, 30 Jul 2023	AU$137.8b	AU$18.1b	AU$2.3b	37.4x	59x	7.6x
Tue, 27 Jun 2023	AU$143.9b	AU$18.0b	AU$2.3b	37.4x	61.8x	8x


AU Market	3.31%
Healthcare	2.78%
Biotech	2.06%
Biotech	2.06%

Company	Last Price	7D	1Y	Valuation
CSL CSL	AU$116.32	8.2% +AU$4.2b	-51.6%	PE28x
TLX Telix Pharmaceuticals	AU$14.50	6.6% +AU$305.4m	-41.8%	PS4.3x
PYC PYC Therapeutics	AU$1.52	24.6% +AU$295.1m	32.2%	PS72.7x
MSB Mesoblast	AU$2.13	9.2% +AU$233.3m	29.9%	PS29.6x
CUV Clinuvel Pharmaceuticals	AU$10.30	15.0% +AU$67.6m	5.9%	PE16x

Announcement • Apr 30

Dimerix Limited Announces Completion of Blinded Assessment of ACTION3 Statistical Assumptions

Dimerix Limited announced that the blinded review of ACTION3 Phase 3 study data to confirm statistical assumptions of the primary endpoint has been successfully completed. This blinded review confirms that the ACTION3 study remains appropriately statistically powered to detect the treatment effect for the proteinuria primary endpoint. Having the ACTION3 Phase 3 study with >90% statistical power for its primary endpoint means that if DMX-200 continues to reduce proteinuria in trial patients as anticipated, then there is a >90% chance that the study will successfully show a statistically significant proteinuria treatment effect at the trial's conclusion. An external statistical blinded review of ACTION3 data has achieved its objective by confirming that the study remains appropriately statistically powered (>90%) to demonstrate a treatment effect for the primary study endpoint of proteinuria; meaning that if DMX-200 continues to reduce proteinuria in trial patients as anticipated, then there is a >90% chance that the study will successfully show a statistically significant proteinuria treatment effect at the trial's conclusion. To maximise the likelihood of a successful study outcome and regulatory success, Dimerix and its commercialisation partners will continue the ACTION3 Phase 3 Study to the final proteinuria endpoint. As previously announced, the FDA has agreed that proteinuria is an appropriate endpoint for full regulatory approval for DMX-200 in ACTION3. Evidence from the PARASOL working group, together with the recent FDA approval of an FSGS therapy in the US based on the proteinuria endpoint, further supports proteinuria as the primary study endpoint for ACTION3. The Company remains well positioned to continue focussing on advancing the ACTION3 Phase 3 clinical trial, as well as the advanced licensing discussions with potential partners in territories not already licensed. The ACTION3 Phase 3 clinical trial adult cohort is fully recruited, with 333 patients; the last patient is expected to receive their last dose in March 2028. Recruitment of pediatric patients aged 12-17 years old remains ongoing as an independent cohort in the trial, and if successful, may allow Dimerix to expand its application for DMX-200 to adolescents in key territories. As previously reported, the ACTION3 Phase 3 study passed a formal futility analysis of the proteinuria endpoint in March 2024 demonstrating the drug was performing better than placebo at that point in time; and a further 7 Independent Data Monitoring Committee (IDMC) reviews to date have not identified safety issues or requested changes to the protocol. In parallel to the blinded review, Dimerix and its commercial partners assessed the changes to the Focal Segmental Glomerulosclerosis (FSGS) landscape and potential endpoints since initiation of the ACTION3 study in 2022, all of which support proteinuria as the primary endpoint. Specifically, the PARASOL working group outcomes provided evidence of proteinuria as a candidate surrogate endpoint for FSGS; FDA provided positive feedback to Dimerix confirming that the proteinuria endpoint is appropriate for the full approval of DMX-200; and, earlier this month, FDA approved a new treatment for FSGS based on proteinuria as an endpoint. A key finding from PARASOL working group analysis was that proteinuria required smaller sample sizes and demonstrated less variability than eGFR for FSGS clinical trials and could therefore reduce risk for potential downstream marketing approval in the US. Collectively, the PARASOL working group analysis, the National Registry of Rare Kidney Diseases UK (RaDaR) analyses, Kaiser Permanente analyses, third party FSGS study data, and FSGS key opinion leaders all suggest that measuring proteinuria change from baseline is a far more statistically achievable endpoint for DMX-200 than eGFR endpoints and may substantially reduce the risk for traditional approval. Given that any application for accelerated approval based on proteinuria would likely require that the ACTION3 use an eGFR-based confirmatory endpoint, which would increase costs, lengthen study timeline and necessitate the splitting of alpha, potentially reducing the probability of success for the final endpoint, Dimerix and its commercial partners have concluded that conducting an interim analysis required for an Accelerated Approval application would not now be the most strategic and optimal course for the trial. The FDA has previously confirmed that the proposed primary endpoint of percent reduction in proteinuria compared to placebo is suitable to support traditional approval of DMX-200 via the 505(b)(1) pathway, should the findings of the ACTION3 be positive, with change in eGFR as a secondary endpoint. Given the successful blinded interim futility analysis in 2024, the company know that DMX-200 was performing better than placebo in reducing proteinuria at that point in time, and with seven independent data monitoring committee reviews completed, the company is confident that DMX-200 is well tolerated. The outcome of this review and the decision to proceed to completion of ACTION3 to support traditional approval helps strengthen the probability of ACTION3 success and ultimately deliver a potential new therapy for patients with FSGS while also reducing risk and adding value for Dimerix shareholders and partners. The ACTION3 Phase 3 study is a pivotal Phase 3, multi-centre, randomised, double-blind, placebo-controlled study of the efficacy and safety of DMX-200 in patients with FSGS who are receiving a stable dose of a blood pressure medication known as an angiotensin II receptor blocker (ARB). Once the ARB dose is stable, patients are then randomised to receive either DMX-200 (120 mg capsule, twice daily) or placebo for a 2-year treatment period. The single Phase 3 trial in FSGS patients is designed to capture evidence of proteinuria reduction and kidney function (eGFR slope) during the trial, aimed at generating sufficient evidence to support marketing approval.

Announcement • Apr 29

Mesoblast Limited Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain

Mesoblast Limited announced that its pivotal Phase 3 clinical trial evaluating rexlemestrocel-L for the treatment of chronic low back pain (CLBP) associated with degenerative disc disease has achieved its patient recruitment target. The placebo-controlled study (MSB-DR004) will follow at least 300 patients randomized to a single intra-discal injection of rexlemestrocel-L or sham control for 12 months. The trial seeks to confirm results from the earlier MSB-DR003 trial where a single intra-discal injection of rexlemestrocel-L resulted in clinically meaningful reductions in pain and opioid usage for up to three years. The trial’s primary endpoint is powered to show a significant difference in reduction of low back pain at 12 months between rexlemestrocel-L and sham controls. Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids. Top-line results are expected in mid-CY2027 after the last randomized patient has completed follow-up. A positive readout will be used in support of an expected regulatory filing in Third Quarter CY2027 for United States Food and Drug Administration (FDA) approval. Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of CLBP due to degenerative disc disease providing eligibility for priority review once the Biologics License Application (BLA) has been filed. CLBP caused by inflammation and degenerative disc disease is a serious condition with a prevalence of over 7 million people in the U.S. alone. The indication is a potential blockbuster for Mesoblast with potential peak year revenue of >USD 10 billion with single digit market penetration. The 300-patient randomized controlled confirmatory Phase 3 trial of Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product candidate rexlemestrocel-L in combination with hyaluronic acid (HA) as delivery agent for injection into the lumbar disc is actively enrolling in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease (DDD) of less than five years duration at multiple sites across the U.S. FDA has previously agreed on the design of this 300-patient randomized, placebo-controlled confirmatory Phase 3 trial, and the 12-month primary endpoint of pain reduction as an approvable indication. This endpoint was successfully met in Mesoblast’s first Phase 3 trial. Key secondary measures include improvement in quality of life and function. A particular focus is on treatment of patients on opioids, since discogenic back pain accounts for approximately 50% of prescription opioid usage in the US. Significant pain reduction and opioid cessation were observed in Mesoblast’s first Phase 3 trial. FDA has designated rexlemestrocel-L a Regenerative Medicine Advanced Therapy (RMAT) for the treatment of chronic low back pain. RMAT designation provides all the benefits of Breakthrough and Fast Track designations, including rolling review and eligibility for priority review on filing of a Biologics License Application (BLA). Back pain is the leading cause of disability in Americans under 45 years, with an annual prevalence in the general US adult population of 10-30%. CLBP caused by inflammation and degenerative disc disease (DDD) is a serious condition with a prevalence of over 7 million people in the US alone. CLBP due to DDD is a leading cause of disability, and is associated with impaired quality of life, severe limitations in ability to perform activities of daily living, reduced ability to work, and negative impacts on mental health. CLBP accounts for approximately 50% of prescription opioid usage in the US, making the condition a significant contributor to the opioid epidemic.

Australian (ASX) Biotech Industry Analysis

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