Gooey.AI

Financial Analyst Report Maker

This workflow creates summarized reports for investors about various companies, it takes input as transcripts from calls with the company and financial reports and generates a summary report as per the formats of the particular investment bank.

👩‍💻 Prompt

```[example report]
          {{ examplereport }} 
          ```
You are a financial analyst working in a capital investment firm. Please follow the steps below: \n1. 
          Analyse and summarise the [press release] and [transcripts] below in triple separators, don't create any output right now. 
          Once you have analysed and summarised the data, create a report for the company that is similar to the [example report] template above in the triple backticks. 
          Use the buy/hold/sell information from the [decision] input provided. Don't analyse your own.
          Ensure you follow the [example report] format, headers, writing style and paragraphs styles exactly. Add only HTML formatting.
          note: Don't make up any information
          note: Add "to be filled by team" for the price target section
          note: If information as per the [example report] template is missing, please add a note "team must fill this information"
          |||[press release] 
          {{ pressrelease }} 
          
          [transcripts] 
          {{ transcripts }} 
          
          [decision]
          {{ decision }}
          |||

🧠 Language Models

ChatGPT 16k (openai)

💪 Capabilities

🧩 Developer Tools and Functions

⌥ Variables

examplereport

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UpHealth, Inc. Hold
(UPH – $0.81 – intraday) Price Target: $1
Righting The Ship, Not Out Of The Storm Yet But We Like
The Progress; Maintain Hold Rating
Quarter and Outlook – Q1 revenue of $36M was ahead of consensus at $35M, and
AEBITDA of ($1.3M) was ahead of the street at ($3.2M). Revenue guidance of
$205M-$233M and AEBITDA guidance $14M-$19M were reiterated. UpHealth
expects to be CF+ in Q3’22. Total cash at Q1 end was $71M. Subsequent Q1 end,
UpHealth repaid its forward share purchase agreement in full (~$19M). We
estimate PF cash to $52M. PF total debt of $124M includes $22M short-term debt
and ~$102M in LT debt. In a separate 8-K, UpHealth announced the appointment
of Sam Meckey to CEO effective July 2022. Current CEO, Ramesh Balakrishnan will
move to Chief Strategy Officer.
Our Take – UpHealth made solid progress in Q1 turning the ship. While we expect
this to be a multi-quarter process, we think initial changes made are positive and
should build a better foundation for predictable revenue growth and profitability.
While we are waiting for the final 10-Q filing (expected Monday, May 16th), results
were ahead of expectations on the top and bottom-line. UpHealth also cleaned up
the balance sheet some when settling the ~$19M forward share purchase
agreement. PF cash and debt stand at $52M and $124M, respectively, which
sufficiently bridges UpHealth to CF+ operations expected Q3’22. Company-wide
operational changes have been implemented including consolidated support
functions, internal controls, and management changes with the appointment of
new CEO Meckey expected in July. Previous collection challenges in the Integrated
Care Management business in Q4 are being addressed, and we expect to see some
collections in mid-2022 positively impacting the financials. While shares are cheap,
we remain at a Hold rating while we track execution. We are optimistic UpHealth
made the right changes and will emerge a stronger organization.
HIGHLIGHTS
• Q1’22 Results – Q1 revenue of $36M was ahead of us and the street at $35M.
AEBITDA is expected to be ($1.3M) vs. consensus at ($3.2M). Integrated Care
Management generated $2.6M in revenue vs. $6.3M in Q1’21 and had a 63%
GM. Virtual Care Infrastructure generated $15.6M in revenue vs. $10.8M in
Q1’21 (pro forma basis) and had a GM of 47%. Services, a combination of Digital
Pharmacy and Behavioral Health, generated revenue of $17.7M vs. $13.5M in
Q1’21 and had a GM of 35%. Aggregate gross margin was 43% vs. 54% in Q1’21.
Q1 AEBITDA loss is expected at ($1.3M) vs. our ($4.8M) and the street at
($3.2M).

• Guidance, Model Adjustments – UpHealth reiterated its 2022 revenue guidance
of $205M-$233M. Management also reiterated its AEBITDA guidance of $14M
to $19M. Management expects 2022 gross margin between 42% and 43%. Our
$205M revenue estimate and $14.6M AEBITDA estimate for 2022 remain

unchanged. We also left our 2023 revenue estimate of $245M (+20% Y/Y) and
AEBITDA of $25.8M (11% margin) unchanged.
• Balance Sheet – Cash at Q1 end is expected at $70.7M. April 9, 2022, UpHealth
repaid its forward share purchase agreement. PF cash stands at $52M. We

estimate debt of $124M which is comprised of $22M short-term and $102M long-
term (convertible note). UpHealth expects to be CF+ by Q3’22 and cash on the

balance sheet sufficiently bridges the Company to this point.
• Longer Term Expectations – UpHealth outlined its expectations of continued
growth over the next five years over 35% Y/Y with 45%-50% gross margins and
15%-20% AEBITDA margins. We think the products and markets merit this growth;
however, we are remaining cautious while the ship is turned and new management
arrives in July. Our 2023 estimates call for 20% growth, 44% GMs, and 11%
AEBITDA margins.
• Potential Collections – Similar to last quarter, in the Integrated Care Management
business, UpHealth provided services to a West Central African customer but did
not recognize revenue due to uncertain creditworthiness. UpHealth is awaiting this
customer to have better clarity into its government funding before recognizing
revenue as funds flow from the government to this customer and then to
UpHealth. The value of this customer is $8.3M/year. In addition, UpHealth is
making significant strides toward collections of accounts receivables from a
European customer and remains optimistic. Collection would be a net positive to
net income and cash but not revenue. The total amount here is ~$15.8M but
UpHealth does not expect to collect this in its entirety.
• Fitting The Pieces Together – There are three primary pieces to UpHealth’s
business: 1) a platform to integrate health care known as Integrated Care
Management (ICM), 2) technological infrastructure to enable care known as Virtual
Care Infrastructure (VCI), and 3) in-house services like behavioral health
management and pharmacy. The ICM platform coordinates local and virtual care
teams to formulate a patient’s (or a population of patients) care regimen
(aggregate, risk stratify, treat, review). VCI enables care to be delivered in an
efficient matter when compared to traditional means as it allows coordination
between virtual and physical care teams. The last piece of UpHealth’s business is
Services, which consists of the digital pharmacy and behavioral health services.

INVESTMENT THESIS AND VALUATION

UpHealth is a healthcare technology company focused on integrating and enabling
efficient patient care with complementary provider services. We think UpHealth is
positioned to drive significant growth through the addition of new customers,
expansion at existing customers and partners, and cross-selling opportunities as it
leverages its six acquisitions with an aggregate market opportunity over $500B. The
three primary pieces to the offering make UpHealth a one-stop-shop for 1) Integrated
Care Management (ICM), 2) Virtual Care Infrastructure (VCI), and 3) Services
(behavioral management, pharmacy). While we think UpHealth has unique offerings

satisfying unmet needs, we think shares will be range-bound in the near-to-
intermediate term. We think execution and balance sheet relief are most important to rating evaluation going forward.
Valuation – Our PT uses a 1.2x revenue multiply applied to our 2022 revenue
estimate of $205M. We subtract net debt of $72M and divide by 180M shares
outstanding (common + RSUs + Warrants + 2021 EIP). We believe a 1.2x revenue
multiple is a trough multiple and see execution and balance sheet relief making the
case for multiple expansion.

transcripts

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09-May-2023 
Corrected Transcript

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call
Total Pages: 11

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
CORPORATE PARTICIPANTS 
Corrected Transcript 09-May-2023 
Nicole Jones 
Vice President, CG Capital 
John A. Bencich 
Chief Executive Officer & Director, Achieve Life Sciences, Inc. 
Cindy A. Jacobs 
President, Chief Medical Officer & Director, Achieve Life Sciences, Inc. 
Jerry Wan 
Principal Accounting Officer, Achieve Life Sciences, Inc.

Thomas Flaten 
Analyst, Lake Street Capital Markets LLC 
Francois Brisebois 
Analyst, Oppenheimer & Co., Inc. 
Michael Higgins 
Analyst, Ladenburg Thalmann & Co., Inc. 
John D. Vandermosten 
Analyst, Zacks Investment Research, Inc. (Small Cap Research)

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

vaping cessation. Cytisinicline treatment resulted in a statistically significant benefit for nicotine e-cigarette  cessation compared to placebo. 
Results for the primary endpoint showed that study participants who received cytisinicline were approximately  three times more likely to quit vaping compared to those who received placebo. Cytisinicline and also continued to  demonstrate exceptional safety and tolerability. 
We are very pleased with another win for cytisinicline and for people who are seeking options to overcome their  nicotine dependence. Nicotine e-cigarette use continues to be a growing concern, with recent reports from CDC  indicating vaping rates in the US are increasing. 
Data recently published indicate that roughly 11 million adults and 2.5 million high school and middle school  students use e-cigarettes to vape nicotine. The CDC indicated in recent weeks the percentage of use has  increased by 2.5%. As this segment of nicotine use continues to grow, an increasing number of people who use  e-cigarettes may start to look for solutions to quit. And currently, there are no medications specifically indicated for  vaping cessation. 
We completed a survey in people using e-cigarettes and found that 73% of participants desired to quit vaping in  the next 3 to 12 months, and the overwhelming majority would be interested in using a naturally-derived  prescription treatment to help them do so. 
Based on this unmet need for treatments, the swift enrollment we observed in the ORCA-V1 trial and the  statistically significant results from the recent top line data announcement, we believe that cytisinicline has the  unique opportunity to become a solution to help address this growing vaping epidemic. 
To touch more on the recent clinical data, I'll now hand the call over to Cindy to go through the ORCA-V1 results  in more detail. 
...................................................................................................................................................................................................................................................... Cindy A. Jacobs 
President, Chief Medical Officer & Director, Achieve Life Sciences, Inc. 
Thanks, John. As I mentioned, the ORCA-V1 top line results that we shared last month showed a statistically  significant benefit for cytisinicline as a treatment for nicotine vaping cessation. Even though this Phase 2 proof-of concept study was not powered to do that. 
Similar to our Phase 3 designs, ORCA-V1 evaluated 3 milligrams cytisinicline dose 3 times daily for 12 weeks,  ORCA-V1 randomized subjects at five clinical sites in the US in a 2:1 ratio, such that a total of 160 subjects were  randomized with 107 receiving cytisinicline for 12 weeks and 53 receiving placebo. 
ORCA-V1 enrollment was completed in approximately four months. The average age of ORCA-V1 subjects was  34 and all of them wanted to quit vaping on the study. Approximately half of the subjects had previously tried to  quit vaping by self-attempt methods. Subjects were stratified based on past smoking history, with 72% identifying  as former or past smokers. 
Dr. Nancy Rigotti of Harvard Medical School served as the primary investigator of the study and ORCA-V1 was  supported via grant funding from NIDA and the NIH. The primary endpoint results for vaping cessation showed  subjects who received cytisinicline had 2.6 times higher odds or likelihood to quit vaping during the last 4 weeks  of treatment compared to subjects who received placebo.
3

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

This endpoint was statistically significant with a p-value of 0.035. The 4 weeks continuous vaping cessation rate  during weeks 9 through 12 was 31.8% for cytisinicline treated subjects compared to 15.1% for those who received  placebo. Importantly, cytisinicline benefit was also observed across all clinical trial sites and demographics, such  as participant age, gender, race and whether they had been past smokers or not. 
Regarding safety, cytisinicline was very well-tolerated with 50.9% of subjects who received cytisinicline reporting  adverse events, compared to 54.7% of subjects in the placebo arm. Adverse events were as expected, mainly  mild to moderate, and there were no serious adverse events reported during the study. 
As these are top line results, we are continuing to analyze the data and look forward to providing additional details  on our findings as we learn more. 
I will now turn the call back over to John. 
...................................................................................................................................................................................................................................................... John A. Bencich 
Chief Executive Officer & Director, Achieve Life Sciences, Inc. 
Thank you, Cindy. Our next key milestone is rapidly approaching as we eagerly await results from our second  NDA-enabling Phase 3 study, which we expect to report later this quarter. The ORCA-3 trial mirrors the design of  the previously reported and highly successful ORCA-2 trial. ORCA-3 is evaluating the efficacy and tolerability of 3  milligrams cytisinicline dose three times daily for either 6 weeks or 12 weeks compared with placebo. 
Biochemically verified continuous abstinence is the primary end point. And similar to ORCA-2, will be evaluated  during the last four weeks of treatment. Each arm will be compared independently to the placebo arm, and  success will be determined if either or both of the cytisinicline treatment arms show a statistical benefit as  compared to placebo. 
Our efforts are now focused on preparing for the data later this quarter and continuing our preparations to support  a new drug application or NDA for cytisinicline in the US. 
At this time. I'll now turn the call over to Jerry to review our financial results for the quarter. ...................................................................................................................................................................................................................................................... Jerry Wan 
Principal Accounting Officer, Achieve Life Sciences, Inc. 
Thanks, John. Looking at our statement of operations, the company incurred a net loss of $9 million for the  quarter ended March 31, 2023, as compared to a net loss of $7.6 million for the same quarter of 2022. Total  operating expenses in the first quarter of 2023 increased to $8.6 million as compared to $7.2 million for the same  quarter of 2022. 
Operating expenses were higher for the quarter ended March 31, 2023, as both the ORCA-3 Phase 3 trial and the  ORCA-V1 Phase 2 trial were fully enrolled during the quarter and had their last subject last visit completed in  March 2023 as compared to the same period in 2022, where only our Phase 3 ORCA-2 was fully enrolled. 
We anticipate our operating expenses to decline in the second quarter in line with the completion of the two  clinical studies. As of March 31, 2023, the company's cash, cash equivalents and restricted cash were $16.6  million as compared to $24.8 million as of December 31, 2023. We believe our current cash balance is sufficient  to provide us with runway into late-2023.
4

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
I'd now like to turn the call back over to John. 
Corrected Transcript 09-May-2023

...................................................................................................................................................................................................................................................... John A. Bencich 
Chief Executive Officer & Director, Achieve Life Sciences, Inc. 
Thanks, Jerry. A final highlight from the first quarter before we conclude today's call. In March, we announced a  refresh to our board of directors to support the future direction of the company. We are pleased to welcome Mr.  Stuart Duty, Mr. Thomas King and Mr. Tom Sellig to the board. 
They each bring extensive leadership in the pharmaceutical and life science industries across capital markets,  strategic transactions, sales and marketing, as well as manufacturing. 
We would also like to thank Mr. Don Joseph, Dr. Martin Mattingly and Mr. Jay Moyes for their years of service and  strategic guidance to Achieve as they will not be standing for re-election at our upcoming Annual Shareholder  Meeting on June 7. 
We have achieved many milestones within the first quarter of 2023 and we expect to continue this exciting year  with the upcoming ORCA-3 read out. We appreciate your continued support and I will now turn the call over to the  operator for questions. 
...................................................................................................................................................................................................................................................... QUESTION AND ANSWER SECTION 
Operator: Thank you. The floor is now open for questions. [Operator Instructions] And our first question comes  from Thomas Flaten from Lake Street Capital. Go ahead, Thomas. 
...................................................................................................................................................................................................................................................... Analyst, Lake Street Capital Markets LLC Q 
Thomas Flaten 
Great. I appreciate you guys taking the questions. John or Cindy, with respect to completing ORCA-3 and then  moving forward. Could you give us some sense of what you think realistic timing for an NDA submission would be  and if there are any critical path items there that we should be aware of that, pre-NDA meeting with FDA or  anything like that, any pre-clinical data that you still need to generate. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Thanks for the question, Thomas. I'm going to hand this one over to Cindy. 
...................................................................................................................................................................................................................................................... President, Chief Medical Officer & Director, Achieve Life Sciences, Inc. A 
Cindy A. Jacobs 
Sure. So, we've been waiting for ORCA-3 results. With ORCA-3 results, now we can coordinate a pre-NDA  meeting with FDA. Obviously, we're going to target that for this year. Timing though, we would need to request the  meeting. 
So, we kind of figure it's going to be at the end of quarter three or quarter three at some time, but we'll find that  out when we get that scheduled. We actually have three Phase 1 studies we're finishing up, things that we need  for the NDA, like PK study on renal impairment.
5

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

We actually have another PK study looking at steady state concentrations with three milligram, three times a day  and also finishing up a TQT study. These are all things that are required in the NDA and all of them will be  completed by the end of this year. So, we're looking at the first half of next year some time for the NDA coming  together. 
...................................................................................................................................................................................................................................................... Analyst, Lake Street Capital Markets LLC Q 
Thomas Flaten 
Excellent. John, any update on the potential for debt refinancing because I know that repayment is looming at the  end of the year as well? 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Yeah. Thanks, Tom on the debt side, so we've been in dialogue with the folks at SVB formerly SVB, now Citizens  Bank. And we do think there is a path towards getting some movement on – an extension or refi of that facility.  So, nothing to announce today. But we do think at least the discussions we've had so far are positive on that front. ...................................................................................................................................................................................................................................................... Analyst, Lake Street Capital Markets LLC Q 
Thomas Flaten 
And then just one quick final one maybe for Jerry, there was a bit of a sequential uptick in G&A, I was curious if  there are any one-timers in there, stock-based comp or bonuses or anything like that? ...................................................................................................................................................................................................................................................... Analyst, Lake Street Capital Markets LLC Q 
Thomas Flaten 
Jerry do you want to take that one? 
...................................................................................................................................................................................................................................................... Principal Accounting Officer, Achieve Life Sciences, Inc. A 
Jerry Wan 
Yeah. Sorry I was just on mute there. Yeah it was just the one-time stock based comp grant that we have  annually at the beginning of January. 
...................................................................................................................................................................................................................................................... Analyst, Lake Street Capital Markets LLC Q 
Thomas Flaten 
Excellent. Appreciate it, guys. Thanks so much. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Thanks, Thomas. 
...................................................................................................................................................................................................................................................... 
Operator: Thank you. And our next question comes from Francois Brisebois from Oppenheimer. Go ahead. 
...................................................................................................................................................................................................................................................... Analyst, Oppenheimer & Co., Inc. Q 
Francois Brisebois 
Thank you for taking the question. The first one here in terms of the ORCA-3 that's you're expecting to read out  this quarter. I just wondering any thoughts on what you would expect maybe odds ratio wise, is this something  where we should compare it to the data that you had shown in the previous Phase 3 ORCA trial?
6

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

Chief Executive Officer & Director, Achieve Life Sciences, Inc. A John A. Bencich 
Yeah. Thanks for the question, Franc. I think in terms of odds ratios, I don't think we have a firm expectation in  terms of what those might look like. I think when we look at the market today and where odds ratios fit for the  existing products that are in the range of 2 to 3, when you go kind of at the low end of NRT to varenicline is at the  higher end. 
So, I think anything in that range or above, we see as being a win. In the ORCA program, so far, at least for  smoking cessation, we've seen odds ratios between 5 and 8. So, we've exceeded kind of those benchmark  requirements. But from the discussions we've had with the key opinion leaders in the space, anything over an  odds ratio of 2 is going to be a meaningful clinical benefit in this setting. 
...................................................................................................................................................................................................................................................... Analyst, Oppenheimer & Co., Inc. Q 
Francois Brisebois 
Okay. That's helpful. And then in terms of manufacturing, as we're getting to that stage here, can you give any  color on what's going on, on the manufacturing side? Any obstacles to overcome or just the process where you  stand right now? Thank you. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
On the CMC side, so we've been working hand in hand with our colleagues over at Sopharma who will be the  manufacturers of record on that front. So, the focus has been, I would say, in two parallel tracks, one is just FDA  inspection readiness. 
So, that's something we'll continue to focus on as we march forward to an NDA filing. And then the other track  would be preparations on supply chain, getting registration batches up and on stability, and then making sure kind  of all the way through the supply chain through final packaging is sorted and those activities are all in process as  well. 
...................................................................................................................................................................................................................................................... Analyst, Oppenheimer & Co., Inc. Q 
Francois Brisebois 
Okay. Great. Then lastly, maybe if I can ask you about vaping, sorry if you mentioned it, but steps going forward,  is this kind of a label expansion? How many trials will we need to potentially get to approval here on the vaping  side? Thank you. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Yeah, thanks, Franc. On the vaping side, as we indicated a couple of weeks back when we released the ORCA V1 results, our belief currently is that a single-Phase 3 trial is likely what the FDA would expect for approval in this  indication. 
That would be under the guise of already being on the market or having an approval for smoking cessation. So,  we're effectively just expanding the indication and I think by having a statistical significant result from ORCA-V1  that reinforces our belief. 
......................................................................................................................................................................................................................................................7

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

Analyst, Oppenheimer & Co., Inc. Q Francois Brisebois 
Thank you. 
...................................................................................................................................................................................................................................................... 
Operator: Our next question comes from Michael Higgins from Ladenburg Thalmann. Go ahead, Michael. 
...................................................................................................................................................................................................................................................... Analyst, Ladenburg Thalmann & Co., Inc. Q 
Michael Higgins 
Thanks, operator. Good evening guys. Congrats on the progress with cytisinicline including ORCA-V1, we're  certainly eager here to see the second Phase 3 ORCA-3 here in Q2. Question on ORCA-3. Can you give us any  sense for the timing here in Q2 as investors start to look out and look at the calendars, when might we see that  data come through? 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
The timing for ORCA-3. We've guided to the second quarter and I think the closest we can get to firming that up  would be second half of this quarter. So, any time after kind of the middle of May, that trial result would be in play. 
...................................................................................................................................................................................................................................................... Analyst, Ladenburg Thalmann & Co., Inc. Q 
Michael Higgins 
Okay. That's helpful. Also on the Phase 3, Cindy, a question for you on the 24-week data that was presented  [indiscernible] (00:17:15) you noted, 82% compliance at 24 weeks. Curious how that compares to cytisinicline or  your expectations for cytisinicline in both ORCA pivotal. Thanks. 
...................................................................................................................................................................................................................................................... President, Chief Medical Officer & Director, Achieve Life Sciences, Inc. A 
Cindy A. Jacobs 
Yeah, I think compliance is actually quite good. I think it may be a little higher than what varenicline reported. It  obviously is probably a component of being in a clinical trial as well as you have the behavioral support  component that continues actually throughout the follow-up period. 
...................................................................................................................................................................................................................................................... Analyst, Ladenburg Thalmann & Co., Inc. Q 
Michael Higgins 
That's helpful. And then one on vaping, obviously, this is an area of increased interest across [ph] society  (00:18:02). Curious in your conversations with investors, how they're seeing vaping relative to their interest in  cigarette smoking. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Yeah. Interesting question, I think. The bread and butter of what we've been doing has been on the smoking  cessation side. And I think people are beginning to appreciate what we just validated here with ORCA-V1 which  has the potential to expand into a segment that currently has no available treatment options and is growing. 
We just saw the latest update of e-cigarette users here in the US increase from about 9 million up to 11 million.  So, this is a growing segment with no available options. And we think this is the right course [indiscernible] 
8

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

(00:18:49) as we move ahead. And I think that's resonated quite strongly as we've been able to socialize the  results. 
...................................................................................................................................................................................................................................................... Analyst, Ladenburg Thalmann & Co., Inc. Q 
Michael Higgins 
Look forward to seeing ORCA-3. Appreciate the questions. Thanks guys. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Thanks, Michael. 
...................................................................................................................................................................................................................................................... 
Operator: [Operator Instructions] And our next question comes from John Vandermosten from Zacks. Go ahead. 
...................................................................................................................................................................................................................................................... Analyst, Zacks Investment Research, Inc. (Small Cap Research) Q 
John D. Vandermosten 
Thank you and good afternoon, John, Cindy and Jerry. As you guys are going into the final stages, are there any  preparations that you're making for commercialization? Our belief is that you're going to work with a partner to do  that. 
But I know sometimes that it makes sense to reach out and work on some – perhaps labeling, packaging, pricing  or outreach to key stakeholders in order to kind of prep to work with the partner, also help your negotiating  position. Is that something that you're planning to do or makes sense to do? 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Yeah. Thanks for the question, John. On the commercialization prep, one of the key areas is supply chain,  making sure that we've got all the blocking and tackling together all the way through final packaging and into  potential distribution. 
So again, we're in the early phases of a lot of that planning to make sure that's on track. I would say, the other  piece that we're looking at to make sure is moving ahead beyond the market access side. 
Now we know that this is a very favorable category given the Affordable Care Act mandates that all FDA  approved smoking cessation products be covered. But there's still a fair amount of work that's required to make  sure that we can get all the pieces in place. So we're ready to move ahead with those contracting discussions. So,  I'd say those are the two primary areas of focus. 
...................................................................................................................................................................................................................................................... Analyst, Zacks Investment Research, Inc. (Small Cap Research) Q 
John D. Vandermosten 
Okay. And regarding labeling. What's the timeline left for that, discussions with the FDA and preparation there? 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
On the labeling front. So, we've already began working with some outside advisors on what the label would look  like. So, that's early days ORCA-3, we'll feed into that. So, we'll need that in hand. But that's an important piece  that we will submit with the NDA. So, the bulk of that work will be done over the course of 2023.
9

Achieve Life Sciences, Inc. (ACHV) Q1 2023 Earnings Call 
Corrected Transcript 09-May-2023

Analyst, Zacks Investment Research, Inc. (Small Cap Research) Q John D. Vandermosten 
Got it. And final one for me, any work done on a brand name yet or directions in terms of how are you going to  eventually market that? 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Sorry, was the question around a brand name? 
...................................................................................................................................................................................................................................................... Analyst, Zacks Investment Research, Inc. (Small Cap Research) Q 
John D. Vandermosten 
Yeah, exactly. Is that anything you've worked on yet? I mean, I know it's probably a challenging thing to do with all  the other names out there, but any work down there yet, any indications of where that might go? ...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Yes, we have been through an exercise to hone in on a brand name and we did get preliminary clearance from  FDA on that. We wouldn't get final approval until it's submitted with NDA. But we have gone through that process,  so that is another piece, at least on the commercialization front that we're ready for. 
...................................................................................................................................................................................................................................................... Analyst, Zacks Investment Research, Inc. (Small Cap Research) Q 
John D. Vandermosten 
Great. Thank you, gentlemen. 
...................................................................................................................................................................................................................................................... Chief Executive Officer & Director, Achieve Life Sciences, Inc. A 
John A. Bencich 
Thanks, John. 
...................................................................................................................................................................................................................................................... 
Operator: And that appears to be the last question at this time. I would now like to turn it back to management  for any closing remarks. 
...................................................................................................................................................................................................................................................... John A. Bencich 
Chief Executive Officer & Director, Achieve Life Sciences, Inc. 
Thanks, operator, and thanks, everyone, for joining us today. It's been an exciting first portion of 2023, and we  look forward to rejoining you soon with results from the ORCA-3 trial later this quarter. So, appreciate the  continued support and we'll talk to you soon. Thanks. 
...................................................................................................................................................................................................................................................... 
Operator: Thank you. This does conclude today's conference. We thank you for your participation. You may  disconnect your lines at this time and have a wonderful day.
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Achieve Life Sciences Reports Financial Results for First Quarter 2023 and Provides Corporate Update Tuesday, May 09, 2023 08:05:00 PM (GMT) 
Company to host conference call at 4:30 PM EDT today, May 9, 2023 
SEATTLE and VANCOUVER, British Columbia, May 09, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced first quarter 2023 financial results and provided an update on the cytisinicline development program. 
Recent Business Highlights 
Released positive Phase 2 ORCA-V1 clinical trial results showing statistically significant vaping cessation benefit for cytisinicline 
Announced accomplishment of key milestones, including last subject dosing and last subject visit, in the Phase 3 ORCA-3 trial evaluating cytisinicline for smoking cessation 
Presented additional analyses from the Phase 3 ORCA-2 trial at the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting 
Appointed three new members to Achieve’s Board of Directors 
“We are excited about our start to 2023, announcing statistically significant trial results from ORCA-V1 in April, and on-track to report topline results from the Phase 3 ORCA-3 trial in the second quarter,” stated John Bencich, Chief Executive Officer of Achieve. “We continue to believe in the tremendous potential of cytisinicline to become the first new FDA-approved treatment for smoking cessation in nearly twenty years, and now with the results of ORCA-V1, the possibility of becoming the first treatment specifically indicated for e-cigarette cessation.” 
ORCA-V1 E-Cigarette Cessation Benefit for Cytisinicline 
Achieve announced successful results from the Phase 2 ORCA-V1 trial in April 2023. Trial participants who received 12 weeks of cytisinicline treatment had 2.6 times higher odds, or likelihood, to have quit vaping during the last 4 weeks of treatment compared to subjects who received placebo (p=0.035). The vaping cessation rate during weeks 9 through 12 was 31.8% for those who received cytisinicline treatment compared to 15.1% for those who received placebo. A benefit in favor of cytisinicline was consistently observed across the secondary endpoints and was observed across clinical trial sites and demographics such as age, gender, race, or whether they had smoked cigarettes in the past. Cytisinicline was well tolerated and no serious adverse events were reported. 
Phase 3 ORCA-3 Last Subject Dosed/Last Subject Visit Completed 
In January 2023 and March 2023, the final subject was dosed, and the last subject last visit was completed, respectively, in the ongoing Phase 3 ORCA-3 trial. ORCA-3 enrolled 792 adults who smoke cigarettes across 20 clinical trial locations in the United States. Study participants were randomized to receive either 6 or 12 weeks of cytisinicline treatment or placebo, and all participants received standard behavioral support for the duration of the study. The primary endpoint is biochemically verified continuous abstinence during the last four weeks of treatment and the trial will be determined successful if either cytisinicline treatment arm shows a statistical benefit compared to placebo. Topline results are on track to be reported in the second quarter of 2023. 
Cytisinicline Data Presentation at SRNT Annual Meeting 
In April 2023, additional analyses from the Phase-3 ORCA-2 trial were reported at the SRNT Annual Meeting confirming that successful smoking cessation was observed in subgroups of people who smoke that received cytisinicline, regardless of age, gender, smoking history, or previous quit attempts. Subjects who received either 6 or 12 weeks of cytisinicline treatment experienced consistently higher rates of smoking cessation. The improvement was observed by the second week of treatment and maintained weekly throughout study treatment and during the 24-week follow-up period; such improvement was not observed in those who received placebo. Study compliance was high with 82% of subjects completing the 12 weeks of treatment. No treatment-related serious adverse events were reported and the majority of adverse events were mild in all subjects. 
Three New Members Appointed to Board of Directors 
In March 2023, the Company announced a refresh to the Board of Directors with the appointment of three new directors, Mr. Stuart Duty, Mr. Thomas King, and Mr. Tom Sellig. The new directors bring extensive capital markets, strategic transaction, sales, marketing, and manufacturing expertise in the pharmaceutical and life sciences industries. 
Financial Results 
As of March 31, 2023, the Company’s cash, cash equivalents, and restricted cash was $16.6 million. Total operating
expenses for the first quarter ended March 31, 2023 were $8.6 million. Total net loss for the first quarter ended March 31, 2023 was $9.0 million. As of May 9, 2023, Achieve had 18,040,760 shares outstanding. 
Conference Call Details 
Achieve will host a conference call at 4:30 PM EDT today, Tuesday, May 9, 2023. To access the webcast, log on to the investor relations page of the Achieve website at http://ir.achievelifesciences.com/events-and-webcasts. Alternatively, access to the live conference call is available by dialing (866) 682-6100 (U.S. & Canada) or (862) 298-0702 (International) and referencing conference ID 13738142. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days. 
About Achieve and Cytisinicline 
Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline. Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.2 
In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.3In 2022, approximately 2.5 million middle and high school students in the United States reported using e-cigarettes.4 Currently, there are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. 
Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of withdrawal symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. 
Forward Looking Statements 
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, safety and tolerability of cytisinicline, the ability to discover and develop new uses for cytisinicline, including but not limited to as an e-cigarette cessation product, and the development and effectiveness of new treatments. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development of cytisinicline; the risk that cytisinicline will not receive regulatory approval or be successfully commercialized; the risk that new developments in the smoking cessation landscape require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic conditions, including inflation, rising interest rates, instability in the global banking sector, and public health crises, such as the COVID-19 pandemic and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. 
Investor Relations Contact 
Nicole Jones 
achv@cg.capital 
(404) 736-3838 
Media Contact 
Glenn Silver 
Glenn.Silver@Finnpartners.com 
(646) 871-8485 
References 
1 World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 
2 U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014.
3 Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 
4 Park Lee E, Ren C, Cooper M, Cornelius M, Jamal A, Cullen KA. Tobacco Product Use Among Middle and High School Students – United States, 2022. Morbidity and Mortality Weekly Report, 2022; 71:45. 
Consolidated Statements of Loss 
(In thousands, except per share and share data) 
Three months ended March 31, 
2023 2022 
Operating expenses: 
Research and development 5,534 4,388 General and administrative 3,044 2,838 Total operating expenses 8,578 7,226 
Loss from operations (8,578) (7,226) Other income (expense) (414) (347) Net loss $ (8,992) $ (7,573) 
Basic and diluted net loss per share $ (0.50) $ (0.80) Weighted average number of basic and diluted common shares 17,917,769 9,458,745 
Consolidated Balance Sheets 
(In thousands) 
March 31, December 31, 
2023 2022 
Assets: 
Cash and cash equivalents $ 16,514 $ 24,771 Prepaid expenses and other current assets 1,710 2,559 Other assets and restricted cash 68 123 Right-of-use assets 109 66 License agreement 1,363 1,418 Goodwill 1,034 1,034 Total assets $ 20,798 $ 29,971 
Liabilities and stockholders' equity: 
Accounts payable and accrued liabilities $ 3,872 $ 5,470 Current portion of long-term obligations 58 58 Convertible debt 16,371 16,071 Long-term obligations 54 69 Stockholders' equity 443 8,303 Total liabilities and stockholders' equity $ 20,798 $ 29,971 
Primary Identifiers: ACHV-US 
Related Identifiers: ACHV-US 
Subjects: Earnings Releases and Operating Results

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```[example report]
          Achieve Life Sciences, Inc. Buy
(ACHV – $to be filled by team – intraday) Price Target: to be filled by team
Positive Trial Results and Milestone Achievements; Strong Potential for Market Expansion
Quarter and Outlook – Achieve Life Sciences, Inc. (ACHV) reported positive results from its Phase 2 ORCA-V1 clinical trial, demonstrating a statistically significant benefit for cytisinicline in vaping cessation. The trial participants who received 12 weeks of cytisinicline treatment had a 2.6 times higher odds of quitting vaping compared to those who received placebo. The vaping cessation rate during weeks 9 through 12 was 31.8% for the cytisinicline group compared to 15.1% for the placebo group. The results were consistent across various demographics and clinical trial sites. Achieve is on track to report topline results from the Phase 3 ORCA-3 trial in the second quarter of 2023. The company also appointed three new members to its Board of Directors, bringing extensive expertise in capital markets, strategic transactions, sales, marketing, and manufacturing in the pharmaceutical and life sciences industries.

Investment Thesis – Achieve Life Sciences is a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence. The positive trial results from ORCA-V1 and the ongoing progress in the ORCA-3 trial highlight the potential of cytisinicline as a treatment for vaping cessation, addressing an unmet need in a growing market. With no FDA-approved treatments specifically indicated for e-cigarette cessation, cytisinicline has the opportunity to become the first treatment in this space. The company's strong pipeline and potential market expansion make it an attractive investment opportunity.

Valuation – Our price target for Achieve Life Sciences is to be filled by team. We used a 1.2x revenue multiple applied to our projected revenue estimate for 2023. The multiple reflects the potential for multiple expansion as the company progresses in its clinical trials and approaches commercialization. Please note that the price target is subject to change based on future developments and market conditions.

Financials – As of March 31, 2023, Achieve Life Sciences had cash, cash equivalents, and restricted cash of $16.6 million. The company reported a net loss of $9.0 million for the first quarter of 2023, primarily due to increased operating expenses related to the completion of clinical trials. Achieve believes its current cash balance is sufficient to support its operations into late-2023.

Risks – Investing in Achieve Life Sciences carries certain risks, including the possibility of regulatory approval for cytisinicline not being obtained or delayed, competition from other smoking cessation products, and the need for additional financing to fund the development and commercialization of cytisinicline. The company's success is dependent on the outcome of its clinical trials and market acceptance of its products.

Conclusion – Achieve Life Sciences has made significant progress in its clinical trials for cytisinicline, with positive results in vaping cessation and ongoing trials for smoking cessation. The company's potential market expansion and strong pipeline make it an attractive investment opportunity. We recommend a Buy rating for Achieve Life Sciences based on its promising prospects in the smoking cessation market.

HIGHLIGHTS
• Positive Phase 2 ORCA-V1 trial results for cytisinicline in vaping cessation
• Ongoing Phase 3 ORCA-3 trial on track for second quarter results
• Appointment of three new members to the Board of Directors
• Strong potential for market expansion in vaping cessation

INVESTMENT THESIS AND VALUATION

Achieve Life Sciences is a late-stage pharmaceutical company focused on the development and commercialization of cytisinicline for smoking cessation and nicotine dependence. The company's recent positive trial results in vaping cessation highlight the potential of cytisinicline as a treatment for this growing market. With no FDA-approved treatments specifically indicated for e-cigarette cessation, cytisinicline has the opportunity to become the first treatment in this space. Achieve's strong pipeline and potential market expansion make it an attractive investment opportunity.

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