Achieve Life Sciences’ 2025 Q4 Call: NDA Timeline Shifts, Vaping Launch Strategy, and Supply Readiness Claims Don’t Match

Date of Call: Mar 24, 2026

Business Commentary:

Regulatory and Clinical Progress:

• Achieve Life Sciences submitted a New Drug Application (NDA) for cytisinicline in June 2025, accepted by the FDA, moving them closer to becoming the first new FDA-approved treatment for nicotine dependence in 20 years.
• The company received a Commissioner’s National Priority Voucher for the vaping cessation indication, recognizing cytisinicline as a national priority to address nicotine dependence.

Commercial Infrastructure and Digital Platform:

• Achieve has built a scalable, data-driven commercial model with an omni-channel digital platform and AI capabilities, enabling precision targeting of physicians and patients.
• The company partnered with Adare Pharma Solutions for U.S.-based manufacturing to secure the supply chain and reduce risks associated with international imports.

Market Opportunity and Public Health Impact:

• Approximately 25 million adults in the U.S. smoke cigarettes, with 15 million attempting to quit each year, highlighting a significant market opportunity for cytisinicline.
• The increasing use of e-cigarettes among adults and the lack of FDA-approved treatments for e-cigarette cessation present a substantial public health need that cytisinicline could address.

Financial Position:

• Achieve reported total operating expenses of $14.7 million for the three months and $54.9 million for the year ended December 31, 2025, reflecting ongoing investment in regulatory, clinical, and commercial infrastructure.
• The company's cash equivalents and marketable securities totaled $36.4 million as of December 31, 2025, supporting continued operations and strategic investments.

Supply Chain and Manufacturing Strategy:

• Achieve is transferring manufacturing to Adare Pharma Solutions in the U.S. to ensure supply chain security and operational readiness ahead of a potential commercial launch in the first half of 2027.
• The decision to move manufacturing was driven by the need for contingency capacity and to mitigate risks from international import uncertainties.

Sentiment Analysis:

Overall Tone: Positive

• Statements include: 'incredible progress', 'momentum behind Achieve', 'we’re about to change that standard of care', 'we remain confident', 'terrific progress', 'on the brink of actually great success'. Management highlights strong clinical/regulatory progress, commercial infrastructure, and a clear vision for launch.

Q&A:

• Question from Thomas Gladen (Lake Street): Launch timing for first half of 2027. Can you talk about the critical path between a late June NDA approval and a first half launch?
  Response: Primary focus is ensuring drug supply; commercial infrastructure and distribution are ready at launch. The additional time allows for more data dissemination, partnerships, and operational setup.

• Question from Thomas Gladen (Lake Street): With respect to manufacturing, did you imply the NDA manufacturer will not supply commercial product, rather Adare will?
  Response: The PDUFA date remains June 20. The decision to transfer manufacturing to the U.S. (Adare) was accelerated for supply chain security and contingency, not to affect the approval timeline.

• Question from Jason Butler (Citizens JMP): Where do you believe awareness currently is with healthcare providers and what additional work will you be doing in 2026 to build awareness? Also, anything on FDA dialogue on the vaping indication since you got the CMPV?
  Response: HCP awareness has been limited pre-approval; focus shifts to disease education and data dissemination closer to launch. FDA dialogue on vaping is progressing, with site selection underway and trial commencement expected in first half of 2026.

• Question from Brandon Folkes (H.C. Wainwright): Does the 1H 2027 launch timeline assume a June 2026 approval? What flexibility is there? Are you looking to add Adare to the NDA before June approval?
  Response: Launch is planned for 1H 2027 post-June 2026 approval. Adare will be added post-approval (around Q3 2026). The timeline accounts for ensuring supply and commercial readiness.

• Question from Brandon Folkes (H.C. Wainwright): How should we think about insurance coverage at launch given the lead time?
  Response: Payer discussions are ongoing and positive, leveraging the ACA's coverage requirement. Initial access may have restrictions, expecting a slow ramp in formulary penetration over the first six months.

• Question from Justin Walsh (JonesTrading): Can you provide additional color on the robustness of the raw plant material supply chain? Are third-party suppliers able to meet expected demand?
  Response: Company has stockpiled more than three years of starting material, with a shelf life of three years, ensuring supply security for the foreseeable future.

• Question from Justin Walsh (JonesTrading): Can you comment on the cytisinicline dosing schedule and any concern about pill burden limiting compliance?
  Response: High adherence rates (>75%) in trials, including a 52-week study, indicate the three-times-daily dosing is well-tolerated and can be timed with meals to address cravings.

• Question from John Vandermosten (Zacks): Have you seen the ICER report on pricing for cytisinicline, and how does that compare with your internal calculations?
  Response: The company provided input to ICER and is pleased with the report's affirmation of unmet need. Pricing details are not yet set and will not be commented on.

• Question from John Vandermosten (Zacks): Where does synthetic API manufacturing stand? How do the three manufacturers (Adare, European, Sopharma AD) fit together?
  Response: Sopharma AD will be added to the NDA post-approval after addressing inspection readiness. Adare (U.S. manufacturer) transfer is for contingency and tariff uncertainty. The synthetic API process is complex but progressing.

Contradiction Point 1

Manufacturing Transfer and NDA Submission Timeline

It directly impacts the regulatory and operational timeline for product launch, potentially affecting investor expectations regarding approval and market readiness.

Brandon Folkes (H.C. Wainwright) - Brandon Folkes (H.C. Wainwright)

2025Q4: Adare will be added to the NDA post-approval, likely in Q3 2026. - Jaime Xinos(CFO)

Does the 1H 2027 launch timeline assume a June 2026 approval, what flexibility exists within that period, and will Adare be added to the NDA before or after the June approval? - Gary Nachman (Raymond James & Associates)

2025Q3: The company plans to engage with the FDA to explore streamlining the agreed-upon clinical trial design to take advantage of this benefit [of the priority voucher]. - Richard A. Stewart(CEO)

Contradiction Point 2

Commercial Launch Strategy for Vaping Indication

It involves a change in market strategy, which could affect the speed and efficiency of market penetration and revenue generation.

Jason Butler (Citizens JMP) - Jason Butler (Citizens JMP)

2025Q4: The complementary retail strategy alongside the specialty distribution route... is seen as the quickest and optimal initial approach. - Jerry Wan(CFO) and Richard A. Stewart(CEO)

Can you discuss the current awareness of cytisinicline among healthcare providers, the additional work planned for 2026 to build awareness, and any updates on FDA dialogue for the vaping indication since receiving the CMPV? - Brandon Folkes (H.C. Wainwright & Co.)

2025Q3: There will be a learning period of about 12-14 months between the launch of the smoking cessation indication and the vaping indication. - Richard A. Stewart(CEO)

Contradiction Point 3

Commercial Supply Chain and Manufacturing Timeline

It reflects conflicting statements on the readiness of commercial operations, which is critical for understanding the feasibility of the stated launch timeline.

Thomas Gladen (Lake Street) - Thomas Gladen (Lake Street)

2025Q4: The primary consideration is securing drug supply... All commercial operations (3PL, serialization, specialty pharmacy, co-pay support) will be ready at launch. - Jaime Xinos(CFO)

What is the critical path between the late June NDA approval and the first half 2027 launch, and is it primarily driven by commercial scale-up or product supply constraints? - Thomas Flaten (Lake Street Capital)

2025Q2: Commercial spending will be incremental and disciplined. There will be an increase in pre-commercial activities over the coming quarters leading up to approval, with a more significant ramp-up expected once approval is received. - Richard A. Stewart(CFO)

Contradiction Point 4

Strategy for Pre-Approval Awareness and Provider Communication

It involves a mismatch in strategy for building market awareness, which could influence pre-launch positioning and stakeholder perception.

Jason Butler from Citizens JMP, what are your key insights on the company's earnings performance? - Jason Butler (Citizens JMP)

2025Q4: Pre-approval awareness efforts have been conservative to comply with regulations. Post-approval, the focus will be on strong, targeted education... - Jaime Xinos(CFO)

Can you discuss the current awareness of cytisinicline among healthcare providers, additional plans for 2026 to build awareness, and any updates on FDA dialogue for the vaping indication since receiving the CMPV? - Gary Nachman (Raymond James)

2025Q2: Early awareness efforts will focus on elevating the conversation about nicotine dependence as a medical condition and generating interest, with more product-specific messaging closer to launch. - Jaime Xinos(CFO)

Contradiction Point 5

Commercial Operations Readiness Timeline

It conflicts with the launch readiness statement, impacting the perceived reliability of the company's operational planning.

Thomas Gladen (Lake Street) - Thomas Gladen (Lake Street)

2025Q4: All commercial operations (3PL, serialization, specialty pharmacy, co-pay support) will be ready at launch. - Jaime Xinos(CEO)

What is the critical path from the late June NDA approval to the first half 2027 launch, and is it driven primarily by commercial scale-up or product supply challenges? - Gary Nachman (Raymond James)

2025Q1: The focus is on three areas: awareness, availability, and access. Availability: Ensuring the drug is in the channel and ready for sale. - Jaime Xinos(CEO)