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SELLAS Life Sciences Group, Inc. (SLS)

Q2 2014 Earnings Call· Mon, Aug 11, 2014

$4.84

-0.76%

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Transcript

Operator

Operator

Good day ladies and gentlemen and welcome to Galena Biopharma Second Quarter 2014 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer-session and instructions will be given at that time. (Operator Instruction) And as a reminder, this conference call is being recorded. I would now like to hand the conference over to Ms. Remy Bernarda, Vice President of Marketing and Communications. Ma’am, you may begin.

Remy Bernarda

Management

Good afternoon everyone and thank you for joining our call today. For those of you listening via telephone, I would encourage you to visit our website for access to the webcast and to find additional information on the Company. During today's discussion we may make Forward-Looking Statements about our programs, such statements include but are not limited to statements about our commercialization plan and the development progress of our clinical product candidates, including patient enrollment, trial initiations and collaborations. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those identified under Risk Factors in our annual report on Form 10-K and other documents filed with the SEC and available on our website. Actual results may differ materially from those contemplated by those forward-looking statements. I would now like to introduce the members of management on the call today who will discuss our business. Mark Ahn our President and CEO; Mark Schwartz, Executive Vice President and Chief Operating Officer who will discuss our commercial business; Brian Hamilton, Executive Vice President and Chief Medical Officer who will discuss our clinical programs and Ryan Dunlap our Vice President and Chief Financial Officer. Mark Ahn will now begin our discussion with an update on our progress and plans going forward.

Mark J. Ahn

Management

Thank you Remy and thanks everyone for joining our second quarter conference call. In addition to a strong second quarter in all programs across the company, we've had two exciting recent announcements, on the commercial side we saw continued strength towards ABSTRAL profitability with the implementation of our Galena Patient Services or GPS program ensuring access and strengthening our competitiveness with steadily increasing market share to 7% in a market that actually declined last quarter. In addition on July 22, we announced that we entered into a definitive agreement to license ondansetron oral soluble film known as Zuplenz. We finalized that process last week and we have already begun preparations for launch in early 2015. Importantly, our lead immunotherapy programs have made significant advances in second quarter. As Brian will discuss, last month we informed our clinical sites that our Phase III NeuVax PRESENT trial has screened sufficient patients to achieve the protocol stated sample size. We've now focused on completing our efforts at randomization activities and heading towards our event driven interim analysis. In addition on April 28, we announced the Department of Defense Grant to provide funding towards a new clinical trial with NeuVax to prevent breast cancer recurrence in high risk HER2 3+ patients. This study will expand the breadth and depth of our NeuVax pipeline as we move into the three plus or so called HER2 positive patient population category in breast cancer. In fortifying our IP portfolio in addition, we received a new U.S. patent for NeuVax providing additional protections for our lead clinical asset through 2028. And for GALE-301 or folate binding protein we presented our preliminary Phase I data at ASCO and announced a completion of our enrollment of our Phase IIa clinical study. Advancements have also been made with our hematology asset…

Mark W. Schwartz

Management

Thank you, Mark. Our ABSTRAL business continues to grow and we remain excited about and committed to the brand. As a reminder, ABSTRAL is a transmucosal immediate-release fentanyl or TIRF product for the treatment of breakthrough cancer pain and opioid tolerant patients. Our commercial organization continues to focus on a strategy to broaden patient and provide access to the product while increasing profitability of the product lines. Their four primary factors have resulted in continued product expansion and a stable business foundation upon which to build. First, ensuring availability reimbursement and insurance coverage; second, optimizing our patient assistance program; third, strengthening our distribution and wholesale partnerships and finally continued development of our prescriber base. In Q2 saw a growth and improvement across a number of key metrics over Q1, we saw an increase of 13% in a number of unique ABSTRAL prescribers with 40% of these new prescribers practicing in a field of oncology or palliative care. With our optimized patient assistance program, our average per prescription price has increased by more than 20%. Our Q2 market share as measured by Wolters Kluwer increased to 7% of prescriptions written despite the fact that the overall branded TIRF market declined in prescription volume over the same period. These improvements are a direct result of our team’s focus and our customer’s belief in the unique product benefits of ABSTRAL. As a reminder, last March, we implemented the Galena Patient Services, or GPS program to provide full-service support to healthcare professionals, pharmacies, and patients to help them navigate the benefits approval process for our products. Increased physician utilization and experience with the GPS has benefited both patients and providers an increased in the number of approved prior authorizations, improved insurance coverage and decrease paper work for the practices, all of which provide from…

Brian L. Hamilton

Management

Thank you, Mark. I am pleased to provide an update on the progress we’ve made with our clinical programs during the second quarter. I will begin with our immunotherapy programs. As a reminder our immunotherapy approach for both NeuVax and GALE-301 is based on the selection of a validated target antigen utilizing a peptide vaccine and targeting patients in the adjuvant setting who have minimal residual diseases after completion of their primary treatment. But remain it some risk of tumor recurrence. The aim with our vaccines is to stimulate the immune system to prevent the recurrence of cancer. As Mark Ahn mentioned we’ve reached a significant milestone with NeuVax last month in our pivotal Phase III PRESENT trial. PRESENT is enrolling women with breast cancers that have initially spread to the local lymph nodes and expressed low or immediate levels of HER2, referred to as 1+ or 2+ expressions. These breast cancer survivors have no evidence have diseases after completing their initial adjuvant therapy. And have to 20% to 25% risk of recurrence; the endpoint for the study is diseases free survival. On July 1, we notified our trial sites that we have screen sufficient patients to achieve the protocol stated samples sizes. With this we are now focused on completing randomization activities and heading towards our event driven interim analysis. I am grateful to our clinical team who is accelerated their enrollment activities over the last six months. To our investigators support to study and to the women who have volunteered for the trial. In addition, our Phase II clinical trial of NeuVax in combination with Herceptin is ongoing and we expect to complete enrollment by the end of next year with a primary endpoint of diseases free survival at two years. We are targeting 300 patients who have…

Ryan Dunlap

Management

Thank you, Bryan, and good afternoon everyone. Net revenue from ABSTRAL sales for the second quarter of 2014 was $2.3 million, an increase of 7% from last quarter and $4.5 million for the first two quarters of 2014. We’ve seen continued growth in market share and continued decline in our gross-to-net deductions, which aren't reflected in the net revenue growth this quarter due to the timing of customer orders and wholesaler and distributor inventory control affecting our ex-manufacturer sales. We believe this is normal during the first year after a new launch, and over time, expect ex-manufacturer sales to align with overall prescription demand trends which have matched up very closely when looking at 2014 year-to-date at the end of July. We’ve increased profitability with a continued decline in our gross-to-net deductions quarter-over-quarter, which is the result of the increasing effectiveness of our GPS Patient Assistance program launched in March. As Mark Schwartz also laid out, the ABSTRAL franchise is growing and becoming more profitable. However, we've also witnessed fluctuating market dynamics within the entire TIRF class, and some market contraction during the second quarter. As a result, while we maintain our net revenue guidance of $11 million to $15 million for the full-year 2014. We're leaning towards the lower end of that range. We'll continue to assess the market uncertainties and landscape and we'll make updates to that guidance as appropriate. Our overall operating loss was $15.8 million for the second quarter of 2014 as compared to $11.8 million last quarter. From a cash flow perspective, we spent $13 million in operating activities this quarter compared to $8 million last year, with a cash in equivalents balance of $39.2 at the end of the second quarter. The increased spend this quarter is a result of the increased rate of enrollment in our Phase III NeuVax program that Dr. Hamilton discussed earlier, as well as non-recurring professional fees incurred related to the ongoing litigation and legal proceedings. Moving forward, we expect net operating cash burn to stabilize in the range of $8 million to $10 million for quarter, due to factors including NeuVax Phase III completing enrollment, increasing profitability from our commercial operations, and our expectation that a majority of our ongoing legal fees will be reimbursed from our insurance carrier. This will be offset by the modest additional commercial resources needed to support Zuplenz and the significant progression of the rest of our development programs. Lastly, I'll mention our loss per share for the second quarter of 2014 was $0.17 per share, which was higher than consensus estimates, driven by the aforementioned increase in the quarter operating expenses, as well as approximately $3.5 million of a non-cash loss on the revaluation of our warrant liability. Overall, we're excited by the progress of our commercial and pipeline investments in building a valuable Company for our shareholders. And with that, I'll turn the call back over to Mark Ahn for closing remarks.

Mark J. Ahn

Management

Thanks, Ryan. With a new approved product to expand our oncology supportive care franchise, and advancement of all of our programs, we made great strides thus far in 2014 to meet our goals and milestones. We're looking forward to continued progress on ABSTRAL sales and competitiveness as measured in market share. We're preparing for the launch of Zuplenz to further leverage our operating infrastructure on the commercial team, and as well as accelerating our clinical development programs, most prominently led by NeuVax in breast cancer. We would now be delighted to open the call for questions.

Operator

Operator

(Operator Instructions) The first question comes from Chad Messer from Needham. Your line is open. Please go ahead. Chad Messer – Needham & Company: Hi, thanks for taking my question. So guidance for ABSTRAL towards the low end of the $11 million to $14 million, I know in the past you've also guided that you intend to franchise to be profitable in 2015. Are you still on track for that?

Ryan Dunlap

Management

Yes, yes Chad. This is Ryan. Thanks for the question. At the low end of our guidance, we're still profitable by the end of 2014. We're looking at about $3.5 million in net revenue for the quarter for us to break even, and that would be in line with our projections to hit that low end of the range. Chad Messer – Needham & Company: Great. Thank you.

Ryan Dunlap

Management

You’re welcome.

Operator

Operator

Thank you. Our next question comes from Ted Tenthoff from Piper Jaffray. Your line is open, please go ahead. Ted Tenthoff – Piper Jaffray & Co.: Great, thank you very much. With enrollment on track in the Phase III study, when should we expect data and how quickly do you think you'd be able to report data once we actually lock the database?

Brian L. Hamilton

Management

So this is Brian Hamilton and thanks for that question. The – because it's an event-driven interim analysis that will be coming up, we're in one respect hoping to get that information in the middle of next year, and in another respect we're hoping it's going to be little later. The more effective the vaccine is, the later that event – the number of events will occur to allow us to do that interim analysis. So, at this time it’s really difficult to predict where that's coming out. We just have not had enough events to get a good trajectory going on that, but we're expecting that initial analysis sometime mid to late next year as a reasonable estimate.

Mark J. Ahn

Management

So, to also answer your question, Ted, on the randomization, as you can imagine, we have 135 sites open. We've told them last month to halt the screening efforts and we're trying to basically continue to get those patients into randomization and wrap up those efforts, so that's – step ones been done. Once we put our last patient in, its three years or 141 events, whichever occurs later from that period, and of course the primary end point for the Phase III is disease free survival at the three-area end point. And then in the interim of course as Brian noted we have that interim analysis at 70 events, which we would expect around mid-year if we look at the Phase II experience as well as the SEER database for high-risk HER2 1+, 2+ patients in this category. Ted Tenthoff – Piper Jaffray & Co.: Great. That's helpful. Thank you.

Mark J. Ahn

Management

Thank you.

Operator

Operator

Thank you. And our next question comes from Vernon Bernardino from MLV & Company. Your line is open, please go ahead. Vernon T. Bernardino – MLV & Co: Hi, thanks for taking my question. I'm just trying to figure out the opportunity for Zuplenz here, and I know Zofran is the injection, whereas Zuplenz is an oral thin film. Just wondering if you could at least talk about how much this is overlap and if one could be used for the other?

Mark W. Schwartz

Management

Yes, Zofran was the original branded ondansetron. Obviously, they both have the same active ingredient. However, Zofran – Zuplenz, excuse me, two Zs. Zuplenz has in fact carved out its own share of the market in the sense that it offers a number of key advantages as a rapidly dissolving film. It works very well in people who are orally compromised either radiation therapy in the mouth and throat, rapid time to dissolution dry mouth, can't swallow or actually or actually they're throwing up and they throw pills up. And so we think that there's some key advantages that this is going to offer out there, and there are no other similar types of products. In many respects we have a bit of the same experience with ABSTRAL in terms of a novel oral formulation, and so time to dissolution, no taste, I know that a lot of the orally dissolving tablets have a very gritty taste that really are difficult for people, again especially if they're orally compromised and it can be taken with no water. So I think it offers a number of key advantages in the field in this particular area. Vernon T. Bernardino – MLV & Co.: Great. Thanks for taking my question.

Operator

Operator

Thank you. And our final question for today comes from Jason Kolbert from Maxim Group. Your lines opened. Please go ahead. Robert LeBoyer – Maxim Group: Hello this is Robert LeBoyer for Jason. And I just had one remaining question about the investigation and will there be anything announced publicly or anything to look for in terms of resolution of the issue?

Mark J. Ahn

Management

Hey, Robert this is Mark. 100% since we are able to confirm the results of the special committee report, which is you can appreciate undergoing legal review, I beg your pardon, to protect this confidentiality and use with both the lawsuits as well as, you know, answer any inquiries from the agency, we're seeking to do that, so the Board has assigned Mr. Einhorn with that task. Per my letter to the shareholders in February when, you know, I made some very clear declarations around you know from my perspective what – what happened, you know, we expect that I haven’t seen a report and but assume is that we are able to present any topline data, I'll sure – I'm anxious to do that and then to let the lawyers take care of the other, remaining pieces and move on after these distractions. In the meantime we've brought in – we've gone internally, we've made a number of them changes, most prominently have gone from part-time general counsel which we've outsourced since the life of our company into having a top shelf high speed low drag attorney in-house, as Margaret Kivinski has joined us as a VP and General Counsel. Robert LeBoyer – Maxim Group: Okay thank you very much.

Operator

Operator

Thank you. I am showing no further questions at this time. I would like to hand the conference back over for closing remarks.

Mark J. Ahn

Management

Well, I would like to thank everyone for joining us on this call and your interest in Galena. We've made a lot of progress over the last three years; we’ve work through a number of challenges recently, but I am grateful that everybody it continue to focus on our team on building value for patients and value for shareholders in that order. We are grateful for the opportunity to work on your behalf everyday and we are grateful for your consideration on the company and we look forward to keeping you abreast of our progress as we go.

Operator

Operator

Ladies and gentlemen, thank you for participating in today’s conference. This concludes our program for today. You may all disconnect and have a wonderful day.